United States
Environmental Protection
Agency
Pesticides and
Toxic Substances
(H-7501C)
540/RS-90-074
Registration Standard For
Pesticide Products
Containing Ethion
As The Active Ingredient
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OMB Control No. 2070-0057
Expires November 1989
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ETHION
AS THE ACTIVE INGREDIENT
OPP Chemical Number: 058401
GS 0090
CAS (DOCKET) NUMBER : 563-12-2
September 29, 1989
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TABLE OF CONTENTS
I. INTRODUCTION 1
II. CHEMICAL COVERED BY THIS STANDARD 3
A. DESCRIPTION OF CHEMICAL 3
B. OTHER IDENTIFYING CHARACTERISTICS 3
C. USE PROFILE 4
III. AGENCY FINDINGS 7
A. SUMMARY 7
B. HEALTH EFFECTS ASSESSMENT 8
C. ENVIRONMENTAL CHARACTERISTICS AND EFFECTS ... 15
D. TOLERANCE REASESSMENT 20
E. CROP GROUP TOLERANCES 26
F. RESIDUE DATA 26
IV. REGULATORY POSITION AND RATIONALE 35
A. REGULATORY POSITIONS AND RATIONALE 35
B. CRITERIA FOR REGISTRATION 38
C. ACCEPTABLE RANGES AND LIMITS 38
D. REQUIRED LABELING 40
V. PRODUCTS SUBJECT TO THIS STANDARD 45
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA 55
A. What are generic data? 48
B. Who must submit generic data? 48
C. What generic data must be submitted? 49
D. How to comply with DCI requirements 49
E. Registrant Requests Regarding Data Requirements
and Agency Responses 52
F. Test Protocols and Standards 52
G. Procedures for requesting a change in test
protocol 53
H. Procedures for requesting extensions of time . . 53
I. Data Format and Reporting Requirements 53
J. Existing stocks provision upon suspension or
cancellation 54
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC
DATA 54
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING . . 55
IX. INSTRUCTIONS FOR SUBMITTAL 55
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APPENDICES
:. DATA APPENDICES
Guide to Tables 62
Table A 65
Table B 97
Table C 101
II. LABELING APPENDICES 104
Summary of label requirements and table 105
40 CFR 156.10 Labeling Requirements 113
Physical/Chemical Hazards Labeling Statements . . . 125
Storage Instructions 126
Pesticide Disposal Instructions 127
Container Disposal Instructions 128
III. BIBLIOGRAPHY APPENDICES 129
Guide to Bibliography 130
Bibliography 132
IV. FORMS APPENDICES 140
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet . . 141
EPA Form 8580-3 Generic Data Exemption Statement . 142
EPA Form 8580-4 Product Specific Data Report . . . 143
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other
Registrants for Development of
Data 145
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a. i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HOT
K+CWHR
LC50
LD50
LOT
LEL
MPI
MRID
Acceptable Daily Intake. Also known as the
Reference Dose or RfD.
Active ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The
estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
End Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
Kernel plus Cob With Husk Removed
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/i 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.
Lowest Dose Tested
Lowest Effect Level
Maximum Permissible Intake
Master Record Identification (number). EPA's
system of recording and tracking studies submitted
to the Agency.
iii
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GLOSSARY OF TERMS AND ABBREVIATIONS (continued)
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts per million
RfD Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
iv
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I.INTRODUCTION
This document is a revised Registration Standard ethion.
In its original Standard, issued in 1982 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 the additional 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.
LThe scientific reviews and Compendium of Acceptable Uses
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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0 Section III sets out the Agency's scientific
assessment of the health risks and environmental
characteristics and effects of the chemical, updated
based on data submitted to the Agency under the original
Registration Standard.
0 Section IV explains the regulatory decisions and
conclusions arising from the Agency's assessment, and
the rationales for its decisions. Section IV also
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 V, VI, VII, VIII and IX 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.
0 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.
0 Appendix II is a series of labeling information
sheets, setting out general labeling information that
must be placed on labeling.
0 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.
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 submittal of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name: Ethion
Generic (Chemical) Name: O,0,0',O'-Tetraethyl S, S»-
methylene bis (phosphorodithioate)
Chemical Structure:
S S
I I
(C2H5O) 2P-S-CH2-S-P (OC2H5) 2
Chemical Family: Organothiophosphate member of the
Organophosphate family.
B. OTHER IDENTIFYING CHARACTERISTICS AND CODES
CAS Registry Number: 563-12-2
EPA Pesticide Chemical Code (Shaughnessy Number):
058401
Empirical Formula: CgH2204P2S4
Molecular Weight: 384.5
Physical/Chemical Characteristics of the Technical
Grade:
EPA Reg No. 279-2280
4787-10
2749-293 (suspended 7/4/85)
Color: colorless to light brown or pale yellow.
Physical state: liquid at room temperature.
Odor: mild dithiophosphate
Melting point: -12° to -15°C
Boiling point: 164-165°C at 0.3 mm Hg.
Specific gravity: 1.215 - 1.230 at 20°C
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Physical/Chemical Characteristics of the Technical
Grade: (continued).
Solubility: Practically insoluble in water; soluble in
most organic solvents.
Vapor pressure: 1.5x 10~6mm Hg at 25°C.
Dissociation constant: Not applicable; TGAI does not
disperse in water.
Octanol/water partition coefficient: 10,000 [GC with
FPD detector].
pH: 5.1 in an equal volume of distilled water.
Storage stability: 95% of ethion remained unchanged
during one year of storage at
25°C.There was <2% deterioration in
three years of storage under the
same conditions. Recommended shelf
life is two years. Do not store
below 20°F to avoid crystal
formation.
Corrosion: Ethion does not corrode stainless steel or
aluminum.
C. USE PROFILE
Type of insecticide: non-systemic insecticide
Year of Initial Registration: 1965
Registered Uses:
Terrestrial Food Crop Use; Alfalfa (seed crop),
almonds, apples, apricots, beans, cherries,
chestnuts, corn (field), cotton, cucumbers,
eggplants, filberts, grapefruit, grapes, lemons,
limes, melons, nectarines, onions (dry & green),
oranges, peaches, pears, pecans, peppers, pimentos,
plums, prunes, sorghum (grain & forage), sorghum
(seed crop), squash (summer), strawberries, tangelos,
tangerines, tomatoes, and walnuts.
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Registered Uses: (continued)
Terrestrial Non-food Crops; Bermudagrass, Junipers,
ornamental evergreens, pine trees , lawns,
ornamental turf, and ornamental plants.
Greenhouse Non-food Crops; Ornamental plants.
Domestic Outdoor Uses; Domestic dwellings, and
lawns.
Pests Controlled: Leaf-feeding insects, mites, and
scales.
Methods of Application: Ground and aerial foliar
applications, furrow treatments
by ground equipment, and seed
treatment.
Annual Usage: 1.2 to 1.5 milion pounds of active
ingredient are used in the United States.
Predominant Usage: Citrus accounts for 86% to 89% of
the total pounds of ethion used in
the United States. The remaining 11%
to 14% is applied to cotton and a
variety of fruit trees, nut trees,
and vegetables. Approximately 55% to
70% of all domestically produced
citrus fruits are treated with
ethion. Less than 2% of the
domestic cotton acreage, and fewer
than 10% of the fruit (other than
citrus), vegetable and nut acreage
is treated with ethion.
Mode of Insecticidal Activity: Toxic action is exerted
by inhibiting enzymes of
the nervous system
through inhibition of
cholinesterase.
Formulations: Emulsifiable solution: 500g/l
Wettable powder: 25%
Dusts: 2%, 3%, and 4%
Emulsifiable concentrates: 4 and 8 Ibs/gal
Granules: 5% and 10%
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U.S. and Foreign Producers and Manufacturers:
Chemi nova (Denmark)
FMC Agricultural Chemical Group (US)
M/S Pesticides (India)
Rhone-Poulenc Agrochemie (France)
Sintesul S.A. (Brazil)
Volrho (India)
Table 1 - Compilation of Ethion Registrations
Federal SLN Total
Single Multiple
active active
ingredient ingredient
Technical 3 003
Dust 1 102
Granular 4 026
Wettable Powder 6 107
Emulsifiable
concentrate 5 28 7 40
Soluble
Concentrate Liquid _0_ 0 0 0
Total 19 30 9 58
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III. AGENCY FINDINGS
A. Summary of Ethion Data Base
The Agency issued a Registration Standard for ethion in
1982. This Registration Standard required that certain data
be submitted to the Agency. As a result, the status of the
ethion data base is listed below. This information is
presented in summary form; a discussion of the data is
presented in the remainder of this section and specific
requirements are detailed in the data tables in Appendix I of
this document:
1. Toxicology
The following toxicological data requirements are
satisfied: acute toxicity, chronic toxicity with the
exception of a non-rodent chronic feeding study,
oncogenicity, teratogenicity, and reproduction. The
requirement for a 90-day non-rodent subchronic feeding
study has been satisfied. Because an acceptable chronic
rodent feeding study is available, the Agency has
determined that the requirement for a subchronic rodent
feeding study is waived. Since an acute neurotoxicity did
not show neurotoxic effects, a 90-day delayed neurotoxic
study is also waived. The requirement for a 21-day dermal
toxicity has been satisfied and 90-day subchronic dermal
toxicity and 90-day inhalation toxicity studies are not
necessary under the registered use patterns. The requirement
for general metabolism studies is reserved. Three metabolism
studies are currently under review by the Agency. The
registrant will be notified if additional studies are
required. The data requirements for mutagenicity are
partially satisfied, a gene mutation study was reviewed and
determined to be acceptable. Additional mutagenicity testing
is required for chromosomal aberration and other mechanisms
of mutagenicity.
2. Residue Chemistry
Data submitted in response to the 1982 Registration
Standard showed that additional plant and animal metabolism
studies, storage stability studies, residue studies in
poultry meat, milk, and eggs, and residue reduction studies
in food crops are required to allow a complete dietary
exposure assessment.
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3. Environmental Effects
The 1982 Ethion Registration Standard required the
following environmental fate studies: hydrolysis,
photodegradation in water and soil, aerobic and anaerobic
soil metabolism, leaching field dissipation (terrestrial) and
fish bioaccumulation (lab). These data were submitted and
reviewed. The only data requirements that have been satisfied
are aerobic soil metabolism and fish accumulation. The
hydrolysis data requirement has been partially satisfied and
additional hydrolysis studies are required. The remaining
environmental fate data are outstanding: photodegradation
(water, soil, and air), anaerobic soil metabolism, mobility
(leaching and adsorption,and volatility), dissipation
(soil), and accumulation (rotational crops).
4. Ecological Effects
The 1982 Registration Standard for ethion required the
submission of two studies relating to ecological effects;
acute avian oral toxicity and acute toxicity to estuarine and
marine organisms. These studies were reviewed and determined
to satisfy the data requirements. Based on ethion's
persistence, expected residues on avian food, bioaccumulation
in fish, and high fish toxicity, additional ecological
effects studies are required: fish early life stage and
invertebrate life cycle; and avian reproduction.
5. Non-Dietary Exposure
The 1982 Registration Standard required the registrants
of ethion products to submit either a full battery of worker
protection/reentry studies or adopt the most restrictive
reentry intervals imposed by the states. No worker
protection/reentry data have been submitted to the Agency for
review. The Agency is requiring product labeling relating to
worker protection, the most restrictive reentry intervals
imposed by the states, and the full battery of worker
protection/reentry studies.
B. Health Effects Assessment
Below is an assessment of the human health risks
associated with the insecticide ethion based upon the data
submitted in response to the 1982 Ethion Registration
Standard, and data previously reviewed and determined to be
acceptable to support the registration of products containing
the active ingredient ethion.
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1. Acute Toxic ity
There are adequate studies available to assess the acute
toxicity of ethion. Technical ethion has a high oral toxicity
to mammals, particularly to females. The acute oral LDM for
male rats is 191 mg/kg and 21 mg/kg for female rats.
Technical ethion has a moderately high dermal toxicity (LD^
838 mg/kg) and inhalation toxicity (LCg,, of 0.45 mg/kg for
females and 2.31 mg/kg for males).
The primary eye irritation study for ethion showed only
slight redness of the conjunctivae and this effect cleared
within 24 hours. In the primary skin irritation study,
technical grade ethion caused slight erythema which cleared
within 48 hours. Ethion was judged not to be a skin
sensitizer and did not cause delayed neurotoxicity in hens at
the dose tested, 2792 mg/kg.
2. s^hcftronic Toxicity
Sufficient data are available to satisfy the subchronic
(21-day) dermal data requirements for ethion that were listed
in the 1982 Registration Standard. In the first study
reviewed, groups of rabbits (6/sex/dose) received dermal
applications of technical ethion at doses 0, 1.0, 3.0, 25,
and 250 mg/kg for 21 days. Inhibition of brain cholinesterase
activity was seen in all treated males and in the 25 and 250
mg/kg females. Both plasma and red blood cell cholinesterase
activities were decreased in 250 mg/kg males and in both the
25 and 250 mg/kg females. Increased incidences of erythema
and desquamation at the application sites were found in both
male and female rabbits of the 25 and 250 mg/kg groups.
In a study classified as supplemental, groups of New
Zealand White Rabbits (6/dose) received dermal applications
of technical ethion at doses of 0, 0.1, 0.25, 0.5, 0.8, 1.. 0,
3.0 and 25 mg/kg for 21 days (6 hrs/day). This study was
designed and conducted to determine a NOEL for male rabbits
using doses which included those lower than 1.0 mg/kg and
similar experimental conditions as the first study which
tested doses above 1.0 mg/kg. The brain cholinesterase
activity was reduced in animals dosed with 0.5 mg/kg or
above, but the decrease did not show a statistical
significance. When the results of the two studies were
combined and analyzed, significant inhibition was seen in
1.0, 25, and 250 mg/kg animals. Based on these results, the
NOEL for the systemic toxicity of ethion was established at
0.8 mg/kg.
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A subchronic dog study was reviewed by the Agency and
determined to be sufficient in satisfying the requirements
set forth in the 1982 Registration Standard for ethion. In
this study groups of dogs (4/sex/dose) received ethion orally
at dietary concentrations of 0, 0.013, 0.063, 0.625, and 7.5
mg/kg/day for 90 days.
The animals in the 7.5 mg/kg/day dose group showed signs
of ataxia, emesis, miosis, and tremors. The male and female
dogs of the 7.5 mg/kg/day dose group showed a decrease in
body weight and food consumption relative to the controls.
Clinical chemistry indicated that ethion significantly
inhibited brain cholinesterase activity in 0.625 and 7.5
mg/kg/day males and females, erythrocyte cholinesterase
activity in 7.5 mg/kg males and females, and plasma
cholinesterase activity in 0.063, 0.625 and 7.5 mg/kg/day
male and female dose groups. The decrease in plasma
cholinesterase activity was dose-related.
No compound related histomorphological changes were
found in ethion treated animals. Based upon the inhibition of
plasma cholinesterase activity, the LEL is 0.063 mg/kg/day
and the NOEL of 0.013 mg/kg/day.
No subchronic 90-Day dermal toxicity and subchronic
inhalation studies for ethion are available for review. These
studies are not required under the present use patterns.
Since ethion has not been shown to cause neurotoxicity in an
acute delayed neurotoxicity study in hens, a subchronic
neurotoxicity study is not required.
3. Chronic Toxicitv/Qncoaenicitv Testing
Chronic Toxicitv
A chronic oral toxicity study in rodents was reviewed
and determined to be sufficient to satisfy the data
requirements specified in the 1982 registration standard.
However, a chronic feeding study conducted with dogs was
reviewed and determined to be supplemental. This study is
inadequate to establish a chronic NOEL and does not satisfy
the data requirements for a chronic feeding study in non-
rodents. A chronic oral toxicity study in a non-rodent
species (preferably dog) is required.
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In the chronic oral toxicity study in rodents, groups of
Sprague-Dawley Rats (80/sex/dose) were fed ethion at
concentrations of 0, 0.1, 0.2. and 2 mg/kg/day. Groups of 20
rats/sex/dose were sacrificed at 6, 12, and 18 months.
Decreased serum cholinesterase was observed in the high dose
males and females, and no other toxic effects were observed.
Based on the cholinesterase inhibition, the systemic NOEL is
0.2 mg/kg/day and the LEL is 2 mg/Jcg/day.
In the chronic oral toxicity study for non-rodents,
groups of beagle dogs (4/sex/dose) were administered ethion
at dietary concentrations of 0, 0.05, 0.15, and 0.5 mg/kg/day
for 2 years. High dose females (0.5 mg/kg) showed decreased
plasma cholinesterase activity. Although no other toxic
effects of ethion were observed, the study was considered
inadequate to establish a chronic NOEL because of
deficiencies.
Oncogenicity
The 1982 Registration Standard for ethion required
oncogenicity studies. These data were reviewed by the Agency
and determined to be acceptable. These data show that under
the conditions of the studies, ethion is not carcinogenic in
rats and mice.
In the rat study, groups of Sprague-Dawley rats
(80/sex/dose) received diets containing ethion at
concentrations of 0, 0.1, 0.2, and 2 mg/kg/day. Interim
sacrifices of 10 rats/sex/dose were carried out at 6, 12 and
18 months. Decreased serum cholinesterase was observed in
high dose males and females. Tumor incidence was comparable
between treated and control animals.
In the mouse study, groups of mice (80/sex/dose)
received diets containing 0, 0.113, 0.225 and 1.2 mg/kg/day
ethion for two years. Decreased plasma cholinesterase
activity was seen in both males and females in the 1.2 mg/kg
dose group; based upon this result, the NOEL for systemic
toxicity is 0.225 mg/kg/day; and the LEL is 1.2 mg/kg/day. No
evidence of oncogenic effects of ethion was found in treated
mice.
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4. Teratocrenicity (Developmental Effects)
The 1982 Registration Standard for ethion required
teratology studies. These data were reviewed by the Agency
and determined to be acceptable. Under the conditions of the
studies reviewed, no teratogenic effects of ethion were
observed. Ethion was administered via gavage to groups of
pregnant female rats (25/dose) at doses of 0, 0.2, 0.6, and
2.5 mg/kg from gestation days 6 to 15. Ethion caused an
increase in the incidence of hyperactivity in the dams. In
the high dose (2.5 mg/kg) group fetuses, an increase in the
incidence of delayed ossification of pubes was seen. Based
upon these findings, the NOEL for maternal toxicity is 0.6
mg/kg; and the maternal LEL is 2.5 mg/kg. The NOEL for
developmental toxicity is 0.6 mg/kg; and the LEL is 2.5
mg/kg.
