&EPA
Unn«d St«m
Environnwrital Protection
Agency
Office of
Pwtickte and Toxic SubctancM
Washington DC 20480
June 1987
Pwicktas
Guidance for the
Reregistration of
Pesticide Products
Containing Folpet
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODCUTS
CONTAINING AS THE ACTIVE INGREDIENT
FOLPET
(031601)
CASE NUMBER 0630
CAS 133-07-3
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OP PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
June 1987
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TABLE OF CONTENTS
I - Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical 4
B. Use Profile 4
III. Agency Assessment 6
A. Summary 6
B. Preliminary Risk Assessment 10
C. Other Science Findings 19
D. Tolerance Reassessment 20
IV. Regulatory Assessment 23
A. Regulatory Positions & Rationales 23
B. Criteria for Registration . 28
C. Acceptable Ranges and Limits . . . 28
D. Required Labeling 29
V. Products Subject to this Standard 33
VI. Requirements for Submission of Generic Data ... 35
A. What are generic data? 35
B. Who must submit generic data? 35
C. What generic data must be submitted? ..... 36
D. How to comply with DCI requirements 36
E. Testing protocols, standards for conducting . 39
acceptable tests - Guidance on evaluating
and reporting data
F. Procedures for requesting a change in .... 39
protocol
G. Procedures for requesting extensions of time . 39
H. PR Notice 86-5 40
I. Existing stocks provisions upon suspension . . 40
or cancellation
VII. Requirement for Submission of 41
Product-Specific Data
VIII. Requirement for Submission of Revised Labeling . . 42
IX. Instructions for Submission 42
A. Manufacturing use products (sole active) . , . 42
B. Manufacturing use products (multiple active) . 43
C. End use products 44
D. Intrastate products ..... 45
E. Addresses . .......... 45
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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 Instruction s
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1
EPA Form 8580-6
EPA Form 8580-4
EPA. Form 8570-27
FIFRA §3(c)(2)(B) Summary Sheet
Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data
Product Specific Data Report
Formulator's Exemption Statement
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GLOSSORY OF TERMS AND ABBREVIATIONS
ADI:
a . i . ;
CAS:
CSF:
EPA:
FIFRA:
LC50:
LD50:
LEL:
MPI :
MRID:
NPDES:
NOEL:
OPP:
OES:
Acceptable Daily Intake
active ingrdient
Chemical Abtract Services (number)
Confidential Statement of Formula
The U.S. Environmental Protection Agency (Agency)
The Federal Insecticide, Fungicide, and Rodenticide Act
Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals,
expressed as weight or volume of test substance per
volume of air or water or per weight of feed
(e.g., mg/1 or ppm).
Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of test
animals when administered by the route indicated,
expressed as weight of substance per unit weight of
test animal (e.g., mg/kg}
Lowest Effect Level
Maximum Permissible Intake
Master Record Identification (number) - EPA's system of
tracking studies used in support of registration
National Pollution Discharge Elimination System
No Observed Effect Level
The Office of Pesticide Programs of the U.S. EPA
The Office of Endangered Species, U.S. Fish and Wildlife
Service
Technical: active ingredient as manufactured
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) as amended September 30,
1978. 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
registration. 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 discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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active ingredient. However, during the review of these data
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
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - 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:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
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EPA has authority under the Data Call-in (DCI ) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve concerns about this pesticide. These data
are listed in the Tables A, B, and C in Appendix I. Failure
to comply with the DCI requirements enumerated in this Registratic
Standard may result in issuance by EPA of a Notice of Intent to
Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants 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 the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common name: Folpet
Chemical name: N-(trichloromethylthio)phthalimide
Chemical Family: Dicarboximides or chlorinated organosulfur
compounds.
CAS Number: 133-07-3
OPP (Shaughnessy) Number: 081601
Empirical Formula: Cgf^C^NC^S
Trade Names: Folpan, Folpex, Phaltan, and Thiophal
Physical Characteristics: White Crystalline Solid
M.W.: 296.5 grams
Melting Point: 177 °C
Boiling Point: 150 °C at 0.02 mm Hg
Solubility: Insoluble in water.
Very low solubility in aliphatic
hydrocarbon solvents. Low
solubility in aromatic, polar,
oxygenated, and halocarbon
solvents.
Volatility: Nonvolatile at ordinary
temperatures.
B. Use Profile
Folpet is a broad-spectrum fungicide which is registered with
the EPA for use in the culture of both food and nonfood crops
and as an industrial fungicide. It is registered for use as
a foliar fungicide to be applied to apples, avocados, black-
berries, blueberries, boysenberries, celery, cherries, citrus
fruits, crabapples, cranberries, cucumbers, currants, dewberries,
garlic, gooseberries, grapes, huckleberries, leeks, lettuce,
loganberries, melons, onions (dry bulb), onions (green),
pumpkins, raspberries, shallots, squash (summer), squash
(winter), strawberries, and tomatoes. It is also registered
for use on ornamental plants and for use in the manufacture
of interior and exterior paints and coatings and in the
manufacture of plastics.
Folpet was first registered in 1962 by the U.S. Department of
Agriculture. There are presently 11 registrants of 18 folpet
manufacturing-use products (MPs). These products contain
from 1.4 to 88 percent folpet. These products are formulated
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into 4% to 88% dusts, 14.5% to 38% wettabLe powders, 5% to 8.82%
wettable powder/dusts, 0.0616% to 0.2288% impregnated materials,
13% to 44% flowable concentrates, 0.27% to 1.0% liquid ready-to-
use products, 0.5% to 0.75% pressurized liquids, a 4% pressurized
dust and a 14.18% water soluble pellet (tablet).
Folpet is compatible with most commonly used fungicides,
insecticides, and adjuvants. It is not compatible with hydrated
Lime, strongly alkaline materials, or emulsifiable concentrate
insecticides. It should not be used in combination with or
closely following oil sprays. Methods of application include
dusting, spraying, or directly incorporating it into paints and
coatings and into plastic formulations. Folpet inhibits normal
cell division of a broad spectrum of microorganisms, however
the precise mechanism of this effect is not understood.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed data submitted to support the registration
of folpet. Numerous data gaps were identified and few definitive
conclusions could be made. Based on available data, the Agency has
reached the following interim conclusions which are discussed in
detail in Section B, which follows:
1. Folpet is a group 62 oncogen (probable human carcinogen) based
on oncogenic responses in two studies with different strains
of mice, the genotoxicity of the chemical, and its structural
similarity to captan, which also is considered by the Agency
to be an oncogen. Folpet causes developmental effects in
laboratory animals.
Due to the lack of data, oncogenic and developmental risk
estimates for dietary exposure were based on tolerances rather
than actual residues in foods and developmental risks to
mixers/loaders/applicators were based on an estimated dermal
absorption rate of 0.4%. Residue chemistry and dermal absorp-
tion data will be received within 4 years and 1 year from
receipt of the Registration Standard, respectively. When
these data are received and reviewed, risk figures may be
lower than assumed for the current risk assessment.
2. Thirty established tolerances for residues of folpet in raw
agricultural commodities (40 CFR 180.191) are inadequately
supported by both residue chemistry and toxicology data.
Additional data in these areas are required.
3. The Agency's review identified missing data necessary to
evaluate the potential hazard to the environment and to
human health associated with the continued use of folpet
as an active ingredient in pesticide products. The missing
data are listed as data gaps in the tables of Appendix I
of this document, and must be submitted in order to
continue existing registration of pesticide products
containing folpet and in order to register new pesticide
products that contain folpet. A summary of the data gaps
are listed below. Please note this is only a summary and
complete details can be obtained by referring to the tables
in Appendix I.
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Toxicology
Acute Inhalation
21-Day - Subchronic Dermal
Chronic Feeding in a Rodent (Reserved*)
Metabolism
Reproduction - Mouse (Reserved)
Mutagenicity - in. vitro Chromosome Aberrations
Dermal Penetration
Ecological Effects
Freshwater Fish Toxicity
- Coldwater Fish Species
- Warmwater Fish Species
Acute Toxicity to Freshwater Invertebrates
Acute Toxicity to Estuarine and Marine Organisms -
Fish, Mollusks, and Shrimp
Fish Early Life Stage
Aquatic Invertebrate Life-Cycle
Fish Life Cycle (Reserved)
Aquatic Organism Accumulation (Reserved)
Crustacean, Fish, Insect Nymph, and Mollusk
Simulated Field Testing - Aquatic Organisms (Reserved)
Actual Field Testing - Aquatic Organisms (Reserved)
Environmental Fate/Exposure
Hydrolysis
Photodegradation in Water
Photodegradation in Soil
Photodegradation in Air (Reserved)
Metabolism - Aerobic Soil
Metabolism - Anaerobic Soil
Metabolism -• Anaerobic Aquatic
Metabolism - Aerobic Aquatic
Leaching and Adsorption/Desorption
Volatility, Laboratory
Field (Reserved)
Studies in Soil
Volatility,
Dissipation
Dissipation Studies in Aquatic Sediment
Dissipation Studies Soil, Long-Term (Reserved)
Accumulation Studies
Accumulation Studies
Accumulation Studies
Accumulation Studies
Accumulation Studies
Reentry Protection -
Reentry Protection -
Reentry Protection -
- Rotational Crops,
- Rotational Crops,
- Irrigated Crops
- Fish
- Aquatic Nontarget
Foliar Dissipation
Dermal Exposure
Inhalation Exposure
Confined
Field (Reserved)
Organisms
*Reserved means
the requirement is qualified, pending further
may or may not indicate that the data is
*\c od-vc^a iuc a. 11 o uiic: j-^^H-LLt;
information that may or may
required. Tier testing may be involved (see EPA PR Notice
85-5).
