f/EPA
            UnitMl StitM
            Environmental Protection
            Agwicy
            Off ice of
            PMticidw and Toxic SubtMnoM
            Washington OC 20460
            Pecticidw
                           540/RS-89-020
Guidance for the
Reregistration of
Pesticide Products
Containing PHORATE
as the Active Ingredient

-------
                      OMB Control No. 2070-0057
                      Expires November 1989
         REGISTRATION STANDARD
         (SECOND ROUND REVIEW)

                FOR THE

REREGISTRATION OF PESTICIDE PRODUCTS

             CONTAINING

                PHORATE

      AS THE ACTIVE INGREDIENT



       CAS REGISTRY NO.  298-02-2

        OP:  Chemical Code  057201

          EPA CASE NUMBER 103
            December,  1988
    ENVIRONMENTAL PROTECTION AGENCY

    OFFICE OF PESTICIDE PROGRAMS

      WASHINGTON, D.C.   20460

-------
                      TABLE OF CONTENTS
I.     INTRODUCTION 	   1

II.    CHEMICAL COVERED BY THIS STANDARD  	   3
       A.  Description of Chemical  	   3
       B.  Use Profile	   5

III.   AGENCY FINDINGS  	   6
       A.  Summary    	   6
       B.  Health Effects Assessment  	   8
       C.  Environmental Characteristics and Effects  .   .  16

       D.  Tolerance Reassessment 	  28
       E.  References Cited in the Science
           Assessment	34

IV.    REGULATORY POSITION AND RATIONALE  	  35

 V.    LABELING STATEMENTS AND COMPLIANCE
       DATES	   41

VI.    PRODUCTS SUBJECT TO THIS STANDARD	47

VII.   REQUIREMENT FOR SUBMISSION OF GENERIC DATA ....  49
       A.  What are generic data?	  49
       B.  Who must submit generic data?	50
       C.  What generic data must be submitted?	50
       D.  How to comply with DCI requirements	51
       E.  Registrant Requests Regarding Data Requirements
           and Agency Responses 	  53
       F.  Test Protocols and Standards	53
       G.  Procedures for Requesting a Change in Protocol  54
       H.  Procedures for Requesting Extensions of Time  .  54
       I.  Data Format and Reporting Requirements   ...  54
       J.  Existing Stocks revision Upon Suspension or
    Cancellation  	  55

VIII. REQUIREMENT FOR SUBMISSION OF PRODUCT SPECIFIC
         DATA	55

IX.   REQUIREMENT FOR SUBMISSION OF REVISED LABELING  .   .  56

 X.   INSTRUCTIONS FOR SUBMISSION   	  56
       A.  Manufacturing-Use Products (Sole Active)  ...  56
       B.  Manufacturing-Use Products (Multiple Active)   .  57
       C.  End-Use Products (Sole Active) 	  58
       D.  End-Use Products (Multiple-Active) 	  58
       E.  Intrastate Products  	  59

-------
                         APPENDICES

                                                         Page

I.    DATA APPENDICES	60

      Guide to Tables	61

      Table A	64

      Table B	96

      Table C	102

II.   LABELING APPENDICES 	 108

      Summary of Label Requirements and Table 	 109

      40 CFR 156.10 Labeling Requirements 	 119

      Physical/Chemical Hazards Labeling Statements .  .  . 128

      Storage Instructions  	 129

      Pesticide Disposal Instructions 	 130

      Container Disposal Instructions 	 131


III.  BIBLIOGRAPHY APPENDICES 	 132

      Guide to Bibliography	133

      Bibliography  	 135

IV.   FORMS APPENDICES  	 152

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

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

EPA Form 8570-27  Product-Specific Data Report

EPA Form 8580-3   Generic Data Exemption Statement


                              ii

-------
             GLOSSARY OF TERMS AND ABBREVIATIONS
ADI     Acceptable Daily Intake.  Also known as the Reference
        Dose or RfD.

a.i.    active ingredient

ARC     Anticipated Residue Contribution

CAS     Chemical Abstracts Service

CSF     Confidential Statement of Formula

EEC     Estimated Environmental Concentration.  The estimated
        pesticide concentration 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

        Median lethal concentration - a statistically derived
        concentration of a substance that can be expected to
        cause death in 50% of test animals.  It is usually
        expressed as the weight of substance per weight or
        volume of water or feed, e.g., mg/1 or ppm.

        Median lethal dose - a statistically derived single
        dose than can be expected to cause death in 50% of
        the test animals, when administered by the route
        indicated (oral, dermal, inhalation).  It is
        expressed as a weight of substance per unit weight of
        animal, e.g., mg/kg.

LEL     Lowest Effect Level

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 Pollutant Discharge Elimination System

NOEL    No Observed Effect Level

                        iii
LD
  50

-------
OPP     Office of Pesticide Programs



PADI    Provisional Acceptable Daily Intake



ppm     parts per million



RfD     Reference Dose



TMRC    Theoretical Maximal Residue Contribution
                             IV

-------
                       I.    INTRODUCTION

     This document  is  a revised Registration Standard for the
subject chemical.   In  its original Standard, issued in
August, 1984, the Agency summarized the available data
supporting the registration of the pesticide and its
assessment of those data to determine whether the pesticide
met the "no unreasonable adverse effects" standard of FIFRA.
The Agency concluded that additional data were necessary to
fully evaluate the  pesticide, and, as part of the issuance of
the Standard, required that registrants supply those data.
The Standard also set  out labeling requirements that the
Agency believed were necessary to ensure that products
containing the pesticide were adequate to protect public
health and the environment  while the data were under
development.

     The Agency has since reviewed trie add-rtional data and
has updated and revised its scientific and regulatory
conclusions concerning the  pesticide in light of expanded
data requirements promulgated in 1984 as 40 CFR Part 158.
The Registration Standard contains the Agency's updated
scientific assessment1 of this pesticide and its currently
registered uses.  As part of its review, the Agency has
reassessed the tolerances for the pesticide and determined
whether they are adequate.  The tolerance reassessment is
included in this Registration Standard.

     Based on the new  data, the Agency has also reviewed the
labeling requirements  for the pesticide and is requiring
label revisions.

     This revised Registration Standard supersedes the
original Registration  Standard in its entirety.

     This document  contains the following sections:

     0 Section II describes the particular pesticide(s)
     covered by this Registration Standard, and gives a brief
     profile of its usage and composition.  Regulatory
     history may be provided as well.

     0 Section III  sets out the Agency's scientific
     assessment of  the health risks and environmental
     characteristics and effects of the chemical, updated
      The scientific reviews and Compendium of Acceptable
L'ses may be obtained from the OPP Public Docket.  Write to
OPP Public Docket, Field Operations Division  (H7506C),
Office of Pesticide Programs, EPA, Washington, D.C.  20460

-------
     based on data submitted to the Agency under the original
     Registration Standard.

     ° Section IV explains the regulatory decisions and
     conclusions arising from the Agency's assessment, and
     the rationales for its decisions.  Section V describes
     the labeling statements required for products
     containing the chemical.  These are divided into
     statements for manufacturing use products and statements
     for end use products.

     0 Sections VI, VII, VIII, IX and X describe what
     products are subject to the data and labeling
     requirements set out in this Registration Standard, and
     what is required of registrants to comply with the
     requirements.

     ° Appendix I contains a series of tables setting out
     data requirements for the chemical.  The tables identify
     which requirements have been satisfied, as well as those
     for which gaps remain.  A Guide to Tables introduces the
     tables.

     ° Appendix II is a series of labeling information
     sheets, setting out general labeling information that
     must be placed on labeling.

     ° Appendix III is a bibliography of the data evaluated
     by the Agency in its assessment.  A Guide to
     Bibliography explains how to read and use the
     Bibliography.

     ° Appendix IV contains the necessary forms to respond to
     receipt of the Standard

     Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable 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 the
products are registered under FIFRA.

-------
            II.  CHEMICAL COVERED BY THIS STANDARD
A.  DESCRIPTION OF CHEMICAL

    The following chemical is covered by this Registration
Standard:

    Common Name:  Phorate

    Generic (Chemical) Name:  O,0-diethyl S-
                              [{ethyIthio)methyl]
                              phosphorodithioate

    Chemical Structure:
                                      S
                                      II
                             (C2H50)2-P-S-CH2-S-C2H5

    Chemical Family:  Systemic organophosphate

    Trade Names:  Thimet, AAstar and Rampart

    Other Chemical
    Nomenclature:  O,0-diethyl S-[(ethyIthio)methyl] ester
                   and 0,0-diethyl-S-(ethylthio)
                   methyl phosphorodithioate

    CAS Registry Number:  298-02-2

    EPA Pesticide Chemical Code (Shaughnessy Number):  057201

    Empirical Formula:

    Molecular Weight:  260.4

    Chemical/Physical
    Characteristics:
                       Color:  pale straw to light brown
                               (TGAI, 2749-106); COlor-
                               less to very light yellow
                               (TGAI, 241-212 and 241-213)

                       Physical state:  liquid  (TGAI,
                                        2749-106, 241-
                                        212 and 241-213)

                       Odor:  characteristic of mercaptan
                              containing compounds (TGAI,
                              241-212 and 241-213)

-------
Boiling Point:  118-120 C, 0.8 mm Hg
                (TGAI, 2749-106)
Specific Gravity:   1.15 at 20 C (TGAI,
                   2749-106); 1.17 at
                   25 C (TGAI for 241-
                   212 and 241-213)

Solubility:  50 mg/1 in water;
             miscible with carbon
             tetrachloride, vege-
             table oils (unspecified),
             xylene, and unspecified
             alcohols, ethers and
             esters (TGAI, 2749-106)

pH:  5-7 (TGAI, 2749-106);
     3.56-3.81 (TGAI, 241-212 and
     241-213)

Viscosity:   80 cps at 21 C (TGAI,
            241-212 and 241-213)

Corrosion:   non-corrosive to steel,
            aluminum, porcelain,
            fiberglass, and phenolic
            resins (TGAI, 241-212 and
            241-213)

-------
 B.   USE  PROFILE

 Type of  Pesticide:   Insecticide and Nematicide

 Year of  Initial Registration:  1959

 Registered Uses:  Terrestrial  food crop use on beans, barley,
                  corn, cotton, hops, peanuts, potatoes,
                  sorghum, soybeans, sugar beets,
                  sugarcane, and wheat.

                  Terrestrial  non-food crop use on lilies
                  (bulb production).

 Pests Controlled:  Various leaf-feeding insects, mites,
                   and soil insects

 Methods  of application:  Soil  and foliar applications
                         (band, broadcast, in-furrow and
                         drilling) using conventional ground
                         and aerial equipment

 Annual Usage:  4.56 million pounds active ingredient  (1987
               estimate)

 Predominant Usage:  Predominant use is on field corn,
                    comprising approximately 70% of
                    annual usage followed by 10% on potatoes,
                    and less than 5% individually on other
                    crops

 Mode of Activity:  Toxic action is exerted by inhibiting
                   enzymes of the nervous system
                   (cholinesteras inhibition)

 Formulations:  Granular (0.2%, 0.4%, 6.5%, 10%,
               15%,  and 20%)

 U.S. Registrants:  American Cyanamid Company,  Uniroyal
                   Chemical Company Inc., Aceto Chemical
                   Company Inc.,  Wilbur Ellis Co., Riverside
                   Terra Corp., Farm Bureau Cooperative, and
                   Platte Chemical Co.

Number of Registrations:   14  federally registered
                          end-use products, 2 technical
                          products,  1 formulation
                          intermediate,  and 19 "special local
                          need" registrations issued under
                          FIFRA section 24(c).

-------
                     III.   AGENCY FINDINGS

A.  SUMMARY

    The Agency has reviewed all data currently supporting the
registration of phorate.  Based on the available data, EPA
has reached the following conclusions.  The points summarized
below are presented in further detail, in the context of
EPA's science findings and additional data requirements, in
Sections B through D.

     1.  The results of acceptable acute toxicity studies
show that technical phorate is in Toxicity Category I by the
oral, dermal and inhalation routes.  Acute intoxication from
phorate is evident from typical cholinergic signs.  The
acute oral administration of phorate to hens did not cause a
delayed neurotoxic effect.

     2.  Based on results of acceptable subchronic and
chronic feeding studies with rats and dogs, cholinesterase
(plasma, blood or brain) is the primary target for phorate.
The occasional suppression of body weight and/or food
consumption observed in these studies are viewed as
secondary effects.  Based on the NOEL for brain
cholinesterase inhibition in a one year dog study (NOEL =
0.05 mg/kg) and applying an uncertainty factor of 100, the
RfD was determined to be 0.0005 mg/kg/day.

     3.  Based on the results of acceptable teratology and
reproduction studies, phorate does not induce teratogenic
effects.  Slight fetotoxic effects in a 3-generation
reproduction study in mice and fetotoxic and maternal
toxicity in a teratology study in rats were the only changes
indicative of developmental toxicity.  The NOEL for
developmental toxicity, 0.23 mg/kg, is based on the fetotoxic
effects observed in the 3-generation mouse study, the lowest
NOEL observed.

     4.  Phorate does not produce oncogenic effects, based on
results of acceptable chronic studies in which ingestion of
phorate did not induce an oncogenic response in rats or
dogs.  Based on a reevaluation of the mouse study, the
evidence does not show that a Maximum Tolerated Dose  (MTD)
was attained.  Confirmatory data are required.

     5.  Phorate did not cause a mutagenic response in
several in vitro  (microbial and mammalian cells) studies or
in an  in vivo dominant  lethal study.

     6.   Results of an acceptable metabolism study using
male rats indicated that a large proportion of phorate
labeled metabolites were excreted  in urine and feces within

-------
24 hours of dosing, while the levels of radioactivity in
tissues were low.  Most of the total radioactivity measured
in urine, kidney, muscle (leg) and liver was composed of a
non-phosphorylated series of phorate metabolites.  The
oxidative, phosphorylated products (metabolites of phorate
which are more potent anticholinesterase compounds through
oxidative desulfuration and/or sulfide oxidation) represented
a minor proportion of the phorate metabolites measured.  A
comparable metabolism study using female rats is required to
fulfill Agency Guideline requirements.

      7.  The Agency is requiring special acute and
subchronic studies to determine if phorate has a systemic
effect on the eye.  Phorate is structurally related to other
organophosphate compounds which have been implicated in
causing human eye effects, such as retinal degeneration and
myopia.

     8.  Based on recently submitted data, phorate does not
appear to be a potential leacher.  However, its sulfone and
sulfoxide degradates show greater persistence and mobility in
soil, and therefore may have a greater leaching potential.
Due to inadequate information on aerobic/anaerobic soil
metabolism and field dissipation of phorate and its
degradates, the requirement for groundwater monitoring
studies is deferred at this time.  However, a terrestrial
field dissipation study is required to be conducted on sandy
loam soil in Long Island, New York.  All samples must be
analyzed for phorate, sulfoxide, and sulfone degradates.

     9.  Based on acceptable laboratory data, technical
phorate is characterized as very highly toxic to birds on an
acute oral basis and highly toxic to birds on a subacute
dietary basis.   Phorate is characterized as very highly toxic
to mammals on a subacute dietary basis.

     10.  Based on acceptable laboratory data, phorate is
characterized as very highly toxic to freshwater fish and
aquatic invertebrates and estuarine and marine organisms.
Based on phorate's high toxicity to aquatic organisms and
reported fish kills, an aquatic field study was required in
the 1984 Standard.  This study is currently in progress and
is due in 1991.  A full assessment of this hazard potential
will be made upon receipt of these data.

     11.  Many of the tolerances for phorate are still not
adequately supported.  Additional data (residue studies,
residue analytical methods, processing and cooking studies,
poultry metabolism study and storage stability data)  are
needed before the Agency can determine the adequacy of
current tolerance levels and perform a tolerance
reassessment.

-------
     12.  Based on data submitted in response to the 1984
Standard, the Agency has calculated the Anticipated Residue
Contribution (ARC) for the U.S.  population average to be
0.000491 mg/kg/day, corresponding to 98% of the RfD.  The ARC
assumes residues are present at  tolerance levels, but takes
into account percent of crop treated, where possible.  For
children l to 6 years of age, the ARC occupies 235% of the
RfD, and for non-nursing infants, the ARC occupies 331% of
the RfD.
B.  HEALTH EFFECTS ASSESSMENT

     Below is an assessment of the human health risks
associated with the insecticide phorate based upon data
submitted in response to the 1984 Phorate Registration
Standard, and data previously reviewed and determined to be
acceptable to support registration of products containing
phorate.

     1.  Acute Toxicitv

     There are adequate acute toxicity studies available for
phorate.  Technical phorate is highly toxic on an acute
oral, dermal, and inhalation basis.  It falls in Toxicity I
by the oral route of exposure based acute LD5Q values of 3.7
and 1.4 mg/kg in male and female rats, respectively. All of
the animals that died in this study exhibited typical signs
of cholinergic intoxication such as salivation, lacrimation,
exophthalmos, muscle fasciculation, excessive urination and
defecation.  Technical phorate is in Toxicity Category I for
dermal exposure based on LD50 values of 9.3 and 3.9 mg/kg in
male and female rats, respectively.  The cholinergic signs
noted for the acute oral study were also observed in the
acute dermal study.  Based on a 1-hour exposure to analytical
grade phorate aerosol, the LC5QS for rat were 60 and 11 mg/m3
for males and females, respectively (Toxicity Category I).
Typical cholinergic signs were observed in intoxicated
animals.  No data are available on the primary eye or primary
dermal irritation properties of phorate. However, these
tests are not required since the toxicity of phorate
prohibits the administration of appropriate dosage levels.
Likewise, no data are available on the primary dermal
sensitization properties of phorate, but this study is not
required because of the high acute toxicity of phorate.

     There is an acceptable acute delayed neurotoxicity study
on file to support registration of products containing
phorate.  The oral administration of technical phorate in
corn oil to 50 randomly selected hens at a dosage level of
14.2 mg/kg (oral LD50 of phorate in white leghorn hens),

                              8

-------
followed by a 21-day  interval and a second administration at
the same dosage  level, did not cause neurological changes
indicative of a  delayed neurotoxic response.

     2.  Subchronic Toxicity

     The Agency  does  not have an acceptable subchronic non-
rodent  (dog) study to support registration of products
containing phorate.   However, the Agency is not making this a
requirement, since acceptable chronic data for the non-rodent
are available.   There is a subchronic rodent (rat) study,
which is flawed  in that histopathology was performed on 3
(not 10) rats/sex in  the control and 3 test groups (2.0, 6.0
and 12.0 ppm).   However, a new subchronic rodent (rat) study
is not  required, since the target endpoint (cholinesterase)
inhibition was satisfactorily identified in this rat study,
and also because results of acceptable subchronic data in
which rodents were administered phorate sulfoxide (a toxic
metabolite of phorate) are consistent with those established
in a non-rodent  study.  In this rat subchronic rat study,
technical phorate was administered in the diet to rats for 90
days at dosage levels of 0.22, 0.66, 2.0, 6.0 12.0 and 18.0
ppm. The 12.0 and 18.0 ppm dosage groups each consisted of 25
rats/sex, each of the remaining groups had 50 rats/sex. Body
weight gain and  food  consumption were suppressed and
mortalities were induced at the 12.0 and 18.0 ppm levels.
Erythrocyte cholinesterase (ChE) activity was inhibited in
females at 2.0 ppm while plasma, red blood cell (RBC) and
brain ChE activity was inhibited in both sexes at the 6.0 ppm
level of phorate. Treatment-related histopathologic changes
were not noted.  The LEL in this study was 2.0 ppm(0.1
nig/kg/day) while the NOEL was 0.66 ppm (0.033 mg/kg/day).

     No data are available on the 21-day subchronic dermal
toxicity of phorate. This study is not required since the
highly toxic nature of phorate prohibits the administration
of dosages that  could induce an adverse effect other than
inhibition of cholinesterase activity.  No data are available
on the subchronic neurotoxicity of phorate.   Since there was
no evidence of delayed neurotoxicity in an acute study in
hens, data from  a subchronic neurotoxicity study are not
required.

     3.   Chronic Toxicitv/Oncoaenicitv Testing

     Chronic toxicity/ oncogenicity studies  are discussed
below.

     Dog Study

     Sufficient chronic toxicity data are available from a
non-rodent (dog)  study.   In this study,  technical phorate was

-------
administered orally in capsules to dogs (6/sex/group) for 1
year at daily dosage levels of 5, 10, 50 and 250 ug/kg.
Compound-related effects included slight body tremors in
high-dose males and females and marginal inhibition of body
weight gain in high-dose males.  Plasma cholinesterase was
inhibited at 50 ug/kg/day in both sexes.  Red blood cell
(RBC) and brain cholinesterase were inhibited in both sexes
at 250 ug/kg/day. The NOEL and LEL for systemic toxicity were
50 and 250 ug/kg/day, respectively.  The LELs for
cholinesterase inhibition were: plasma-50 ug/kg/day; RBC and
brain-250 ug/kg/day.  The corresponding NOELs were: plasma-10
ug/kg/day; RBC and brain-50 ug/kg/day.

     Rat Study

     The available rodent chronic feeding study using
technical phorate only partially satisfies the requirement
for chronic toxicity testing in that although the target
endpoint (inhibited cholinesterase activity) was identified,
the study did not achieve an NOEL.  However, this study does
not have to be repeated, since a NOEL and LEL, based on the
same endpoint, were adequately achieved in a subchronic
feeding study in rats (see discussion above under subchronic
Toxicity).

     In this study, rats (50/sex/group) received technical
phorate in the diet at levels of 1 (0.05 mg/kg), 3 (0.15
mg/kg) and 6 (0.30 mg.kg) ppm for a period of 2 years.
Plasma ChE activity was inhibited in low-dose (1 ppm) males
at 24 months and in mid-dose (3 ppm) males at 24 months and
females at 6, 12 and 24 months.  Brain ChE activity was also
inhibited in females at this dosage level. Plasma ChE was
inhibited in high-dose (6 ppm) males at 12 and 24 months and
high-dose females at 3,6, 12 and 24 months. Brain and RBC
(measured only at termination) ChE activity were each
inhibited in both sexes at the high dosage level. Survival as
well as body weight gain and food consumption were suppressed
in high-dose females.  There was a possible relationship
between treatment and forestomach irritation in high-dose
males and females.  The LEL, based on plasma ChE inhibition
in males, was 1 ppm (0.05 mg/kg/day); the NOEL was not
determined.  The chronic toxicity portion of this study was
determined to be unacceptable because measurements of the
hematology and blood chemistry parameters, as well as the
urine and ChE analyses, were performed with only 5
rats/sex/group instead of the required 8-10.

     Mouse Study

     There is an acceptable mouse chronic toxicity study to
support registration of products containing phorate.  In
this study, technical phorate was administered to mice

                              10

-------
 (50/sex/group)  in the diet for 78 weeks at concentrations of
 1 ppm  (0.15 mg/kg),  3 ppm  (0.45 mg/kg) and 6 ppm  (0.9 mg/kg).
 The histopathologic  findings were considered incidental or
 part of the spontaneous disease process of mice and no
 apparent association between these findings and the ingestion
 of phorate was  apparent.  There were no consistent clinical
 signs  that were compound-related.  The only effect observed
 was a  slight decrease in weight gain in high-dose females
 during the first 25  weeks of the study.  Accordingly, the LEL
 was 6 ppm (0.9  mg/kg/day) and the NOEL was 3 ppm  (0.45
 ing/kg/day).

 4.  Oncogenicity

     The rat and mouse chronic toxicity/oncogenicity studies
 discussed above did  not reveal any evidence that phorate was
 oncogenic under the  conditions of those studies.  The rat
 oncogenicity study is acceptable for meeting the requirement
 for oncogenicity.  However, based upon a reevaluation of the
 mouse study, the evidence does not show that an MTD was
 attained.  The  Agency is requiring a short- term mouse study
 to determine if any  of the dietary levels administered in
 this study will inhibit acetylcholinesterase activity
 (plasma, brain  and/or red blood cell).  The requirement for a
 new mouse oncogenicity study is reserved pending the results
 of this special study.

 5.  Developmental Toxicity  (Teratogenicity)

     Sufficient data are available to satisfy the data
 requirements for teratogenicity studies in two species.

     In the first study, technical phorate in corn oil was
 administered daily by oral intubation to pregnant rats
 (minimum of 23/group) from day 6 to day 15 of gestation at
 dosages of 0.125, 0.25 and 0.50 mg/kg.   Maternal mortalities
 were observed in the high-dose group.  An increased incidence
 of enlarged hearts was observed in high-dose fetuses (this
 cardiac enlargement  is considered a transient, non-
 teratogenic response).  No teratogenic effects were observed
 in this study at any dosage level.  Therefore, the LEL for
 developmental toxicity, based on embryotoxicity, and maternal
 toxicity was 0.50 mg/kg and the corresponding NOEL for each
was 0.25 mg/kg.

     In the second study, technical phorate, in corn oil, was
administered via oral gavage to groups of 20 pregnant rabbits
on days 6-18 of gestation at dosage levels of 0.15, 0.5, 0.9
and 1.2 mg/kg/day.   Maternal toxicity was evident at the 0.5,
0.9 and 1.2 mg/kg dosage levels, based on body weight loss
during treatment and compound-induced mortality.   Noted
malformations were: open eyes and curved scapula in one 1.2

                              11

-------
mg/kg litter and angulated hyoid arches in a small number of
fetuses in the 0.9 and 1.2 mg/kg dosage groups.  After
careful consideration of these data, the Agency considers the
changes to be secondary to maternal toxicity.  These changes
are not considered to be biologically significant under the
conditions of the study.  There was no clear evidence that
phorate induced a teratogenic response.  The LOEL and NOEL
for maternal toxicity in this study was 0.5 and 0.15 mg/kg,
respectively and the NOEL for developmental toxicity was 1.2
mg/kg, the highest dosage administered.

6.  Reproduction

     There is an acceptable study available for technical
phorate to satisfy the requirements for reproductive testing.
In this study, technical phorate was administered in the diet
to mice at dietary levels of 0.6 (0.09 mg.kg), 1.5 (0.23
mg/kg) and 3.0 ppm (0."45 mg/kg).  Compound administration was
initiated 7 weeks before the first mating.  The study
involved 3 generations with 2 litters (a and b) per
generation.  The only apparent indication of reproductive
toxicity were slight reductions in the lactation and
viability indices2 in the Fib at the highest dose level.
Therefore, a conservative LEL in this study was 3.0 ppm (0.45
nig/kg/day) and the NOEL was 1.5 ppm (0.23 mg/kg/day).

7.  Mutagenicity

     Sufficient data are available to satisfy the data
requirements for mutagenicity testing.  Technical phorate did
not induce a genotoxic response in any of the tests listed
below.

a. Gene mutation:  Reverse mutation assay employing  S.
tvphimuriumf strains TA 100, TA 1535, TA 1537 and TA 1538 at
dosages up to 1,000 ug/plate, with and without metabolic
activation; reverse mutation in E.  coli WP2(uvrA-) at
dosages up to 1,000 ug/plate, in the presence and absence of
metabolic activation; and test for chemical induction of gene
mutation at the HGPRT locus in cultured Chinese Hamster
Ovary (CHO) Cells at dosages up to 92 ug/ml, with and
without metabolic activation.

b.  Structural chromosome aberration tests:  Dominant lethal
test in mice (ICR/SIM strain) at dosages up to 20 mg/kg in
the diet; and chromosome aberrations in vivo in mammalian
bone marrow cells at IP dosages up to 2.5 and 1.5 mg/kg in
     2 Viability index = number of pups alive at five days /
number of pups born alive X 100.  Lactation index = number of
pups weaned / number of pups alive at five days X 100.
                              12

-------
males and females, respectively.

c.  Tests for other genotoxic effects:  Mitotic recombination
of Saccharomyces cerevisiae D3 at a concentration of 5%, with
and without metabolic activation; preferential toxicity
assays in DNA repair-proficient and -deficient strains of E.
coli (strains W3110 and p3478, respectively) at a level of
1,000 ug/plate; preferential toxicity assays in DNA repair -
proficient and -deficient strains of Bacillus subtilis
(strains H17 and M45, respectively) at 1,000 ug/plate and
unscheduled DNA synthesis (UDS) in human fibroblasts (Wl-38
cells) at concentrations up to 10-3 M.

8.  General Metabolism

     Data are available from an acceptable rat metabolism
study in which one dosage level was administered to male rats
An additional metabolism study in female rats is required.

     In this study, each of 12 male rats received a single
oral dose (via gavage) of 14C-phorate suspended in corn oil.
Groups of 3 animals were killed 24, 48, 96 and 192 hours
after dosing.  Six additional rats were dosed in the same
manner in order to fully characterize various tissue
metabolites.  Urine, feces, liver, kidney, muscle(leg), skin,
fat and blood were collected for analysis at selected post
dosing time intervals.

     Approximately 77.2 and 11.7% of the administered 14C was
recovered in urine and feces, respectively, during the first
24-hour collection period.  Total radioactivity levels in all
tissues represented less than 5 and 1% of the 14C at 6 and 24
hours post dosing, respectively.  Blood, skin, muscle and
liver contained 4.69, 2.48, 1.94 and 1.19%, respectively, of
the original dose at 6 hours after compound administration.
Two of the 10 metabolites identified in urine were non-
phosphorylated compounds: ethyl(methylsulfinyl) methylsulfone
and (ethylsulfonyl) (methylsulfonyl) methane.  These
relatively non-toxic compounds comprised approximately 71% of
the radioactivity present in the urine.  Approximately 9 and
10% of the urinary 14C was associated with the oxidative
organo-phosphorous metabolites  O, O,-diethyl S-(ethyl-
sulfonyl)  methyl phosphoro thioic acid and (ethylsulfinyl)
methyl,  methyl sulfone, respectively.   Unchanged parent
compound accounted for only 0.5% of the recovered urinary 14C
and the  remaining phosphorylated compounds plus one uniden-
tified metabolite collectively comprised less than 10% of the
urinary  radioactivity.   The identified oxidative,  phosphory-
lated compounds were:   1) Phosphorodithioic acid,  0,0-diethyl
S-(ethylsulfonyl)  methyl; 2)  Phosphorothioic acid, 0,0
diethyl  S-(ethylsulfinyl) methyl; 3) Phosphorodithioic acid,
0,0 diethyl  S-(ethylsulfinyl)  methyl;  and 4)  Phosphorothioic

                             13

-------
acid, 0_,()-diethyl S-(ethylthio )methyl ester.  The proportions
of phosphorylated and non-phosphorylated metabolites in
individual tissues were similar to those observed in urine.