Groups of artificially inseminated female rabbits
(17/dose) received (via gavage) ethion at doses of 0, 0.6,
2.4, and 9.6 mg/kg from gestation days 6 to 18. In the mid
and high dose females, an increased incidence of orange-
colored urine and reduced body weight gain was seen. Reduced
food consumption was also found in high dose females. An
increased incidence of fused sternal centra in the fetuses of
the high dose group was found. Based upon these findings, the
NOEL for maternal toxicity is 0.6 mg/kg and the LEL is 2.4
mg/kg; the NOEL for developmental toxicity is 2.4 mg/kg and
the LEL is 9.6 mg/kg.
5. Reproduction and Fertility Effects
Reproductive and fertility effects data were required in
the 1982 Registration Standard for ethion. These studies were
reviewed by the Agency and determined to be acceptable in
supporting the registration of ethion. Ethion has a
reproductive NOEL of 1.25 mg/kg/day (HDT) and a systemic NOEL
of 1.25 mg/kg/day for males and 0.2 mg/kg/day for females.
These findings were based on tests in which ethion was
administered to groups of F0 Fx, and F2 male and female rats
(15 males/dose and 30 female's/dose) at dietary concentrations
of 0, 0.1, 0.2, and 1.25 mg/kg/day. A decrease in serum
cholinesterase activity was observed in the F1 and F2 high-
dose females (1.25 mg/kg/day).
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6. Mntaoenicitv Testing
The mutagenicity data submitted as a requirement of the
1982 Registration Standard were determined to be insufficient
in satisfying the data requirements for mutagenicity testing.
One study, an in vivo cytogenic assay in male rats, was not
conducted according to the accepted procedures for performing
rat bone marrow cytogenetic assays. Additional studies are
necessary to fulfill this requirement.
There were no mutagenic effects observed in the studies
reviewed for this registration standard.
Gene mutation test
An acceptable Ames assay was reviewed and the data show
that ethion at the concentration range of 0.625 to 10.0 nl/ml
does not produce mutagenic effects in five strains of
Salmonella tvphimurium (TA-98, TA-100, TA-1535, TA-1537, and
TA-1538).
Structural chromosome aberration test
An in vivo cytogenetic assay in male rats was reviewed.
In this study, 5 male rats/dose group received ethion at
doses of 0, 4.7, 14, 47, and 140 mg/kg. All the animals in
the 140 mg/kg died. The data indicated that ethion at a dose
range of 4.7 to 47 mg/kg did not induce chromosome
aberrations in male rats. However, this study is unacceptable
and another study is required.
Test for other aenotoxic effects
An unscheduled DNA synthesis (UDS) in rat primary
hepatocyte study was reviewed and no evidence of induction of
UDS was found at the ethion dose levels of 100, 500, 2500,
5000, and 10,000 ug/plate. However, this study is not
acceptable and another genotoxic effects study is required.
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7. Special Studies
The 1982 Registration Standard for ethion required a
general metabolism study. Three studies were submitted in
response to the Registration Standard. They are currently
under review. The registrant will be notified if additional
studies are required.
Domestic animal safety
Studies are not required at this time.
Dermal Absorption
Dermal absorption studies are not required at this time.
8. Information on Human Effects
A study with human volunteers for an assessment of the
effects of ethion on human plasma and erythrocyte
cholinesterase activity was reviewed.
A group of adult male volunteers (9) was randomly
divided into a control group (3 males) and a treatment group
(6 males). The treatment group received ethion serially and
orally (gelatin capsule) at dose levels of 0.05, 0.075, 0.1,
and 0.15 mg/kg. Significant reduction of plasma
cholinesterase activity was seen at doses of 0.075 mg/kg and
above. Based upon the data reviewed, a NOEL of 0.05 mg/kg/day
and a LEL of 0.075 mg/kg/day were established.
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C. Environmental Characteristics and Effects
1. Ecological Effects
In the 1982 Ethion Registration Standard, the Agency
determined that the Avian Dietary LC^ the Acute Fish LC^ and
the Acute Toxicity to Freshwater Aquatic Invertebrates were
acceptable in supporting the registration of ethion. The
Agency required the submission of two studies relating to the
ecological effects: Acute Avian Oral Toxicity, and Acute
Toxicity to Estuarine and Marine Organisms. An updated
ecological effects profile is provided below.
Avian Acute Oral and Dietary Toxicitv
The avian acute oral and dietary toxicity ranged from
practically nontoxic to highly toxic depending on the species
of bird. These tests showed that ethion is highly toxic to
songbirds (Red-winged blackbird LD^ = 45 mg/kg) and
moderately toxic to medium size birds such as the bobwhite
quail (LDgg = 128.8 mg/kg) and starlings (LD^ >304 mg/kg).
Avian dietary studies showed that ethion is practically
nontoxic (LC^, >5000 mg/kg) to larger upland gamebirds and
waterfowl (ring-necked pheasant and Mallard duck). No
additional avian toxicity studies are required.
Avian Chronic Toxicity Testing
Chronic toxicity testing (avian reproduction) is
required to support registration when:
1. The pesticide is persistent in the environment to the
extent that toxic amounts on avian food could be
present.
2. Use of the compound may subject birds to repeated or
continuous exposure.
3. The pesticide is stored or accumulated in plant or
animal tissue.
Because of ethion's persistence, demonstrated
bioaccumulation potential, and acute avian toxicity, an avian
reproduction study is required.
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Aquatic Organisms - Acute Toxicity
Based on the Agency's review of available aquatic
studies, technical ethion is very highly toxic to freshwater
and marine fish. Acute toxicity ranges from an LC^ of 49 ppb
for Atlantic silversides to an LC^ of 720 ppb for cutthroat
trout and flathead minnows.
Ethion was found to be very highly toxic to freshwater
invertebrates (Pteronarcvs. Daphnia. Simocephalus, and
Gammarus). The acute toxicity ranged from 0.056 to 4.7 ppb.
The toxicity of ethion to marine/estuarine invertebrates is
also very high, ranging from 5.6 ppb to 15 ppb. No additional
testing is required. .
Ethion is moderately toxic to oyster embryos. A NOEL was
calculated to be 1.1 ppm. No additional testing is required.
Ethion was found to readily accumulate in the tissues of
fish. Edible fish tissue sampled after 14 and 42 days of
exposure to ethion (0.66 - 2.6 ppb) contained 29% of the
tagged ethion residues, and the viscera contained 41 % of the
tagged ethion residues.
Honeybee Acute Toxicitv
As indicated in the 1982 Registration Standard, ethion
was found to be practically non-toxic to honeybees (LD^
20.55 ug/bee). No additional data requirements pertaining to
honeybee toxicity will be imposed at this time.
Endangered Species
Because of the demonstrated toxicity of ethion to
nontarget fish and aquatic invertebrates, ethion has been
identified by the Office of Endangered Species (OES) , U.S.
Fish and Wildlife Service (FWS) as being likely to negatively
impact endangered aquatic organisms when applied to certain
crops (i.e., citrus, corn, sorghum and cotton). The Agency is
developing a program to reduce or eliminate exposure to these
vulnerable organisms, and will issue notice of any product
labeling requirements, other than those identified in this
registration standard, when the program has been developed
and implemented.
16
-------
Summary of Risk Assessment for Avian and Aquatic Organisms
Ethion is very highly toxic to several species of
freshwater and marine fish and aquatic invertebrates.
Although chronic testing and an adequate field testing have
not been submitted to the Agency for review, the calculated
EEC values strongly suggest that certain agricultural uses of
ethion (runoff from citrus groves in particular) may result
in acutely toxic situations for aquatic organisms. A field
dissipation study is required.
Ethion appears to pose little acute hazard to upland
gamebirds and waterfowl at current application rates, but may
present an acute hazard to small songbirds feeding in the
treated area.
2. Environmental Fate
In the 1982 Ethion Registration Standard, the Agency
required the following environmental fate testing;
hydrolysis, photodegradation in water and soil, aerobic and
anaerobic soil metabolism, leaching, field dissipation
(terrestrial), and fish bioaccumulation (lab). The data
submitted in response to the 1982 standard have been
reviewed. The only data requirements that have been satisfied
are aerobic soil metabolism and fish bioaccumulation.
Additional studies for photodegradation (in water, soil and
air), anaerobic soil metabolism, leaching, field dissipation
(terrestrial), and fish accumulation are required.
The hydrolysis data requirement has been satisfied for
pH 5 and 7. The hydrolysis study for pH 9 has been classified
as supplemental because of the possibility that the buffer
(borate) may have reacted with the parent or degradates. The
registrant has the option of addressing this issue or
conducting another study using a different buffer. Additional
studies are required to satisfy the remaining environmental
fate requirements.
The 1982 Registration Standard data requirements for
environmental chemistry did not include laboratory volatility
tests. Since the issuance of the 1982 standard, the Agency
has instituted specific criteria for requiring laboratory
volatility. A laboratory volatility study is required for
ethion.
17
-------
The data requirements for confined accumulation in
rotated crops and field accumulation for rotated crops were
waived in the 1982 standard. The waiver was granted based on
usage estimates at that time. However based on current use
estimates of ethion, the data requirements for confined
accumulation in rotated crops are now being imposed. The
field accumulation data for rotated crops are reserved.
While the data base regarding environmental fate for
ethion is incomplete, the Agency has made the following
determination based on aerobic soil metabolism. A major
degradation pathway for ethion appears to be soil metabolism,
with C02 forming the principal degradate.
The bioaccumulation of ethion residues in fish cannot be
fully assessed until persistence and mobility data are
provided from the field dissipation and leaching studies.
However, based on acceptable and supplemental data, ethion
appears to be resistant to hydrolysis (except at very
alkaline pH), photolyses in water and on soil (half-lives of
58 and 51 days, respectively), degrades with a half-life of
69-102 days (in the aerobic soil metabolism study), and its
major metabolite is carbon dioxide.
3. Ground water and Leaching Assessment
The 1982 Registration Standard did not address the issue
of ground water contamination. The Agency has reviewed
supplemental data and determined that ethion is immobile and
moderately persistent. Ethion is chemically bound to nearby
soil particles and is not expected to leach. No ground water
monitoring requirements for ethion are being-imposed at this
time. However a field dissipation study to determine the
depth of leaching is required.
18
-------
4. Worker Protection
The Agency has determined that ethion presents an acute
hazard to exposed persons as evidenced by the acute toxicity
classification shown in Table 2 and the plasma red blood cell
and brain cholinesterase inhibition in both the 21-day dermal
studies in rabbits and the 90-day feeding studies with dogs
and rats.
TABLE 2 - Acute Toxicity for Major Routes of
Exposure to Ethion
Route of Exposure Test Results
Acute Oral LD^ = 191 mg/kg (males)
= 21 mg/kg (females)
Acute Dermal LD^ = 838 mg/kg
Acute Inhalation LC^ =0.45 mg/kg (females)
= 2.31 mg/kg (males)
The 1982 Ethion Registration Standard cited a
significant history of pesticidal poisoning incidents
associated with the use of ethion. Between 1976 and 1985,
ethion was one of the top ten pesticides associated with
reentry poisonings in California.
Based on the acute hazard to exposed persons the 1982
Registration Standard recommended the following:
For each crop, the registrant must propose an acceptable
reentry interval. This proposed interval may be based on any
of the following:
a. The longest (most restrictive) existing reentry
interval imposed by the States (currently those
in California - 30 days for citrus, 14 days for
peaches, nectarines, and grapes, 2 days for
other crops) .
b. Data on dissipation of foliar residues (decline
curve), on human exposure to those residues, and
on the inherent toxicity of the chemical.
c. Determination of the time beyond which there are
no detectable foliar residues (under appropriate
climatic conditions) in the areas where the
chemical will be applied.
19
-------
The registrants of products containing ethion had until
December 31, 1985 to submit the required data or adopt the
most restrictive state imposed reentry intervals. Since none
of the reentry data criteria specified in the 1982
Registration Standard have been submitted to the Agency for
review, the Agency is requiring that the registrants of
ethion products adopt the most restrictive reentry intervals
imposed by the States. The following interim reentry
intervals will be imposed until appropriate exposure data has
been received from the registrants and evaluated by the
Agency:
Crop Reentry interval after last application
Citrus 30 Days
Peaches 14 Days
Nectarines 14 Days
Grapes 14 Days
All other crops 2 Days
D. Tolerance Reassessment
1. Tolerances Issued
Tolerances for residues of ethion in or on raw
agricultural commodities and animal products are published in
40 CFR 180.173. Food and feed additive tolerances for ethion
have been established for dried tea and raisins and are
published in 40 CFR 185.2750 (formerly 21 CFR 193.190). A
feed additive tolerance for ethion has been established for
dehydrated citrus pulp and is published in 40 CFR 186.2750
(formerly 21 CFR 561.230). All tolerances are expressed in
terms of ethion and its oxygen analog (S-
[[diethoxyphosphinothioyl)thio]methyl]0,0-diethyl
phosphorothioate]. EPA has evaluated the residue and toxicity
data supporting these tolerances and the data submitted in
response to the 1982 Registration Standard. The following
were considered during this evaluation:
o Whether the tolerances are adequate to protect the
public health, including that of sensitive
subpopulations.
o Whether the current tolerances and food/feed additive
regulations are sufficient to cover the actual
residues resulting from use (including uses registered
under FIFRA sec. 24(c)).
o Whether group tolerances can be established in
accordance with 40 CFR 180.34(f).
20
-------
o Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are
necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
The regulatory determinations resulting from EPA's
review are set out in Section IV.A., Regulatory Positions and
Rationales.
21
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TABLE 3 - Summary of Tolerances Issued for Ethion
Commodities
Tolerances (PPM) Maximum Residue Level
i International
IIS
'Canadian
Almonds
Almond, hulls
Apples
Apricots
Beans
Cattle, fat
Cattle, meat
Cattle, mbyp
Cherries
Chestnuts
Citrus
Citrus, pulp
Corn, fodder
Corn, forage
Corn, grain
Cottonseed
Cucumbers
Eggs
Eggplants
Filberts
Goats, fat
Goats, meat
Goats, mbyp
Grapes
Raisins
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses, meat
Horses, mbyp
Melons
Milk, fat
Nectarines
Onions
Peaches
Pears
Pecans
Peppers
Pimentos
Plums (fresh prunes)2
Poultry, fat
Poultry, meat
Poultry, mbyp
0.1
5.0
2.0
0.1
2.0
2.5
2.5
1.0
0.1
0.1
2.0
10
14
14
0.1
0.5
0.5
0.2
1.0
0.1
0.2
0.2
0.2
2.0
4.0
0.2
0.2
0.2
0.2
0.2
0.2
2.0
0.5
1.0
1.0
1.0
2.0
0.1
1.0
1.0
)2.0
0.2
0.2
0.2
0.1
2
none
1
2.5
2.5
2.5
none
none
2
none
none
none
none
0.1
none
0.1
none
none
none
none
2
none
none
none
none
none
none
0.1
none
none
0.1
1.0
2
none
0.1
0.1
1.0
none
none
none
Mexican
0.1
2
none
2
none
none
none
none
O.l
2
none
14
0.1
0.5
0.5
none
1
0.1
none
none
none
2
none-
none
none
none
none
none
2
none
none
1
1.0
1
0.1
1
none
none
none
none
Codex '
O.I1
21
O.I1
none2
2.51
I1
O.I1
O.I1
21
2
none
none2
0.053
0.51
0.51
0.21
I1
O.I1
0.21
0.21
0.21
21
0.21
0.21
0.21
0.21
0.21
0.21
21
0.24
l.O1
I1
l.O1
21
O.I1
I1
2
none
2.01
0.21
0.21
0.21
22
-------
Summary of Tolerances Issued for Ethion (cont.)
Commodities
Tolerances (PPM) Maximum Residue Level
I International 1
US ' Canadian Mexican Codex'
Sheep , fat
Sheep , meat
Sheep , mbyp
Sorghum,, forage
Sorghum , grain
Squash , summer
Strawberries
Tea (dried)
Tomatoes
Walnuts
~ ~~.
0.2
0.2
0.2
2.0
2.0
0.5
2.0
10.0
2.0
0.1
none
none
none
none
none
0.1
1.0
none
0.5
none
none
none
none
2.0
2.0
0.5
2.0
none
2
0.1
0.21
0.21
0.21
none2
none2
0.51
2.01
5.0s
21
O.I1
1. Established Codex Maximum Residue Level
numerically identical to U.S. Tolerance.
(MRL) is
2. No Codex MRL has been established, therefore, no questions
of compatibility exist with respect to Codex MRL.
3. A Codex MRL of 0.055 ppm exist for residues of ethion
per se in or on maize. This level is lower than that of
the U.S..
4. U.S. Tolerance is higher.
5. (Green, black tea): An assessment regarding the potential
for compatibility between the permanent Codex MRL and the
U.S. tolerance will not be made until the adequacy of the
U.S. tolerance has been ascertained.
23
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2. Residue Data
An update on the residue chemistry data supporting
tolerances for ethion is as follows:
A. Nature of Residue in Plants
No information regarding the uptake or metabolism of
ethion by plants was available for review in the 1982
Registration Standard. The 1982 Standard required data
depicting the metabolism of [14C]ethion in plants and data
from a [ C]ethion study to determine the uptake and
distribution of ethion and/or its degradation products. Data
were submitted in response to the outstanding requirements.
These data were reviewed and the Agency concluded that the
metabolism of ethion in citrus fruits was adequately
described. The following are required:
o Data depicting the distribution and metabolism of
methylene-labeled [14C] ethion in or on grapes
and cottonseed.
B. Nature of Residue in Animals
The nature of residues of ethion in animals is not
adequately understood. The data reviewed in the residue
chemistry chapter of the 1982 Standard was judged to be
insufficient because only the distribution of P-residues in
the tissues and milk of cattle were depicted and none of the
residues were characterized. The 1982 standard required data
depicting the rates and routes of elimination of radiolabeled
ethion from food animals (including a materials balance),
identification of metabolites formed, the sites of
metabolism, and the relative levels of ethion and metabolites
and their distribution in cattle tissues and milk. Data
pertaining to metabolism in ruminants and poultry were
submitted in response to these requirements and reviewed. The
data were deemed insufficient due to a lack of
characterization of residues in tissues, milk, and eggs. The
following additional data are required:
o Metabolism studies utilizing ruminants and poultry.
o Data depicting the nature of ethion residues in swine
are reserved but will be required if the metabolism
studies conducted with ruminants and poultry reveal
that the metabolism of ethion differs from that in
rats.
