xvEPA
540/RS-87-136
September 1986
Guidance for the
Reregistration of
Pesticide Products
Containing Propargite
as the Active
ient
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540/RS-87-136
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PROPARCITE
AS THE ACTIVE INGREDIENT
Case No. 0243
September 30, 1986
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
LIST OF APPENDICES iii
GLOSSARY OF ABBREVIATIONS AND ACRONYMS iv
INTRODUCTION . . 1
1. CHEMICAL COVERED BY THIS STANDARD 4
1.1 Description of the Chemical 4
1.2 Use Profile 4
1.3 Registration History ot Propargite 5
2. AGENCY ASSESSMENT 6
2.1 Summary Science Statement 6
2.2 Toxicological Characteristics and Concerns 7
2.3 Environmental Fate 14
2.4 - Ecological Characteristics and Concerns 15
2.5 Tolerance Reassessment 18
3. REGULATORY POSITION AND RATIONALE 27
3.1 Statements of Positions and Rationales 27
3.2 Criteria for Registration 31
3.3 Acceptable Ranges and Limits 31
3.4 Required Labeling .. 32
4. ' PRODUCTS SUBJECT TO THIS STANDARD 38
4.1 Manufacturing-Use Products 38
4.2 End-Use Products 38
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5. REQUIREMENT FOR SUBMISSION OF GENERIC DATA . ;.. 4G)
5.1 What Are Generic Data? 40
5.2 Who Must Submit Generic Data? 40
5.3 What Generic Data Must Be Submitted? 41
5.4 How to Comply With DCI Requirements 41
5.5 Procedures for Requesting a Change in Testing
Protocol 43
5.6 Procedures for Requesting Extensions of Time .... 44
5.7 Existing Stock Provisions Upon Suspension or
Cancellation 44
6. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA .. 46
7. REQUIREMENT FOR SUBMISSION OF REVISED LABELING 47
8. INSTRUCTIONS FOR SUBMISSION 48
8.1 Manufacturing-Use Products 48
8.2 End-Use Products 49
8.3.. Intrastate Products . 50
8.4 Where to Send Required Information 50
ii
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of Label Requirements and Table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
*^^^™—^^~™~ " —^^^^^^ ^
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants
for Development of Data
Product-Specific Data Report (End-Use
Products)
Formulator's Exemption Statement
iii
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GLOSSARY OF ABBREVIATIONS AND ACRONYMS
A acre
a.i. active ingredient
A/D adult toxicity/developmental toxicity
CDFA California Department of Food and Agriculture
CFR Code of Federal Regulations
CR California Recipe (a propargite product formulation)
DCI data call-in
EC emulsifiable concentrate
EEC estimated environmental concentration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
g gram
gal gallon
HOT highest dose tested
kg kilogram
1 liter .
LC5Q concentration of test chemical- at which 50% of the
test subjects die
LD5Q dosage level of test chemical at which 50% of the
test subjects die
LEL 'lowest effect level
MBYP meat by-products
mg milligram
ml milliliter
MPI maximum permitted intake
MTD maximum tolerated dose
NOEL no observable effect level
PADI provisional acceptable daily intake
PMPI -provisional maximum permitted intake
ppm parts per million
TLC thin layer chromatography
TMRC theoretical maximum residue contribution
WP wettable powder
IV
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INTRODUCTION
The Registration Standards Program
EPA has established the Registration Standards program
to provide an orderly mechanism by which pesticide products
containing the same active ingredient can be reviewed and
standards set for compliance with the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). The standards are
applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme, giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess
the potential hazards arising from the currently registered
uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine
whether the pesticide meets the "no unreasonable adverse effects"
criteria of FIFRA. In its review, EPA identifies:
1. Studies that are acceptable to support the data requirements
for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued registra-
tion. The additional studies may not have been required
when the product was initially registered or may be needed to
replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product is
not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained in
this document but is available upon request^, focuses on the
pesticide active ingredient. The scientific review primarily
The scientific reviews are available upon request from the
Information Services Section, Room 236, CM|2, 1921 Jefferson
Davis Highway, Arlington, Va. 22202 (Tel: 703-557-4453). .
Approximately 90 days after issuance of this Standard, the
reviews may be purchased from the National Technical Informa-
tion Service, 5285 Port Royal Road, Springfield, Va. 22161.
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discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide
active ingredient. During the review of those data, however,
the Agency is also looking for potential hazards that may be
associated with the end-use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end-use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a reg-
ulatory position, contained in this Registration Standard, on
the pesticide and each of its registered uses. (See Section 3,
"Regulatory Position and Rationale.") Based on its regulatory
position, the Agency may prescribe a variety of steps to be
taken by registrants to maintain their registrations in compliance
with FIFRA. These steps may include the following:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the pesticide
to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modi-fication of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a "Notice of Intent to Cancel" or a "Notice ot
Intent to Suspend" (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a Special
Review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the pesticide.
If the Agency determines that the risks of the pesticide's use
outweigh the benefits of use, the Agency may propose additional
regulatory actions, such as cancellation of uses of the pesticide
that have been determined to cause unreasonable adverse effects
on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA section 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, its toxi-
cology, and environmental characteristics and fate. This
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Registration Standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide. These data are
listed in the Tables A and B in Appendix I. Failure to
comply with the DCI requirements enumerated in this Registration
Standard may result in issuance by EPA ot a "Notice of Intent
to Suspend" the affected product registrations.
Registrants are reminded that FIFRA section 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. You should notify the Agency of any
information, including interim or preliminary results of studies,
if those results suggest possible adverse effects on man or the
environment. This requirement continues as long as your products
are registered by the Agency.
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1. CHEMICAL COVERED BY THIS STANDARD
1.1 DESCRIPTION OF THE CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name;
Chemical Name;
Empirical Formula;
Trade Names;
Chemical Abstracts
Service (CAS) No.;
OPP (Shaughnessy) No.;
Physical Characteristics:
Propargite
2-(p-tert-butylphenoxyJcyclohexyl
2-propynyl sulfite
C19H2604S
Omite, Comite, and Uniroyal D014
2312-35-8
097601
Viscous liquid. Dark amber color.
Faint solvent odor to very taint
solvent odor. Specific gravity =
1.085 - 1.115 at 25°C; Bulk density =
40.92 lb/ft3. Solubility in water,
about 0.5 ppm at 25°C, miscible with
organic solvents such as acetone,
benzene, and ethanol. .No evidence of
breakdown in 1 year. F^ash Point: at
least 38.5°C.
1.2 USE PROFILE
Propargite is an acaricide registered for the control of
mites (clover, European red, Pacific spider, strawberry spider,
twospotted spider, McDaniel spider, Banks grass, Southern red,
citrus red, citrus rust, false spider, sixspotted, Texas citrus,
Willamette spider, and Southern red). Propargite's mode of
activity involves residual killing action. Propargite was
first registered in 1969 and is available as a 85 percent
active ingredient technical product and as a 25 percent active
ingredient formulation intermediate product for formulating
propargite end-use products. Propargite is formulated as
5, 6, and 6.55 pounds per gallon emulsifiable concentrates (ECs);
a 4 percent dust; and a 30 percent wettable powder (WP). The
emulsifiable concentrates are the most widely used formulations.
Registered propargite products are formulated with propargite as
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the sole active ingredient and in combination with other active
ingredients.
The major agricultural uses of propargite are for mite
control in the production of field and vegetable crops (field
corn, cotton, grapes). Propargite is also registered for use
after planting on nonfood crops (ornamentals), aquatic food
crops (cranberry), and greenhouse nonfood crops (ornamentals).
Of the total amount of propargite applied in the United States,
approximately 67 percent is applied to field corn, cotton, and
grapos. Application rates for terrestrial food crops range
from 0.75 - 6.75 pounds active ingredient per acre (a.i./A).
Application rates range from 0.3 - 0.45 pounds a.i./A for
terrestrial non-food crops uses.
Propargite is applied primarily through the use of high
volume (350 - 800 gal/A) or low volume (25 - 100 gal/A) air
blast ground sprayers. Fixed wing or rotary aircraft may be
used when orchards are too wet for ground rigs or when critical
timing precludes ground rigs from covering the orchard in time
to adequately control pests.
Uniroyal chemical is the sole domestic producer of propargite
There are no foreign producers.
1.3 REGISTRATION HISTORY OF PROPARGITE
Pro'pargite was patented by Uniroyal Chemical in 1966 and
was first registered for use in 1969. Technical propargite is
being produced in the United States by Uniroyal Chemical of
Bethany, Connecticut. There are three registrants of products
containing propargite: Chevron Chemical Company, FMC Corpora-
tion, and Uniroyal Incorporated. Currently, there are approxi-
mately 69 products registered, of those 59 are intrastate
registrations. There are 32 section 24(c) registrations.
Two data call-in notices have been issued on propargite.
The first notice, dated March 14, 1986, was issued because
some of the raw data in residue studies (cattle, poultry, and
apples) and rotational crop accumulation studies were incomplete
or missing. Registrants were requested to either make .available
to the Agency acceptable, complete raw data pertaining to the
existing studies, or submit new, replacement studies. The second
data call-in notice, dated May 23, 1986, was for worker reentry
data, requested because a potential for fieldworker poisoning
from propargite exists.
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2. AGENCY ASSESSMENT
This section of the Standard is the Agency's summary
assessment of. the known safety of propargite: its toxicity
to non-target animal species and its effects on the ecology
and physical environment. This assessment is based on a review
of currently available published and unpublished data and
other literature on propargite (cited in the Registration
Standard Bibliography).
2.1 SUMMARY SCIENCE STATEMENT
Propargite has a low acute (category III) oral, dermal, and
inhalation toxicity. It is in toxicity category I, however,
for primary eye and primary skin irritation, and cases of severe
dermatitis afflicting field workers reentering treated fields
have been reported.
Chronic testing reveals that propargite appears to have
little effect on laboratory animals and only at higher dosage
levels; effects reported include depressed body weights and
rates of weight gain. Oral subchronic test results appear to
parallel those for chronic testing. Propargite is not terato-
genic in rabbits and rats.
Insufficient data exist to'fully assess the dermal sensiti-
zation, subchronic dermal toxicity, subchronic inhalation toxi-
city, reproductive effects, metabolism, and mutagenicity of
propargite. Reentry data are necessary in order to establish
permanent worker reentry intervals.
Propargite is relatively nontoxic to honeybees and avian
species. It is very highly toxic to freshwater fish. The
actual threat to aquatic organisms (including endangered species)
cannot be accurately assessed at this time due to the insuffi-
ciency of environmental fate data. Additional testing is also
needed to determine the effects of end-use products on coldwater
and warmwater species of fish, aquatic invertebrates, and estu-
arine and marine organisms.
The Agency assessed the current residue tolerances for
propargite and reached the following conclusions:
1. The metabolism of propargite in both plants and animals is
not sufficiently understood. Additional metabolism data are
necessary.
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2. The Agency does not have any relevant storage stability
data for propargite. Such data are necessary.
3. With submission of previously mentioned metabolism and
storage stability data, sufficient data will exist to
determine the adequacy ot tolerances for certain propargite
uses; additional crop residue data are needed tor other
propargite uses.
4. Processing studies are required for potatoes, oranges, apples,
plums, grapes, corn, sorghum, cottonseed, hops, and peanuts
to more accurately assess residues in or on processed foods.
2.2 TOXICOLOGICAL CHARACTERISTICS AND CONCERNS
This subsection summarizes the results of studies and
reports to the Agency relating to the acute, subchronic, chronic,
reproductive, teratogenic, and mutagenic effects of propargite.
Also discussed are the potential for and risks of human exposure
to the chemical.
ACUTE TOXICITY
Based on acute oral LD5Q testing with rats, dermal LD5Q
testing with rabbits, and acute inhalation LC5Q testing with
rats, technical propargite has been placed in toxicity cate-
gory III.
*
In the oral test with rats, five groups of five male and
five female rats received dosages of 1.0, 2.0, 3.0, 4.0, and
5.0 g/kg of bodyweight. The acute oral LD5Q was determined
to be 2.2 g/kg.
The dermal test consisted of applying the test substance
at dosage levels of 0.316, 1.0, 3.16, and 10.0 ml/kg of body-
weight to abraded and intact skin of four male and four female
albino rabbits. The exposure period was 24 hours. The acute
dermal LD5Q was reported to be 3.16 (1.63 - 6.15) ml/kg.
For the inhalation test, three groups of five male and
five female Wistar albino rats were exposed to the aerated
test material at dosages of 0.15, 0.25, and 2.5 mg/1 for
a period of 1 hour. No deaths occurred in the saturated
atmosphere, and no signs of gross pathology or toxicity were
observed during the 14-day observation period. The acute
inhalation LC$Q was determined to be greater than 2.5 mg/1.
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Propargite is in toxicity category I for primary eye and
skin irritation. A single application of 0.1 ml of technical
propargite into the unwashed eyes of six albino rabbits produced
severe irritation (irritation score: 33.7/110.0). Corneal
effects that were not reversible after 14 days were observed in
four of six rabbits. This study satisfies the requirement
for data on primary eye irritation.
In a primary skin irritation study, propargite technical was
applied to intact and abraded skin of six albino rabbits for 24
hours. The compound caused second degree chemical burns to all
rabbits tested (primary skin irritation score: 7.1/8.0). Thus,
propargite is considered extremely irritating to rabbit skin.
This study satisfies the requirement for data on primary skin
irritation.
A sensitization study is required on.technical propargite,
preferably in the guinea pig. The existing study is insufficient
because dates for dosing and scoring were not given in the raw
data. (This study can be upgraded if the missing information
is provided by the data submitter.)
SUBCHRONIC TOXICITY (ORAL)
A subchronic 90-day feeding study with technical propargite
has been conducted in the rat. The test compound was fed to
five groups of weanling albino rats consisting of five males
and five females each for 90 days at dosage levels of 10, 20,
40, 100, and 200 mg/kg body weight per day in the dj.et. A
control group of 15 males and 15 females was used and received
no treatment. Clinical examination, including hematological
and blood chemical examinations, disclosed no abnormalities.
Growth was retarded in the 100 mg/kg group and to a greater
extent in the 200 mg/kg group. Marked reduction in .absolute
organ weights in the 200 mg/kg group was observed. Gross and
microscopic examination of liver, kidneys, adrenals, and gonads
of the rats disclosed no significant abnormalities in any of
the treated groups. The no observable effect level (NOEL) is
40 mg/kg/day. Although less than 10 rats/sex/dose were employed,
the use of five dose levels in the study satisfies the requirement
for a 90-Day feeding study. ^.^ •
In another subchronic 90-day oral feeding study, male and
female beagle dogs were fed at a dietary level from 2000 to
2500 ppm. Signs of apparent compound effects among the test
dogs were decreased appetite and body weight loss. The test
animals were comparable with the controls in appearance, behavior,
elimination,-results of clinical laboratory studies, organ
weights, organ/body weight ratios, and gross necropsy findings.
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The NOEL is less than 2000 ppm. Because the NOEL could not be
specifically determined, the study is considered only supple-
mentary. (However, the subchronic data requirements are
satisfied with a 2-year dog study with a NOEL greater than
900 ppm (highest dose tested - HOT) (core minimum)).
SUBCHRONIC TOXICITY (DERMAL)
There are no data available related to the subchronic
dermal toxicity for technical propargite. Data from a subchronic
21-day dermal toxicity are required by 40 CFR Part 158 to
support the registration of each manufacturing-use product and,
also, each end-use product with a potential for significant
human dermal exposure from its regulated use.
SUBCHRONIC TOXICITY (INHALATION)
There are no data available related to the subchronic
inhalation toxicity of technical propargite. Data from a
subchronic 90-day inhalation toxicity study are required by 40
CFR Part 158 to support the registration of each manufacturing-
use product and, also, each end-use product with a potential
for significant human inhalation exposure from its regulated
use.
CHRONIC FEEDING/ONCOGENICITY
m
There are available a 2-year chronic feeding study in
dogs and chronic feeding/oncogenicity studies in mice and
rats. A discussion of these studies follows.
Chronic Feeding Data; In a chronic feeding study, four male
and four female purebred beagle dogs were fed propargite for 2
years at 0, 100, 300, and 900 ppm. Growth and food intake
were comparable to the control group. No adverse effects were
observed by the hematology, blood chemistry determinations, or
urine examinations. Gross postmortem examination failed to
reveal any dose^related effects. No significant microscopic
changes in the organs and tissues examined were observed. The
NOEL is 900 ppm (HOT). This study satisfies the requirement
for a chronic feeding study in a non-rodent.
Feeding/Oncogenicity Data; Sixty male and sixty female albino
mice (CD-I outbred from Charles River Breeding Laboratories)
per dose group were fed propargite for 18 months at 0, 50,
160, 500, and 1000 ppm. Daily observations of the animals for
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18 months revealed no untoward effects on food consumption,
body weights, hematology, and survival. Variable organ weight
changes in the kidney, adrenal, and uterus were not supported
by any pathology in these organs. The NOEL is greater than
1000 ppm. Because the 30-day range-finding study demonstrated
decreased body weight gain in females at 1350 ppm and in males at
3000 ppm, the highest dose selected of 1000 ppm for oncogenicity
testing is sufficiently close to an apparent maximum tolerated
dose (MTD) of 1350 ppm to conclude that this study satisfies
the requirement for an oncogenicity study in one species of
rodent.
In another feeding/oncogenicity study, 25 male and 25
female weanling rats of the FDRL strain were fed propargite
at 0, 100, 300, and 900 ppm for 2 years and 2000 ppm for 1.5
years. Fifteen rats of each sex were used as controls. No
dose-related responses were disclosed by hematology, blood
chemistry determinations, or urinalysis. Scattered instances of
lower mean body weight gains at weeks 26 through 104 were noted
in females receiving diets of 100, 300, and 900 ppm when compared
to the control values. However, the mean body weight gain for
females in all treated groups was about 6 percent reduced at
104 weeks of the study when compared to the control values,
which appears not to be statistically.significant. At 74 weeks
the mean body weight of rats fed 2000 ppm (HOT) was significantly
reduced for both males and females and appeared to be a compound-
related effect. This group also consumed less food and had a
lower mean body weight gain when compared to the control group.
The NOEL- = 900 ppm. This study is considered supplementary
and does not satisfy the requirement as a chronic geeding/onco-
genicity study as too few animals were examined histologically
at 900 and 2000 ppm. A chronic feeding study in the rodent is
required, as is an oncogenicity study in a second rodent species
(rat).
NEUROTOXICITY
Propargite is not related to a known group of cholinester-
ase inhibitors, such as organophosphate chemicals; therefore,
neurotqxicity data on propargite have not been required.
METABOLISM
A review of the in vivo metabolism study in the rat
indicated that the data are deficient in the following areas
1. Low and upper dose levels should be used in the study.
The low dose should should correspond to a NOEL, and
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the upper dose should produce toxic or pharmacologic signs
but not produce severe effects or high incidence of mortal-
ity.
2. At least 10 animals (5 males and 5 females) should be
used at each dose level.
3. The amount and rate of absorption should be determined.
4. Distribution of the test chemical among tissues, organs,
and fluids should be determined.
5. Significant metabolites should be identified and quantified.
These study requirements are cited in section 85-1,
"Metabolism Study, Pesticide Assessment Guidelines, Subdi-
vision F," October 1982.
TERATOGENICITY
Teratogenicity studies are available in the rabbit and
rat for propargite.
Four groups of 17 pregnant female rabbits were fed diets
of the test material containing 0, 2.0, 6.0, 10.0, and 18.0
mg/kg/day on gestation days 6 through 18. Maternal toxicity
was observed in all groups and consisted of adipsia and anorexia,
while depression of behavioral'activity was noted more frequently
in high dose groups (10.0 and 18.0 mg/kg/day). A dose-related
decrease in body weight gain in the does was noted at 6 mg/kg
and above. The decrease was statistically significant in the
highest group (18.0 mg/kg/day). The fetuses showed delayed
ossification at 6.0 mg/kg and above; this was considered related
to maternal toxicity of the test compound. Fetotoxicity was
evidenced by increased resorptions and reduced fetal body
weight at 6.0 mg/kg/day and reduced fetal viability at the two
highest groups (10.0 and 18.0 mg/kg/day) with a NOEL of 2.0
mg/kg/day.
Teratogenic NOEL; 10 mg/kg/day (too few fetuses at the
highest dose 18.0 mg/kg for evalua-
tion).
Maternal Lowest Effect
Level (LEL); 6 mg/kg (decrease in body weight gain)
Maternal NOEL; 2 mg/kg
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Fetotoxic LEL ; 6 mg/kg (delayed ossification, increased
resorptions, decreased fetal body weight)
Fetotoxic NOEL; 2 mg/kg
The adult toxicity/developmental toxicity (A/D) ratio =
Maternal LEL/Fetotoxic LEL = 6/6 = 1
In the rat study, Propargite was administered by gavage
to pregnant rats from day 6 through day 15 of gestation at
levels of 0> 6, 25, or 105 mg/kg body weight per day. An
increase in maternal toxicity and mortality was observed at the
highest dose tested (105 mg/kg/day).
Teratogenic NOEL; > 105 mg/kg/day
Maternal NOEL; 25 mg/kg
Fetotoxic LEL; 25 mg/kg/day (increased missing
sternebrae)
Fetotoxic NOEL; 6 mg/kg/day
The A/D ratio = Maternal LEL/Fetotoxic LEL = 105/25 = 4.
This study is considered as core minimum and satisfies the
data requirements.
REPRODUCTION AND FERTILITY
A three-generation reproduction study was carried out with
25 male and 25 female rats fed 0 or 100 ppm propargite for one
generation; the dose of the treatment group was increased
to 300 ppm *f or the next two generations. The study results
revealed no significant effects on either fertility or reproduc-
tive performance. Neonatal viability and lactation efficiency
of the dosage group, as evidenced by the survival and growth
of the young rats from birth to weaning, were comparable to
that of the control group. Mean body weight of the pups was
also comparable with the mean body weight of the control group.
The NOEL is greater1 than 300 ppm.
This study is considered as supplementary, as only one dose
was used for each generation.
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MUTAGENICITY
Propargite was tested for mutagenic activity in a series
of ir\ vitro microbial assays employing Salmonella and
Saccharomyces indicator organisms. The compound was tested
directly and in the presence of liver microsomal enzyme
preparations from Aroclor-induced rats. The nonactivation and
activation test results were all negative. Propargite did not
induce any mutagenic activity in any of the assays conducted
and was considered not mutagenic under these test conditions.
Additional categories of mutagenicity testing are required for
propargite.
RISKS OF HUMAN EXPOSURE
The Agency has not quantified the exposure to mixer/loaders
and applicators handling or applying propargite. Propargite -
is not highly toxic by the dermal or inhalation route; however,
it is extremely irritating and corrosive to the eyes and skin.
Occupational exposure to the skin can be substantially reduced
by the use of appropriate protective clothing during handling.
Chemical resistant protective gloves will reduce dermal contact
with the hands. During mixing/loading the hands frequently
receive 50 to 99 percent of the total dermal exposure. Goggles
or a face shield will provide protection to the eyes in case of
accidental splashing during mixing/loading. Long sleeve shirts
and long pants will limit the surface area of the body directly
exposed "to propargite from splashing during mixing/loading and
spray contact during application, or foliar contact during early
worker reentry to treated areas.
Due to the irritating effects to the eyes and skin,
propargite has caused reentry problems in California over the
years. The California Department of Food and Agriculture
(CDFA) established a reentry interval of 14 days in response to
a number of validated reentry poisoning episodes after the use
of propargite. A 1980 episode involved over 50 field workers,
who reentered treated vineyards 2 to 4 days after pesticide
application. Another major poisoning episode occurred in 1986
after use of the propargite "California Recipe" (CR)* formula-
tion: over 100 cases of severe dermatitis were reported among
field workers picking citrus. In response to that episode, the
CDFA proposed the establishment of a 35-day reentry interval
for use of the CR formulation. The CR formulation has since
been voluntarily withdrawn from the market in California.