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Product Chemistry
Description of Beginning Materials and Manufacturing Process
Discussion of Formation of Impurities
Preliminary Analysis of Product Samples
Certification of Ingredient Limits
Analytical Methods to Verify Certified Limits
Physical and Chemical Characteristics:
Color
Physical State
Odor
Melting Point
Density, Bulk Density, or Specific Gravity
Solubility
Dissociation Constant
Octanol/Water Partition Coefficient
pH
Stability
Residue Chemistry
Nature of Residues in Plants
Nature of Residues in Livestock
Residue Analytical Method for Plant Residues
Residue Analytical Method for Animal Residues
Storage Stability Data
Magnitude of Residues for Each Food Use
Bulb Vegetable Group:
- Garlic, Leeks, Onions (dry bulb)
- Onion (green) and Shallots
Leafy Vegetables (except Brassica Vegetables) Group:
- Celery and Lettuce
Fruiting Vegetables (except Cucurbits) Group:
- Tomatoes
Cucurbit Vegetable Group:
- Cucumbers, Melons, Pumpkins, Squash (summer),
Squash (winter)
Citrus Fruit Group:
- Grapefruit, Lemons, and Oranges
Pome Fruits Group:
- Apples and Crabapples
Stone Fruit Group:
- Cherries
Small Fruit and Berries Group:
Blackberries, Blueberries, Boysenberries, Cranberries,
Currants, Dewberries, Gooseberries, Grapes, Huckleberries,
Loganberries, Raspberries, and Strawberries
Avocado
Kiwifruit (pending use)
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4. The Agency has also determined that certain label restrictions
and revisions are necessary. These include:
Ingredient Statement
Precautionary Statements
Environmental Hazards Statements
Use of Water from Treated Cranberry Bogs
Applicator Restriction for Greenhouse Uses
Protective Clothing Requirements
Reentry Interval
Signal Word Revision
The Regulatory Position and Rationale section discusses the
Agency's position on each of these restrictions and the Required
Labeling section contains the specific wording required for each
of the labeling revisions.
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B. PRELIMINARY RISK ASSESSMENT
Numerous data gaps exist for folpet and few definitive conclusions
can be made pending receipt of the required data. The following
assessment is based on the data available and, therefore, is
subject to change.
1. Acute Toxicity. Adequate data are not available to determine
conclusively the acute toxicity of folpet. However, based on the
available acute eye irritation data, folpet is classified
as a Toxicity Category II pesticide and must bear labeling with
the signal word "WARNING".
Studies with rabbits indicate that technical folpet causes
reversible corneal opacity that can be prevented by immediately
washing the exposed eyes.
Acceptable data are not available to satisfy the testing
requirement for acute inhalation toxicity. The data which
are available indicate that the 4-hour LC5Q in rats is 1.3 to
5.0 mg/L, and in mice is greater than 6 mg/L. An acceptable
acute inhalation study is required.
The acute oral LD$Q in mice is 2.44 g/kg, in male rats is
43.8 g/kg, and in female rats is 19.5 g/kg. The acute dermal
LD5Q for rabbits is greater than 5.0 g/kg, the only dose tested.
Studies with rabbits indicate that technical folpet does not
cause primary skin irritation. It is however, a skin
sensitizer.
2. Subchronic Toxicity. Adequate data are not available to
determine conclusively the subchronic toxicity of folpet.
A 90-day feeding study in the rat demonstrated decreased
growth, decreased relative brain weights, decreased total
blood protein, and histological evidence of irritation to the
stomach after exposure to dietary concentrations of
10,000 ppm (1000 mg/kg/day), the highest dose tested. The
NOEL for these effects was 3000 ppm (300 mg/kg/day).
A 90-day feeding study in which dogs were administered
technical folpet by capsule demonstrated that a dose of
4000 mg/kg/day could not be tolerated, as all males and 1/4
females were sacrificed in a moribund condition. Dose-related
decreases in weight gain were noted in all treated dogs; a
NOEL for this effect was not established at the lowest dose
tested (LOT) of 790 mg/kg/day. A dose-related increase in
testicular atrophy was also noted at all doses tested; a NOEL
for this effects was not established.
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There are no data available on subchronic dermal toxicity. A.
subchronic dermal study is required because folpet has
registered indoor and outdoor domestic uses that can result
in dermal exposure.
There are no data on subchronic inhalation toxicity of folpet;
the need for such data will be determined after an acceptable
acute inhalation toxicity study is submitted and reviewed.
Chronic Feeding/Oncogenicity Data. A. chronic feeding study
in rats is not acceptable at present; additional data are
required to make that study acceptable. Tn that study a dose-
related increase in the incidence of hyperkeratosis/acanthosis,
erosion and ulceration of the stomach were noted in mid- and
high-dose males and females. The NOEL for these lesions was
200 ppm (the lowest dose tested). Until the analysis of test
diets and an explanation of the findings of "medullary tubule
hyperplasia of the ovary, spongiosis hepatis and foci of
vacuolated hepatocytes of the liver" are submitted, the NOEL
is considered tentative. Deadline for submission of these
data are within three (3) months from the registrants' receipt
of this Registration Standard.
A one-year chronic oral toxicity study in dogs at doses of
10, 60 and 120 mg/kg/day administered in gelatin capsules
caused non-significantly reduced mean body weight gains in
both males and females at 60 and 120 mg/kg/day. Mean food
consumption was also reduced in these animals. Cholesterol,
total protein, albumin, and globulin values were decreased in
mid- and high-dose males and high-dose females. There were
no organ weight changes or histologic findings that were
considered to be associated with the doses of administered
folpet. Based on changes in body weight and clinical
biochemistry, the Lowest Observed Effects Level (LOEL) was
60 mg/kg/day, which results in a NOEL of 10 mg/kg/day.
A. Mouse Studies - Oncogenicity
In a CD-I mouse oncogenicity study (Wong et al, MRID 125718)
folpet caused a statistically significant, dose-related
increase in the incidence of duodenal adenocarcinomas, The
mice were fed a diet containing 0, 1000, 5000, and 12000 ppm
(0 mg/kg, 142.9 mg/kg, 714.5 mg/kg, and 1714.8 mg/kg,
respectively). The oncogenic effect occurred in both sexes
with an incidence of about 50 percent at the highest dose
tested, which was 10,000 ppm (1429 mg/kg) when calculated on
a time-weighted average dose using analytical diet concentra-
tions .
This tumor was not observed in any control mice in this study.
Duodenal adenocarcinoma is an uncommon tumor in CD-I mice,
and was observed mainly in animals at final sacrifice, although
11
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this tumor was noted in animals that died during the test as
early as week 55 for males and week 79 for females. The
treatment did not affect survival of the mice. The tumors
noted in the duodenum were accompanied by a large increase in
the incidence of mucosal hyperplasia, a preneoplastic change,
in all treatment groups. A NOEL for this effect was not
established because the incidence was statistically increased
in all dose groups.
An apparent dose-related increase in the incidence of papilloma
of the stomach, a benign tumor, was also noted in this study
in mid- and high-dose males, but not females. This increase
was statistically significant by the trend test; however,
pair-wise comparisons did not yield a significant result. A
similar dose-related increase in the incidence of mucosal
hyperplasia and other concurrent toxicity to the stomach was
not noted in either sex.
A virtually identical response was observed in a 2-year
feeding study conducted with the B6C3F1 mouse (Rubin, MRID
151075), in which animals were exposed to diets containing 0,
1000, 3500, and 7000 ppm (0 mg/kg, 142.9 mg/kg, 500.1 mg/kg,
and 1000.3 mg/kg, respectively) of folpet.
A dose related increase in the incidence of duodenal adeno-
carcinomas was observed in all test groups. The observed
incidence was about 50% at the highest dose tested in both
males and females. This tumor was noted only in treated
mice, and was not observed in any control animals.
The observed oncogenic response in the duodenum was accompanied
by a dose-related increase in the incidence of hyperplasia
and proliferation of duodenal mucosal glands, which was noted
in all male and female treatment groups, but not in any
control animals. A NOEL for mucosal hyperplasia was not
established in this study.
A statistically significant increase in the incidence of
papillomas of the nonglandular stomach was also noted in high-
dose females, which was significant for trend as well as by
pair-wise comparison. This effect was accompanied by an
increased incidence of hyperkeratosis/acanthosis of the
esophagus and nonglandular mucosa of the stomach, which was
noted in all male and female treatment groups, with no reported
incidence in control animals.
In addition to the response in the gastrointestinal tract,
an increased incidence of malignant lymphoma was noted in
high-dose females (41%, as compared to an incidence of about
25% in control, low- and mid-dose groups). This effect was
statistically significant (p < 0.005).
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B. Rat Studies - Oncogenicity
In an oncogenicity study in Sprague-Dawley rats, diets
containing 0, 200, 800, and 3200 ppm (0 mg/kg, 10 mg/kg,
40 mg/kg, and 160 mg/kg, respectively) of folpet did not
cause an oncogenic response. A second oncogenicity study in
the rat is currently under review.
C. Oncogenicity Classification
On the basis of the clear oncogenic response in two mouse
studies with two strains of mice, the demonstrated genotoxicity
of folpet, and structural similarity to the oncogen captan,
the Agency concluded that folpet should be classified as a
group B2 oncogen (probable human carcinogen) under the Agency's
Guidelines for Carcinogen Risk Assessment (51 Federal Register
33992, September 24, 1986).
D. Risk of Oncogenicity
1. Dietary
A Qi* of 3.49 x 10~3 has been calculated for the CD-I mouse
study- The results of the B6C3F1 mouse study were similar.
Based on the estimated exposure from residues at tolerance
levels of 0.09 mg/kg/day (obtained under the "Food Factor"
system), and assuming 100% of all foods have tolerance level
residues and 100% of the crop is treated with folpet, the
cancer risk from dietary exposure to folpet is calculated as:
Risk = Exposure x Qx* = 0.09 x 3.49 x 10~3 = 3.1 x 10~4
The Agency is requiring residue data for each of the registered
crop uses of folpet. These data are required to be submitted
within 42 months after receipt of this Standard by the
registrant. The dietary risks are expected to be lower than that
presented above, when dietary risks are calculated"based on
actual residues of folpet.
Information from monitoring studies conducted by the Food
and Drug Administration (FDA) and by the National Food
Processor's Association (NFPA), support the Agency's expectation
that dietary risks will be significantly reduced based on
actual residues in food, and percent of crop treated. Using
the residue levels of folpet reported by FDA and NFPA from
sampling of raw agricultural commodities, and considering
percent of crop treated, the oncogenic risk from dietary
exposure to folpet is calculated to be 7 x 10"^ . The
information from FDA and NFPA is a result of random sampling
of raw agricultural commodities and is, therefore, incomplete.
After receipt and review of the residue data required through
this Registration Standard, the Agency will be able to more
accurately calculate the dietary oncogenic risks from folpet
use.
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2. Dermal Exposure (mixers/loaders/applicators)
To determine the estimated dermal absorption of folpet the
Agency reviewed 1) data on structurally similar chemicals
(i.e., captan and captafol) and 2) an unpublished study
(MRID 40199101) which assessed the dermal penetration
potential of 14 chemicals (including folpet). While this
study is not sufficient to fulfill guideline requirements
it can be used to perform a preliminary assessment of the
dermal penetration potential of folpet. A dermal penetration
study on folpet is being required through this Registration
Standard.
These data indicate that the appropriate value for dermal
risk calculation is 2.7% absorption over 72 hours. Using the
Agency's average exposure estimates of 7 mg/kg and a duration
of exposure of 11.3 hours, the dermal penetration potential
was corrected by a factor of 11.3/72, resulting in a value of
0.42% dermal penetration of folpet.
