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
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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
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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
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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
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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
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OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued in
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
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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.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name: 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)
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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)
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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).
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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
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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.
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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
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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
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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
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(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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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.
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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.
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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.
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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
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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%.
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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
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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.
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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
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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.
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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/
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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.
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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*
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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)
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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/
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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
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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
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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
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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
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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
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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
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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
-------
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HAIAMMTOMUMAW
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tTATIUtNT Of rftACTCAL TfltATUCNT
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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
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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
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(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
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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
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§ 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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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IV. FORMS APPENDICES
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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
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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
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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
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