* The CR formulation is believed to persist on foliage con-
siderably longer than other propargite formulations.
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The CR formulation has been marketed in 13 other States,
and the Agency has requested information on worker incidents
from those States. Thus far, only four States have responded,
and no adverse effects have been reported. The reentry problem
is currently being evaluated, and the registrant of this formu-
lation has voluntarily dropped all uses from the label other
than for grapes, citrus, apples, almonds, hops, ornamentals,
strawberries, and cherries.
The Agency does not have adequate data to set appropriate
reentry times for the respective propargite formulations. It
has compared dislodgeable residue data from a CDFA report with
CDFA analysis of residues from the groves where the CR episode
occurred and has concluded that dislodgeable residues of the CR
formulation may persist longer than dislodgeable residues of the
wettable powder formulation. The citrus foliar residues at 13
days after application of the CR formulation range from 1.46 to
2.91 ug/cm^ (seven values, mean = 2.13, SD = 0.57), whereas
residues 8 days after application of the wettable powder formu-
lation to grapes range from 0.10 to 0.40 ug/cm^ (four values,
mean = 0.23, SD = 0.13). Until additional required reentry data
can be provided and evaluated, the EPA is imposing interim re-
entry interyals of 7 days for all agricultural uses except
strawberries, and 3 days for strawberries. These differing
reentry intervals are because human exposure tends to be higher
in tall crops such as tree fruit because of the greater amount of
foliage contacted during work.
2.3 ENVIRONMENTAL FATE
»'
Based on the data cited in this registration standard,
there seems to be no reason to be concerned about the leaching
of the parent chemical into groundwater. The environmental
fate of this, chemical still needs to be properly characterized,
however, with special emphasis on possible metabolites. The
following data summaries are derived from the reviewed studies
that were found to be scientifically valid but do not fulfill
the data requirements. These data summaries may change when
additional information is received and reviewed.
Under anaerobic conditions, [^^C]propargite (ring-labeled,
99.94% pure), at 1 and 10 ppm in sandy loam soil, degraded
with a half-life of 3 to 6 and greater than 12 months,
respectively, when incubated in the dark at 25°C. The major
degradate was [l^Clglycol ether representing a maximum of 38.4
percent of the applied ^^C after 12 months. Unidentified polar
compounds represented less than 3.4 percent of the applied
during the study.
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Propargite (purity unspecified) at 0.05 to 0.4 ppm
was adsorbed and desorbed more readily in silt loam than in
loamy soil. The Freundlich K values for adsorption and desorp-
tion in loamy sand were 86.1 and 292, respectively, and in
silt loam were 698.2 and 6918, respectively.
[l^ClPropargite residues (uncharacterized) were detected
in the leachate of 1-inch sandy loam and clay loam soil columns
leached with 3 inches of water. Approximately 1.52 and 0.95
percent of the applied radioactivity was detected in the sandy
loam and clay loam leachates, respectively.
[14c]pr0pargite (95.9% pure) was immobile in sand and
sandy loam soils, based on TLC tests. [^-^CjPropargite
(95.6% pure) at 0.5 Ib active ingredient per acre (a.i./A) was
relatively immobile in the runoff from a silt loam soil (10°
slope) with 0.5 percent of applied detected in runoff water
after application of 9 inches of water.
Propargite (30% WP or 75% EC) at 10.8 ppm or 5 Ib a.i./A
dissipated from the upper 6 inches of three soils in California
and Vermont with a half-life of 4 weeks. The degradate,
glycol ether, was not detected (< 0.1 ppm) in any sample.
Confined rotational crop studies show potential for uptake
of propargite residues at intervals of less than one year.
The following data are needed to fully assess the environ-
mental fate and transport of propargite for its current uses:
hydrolysis studies; photodegradation studies on soil and in
water and air; aerobic and anaerobic soil metabolism studies;
anaerobic and aerobic aquatic metabolism studies; Jeaching
and adsorption/desorption studies; laboratory and possibly
field volatility studies; terrestrial, aquatic, and long-term
field dissipation studies; accumulation studies on confined
and field rotational crops, irrigated crops, fish, and aquatic
nontarget organisms; and reentry studies.
2.4 ECOLOGICAL CHARACTERISTICS AND CONCERNS
The relative lack of environmental fate data permits only
a preliminary assessment of the hazards to non-target organisms.
It appears, however, that risks to birds are unlikely, while
risks to various aquatic organisms may be high based on acute
studies in the laboratory and preliminary estimated environmental
concentrations (EECs).
Toxicity data are not yet available for mollusks. Because
fish usually serve as an intermediate host for larval mussels
(glochidia), however, adverse effects on fish could adversely
affect the mussel's habitat. The following discussion addresses
these hazards.
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AVIAN SPECIES
Propargite is practically nontoxic to avian species on an
acute oral and subacute dietary basis. The acute oral 1,050
value for the technical grade material (88% a.i.) was reported
to be greater than 4640 mg/kg. Reported subacute dietary LC$Q
values for the technical and formulated product (57% a.i.) to
bobwhite quail were 3401 and greater than 5620 ppm, respectively,
Since propargite may be applied repeatedly, however, to cotton,
citrus, grapes, and apples, birds may be subjected to repeated
or continued exposure to the pesticide or its major metabolites
or degradates. This would occur especially preceding or during
the breeding season. For this reason, the Agency is requiring
avian reproduction studies. Depending upon the results of the
avian reproduction studies, residue level monitoring data may be
required
NON-TARGET MAMMALS
The toxicity of propargite to mammals is low (rat LD5Q >
2200 mg/kg). Therefore, it is unlikely that mammals would be
acutely affected by a single application. Sinc^ propargite use
patterns call for repeat applications, mammals such as rabbits,
may be exposed to residues causing reproductive effects when
propargite is applied to alfalfa and orchards. The potential for
chronic effects cannot be determined until receipt ot an acceptable
2-year rat reproduction study. Depending upon the results of this
study, residue monitoring of mammalian feed items from alfalfa
and orchard use may be required.
NON-TARGET INSECTS AND MITES
Studies indicate that propargite is low in toxicity to
honeybees and to certain predacious beetles and mites. There-
fore, it is unlikely that these non-target species would be
affected by'applications of propargite made in accordance with
label instructions.
AQUATIC SPECIES
The Agency is concerned about the direct and indirect
hazards that this material may pose to aquatic specias. Based
upon laboratory data, the Agency has characterized propargite
as very highly toxic to aquatic invertebrates, highly toxic to
cold and warmwater fish species and highly toxic to practically
nontoxic to estuarine and marine organisms. Terrestrial
residue analysis and aquatic runoff modeling further indicate
that certain^use patterns of propargite could result in exposure
of certain aquatic organisms to potentially hazardous levels
of the pesticide.
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The potential for aquatic contamination is greatest, of
course, for those uses in which propargite is introduced direct-
ly into the aquatic environment. This occurs during appli-
cation of the pesticide to an "aquatic" crop, cranberries, but
also could occur inadvertently through treatment of terrestrial
crops, specifically, corn, cotton, and citrus. Such an occur-
rence would be the result of a wide dispersion spray operation,
involving the application of propargite to fields traversed with
irrigation systems ot interconnected ditches, canals, creeks,
streams, and ponds. Lesser but significant contamination could
result from drift, runoff, or soil erosion - the propargite being
introduced indirectly to lakes, streams, ponds, other bodies of
water, and wetlands. Environmental fate data indicate that
propargite is immobile in sandy soils, and its persistence
varies with pH in turbid or ground waters (half-life ranging
from 2 to 55 days and perhaps even greater under certain condi-
tions) .
Because of these aquatic contamination concerns, the Agency
is recommending precautionary labeling for aquatic organisms.
The Agency is requiring additional fish, invertebrate, and
estuarine and marine organism tests, using an end-use product to
evaluate the potential toxicity to these organisms from terres-
trial crop application with a potential for aquatic contamination.
The Agency is also requiring additional field monitoring data
designed to measure propargite residues in water from terrestrial
applications to citrus, corn, and cotton.
ENDANGERED SPECIES
Based on terrestrial residue analysis, aquatic runoff
modeling, and "cluster analysis11*, it appears that certain use
patterns of propargite involve sufficient exposure to pose a
potential hazard to certain endangered/threatened species.
These species are cited in the following list. Respective use
sites posing this hazard are in parenthesis.
* In cluster analysis, all pesticides with the same use patterns
are considered together. The Fish and Wildlife Service, Depart-
ment of the Interior screens all the pesticides for a particu-
lar major crop or use pattern and prepares a biological opinion
addressing all listed species that might be affected by the
pesticides. Cluster analysis has been done on cotton, corn,
small grains, sorghum, soybeans, rangeland, forest, and
mosquito larvicide use patterns. Propargite has labeled
uses for some of these sites, namely, cotton, corn, and sorghum.
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Mollusks (corn, sorghum, and cotton)
Slackwater darter (corn and cotton)
Scioto madtom (corn)
Woundfin (corn and sorghum)
Pecos gambusia (cotton)
Comanche Spring pupfish (cotton)
Propargite is registered for several uses that have not
been reviewed in the cluster approach or in registration submis-
sions. It is anticipated that little exposure to listed
species will occur with the rest of the registered propargite
use sites: almonds, apricots, beans, cranberries, hops, mint,
peaches, peanuts, plum, walnuts, and ornamentals. Though a
review of these crops in the future crop reviews may add endan-
gered species to the list thus far established, few additions
are likely because of the broad geographical distribution of
the crops that have already been reviewed.
2.5 TOLERANCE REASSESSMENT
Tolerances have been established for residues of propargite
in a variety of raw agricultural commodities, in meat, fat, and
meat byproducts (40 CFR 180.259), and in processed food (21 CFR
561.330) and feed (21 CFR 193.370). The Agency has evaluated the
residue and toxicology data supporting these tolerances, and
has made the regulatory determinations discussed in the following
subsections.
PROPARGITE METABOLISM DATA ASSESSMENT
A review of available data on the nature of the residues in
plants led to the conclusion that the metabolism of propargite
in plants is not adequately understood. Additional data depicting
the uptake, distribution, and metabolism of ^C-labeled propargite
in representative mature crops are needed. This data, preferably,
should utilize an orchard tree fruit, potatoes, and corn grain
and forage. The available plant metabolism data are not adequate
because radiolabeled studies on the uptake, translocation and
metabolism of propargite in plants show that (a) polar metabo-
lites have not been adequately identified in bush beans; and
(b) other than propargite itself, no metabolites were" identified
in peaches and corn. An investigation of l^C-residues in bean
plants resulting from foliar application revealed that the
major residue consisted of parent compound (I) and metabolites
II and III (propargite glycol ether and p-t-butylphenol, respect-
ively) but, of these, only compound III was confirmed by co-
chromatography with analytical standards.
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-19-
Radiolabeled studies on the metabolism and translocation
of propargite in poultry (including eggs) and ruminants (including
milk) are likewise insufficient. The only in vivo ruminant
metabolism study submitted was not adequate because (a) the
time of sacrifice of the animals after the final treatment was
not provided; (b) residues were not adequately characterized in
any of the samples examined; and (c) the dosage regimen (number
of doses administered, timing of dosing, etc.) was not described
in sufficient detail. A submitted poultry study is inadequate
because numerous obvious errors in computation of residue
concentrations were found, and, with the information provided,
the Agency was not able to calculate the correct values with
any reasonable degree of certainty. Therefore, additional data
are required.
STORAGE STABILITY DATA ASSESSMENT
The Agency does not have any relevant storage stability
data for propargite. Therefore, storage stability data are
required to support all established tolerances for residues.
Storage intervals and conditions of storage of samples used
must be submitted. 'These data must be accompanied by data
depicting the percent decline in residues at the times and
under the conditions specified. On receipt of these data, the
adequacy of the aforementioned tolerances will be reevaluated.
PLANT TOLERANCES ASSESSMENT
Propargite is registered for use on almonds, "apples, apri-
cots, beans (dry, green, and lima), cranberries, corn (field
and sweet), cotton, figs, grapefruit, grapes, hops, lemons,
mint, nectarines, oranges, peaches, peanuts, pears (nonbearing
and postharvest), plums, potatoes, prunes, sorghum (milo), straw-
berries, tea (dried), and walnuts. The following numbered para-
graphs discuss the Agency position on the tolerances for these
crops and the present adequacy or inadequacy of supportive data.
1. Sufficient data are available to ascertain the adequacy
of the established tolerances for residues of propargite in or
on succulent beans; cottonseed; cranberries; mint; peanut nut-
meats, forage, hay, and hulls; potatoes; and sorghum forago and
fodder (40 CFR §180.259 and 21 CFR §193.370), provided requested
data for plant and animal metabolism and storage stability are
submitted. It should be noted that the adequacy of established
tolerances may change after information on the nature of the
residues (metabolism) in plants and animals is submitted and
evaluated.
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-20-
2. Insufficient data are available to ascertain the adequacy
of the established tolerances for residues of propargite in or
on almond nutmeats and hulls, apples, apricots, dry beans, citrus
pulp, sweet corn (kernals plus cob with husks removed), corn
forage and fodder, fresh figs, grapes, grape pomace, grapefruit,
hops, dried hops, oranges, pears, peaches, plums, raisins, grain
sorghum, strawberries, tea, and walnuts (40 CPR §180.259, 21 CFR
§561.330 and 21 CFR §193.370). The current tolerance on apples
(3 ppm) is inadequate to cover the residues, and a petition to
increase this to 10 ppm is under review. This will involve
increasing the tolerance on apple pomace. Since the nature of
the residues in plants and animals has not been adequately
defined, however, action on the petition has been delayed until
the earlier tier studies are completed and the Agency has
evaluated the metabolites.
3. Processing studies are needed tor potatoes, oranges,
apples, plums, grapes, corn, sorghum, cottonseed, hops, and
peanuts.
4. Tolerances for residues of propargite in or on sugar
beets and sugar beet tops have been proposed and the data in
support of these pending tolerances are now under review.
5. In addition to the conclusions stated previously regard-
ing established tolerances, the Agency has made the following
determinations:
(a) The commodity definition of "peanut forage" should be
amended to "peanut vines" because the latter as the appro-
priate commodity definition.
(b) The postharvest application of propargite to cherry trees
and avocados constitutes a food use. Therefore, tolerances
for residues on cherries and avocados are required. For
cherries, residue data on sweet and tart varieties are
needed.
ANIMAL (PRODUCT) TOLERANCES ASSESSMENT
There are no Federally registered uses for propacgite on
animals. There are tolerances on animal products, however,
as certain animals raised for meat or dairy purposes can be
expected to ingest propargite-treated feed.
The maximum reasonable dietary intake of residues of
propargite by beef cattle is 26 ppm if the diet consists of 50
percent sorghum grain (10 ppm), 20 percent of either corn
forage, corn fodder, peanut vines or peanut hay (each 10 ppm),
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-21-
25 percent almond hulls (55 ppm), and 10 percent dried apple
pomace (80 ppm) - (established tolerances for residues are in
parenthesis). The maximum dietary intake by dairy cattle is
37 ppm if the diet consists of 50 percent mint hay, 10 percent
apple pomace, and 40 percent sorghum grain. The maximum dietary
intake by swine is 12.7 ppm if the diet consists of 80 percent
grain sorghum, 10 percent dry pomace, and 10 percent bean cannery
residue. The maximum dietary intake by poultry is 11 ppm based
on a diet consisting of 60 percent grain sorghum, 5 percent dry
apple pomace, and 30 percent corn grain.
As stated in a previous subsection, at present, the nature
of any residue in animals resulting from dietary intake of propar-
gite is not adequately understood. Upon receipt of metabolism
studies utilizing ruminants and poultry, the appropriateness
of tolerances for residues in animal products will be determined
and, with consideration for any newly found metabolites of
toxicological concern, the adequacy of the available data
regarding the magnitude of residues in animal products will be
determined. Also, at that time, pertinent sample storage and
storage stability information for animal commodities will be
required.
PROPARGITE SPECIAL LOCAL NEED (SLN) REGISTRATIONS/INTRA-
STATE PRODUCTS
Propargite is registered for use on the following crops
grown for seed: alfalfa, sweet.corn, clover, and cucurbits.
Alfalfa grown for seed (EPA SLN No. OR-790005) may be treated
with the 6 Ib/gal EC formulation (1.52 - 2.25 Ib a".i./A) and
the 6.55 Ib/gal EC formulation (1.2 - 2.04 Ib a.i./A, EPA SLN
No. UT-790015). Sweet corn and clover grown for seed may be
both treated with the 6.55 Ib/gal EC formulation (1.2 - 2.04 Ib
a.i./A) in Washington (EPA SLN No. WA-770012). Sweet corn
grown for seed may be treated with the 6.55 Ib/gal EC formul-
ation at 1.2 - 2.04 Ib a.i./A in Oregon (EPA SLN No. OR-770013).
Cucurbits grown for seed may be treated with the 6.55 Ib/gal EC
formulation at 1.6 Ib a.i./A in California (EPA SLN No. CA-760179)
In addition, intrastate labels exist that permit use of
the 6.55 Ib/gal EC formulation on alfalfa grown for seed at
1.23 - 1.64 Ib a.i./A in Nevada (EPA No. 400-6441), California
(EPA No. 400-6460), and Oregon (EPA No. 400-6529); or at 1.23 -
2.04 Ib a.i./A in Washington (EPA No. 400-6506) and Idaho
(EPA No. 400-6478). Clover grown for seed may be treated with
the 6.55 Ib/gal EC formulation at 1.23 - 1.64 Ib a.i./A in
California (EPA No. 400-6458).
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No tolerances exist for residues of propargite in or on
cucurbits, alfalfa, or clover. The seeds of pumpkins and
squash could be diverted to human consumption and successive
cuttings of alfalfa and clover for animal feed could be taken
following harvest for seed. Consequently, the uses on cucurbits,
alfalfa, and clover are considered food uses requiring the
submission of residue data in support of appropriate tolerances.
TOXICOLOGY DATA USED TO EVALUATE TOLERANCES
The toxicology data considered in support of the tolerances
include a chronic feeding study in purebred beagle dogs with
a NOEL of 900 ppm, a rabbit and rat teratology study with a
teratogenic NOEL for rabbits of 10 mg/kg/day, and teratogenic
NOEL for rats greater than 105 mg/kg/day.
Because of the absence of adequate reproduction and chronic
feeding studies in the rodents, a provisional acceptable daily
intake (PADI) was established using a 2-year dog feeding
study with a NOEL of greater than 900 ppm (22.5 mg/kg) HOT.
Using a conservative thousandfold safety factor, the PADI was
calculated -to be 0.225 mg/kg/day. The provisional maximum
permitted intake (PMPI) for a 60 kg human is calculated to be
1.3500 mg/day. The current theoretical maximum residue contri-
bution (TMRC) for propargite, based on the published and the
Agency approved tolerances is 1.5153 mg/day for a 1.5 kg diet,
and the PADI utilized is 112 percent.
Although exceeding the PADI by 12 percent is of concern to
the Agency, the public should be in no danger from'dietary
exposure while the Agency awaits residue data. The TMRC is
based on the assumption that 100 percent of the crop for which
a tolerance is established is treated with propargite. Of the
major uses of propargite - on almonds, grapes, and cotton -
the actual percentages of crops treated are 70 to 80, 35 to 90,
and less than 5, respectively. The estimated percentage ot the
remaining crops treated with propargite is low. Therefore,
selectively adjusting the TMRC to reflect the actual percentage
of crop treated would reduce the TMRC to a percentage level of
the PADI significantly lower than 112 percent.
The Agency recognizes that the statistical significance
of the Food and Drug Administration's market basket survey
is limited, but results from this monitoring can function as
an indicator of immediate dietary exposure risks. Monitoring
activity for the past several years shows that, although
present, propargite residues are consistently below established
tolerances, which further alleviates the Agency's immediate
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-23-
concern over propargite's use while collecting data for a tol-
erance reassessment.
In summary, preliminary information suggests that actual
dietary exposure to propargite is much lower than that predicted
by the TMRC. Since the TMRC, however, does exceed the PADI by
12 percent, new tolerances/uses will not be issued if they
contribute significantly to the TMRC and/or result in a signifi-
cant increase in dietary exposure.
TOLERANCES ISSUED
The following tables list the present commodity tolerances
for propargite.
PRESENT TOLERANCES FOR PROPARGITE
COMMODITY
Almonds
Almonds, hulls
Apples
Apple pomace
(dried)
Apricots
Beans, dry
Beans, succulent
Cattle, fat
Cattle, meat by-
products (MBYP)
Cattle, meat
TOLERANCE (PPM)
Internatl .
U.S. Canada Mexico (Codex)
0.1 - - 0.1
55.0 - - 55.0
3.0 3.0 3.0. 5.0
80.0 -
7.0 -
0.2 5.0 0.2 0.2
20.0 - - 20.0
0.1 - . -
0.1 -
0.1 - - -
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-24-
PRESENT TOLERANCES FOR PROPARGITE
(Continued)
COMMODITY
Citrus pulp
(dried)
Corn, fodder
Corn, forage
Corn, fresh (incl.
sweet) (K+CWHR*)
Corn, grain
Cottonseed
Cranberries
Eggs
Figs (fresh)
Figs (dried)
Goats, fat
Goats, meat
Goats, MBYP
Grapefruit
Grapes
Grape pomace
(dried)
Hogs, fat
TOLERANCE (PPM)
Internatl .
U.S. Canada Mexico . (Codex)
40.0 -
10.0 - 10.0 10.0
10.0 - 10.0 10.0
0.1 - 0.1 0.1
0.1 - 0.1 0.1
0.1 - 0.1 0.1
10.0 5.0 - 10.0
0.1 - - 0.1
3.0 - 3.0 2.0
9.0 ' - 9.0.
0.1 - -
0.1 -
0.1 -
5.0 5.0 2.0 5.0
10.0 7.0 10.0 10.0
40.0 -
%* -« •
0.1
* Kernel plus cob with the husk removed.
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-25-
PRESENT TOLERANCES FOR PROPARGITE
(Continued)
COMMODITY
Hogs, meat
Hogs, MBYP
Hops
Hops (dried)
Horses, fat
Horses, MBYP
Horses, meat
Lemons
Milkfat (0.08 in
whole milk)
Mint
Nectarines
Oranges
Peaches
Peanuts
Peanuts, forage
Peanuts, hay
Peanuts, hulls
Pears
TOLERANCE (PPM)
U.S. Canada
0.1
0.1
15.0
30.0 30.0
0.1
0.1
0.1
5.0 5.0
2.0
50.0 .
4.0
5.0 5.0
7.0 7.0
0.1 0.1
10.0
10.0
10.0
3.0 3.0
Internatl .
Mexico (Codex)
-
-
- -
30.0
-
-
-
2.0 5.0
0.1
50.0
7.0
2.0 5.0
7.0 7.0
1.0 0.1
10.0 10.0
10.0 10.0
-' -
3.0 5.0
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-26-
PRESENT TOLERANCES FOR PROPARGITE
(Continued)
COMMODITY
Plums (fresh
prunes)
Potatoes
Poultry, fat
Poultry, MBYP
Poultry, meat
Raisins
Sheep, fat
Sheep, MBYP
Sheep, meat
Sorghum, fodder
Sorghum, forage
Sorghum, grain
Strawberries
Tea (Dry)
Walnuts
TOLERANCE (PPM)
Internatl .