An analysis of dermal exposure to mixers, loaders, and
applicators showed that the greatest chronic exposure results
from the treatment of grapes, 24.8 mg/kg/yr. This value is
due solely to dermal exposure. The analysis was based on an
assumption that there would be insignificant exposure from
inhalation. Based on 0.42% dermal penetration and the Qj_* of
3.49 x 10~3 the oncogenic risk to mixers, loaders and
applicators is calculated as follows:
Cancer Risk = Exposure x QI*
Cancer Risk = 24.8 mg/kg/yr x 0.42% x 3-49 x 10~3
365 days/yr
= 9.95 x 10-7
The risk calculated above is based on the incidence of duodenal
tumors observed in the mouse feeding studies. As the half-
life of folpet per s£ in blood is approximately one minute,
there is little likelihood in the Agency's opinion that dermal
exposures could result in duodenal tumors. However, the
induction of skin tumors as a result of dermal exposures is a
possibility that must be considered. Further, a high degree
of skin toxicity (hyperkeratosis, and other effects) was
noted in the mouse oncogenicity study, which suggests that
skin may also be a target for folpet toxicity in exposed
humans.
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4. Developmental Toxicity Acceptable studies have been submitted
in two species to satisfy this Guideline requirement. These
studies are discussed below.
A. Developmental Effects Toxicity Studies
A teratology study in the rat tested the effects of 0, 10,
60, and 360 mg/kg/day by gavage. No evidence of teratogenicity
was noted at the highest dose tested of 360 mg/kg/day. The
NOEL for maternal toxicity was 10 mg/kg/day based on decreased
body weight gain and increased incidence of clinical signs of
toxicity at doses of 60 and 360 mg/kg/day. The NOEL for
developmental toxicity was established as 60 mg/kg/day based
on slight increases in ossification delay observed in fetuses
from high-dose dams. Although this finding has minimal
toxicological relevance and was not statistically significant,
it is considered to be treatment-related.
A teratology study in the New Zealand White rabbit tested the
effects of 0, 10, 20, and 60 mg/kg/day by gavage, and
demonstrated a teratogenic response in the form of hydro-
cephalus and altered development of skull bones (irregularly
shaped fontanelles, holes in parietal bones). An increased
incidence of these effects was noted in fetuses of mid- and
high-dose animals. The NOEL for developmental toxicity is
therefore, 10 mg/kg/day. Maternal toxicity in the form of
decreased food consumption and body weight gain was also
noted in mid- and high-dose rabbits; the NOEL for maternal
toxicity is also 10 mg/kg/day.
A second teratology study in the New Zealand White rabbit
assessed the developmental effects of 60 mg/kg/day administered
by gavage in a "pulse dosing" schedule. In this study- the
dose (60 mg/kg/day) previously demonstrated to produce
hydrocephalus (when administered over the entire gestation
period) was administered to different groups of rabbits for
3-day periods during gestation. A treatment-related increase
in the incidence of hydrocephalus was not produced by this
treatment paradigm; however, increases in the incidence of
"irregularly shaped fontanelles" were observed in rabbits
dosed over days 13 to 15 of gestation. Maternal toxicity in
the form of alterations in food consumption and weight gain
was also noted in treated does. Since only a single dose was
tested, 60 mg/kg/dayr a NOEL for developmental toxicity was
not established in this study.
A teratology study conducted in HY/CR rabbits tested the
developmental effects of folpet when administered at doses of
10, 40, and 160 rng/kg/day by gavage over days 7 to 19 of
gestation. The NOEL for developmental toxicity was tentatively
established as 10 mg/kg/day, based on findings of delayed
ossification at 40 mg/kg/day. The NOEL for maternal toxicity
was established as 40 mg/kg/day, based on clinical signs and
decreases in body weight gain at 160 mg/kg/day. The NOEL's
are provisional values pending further clarification by the
registrants of some of the effects noted in the study.
15
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B. Risk of Developmental Effects
1. Dietary
Developmental effects toxicity of folpet was demonstrated in
the rabbit teratology study discussed above. The risk of
this hazard was analyzed using the Tolerance Assessment System
(TAS) (Saunders, et_ a^, 1986, Introduction to the Tolerance
Assessment System, an EPA Publication). The acute (single-
day) exposure to folpet from consumption of food containing
tolerance level residues was determined for females aged 13
years and older. The average single-day dietary exposure for
this group was calculated to be 0.11 mg/kg/day- Using the
NOEL of 10 mg/kg/day for maternal and developmental toxicity
in the rabbit teratology study, this exposure results in a
Margin-of-Safety (MOS) of 90 for the average consumer of
foods (containing residues at tolerance levels) in this
population subgroup.
If the distribution of food consumption within this subgroup
is considered, the TAS analysis indicates that 15% of the
subpopulation is predicted to have a single-day intake of
0.2 mg/kg/day or greater, and the highest 5% of the consumers
in this subpopulation is predicted to have a single-day
intake of 0.3 mg/kg/day or greater. These exposures result
in MOS"s of 50 and 33, respectively. As these values are
based on tolerance levels rather than actual residues in or
on food at the time of consumption, a more meaningful dietary
risk assessment for developmental hazard would require better
estimates of actual residues of folpet that are consumed
with food. The Agency will refine its dietary risk assessment
when additional data are submitted and reviewed.
2. Mixers/Loaders/Applicators
An acute exposure analysis performed by the Agency indicates
that an acute exposure of 7 mg/kg/day would be predicted for
a mixer/loader/applicator. This exposure would result in a
MOS of 340 based on 0.42% dermal penetration and the NOEL for
developmental toxicity of 10 mg/kg/day noted in the two rabbit
studies.
The highest predicted acute dermal exposure from homeowner
uses is 0.05 mg/kg/day, which produces a MOS of 47,000 based
on 0.42% dermal penetration.
There are no exposure data available to estimate developmental
risks to applicators of paint and stain end-use products
containg folpet. Exposure data which are being required
through this Registration Standard will allow the Agency to
more realistically assess the exposure and potential risk to
this group of people.
16
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Exposure of industrial workers to folpet may occur during
addition of folpet formulations to paints, stains, and PVC
products. No exposure data are available for folpet use in
factory settings. However, information on exposure potential
to captan (a structurally related chemical which is also
used as a paint and plastic additive) indicates that
exposure in this setting will be negligible when gloves,
protective clothing, respiratory protective devices, and work
area ventilation are employed. Protective measures such as
these are commonly prescribed by the Occupational Safety and
Health Administration which has the authority to set work
place standards in paint, stain, and plastics manufacturing
plants.
Risks to mixers, loaders, and applicators of agricultural and
commercial ornamental plant uses will be reduced by requiring
each to wear minimal protective clothing (including long
sleeved shirt, long pants, and (if the product is a dust,
granular, or wettable powder) a dust mask. Prohibition on
entering treated areas within 24 hours after application
without protective clothing will reduce exposure of workers
to folpet. These risk reduction measures are found in Section
D, Required Labeling.
5. Reproduction. A two-generation reproduction study in the rat
tested the effect of diets containing 0, 200, 800, and 3600
ppm of folpet. A NOEL for developmental/reproductive toxicity
was based on decreased fertility and decreases in pup body
weight gain in second generation (Fl) rats fed diets containing
3600 ppm nominal (3200 ppm actual, which is corrected for
percentage of active ingredient and breakdown based on analysis
of feed, equivalent to 160 mg/kg/day). The NOEL for parental
toxicity was 800 ppm nominal (690 ppm actual, equivalent to
34.5 mg/kg/day).
A mouse somatic cell mutation assay, which is in essence a
one-generation feeding study, demonstrated statistically
significant decreases in mouse pup survival at all dose
levels, with a LOEL of 76 ppm (10.9 mg/kg/day), the lowest
dose tested. It is possible that the NOEL for this apparent
effect will be lower in the mouse than the value ultimately
established in the rat, especially since histopathological
examinations were not conducted in the mouse study which may
have revealed other toxic effects. Historical control data
for the mouse reproductive effects have been received, but
not reviewed. If these data do not resolve all questions
concerning potential reproductive toxicity in the mouse,
additional studies in the mouse will be required to further
evaluate the effect.
17
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Mutagenicity. Folpet is mutagenic in Salmonella, E. Coli,
mouse lymphoma cells and in the in vrvo, Drosophila sex-
linked, recessive lethal assay- Folpet is mutagenic in these
test systems without metabolic activation. Metabolic activation
with rat liver S-9 fraction generally diminishes the mutagenic
activity of folpet.
Folpet was negative for in vivo gene mutations in the mouse
somatic cell mutation assay (mouse spot test). However,
significant pup mortality was noted in this assay and further
evaluation of this non-mutagenic finding is requried.
Folpet is negative for jlri vivo chromosome damage in the rat
bone marrow cytogenetics^assay and in the mouse dominant
lethal assay.
Folpet was negative in the mouse micronucleus assay; however,
the study was unacceptable due to inadequate dose levels.
Folpet was negative in the dominant lethal study in rats;
however, the study was unacceptable due to the lack of a
rationale for the selection of dose levels, and the lack of
individual animal data.
Although acceptable in vivo studies have been submitted,
because of the demonstrated lability of folpet in blood, and
the fact that this compound has been shown to cause intestinal
tumors, additional testing for chromosomal aberrations in an
in vivo test system is required to further elucidate the
genotoxic properties of folpet.
Folpet is positive in B. subtilis and JJ. coli DNA repair
assays, and in yeast for mitotic recombination. Metabolic
activation either had no effect or decreased mutation frequency
in the yeast assay (metabolic activation is not routinely
employed in the bacterial DNA repair assay).
18
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C. OTHER SCIENCE FINDINGS
Environmental Fate. Environmental fate data are limited
to two hydrolysis studies, two photodegration in soil studies,
and one mobility (leaching adsorption/desorption) study. None
of these studies are adequate to assess the environmental
fate of folpet. There are no acceptable environmental fate
data that meet EPA Guideline requirements. The required
environmental fate data under this Registration Standard are
listed in the Appendix in Table A.
Ecological Effects. Adequate data to meet EPA Guideline
requirements are available for the following studies;
Acute Oral Toxicity for Upland Game Bird
Species
Subacute Dietary Study - Bobwhite quail
Subacute Dietary Study - Mallard duck
Avian Reproduction Study - Bobwhite quail
Avian Reproduction Study - Mallard duck
Freshwater Fish Toxicity - Coldwater fish
on Typical End-Use Product
Acute oral toxicity studies indicated that folpet is slightly
toxic to upland game bird species. Subacute dietary toxicity
studies with bobwhite quail and mallard duck also indicate
that folpet is slightly toxic to birds when it was ingested in
the diet of these birds. The avian reproduction studies
indicate that technical folpet is not expected to cause repro-
ductive impairment.