24
-------
C. Residue Analytical Methods
The qualitative nature of the residue in plants and
animals has not been adequately described. Therefore, the
adequacy of the available analytical methods cannot be
ascertained. The GLC/FPD Method for organophosphate compounds
published in PAM Vol. I (Protocol II) is in PAM Vol. II as
Method I. This method is adequate for enforcement of
tolerances for the combined residues of ethion and ethion
monooxon in or on plant and animal commodities. However
additional analytical methods may be required if the required
metabolism studies indicate that additional metabolites
constitute residues of toxicological concern in or on plants
and livestock.
Methods II and III published in PAM Vol. II will be
deleted, since these methods are inadequate for tolerance
enforcement. The colormetric method (II) does not determine
ethion monooxon or ethion dioxon levels and the
cholinesterase inhibition method (III) lacks specificity.
D. Storage ?t?foility Data
No data pertaining to storage stability were discussed
in the residue chemistry chapter of the 1982 Ethion
Registration Standard and no data requirements for this topic
were specified. The Agency now requires that storage
intervals and sample storage conditions be reported for all
residue data submitted in support of tolerances and that the
residue data be accompanied by data depicting the stability
of all residues of concern in storage. Data regarding the
stability of ethion, ethion monooxon, and ethion dioxon in
extracts of apples, corn grain, silage and stover, cucumbers,
grapes, and oranges were reviewed by the Agency for the
second round review of ethion. These data indicate that
ethion, ethion monooxon, and ethion dioxon are stable in
extracts of these commodities for up to 6 months of storage
at -18°c in glass jars. Additional data reviewed indicate
that residues of ethion in fortified surface and pulp extract
of strawberries are stable for 227 days stored in brown
bottles at 5-8°C. No data are available on the stability of
these residues in processed commodities, meat, milk, poultry,
or eggs. The following data are required:
o The sample storage conditions and intervals must be
supplied for all required and previously submitted
residue data for plant and animal commodities. This
information must be accompanied by storage
stability data reflecting these time intervals and
conditions.
25
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E. Crop Group Tolerances
The available data are insufficient to determine whether
crop group tolerances are appropriate for the crop groupings
listed below:
Bulb Vegetables Legume Vegetables
Fruiting Vegetables Cucurbit Vegetables
Pome Fruits Stone Fruits
Small Fruits & Berries Tree Nut Group
Cereal Grains
Forage, Fodder, and Straw of Cereal Grains
Before granting crop group tolerances for ethion, the
Agency is requiring additional residue data for
representative crop group members.
F. Residue Data
1. The available data support the established tolerances
for the combined residues of ethion and its oxygen analog in
or on apricots, cherries, and corn (forage). However, these
conclusions may change based on the Agency's review of the
outstanding plant metabolism and storage stability data.
2. The available data reviewed indicate that the
established tolerances for the combined residues of ethion
and its oxygen analog in or on citrus fruits, apples, and
pears are too low. Tolerance revisions and/or amended use
directions (i.e. lower maximum application rates or
implementation of preharvest intervals) must be proposed for
the crops and appropriate supporting residue data must
submitted to the Agency for evaluation. (For crop specific
data requirements, refer to the Data Appendices, Table A -
Generic Data Requirements for Ethion, Residue Chemistry
171-4).
3. Additional data are required to assess the
established tolerances for the combined residues of ethion
and its oxygen analog in or on onions, beans (succulent and
dried), tomatoes, peppers, melons, summer squash, peaches,
plums (fresh prunes), grapes, strawberries, almonds, almond
hulls, pecans, walnuts, corn grain, sorghum grain, corn
fodder, sorghum forage, cottonseed, and dried tea. (For crop
specific data, refer to the Data Appendices, Table A -
Generic Data Requirements for Ethion, Residue Chemistry
171-4).
26
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The TAS chronic exposure analysis uses tolerance level
residues and assumes that 100 percent of the crop is treated
to estimate the Theoretical Maximum Residue Contribution
(TMRC) for the overall population and 22 population
subgroups. For an exposure estimate more closely
approximating actual exposure, the Anticipated Residue
Contribution (ARC), can be calculated using the anticipated
residue data. Anticipated residue data used in the chronic
exposure assessment for ethion consisted of FDA surveillance
monitoring data; processing studies; field residue data for
livestock feed items (corn and sorghum), and livestock
feeding studies submitted by the registrant. The TMRC and ARC
exposure summaries for the overall population, non-nursing
infants, and children age 1 to 6 are compared below:
Ethion TMRC-ARC Exposure Summary
Overall U.S. Non-Nurs. Children
Population Infants Age 1 -6
TMRC 0.016696s 0.042388 0.038054
3339.3b 8477.7 7610.7
ARC 0.000567 0.000417 0.000551
113.3 83.4 147.8
a Estimated exposure in mg/kg body weight/day.
b Exposure expressed as a per cent of the PADI.
The Agency has concluded that no chronic health effect
is expected from the use of ethion even though the PADI has
been exceeded for the overall U.S. population and children
(1-6) because the primary residue contribution is due to tea,
based on the established tolerance for the raw, unbrewed
commodity. When the required brewing study has been received,
it is expected that the anticipated residues from tea will be
significantly reduced.
Acute Exposure Analysis
The TAS acute exposure analysis estimates the
distribution of single-day exposure for the overall U.S.
population and certain population subgroups. The analysis
evaluates individual food consumption, as reported by
respondents in the 1977-78 USDA Nationwide Food Consumption
Survey (NFCS), and accumulates exposure to ethion for each
food consumed for which an ethion residue value exists. [Each
analysis assumes that ethion residues are present at
anticipated residue levels (ARC) in the entire supply of a
food commodity and that 100% of the commodities are treated].
28
-------
4. The data requested for crops listed parenthetically
may, by translation, be used to assess the tolerances for
residues in or on the following commodities: eggplants and
pimentos (peppers), cucumbers (summer squash), filberts and
chestnuts (walnuts), pears (apples).
It should be noted, however, that translated data, for
instance cucumbers for residues on summer squash, may not be
used to support a crop group tolerance.
5. The adequacy of the established food additive
tolerance for residues in raisins and the need for a feed
additive tolerance for residues in dry grape pomace and
raisin waste will be determined on receipt of the data
requested to assess the established tolerance for residues in
or on grapes. The established feed additive tolerance for
residues in dried citrus pulp and the need for a food
additive tolerance for residues in citrus oil will be
determined on receipt of the data requested to assess the
established tolerance for residues in or on citrus fruits.
6. Processing studies are needed for corn, sorghum,
tomatoes, beans, plums (fresh prunes), and cottonseed.
7. Data must be submitted and a tolerance must be
proposed for residues in or on sorghum fodder. If not, then a
feeding restriction must be imposed.
8. The adequacy of the tolerances covering residues of
ethion in meat, milk, and eggs, cannot be determined until
the outstanding data for plant and animal metabolism, storage
stability, and magnitude of residue in feed commodities have
been evaluated.
3. Exposure Analysis;
Chronic Exposure Analysis
The chronic TAS analysis used a reference dose (PADI) of
0.0005 mg/kg body weight/day, based on a NOEL of 0.05 mg/kg
body weight/day and an uncertainty factor of 100 from a 21-
day human oral dosing study. The acute TAS analysis used a
NOEL of 0.05 mg/kg body weight for cholinesterase inhibition
from a human study. This is the same NOEL on which the
reference dose for chronic exposure is based.
27
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The exposure distribution is compared to the NOEL
observed in the acute toxicity study. Margins of Safety (MOS)
for the average consumer are calculated according to the
following relationship (shown for the overall U.S.
population):
Average MOS = NOEL/Exposure (ARC)
=0.05 mg/kg / 0.008219 mg/kg
= 6
The following considerations were used in conducting the
TAS acute exposure analysis:
1. The entire supply of commodities that may be treated with
ethion do in fact contain ethion residues at the maximum
levels observed in field studies or at tolerance levels.
Tolerance levels were used for strawberries, pears (fresh and
dried), tea, watermelon, tomatoes, and beans because
available field study data are inadequate. Also proposed
tolerances were used for apples and pears since available
data indicate that the established tolerance is too low.
2. All foods on which ethion residues may exist that were
consumed by a participant in the NFCS are assumed to be eaten
at one meal. (Usually exposure would likely occur over an
extended period throughout the day but TAS assumes that the
entire exposure occurs at one sittingand therefore is
conservative).
3. Exposure analyses were conducted for the general U.S.
population, infants, children aged 1-6, adult females and
adult males. It is estimated that 94% of infants will consume
at least one food on which ethion is registered; it is
estimated that essentially every member of the overall
population, children aged 1 to 6, and adult females and males
consume at least one commodity which may have ethion
residues. These estimates are also based on the NFCS Survey.
Based on exposure distributions calculated from all
commodities on which ethion may be used, 45 percent of the
general population is expected to have a MOS of less than 10
for cholinesterase inhibition. The percentage of consumers in
subgroup population expected to have a MOS of less than 10
is: infants (61%); children aged 1 to 6 (63%); adult females
(40%); adult males (41%).
29
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In addition to the analyses described above, separate
TAS acute exposure analyses were conducted for specific food
commodities and commodity groups. The results of the analyses
are presented in Table 4 under the categories listed.
o Percentage of the population expected to consume at least
one food which may contain ethion residues (% Consumers).
o The average Margin of Safety (Avg. MOS) for those members
of the population expected to consume at least one food
which may contain ethion residues based on average
consumption (exposure) of the specific food.
o The percentage of the population expected to have an MOS of
less than 10 (% Cons. <10).
o The minimum Margin of Safety (Min. MOS) is lowest Margin of
Safety expectected for some member of the population
subgroup. The low MOS would be expected for those
individuals having the highest exposure, presumably
those who eat the most.
The results of this commodity specific TAS analysis show
that:
1. There are seven commodity groups for which no member of
any of the TAS population groups is expected to have a MOS
less than 10 because of ethion residues: grapefruits,
apricots, cherries, and nectarines, eggs, grains, meats, nuts
and poultry.
2. There are eight commodity groups for which the minimum MOS
for all five TAS population groups is less than 10: apples,
and pears; grapes; melons; tomatoes; dry beans; succulent
beans; strawberries and citrus fruits other than oranges and
grapefruit; and plums and prunes.
3. There are four commodity groups for which the average MOS
is generally greater than 10 but one or more population
groups have a segment of the population estimated to have a
MOS for cholinesterase inhibition less than 10: peaches;
miscellaneous vegetables (such as onions, peppers, and
squash); tea; and oranges.
30
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TABLE 4: ETHION ACUTE EXPOSURE ANALYSIS SUMMARY
TOTAL
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
APPLES and PEARS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
GRAPES
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
MELONS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
TOMATOES
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
DRY BEANS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
% Consumers
100
94
100
100
100
33
49
43
30
32
27
5
35
24
27
3
4
2
3
3
55
29
51
55
57
12
3
14
11
13
Avg. MOS
6
2
3
8
8
7
1
4
10
11
16
4
8
18
22
6
7
3
7
7
18
14
9
22
22
12
9
12
28
27
%Cons.
< 10
45
61
63
40
41
43
81
47
41
38
16
30
20
18
14
53
62
83
51
45
16
15
38
12
12
8
34
29
3
4
Min
MOS
< 1
< 1
< 1
< 1
< 1
< 1
< 1
< 1
1
1
1
< 1
< 1
1
1
< 1
2
< 1
< 1
< 1
2
1
1
3
3
3
2
2
6
6
31
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TABLE 4: ETHION ACUTE EXPOSURE ANALYSIS SUMMARY (cont'd)
%Cons. Min
% Consumers Avg. MOS < 10 MOS
SUCCULENT BEANS
U.S. Population 16 15 17 2
Nursing Infants 10 3 84 < 1
Children Aged 1-6 14 8 51 1
Adult Females 15 17 12 3
Adult Males 16 18 10 3
STRAWBERRIES and OTHER CITRUS
U.S. Population 31 200 1 6
Infants 3 35 6 1
Children Aged 1-6 28 111 2 3
Adult Females 32 219 1 7
Adult Males 32 236 1 7
PLUMS/PRUNES
U.S. Population 2 29 5 3
Infants 5 7 50 1
Children Aged 1-6 1 13 27 3
Adult Females 2 37 1 8
Adult Males 2 39 1 8
PEACHES
U.S. Population 20 85 2 6
Infants 17 9 52 2
Children Aged 1-6 24 48 6 3
Adult Females 18 112 0 13
Adult Males 19 114 0 13
MISCELLANEOUS VEGETABLES
U.S. Population 61 150 1 8
Infants 28 166 1 7
Children Aged 1-6 59 98 1 3
Adult Females 59 157 1 8
Adult Males 63 175 0 10
TEA
U.S. Population 27 43 1 8
Infants 2 13 24 2
Children Aged 1-6 14 21 6 5
Adult Females 34 45 0 10
Adult Males 27 50 0 10
32
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TABLE 4: ETHION ACUTE EXPOSURE ANALYSIS SUMMARY (cont'd)
% Consumers Avg. MOS
%Cons.
< 10
Min
MOS
ORANGES
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
GRAPEFRUIT
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
30
18
34
29
28
5
< 1
1
6
5
APRICOTS, CHERRIES, NECTARINES
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
EGGS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
GRAINS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
MEATS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
20
13
27
17
19
90
34
92
90
92
98
59
99
98
99
98
49
99
98
99
143
47
58
195
218
198
33
63
205
244
12500
5556
6250
16667
16667
1250
472
526
1852
1613
555
521
296
746
581
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
17
7
13
25
25
25
13
17
25
50
725
151
472
758
1042
0
0
0
0
0
25
17
13
25
25
50
50
50
50
50
50
50
50
50
50
50
50
50
50
50
33
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TABLE 4: ETHION ACUTE EXPOSURE ANALYSIS SUMMARY (cont'd)
% Consumers Avg. MOS
%Cons.
< 10
NUTS
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
12
2
16
10
12
4545
2632
2941
5000
5000
0
0
0
0
0
Min
MOS
50
50
50
50
50
POULTRY
U.S. Population
Infants
Children Aged 1-6
Adult Females
Adult Males
25
24
28
25
24
4167
2000
2273
5000
5000
0
0
0
0
0
50
50
50
50
50
Summary of Exposure Analysis
In summary, the Agency has concluded that the use of
ethion will not result in chronic health effects, since the
anticipated residue analysis for chronic exposure does not
significantly exceed the PADI for ethion.
There does not appear to be a health risk from short
term exposure to ethion residue on grapefruit, stone fruits
other than peaches and plums, eggs, grains, meat nuts, and
poultry. However, based on the limited data/information
available, short term exposure to ethion from residues on
peaches, vegetables, tea, and oranges may result in acute
cholinesterase inhibition for selected populations, infants
and children. Also, short term exposure to ethion residues on
apples and pears, grapes, melons, tomatoes dry beans,
succulent beans, strawberries (pooled with citrus other than
oranges and grapefruit), and plums or prunes may result in
acute cholinesterase inhibition in all population groups.
Therefore, to permit more accurate, realistic estimates of
acute exposure, anticipated residue data are being called in
under 40 CFR 158.240 (Reduction of Residue).
34
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationales
Based on the review and evaluation of all available data
and other relevant information on ethion, the Agency has made
the following determinations. Where label revisions are
imposed, specific language has been set forth in the Labeling
Section of this Registration Standard.
1. The Agency is considering further regulatory action based
on the Agency's dietary exposure concerns.
RATIONALE: The Agency has determined that certain current
tolerances may not provide an adequate margin of1 safety in
humans. Short term exposure to ethion residues on apples and
pears, grapes, melons, tomatoes, dry beans, succulent beans,
strawberries (pooled with citrus other than oranges and
grapefruit), and plums and prunes may result in acute
cholinesterase inhibition for all TAS population groups. The
Agency also has determined that short term exposure to ethion
residues on peaches, vegetables, tea, and oranges may result
in acute cholinesterase inhibition in selected TAS
populations, infants and children.
2. The Agency is not imposing the Restricted Use
Classification on all pesticide products containing ethion.
RATIONALE; At present three ethion products are classified
Restricted Use because of their high dermal and inhalation
toxicity. Two of these products contain 81.9% active
ingredient and the other contains 81% acitve ingredient. The
Agency will make a decision regarding the Restricted Use
Classification on a product-by-product basis for the
remaining products after evaluating the product specific
toxicity data submitted in response to Table C.
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3. The Agency is not requiring the addition of a ground water
advisory statement.
RATIONALE; While certain Environmental Fate Data are
incomplete, a review of the available data indicate that
ethion is moderately persistent, immobile in soil and is not
expected to leach. After a review of the terrestrial field
dissipation study, the Agency will determine what regulatory
action, if any, is appropriate to protect ground water.
4. Because of the high acute toxicity and documented
incidents of farmworker pesticidal poisonings, the following
reentry intervals are being imposed on products containing
ethion with agricultural use patterns.
Citrus 30 Days
Peaches
Nectarines
Grapes 14 Days
All other crops ...2 Days
RATIONALE: The 1982 Registration Standard for ethion imposed
a 24-hour reentry interval for all crops treated with ethion
because of inadequate information on the possible hazards to
agricultural workers in orchards and fields. The 24-hour
reentry interval was intended as an interim measure and was
imposed until adequate reentry data could be generated and
evaluated by the Agency. To this end, the 1982 Registration
Standard gave the registrants of ethion the option of either
developing reentry data or adopting the most restrictive
reentry intervals imposed by the States. Since no reentry
data have been submitted to the Agency for review, EPA is
requiring the registrant of ethion to adopt the most
restrictive state imposed reentry intervals.
5. No significant new food uses or increases of tolerances
for food or feed items treated with ethion will be considered
until the outstanding residue chemistry studies have been
submitted and reviewed by the Agency.
RATIONALE; Available animal and plant metabolism and
magnitude of residues in plants and livestock data, are
insufficient and/or lacking. These data deficiencies preclude
the Agency from conducting a full tolerance reassessment.
36
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6. While the required data are under development all
currently registered products containing ethion as an active
ingredient may be sold, distributed, formulated, and used,
subject to the terms and conditions specified in the
Standard. Registrants must agree to develop and provide
additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
RATIONALE; Under FIFRA, the Agency may choose not to cancel
or withhold registration if the data are missing or
inadequate (see FIFRA section 3(c)(2)(B) and 3(c)(7)). The
issuance of this Standard provides the mechanism for
obtaining necessary data. The data will be reviewed and
evaluated, after which the Agency will determine if
additional regulatory actions are necessary.
7. The Agency has identified certain data that will receive
immediate review when submitted.