U.S. Canada Mexico (Codex)
7.0 5.0 - 7.0
0.1 - 0.1 0.1
0.1 - - 0.1
0.1 - - 0.1
0.1 - -
25.0 -
0.1 -
0.1 -
0.1
10.0 - 10.0 10.0
10.0 - 10.0 10.0
m
10.0 - 10.0 5.0
7.0 7.0 7.0 7.0
10.0 0.1 - 5.0
0.1 - 0.1 0.1
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-27-
3. REGULATORY POSITION AND RATIONALE
This section of the Standard states and explains the basis
for Agency positions regarding the need for additional data and
labeling requirements. It also provides directives for the proper
labeling of manufacturing-use and end-use products.
3.1 STATEMENTS OF POSITIONS AND RATIONALES
1. None of the risk criteria listed in 40 CFR 154.7 has
been exceeded for propargite. Therefore, no referral to Special
Review is being made at this time.
Rationale; The available laboratory data indicate that
propargite is very highly toxic to fish. Terrestrial
residue analysis and aquatic runoff modeling further indi-
cate that certain use patterns of propargite could
result in exposure of certain aquatic organisms (including
endangered species) to potentially hazardous levels of the
pesticide. The Agency has not received any reports, however,
on fish kills associated with the use of propargite during
its use history. Additional data are needed before the
Agency can complete a full assessment of this hazard
potential. After the evaluation of required environmental
fate data, chronic fish and aquatic invertebrate data,
and residue level monitoring studies, the Agency will
determine whether to initiate a public interim review
process by placing the chemical in Special Rev-iew.
2. Tho Agency will not issue tolerances for significant
new food uses.
Rationale; Until such time as reassessment of the
present tolerances for propargite is completed, the
Agency will not issue tolerances for significant new
food uses. The Agency needs additional residue and
metabolism data in order to characterize the nature of
residues in plants and animals. The Agency also needs
processing data on certain crops to determine actual
dietary exposure.
3. The Agency is imposing an interim 6-month rotational
crop restriction on product labels. (Refer to section 3.4
for labeling requirements.)
Rationale; There is no rotational crop restriction on
current labels with propargite as the active ingredient.
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Rotational crop data that has been submitted, however,
. while unacceptable, does suggest that a restriction
will be needed, since these data show potential for
uptake of propargite residue in follow-up crops.
Therefore, on an interim basis, a 6-month restriction is
being imposed. Upon receipt and evaluation of acceptable
rotational crop data, the Agency will determine whether
a different rotational crop restriction or rotational
crop tolerances are needed.
4. The Agency is imposing an interim label restriction
prohibiting the use of water leaving propargite treated
cranberries fields to irrigate crops grown for food or
feed. (Refer to section 3.4 for labeling requirements.)
Rationale; The Agency does not have data to determine
residue uptake and levels in representative crops that
could be irrigated with water from a cranberry field
treated with propargite. Such studies .are needed to
establish label restrictions to prevent residues in
irrigated crops and/or to provide information for a
determination as to whether tolerances may be needed in
the irrigated crops.
5. The Agency is imposing an interim 3-day reentry
interval for strawberries and 7-day reentry interval for
all other agricultural uses on the label. This restriction
will be reevaluated upon receipt and review of adequate reentry
data. (Refer to section 3.4 for labeling requirements.)
Rationale: There is a Federally required 7-day reentry
interval that was requested by the registrant for use
of propargite on grapes and avocadoes. Incidents of
severe dermatitis in workers reentering fields treated
with the propargite indicate that a need for fieldworker
protection does exist for crops other than grapes and
avocadoes. Human exposure tends to be highest in tall
crops, such as tree fruit, because of the amount of foli-
age contacted during work. The Agency perceives that the
need for protection is somewhat less for low crops such
as strawberries, and believes that a 3-day pre-harvest
interval provides an adequate margin of safety during
the interim until reentry data are submitted. "-
6. The Agency is requiring endangered species labeling
for certain uses of propargite. (Refer to section 3.4 for
labeling requirements.)
Rationale: The Agency has evaluated the potential for
propargite to jeopardize endangered species in areas in
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which this pesticide is used. Analyses of terrestrial
residue and aquatic runoff modeling indicate that certain
use patterns of propargite could result in a hazard to
endangered/threatened species.
7. Precautionary labeling for aquatic organisms are
being required for aquatic and non-aquatic uses. (Refer to
section 3*4 for labeling requirements.)
Rationale; Due to the high acute toxicity of propargite
to aquatic organisms, the Agency is concerned about the
direct and indirect hazards propargite may pose to aquatic
environments. (Refer to section 2.4 for information on
risks to endangered species.)
8. Although the Agency is requiring precautionary
labeling for aquatic organisms, it will not restrict certain
uses of propargite to certified applicators at this time.
Rationale; Available data indicate that propargite is
highly toxic to fish and aquatic invertebrates (including
freshwater and estuarine organisms). Analysis of terres-
trial residue and aquatic runoff modeling indicate that
certain use patterns of propargite could result in a hazard
to aquatic organisms, however, the Agency has not received
any reports on fish kills following propargite application
during its long use history. Fish, invertebrate and
estuarine/marine organism tests, using an end-use product,
plus environmental fate data are required to complete the
hazard assessment for aquatic organisms. Should additional
data demonstrate that propargite poses risks to aquatic
organisms that could be mitigated by increased controls
in application, restricted use classification may be
required.
9. The Agency is requiring data on cucurbits, alfalfa,
and clover, which are registered under section 24(c) Special
Local Need registrations.
Rationale; No tolerances exist for the seed treatment uses
of propargite because they were not required at the time
these uses were registered by the U.S. Department of
Agriculture (USDA). USDA had concluded, based upon the
analytical methodology available at the time, that no
residues were or would be present in plants as a result
of seed treatment by any pesticide. Thus, all seed treat-
ments were considered to be non-food uses. EPA now con-
siders that tolerances should be established for all
seed treatment uses unless it can be shown by data from
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a radiolabeled chemical study that no uptake of residues
occurs from the treated seeds into the aerial or edible
portion of the growing crop.
10. The Agency will require that protective clothing be
worn by mixer/loaders and applicators. Product labels must be
revised to specify that mixer/loaders wear goggles or a face
shield, chemical-resistant apron, mid-forearm to elbow-length
chemical resistant gloves, a long-sleeve shirt, and long
pants. Applicators will be required to wear a long-sleeve
shirt and long pants or coveralls, and a wide-brimmed hat
during upward spraying. (Refer to section 3.4 for labeling
requirements.)
Rationale; Protective clothing is necessary to minimize
exposure to workers during mixing, loading, and applying
propargite or during early reentry to treated fields.
There is definitely a risk of exposure to this pesticide,
and, while insufficient data exists to establish its
dermal sensitization potential, numerous cases of skin
irritation have been reported related to its use.
11. The Agency'will require quantitive data on the
permeability and breakthrough times of various materials
used for chemical resistant gloves. This data will be required
for all liquid formulations of propargite.
Rationale; Because of the potential dermal irritation
and skin sensitization hazard to handlers of propargite,
the"incident history, and 'use patterns of propargite,
there is a need to know which materials are most
effective in protection against propargite contamination.
Quantitative permeation and breakthrough time data are
not available to adequately assess the protective value
of vari,o.us glove materials that are currently available.
The generation and submission of these data will aid the
Agency in determining which types(s) of material(s) to
specify for the chemical resistant gloves.
12. While the data gaps are being filled, currently regis-
tered manufacturing-use products (MPs) and end-use products
(EPs) containing propargite as the sole active ingredient may
be sold, distributed, formulated, and used in the United States,
subject to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional data,
as specified in Tables A and B of the Data Appendices, in
order to maintain existing registrations.
Rationale; While the currently available data are not
adequate to support the registration of any registered
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propargite product unconditionally under FIFRA section
3(c)(5), the available data do support the conditional
registration of all of the currently registered products.
Under FIFRA, the Agency does not normally cancel or withhold
registration simply because data are missing or inadequate
(see FIFRA sections 3(c)(2)(B) and (3)(c)(7)) unless avail-
able data indicate that use of the product is likely to
cause unreasonable adverse effects on the environment.
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and
evaluated. The Agency will then determine whether
additional reguLatory changes are necessary.
13. The Agency will issue registrations for substantially
similar products. New uses, however, will be issued only on
a case-by-casf basis after considering the effects on the
theoretical maximum residue concentrations (TMRC) and the
maximum permitted intake (MPI).
Rationale; 'The Administrator has the authority under
FIFRA sections 3(c)(2)(B) and 3(c)(7) to require regis-
trants to provide data needed to support new or contin-
uing registrations.
3.2 CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain propargite as the solo active ingredient,
bear required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed
in this section.
3.3 ACCEPTABLE RANGES AND LIMITS
Product Composition Standard: To be registered or reregistered
under this Standard, manufacturing-use products (MPs) must
contain propargite as the sole active ingredient. 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 ingre-
dients that are present in products, as well as impurities
found at greater than 0.1 percent.
Acute Toxicity Limits; The Agency will consider registration
of technical grade and MPs containing propargite provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
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Use Patterns: TO be-registered under this Standard, MPs
may be labeled for formulation into end-use products (EPs)
only for the commodities listed below:
TERRESTRIAL FOOD CROPS
(Agricultural Crops)
Almonds
Apples
Apricots
Avocadoes(post-harvest)
Beans (green, dry, and lima)
Cherries
Corn, field
Corn, sweet
Cotton
Figs
Grapefruit
Grapes
Hops
Lemons
Mint
Nectarines
Oranges
Peaches
Peanuts
Pears
Plums
Potatoes
Prunes
Sorghum, milo
Strawberries
Walnuts
Cranberries
AQUATIC FOOD CROPS
(Agricultural Crops)
TERRESTRIAL NON-FOOD CROPS
(Ornamental Plants)
Carnations
Chrysanthemums
Roses
GREENHOUSE NON-FOOD CROPS
(Ornamental Plants)
Carnations
Chrysanthemums
Roses
3.4 REQUIRED LABELING
*» -*
All MPs (and EPs, if covered by this Standard) must bear
appropriate labeling as specified in 40 CFR 162.10. Appendix II
contains information on label requirements. No MP or EP con-
taining propargite may be released for shipment by a registrant
or producer of that product 12 months after the registrant's
or producer's receipt of this Registration Standard, unless
the product bears an EPA-approved amended label that complies
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with this Standard. No MP or EP containing propargite may
be distributed, sold, offered for saler held for sale, shipped,
delivered for shipment/ or received and (having so received)
delivered or offered to be delivered by any person 24 months
after issuance of this Standard, unless the product bears an
EPA-approved amended label that complies with this Standard.
The following information must appear on the labeling.
INGREDIENTS STATEMENT
The ingredient statement for MPs must list the active
ingredient as: •
Propargite, 2-(p-tert-butylphenoxy)cyclohexyl
2-propynyl sulfite
PRECAUTIONARY STATEMENTS
This subsection describes the precautionary statements that
must appear on the labels of MPs or EPs.
Manufacturing-Use Products
1. Labels for MPs must bear the following statement under
the head-ing "Environmental Hazards":
"This pesticide is toxic to fish. Do not discharge effluent
containing this product into lakes, streams, ponds, estu-
aries, oceans, or public waters unless this product is
specifically identified and addressed in an 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."
2. All MPs must bear the following protective clothing
statement:
"Mixer/loaders must wear goggles or a face shield, chemical-
resistant apron, long-sleeved shirt and long pants or
coveralls, and mid-forearm to elbow length chemical-resist-
ant gloves when mixing, loading, or otherwise handling
the concentrate."
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3. The directions for use must include the following
statement:
"Formulators using this product are responsible for EPA
registrations for their formulated product(s)."
End-Use Products
1. All EPs for use on cranberries must bear the following
statement under the heading "Environmental Hazards":
"This pesticide is toxic to fish. Do not apply directly
to water except as specified on this label. Drift and
runoff from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate
water by cleaning of equipment or disposal of wastes."
2. All EPs for terrestrial food and non-food use must
bear the following statement under the heading "Environmental
Hazards":
"This pesticide is toxic to fish. Do not apply directly
to water or wetlands (swamps, bogs, marshes, and potholes).
Drift and runoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not contami-
nate water by cleaning of equipment or disposal of wastes."
3. - In the absence of crop rotation data, the following
crop restriction must be placed on all EPs that may be used in
a situation where rotation with crops used for food or feed
that are not registered with propargite may occur:
"Do not plant any food or feed crop in rotation within
6 montfcs after -last application of propargite unless
the crop is a registered use for propargite."
4. All EPs registered for use on crops whose culture
requires hand labor must bear the following worker reentry state-
ment:
"Do not allow worker reentry into treated fields within 3
days of application, for strawberries, and withfh*7 days,
for all other agricultural uses of propargite, unless
appropriate protective clothing is worn. Protective cloth-
ing means at least a hat or other suitable head covering,
a long-sleeved shirt and long-legged trousers or a coverall-
type garment (closely woven fabric covering the body,
including the arms and legs), chemical-resistant gloves,
socks, and shoes."
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5. All EPs registered for use on cranberries must bear the
following irrigated crops restriction:
"Do not use water leaving propargite treated fields to irri-
gate crops used for food or feed that are not registered
for use with propargite."
6. All EPs registered for use on terrestrial food, aquatic
food and nonfood crops must bear the following protective clothing
statement:
"Mixer/loaders must wear goggles or a face shield, chemical-
resistant apron, long-sleeve shirt, long pants, and
mid-forearm to elbow length chemical-resistant gloves.
Applicators must wear a long-sleeve shirt and long pants,
and chemical-resistant gloves while applying this pesticide.
Applicators must also wear a wide-brimmed hat during
upward directed spraying.
Any article of clothing worn while applying product must be
cleaned before re-use. Clothing should be laundered separ-
ately from household articles. Clothing that has been
drenched or has otherwise absorbed concentrated pesticide
must be disposed of in a sanitary landfill, incinerated,
or burned if allowed by State and local authorities."
7. All EPs registered for use on terrestrial and aquatic
food crops must bear the following endangered species labeling:
"The use of any pesticide in a manner that may kill or
otherwise harm an endangered or threatened species or ad-
versely modify their habitat is a violation of Federal
laws. The use of this product is controlled to prevent
death or harm to endangered or threatened species that
occur in the following counties or elsewhere in their
range.
Before using this pesticide in the following counties, you
must obtain the EPA Cropland Endangered Species Bulletin.
The use of this pesticide is prohibited in these counties
unless specified otherwise in the Bulletin. The EPA Bulletin
is available from either your local pesticide distributor,
your County Agricultural Extension Agent, the Endangered
Species Specialist in your State Wildlife Agency Headquar-
ters or the appropriate Regional Office of the U.S. Fish
and Wildlife Service (FWS). THIS BULLETIN MUST BE REVIEWED
PRIOR TO PESTICIDE USE."
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STATE (Regional office FWS)
Species
ALABAMA (Atlanta, GA )
Slackwater darter
Alabama cavefish
Freshwater mussels
ARIZONA (Albuquerque, NM)
Woundf in
Gila topminnow
ARKANSAS (Atlanta, GA)
Freshwater mussels
Leopard darter
KENTUCKY (Atlanta, GA)
Freshwater mussels
MISSISSIPPI (Atlanta, GA)
Bayou darter
NEVADA (Portland, OR)
Woundfin
NEW MEXICO (Albuquerque, NM)
Pecos gambusia
OHIO (Twin Cities, MN)
Scioto madtom
OKLAHOMA (Albuquerque, NM)
Leopard dater
TENNESSEE (Atlanta, GA)
Slackwater darter
Freshwater mussels
COUNTY
LAUDERDALE
LIMESTONE
MADISON
LAUDERDALE
COLBERT
JACKSON
MARSHALL
MORGAN
MOHAVE
GRAHAM
MAR I CO PA
PI MA
CLAY
CLARK
CROSS
LAWRENCE
PINAL
SANTA CRUZ
RANDOLPH
SHARP
ST. FRANCIS
POLK
BALLARD
EDMUNDSON
JACKSON
LAUREL
MARSHALL
McCRACKEN
PULASKI
ROCKCASTLE
WARREN
WAYNE
CLAIBORNE
COPIAH
CLARK
C HAVES
EDDY
CHAMPAGNE
FRANKLIN
LOGAN
MADISON
PICKAWAY
UN TON
Me CURTAIN
PUSHMATAHA
LAWRENCE
WAYNE
B LOU NT
CLAIBORNE
DECATUR
FRANKLIN
HANCOCK
HARDIN
LINCOLN
LOU DON
MARSHALL
MAURY
RHEA
ROANE
SCOTT
SEQUATCHIE
SMITH
SULLIVAN
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STATE (Regional office FWS)
Species
TEXAS (Albuquerque, NM)
Commanche Springs
_j?upf ish
Pecos gambusia
San Marcos gambusia
Fountain darter
UTAH (Denver, CO)
Woundf in
VIRGINIA (Newton Corners, MA)
Freshwater mussels
COUNTY
JEFF DAVIS
REEVES
JEFF DAVIS
PECOS
REEVES
HAYS
HAYS
COMAL
WASHINGTON
LEE
RUSSELL
SCOTT
SMYTH
TAZEWELL
WASHINGTON
WISE
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4. PRODUCTS SUBJECT TO THIS STANDARD
All products containing the pesticide identified in section 1.1
are subject to certain requirements for data submission or changes
in composition, labeling or packaging of the product. The applicable
requirements depend on whether the product is a manufacturing-use or
end-use product and whether the pesticide is the sole active in-
gredient or one ot multiple active ingredients.
4.1 MANUFACTURING-USE PRODUCTS
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 sections 3.3 and 3.4 it they pertain to the manufac-
turing-use product.
2. The data requirements listed in Tables A and B^.
' 3. The labeling requirements specified for manufacturing-use
products in sections 3.3 and 3.4.
4. Administrative requirements (application forms, Confidential
Statement of Formula, data compensation provisions) associated
with reregistration.
Manufacturing-use products containing this pesticide as one
of multiple active ingredients are subject to the data requirements
listed in Table A.
4.2 END-USE PRODUCTS
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 sections 3.3 and 3.4 if they pertain to the end-use
product.
2. If not eligible for the formulator's exemption^, the data
requirements listed in Tables A and B.
Footnotes are explained at the end of section 4.
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4. The labeling requirements specified for end-use products
in section 3.4.
End-use products containing this pesticide as one of multiple
active ingredients are subject to, if not eligible for the formu-
lator's exemption, the data requirements listed in Tables A and
B. (Registrants eligible for the formulator's exemption do not
need to submit required data if other registrants fulfill data
requirements.)
FOOTNOTES
2 Data requirements are listed in the two 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 fables A and B need not be submitted
by a producer who is eligible for the formulator's exemption for
that active ingredient.
3 If you purchase from another producer and use as the source of
your active ingredient only EPA-registered products, you are
eligible for the formulator's exemption for generic data concern-
ing 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 those
data requirements.
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5. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA section 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.*
5.1 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 ot whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirements 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. •
5.2 WHO MUST SUBMIT GENERIC DATA?
All current registrants are 'responsible for submitting
generic data in response to a data request under FIFRA section
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to require
a registrant who qualifies for the formulator's exemption (FIFRA
section 3(c)(2)(D) and 40 CFR §152.85) to submit generic data in
response to a DCI notice if tho registrant who supplies the
active ingredient in his product is complying with the data
request.
If you are not presently eligible for a formulator's 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 Formulator's Exemption Statement form.
Registrations granted after issuance of this Standard will be
conditioned upon submission or citation of the data listed in
this Registration Standard.
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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 submission 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 section
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 section 6(e)).
5.3 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.
5.4 HOW TO COMPLY WITH PCI REQUIREMENTS
Within 90 days of your receipt of this Registration Standard,
you must submit to EPA a completed copy of the form entitled
"FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form 8580-1,
enclosed) for each of your products. On that form you must state
which of the following six methods you will use to comply with
the DCI requirements:
1. - You will submit the data, and either—
(a) Submit the existing data that you believe will
satisfy the data requirements, or
(b) State that you will secure the data or have made a
contract to have any necessary studies completed within
the applicable time period.
If (b) applies, you must also send a copy of your response
to the Office of Compliance Monitoring's (OCM's) Laboratory Data
Integrity Program. Additionally, within 90 days of a commitment
to generate data, you must submit to OCM the name and location of
the laboratory carrying out each required test, along with the
estimated starting date for testing. You should also send to OCM
a copy of the transmittal or cover letter for each final report
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submitted to the Agency. After the initial response has been
made to a FIFRA section 3(c)(2)(B) notice, and dates or protocols
have been committed to and accepted by EPA, you must submit any
subsequent request for a time extension or modification in the
protocol to OCM. This information should be sent to the address
for OCM given in section 8.4 of this Standard.
2. You have entered into an agreement with one or more regis-
trants 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 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: (a) your letter
offering to join in an agreement and the other registrant's
acceptance of your offer, (b) a written statement by the parties
that an agreement exists, or (c) a written statement by the person
who will be submitting the data that you may rely upon its
submission. 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.
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 noncompliance
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 Devel-
- opment of Data" (EPA Form 8580-6, enclosed).
(b) Provide EPA with a copy of your offer to the other regis-
trant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its
equivalent:
"[Your company name] offers to share in the burden of
producing the data required by FIFRA section 3(c)(2)(B)
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in the [name of active ingredient] Registration Standard
upon terras to be agreed or failing agreement to be bound
by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii)."
The remainder of your offer may not in any way attempt to limit
this commitment. If the other registrant to whom your offer is
made does not accept your offer, and if the other registrant
informs us on a DCI Summary Sheet that he will develop and submit
the data required under the DCI, then you may qualify for this
option. In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share in the
burden of developing the data. In addition, the other registrant
must fulfill its commitment to develop and submit the data.
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 tho 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 requirement applies, EPA does not
anticipate that many waivers will be granted. A request for
waiver does not automatically extend the timeframes for developing
required data, and if your waiver request is denied, your
registration may be suspended if you fail to submit these data.
5. You request that EPA amend your registration by deleting the
uses for which the data are needed. You are not required to
submit data for uses that are no longer on your label.
6. You request voluntary cancellation of the registration of
your product(s) for which the data are needed.
5.5 PROCEDURES FOR REQUESTING A CHANGE IN TESTING PROTOCOL
If you will generate the required data and plan to use test
procedures that deviate from (or are not specified in) either
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
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols. A
request for protocol approval will not automatically extend the
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timeframe for submission of the data, nor will extensions generally
be given to conduct studies due to submittal of inappropriate
protocols.
5.6 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. Any request for a time extension that
is made as an initial response to a section 3(c)(2)(B) request
notice must be submitted in writing to the Product Manager listed
at the end of this section and must be made before the deadline
for response. Once dates have been committed to and EPA has
accepted these commitments, any subsequent requests for a time
extension must be submitted in writing to the Office of Compliance
Monitoring.
EPA will view failure to request an extension before the
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. Time extensions may be considered
when joint data development is planned, or when the Agency must
approve a new or modified protocol before the study can be begun.
A request for an extension does not automatically extend the
timeframe for submission of the data. If EPA denies your request
for a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of your
products.
5.7 EXISTING STOCKS PROVISION UPON SUSPENSION OR CANCELLATION
** -«
EPA will permit continued sale and distribution of existing
stocks of a pesticide product which has been suspended or cancelled
if doing so would be consistent with the purposes of the Act.
However, the Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
section 3(c)(2)(B), an existing stocks provision is not consistent
with the Act. Accordingly, the Agency does not anticipate granting
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-45-
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 distri-
bution; and
2. Demonstration that such a provision would be consistent
with the provisions of FIFRA.
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-46-
6. 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. In order to comply with the product-specific
data requirements, you must follow the same procedures as for
generic data. (See sections 5.4, 5.5, 5.6, and 5.7.) You should
note, however, that product chemistry data are required for every
product, and the only acceptable responses are options 1 (submit
data) or 6 (cancellation of registration), listed under section
5.4.