Supplementary data indicate that technical folpet may be
very highly toxic to invertebrates. Data from a study with a
typical end-use product of folpet indicate that folpet is
toxic to aquatic invertebrates.
Studies with typical end-use products indicate that folpet
is highly toxic to both rainbow trout and bluegill sunfish.
Rainbow trout was the most sensitive species and the folpet
product tested was classified in the very highly toxic range
of toxicity for this species.
Available data on pesticides which have use-patterns similar
to folpet and which have been reviewed in consultation with
the Office of Endangered Species suggest the use of folpet
may harm endangered species. The Agency will consult with
the Office of Endangered Species to determine whether currently
registered uses of folpet will place endangered species in
jeopardy. If this consultation indicates that endangered
species are likely to be jeopardized from use of folpet, the
Agency will develop labeling restrictions to protect these
species.
Folpet is relatively non-toxic to honeybees. Adequate data
are available on the acute toxicity of folpet to honeybees.
19
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D. TOLERANCE REASSESSMENT
The established tolerances for folpet are presently expressed
as the fungicide folpet (N-(trichloromethylthio)phthalimide)
without specifying the metabolites. The Agency has no data on
the metabolism of folpet in plants. Metabolism studies with
grapes, apples, and lettuce exposed to the maximum quantity
permitted under existing registered labeling must be conducted to
resolve this data gap. Both ring- and carbonyl-labeled C^-4 folpet
must be used in these studies.
There are no established tolerances for folpet residues in
animal fat, meat, and meat by-products, or in eggs or milk.
There are no studies available on the metabolism of folpet in
animals. Therefore, metabolism studies with ruminants and poultry
using both ring- and carbonyl-labeled cl4 folpet are needed at
a level sufficient to make residue identification and quantifica-
tion possible. Milk and eggs must be collected twice daily
during the dosing period. Animals must be slaughtered within 24
hours of the final dosing. The distribution and characterization
of residues must be determined in milk, eggs, liver, kidney,
muscle, and fat. Metabolism studies utilizing carbonyl-labeled
captan may be useful as a substitute for the required carbonyl-
labeled studies with folpet because the carbonyl group is identical
for both compounds.
The gas-liquid chromatography (GLC) method of analysis for
folpet listed in the Pesticide Analytical Manual (PAM), Volume
II, Section 180.191, which is specific for folpet, is acceptable
for plant commodities. If additional metabolites of concern are
found in plants or animals, adequate methods for analyzing the
metabolites must be submitted.
20
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The following table lists the present tolerances in parts per
million (ppm) for residues of folpet:
Raw Agricultural Commodity
Residues of Folpet Parts per Million
U.S. Canada Mexico Codex
Apples
Avocados
Blackberries
Blueberries
Boysenberries
Celery
Cherries
Citrus Fruits
Crabapple
Cranberries
Cucumbers
Currants
Dewberries
Garlic
Gooseberries
Grapes
Huckleberries
Leeks
Lettuce
Loganberries
Melons
Onions (dry bulb)
Onions (green)
Pumpkins
Raspberries
Shallots
Squash (Summer)
Squash (Winter)
Strawberries
Tomatoes
25
25
25
25
25
50
50
15
25
25
15
25
25
15
25
25
25
50
50
25
15
15
50
15
25
50
15
15
25
25
25
25
25
25
25
30
25
15
25
25
15
25
25
15
25
25
25
25
25
25
15
25
25
15
25
-
15
15
25
25
25
25
-
-
-
50
-
15
-
-
15
-
-
15
25
-
-
-
50
-
15
15
50
-
-
-
15
15
25
3
10
-
-
25
-
-
15
10
-
-
2
-
-
-
-
25
-
-
15
-
2
2
2
-
15
-
-
—
20
5
The following table lists a request for EPA Pesticide Petition
for establishing tolerances for residues of folpet.
Raw Agricultural
Commodity
EPA Pesticide
Petition No.
Proposed Parts per Million
of Folpet
U.S. Canada Mexico Codex
Kiwifruit
4E3079
10
21
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There are presently no data on the storage stability of
residues of folpet and degradates of folpet in raw agricultural
commodities derived from plants and animals. Information on the
duration and conditions of sample storage prior to residue analysis
and on the stability of folpet under the storage conditions used
must be submitted to support established tolerances.
Data gaps exist for each of the raw agricultural commodities
listed in the above tables. Of particular concern is the lack of
data on the potential metabolites, the potential for residues of
folpet to exist in processed commodities derived from these raw
agricultural commodities, and the potential for residues in fat,
meat, meat by-products, milk, and eggs of domestic animals. The
data requirements to support established tolerances as listed in
40 CFR 180.191 are given in Table A, Appendix I.
There are no direct animal treatments for folpet on livestock
or poultry. At the present time, it is not possible to calculate
the maximum expected intake of folpet residues by dairy cattle,
beef cattle, poultry, or swine. The only feed items of crops
with registered uses are tomato pomace, grape pomace, citrus
fruit pulp, and apple pomace; no tolerances exist for folpet
residues in these commodities. If the required animal metabolism
data demonstrate that detectable residues of concern may occur in
animals from registered uses, then data quantitating the magnitude
of the residue in animals will be required. Specific data
requirements will be detailed at that time.
The Theoretical Maximum Residue Contribution (TMRC) from
established tolerances is 7.362 mg/day (equivalent to an exposure
of 0.1227 mg/kg/day for a 60 kg person) based on a 1.5 kg diet
and a 60 kg person. Based on a one-year chronic oral toxicity
study in dogs, the Provisional Acceptable Daily Intake (PADI)
was established at 0.10 mg/kg/day, based on the NOEL of
10 mg/kg/day and a 100 fold uncertainty factor to account for
data gaps and extrapolation from animal data to humans. The
Maximum Permissible Intake (MPI) for a 60 kg person is, therefore,
6.0 mg/day. Using this value, existing tolerances utilize 123%
of the PADI, based on non-oncogenic effects. The TMRC is a
conservative estimate because it does not consider the effect of
processing on residue levels in the raw agricultural commodities,
that actual residue levels may be lower than the established
tolerances, and that less than 100 percent of the crop is treated.
Available FDA monitoring data for folpet indicate that actual
residues are less than tolerance levels.
22
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IV. REGULATORY ASSESSMENT
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data on folpet,
the Agency has made the following determinations:
1. The Agency will not place Folpet into Special Review at
this time.
Rationale; Studies with folpet demonstrate that a) it is a
probable human carcinogen (group B2), b) is a mutagenic agent
in certain assays for mutagenicity, c) results in developmental
effects (toxicity) in rabbits and may be a potential human
teratogenic pesticide, and d) is highly toxic to fish (see
Section III, Agency Assessment). However, data currently
available to the Agency do not demonstrate that the risk is
of concern in terms of the degree of risk to individual
humans or the number of humans at some risk (Criteria for
Initiation of Special Review, 40 CFR 154.7). Further, data
are not available which demonstrate that use may result in
residues in the environment which will equal or exceed
concentrations acutely or chronically toxic to non-target
organisms.
a) Based on a Q^* of 3.5 x 10~3 and the estimated Theoretical
Maximum Residue Contribution obtained under the "Food Factor"
system, the cancer risk from dietary exposure is 3.1 x 10~4.
This risk estimate is based on tolerance level residues and
100% of crop treated, As demonstrated by monitoring data
provided by the Food and Drug Administration and the National
Food Processors Association (see Section III, Agency Assessment),
actual residues of folpet are likely to be significantly
lower. When residue data required through this Registration
Standard are received and reviewed, the Agency will reassess
the risks from dietary exposure and consider whether further
regulatory action is warranted. Oncogenic risks from dermal
exposure are not considered likely because folpet's half-life
in blood is only one minute.
b) While folpet is a mutagenic agent in certain assays for
mutagenicity and may have mutagenic potential in humans.
Additional data must be submitted to evaluate the potential
for mutagenicity of folpet. Specifically, an _in vitro study
of chromosome aberration must be submitted to the Agency to
further evaluate the potential mutagenicity of folpet.
23
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c) The Agency has calculated the single-day dietary exposure
for females aged 13 years and older to be 0.11 mg/kg/day.
Using the NOEL from the rabbit teratology study (10 mg/kg/day)
for maternal and developmental toxicity, this exposure would
result in a margin-of-safety (MOS) of 90.0 for developmental
effects. As these values are based on tolerance level residues
rather than actual residues on food, data are likely to
indicate that the MOS is significantly higher.
When residue data are submitted as required by this
Registration Standard, the Agency will recalculate the
developmental effects risk from dietary exposure and
determine whether further regulatory action is warranted.
Based on the NOELs for maternal and developmental toxicity;
an acute exposure estimate of 7 mg/kg/day for mixers,
loaders and applicators; and an assumed dermal absorption
of 0.4%, the MOS for developmental effects for mixer,
loaders, and applicators is 340. The highest predicted
dermal exposure for homeowner use is 0.05 mg/kg/day resulting
in a MOS of over 47,000.
d) While data demonstrate that folpet is highly toxic to
fish the Agency lacks data to demonstrate whether exposure
will be significant from currently registered uses of
folpet. Data required through this Registration Standard
will allow the Agency to reassess the risk to aquatic
organisms and determine whether further regulatory action
is necessary.
2. The Agency will not register any new food uses of folpet
until additional residue chemistry and chronic toxicology
data are submitted as required through this Registration
Standard; are found to be acceptable for assessing the
proposed uses; and demonstrate that the proposed uses will
not result in unreasonable risk.
Rationale; Based on available data the TMRC utilized 123%
of the PADI. Until data are available to definitively
demonstrate that residues do not occur at tolerance levels
and to further define the potential risk from exposure,
the Agency will not grant any food uses or tolerances.
Existing regulations specify data requirements for food
crop uses. As there are data gaps for existing food uses,
no further food use registrations will be acceptable until
these data gaps have been resolved.
24
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3. In order to meet the statutory standard for continued
registration, the Agency is requiring all folpet products
to be labeled with the Signal Word "WARNING" and to bear
appropriate labeling precautions for potential risk of
hazard from eye exposure.
Rationale; Technical folpet, in a primary eye irritation study
with rabbits, caused corneal opacity that was present up to
7 days, but was not present after 10 days. The effects
were prevented by immediately washing the eyes. Data are not
available to assess the potential of other formulations
containing less folpet to cause these effects. Until
acceptable data are submitted which demonstrate that a
particular product does not warrant classification as Toxicity
Category II, all products containing folpet must bear labeling
specified for Toxicity Category II, to protect against the
potential eye hazard associated with folpet.