     A comparable study in female rats is required.   The
administration of a single dosage level in the male rat study
is acceptable since the high acute oral toxicity of this
compound does not allow much flexibility in dosage selection;
a lower dose level might be detrimental to quantitative work
with minor metabolites while a higher dose might cause
mortalities.  However, since females are generally more
sensitive to adverse effects from phorate than males, it may
be necessary to administer a lower dosage level to females
than that (0.8mg/kg) given to males.

9.  Special Studies

a.  Phorate sulfoxide (metabolite)

     Phorate sulfoxide was administered to rats (35/sex in
treated groups and 50/sex in the control group) at dietary
levels of 0.32 ppm (0.016 mg/kg), 0.80 ppm (0.040 mg/kg) and
2.0 ppm (0.10 mg/kg) for 90 days.  Sporadic inhibition of RBC
and plasma ChE activity was observed in females at the 0.8
ppm level.  RBC, plasma and brain ChE activity were each
inhibited in females while marginal inhibition of RBC and
plasma ChE activity was noted in males at 2.0 ppm.  No other
dosage-related adverse effects were reported in this study.
The NOEL and LEL in this study, based on inhibition of ChE
activity, were 0.32 (0.016 mg/kg) and 0.8 ppm  (0.04 mg/kg)
respectively.

       Phorate can be metabolized to more potent
anticholinesterase compounds through oxidative desulfuration
and/or sulfide oxidation.  The oxidation products include the
sulfoxide and sulfone derivatives of phorate and phorate
oxygen analogue. However, findings of the rat metabolism
study showed that the oxidative, phosphorylated products
represented a minor proportion of the phorate metabolites
measured in tissues, feces and urine.  Additional toxicity
studies with the oxidative metabolites may be required, if
significant residue levels are detected in the required
residue studies.

b.  Toxic Effects on the Eye

     In Japan, organophosphate pesticides have been observed
to produce toxic effects on the eye.   In the 1950's and
1960Ts, Japanese workers noted extensive human poisoning by
organophosphate pesticides producing a syndrome of effects on
vision ranging in severity from myopia to congestion or
atrophy of the optic nerve.  The Japanese reseeirchers were

                              14

-------
able to duplicate the effects on refraction in an
experimental study on dogs utilizing the organophosphates
fenitrothion and ethylthiometon.  Experimental studies with
the organophosphate fenthion on rats by another Japanese
scientist demonstrated a syndrome of toxic effects on the
eye beginning with functional abnormalities in electrical
activity and culminating in retinal degeneration following
chronic dosing.  In addition, the Agency has received
reports of chronic studies of ethyl and methyl parathion
in rats which demonstrated retinal atrophy.

     Since phorate is an organophosphate, special acute and
subchronic eye studies are required to investigate its
potential systemic toxicity to eyes.

   10.  Pesticide Incidents

     Based on data obtained from California (the only State
which enforces mandatory reporting of occupational pesticide
incidents and, at present, the only reliable source of
information), physicians treated an average of 3.1 phorate
poisonings each year from 1980 through 1986.  An additional
0.4 cases per year were reported as either due to skin or eye
injury.  Of the total 25 illnesses reported in this period, 3
were applicators, 5 were due to exposure to residues or
drift, 7 were emergency response personnel; 3 were
mixer/loaders, and 7 were due to other circumstances.
Between 1980 and 1986, there were 2 reported hospitalized
cases of occupational phorate poisoning.

     Data for 1980 through 1986 from California were examined
to determine the number of applications reported by licensed
pest control operators and all applications of restricted
chemicals, which must be reported under California law.  Data
were examined for 45 selected insecticides and a ratio was
calculated based on the number of poisonings per 1000
applications.

     For phorate, there were 0.8 poisonings per 1000
applications reported during the time period 1980 to 1986.
The average value for all 45 pesticides was 0.5, the median
was 0.3.  The majority of poisonings occurred in the first
half of the 1980-86 time period.  During the second half of
this time period, phorate was responsible for 0.3 poisonings
per 1000 applications.  The data indicate that phorate had a
slightly above average potential to produce systemic
cholinesterase depression poisonings during the period 1980
to 1986.

    11.  Worker Exposure

     In the 1984 Standard,  the Agency expressed concern

                              15

-------
regarding dermal and inhalation exposure to handlers and
other workers subject to continual exposure to granular
formulations should the granules fracture during shipping and
handling.  A product integrity study on a typical end-use
granular formulation was required to assess this possibility.

     A product integrity study was submitted for a 20G
(granular) formulation.  This study showed that the potential
airborne level of respirable particles was not significant.
Based on the results of this study, the Agency has concluded
that the 20G granular formulation does not pose an inhalation
hazard under normal use conditions.  A study of this type
would not be expected to provide useful information on dermal
exposure.  Phorate is highly toxic by the dermal route of
exposure.  The Agency believes that the revised and updated
protective clothing statements required under this Standard
will adequately protect individuals against any potential
hazard resulting from dermal exposure.
C.  ENVIRONMENTAL CHARACTERISTICS AND EFFECTS

    1.   Ecological Effects

     In the 1984 Phorate Registration Standard, the Agency
required submission of various studies.   An update on the
ecological effects profile is provided below.


        Avian and Mammalian Testing

     Based on acceptable laboratory data, technical phorate
is characterized as very highly toxic to birds on an acute
oral basis and highly toxic to birds on a subacute dietary
basis.   The LD50 values range from 0.62 for mallard duck to
12.8 mg/kg for chukar.  Upland game birds appear to be
slightly less sensitive on an acute basis than waterfowl or
songbirds.  However, all classes of birds have been killed
by exposure to phorate in agricultural fields, as indicated
in field tests.  On a dietary basis, technical phorate is
highly toxic to birds with reported LC50 values ranging from
248 ppm for waterfowl to 441 ppm for upland gamebirds.

     An avian reproduction study showed that long-term
dietary exposure of 60 ppm technical phorate significantly
impaired the ability of mallard ducks to produce a normal
number of eggs and offspring.  Data on the bobwhite quail
were determined to be unacceptable, since the production of
eggs in 25% of the control pairs of bobwhite was signifi-
cantly below normal.  A new study using bobwhite quail is
required.  Since there are still gaps in the environmental
fate data base for phorate and its degradates, the
probability of reproductive effects occurring in the field

                              16

-------
cannot be predicted.   It may be that under flooded
conditions phorate  is  more persistent.  If the required
anaerobic soil metabolism and other environmental fate data
indicate that phorate  is more persistent in flooded areas
(e.g. wetland), then a field study to examine reproductive
effects in waterfowl residing in wetland areas will be
necessary.

     There is sufficient information to characterize
technical phorate as very highly toxic to small mammals on a
dietary basis, with a  reported LC5Q value of 28 ppm.

     In simulated field studies using a 20 percent granular
(20 G) formulation  applied to cornfields at rates of 1.33 and
2.62 Ib ai/A, a significant number of mortalities in bobwhite
quail and wild songbirds occur.  In addition, there was a
significant depression in the amount of brain ChE in birds
that ingested the granules.  In an avian pen field test in
which a 10G formulation was applied at rates of 0.05 and 0.3
ib ai/A, pheasants  were not affected at the lower rate.
There was a 3% mortality rate at the higher rate.  In another
study in which a 10G formulation was applied to fields of
beets and brussels  sprouts at rates of 1.5 and 2.3 ib ai/A to
beets and 1.5 ai/A  to  brussels sprouts, a dead vole, linnet,
and partridge were  found on the fields of brussels sprouts.
The gut contents of the vole and partridge contained 0.25 and
0.05 ppm phorate residues, respectively.  No dead animals
were found in the beet fields.

     The 1984 Standard required submission of terrestrial
field testing (Level 1) because of phorate»s high acute
toxicity and reported kills.  In response to the Standard, a
screening-type terrestrial field study was conducted in
which a 20G formulation was applied to corn by three
different methods of application (banded at-planting, band at
cultivation, and aerial over the plants).   Bird carcasses
were found in each phase of the study.  This study also
resulted in mammalian mortality under each application
technique.  The data indicate that residues of phorate and
its degradates appear to be toxic to birds and mammals for as
long as 2 to 3 weeks.   Aerial application appeared to be more
hazardous than soil application.

      Risk to Terrestrial Organisms

    The Agency is concerned about the risk to avian species
posed by the use of granular pesticides, including phorate.
In addition to indirect exposure from pesticide residues on
avian feed items, birds may be directly exposed to the
pesticide by ingesting  pesticide granules as they forage for
food and grit on the soil,  thus consuming discrete doses of
phorate.

                             17

-------
     To evaluate this risk, the Agency evaluated both
toxicity and exposure.

     Toxicity

     As indicated under "Avian and Mammalian Testing",
laboratory studies have demonstrated that phorate is very
highly toxic to birds on an acute oral basis (LD50) and
highly toxic to birds on a dietary basis (LCSQ).  Toxicity
was further analyzed by estimating the number of granules,
that, if ingested by a bird, would be equivalent to its LD5Q.
The 1*050 value was chosen for toxicity analysis because birds
encounter granules as discrete doses, which is similar to the
type of exposure in a laboratory LD,-Q test.  The following
factors were considered in this toxicity analysis: (1) LD50
values, (2) average body weights of birds, (3) weight of the
granule or reasonable estimate of its weight, and (4) percent
active ingredient (a.i.).

     The results of this analysis indicate that the following
number of granules would be equivalent to the LD5Q from the
phorate 15G and 20G formulations:

  	Waterfowl	Songbird	Game
           15G       49              4               99
           20G       10              1               21

     Based on the literature (Balcomb 1980, Wentworth 1968,
Bent 1963 and Kenaga 1974), the Agency estimates that 0.1% to
1.0% of the daily food intake of a bird is in the form of
grit and seeds.  If pesticide granules are available, they
will comprise part of this grit and seed consumption.  Based
upon this range for intake, the average body weights of birds
and the median weight of a pesticide granule, it is estimated
that waterfowl may pick up 120 to 1200, gamebirds 53 to 530
and songbirds 25 to 250 pesticide granules.  However, limited
field reports suggest that birds are not likely to consume
more than 50 pesticide granules.

     Using this consumption limit of 50 pesticide granules,
the table above indicates that birds can readily consume an
LD50 dose of phorate, with the exception of upland gamebirds
consuming phorate 15G.  This shows that birds can reasonably
consume enough phorate granules to die.

Exposure

     Many different species of birds may be present when
phorate is applied.  These birds may be exposed to phorate
granules when they feed on avian food items containing
phorate residues.  They may also consume the granules

                              18

-------
directly while foraging for seed or dietary grit on or below
the soil surface.  In addition, predatory birds may be
secondarily exposed to vertebrates poisoned from exposure to
granular pesticides or directly from the granules themselves.

     The number of granules a bird will encounter depends on
the rate of application and the number of granules present on
or near the soil surface.  The Agency believes that all
applications of phorate (at planting, banded and cultivation
treatments, as well as aerial application) will result in a
number of granules present at or near the surface, and thus
easily accessible to foraging wildlife.

     To evaluate exposure, the number of granules present
after application on the soil surface was estimated.  A
square foot was chosen as the unit area for exposure because
birds feeding on treated fields would be able to quickly
search a square foot area for food or grit.  For these
calculations, it was assumed that 15 percent of the applied
granules are present on the surface after band application
(Erbach and Tellefson 1983), 1 % after in-furrow application
(Hummel 1983) and 100 % after broadcast (aerial) application.
Determination of Risk

     The avian risk from phorate use is dependent on both
toxic ity and exposure.  The risk was evaluated for corn,
cotton, and potatoes using the following formula:

           no. of Granules/square foot
RISK  = ---------------------------
           no. of granules equal to LD5Q

      =    no. of LDso doses/ square foot
     Avian risk equals the number of LD5Q doses per square
foot.  If the result is equal to or greater than 1, the
pesticide may pose a serious risk to birds3.  The greater the
number, the greater the risk (see Table 1 below).
     3    Based on the results of several laboratory and
field studies, DeWitt (1966) studied the relationship between
the quantities of pesticide toxicant that birds ingested in
the laboratory to the amount of pesticide deposited per unit
area in the field during agricultural operations and
concluded that birds may be expected to die if the quantity
of toxicant in a square foot area equals or exceeds the
amount of toxicant that causes 50% mortality in a laboratorv
study.
                             19

-------
Table 1.  Risk to Avian Species Based on Estimates


Formulation
Corn
15G
15G
20G
20G
Cotton
15G
15G
15G
15G
20G
20G
20G
20G
Potatoes
15G
15G
15G
20G
20G
20G

^^

1.3
1.0
1.3
1.0

0.5
1.6
1.6
2.1
0.5
1.6
1.6
2.1

3.5
2.1
3.5
2.1
2.1
3.5

Method

Banded
Broadcast
Banded
Broadcast

In-furrow
In-furrow
Banded
Banded
In-furrow
In-furrow
Banded
Banded

In-furrow
Banded
Banded
In-furrow
Banded
Banded
No. of
Granules
on Surface

683
817
145
174

49
157
1009
1324
10
33
214
281

305
1177
1962
49
250
417
Sonobirds
Granules

4
4
< 1
< 1

4
4
4
4
< 1
< 1
< 1
< 1

4
4
4
< 1
< 1
< 1
ID50S
Sa Ft

174
208
174
210

13
40
257
338
12
40
258
339

78
300
500
59
301
502
Waterfowl
Granules

49
49
10
10

49
49
49
49
10
10
10
10

49
49
49
10
10
10
^50
Sa Ft

14
17
14
17

1
3
21
27
1
3
21
27

6
24
40
5
24
40
Game Birds
Granules

99
99
21
21

99
99
99
99
21
21
21
21

99
99
99
21
21
21
^50
Sa Ft

7
8
7
8

< 1
2
10
13
< 1
2
10
13

3
12
20
2
12
20
               20

-------
           The values in  this Table indicate that sufficient
      granules of phorate are estimated  to be present  to kill
      significant numbers of birds  feeding in agricultural fields.
      For songbirds  and waterfowl,  the number of LD50s/sq ft  is
      greater than 1 in all cases.   This prediction  is corroborated
      by field studies and bird kill incident reports  (see Table
      2).

                  Table 2.   Reported Bird Kill Incidents From Phorate
Date of
Kill
11/78
State
California
Number and Kind
of Birds Killed
Ring-billed gull,
Nature of Incident
Found dead in field

treated 2 days
02/19/81
Fresno County,
CA
02/22/81
Merced County,
  CA
10/82
Potter County,
  SD
                           cattle egret, long-
                           billed curlew (total
                           of 195 birds)
2000 dead blackbirds,
2 pheasants, several
pigeons
100 waterfowl,  100
birds of other  species
as sparrows,  black-
birds, killdeer,
larks

133 mallards; 51 pin-
tails; 46 wigeons; 36
gadwalls; 12  green-
winged teals; l white-
fronted goose;  3
Canada geese; 6 marsh
hawks; 2 red-tailed
hawks; and 4  great
horned owls
earlier with phorate and irrigated.
Brain ChE activity was inhibited
92%.  Ingesta contained phorate
residues.

Thimet 15G was applied aerially on
February 19 to wheat field.  Thimet
residues (24 ppm)  detected in gizzard
linings.  Standing water found in
irrigation ditches was believed to be
means of exposures.

Thimet 15G was aerially applied to
alfalfa fields south of site where
birds found.  Granules found on the
site.  31 to 54 ppra Thimet residues
in birds.

Thimet 15G was applied at the rate of
6 Ib/A on the border of a winter
wheat field on September 10, 1982.
Birds were found in an intermittent
wetland basin (4 to 5 acres, 6 to 8
inches deep) several days after heavy
rains.   Two empty  bags of Thimet were
in the area.  Water and sediment
samples were collected October 18.
Mean Thimet residues of l ppb in
water and 15 ppb in sediment; mean
Thimet sulfoxide residues of 7 ppb in
water and 51 ppb in sediment.
                                         21

-------
10/82
Lyman County,
  SD
01/16/87
Solano County,
  CA
38 mallards; 4 gad-
walls; wigeons; 6
pintails; 7 green-
winged teals; 1 red-
tailed hawk; and 1
golden eagle
Red-tailed hawk
11/04/86   Tulelake, CA    50 mallards, 50
                         pintails
02/16/87   Jefferson       Bald eagle
            County, ID

12/05/82   Potter County,   Bald eagle
            SD
Thimet 15G was applied to winter
wheat field.  Birds were found in an
intermittent wetland basin  (1 acre,
6 to 8 inches deep) several days
after heavy rains.  Two empty bags of
Thimet were in the area. Water and
sediment sampled October 20.  Mean
Thimet residues of 7 ppb in water
and 14 ppb in sediment; mean Thimet
sulfoxide residues of 18 ppb in water
and 30 ppb in sediment.

The hawk was found in stressed
condition in a mud field and died at
a rehabilitation facility.  Severe
brain ChE depression.  Fecal material
contained residues of phorate-type OP
and phorate was being used  in area.
Death was attributed to phorate.

Birds were found on agricultural land
and deaths were attributed  to
phorate.

Death attributed to phorate.
                                     Suspected phorate poisoning.
              Aquatic  Organisms  Testing

           Based on  acceptable  laboratory data, technical  phorate
      is  characterized as very highly toxic  to freshwater  fish and
      invertebrates.   The LC50 values were 6 to 13 ppb  for trout
      (coldwater fish),  2 to 5 ppb for bluegills and bass
      (warmwater fish),  280 ppb  for catfish  (warmwater  fish), 0.68
      ppb to 9 ppb for amphipods and stoneflies, and 50 ppb for
      decapods.  Technical phorate is very highly toxic to
      estuarine fish and invertebrates.  The EC5Q ranges are 0.11
      to  1.9 ppb for shrimp and  1.3 to 5.0 ppb for spot and
      sheepshead minnow.  The EC5Q value for moHusks is 900 ppb.
      A study in which the inhibition of brain AChE was determined
      in  adult sheepshead minnows indicates  that prior  to  death
      AChE activity  falls below  17.7 percent of normal  following
      exposure to lethal concentrations.

             One study on the early life stage of estuarine fish
      indicates that 0.41 ppb is significantly toxic to juveniles
      for an exposure  period of  28 days postfertilization.  The
                                      22

-------
maximum acceptable toxicant concentration  (MATC)  is between
0.24 and 0.41 ppb.  A study on the  life cycle of  shrimp
indicates that  28-day survivability is significantly reduced
at 0.21 ppb.  The MATC is between 0.09 and 0.21 ppb.  These
studies are deficient as the raw data were not submitted as
required in the 1984 Standard.  If  the data are unavailable,
new studies are required.  An early life stage study with
freshwater fish was determined to be unacceptable because of
the high mortality in the control fish embryos (>50%).  A new
study  is required.  An invertebrate life cycle study is
incomplete.  The raw data must be submitted.  If  the data are
unavailable, a  new study is required.

       There is sufficient information to characterize a 20G
formulation as  very highly toxic to freshwater fish and
invertebrates.  The LC50 values were 45 ppb for rainbow
trout, 12 ppb for bluegill and  2200 ppb for channel catfish.
The LC50 values for invertebrates ranged from 37  ppb for
daphnids to 65  ppb for mayfly nymphs.  The 20G formulation ia
also very highly toxic to estuarine fish and invertebrates.
The LC50 values are 8.2 ppb for sheepshead minnow; 1.4 ppb
for shrimp; and 17 ppb for oysters.

       Based on phoratefs very high toxicity to aquatic
organisms, high levels of phorate measured in ponds and
reports of fish kills (see Table 2), an aquatic field study
was required in the 1984 Standard.  This study is currently
in progress  (see discussion under Hazards below).

      Risk Assessment for Aquatic Organisms

       Aquatic  organisms may be at  risk from exposure to
phorate via its terrestrial uses (run-off and drift).The
laboratory toxicity data indicate that phorate is very
highly toxic to freshwater and estuarine fish and
invertebrates.  Based on one reported incident in Illinois in
1970, a significant amount of phorate and its degradates were
present in the water of ponds that received the surface
runoff from rainfall following applications of phorate to
cornfields.  Residue concentrations in the three ponds ranged
from 6.8 to 32.3 ppb 2 weeks after the application.   Several
days after the  applications and heavy rainfalls,  dead fish,
predominantly bass and bluegill, were observed in the ponds.
An estimated 2000 to 3000 died within one pond alone.
Although the cornfields were also treated with pesticides
other than phorate, the deaths were attributed to phorate,
since the measured residues were greater than the LC5Q values
for some warmwater fish and phorate is more toxic than the
other pesticides identified in this incident.

       Although there are no acceptable fish and  invertebrate
chronic toxicity data, the estuarine fish and shrimp data

                             23

-------
indicated that survivability was significantly reduced at
phorate concentrations <0.41 ppb.  Residue levels of 0.4 to
0.6 ppb were measured in two of the ponds approximately 6
weeks after treatment, and 12.1 ppb phorate was measured in
the third pond 37 days postapplication following seven
rainfall events.  These residue values indicate that phorate
is present at levels that can kill aquatic organisms acutely
or produce long-term population effects.

          These data, including the fish kill reports and
residue data, were originally reviewed in the 1984 Standard.
Based on these findings, a field study was required to
measure the effects of phorate on the stability of aquatic
ecosystems and populations.  A 2-year pond study is currently
in progress in the corn region of Iowa .   Following the
completion of this study and other data required in this
Standard, an assessment of aquatic risks can be completed.

        Honeybee Acute Toxicity

       There is little or no exposure expected to beneficial
insects resulting from phorate granular formulations.  No
data are required.

        Endangered Species

      Because of the demonstrated toxicity of phorate to
nontarget fish, aquatic invertebrates, birds, and mammals,
phorate was identified by the U.S. Fish and Wildlife Service
(USFWS) as likely to jeopardize endangered animal species,
including endangered insects, when used on crops.  Based on
this determination, USFWS specified reasonable and prudent
alternatives to avoid jeopardizing the continued existence of
the identified species by these uses.  EPA is working with
USFWS and other Federal and State agencies to implement the
alternatives in a technically sound manner.

    2.  Environmental Fate

       In the 1984 Registration Standard, the Agency required
     4  The study design is based on comparing two reference
ponds with two ponds that will receive runoff containing
residues of phorate.  A base-line study is currently in
progress to gather data on the natural populations in the
ponds and to characterize the abiotic components of the ponds
such as productivity and respiration.  In 1989 the cornfields
surrounding the two treatment ponds will be treated with an
at-planting application and, later in the season, with an
aerial broadcast application.
                              24

-------
 a full  battery  of  environmental  fate  testing,  except  for
 spray drift  data.   Subsequent  to the  issuance  of  the
 Registration Standard,  all  registrants withdrew phorate's
 sole aquatic food  use on  rice, and  as a  result, study
 requirements triggered  by aquatic food crop  use  (anaerobic
 aquatic metabolism, aerobic aquatic metabolism, aquatic soil
 dissipation, accumulation in aquatic  nontarget organisms, and
 accumulation in irrigated crops)  were no longer required.

 The data  submitted in response to the 1984 Standard have been
 reviewed  and, with the  exception of leaching and
 absorption/desorption,  do not  fulfill the data requirements.
 An update on the environmental chemistry profile  is as
 follows:

 Leaching  and Adsorption/Desorption  Studies

        Based on acceptable batch equilibrium studies, 14C
 phorate was  very mobile to mobile in  loamy sand,  sandy loam,
 silt loam, and  loam soils.  Ka(js  values  calculated using the
 Freundlich equation were  1.53 for loamy  sand soil, 3.13 for
 the sandy loam  soil, 7.54 for the silt loam  soil, and 19.9
 for the loam soil.  These Freundlich  Kad values determine the
 mobility  of  the pesticide and its degradates in different
 types of  soil.  Soil/solution partition  coefficient values
 (Koc) were 450, 505, 512, and 705 for the loamy sand, sandy
 loam, silt loam, and loam soils,  respectively, and soil
 distribution coefficient  (Kd) values  obtained  following
 desorption were 2.53, 5.25, 4.10, and 13.2.

        Aged  (10 days) residues of 14C phorate  were mobile in
 24-inch columns of  sandy  loam and loamy  sand soil and were
 slightly  mobile in  21-inch columns  of silt loam and clay loam
 soil.   Only  low levels of phorate were detected in the
 leachates.   Phorate sulfoxide and phorate sulfone were only
 detected  in  the leachates from the  sandy loam  and loamy sand
 soil columns.   In the sandy loam  and  sandy soil columns,
 phorate and  the degradate phorate sulfoxide  accounted for
 approximately 35 to 68 and 20 to  36 percent  of the applied
 radioactivity,  respectively.  Phorate sulfone was detected
 primarily in the silt loam and clay loam soil  columns and
 accounted for approximately 10 and  30 percent  of the applied
 radioactivity in these soils.   Phorate sulfone was 0.8
 percent of the applied 14C phorate  in the loamy sand and
 sandy loam soils.

Aerobic Soil Metabolism Studies

       Based on preliminary data, [14C]phorate degraded with
a half-life of  <3 days in sandy loam soil.   Phorate declined
 from 0.85 ppm at 0 days posttreatment to 0.16 ppm at 6 days
posttreatment, then to 0.00  ppm  (detection limit not

                             25

-------
reported) at 31 days posttreatment.   The degradate phorate
sulfoxide reached a maximum concentration 0.62 ppm at 6 days
posttreatment, then declined to 0.08 ppm at 120 days
posttreatment.  Phorate sulfone reached a maximum
concentration of 0.66 ppm at 31 days posttreatment and then
declined to 0.57 ppm at 120 days posttreatment.

       This study will be acceptable conditioned upon
submission of freezer storage stability data and
specification of the purity of the test substance.
Otherwise, a new study is required.

Terrestrial Field Dissipation Studies

       Three studies were received by the Agency for review.
In one study, phorate dissipated with a half-life of <3 days
from the upper 3 inches of two field plots of sandy loam soil
following application of phorate.  The calculated half-life
was 2 days.  Phorate declined from 1.01 to < 0.05 ppm in the
0- to 3-inch soil depth, maximum concentrations of phorate
sulfoxide and phorate sulfone were 0.26 ppm (day 7
posttreatment) and 0.11 ppm (day 15  posttreatment),
respectively, and declined to < 0.05 ppm by day 60
posttreatment.

       At a site in Illinois, phorate dissipated with a half-
life of 9 to 15 days from the upper 3 inches of two field
plots of silt loam soil following the application.  The
calculated half-life (derived from the residue decline curve
plotted on a graph) was 19 days.  Phorate declined from a
maximum of 0.75 ppm at 3 days posttreatment to < 0.05 ppm by
59 days posttreatment in the 0- to 3-inch soil depth.  At all
other soil depths (down to 18 inches), phorate concentrations
were < 0.05 ppm throughout the study.  In the 0- to 3-inch
phorate soil depth, maximum concentrations of phorate
sulfoxide and phorate sulfone were 0.73 ppm (day 30
posttreatment) and 0.42 ppm (day 30  posttreatment),
respectively, and declined to 0.05 and 0.26 ppm by day 180
posttreatment.  Phorate sulfoxide and phorate sulfone were <
0.05 ppm at all other so.il depths.  Phorate oxygen analogue
was < 0.05 ppm at all sampling intervals.

       At a site in Iowa, phorate dissipated with a
calculated half-life of 12 days in silt loam soil treated
with phorate, declining from 10.2 ppm immediately
posttreatment to 5.34 ppm by day 7,  to 0.25 ppm by day 30,
and to < 0.05 ppm by day 92.  Phorate was < 0.05 ppm in the
3- to 6-, 6- to 9-, and 9- to 12-inch sampling depths at all
sampling intervals.  In the 0-to 3-inch soil depth, phorate
sulfoxide declined from a maximum of 2.92 ppm at 7 days
posttreatment to 0.18 ppm at 180 days posttreatment.  Phorate
was < 0.05 ppm at all sampling depths and intervals except

                             26

-------
for day 30 in the 6-to 9-inch depth (0.06 ppm).   In the 0- to
3-inch depth, phorate sulfone reached a maximum of 1.93 ppm
at 60 days posttreatment and declined to 0.13 by day 180.  In
the 3- to 6-inch depth, phorate sulfone reached a maximum of
0.16 at 180 days.  Phorate sulfone was < 0.05 ppm at all
sampling intervals at the lower depths except at day 30 in
the 6- to 9-inch depth (0.07 ppm).  Phorate oxygen analog was
< 0.05 ppm at all sampling depths.

       These studies will be acceptable conditioned upon
submission of freezer storage stability data of phorate and
its degradates of samples frozen prior to analysis.
Otherwise, a new study must be conducted.

Accumulation in Confined Rotational Crops Studies

       [13'14C]Phorate residues accumulated in lettuce, corn,
and a root crop planted 1, 3, and 12 months after
[13/14]phorate was applied to sandy loam soil.  Maximum
accumulation occurred in crops planted at 1 month
posttreatment; [13»14C]residues at harvest were 0.47 ppm in
lettuce; 0.75 and 0.53 ppm in beet tops and roots; and 0.32,
0.03, and 0.02 ppm in corn fodder, kernels, and cobs.  In
crops planted at 3 and 12 months posttreatment,  total
[13«14c]residues at harvest were 0.03 ppm in lettuce, 0.05 to
0.06 and 0.02 to 0.03 ppm in radish tops and roots, up to
0.02 ppm in corn fodder, and below 0.01 in corn kernels and
cobs.  Parent phorate was detected in corn plants (O.016 ppm)
and beet tops .063 ppm), but not in beet roots or lettuce.
The primary degradate in all crops was the nonphosphorylated
disulfone.  Other degradates detected included phorate
sulfone and phorate sulfoxide.

       [13'14C]Phorate residues dissipated with a half-life
of 1 to 3 months from the upper 3 inches of sandy loam soil.
At 12 months posttreatment, [13'14C]residues were detected at
0.18 ppm at the 0- to 3-inch soil depth and at 0.01 ppm or
less at lower soil depths.  Parent phorate accounted for <2
percent of the extractable radioactivity from any soil
sample.  The primary degradate in the soil was phorate
sulfone, which accounted for 72% (0.748 ppm), 75% (0.074
ppm), and 29% (0.012 ppm), respectively of the extractable
radioactivity from the 1-, 3-, and 12-month soil samples,
respectively.  Other degradates detected include
nonphosphorylated disulfone, phorate sulfoxide,  and several
unknowns.

       This study only partially satisfies the requirement
for a confined rotational crop study, because not all of the
test substances (phorate, phorate sulfoxide and phorate
sulfone) were completely characterized and, except for one
sampling interval, the residues in the soil were not analyzed

                              27

-------
at the time of harvest of the rotational crop.   Also, the
study was conducted with 1.5 Ib ai/A instead of the maximum
label rate.  If this missing information is submitted and
determined to be acceptable by the Agency, the study will
only be adequate to support a maximum label rate of 1.5 ai/A.
Alternatively, the registrant may choose to conduct a new
study.