RATIONALE; Certain of the data being required by the Agency
are essential to resolve risk concerns, or may generate 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:
Data Requirement
158.390
158.75
158.77
158.390
158.240
Guideline No.
132-1, 132-1(2)
133-3&4
231, 323, 333
133-3&4, 232,
234, 132-1
81-1 thru 6
171-2 thru 5
(including all
residue reduction
data)
Description
Reentry Protection
Applicator Exposure
Monitoring
Non-occupational
post-application
monitoring
Acute toxicology
(Product Specific)
Residue Chemistry
37
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain ethion, bear required labeling, and
conform to the product composition, acute toxicity limits,
and use pattern requirements listed in this registration
standard.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain this pesticide.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits,
stating maximum and minimum amounts of the active ingredient
and inert ingredients which are present in products, as well
as impurities found at greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing this pesticide
provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category in
which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The EPA Compendium of
Acceptable Uses (for availability, see page 1) lists all
registered uses, as well as approved maximum application
rates and frequencies.
Terrestrial Food Crop Use:
Alfalfa (seed crop), almonds, apples, apricots, beans,
blueberries, cherries, chestnuts, corn (field), cotton,
cucumbers, eggplants, filberts, garlic, grapefruit,
grapes, leeks,lemons, limes, melons, nectarines, onions
(dry & green), oranges, peaches, peanuts, pears, pecans,
peppers, pimentos, plums, prunes, sorghum (graino&
forage), sorghum (seedcrop),squash(summer),strawberries,
tangelos, tangerines, tomatoes, and walnuts.
38
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Terrestrial Non-food Crops;
Bermudagrass, Junipers, ornamental evergreens, pine
trees, lawns, ornamental turf, and ornamental
plants.
Greenhouse Non-food Crop;
Ornamental plants.
Domestic Outdoor Uses;
Domestic dwellings.
39
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D. LABELING
In order to remain in compliance with FIFRA, products
must bear appropriate labeling as specified in 40 CFR 156.10
and this Standard, or must be revised to conform to those
specifications. Appendix II contains information on label
requirements.
No pesticide product containing this pesticide may be
released for shipment by the registrant after September 30,
1990, unless the product bears an amended label which
complies with the requirements of this Standard.
No pesticide product containing this pesticide may be
distributed or sold after September 30, 1991, unless the
product bears an amended label which complies with the
requirements of this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the
active ingredient as:
ACTIVE INGREDIENT
0,0,0',0' - Tetraethyl S,S'-methylene
bisphosphorodithioate %
INERT INGREDIENTS %
2. Organophosphate Statement
The label must state that this product contains an
organophosphate. This must be identified as part of the
product name, or as part of the product identification, or as
a separate statement. It may not appear only within the
ingredients statement.
40
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3. Use Pattern Statements
a. Manufacturing-Use Products
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites, which are listed
in Compendium of Acceptable Uses. However, no use may be
included on the label where the registrant fails to agree to
comply with the data requirements in TABLE A for that use
pattern.
b. End Use Products
All end use product labeling with agricultural uses must
be revised to explicitly specify preharvest intervals, the
maximum number of applications to the crop per season, and
the maximum interval between treatments. If these statements
must be supported by data, then the time frame specified in
the Table A is applicable, otherwise these labeling revisions
must be submitted to the Agency within one year of the date
of receipt of this document.
4. Precautionary Statements:
Environmental Hazard Statements
a. Statements for Manufacturing-Use Product
"Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public water
unless this product is specifically identified and addressed
in a NPDES permit. Do not discharge effluent containing this
product into sewer systems without previously notifying the
sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
b. Statements for End-Use Products
"This pesticide is toxic to fish, and aquatic
invertebrates. Fish and aquatic invertebrates may be killed
in areas where this pesticide is used. Do not contaminate
water when disposing of equipment washwaters."
41
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2. Worker Protection Statements
a. Statements for End Use Products
The protective clothing labeling statements listed below
are required on all products containing ethion with the
signal words DANGER or WARNING that are applied to
agricultural sites, structural pest control sites, or
greenhouses.
"Do not rub eyes or mouth with hands. If you feel sick in any
way STOP work and get help right away. See Practical
Treatment Section of this label.11
"Do not apply this product in a way that will contact
unprotected workers, either directly or though drift. Only
protected handlers may be in the area during application."
"USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE CLOTHING AND
EQUIPMENT DURING MIXING/LOADING, APPLICATION, REPAIR AND
CLEANING OF MIXING, LOADING, AND APPLICATION EQUIPMENT,
DISPOSAL OF THE PESTICIDE, AND EARLY REENTRY INTO TREATED
AREAS: Protective suit of one or two pieces covering all
parts of the body except head, hands, and feet; chemical
resistant gloves; chemical resistant shoes (or chemical
resistant shoe covers or chemical resistant boots); and a
NIOSH or MSA approved respirator. In addition, mixer/loaders
must wear a chemical resistant apron and face shield or
goggles.
During equipment repair and cleaning, the respirator need not
be worn. During early reentry after sprays have dried or
dusts have settled and vapors have dispersed, the respirator
need not be worn.
IF MIXING/LOADING IS PERFORMED USING A CLOSED SYSTEM, THE
FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT MAY BE WORN AS AN
ALTERNATIVE: long-sleeved shirt and longlegged 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 protection during equipment repair or cleaning,
reentry, or pesticide disposal work.
IMPORTANT! If pesticide comes in contact with skin,
immediately wash off with soap and water. Always wash hands,
face, and arms with soap and water before smoking, eating,
drinking, or when using toilet.
42
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AFTER WORK: Wash gloves with soap and water before removing
them. Take off all work cloths and shoes. After removing
clothing shower using soap and water, then put on clean
clothes. Do not reuse contaminated clothing. Personal
clothing worn during work must be laundered separately from
household items. Store protective clothing separate 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.
Protective clothing and equipment that becomes heavily
contaminated or drenched must be destroyed according to state
and local regulations. HEAVILY CONTAMINATED OR DRENCHED
CLOTHING CANNOT BE ADEQUATELY DECONTAMINATED.
DURING AERIAL APPLICATION, HUMAN FLAGGERS MUST BE IN A
TOTALLY ENCLOSED VEHICLE."
Reentry Intervals
All products with directions for use on agricultural
cultural crops must bear the following reentry intervals and
statements listed below:
Citrus 30 Days
Peaches
Nectarines
Grapes 14 Days
All other crops ...2 Days
"Do not enter or allow entry into treated areas until
(sprays have dried/dusts have settled/vapors have dispersed,
as applicable) to perform hand labor tasks. A person may
enter the area to perform other tasks only if the person is
wearing the personal protective clothing listed on the
label."
"After (sprays have dried/dusts have settled/vapors
dispersed, as applicable) do not enter or allow entry into
the treated area until the reentry interval has expired,
unless the person entering the treated area is wearing the
personal protective equipment listed on the label for early
reentry."
43
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Restricted Use;
Three ethion products, two containing 81.9% active
ingredient and one containing 81% acitve ingredient, have
been classified Restricted Use based on their dermal and
inhalation toxicity. These products must bear the following
restricted classification in their product labeling:
"RESTRICTED USE CLASSIFICATION
Due to acute dermal and inhalation
toxicity.
For retail sale to use only by Certified
Applicators or persons under their direct
supervision and only for those uses covered
by the Certified Applicator's Certification."
For all other products containing ethion, the Agency
will make a determination concerning the Restricted Uses
classification after review and evaluation of the Product
Specific Acute Toxicity Data listed in Table C.
44
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain
requirements for data submittal or changes in composition,
labeling or packaging of the product. The applicable
requirements depend on whether the product is a manufacturing
or end use product and whether the pesticide is the sole
active ingredient or one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
2Data 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
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.
45
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B. Manufacturing use products containing this pesticide as
one of multiple active ingredients 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 B3
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.
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.
3Data 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
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.
46
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2. If eligible for the generic data exemption4, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
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.
4If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data exemption for generic data concerning
that active ingredient (Table A) and product-specific data for the
registered manufacturing use product you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in common
with yours, you individually lose the exemption and become subject
to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end-use
producers lose the exemption, and become subject to the data
requirements in Table A.
47
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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
registration of products containing this active ingredient.5
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often
required for ecological effects studies and applies to all
products having that formulation type. These are classed as
generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 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.
5.
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
48
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If you are not now eligible for a generic data
exemption, you may qualify for one if you change your source
of supply to a registered source that does not share
ownership in common with your firm. If you choose to change
sources of supply, the Confidential Statement of Formula must
identify the new source(s) and you must submit a Generic Data
Exemption statement.
If you apply for a new registration for products
containing this active ingredient after the issuance of this
Registration Standard, you will be required to submit or cite
generic data relevant to the uses of your product if, at the
time the application is submitted, the data have been
submitted to the Agency by current registrants. If the
required data have not yet been submitted, any new
registration will be conditioned upon the new registrant's
submittal or citation of the required data not later than the
date upon which current registrants of similar products are
required to provide such data. See FIFRA sec. 3(c)(7)(A).
If you thereafter fail to comply with the condition of that
registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with 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
49
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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.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the PCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
a. 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).
b. 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
50
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must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec. 3(c) (2) (B)
in the [name of active ingredient] Registration Standard upon
terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FIFRA section
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit and
submit the required data in the specified timeframe. In such
cases, the Agency generally will not grant a time extension
for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses , you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use
factors that lead you to believe that a requirement does not
apply. Since the Agency has carefully considered the
composition and uses of pesticide products in determining
that a data require-ment applies, EPA does not anticipate
that many waivers will be granted. A request for waiver does
not extend the time-frames for developing required data, and
if your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration bv
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.
51
-------
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
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
52
-------
G. Procedures for requesting a change in
test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning
testing, because the Agency will not ordinarily accept as
sufficient studies using unapproved protocols. A request for
protocol approval will not extend the timeframe for submittal
of the data, nor will extensions generally be given to
conduct studies due to submittal of inappropriate protocols.
The Agency will respond in writing to your request for
protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future
claim that there was insufficient time to submit the data.
While EPA considers your request, you must strive to meet the
deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity
or adequacy of funding, since the Agency believes that with
proper planning these can be overcome. The Agency will
respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
.All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR Notice 86-5
(issued July 29, 1986). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
53
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J. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is suspended
for failure to respond to a DCI request under FIFRA sec.
3(c)(2)(B), an existing stocks provision for the registrant is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
information must be included in any request for an existing stocks
provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale or
distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing using a
specific formulated product, and, unlike generic data, generally
support only the registration of that product. All such data must
be submitted by the dates specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided that
it will not routinely require product-specific data for end use
products at this time. Therefore, Table C may not be contained in
this Registration Standard; if there is no Table C, you are not
required to submit the data at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data) or
VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the product's
registration.
54
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and its
uses. General labeling requirements are set out in 40 CFR 156.10
(see Appendix II - LABELING and SUMMARY). In addition, labeling
language specific to products containing this pesticide is
specified in Section IV.D of this Registra-tion Standard.
Responses to this Registration Standard must include draft
labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in 8-1/2 x
11 files. Draft labeling must indicate the intended colors of the
final label, clear indication of the front panel of the label, and
the intended type sizes of the text.
If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in
Section IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard must
be sent to the following address:
Document Processing Desk (RS-0090)
Office of Pesticide Programs - H7504C
U. S. Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
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.
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.
55
-------
2. Within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
c. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table Af you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
4. Within the times set forth in Table B, you must submit
all product specific data.
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)
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
56
-------
2. Within 9 months of receipt of this document, you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
c. Product Specific Data Report (EPA Form 8580-4).
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.
4. Within the time frames set forth in Table B, you must
submit all product specific data.
57
-------
C. End Use Products containing the subject pesticide as sole
active ingrGdient.
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. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table Af you must submit all
generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
4. Within the times set forth in Table C, you must submit all
product specific data.
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).
58
-------
2. Within 9 months from the receipt of this document, you
must submit:
a. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
b. Five 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.
4. Within the times set forth in Table C, you must submit all
product specific data.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted by
that date, no product may be released for shipment by the producer
after July 31, 1988.
59
-------
I. DATA APPENDICES
60
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
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:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns are
the same as those given in 40 CFR Part 158. The following letter
designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic , food
D = Aquatic, non-food
E = Greenhouse , food
61
-------
TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
4. Does EPA have data? (Column 4). This column indicates one of
three answers:
YEg - 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.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional
information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
62
-------
TGUIDE-3
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 3 indicates that the Agency
has only partial data or no data, this column will usually
indicate YES. In some cases, even though the Agency does not have
the data, EPA will not require its submission because of the
unique characteristics of the chemical; because data on another
chemical can be used 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 6 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
-------
DATA TABLES
64
-------
TABLE A. GENERIC DMA REQUIREMENTS FOR TOE ETHION TECHNICAL GRADE OF THE ACTIVE INGREDIENT.
Data Requirement
Test
Substance
Does EPA Must additional
have data to data be submitted Time Frame
satisfy this Bibliographic under FIFRA, Sec. For Data
requirement? Citation 3(c)(2)(B)? Submission
40 CFR §158.155-190 Product Chemistrv
Product Composition
61-2. Beginning Materials and
Production Process
61-3. Formation of Impurities
TGAI
TGAI
Partially
Partially
00132773
00132773
00157088
00157088
Analysis and Certification of Product Inoredients
62-1. Preliminary Analysis
Physical and Chemical
Characteristics
63-2. Color
63-3. Physical State
63-4. Odor
63-5. Melting Point
63-6. Boiling Point
63-7. Density, Bulk Density or
Specific Gravity
63-8. Solubility
63-9. Vapor Pressure
63-10. Dissociation Constant
63-11. Octanol/Water Partition
Coefficient
63-12. pH
63-13. Stability
Other Requirements;
64-1. Submittal of Samples
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
N/A
Partially
Yes
Yes
Partially
N/A
Partially
Partially
Partially
Partially
N/A
Partially
Partially
Partially
N/A
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
N/A
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
Yes1
Yes2
Yes3
No
No
Yes*
NO
Yes,
A
Yes4
A
Yes4
Yes4
No
Yes4
Yes4
Yes4
No
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
12 months
o\
Ul
1. For the Aceto 95% T (EPA Reg. No. 2749-293) the following information must be provided: a description
of the procedures used to assure consistent composition of the substance produced (quality control methods),
-------
TNKF. A. (Continued).
the name and address of the producer of each beginning material and information concerning the composition
of each, the nature of the process (batch or continuous), the proportions of beginning materials and the
order in which they are added, the duration of each step of the process and a flow chart of the chemical
equations. For the Cheminova 94% T (EPA Reg. No. 4787-10), the name and address of the producer of each
beginning material must be provided.
2. For the Aceto 95% T (EPA Reg. No. 2749-293) a discussion regarding the origin of the following
potential impurities must be provided: (i) each impurity associated with the active ingredient which was
found to be present in any analysis of the product conducted by or for the registrant, and (ii) each
impurity which the registrant has reason to believe may be present in the product at a level equal to or
greater than 0.1% (w/w) based on the composition of each starting material, intended and side reactions
which may occur in the production of the product, the possible degradation of ingredients in the product
after production, post-production reactions between the ingredients in the product, possible contamination
from packaging materials or production equipment, and process control, purification and quality control
measures. For the ETC 88% T (EPA Reg. No. 279-2280) and the Cheminova 94% T (EPA Reg. No. 4787-10)
discussion of the possible degradation of ingredients in the product after production, and post-production
reactions between the ingredients in these products is required.
3. For the analytical method used for sample analysis of the FMC 88% T (MRID 00132773), statements of
accuracy must be submitted. Also, the FMC and Cheminova products must be analyzed (using validated methods)
for all impurities discussed under 61-3 (MRID NQs. 00132773 and 00157088) that are of toxicological concern
or may be present at > 0.1% (w/w). For the Aceto 95% T (EPA Reg. No. 2749-293) five or more representative
batch samples must be analyzed for the amount of active ingredient and each impurity present at 0.1% or
greater. Complete and detailed descriptions of the methods used for sample analysis must be submitted,
including statements of their precision and accuracy. The preliminary analysis report should include the
identity and quantity of each ingredient for which analysis is conducted along with the mean and relative
standard deviation of the analytical results. Based on the preliminary analysis, a statement of the
composition of the technical grade of active ingredient must be provided.
4. As required in 40 CFR §158.190 and more fully described in the Pesticide Assessment Guidelines,
Subdivision D, Guidelines Reference Nos. 63-2 through 63-13, data must be submitted for the physical and
chemical characteristics of the technical grade of the active ingredient. All of these data except for
color, physical state, melting point and dissociation constant are required for the Aceto 95% T (EPA Reg.
No. 2749-293). In addition, data are required on the following specific physical/chemical characteristics
for the products indicated by EPA Reg. Nos. in parentheses: descriptive definition of odor (4787-10);
-------
TPBLE A. (Continued).
solubility as determined in g/100 ml of solvent (279-2280 and 4784-10); vapor pressure and octanol/water
partition coefficient determined using the purified active ingredient (279-2280 and 4784-10); pH (279-2280)
and temperature used to determine pH (4787-10); and stability (279-2280 and 4787-10).
ON
-------
TABLE A. GENERIC DMA REQUIREMENTS FCR ETHICN.
Most addi- Time frame
Test Does EPA Bibliographic tional data for
Data Requirement substance have data? citation be submitted? submission1
158.240 Residue Chemistry
171-2. Chemical Identity2
171-3. Directions for use
171-4. Nature of the residue
(Metabolism)
- Plants
171-4. Nature of the residue
(Metabolism)
- Livestock
171-4. Residue analytical
methods
EP
(See Index)
PAIRA and Partially
plant metabo-
lites
PAIRA and Partially
plant metabo-
lites
00155869 00155870
TGAI and
metabolites
Yes
00073144
00155875
00034468 00073062
00073094 00073105
00073100
Yes"
00155874 Yes"
Reserved
24 Months
24 Months
24 Months
24 Months
171-4. Storage stability
TEP, or TGAI Partially 00073152 00155504
and metabo-
lites
Yes'
24 Months
(continued).
ON
-------
TABLE A. GENERIC DATA PEQUIREMEOTS FOR ETHICN.
Must addi-
Test Does EPA Bibliographic tional data
Data Requirement substance have data? citation be submitted?