4. In order to meet the statutory standard for continued
registration, the Agency is requiring an interim 24-hour
reentry interval for agricultural crop uses of folpet
until required reentry data have been submitted, evaluated
and found to support a different reentry interval.
Rationale: Folpet meets the toxicity criteria of 40 CFR
158.140 related to reentry restrictions because there is
evidence which indicates that it is oncogenic, mutagenic and
causes developmental effects. It also meets the exposure
criteria for requiring a reentry period, because it is registered
for uses which involve substantial exposure of agricultural
workers to residues of folpet. Until data are submitted, as
required in Appendix I, which demonstrate that either a
longer or shorter reentry interval is appropriate for folpet,
the interim 24-hour reentry interval will serve to reduce
post-application exposure to folpet.
5. The Agency is requiring the following studies to support all
existing tolerances in agricultural commodities: plant and
animal metabolism, storage stability, and analytical
methodology.
Rationale; Metabolism of folpet in plants and animals has
not been adequately defined. Plant and animal metabolites
have not been quantified. No storage stability data are
available for plant and animal tissues.
25
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5. The Agency is requiring additional residue chemistry data for
all established tolerances for folpet. Processing studies are
required for tomato pomace, grape pomace, citrus fruit pulp,
and apple pomace. If animal metabolism data demonstrate
that detectable residues of concern may occur in animals from
registered uses, then data quantitating the magnitude of the
residue in animal tissues will be required.
Rationale; Residue chemistry data gaps exist for these
areas and such data are required to support the established
tolerances for residues of folpet. These data are required
to quantify human dietary exposure and for regulating the
use of folpet to protect the public.
7. In order to meet the statutory standard for continued
registration, the Agency is requiring the use of certain
minimum protective clothing and equipment for manufacturing-
use products (MPs) and end-use products (EPs). The required
labeling language is found in Section IV.D. of this document.
Rationale: Based on the potential risk of oncogenicity,
developmental effects observed in the rabbit teratology
studies and the positive mutagenicity studies, the Agency
finds these requirements necessary to protect the public.
The specific protective clothing and equipment requirements
will reduce exposure to folpet products and decrease the
risk of use.
8. In order to meet the statutory standard for continued regis-
tration, the Agency is requiring labeling of all MPs and all
EPs to reflect the high toxicity of folpet to fish and to provide
proper use precautions. The required labeling is found in
Section IV.D. of this document.
Rationale; Studies with fish demonstrate that folpet is
highly toxic to rainbow trout and bluegill sunfish. Discharge
of effluent containing folpet into lakes, streams, ponds,
estuaries, oceans or public water must be regulated to minimize
exposure to aquatic organisms.
9. In order to meet the statutory standard for continued regis-
tration, the Agency will require all products bearing
directions for incorporation of folpet during manufacture
of paints, building materials and fabrics to clearly
indicate on the front panel that they are "For Industrial
Use Only". Such products must not include uses other
than those that are classified as industrial uses as
described in 40 CFR Part 158, Appendix A. 12.
26
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Rationale; Industrial processes that incorporate folpet
into manufactured products will result in negligible exposure
to workers when gloves, protective clothing, respiratory
protective devices and workplace ventilation are employed as
commonly prescribed by OSHA (see Preliminary Risk Assessment,
section III.B.4.). The Agency believes that users of folpet
products in these industrial, manufacturing settings will be
adequately protected from exposure based on OSHA standards.
Since the labeling of folpet products intended for these uses
will not carry any protective clothing requirements under
FIFRA, the Agency must ensure that these products are not
used outside the setting over which OSHA has workplace safety
authority. Labeling which clearly states that these products
are for industrial use only, will provide that assurance.
10. In order to meet the statutory standard for continued regis-
tration, the use-pattern for foliar application of folpet
in the culture of cranberries must reflect use-precautions to
protect fish and aquatic organisms in the neighboring
areas. The required labeling language is found in Section
IV.D. of this document.
Rationale: Studies with fish demonstrate that folpet is
highly toxic to rainbow trout and bluegill sunfish. Drift
from foliar applications of folpet to cranberries may be
hazardous to fish and other aquatic organisms in the aquatic
areas adjacent to the areas being treated.
11. While the data gaps are being filled currently registered MPs
and EPs containing folpet as an active ingredient may be
sold, distributed, formulated and used, subject to the terms
and conditions specified in this Standard. Registrants must
provide or agree to develop additional data, as specified
in the Data Appendices of this document, in order to main-
tain existing registrations.
Rationale: Under FIFRA, the Agency may choose not to cancel or
withold pesticide registration if data are missing or inade-
quate (See FIFRA sections 3(c)(2)(B) and 3(c)(7)).
Issuance of this Registration Standard provides a mechanism
for identifying data needs. These data will be reviewed
and evaluated, after which the Agency will determine if
additional regulatory action is warranted.
27
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain folpet as the sole active ingredient, bear required
labeling, and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain folpet 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 ingre-
dient and inert ingredients that are present in products, as
well as impurities found at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing folpet provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
3 . Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the uses listed below. The Use Index lists all registered
uses, as well as approved application rates and frequencies.
- Terrestrial food crops; apples, avocados, blackberries,
blueberries, boysenberries, celery, cherries, citrus
fruits, crabapples, cranberries, cucumbers, currents,
dewberries, garlic, gooseberries, grapes, huckleberries,
leeks, lettuce, loganberries, melons, onions (dry bulb),
onions (green), pumpkins, raspberries, shallots, squash
(summer), squash (winter), strawberries, and tomatoes.
- Domestic outdoor; ornamental plants, in paints and
coatings, and in plastics as listed in the EPA Use
Index.
- Domestic indoor; ornamental plants, in paints and
coatings, and in plastics as listed in the EPA Use
Index.
28
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D. REQUIRED LABELING
All products must bear appropriate labeling as specified in
40 CFR 162.10 and PR Notices 83-2 and 83-3. Appendix II contains
information on label requirements,
No pesticide product containing folpet may be released
shipment by the registrant after August 1, 1988 unless the
product bears an amended label which complies with the requi
ments of this Standard.
for
requ ire-
No pesticide product containing folpet may be distributed,
sold, offered for sale, held for sale, shipped, delivered for
shipment, or received and (having been so received) delivered or
offered to be delivered by any person after August 1, 1989
unless the product bears an amended label which complies with
the requirements of this Standard.
In addition to the above, the following information must
appear on the labeling of folpet products by the dates stated
above for products relased for shipment and in commerce.
1. Ingredients Statement
The ingredient statement for MPs and EPs must identify
the active ingredient as:
Active Ingredients By Wt.
Folpet (N-(Trichloromethylthio)
phthalimide) %
Inert Ingredients %
2. Precautionary Statements
a. All products, MPs and EPs, must bear the following
precautionary statement:
"WARNING
Causes substantial but temporary eye injury. May cause an
allergic skin reaction. Harmful if swallowed or inhaled.
Do not get in eyes, on skin or on clothing. Avoid breathing
dust or liquid aerosols. Wear goggles or face shield
when handling. Wash thoroughly with soap and water
after handling. Remove contaminated clothing and
separately launder clothing before reuse."
29
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3. Environmental Hazards Statements
a. Manufacturing-Use Products
All MP labeling must bear the following environmental
hazard statement:
"This product is highly toxic to fish. Do not discharge
effluent containing this product into lakes, streams,
ponds, estuaries, oceans or public water unless this
product is specifically identified and addressed in an
NPDES permit. Do not discharge effluent containing
this product to sewer systems without previously
notifying the sewage treatment plant authority. For
guidance contact your State Water Board or Regional
Office of the EPA."
b. End-Use Product Statements
i. All EP labeling which permits foliar application
and which does not contain directions for use on cranberries,
must bear the following environmental hazard statement:
"This pesticide is highly 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 contaminate water by
cleaning of equipment or disposal of wastes."
ii. All EP labeling which permits foliar application
and which does contain directions for use on cranberries,
must bear the following environmental hazard statement:
"This pesticide is highly toxic to fish. Do not
apply directly to water or wetlands (swamps, bogs,
marshes, and potholes) except in the cultivation of
cranberries. In all cases, 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."
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4. Use Statements and Worker Protection
a. Manufacturing Use Products - None
b. End Use Products - The following statements must be
included in the "directions for use" as specified:
i. All EPs labeled for Agricultural Uses, Commercial
Ornamental Plant Uses, and Greenhouse Uses must bear the
following statement:
"Wear goggles or face shield, long sleeved shirt and
long pants when mixing, loading and applying this
product. Wash thoroughly with soap and water after
handling. Remove contaminated clothing and separately
launder clothing before reuse."
ii. EPs in the form of a dust, granular, or wettable
powder which are labeled for Agricultural Uses,
Commercial Ornamental Plant Uses, and Greenhouse Uses
must bear the following statement in addition to that
specified in 4.b.i. above:
"A dust mask or similar protection against particle
inhalation must be worn when mixing, loading and
applying this product."
iii. All EPs which are labeled for use in Commercial
Greenhouses must bear the following statement in addition
to the appropriate statements in 4.b.i and 4.b.ii. above:
"Only the applicator is permitted to be in the
greenhouse during application of folpet. Greenhouse
vents must be open during application and remain
open for at least 1 hour after application."
iv. All EPs labeled for Homeowner or Household
Uses (Yards and Gardens, Houseplants) must bear the
following statement:
"Wear goggles or face shield when handling. Remove
contaminated clothing and separately launder clothing
before reuse. Wash thoroughly with soap and water
after handling."
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v. All EPs labeled for Agricultural Crop Use
(except seed piece and plant propagule treatments)
must bear the following statements:
"Do not enter treated areas for 24-hours after
application unless wearing long sleeved shirt,
long pants, and a dust mask or similar protection
against particle inhalation."
"Water from cranberry bogs in which cranberry plants
have been treated with folpet, must not be used for
irrigation of crops unless folpet is registered
for use on that crop."
vi. All EPs labeled for Industrial Use, for
incorporation of folpet during the manufacture of paints,
building materials and fabrics, must include the following
statement on the front panel of the label:
"For Industrial Use Only"
Such product labeling may not include uses
other than those classified as "industrial" uses as
described in Appendix A.12. of 40 CFR Part 158.
5. Statements of Practical Treatment
All MPs and EPs must bear the following statements of
practical treatment:
"If in eyes; Flush with plenty of water. Call
a physician.