       No data were submitted for field rotational crops.
However, the Agency is now reserving this requirement pending
the results of the confined rotational crop study.

Fish Accumulation studies

       A fish accumulation study submitted in response to the
1984 Standard was reviewed and determined to be unacceptable
since the test substance was incompletely characterized, the
fish may have only been exposed to the parent compound, and
degradate characterization results from the fish tissue
samples were reported in terms of percent recovered
radioactivity from the TLC plates rather than percent of
total (initial) sample radioactivity.  A new study is
required.

Groundwater

       The 1984 Registration Standard indicated that phorate
has some potential to leach through the soil and contaminate
ground water.   Based on recently submitted data, phorate
does not appear to be a potential leacher.  However, its
sulfone and sulfoxide degradates show greater persistence and
mobility in soil, and therefore may have a greater leaching
potential.  Due to inadequate information on
aerobic/anaerobic soil metabolism and field dissipation of
phorate and its degradates, the requirement for groundwater
monitoring studies is deferred at this time.  However, a
terrestrial field dissipation study is required to be
conducted on sandy loam soil in Long Island, New York.
Depending on the results of this and other required
environmental fate studies, the need for ground water
monitoring studies will be determined.
 D.  TOLERANCE REASSESSMENT

       l.  Tolerances Issued

       Tolerances for residues of phorate in or on food and
feed commodities are published in 40 CFR 180.206.  A
tolerance for residues of phorate on the processed feed
commodity, dried sugarbeet pulp, is published in 21 CFR
561.290.  Tolerances are expressed in terms of phorate and

                              28

-------
its cholinesterase-inhibiting metabolites.  EPA has evaluated
the residue and toxicology data supporting these tolerances
based on data submitted in response to the 1984 Standard.
The following were considered during this evaluation:

   0  Whether the current tolerances and food additive
regulations are sufficient to cover the actual residues
resulting from use (including FIFRA section 24(c) uses).

   0  Whether group tolerances can be established in
accordance with 40 CFR 180.34(f).

   0  Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are
necessary.

    0  Whether the tolerances are expressed accurately and in
the current terminology.

       The Agency's findings as a result of this evaluation
are summarized below.  The regulatory results of the Agency's
review are set out in Section IV Regulatory Position and
Rationale.

       2. Residue Data

       An update on the residue chemistry data in support of
phorate tolerances is as follows:

       a.  The nature of the residue in plants is adequately
understood and no additional data are required.  The
metabolites of phorate in plants are listed in Table 3.   The
available evidence indicates that phorate is metabolized in
plants by oxidation of the thioether sulfur and then the
thiono sulfur to yield the organosoluble metabolites II, III,
V, and VI.  Varying smaller amounts of the water-soluble
metabolites X-XIII occur as a result of hydrolysis of the
sulfoxide and sulfone metabolites.  Although the metabolism
of phorate in plants is well documented, particularly with
respect to bean plants, it is noted that all of the in-depth
plant metabolism studies employed [32P]phorate rather than
t -^CJphorate, an(i could not detect the dephosphorylated
metabolites VII, VIII, and IX found in ruminants, if they
indeed occur (see under b below).  However, the Agency has
concluded that these metabolites are not of toxicological
concern, and therefore the metabolism of phorate in plants is
adequately understood.  No additional data are required.
                              29

-------
Table 3. Phorate and its Metabolites in Plants and Animals
       Common Name and Chemical Name      Found In:


  I.   Phorate 0,0-diethyl S-[(ethylthio)methyl]phos-
       phorodithioate
                                          Alfalfa leaves
                                          Bean leaves
                                          Carrot roots
                                          Corn foliage
                                          Cotton leaves
                                          Cotton leaves
                                          Cotton leaves
                                          Oat foliage

 II.   Phorate sulfoxide 0,0-diethyl S-[ (ethylsulf inyDmethyl]-
       phosphorodithioate
                                          Alfalfa leaves
                                          Bean leaves
                                          Carrot roots
                                          Corn foliage
                                          Cotton leaves
                                          Cotton leaves
                                          Cotton leaves
                                          Lemon leaves
                                          Oat foliage
                                          Pea foliage
                                          Potato tuber
                                          Radish root

 III.   Phorate sulfone O,0-diethyl  S-[ (ethylsulfonyDmethyl]-
       phosphorodithioate
                                          Alfalfa  leaves
                                          Bean leaves
                                          Carrot roots
                                          Corn foliage
                                          Cotton leaves
                                          Lemon  leaves
                                          Pea foliage
                                          Potato tuber
                                          Radish root

  IV.   Phorate oxygen analog  0,O-diethyl  S-[(ethylthio)methyl]
       phosphorothiolate
                                          Carrot root
                                          Potato tuber
                                          Radish root
                                          Goat milk,
                                             tissue
                                30

-------
Table 3. Phorate and its Metabolites in Plants and Animals

       Common Name and Chemical Name      Found In:
  V.   Phorate oxygen analog sulfoxide 0,0-diethyl S-[(ethylsul-
       finyl) methylJphosphorothiolate
                                          Alfalfa leaves
                                          Bean leaves
                                          Carrot roots
                                          Corn foliage
                                          Cotton leaves
                                          Lemon leaves
                                          Oat foliage
                                          Pea foliage
                                          Potato tuber
                                          Radish root
                                          Goat milk,
                                          tissue

  VI.  Phorate oxygen analog sulfone 0,0-diethyl S-[(ethylsul-
       fonyl)methyl]phosphorothiolate
                                          Bean leaves
                                          Carrot roots
                                          Corn foliage
                                          Cotton leaves
                                          Lemon leaves
                                          Oat foliage
                                          Potato tuber
                                          Radish roots
                                          Goat milk,
                                          tissue

 VII.  (ethylsulfonyl)(methylsulfonyl)methane
                                          Goat, milk
                                          tissue

VIII.  (ethylsulfinyl)(methylsulfonyl)methane
                                         Goat, milk
                                         tissue

IX.     (ethylsulfonyl)(methylsulfinyl)methane
                                          Goat milk,
                                          tissue

X.     Phosphoric acid
                                          Bean leaves
                                          Cow urine
                               31

-------
Table 3. Phorate and its Metabolites in Plants and Animals

       Common Name and Chemical Name      Found In:
XI. 0,O-diethyl phosphoric acid
                                          Bean leaves
                                          Cotton leaves

XII.   0,O-diethyl phosphorothioic acid
                                          Bean leaves
                                          Cow urine
    b.  The nature of the residue in animals is not totally
understood.  Metabolism studies utilizing poultry are required.
No additional data are_ required for ruminants (cows and goats).
The metabolites of phorate in ruminants are listed in Table 3.
In ruminants fed radiolabeled 14C phorate5,   cleavage of the
sulfur-phosphorus bond of phorate (I), methylation of the
resulting mercaptan to a sulfide, and oxidation resulted in the
formation of metabolites VII, VIII, and IX.  These metabolites
comprised 94-99.5% of the recovered radioactivity in goat milk
and tissues.  In contrast, phorate (I) and its phosphorylated
metabolites (II-V) collectively accounted for <0.2% of the
recovered radioactivity in milk and <0.01-1.5% in tissues.  The
dephosphorylated metabolites (VII, VIII, and IX) have not been
identified in plant metabolism studies; however, those studies
employed [32P]phorate rather than [14C]phorate.  The Agency has
determined that these metabolites are of no toxicological
concern.

     c. Validation data and/or descriptions of analytical
methods are required for various procedures submitted by
American Cyanamid to determine their suitability for data
collection and enforcement purposes.  The validation data must
reflect separate fortifications of phorate and its sulfoxide,
sulfone, oxygen analog, oxygen analog sulfoxide and oxygen
analog sulfone for each commodity tested.
     5  In the 1984 Standard it was concluded that the nature of
the residue  in animals was not adequately understood.
Additional data on the metabolism of  [32P]phorate, [32P]phorate
sulfoxide, and [32P]phorate sulfone by ruminants were required.
The Agency subsequently reassessed the animal metabolism data and
determined that metabolism studies using  [14C]phorate alone would
suffice.
                                32

-------
      d.  Data using PAM protocols I -IV are needed for phorate
and metabolites sulfone, sulfoxide, oxygen analog sulfone, and
oxygen analog sulfoxide in various commodities.

      e.  The available data support the established tolerances
for the combined residues of phorate and its cholinesterase-
inhibiting metabolites in or on potatoes, sugar beets, sugar beet
tops, sugar beet pulp, and soybeans.

       f.  Data are not adequate to support many of the
established tolerances for phorate.  Data on the magnitude and
levels of residues of phorate and its degradates in individual
raw agricultural commodities, animal products, processed food
andfeed items, and cooked items are required.  Sample histories
and storage stability data are required for various commodities.

      3. Toxicology

     In the 1984 Standard, a NOEL from an acceptable chronic
feeding study was not available, and therefore, a provisional
value for an acceptable daily intake (PADI) was established on
the basis of a NOEL from a subchronic (90-day) feeding study in
rats.  In this study, a 200-fold safety factor was used with a
NOEL value of 0.66 ppm (0.033 mg/kg based primarily on RBC
cholinesterase inhibition in females) to derive a PADI value of
0.000165 mg/kg and a maximum permissible intake (MPI) value of
0.0099 mg/day for a 60 kg person.

     The current RfD for phorate is based upon a l-year dog
study in which technical phorate was administered in capsules to
beagle dogs for 1 year at daily dosage levels of 0.005, 0.010,
0.050 and 0.250 mg/kg.  The highest dosage caused slight tremors
in both sexes and marginal inhibition of body weight gain in
males.  Plasma cholinesterase was inhibited at 0.05 mg/kg/day in
both sexes; RBC and brain cholinesterase were inhibited in both
sexes at 0.250 mg/kg/day.   The corresponding NOELs were: systemic
toxicity = 0.050 mg/kg/day, plasma cholinesterase inhibition =
0.010 mg/kg/day, RBC and brain cholinesterase inhibition = 0.050
mg/kg/day.  Based on the NOEL for brain cholinesterase
inhibition in this study and an uncertainty factor of 1006, the
Agency has established 0.0005 mg/kg/day as the RfD.

     The Agency has performed a preliminary dietary exposure
analysis using tolerance level residues and percent of crop
treated where possible.   The ARC for phorate for the U.S.
population average is 0.000491 mg/kg/day.  The ARC is based on
current tolerance levels,  including those commodities for which
     6  An uncertainty factor of 100 was used, since systemic
toxicity was observed at the NOELs for RBC and brain
cholinesterase.
                                33

-------
phorate is no longer registered or used (these tolerances will be
revoked), and has been adjusted, where possible, based on percent
of crop treated.  For the U.S. population average, the ARC
occupies 98% of the ADI.   For children 1 to 6 years of age, the
ARC occupies 235% of the ADI, and for non-nursing infants, it
occupies 331% of the ADI.  Due to the significant contribution
made by milk to the diet of children and non-nursing infants,
data regarding the reduction of residues through processing
(pasteurization) are required.  EPA believes that residues in
pasteurized milk will be significantly lower than in raw milk.
and that dietary exposure of children and infants to phorate
will be concomitantly lower.  In addition, processing studies are
required for potatoes, corn, sorghum, wheat, and sugarcane, and
cooking data are required for potatoes, red meat, poultry and
eggs.  Cooking and processing of RACs are expected to signifi
cantly reduce phorate residues in the diet.

E.   REFERENCES CITED IN THE SCIENCE ASSESSMENT

Balcomb, R. 1980.  Granular pesticides: Restricted classification
    based on the hazard to avian wildlife.  Presented to the
    USEPA Scientific Advisory Panel, 5 Mar 1980.  Ecologicale
    Effects Branch, OPP, HED.

DeWitt, J.B. (1966). Methodology for Determining Toxicity of
    Pesticides to Wild Vertebrates.  The Journal of Applied
    Ecology. Vol 3: 275-278.)

Erbach, D. and J. Tollefson 1983.  Incorporation of granular soil
    insecticides by corn planters.  Trans. ASAE-1983.  Amer.
    Soc. Agric. Eng. 0001-2351/83/2603-0696.

Hummel, J.W. 1983. Incorporation of granular soil insecticides by
    corn planters.  Trans. ASAE-1983.  Amer. Soc. Agric. Eng.
    Paper No. 83-1017/83-7008.

Kenaga, E.E. 1974.  Evaluation of the safety of chlorpyrifos to
    birds in areas treated for insect control.  In F.
    Gunther, ed., Residue Reviews, Vol. 50.  Springer-Verlag.

Wentworth, B. C. 1968.  Avian birth control potentialities with
    synthetic grit.  Nature 220:1243-1245.

Bent, A.C. 1963.  Life histories of North American Gallinaceous
    birds.  Dover Publ., Inc. NY, NY.
                                34

-------
            IV.   REGULATORY POSITION AND RATIONALE

 A.   SUMMARY OF  REGULATORY POSITIONS AND RATIONALES

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

     1.   The Agency is conducting  a  comparative avian  risk
 assessment of various granular pesticides including phorate.
 Based on this assessment,  regulatory action may be taken.

        Rationale:   Based on a high  acute toxicity of  phorate to
 avian species and  the current registered use patterns of
 phorate,  there  is  a high potential  for  adverse effects to avian
 species from exposure to phorate  granules at or near  the  soil
 surface.   This  potential for exposure to phorate is demonstrated
 from results of Level I  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.   Based  on this assessment,  the
 Agency will determine whether regulatory action should be taken.

      2.   The Agency will assess the hazards to aquatic organisms
 upon receipt of an aquatic  organism field study.   At  this time
 the  Agency will determine whether further regulatory  action is
 necessary.

        Rationale;   Available field reports and laboratory data
 indicate  that the  concentrations  of phorate in the aquatic
 environment resulting from  the  registered uses of  phorate might
 expose  aquatic  species to residue levels exceeding risk criteria
 for  Special Review.  (Refer  to Section C.3.  in Chapter III of this
 document  for  a  discussion of  the  potential  risks to aquatic
 organisms.)   In the  1984 Standard,  the Agency required submission
 of an aquatic field  study to  assess  potential risks to aquatic
 organisms.  The aquatic  organism  study  is currently underway and
 is due by  1991.   Upon receipt and evaluation of the aquatic
 organism  field  study, a  determination will  be made regarding
 whether regulatory action,  including a Special Review, is
 warranted.

      3.  The USFWS has determined that certain uses of phorate,
 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 require-
ments issued in PR Notices  87-4 and 87-5 have been withdrawn.

        Rationale;   Because of the demonstrated toxicity of

                                35

-------
phorate to nontarget fish, aquatic invertebrates, birds, and
mammals, phorate was identified by the USFWS as likely to
jeopardize endangered animal species, including endangered
insects, when used on crops. Based on this determination, USFWS
specified reasonable and prudent alternatives to avoid
jeopardizing the continued existence of the identified species
by these uses.  EPA is working with USFWS and other Federal and
State agencies to implement the alternatives in a technically
sound manner.

      In order to reduce or eliminate exposure to these species
to a point where use does not result in jeopardy, EPA required
special labeling on end-use products of phorate under PR Notices
87-4 and 87-5.  Subsequent issuance of PR Notice 88-1 withdrew PR
Notices 87-4 and 87-5 pending development of a more focused
program to protect endangered species from adverse effects in the
use of pesticides.  When the program is fully developed, notice
of any labeling necessary to protect endangered species will be
issued.

      4. In order to meet the statutory standard for continued
registration, the Agency has determined that phorate products
must bear revised and updated labeling for hazards to nontarget
organisms.  Refer to Section V for the wording of these
statements.

        Rationale;  Label statements are required since
available data show that phorate is very highly toxic to birds,
mammals and aquatic organisms, and highly toxic to mammals.

       5.  The Agency is requiring submission of special acute
and subchronic eye studies.

          Rationale;  Studies available to the Agency have
implicated some of the organophosphates in causing effects such
as retinal degeneration and myopia.  Because of this concern
(refer to Section IIIB for a discussion), the Agency is now
requiring submission of special acute and subchronic studies,
such as electroretinogram and direct corneal measurements.  The
data will provide the information necessary to confirm or deny
the potential for phorate to cause retinal degeneration and
myopia in the human eye.  Pending receipt and evaluation of these
studies, the Agency will determine whether labeling modifications
or other regulatory action is warranted.

      6.  The Agency will not approve significant new food uses'
      7  "New use"  is defined  in  40 CFR  152.3(p).   In the case of
new  food  or feed  use, the Agency will  generally  consider as
significant an  increase  in the  TMRC of greater than 1%.

                                36

-------
 for  phorate  until  residue  data  sufficient to perform  a  tolerance
 reassessment have  been submitted.

           Rationale:   In the  1984  Standard, the Agency  expressed
 concerns  about  the human dietary exposure to phorate  and  its
 metabolites  and considered initiating Special Review, but
 withheld  action pending receipt of metabolite toxicity  and
 residue chemistry  data to  evaluate the magnitude of human
 dietary exposure to phorate and its metabolites.  Based on data
 submitted under this  Standard,  the Agency no longer believes that
 phorate will cause adverse effects to humans for the  reasons
 given below.

     a.  The  Anticipated Residue Contribution (ARC) for  the U.S.
 population average is 0.000491  mg/kg/day, corresponding to 98% of
 the  RfD (for children 1 to 6  years of age, the ARC occupies 235%
 of the RfD,  and for non-nursing infants, the ARC occupies 331% of
 the  RfD).  This is considerably lower than the calculations
 derived from available data in  the 1984 Standard, in which the
 TMRC to the  human  diet represented 1030.71% of the PADI.  Due to
 the  significant contribution  made  by milk to the diet of
 children  and non-nursing infants,  data regarding the reduction of
 residues  through processing (pasteurization) are required.  In
 addition,  processing  studies  are required for potatoes, corn,
 sorghum,  wheat,  and sugarcane,  and cooking data are required for
 potatoes,  red meat, poultry and eggs.  The Agency expects that
 cooking and  processing of  meat  and milk will reduce residues of
 phorate to levels  which will  be of little or no concern.

     b.  Plant metabolism studies reviewed by the Agency for the
 1984 Standard indicated that  the major portion of the residues of
 phorate consisted  of  the oxidation products, sulfone and
 sulfoxide.  However,  based on limited acceptable residue data
 submitted  in  response to the  1984  Standard, the combined levels
 of phorate and  its  oxidation  products have been shown to be very
 low.  However, many of  the  tolerances for phorate are still not
 adequately supported.   Additional  data (residue studies,
 processing and cooking  studies, residue analytical methods,
 poultry metabolism  study and  storage stability data)  are needed
 before the Agency can determine the adequacy of current tolerance
 levels and perform  a  tolerance  reassessment.  Because of these
 extensive  residue chemistry data gaps, significant new uses will
not be granted until  these data gaps have been filled.

     7.   The Agency is  imposing a  48-hour reentry interval for
all uses of phorate on  an  interim basis pending submittal and
evaluation of required  reentry data.   Based upon foliar and soil
dissipation studies,  registrants must propose a reentry interval
 in accordance with the Pesticide Guidelines, Subdivision K.

       Rationale;  Data are not available to establish
                                37

-------
definitive reentry intervals for ground and aerial applications
of phorate granular products.   Establishment of interim reentry
intervals is based on the high acute toxicity properties of
technical grade phorate.

      8.  The Agency is imposing revised and updated worker
safety and protective clothing statements for EPs containing
phorate.  Refer to Section V for the wording of these statements.

       Rationale;  The Agency is concerned that exposure to
phorate could present a health risk to agricultural workers due
to the high acute toxicity of the technical grade of this
pesticide.  Revised and updated protective measures are being
imposed to minimize this exposure.

      9.  The Agency will continue to restrict the use of
products containing phorate.

        Rationale;  All granular formulations containing 5%
phorate and greater were classified as restricted use pesticides
under the 1984 Standard based upon a very high acute toxicity to
humans and avian species.  In addition, all granular formulations
containing less than 5% phorate were classified restricted use
pesticides pending receipt and evaluation of data.  Registrants
of products containing less than 5% phorate chose to restrict
their products, rather than to submit data. The Agency will
continue to restrict the use of all products containing phorate,
having determined that phorate meets the risk criteria of 40 CFR
152.170 due to acute oral and dermal toxicity and bird toxicity.

     10.  The Agency is deferring requirement for a groundwater
monitoring study, pending receipt and evaluation of a terrestrial
field dissipation study and other required environmental fate
studies.

        Rationale;  In the 1984 Standard, the Agency determined
that phorate had some potential to leach through soil and
contaminate groundwater, particularly where soils were sandy and
aquifers shallow.  Simulation of the leaching potential of
phorate using computer modeling predicted some mobility in sandy
soils, but none in loam soils under typical phorate use
conditions.

    Based on recently submitted data, phorate does not appear to
be a potential leacher.  However, its sulfone and sulfoxide
degradates show greater persistence and mobility, and therefore
may have a greater leaching potential.  A terrestrial field
dissipation study is required to be conducted in Long Island, New
York.  Depending on the results of this and other required
environmental fate studies, the need for a groundwater monitoring
study will be determined.
                                38

-------
     11.  The Agency will revise commodity definitions for
certain raw agricultural commodities listed in 40 CFR 180.206.

       Rationale;  Certain listings in 40 CFR 180.206 are not
appropriate and will be corrected by the Agency:

         a.  The tolerance listing for wheat (green fodder) will
be revised to read "wheat fodder".  This is the appropriate
commodity definition.

         b.  The designation "(N)" for negligible residues listed
with the tolerances for milk, and meat, fat, and meat byproducts
of cattle, goats, hogs, horse, poultry, and sheep and in eggs
will be deleted.  The Agency no longer sets "negligible" residue
tolerances.

       12.  The Agency will revoke tolerances associated with the
commodities alfalfa (fresh), alfalfa (hay), lettuce, rice, grass
(bermuda straw), and tomatoes.

       Rationale;  These crops no longer have any federally
registered uses.  Therefore, the Agency intends to revoke the
tolerances for these commodities.

        13.  The Agency intends to propose tolerances for corn
fodder, bean hay, wheat hay and cotton forage.

         Rationale;  The Agency has determined that (1) 0.5 ppm
is an appropriate tolerance level for bean hay and corn fodder,
(2) 0.2 ppm is an appropriate tolerance level for cotton forage
and (3) 1.5 ppm is an appropriate tolerance level for wheat hay.
The Agency intends to propose these tolerance levels, unless the
registrant submits labeling containing restrictions against the
feeding of corn fodder, bean hay, wheat hay and cotton forage to
livestock.  The registrant must inform the Agency within 90 days
of receipt of the Standard of what he intends to do.

        14.  For the crops sugarcane and cotton forage, the
registrant is given the choice of developing and submitting data
in support of tolerances, or of adding label restrictions against
the feeding and grazing of treated crops to livestock.   Each
registrant must inform the Agency within 90 days as to whether he
will propose tolerances or adopt the grazing/feeding
restrictions.  If he selects the label restrictions, labeling
submitted at the 9 month deadline must include the
grazing/feeding prohibitions.  Refer to Section V for acceptable
wording of a grazing/feeding restriction cotton forage and
sugarcane.

         Rationale;  These raw agricultural commodities are used
as feed and forage for livestock and tolerances are required.  A
label restriction prohibiting grazing/feeding will preclude

                                39

-------
residues in meat and milk.

        15.  A comparison has been made between the U.S.
tolerances and Coded MRLs.   Although there are some inconsistence
between them, the Agency cannot revise the U.S. tolerances.

       Rationale:  Codex MRL's have been proposed on potatoes,
sugar beets, sugar beet leaves and tops, and peanut hay at
levels lower than the U.S.  tolerances for these commodities.
The available data indicate that, following registered use,  the
combined residue of phorate and its cholinesterase-inhibiting
metabolites may exceed the proposed Coded MRL tolerances.
Therefore, the U.S. tolerance cannot be decreased to achieve
compatibility with the pending Coded MRL's.

       Other comparisons between the U.S. tolerances and Codex
MRL's include the following:

         a.  Codex MRL's have been proposed for beans, wheat
grain, cottonseed, meat and egg, and poultry tissue and eggs.
These levels are identical to that of the U.S. tolerance.  The
Codex MRL proposed for milk is higher than the U.S. tolerance.

         b.  No Codex MRL's have been established for bean vines,
corn, sorghum grain, sorghum fodder, corn forage, wheat straw,
and sugarcane (U.S. tolerances exist for these).  Therefore,  no
questions of compatibility exist with respect to the MRL.

         c.  A Codex MRL has been proposed for dry soya beans.
There is no U.S. tolerance for this commodity.

        16.  The Agency has identified certain data that will
receive priority review when submitted to the Agency.

          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 as soon as they are received by the Agency:

          Section 158.340 Toxicology

          85-1      General Metabolism
                    Special Testing for Eye Effects
                    Short-term Mouse Study

          Sections 158.290. 158.140 and 158.440 Environmental


          161-2,-3  Photodegradation
          162-1,-2  Aerobic and Anaerobic Soil Metabolism
          163-2     Lab Volatility

                                40

-------
          164-1     Soil Dissipation
          165-1     Confined Rotational Crops
          165-4     Fish Accumulation
          132-1     Foliar and Soil Dissipation

          Section 158.490 Wildlife and Aquatic Organisms
          71-4
          72-3

          72-4

          72-4

          72-4

          72-4
          72-7
Avian Reproduction
Estuarine and Marine Organisms Testing
using a TEP
Fish Early Life Stage and Invertebrate
Life Cycle (Freshwater Fish)
Fish Early Life Stage and Invertebrate
Life Cycle (Freshwater Invertebrates)
Fish Early Life Stage and Invertebrate
Life Cycle (Estuarine Fish)
Fish Early Life Stage and
Invertebrate Life Cycle (Estuarine
Invertebrates)
Field Testing With Aquatic Organisms
          Section 158.240 Residue Chemistry

                    Residue Analytical Methods
                    Poultry Metabolism Studies
                    Storage Stability Studies
                    Residue Data
                    Cooking and Processing Studies

        17.  While data gaps are being filled, currently
registered products containing phorate may be sold, distributed,
formulated, and used, subject to the terms and conditions
specified in this Standard.  However, significant new uses will
not be registered. 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 withhold registration even 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.  The Agency has elected not to
consider registration of any significant new food uses while data
gaps are being filled and data evaluated.

V. REQUIRED LABELING STATEMENTS AND COMPLIANCE DATES

    All products must bear appropriate labeling as specified in
40 CFR 156.10 and below.

    Pesticide products containing this pesticide as an active

                                41

-------
ingredient may not be released for shipment by the registrant
after January 31. 1990  unless the product bears amended
labeling that complies with the requirements of FIFRA, as set out
in this Registration Standard.

    Pesticide products containing this pesticide as an active
ingredient may not be distributed, sold, offered for sale, held
for sale, shipped, delivered for shipment, or received (and
having been so received) delivered or offered to be delivered by
any person after January 31. 1991  unless that product bears
amended labeling that complies with the requirements of this
Standard.

A.  MANUFACTURING USE PRODUCTS

    1.  The ingredient statement for MPs must declare the active
ingredient as:

        Phorate:   0,O-diethyl S-[(ethylthio)
                   methyl] phosphorodithioate

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

         "An insecticide for formulating use only."

    3.  In the directions for use, the following statement must
appear:

        "Formulators using this product are responsible for
obtaining EPA registration of their formulated product."

    4.  In the directions for use, the following statement
regarding acceptable use patterns must appear:

        "For formulation into end-use insecticide products
intended only for (list acceptable sites)."8

     5.  If detailed instructions for formulating are not
provided on the label, the following statement must appear:

         "Refer to attached Technical Bulletin for formulating
and other information."
     8  The Use Index (EPA Compendium of Acceptable Uses) (for
availability see Section I) lists all federally-registered uses
of phorate, as well as approved maximum application rates and
frequencies.  No use may be included on the label where the
registrant fails to agree to comply with the data requirements
for that use pattern.
                                42

-------
     6.  The following statements are required to appear under
the "Environmental Hazards" heading:

         11 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 NPDES
Permit. Do not discharge effluent containing this product to
sewer systems without previously notifying the sewage treatment
plant authority. For guidance, contact your State Water Board or
Regional Office of the EPA."
B.  END USE PRODUCTS

     1.  The ingredient statement for EPs must declare the
active ingredient as:

            Phorate:    0,0-diethyl S-[(ethylthio)
                        methyl] phosphorodithioate

      2.  All EPs must bear the following restricted-use
classification statement:

                  "RESTRICTED  USE  CLASSIFICATION
     Due to acute oral and dermal toxicity and avian hazards

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."

     3.  All EPs must bear the following environmental hazards
statement:

         "This pesticide is extremely toxic to fish and
wildlife. Birds feeding in treated areas may be killed.  Do not
apply directly to water or wetlands (swamps, bogs, marshes, and
pot-holes).  Drift and runoff may be hazardous to aquatic
organisms in neighboring areas.  Collect or incorporate granules
that are spilled during loading or are visible on soil surface in
turn areas.  Do not contaminate water when disposing of equipment
washwaters."

     4.  All EPs (other than the granular formulations between 5
and 10%) must bear the following protective clothing statements
and work safety rules:

PERSONAL PROTECTIVE EQUIPMENT

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

                                43

-------
PESTICIDE.  A protective suit of one or two pieces covering all
parts of the body except head, hands, and feet; chemical
resistant gloves; chemical resistant shoes, shoe covering, or
boots.

Unless a chemical resistant protective suit is otherwise
required, mixers/loaders must wear a chemical resistant apron and
goggles or a face shield.

IF APPLICATION IS PERFORMED USING AN ENCLOSED CAB OR COCKPIT,
THE FOLLOWING -PROTECTIVE CLOTHING AND EQUIPMENT 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 when exiting.  This clothing is
inadequate to protect you during equipment repair or cleaning,
reentry, or pesticide disposal work.  Do not allow contaminated
clothing to come in contact with the insides of the cab.

IMPORTANT!  If pesticide comes in contact with skin, wash off
with soap and water.  Always wash hands, face, and arms with
soap and water before smoking, eating, drinking, or using the
toilet.

AFTER WORK:  Before removing gloves, wash them with soap and
water.  Take off all work clothes and shoes.  Shower using soap
and water.  Wear clean clothes.  Do not reuse contaminated
clothing.  Personal clothing worn during work must be laundered
separately from household articles.  Store protective clothing
separately from personal clothing.  Clean or launder protective
clothing after each use.  Clothing and protection equipment
heavily contaminated must be destroyed according to state and
local regulations.  HEAVILY CONTAMINATED CLOTHING CANNOT BE
ADEQUATELY DECONTAMINATED.

DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE PROHIBITED UNLESS
IN A TOTALLY ENCLOSED VEHICLE.
WORK SAFETY RULES

    REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH AS ARE
CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING, CAUSE PROLONGED
SUSCEPTIBILITY 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

                                44

-------
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 Telecommunications
Network for recommendations regarding such blood tests, poisoning
management, emergency treatment, and other information regarding
the toxicity of phorate.  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.

     5.  All EPs (excluding the granular formulations between 5
and 10%) must bear the following protective clothing statements
and work safety rules:

PERSONAL PROTECTIVE EQUIPMENT

WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING LOADING,
APPLICATION, EQUIPMENT REPAIR/CLEANING, AND DISPOSAL OF THE
PESTICIDE.  A protective suit of one or two pieces covering all
parts of the body except head, hands, and feet; chemical
resistant gloves; chemical resistant shoes, shoe covering, or
boots.  Wear goggles and a pesticide respirator approved by NIOSH
or MSHA.

Unless a chemical resistant protective suit is otherwise
required, mixers/loaders must wear a chemical resistant apron and
goggles or a face shield.

The respirator need not be worn during equipment repair and
cleaning and during early reentry after dust has settled.

IF APPLICATION IS PERFORMED USING AN ENCLOSED CAB OR COCKPIT,
THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT 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 when exiting.  This clothing is
inadequate to protect you during equipment repair or cleaning,
reentry, or pesticide disposal work.  Do not allow contaminated
clothing to come in contact with the insides of the cab.

IMPORTANT!  If pesticide comes in contact with skin, wash off
with soap and water.   Always wash hands, face, and arms with
soap and water before smoking, eating, drinking, or using the
toilet.
                                45

-------
ABATER WORK:  Before removing gloves, wash them with soap and
water.  Take off all work clothes and shoes.  Shower using soap
and water.  Wear clean clothes.  Do not reuse contaminated
clothing.  Personal clothing worn during work must be laundered
separately from household articles.  Store protective clothing
separately from personal clothing.  Clean or launder protective
clothing after each use.  Respirators must be cleaned and filters
replaced according to instructions included with the respirator.
Clothing and protection equipment heavily contaminated must be
destroyed according to state and local regulations.  HEAVILY
CONTAMINATED CLOTHING CANNOT BE ADEQUATELY DECONTAMINATED.

DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE PROHIBITED UNLESS
IN A TOTALLY ENCLOSED VEHICLE.

WORK SAFETY RULES

    REPEATED EXPOSURES TO CHOLINESTERASE INHIBITORS SUCH AS ARE
CONTAINED IN THIS PRODUCT MAY, WITHOUT WARNING, CAUSE PROLONGED
SUSCEPTIBILITY 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 Telecommunications
Network for recommendations regarding such blood tests, poisoning
management, emergency treatment, and other information regarding
the toxicity of phorate.  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.

     6.  All EPs must bear the following reentry statements:

REENTRY

After dusts have settled, do not enter or allow entry into the
treated area until the 48 hour reentry interval has expired,
unless the person entering the treated area is wearing the
personal protective equipment listed below for early reentry.

For early reentry into treated areas wear a protective suit of

                                46

-------
 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.

      7.  All  EPs allowing for use on peanuts must bear the
 following grazing  and  feeding restrictions:

         "Do  not graze or feed treated hay or forage to
 livestock."

      8.  All  EPs allowing for use on cotton forage must bear the
 following restriction  (in the absence of supporting residue
 chemistry data):

         "Do  not feed  treated hay or forage to  livestock."

      9.  All  EPs allowing for use on sugarcane  must bear the
 following restriction  (in the absence of supporting residue
 chemistry data):

         "Do  not graze or feed treated hay or forage to
 livestock."

           VI.  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 B9.
     9Data 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 Registration

                                47

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

     4.  Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with reregistration.

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 exemption10, the
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.

     10If 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.
                                48

-------
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 requirements
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.

     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.11

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
     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.

     -^Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.

                                49

-------
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 40 CFR 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 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

                                50

-------
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 DCI 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
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 consortium
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.
                                51

-------
     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 DCI.  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).

      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 sec. 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

                                52

-------
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.

     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 required 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

                               53

-------
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, B.C. 20006.

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

                                54

-------
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.

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

                                55

-------
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.

    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:   Phorate Registration Standard


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:

         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.

                                56

-------
        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 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.

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 8580-1).

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

                                57

-------
 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.

    3.  Within the times set forth in Table A,  you must submit
all generic data, unless you are eligible for the generic data

                                58

-------
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.
                               59

-------
I. DATA APPENDICES
     60

-------
                             TGUIDE-1

                         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.

     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:

l.   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
                            61

-------
                             TGUIDE-2
     F = Greenhouse, non-food
     G = Forestry
     H = Domestic outdoor
     I = Indoor

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:

     YES - 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 not 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.

     NQ - 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
                                62

-------
                            TGUIDE-3
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 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.
                            63

-------
                                                                   64
               Table A
Generic Data Requirements for Phorate
Does EPA
Have Data to
Test Satisfy This
Data Requirement Substance Reouirement?
Part 158 . Suboart C - Product Chemistry
Product

61-2 -


61-3 -

Identity and Composition

Description of Beginning
Materials and
Manufacturing Process
Discussion of Formation
of Impurities
Analysis and Certification of Product

62-1 -

Physical
63-2 -

63-3 -

63-4 -


63-5 -

63-6 -


Preliminary Analysis of
Product Samples
. and Chemical Characteristics
Color

Physical State

Odor


Melting Point

Boiling Point



TGAI


TGAI

Inoredients

TGAI


TGAI

TGAI

TGAI


TGAI

TGAI




Partially


Partially



Partially


Yes

Yes

Yes


N/A

Partially

Bibliographic
Citation



00146524,
00155595

00146524,
00158941


00146524


00146524,
00149814
00146524,
00149814
00146524,
00158941



00146524,
00149814
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data l/
3(c)(2HB)? Submission


2/
Yes 9 Months


Yes 9 Months


4/
Yes 12 Months


NO

NO

NO

5/
No
£/
Yes 9 Months


-------
                                                                                                                   65
                                                     Table A
                                     Generic Data Requirements for Phorate (cont'd)
Data Requirement
                                         Does EPA   Must Additional
                                         Have Data to            Data Be Submitted     Timeframe
                                       Test      Satisfy This   Bibliographic    Under FIFRA Section
                                     Substance   Requirement?     Citation      3(c)(2HB)?	
                                                                                                       For Data I/
                                                                                                      Submission
Part 158. Subpart C - Product Chemistry

Physical and Chemical Characteristics (cont'd)
63-7  - Density, Bulk Density,
          or Specific Gravity

63-8  - Solubility
63-9  - Vapor Pressure
63-10 - Dissociation Constant
                                       TGAI
                                                     Yes
63-11 - Octanol/Water Partitioning     PAI
          Coefficient
63-12 -
63-13 - Stability
                                     TGAI  or PAI   Partially


                                     TGAI  or PAI   Partially


                                     TGAI  or PAI     N/A

                                                  Partially
                                       TGAI
                                       TGAI
                                                     Yes
                                                  Partially
00146524,
00149814

00146524,
00158941

00146524,
00149814
00146524,
00149814

00146524,
00158941

00146524
                                                                                      NO
Yes2/



No


YeslQ/
                                                                                                       9 Months
                                                                                                       9 Months
                                                                                                       9 Months
                                                                                                       9 Months

-------
                                                                                                                     66

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


Part 158, Subpart C - Product Chemistry (cont'd)

 I/Due dates  refer to number  of months following receipt of this Registration Standard, unless  otherwise indicated.
 2/lnformation must be submitted for the American Cyanamid 85% Ts (EPA Registration Nbs. 241-213 and 241-212) and the
   89.4% T (EPA Registration No. 2749-106) regarding the relative amounts of beginning materials and the order in which
   they  are  added, the  equipment used to produce each intermediate and  the  final product, reaction  conditions,  the
   duration of  each step  of the  process,  and quality control  measures.    In addition, the name and address  of  the
   manufacturer, producer,  or  supplier  of  each beginning material used  in the manufacture of each product must be
   provided for the Aceto product, as well as a  statement regarding the  nature of the process (batch or continuous),
   and flow chart with chemical equations of each intended chemical reaction.
 3/For the 89.4% T  (EPA Registration No. 2749-106),  a detailed discussion of all iirpurities that are or may be present
   at  >  0.1%,  based on knowledge  of  the beginning materials,  chemical  reactions  (intended  and  side)   in  the
   manufacturing process, and any contamination during and after production must be submitted.
 4/Five or more representative batches of the Aceto 89.4% T (EPA Registration No.  2749-106)  must be analyzed for the
   amount  of active  ingredient  and  each  iirpurity for  which  certified  limits  are  required.    Complete  detailed
   descriptions of the  analytical methods used  for analysis  of  the  Aceto  89.4% T  and  the  Cyanamid  85% Ts  (EPA
   Registration Nbs. 241-213 and 241-212) along with validation data (accuracy and precision) must also be submitted.
 5_/Data not required because the technical product is mobile liquid at 20 to 25 °C.
 £/The submitted data  satisfy the requirements for the  89.4% T (EPA Registration No. 2749-106).  The submitted data do
   do not satisfy  these  requirements  for the 85%  Ts  (EPA Registration Nbs. 241-213 and 241-212) because details of the
   methodology used were not provided.  These data are required.
 I/The submitted data satisfy the  requirements for the 89.4% T (EPA Registration No. 2749-106).   No data were submitted
   regarding  solubility  in polar  (other than distilled water) and nonpolar solvents for the 85%  Ts (EPA Registration
   No. 241-213 and 241-212).  These data are required.
 S/The  submitted  data do not  satisfy the  requirements for  the 85%  Ts  (EPA Registration  Nos. 241-213  and 241-212)
   because the  methodology was  not described.   The submitted data do  not satisfy these requirements  for the  89.4% T
    (EPA  Registration No.  2749-106) because  the vapor pressure was not measured at 25 °C.  In addition, the method used
   must  be provided.
 2/The  submitted  data do  not  satisfy  the requirements  for the  85% T  (EPA Registration No.  241-213)  because  the
   temperature was not reported and the method was  not provided.  The submitted data do not satisfy these requirements
   for the 89.4% T (EPA Registration No. 2749-1Q6) because a Kow value was not clearly reported and the method used was
   not provided.   These data are required.
 10,/Tfo quantitative data were submitted to  satisfy the  requirements for the 85% Ts (EPA Registration Nos. 241-213 and
   241-212).  No data  regarding stability were submitted for the 89.4% T (EPA Registration No.  2749-106).

-------
                                                                                                                    67
                                                       Table A
                                        Generic Data Requirements for Phorate
Data Requirement 	
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation 	
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data I/
Scission
Sec. 158.240 Residue Chemistry

171-4 - Nature of the Residue
          (Metabolism)
          - Plants

171-4 - Nature of the Residue
          (Metabolism)
171-4 - Residue Analytical
          Methods
171-4 - Storage Stability
  PAIRA
PAIRA and
Plant
Metabolites
   Yes
Partially
TGAI and     Partially
Metabolites
TEP and      Partially
Metabolites
00034557, 00092876,
00092877, 00153487
00092877, 00156201
              00033566,
              00035909,
              00052243,
              00092875,
              00092887,
              00092890,
              00092905,
              00092933,
              00092979,
              00160048,
              00161576,
              40197201,
              40197203,
              40586504,
          00035323,
          00044747,
          00092848,
          00092878,
          00092889,
          00092891,
          00092911,
          00092940,
          00092988,
          00161575,
          40000601,
          40197202,
          40263401,
          40586505
              40386302, 40386303,
              40386304, 40386305,
              40386306
NO
               18 Months
Yes4<5.5,77    15 Months
                                          15 Months

-------
                                                                                                                     68
                                                        Table A
                                     Generic Data Requirements for Phorate (cont'd)
Data Reouirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Reouirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data I/
Submission
Sec 158.240 Residue Chemistry

171-4 - Magnitude of the Residue
          in Plants^0-/

        Root and Tuber Vegetables

        - Potatoes (Processed)         TEP


        - Sugar Beets                  TEP
        Leaves of Root and Tuber
          Vegetables

        - Sugar Beet Tops              TEP
        Legume Vegetables

        - Beans                        TEP
           Partially


           Partially
           Partially
              00092887, 40174517,
              40197204, 40197207

              00092856, 00092875,
              00092893, 00153487,
              40174518
              00092856, 00092875,
              00092893, 40174518
                           Y6&14/
                                          24 Months
                                          18 Months
               18 Months
           Partially     40197206, 40174519
        - Soybeans

        Foliage of Legume
          Vegetables
TEP
   Yes
00092930, 40174522
NO
        - Bean Vines and Hay
TEP
Partially
40197206, 40174519
               18 Months

-------
                                                                                                                     69
                                                        Table A
                                     Generic Data Requirements for Phorate (cont'd)
Data Requirement
  Test
Substance
          Does EPA
          Have Data to
          Satisfy This
          Requirement?
Bibliographic
  Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(C)(2)(B)?	
Timeframe
 For Data I/
Submission
Sec 158.240 Residue Chemistry

171-4 - Magnitude of the Residue
          in Plants (cont'd)

        Cereal Grains

        - Corn, Field and Fresh
        - Sorghum
          Processed Sorghum Products

          Wheat



          Processed Wheat Products

          Barley Grain

          Processed Barley Grain
TEP
TEP
TEP

TEP




TEP

TEP

TEP
             Partially
             Partially
             No

             Partially



             No

             No

             No
00092884, 00142921,
00158330, 00160047,
00161821, 40000602,
40174523

00033562, 00034566,
00044614, 00052243,
00092914, 00092938,
00093008, 00094695,
40174520
00033560, 00092990,
00092926, 00014314,
00160048
  YcclQ.18.19.20/
  YCg10.21./
                       Yes23/

                       Ye&24/
18 Months
18 Months
                      24 Months

                      24 Months



                      24 Months

                      18 Months

                      24 Months

-------
                                                                                                                    70
                                                       Table A
                                     Generic Data Requirements for Phorate  (cont'd)
Data Reouirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B>?
Timeframe
For Data I/
Submission
Sec.  158.240 Residue Chemistry

171-4 - Magnitude of the Residue
          in Plants (cont'd)

        Forage, Fodder,  and Straw
          of Cereal Grains

        - Corn Forage and Fodder
TEP
        - Sorghum Forage and Fodder    TEP
        - Wheat Forage, Hay, and       TEP
            Straw
        -Barley Forage, Hay and        TEP
            Straw

        Miscellaneous Commodities

        - Cottonseed                   TEP

        - Peanuts                      TEP
Partially
           Partially
           Partially
           Partially


           Partially
00092884, 00142921,
00158330, 00160047,
40174514

00033562, 00034566,
00044614, 00052243,
00092914, 00092938,
00093008, 00094695,
40174520

00033560, 00092990,
00092926, 00014314,
00160048, 40174516
              00092846, 00092848,
              00092925, 40174521

              00052383, 00092886,
              00161575, 40174515,
              40197209, 40386301,
              40586501
Yes22/



Yes20./




yes31/


Yes3-2/
               18 Months
                                                        18 Months
                                                        18 Months
                                                                   18 Months
                                          18 Months
                                          18 Months

-------
                                            Table A
                         Generic Data Requirements  for Phorate (cont'd)
                                                                                                      71
Test
Does EPA     Must Additional
Have Data to    Data Be Submitted              Timeframe
Satisfy This Bibliographic Under FIFRA Section    For Data I/
                                                                                              Submission
j-»o.i-a. fVG^ui.j.j.v^iR^i.L. 	
Sec. 158.240 Residue Chemistry
- Sugarcane
- Sugarcane Bagasse
- Hops

TEP
TEP
TEP

Partially 00044751, 00161576 Yes10 • 33/
No Yes^4/
No Yes^5-/

18 Months
24 Months
24 Months2/
171-4 - Magnitude of Residue in
   Meat/Mi Ik/Poultry/Eggs
  TGAI or
  Plant
Metabolites
                                      Partially
                           00092978
                                                                       24 Months2/

-------
                                                                                                                   72

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

Sec. 158.240 Residue Chemistry (cont'd)

 I/Due dates refer to the number of months following receipt of the Registration Standard,  unless otherwise
   indicated.
 2/Metabolism studies are  required utilizing poultry.   [These studies were  not required in the  1984  Standard,  but
   were required in a later  review for an amended registration. ]  Animals must be dosed orally for a minimum of  3
   days with [14C]phorate at a level sufficient to make residue  identification and  quantification possible.   Eggs
   must be  collected  twice a day  during the dosing period,  and hens must  be sacrificed  within 24 hours of the
   final dose.   The distribution and identity of residues must be determined  in eggs, liver, kidney,  muscle, and
   fat.  Samples from these studies must also be analyzed using enforcement methods to ascertain that tolerance
   enforcement  methods are capable of adequately recovering all residues  of toxicological concern.
 J2/Swine metabolism data are also required if the metabolism studies with ruminants  and  poultry   reveal  that   the
   metabolism of phorate in these animals differs from that in rats.
 4/An analytical method and appropriate supporting validation data must be submitted which  permit individual
   identification and quantification  of phorate and  its  oxidation products phorate sulfone,  phorate  sulfoxide,
   phorate  oxygen  analog  sulfone, and  phorate oxygen analog sulf oxide in  or on  plant and  animal  commodities.'
   Validation data must  support the stated limits of  detection.
 5/Validation data must  be submitted on American Cyanamid  Methods  M-1637,  M-1642, M-1672, M-1722,  M-1724, M-1706,
   M-1725,  M-1734,  M-1752, and M-1780, and descriptions and validation data  must be submitted for Methods  M-1559 and
   M-1618.   The validation data  must reflect separate  fortifications of  phorate and its sulfoxide, sulfone,  oxygen
   analog,  oxygen analog sulfoxide, and oxygen analog sulfone  for  each commodity tested.
 f/Residues of  phorate and its sulfone, sulfoxide, oxygen  analog sulfone.  and oxygen analog sulfoxide metabolites
   occurring in or on plant commodities, meat, milk, poultry, and eggs  must be subjected to analysis by PAM Vol. I
   method 242.2  (multiresidue  protocol IV).   Residues  of the sulfone,  sulfoxide,  oxygen  analog, and oxygen analog
   sulfoxide metabolites of phorate occurring in on raw agricultural  commodities, meat, milk, poultry,  and eggs  must
   be subjected to analysis by PAM Vol.  I methods 211.1/212.1/252 (multiresidue protocol I).  Residues of  the oxygen
   analog,  oxygen analog sulfone,  and oxygen analog sulfoxide metabolites  of phorate  occurring in or on plant commo-
   dities,  meat, milk,  poultry,  and  eggs must be  subjected to  analysis  by PAM Vol. I method 232.4  (multiresidue
   protocol III).   Residues of the oxygen analog sulfoxide and oxygen  analog  sulfone metabolites of phorate occurring
   in or on plant commodities, meat, milk, poultry, or  eggs must  be subjected  to analysis by PAM Vol.  I  method 232.3
   (multiresidue protocol  II).   Multiresidue protocols are published in PAM Vol.   I,  Appendix  II and are available
   from the National Technical Information Service under Order No.  PB  203734/AS.
 2/The nature of the residues in poultry is not adequately understood.  If the  requested poultry metabolism studies
   reveal the presence of  additional  residues  of toxicological concern in commodities, additional validated  methods
   for data collection and tolerance enforcement may be  required.

-------
                                                                                                                   73

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

Sec. 158.240 Residue Chemistry (cont'd)

 3/A11 residue data required in this Standard must be accompanied by information specifying the storage intervals and
   conditions for  samples  analyzed.   Data must also be submitted depicting the storage  stability of the residues of
   concern under the same  conditions  and  intervals  specified.   In laboratory tests using fortified samples, the pure
   active ingredient and pure metabolites (if necessary) must be used.   However, if field weathered samples are used,
   the test substance must be a typical end-use product.
 2/Data are required depicting the intervals and conditions  of the storage of samples  used to collect residue data
   for snap beans, (MRID Nos.  40174519  and 40197206), corn  grain (MRID No.  00158330),  sweet  corn (MRID 00160047),
   corn  forage   (MRID  Nos. 00160047  and 00158330),  processed  commodities  of corn  grain  (MRID Nos.  40000602  and
   40174523),  wheat grain,  forage,  and straw (MRID  No.  00160048),  cottonseed  and cottonseed  forage  (MRID  No.
   40174521),  peanut nutmeats and hulls  (MRID  No.  00161575),  cottonseed and cottonseed  forage (MRID No. 40174521),
   peanut nutmeats and hulls (MRID No. 00161575), processed commodities of peanuts (MRID No. 00161575), and sugarcane
   (MRID NO. 00161576).
ipyin  all  cases where additional  residue  data are  required  if  detectable  (>  0.05 ppm)  residues  of  phorate  are
   observed, then  analyses of  those commodities using validated methodology which determines phorate  and each of its
   metabolites separately are required.
li/Data are required depicting phorate residues  of concern in  chips,  granules,  and wet and dry peel from potatoes
   bearing measurable weathered residues.   If residues concentrate in peel or granules, appropriate feed/food additive
   tolerances must be proposed.
12/Data are required depicting the phorate residues  of concern in french fried potatoes,  baked whole potatoes with
   peel, baked  potato  flesh,  baked potato  peel,  boiled whole  potatoes with  peel, and boiled  potato flesh prepared
   from potatoes bearing measurable weathered  residues.  All  major degradation products accounted for and identified
   in the cooked samples.
13,/Data are required depicting phorate,  phorate  sulfoxide, phorate sulfone,  phorate oxygen analog,  phorate oxygen
   analog  sulf oxide,  and  phorate oxygen analog  sulfone,   each quantitated separately,  in or on sugar  beet roots
   harvested  30 days  following postemergence  soil application of  a  representative G  formulation at  1.5  Ib ai/A
   followed by  foliar  application of  a G  formulation at 1.5 Ib ai/A.  The use of aerial and ground equipment must be
   represented  in separate  tests.   Alternatively,  data  depicting  these residues  in  or on the  samples  bearing
   detectable combined residues reported in MRID No. 40174518 (Report No. C-2919)  may satisfy these requirements.   In
   addition, the registrants  must amend all pertinent product labels to  specify a number of foliar applications per
   season or  a  maximum seasonal application rate,  which must be consistent with  that  reflected in the residue data
   used to support the tolerance.
14/Data are required depicting phorate,  phorate  sulfoxide, phorate sulfone,  phorate oxygen analog,  phorate oxygen
   analog  sulfoxide,   and  phorate 'oxygen analog sulfone,  each quantitated  separately,  in or  on sugar  beet tops
   harvested  30 days  following postemergence  soil application of  a  representative G  formulation at  1.5  Ib ai/A
   followed by foliar application of a G formulation at 1.5 Ib/A.  The use of aerial and ground equipment must be

-------
                                                                                                                   74

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

Sec. 158.240 Residue Chemistry  (cont'd)

  represented in separate tests.  Alternatively, data depicting these residues in or on the samples bearing
  detectable combined residues  reported  in MRID No.  40174518 (Report No.  C-2919) may satisfy these requirements.
  The registrants must amend all pertinent product labels to specify a number of foliar applications per season
  or a maximum seasonal application rate, which must be consistent with that reflected in the residue data used
  to support the tolerance.
15/Data are  required depicting the combined residues of  phorate in or on dry beans  harvested following at-planting
   soil application  of  a representative  G formulation at 2.1  Ib ai/A.  Although adequate data  on succulent beans
   have been submitted,  data on  dry beans were  submitted only from MI  which  does  not adequately  represent the
   Central U.S.  and no  data from the western states  were  submitted.   Moreover, data  from only  two samples were
   reported.   Agency interpretation of  existing  Guidelines regarding the  volume of  data required  and geographic
   representation  of test  states  has become  stricter.   Therefore,  the data  on dry beans  do not  fulfill Agency
   requirements.
16/Data are  required depicting phorate,  phorate  sulfoxide,  phorate  sulfone,  phorate oxygen analog,  phorate oxygen
   analog sulf oxide, and phorate oxygen analog sulfone, each quant itated separately, in or on bean vines harvested 60
   days following band soil application made at planting of a representative G formulation at 2.1 Ib ai/A.
17/Since hay is a raw agricultural commodity of beans, a tolerance must be proposed for bean hay.  The available data
   indicate that a tolerance of 0.5 ppm would be appropriate.  Alternatively, the registrant may propose a restriction
   of the feeding of bean hay to livestock
IS/Data are  required depicting the  combined residues of phorate in  or on  field corn harvested 90  days following a
   foliar application, using  aerial  equipment,  of  a G formulation at 3 Ib ai/A.   Soils must be previously treated at
   planting with a G formulation at  1.3  Ib ai/A;  fields must be irrigated  as soon as  possible following the foliar
   treatment.   Alternatively,  the  registrant may elect to cancel this use permitted under EPA SLN Nos. WA840040 and
   WA8400386.
19/When an appropriate tolerance for residues in or on corn grain is determined,  a food/feed additive tolerance must
   be established  for flour at 2X,  meal at  3X and refined  oil  at  6X (toxicological considerations permitting).
2Q./A processing study depicting the combined residues of phorate and its cholinesterase-inhibiting metabolites in
   wet-milled corn starch, crude oil and refined oil, and in corn grain dust from the processing of field com bearing
   measurable,  weathered residues is  required.    If  residues concentrate in any product, an  appropriate food/feed
   additive tolerance must be proposed.
21/Data are  required depicting the combined residues of  phorate and its  cholinesterase-inhibiting metabolites in or
   on sorghum grain  harvested 28 days following the last of two applications (soil application at planting at 1.3 Ib
   ai/A followed by foliar application  at 1  Ib ai/A)  using a  G formulation.   Aerial and ground equipment must be
   represented  in separate tests.  '

-------
                                                                                                                   75

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

Sec. 158.240 Residue Chemistry (cont'd)

22/A processing study  is  required  depicting the  combined  residues  of phorate and  its cholinest erase-inhibit ing
   metabolites in milled products (flour and starch) and grain dust from the processing of sorghum bearing measurable,
   weathered residues.   If residues concentrate  in any product,  appropriate food/feed additive  tolerances must be
   proposed.
23/A processing study is required depicting combined residues of phorate and its cholinesterase-inhibiting metabolites
   in milled products (bran, flour, middling,  and shorts) and  in grain dust  from the processing  of wheat bearing
   measurable, weathered residues.  If residues concentrate in any product, appropriate food/feed additive tolerances
   must be proposed.
24/Residue data depicting phorate residues of concern on barley grain treated with 20G formulation as a postemergent
   broadcast spray at a rate of 1.0 Ib a.i./A are required.  Grain must be harvested within 60 days of treatmait.  The
   data must reflect the maximum number of treatments desired (this must be specified on the label).  Studies
   reflecting one band application of 1.0 Ib a.i./A (0.25 oz a.i./lOOO ft of row at an 8 inch row spacing) at planting
   using the 20G formulation are also required.  These experiments should be carried out in the States of ID and WY
   which are where these SLNs are registered.
25/A processing study is required.  The processing study for wheat will be translated to barley.  Alternatively, the
   registrant(s) may wish to cancel the SLNs ID880003 and WY880001.
26/Since fodder is a raw agricultural commodity of field corn, a tolerance must be proposed for field com fodder.
   The data reviewed previously indicated that a tolerance of 0.5 ppm would be appropriate.
22/Data are required  depicting  the combined residues of phorate  and its cholinesterase-inhibiting metabolites in or
   on sorghum fodder harvested 28 days  after the  last of the following treatments:  soil banded at-plant application
   of a G formulation using ground equipment at 1.3 Ib ai/A followed by one foliar application at 1 Ib ai/A by aerial
   equipment.
23/Tne registrant  must  propose  appropriate tolerances  for the  combined residues of phorate  and its cholinesterase-
   inhibiting metabolites in or on sorghum forage and hay based on appropriate supporting  residue data.  In addition,
   an appropriate pregrazing interval must be established for forage.
23/Since hay is a raw agricultural commodity of wheat, a tolerance must be proposed for wheat hay.  The available
   data indicate  that a  tolerance  of  1.5  ppm would  be appropriate.    Alternatively,  the registrant  may propose a
   restriction of the feeding of wheat hay to livestock.
3_0_/Residue data depicting phorate residues of concern on barley forage, hay and straw treated with the 20G
   formulation as a postemergent broadcast spray at a rate of 1.0 Ib a.i./A are required.  The data must reflect the
   maximum number of treatments desired (this must be specified on the label).  Data for forage only is not needed if
   the present label restriction prohibiting grazing of treated barley is maintained, for  the postemergent
   application.  Studies on barley forage, hay and straw reflecting one band application of 1.0 Ib a.i./A at planting
   using the 20G formulation are  also required.   All experiments must be conducted in ID  and WY which is where these
   SLNs are registered.   Alternatively,  the registrant(s) may wish to cancel SLNs ID880003 and WY880001.