171-4. Magnitude of residue in
Plants
Bulb Vegetables
- Onions TEP
Legume Vegetables
- Beans TEP
Fruiting Vegetables
- Eggplant TEP
- Peppers TEP
- Pimentos TEP
- Tomatoes TEP
Cucurbit Vegetables
- Cucumbers TEP
- Melons TEP
- Squash TEP
Citrus Fruits Group TEP
Partially
Partially
Partially
Partially
No
Partially
Partially
Partially
Partially
Partially
00073085 00073121 Yes8
00073152
00073085 00073152 Yes9
Yes10
00073095 Yes11
00073189 Yes^
N/A YesiA
00073133 Yes1*
Yeslb
00073806 00153160 Yesf^
00073152 00153160 Yesf'
00153160 Yes1B
00073143 00155580 Yes19
Time frame
for
submission
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
(continued).
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR EKECN.
Data Requirement
Pome Fruits
- Apples
- Pears
Stone Fruits
- Apricots
- Cherries
- Nectarines
- Peaches
- Plums (fresh prunes)
Small Fruits and Berries
- Grapes
- Stravfoerries
Tree Nuts
- Almonds
- Chestnuts
- FiOJDerts
- Pecans
- Walnuts
Must addi-
Test Does EPA Bibliographic tional data
substance have data? citation be submitted?
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Yes
Yes
Partially
Partially
Partially
Partially
Partially
Partially
No.
Partially
No
Partially
00073808 00155850
00073083 00073152
00109285 00155850
00073162
00073162
00073195
00073082 00073083
00073083 00073145
00109285
00073083 00073808
00109285 00155850
00034874 00073152
00073095
N/A.
00073162
N/A.
00073162
Yes20
Yes21
Reserved22
Reserved
Y6S24
Yes24
Yes25
Yes26
Yes27
Yes28
Yes29
Yes3°
Yes::;:
Yes32
Yes33
Time frame
for
submission
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
Cereal Grains
(continued).
-------
TART.E A. GtMERIC DMA REQUIREMENTS FOR ETKECN.
Data Requirement
- Corn
- Sorghum
Test
substance
TEP
TEP
Forage, Fodder, and Straw
of Cereal Grains Group
- Corn forage and fodder TEP
- Sorghum forage and TEP
fodder
Miscellaneous
- Cottonseed
- Tea
171-4. Magnitude of residue in-
Meat/Mi Ik/Poultry/Eggs
171-5. Reduction of Residue
TEP
TEP
TGAI or
plant
metabolites
TEP
Must addi-
Does EPA Bibliographic tional data
have data? citation be submitted?
Partially 00073132 00073175 Yes3J
00159983 Yes'
Partially 00034311 Yes3*
YesJ7
Partially 00073173 Yes3®
Partially 00034311 YesJ9
Partially 00073158 00073160 Yes40
Yes41
Partially 00073053 Yes42
Partially 00073153 00073138 Reserved43
00073161 00155850
No Yes44
Time frame
for
submission
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
1. Data must be submitted within the indicated time frame, based on the date of this Guidance Document.
-------
TABLE A. GENERIC DMA REQUIREMENTS FCR ETHICN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
2. The same chemical identity data are required as under 158.150-190, with emphasis on impurities that
could constitute residue problems. Refer to Product Chemistry Data Requirements tables.
3. The registrant must amend all pertinent labels to specify a maximum single application rate and a
maximum seasonal application rate or a limit on the number of applications permitted per season; rates must
be expressed in terms of amount of active ingredient per unit area. In addition, the minimum time interval
between repeat applications must be specified. All requested residue data must reflect the maximum number
of applications and minimum interval between treatments specified on the labels or proposed by the
registrant to appear on the labels.
4. Data depicting the distribution and metabolism of methylene-labeled [ c]ethion in or on grapes and
cottonseed. A completely characterized test substance representative of technical ethion (including
impurities) used in commercial formulations must be applied foliarly at rates sufficiently high to permit
characterization of C-residues. The identities of residues in or on mature plant parts must be determined
and confirmed in order to elucidate terminal residues. Quantitative data must also be provided.
Representative samples must be analyzed using GLC/FPD Method I in JAM Vol. II to ascertain that all residues
of concern are determined. The Registrant is urged to complete and submit all plant metabolism studies to
the Agency for review prior to initiating residue field trials and processing studies.
5. Metabolism studies utilizing ruminants and poultry. Animals must be dosed orally for a minimum of 3
days with [ C]ethion at a level sufficient to make residue identification and quantification possible.
Milk and eggs must be collected twice a day during the dosing period. Animals must be sacrificed within 24
hours of the final dose. The distribution and identity of residues must be determined and confirmed in
milk, eggs, liver, kidney, muscle, and fat. Samples from these studies must also be analyzed using the
GLC/FPD Method I in PAM, Vol. II to ascertain that the methods are capable of adequately recovering and
identifying all residues of toxicological concern. Data depicting the nature of ethion residues in swine
are also required if the required metabolism studies with ruminants and poultry reveal that the metabolism
of ethion in these animals differs from that in rats.
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR ETHICN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
6. Additional analytical methods may be required if the metabolism studies requested indicate that
additional metabolites constitute residues of toxicological concern in or on plants or livestock.
7. The sanple storage conditions and intervals must be supplied for all required and previously submitted
residue data for plant and animal commodities. Storage stability data in support of previously submitted
residue data are required for only those samples deemed to be useful for tolerance assessment. Data are
also required which depict the decline in levels of ethion residues of concern in commodities stored under
the range of conditions and for the range in intervals specified. Crop samples bearing measurable weathered
residues or fortified with ethion residues of concern and fortified meat, milk and egg samples must be
analyzed immediately after harvest or fortification and again after storage intervals that represent actual
residue sample storage conditions and allow for reasonable delays in sample analysis. In laboratory tests
using fortified samples, the pure active ingredient and pure metabolites must be used. However, if field
weathered samples are used, the test substance must be a typical end-use product. For additional guidance
on conducting storage stability studies, the Registrant is referred to an August, 1987 Position Document on
the Effects of Storage on Validity of Pesticide Residue Data available from NITS under order no. PB
88112362/AS.
8. Data depicting the ethion residues of concern in or on green and dry bulb onions harvested following
multiple broadcast soil-incorporated applications of the 10% G formulation at 4 Ib ai/A. Tests must be
conducted in ID and OR.
9. Data depicting ethion residues of concern in or on beans (succulent and dried) harvested 2 days
following the last of multiple foliar applications of the 4% D formulation at 0.8 Ib ai/A, a representative
EC formulation at 0.5 Ib ai/A and the 25% WP at 0.5 Ib ai/A. Data depicting ethion residues of concern in
or on beans harvested 4 days following the last of multiple foliar applications of the 4% D at 1.6 Ib ai/A
and the 25% WP and an EC formulation at 1 Ib ai/A. Only ground application data are needed for the 25% WP
tests. For the other formulations, both aerial and ground data must be submitted. Tests must be conducted
in CA(12% dry), ME (21% dry, 7% succulent), NE(13% dry) or C0(10% dry), NY(10% succulent),. ND( 19% dry),
QR(23% succulent), and WI(41% succulent) which accounted for ca. 80% of the 1987 dry bean production (Ag.
-------
TAHLE A. GENERIC DMA REQUIREMENTS FCR ETHICN.
Data Requirement
Test
substance
Does EFA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
Statistics Board, MASS, USDA, 1988, Annual Crop Statistics, p. 48) and 80% of the 1986 snap bean production
(Ag. Statistics Board, NASS, USDA, 1987, Vegetables, 1986 Summaryf p. 45).
10. Data depicting the potential for concentration of ethion residues of concern in or on the cannery
residue from beans bearing measurable, weathered residues. If the data indicate the potential for
concentration of residues, the registrant must propose an appropriate feed additive tolerance.
11. The data requested for peppers will be translated to eggplants.
12. Data depicting the ethion residues of concern in or on peppers harvested on the day of the last of
multiple foliar applications of the 25% WP, the 4% D, and a representative EC formulation at 0.5 Ib ai/A.
Only ground application data are needed for the 25% WP tests. For the other formulations, both aerial and
ground data must be submitted. Tests must be conducted in CA(18% sweet, 27% hot), FL(23% sweet, 2% hot),
and TX(16% sweet, 10% hot). These states accounted for ca. 57% of the 1982 sweet pepper production and ca.
79% of the 1982 hot pepper production if TX is representative of EM(40%) (1982 Census of Agriculture, Vol.
1, Part 51, p. 349).
13. The data requested for peppers will be translated to pimentos.
14. Data depicting the ethion residues of concern in or on tomatoes harvested 2 days following the last of
multiple foliar applications of the 25% WP and a representative EC formulation at 0.5 Ib ai/A and the 4% D
formulation at 0.8 Ib ai/A. Only ground application data are needed for the 25% WP tests. For the other
formulations, both aerial and ground data must be submitted. Tests must be conducted in CA which accounted
for ca. 26% of the tomatoes grown for fresh market and 85% of the tomatoes grown for processing in 1985.
Also, tests must be conducted in FL where 47% of the fresh market tomatoes were grown and in OH, IN, or MI,
which together produced ca. 10% of the tomatoes grown for processing (preliminary 1985 data, Agricultural
Statistics. 1986, p. 172, USDA).
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TABLE A. GENERIC DATA REQUIREMENTS FOR ETHTCN.
Must addi- Time frame
Test Does EPA Bibliographic tional data for
Data Requirement substance have data? citation be submitted? submission
15. A processing study depicting the combined residues of ethion and ethion monooxon in products (dry
pomace, puree, catsup, and juice) processed from tomatoes bearing measurable weathered residues. If
residues concentrate in any product, an appropriate food/feed additive tolerance must be proposed.
16. Registrants must either impose a 3-day PHI on all labels that permit use on cucumbers, remove cucumbers
from all ethion labels, or submit data to reflect the current 0-day PHI as required under the "Summer
Squash" section. If data are submitted for summer squash, they may be translated to fulfill the
requirements for cucumbers.
17. Data depicting ethion residues of concern in or on melons (cantaloupes or mustanelons) harvested the day
of the last of multiple foliar applications of the 25% WP formulation at 1 Ib ai/A applied with ground
equipment, and a representative EC formulation at 1 Ib ai/A and the 4% D at 1.6 Ib ai/A applied with ground
and aerial equipment, in separate tests. Tests must be conducted in CA(58%) and TX(21%), since these states
accounted for ca. 80% of the 1982 cantaloupe acreage (1982 Census of Agriculture. Vol. 1, Part 51, p. 229).
18. Data depicting ethion residues of concern in or on squash harvested on the day of the last of multiple
foliar applications of the 25% WP formulation at 0.5 Ib ai/A applied with ground equipment, and a
representative EC formulation at 0.5 Ib ai/A applied with ground and aerial equipment. Tests must be
conducted in CA(15%), FL(21%), GA(7%) or NC(4%), MA(4%) or NY(4%), MI(4%), and NJ(6%) which collectively
accounted for ca. 70% of the 1982 squash acreage (1982 Census of Agriculture. Vol. 1, Part 51, p. 353).
Alternatively, all registrants may impose the 3-day PHI specified on FMC labels.
19. The registrant must propose a revised tolerance for ethion residues of concern in or on citrus fruits
and submit appropriate supporting residue data for the representative commodities grapefruit, oranges, and
LD
-------
TABLE A. GENERIC DMA REQUIREMENTS FCR EIHICN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
lemons. The data must reflect six applications of the 25% WP and a representative EC formulation made at
90-day intervals to oranges and grapefruits and a single application to lemons at 7.5 Ib ai/A. Oranges and
grapefruits must be harvested on the day of the final treatment and at regular intervals thereafter, and
lemons must be harvested 21 days posttreatment. Alternatively, the registrant may propose amendments in the
registered uses and a revised tolerance if necessary, and submit appropriate supporting residue data. Tests
on grapefruit must be conducted in FL(100%), tests on lemons in CA(75%), tests with oranges in CA(32%) and
FL(66%), since these states reflect 1987 U.S. production of ca. 100%, 75%, and 98%, respectively, for
grapefruit, lemons, and oranges (Agricultural Statistics Board, NASS, USDA, Crops Database, Jan. 1988). It
should be noted that any proposed increase in the tolerance must also be evaluated in terms of toxicological
considerations. A decision as to the adequacy of the established feed additive tolerance for residues in
dried citrus pulp and the appropriate level for a food additive tolerance for residues in citrus oil will
not be made until an adequate tolerance for residues in or on citrus fruits has been established.
20. The registrant must propose a revised tolerance for ethion residues of concern in or on apples and
submit residue data depicting ethion residues of concern in or on apples harvested: (i) 20 days following
two applications of the 4% D and 4 or 8 Ib/gal EC formulations at 2.5 Ib ai/A; (ii) 40 days following two
applications of the 4% D at 3.6 Ib ai/A, and the 25% WP and 4 or 8 Ib/gal EC formulations at 5 Ib ai/A; and
(iii) 60 days following four applications of the 4% D at 3.6 Ib ai/A, and the 25% WP and 4 or 8 Ib/gal EC
formulations at 5 Ib ai/A. Applications must be made at 10-day intervals during the fruiting season. Only
ground application data are needed for the 25% WP tests. For the other formulations, both aerial and ground
data must be submitted. Alternatively, the registrant may propose amendments in the registered uses and a
revised tolerance if necessary and submit appropriate supporting residue data. Tests must be conducted in
CA(7%), MI(11%), NY(10%), and WA(42%) which collectively accounted for ca. 70% of 1987 U.S. apple production
(Agricultural Statistics Board, NASS, USDA, 1988, Crops Database, 1/88). It should be noted that any
proposed increase in tolerance level must also be evaluated in terms of toxicological considerations.
21. The data requested for apples will be translated to pears.
o\
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TABLE A. GENERIC DATA REQUIREMENTS FCR ETHICN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
22. On receipt of the required plant metabolism and storage stability data, the need for additional data
will be determined.
23. The data requested for peaches will be translated to nectarines.
24. Data depicting ethion residues of concern in or on peaches harvested 30 days following the last of two
foliar applications made during the fruiting period using: (i) the 4% D at 2.4 Ib ai/A and an EC formulation
at 1.75 Ib ai/A; and (ii) the 25% WP at 1-1.5 Ib ai/A plus 4-6 gallons of summer oil. Only ground
application data are needed for the 25% WP tests. For the other formulations, both aerial and ground data
must be submitted. Tests must be conducted in CA(100% cling, 34% freestone), MI(4%), NJ(5%) or PA(6%), and
SC(23%) which collectively accounted for ca. 70% of the 1987 U.S peach production (Ag. Statistics Board,
NASS, USDA., 1988, Annual Crop Statistics).
25. Data depicting ethion residues of concern in or on plums harvested 21 days following the last of three
foliar applications, applied during the fruiting period, using the 4% D and a representative EC formulation
at 1.75 Ib ai/A and plums harvested 45 days following the last of two foliar applications using the 25% WP
formulation at 2.5 Ib ai/A and the 4% D formulation at 2.4 Ib ai/A. Only ground application data are needed
for the 25% WP tests. For the other formulations, both aerial and ground data must be submitted. The tests
must be conducted in CA(100%) which accounted for 100% of the 1987 U.S. plum production (Ag. Statistics
Board, NASS, USDA., 1988, Annual Crop Statistics).
26. A processing study depicting ethion residues of concern in prunes processed from plums bearing
measurable weathered residues. If residues concentrate, an appropriate food additive tolerance must be
proposed.
27. Data depicting ethion residues of concern in or on grapes harvested: (i) 15 days following the last of
two foliar applications, made during the fruiting season, of the 4% D formulation at 1.2 Ib ai/A ; (ii) 30
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR ETHICN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
days following a single foliar application of the 25% WP and the 8 Ib/gal EC formulation at 2.25 Ib
and (iii) 60 days following the last of multiple applications of the 25% WP and an EC formulation at 1.25 Ib
ai/A. Only ground application data are needed for the 25% WP tests. For the other formulations, both
aerial and ground data must be submitted. Tests must be conducted in CA which accounted for ca. 90% of the
1987 U.S. grape production (Agricultural Statistics Board, MASS, USDA, 1988, Crops Database, 1/88). The
adequacy of the food additive tolerance for residues in or on raisins and the need for feed additive
tolerances for residues in other processed commodities will be addressed on receipt of the data requested
for grapes.
28. Data depicting the ethion residues of concern in or on strawberries harvested 2 days following the last
of multiple foliar applications of the: (i) the 4% D at 1.2 Ib ai/A and an EC formulation at 1 Ib ai/A using
aerial and ground equipment; and (ii) the 25% WP at 1 Ib ai/A using ground equipment. Tests must be
conducted in CA, since this state accounted for ca. 80% of the 1986 U.S. strawberry production (Ag.
Statistics Board, NASS, USDA, 1987, Vegetables, 1986 Summary, p. 27).
29. Data depicting ethion residues of concern in or on almond nutmeat and hulls harvested 30 days following
a foliar application of an EC formulation at 2.5 Ib ai/A in 200 gallons of water/A using ground equipment,
and in 15 gallons of water/A using aerial equipment, in separate tests. Tests must be conducted in CA,
which accounted for ca. 99% of 1982 U.S. almond production (1982 Census of Agriculture, Vol. 1, Part 51, p.
367).
30. The data requested for walnuts will be translated to chestnuts.
31. The data requested for walnuts will be translated to filberts.
32. Data depicting ethion residues of concern in or on pecan nutmeats harvested at maturity following the
last of two foliar applications made during the fruiting period, of an EC formulations at 2.5 Ib ai/A, using
CO
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR ETHICN.
Data
Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
ground and aerial equipment in separate tests, and of the 25% WP at 2.5 Ib ai/A using ground equipment. The
second application must be made just prior to husk split. Tests must conducted in GA(34%) and TX(32%),
which accounted for ca. 70% of 1985 U.S. pecan production (Agricultural Statistics. 1986, p. 234).
33. Data depicting ethion residues of concern in or on walnut nutmeat harvested at maturity following the
last of two foliar applications made during the fruiting period, of an EC formulation at 2.5 Ib ai/A, using
ground and aerial equipment in separate tests, and of the 25% WP at 2.5 Ib ai/A using ground equipment. The
second application must be made just prior to husk split. Tests must be conducted in CA, which accounted
for 99% of 1982 U.S. walnut production (1982 Census of Agriculture. Vol. 1, Part 51, p. 368).
34. Data depicting ethion residues of concern in or on corn grain harvested 50 days after application of a
representative EC at 1 Ib ai/A using aerial equipment. Tests must be conducted in IL(17%) or IA(18%),
IN(9%) or CH(5%), MN(9%), NE(11%), and TX(2%), which collectively accounted for ca. 75% of 1987 U.S. corn
grain production (Agricultural Statistics Board, MASS, USDA, 1988, Crops Database, 1/88).