If swallowed; Promptly drink a large guantity
of milk, egg whites, gelatin solution, or,
if these are not available, drink large quantities
of water. Do not drink alcohol."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered "products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec,
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe, In
such cases, the Agency generally will not grant a time extension
for submitting the data.
4 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 are not now 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.
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 sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of. the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into^ an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You requestthat.EPA, not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B) (iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request.a.waiver^ of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request _th_at EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the_ registration
of your product(s) for which the data are needed^
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E. Testing Protocols, Standards for Conducting Acceptable
Tests/ Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note , however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W. , Washington, D.C.
20006.
F * Procedures ^Qc requesting a change in testing protocol .
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use,
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G . Procedures for requesting extensions of__t_in\e_ .
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
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extension which 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 by the 90-day 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 at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission 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.
A request for an extension does not 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.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. 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 IV.D of this Registra-
tion 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 IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit 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.^
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, 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 Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring. )
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
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.
d. Product Specific Data Report (EPA Form 8580-4).
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 schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 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 (EPA Form 8570-27),
if applicable.
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2< Within the time frames 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 schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit 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 (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. 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 indication 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 IV
(Regulatory Position and Rationale).
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D. Intrasjtate Products containing the subject pesticide either
as sole active ingredient or in combination with other
act iye ing re d i e n t s•
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Richard F. Mountfort (PM 23)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Commpliance
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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APPENDIX I
DATA APPENDICES
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
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,
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TGUIDE-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
tiKTs 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.
N0_ ~ 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 5 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.
48
-------
TAJBLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Does B?A Have Data
To Satisfy This Must Additional
Test 1/ Use 2/ Requirement? (Yes, Bibliographic Data Be _3/
Data Requirement Substance Patterns No or Partially) Citation Submitted? (Time)
§158.135 Toxicology
ACUTE TESTING :
81-1
81-2
81-3
81-4
£81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritaion - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization
- Acute Delayed
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TCAI
A,B,C,D,E,F,G,H,I
A,B,C,D,E,F,G,H,I
A,B,C,D,E,F,G(H,I
A,B,C,D,E,F,G,HfI
A,B,C,D,E,F,G,H,I
A,B,C,D,E,F,G,H,I
N/A
Yes
Yes
No
Yes
Yes
Yes
00144057, 00137695
00141728
001 60444
001 60430
001 60431
No
No
Yes (9 months)
No
No
No
N/A
Neurotoxicity -
9JBCHRONIC TESTING:
82-1 - 90-Day Feeding -
-Rodent
-Non-rodent (dog)
TGAI
TGAI
A,C,D,E,I
A,C,D,E,I
Yes
No
00115269
No
Yes5 (18 months)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POLPET
Does EPA Have Data
To Satisfy This
Test I/ Use 2/ Requirement? (Yes,
Substance Patterns No or Partially)
Data Requirement
Bibliographic
Citation
Must Additional
Data Be 3/
Submitted? (Time)
§158.135 Toxicology (Cont.)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal^
82-4 - 90-Day Inhalation
Rat
82-5 - 90-Day Neurotoxlcity-11
Hen/Mammal
CHRONIC TESTING:
83-1 - Chronic Toxicity -
-Rodent, and
-Non-rodent
83-2 - Oncogenicity Study -
-Rat, and
-Mouse
83-3 - Teratogenicity -
-Rat, and
-Rabbit
83-4 - Reproduction,
2-generation
-Rat
-Mouse
TGAI A,B,C,D,E,P,G,H,I No
TGAI N/A
TGAI Reserved6
TGAI
TGAI
TGAI
TGAI
TGAI
N/A
A,C,D,E
A,C,D,E
A,C,D,E
A,C,D,E
Yes (12 months)
No
Reserved6
No
Partially 00151560
Yes 00161315
Reserved?
No
Yes
Yes
Yes
Yes
00151560 No
00125718, 00151075 No
00132456, 00132457 No
00160432 No
Yes 00151489 No
Partially 00148625, 00149567 ReservedS
-------
TABLE A
GENERIC DATA.REQUIREMENTS FOR FOLPET
Data Requirement
Test I/
Substance
Use 2/
Patterns
Does EPA Have Data
To Satisfy This
Requ irement? ( Yes ,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be 3/
Submitted? (Time)
§158.135 Toxicology (Continued)
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
TGAI A,C,D,E Yes
TGAI A,C,D,E Partially9
TGAI A,C,D,E Yes
00160435,00132582,GS0630-001 No
00143567,00148625
00153085,00132582 Yes
(12 months)
00132582
No
85-1 - General Metabolism PAI or PAIRA A,C,D,E No
A
85-2 - Domestic Animal Safety^ Choice
85-3 - Dermal Penetration PAIRA A,C,D,E No
Yes (24 months)
No
Yes (12 months)
I/ Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
~ test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aqautic, Food Crop;
~~ D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted within the number of months specified below, starting from date of receipt of this Standard.
4/ This study is not required.
V Additional subchronic toxicity will not be required if an acceptable chronic feeding study in a non-rodent
~~ species is submitted.
6/ This requirement is reserved pending submission and review of acute inhalation toxicity data.
T/ Data from a chronic toxicity study in a rodent species will be required 50 months from the date of reciept of
~~ this Standard, unless the following information regarding the rat study (EPA MRID 00151560) are submitted within
3 months from the date of receipt of this Standard and found acceptable: (a) results of diet analyses and (b)
an explanation of the findings described as "medullary tubule hyperplasia of the ovary" and "spongiosis hepatis"
of the liver, particularly as it relates to "fatty change" and "foci of vacuolated hepatocytes" in that tissue.
8/ Historical control data are required to complete the evaluation of reproductive effects in mice. If the
~~ additional data do not satisfy this data requirement, a new two generation reproductive study in mice must be
submitted within 50 months from the date of receipt of this Standard.
9/ This requirement is only partially satisfied by the submitted in vivo studies. Additional testing for chromosomal
~~ aberrations in an in vitro test system is required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Data
§158
Requirement Test Use Does EPA Bibliographic
Substance1/ Pattern2/ Have Data? Citation
.145 Wildlife and
Must Additional Time Frame
Data be for
Submitted? Submission^/
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-4
71-5
- Acute Avian Oral Toxicity TGAI
- Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and
- Waterfowl
- Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
- Simulated Field Testing TE?
- Mammals , and
- Birds
- Actual Field Testing TE?
- Mammals, and
- Birds
A.C.H Yes 00112793
Partially 001 1 51 98V
A,C,H Yes 00112794
A,C Yes 00112795
A,C YesV 00098004
A,C Yes 00098005
_ No
No
_ No
No
No
No
No
No
No
No
No
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Data
§158
Requirement
.145 Wildlife and
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1
ji
jO
72-2
72-3
72-4
72-5
- Freshwater Pish Toxicity
- Coldwater Pish Species,
and
- Warmwater Fish Species
- Acute Toxicity to
Freshwater Invertebrates
- Acute Toxicity to
Estuarine and Marine
OrganismslPy
- Fish
- Mollusk
- Shrimp
- Fish Early Life Stage,
and
- Aquatic Invertebrate
Life-Cycle!!/
- Fish - Life-Cycle
TGAI
TEP.8/
Degradate
TGAI
TEP.8/
Degradate
TGAI
TEP8/
Degradate
TGAI and
Degradate
TGAI and
Degradate
TGAI
A,C,H
A,C
A,C
A,C
A,C
A,C
A,C,H
A,C
A,C
A
A
A
A
A,B
No
Yes
Yes
Partially
Partially
No
Partially
Partially
No
Partially
Partially
Partially
No
No
No
No
No
_
00160475
00160473
GS0144-012I/
000740099/1/
-
00074010
GS0144-012I/
-
00074008
00070507
GS0144-012Z/
—
-
-
—
-
Yes6/
No
Yes
Yes6/
Yes
Yes
Yes6/
Yes
Yes
Yesj>/
Yes6/
Yes6/
Yes
Reservedl2/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
72-6 - Aquatic Organism TGAI, PAI OR No - Reserved
Accumulation Degradation
Product
- Crustacean
- Fish
^
- Insect Nymph
- Mollusk
72-7 - Simulated Field Testing TEP A,B No - Reserved^
- Aquatic Organisms
- Actual Field Testing TEP A,B NO - Reserved!!/
-Aquatic Organisms
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pured active ingredient; TEP =
Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food Crop;
C = aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G = Forestry; H = Domestic Outdoors; I = Indoors.
3/ Data must be submitted no later than indicated below after receipt of this document.
¥/ The study may meet guideline requirements if the stuy methodology were described.
-------
GENERIC DATA REQUIREMENTS FDR FOLPET
Footnotes (continued)
To Satisfy This Date Be Submitted
Use2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition1/ Pattern No or Partially) Citation 3(c)(2)(b)?3/
5J Avian reproduction study is required since repeat applications are indicated for all crops.
_6/ Due to the rapid degradation reported in the Daphnia study, MRID 00070507, flow-through studies are
required to determine the toxicity of folpet.
1] These studies may be used to represent degradate testing provided the outstanding environmental fate
data indicate sufficient amounts of the degradate are available for the duration of the test period.
8/ Testing on the typical end-use product (TEP) can be required if the EEC is equal or greater than the L.C5Q
or if direct application to water occurs when used as directed. The use on cranberries would meet the
latter criteria and the use on citrus the first criteria.
9/ This study lacks pertinent data necessary to determine if the Guideline requirements have been fulfilled.
1 ()/ Acute estuarine and marine studies are indicated for crops which are grown in excess of 300,000 acres
in coastal counties. The use on citrus meets these criteria.
11 / Fish early life stage and aquatic invertebrate life-cycle study are required since all application rates
will result in an EEC which will exceed the 1/100th of the LC5Q and repeat applications every 7 days
01 for the majority of crops.
01 12/ Reserve pending the results of the fish early life stage and aquatic invertebrate life-cycle studies and
environmental fate data.
1 3/ Simulated or actual field testing - aquatic organisms study is reserved due to the lack of environmental
~~ fate data, fish early life stage and aquatic invertebrate, and acute fish and invertebrate L.C5Q-
-------
TABLE A
GENERIC DATA RETIREMENTS FOR FOLPET
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
U1
§1 58.1 55 Nontarget Insect
NONTABGET INSECT TESTING -
POLLINATORS:
1 41 -1 - Honey bee acute
contact toxicity TGAI
1 41 -2 - Honey bee - toxicity TEP
of residues on
foliage
1 41-4 - Honey bee subacute
feeding study
141-5 - Field testing for TE?
pollinators
A,B,H
A,B,H
Yes
No
00036935
(Reserved)5/
A,B,H
No
No
No4/
No4/
1 / Composition: TGAI = Technical grade of the active ingredient; TE? = 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/ Data must be submitted within the number of months specified below, starting from the date of receipt of this
Registration Standard.