Failure to comply with the product-specific data requirements
for your products will result in suspension of the product's
registration.
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-47-
7. REQUIREMENT FOR SUBMISSION 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
§162.10 (see Appendix II - LABELING and SUMMARY). In addition,
labeling requirements specific to products containing this
pesticide are specified in section 3.4 of this Registration
Standard. Applications submitted in response to this notice must
include draft labeling for Agency review.
If you fail to submit revised labeling as required, which
complies with 40 CFR §162.10 and the specific instructions in
section 3.4, EPA may issue a Notice of Intent to Cancel the
registration of your product under FIFRA section 6(b)(l).
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-48-
8. INSTRUCTIONS FOR SUBMISSION
The following submission instructions pertain to propargite
manufacturing-use, end-use, and intrastate product registrations.
8.1 MANUFACTURING-USE PRODUCTS
For manufacturing-use products containing propargite as the
sole active ingredient—
1. Within 90 days from receipt of this document, you must submit
to the Product Manager in the Registration Division for each
product subject to this Registration Standard:
(a) The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
(b) Confidential Statement of Formula (EPA Form 8570-4).
(c) Formulator's Exemption Statement, if applicable.
(d) Product-Specific Data Report (EPA Form 8580-4).
(e) Evidence of compliance with data compensation require-
ments of FIFRA section 3(c)(l)(D). Refer to 40 CFR
152.80 - 152.99.
2. Within 12 months from receipt of this document, you must
submit to the Product Manager:
(a) Two copies of any required product-specific data (See
Table B).
If on the Summary Sheet, you either (a) commit to develop the
data, (b) present arguments that a data requirement is not
applicable or should be waived, or (c) submit protocols or
modified protocols for Agency review, you must submit-a copy of
the Summary Sheet (and any supporting information) to the OCM,
which will be monitoring the data generated in response to this
notice. This submission is in addition to responding to the
Product Manager, and should be submitted to the OCM at the
address given at the end of this section. (Actual studies are
not to be submitted to the OCM.)
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-49-
(b) Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should 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. The draft label 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.
3. Within the times set forth in Table A, you must submit to the
Registration Division all generic data, unless you are eligible
for the formulator's exemption. If for any reason, any test
is delayed or aborted so that the agreed schedule cannot be met,
immediately notify the Product Manager and the Office of Compli-
ance Monitoring of the problem, the reasons for the problem,
and your proposed course of action.
For manufacturing-use products containing propargite in
combination with other active ingredients—
1. Within 90 days from receipt of. this document, you must
submit to the Product Manager in the Registration Division:
(a) FIFRA section 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA form 8580-1).
(b) Confidential Statement of Formula (EPA Form 8570-4).
(c) Formulator's Exemption Statement, if applicable.
2. Within the timeframes set forth in Table A, you Tnust submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot
be met, immediately notify the Product Manager and the OCM
of the problem, the reasons for the problem, and your proposed
course of action.
8.2 END-USE PRODUCTS
For end-use products containing propargite alone or in combin-
ation with other active ingredients—
1. Within 90 days from receipt of this document, you must submit
to the Product Manager in the Registration Division:
(a) FIFRA Section 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
-------
-50-
(b) Confidential Statement of Formula (EPA Form 8570-4).
(c) Formulator's Exemption Statement, if applicable.
2. Within 12 months from receipt of this document you must
submit to the Product Manager three copies of draft labeling,
including the container label and any associated supplemental
labeling. Labeling should 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. The draft labeling must
indicate the intended colors of the final label, clear indica-
tion of the front panel of the label, and the intended type
sizes of the text. End-use product labeling must comply
specifically with the instructions in section 3.4.
8.3 INTRASTATE PRODUCTS
Intrastate products containing propargite either as sole
active ingredient or in combination with other active ingredients
are being called in for full Federal registration. Producers of
these products are being sent a letter instructing them how to
submit an application for registration.
8.4 WHERE TO SEND REQUIRED INFORMATION
The required information must be submitted to the following
address: -
m
George T. LaRocca, PM-15
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, DC 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
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I. DATA APPENDICES
-------
TGUIDE-l
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
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
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
-------
TGUIUE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
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 infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must -additional data be submitted? (Column 6). . This
column indicates whether the data must be submitted.to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 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 S^requires
that data be submitted, this column indicates when the "data
are to be submitted, based on the issuance date of the Regis-
tration 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.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Timetrame
Test Use Does EPA Bibliographic Must Additional for Data
Substance Patterns Have Data?V Citation Data be Submitted? Submission
Data Requirement
§158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and Disclosure
of Ingredients TGAI
61-2 - Description of Beginning
Materials and Manufacturing
Process TGAI
61-3 - Discussion of Formation of
Impurities TGAI
Analysis of Product Ingredients
62-1 - Preliminary Analysis of Product
Samples TGAI
Physical and Chemical Characteristics
A,B,C,F
A,B,C,F
A,B,C,F
A,B,C,F
No
No
No
No
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
63-2
63-3
63-4
63-5
63-6
- Color
- Physical
- Odor
- Melting
- Boiling
State
Point
Point
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,
A,B,
AD
f Of
A LI
/ Df
A,B,
c,
c,
c,
c,
c,
F
F
F
F
F
No
NO
NO
No
No
Yes
Yes
Yes
Yes
Yes
6
6
6
6
6
Months
Months
Months
Months
Months
-------
TXBIE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Test
Data Requirement Substances
Time frame
Use Does EPA Bibliographic Must Additional for Data
Patterns Have Data?!/ Citation Data be Submitted? Submission
§158.120 Product Chemistry (cont'd)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Other
64-1 -
- Density, Bulk Density, or
Specific Gravity TGAI
- Solubility TGAI or PAI
- Vapor Pressure TGAI or PAI
- Dissociation Constant TGAI or PAI
- Octanol/Water Partition
Coefficient PAI
- pH TGAI
- Stability TGAI
Requirement
- Submittal of Samples TGAI or PAI
.A,B,C,F No
A,B,C,F No
A,B,C,F No
A,B,C,F No
A,B,C,F No
A,B,C,F No
A,B,C,F No
A,B,C,F No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
HeservedV
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ If samples are needed, the Agency will request them.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR PRQPARGITE
Data Requirement
Test
Substances*/
Does EPA
Have Data?
Bibliographic
Citation
Timeframe
Must Additional for Data
Data be Submitted? Submission W
§158.125 Residue Chemistry
171-4 - Nature of Residue (metabolism)43/
- Residue Studies
o Plants
o Livestocks
PAIRA
PAIRA
Partially
Partially
00025749,00029103
00130618
00112360
Yes3/
18 Months
18 Months
171-4 - Residue Analytical Method*3/
o Plant Residue TGAI and Metabolites Yes
o Animal Residues
TGAI and Metabolites Yes
TGAI and Metabolites
o Storage Stability
Data
Magnitude of Residue43/
- Residues Studies for
Each Food Use
Root and Tuber Vegetables8/ TEP
Group
No
00025751,00036033,
00037347,00112355,
00112359,00112361,
00112363,00112365
00025751,00036033,
00037347,00112355,
00112359,00112361,
00112363,00112365
Yes2/
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Test
Data Requirement Substances!/
§158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of Residue (cont'd)
o Potatoes TEP
o Legume Vegetables^/
Group
Beans (dry and succulent) TEP
o Citrus Fruit Group!2/
0 Grapefruit TEP
o Lemons TEP
o Oranges TEP
- Pome Fruits Groupl5/
o Apples TEP '
o Pears i TEP
- Stone Fruitsjjj/
o Apricots TEP
o Nectarines TEP
Does EPA
Have Data?
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Timetrame
Bibliographic Must Additional tor Data
Citation Data be Submitted? Submission2, V
00112347,00112361 Yes^/
00038033,00064067 Yesj^/
00112347,00112361, Yes^3/
00112397
00112360,00112408 Yes^3/
00069174,00112347, yesl3
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Data Requirement
Test
Substances I/
Timeframe
Does EPA Bibliographic Must Additional tor Data
Have Data? Citation Data be Submitted? Submission2/5/
§158.125 Residue Chemistry (cont'd)
o Peaches TEP
o Plums (fresh prunes) TEP
0 Cherries TEP
- Small Fruits Group24/
o Cranberries TEP
o Grapes TEP
o Strawberries
Tree Nuts Group27/
o Almonds
o Walnuts
Cereal Grains Group3°/
o Corn
o Sorghum
TEP
TEP
TEP
TEP
TEP
Partially
Partially
No
Yes
Partially
Yes
Partially
Partially
Partially
Partially
00112344,00112345
00067553,00112345
00112400
00048326,00006678,
00112345,00112355,
00112465
00112336,00112355,
00112358
00800225,00112342,
00112355
00112339,00112345,
01)138427
00043251,00044638,
00079227,00086708,
000112361,00112401
00038032,00038036
Yesl3/21/
No
Yes28y
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Data Requirement
Test
Substances*/
Timeframe
Does EPA Bibliographic Must Additional for Data
Have Data? Citation Data be Submitted? Submission2/5/
§158.125 Residue Chemistry (cont'd)
- Forage/ Fodder, and Straw33/
of Cereal Grains Group
o Corn Forage, Fodder,
and Silage
o Sorghum Forage, Fodder,
Silage and Hay
- Miscellaneous Commodities
TEP
TEP
Partially 00044638,00079227, Yes^4/
00086708,00112361,
00112401
Yes 00038032,00038036 No
18 Months
o
0
O
O
0
O
0
o
Avocadoes
Cottonseed
Figs
Hops
Mint;
Peanuts <
i
Tea
Alfalfa, Clover
TEP
TEP
TEP
TEP
TEP
i
TEP
TEP
TEP
No
Partially
Yes
Partially
Yes
Partially
No
No
00030794,0094938,
00112363,00131893
00037396
00112355,00112358,
00112398
00112361,00138428
00038650,00044291,
00047994
Yes35y
Yes26/
No3,7/
Yesj38/
No
Yes39y
Yesj^/
Yes41
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
Cucurbits (grown
for seed)
-------
4,0
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Timeframe
Test Does EPA Bibliographic Must Additional for Data
Data Requirement Substances1/ Have Data? Citation Data be Submitted? Submission2/5/
§158.125 Residue Chemistry (cont'd)
- Magnitude of the Residues43/ TGAI or Partially 00112360 Yes^2/ 18 Months
in Meat, Milk, Poultry, Plant
and Eggs Metabolites
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ici
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
FOOTNOTES FOR PREVIOUS PAGES
S158.125 Residue Chemistry
I/ Composition: TGAI = Technical grade of the active ingredient, PAIRA = Pure active ingredient, radiolabeledj
TEP - Typical end-use product; EP = End-use product.
2/ Due dates refer to number of months following receipt of the Guidance Document or. as otherwise indicated.
3/ Data must be submitted depicting the uptake, distribution, and metabolism of 14c-labeled propargite in
representative mature crops, preferably an orchard tree fruit, potatoes, and corn grain and forage, following
foliar application at a rate sufficiently high to permit 14C-residue characterization.
Representative samples from the above-described tests must also be analyzed using accepted enforcement methods
to ascertain that these methods will determine all possible metabolites of concern.
4/ Metabolism studies utilizing ruminants and poultry must be submitted. Animals must be dosed for a minimum of
three (3) days with ring-labeled U^c] propargite at a level sufficient to make residue identification and
quantification possible. Milk and eggs must be collected twice daily during the dosing period. Animals must
be sacrificed within 24 hours of the final dose. The distribution and characterization of residues must be
determined in milk, eggs, liver, kidney, muscle, and fat.
Representative samples from the above described tests must also be analyzed by current enforcement methods to
ascertain their validity.
5/ Progress reports on metabolism data storage stability and crop field trials is required 9 months after receipt
of this Guidance Document.
6/ If the requested data regarding the nature of the residue in plants and animals reveal additional metabolites
of toxicoligical concern additional analytical methods for data collection and enforcement may be required.
7/ Storage intervals and conditions of storage of samples used to support all established tolerances for residues
must be submitted.? These data must be accompanied by data depicting the percent decline in residues at the
times and under tHe conditions specified.
All residue data requested in this standard must be accompanied by the data regarding storage length and
conditions of storage of samples analyzed. These data must be accompanied by the data depicting the
stability of residues under the conditions and for the time intervals specified.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
FOOTNOTES FOR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
8/ A crop group tolerance is not appropriate at this time since residue data and proposed usesd are required tor
two additional group members (sugar beets and'turnips).
9/ Data on processed products of potatoes, depicting residues in granules, chips, and dried potatoes processed
from potatoes bearing measurable weathered residues must be sutmitted. If residues are found to concentrate
upon processing, appropriate food/feed additive tolerances must be proposed.
10/ A crop group tolerance is not appropraite at the present time since residue data and proposed uses are required
for peas (one succulent and one dried) and soybeans.
ll/ Additional data must be submitted to assess the established tolerances for residues in or on dry beans since no
data were submitted reflecting use of the 30% WP being used in California under SLN CA-830025. The data must be
submitted from tests conducted in California in which dry beans are harvested 28 days after the last of five
applications of the 30% WP formulation at 2.25 ib ai/A, applied in a minimum of 10 gal water.
12/ A crop group tolerance is not appropriate at the present time since additional residue data are required on
grapefruits, oranges and lemons.
13/ Additional data reflecting residue trials using all of the different formulations (CR, 30W, etc) to be used on
grapefruit, lemons, oranges, apples, pears, apricots, peaches, plums (fresh prunes), grapes are required. These
studies should reflect the maximum proposed use, minimum pre-harvest interval (PHI's), low volume sprays (if
desired) and trials in all geographical area where the subject formulations are to be used. Refer to other
footnotes specific to the above crops l:or additional data requirements.
14/ Data depicting residues in dried pulp, oil, molasses, and juice processed from oranges bearing measureable
weathered residues must be submitted. Upon receipt of these data, the established food/feed additive tolerance
for dried citrus pulp will be evaluated and appropriate food/feed additive tolerances will be proposed Cor oil,
molasses, and juice.
15/ A crop group tolerance is not appropriate at the present time since additional data is required to support the
established tolerances for residues in/on apples and pears.
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4,3
TABLE A
GENERIC DIVTA REQUIREMENTS FOR PRQPARGITE
FOOTNOTES FOR PREVIOUS PAGES (continued)
S158.125 Residue Chemistry
16/ The established tolerance must be amendec based on appropriate supporting data reflecting residues likely to result
in or on apples harvested 7 days following three foliar applications using the 5 Ib/gal EC formulation at 3.75 Ib
ai/A. Data must also be submitted reflecting residues in or on applies harvested 7 days following three foliar
applications using the 30% WP formulation at 3.6 Ib ai/A. v Tests must be conducted in WA, NY, MI, CA, and VA which
comprise States producting ca. 69% of the total U.S. apple crop (Agricultural Statistics (1984), p. 187).
Data must be submitted reflecting residues in dehydrated apple pomace processed from apples bearing measurable
weathered residues. If residues are found to concentrate in deydrated apple pomace an appropriate feed additive
tolerance must be proposed.
IT/ Data reflecting residues of propargite in or on pears treated with multiple foliar and postharvest applications
using the 30% WP formulation at 2.25 Ib ai/A must be submitted. The registrant must propose a maximum number of
applications or the maximum seasonal use rate and submit data supporting such use. Tests must be conducted in
WA which represents 60.6% of the U.S. pear production (Agricultural Statistics (1984), p. 218).
18/ A crop group tolerance is not appropriate at the present time since additional data are required to support the
established tolerances for residues in or on peaches and residue data and proposed uses are required tor one
additional group member (cherries, sweet or sour).
19/ Data in or on apricots must be submitted, reflecting residues of propargite following two post harvest applications
with the 6 Ib/gal EC formulation at 2.25 Ib ai/A/ application. Applications must be made in a minimum of 10 gal of
water/A using aerial equipment. Tests must be conducted in CA because this is the only State in which the 6 Ib/gal
EC formulation is registered for use on apricots.
20/ Additional residue data for nectarines grown in California (97% of all nectarines grown in the United States are
produced in California) are required. These trials should reflect the maximum proposed use and number of treatments,
minimum PHI's, application of all formulations to be used on nectarines, low volume sprays, (if desired) and ground
aerial appliction.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
FOOTNOTES FOR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
2I/ Data reflecting residues of propargite in or on peaches harvested 28 days after the last of two foliar applications
of the 5 Ib/gal EC formulation at 4.69 Ib ai/A as a concentrate spray must be submitted. Tests must be conducted in
CA, and PA which collectively produced about 64% of the 1983 U.S. peach crop (Agricultural Statistics (1984), p. 215).
Data must be submitted on peaches reflecting residues of propargite treated with two foliar applictions using the
30% WP formulation. Samples must be harvested at sufficiently spaced intervals to determine residue decline, so
that an appropriate PHI may be proposed. Tests must be conducted in CA, and PA.
22/ Data depicting residues frcm dried prunes (plums) processed from fresh fruit bearing measurable weathered resid
are required. If residues are found to concentrate in dried prunes, an appropriate feed additive tolerance must
be proposed.
23/ The application of propargite to cherry trees (postharvest) is considered a food use. Therefore a tolerance for
residues on cherries is required. Residue data for sweet and tart varities are needed.
24/ A crop group tolerance is not appropriate at the present time because additional data are required to support the
established tolerance for residues in or on grapes and proposed uses and residue data are required for two additional
group members (blueberries and a member of the Rubus genus).
25/ Data depicting residues of propargite in or on grape samples harvested 21 days following two applications using the
30% WP formulation at 2.7 Ib ai/A must be submitted. Tests must be conducted using aerial equipment and must be
performed in Kern, Tulare, Fresno, and San Joaquin counties in CA, the only State in which this formulation is
registered for use (EPA SLN No. CA-780184).
Data depicting propargite residues in or on r*aisin waste and juice processed frcm grapes containing measurable
weather residues must be submitted. If residues are found to concentrate in any of the above processed products,
then appropriate food/feed additive tolerances must be proposed.
Additional data must be submitted, reflecting residues ot propargite in or on raisins and dried grape pcmace
processed from grapes bearing measurable, weathered residues.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
FOOTNOTES ttDR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
26/ Data submitted from the CR formulation indicted that residues of propargite on strawberries may exceed the 7 ppm
tolerance when this formulation is employed. Application of the 30 W formulation in reduced volume of spray per
acre would not be expected to produce residues of propargite in excess of the tolerance. Additional residue data
for strawberries are required. These trials should reflect application of the CR and any other formulations to be
applied to strawberries. The experiments should reflect the maximum proposed use, the maximum proposed use,
minilnum PHI's, reduced volumes of spray (if desired) and the studies conducted in California, Floridia, and New York
which account for about 90% of the U.S. strawberry production.
27/ A crop group tolerance is not appropriate at the present time because additional data is required to support the
established tolerances on almonds and walnuts and a proposed use and residue data are required for one additional
member of the group (pecans).
28/ Data depicting propargite residues of concern in or on almond nutmeats and hulls harvested 2d days after the latter
of two applictions of the 6 Ib ai/gal EC formulation at 3 Ib ai/A/application using both aerial and ground equipment
are required. Tests must be conducted in California because virtually all domestically grown almonds are grown in
California.
, *
In addition to the above data requirement for almond, residue data for the CR formulation of propargite are required.
These studies should reflect the maximum proposed use, minimum PHI's, low volume sprays (if desired), and application
of all formulations to be used on almonds.
29/ Data depicting propargite residues of concern in or on walnuts following two ground and, in separate tests, aaerial
applictions, at 6.75 Ib ai/A or 3 Ib ai/A, respectively are needed. Samples should be collected 14 days after the
last of two treatments. Tests should be conducted in California, where > 99% of U.S.-grown walnuts are produced.
Alternatively, the registrant may propose a 21-day preharvest interval (PHI) for the residues of propargite in or
on walnuts, because the data support this longer PHI.
In addition to the above data requirement for walnuts, residue data for the CR formulation of propargite are required.
These studies should reflect the maximum proposed use, minumum PHI's low volume sprays (if desired) and application
of all formulations to be used on walnuts!
\
30/ A crop group toletance is not appropriate at the present time because additional data are needed to support the
established tolerances for residues in/or corn sorghum and proposed uses plus appropriate residue data are required
for two additional group members (rice and wheat).
-------
TABLE A
GENERIC DATA REQUIREMENTS tXJR PKQPARGITE
FOOTNOTES FOR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
31/ Data reflecting residues of propargite in or on filed corn following treatment with an EC formulation at 2.5 Ib ai/A
applied using both aerial (including ULV tests from CO, KS, and NM) and ground equipment and harvest at the shortest
permissible posttreatment interval, 30 days, must be submitted. Tests must be conducted in IA (18%), IL (15%), NB
(11%), WI (5%), and OH (5%), which represent the major corn-growing regions in'the U.S.
Data reflecting residues of propargite on field corn resulting from two applications of the 6.55 Ib/gal EC
formulation at 1.64 Ib ai/A/application using both ground and aerial equipment are required. The applications
should be made at a 3-week interval or the second appliction made at the earliest interval at which a reinfesta-
tion may occur. Samples should be collected 3D days after the second application and tests must be conducted
in KS to support the registered state use (EPA SLN NO. KS-810031).
For overhead sprinkler application, the registrant must propose a maximum number of applications per season and
submit supporting data reflecting such use following application of the 6.55 Ib/gal EC formulation of
propargite at 2.5 Ib ai/A when plants are approximately 6 ft high. Samples must be collected 30 days after
application and tests must be conducted in TX to support a registered State use (EPA SLN No. TX-81U041).
Data depicting residues in wet and dry milled products, including crude and retined oils, processed for field corn
grain bearing measurable weathered residues are required. Exaggerated application rates may be needed to obtain
measurable residues in field corn grain. If concentration occurs, appropriate food/teed additive tolerances must
be proposed. Data must be submitted reflecting residues of propargite in or on fresh corn (including sweet corn
kernels plus cobs with husks removed) following a single application of the b.55 Ib/gal EC at 2.5 Ib ai/A using
both ground and aerial equipment. Data reflecting 2.gal spray/A ULV application must also be submitted. Samples
must be collected 30 days after treatment and tests must be conducted in CA, the only State in which use of
propargite on sweet, corn is registered.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROARGITE
FOOTNOTES FOR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
32/ Data reflecting residues of propargite in or on sorghum grain following a single application ot either the 6 Ib/gal
or 6.55 1/gal EC formulation at 1169 Ib ai/A must be submitted. Applications must be made using both aerial and
ground equipment and sorghum grain samples must be collected 30 days after treatment. Tests must be conducted in
TX, NB, and KS which produce approximately 70% of the total U.S. - grown sorghum crop.
Data depicting residues in flour and milled products processed from sorghum grain bearing measurable weathered
residues are required. If concentration occurs, appropriate food/teed additive tolerances must be proposed.
33/ A crop group tolerance is inappropriate at the present time since additional data are required to support the
established tolerances on corn and sorghum and proposed uses plus residue data are required on one additional
group member (wheat).
34/ For overhead sprinkler irrigation application, the registrant must propose a maximum number of applications on
corn plants per season and a minimum interval between successive applications. Data must be submitted in
support of the proposed use; applications should be made when plants are 5 to 6 ft high using the 6.55 Ib/gal EC
formulation at 2.5 Ib ai/A/application. Forage samples should bve collected 30 days after the last application
and fodder samples should be collected as soon after the 30-day preharvest interval as good agricultural practice
permits. Tests must be conducted in TX (EPA SLN No. TX-810041). Alternatively, the registrant may propose a teed
restriction prohibiting the use of corn forage, fooder, and silage by livestock following treatment of corn plants
with propargite using overhead irrigation methods.