35. Data depicting ethion residues of concern in or on crude and refined oil, starch, grits, meal, flour
and grain dust processed from corn grain bearing measurable, weathered residues. It is recommended that an
exaggerated application rate be used to assure the presence of measurable residues in the raw agricultural
commodity. If the data indicate a potential for concentration, the registrant must propose an appropriate
food/feed additive tolerance.
36. Data depicting ethion residues of concern or on sorghum grain harvested 30 days after the last of three
applications, made at 4-day intervals, of the 25% WP and a representative EC at 0.5 Ib ai/A. Cnly ground
application data are needed for the 25% WP tests. For the EC formulation, both aerial and ground data must
be submitted. Tests must be conducted in KS(37%), NE(15%) and TX(23%) which collectively accounted for ca.
75% of 1987 U.S. sorghum production (Agricultural Statistics Board, MASS, USDA, 1988, Crops Database, 1/88).
-------
TABLE A. GENERIC DATA.
FOR ETHICN.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
37. Data depicting the potential for concentration of residues in or on flour, starch and grain dust
processed from sorghum grain bearing measurable, weathered residues. If the data indicate the potential for
concentration of residues, the registrant must propose an appropriate food/feed additive tolerance.
38. Data depicting ethion residues of concern in or on corn fodder harvested 50 days after the last of
several foliar applications of a representative EC at 1 Ib ai/A using ground and aerial equipment, in
separate tests. Tests must be conducted in IL(17%) or IA(18%), IN(9%) or CH(5%), MN(9%), NE(11%), and
TX(2%), which collectively accounted for ca. 75% of 1987 U.S. corn production (Agricultural Statistics
Board, NASS, USDA, 1988, Crops Database, 1/88). Also, the feeding restriction imposed on fodder is
impractical and unenforceable; therefore, it should be removed from the label.
39. Data depicting ethion residues of concern in or on sorghum forage and fodder harvested 30 days after
the last of three applications made at 4-day intervals of the 25% WP and a representative EC at 0.5 Ib ai/A,
in separate tests. Only ground application data are needed for the 25% WP tests. For the EC formulation,
both aerial and ground data must be submitted. Tests must be conducted in KS(37%), NE(15%) and TX(23%)
which collectively accounted for ca. 75% of 1987 U.S. sorghum production (Annual Crop Statistics, Jan. 1988,
Ag. Statistics Board, NASS, USDA). A tolerance for residues in or on fodder must be proposed.
Alternatively, a label restriction prohibiting feeding of fodder to livestock may be imposed.
40. Data depicting ethion residues of concern in or on cottonseed harvested at maturity following the last
of multiple applications of the 4% D and an EC formulation at 1.6 and 1.5 Ib ai/A, respectively, applied
using ground and aerial equipment, in separate tests, and the 25% WP at 1.5 Ib ai/A applied with only ground
equipment. The final application must be made just prior to boll opening. Tests must be conducted in
CA(25%), MS(12%) and TX(31%) which collectively accounted for ca. 70% of 1985 U.S. cottonseed production
(Agricultural Statistics. 1986, p. 108).
CO
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TABLE A. GENERIC DATA REQUIREMEOTS FCR ETHICN.
Data Requirement
Test
substance
Does EPA
nave data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
41. Data depicting the potential for concentration of ethion residues of concern in cottonseed hulls, crude
oil, meal, refined oil and soapstock processed from cottonseed bearing measurable, weathered residues. If
the data indicate a potential for concentration of residues in any processed commodity, an appropriate
food/feed additive tolerance must be proposed.
42. The registrant must submit current specimen labels in English and appropriate supporting residue data
from tests conducted in those countries specified on the labels. The registrant must propose a maximum
number of applications per season or a total seasonal use rate. The requested data must reflect this
maximum number.
43. On receipt of the data requested in the sections entitled "Qualitative Nature of the Residue in
Animals", and "Magnitude of the Residue in Plants" the established tolerances for residues in animal
products will be assessed and additional feeding studies may be required.
44. The Agency is now imposing the additional requirement of a tea brewing study. This study must be
designed such that the percent reduction in residues of concern during the brewing process can be
determined. Tea used in the brewing study must bear measurable, weathered residues at levels as close to
the established tolerance as possible. Studies depicting the degradation of ethion residues in transit and
storage are required for the following commodities: apples, grapes, melons, tomatoes, dry and succulent
beans, strawberries, plums, peaches, oranges, cucumbers, squash, peppers, onions, and tea. Samples must be
analyzed at harvest, and at fixed intervals thereafter. Commodities must be kept under conditions of
commercial storage and shipment for the minimum and maximum time that each commodity would be in storage or
transit between harvest and sale to the consuming public. Information regarding the average and range of
conditions and length of commercial storage must be adequately documented, studies may be terminated when
the maximum practical length of storage following harvest has elapsed or when it can be statistically
determined that average levels at three consecutive time points have reached the limits of detection for all
CO
-------
A. GENERIC DATA REQUIREMENTS FOR EIHION.
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for .
submission
residues of concern. Due to the complexity of this data requirement, the registrant is urged to submit a
protocol for Agency review prior to initiating studies. Also, raw agricultural commodities (RACs) bearing
measurable weathered residues at or near the tolerance level must be processed as described below. Residues
of concern must be determined in both the RAC and the final food form, as consumed. These data may be used
in conjunction with the degradation studies required above and other required and previously submitted
processing data to permit more realistic estimates of potential short-term dietary intake of residues of
ethion.
Washing - Apples, Grapes, Tomatoes, Strawberries, Plums, Peaches, Cucumbers, Peppers, Oranges
Cooking - Apples, Grapes, Tomatoes, Dry and Succulent Beans, Peaches, Squash, Peppers, Onions
Peeling - Melons
CO
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Table A
Generic Data Requirements for Ethion
Does EPA Have
Data to Satisfy Must Additional
This Require- Data Be Submitted Timeframe
Use ment? (Yes, Bibliographic Under FIFRA Section For Data
Composition Pattern No. Partiallv) Citation 3(c)(2)(B)? Submission
Data Reouirement
158.130 Environmental Fate
DBGRADATICiSr STUDIES - IAB;
161-1 Hydrolysis
PHOTODEGRADATIGN;
161-2 In Water
161-3 On Soil
161-4 In Air
METABOLISM STUDIES - LAB:
PAIRA A,B,F,H Partial
PAIRA
A,B
PAIRA OR A,B
TGAI
PAIRA OR A,B
TGAI
Nt>
NO
NO
00155507
Yes1/
Yes
Yes
Yes
12 Months
12 Months
12 Months
12 Months
162-1 Aerobic Soil
162-2 Anaerobic Soil
PAIRA A,B,F,H Yes
PAIRA OR A,B, NO
TGAI
00155510
NO
Yes
24 Months
CO
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Data Requirement
Table A
Generic Data Requirements for Ethion
Does EPA Have
Data to Satisfy Must Additional
This Require- Data Be Sutmitted Timeframe
Use ment? (Yes, Bibliographic Under FIFRA Section For Data
Composition Pattern Mb. Partially) Citation 3(C)(2)(B)? Submission
(continued)
METABOLISM STtlPTFr? ~
162-3 Anaerobic Aquatic
162-4 Aerobic Aquatic
MOBILITY STUDIES;
163-1 Leaching and
Adsorption/Des.
163-2 Volatility (Lab)
163-3 Volatility (Field)
STUDIES-FIELD:
164-1 Soil
164-2 Aquatic (Sediment)
PAIRA CR
TGM
FAIRA OR
TGAI
PAIRA A,B,F,H No
TEP
TEP
TEP
TEP
A,B,F
A,B,F
A,B,H
NO
NO
NO
NO2/
NO2/
Yes3/
12 Months
Yes 12 Months
Reserved4/
Yes
No2/
24 Months
CO
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Table A
Generic Data Requirements for Etnion
Data Requirement
Does EPA Have
Data to Satisfy
This Require-
Use ment? (Yes,
isition Pattern Nb. Partially)
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2HBl? SuftnlSSion
158.130 Environmental Fate
(continued)
DISSIPATION
164-3 Forestry TEP
164-4 Combination and TEP
Tank Mixes
164-5 Soil, Long-Term TEP
A,B,H
No
NbV
Reserved6/
ACCUMULATION STUDIES;
165-1 Rotational Crops
(Confined)
165-2 Rotational Crops
(Field)
165-3 Irrigated Crops
165-4 In Fish
165-5 In Aquatic Non-
Target Organisms
PAIRA A,B
TEP A,B
NO
NO
TEP
PAIRA/
TGAI
TEP
A,B
Yes
00153553
00155515
Yes
Reserved^/
Nb2/
Nb
Nb
24 Months
CO
Ul
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Table A
Generic Data Requirements for Ethion
158.130 Environmental Fate Footnotes;
I/ This data requirement is satisfied for pH 5 and pH 7. However, due to the fact that the borate buffer may
have caused ethion to degrade or reacted with its degradates. The registrant has the option of addressing
this concern in a written explaination or the pH 9 experiment should be repeated using another buffer.
2/ Not required because ethion has no aquatic or forestry uses.
3/ Batch equilibrium (adsorption/desorption) is required for the domestic outdoor and greenhouse uses.
4/ This study may be required, depending on the results of the laboratory volatility study.
5/ This data requirement is not being imposed at this time.
6/ This data may be required, depending on the results of the field dissipation studies.
7/ This data may be required, depending on the results of the confined rotational crop study.
CO
ON
-------
Table A
Generic Data Requirements for Ethion
Data Requirement Composition
158.390 - Reentry Protection;
132-1 Foliar Dissipation
132-1(2) Soil Dissipation
133-3 Dermal Exposure
TEP
TEP
TEP
133-4 Inhalation Exposure TEP
158.75 - Applicator Exposure Monitorina:
231 Estimation of dermal
exposure at outdoor sites.
323 Estimation of inhalation
exposure at outdoor sites.
333 Estimation of dermal
TEP
TEP
TEP
Use
Pattern
A,B,F,H
A,B,F,H
A,B,F,H
A,B,F,H
A,B,F,H
A,B,F,H
A,B,F,H
Does EPA Have
Data to Satisfy
This Require-
ment? (Yes, Bibliographic
No, Partially) Citation
No
No
No
No
No
No
No
Must additional
Data Be Submitted
Under FIFRA Section
3(C)(2)(B)?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
24 Months
exposure at indoor sites.
CO
-------
Table A
Generic Data Requirements for Ethion
Does EPA Have
Data to Satisfy Most Additional
This Require- Data Be Submitted Timeframe
Use ment? (Yes, Bibliographic Under FIFRA Section For Data
158.75 & 158.390 - Nm-Qccppational
Post-Application Exposure Monitoring;
133-3 Dermal Exposure TEP A,B,F,H No
133-4 Inhalation Exposure TEP A,B,F,H No
232, 234
132-1 Foliar Dissipation TEP A,B,F,H No
Yes 24 Months
Yes 24 Months
Yes 24 Months
-------
Table A
Generic Data Requirements for Ethion
Data Requirement
158.135 Toxicology;
ACUTE TEbTlTflG;
81-1 Acute Oral Rat
81-2 Acute Dermal
81-3 Acute Inhalation
- Rat
81-4 Eye Irritation
-Rabbit
81-5 Dermal Irritation
-Rabbit
81-6 Dermal Sensitization
-Guinea Pig
81-7 Acute Delayed
Neurotoxicity - Hen
SUBCHRCNIC TESTING:
82-1 90-Day Feeding
- Rodent
- Non-rodent
Composition
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A
A
A
A
A
A
A
A
A
Does EPA
Have Data to
Satisfy This
Requi rement ?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Bibliographic
Citation
00157590
00157590
00163159
00157590
00157590
00157590
00141205
00158376
40773301
Most Additional
Data Be Submitted
Under FIFRA Section
3(c)(2HB)?
No
No
No
No
No
No
No
No2/
No
Timeframe
For Data
Submission
CD
-------
Table A
Generic Data Requirements for Ethion
Data
Rprmi rpsnent.
158.135 Toxicology; (Cont. )
82-1
82-3
82-4
82-5
21-Day Dermal
90-Day Dermal
90-Day Inhalation
90-Day Neurotoxicity
Composition
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A
A
A
A
Does EPA
Have Data to
Satisfy This
Requirement?
Yes
No
No
No
Bibliographic
Citation
00155498
00155499
Must Additional
Data Be Submitted
Under FIFRA Section
3(cM2)(B)?
No
No3/
No3/
NbV
Timeframe
For Data
Submission
CHRGSIIC TEbU'U]G;
83-1
83-2
83-3
83-4
Chronic Toxicity -
Rodent
Non-rodent
Qncogenicity Study -
Rat
Mouse
Teratogenicity
Rat
Rabbit
Reproduction
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
Yes
No
Yes
Yes
Yes
Yes
Yes
00148991
00148991
00148989
00131852
00131853
00148990
No
Yes
No
No
No
No
No
48 Months
-------
Table A
Generic Data Requirements for Ethion
Data Requirement
Composition
Does EFA
Have Data to
Use Satisfy This
Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(cH2HB)? Submission
158.135 Toxicology: (Cent.)
MUTAGENICITY TESTING;
84-2 Gene Mutation
84-2 Chramosomal Aberration
84-2 Other Mechanism of
Mutagenicity
TGAI A Yes
TGAI A No
TGAI A No
00144351
No
Yes
Yes
12 Months
12 Months
SPECIAL TESTING;
85-1 General Metabolism
EAI or TGAI
Yes
00155871
00155872
00155873
Reserved4/
I/ Since an acute neurotoxicity did not show neurotoxic effects, a 90-day delayed neurotoxicity study is not required.
2/ Since an acceptable chronic rat study is available, the requirement of a subchronic rat study is waived.
3/ Not required under the registered use patterns.
4/ These studies are currently under review by the Agency. Registrant will be notifed if additional studies are
required.
-------
Table A
Generic Data Requirements for Ethion
Does EPA Have
Data to Satisfy
This Require-
Use ment? (Yes,
Composition Pattern NoP Partially)
S158.490 - Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 -Avian Acute Oral Toxicity
- Upland game bird
71-2 - Avian Dietary
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Birds and Mammals
Aquatic Organism Testing
72-1 - Freshwater Fish I£5o
72-2 - Freshwater
Invertebrate LC5Q
TGAI A,B,H
TGAI A,B,H
TGAI
Yes
Yes
Nb
Nb
Nb
TGAI A,B,H
TGAI A,B,H
Yes
Yes
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
=ition 3(cH2HB)?
00146309
00146310
00022023
00003503
00003503
No
No
Nb
Yes1/
No
Nb
Nb
24 Months
-------
Table A
Generic Data Requirements for Ethion
(cont'd)
Data Requirement
Does EPA Have
Data to Satisfy
This Require-
Use ment? (Yes,
Composition Pattern Mo. Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission
S158.490 - Wildlife and Aquatic Organisms
Aquatic Organism Testing
(continued)
72-3 - Estuarine and Marine TGAI
Organisms ££50
72-4 - Fish Early Life Stage TGAI
and Invertebrate
Life Cycle
72-5 - Fish Life Cycle TGAI
72-6 - Aquatic Organisms TGAI
Accumulation
72-7 - Simulated or Actual
Field Testing
-Aquatic Organisms TGAI
A,B,H
A,B,H
A,B,H
A,B,H
Yes
Nb
Nb
Yes
00155517
00155516
00155518
00153553
No
Yes2/
Reserved3/
No
24 Months
A,B,H
Yes
Reserved3/
Osl
-------
Table A
Generic Data Requirements for Ethion (cont'd)
s 158.490-Mildlife and aquatic Organisms Footnotes;
l/ Ihis study is required because of ethion's persistence in the environment, expected residue levels on avian food,
accumulation in plant and animal tissue, and the exposure potential to birds.
2/ These studies are required because ethion is persistent in water, bioaccumulates in fish tissue, acutely toxic,
and there is a high potential exposure.
3/ These studies may be required pending the en^ronmental fate data on field dissipation and the results of a fish
early life stage and daphnid life-cycle study.
-------
Table A
Generic Data Requirements for Ethion
Data Requirement
Composition
Does EPA
Have Data to
Use Satisfy This
Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(cH2)(B)? Submission
S158.155 Nontaraet Insects
NCNIARGET INSECT TESTING -
141-1 - Honey Bee Acute TGAI A,B
Contact LD50
141-2 - Honey Bee - Toxicity TEP A,B
of residues on
foliage
141-4 - Honey Bee Subacute Reserved2/
Feeding Study
141-5 - Field Testing for TEP A,B
pollinators
NCNTARGET INSECT TESTING - AQUATIC INSECTS
Yes
No
00036935
NO
Nb1/
No1/
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect
Life Cycle Study
142-3 - Simulated or
Actual Field
Testing for0
Aquatic Insects
Reserved3/
Reserved3/
Reserved3/
NQNTIRRGET INSECT TESTING - PREDATORS AND
en
143-1
thru
143-3
Reserved3-/
-------
Table A
Generic Data Requirements for Ethion (cont'd)
S158.155 - Nontarget Insects Footnotes;
l/ As Data from the acute contact test indicate low toxicity; no further testing is required.
2/ This requirement is reserved pending development of test methodology.
3/ This requirement is reserved pending Agency decision as to whether the data requirement should be established.
ON
-------
Table B
Generic Data Requirements for Ethion
Data
158.
81-1
81-2
81-3
81-4
81-5
81-6
Requirement C
135 Toxicology;
Acute Oral Rat
Acute Dermal
Acute Inhalation
- Rat
Eye Irritation
-Rabbit
Dermal Irritation
-Rabbit
Dermal Sensitization
-Guinea Pig
Proposition
MP1/
MP1/
MP1/
MP1/
MP1/
MP1/
Use
Patterns
All
All
All
All
All
All
Does EPA
Have Data to
Satisfy This
Requi rement ?
Yes
Yes
Yes
Yes
Yes
Yes
Bibliographic
Citation
00157590
00157590
00163159
00157590
00157590
00157590
00141205
Must Additional
Data Be Submitted Timef rame
Under FIFRA Section For Data
No
No
No
No
No
No
I/ Data derived from acute toxicity tests conducted on the TGAI will satisfy this requirement.
-------
TABLE B. PRODUCT SPECIFIC IMA
FOR ETHION MANUFACTURING-USE PRODUCTS.
Test
Data Requirement Substance
40 CFR
«M Hft r 1 RE;-! QO Prnrhirt- OramislTY
Does EPA Must additional
have data to data be submitted Time Frame
satisfy this Bibliographic under FIFRA Sec. For Data
requirement? Citation 3(c)(2)(B)? Submission
Product Comcosition
61-1.
61-2.
61-3.
Analys
62-1.