4/ As data from the acute contact study show low toxicity to honeybees, no faruther testing is required.
5/ Reserved pending development of test methodology.
-------
TAELE A
GENERIC DATA REQUIREMENTS EOR POLPET
Data Requirement
Test Use Does EPA Bibliograpic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
NONTAFGET INSECT TESTING -
AQUATIC INSECTS:
1 42-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
1 43-1 - NONTABGET INSECT
thru TESTING - PREDATORS
1 43-3 AND PARASITES
(Reserved)^/
(Reserved)^/
(Reserved)^/
(Reserved)6/
6/ Reserved pending Agency decision as to whether the data requiraemnt should be established.
-------
TABLE A
GENERIC DATA. REQUIREMENTS FOR FOLPET
Data Requirement
Test Use Does EPA Bibliographic
Substance^ Patterns^ Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission^
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
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:
TGAI or PAIRA A,B,C,F,H
TGAI or PAIRA A,B,C
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B,F,H
TGAI or PAIRA A
TGAI or PAIRA B,C,H
TGAI or PAIRA B,C,H
163-1 - Leaching and TGAI or PAIRA A,B,C,F,H
Adsorption A) esorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
A,F
A,F
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Reserved^
Yes
Yes
Yes
Yes
Yes
Yes
Reserved^
9 Months
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
12 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
en
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES -FIELD:
164-1 - Soil TEP A,B,H
164-2 - Aquatic (Sediment) TEP C
164-3 - Forestry TEP
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term TEP C
ACCUMULATION STUDIES:
165-1 - Rotational Crops PAIRA A,C
(Confined)
165-2 - Rotational Crops TEP A,C
(Field)
165-3 - Irrigated Crops TEP C
165-4 - In Fish TGAI or PAIRA A,B,C
165-5 - In Aquatic Non-Target TEP C
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No5
No6
Reserved'
Yes
Reserved^
Yes
Yes
Yes
27 Months
27 Months
39 Months
39 Months
12 Months
12 Months
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
§158.140 Reentry Protection
132-1 -
132-2 -
132-3 -
<»I.32-4 -
o
§158.75
231
233 -
234 -
Foliar Dissipation TEP
Soil Dissipation TEP
Dermal Exposure TEP
Inhalation Exposure TEP
Other Exposure Data
Dermal Exposure TEP
Dermal Exposure TEP
Inhalation TEP
A,B No
A No
A,B No
A,B No
H No
I No
I No
Yes9
No
Conditional10
Conditional11
Yes12
Yes12
Yes13
27 Months
27 Months
27 Months
15 Months
15 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Environmental Fate Continued:
FOOTNOTES:
I/ Composition: TGAJ = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
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_/ Data must be submitted within the indicated timeframes, which begin on the date of the Guidance Document (see
front cover for this date).
4/ Study reserved pending the results of an acceptable laboratory volatility study.
B_y No forestry uses were identified under this Standard.
6/ Data requirements for combinations and tank mix uses are currently not being imposed by this Standard.
_?/ Data Requirement is reserved pending the results of an acceptable confined dissipation study.
8/ Data requirement is reserved pending the results of an acceptable confined rotational crop study.
9/ For each end-use, the registrant is required to propose an acceptable reentry interval based either upon:
(a) dissipation of residues (decline curve), on human exposure to those residues, and on toxicity of the residues;
or (b) determination of that time beyond which there are no detectable dislodgeable or irihalable residues remain-
ing in the worker environment. If the registrant has reason to believe that an end-use will not cause human
exposure to residues, a request for waive from the data requirement should be submitted.
10/ Dermal exposure monitoring data may be submitted at the registrant's option.
ll/ If dermal exposure monitoring data are submitted, inhalation exposure data are required.
12/ Dermal exposure monitoring must be conducted to determine whether applicators of paints and stains containing
folpet are at significant risk. Dermal exposure to applicators of paints containing folpet shall be measured
during application of paints by brush and roller to bathrooms. Dermal exposure for applicators of stains
containing folpet shall be measured during the application of the stains by brush and air sprayer. Studies
must be carried-out according to the EPA Pesticide Assessment Guidelines, Subdivision U, Applicator Exposure
Monitoring. Subdivision U is available through the National Technical Information Service (NTIS). Protocols
must be approved by the Agency prior to initiating the studies. Protocols must be submitted to EPA for
approval within 90 days of your receipt of this Standard.
13/ Inhalation exposure monitoring data are required to determine whether applicators of paint containing
folpet and persons entering rooms painted with folpet-treated paint are at significant risk. Inhal-
ation exposure for applicators of paints containing folpet shall be measured during the application of
paints by brush and roller to bathrooms. This monitoring should be conducted concurrently with the dermal
exposure monitoring requirement. Quantity of folpet in the air of painted rooms shall be monitored until
air concentrations attain a steady state or for 30 days after application, which ever is less. Studies must
be conducted according to the EPA Pesticide Assessment Guidelinge, Subdivision U, Applicator Exposure Monitoring.
Protocols must be submitted to EPA for approval within 90 days of your receipt of this Standard.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Must Additional Timef rame
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance1/ Pattern Have Data? Citation Submitted? Submission2/
§158.
171-4
M
171-4
171-4
125 Residue Chemistry
- Nature of Residue
(Metabolism)
- Plants PAIRA Food Uses No — Yes3/
- Livestock PAIRA & Plant Food Uses No — Yes4/
Metabolites
- Residue Analytical
Method
- Plant Residues TGAI & Food Uses Partially See Footnote A YesV
Metabolites
- Animal Residues TGAI & Food Uses No — Yes5/
Metabolites
- Storage Stability TEP Food Uses No — Yes6/
Data
18 Months
18 Months
33 Months
33 Months
33 Months
A Bibliographic Citations: 00054015, 00083393, 00083400,
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Test Use Does EPA Bibliographic
Data Requirement Substance1/ Pattern Have Data? Citation
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the
Res i due — Res i due
studies for each
food use.
- Bulb Vegetable TEP Garlic No
w Group9
OJ
TEP Leeks No
TEP Shallots No
TEP Onions Partially 00090170
(Dry bulb)b
TEP Onions Partially 00090170
(Green)
Must Additional Timeframe
Data be for
Submitted? Submission2/
Yes 36 Months
Yes 36 Months
Yes 36 Months
Yes 36 Months
Yes 36 Months
Leafy Vegetables
(except Brassica
Vegetables) Groupc
TEP
TEP
Celeryd
Lettuces
Partially
Partially
00090170
00090170
00083402
Yes
Yes
36 Months
36 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Test Use Does EPA
Data Requirement Substance-*-/ Pattern Have Data?
§158.125 Residue Chemistry (continued)
- Fruiting Vegetables TEP Tomatoes^ Partially
(except Cucurbits)
Group*
- Cucurbit Vegetable TEP Cucumbers1"- Partially
Grouph
Me Ions 3 Partially
Pumpkins^ No
Squash No
(summer)-'-
Squash No
(winter)™
- Citrus Fruits TEP Grapefruit Partially
Group0
Oranges Partially
Must Additional Timeframe
Bibliographic Data be for
Citation Submitted? Submission2/
00090170
00090170
00090170
—
—
—
00083390
00090170
00098759
00053326
00098759
00090170
00083390
Yes 42 Months
Yes 36 Months
Yes 36 Months
Yes 36 Months
Yes 36 Months
Yes 36 Months
Yes 42 Months
Yes 42 Months
Lemons
Partially
Yes
42 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Test Use Does EPA
Data Requirement SubstajaceV Pattern Have Data?
§158.125 Residue Chemistry (continued)
- Pone Fruits Group0 TEP ApplesP
Crabapples^
- Stone Fruit Group£ TEP Cherries3
- Small Fruit and TEP Blackberries0
g, Berries Groupt
01 " Blueberriesv
Boysen-
berriesw
Cranberries*
CurrantsV
Dewberries2
iSoose-
berriesaa
Grapesbb
Partially
No
Partially
Partially
Partially
No
Partially
Partially
No
Partially
Partially
Bibliographic
Citation
00083401
—
00090170
00090170
00090170
—
00083392
00090170
00090170
00053865
00090170
Must Additional Timeframe
Data be for
Submitted? Submission^/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
42 Months
36 Months
36 Months
36 Months
36 Months
36 Months
36 Months
36 Months
36 Months
36 Months
42 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
Test Use
Data Requirement Substance-!-/ Pattern
§158.125 Residue Chemistry (continued)
Huckle-
berriescc
Loganber-
ries^
lilaspber-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POLPET
§158.125 Residue Chemistry (continued)
1_/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TE? = Typical end-use product; E? = End-use product.
2_/ Data must be submitted no later than the number of months indicated below from the date of receipt of this
Registration Standard.
3/ Depiction of the distribution and metabolism of both ring- and carbonyl-labeled ['^C]folpet (i) in mature grapes
after the full season foliar applications permitted;" (ii) in mature apples after the full season regimen of foliar
applications permitted; and (iii) in lettuce after the full season regimen of foliar applications permitted. All
applications must be made at rates sufficiently high to permit complete characterization of folpet residues.
Metabolism studies utilizing carbonyl-labeled captan may be useful as a substitute for the required carbonyl-
labeled experiments with folpet.
4_/ Metabolism studies utilizing ruminants and poultry. Animals must be dosed for 3 days with both carbonyl- and
ringlabeled [^^C] folpet 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 killed within 24 hours of the
final dose. The distribution and characterization of residues must be determined in milk, eggs, liver, kidney,
muscle, and fat. Metabolism studies utilizing carbonyl-labeled captan may be useful as a substitute for the
required carbonyl-labeled experiments with folpet.
5/ The submitted GLC and colorimetric methods are adequate for determination of folpet in or on plant commodities
with the exception of colorimetric methods which do not specify grinding or homogenization of tissues for extraction
of more than surface residues. Field treated samples subjected to residue determination using colorimetric methods
RM-1 ? RM-1A, or RM-1B must be ground or homogenized as part of the extraction procedure.
For enforcement purposes, Method I in the Pesticide Analytical Manual (PAM), Vol. II, Sec. 180.103, which is
specific for folpet, is acceptable for plant commodities. This method has undergone a successful method tryout
on carrots, cabbage, and soybeans (Pomerantz, 1968). Methods for analysis of milk and animal tissues have been
included in the submitted procedure RM-1 (MRID 0005401 5), however no tolerances exist at present for folpet
residues in or on animal tissues or milk.