Data reflecting are residues of propargite in or on corn forage and fooder following ULV aerial application of either
the 6 Ib/gal or 6.55 Ib/gal EC formulations a 2.5 Ib ai/A are required. Forage samples should be collected 30 days
after treatment and fodder samples should be collected as soon after the 30-day preharvest interval as good
agricultural practice permits. Tests must be conducted in KS, CO, and MM (States in which ULV application is
currently permitted).
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
FOOTNOTES FOR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
35/ The postharvest use of avocados is considered to be a food use and therefore residue data and tolerance pro-
posals are required. The residue trials should reflect the maximum proposed use, minimum PHI,s low volumne
sprays (if desired) ground and aerial applications and treatments employing all formulations to be used on
avocadoes.
36/ Data reflecting residues in meal, hulls, soapstock, and crude and refined oil processed from seed bearing
measurable weathered residues must be submitted. Exaggerated rates may be needed to obtain measurable residues
in cottonseed. If residues are found to concentrate in any of these processed products, appropriate food/feed
additive tolerances must be proposed.
37/ Available data support the established tolerance for residue of propargite. in or on fresh figs but not the
established 9.0 ppm food additive tolerance for residues in or on dried figs. The available data show that
residues may concentrate up to 6X in or on dried figs; therefore, the registrant must propose a food additive
tolerance increase from 9 ppm to 18 ppm.
In addition, residue data on figs treated with the CR, CRS, and 30 WS formulations are needed. These trials
should reflect the maximum proposed use, minimum PHI's, and low volume sprays, if desired. Depending on the
results of the additional residue studies, a higher food-additive tolerance level tor dried figs may be needed.
38/ Data depicting residues of concern in or on fresh and dried hops harvested 14-days after the last of two treat-
ments with the 6 Ib/gal EC formulation at 1.5 Ib ai/A/application are required. Studies should be conducted in
WA because this state produces approximately 75% of the U,S. - grown hops crop (Agricultural Statistics, 1984, p.
259).
Data depicting residues of concern in or on fresh and dried hops harvested 14 days after the last of two appli-
cations with the 6 Ib/gal EC formlulation at 4 Ib aVA/application are required. Test must be conducted in ID
to reflect the use allowed of the interstate products (State Reg. No. 3917-5585.).
Additional residue data for fresh and dried hops treated with propargite should be carried out in Washington and
should reflect the maximum proposed use, minimum PHI's, low volume sprays, if desired, and application of all
formulations (current and proposed) to be used on hops.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PRDPARGITE
FOOTNOTfcS FOR PREVIOUS PAGES (continued)
§158.125 Residue Chemistry
39/ Data reflecting residues in meal, soapstocK, and crude and refined oil processed from seed bearing measurable
weathered residues must be submitted. If residues are found to concentrate in any of these processed products,
appropriate food/feed additive tolerances must be proposed.
40/ The registrant must propose a maximum number of applications or maximum seasonal use rate and submit data
reflecting residues in or on dried tea leaves following multiple foliar applications of the 5 Ib/gal EC formulation
at 0.38 Ib ai/A. Samples must be collected 7 days after the final application.
41/ Propargite is registered on alfalfa, sweet corn, clover and cucurbits grown for seed. No tolerances exist for
residues of propargite in or on cucurbits, alfalfa or clover. The seeds of certain cucurbits (pumpkins and squash)
could be directed to human consumption and successive cuttings of alfalfa and clover tor animal feed could be
taken following harvest for seed. These residue data and proposed tolerances are required.
42/ These are no federally registered uses for propargite on animals. Presently, the natuare of the residue in animals
is not adequately understood. On receipt of the data requested in the section entitled "Natuare of the Residue in
Animals," the appropriateness of tolerances for residues in animal products will be determined and, considering any
newly found metabolite of toxicological concern the adequacy of the avaiable data regarding the magnitude of residues
in animal products will be determined. Also at that time, pertinent sample storage and storage stability information
for animal commodities will be required since such information was not provided with the studies submitted.
43/ Since completion of these data requirements requires* a tiered approach (metabolism -> residue analytical method ->
crop field trials/storage stability/processed foods and feeds -> meatAiilk/poul'try/eggs), the registrants must
submit a proposed timeframe schedule for data submissions within 90 days after receipt to this Guidance Document.
Allowances to the required time lines will be made only if sufficient justification is provided, i.e., the regis-
trant states he does not have this data and due to the seasonal nature of the crop and the tiered approach
requirement, additional time is needed to satisfy the data requirement. The Agency reserves the right to request
necessary studies earlier than the pericJd specified in the above tables and/or proposed timeframes.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-IAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In Water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test
Composition1/ :
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
i
TGAI or PAIRA
TEP
TEP
Use
Patterns2/
A,B,C,F
A,B,C
A
A
A,B,F
A
A,C
C
A,B,C,F
A,F
A,F
Does EPA
Have Data?
No
No
No
No
No
No
No
No
Partially
No
No
Bibliographic Must Additional
Citation Data be Submitted?
— Yes
Yes
Yes
— No
Yes
— Yes
Yes
— Yes
OU100290, *es_4/
UU112414
Yes
ReservedV
Time^rame
tor Data
Submissions/
9 Months
9 Months
9 Months
27 Months^/
27 Months7/
27 Months.7/
27 Months^/
12 Months
12 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Data Requirement
§158.130 Environmental Fate
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops <
165-4 - In Fish
Test Use
CcmpositionV Patterns^/
(cont'd)
TEP A,B,
TEP C
TEP
TEP A,C
PAIRA A,C
TEP A,C
«
TEP C
TGAI or PAIRA A,B,C,F
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No —
No
No
No
No
Must Additional
Data be Submitted?
Yes
Yes
No
No
Reserved^/
Yes^/
Yes^/
Yes
Yes
Time frame
tor Data
Submission3/
27 Months
27 Months
39 Months
50 Months
39 Months
12 Months
165-5 - In Aquatic Nontarget
Organisms
TEP
No
No
-------
FOOTNOTE TOR PREVIOUS PAGES
158.130 ENVIRONMENTAL FATE
I/ Composition: TGAI = Technical grade of;the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows; A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food C
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G•= Forestry; H = Domestic Outdoor; I
Indoor.
3/ Due dates refer to number of months following receipt of the Guidance Document or as otherwise indicated.
4/ An aged leaching study must be submitted.
5/ Contingent upon results of lab volatility study.
6/ Pending results of field dissipation study and aerobic soil metabolism study.
7/ A progress report is due 8 months fron receipt of this Guidance Document and semi-annually afterwards.
8/ Data have been submitted, however they do not meet Guideline requirements. The data do suggest uptake
will occur.
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73
TABLE A
GENERIC DATA REQUIREMENTS FOR PKOPARGITfc
Timetrame
Test :Use Does EPA Bibliographic Must Additional for Data
Data Requirement Composition Patterns Have Data? Citation Data be Submitted? Submission
§158.75 - OTHER EXPOSURE DATA
Glove Permeability A,B No Yesj/ 6 months-
acceptable
' protocol
14 Months-
final report
I/ Quantitive data must be submitted regarding the permeation and breakthrough time of chemical resistant gloves
used as protective clothing and equipment for all liquid formulations. It these data are not available, they
must be generated using methods described in American Society of Testing and Materials (ASTM) 739-81-Standard
Test Method for Resistance of Protective Materials to Permeation by Hazardous Liquid Chemicals. Because this
type of testing is relatively new, it is recommended that testing protocols for permeation studies be submitted
prior to initiation of any study.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PRDPARGITE
Data
§158
Requirement
.135 Toxicology
Test
SubstanceV
'use
PatternsV
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be Submitted?
Timeframe
for Data
Submission^/
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Oral LD5Q - Rat
- Dermal ID$Q - Rabbit
- Inhalation !£$Q - Rat
- Delayed Neurotoxicity -
TGAI
TGAI
TGAI
A,B,F
A,B,F
A,B,F
Yes
Yes
Yes
00048807
00048808
00061586
No
No
No
No
Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding -
Rodent, Nonrodent
82-2 - 21-Day Dermal - Rabbit
82-3 - 90-Day Dermal - Rabbit
82-4 - 90-Day Inhalation -
Rat
82-5 - 90-Day Neurotoxicity -
Hen/Mammal
TGAI
A,B,F Not Required^/ —
TGAI
A,B,F
TGAI A,B,F
TGAI , A,B,F
TGAI
TGAI
A,B,F
Yes
No.
No
No
00076401,
00076402
A,B,F Not Required^/
Yes
No6/
Yes
No
9 Months
9 Months
-------
75-
TABLE A
GENERIC DATA REQUIREMENTS FOR PHDPARGITE
FCX1TNOTES FOR PREVIOUS PAGES
§158.135 Toxicology
I/ Composition: TGAI = Technical grade of the active ingredient.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I =
Indoor.
3/ Due dates refer to number of months following receipt of the Guidance Document or as otherwise indicated.
4/ Propargite does not relate to a known group of cholinestease inhibitors such as organophosphates, therefore a
neurotoxicity study is not required
5/ Subchronic dog study requirement satisfied by 2-year feeding study in dog.
6/ Based upon acute data, propargite is not absorbed through the skin; therefore, a 90-day study is not required.
7/ A second chronic feeding study is required on technical propargite in a rodent, preferably in the rat.
8/ A second rodent oncogenicity study is required (other than mouse).
9/ Additional mutagenicity testing should include gene mutation in mammalian cells, structural chromosomal aberrations,
and other genotoxic effects, e.g., numerical chromosomal aberrations or direct DMA damage/repair.
1Q/ A repeated metabolism study must be submitted. Data on file have been found to be deficient in several areas.
<
ll/ Data base does not mandate testing since, based on acute dermal toxicity, propargite will not be absorded through
the skin.
12/ Propargite is not registered for domestic animal use.
13/ A progress report is due 8 months from receipt of the Guidance Document an semi-annually afterwards.
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-76
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Tune frame
Test Use Does EPA Bibliographic Must Additional for Data
Data Requirement Composition Patterns Have Data? Citation ' Data be Submitted? Submission
S158.75 - OTHER EXPOSURE DATA
Glove Permeability A,B No Yes£/ 6 months-
acceptable
protocol
14 Months-
final report
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Timeframe
Test Use Does EPA Bibliographic Must Additional for Data
Composition^/ Patterns^/ Have Data? Citation Data be Submitted? Submissions/
Data Requirement
§158.140 Environmental Fate (cont'd)
Subpart K Reentry
132-1
132-1
133-3
133-4
- Foliar Dissipation
- Soil Dissipation
- Dermal Exposure
- Inhalation Exposure
TEP
TEP
TEP
TEP
A,C,F
A,C,F
A,C,F
A,C,F
No
No
No
No
Yes
Yesjj/
Nqty
Nq6/
NOVEMBER, 1987^
NOVEMBER, 1987^
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows; A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I =
Indoor.
3/ Due dates refer to number of months following receipt ot this Guidance Document or as otherwise indicated.
4/ This data has already been required under the propargite Reentry Call-in Notice issued May 22, 1986. The due date
for submission of this data reflects the time alloted by the Data Call-in Notice.
«
5/ This data is required for propargite products registered for use on potatoes and peanuts since human tasks would
involve substantial exposure to residues sorbed to soil.
6/ Data are required only if appropriate surrogate data are unavailable (i.e for soil dissipation) and the applicant
chooses the allowable exposure level method for reentry interval.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Timerrame
Test Use Does EPA Bibliographic Must Additional for Data
SubstanceV Patterns ^/ Have Data? Citation Data be Submitted? Submission3/
Data Requirement
§158.135 Toxicology (cont'd)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
2 Species: Rodent
and Nonrodent
83-2 - Oncogenicity -
2 Species: Rat and
Mouse Preferred
83-3 - Teratogenicity -
2 Species
83-4 - Reproduction - Rat
2-Generation
TGAI
TGAI
TGAI
TGAI
A,B,F
A,B,F
A,B,F
A,B,F
Partially 00076402
Partially 00130942
Yes
No
00105990,
00041386
Yes^/
No
Yes
50
50 Months^3/
39 Months13/
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Dermal Penetration
86-1 - Domestic Animal Safety
TGAI
TGAI
TGAI
A,B,F
A,B,F
A,B,F
TGAI A,B,F
Choice A,B,F
Choice A,B,F
Partially 00066497
NO
NO
NO '
Not Reguired^/ —
Not Required^/ —
Yes
Yes
9 Months
12 Months
12 Months
24 Months^/
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Timeframe
Test Use Does EPA Bibliographic Must Additional for Data
CotrpositionV Patterns^/ Have Data? Citation Data be Submitted? SubmissionV
Data Requirement
§158.145 Wildlife and Aquatic Organisms
SPECIAL TESTING
70-1 - Residue level Monitoring TEP
(Aquatic)
-Residue Level Monitoring TEP
(Terrestial)
No
No
Reserved^V
6 months-
Acceptable
Protocol
18 Months
Final Report
Avian and Manrnalian Testing
71-1
71-2
71-3
71-4
71-5
- Avian Oral ID$Q
- Avian Dietary ££50
a. Upland game bird
b. Waterfowl
- Wild Mammal Toxic ity
- Avian Reproduction
- Simulated and Actual Field
Testing - Manroals & Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
A,B,C,F
A,B,C,F
A,B,C
A,B,C
A,B,C
A,B,C
i
Yes 00052454
Yes 00113471
Yes 00052454
N/A
No
No
No
No
No
No
Yesfy
Reservedly
24 Months^/
Aquatic Organism Testing .
72-1
72-2
- Freshwater Fish IC$Q
a . Warmwater
b. Coldwater
c. Warmwater
d . Coldwater
- Acute ££50 Freshwater
Invertebrates
TGAI
TGAI
TEP
TEP
TGAI
TEP
A,B,C
A,B,C
C
C
A,B,C,F
C
Yes 00066498
Yes OOU66498
! NO
• No
Yes 00068752
No
No
No
Yes6/
Yes$/
No
Yes6/
9 Months
9 Months
9 Months
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TABLE A
GENERIC DATA RhigUIRtMENTS FOR PROPARGITE
Data
§158
72-3
72-4
72-5
72-6
Requirement
.145 Wildlife and Aquatic
(cont'd)
- Acute LC5Q Estuarine &
Marine Organisms
Shrimp
Fish
Mollusk
- Fish Early Lifestage
-Aquatic Invertebrate
Lifecycle
- Fish Lifecycle
- Aquatic Organism
Test
Compos it ion V ;
Organisms
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
TGAI
TGAI
Use
Patterns2/
A,C
C
A,C
C
A,C
C
A,C
A,C
A,C
A,C
Does EPA
Have Data?
Yes
No
No
No
No
No
Yes
Yes
No
No
Bibliographic Must Additional
Citation Data be Submitted?
00112395 No
Yes
YesT/
Yes
YesT/
00126739 No
00142594 No
Reserved^/
Reserved^/
Time frame
tor Data
Submissions/
12 Months
12 Months
12 Months
12 Months
12 Months
Accumulation
72-7 - Simulated or'Actual Field
Testing of'Aquatic
Organisms
TEP
A,C
No
Reserved^/
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
POOTNOTES FOR PREVIOUS PAGES
§158.145 Wildlife and Aquatic Organisms
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; TEP = Typical end-use
product.
2/ The use patterns are coded as follows: A = Terrestrial, toed crop; B = Terrestrial, nonfood; C = Aquatic, food
crop; D = Aqua tic, nonfood; E = Greenhouse, food crop; F = Greenhouse, nonfood; G = Forestry; H = Domestic outdoor;
I = Indoor.
3/ Due dates refer to number of months following receipt of this Guidance Document or as otherwise indicated.
4/ To support citrus, cotton, grapes, and apple use patterns.
5/ Reserved pending receipt and review of avian reproduction and pertinent environmental fate characteristics.
6/ .Test must be conducted to support the cranberry use, using the 6 Ib/gal EC registered for canberry use. If the
product is more toxic than the technical material, the terrestrial food crop uses are also subject to this data
requirement.
7/ Test must be conducted to support the cranberry use. If the product is more toxic than the technical material and
the results of hydrolysis and photolysis studies indicate persistence then the corn, cotton, and citrus uses are
also subject to this data requirement.
8/ Reserved pending receipt and review of fate data such as hydrolysis and photolysis and results of lower aquatic
organism tier studies.
9/ A progress report is due 8 months from receipt of this Guidance Document and semiannual thereafter.
10/ Residue level monitoring data is required to support the registration of propargite use on corn, cotton, and citrus.
Data on residue levels in runoff, water, and• in the water and sediments of representative streams and ponds in or near
treatment areas is required. Monitoring should begin immediately after typical maximum-rate applications of
propargite to corn,j[ cotton, and citrus crops. Monitoring should continue throughout the growing season and tor six
months after the last application. Monitoring must be done on a minimum of six sites selected to be
representative of the various sites where the crops are grown. For corn, selected sites must include sites fron the
southern States. Registrants must submit acceptable protocols before beginning the studies.
ll/ Terrestrial residue level monitoring data is dependent upon the results of the avian reproduction and/or the 2 year
rat reproduction studies.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PRQPARGITE
Data Requirement
Composition*/
Use
Patterns2/
Does EPA
Have Data
To Satisfy
This Requirement?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for Data
Submission3/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honeybee Acute
Contact LD5Q
141-2 - Honeybee - Toxicity
of Residues on
Foliage
141-4 - Honeybee Subacute
Feeding Study
141-5 - Field Testing For
Pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect
Lifecycle Study
TGAI
TEP
A,B
A,B
Yes
Yes
00036935
00060628
No
No
[Reserved]^/
TEP
A,B
No
No5/
[Reserved]*;/
[Reserved ]jy
A
I/ Composition; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food
Crop; D = Aquatic, Nonfood; E •= Greenhouse, food Crop; F = Greenhouse, Nonfood, G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Due dates refer to the number of months following receipt of the Guidance Document or as otherwise indicated.
4/ Reserved pending development of test methodology.
5/ As acute and residual toxicity tests indicate low toxicity to honeybees, no further testing is required.
6/ Reserved pending Agency decision as to whether the data requirement should be established.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPARGITE
Does EPA
Have Data Must Additional Timeframe
Use' To Satisfy Bibliographic Data be for Data
Data Requirement Composition*/ PatternsV This Requirement? Citation Submitted? SubmissionV
§158.155 Nontarget Insect (cont'd)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects [Reserved]^/
143-1 - NONTARGET INSECT TESTING -
thru PREDATORS AND PARASITES
143-3 [Reserved]6/
6/ Reserved pending Agency decision as to whether the data requirement should be established.
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPARGITE
Data Requirement
Test Use
Substance^/ Patterns
Must Additional Timeframe
Does EPA Bibliographic Data Be tor Data
Have Data?2/ Citation Submitted? .Submission
158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and Disclosure MUP A,B,C,F
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples
62-2 - Certification of Ingredient
Limits
62-3 - Analytical Methods to Verify
Certified Limits
Other Requirements
64-1 - Submittal of Samples
4
MUP A,B,C,F
MUP A,B,C,F
MUP A,B,C,F
MUP A,B,C,F
MUP A,B,C,F
i
MUP A,B,C,F
No
No
NO
No
No
NO
NO
Yes
Yes
Yes
Yes
Yes
Yes
Heserved3/
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
I/ The 85% and 25% technical products serve as manufacturing use products.
2/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations tor the old data are not applicable.
3/ If samples are needed, the Agency will request them.
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Data Requirement
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPARGITE
Must Additional Timeframe
Does EPA Bibliographic Data Be for Data
Have Data? Citation Submitted? Submissions/
Test Use
Substance \/ Patterns2/
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity
81-2
81-3
81-4
81-5
81-6
- Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Primary Eye Irritation
- Primary Dermal Irritation
- Dermal Sensitization
MP
MP
MP
TGAI
TGAI
TGAI
A,B,F
A,B,F
A,B,F
A,B,F
A,B,F
A,B,F
Yes
Yes
Yes
Yes
Yes
Partially
00048807
00048808
00061586
00066496
00066495
0067558
No
No
No
No
No
Yes4 9 Months
I/ Composition: MP = Manufacturing-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = .
Domestic, Outdoor; I = Indoor.
\
3/ Due dates refer to* number of months following receipt of guidance Document or as otherwise indicated.
4/ The existing study is unacceptable at the present time since no dates for dosing and scoring were given in the raw
data, no information was given on when the challenge dose was administered nor if scoring was done at the required
times following the protocol. Unless this information is furnished, a repeat study is required.
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II. LABELING APPENDICES
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n
SUMMARY-1
LABEL CONTENTS
4U CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name/ brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label 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 162.10(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 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
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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 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
« '
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. *• [40 CFR 162.10(h) (1) ( iii) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - TfiV
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 162.10(h)(2)].
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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 or damage. [40 CFR 162.10{h)(2)(i) ]
Item SB. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed-classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
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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
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 "Che
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.
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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 adverjse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic 'printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
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SUMMARY-*
LABELING REQUIREMENTS OF THE FIPRA, 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 4
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
«
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel.
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center 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, must
be qualified by "Packed for . . . ,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked. ,
Note type size requirements.
Note type size requirements.
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SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precau t 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 toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
<
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category Ii
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
\
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
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SUMMARY-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
PLACEMENT 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
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHUM
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 STOR,
CONT/DIS, and PEST/DIS tor further
information and required statements.
May be in metric as well as U.S. units
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fltLlO
General-CD Content* of the
label. Every pesticide product! shall
bear a label containing tt*^ inf orma*
tfon specified by the Act and the regu-
lations In this Put. The content* of a
label must show clearly and promi-
nently the following
•O) The name, brand, or trademark
tinder which the product is sold as pre- .
scribed in paragraph (b) of this see-
tion:
(ID The name and address of the
whom produced as prescribed in para-
graph (c) of this section:
(Ui) The net contents as prescribed
m paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
Of thla
-------
Environmental Protection .Agency
(v) The producing establishment
number as prescribed in paragraph (f )
of this section;
(vl) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion:
(vti) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(vlll) The directions for use as pre-
scribed In paragraph U) of this section;
and
(iz) The WE classification^) as pre-
scribed in paragraph (J) of this section.
(2) Prominence and legibility. (0 All
words, statements, graphic representa-
tions. designs or other information re- .
quired on the laBeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed, with such
eonspicnousness . (as compared with
other words, 'statements, «***rfg*»«, 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 tinder custom-
ary conditions of purchase w*4 me.
(ii) All required label text must
CA) Be set In 6-point or larger type;
-------
§ 162.10
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser,
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pestidde or its ingredient*, including
statements such as "safe,** "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets'* with
or without such sTquallf ying phrase as
"when used as directed": and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents'*:
(B) "Among the least toxic chemi-
cals known"
MBT of the
40 CFR Ch. I (7-145 Edition)
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pestidde was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by • • V or "Sold by • • •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tests. (1) The net weight or measure
of content shall be exdusive of wrap-
pers or other mntfrliU and shall be
the average content unless explidtly
stated as a minimum quantity.
(2) If the pestidde 1s a liquid, the
net content statement shall be hi
terms of liquid measure at 68* P (20*C) -.
and shall be expressed in conventional'
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pestidde is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
4MhM*4> AV&4* ^4V A^AOMfe A**4 •tm^H B%-A CttM 6>A^^^MM 4kf
^90A^vC^lw SVMSBvC^^llC^AH SB&^^B^BA BwC 1U wC^^^DX TJI
weight expressed as avoirdupois
pounds and ounces.