62-2.
62-3.
Product Composition
Beginning Materials & Produc-
tion or Formulation Process
Formation of Impurities
is and Certification of Product
Preliminary Analysis
Certified Limits
Enforcement Analytical
Methods
MP
MP
MP
Partially
Partially
Partially
Reg. Jackets
00132773
00132773
00157088
00157088
Yes
Yes
Yes
Inoredients
MP
MP
MP
Partially
Partially
Partially
00132773
00157088
Reg. Jackets
00132773
00157088
Yes
Yes
Yes
•a
j
12
12
12
12
12
12
months
months
months
months
months
months
Physical and Chemical Characteristics
63-2.
63-3.
63-4.
63-7.
63-12.
62-14.
62-15.
63-16.
63-17.
63-18.
63-19.
63-20.
Other
Color
Physical State
Odor
Density, Bulk Density, or
Specific Gravity
pH
Oxidizing or Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Requirements;
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Yes
Yes
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00132773
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
00157088
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
7
/
7
/
7
/
7
/
7
/
7
/
7
/
7
/
7
/
7
/
12
12
12
12
12
12
24
12
12
24
months
months
months
months
months
months
months
months
months
months
64-1. Sutmittal of Samples
N/A
N/A
N/A
-------
T2BLE B. (Continued).
1. For the FMC 88% T (279-2280) and the Aceto 95% T (2749-293), new CSFs must be provided with the
chemical name and nominal concentration of the active ingredient and each impurity of toxicological
significance associated with the active ingredient or present in any sample at a level > 0.1% (w/w). For
the Cheminova 94% T (4787-10), the nominal concentration of the active ingredient must be provided so that
the Agency may calculate certified limits according to 40 CFR 158.175(b) (2). Also, if additional impurities
of toxicological concern or present at 2 0.1% (w/w) are found in the tests required under 62-1 (preliminary
analysis) for the Qieminova 94% T (4787-10), a new CSF reflecting such impurities will be required.
2. For the Aceto 95% T (EPA Reg. No. 2749-293) the following information must be provided: a description of
the procedures used to assure consistent composition of the substance produced (quality control methods),
the name and address of the producer of each beginning material and information concerning the composition
of each, the nature of the process (batch or continuous), the proportions of beginning materials and the
order in which they are added, the duration of each step of the process and a flow chart of the chemical
equations. For the Qieminova 94% T (EPA Reg. No. 4787-10), the name and address of the producer of each
beginning material must be provided.
3. For the Aceto 95% T (EPA Reg. No. 2749-293) a discussion regarding the origin of the following
potential iirpurities must be provided: (i) each impurity associated with the active ingredient which was
found to be present in any analysis of the product conducted by or for the registrant, and (ii) each
impurity which the registrant has reason to believe may be present in the product at a level equal to or
greater than 0.1% (w/w) based on the composition of each starting material, intended and side reactions
which may occur in the production of the product, the possible degradation of ingredients in the product
after production, post-production reactions between the ingredients in the product, possible contamination
from packaging materials or production equipment, and process control, purification and quality control
measures. For the FMC 88% T (EPA Reg. No. 279-2280) and the Cheminova 94% T (EPA Reg. No. 4787-10)
discussion of the possible degradation of ingredients in the product after production, and post-production
reactions between the ingredients in these products is required.
4. For the analytical method used for sample analysis of the FTC 88% T (MRID 00132773), statements of
accuracy must be submitted. Also, the FMC and Cheminova products must be analyzed (using validated methods)
for all impurities discussed under 61-3 (MRID Nbs. 00132773 and 00157088) that are of toxicological concern
or may be present at > 0.1% (w/w). For the Aceto 95% T (EPA Reg. No. 2749-293) five or more representative
batch samples must be analyzed for the amount of active ingredient and each impurity present at 0.1% or
greater. Complete and detailed descriptions of the methods used for sample analysis must be submitted,
-------
TABLE B. (Continued).
including statements of their precision and accuracy. The preliminary analysis report should include the
identity and quantity of each ingredient for which analysis is conducted along with the mean and relative
standard deviation of the analytical results. Based on the preliminary analysis, a statement of the
composition of the technical grade of active ingredient must be provided.
5. For the FMC 88% T and the Aceto 95% T, updated CSFs (on EPA Form 8570-4) must be provided in which
upper limits are provided for each toxicologically significant impurity associated with the active
ingredient and found to be present in any sample of the product. Limits should be based on the sources and
magnitude of variability in the manufacturing process and the stability of the ingredients following
production. The registrant must certify the accuracy of the information presented, and that the certified
limits will be maintained. An explanation of how each certified limit was established (e.g., sample
analysis using a validated analytical procedure, quantitative estimate based on the amount of ingredient
used, etc.) must be provided, along with information on the accuracy and precision of any analytical
procedures used. Also, if the data required under 62-1 (preliminary analysis) for the Oieminova 95% T
reveal additional impurities of toxic concern, a new CSF with upper limits for such impurities must be
provided.
6. For the Aceto 95% T, analytical methods which are suitable for enforcement purposes must be provided for
each impurity that is determined to be toxicologically significant. Suitability for enforcement purposes
shall be determined from validation studies of method accuracy and precision submitted by the registrant.
Information regarding the accuracy of methods submitted for analysis of impurities in the FM3 88% T (MRID
00132773) must be submitted. Also, if additional impurities of toxicological concern are found in the ETC
88% T or the Qieminova 94% T in the tests required under 62-1 (preliminary analysis), methods suitable for
enforcement of certified limits for such impurities will be required.
7. As required in 40 CFR §158.190 and more fully described in the Pesticide Assessment Guidelines,
Subdivision D, Guidelines Reference Nos. 63-2 through 63-20, data must be submitted for the physical and
chemical characteristics of manufacturing-use products. All of these data except for color, physical state,
melting point and dissociation constant are required for the Aceto 95% T (EPA Reg. No. 2749-293). In
addition, data are required on the following specific physical/chemical characteristics for the products
indicated by EPA Reg. Nbs. in parentheses: descriptive definition of odor (4787-10); pH (279-2280) and
temperature used to determine pH (4787-10); oxidizing or reducing action (279-2280 and 4787-10); viscosity
(method used to determine 4787-10); miscibility (4787-10 and temperature for determination of 279-2280); and
methods used to determine corrosion characteristics (279-2280 and 4787-10).
o
o
-------
Table C
Product-Specific Data Requirements for End-Use Products Containing Ethion
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No. or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2HB)?
Timeframe
for Data
Submission
Part 158 f Subpart C. Product Chemistry
Product Identity and Composition
61-1 - Product Identity and EP Nol/
Composition
61-2 - Description of Beginning EP Nbl/
Materials and Manufac-
turing Process
61-3 - Discussion of Formation EP Nbl/
of Impurities
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of EP
Product Samples
62-2 - Certification of EP
Ingredient Limits
Physical and Chemical Characteristics
63-7 - Density, Bulk Density, EP Nol/
or Specific Gravity
63-12 - pH EP Nbl/
&
.-63-15 - Flammability EP Nbl/
Yes2/
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
-------
Table C
Product-Specific Data Requirements for Old-Use Products Containing Ethion
Part 158r Subpart C. Product Chemistry Footnotes
I/Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient in each intentionally added inert must be provided. For the active ingredients, the following must
also be provided: the product, common and trade names; the molecular, structural, and empirical formulas; the
molecular weight or weight range; and any experimental or internally assigned code numbers.
^/Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
4/A detailed discussion 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 must be submitted.
5/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used. Required for products produced by an integrated system.
ij/Upper and lower limits for the active ingredients and each intentionally added inert, and upper limits for each
inpurity present at > 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g.,
sample analysis using validated analytical procedures, quantitative estimates based on amounts of ingredients
used, etc.). Limits for impurities not associated with the active ingredient need be provided only if they are
considered to be of toxicological significance, regardless of the concentration at which they are present.
Certification must be submitted on EPA Form 857 Rev. 2-85.
2/Density or specific gravity, pH, and flairanability information must be submitted for each product as part of the
Confidential Statement of Formula. Other physicochemical characteristics (color, physical state, odor, melting
point, solubility, vapor pressure, dissociation constant, partition coefficient, and stability) as required in 40
CFR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, are not required at
this time.
S/Data required if the test substance is dispersible in water.
5/Data required if the product contains combustible liquids.
-------
Table C
Generic Data Requirements for Ethion
Data Requirement
158.135 Toxicoloqy:
81-1 Acute Oral Rat
81-2 Acute Dermal
81-3 Acute Inhalation
- Rat
81-4 Eye Irritation
-Rabbit
81-5 Dermal Irritation
-Rabbit
81-6 Dermal Sensitization
ComDOsition
EP
EP
EP
EP
EP
EP
Use
Patterns
All
All
All
All
All
All
Does EPA
Have Data to
Satisfy This
Requirement?
No
No
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2HB)?
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
For Data
Submission
24 Months
24 Months
24 Months
12 Months
12 Months
12 Months
-Guinea Pig
CD
-------
II. LABELING APPENDICES
10
-------
SUM11ARY-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 text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [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 estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It roust 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)]
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)]
105
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT-LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 156.lO(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* [40 CFR 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 70. 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.iO(h)(1)(ill)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.56(h)(l)(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)].
106
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SUMMARY-3
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 of 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 sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of Part 152. Subpart I. You will be notified
of the Agency's classification decision.
107
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SUMMARY-4
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.
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 simul-
taneously. 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.
108
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29. 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[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.
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SdMARY-6
LABELING REQUIREMENrS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OP REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
Ail products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
Mono
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
•
If registrant is not the producer, mu:
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container Instead 01
the label.
Text must run parallel with other to* 1
on thu panel.
All front panel precautionary statemer
must be -jroupud together, preferably
blocked.
Note type size requirements.
",• •
Note type size requirements.
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SUMMARY-7
ITEM
7C
7D
7E
8
X
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precaut ionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral , der-
mal, or inhala-
tion toxic ity
All products
in Categories
I. II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precaut ionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings In
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
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SlftlAKY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACtMfcNT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Lined lately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
cottons
Refer to Appendix II guide
PWS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement Is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STCR.
CCNT/DIS. and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
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Chapter I—Environmental Protection Agency
$156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (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 para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility, (i) All words, statements,
graphic representations, designs or other information required 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, state-
ments, 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 customary 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 applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
113
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perticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers--(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, 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 products 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 discharge 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-pesticidal 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 purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(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 impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
-------
(ix) Claims as to the safety of the pesticide or *ts ingredients,
including statements such as "safe," "nonpoisonous," "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 comparative statements on the safety
of the product* including but not limited tot
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals 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 provisionally 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 microfilm 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 additional name
pursuant to $ 162.6(b)(4).
(c) Name and address of producer,, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears 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 ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers 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*F (20*C) and shall be
expressed in conventional American units'of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, 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."
115
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(•) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." 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 parallel 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 registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—-(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
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 contain 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 normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the 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 statement 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.
116
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(3) Names to be used in ingredient statement. The name usf»
-------
Hazard Indicators
_
Or., u^
Inhalation LC
3W
Oanut LO^
Eya af facts
Skin at tact*
1-
Up to and
Including
so as/kg
Up to and
Including
.2 «g/l lt«r
Up to and
Including
200 «gAg
Corroslva;
cornaat opacity
not ravarslbla
•Ithln 7 days
Corroslva
To*tclt> c
II
Fro* 90 thru
900 «g/kg
Fro» .2 thru
2 «g/l Itar
from 200
thru 2000
Comaal opacity
raxarslbla
vlthln 7 days;
Irritation
persisting for
7 days
Savara Irritation
•t 72 hours
atagortas
III
Fro* 900 thru
9000 »gAg
F-o» 2 thru
20 •g/Mtar
Fro* 2.000 thru
20.000
No cornaaf opacity;
Irritation
ravarslbla
vlthln 7 days
Moda-ata Irritation
at 72 hours
IV
Graatar than
9000 «g/kg
Graatar than
20 «g/l Itar
Graatar than
20.000
No Irritation
Mild or slight
Irritation at
72 hours
hazard signal word.--(A) Toxicity Category I.
criteria of Toxicity
(i) Human
pesticide products meeting the
shall bear on the front panel the
All
I
Category
,.. .__... r signal word "Danger." In
the product was assigned to Toxicity Category I on
,._ , j_u-,-fcj — — dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
addition if
the basis of its oral, inhalation or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
(B) Toxicity Category II. All pesticide products meeting the
.-_ _* -_:..•_.-,... /-.I .. j shall bear on the front panel*
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide
III shall bear
All pesticide
IV shall bear
products meeting the
on the front panel
products meeting the
on the front panel
118
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(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 prevent
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 pesticide 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, marketing, 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 Administrator waive this
requirement.
(iii) Statement of practical treatment*-(A) Toxicity
Category I. A statement of practical treatment (first aid or
other)shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment 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)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient 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 requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
119
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard* and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) 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. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxic ir,
category
Precautionary statements by to* I city category
Oral. Inhalation, or dermal tp»lctt>
Skin and eye local effects
I .
II .
Ill .
IV .
Fatal (poisonous) If swallowed (Inhaled or
abso-bed through sklnl. Oo not breathe
vapo* Idustl or spray mlstl. Oo not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
requ'rod.l.
May be fatal If swallowed (Inhaled or
absorbed through the sklnl. Oo not breathe
vapo-s (dust or spray mlstl. Oo not get In
•yes, on skin, or on clothing. (Appropriate
first aid statements required.!.
Harmful If swallowed (Inhaled or absorbed
through the skint. Avoid breathing vapors
(dust or spray mlstl. Avoid contact with
skin (eyes or clothing!. (Appropriate
first aid statement required.!.
(No precautionary statements required.1.
Corrosive, causes eye and sktn damage lor
skin Irritation]. Oo not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves then handling.
Harmful or fatal If swalloved.
(Appropriate first aid statement required.I
Causes eye (and sklnj Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swel loved. (Appropriate 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.1,
(ii) Environmental hazards. 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 -
120
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD$Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LCso of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LDso of 100 mg/kg or less, or
a subacute dietary LC$Q 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 application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate 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 disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at of below 20' f; If there It •
flashback at any valve opening.
Flash point above 20*F and net over »Q*F or If
the flame extension Is *ore than 18 In. long
at a distance of 6 In. fro* the flame.
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surface*. Oo not puncture or Incinerate
container. Exposure to temperatures above
I30*F My cause bursting.
Flammable. Contents under pressure. Keep a»ay
fro* 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 punctur* or
Incinerate container. Exposure to tempera-
tures above 150*F may cause bursting.
(B) NONPRESSURI ZED CONTAINERS
At or belo* 20*F ......| Extremely flammable. Keep a«9y from fire,
| sparks, and Heated surfaces.
Above 20*F and not over 80*F •••! Flammable. Keep a«ay from heat and open flame.
Above 80*F and not over 150*F .........(Do not use or store near heat or ooen flame.
121
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( i) Directions for Use— (1) General requirements-'-( i ) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(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
accompanies the pesticide provided that:
(A) If required by the Agency/ such printed or graphic matter
is securely attached to each package of the pesticide, 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 directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(i i i) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
Q) 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 processes;
(2) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
U) 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 effects 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 pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided 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;
\22
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(.2) The label clearly states that the product
-------
(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 products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general 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 directions only for
general use(s) and the other bearing directions for restricted
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 S 162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement 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 classification on the front panel as described
below:
(i) Front panel statement of restricted 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 5 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "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 persons under
their direct supervision and only for those uses covered by the
Certified 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 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978;
amended at 53 FR 15952, May 4, 1983!
124
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks.
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
125
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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.
126
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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 oust 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."
127
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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, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
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!, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
I/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
128
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III. BIBLIOGRAPHY APPENDICES
129
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
130
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author.- As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123A56, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
13
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethion Standard
MRID Citation
00022023 Anon. (1968) Phostoxin as a sanitation control measure. [Without
Title] 13(7):274-277. (Also in unpublished submission received
on unknown date under 6F0508; submitted by Phostoxin Sales,
Inc., Alhambra, Calif.; CDL:090598-B)
00034311 Stanovick, R.P.; Ursel, J.; Martin, N. (1964) Determination of Eth-
ion Residues in or on Field-Treated Grain Sorghum. Method
M-1343 dated Mar 19, 1964. (Unpublished study received Apr 20,,
1964 under 279-1254; submitted by FMC Corp., Philadelphia, Pa.;
CDL:002322-B)
00034468 FMC Corporation (19??) Blank and Recovery and Analytical Data.
(Unpublished study received Apr 28, 1964 under 279-1254; CDL:
002323-C)
00034874 FMC Corporation (1962) Ethion Residues on Strawberries Treated
with Ethion 4 Miscible: R-544. (Unpublished study received
May 14, 1962 under 279-1254; CDL:002320-A)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00073053 Niagara Chemical (1966) Data Establishing That Ethion May Reason-
ably Be Expected To Be a Component of Dried Tea Leaves and Dried
Tea Concentrates. (Compilation; unpublished study received
Oct 13, 1966 under 1HOOOO ; CDL:221561-C)
00073062 Niagara Chemical (1960) [Ethion Residues in or on Citrus]. (Com-
pilation; unpublished study received Apr 28, 1964 under PP0316;
CDL:092597-A)
00073082 Niagara Chemical (1957) Time Studies To Show Decrease of Residue
with Time. (Unpublished study received Aug 1, 1958 under
PP0189; CDL:090217-P)
00073083 Niagara Chemical (1958) Residues of Ethion on and in Field Treated
Crops at Harvest Time. (Unpublished study received Aug l, 1958
under PP0189; CDL:090217-Q)
-1-
132
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethion standard
MRID Citation
00073085 Niagara Chemical (19??) Time Studies To Show Change of Residues
with Time. (Unpublished study received Dec 18, 1958 under
PP0192; CDL:090220-B)
00073094 Niagara Chemical (1961) The Results of Tests on the Amount of Resi-
due Remaining, Including a Description of the Analytical Method
Used: [Ethion]. (Unpublished study received Apr 1, 1961 under
PP0316; CDL:090336-B)
30073095 Niagara Chemical (1960) The Results of Tests on the Amount of Resi-
due Remaining, Including a Description of the Analytical Method
Used: [Ethion!. (Unpublished study received Jan 3, 1961 under
PP0308; CDL:090328-A)
)0073100 FMC Corporation (19??) Rresults of Tests the Amount of Residue
Remaining and Description of Analytical Method: Residue Analysis
of Ethion Using MCMG Analytical Procedure. Undated method.