-------
                                                                                                                   76

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

Sec. 158.240 Residue Chemistry (cont'd)

21/Data are required depicting residues of phorate, phorate sulfoxide, phorate sulfone, phorate oxygen analog,
   phorate oxygen analog  sulf oxide,  and phorate  oxygen analog  sulfone in  or on cotton forage harvested  60  days
   following the  last  of two applications (banded in-furrow soil application at planting  at  1.6  Ib ai/A followed by
   sidedness soil application at 2.2 Ib ai/A) using a G formulation.  Also, since cotton forage is a raw agricultural
   commodity of cotton,  a tolerance must be proposed  accompanied by appropriate supporting  residue  data.   Based on
   the available  residue data, a tolerance  of  0.2  ppn would be appropriate.   Alternatively, a feeding restriction on
   cotton forage may be proposed.
.22 The registrant must propose a tolerance for the combined residues of phorate and its cholinesterase-inhibiting
   metabolites in or on peanut hulls,   the  available data indicate that a tolerance of 0.3 ppn would be appropriate.
   In addition,  the registrant  must propose  a  PHI.    The  available data indicate that  a PHI  of 90 days  would be
   suitable.
13/Since forage is a raw agricultural commodity of sugarcane, a tolerance and a pregrazing interval must be
   established and  appropriate  residue data submitted for  this  commodity.   The residue  data must include adequate
   samples  from  various posttreatment  harvest intervals.   Alternatively, grazing and feeding  restrictions  may be
   imposed.
14/Data are required depicting the potential for concentration of residues in bagasse processed from sugarcane
   bearing measurable  weathered residues  (The Agency had  determined that a processing study on  sugarcane  was not
   needed, since  it was  concluded that residues of phorate are destroyed by the lime  and  carbonation process and do
   not concentrate  in  the processed fractions.  However, the Agency now believes  that bagasse  fraction will not be
   subjected to the lime  and carbonation  process,  and therefore residues of phorate may concentrate in the bagasse.
   If the  data indicate a potential for concentration of  residues,  an appropriate food  additive  tolerance must be
   proposed.
35/Residue data are needed for dried and spent hops processed from fresh hops.  Residue data depicting phorate
   residues of concern on  hops treated with the 10G and 20G formulations at a rate of 2 to 3 Ib a.i./A as a band over
   the row after  crowns have begun to grow are required.  Hops should be harvested within 42 days of treatment.
   Analyses  should  be performed on green,  dried  and spent  (extracted) hops.   Tests  should be carried out  in the
States
   of WA and OR which is where the SLN's are registered.  Alternatively, the registrant(s)  may
   chose to cancel the 24(c) uses in the States of Washington (WA840044 and WA840035)  and Oregon  (OR880002).
3£/Data are required depicting the combined phorate residues of concern in pasteurized milk; beef fat baked, boiled,
   broiled, and  fried;  and lean beef baked, boiled, broiled, and fried.   Samples  fortified with phorate and each of
   its cholinesterase-inhibiting metabolites must  be subjected to each of the  cooking processes specified above and
   all major degradation products accounted for and identified.
22/Data. are required depicting the combined phorate residues of concern in whole eggs, egg yolks, and egg whites,
   each baked, boiled,  and fried; chicken  flesh plus  skin  without bone, and chicken  flesh alone each baked, fried,
   and  boiled.   Samples   fortified  with phorate  and each of  its  cholinesterase-inhibiting  metabolites must  be
   subjected to  each of the cooking  processes specified  above and all major degradation  products  accounted for and
         -P-i or*

-------
                                                                                                                    77
                                                       Table A
                                        Generic Data Requirements for Phorate
Data Requirement
    Test
  Substance
          Does EPA
          Have Data to
  Use     Satisfy This
Patterns  Requirement?
Bibliographic
  Citation
Must Additional
Data Be Submitted    Timeframe
Under FIFRA Section   For Data I/
3(c)(2)(B)?	Submission-
Sec .  158 . 290 Environmental Fate

Degradation Studies - Lab

161-1 - Hydrolysis

Photodeoradation

161-2 - In Water

161-3 - On Soil

161-4 - In Air

         m Studies - Lab
TGAI or PAIRA   A,B




TGAI or PAIRA   A,B

TGAI or PAIRA   A,B

TGAI or PAIRA   A
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TGAI or PAIRA   A,B
TGAI Or PAIRA
             No



             NO

             No

          Partially



          Partially



             No
162-3 - Anaerobic Aquatic   TGAI or PAIRA   N/A        No

162-4 - Aerobic Aquatic     TGAI or PAIRA   N/A        No
   40386307
                                           40077301
    Yes2-/



    Yes3-/

    Yes4-/

  Reserved^/



    Yes6-/



    Yes2/



    No

    No
                                       9 Months



                                       9 Months

                                       9 Months
                                       27 Months
                              (12 Months - Progress
                                       Report)

                                       27 Months
                              (12 Months - Progress
                                       Report)

-------
                                                                                                                    78
                                                       Table A
                                        Generic Data Requirements for Phorate  (cont'd)
Data Requirement
                      Does EPA
                      Have Data to
  Test        Use     Satisfy This
Substance   Patterns  Requirement?
                                       Must Additional
                                       Data Be Submitted   Timeframe
                        Bibliographic  Under FIFRA Section  For Data  I/
                        	Citation     3(c)(2HB)?	Submission
Sec. 158.290 Environmental Fate (cont'd)

Mobility Studies

163-1 - Leaching and        TGAI or PAIRA   A,B
          Adsorption/
          Desorption
164-2 - Aquatic (Sediment)
   TEP
N/A
                         Yes
163-2 - Volatility
163-3 - Volatility
Dissipation Studies
164-1 - Soil
(Lab)
(Field)
- Field

TEP
TEP

TEP
A
A,B

A
NO
No

Parti;
No
                           40174524
                           40174525
                                                                       40432001,
                                                                       40586506
                                No
                                                                                                          12 Months
                                                                                       Reserved^/
                                                         Yesl°-/
                                                              27 Months
                                                     (Acceptable Protocol-
                                                     for Long Island Study
                                                     90 Days)
                                                     (12 Months - Progress
                                                      Report)
No
164-3 - Forestry

164-4 - Combination and
          Tank Mixes
   TEP

   TEP
N/A

N/A
NO

NO
No

No

-------
                                                                                                                    79
                                                       Table A
                                        Generic Data Requirements for Phorate (cont'd)
Data Requirement
                        Does EPA
                        Have Data to
    Test        Use     Satisfy This
  Substance   Patterns  Requirement?
                                       Must Additional
                                       Data Be Submitted    Tiuneframe
                        Bibliographic  Under FIFRA Section   For Data I/
                          Citation     3(c)(2)(B)?	Submission
Sec. 158.290 Environmental Fate (cont'd)

Dissipation Studies - Field  (cont'd)
164-5 - Soil, Long-Term

Accumulation Studies

165-1 - Rotational Crops
          (Confined)

165-2 - Rotational Crops
          (Field)

165-3 - Irrigated Crops

165-4 - In Fish
     TEP
     PAIRA
     TEP
     TEP
Sec., 158.390 Reentry Protection

132-1 - Foliar Dissipation       TEP
132-1 - Soil Dissipation
     TEP
A
N/A
TGAI or PAIRA   A,B
                A,B
NO



Partially


No


No

Partially





No



No
Reserved^/
                        40386311
                        40386310
                        40386311
Reserved^/


No

Yes15./
                   39 Months^3-/
12 Months
                                                             18 Months
                                                  (Acceptable Protocol
                                                    90 Days)

                                                             18 Months
                                                  (Acceptable Protocol
                                                    90 Days)

-------
                                                                                                                    80
                                                       Table A
                                        Generic Data Requirements for Phorate (cont'd)
Data Requirement
  Test
Substance
          Does EPA
          Have Data to
  Use     Satisfy This
Patterns  Requirement?
               Most Additional
               Data Be Submitted    Timeframe
Bibliographic  Under FIFRA Section   For Data I/
  Citation	3(c) (2) (B)?	Submission
Sec. 158.390AR
 Reentry Protection (cont'd)
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
TEP
TEP
A,B
A,B
No No^/
No Noi^/
 I/Due dates refer to number of months following receipt of this Registration Standard, unless otherwise indicated.
 2/The study does not fulfill this data requirement because it was not specified that the test solutions were sterile.
   The material balances following TLC analysis were  incomplete;  degradates were inadequately characterized and were
   not quantified; and the description of the analytical methodology was incomplete.   A new study is required.
 J/The study does not  fulfill  the requirement because it was not specified if the test solutions were sterile.   Also,
   the material balances following TLC analysis were  incomplete,  degradates were inadequately characterized and were
   not quantified, the test solutions were not buffered, the description of the analytical methodology was incomplete,
   and the spectral energy distribution of the artificial light and its comparison to natural sunlight were
   inadequately described.   A new study is required.
 4/The study does not fulfill the requirement because up to 48% of the applied radioactivity remained unaccounted for.
   Also, the treatment rate was not specified,  no precautions were taken to minimize the loss of the test substance by
   volatilization, the description of the  analytical  methodology  was incomplete, the photolysis chamber was not
   adequately described, and the spectral energy distribution of the artificial  light and  its  comparison to natural
   sunlight were inadequately presented.   A new study is required.
 5/The study submitted only partially fulfills the data requirement because in the photolysis in air sampling
   bags study, the test  substance was  incompletely characterized, the temperature was 52 to 60 °C rather than 30 °C,
   the intensity of the  natural sunlight was not  reported, and the material balances were incomplete; and in the
   photolysis in a large volume atmosphere chamber study,  the temperature was 51 to 59 °C rather than 30 °C, the
   intensity of the natural sunlight was not reported, degradates were not characterized, and material balances were
   not reported.  However, the data requirement is now reserved pending receipt and evaluation of an acceptable
   laboratory volatility study.

-------
                                                                                                                    81

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

Sec.s 158.290. 158.390. and 158.440 Environmental Fate (cont'd)

 Vine study does not  fulfill  the  requirement because the purity of the test substance was not specified.   Also,  the
   soil_samples and soil extracts were stored prior to analysis, but storage stability data were not provided.
   Within 90 days, the registrant must inform the Agency of the option chosen (1)  to provide the missing information
   to upgrade the study or, (2) to submit a new study.  If the registrant chooses to submit a new study,
   the data are due 27 months from receipt of the Standard.  An annual report is due 12 months from receipt of the
   Standard, and annual reports are due  thereafter.   If the registrant chooses to provide the missing information,
   the data are due 6 months from receipt of the Standard.
I/The study does not fulfill the requirement because  material  balances for samples taken at  30 and  39  days after
   anaerobic conditions were established were incomplete, and the experimental design was inadequate to accurately
   assess the degradation of phorate under anaerobic conditions.  In addition, the purity of the test substance was
   not specified and soil samples and soil extracts were stored prior to analysis, but storage stability data were not
   provided.  A new study  is required.   The data are also required because of a concern for the potential exposure  of
   waterfowl to phorate residues in wetlands.
 3/The study does not  fulfill  the  requirement because material balances were incomplete, soil from the volatilization
   samples was not sampled immediately posttreatment,  and the relative humidity was not reported.   A new study is
   required.
 3/This data requirement is now reserved pending the results of the laboratory volatility study.
10 A field terrestrial dissipation study is  required  to be conducted in accordance with the Subdivision N Guidelines,
   if the  registrant  cannot provide the missing  information (reporting of field maintainance  practices  at Danville,
   Iowa,  specify time soil samples were  frozen prior  to analysis,  provide freezer storage stability data, and clarify
   why the concentration of phorate in the 0-3"  depth was 10.2 ppm immediately posttreatment, rather than the expected
   1 ppm based on the reported application rate of 11 Ib ai/A).  Within 90 days, the registrant must inform the Agency
   of the option  chosen:  (1)  to provide the missing  information to upgrade the study or,  (2)  to  submit  a new study.
   If the  registrant  chooses to submit  a new study,  the data are  due 27 months  from  receipt of  the Standard.   An
   annual report  is  due 12 months from receipt of the Standard.    If the registrant chooses to  provide  the missing
   information, the data are due 6 months from receipt of the Standard.

   In addition, a terrestrial field dissipation study must be conducted on sandy loam soil in Long Island, NY.   Soil
   core samples must be collected down to 3 feet.   All samples must be analyzed for phorate and the phorate sulfoxide
   and sulf one degradates.   The minimum limits of detection (MDL)  for detecting phorate,  phorate sulf oxide, and
   sulf one in  soil  should approach 10 ppb,  if  feasible.  The  current method of analysis  for  phorate, the sulfoxide
   and sulfone degradates uses an  MDL that  is too high.   A protocol is required.   The registrant must discuss the MDL
   with the Agency prior to initiating the study.   Following the submission and evaluation of such a study, the Agency
   will determine the need for ground water monitoring studies.

-------
                                                                                                                    82

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

Sec.s 158.290, 158.390, and 158.440 Environmental Fate (cont'd)

ii/Data will be required if the results from the aerobic soil metabolism (162-1) and/or soil field dissipation studies
   (164-1) show that 50% phorate remains in the soil prior to the recommended subsequent application.
12/Ihe study only partially fulfills the requirement because not all of the residues of the test substances (phorate,
   phorate sulfoxide,  and phorate  sulfone) were  completely characterized and  except for one  sampling interval,  the
   residues  in the  soil  were not analyzed at  the time  of harvest  of  the rotational  crop.    Also,  the study  was
   conducted with 1.5 Ib ai/A instead of the maximum label rate. It should be noted that if this study is made
   acceptable  upon  evaluation of additional  data  listed in the  data evaluation record,  it  will only  support
   application rates on pesticide labeling of up to 1.5 Ib ai/A.
13/Within 90 days, the registrant must inform the Agency of the option chosen: (1)  to provide the missing information
   to upgrade the study or, (2) to submit a new study.   If the registrant  chooses to submit a new study,
   the data are due 39 months from receipt of the Standard.  An annual report is due 12 months from receipt of the
   Standard, and interim reports are due annually thereafter.   If the registrant chooses to provide the missing
   information, the data are due 6 months from receipt of the Standard.
14/Nb data were submitted by the registrant.   However,  this requirement is now reserved, depending on the results of
   the confined rotational crop study.
15,/Ihe study only partially fulfills  the  requirement because the test substance was incompletely characterized, the
   fish may only have been exposed to the parent compound,,  and degradate characterization results from the fish tissue
   samples were reported in terms of percent recovered radioactivity from  the TLC plates rather than percent of total
   (initial) sample radioactivity.  A new study is required.
1£/A foliar dislodgable study is required for corn.  Soil dissipation studies are required for peanuts and potatoes
   (protocols have already been reviewed for these crops).   No data are required for foliar dislodgable residues for
   peanuts and potatoes.  For other end-uses,  the registrant is required to propose an acceptable reentry interval
   based upon data (1) on dissipation of residues (decline curve), on human exposure to those residues,  and on
   toxicity of the residue, or (2) on the determination of that time beyond which there are no detectable
   dislodgeable or inhalable residues remaining in the worker environment.
17/These data may be submitted at the registrant's option.

-------
                                                                            83
               Table A
Generic Data Requirements for Phorate
Data
Sec.
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Requirement
158.340 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity
Test
Substance

TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns

A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA
Have Data to
Satisfy This
Requirement?

Yes
Yes
Yes
No
No
No
Yes
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data I/
Citation 3(c)(2)(B)? Submission

00126343 NO
00126343 NO
00126343 No
NO2-/
No2-/
NO2-/
00152640 NO
Subchronic Testing
82-1


- 90-Day Feeding -
Rodent
Non-rodent

TGAI
TGAI

A,B
A,B

Yes
NO

00056714 NO3-/
No4/

-------
                                                                            84
               Table A
Generic Data Requirements for Phorate (cont'd)
Data Requirement
Sec. 158.340 Toxicology
Subchronic Testincr (cont'd)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
Chronic Testincr
83-1 - Chronic Testing
- Rodent

- Nonrodent
83-2 - Oncogenicity
- Rat
- Mouse
Test
Substance

TGAI
TGAI
TGAI
TGAI

TGAI

TGAI

TGAI
TGAI
Use
Patterns

A,B
A,B
N/A
A,B

A,B

A,B

A,B
A,B
Does EPA
Have Data to
Satisfy This
Reouirement?

No
No
No
No

Partially

Yes

Yes
Partially
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data I/
Citation 3(cH2HB)? Submission

No2/
No5-/
Nc£/
No?/

00122774, NO8-/
00122773
40174527 NO

00122774 NO
00122774 Reserved9-/^/

-------
                                                                                                                    85
                                                       Table A
                                        Generic Data Requirements for Phorate (cont'd)
Data Requirement
                      Does EPA
                      Have Data to
  Test        Use     Satisfy This
Substance   Patterns  Requirement?
                                       Must Additional
                                       Data Be Submitted    Timef rame
                        Bibliographic  Under FIFRA Section   For Data I/
                          Citation     3(c)(2)(B)?	Submission
Sec. 158.340 Toxicology

Chronic Testing  (cont'd)

83-3 - Teratogenicity
       - Rat

       - Rabbit

83-4 - Reproduction

Mutagenicitv Testing

84-2 - Gene Mutation
84-4 - Other Mechanisms of
         Mutagenicity
TGAI
TGAI
TGAI
A,B
A,B
A,B
Yes
Yes
Yes
00122775
40174528
00092853
NO
NO
NO
   TGAI
84-2 - Chromosome Aberration     TGAI
   TGAI
Special Testing

85-1 - General Metabolism   PAI or PAIRA
A,B
              A,B
A,B
              A,B
Yes
           Yes
Yes
           Partially
00132582,
00151633

00132582,
00155597

00132582
                40291601
                                                                                       NO
                                NO
No
                Yesi°-/           24 Months
                        (Acceptable Protocol -
                                90 Days)
                        (12 Months - Progress
                            Report)

-------
                                                                                                                    86
                                           Table A
                                        Generic Data Requirements for Phorate (cont'd)
Data Reouirement
  Test
Substance
Sec. 158.340 Toxicology

Special Testing (cont'd)

       Eye Effects

       a.  Acute Oral (Rat) Study

       b.  Subchronic Oral (Rat) Study

       c.  6-Month Oral Study  (Dog,
             Rabbit, or Monkey)

       Oxidation Products

       Product Integrity Study

       Short-term Mouse Study
          Does EPA
          Have Data to
  Use     Satisfy This
Patterns  Requirement?
A,B
A,B
A,B
A,B
A,B
A,B
NO
NO
No
NO
Yes
NO
               Must Additional
               Data Be Submitted    Timeframe
Bibliographic  Under FIFRA Section   For Data I/
  Citation     3(c)(2)(B)?	Submission
                                                         Reserved^/
                                           40586507
                                                                             9  Months

                                                                            15  Months

                                                                            18  Months
                                                                            12 Months
                                                                        (90 Days -
                                                                   Acceptable  Protocol)

-------
                                                                                                                    o/
                                                       Table A
                                        Generic Data Requirements for Phorate (cont'd)
Sec. 158.340 Toxicology (cont'd)
 I/Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
   indicated.
 2/The data are not required, since the highly toxic nature of phorate prohibits the administration of dosage levels
   that could possibly induce an adverse effect other than the possible inhibition of cholinesterase activity.   Also,
 ,  the subchronic dermal study can be expected to show no effect other than cholinesterase inhibition and subsequent
   lethality secondary to this inhibition.
 .2/Tnis study was considered deficient because histopathology was  performed on 3 (not 10) rats/sex in the control and
   test  groups.  However,  the NOEL  and  LEL,  which were based on  the  most  sensitive endpoint  (inhibition  of
   cholinesterase activity), were  acceptable  as  well as consistent with those established in a  non-rodent study.   A
   new study is not required.
 4/This study is not required because an acceptable chronic study in a non-rodent species is available.
 jj/This study is not required because the registered use patterns of phorate should not result in repeated dermal
   contact.
 £/This study is not required  because the registered use patterns of phorate should not result in repeated inhalation
   exposure.
 I/This study is not required because there was no indication of delayed neurotoxicity in the acute study in hens.
 ^/Although the NOEL, which was based on inhibited cholinesterase activity, was not achieved in the submitted chronic
   feeding study in rats, a NOEL, based on the same endpoint, was achieved in a subchronic study in rats.
 2/The requirement for a new mouse oncogenicity study is reserved pending Agency review and evaluation of the required
   short-term mouse study.
10./Submitted data were from a study  that was performed with male rats  only.   A comparable study  in female  rats is
   required.  The administration of a single dosage  level in the male study  is acceptable since the high acute oral
   toxicity  of  this compound  does not  allow much flexibility in  dosage selection.   A  lower  dose level might be
   detrimental  to  quantitative work with minor metabolites  while a higher dose  might cause mortalities.   However,
   since  females  are generally more  sensitive  to adverse effects  from phorate than males,  it may  be necessary to
   administer a lower  dosage  level to  females than that  (0.8 mg/taj) given to males.   A  protocol  must be submitted
   within 90 days of receipt of this Standard.
il/Since data from various  studies have  demonstrated adverse ocular effects from other organophosphates, data are now
   being  required to investigate  the potential  ocular toxicity of  phorate special acute  and  subchronic studies are
   required confirm or deny the potential for phorate to cause adverse eye effects as follows:

-------
                                                       Table A
                                        Generic Data Requirements for Phorate (cont'd)
Sec. 158.340 Toxicology (cont'd)
   a.  Acute oral (rat) study.  Acute sublethal doses must be administered. Tests are to be performed pretest, at 4
        days and repeated at  intervals until  full  recovery.   Observations must include (l) cholinesterase activity
        (blood) and  (2) retinal electrical activity (electroretinography).
   b.  Subchronic oral  (rat)  study.   Test must include 3 orally treated and 1 control group, 10 rats/sex/group.
       Observations must be made pretest,  and at intervals for at least 90 days; doses must on the results of the
       acute study.  Observations must also include  (1)  cholinesterase activity (blood, brain at termination); (2)
       retinal electrical activity  (electroretinography);  (3)  ophthalmoscopic  observations;  (4)  fundus
       observations/photographs; (5) clinical observations of  potential  cholinergic  signs; (6)  body weights and; (7)
       histopathology of the eye, light and EM, including intra and extraocular muscle, optic nerve and retina.
   c.  Six month oral  (dog  or rabbit or monkey)  study.  Test must include 3 orally treated and one control group, 5
       animals/sex/group.  Observations must be made pretest and at intervals for at least 6 months.  Observations
       must include (1) cholinesterase activity (PEG, plasma; at termination brain, oculomotor muscle, retina); (2)
       retinal electrical activity (electroretinography); (3) corneal sensitivity; (4) slit lamp biomicroscopic
       examinations; (5) corneal thickness; (6) corneal curvature; (7) ophthalmoscopic/fundus
       observations/photographs; (8) intraocular pressure; (9) refractivity of cornea and lens; (10) clinical
       observations of potential cholinergic signs; and (11)  body weights and histopathology of the eye; light and EM,
       including intra- and extraocular muscle, optic nerve and retina.
12/Residue data submitted in response to the 1984 Standard have shown that oxidation products of phorate in plants are
   so low that they are of little concern.  However,  the data base for residue chemistry is not complete.   Additional
   toxicity studies with the oxidative metabolites  may be required, if significant residue levels of the oxidative
   metabolites are detected in the required residue studies.
13/Based on the product integrity study submitted in response to the 1984 Standard under this data requirement, the
   Agency concluded that the 20G formulation does not pose an inhalation hazard under normal use conditions, and that
   therefore an inhalation study using a 20G formulation is not required.
14/Based on a reevaluation of the mouse oncogenicity study, the evidence does not show that an MID was attained in
   this study.  The Agency is requiring that a short-term study be performed to determine if any of the dietary levels
   administered in the mouse oncogenicity study will inhibit acetylcholinesterase activity (plasma, brain and/or red
   cell).   The registrant must discuss details of the test protocol prior to initiating the study.  The mouse
   oncogenicity study may be upgraded depending on the results of this study.

-------
                                                                                                                  89
                                                  Table A
                                       Generic Data Requirements for Phorate
Data :
Sec.
Avian
71-1
71-2


71-3
71-4


158.490 - Wildlife and ;
, and Mammalian Testing
- Avian Single Dose
Oral 11)50
- Avian Dietary LC50
- Upland Game Bird
- Waterfowl
- Wild Mammal Toxic ity
- Avian Reproduction
- Upland Game Bird
Test
Substance Pattern
Aquatic Organisms
TGAI A,B

TGAI A,B
TGAI A,B
TGAI A,B

TGAI A,B
Does EPA Have
Data to Satisfy
Use This Require-
ment?

Yes

Yes
Yes
Yes

No
Bibliographic
Citation

001600012./,
000205602-/,
050083632-/

00022923
00022923
00162745


Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data I/
3(c)(2)(B)? Submission

No

No
No
No

Yes3-/ 24 Months
     - Waterfowl               TGAI

71-5 - Simulated Field         TEP
       Testing for Birds
       and Mammals
A,B

A,B
Yes

Yes
00158334

00074623,00084503
00074624,00074625,
00074626,00074627,
00087553,00092832,
00092834,00052237,
No
                                                                                                       (12 Months -
                                                                                                   Progress Report)

-------
                                                                                  90
                   Table A
Generic Data Requirements for Phorate (cont'd)
Data Requirement
Sec. 158.490 - Wildlife and
Avian and Mammalian Testing
71-5 - Actual Field Testing
for Birds and
Mammals
Aquatic Organism Testing
72-1 - Freshwater Fish LC50
- Warmwater


- Coldwater



72-2 - Freshwater
Invertebrate 1X50



Test Use
Substance Pattern
Aquatic Organisms
(cont'd)
TEP A,B




TGAI A,B
TEP A,B

TGAI A,B
TEP A,B


TGAI A,B


TEP A,B

Does EPA Have Must Additional
Data to Satisfy Data Be Submitted Timeframe
This Require- Bibliographic Under FIFRA Section For Data I/
ment? Citation 3(c)(2)(B)? Submission


Yes 40165901 NO




Yes 00003503 No
Yes 00090490 , Nc4/
00161822
Yes 00003503 NO
Yes 00090491 , Nb4/
00161823,
00161824
Yes 00003503 , No2-/
00085219,
00097842
Yes 00161825 , No5-/
00161826

-------
                                                                                                                   91
                                                     Table A
                                  Generic Data Requirements for Phorate (cont'd)
Data
Sec.
Requi rement
Test
Substance
Use
Pattern
158.490 - Wildlife and Aouatic Oraanisms
TVguatic Organism
72-3 - Estuarine
Organisms
- Fish
72-3 - Estuarine
Organisms
- Shrimp
- Oyster
Testing (cont'd)
and Marine
LC50
TGAI
TEP
and Marine
LC50 (cont'd)
TGAI
TEP
TGAI
TEP
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA Have
Data to Satisfy
This Require-
ment?
Yes
Yes
Yes
No
Yes
Yes
Bibliographic
Citation
00066341
40001802
00066341
00066341
40004201
Must Additional
Data Be Submitted Timef rame
Under FIFRA Section For Data I/
3(c)(2)(B)? Submission
No
No5/
No
Yes^L-5-/ 12 Months
No
No5/
72-4 - Fish Early Life Stage
       and Invertebrate
       Life Cycle
     - Freshwater  -
       - Fish
       - Invertebrates
TGAI
TGAI
A,B
A,B
   NO
Partially
00158336
15 Months
15 Months

-------
                                                                                                                    92
                                                                   Table A
                                           Generic Data Requirements for Phorate  (cont'd)
Data Requirement
     Test     Use
Substance   Pattern
 Does EPA Have                Must Additional
 Data to Satisfy              Data Be Submitted    Timeframe
 This Require- Bibliographic  Under FIFRA Section   For Data I/
 ment?	Citation     3(c)(2HB)?	Submission
Sec. 158.490 - Wildlife and Aouatj.c Organisms

Aquatic Organism Testing  (cont'd)

     - Estuarine
       - Fish                  TGAI

       - Invertebrates         TGAI

72-5 - Fish Life Cycle         TGAI

72-6 - Aquatic Organisms       TGAI
         Accumulation
         (Fish)

72-7 - Simulated or Actual     TEP
         Field Testing
         Aquatic Organisms
              A,B

              A,B

              A,B

              A,B




              A,B
Partially

Partially

   No

   No



   No
00066341

00066341
Yes9-/        15 Months

Yes9-/        15 Months

Reserved^0-/

Reserved^0-/
                                  January, 1991
 I/Due dates  refer to number of months  following receipt of this Registration  Standard,  unless otherwise indicated.
 2/Collectively, the data satisfy the requirement.
 3_/The submitted bobwhite study was determined to be unacceptable, since the production of eggs in 25 percent of the
   control pairs was significantly below normal.  A new study is required. Also, the mallard reproduction study
   indicated that  long-term exposure significantly impairs reproduction.  The requirement for a reproduction study of
   waterfowl in wetland areas is' reserved pending on the results of the environmental fate data.

-------
                                                                                                                    93

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

Sec. 158.490 - Wildlife and Aquatic Organisms (cont'd)
 4/The TEPs were Thimet 600 EC (90490, 90491) and Thlmet 20G (161822,  161823,  161824).   Liquid formulations are no
   longer registered.  The studies with Thimet 20G satisfy any granular formulation of phorate up to 20% ai.
 5/The TEP was Thimet 20G.  Acceptable studies done with this formulation satisfy any granular formulation of phorate
   up to 20% ai.
 £/The submitted study does not fulfill the data requirement because the test  specimens were in different age classes
   and different stages of development.  A new study is required.
 JZ/The submitted study was determined to be unacceptable because the mortality of the control fish embryos was
   excessively high  (> 50%).  A new study is required.
 S/The submitted study was determined to be unacceptable because the raw data  needed to analyze the study were not
   submitted.   Upon  submission of all raw data on mortality and reproduction for each  replicate  daphnid chamber  for
   each day that observations were made on survival and offspring production,  the evaluation of the study will be
   completed.  Within 90 days, the registrant must inform the Agency of the option chosen:   1) to provide the missing
   information  to upgrade the study,  or 2) to submit  a new study.   If the registrant  chooses  to provide the missing
   information, these data are due 6  months  from receipt of the Standard.  If the registrant chooses  to submit a new
   study, the data are due 15 months from receipt of the Standard.
 2/These studies are required based upon the laboratory bioassays and estimated/actual residues in the environment.
   The estuarine mysid shrimp life cycle test and sheepshead minnow embryo-juvenile test are deficient but can fulfill
   data requirements upon submission of additional data.  Raw data for each replicate on mortality, hatching, and  size
   of juveniles, must be submitted for the sheepshead minnow test so that the  statistical analyses can be verified.
   The DO and pH measurements and raw data for each replicate must be submitted for the mysid shrimp test so effects
   on survivability and reproduction can be verified.  Submission of these missing data were required in the Guidance
   Document, 1984. If these data are unavailable, new studies are required. Within 90 days, the registrant must inform
   the Agency  of  the option chosen:   (1) to  provide the missing information to upgrade the  study,  or  (2)  to submit a
   new study.   If the registrant chooses  to submit a new study,  the data  are due 15 months from  receipt  of  this
   Standard.   If  the registrant  chooses to provide the missing information, these data are  due 6 months from receipt
   of this Standard.
IP/This study is reserved pending the results of environmental fate data and a fish early life stage study.
1I/A pond study consisting of two reference ponds and two treatment ponds in the corn region of Iowa is currently
   underway.  The schedule calls for a baseline study to be conducted in 1988  and the treatment study to be conducted
   in 1989.  The new due date for this submission of this study is January, 1991.