(4) In all eases, net content shall be
stated hi terms of the largest suitable
units, Le« "1 pound 10 ounces'* rather
than "26 ounces.'*
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum eon-
v6Q« OF AsTOimd ftO ftYCXAffC U DGHBiCSft*
ble only to the extent ttuCt it repre-
sents deviation unavoidable hi good
manufacturing practice. Variation
DCxOVr ft srtfttftfl VUXuD&Ui&i Is QO% DdTQl**
tod. In no case shall-the avenge eon-
tent of ftw package! fa a Th*r*tn*"Ti^ fmn
below the stated average content.
(e) Product registration number.
The registration number •imtgnfrt to
the pestidde product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No." or the phrase "EPA Reg,
No." The registration number shall be
set in type of a stee and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to tt The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply ircomm^ndation
-------
oft,
Environmental Protection Agency
§ 162.10
or endorsement of the product by the
Agency.
(f) Producing establishment* regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA EsL", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immfdlat*
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statem«nt-U) Gener-
al The label of each pesticide product
must bgar a stZtedXent which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if 'the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
as elemental ar-
senic. The active Ingredients must be
designated by the term "active ingredi-
ents" and the Inert ingredients by the
term "inert ingredients.'' or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pestidde, the
term "analysis" shall not be used as a
heading for thy ^g'Tdifnt itatmifirt.
(2) Position of ingredient statement
(D The ingredient tfr.t^mfTit is ncr-
mally required on ttw front panel of
the label If there is an outside con-
tainer or wrapper through which the
must mt
Ingredient
also appear on such outside
or wrapper. If the site or form of the
package makes It Impracticable to
place the *"g*f^iifnt its t PHI nut on ttn>
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
(ID The text of the Ingredient state-
ment must run parallel with other
text on the panel on which it appears,
must be clearly
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The,
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25
-------
§ 16X10
..•
(h) Warning* and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxioological
hazard induding hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments fftTtn*rn
•w
<* «o
not
Jftm*n0/»
SOOftavSOOO.
•Mn7
T*f
«7t
72 tain.
(i) Hitman fuutard signal wont— (A)
Toxidty Category L AH pesticide prod-
ucts meeting the criteria of Toxidty
Category I shall bear on the front
panel the signal word •Danger." In ad-
dition if the product was assigned to
Toxidty Category I on the basis of its
oral, frihftlftiftn or dcr™*! toxldty (as
from skin ***** eye Iflcul ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in *J***M*»
proximity .to the word "poison.**
tox-
ldty. Tne Agency may, however.
permit rMsonahle variations to the
pi«jvMiif>nt 0f ^|^ ttatftpftrt of pr%fttl-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
-------
\00
Environmental Profccfipn Agency
§ 162.10
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 (hXIXiiiXA) of
this section. The applicant may. how-
ever, include such a front panel state-
ment at *MT option. StatCTftf^te of
Stoat
tram pm to
StoUL-
101018.
IS to XI.
practical treatment are. however, re-
quired elsewhere on the label fa
accord with paragraph (hX2) of this
section if they do not appear on the
front paneL
(iv) Placement and prominence. All
the require front panel warning state-
ments shall ffir grouped together on
the label, and shall appear with suffi-
cient prominence .relative to other
front panel text and graphic material
to make them unlikely to be over-
looked ntdfif fMKfrrnia^y Conditions Of
14
M
-KMPOUI
W
12
purchase and use. The following table
shows the ™<"<»*'"m type size require-
ments for the front panel warning
statements on various sizes of labels;
(2) Other required warning* and pre-
cautionary statement*. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements'* M***
under appropriate subheadings of
"Hazard to Humans ***** Domestic Ani-
mals/* "Environmental Hazard** and
"Physical or Chemical Hazard.**
(1) HaMard to humans and domestic
animals. (A) Where a hazard exists to
humans or itirnifTtk? •»«<«*'«<• precau-
tionary statements are required Indi-
cating toe particular hazard* the
routed) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary itrfi^mgntg. These
statements must be modified or ex-
panded to reflect specific hazards.
tool
CIO Environmental hasards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential tf**W*D^i
injury or damage. Examples of the
hazard statements «nd the drcum-
-------
lot
§ 162.10
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active ingredient
with a mammalian acute oral LD« of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC~ of 1 ppm or less.
the statement This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LD* of 100
mg/kg or less, or a subacute dietary
LC* of 500 ppm or less, the statement
-This Pesticide,!* Toxic to Wildlife" is
required. * ~~
(D) If either accident history or field
studies demonstrate th**r use of the
40 CFR Ch. I (7-145 Edition)
pesticide may result in fatality to
birds, fish or mammals, the statement
This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural 'crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(Ill) Physical or chemical hazard*.
Warning statements on the flammabnV
ity or explosive characteristics of the
pesticide are required as follows:
1
poM « or Mow ST ft I *•» h •
nrFoM-natowrWForfflio
to man ffionlo to tang « • mnm*
Do flat punch** or
tar F
Do not puncura or Mranao
bow 190* F ray CMM
Oo not UM or Mora raw
A^4 ^^MA^M ^^
noi puncurw or
OOMTA
Oo not MM or
O) Direction* for Pte-
-------
Environmental Protection Agency
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufiwfoiHng processes.
provided that:
(.1) The label clearly shows that the
product to intended for use only in
manufacturing processes and specifies
the typeCs) of products involved.
(2) Adequate Information such as
technical data sheets or bulletins, to
available to the trade specifying the
type of product involved and its
proper use In manufacturing process-
(J) The product wQl not come into
the hands of the general public except
after incorporation, into finished prod*
W) The Administrator determines
that such directions are not necessary
to prevent .unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use nay
be omitttd from the l^^llng of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label dearly states that the
product is for use only by physicians
or veterinarians!
' (2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) 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 ^^""g of pesti-
cide products which are intended for
use only by f crnralators In preparing
pesticides for sale to the public, pro-
vided that
U) There to information readily
available to Mi* fonnulators on the
composition, tozidty, w**i**fa of use,
applicable restrictions or Mm*
.
and effectiveness of the product for
pesticide purposes;
(1) The label clearly states that the
product to Intended for use only in
formulating,
or repacking for use as a pesticide and
specifies the typeCs) of pesticide prod-
ucts Involved:
(J) The product as finally manufac-
tured, formulated, mixed, or* repack-
aged is registered; and
§ 162.10
<4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment
(2) Content* of Direction* for Ute.
The directions for use shall Include
. the following, under the f»^fogw -Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed In 162.KXJ) immedi-
ately under the hM*tiT^g -Directions
for Use."
Ui) Immediately below the ststc-
ment of use classification, the state-
ment -It to a violation of Federal law
to use this product in a manner incon-
sistent with its labeling.** •
(ill) The steed) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pestts) associated
with each site.
(v) The dosage rate atsodated with
each site and pest
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and typed) of application ap-
paratus or ypiUpnuent required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without *f ™«<»*g unreasonable
adverse effects on the environment
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied^ meeting the requirements
concerning reentry provided .by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
^Tu*tnn*tliyns shfTI be grouped and
appear under the heading -Storage
and Disposal." This heading must be
set In type of the same minimum atoea
as required for the child hazard
ing. (See Table in 116240(hXlXfr))
(x) Any limitations or restrictions .
use required to prevent unreasonable
(A) Required intervals between ap-
plication and harvest of food or feed
(O Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
-------
§162.11
103
40 CFR Ch. I (7-1-aS Edition)
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who fc physically present
. and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
^M» front panffli a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use la restricted to certified
appUcatorc, the following statement is
required: 'Tor retail .sale to and use
only by Certified Applicators or per-
sons Mpd** pi»
-------
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.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
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.
D. Flashpoint above
150°F.
None required.
-------
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 placettoent in
locked storage areas.
-------
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)
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.
Plastic containers
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.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
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.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and looal
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
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.
-------
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 (see list in this Appendix) or are assigned to Toxicity Category
I on the basis of oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
•Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
(see list in this Appendix) 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."
-------
PEST/DIS-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E* LIST (with RCRA I and CAS I
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
0,0-Diethyl Opyrazinyl
phosphorothioate (Zinophos®)
Dimethoate
0,0-Dimethyl Oyp-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
dimetnanonaphthalene (Isodrin)
Hydrocyanic acid
Methcnyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octane thyIpyrophosphoramide
(CMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P003
P070
P004
P005
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-a
107-19-7
26628-22-8
143-33-9
62-74-8
-------
PEST/DIS-3
Strychnine and salts P108 57-24-9
60-41-3
0,0,0,<>Tetraethyl P109 3689-24-5
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill 107-49-3
Thallium sulfate P115 7446-18-6
Thiofanox P045 39196-18-4
Toxaphene P123 8001-35-2
Warfarin (>0.3%) P001 81-81-2
Zinc phosphide (>10%) P122 1314-84-7
50 ACTIVES
F027
F027
F027
F027
F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENIACHLC»DPHENOLS
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro-
phenoxy) ethyl ether
Dehydroabietylainnonium
pentachlorophenoxide
Erbon
O-ethyl O-(2r4,5-trichlorophenyl)
ethylphosphonothioate
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(Hexachlorophene)
—Potassium salt of
—Sodium salt of
—Disodium salt of
Pentachlorophenol
—Potassium salt of
—Sodium salt of
—Zinc salt of
—Zinc salt of N-alkyl
(Cig-Cis)-lr3-propanediamine
—Pentachlorophenyl laurate
Potassium trichlorophenate (2,4,6)
Potassium trichlorophenate (2,4,5)
Silvex
—2-Butoxyethyl ester
—Butoxypolypropoxypropyl ester
—Butoxypropyl ester
—Diethanolamine salt
—Diisopropanolamine salt
—Dimethylamine salt
—Dipropylene glycol isobutyl
ether ester
—Ethanolamine salt
—2-Ethylhexyl ester
—Iscoctyl ester
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
-------
PEST/DIS-4
—Isopropanolamine salt F027 53404-13-0
—Monohydroxylaluminum salt F027 69622-82-8
—Pcjlypropoxypropyl ester F027 83562-66-7
—Potassium salt F027 2818-16-8
—Propylene glycol isobutyl F027 53466-84-5
ether ester
—Sodium salt F027 37913-89-6
—Triethanolamine salt F027 17369-89-0
—Triethylamine salt F027 53404-74-3
—Triisopropanolamine salt F027 53404-75-4
—Tripropylene glycol isobutyl F027 53535-30-1
ether ester
Sodium 2-(2,4,5-trichlorophenoxy) F027 3570-61-4
ethyl sulfate
Tetrachlorophenols F027 25167-83-3
—Alkylamine*amine salt (as in F027
fatty acids of coconut oil)
—Potassium salt F027 53535-27-6
—Sodium salt F027 25567-55-9
2,4,5-Trichlorophenol F027 95-95-4
2,4,6-Trichlorophenol F027 88-06-2
2,4,5-Trichlorophenol salt of F027 53404-83-4
2,6-bis[(dimethylaraino)methyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt F027 136-32-3
2,4,6-Trichlorophenol, sodium salt F027 3784-03-0
2,4,5-Trichlorcphenoxyacetic acid F027 93-79-8
—Alkyl C-12 amine salt F027 53404-84-5
—AUcyl C-13 amine salt F027 53404-85-6
—Alkyl C-14 amine salt F027 53535-37-8
—N,N-diethylethanolamine salt F027 53404-86-7
—Dimethylamine salt F027 6369-97-7
—N,N-dimethyllinoleylamine salt F027 - 53404-88-9
—N,N-dimethyloleylamine salt F027 53404-89-0
—N-oleyl-l,3-propylene F027 53404-87-8
diamine salt
—Sodium salt F027 13560-99-1
—Triethanolamine salt F027 3813-14-7
—Triethylamine salt F027 2008-46-0
—Alkyl (C3H7 - C7H9) ester F027
—Amyl ester F027 120-39-8
—Butoxyethoxypropyl ester F027 1928-58-1
—2-Butoxyethyl ester F027 2545-59-7
—Butoxypropyl ester F027 1928-48-9
—Butyl ester F027 93-79-8
—Dipropylene glycol isobutyl F027 53535-31-2
ether ester
—2-Ethylhexyl ester F027 1928-47-8
—Isobutyl ester F027 4938-72-1
-------
—Isopropyl ester
—Propylene glycol isobutyl
ether ester
—Tripropylene glycol isobutyl
ether ester
4-(2,4,S-Trichlorophenoxy)butyric
acid [2,4,5-TB]
2-{2,4,5-Trichlorophenoxy)ethy1
hydrogen sulfate [2,4,5-TES]
l/4',5'-Trichloro-2l-(2f4,5-
trichlorophenoxy)
methanesulfonanilide [Edolan U]
Ill
PEST/DIS-5
F027
F027
F027
: F027
F027
F027
93-78-7
53466-86-7
53535-32-3
93-80-1
69633-04-1
69462-14-2
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f )]
Acetone
Acrylonitrile*
Amitrole
Benzene*
Bis ( 2-ethylhexyl )phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chloroacetaldehyde )
Chlordane , technical*
Chlorobenzene*
A ^*Vi 1 1
4**v»iuoLU"iu cmsox
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1 / 3 , 4-metheno-
2H-cyclobuta [c,d]-pentalen-2-one
fmm « * a ll
v Kepone f cnioraecone )
1 , 2-Di hrano-3-chloropropane ( DBCP )
Dibutyl phthalate
S-2,3-(Dichloroallyl diisopropyl-
thiocarbamate) (diallate,Avadex)
o-Dichlorobenzene*
p-Dichlorobenzene*
Dichlorodifluoraaethane
(Freon 12«)
3 , 5-Dichloro-N- ( 1 , l-dinethyl-2-
propynyl) benzamide
(pronamide, Kerb*)
Dichloro diphenyl dichloroethane
(ODD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2 , 4-Dichlorophenoxyacetic ,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2 , 3-epoxypropane )
Ethyl acetate
Ethyl 4,4' -dichlorobenz i late
( chlorobenz ilate )
RCRA 1,
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
U066
U069
U062
U070
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
and CAS 1
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
m
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
^
141-78-6
510-15-6
*Proposed for deletion by TCLP proposal
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane *
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol*
Pyridine*.
Resorcinol
Safrole
Selenium disulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
TrichloromonofluorcnB thane
(Freon 11«)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-U6-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
-------
PEST/DIS-8
2,4,5-Trichlorcphenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin «0.3%) U248 81-81-2
Xylene U239 1330-20-7
Zinc phosphide «10%) U249 1314-84-7
83 ACTIVES
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(baas)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thorouqhly before discardinq 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:
Contai-n'er 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 ofter
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 1, 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 wordinq)
V Manufacturer may replace this phrase with one indicating
~~ whether and how fiber drum may be reused.
-------
.(f
III. USE INDEX APPENDIX
-------
\n
EPA Index to Pesticide Chemicals
PROPARGITE
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP " 2
(Agricultural Crops) ' 2
Alfalfa (seed crop) 2
Almond 2
Apple 3
Apricot 3
Avocado (non-bearing) 4
Beans (green, dry, and lima) 4
Cherry (non-bearing and postharvest) 4
Clover (seed crop) 4
Corn, Field 5
Corn, Sweet 5
Corn, Sweet (seed crop) 6
Cotton 6
Cucurbits (seed crop) 7
Figs 7
Grapefruit 7
Grapes 8
Hops 9
Lemons „ 9
Mint 10
Nectarine 10
Orange 7
Peach 11
Peanuts 12
Pear (non-bearing and postharvest) 12
Plum 13
Potato 13
Prune 13
Sorghum, Milo " 14
Strawberry 14
Walnut 15
TERRESTRIAL NON-FOOD CROP 16
(Ornamental Plants and Forest Trees) 16
Carnations (including nursery stock) 16
Chrysanthemums (including nursery stock) 16
Roses (including nursery stock) 16
Ornamentals (including nursery stock) 16
GREENHOUSE NON-FOOD CROP 17
(Ornamental Plants and* Forest Trees) T7
Carnations 17
Chrysanthemums ~ 17
Roses 17
Ornamentals 17
Issued: 7-22-85 III-097601-1
-------
EPA Index to Pesticide Chemicals
PROPARGITE
TABLE OF CONTENTS
Site Name Page
AOJJATIC FOOD CROP ' , 18
(Agricultural Crops) 18
Cranberry 18
Issued: 7-22-85 III-097601-ii
-------
\\°\
EPA Compendium of Acceptable Uses
097601 PROPARGITE*
TYPE PESTICIDE; Acarlcide
FORMULATIONS;
Tech (85Z)
FI (25%)
D (4Z)
WP (30Z)
EC (5 Ib/gal, 6 Ib/gal, 6.55 Ib/gal)
GENERAL WARNINGS AMD LIMITATIONS; Do not mix with alkaline materials such
as lime, lime sulfur, or bordeaux mixture as the effectiveness of propar-
gite will be reduced. Mixer/loaders must wear goggles or a face shield,
waterproof apron, long-sleeve shirt, long pants, and unlined waterproof
gloves. Applicators must wear a long-sleeve shirt and long pants while
applying this pesticide. Applicators must also wear a wide-brimmed hat
during upward directed spraying. Leaf injury and fruit spotting may occur
if the following conditions are hot observed: 1) do not apply when air
temperatures are above 90 F (32.2 C) unless otherwise specified; 2) do not
tank mix with azlnphos methyl emulsifiable concentrates; 3) do not tank
mix with horticultural oil sprays or within 14 days prior to or following
a horticultural oil spray; 4) do not apply with spray adjuvants. Do not
enter or allow entry Into treated areas within 24 hours unless protective
clothing is worn. Thorough coverage is essential for effective control.
Refer to appropriate labeling for ENDANGERED SPECIES RESTRICTIONS.
Agricultural Crop Tolerances (other than those listed in the text):
Tea, dried 10 ppm
Dairy, Livestock, and Poultry Tolerances;
Cattle (fat, meat, meat byproducts) 0.1 ppm
Eggs 0.1 ppm
Goats (fat, meat, meat byproducts) 0.1 ppm
Hogs (fat, meat, meat byproducts) 0.1 ppm
Horses (fat, meat, meat byproducts) 0.1 ppm
Milk 0.08 ppm
Milk (fat) 2 ppm
Poultry (fat, meat, meat byproducts) 0.1 ppm
Sheep (fat, meat, meat byproducts) 0.1 ppm
*2-(p-tert-butylphenoxy)cyclohexyl 2-propynyl sulfite
Oml te
Issued: 7-22-85 III-097601-1
Provisional Update: 9-10-86
-------
r\
jv>
Site and Pest
EFA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Do not graze or feed livestock on
cover crops grown among the trees and vines Hated In this report.
3001BA
Alfalfa (seed crop)
I3001AA
ir-
Almond
AVABA
AVASA
AVBAA
AVBDA
AVBEA
Clover mite
European red mite
Pacific spider mite
Strawberry spider
mite
Tvospotted spider
mite
1.35-6.75
Ib/A
(30Z WP)
No tolerance established.
This use only occurs on Special
Local Need (24-C) labeling and has
not been characterized in this en-
try. Refer to appropriate labeling
for use information and limitations.
0.1 ppm (almond)
55 ppm (almond, hulls)
28 day preharvest interval through
6.75 pounds per acre (vettable pow-
der) and 3 pounds per acre (emulsi-
fiable concentrate) for foliar ap-
plication.
Do not make more than 2 applications
per year.
Use limited to CA.
Foliar application. Apply in 500
to 1,500 gallons of water per acre.
2.25-3 Ib/A Use limited to CA.
(6 Ib/gal EC) Foliar application. Apply in a
ainlmum of 15 gallons of water per
acre by aircraft and in a minimum
of 50 gallons of water per acre by
ground equipment.
Issued: 7-22-85
III-097601-2
-------
'04001AA
Site and Pest
Apple
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Fonaulation(s)
3 ppm
80 ppm (dried pomace)
7 day preharvest Interval through
3.75 pounds per acre for foliar ap-
plication.
Do not make more than 3 applications
per year. Do not tank mix with di-
azinon when temperatures are expect-
ed to exceed 95 P (35.0 C).
CLAVASA
ILAVBAA
ELAVBEA
European red mite dilute
Pacific spider mite 0.3125-0.469
Twospotted spider lb/100 gal
mite [400-800
gal/A]
or
concentrate
1.25-3.75
Ib/A
[in 50-100
gal/A]
(5 Ib/gal EC)
Foliar application.
ILAVASA
ILAVAYA
tLAVBAA
ILAVBEA
k
?05001AA
1.5-3.6 Ib/A
(30Z WP)
European red mite
McDaniel spider
mite
Pacific spider mite 0.375-0.45
Twospotted spider
mite
lb/100 gal
[400-800
gal/A]
(30Z WP)
Foliar application. Apply in 500
to 800 gallons of water per acre.
Foliar application. For use in
areas east of the Rocky Mountains.
Do not reduce the rate per acre when
applying by concentrate equipment.
Apricot
ILAVBAA
CLAVBEA
7 ppm
14 day preharvest interval through
2.7 pounds per acre for foliar ap-
plication.
Postharvest application through 2.25
pounds per acre.
Do not make more than 2 applications
per year.
Pacific spider mite 1.35-2.7 Ib/A Foliar application. Apply-in 300
Twospotted spider (30Z WP) to 600 gallons of water per-acre.
mite
1.5-2.25 Ib/A Use limited to CA.
(6 Ib/gal EC) Postharvest application. Apply by
aircraft in a minimum of 10 gallons
of water per acre.
Issued: 7-22-85
III-097601-3
-------
EPA Compendium of Acceptable Uses
FROPARGITE
Site and Pest
8000DA
Avocado (non-bearing)
Dosages and Tolerance, Use, Limitations
Formulation(s)
No tolerance established.
This use only occurs on Special
Local Need (24-C) labeling and has
not been characterized in this en-
try. Refer to appropriate labeling
for use information and limitations.
'8001AA
Beans (green, dry, and lima)
JWBEA
Tvospotted spider
mite
1.64-2.53
Ib/A
(6, 6.55 lb/
gal EC)
05002AA
05002DA
Chei
vest]
(non-bearing and posthar-
LAVASA
LAVAYA
LAVBAA
LAVBEA
23003BA
European red mite
McDanlel spider
mite
Pacific spider mite
Tvospotted spider
mite
Clover (seed crop)
1.8 Ib/A
(30% WP)
0.2 ppm (beans, dry)
20 ppm (beans, succulent)
7 day preharvest interval through
2.5 pounds per acre for foliar ap-
plication (succulent beans).
28 day preharvest Interval through
2.5 pounds per acre for foliar ap-
plication (dry beans).
Do not make more than 2 applications
per year.
Do not use on varieties grown for
fresh market or on varieties whose
value is linked to pod appearance
as pods may be spotted.
Do not feed or forage treated vines
or trash after harvesting.
Use limited to areas west of the
Rocky Mountains.
Apply in a minimum of 5 gallons of
water per acre by aircraft and in a
minimum of 20 gallons of water per
acre by ground equipment.
»'
N.P.
Non-bearing trees are those trees
that will not bear fruit within 1
year of the last propargite applica-
tions.
Foliar application to non-bearing
trees or postharvest application.
Apply in 400 gallons of water per
acre.
No tolerance established.
This use only occurs on Special
Local Need (24-C) labeling and has
not been characterized in this en-
try. Refer to appropriate labeling
for use information and limitations.
Issued: 7-22-85
III-097601-4
-------
EPA Compendium of Acceptable Uses
FROPARGITE
Site and Peat Dosages and Tolerance, Use, Limitations
Formulation(s)
28006AA Corn, Field 0.1 ppm (corn, grain)
10 ppm (corn (fodder, forage))
30 day preharvest Interval through
2.5 pounds per acre for foliar ap-
plication.
56 day preharvest interval through
1.5 pounds per acre (CA only).
Do not make more than 1 application
per year.