Unpublished study received Aug. 1, 1966 under 7F0519; CDL:
092005-E)
)0073105 Niagara Chemical (19??) Colorimetric Method for the Determination
of Ethion Residues on Crops. (Unpublished study received on un-
known date under unknown admin, no.; submitted by FMC Corp.,
Philadelphia, Pa.; CDL:119615-A)
)0073121 Niagara Chemical (1958) Report of Residue Determinations of Ethion
in Onions. (Unpublished study received May 22, 1958 under un-
known admin, no.; submitted by FMC Corp., Philadelphia, Pa.;
CDL:127165-A)
)0073132 Niagara Chemical (1961) Ethion Residue Data: Field Corn. (Unpub-
lished study received Mar 1, 1961 under unknown admin, no.; sub-
mitted by FMC Corp., Philadelphia, Pa.; CDL:119608-A)
)0073133 Niagara Chemical (1959) Ethion Residues on Tomatoes. (Unpublished
study received Feb 2, 1959; Apr 20, 1959 under PP0214; CDL:
092492-A)
30073138 Niagara Chemical (1960) Ethion Residue Analysis of Liver Samples
from Ethion Cow Feeding Study. (Unpublished study received Mar.
10, 1970 under PP0253; CDL: 092529-D)
-2-
133
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethion Standard
MRID Citation
00073143 FMC Corporation (1959) Results of Tests on the Amount of Residue
Remaining and Description of Analytical Method: [Ethion].
Includes method entitled: Infrared determination of ethion
residues on and in citrus fruits. (Unpublished study received
Mar 10, 1960 under PP0253; CDL:090279-A)
00073144 Bowman, J.S. 1960 Final Report: Subaeute Feeding - Dairy Animals.
(Unpublished study received Mar. 10, 1960 under PP0253; submitted
by FMC Corp., Middleport, N.Y. CDL:90279-B)
00073145 FMC Corporation (1959) [Residue Data for Ethion in Several Fruits].
(Unpublished study received Feb. 23, 1960 under PP0246 ; CDL:
090273-A)
00073152 Niagara Chemical (1958) [Residue Data for Ethion in Fruit]. (Un-
published study received May 1, 1959 under PP0214; CDL:090241-G)
00073153 Shuttleworth, J.M.; Burt, J.E.; Gruenauer, M.H.; et al. (1971)
Residue Determinations of Ethion and Its Oxygen Analogs in Milk
and Cow Tissue: M-2808. (unpublished study received Dec 12, 1969
OF0920; submitted by FMC Corp., Middleport, N.Y.; CDL: 093218-A)
00073158 Hinstridge, P.A.; Yaffe, J.; Cardenas, B.; et al. (1970) Ethion
Residues on Cottonseed—Process Study: R-1156. ' (Unpublished
study received May 28, 1970 under OF0920; prepared in coopera-
tion with Texas A & M Univ., submitted by FMC Corp., Middleport,
N.Y.; CDL:091575-C)
00073160 FMC Corporation (1967) Results of Tests of the Amount of Residues
Remaining and Description of Analytical Methods: [Ethion!.
Includes methods dated Apr 3, 1957 and Feb 28, 1958. (Unpub-
lished study received May 28, 1970 under OF0920; CDL:091575-E)
00073161 Shuttleworth, J.M.; Bowin, R.J.; Radaker, L.; et al. (1969) Deter-
mination of Ethion Residues in Eggs and Poultry Tissues: M-2548.
(Unpublished study received May 28, 1970 under OF0920; submitted
by FMC Corp., Middleport, N.Y.; CDL:091575-G)
00073162 FMC Corporation (1967) Results of Tests of the Amount of Residues
Remaining and Description of Analytical Methods: [Ethion]. (Un-
published study received May 27, 1970 under OF0918; CDL:
091573-C)
-3-
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 Ethion Standard
MRID Citation
00073173 Shuttleworth, J.M.; Arnold, R.W.; Gruenauer, M.H.; et al. (1971)
Determination of Ethion, Ethion Monooxon and Ethion Dioxon Res-
idues in Corn Forage: M-2922. Includes method dated Aug 31,
1971. (Unpublished study received Sep 9, 1971 under 1F1104;
submitted by Niagara Chemical, Div. of FMC Corp., Los Fresnos,
Tex.; CDL:090869-A)
00073175 Niagara Chemical (1970) Results of Tests of the Amount of Residues
Remaining and Description of Analytical Methods: [Ethion]. (Un-
published study received Sep 9, 1971 under 1F1104; CDL:090869-C)
00073189 FMC Corporation (1960) Blank and Recovery and Analytical Data.
(Compilation; unpublished study received Mar 23, 1960 under un-
known admin, no.; CDL:124930-A)
00073195 FMC Corporation (19??) Ethion—Nectarine. (Unpublished study re-
ceived Jan 7, 1967 under 7F0519; CDL:090614-E)
00073806 Niagara Chemical (1962) [Residues of Ethion in Fruit after Drying].
(Compilation; unpublished study received Mar 5, 1962 under
PP0351; CDL:092635-C)
00073808 FMC Corporation (1958) [Residues of Ethion: Peaches, Cotton and
Various Crops]. (Compilation; unpublished study received May
16, 1958 unde 279-1254; CDL:119616-A)
00109285 FMC Corp. (1972) [Residues of Ethodan in Oranges, Apples and Other
Crops]. (Compilation; unpublished study received Jul 27, 1982
under 279-2280; CDL:247912-A)
00131853 Hoberman, A.; Christian, M.; Christian, G.; et al. (1983) Terato-
genic Potential of Ethion Technical Administered Orally via
Stomach Tube to New Zealand White Rabbits: (Segment II Evalua-
tion) : 106-002; A82-679. Final rept. (Unpublished study re-
ceived Aug 17, 1983 under 279-2280; prepared by Argus Research
Laboratories, Inc., submitted by FMC Corp., Philadelphia, PA;
CDL:251005-B)
-4-
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 Ethion Standard
MRID Citation
00131852 Hoberman, A.; Christian, M.; Christian, G. (1983) Teratogenic Po-
tential of Ethion Technical in Pregnant Crl:COBS CD (SD) BR
Charles River Rats: Project 106-001; A81-646. Final rept. (Un-
published study received Aug 17, 1983 under 279-2280; prepared
by Argus Research Laboratories, Inc., submitted by FMC Corp.,
Philadelphia; PA; CDL:251005-A)
00132773 FMC Corp. (1983) Product Chemistry for Ethion: Technical and Manu-
facturing-Use Product. (Compilation; unpublished study received
Nov 10, 1983 under 279-2280; CDL:251799-A)
00141205 Freeman, C. (1984) Skin Sensitization of Ethion Technical in Guinea
Pigs: Study No. A83-1108. Unpublished study prepared by FMC
corp. 36 p.
00144351 Haworth, S. (1984) Salmonella/Mammalian-microsome Plate Incorpora-
tion Mutagenicity Assay (Ames Test): Study No. T2266-501. Un-
published study prepared by Microbiological Associates.
36 p.
00146309 Beavers, J. (1984) An Acute Oral Toxicity Study in the Bobwhite
with FMC 1240: Final Report: Wildlife International Ltd. Project
No.: 104-155. Unpublished study prepared by Wildlife Inter-
national Ltd. 29 p.
00146310 Beavers, J. (1984) An Acute Oral Toxicity Study in the Mallard with
FMC 1240: Final Report: Wildlife International Ltd. Project No.
104-156A. Unpublished study prepared by Wildlife International
Ltd. 29 p.
00148989 Morrow, L. (1985) Lifespan Oncogenicity Study in Mice Utilizing
Ethion (FMC 1240) Technical: American Biogenics Corporation
Study No. 410-0867. Unpublished FMC Study No. A82-726 prepared
by American Biogenics Corp. 3210 p.
00148990 Enloe, P.; Salamon, C. (1985) Three-generation Reproduction Study
in Albino Rats with Ethion (FMC 1240) Technical: American Bio-
genics Corporation Study No. 450-0868. Unpublished FMC Study
No. A82-722 prepared by American Biogenics Corp. 2627 p.
00148991 Morrow, L. (1985) Twenty-four Month Combined Chronic Oral Toxicity
and Oncogenicity Study in Rats Utilizing Ethion (FMC 1240) Tech-
nical: American Biogenics Corporation Study No. 410-0866. Un-
published FMC Study No. A82-725 prepared by American Biogenics
Corp. 3858 p.
-5-
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 Ethion standard
MRID citation
00153160 Martin, F. (1985) Determination of Ethion, Ethion Monoxon, Ethion
Dioxon Residues in/on Cucurbits (Cucumber, Melon, Squash): Proj-
ect No. G237. Unpublished study prepared by FMC Corp. 27 p.
00153553 Forbis, A.; Georgie, L.; Bunch, B. (1985) Uptake, Depuration and
Bioconcentration of :Carbon 14:-Ethion by Bluegill Sunfish
(Lepomis macrochirus): ABC Final Report #32423. Unpublished
FMC Corporation's Study No. 237E54E01 prepared by Analytical
Bio-Chemistry Laboratories, Inc. 47 p.
00155498 Weiner, M. (1985) Twenty-one Day Repeated Dose Dermal Toxicity
Study in Rabbits with FMC 1240 Technical (Ethion): Study No.
A84-1369. Unpublished study prepared by FMC Corp. 299 p.
00155499 Weiner, M. (1985) Twenty-one Day Repeated Dose Dermal Toxicity
Study in Male Rabbits with FMC 1240 Technical (Ethion): Study
No. A84-1502. Unpublished study prepared by FMC Corp. 274 p.
00155504 Martin, F. (1985) Cold Storage Stability of Ethion, Ethion Mono-
oxon, and Ethion Dioxon in/on Various Crops and Soils: P-1296:
FMC Study No. 237CSSR01. Unpublished study prepared by FMC
Corp. 35 p.
00155507 Reynolds, J. (1984) Hydrolysis of Ethion: P-0801: Study No. S 237
83 01. Unpublished study prepared by FMC Corp. 21 p.
00155510 Puhl, R.; Conley, J.; Blair, J. (1985) Aerobic/Anaerobic Soil Me-
tabolism of Ethion: Study No. 6015-210. Unpublished FMC Report
No. PC-0029 and Study No. 237E21E01 prepared by Hazleton Labo-
ratories America, Inc. 67 p.
00155515 Markle, J. (1985) Analysis of :Carbon l4:-Ethion Residues in Blue-
gill Sunfish and Water: RAN-0168: Study No. 237E54E01. Unpub-
lished study prepared by FMC Corp. 31 p.
00155516 Ward, G. (1985) Toxicity Test Report: Acute Toxicity of FMC 1240
Technical to Pink Shrimp (Penaeus duorarum): ESE No. 85-322-
0200-2130. Unpublished FMC Study No. A84-1192 prepared by En-
vironmental Science and Engineering, Inc. 33 p.
-6-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethion Standard
MRID Citation
00155517 Ward, G. (1985) Toxicity Test Report: Acute Toxicity of FMC 1240
Technical to the Atlantic Silverside (Menidia menidia): ESE No.
85-322-0210-2130. Unpublished FMC Study No. A84-1218 prepared
by Environmental Science and Engineering, Inc. 32 p.
00155518 Ward, G. (1985) Toxicity Test Report: Acute Toxicity of FMC 1240
Technical to Embryos and Larvae of the Eastern Oyster (Crasso-
strea virginica): ESE No. 85-322-0300-2130. Unpublished FMC
Study No. A85-1762 prepared by Environmental Science and Engi-
neering, Inc. 19 p.
00155580 Miller, P.; Wetters, J.; McKellar, R.; et al. (1986) Residues of
Chlorpyrifos and 3,5,6-Trichloro-2-pyridinol in Broccoli, Cab-
bage and Mustard Greens following Multiple Applications of Lors-
ban and/or Dursban Insecticides: GH-C 1788. Unpublished study
prepared by Dow Chemical U.S.A. 52 p.
00155850 FMC Corp. (19??) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method
Used. Unpublished compilation. 347 p.
00155869 Patterson, H. (1985) ETC No. 01030: Evaluation of Ethion Fate and
Behavior in/on Oranges: WP507154. Unpublished FMC Report No.
PC-0030 and Study No. 237CITM01 prepared by Biological Test
Center. 83 p.
00155870 Selim, S. (1985) Analysis of Ethion and Its Metabolites in/on Oran-
ges and Orange Leaves: WP511176. Unpublished FMC Report No. PC-
0028 and Study No. 237CIT01 prepared by Biological Test center,,
26 p.
00155871 Selim, S. (1985) Absorption, Distribution and Excretion Studies of
Ethion in the Rat: Study No. P00911. Unpublished FMC Report No.
PC-0031 and Study No. 237RATM01 prepared by Biological Test
Center. 103 p.
00155872 Selim, S. (1985) Rat Blood Kinetics of Ethion following a Single
Oral Dose: Study No. P00970. Unpublished FMC Report No. PC-
0036 and Study No. 237RATM02 prepared by Biological Test Center.
35 p.
-7-
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 Ethion Standard
MRID Citation
00155873 Selim, S. (1985) Analysis of Metabolites in Urine of Rats Dosed with
Ethion: WP512122: Interim Report: Unpublished FMC Report No. PC-
0035 and Study No. 237RATM01 prepared by Biological Test Center.
34 p.
00155874 Puhl, R.; Jobsis, C.; Zietlow, D. (1985) Metabolism Study of Car-
bon 14:-Labelled Ethion in Lactating Goats: Final Report: Study
No. 6124-104. Unpublished FMC Report No. PC-0027 and Study No.
237GOAM01 prepared by Hazleton Laboratories America, Inc.
116 p.
00155875 Puhl, R. ; Bodden, R.; Zietlow, D. (1985) Poultry Metabolism Study
on Ethion: Final Report: Study No. 6124-103. Unpublished FMC
Report No. PC-0026 and Study No. 237POUM01 prepared by Hazleton
Laboratories America, Inc. 123 p.
00157088 Cheminova (1985) Product Chemistry: Ethion Technical. Unpublished
study. 87 p.
00157590. Cuthbert, J.; Carr, S. (1986) Ethion 95% Technical: Acute Toxicity
Tests: IRI Project No. 234117: Report No. 3467. Unpublished
study prepared by Inveresk Research International. 54 p.
00158376 Roberts, N.; Phillips, C.; Gopinath, C.; et al. (1986) Acute De-
layed Neurotoxicity Study with FMC 1240 in the Domestic Hen:
FCC 81/851263. Unpublished study prepared by Huntingdon Re-
search Centre Ltd. 64 p.
00159983 Barrett, G. (1986) Determination of Ethion, Ethion Monooxon and
Ethion Dioxon Residues in/on Field Corn Grain Treated with Ethi-
on Insecticide: Report No. RAN-0172. Unpublished study prepared
by FMC Corp. 18 p.
00163159 Fieser, S. (1983) Acute Inhalation Toxicity Study in Rats: Ethion
Technical (FMC1240): FMC Study No. A83-873: Hazleton No. 104-
214: Final Report. Unpublished study prepared by Hazleton
Laboratories America, Inc. 40 p.
40773301 Bailey, D. E. (1988) 90-Day Subchronic Toxicity Study of Ethion
Technical in Dogs (A86-1990). Hazleton Laboratories America,
Inc.; HLA Study No. 104-229. June 12, 1988.
-8-
139
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IV. FORM APPENDICES
140
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EPA Form 8580-1
OMB Approval NO. 2070-0057
Expires 11/30/89
FIFKA SECTION 3ICX2HB) SUMMARY SHEET
NO
MIOOUCT NAM«
APPLICANT S NAMC
OATI CuiOAMCt DOCUMENT ISSUED
With ruotct to t»«i raoufftmtflt to wbmit "trwit" dan impaori by t*i f If UA •ciia* J(C)IZHI) natic* canumtd at tti« rt<«ftnctd
Gwdinci Oocumint. I im ntoendin« * Oil fellotNiif moMitf:
C1. I will wbmn don «i wnity minnar to anofy ttit feflowM| ntHifiMima H ifu OM aracidurn I wiN w« dtmott from lor arc not
««if«4 ml tfw M»i*tmiw CwioXWm ar tfw *TotoeaU cantunod M flu Mapara of Export Croups to IM Clumcoti Group. OECO
Cham«oit TORMO. frofromfflo. I ondoai tN pratoeatt that I «nH MO:
01 I fcavt Mttrtd i«ti on oaroomaM wit* am or mart athor raiamiiu un«or fIFBA wnan 3IC)(2)(l)(
-------
CMB Approval No- 2070-0057
Eviration Date 11/30/89
GENERIC EMA 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 submission of "generic" data on the active
ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the
product contains the active ingredient solely as the result of the incorporation into
the product of another product which contains that active ingredient, which is
registered under FIFRA Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential 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
commits 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 8580-3
142
-------
OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No.
PRQHX.T SPECIFIC DA3& REPCRT
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRQCUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Te?t
Identity of
inoredients
Statement of
composition
Test not
required
for m/
product
listed
above
(check
below)
Discussion of
formation of
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physic?] st,3te
OdoiL
Meltina point
Boilina point
Density, bulk-
density, or
specific Gravity
Solubility
Vapor pressure
Dissociation
constant
OctanolArater
partition
coefficient
pH
I am complying with
-------
CMB Approval NO. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPCRT (cont'd)
! Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
{cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stabilitv
Qxidi zing/reducing
reaction
Flairmabilitv
RxplnrtehilitV
Storaoe "Tti^ility
Viscosity
Miscibilitv
Corrosion
characteristics
Dielectric break-
down voltaae
Acute oral
toxicity , rat
Acute dermal
toxicity f ra}S?i \
Acute inhalation,
toxicity, rsifc
Primary eye
irritation . r?W1 1
Primary dermal
irri'i'^'tiQTi
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicity, hen
Test not
required
for my
product
listed
above
(check
below)
I am complying with
d^jftiS reouirements bv
Citing MtDD
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
VKID Numbers
Assioned
EPA Form 8580-4 (cont'd)
I M
-------
EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
(To
CERTIr (CATION OP ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
MR DEVELOPMENT Of DATA
1. I am duly autftontad to r%cr»^m ttw following firm(i) who art woiact to d»a
mants of • Notiot undar FIFRA Section 3(eH2)(8> containad M aGtudanot Oo
to twbmit data concat mng iht act»v«. my firm wouM prtfar to antw
M tfta oon of dawiooini. 0w following raquirad
My firm Hai affarvd M «rrttin| fa anejr Mtt aadi M tejrooam. Caaiai af Kia affan an anadtat That affv «at
tow* ay an arMntian tfaeaiM «ndar FIFIU Jacbaa «ci<2)(l)
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