-------
                                                                                                                     94
                                                           Table A
                                        Generic Data Requirements for Phorate
Data Requirement
                     Does EPA
                     Have Data to
  Test      Use      Satisfy This   Bibliographic
Substance   Patterns   Requirement?	Citation
                            Must Additional
                            Data Be  Submitted   Timeframe
                            Under FIFRA Section For I/
                            3(c)(2HB)?	Submission
Sec. 158.590 Nbntaraet Insects

          INSECT TESTING -
141-1 - Honey Bee Acute          TGAI
        Toxic ity

41-2 - Honey Bee - Toxic ity TEP
        of Residues on
        Foliage

141-4 - Honey Bee Subacute       TEP
        Feeding Study

141-5 - Field Testing for        TEP
        Pollinators
             A,B



             A,B




             A,B



             A,B
          INSECT TESTTK[n - AQUATIC INSECTS

142-1 - Acute Toxic ity to   Reserved3-/
        Aquatic Insects

142-2 - Aquatic Insect      Reserved3-/
        Life Cycle Study

142-3 - Simulated or        Reserved3-/
        Actual Field
        Testing for
        Aquatic Insects
No
No
No
No

-------
                                                                                                                    95
                                                       Table A
                                        Generic Data Requirements for Phorate (cont'd)
                                                    Does EPA                       Most Additional
                                                    Have Data to                   Data Be Submitted    Timeframe
                               Test        Use      Satisfy This   Bibliographic   Under FIFRA Section    For I/
                               Substance   Patterns Requirement?     Citation      3(c)(2HB)?	Submission
Data Requirement
Sec. 158.590 Nontaraet Insects (cont'd)

NQWTARGET INSECT TESTING - PREDATORS AND PARASITES
143-1
thru
143-3
                            Reserved^/
I/Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
  indicated.
2/This study is not required.  Since this pesticide is registered only in granular form, there is no potential for
  bee exposure.
3,/This requirement is reserved pending development of test methodology and/or decisions as to whether data should be
  required.

-------
                                                              Table B
               Product-Specific Data Requirements  for Manufacturing-Use Products Containing Ehorate
                                                                                                                    96
Data Requirement
                                               Does EPA
                                              Have Data to
                                    Test      Satisfy This
                                    Substance Requirement?
              Bibliographic
                Citation
                    Most Additional
                    Data Be Submitted     Timef rame
                    Under FIFRA Section    For Data I/
                    3(c)(2)(B)?	Submission
Part 158, Subpart C - Product Chemistry

Product Identity and Composition

61-1  - Product Identity and         MP
        Disclosure of Ingredients

61-2  - Description of Beginning     MP
        Materials and
        Manufacturing Process

61-3  - Discussion of Formation of   MP
        Impurities
                                               Partially


                                               Partially



                                               Partially
Analysis and Certification of Product Ingredients

                                     MP         Partially
62-1  - Preliminary Analysis of
        Product Samples

62-2  - Certification of
        Ingredient Limits

62-3  - Analytical Methods to
        Verify Certified Limits
                                     MP
                                     MP
Partially


Partially
              00146524,
              00146524, 00155595
              00146524, 00158941
              00146524
00146524
00146524, 00149814
                           Yes2-/
                           Yes4/
                           Yes5-/
                                                                                         Yes2/
 9 Months
                                           9 Months
 9 Months
12 Months
                                                                                                        12 Months
12 Months

-------
                                                                                                         97
                                         Table B
Product-Specific Data Requirements for Manufacturing-Use Products  Containing Phorate (cont'd)
Data Requirement
Part 158
Physical
Physical
63-2 -
63-3 -
63-4 -
63-7 -
, Subpart C -
and Chemical
and Chemical
Color
Does EPA Must Additional
Have Data to Data Be Submitted Timef rame
Test Satisfy This Bibliographic Under FIFRA Section For Data I/
Substance Requirement? Citation 3(cH2)(B)? Submission
Product Chemistry
Characteristics (cont'd)
Characteristics
MP Yes 00146524, 00149814
Physical State MP Yes 00146524, 00149814
Odor
Density, Bulk
MP Yes 00146524, 00158941
Density, or MP Yes 00146524, 00149814


No
No
No
No
        Specific Gravity
63-12 - pH
62-14 - Oxidizing or Reducing
        Action
62-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
MP
MP

MP
MP
MP
MP
MP
                                         Yes        00146524, 00158941
                                      Partially     00146524, 00158941
Partially
Partially
Partially
Partially
   Yes
                                                    00146524, 00158941
                                                    00146524, 00158941
                                                    00146524, 00158941
                                                    00146524, 00158941
                                                    00146524, 00158941
Yes10/
 9 Months

 9 Months
 9 Months
15 Months
 9 Months

-------
                                                                                                                    98
                                                           Table B
          Product-Specific Data Requirements for Manufacturing-Use Products Containing Phorate (cont'd)
Data Requirement
            Does EPA
            Have Data to
  Test      Satisfy This   Bibliographic
Substance	Requirement?     Citation
                   Must Additional
                   Data Be Submitted
                   Under FIFRA Section
                   3(cH2HB)?	
                   Timeframe
                    For Data I/
                   Submission
Part 158. Subpart C - Product Chemistry

Physical and Chemical Characteristics (cont'd)

63-20 - Corrosion Characteristics   MP

Other Requirements

64-1  - Submittal of Samples        N/A
              Partially
00146524
Yes15_/
15 Months
I/Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/For the 89.4% T (EPA Registration No. 2749-106),  the registrant must provide a fully completed EPA Form 8570-4
that includes  the  correct chemical name, the molecular, structural, and empirical  formula,  and upper certified limit
for each impurity for which a certified limit is required.   For the Cyanamid 85% Ts (EPA Registration Nos. 241-212 and
241-213), the  certified limits  of each active ingredient must be provided.  Also, the name  and upper certified limit
must be provided for each impurity or group of impurities for which a certified limit is required.  The information on
ingredient limits must be submitted on EPA Form 8570-4 (Rev. 2-85).
3/Information must be submitted for  the  American Cyanamid  85% Ts (EPA Registration Nbs.  241-213 and 241-212)  and
the Aceto Chemicals 89.4% T  (EPA Registration No.  2749-106) regarding the relative amounts of beginning materials and
the order  in which they  are  added,  the equipment  used to  produce  each intermediate and the  final  product,  reaction
conditions, the duration of each step of the process, and quality control measures.   In addition, the name and address
of the manufacturer, producer,  or supplier  of each beginning material used in the manufacture of oach product must be
provided for the Aceto  product,  as well  as  a statement regarding the nature of the process (batch or continuous), and
flow chart with chemical equations of each intended chemical reaction.
4/For the 89.4% T (EPA Registration No. 2749-106),  a detailed discussion must be submitted of all impurities that
are or may be present at > 0.1%, based on knowledge of the beginning materials, chemical reactions (intended and side)
in the manufacturing process, and any contamination during and after production.]
5_/Five or more representative batches of the Aceto  89.4% T  (EPA Registration No.  2749-106) must be analyzed for the
amount of active ingredient and each impurity for which certified limits are required.   Complete validation data

-------
                                                                                                                  99
                                                      Table B
            Product-Specific Data Requirements for Manufacturing-Use Products Containing Phorate (cont'd)

-U158.150-190 Product Chemistry Footnotes (cont'd)

 (accuracy and precision)  must be submitted for the Aceto  89.4% T and the American  Cyanamid 85% Ts (EPA Registration
Nbs. 241-213 and 241-212).
£/For the 89.4% T (EPA Registration No.  2749-106)  correct chemical names of the impurities must be associated with
the certified limits, and a statement of how  the  certified limits were determined must be provided.  For the Cyanamid
85% Ts  (EPA Registration Nos. 241-212 and 241-213),  upper and lower limits  for  each active ingredient, upper limits
for  each  impurity present  at >  0.1% (w/w),  and  each additional  "toxicologically significant" impurity that may be
present at  < 0.1% must be certified.  An explanation of how each limit was established (e.g., sample analysis using a
validated  analytical procedure,  quantitative estimates  based  on the  amounts  of  ingredients used,  etc.) must  be
provided, along with information on the accuracy and precision of the procedures used. Certifications must be submitted
on EPA Form 8570 (Rev. 2-85) for all manufacturing-use products.
I/For the 89.4% T (EPA Registration No.  2749-106), analytical methods for the verification of certified limits must
be  provided, including  a  full  description  of how  each  of the  impurities  is determined.   The  methods must  be
accompanied by validation studies indicating  its  accuracy and precision.  Validation data must also be submitted for
the analytical methods used for the 85% Ts  (EPA Registration Nos. 241-213 and 241-212).
£/Data not required because the test substance is not dispersible in water.
S/No useful data were submitted to fulfill  the requirements for the 85% Ts (EPA Registration Nos. 241-213 and 241-212)
or  for the  89.4% T  (EPA Registration No. 2749-106).   Data are required  if the  product contains oxidizing or reducing
agents.
10/The submitted data do not satisfy the  requirements  for the 85% Ts  (EPA  Registration  Nos. 241-213 and 241-212) or
for the 89.4% T  (EPA Registration No.  2749-106)  because a flashpoint and a  method of determination was not provided.
These data are required if the product is a combustible liquid.
il/The submitted data do not satisfy the requirements for the 85% Ts  (EPA Registration Nos.  241-213 and 241-212) and
the  89.4%  T (EPA Registration No.  2749-106)  because the methodology was  not described.   Data are  required if the
product is potentially explosive.
12/The submitted  data do not satisfy the requirements for  the 85% Ts  (EPA Registration Nos.  241-213 and 241-212)
because the analytical method was  not specified.   The submitted information do not satisfy these requirements for the
89.4% T (EPA Registration No. 2749-106)  because the appropriate test conditions were not followed.
JL3_/The submitted  data satisfy  the requirements  for the  85% Ts  (EPA Registration Nos.  241-213  and  241-212).   The
submitted  information do not satisfy these  requirements  for the  89.4%  T  (EPA Registration  No.  2749-106)  because
viscosity must be reported  in appropriate  conventional  unit and determined at 20  or  25  *C.   Data are required if the
product is a liquid.
14/Data not required because none of the phorate manufacturing-use products are emulsifiable  liquids to be diluted
with petroleum solvents.

-------
                                                                                                                     100
                                                   Table B
            Product-Specific Data Requirements for Manufacturing-Use Products Containing Phorate (cont'd)

-U158.150-190 Product Chemistry Footnotes (cont'd)


i5/The  submitted data satisfy  the requirements  for  the 85%  Ts (EPA Registration  Nbs. 241-213  and 241-212).   The
submitted  information  do not satisfy these  requirements for the 89.4%  T (EPA Registration No.  2749-106)  because no
test substances or test  conditions were  specified.  The following additional data are required:  As required i 40 CFR
158.190 and more fully described in the Pesticide Assessment Guidelines,  Subdivision D, data must be submitted for the
89.4% T (EPA Registration No. 2749-106) regarding vapor pressure,  octanol/water  partitioning coefficient,  stability,
oxidizing   or  reducing  action,  flammability,   explodability,   storage   stability,  viscosity,  and   corrosion
characteristics.    Data  on  boiling  point,  solubility,  vapor  pressure,  octanol/water  partitioning  coefficient,
stability, oxidizing or  reducing  action, flammability,  explodability,  and storage stability must be submitted for the
85% Ts  (EPA Registration Nos. 241-213 and 241-212).

-------
                                                                                                                    101
                                                    Table B
                Product-Specific Data Requirements for Manufacturing-Use Products Containing Pnorate
Data
Sec.
Test
Requirement Substance
158.340 Toxicology
Use
Patterns

Does EPA
Have Data to
Satisfy This
Requirement?

Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data I/
Citation 3(c)(2)(B)? Submission-

Acute Testing
81-1
81-2
81-3
81-4
- Acute Oral - Rat MP2-/
- Acute Dermal MP
- Acute Inhalation - Rat MP
- Eye Irritation - Rabbit MP
A,B
A,B
A,B
A,B
Yes
Yes
Yes
NO
00126343 No3-/
00126343 NO3-/
00126343 NO3-/
N04/
81-5 - Dermal Irritation

       - Rabbit                  MP

81-6 - Dermal Sensitization

       - Guinea Pig              MP
A,B
A,B
NO
NO
No5-/
I/Due dates refer to number of months following receipt of the Registration Standard, unless otherwise indicated.
2/Formulation intermediates are included in the category of manufacturing-use products.
3_/Data are adequate to support currently registered MP products containing phorate at 85% a.i. and above.
4/Testing is not required since phorate is too toxic to allow the use of appropriate dose levels required for
  adequate testing.
5/Testing is not  required.   In addition to phorate's high acute toxicity, the  chemical structure of phorate does not
  indicate a possible dermal sensitization potential.

-------
                                                              Table C
               Product-Specific Data Requirements for End-Use Products Containing Phorate
                                                                                                                       K
Data Requirement
           Does EPA
          Have Data to
Test      Satisfy This
Substance Requirement?
Bibliographic
  Citation
Must Additional
Data Be Submitted     Timeframe
Under FIFRA Section    For Data I/
3(cH2UB)?	Submission
Part 158. Subpart C - Product Chemistry

Product Identity and Composition

61-1  - Product Identity and         EP
        Disclosure of Ingredients

61-2  - Description of Beginning     EP
        Materials and
        Manufacturing Process

61-3  - Discussion of Formation of   EP
        Impurities
           NO
           No
          NO
                                                    Yes
                                                    Yes
                                                    Yes
Analysis and Certification of Product Ingredients
62-1  - Preliminary Analysis of      EP
        Product Samples

62-2  - Certification of             EP
        Ingredient Limits

62-3  - Analytical Methods to        EP
        Verify Certified Limits
          No
          No
          No
                                                    Yes
                                                    Yes
                                           9 Months
                                           9 Months
                                           9 Months
                                          12 Months


                                          12 Months


                                          12 Months

-------
                                                                                                        103
                                         Table C
Product-Specific Data Requirements for Manufacturing-Use Products Containing Phorate (cont'd)


Data Requirement
Part 158. Subpart C - Product Chemi
Physical and Chemical Characteristi
Physical and Chemical Characteristi
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
62-14 - Oxidizing or Reducing
Action
62-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility


Test
Substance
stry
.CB (cont'd)
.cs
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Does EPA
Have Data to
Satisfy This Bibliographic
Requirement? Citation
No
No
NO
NO
NO
NO
NO
NO
NO
NO
NO
Must Additional
Data Be Submitted
Under FIFRA Section
3(C)(2HB)?
Yes
Yes
Yes
Yes
No3-/
Yes
No3-/
Yes
Yes
No3-/
No3-/

Timeframe
For Data I/
Submission
9 Months
9 Months
9 Months
9 Months

9 Months

9 Months
15 Months



-------
                                                                                                                   104
                                                           Table C
          Product-Specific Data Requirements for Manufacturing-Use Products Containing Phorate (cont'd)
Data Requirement
Part 158 f Subpart C - Product Chemistry

Physical and Chemical r*har;yteristics (cont'd)

63-20 - Corrosion Characteristics   EP

Other Requirements

64-1  - Sutmittal of Samples        N/A
Does EPA
Have Data to
Satisfy This   Bibliographic
                       .on
  Test
Substance   Requirement?
    No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
                                                  Yes
                                                                                                        Timeframe
                                                                                                         For Data I/
                      15 Months
I/Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/Qnly required for products produced by an integrated system.
,3/Nbt required, since all EP products are granular formulations.

-------
                                                                                                                105
                                                       Table C
         Product Specific Data Requirements for End-Use Products Containing Phorate Granular Products 10-20%

                                                    Does EPA                       Must Additional
                                                    Have Data to                   Data Be Submitted    Timeframe
                                Test        Use     Satisfy This    Bibliographic  Under FIFRA Section   For Data I/
Data Requirement	Substance   Patterns  Requirement?	Citation	3(c) (2) (B)?
Sec. 158.340 Toxicology

Acute Testing

81-1 - Acute Oral - Rat          TEP2/      All        Yes             00093038        No

81-2 - Acute Dermal Toxicity     TEP        All        No                              Yes                9 Months
         - Rabbit
81-3 - Acute Inhalation Toxicity TEP        All        Partially       40586507        Yes^/              9 MDnths
         - Rat

81-4 - Primary Eye               TEP        All        Yes             00093038        No
         Irritation - Rabbit

81-5 - Primary Dermal            TEP        All        Yes             00093039        No
          Irritation - Rabbit

81-6 - Dermal Sensitization -    TEP        All        No                              No^/
         Guinea Pig


I/Due dates refer to the number of months following receipt of the Registration Standard, unless otherwise indicated.
  Studies using the 15G or 20G will suffice for a single active granular formulation between 10% and 20%.
2/Includes both  single active ingredient and multiple active ingredient formulations.
I/Not required for the Thimet 20G (EPA Reg No, 241-212) product.  Required for other formulation types.
4/Not required because acute dermal and eye studies indicate that the .product is too toxic to test.

-------
                                                                                                               106
                                                       Table C
          Product Specific Data Requirements for End-Use Products Containing Phorate Granular Products 1-10%
Data Requirement
                      Does EPA
                      Have Data to
  Test        Use     Satisfy This
Substance   Patterns  Requirement?
                                       Most Additional
                                       Data Be Submitted    Timeframe
                        Bibliographic  Under FIFRA Section   For Data I/
                          Citation     3(c)(2)(B)?	Submission-
Sec. 158.340 Toxicology

Acute Testing

81-1 - Acute Oral - Rat

81-2 - Acute Dermal Toxicity
         - Rabbit
   TEP-/

   TEP
All

All
Nb

NO
Yes

Yes
9 Months

9 Months
81-3
81-4
81-5
81-6
- Acute Inhalation Toxic ity TEP
- Rat
- Primary Eye TEP
Irritation - Rabbit
- Primary Dermal TEP
Irritation - Rabbit
- Dermal Sensitization - TEP
Guinea Pig
All
All
All
All
No
No
No
NO
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
I/Due dates refer to the number of months following receipt of the Registration Standard,  unless otherwise indicated.
2/Includes both  single active ingredient and multiple active ingredient formulations.

-------
                                                       Table C
          Product Specific Data Requirements for End-Use Products Containing Pnorate Granular Products < 1%
Data
Sec.
Does EPA Mast Additional
Have Data to Data Be Submitted Timeframe
Test Use Satisfy This Bibliographic Under FIFRA Section For Data I/
Requirement Substance Patterns Requirement? Citation 3(cH2)(B)? Submission-
158.340 Toxicology


Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral - Rat TEP2-/ All No
- Acute Dermal Toxic ity TEP All No
- Rabbit
- Acute Inhalation Toxicity TEP All No
- Rat
- Primary Eye TEP All No
Irritation - Rabbit
- Primary Dermal TEP All No
Irritation - Rabbit
- Dermal Sensitization - TEP All No
Guinea Pig
Yes
Yes
Yes^/
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/Due dates refer to the number of months following receipt of the Registration Standard, unless otherwise indicated.
2/Includes both  single active ingredient and multiple active ingredient formulations.
3/Required if product consists of; or produces inhalable particles, such as fines, when mixed, loaded or used.

-------
II.  LABELING APPENDICES
          108

-------
                           SUMMARY-1

                         LABEL CONTENTS

   40 CFR 156.10 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 156.10(d)]

   Item 4.  EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it.  The registration number
and the required identifying phrase must not appear in such a
manner as to suggest or imply recommendation or endorsement of
the product by the Agency.  [40 CFR 156.10(e)]

   Item 5.  EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment 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 156.10(f)]
                               109

-------
                           SUMMARY-2

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

   Item SB.  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 156.10(h)(1)(ii)]

   Item 7B.  SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement.
[40CFR 156.10(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 156.10(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 156.10(h)(1)(iii)]
                            110

-------
                           SUMMARY-3

   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 156.10(h)(1)(iii)].

   Item 8.  SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS."  The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline.  Each of the
three hazard warning statements must be headed by the
appropriate hazard title.  [40 CFR 156.10(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 156.10(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 156.10(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 S6C. 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.
                               Ill

-------
                           SUMMARY-4

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

   If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration.  During the
Agency's review of your application, your proposed
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 156.10(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.
                                112

-------
                           SUMMARY-5

        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
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.
                                113

-------
                           SUMMARY-6

   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 156.10]

                      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.
                                114

-------
               SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED

ITEM
1
2
3
4
5
6A
6B
7
7A
7B

LABEL FT,FMFT\TT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warnina)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
ai/unit area
All products
All products
All products
pTAmMFWP
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
immediately
before or
following
Rea. No.
Immediately
following
product name
Directly below
the main
ingredients
statement

Above signal
word
Immediately
below child
hazard
warnina

COMMENTS

If registrant is not the producer, must
be qualified by "Packed for . . . ,"
"Distributed by . . . ." etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other tvoe.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.

All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
                           115

-------
                  SUMMARY-8




LABELING REQUIREMENTS OF THE FIFRA.  AS AMENDED (cont'd)

ITEM
1C
TD
7E
8
8A
8B

LABET. TT.TTVIFTJr
Skull & cross-
tones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
hazards 	
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicitv
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT
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
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all

Top or side
of back panel
preceding
directions
for use
Same as above
Same as above

COMMENTS



Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
                116

-------
 fME CAUnONAMV fTATUMMTS
   HAIAMMTOMUMAW
   • OOUCfTO AMMAU
      CAUTION
  •MVnOMUBfTAI. HAZAMM
     MAZAMM
• k • «*•• rt
      to •
   M«fTIIV STATIMfMT
                              PRODUCT
                                  NAME
                           AOTWI MdMOCMTi ,
                           MMT NQMCONTS:,

                           fOTAL:
                                              lOOOOt
                           1H« mOOUOT OONTAMS  IM Of  fCH OAUON
                          KEEP OUT OF REACH OF CHILDREN
                                CAUTION
                              tTAWMMT Of rfUCTBAL TMATMCNf
                       rtWAUOWtO:
                       Kl MM f AMIL KM AOOmONAL fMOAUTIONAIIV •TATIUCHT*
                       TOWNL «TAT1 ==
                       ••TAMJMMINT Mtt
                       IT A MOtnUTttN Na
                                 NtTCONTOff>,
                                     117
                                                              awr:
                                                              atari
                                                              ONO*.
 STORAGE AND
   DISPOSAL
•TOUAOisa
                                                                WAWIANTV fTATaJKNT

-------
ratCAUnONAirf tUttMfNTt


  HAZAflOtTOHUUANt

  «• OOMftTC AMMALtl


     DANK*
 STORAGE AND

 r DISPOSAL
RESTRICTED USE


,   PESTICIDE
(reason for clasnlfytnr)
*M-n wo tn OMU n comnro
 WBU OtMCr •UrarVUKH MO o _
  wt axnno) ArrucMwt cnhrtcxria*
                             PRODUCT

                                  NAME
                          ACTWt MONtMNT: ___^______  »





                          WfAl:                100.00ft





                          TMtMOOUCrCONTAMt  LM OT   rtMOAUON
                         KEEP OUT OF REACH OF CHILDREN


                            DANGER —POISON
 tTATIUtNT Of rftACTCAL TfltATUCNT
                      VMIvtt:
                                  OOmONAL rAMAUnONAftV tTATtUCNTt
                      TOWtitTATt	

                      ltTAMJtHMINTMO.S=

                      IP A WMTfUTCN NO.:
                                NtTOONTINTt:
                                                               CMOT:
                                                               CHOP:
                                                                 WARRANTY ITATtMfMT
                                        118

-------
                40 CFR Ch. I (7-1-87 Edition)
         ISU
       § BE. 10  Labeling requirements.
         (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-
119

-------
scribed  in  paragraph  (b) of this sec-
tion:
  (ii)  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
in paragraph (d) of this section;
  (iv)   The   product    registration
number as prescribed in paragraph (e)
of this section;
  (v)  The  producing   establishment
number as prescribed in paragraph (f)
of this section;
  (vi) An ingredient statement as pre-
scribed  in  paragraph  (g) of this sec-
tion;
  (vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
  (viii) The directions for use  as pre-
scribed in paragraph (i) of this section;
and
  (ix) The  use classification(s)  as pre-
scribed in paragraph (j) of this section.
  (2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on  the labeling by the Act or
the regulations in this  part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness  (as compared  with
other words, statements, designs, or
graphic  matter on  the  labeling) and
expressed in such terms  as to render it
likely to be read and  understood by
the ordinary individual under custom-
ary conditions of purchase and use.
  (ii) All required label text must:
  (A) Be set in 6-point or larger type:
  (B) Appear on  a clear contrasting
background; and
  (C) Not be obscured or crowded.
  (3) Language to be used. All required
label  or labeling text shall appear  in
the  English  language.  However, the
Agency may require or the applicant
may propose additional text in  other
languages as is considered necessary  to
protect  the public. When additional
text in  another language is necessary.
all  labeling requirements will be ap-
plied equally to both the English and
other-language  versions of the  label-
ing.
  (4)  Placement of Label—(i) General.
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product.  For pur-
poses of this Section,  and  the mis-
branding provisions of the  Act, "se-
curely attached" shall mean  that  a
label  can reasonably be  expected  to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper  or outside container through
which the label cannot be clearly read,
the  label must  also be  securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
  (ii)  Tank cars  and other bulk con-
tainers—(A) Transportation. While  a
pesticide product is in transit,  the ap-
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those  provisions concerning the  la-
beling, marking and placarding of haz-
ardous materials  and the vehicles car-
rying them, define the  basic Federal
requirements.  In addition, when any
registered pesticide  product is trans-
ported in a tank car,  tank  truck  or
other mobile or portable bulk contain-
er, a  copy of the accepted label must
be attached  to  the shipping  papers.
and left with the consignee at the time
of delivery.
  (B) Storage.  When  pesticide prod-
ucts   are stored  in bulk  containers.
whether  mobile or stationary,  which
remain in the custody  of  the  user,  a
copy of the label  of labeling,  including
all appropriate directions for use, shall
be securely attached  to the container
in the immediate vicinity of the dis-
charge control valve.
  (5)  False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act,  a pesticide or a  device declared
subject  to  the  Act   pursuant  to
§ 162.15,  is misbranded if its labeling is
false  or  misleading  in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or  representations  in  the  labeling
which constitute  misbranding include:
  (i)  A false or misleading statement
concerning  the  composition  of  the
product;
  (ii) A false or misleading statement
concerning  the  effectiveness  of  the
product as a pesticide or device;
  (iii) A  false  or misleading statement
about the  value of  the product for
                                   120

-------
 § 162.10
         40 CFR Ch. I (7-1-87 Edition)
 purposes other than as a pesticide or
 device:
   (iv) A false or misleading comparison
 with other pesticides or devices;
   (v) Any statement directly or indi-
 rectly  implying that the pesticide or
 device  is recommended or endorsed by
 any  agency of the Federal  Govern-
 ment;
   (vi) The name of a  pesticide which
 contains two or more  principal active
 ingredients if the  name suggests one
 or more but not  all  such principal
 active  ingredients  even  though the
 names  of the other  ingredients are
 stated elsewhere in the labeling;
   (vii) A true statement used in such a
 way as  to give a false or misleading im-
 pression to the purchaser;
   (viii)  Label disclaimers which negate
 or detract from labeling statements re-
 quired under the Act and these regula-
 tions;
   (ix) Claims  as to the safety of the
 pesticide or its  ingredients, including
 statements such as  "safe," "nonpoison-
 ous,"  "noninjurious,"  "harmless"  or
 "nontoxic to humans  and pets" with
 or without such a qualifying phrase as
 "when used as directed"; and
   (x) Non-numerical and/or compara-
 tive statements on the safety of the
 product, including but not limited to:
   (A) "Contains  all natural  ingredi-
 ents";
   (B) "Among the  least toxic chemi-
 cals known"
   (C) "Pollution approved"
   (6)  Final printed  labeling, (i) Except
 as provided in paragraph (a)(6)(ii) of
 this  section,  final printed  labeling
 must be submitted  and accepted prior
 to registration. However, final printed
 labeling need  not be submitted until
 draft label texts have  been provision-
 ally accepted by the Agency.
  (ii)  Clearly legible reproductions or
 photo reductions will be accepted for
 unusual labels  such  as  those  silk-
 screened directly onto glass or metal
 containers or large bag or drum labels.
 Such reproductions must be of micro-
 film reproduction quality.
  (b)  Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product  is  sold
shall  appear on the front panel of the
label.  •
   (2) No name,  brand,  or  trademark
 may appear on the label which:
   (i) Is false or misleading, or
   (ii) Has not been approved by the
 Administrator through registration or
 supplemental registration as  an addi-
 tional name pursuant to § 162.6(b)(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 *  * *," "Distribut-
 ed by * *  *," 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
 stated as a minimum quantity.
  (2) If the  pesticide  is a liquid,  the
 net  content  statement  shall  be  in
 terms of liquid measure at 68°  P (20°C)
 and shall be expressed in conventional
 American units 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-
 tent 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
                                   121

-------
Environmental Protection Agency

registration shall appear on the label,
preceded by the phrase  "EPA Regis-
tration No.," or the phrase "EPA Reg.
fjo." The registration number shall be
set in type of a size and style similar to
other  print on  that part of  the label
on which it appears and shall run par-
allel to it. The registration number
and the  required  identifying phrase
shall not appear in such a manner as
to suggest or  imply  recommendation
or endorsement of  the product by the
Agency.
  (f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA  Est.", of the
final establishment at which  the prod-
uct  was produced may appear in  any
suitable location on the label or imme-
diate container. It must appear on the
wrapper  or outside container of  the
package if the EPA establishment  reg-
istration  number  on  the immediate
container  cannot  be  clearly  read
through such wrapper or container.
  (g) Ingredient statement—(1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight  of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form,  a statement of the
percentages of total and water-soluble
arsenic  calculated as  elemental ar-
senic.  The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar  forms of these  terms when appro-
priate. Both  terms  shall be in  the
same type size,  be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent  active ingredients.
Unless the ingredient  statement  is a
complete analysis of the pesticide, the
term "analysis" shall not be  used as a
heading for the ingredient statement.
  (2) Position of ingredient statement
(i)  The ingredient statement is nor-
mally required on  the front  panel of
the label. If  there is an outside con-
tainer or wrapper  through which the
ingredient statement cannot be clearly
read,  the ingredient statement must
also appear on  such outside  container
                            § 162.10

or wrapper. If the size or form of the
package  makes  it  impracticable  to
place the ingredient statement on the
front  panel  of the label, permission
may be  granted for  the  ingredient
statement to appear elsewhere.
  (ii) The text of the ingredient state-
ment  must  run parallel  with  other
text on the panel on which it appears,
and must be clearly  distinguishable
from and must not be placed in the
body of other text.
  (3) Names to be used in ingredient
statement. The name used for each in-
gredient   shall   be   the  accepted
common  name,  if there is  one, fol-
lowed by the chemical  name. The
common name may be used alone only
if it is well known. If no common name
has been established, the  chemical
name  alone shall be used. In no case
will the use of a trademark or proprie-
tary name  be permitted unless such
name  has been accepted as a common
name  by the  Administrator under the
authority of section 25(c)(6).
  (4) Statements  of percentages. The
percentages  of  ingredients  shall  be
stated in  terms 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
the uses  of the  pesticide product are
expressed as  weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of  the pesticide formulation
shall  also  appear in  the  ingredient
statement.
  (5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation  between manufac-
turing batches,  the  value  stated  for
each  active ingredient shall  be the
lowest percentage   which  may  be
present.
  (6)  Deterioration.  Pesticides  which
change in  chemical composition sig-
nificantly must meet the following la-
beling requirements:
  (i) In  cases where it is determined
that a pesticide formulation changes
chemical  composition significantly,
the product must bear the following
statement in a prominent position on