LAVBEA Twospotted spider 1.5 Ib/A Use limited to CA.
mite (6 Ib/gal EC) Foliar application. Apply in a min-
. imum of 10 gallons of water per acre
by aircraft and in 20 to 50 gallons
of water per acre by ground equip-
. nent.
LAVAKA Banks grass mite 1.64-2.5 Ib/A Foliar application. Apply when mite
LAVBEA Twospotted spider (6, 6.55 lb/ infestations are beginning to build
I mite gal EC) and corn plants are still small
| enough (usually 3 to 4 feet) to al-
" low for good coverage. Apply in a
minimum of 5 gallons of water per
acre (2 gallons per acre in KS, CO,
[ • NM) by aircraft and in a minimum of
20 gallons of water per acre by
F ~ ground equipment.
15005AA Corn, Sweet 0.1 ppm (corn, fresh (including
sweet K+CKHR))
F 10 ppm (forage, fodder)*
30 day preharvest Interval through
£' 2.5 pounds per acre for foliar ap-
plication.
* Do not make more than 1 application
per year.
LAVANA Banks grass mite 1.64-2.5 Ib/A Use limited to CA.
LAVBEA Twospotted spider (6.55 Ib/gal Foliar application. Apply when mite
mite EC) infestations are beginning to build
and corn plants are still small
(usually 3 to 4 feet) to allow for
good coverage. Apply in a minimum
of 2 gallons of water per acre by
aircraft and in a minimum of 20 gal-
lons of water per acre by ground
equipment.
Issued: 7-22-85 III-097601-5
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(a)
5005BA
Corn, Sweet (seed crop)
8007AA
Cotton
0.1 ppm (corn, fresh (including
sweet K+CWHR))
This use only occurs on Special
Local Need (24-C) labeling and has
not been characterized in this en-
try. Refer to appropriate labeling
for use information and limitations.
0.1 ppm (cottonseed)
Do not apply after bolls open
through 1.64 pounds per acre for
foliar application.
Do not make more than 3 applications
per year.
Do not feed treated foliage or cot-
ton trash to livestock.
Ground concentrate sprayers designed
for row applications may be used
providing the same dosage rate per
acre is maintained.
A.TOAA
AVBDA
4VBEA
Pacific spider mite 0.84-0.94
Strawberry spider Ib/A
mite
Twospotted spider
mite
Foliar application. Apply for early
season control after plants have
(6, 6.55 lb/ hardened (usually when plants are
gal EC) between 6 to 12 inches tall). Apply
in 15 to 30 gallons of water per
acre by ground equipment.
1*23-1.69 Foliar application. Apply mid sea-
Ib/A con to layby. Apply in 25 to 40
(6, 6.55 lb/ gallons of water per acre'by ground
gal EC) equipment.
1.64-1.69 Foliar application. Apply mid sea-
lb/A son to layby. Apply In 5 to 15 gal-
(6, 6.55 lb/ Ions of water per acre by aircraft.
gal EC)
0.82-1.64
Ib/A
(6.55 Ib/gal
EC)
Use limited to areas east of the
Rocky Mountains.
Foliar application. Apply mid sea-
son to layby. Apply in 5 to 15 gal-
lons of water per acre by airtfraft
and in 25 to 40 gallons of water per
acre by ground equipment.
Issued: 7-22-85
III-097601-6
-------
Site and Feat
Cotton (continued)
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
1.64 Ib/A
(6.55 Ib/gal
EC)
1.64-1.69
Ib/A
(6, 6.55 lb/
gal EC)
10000BA
Cucurbits (seed crop)
06005AA
XAVBAA
XAVBDA
k
3AVBEA
Use limited to AZ and CA.
Foliar application. Apply at layby.
Apply in 5 to 15 gallons of water
per acre by aircraft and in 25 to
50 gallons of water per acre by
ground equipment.
Foliar application. Apply from lay-
by to boll opening. Apply in 5 to
15 gallons of water per acre by air-
craft and in 25 to 50 gallons of
water per acre by ground equipment.
No tolerance established.
This use only occurs on Special
Local Need (24-C) labeling and has
not been characterized in this en-
try. Refer to appropriate labeling
for use Information and limitations.
Lgs 3 ppm (figs)
9 ppm (figs, dried)
14 day preharvest interval through
1.35 pounds per acre for foliar
application.
Do not make more than 2 applications
per year.
Pacific spider mite 0.9-1.35 Ib/A Foliar application. Apply in 200
Strawberry spider (30Z WP) to 400 gallons of water per acre.
mite
Twospotted spider
mite
'02002AA
'02006AA
Grapefruit
Orange
XAVARA
ILAVBEA
Citrus red mite
Twospotted spider
mite
5 ppm
40 ppm (dried citrus pulp)
7 day preharvest interval through
6.14 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year. ^
3.15-4.5 Ib/A Use limited to CA.
(30Z WP) Foliar application. Apply in 1,000
gallons of water per acre.
Issued: 7-22-85
III-097601-7
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Grapefruit cluster (continued)
JWARA
JLJBCA
JUJAAA
«AVAHA
AVAKA
Citrus red mite
Citrus rust mite
False spider mites
Sixspotted mite
Texas citrus mite
IL014AA
1.5-6.14 Ib/A Use limited to FL and TX.
(6, 6.55 lb/ Foliar application. Apply in 600
gal EC) to 1,500 gallons of water per acre.
1.17-2 lb/500 Use limited to FL and TX.
gallon tank Foliar application.
(6, 6.55 lb/
gal EC)
1.64-2.53
Ib/A
(6, 6.55 lb/
gal EC)
AVBAA
AVBDA
&VBEA
AVAIA
Pacific spider mite 1.6 Ib/A
Strawberry spider (42 D) .
mite
Twospotted spider
mite
Willamette spider
mite
Use limited to FL and TX.
Foliar application. Apply in a
minimum of 10 gallons of water per
acre by aircraft or in 25 gallons
of water per acre by concentrate
ground equipment.
10 ppm
25 ppm (raisins)
40 ppm (dried grape pomace)
14 day preharvest Interval through
1.6 pounds per acre (dust) for foli-
ar application.
21 day preharvest interval through
2.7 pounds per acre (wettable pow-
der) for foliar application.
Do not make more than 2 applications
per year.
Use limited to CA.
Foliar application.
1.35-2.7 Ib/A Foliar application. Apply in 350
(30Z WP) to 600 gallons of water per acre.
Issued: 7-22-85
III-097601-8
-------
Site and Pest
08020AA
EPA Compendium of Acceptable Uses
PROPARGITE
• Dosages and Tolerance, Use, Limitations
Fonnulatlon(s)
15 ppm
30 ppm (dried hops)
14 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year.
Do not feed hop refuse or cones to
livestock. Spent hops from the ex-
tract operation may be fed to live-
stock.
Do not tank mix with diazinen if air
temperatures are expected to exceed
95 F (35.0 C).
;LAVBEA
Twospotted spider
mite
1.35 Ib/A
(30Z WP)
or
1.5 Ib/A
(6 Ib/gal EC)
Foliar application. Apply in 200
gallons of water per acre.
02004AA
Lemons
JLAVARA
LAVARA
1AVBEA
Citrus red mite
Citrus red mite
Twospotted spider
mite
5 ppm
40 ppm (citrus pulp)
. 7 day preharvest interval through
4.5 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year. Applications may cause
Injury on new growth (feather
growth).
»
3.15-4.5 Ib/A Use limited to AZ.
(30Z WP) Foliar application. Apply in 600
to 1,500 gallons of water per acre.
Use limited to CA.
Foliar application. Apply in 1,000
gallons of water per acre.
Issued: 7-22-85
III-097601-9
-------
08027AA
Site and Pest
Mint
LAVBEA
Twospotted spider
mite
05003AA
Orange
Nectarine
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Formulation(s)
50 ppa
14 day preharvest Interval through
2.25 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year.
Do not feed spent mint hay to live-
stock.
1.5-2.25 Ib/A Foliar application. Apply in a
(6 Ib/gal EC) minimum of 10 gallons of water per
acre by aircraft and in 20 to 50
gallons of vater per acre by ground
equipment .
See Grapefruit cluster.
LAVACA
4AVBAA
Brown mite
Pacific spider mite (30Z WP)
14 day preharvest Interval through
2.7 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year.
1.35-2.7 Ib/A Foliar application. Apply in 300
to 600 gallons per acre.
2.25-2.7 Ib/A Foliar application. Apply in a min-
(30Z WP) imum of 20 gallons of water per acre
by aircraft.
Issued: 7-22-85
111-097601-10
-------
'05004AA
Site and Pest
Peach
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Formulation(s)
7 ppm
14 day preharvest interval through
4.5 pounds per acre for foliar ap-
plication of wettable powder formu-
lations.
28 day preharvest interval through
4.69 pounds per acre for foliar ap-
plication of emulslfiable concen-
trate formulation.
Do not make more than 2 applications
per year.
LAVASA
LAVAYA
LAVBAA
LAJAIA
LAVBDA
LAVBEA
European red mite
McDaniel spider
mite
Pacific spider mite
Peach silver mite
Strawberry spider
mite
Twospotted spider
mite
1.35-4.5 Ib/A Foliar application. Apply in 300
(30Z WP) to 1,000 gallons of water per acre.
2.25-3.15 Use limited to CA. .
Ib/A Foliar application. Apply in a min-
(30Z WP) imum of 20 gallons per acre by air-
craft.
Foliar application. For use in
areas east of the Rocky Mountains.
Do not reduce the rate per acre when
applying by concentrate equipment.
0-375-0.45
lb/100 gal
[400-1,000
gal/A]
(30Z WP)
dilute
0.313-0.47
lb/100 gal
[300-1,000
gal/A]
or
concentrate
0.94-4.69
Ib/A
[in 50-200
gal /A]
(5 Ib/gal EC)
Use limited to areas other than the
southeastern United States.
Foliar application.
Issued: 7-22-85
III-097601-ll
-------
1015AA
Site and Pest
Peanuts
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
0.1 ppm (peanuts)
10.0 ppm (forage, hay, hulls)
14 day preharvest Interval through
1.69 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year. Do not plant rotational
crops within 6 months of the last
application.
IVBEA
Tvospotted spider
mite
0.9-1.5 Ib/A
(30Z V?)
or
1.64-1.69
Ib/A
(6, 6.55 lb/
gal EC)
1003DA
Pear (non-bearing and postharvest)
Foliar application. Premlx vettable
powder with a small amount of water
to form a slurry before adding to
spray tank. Apply in sufficient
water to provide complete coverage
of foliage when using low gallonage
equipment.* Apply in a minimum of
20 gallons of water per acre. Apply
emulsifiable concentrate in a mini-
mum of 5 gallons of water per acre
by aircraft and in a minimum of 20
gallons of water per acre by ground
equipment.
3 ppm
Non-bearing trees are those trees
that will not bear fruit within 1
year of last application.
OTASA
AVBEA
European red mite
Tvospotted spider
mite
1.5-2.25 Ib/A Foliar application to non*-bearing
(30Z WP) trees or postharvest application.
0.375-0.45
lb/100 gal
[400-500
gal/A]
(30Z WP)
Foliar application to non-bearing
trees or postharvest application.
For use in areas east of the Rocky
Mountains.
Issued: 7-22-85
111-097601-12
-------
•Jl
Site and Pest
OS005AA
05006AA
LAVASA
LAVBAA
LAVBEA
European red mite
Pacific spider
mite
Tvospotted spider
mite
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Formulation(s)
7 ppm (plums (fresh prunes))
~14 day preharvest interval through
4.5 pounds per acre for foliar ap-
plication of wettable powder formu-
lations.
28 day preharvest interval through
4.7 pounds per acre for foliar ap-
plication of emulsifiable concen-
trate.
Do not make more than 2 applications
per year.
1.35-4.5 Ib/A Foliar application. Apply in a min-
(302 WP) imum of 20 gallons of water per acre
by aircraft and in 300 to 1,000 gal-
lons of water per acre by ground
equipment.
14013AA
Potato
LAVBEA
Tvospotted spider
mite
0.375-0.45
lb/100 gal
[400-1,000
gal/A]
(30Z WP)
dilute
0.313-0.47
lb/100 gal
[300-1,000
gal/A]
or
concentrate
0.94-4.7 Ib/A
[in 50-200]
(5 Ib/gal EC)
Foliar application. For use in
areas east of the Rocky Mountains.
Do not reduce the rate per acre when
applying by concentrate equipment.
Foliar application.
1.13-2.25
Ib/A
0.1 ppa
14 day preharvest interval through
2.25 pounds per acre for foliar ap-
plication.
Do not iiake more than 2 applications
per year.
Use limited to the Pacific North-
west.
(6, 6.55 lb/ Tollar application. Apply in a
gal EC) minimum of 10 gallons of water per
acre by aircraft and in 20 to 50
gallons of water per acre by ground
equipment. Apply the high rate when
Issued: 7-22-85
111-097601-13
-------
Site and Pest
Potato (continued)
'28019AA
Prune
Sorghum, Milo
EPA Compendium of Acceptable Uses
PROFARGITE
Dosages and Tolerance, Use, Limitations
FormulationCs)
the crop is under extreme mite pres-
sure.
See Plum cluster.
10 ppa (sorghum (fodder, forage,
grain))
30 day preharvest interval through
1.69 pounds per acre for foliar
application (grain).
60 day preharvest interval through
1.69 pounds per acre for foliar
application (silage).
Do not make more than 1 application
per year. Test spray a small area
for phytotoxlcity before treating a
large area.
HAVANA
ILAVBEA
Banks grass mite
Tvospotted spider
mite
1.13-1.69
Ib/A
(6, 6.55 lb/
gal EC)
'01016AA
Strawberry
Use limited to areas east of the
Rocky Mountains.
Foliar application. Apply in a
minimum of 5 gallons of water per
acre by aircraft and in a minimum
of 20 gallons of water per acre by
ground equipment.
7 ppm
3 day preharvest interval through
3.15 pounds per acre of wettable
powder formulation and 1.6 pounds
per acre of dust formulation for
foliar application.
Do not make more than 3 applications
per crop season (bloom to harvest).
Do not make more than 3 applications
in any 21 day period during the har-
vesting season for wettable powder
formulations (dosages 0.75 pound per
acre or 100 gallons) and in any 40
day period for dust formulations and
wettable powder formulations (dos-
ages 1.35 to 3.15 pounds per acre).
Do not apply at daytime temperatures
above 80 F (26.7 C) as fruit burn
may occur. Do not tank mix with
other chemicals or spray adjuvants
as leaf and fruit injury may occur.
Issued: 7-22-85
111-097601-14
-------
LAVBAA
LAVBDA
LAVBEA
LAVBEA
03012AA
LAVASA
LAVBEA
Site.and Pest
EPA Compendium of Acceptable Uses
FROPARGITE
Dosages and Tolerance, Use, Limitations
Formulation(s)
Strawberry (continued)
Pacific spider mite i.g Ib/A
Strawberry spider (4% D)
mite
Twospotted spider
mite 1.35-3.15
Ib/A
(30% WP)
Twospotted spider
mite
Walnut
European red mite
Twospotted spider
mite
0.75 Ib/A
or
0.75 lb/100
gal/A
(30* VP)
Use limited to areas west of the
Rocky Mountains.
Foliar application.
Foliar application. Apply in 100
to 200 gallons of water per acre.
Use limited to FL and LA.
Foliar application.
2.25-6.75
Ib/A
(30Z WP)
0.1 ppm
14 day preharvest interval through
6.75 pounds per acre for foliar ap-
plication.
Do not make more than 2 applications
per year.
Use limited to CA.
Foliar application. Apply in 500
to 1,500 gallons of water per acre
by ground equipment.
1.5-6.75 Ib/A Foliar application. Apply In 500
(6 Ib/gal EC) to 1,500 gallons of water per acre
by ground equipment.
2.25-3 Ib/A Foliar application. Apply in a
(6 Ib/gal EC) minimum of 20 gallons of water per
acre by aircraft.
Issued: 7-22-85
111-097601-15
-------
1-J
EPA Compendium of Acceptable Uses
PROPARGITE
Site and Pest
Dosages and Tolerance, Use, Limitations
Fonnulation( s)
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
General Warnings and Limitations; Because cultivar reaction and cultur-
al practices differ widely* the user should initially treat only a small
portion of the crop to confirm plant safety under their conditions. Re-
peat applications are normally necessary for extended control.
Carnations (including nursery
stock)
Chrysanthemums (Including nursery
stock)
Roses (including nursery stock)
Use on roses is limited to green-
house, slat, and saran grown.
Twospotted spider
mite
100 gal
[spray to
wet]
(30Z WP)
(Roses (field grown))
Pacific spider mite 0.45-1.35
Twospotted spider Ib/A
mite (30Z VP)
Ornamentals (including nursery
stock)
0.3-0.45 lb/ Foliar application. For use in
Twospotted spider
mite
0.45 Ib/A
[spray to
wet]
(30Z WP)
areas east of the Rocky Mountains.
Foliar application to field grown
roses. Apply in 50 to 300 gallons
of water per acre.
Foliar application.
Issued: 7-22-85
111-097601-16
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
QIEENHOUSE NON-FOOD CROP
(Ornamental Plants and Forest Trees)
General Warnings and Limitations; Because cultivar reaction and cultur-
al practices differ widely, the user should Initially treat only a small
portion of the crop to confirm plant safety under their conditions. Re-
peat applications are normally necessary for extended control.
31057CA Carnations
'31065CA Chrysanthemums Use on roses is limited to green-
34120CA Roses house, slat, and saran grown.
iLAVBEA Twospotted spider 0.3-0.45 lb/ Foliar application to greenhouse
i mite 100 gal grown plants. For use in areas
:~ [spray to east of the Rocky Mountains.
wet]
. (30Z WP)
34120CA (Roses)
LAVBAA Pacific spider mite 0.45 Ib/A Foliar application to greenhouse
1AVBDA Strawberry spider (30Z WP) grown plants. Apply in 150 gallons
mite of water per acre.
1AVBEA Twospotted spider
1 mite
32000CA Ornamentals
LAVBEA Twospotted spider 0.45 Ib/A Foliar application to greenhouse
mite [spray to grown plants.
wet]
(30Z WP)
Issued: 7-22-85 111-097601-17
-------
Site and Pest
EPA Compendium of Acceptable Uses
PROPARGITE
Dosages and Tolerance, Use, Limitations
Formulation(s)
0101OAA
ACPATIC FOOD CROP
(Agricultural Crops)
Cranberry
10 ppm
Prebloom application through 2.81
pounds per acre.
14 day preharvest Interval through
1.41 pounds per acre for foliar ap-
plication.
Do not make more than 1 prebloom and
1 foliar application per year. When
applying through an irrigation sys-
tem, maintain approximately a ratio
of 4 to 1 (diluent to product) in
the slurry tank. Do not apply if
air temperatures are above 85 F
(29.4 C).
Irrigation Use Precautions; 1) Ap-
ply only through systems containing
anti-siphon and check valves which
will prevent water source contamina-
tion and overflow of the slurry
tank, and containing interlocking
controls between the metering device
and the water pump to insure simul-
taneous shut-off. 2) Constant agi-
tation must be maintained in the
chemical supply tank during the en-
tire period of application. 3) In-
ject the product with a positive
displacement pump into the main line
ahead of a right angle turn, to In-
sure adequate mixing. 4) Applica-
tion of more than label recommended
quantities of irrigation water per
acre may result in decreased perfor-
mance by removing the chemical from
the zone of effectiveness. 5) Do
not apply when wind speed favors
drift, when system connections or
fittings leak, when nozzles do not
provide uniform distribution' Ur when
lines containing propargite must be
dismantled amd drained. 6) Greater
accuracy in calibration and distri-
bution will be achieved by injecting
a larger volume of more dilute slur-
ry per hour. 7) Where sprinkler
distribution patterns do not overlap
Issued: 7-22-85
111-097601-18
-------
i VI
EPA Compendium of Acceptable Uses
PROPARGITE
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Cranberry (continued)
sufficiently unacceptable mite con-
trol may result. Where sprinkler
distribution patterns overlap exces-
sively crop injury may result.
Do not use water leaving propargite
treated fields to irrigate crops
used for food or feed which are not
registered for use with propargite.
Use limited to MA.
XAVAMA Southern red mite 1.41-2.81 Prebloom application. May be ap-
lb/300 gal/A plied through an irrigation system.
(6 Ib/gal EC)
1.41 lb/300 Foliar application. May be applied
gal/A through an irrigation system.
(6 Ib/gal EC)
AERIAL. MOTHPROOFING AND TANK MIX APPLICATIONS
1001500 Aerial Application
VAAAAAA
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Almond, Apricot, Beans, Corn
(Field), Corn (Sweet), Cotton,
Grapefruit, Mint, Orange,'Nectarine,
Peach, Peanuts, Plum, Potato, Prune,
Sorghum, Walnut
Issued: 7-22-85 111-097601-19
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Listing of Registered Pesticide Products by Formulation
>85. 0001 85Z technical chemical
propargite (097601)
000400-00095
325. 0002 251 formulation intermediate
propargite (097601)
000400-00105
004.0003 41 dust
030. 0006
:
i05. 0012
t
f
106.0012
\
106.5512
propargite (097601)
000239-02430 000400-00088
301 vettable ponder
propargite (097601)
000400-00082
5 Ib/gal emulsifiable concentrate
propargite (097601)
000400-00083
6 Ib/gal emulsifiable concentrate
propargite (097601)
000400-00089 000400-00154
6.55 Ib/gal emulsifiable concentrate
propargite (097601)
000400-00104
999999 State Label Registrations
AL Reg. Ho.
000400-06446
AZ Reg. No.
000400-06448
CA Reg. No.
000239-02430
000400-06456
000400-06460
002935-06640
010972-06549
CO Reg. No.
000400-06452
CT Reg . No .
000400-06470
000400-06449
000400-06453
000400-06457
002935-06580
005967-05175
010972-08688
000400-06454
000400-06458
002935-06587
010965-10028
000400-06455
000400-06459
002935-06639
010972-06543
Issued: 7-22-85
111-097601-20
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Listing of Registered Pesticide Products by Formulation (continued)
DE Reg. No.
000400-06469 -
FL Reg. No.
000400-06462 000400-06463 000400-06465
GA Reg. No.
000400-06482
ID Reg. No.
000400-06474 000400-06475 000400-06476 000400-06477
000400-06478 000400-06479 008917-05585
KS Reg. No.
000400-06495
MA Reg. No.
000400-06487 000400-06488
MI Reg. No.
000400-06486
""••s
NH Reg. No.
000400-06439
NJ Reg. No.
000400-06438
HI Reg. No.
000400-06442
NV Reg. No.
000400-06440 000400-06441
NT Reg. No.
000400-06437
OR Reg. No.
000400-06527 000400-06528 000400-06529 001871-08937
001871-08952
PA Reg. No.
000400-06525
TX Reg. No.
000400-06514
VA Reg. No.
000400-06509
Issued: 7-22-85 111-097601-21
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Listing of Registered Pesticide Products by Formulation (continued)
VT Reg. No*
000400-06510
WA Reg. No.
000400-06502 000400-06503 000400-06504 000400-06505
000400-06506
Issued: 7-22-85 111-097601-22
-------
EPA Compendium of Acceptable Uses
PROPARGITE
Appendix A-2
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical "Name
057801 diazinon 0,0-diethyl 0-(2-isopropyl-6-methyl-4-
pyrimidlnyl) phosphorothioate
— Use EPA Acceptable Common/Chemical Name
Issued: 7-22-85 111-097601-23
-------
BIBGUIDE-l
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.
-------
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 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00006678 Guardigli, A.; Taschenberg,^E.F.; Stafford, E.M. (1967) Laboratory
Analytical Data Sheet for Residues: Field Test Project No. BB
67-100. (Unpublished study including field test project no. PA
67-25, received Jun 14, 1968 under 8F0668; prepared by Rhodia,
Inc., submitted by Chipman Chemical Co., Inc., Burlingame,
Calif.; CDL:091170-F)
00025749 Wong, D.T.L.; Tortora, N.J.; Fuller, G.B.; et al. (197b) Transloca-
tion and Fate of Propargite-14C on Blue Lake Bush Beans: Project
No. 7834. (Unpublished study received Dec 27, 1978 under 400-
82; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:
241586-B)
00025751 Devine, J.M.; Sisken, H.R. (1972) Use of the flame photometric
detector for determining residues of Omite 2-(p-tert-
butylphenoxy)cyclohexyl propargyl sulfite in various crops.
Journal of Agricultural and Food Chemistry 20(1):59-61. (Also
in unpublished submission received Dec 27, 1978 under 400-82;
submitted by Uniroyal Chemical, Bethany, Conn.; CDL:241586-D)
00029103 Henderson, S.K. (1979) Degradation of Omite (Phenyl-14C) on Red-
haven Peaches: Project No. 7952. (Unpublished study received
Dec 17, 1979 under 6F1726; submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:099234-A)
00030794 Uniroyal Chemical (1973) Summary. (Unpublished study received Jun
16, 1980 under 400-104; prepared in cooperation with Morse Labo-
ratories, Inc.; CDL:242671-A)
00036033 Devine, J.M. (1973) Determination of Omite...Residues in Peanuts:
Report No. 152. Method dated Apr 13, 1973. (Unpublished study
received May 31, 1973 under 3F1402; prepared by State Univ. of
New York—Oswego, Lake Ontario Environmental Laboratory, submit-
ted by Uniroyal Chemical, Bethany, Conn.; CDL:094520-B)
00036285 Uniroyal, Incorporated (1974) Basic Omite Toxicology Studies. (Un-
published study received Mar 28, 1975 under 5F1609; CDL:
094398-B)
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.)
-1-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00037396 Scott, D.C.; Klanro, R. (1973) Residue Data for Omite on Figs.
(Unpublished study received Jun 1, 1973 under 3F1402; prepared
in cooperation with Horse Laboratories, Inc. and California,
Dried Fig Advisory Board, submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:095348-G)
00037397 Devine, J.M. (1973) Residue Data for Omite on Peanuts. (Unpub-
lished study received Jun 1, 1973 under 3F1402; prepared in co-
operation with Morse Laboratories, Inc. and State Univ. of New
York—Oswego, Lake Ontario Environmental Laboratory, submitted
by-Uniroyal Chemical, Bethany, Conn.; CDL:095348-H)
00038032 Uniroyal Chemical (1974) Residues in PPM: Sorghum: Omite. (Unpub-
lished study received Jul 8, 1975 under 4F1520; prepared in co-
operation with Morse Laboratories, Inc. and State Univ. of New
York—Oswego, Lake Ontario Environmental Laboratory; CDL:
095384-A)
00038033 Uniroyal Chemical (1974) Residues in PPM: Beans: Omite. (Unpub-
lished study received Jul 8, 1975 under 4F1520; prepared in co-
operation with Morse Laboratories, Inc.; CDL:095384-B)
00038036 Uniroyal Chemical (1974) The Results of Tests on the Amount of Res-
idue Remaining, Including a Description of the Analytical Meth-
ods Used: Omite. (Unpublished study received Jun 25, 1974 un-
der 4F1520; prepared in cooperation with Morse Laboratories,
Inc.; CDL:095367-B)
00038650 Scott, D.C.; Rlamm, R.; Devine, J.M. (1973) Summary.of Section D:
Omite. (Unpublished study received on unknown da£e under
3F1402; prepared in cooperation with Morse Laboratories, Inc.
and others, submitted by Uniroyal Chemical, Bethany, Conn.; CDL:
093753-B)
00041386 Knickerbocker,:M.; Re, T.A. (1979) Teratologic Evaluation of Omite
Technical in Sprague-Dawley Rats: Laboratory No. 5992b. (Un-
published study received Mar 22, 1979 under 400-95; prepared by
Food and Drug Research Laboratories, Inc., submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:241931-A, 241932)
00044291 Morse Laboratories, Incorporated (1980) Residues in PPM. (Unpub-
lished study received May 12, 1980 under 400-104; submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:243164-A) "*
00047994 Morse Laboratories, Incorporated (1980) Residue Studies on Pea-
nuts. (Unpublished study received Aug 14, 1980 under 400-104;
submitted by Uniroyal Chemical, Bethany, Conn.; CDL:243080-A)
-2-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00048326 Uniroyal Chemical (1974) Background Information on the Request for
the Deletion of California Only from the Dosage Instructions on
Grapes for Omite-30W and Omite-4D. (Compilation; unpublished
study received Mar 21, 1975 under 400-82; CDL:225995-A)
Q0048807 Carson, S. (1963) Approximate Acute Oral LD50 in Rats: Laboratory
No. 85371. (Unpublished study received Mar 10, 1977 under 400-
89; prepared by Food and Drug Research Laboratories, Inc., sub-
mitted by Uniroyal Chemical, Bethany, Conn.; CDL:228650-A)
00048808 Weir, R.J.; Clarke, 0. (1967) Final Report: Acute Dermal Appli-
cation—Rabbits: Project No. 798-125. (Unpublished study re-
ceived Mar 10, 1977 under 400-89; prepared by Hazleton Labora-
tories, Inc., submitted by Uniroyal Chemical, Bethany, Conn.;
CDL:228650-B)
00052454 Fink, R. (1974) Final Report: Eight-Day Dietary LC50— Mallard
Ducks: Project No. 117-101. (Unpublished study received Mar 28,
1975 under 5F1609; prepared by Truslow Farms, Inc., submitted by
Uniroyal, Inc., Mishawaka, Ind.; CDL:094398-D)
00060628 Johansen, C.A. ; Eves, J. (1965) Bee Poisoning Investigations, 1965:
Report No. G-1705; Report No. 17338. (Unpublished study, in-
cluding letter dated Jun 12, 1973 from C.A. Johansen to A.D. Co-
hick, received Mar 27, 1974 under 4F1485; prepared by Washington
State Univ., Dept. of Entomology, submitted by Chemagro Corp.,
Kansas City, Mo.; CDL: 092011-1)
00061586 Shapiro, R. (1977) Acute Inhalation LC50: Report No. T-277. (Un-
published study received Dec 29, 1977 under 400-95; prepared by
Nutrition International, Inc., submitted by Uniroyal Chemical,
Bethany, Conn.; CDL:235325-E)
00064067 Uniroyal Chemical (1974) The Results of Tests on the Amount of Re-
sidue Remaining, Including a Description of the Analytical Meth-
ods Used: Omite. (Compilation; unpublished study received on
unknown date under 4F1520; CDL:094031-B)
00066495 Phillips, B.M.; Paa, H. (1977) Report to Uniroyal Chemical: Primary
Skin Irritation Test with Omite Std. in Albino Rabbits: IBT
No. 8530-10831. (Unpublished study received Dec 29, 1977 under
400-95; prepared by Industrial Bio-Test Laboratories, Inc., sub-
mitted by Uniroyal Chemical, Bethany, Conn.; CDL:233986-B)
-3-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00066496 Baker, R.G. (1976) Report to Uniroyal Chemical, Division of Uni-
royal, Inc.: Eye Irritation Tests with GMS # 4838-A, GMS # 4838-
B and QMS I 4838-C in Albino Rabbits: IBT No. 8530-09582. (Un-
published study received Dec 29, 1977 under 400-95; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:233086-C)
00066497 Brusick, D.J.; Vteir, R.J. (1977) Mutagenicity Evaluation of D014:
LBI Project No. 2683. Final rept. (Unpublished study received
Dec 29, 1977 under 400-95; prepared by Litton Bionetics, Inc.,
submitted by Uniroyal Chemical, Bethany, Conn.; CDL:233086-E)
00066498 Kuc, W.J. (1977) Acute Toxicity of Omite Technical, Batch 24 Lot
BL 8190 to the Bluegill Sunf ish, Lepomis macrochirus Raf inesque
and Rainbow Trout, Salmo gairdneri Richardson: UCES Project I
11506-29-02. (Unpublished study received Dec 29, 1977 under
400-95; prepared by Union Carbide Corp., submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:233086-G)
00067553 Uniroyal Chemical (1972) Summary of Plum Residue Data. (Compila-
tion; unpublished study received Jun 17, 1973 under 3F1305;
CDL:092209-B)
00067558 Brett, B. (1976) Report to ...: Skin Sensitization Tests with
Two Samples in Albino Guinea Pigs: IBT No. 8530-08373. (Un-
published study received Jun 22, 1977 under 400-82; prepared
by Industrial Bio-Test Laboratories, Inc., submitted by Uni-
royal Chemical, Bethany, Conn.; CDL:230690-C)
00068752 Vilkas, A.G. (1977) Acute Toxicity of Omite Technical to the Water
Flea (Daphnia magna Straus): ES Proj. t 11506-29-t)2. (Unpub-
lished study received Jan 19, 1978 under 400-89; prepared by
Union Carbide Corp., submitted by Uniroyal Chemical, Bethany,
Conn.; CDL:232723-A)
00069174 Uniroyal Chemical (1972) Sunmary of Coroite Residue Studies on Or-
anges in Florida. (Unpublished study received Nov 15, 1972 un-
der unknown admin, no.; CDL:231112-B)
00073626 Anon. (19??) Omite(R) Dust Base Concentrate: An Agricultural
Hiticide for Formulating Use. (Technical bulletin; also in un-
published submission received Mar 14, 1974 under 400-105; sub-
mitted by Uniroyal Chemical, Bethany, Conn.; CDL:225071-A)
-4-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00076401 Carson, S. (1964) Subacute Feeding Studies with D-014 in Rats:
Laboratory No. 85603. (Unpublished study received Apr 10, 1967
under 400-82; prepared by Food and Drug Research Laboratories,
Inc., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:
090718-C)
00076402 Oser, B.L. (1966) Chronic (2-year) Feeding Studies with D-014 in
Rats and Dogs: Laboratory No. 86000; Laboratory No. 86014.
(Unpublished study received Apr 10, 1967 under 400-82; prepared
by Food and Drug Research Laboratories, Inc., submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:090718-D)
00079227 Uniroyal Chemical (1981) Summary of Omite Residues in Field Corn
Treated with Comite. (Compilation; unpublished study, including
published data, received Jul 23, 1981 under 400-104; CDL:
245609-A)
00080225 Von Schmeling, B. (1978) Letter sent to James M. Rea dated May
15, 1978: Omite-30W (EPA Reg. No. 400-82): Omite-6E (EPA
Reg. No. 400-89): Almond petition 6F1814, sub. 6-4-76. (Un-
published study received May 23, 1978 under 6F1814; submitted
by Uniroyal Chemical, Bethany, Conn.; CDL:070199-A)
00086708 Uniroyal Chemical (1981) Residues of Propargite in Com. (Com-
pilation; unpublished study received Sep 14, 1981 under KS 81/
31; submitted by state of Kansas for Uniroyal Chemical; CDL:
246186-B)
00086709 Uniroyal Chemical (19??) Omite (R) Acaricide. ?: Uniroyal.
(Technical data sheet; also in unpublished submission received
Sep 14, 1981 under KS 81/31; submitted by state of Kansas for
Uniroyal Chemical; CDL:246186-C)
00094938 Williams, M.; Buckley, P.M. (1981) Residues in PPM. (Unpublished
study received Nov 10, 1981 under 400-104; submitted by Uniroyal
Chemical, Bethany, Conn.; CDL:246844-B)
00100290 Dannals, L.E.; Kucharczyk, N.; Smith, A.E. (1972) Fate of
Omite(R) in the Environment. Status rept. no. 1. (Unpub-
lished study received Sep 28, 1972 under 3F1305; submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:094120-A)
00105990 Serota, D.; Fezio, W.; Wolfe, G.; et al. (1982) Teratology Study
in Rabbits: Omite Technical: Project No. 798-195. Final rept.
(Unpublished study received Jun 30, 1982 under 400-82; prepared
by Hazleton Laboratories America, Inc., submitted by Uniroyal
Chemical, Bethany, CT; CDL:247788-A)
-5-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00112336 Uniroyal Chemical (1973) Omite: Residues in Strawberries. (Com-
pilation; unpublished study received Aug 17, 1973 under 400-82;
CDL:009024-A)
00112339 Uniroyal Chemical (1972) Omite: Residues in Walnuts. (Compi-
lation; unpublished study received Oct 17, 1972 under 400-89;
CDL:023357-A)
00112342 Uniroyal Chemical (1974) Omite: Residues in Almonds. (Compi-
lation; unpublished study received May 1, 1974 under 400-89;
CDL:023359-A)
00112344 Uniroyal Chemical (1969) Omite Residues in Peaches. (Compi-
lation; unpublished study received Nov 25, 1969 under 400-82;
CDL:026727-B)
00112345 Uniroyal Chemical (1967) The Results of Test on the Amount of Res-
idue Remaining, Including a Description of the Analytical
Method Used: Omite. (Compilation; unpublished study received
Dec 15, 1967 under 8G0698; CDL:091216-A)
00112347 Uniroyal Chemical (1974) Residue Data: Omite—Potatoes and Cit-
rus. (Compilation; unpublished study received May 1, 1974
under 400-104; CDL:026597-B)
00112348 Walton, H. (1974) Report to Uniroyal Chemical: 21-day Subacute Aer-
osol Inhalation Toxicity Study with Comite in Albino Rats: IBT
No. 663-04206. (Unpublished study received Feb 25, 1974 under
400-104; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Uniroyal Chemical, Bethany, CT; CDL:028125-A)
00112355 Uniroyal Chemical (1969) Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method
Used. (Compilation; unpublished study received Oct 1, 1969
under 9G0830; CDL:091434-A)
00112358 Uniroyal Chemical (1969) The Results of Tests on the Amount of Res-
idue Remaining, Including a Description of the Analytical Method
Used: Omite. (Compilation; unpublished study received May 20,
1970 under OF0910; CDL:091564-B)
00112359 Uniroyal Chemical (1972) Study: Omite Residue in Milk, Eggs and
Animal Tissue. (Compilation; unpublished study received Jan
22, 1973 under OF0988; CDL:091701-A)
-6-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00112360 Uniroyal Chemical (1972) Response to EPA Letter 1-5-72: Reference
to Petition OF0988 and Food Additive Petition OH2554: Omite.
(Compilation; unpublished study received Jun 13, 1972 under
OF0988; CDL:091702-A)
00112361 Uniroyal Chemical (1972) Omite: Residues in Clover and Other
Crops. (Compilation; unpublished study received Oct 3, 1972
under 2F1272; CDL:091803-A)
00112363 Uniroyal, Inc. (1972) Comite: Residue Studies in Cottonseed. (Com-
pilation; unpublished study received Feb 26, 1973 under 2F1288;
CDL:092183-B)
00112365 Lane, J. (1967) Method of Analysis for Omite in Various Crops.
(Unpublished study received Feb 16, 1967 under 7G0569; submitted
by U.S. Rubber Co., Bethany, CT; CDL:092857-A)
00112384 Uniroyal, Inc. (1975) Omite Residue Studies on Apples and Cattle.
(Compilation; unpublished study received Jan 7, 1976 under
6F1726; CDL:097885-B)
00112386 Uniroyal, Inc. (1976) The Name, Chemical Identity and Composition
of the Pesticide Chemical: Omite. (Conpilation; unpublished
study received Apr 8, 1976 under 6F1774; CDL:097886-A)
00112395 Sleight, B. (1972) Acute Toxicity of Omite to Grass Shrimp ... and
Fiddler Crab (Uca pugilator). (Unpublished study received Jan
24, 1974 under unknown admin, no.; prepared by Bionomics, Inc.,
submitted by Uniroyal Chemical, Bethany, CT; CDL:131292-A)
00112397 Uniroyal Chemical (1976) Study: Omite Residue in Grapefruit and
Oranges. (Compilation; unpublished study received Apr 29, 1976
under 400-104; CDL:224314-A)
00112398 Uniroyal Chemical (1976) Study: Omite Residue in Hops. (Ccropila-
tion; unpublished study received May 27, 1976 under 400-82; CDL:
225473-A)
00112400 Uniroyal Chemical (1977) Study: Omite Residues in Cranberries and
Other Specified Fruits. (Compilation; unpublished study re-
ceived Aug 1, 1977 under 400-89; CDL:230938-A)
00112401 Uniroyal Chemical (1977) Study: Omite Residue on Cornr^fCompila-
tion; unpublished study received Nov 23, 1977 under 400-104;
CDL:232329-A)
-7-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
. Registrations Under the Propargite Standard
MRID CITATION
00112405 Uniroyal Chemical (1976) Residues of Omite in Grapes. (Unpub-
lished study received Sep 14, 1976 under 400-82; CDL:233084-A)
00112408 Uniroyal Chemical (1978) Residue Summary: Omite in Lemons.
(Compilation; unpublished study received Sep 15, 1978 under
400-82; CDL:235312-A)
00112414 Caplan, J. (1979) Absorption—Desorption of 14C-Omite: Laboratory
No. 9PL-30-S. (Unpublished study received Mar 8, 1979 under
400-82; prepared by Biospherics, Inc., submitted by Uniroyal
Chemical, Bethany, CT; CDL:241269-D)
00113471 Fink, R.; Beavers, J. (1977) Eight-day Dietary LC50—Bobwhite
Quail: Omite Technical: Project No. 117-124. Final rept. (Un-
published study received Oct 19, 1977 under 400-82; prepared by
Wildlife International Ltd., submitted by Uniroyal Chemical,
Bethany, CT; CDL:232341-A)
00126739 Forbis, A.; Franklin, L.; Boudreau, P.; et al. (1983) Early Life
Stage Toxicity of Omite to Fathead Minnows ... in a Flow-through
System: Early Life Stage Final Report 129634. (Unpublished
study received Apr 8, 1983 under 400-104; prepared by Analytical
Bio-Chemistry Laboratories, Inc., submitted by Uniroyal Chemi-
cal, Bethany, CT; CDL:249886-A)
U0130618 Uniroyal Chemical (1983) Propargite Plant Metabolism Studies to
Support Pending Tolerances. (Compilation; unpublished study
received Jul 22, 1983 under 400-89; CDL:250896-A)
00130942 Cox, G.; Re, T. (1979) Chronic Oncogenic Evaluation of Omite in CD-
1 Mice following 78-weeks of Dietary Treatment:'Laboratory
No. 5036. (Unpublished study received Mar 20, 1979 under un-
known admin, no.; prepared by Food and Drug Research Laborato-
ries, Inc., submitted by Uniroyal Chemical, Bethany, CT; CDL:
251067-A; 251068)
00131893 Uniroyal Chemical (1983) Summary of Residue Data and Method: Co-
mite and Others. (Compilation; unpublished study received Sep
9, 1983 under TX 83/28; CDL:251200-A)
00138427 United States Rubber Co. (1968) Residue Studies: Omite. (Compi-
lation; unpublished study received Apr 28, 1969 under 9F0803;
CDL:091386-A) '*
-8-
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propargite Standard
MRID CITATION
00138428 Uniroyal Chemical (1975) Study: Omite Residue in Mint Crops.
(Compilation; unpublished study received Apr 29, 1976 under 400-
104; CDL:224313-A)
00142594 Forbis, A.; Franklin, L. (1984) Chronic Toxicity of Omite to
Daphnia magna under Flow-through Test Conditions: ABC Final Re-
port 131133. Unpublished study prepared by Analytical Bio-Chem-
istry Laboratories, Inc. 172 p.
GS0243-001 Uniroyal Chemical Co. (1975) [Propargite Residues in Tea.]
Unpublished compilation. 38 p.
GS0243-002 Morse Laboratories, Inc. (1972) [Propargite Residues in Meat
and Milk.] Unpublished document. 12 p.
-9-
-------
FIFHA SECTION 3(C)(2)(6) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAMi
I DATE GUIDANCE DOCUMENT ISSUED
With rwptet to mt nqutrtnuiR to «tanrt >mrien dm impo»d by tin FIFRA action 31CH2IIBI nouct connmto m tni rttwtnc«d
Guidtnct Document,itm mooodmt in ttw following rantr.
•_; 1. I will wbrnrt din in • tbntlY nwmur to Mofy thiioUowmfl muimn«>tt If thitm pronouns I will mt ornnt from (or art mn
RKifitd in) tni Riotntttion Guidttintt or tta Protocoii eoflttintd in ttw Rtpora ol imn Srouw to me CntmeaU Group. OECC
ChtmiaU Tvting ProanmnM, I ondon tlw protocols thtt 4 wilt v».
O 2. I tavt Mtwtd into.on itrwmom with em or man athtr ngtaruw undtr FIFRA action 3(C)(2)(B)(iij to wary tht tollowinf dm
rMtuinmonti. THt tKtt, nd wiy rtqund protocott, will bt vibmitttd to EPA by:
NAME OF OTHER REGISTRANT
01 I ondoa • compttttd "Cwtitiotion of Atttmpt to Eimr Into M Agmmint with Othw Rigamnts for 0wtlopmtni of Dm" whr.
rapid to tno toUowini don nqvinnonic
D4. Iraquonthnyou•mmdarvi«|iRntionbvdil«in|ttifollowin|urn(thiioptioniinotoiiwIabittoapolicamsforntwDradutti):
I rao^nvoiuinwYcarciUition of trwnotention of thtt product (Tna
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
frrnn §580-1 (1042)
-------
V. FORMS APPENDICES
-------
Appendix II-
QMS Approval 2070-0057 (expires 5/31/86)
ITo outlify. certify £LL Iburltttml
CERTIFICATION OF ATTEMPT TO ENTER
WTO AN AGREEMENTWITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly euthorixed to represent the following firm(t) who are subject to the require-
ments of • Notice under FIFRA Section 3lc)(2)lB) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIKM
IPA COMPANY NUMBE*
(Thii firm or group of firms is referred to below as **my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, H necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the con of developing, the following required
items or data:
3. My firm IMS offered in writine. to enter into such an agreement Copies of the often an attached. Teat offer net irrevoctWi and included en offer to be
bound by m arbitration demon under FIFRA Section 3(c)(2)(B)(ii) If final agreement on eU terms could oot be reached otherwise. This offer was medt
to the following finals) on the following databJ*
DATE OF OFFER
However, none of those firm(s) ecceoted my offer.
4. My firm requests that EPA not suspend the ragistration(s) of my firm's productU), H any of the firms named in paragraph (3) abo
have agreed to submit the data lined in paragraph (2) above in accordance with the Notio*. I understand EPA will promptly infor
me whether my firm must submit data to avoid suspension of its registration^ under FIFRA Section 3(c)(2)(B). (This stateme
does not apply to applicants for new products^ I give EPA permission to disclose this statement upon request
TVPKD NAME
SIGNATURE
CATC
-------
EPA Reg. No._
PPDDUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
$158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Meltirxj point
Boiling point
Density, bulk-
-density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pfl
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
m
(For EPA Use Only)
Accession Numbers
Assigned
-
• -«•. •
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidiz ing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
PORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Nane_
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s);
(2) Each active ingredient listed in paragraph (1) is present solely as
the result of the incorporation into the product (during formulation or
packaging) 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) Indicate by circling (A) or (b) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) 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 active ingredient(s) listed in paragraph (1).
OR
»
(B) The Confidential Statement of Formula dated ^_^^ on
file with the EPA is complete, current, and accurate and contains the
information required on the current CSF Form No. 8570-4. The registered
source(s) of the active ingredient(s) listed in paragraph (1) is/are listed
below:
Active Ingredient Source: Product Name and Reg. No.
Signature_
Date Title
------- |