-------
§ 162.10
         40 CFR Ch. I (7-1-87 Edition)
the label: "Not  for sale or use after
[date]."
  (ii) 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  ingredients) to be listed in the
ingredient statement if  he  determines
that such  ingredient(s) may  pose a
hazard to man or the environment.
  (h)   Warnings  and   precautionary
statements.  Required  warnings  and
precautionary statements  concerning
the  general   areas  of  toxicological
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:
Hazard indicators
Oral LD» 	
Inhalation LC». 	
Eye effects
Skin effects

Toxicity categones
1
Up to and including 50
mg/kg.
Up to and including 2
mg/ liter.
Up to and including 200
mg/kg.
Corrosive; corneal
opacity not reversible
within 7 days.
Corrosive 	

II
From 50 thru 500 mg/kg..
From 2 thru 2 mg/liter 	
From 200 thru 2000 	
Corneal opacity
reversible within 7
days: imtation
persisting for 7 days.
Severe imtation at 72
hours.
Ill
From 500 thru 5000 mg/
kg.
From 2. thru 20 mg/liter ..
From 2.000 thru 20,000. ..
No corneal opacity;
imtation reversible
within 7 days.
Moderate imtation at 72
hours.
IV
Greater than 5000 mg/
kg.
Greater than 20 mg/ liter.
Greater than 20.000
No imtation.
Mild or slight imtation at
72 hours.
  (i) Human hazard signal word—(A)
Toxicity 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-
dition if the product was assigned  to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin  and eye  local ef-
fects) the word "Poison" shall appear
in red on a  background of  distinctly
contrasting  color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
  (B) Toxicity Category II.  All  pesti-
cide products meeting the criteria  of
Toxicity Category 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—(A)  Toxicity  Category  I.  A
                             123

-------
Environmental Protection Agency
                                                              § 162.10
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-
icity.   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 not
required on the front panel except  as
described in paragraph (h)(l)(iii)(A)  of
this section. The applicant may, how-
ever,  include such a front panel state-
ment at   his  option.  Statements  of
practical  treatment are,  however, re-
quired  elsewhere  on the   label  in
accord with paragraph (h)(2j  of this
section  if  they do  not appear  on the
front panel.
  (iv) Placement  and  prominence. All
the require front panel warning state-
ments shall  be  grouped  together on
the label,  and shall appear with suffi-
cient  prominence  relative   to  other
front panel  text  and graphic material
to make  them  unlikely  to  be  over-
looked under customary  conditions  of
purchase  and use. The following table
shows the minimum type size require-
ments for the  front  panel warning
statements on various sizes of labels:
                                                             Points
Size of label front panel in square
inches
5 and under 	
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30 	

Required
signal
word, all
capitals
6
10
12
14
18

"Keep out
of reach of
children"
6
6
8
10
12

                                 (2) Other required warnings and pre-
                                cautionary  statements. The warnings
                                and  precautionary statements as  re-
                                quired below shall appear together on
                                the label under the  general  heading
                                "Precautionary    Statements"    and
                                under   appropriate   subheadings  of
                                "Hazard to Humans and Domestic Ani-
                                mals,"  "Environmental  Hazard"  and
                                "Physical or Chemical Hazard."
                                 (i)  Hazard to humans and domestic
                                animals. (A) Where a hazard exists to
                                humans or  domestic  animals, precau-
                                tionary statements are required  indi-
                                cating  the  particular   hazard,   the
                                route(s) of  exposure  and the precau-
                                tions  to be  taken to avoid accident.
                                injury or damage. The precautionary
                                paragraph shall be  immediately  pre-
                                ceded by 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.
  Toxicity
  category
                               Precautionary statements by toxicity category
                Oral, inhalation, or dermal toxicity
                                             Skin and eye local effects
IV.
Fatal (poisonous) if swallowed [inhaled or absorbed
 through skin]. Do not breathe vapor [dust or spray
 mist]  Do not get in eyes, on skin, or on clothing
 [Front panel statement of practical treatment re-
 quired ].
May be fatal  if swallowed [inhaled or  absorbed
 through the skin]. Do not breathe vapors [dust or
 spray  mist] Do not get in eyes, on skin, or on
 clothing [Appropnate first aid statements required.].
Harmful if swallowed [inhaled or absorbed through the
 skin].  Avoid breathing vapors [dust or spray mist].
 Avoid contact with skin [eyes or clothing]. [Appro-
 priate first aid statement required.].
[No precautionary statements required.]	
j Corrosive, causes eye and skin damage [or skin
|  imtation]. Do  not get in eyes, on  skin,  or on
  clothing. Wear goggles or face shield and  rubber
  gloves when handling. Harmful or fatal if swallowed.
  [Appropriate first aid statement required.]
 Causes eye [and skin] irritation Do not get in eyes.
  on skin, or on clothing. Harmful if swallowed. [Ap-
  propriate first aid statement required.]

 Avoid contact  with skin, eyes or clothing. In case of
  contact immediately flush eyes or skin with plenty of
  water. Get  medical attention if irritation persists.

 [No precautionary statements required.]
  (ii) Environmental hazards. Where a
hazard exists to non  target organisms
excluding  humans and domestic  ani-
mals, precautionary statements are re-
                                quired  stating  the  nature  of  the
                                hazard  and the  appropriate precau-
                                tions   to  avoid  potential   accident,
                                injury or  damage. Examples  of the
                                      124

-------
  (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.
  (F)  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(s)  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)(l)(iv)), 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 FR 32329,
Aug. 1. 1975; 40 FR 36571. Aug. 21. 1975. as
amended at 43 FR 5786. Feb. 9.1978]
                                  125

-------
Environmental Protection Agency
                            § 162.10
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:
  (1) The label clearly shows that the
product  is intended  for  use only in
manufacturing processes and specifies
the type(s) of products involved.
  (2) 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;
  (3) 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:
  (1) The label clearly states that the
product is  for use only by physicians
or veterinarians;
  (2) The  Administrator  determines
that  such directions  are not necessary
to prevent  unreasonable adverse  ef-
fects on man or the  environment; and
  (3) The product is also a drug  and
regulated under the provisions of the
Federal Food, Drug and Cosmetic  Act.
  (C) Detailed directions  for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public,  pro-
vided that:
  (1)  There  is  information readily
available to  the formulators on  the
composition, toxicity, methods  of  use,
applicable  restrictions or limitations,
and effectiveness  of the product for
pesticide purposes;
  (2) The label clearly states that the
product  is intended  for  use only in
manufacturing,  formulating,  mixing,
or repacking for use  as a pesticide and
specifies the type(s)  of pesticide prod-
ucts involved;
  (3) The product as finally manufac-
tured,  formulated, mixed, or repack-
aged is registered; and
  (4)  The Administrator  determines
that such directions are not necessary
to prevent  unreasonable adverse  ef-
fects on man or the environment.
  (2) Contents of Directions for Use.
The directions for  use shall include
the following,  under the headings "Di-
rections for Use":
  (i) The statement of use classifica-
tion as prescribed in 162.10(j)  immedi-
ately  under the  heading "Directions
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-
sistent with its labeling."
  (iii) The site(s)  of application, as for
example the crops, animals, areas, or
objects to be treated.
  (iv)  The  target  pest(s)  associated
with each site.
  (v) The dosage rate associated with
each site and pest.
  (vi)  The method of application,  in-
cluding instructions for dilution, if  re-
quired, and  type(s) of application ap-
paratus or equipment required.
  (vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
  (viii) Specific limitations on reentry
to areas where the pesticide has been
applied,  meeting  the requirements
concerning  reentry  provided  by  40
CFR Part 170.
  (ix) Specific directions  concerning
the storage  and disposal of the pesti-
cide and its container, meeting the  re-
quirements of  40  CFR Part 165. These
instructions  shall  be  grouped and
appear  under the heading  "Storage
and Disposal." This heading must  be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in § 162.10(h)(l)(iv))
  (x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
  (A) Required intervals between ap-
plication and  harvest of food or feed
crops.
  (B) Rotational crop restrictions.
                                     126

-------
§ 162.10
             40 CFR Ch. I (7-1-87 Edition)
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 LD50 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 LC50 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 LD50 of  100
mg/kg or less, or a subacute dietary
LC50 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.
      (E) 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."
      (iii)  Physical  or chemical hazards.
    Warning statements on the flammabil-
    ity or explosive characteristics  of  the
    pesticide are required as follows:
               Flash point
                                                       Required text
                               (A) PRESSURIZED CONTAINERS
Flash point at or below 20" F. if there is a flashback at
 any valve opening.
Flash point above 20' F and not over 80' F or if the
 flame extension is more than 18 in long at a distance
 of 6 in from the flame.
All other pressurized containers	
Extremety 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 open flame. Do not puncture or incinerate container.
 Exposure to temperatures above 130* F may cause bursting.
Contents under pressure. Do not use or store near heat or open
 flame. Do not puncture or  incinerate container. Exposure to
 temperatures above 130* F may cause bursting.
                             (B) NONPRESSURIZED CONTAINERS
At or below 20' F..
Above 20* F and not over 80' F....
Above 80' F and not over 150' F.
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 or open flame.
  (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.
      (iii)  Exceptions to  requirement for
    direction for  use—(A) Detailed direc-
                                     127

-------
                    PHYSICAL-CHEMICAL HAZARDS

Criteria                                Required Label Statement

I.   Pressurized Containers
     A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
         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.
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.
                              128

-------
                              STOR-1

               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.
                                 129

-------
                            PEST/DIS-1

                 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."
                             130

-------
                             CONT/DIS-1

                   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
 (bottles, cans, iars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
 Non-aerosol products  Do not reuse bag.   Discard bag in trash.
 (baas)	I	
 Aerosol products
Replace cap and discard containers in
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)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/ P dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
L/ Manufacturer may replace this phrase with one indicating whether
   and how fiber drum may be reused.
                                131

-------

-------
IV.  BIBLIOGRAPHY APPENDICES

-------
           Guide to Use of This Bibliography

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

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

IDENTIFICATION OF ENTRIES.  The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number.  This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for a further 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.

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.
                         133

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

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

d.   Trailing Parentheses.  For studies submitted to
     the Agency in the past, the trailing parentheses
     include (in addition to any self-explanatory text)
     the 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.
                      134

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

   MRID       Citation

00003503 Johnson, W.; Finley, M.  (1980)  Handbook  of Acute Toxicity of
            Chemicals to Fish and Aquatic Invertebrates:  Resource  Publi-
            cation 137.  US Fish and Wildlife Service,  Washington, D.C.
            106 p.

00014314 Tamplin, C.B.  (1971) Thimet: and Thimet  Oxygen Analog Sulfone
            (TOAS) Residues in Wheat (Green,  Grain,  and Straw).   (Unpub-
            lished study received on unknown  date under unknown admin, no.;
            prepared by Hazleton Laboratories, Inc., submitted by  American
            Cyanamid Co.,  Princeton, N.J.; CDL:098595-B)

00020560 Schafer, E.W.  (1972) The acute  oral  toxicity  of  369  pesticidal,
            pharmaceutical and other chemicals to wild  birds.   Toxicology
            and Applied Pharmacology 21(? ):315-330.   (Also in unpublished
            submission received  Apr 25,  1978  under  476-2180;  submitted by
            Stauffer Chemical Co., Richmond,  Calif.; CDL:233577-C)

00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al.  (1975)  Lethal Dietary
            Toxicities of Environmental  Pollutants  to  Birds:  Special Scien-
            tific Report—Wildlife No.  191.    (U.S.  Dept.  of the Interior,
            Fish and Wildlife Service, Patuxent Wildlife  Research  Center;
            unpublished report)

00033560 Orloski, E.J.; Nielsen, R.S.; Papke,  C.C.;  et  al.  (1972)  Thimet
            10G: Residues in Wheat Silage, Grain and Straw: Report
            No. C-321.  (Unpublished study received  Sep 1, 1972 under 241-
            53; prepared in cooperation with  Hazleton Laboratories,  Inc.,
            submitted by American Cyanamid Co., Princeton, N.J.; CDL:
            001751-B)

00033562 Weis, M.E.; Stanovick,  R.P.; Morris,  J.S.;  et  al.  (1970)  [Thimet
            Residues in Sorghum].  Includes undated  methods entitled:  Gas
            chromatographic procedure for the determination of  the total
            Thimet in grain sorghum (grain, silage,  and fodder); Gas chroma-
            tographic procedure  for the determination of  Thimet: and the
            metabolites of Thimet in sorghum  fodder  and grain.   (Unpublished
            study received Sep 11, 1970 under  241-53; prepared in  coopera-
            tion with Hazleton Laboratories,   Inc.  and others,  submitted by
            American Cyanamid Co., Princeton,  N.J.;  CDL:001741-B)

00033566 American Cyanamid Company (19??) Method of  Analysis  of Thimet in
            Crops.  (Unpublished study received Mar  26, 1965  under 241-53;
            CDL:001724-D)


                                      135

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

   MRID       Citation

00034557 Metcalf, R.L.; Fukuto,  T.R.; March, R.B.  (1957)  Plant Metabolism  of
            Dithio-Systox and Thimet.   (Unpublished study received Oct  14,
            1957 under 241-34; prepared by Univ. of California—Riverside,
            Citrus Experimetn Station,  submitted by American Cyanamid Co.,
            Princeton, N. J. ; CDL-.001659-F)

00034566 Orloski, E.J.; Manuel,  A.J. ; Magnani, L. ; et al.  (1966)  Thimet:
            Residues in Milo Fodder: Report No. C-108.   (Unpublished study
            received Feb  14, 1966 under 241-53; submitted by American Cyana-
            mid Co., Princeton, N.J.; CDL:001728-A)

00035323 American Cyanamid Company  (19??) [Thimet in Corn].  Includes un-
            dated method  entitled:  Method of Analysis of  Phorate  (Thimet)  in
            Corn.   (Unpublished  study received Nov 25,  1968 under 241-209;
            CDL:002023-B)

00035909 Castro, C.; Miller, H.;  Metz,  F.I.; et al.  (1969)  Thimet:  600:
            Residues in Cottonseed.  Includes undated method entitled:  Gas
            chromatographic procedure for the determination of the total
            Thimet: residue in cottonseed and Safflower Seed.   (Unpub-
            lished study  received Jul 10, 1972 under 241-102; prepared  in
            cooperation with Midwest Research Institute and Growers  Scien-
            tific Service, submitted by American Cyanamid Co. , Princeton,
            N.J. ; CDL.-001993-B)

00044614 Higham, J.W.; Resell, R.;  Munson, D.;  (1969) Total Tnimet:Res-
            idues in Sorghum (Fodder and Grain): Report No. C-188.   (Unpub-
            lished study  received Oct  28,  1970  under 241-102;  submitted by
            American Cyanamid Co., Princeton,  N.J.;  CDL:101283-B)

00044747 Rivers, J.B.  (1968) Determination of Thimet and  Thimet Oxygen  An-
            alog Sulfone  in Cattle  Tissue and Milk Using  an Oxidative
            GLC-Phosphorus Technique: Lab No. 1492-7-11.-.(Unpublished  study
            received on unknown  date under-241-102; prepared by United
            States Laboratories,  Inc.,  submitted by American Cyanamid Co.,
            Princeton, N.J.; CDL:093055-D)

00044751 Parkins, M.D. (1965) Analysis  of Sugar Cane Samples for  Possible
            Residues of Total Thimet: Technical Report: Lab. No.  5K8038.
            (Unpublished study including letter dated Nov l, 1967 from
            A.J. Tafuro to E.J.  Orloski,  received Jul 30, 1968 under
            241-102; prepared by Diablo Laboratories, submitted by American
            Cyanamid Co., Princeton, N.J.; CDL:093055-Q)
                                      136

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

   MRID       Citation

00052237 Roever, K.  (1971) Wildlife—Thimet:  Exposure Study:  WestAg
            71033.   (Unpublished  study received Apr  22,  1970  under 241-102;
            submitted by American Cyanamid  Co., Princeton, N.J.;  CDL:
            001992-E)

00052243 Papke, C.C.; Weis, M.E.; Morris, J.S.; et al.  (1970) Thimet:
            and Thimet Oxygen Analog Sulfone  Residues in Grain Sorghum
            (Grain, Silage, and  Fodder).  Includes undated method entitled:
            Gas chromatographic procedure for the  determination of Thi-
            met: and the metabolites of Thimet  in  sorghum fodder  and
            grain.   (Unpublished  study including report  no. C-188, received
            Jul 10, 1972 under  241-102; prepared in  cooperation with Hazle-
            ton Laboratories, Inc. and Univ.  of Nebraska,  submitted by Amer-
            ican Cyanamid Co., Princeton,  N.J.; CDL:001993-H)

00052383 Woolford, M.H., Jr.  (1959)  [Residue  Determination of Thimet-
            Treated Peanuts].   Includes methods entitled: Procedure for  the
            determination of Thimet Phorate residues  in  peanuts and Proce-
            dure for the determination of Thimet Phorate residues:  Peanut
            foliage and peanut hay.  (Unpublished  study  received  Dec 30,
            1959 under 241-53; submitted by American  Cyanamid Co.,, Prince-
            ton, N. J. ; CDL-.001701-C)

00056714 Tusing, T.W.  (1956) Progress  Report: Subacute Feeding.   (Unpub-
            lished study including letters dated Jan  25,  1956 and Mar  2,
            1956 from T.W. Tusing to D.O. Hamblin,  received on unknown date
            under unknown admin, no.;  prepared by  Hazleton Laboratories,
            submitted by American Cyanamid Co., Princeton, N.J.;  CDL:
            103361-M)

00066341 U.S.  EPA.  1981.   Research and Development.  Acephate, Aldicarb,
            Carbophenothion,  DEF, EPN,  Ethoprop, Methyl Parathion and Phorate:
            Their Acute and Chronic Toxicity, Bioconcentration Potential and
            Persistence as Related to Marine Environments.  U.S.  EPA,
            Environmental Research Laboratory, Gulf Breeze,  FLA,  EPA-600/4-81
            -041,  May 1981.

00074623 Fink, R.; Beskid, J.C.  (1981)  Final  Report:  Simulated Field Study—
            Bobwhite Quail:  Project No. 130-131A.    (Unpublished study  re-
            ceived May 21, 1981 under  241-257; prepared  by Wildlife Inter-
            national Ltd., submitted by American Cyanamid Co., Princeton,
            N.J. ;  CDL:245263-B)
                                      137

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

   MRID       Citation

00074624 Fink, R.; Beskid, J.C. (1981) Final Report:  Simulated  Field Study—
            Bobwhite Quail: Project No. 130-131B.  (Unpublished study  re-
            ceived May 21, 1981 under 241-257; prepared by Wildlife  Inter-
            national Ltd., submitted by American Cyanamid Co., Princeton,
            N.J.;  CDL:245263-C)

00074625 Fink, R.  ; Beskid, J.C. (1981) Final Report:  Simulated  Field Study—
            Bobwhite Quail: Project No. 130-131C.  (Unpublished study  re-
            ceived May 21, 1981 under 241-257; prepared by Wildlife  Inter-
            national Ltd., submitted by American Cyanamid Co., Princeton,
            N.J.;  CDL:245263-D)

00074626 Fink, R.; Beskid, J.C. (1981) Final Report:  Simulated  Field Study—
            Bobwhite Quail: Project No. 130-131D.  (Unpublished study  re-
            ceived May 21, 1981 under 241-257; prepared by Wildlife  Inter-
            national Ltd., submitted by American Cyanamid Co., Princeton,
            N. J. ;  CDL:245263-E)

00074627 Bonn, W.R. (1981) Thimet: Phorate: (CL  35 ,024/20-G): Residues
            of Total CL  35,024-related Compounds in Gastrointestinal Tracts
            of 10  Birds  (Princeton, 1980) (C-0253): Report No. C-1860.   (Un-
            published study received May 21, 1981 under 241-257; submitted
            by American Cyanamid Co.,  Princeton,  N.J.; CDL:245263-F)

00084503 Fink, R.   (1981)  Letter  sent  to  Edward M.  Lignowski dated Jul 15,
            1981  [Thimet 20G studies].  (Unpublished study received  Aug  10,
            1981  under 241-257; prepared by Wildlife International,  Ltd.,
            submitted by American Cyanamid Co., Princeton, N.J.; CDL:
            245917-A)

00085219 Sanders,  H.O. (1972) Toxicity of Some Insecticides  to  Four  Species
            of Malacostracan Crustaceans.   By U.S.  Fish and  Wildlife Serv-
            ice,  Fish-Pesticide Research Laboratory.    Washington, D.C.:
            USFWS.  (Technical papers of the Bureau of Sport Fisheries and
            Wildlife 66;  published study;  CDL:232666-T)

00087553 Roman, M. (1981) Thimet: Phorate (CL  35 ,024/20-G):  Residues of
            Total  CL 35,024-related Compounds in Soil and Corn  Plants  (BAND;
            MD, 1980)  (Simulated Field Study—Quail): Report No. C-1942.
            (Unpublished study received Nov 25,  1981 under 241-257;  submit-
            ted by American Cyanamid Co.,  Princeton,  N.J.;  CDL:246296-A)
                                      138

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

   MRID       Citation

00090490 McCann, J.A.  (1971)  [Thimet  600: Rainbow  Trout (Salmo gaird-
            reri)]: Test No.  339.   (U.S.  Agricultural  Research Service,
            Pesticides Regulation  Div., Animal  Biology Laboratory;  unpub-
            lished study; CDL:130247-A)

00090491 McCann, J.A.  (1970)  [Thimet  600: Bluegill (Lepomis  macrochir-
            us)]: Test No.  305.   (U.S.  Agricultural Research Service,
            Pesticides Regulation  Div., Animal  Biology Laboratory;  unpub-
            lished study; CDL:130247-B)

00092832 American Cyanamid  Company (1968) Effects  of Pesticides on Wildlife:
            Project No. W-116-R-1.   (Unpublished study,  including  letters
            dated Nov 20, 1970  from W.W.  Roberts to A.J.  Tafuro and from
            G.L. Zorb to Anthony Tafuro,  received  Dec  7,  1970 under 241-53;
            CDL:001743-A)

00092834 Cyanamid of Great  Britain Limited  (1964)  Report  on  Field  Observa-
            tions of Toxicity of Phorate  Granules  to Wild Life:  CDL/SJB/
            D.2.91.  (Unpublished  study received Jan 26,  1965 under 241-53;
            submitted by American  Cyanamid  Company,  Princeton,  N.J.;  CDL:
            001797-D)

00092846 American Cyanamid  Company  (1961) [Thimet  Residue Information on
            Cotton].  Includes method  dated Jan 13,  1961.   (Compilation;
            unpublished study received Mar  6, 1961  under  241-53; CDL:
            026939-E)

00092848 Hill, R.  (1963) Analysis  of  Cottonseed Oil &  Meal for Possible
            Residues of Thimet & Thimet Oxygen  Analog  Sulfone.   Method dated
            Nov 1, 1963.  (Unpublished  study received  May 13, 1964 under
            241-53; prepared by Diablo Laboratories, Inc., submitted  by
            American Cyanamid Co., Princeton, N.J.; CDL:026944-B)

00092853 Moid,I. J., Shaffer,  C.B., Ribelin, W.E., et al.  (1965)   Thimet-(R)
         Systemic Insecticide: Successive Generation Studies  With Mice: Report
         No.  65-136. (Unpublished study received on unknown date under PP0378,
         submitted by American Cyanamid Co., CDL:092661-M)

00092856 American Cyanamid Company (1962) [Residue  Study  of  Thimet on Sugar
            Beets].   (Compilation; unpublished  study received 1963  under
            PP0378; CDL:092663-A)

00092875 American Cyanamid Company (1962) [Residues  of  Thimet on Sugar
            Beets].   (Compilation; unpublished  study,  including  published
            data, received on unknown date under 241-36; CDL:092661-R)

                                      139

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

   MRID       Citation

00092876 Bowman, J>S>: Casida, J>E>  (1957) Metabolism of the systemic
            insecticide Thimet in plants.  Journal of Agric.  and Food Chemistry
            5(3):192-197.  (Also in  unpublished submission received by American
            Cyanamid Co., Princeton,  N>J>:CDL:092661-U).

00092877 Bowman, J.S.; Casida, J.E.   (1958) Further studies on  the  metabolism
            of thimet by plants, insects, and mammals.  Journal  of Economic
            Entomology 51 (6):838-843.   (Also in unpublished  submission  re-
            ceived on unknown date under  241-36;  submitted by  American
            Cyanamid Co., Princeton,  N.J.; CDL:092661-W)

00092878 Palmer, L.E.; Williams, E.F. (1956) Analysis of  Thimet  0,0-Di-
            ethyl S-Ethylthiomethyl  Phosphorodithioate  (Dithioate).   (Un-
            published study received Feb  20, 1956 under 241-36;  submitted
            by American Cyanamid Co., Princeton, N.J.;  CDL:092661-X)

00092884 American Cyanamid Company (1966) Summary of Thimet  Residues  in
            Corn.    (Compilation; unpublished study, including  lab.  nos.
            4J7528, 4J7538, 4J7538B, ..., received Aug  2, 1966 under
            7F0521; CDL:092807-G)

00092886 American Cyanamid Company (1964) [Residues of  Thimet  on Peanuts].
            (Compilation of reports  by  Diablo Laboratories,  Inc.;  unpub-
            lished study, including lab. nos. 4J7511, 2H7286 and 4J7531,
            received Aug 2, 1966 under 7F0521;  CDL:092807-J)

00092887 Orloski, E.J.; Manuel,  A.J.; Barksdale K.; et  al.  (1966)  Thi-
            met Residues in Potatoes: Report No.  C-102.   (Unpublished
            study received Aug 2, 1966  under 7F0521; submitted by  American
            Cyanamid Co., Princeton,  N.J.; CDL:092807-K)

00092889 Blinn, R.C.  (1965) Identification of Residues  of Thimet:  Pho-
            rate and  Its  Metabolites  in Sugar  Beets  by Use  of Thin-layer
            Chromatography and Micro-infrared  Spectrophotometry: PD-M 2:
            70-83.   Includes method  dated May  14, 1965.  (Unpublished  study
            received on unknown  date  under  PP0378;  submitted by American
            Cyanamid Co., Princeton,  N.J.; CDL:092664-A)

00092890 Blinn, R.C.  (1963) Thin-layer  chromatographic  isolation and  infra-
            red or colorimetric  identification of Thimet  residues.   Journal
            of the Association of Official Agricultural Chemists 46(6):952-
                                      140

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

   MRID       Citation

            960.   (Also in unpublished submission received on  unknown  date
            under PP0378;  submitted by American Cyanamid Co.,  Princeton,
            N.J.; CDL:092664-B)

00092891 Fahey, J.E.; Rusk, H.W. (1961) Determination of Organic  Phosphorus
            Residues.  (U.S. Agricultural Research Service, Entomology Re-
            search Div.;  unpublished study;  CDL:092664-C)

00092893 American Cyanamid Company  (1962)  [Thimet Residues  on Sugar Beets].
            (Compilation;  unpublished study received on unknown date under
            PP0378; CDL:092664-E)

00092905 Diablo Laboratories (1962) Evaluation of Thimet Residues in Corn:
            Technical Report:  Lab.  No. 2G6666.  Method dated Dec  14,  1962,
            including method A dated Jan 13, 1966.   (Unpublished  study re-
            ceived Aug 2,  1966 under 7F0521; submitted by American Cyanamid
            Co., Princeton,  N.J.; CDL:092808-C)

00092911 American Cyanamid Company (19??) Method of Analysis for  Phorate
            and Metabolites in Milk.   (Unpublished study received Feb  25,
            1969 under 8F0673;  CDL:092974-C)

00092914 American Cyanamid Company (1968) [Thimet Residue in Grain and
            Straw].  (Compilation;  unpublished study received  May 24,  1968
            under 241-53;  CDL:093037-B)

00092925 American Cyanamid Company (1969) [Thimet Residue in Cotton Prod-
            ucts].   (Compilation;  unpublished study received Jan  2,  1970
            under OF0938;  CDL:093243-B)

00092926 American Cyanamid Company (1969) [Thimet Residues in  Wheat].   (Com-
            pilation; unpublished study received Jan 2, 1970 under OF0938;
            CDL:093243-C)

00092930 American Cyanamid Company  (1973) Summary of Residue Studies:  [Thi-
            met].   Includes method  M-133 dated Nov 12, 1970; method M-415
            dated May 4,  1973.   (Compilation; unpublished study received
            Feb 6, 1974 under  4F1465;  CDL:093903-A)

00092930 American Cyanamid Company  (1973) Summary of Residue Studies:  [Thi-
            met].   Includes method  M-133 dated Nov 12, 1970; method M-415
            dated May 4,  1973.   (Compilation; unpublished study received '
            Feb 6, 1974 under  4F1465;  CDL:093903-A)
                                      141

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

   MRID       Citation

00092933 American Cyanamid Company (19??) Gas Chromatographic Procedure
            for the Determination of the Total Thimet: Phorate Residue
            in Soybeans, Soybean Meal, Soybean Oil, Foliage and Hay.   Un-
            dated method.  (Unpublished study received Feb 6, 1974  under
            4F1465; CDL:093904-D)

00092938 Higham, J.W. (1969)  Total Thimet: Residues  in Sorghum  (Fodder
            Grain): Report No. C-188.   (Unpublished  study received
            on unknown date under PP0727;  prepared by American Cyariamid
            Co., submitted by ?;  CDL:098421-A)

00092940 American Cyanamid Company (19??) The Determination of Thimet
            Phorate Residue Toxins in Plant Materials.  Undated method.
            (Unpublished study received on unknown date under PP0727; pre-
            pared by American Cyanamid Co., submitted by  ?;  CDL:098421-C)

00092978 Hill, R.  (1961) Phorate Evaluation Program: Laboratory No.  2F4036.
            (Unpublished study received Sep 8, 1970 under unknown admin.
            no.; prepared by Diablo Laboratories, Inc., submitted by Amer-
            ican Cyanamid Co., Princeton, N.J.;  CDL:120350-AD)

00092979 Higham, J.; Manuel,  A.; Snyder, E.  (1969) Total  Thimet: Resi-
            dues in Chicken Tissues (Muscle, Fat, Liver,  Kidney and Eggs):
            Report No. C-205.   (Unpublished study received Sep 8,  1970 under
            unknown admin,  no.; submitted by American Cyanamid Co.,  Prince-
            ton, N.J.; CDL:120350-AE)

00092988 American Cyanamid Company (1962) Residue Data on Beans.   Includes
            method dated Mar 21, 1962 and undated method  15 H.   (Compila-
            tion; unpublished study received Apr 6, 1962  under unknown
            admin,  no.;  CDL:121702-A)

00092990 American Cyanamid Company  (1961)  [Thimet  Residues—Wheat].  In-
            cludes undated methods I 5 g and I  5 h.   (Compilation;  unpub-
            lished study received Jul 30, 1962 under unknown admin,  no.;
            CDL:122057-A)

00093008 American Cyanamid Company (1969) Residue Data: [Thimet].   (Compi-
            lation; unpublished study received 1970 under 241-EX-53; CDL:
            123165-B)

00093038 Fisher, J>E> (1979)  Toxicity Data Report:  (Thimet): Report
            No. A79-103.  (Unpublished study received Jun  11,  1979  under
            241- 257; submitted by American Cyanamid Co., Princeton,
            N.J.;CDL:238595-A)

                                      142

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

   MRID       Citation

00093039 Baugher,  D>G> (1979)   Twenty-four Hour Wet  Dermal  Toxicity of Thimet
            20-G Soil and Systemic Insecticide.  (Unpublished  study received Jun
            11, 1979 under 241-257; submitted by American Cyanamid Co.,
            Princeton, N.J.:  CDL:238595-B).

00094695 American Cyanamid Company (1982) Residues of Thimet.  Includes
            method M-165 dated Mar 3, 1971.   (Compilation; unpublished study
            received Feb 2, 1982 under 241-257;  CDL:246742-A)

00097842 Sanders,  H.   (1969) Toxicity of Pesticides to the  Crustacean Gam-
            marus  iacustris.   By U.S. Fish and Wildlife Service,  Fish-pesti-
            cide Research Laboratory.   Washington,  DC: USFWS.   (Technical
            Papers of the Bureau of Sport Fisheries and Wildlife,  25;  pub-
            lished study; CDL:091932-T)

00122773 Manus, A.; Goldsmith, L.; Serkerke,  H.; et al. (1982) Thimet Soil
            and Systemic Insecticide: 18-month Chronic Toxicity and  Poten-
            tial Carcinogenicity Study in Mice: LBI Project No. 20820.
            Final  rept.   (Unpublished study received Dec 30,  1982  under
            OE2391; prepared  by Litton Bionetics, Inc., submitted  by
            American Cyanamid Co.,  Princeton,  NJ;  CDL:071329-A)

00122774 Manus, A.; Goldsmith, L.; Maloney, D.; et al.  (1982) Thimet Soil
            and Systemic Insecticide: 24-month Chronic Toxicity and  Poten-
            tial Carcinogenicity Study in Rats: LBI Project No. 20821.   Fi-
            nal rept.  (Unpublished study received Dec 30, 1982 under
            OE2391; prepared  by Litton Bionetics, Inc., submitted  by Ameri-
            can Cyanamid Co.,  Princeton,  NJ;  CDL:071330-A;  071331)

00122775 Bellies,  R.   (1979) Teratology Study in Rats: Thimet  Phorate:  LBI
            Project No.  20819.   Final rept.   (Unpublished  study received
            Dec 30,-1982 under OE2391; prepared by Litton  Bionetics, _sub-
            mitted by American Cyanamid Co.,  Princeton,  NJ; CDL:071332-A)

00126343 Newell, G.;  Dilley,  J. (1978) Teratology and Acute   Toxicology  of
            Selected  Chemical  Pesticides  Administered by Inhalation.   By
            Stanford  Research Institute.    Research Triangle Park, NC: U.S.
            Environmental Protection  Agency,  Office  of Research and
            Development,  Health Effects Research Laboratory.  (EPA-600/1-78-003;
            contract  no.  68-02-1751;  available from: NTIS:  PB277077;  also  in
            unpublished  submission received Mar 10,  1983 under 352-325;
            submitted by E.I.  du Pont de Nemours & Co., Inc., Wilmington,'  DE;
            CDL:249679-I)
                                      143

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

    Citation
00132582 Simmon, V.; Mitchell,  A.;  Jorgenson,  T.  (1977)  Evaluation of  Se-
            lected Pesticides as Chemical Mutagens: In vitro and  in vivo
            Studies.   By Stanford Research Institute.   Research  Triangle
            Park,  NC:  Health Effects Research Laboratory.    (Environmental
            health effects research series
            no.  68-01-2458; available from
            Service, Springfield, VA 22161
                                  EPA-600/1-77-028; contract
                                  National  Technical  Information
                                  also  in unpublished submission
            received Nov 28, 1980 under unknown admin, no.; submitted by
            Stauffer Chemical Co.,  Richmond,  CA;  CDL:251563-H)

00142921 American Cyanamid Co. (19??) Residue Studies: :AASTAR Insecticide
            in Corn:.   Unpublished  compilation.   44 p.

00146524 American Cyanamid Co. (19??) Product Chemistry:   :Thimet Technical
            and Thimet MC-85:.   Unpublished compilation.   59  p.

00149814 J.  D. Campbell & Sons Ltd.  (1984)  :Product Chemistry Data::
            Technical Phorate.   Unpublished study.   4  p.

00151633 Thilagar, A. (1985) Test for Chemical Induction  of Gene Mutation
            at the HGPRT Locus in Cultured Chinese Hamster Ovary (CHO)  Cells
            with and without Metabolic Activation: AC 35,024: Sitek's Study
            No. 0007-2500.   Unpublished American Cyanamid Co.s Study No.
            980-85-133 prepared by  Sitek Research Laboratories.   53 p.

00152640 Fletcher, D. (1984) 42-day Neurotoxicity  Study with Phorate in
            Mature White Leghorn Chickens: BLAL No. 83 DN 103.  Unpublished
            study prepared by Bio-Life Associates,  Ltd.   51  p.

00153487 American Cyanamid Co. (1984) .-Thimet Residue and Metabolism Data:.
            Unpublished compilation.   122 p.
00155595 Vieira, E. (1985) Thimet  (HL-85-069; WORMS #6099): Corrosion.
            published study prepared by American Cyanamid Co.   11 p.
                                                               Un-
00155597 Ivett, J. (1986) Chromosomal Aberrations in vivo  in  Mammalian  Bone
            Marrow Cells on AC 35,024: Second Amended Final Report:  LBI
            Project No.  22202.  Unpublished study prepared by Litton Bione-
            tics.   50 p.

00156201 Hussain,  M.  (1986) Thimet Insecticide, Phorate  (CL 35,024):  Meta-
            bolic  Fate of Carbon-14 Labeled CL  35,024 in Milk and Various
            Tissues of Lactating Goats: Report No. PD-M Volume 23-3.  Unpub-
            lished study prepared by American Cyanamid Co.   47 p.
                                      144

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

   MRID       Citation

00158330 American Cyanamid Co. (1986) Thimet Phorate  (CL  35,024/20-G):  Res-
            idue of Total CL  35 ,024-related Compounds  in  Field  Corn:  Project
            No.  0109.   Unpublished study prepared by Hazleton Labs  America,
            Inc. and American Cyanamid Co.   70  p.

00158334 Beavers, J.  (1986) Phorate  Technical:  A  One-generation Reproduction
            Study with the Mallard (Anas platyrhynchos):Final Report:
            Project No.130-142.  Unpublished study prepared by  Wildlife
            International Ltd.  104 p.

00158336 Surprenant, D.   (1986) The Chronic Toxicity  of :Carbon-14:-AC35,024
            to Daphnia magna under Flow-through Conditions: Report  No.
            BW-86-3-1966.  Unpublished study prepared  by  Springborn
            Bionomics, Inc.   56 p.

00158941 Baldi,  A. (1985) Letter sent to W. Miller dated  Aug  29, 1985:
            Phorate Technical  Insecticide: :Product chemistry data:.  Pre-
            pared by Aceto Agricultural Chemicals Corp.  6 p.

00160001 Tucker, R.  K. and D.  G.  Crabtree,  Handbook of Toxicology of Pesticides
            Wildlife,  USDI,  FWS,  Resource Publication 84,  June 1970.

00160047 Higham, J. (1986) :Thimet Phorate  (CL  35,024/20-G): Residue  of
            Total CL 35,024-Related Compounds in Sweet  Corn:.   Unpublished
            compilation prepared by American Cyanamid Co.   61  p.

00160048 Higham, J. (1986) :Thimet Phorate  (CL  35 ,024/20-G): Residue  of
            Total CL 35,024-Related Compounds in Wheat:.  Unpublished  com-
            pilation prepared by American Cyanamid Co.   100 p.

00161575 Higham, J. (1986) Thimet Phorate  (CL 35,024/20-G): Residues  of
            Total CL  35,024-Related Compounds in Peanut Plant,  Meats, Hulls,
            and  Hay (IF + PEG: TX, 1985)  (C-2772).   Unpublished compilation
            prepared by American Cyanamid Co.   72 p.

00161576 Bohn, W. (1986) Thimet Phorate  (CL 35,024/20-G):  Residues  of Total
            CL 35,024-Related Compounds in Sugar Cane  (IF: FL,  1985)  (C-
            2776):  Report No.   C-2779: Experiment No. 60928-85-T22A(6369).
            Unpublished study prepared by American Cyanamid Co.   21  p.

00161821 American Cyanamid Co. (1986) Phorate Registration Standard:  Addi-
            tional Field Corn Residue Data.   Unpublished compilation.   24  p.

00161822 Nicholson, R.;  McNabb, T. (1986) Acute Toxicity  of Thimet  20G  to
            Rainbow Trout (Salmo gairdneri): Report #BW-86-6-2051;  Study

                                      145

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

   MRID       Citation

            #451.1285.6108.103.   Unpublished study prepared by Springborn
            Bionomics, Inc.   34 p.

00161823 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet  20G  to
            Bluegill (Lepomis macrochirus):  Report #BW-86-6-2052; Study

            #451.1285.6108.100.   Unpublished study prepared by Springborn
            Bionomics, Inc.   33 p.

00161824 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet  20G  to
            Channel Catfish (Ictalurus punctatus): Report #BW-86-6-2056;
            Study #451.1285.6108.107.  Unpublished study prepared by Spring-
            born Bionomics,  Inc.   34  p.

00161825 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet  20G  to
            Daphnids (Daphnia magna): Report #BW-86-6-2055; Study #451.1285.
            6108.110.   Unpublished study prepared by Springborn Bionomics,
            Inc.   32 p.

00161826 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet  20G  to
            Midge Larvae (Paratanytarsus parthenogenica) : Report #BW-86-6-
            2057; Study #451.1285.6108.111.   Unpublished study prepared by
            Springborn Bionomics,  Inc.   32 p.

00162745 McCann,  J.A., Teeters,  W. , Urban, D.J., Cook,  N. Short-term dietary
            test on small mammals;  Avian Mammalian Wildlife Toxicology:  Second
            Conference.  ASTM STP 767. D.W. Lamb and E.E.  Kenaga,  Eds., American
            Soc.  for Testing and Materials,  1981,  p 132-142.

05008363 Hudson,  R.H.; Haegele, M.A.; Tucker, R.K.  (1979) Acute oral and
            percutaneous toxicity of  pesticides to mallards: correlations
            with mammalian toxicity data.  Toxicology and Applied
            Pharmacology 47(3):451-460.

40000601 Potts, C. (1986) Thimet Phorate  (CL 35,024) Validation of  GC Method
            M-1672 for the Determination of Total  CL  35,024-Related Residues
            in Oil and Meal :Corn::  Project no. 0109.  Unpublished  study
            prepared by American Cyanamid Co.   18  p.

40000602 Potts, C. (1986) Thimet Phorate  (CL 35,024/20-G) Residues  of Total
            CL 35,024-Related Compounds in Corn, Oil, and Meal  (Band,  Cult,
            Fol;  II, 1985): Project no. 60918/85/T10R/6328.  Unpublished
            study prepared by American Cyanamid Co.  20 p.
                                      146

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

    Citation
40001802 Suprenant, D.  (1986) Acute Toxicity  of  Thimet  20G to Mysid Shrimp
            (Mysidopsis bahia):  Acute Toxicity - Estuarine  and Marine
            Organisms: Project  ID: BW-86-6-2135.   Unpublished study prepared
            by Springborn Bionomics,  Inc.  39 p.

40004201 Suprenant, D.  (1986) Acute Toxicity  of  Thimet  20G to Quahog Clam
            (Mercenaria mercenaria):  Acute Toxicity—Estuarine and  Marine
            Organisms: Laboratory Project ID: BW-86-6-2139.   Unpublished
            study prepared by Springborn Bionomics, Inc.  31 p.

40077301 Lavin, M.  (1986) Aerobic Soil  Metabolism  of  :Carbon 14:-Phosphate:
            Final Report: Project ID:   #33733.   Unpublished study prepared
            by Analytical Bio-Chemistry Laboratories,  Inc.  961 p.

40165901 Dingledine, J.; Jaber, M. (1987) An  Evaluation of the Effects of
            Thimet 20-G upon Terrestrial Wildlife  Species  under Actual Use
            Conditions: Laboratory Project ID: 130-139.   Unpublished study
            prepred by Wildlife International, Ltd.  494 p.

40174514 Roman, M.  (1987) Thimet Phorate  (CL  35,024):   Residues of CL  35,024
            and Its Five Potential Metabolites in  Green Corn Plants and Corn
            Straw: Project No.  0109:  Report No.  C-2869.   Unpublished study
            prepared by American Cyanamid Co.   24 p.

40174515 Roman, M.  (1987) Thimet Phorate  (CL  35 ,024/20-G) :   Residues of CL
            35,024 and Its Five Potential Metabolites in Green and  Dry Pea-
            nut Plants: Project No. 0109: Report No. C-2875.   Unpublished
            study prepared by American Cyanamid Co.  23  p.

40174516 Roman, M.  (1987) Thimet Phorate  (CL  35,024/20-G):   Residues of CL
            35,024 and Its Five Potential Metabolites in Green and  Dry
            Wheat Plants: Project No. 0109: Report No.  C-2876.  Unpublished
            study prepared by American Cyanamid Co.  30  p.

40174517 Bohn, W. (1987) Thimet Phorate  (CL 35,024/20-G):   Residues of CL
            35,024—Related Compounds in Potato Tubers:   Project No.  0109:
            Report Nos. C-2849.   Unpublished  compilation prepared by Ameri-
            can Cyanamid Co.   9  p.

40174518 Higham, J.  (1987) Thimet Phorate  (CL 35,024/20-G):   Residues  of  CL
            35,024—Related Compounds in Sugar Beets:  Project  No. 0109.   Un-
            published compilation prepared by American  Cyanamid Co.   57 p.'
                                      147

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

   MRID       Citation

40174519 Higham, J. (1987)  Thimet Phorate (CL 35 ,024/20-G):  Residues  of  CL
            35,024—Related Compounds in Beans:  Project No. 0109.  Unpub-
            lished compilation prepared by American Cyanamid Co.   63  p.

40174520 Higham, J. (1987)  Thimet Phorate (CL 35,024/20-G):  Residues  of  CL
            35,024—Related Compounds in Sorghum: Project No. 0109.  Unpub-
            lished compilation prepared by American Cyanamid Co.   36  p.

40174521 Higham, J. (1987)  Thimet Phorate (CL 35 ,024/20-G):  Residues  of  CL
            35,024—Related Compounds in Cotton: Project No. 0109.   Unpub-
            lished compilation prepared by American Cyanamid Co.   42  p.

40174522 Higham, J. (1987)  Thimet Phorate (CL 35,024/20-G):  Residues  of  CL
            35,024—Related Compounds in Soybeans: Project No. 0109.   Unpub-
            lished compilation prepared by American Cyanamid Co.   69.

40174523 Potts,  C. (1987) Thimet Phorate  (CL 35,024/20-G):  Residues of  To-
            tal  CL 35,024—Related Compounds  in Corn Grits, Flour, Hulls,
            and  Presscake:  Project No. 0109:  Report No. C-2865.   Unpublished
            compilation  prepared by American  Cyanamid Co.   20  p.

40174524 Mangels,  G. (1987) Thimet Insecticide, Phorate (AC 35,024):   Ad-
            sorption/Desorption on Soil:  Project No. 0109:  Report No.  PD-M
            Volume 24-18.  Unpublished study prepared by American Cyanamid
            Co.   37 p.

40174525 Sanders,  P. (1987) Thimet Insecticide, Phorate (AC 35,024):   Aged
            Soil Column  Leaching:  Project No. 0109: Report No. PD-M  Volume
            24-17.  Unpublished study prepared by American Cyanamid  Co.   142
            P-

40174527 Shellenberger,  T.; Tegeris,  A.  (1987) One-year Oral Toxicity  Study
            in Purebred  Beagle Dogs with AC 35,024: Laboratory Project Id:
            85015.  Unpublished study prepared by Tegeris  Laboratories,  Inc.
            881  p.

40174528 Schroeder, R.  (1987) A Teratology Study with Phorate in Rabbits:
            Project No.  86-3039.   Unpublished study prepared by  Bio/Dyna-
            mics,  Inc.   359 p.

40197201 Potts,  C. (1987) Thimet Phorate  (CL 35,024): Validation of  GC
            Method M-1724 for the Determination of Total CL 35,024-Related
            Residues in  Corn Germ: Method of Analysis—Validation: Project
            No.  0109;  Report No.  C-2906.  Unpublished study prepared by
            American Cyanamid Co.   16 p.

                                      148

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

   MRID       Citation

40197202 Higham, J. (1987) Thimet Phorate  (CL  35,024):  Validation of GC
            Method M-1722 for the Determination of Total  CL  35,024-Related
            Residues in Sorghum Plant (Green and Dry) and Grain:  Method of
            Analysis—Validation:  Project No.  0109; Report No.  C-2894.   Un-
            published study prepared  by American Cyanamid Co.  20 p.

40197203 Peterson, R.  (1987) Thimet Phorate (CL 35,024):  Validation  of  Gas
            Chromatographic Method M-1725 for the Determination  of Total CL
            35 ,024-Related Residues in Peanut Oil: Method of. Analysis—Vali-
            dation: Project No. 0109; Report No. C-2910.   Unpublished study
            prepared by American Cyanamid Co.   15  p.

40197204 Roman,  M. (1987) Thimet Phorate  (CL 35,024/20-G) :"' Residues  of  CL
            35,024 and Its Five Potential Metabolites in  White  Potato
            Tubers: Nature of Residues: Project No. 0109;  Report No.  C-2903.
            Unpublished study prepared by American Cyanamid Co.   14 p.

40197206 Higham, J. (1987) Thimet Phorate  (CL  35,024/20-G):  Residues of
            Total CL 35,024-Related Compounds in Green  Beans  and Plants:
            Magnitude of Residues:  Project No.  0109; Report  No.  C-2884.   Un-
            published study prepared  by American Cyanamid Co.  12 p.

40197207 Shimel, K. (1987) Thimet Phorate  (CL 35 ,024/20-G):  Residues of
            Total CL 35,024-Related Compounds in Processed Potato Flakes,
            Chips, Granules and Potato Tubers:  Magnitude  of  Residues:
            Project No.  0109; Report No. C-2923.  Unpublished study  prepared
            by American Cyanamid Co.   29 p.

40197209 Peterson, R.  (1987) Thimet Phorate (CL 35,024/20-G): Residues  of
            Total CL 35,024-Related in Peanut Commodities  (Refined and  Crude
            Oil  and Peanut Meats):  Magnitude of Residues:  Project No. 0109;
            Report No.  C-2927.  Unpublished study prepared by American
            Cyanamid Co.   13 p.

40263401 Potts,  C. (1987) Thimet Phorate  (CL 35,024): Residues  of Total CL
            35,024—Related Compounds in Corn Soapstock and  a Summary of
            Residues in All Corn Processed Commodities:  Project  No.  0109,
            Report No.  C-2932.  Unpublished study prepared by American
            Cyanamid Co.   15 p.

40291601 Hussain, M.  (1987) Thimet Insecticide, Phorate  (CL  35,  024): DisT
            position and Metabolic  Fate of Carbon-14 Labeled  CL  35,  024 in
            the  Rat:  General Metabolism—Rat:  Project No.  0109;  Report  No.
            PD-M Volume 24-23.  Unpublished study prepared by American  Cy-
            anamid Co.   135 p.

                                      149

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

   MRID       Citation

40386301 Peterson, R. (1987) Thimet Phorate  (CL  35 ,024/20-G): Residues of
            Total CL 35,024—Related Compounds  in  Peanut  Presscake  (Expeller
            and Solvent Extracted) ...: Magnitude of Residues, Processed
            Commodities:  Laboratory Project ID:  0109.  Unpublished study
            prepared by American Cyanamid Co.   10 p.

40386302 Bonn,  W.  (1987) Thimet Phorate  (CL 35,024): Freezer  Stability of
            Total CL35,024—Related Residues in Potato Tubers. Freezer Sta-
            bility of Residues: Laboratory Project ID: 0109.  Unpublished
            study prepared by American Cyanamid  Co.   7  p.

40386303 Roman, M. (1987) Thimet Phorate  (CL 35,024):  Freezer Stability  of
            Total CL 35,024—Related Residue in Corn Commodity:  Green Plants
            Straw and Grain. Freezer Stability  of  Residues:  Laboratory Proj-
            ect ID: 1090.  Unpublished study prepared  by  American Cyanamid
            Co.  11 p.

40386304 Potts, C. (1987) Thimet Phorate  (CL 35,024):  Freezer Stability  of
            Total CL 35,024—Related Residues in Refined  Corn Oil and Corn
            Meal.  Freezer Stability of Residues: Laboratory Project ID:
            0109.  Unpublished study  prepared by American  Cyanamid Co.   9 p.

40386305 Peterson, R. (1987) Thimet Insecticide Phorate (CL  35,024): Freezer
            Stability of Total CL 35,024—Related Residues in Sugar  Beet
            Roots and Tops. Freezer Stability of Residue:  Laboratory Project
            ID: 0109.  Unpublished study prepared by American Cyanamid Co.
            8 p.

40386306 Bonn,  W.  (1987) Thimet Phorate  (CL 35,024): Freezer  Stability of
            Total CL 35,024—Related Residues in Wheat Grain, Straw  and
            Green Plants.  Freezer Stability of  Residues:  Laboratory Project
            ID: 0109.  Unpublished study prepared by American Cyanamid Co.
            11  p.

40386307 Miller,  G.  (1987) Thimet Insecticide (AC  35,024): Air Photolysis:
            Photodegradation in Air:  Laboratory Project ID: 0109.  Unpub-
            lished study prepared by  University  of Nevada.  50 p.

40386310 Forbis,  A.  (1987) Uptake, Depuration and Bioconcentration of Car-
            bon 14:-AC 35024 to Bluegill  Sunfish  (Lepomis machrochirus): Fi-
            nal Report:  Laboratory Project ID:  35373;  Protocol No.:
            981-86-180.   Unpublished study prepared  by Analytical Bio-chemi-
            stry  Laboratories,  Inc.   323  p.
                                      150

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

   MRID       Citation

40386311 Hussain, M.   (1987) Thimet Insecticide  Phorate  (CL  35,024):  Metabo-
            lic Fate of CL 35,024 in Bluegill  Sunfish  (Lepomis  macrochirus):
            Accumulation in Fish: Laboratory Project ID:  0109.   Unpublished
            study prepared by American Cyanamid Co.   20 p.

40432001 Bonn, W.  (1987) Thimet Insecticide, Phorate  (CL  35,024/20-G):  Dis-
            sipation of Residues of CL 35,024  and Its  Degradates in  Soil:
            Field Dissipation—Soil:  Project No. 0109: Report No.  C-3024.
            Unpublished study prepared by American Cyanamid Co.   115  p.

40586501 Potts, C.  (1987)  Thimet phorate  (CL35,024/20-G):  Residues of Total
            CL35,024-Related Compounds in Peanut Soapstock:  Project 0109:
            Report C-3007.   Unpublished study prepared by American Cyanamid
            Co.  11 p.

40586504 Peterson, R. (1987) Thimet phorate  (CL35,024):   Validation  of  GC
            Method M-1752 for the Determination of Total  CL  35,024-Related
            Residues  in Peanut Presscake: Project 0109: Report  C-2985.  Un-
            published study prepared by American Cyanamid Co.  14 p.

40586505 Potts, C. (1987) Thimet phorate  (CL35,024):   Validation of  GC  Me-
            thod M-1752 for the Determination  of Total CL 35,024-Related Re-
            sidues in Peanut Soapstock: Project 0109:  Report C-3012.  Unpub-
            lished study prepared by American Cyanamid Co.  14 p.

40586506 Higham, J.;  Roman, M.; Shimel, K.  (1988) Thimet  phorate (CL35,024/
            20-G):   Residues of CL 35,024 and  Its Metabolites in Soil:  Pro-
            ject 0109.  Unpublished study prepared by  American  Cyanamid Co.
            157 p.

40586507 Acton, C.; Good,  T.; Martin,  C.  (1988) Thimet 20G:  Product Integrity
            Study (EPA Guideline No.  85-2).  Project  0432.   Unpublished study
            prepared by American Cyanamid Co.  60 p.
                                      151

-------
IV.     FORMS APPENDICES

-------
         EPA  Form  8580-1
OMB Approval  NO.   2070-0057
Expires  11/30/89
               PIFHA SECTION 3(C)(2»(BI SUMMARY SHEET
                                                                            EPA REGISTRATION NO
PRODUCT NAME
APPLICANT S NAME
                                                                            DATE GUIDANCE DOCUMENT ISSUED
 With r«ip«ct to rh« rtquiremtnt to submit "gen«r<" diti impoitd by tht FIFRA nction 3(C)(2)(8I notiCI conmn*d in th» r«ft'«nc«d
 Guidincc Document. I »rn responding in tt\t following minntr.
    O I.  I will nbmit diti m i timily minnir to atrff» tt\i following rtquirmtntL If ttii ttfl proctdurti I will u* divnu from (or vt not
         tpKi(i«d m) ttii Rtftrtntion Guidilinn or tni Protocoli contumd in thi Rtportt of Eicxn Groups to tni Chimcj^i Group, OECO
         Chimicili Ttnmg Prognmmc. I melon ttii protocols (hit I will an:


     Attach  separate  page  with  a list  of  the  data  requirements  your
     company agrees  to  satisfy.
    D 2.  I hiv« ennrcd into in »$rwm»nt with OM or mori othir riflamnti un^ir FIFRA nction 3(C)(2)(8l(ii) to ansty C\t followmj diti
         nquinmtnts. Tht ttns. ind iny nquirtd protocols, will b« lubmitttd to EPA by:

 NAME Of- OTMgq REGISTRANT

                   Attach  list  of  data  requirements
    D 3. I tncloa i complitid "Cirtifeition o< Antmpt to Entir Into in Agrnmint with Othir Rt^inrinu lor Ocvilopm«m of Oiu" with
         rupict to th( following dia nquinmtntt
    (~J 4. I nquet tnn you im«nd my rtgiimtion by dtlitmg thi lodowiog uui (this option a not «v«iUol« to «;plicjn;i for n proCucu):
    O S. I rtqutn valuntwy cincillition of thi riginntion al this product. (This option ts not tvtiliblt to tppl
-------
            EPA  Form  8580-6
                                                           OMB Approval  No.   2070-0057
                                                           Expires  11/30/89
(To Qutlify. certi
                       four ittmtl
                                         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(t) who are «ub(«ct to the require-
    menu of a Notice under FIFRA Section 3(cl(2l(8) conuined in a Guidance Document
    to ujbmit dan concerning the active ingredient:
                                                                                   GUIDANCE DOCUMENT DATE
                                                                                 ACTIVE INGREDIENT
                                     NAME Of FIRM
                                                                                           Ef A COMPANY NUMBER
  (Thu firm or group of firrm it referred to txlow «i "my firm".)
 2. My firm U willing to develop and iubmit th« data as required by that Notice, if neceoary. Howevar. my firm would prefer to enter
    into an agreement with ooe or more other registrant* to develop jointly, or to tKtre in the co»t of developing, the following required
    itomi or data:
 3. My firm ha* offtnK) in writing to anttr into aueh an aontamaiTt. Cop'wt of th« offtn m trtach»d. That oH»r w*i irmocabU and incluoWd an oftir to tn
   bound by an trbrtnrtion dictti'on und«r FIFRA Saction 3(c)(2)(8)(iii) if final agrMmint on all armi could not tx r**ch*d ottiarwiat. Thit orftr w«t mad*
   to ttic following firmfij on rh« following dattil):
                                    NAMC Of
                                                                                              DATE OF OFFER
Howew, none of thov> firm(t) acoaptad my off«f.
4. My firm r»qu«m th«t EPA not iu«p«nd th« n»giftr«tJon(»l of my firm'i product(j). if any of th« firmi rum«d in paragraph (3) above
   have agr««d to lubmit tfc« data lirttd in paragraph (2) ibov« in accordance with th« Notica. I unoarttand EPA wi.l promptly inform
   ma wh«h«f my firm mun submit datl to tvokl *u
-------
US Environmental Protection Agency Registration Standard for:
Washington, DC 20460
V>EPA Product Specific
Data Report
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63^
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test

Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Rammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage

Acute oral toxicity, rat
Acute dermal toxicity, rabbit
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitization
Testing not
required for my
product listed
above
(Check below)


































EPA Registration Number
I am complying with
Data Requirements by -
Citing MR ID No.


































Submitting Data
(Attached)
(Check below)


































Form Approved
OMB #2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned


































Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Name and Title Signature
Date
EPA Form 8580-4 (R«v. 5-68) Previous edition is obsolete.
                                                                     155

-------
                                                                 CMB Approval No. 2070-005
                                                                 Expiration Date 11/30/89
                             GENERIC EftTA EXEMPTION! STATEMENT

EPA Product Registration Number:	

Registrant's Name and Address:   	
     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 sutmission 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 sutmit 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 FIFRA
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 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
required generic data.  If the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet requirements 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 comnits to
submit and submits the required 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
                                               4U.S. GOVERNMENT PRINTING OFFICE: 19 89- 6 1 7-0 0 3 / 0 >t8 s 1
                                            156

-------