It should be noted that the nature of the residue in plants and animals has not been adequately described. If
additional metabolites of concern are found in plants or animals, the conclusions stated above may change.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
$158.125 Residue Chemistry (continued)
6/ All of the residue data requested in this Standard must be accompanied by information on the duration and conditions
of sample storage prior to residue analysis and on the stability of folpet under the storage conditions used.
7/ No conclusion can be made because a petition for establishing tolerances for residues in or on this raw agricultural
commodity is pending with EPA.
a/ A crop group tolerance is not appropriate at the present time for the following reasons:
o Additional data are required to support the established tolerances for residues in or on green and dry bulb
onions.
o Data are required to support the established tolerances for residues in or on an additional representative
commodity (garlic, leeks, or shallots).
00
.b/ Data depicting folpet residues of concern in or on green and dry bulb onions treated several times foliarly with a
WP formulation at 4 Ib ai/A. Foliar applications should begin prior to the normal time of disease development and
continue at 7-day intervals until the day of harvest. The registrant must propose a maximum permissible number of
applications or maximum Ib ai/A/season rate. Required tests must reflect the maximum seasonal rate proposed.
Tests should be conducted in CA (30%), TX (14%), OR (14%) and MI (6%), or NY (7%), which represent the major
1983 U.S. onion production regions (Agricultural Statistics, 1984, p. 162). These data will be translated to
leeks, shallots, and garlic. If aerial application is envisioned, studies using this mode of application will
also be needed.
c/ A crop group tolerance is not appropriate at the present time for the following reasons:
o Additional data are required to support the established tolerances for folpet residues in or on celery and
lettuce (head and leaf).
o Residue data are required for one additional group member (spinach).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
d/ The data are insufficient to assess the established tolerance because no data were submitted reflecting residues
of folpet in or on celery harvested following multiple applications at the maximum registered rate and analytical
procedures (surface extraction or sample maceration) used for residue analysis were unspecified. The following
additional data are required:
o Data reflecting residues of folpet in or on celery harvested 7 days after the last of multiple applications of
a WP formulation at 2 Ib ai/A. The first application must be made as soon as the plants are established and
repeat applications must be made every 7 days throughout the season up to 7 days before harvest. Tests must
be conducted in CA (70%), FL (19%), and MI (8%), which collectively produce 97% of domestic celery (Agricul-
tural Statistics, 1984, p. 156). The registrant must propose a maximum number of applications per season or a
maximum seasonal use rate. The submitted data must reflect this proposed maximum. If aerial applications are
envisioned studies reflecting this mode of treatment will also be needed.
s/ The data are inadequate to assess the established tolerance for residues of folpet in or on lettuce because:
(i) no data were submitted reflecting multiple applications at the maximum use rate and harvest at the minimum
posttreatment interval; (ii) the analytical procedures used for residue analysis (surface extraction or sample
maceration) were unspecified; and (iii) the type of lettuce (head or leaf) was not specified. Therefore, the
following must be submitted:
o Data depicting residues of folpet in or on head and leaf lettuce resulting from multiple applications of a WP
formulation at 2 Ib ai/A. Samples must be harvested for residue analysis immediately after the final appli-
cation. Tests must be conducted in CA (71%), and FL (4%), which together produce 75% of domestic lettuce
(Agricultural Statistics, 1984, p. 160). The registrant must propose a maximum number of applications per
season or a maximum seasonal rate. The submitted data must reflect this proposed maximum. if aerial applica-
tions are envisioned, studies reflecting this type of treatment will also be needed.
f/ A crop group tolerance is inappropriate at the present time for the following reasons:
o Additional data are required to support the existing tolerance for folpet residues in or on tomatoes.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
o Residue data are required for one additional group member (peppers); folpet formulations are registered for use
only on tomatoes at the present time.
g/ The available data are insufficient to support the established tolerance for residues of folpet in or on tomatoes
because: (i) no data were submitted concerning residues in or on tomatoes following multiple foliar applications;
(ii) no method recovery data were submitted and analytical procedures (surface extraction or sample maceration)
were unspecified; (iii) no data were submitted concerning residue concentration during processing; and
(iv) geographic representation was poor. The following additional data are required:
o Data depicting folpet residues of concern in or on tomatoes following multiple foliar applications at 4 Ib/ai/A.
Foliar applications should begin at first bloom and continue at 7- to 10-day intervals until the day of harvest.
Tests should be conducted in CA, where ~85% of tomatoes grown for processing are produced, and FL where
~50% of U.S. fresh market tomatoes are produced (Agricultural Statistics, 1984, p. 173). If aerial applica-
^ tions are envisioned, studies reflecting this type of treatment will also be needed.
o Data depicting residues in wet and dry pomace, puree, catsup and juice processed from tomatoes bearing
measurable weathered residues. If residues concentrate in any of these processed commodities, appropriate
food/feed additive tolerances must be proposed.
h/ A crop group tolerance is not appropriate at the present time for the following reason:
o Additional data are required to support the established tolerances for folpet residues in or on cucumbers,
melons, and summer squash.
i/ The data are inadequate to assess the established tolerance for residues of folpet in or on cucumbers for the
following reasons: (i) no data were submitted reflecting residues in or on cucumbers harvested immediately after
the last of multiple foliar applications; (ii) no data were submitted reflecting residues resulting from soil
treatment with folpet; (iii) it was not specified in the submitted studies whether residues were extracted only
from the surface or from macerated portions of cucumbers; and (iv) geographic representation was inadequate.
Therefore, the following must be submitted:
o Data reflecting residues of concern in or on cucumbers resulting from multiple foliar applications of a WP
formulation at 2 Ib ai/100 gal (200 gal/A) and a directed soil application at 4 Ib ai/A. Foliar applications
must begin when the first true.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
2/ The data are inadequate to assess the established tolerance for residues of folpet in or on melons because no
data were submitted reflecting multiple applications at the maximum use rate and harvest at the minimum posttreat-
ment interval. Therefore, the following must be submitted:
o Data depicting residues of folpet in or on melons resulting from multiple foliar applications of a WP formulation
at 2 Ib ai/100 gal (200 gal/A). Samples must be harvested for residue analysis immediately after the final
application. Tests must be conducted in CA (52%), and TX (20%), which collectively represent 72% of the U.S.
cantaloupe production regions (1982 Census of Agriculture, p. 339). The registrant must propose a maximum
number of applications per season or a maximum seasonal rate. The submitted data must reflect this proposed
maximum rate. If aerial applications are envisioned, studies reflecting this type of treatment will also be
needed.
k/ No data were submitted for pumpkins. Data requested for cantaloupes will be used to assess the established
? tolerance. Note that translated data may not be used to support a crop group tolerance.
I/ No data were submitted for summer squash. Data requested for cucumbers will be used to assess the established
tolerance. Note that translated data may not be used to support a crop group tolerance.
m/ No data were submitted for winter squash. Data requested for cantaloupes will be used to assess the established
tolerance. Note that translated data may not be used to support a crop group tolerance.
n/ The submitted data for both oranges and grapefruit are inadequate to evaluate the established tolerance for folpet
residues in or on citrus fruit because: (i) no data were submitted depicting residues in or on lemons, which is
a representative commodity of the citrus fruit group; (ii) none of the submitted data depicted residues in citrus
fruit after a full season regimen of applications as currently permitted under the registered uses; and (iii) it
was not specified whether samples were macerated or merely surface extracted for folpet residue analyses; if
samples were only surface extracted the residue data are not acceptable. The submitted data for residues in
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
orange pulp and molasses are sufficient to show that folpet residues do not concentrate in these processed products
of citrus fruits; however, data are still needed to determine whether concentration of folpet residues occurs in
oil or juice processed from citrus fruit. The following additional data are required:
o Data depicting folpet residues of concern in or on grapefruits (and in separate studies, oranges and lemons)
following multiple foliar applications throughout the. growing season at 2 Ib ai/100 gal of spray suspension
sprayed until runoff. The registrant must propose maximum single application rates and maximum seasonal
application rates or minimum intervals between applications. Tests with grapefruits should be conducted in
FL (65%), TX (18%), and CA (12%), where 95% of U.S. grapefruits are produced (Agricultural Statistics, 1984,
p. 200). Tests with oranges should be conducted in FL (61%), and CA (35%), which collectively produce 96%
of U.S. oranges (ibid, p. 200). Tests with lemons should be conducted in CA (80%), and AZ (20%), where
virtually all (100%) U.S. lemons are produced (ibid, p. 200). If aerial applications are envisioned,
studies reflecting this mode of treatment will also be needed.
~j
NJ
o Data depicting residues in wet and dry citrus pulp, dried peel, juice, oil, and molasses processed from oranges
bearing measurable weathered residues. If residues concentrate in any of these processed commodities, appropriate
food/feed additive tolerances must be proposed.
p_/ A crop group tolerance is not appropriate at the present time for the following reasons:
o Additional data are required to support the tolerance for folpet residue in or on apples.
o A use must be proposed and residue data must be submitted in support of a tolerance for pears, a representative
commodity.
jp/ The submitted data are not adequate to support the established tolerance for folpet residues in or on apples
because: (i) except for one test, it was not specified whether samples were macerated for extraction or only
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
surface extracted for subsequent residue analysis; and (ii) geographic representation was inadequate. The
following data are required:
o Data depicting folpet residues of concern in or on apples resulting from multiple applications of a WP formulation
at 8 Ib ai/A/applications of a WP formulation at 8 Ib ai/A/application. Samples must be harvested for residue
analysis immediately after the final application. Tests must be conducted in WA (35%), NY (12%), MI (10%), and
CA (6%), which together produce 63% of domestic apples (Agricultural Statistics, 1984, p. 187). The registrant
must propose a maximum number of applications per season, or a maximum seasonal rate. The submitted data must
reflect this proposed maximum rate.
o Residue data from wet pomace, dried pomace, and juice processed from apples bearing measurable weathered residues.
Appropriate food/feed additive tolerances must be proposed should concentration of residues occur in processed
products.
w
q/ No data were submitted for crabapples. However, since the registered use on crabapples is identical to that on
apples, the requested data for apples will be translated to crabapples. Note that translated data may not be
used to support a crop group tolerance.
r/ A crop group tolerance is not appropriate at the present time for the following reasons:
o Additional data are required to support the established tolerance for residues of folpet in or on cherries.
o Data are required for peaches and plums or prunes, representative commodities of this group. (Currently, no
registered uses exist for these crops.)
s/ The available data are insufficient to evaluate the established tolerance for residues of folpet in or on cherries
~ because: (i) no method recovery or control residue data were submitted and analytical procedures (surface
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
$158.125 Residue Chemistry (continued)
extraction or sample maceration) were unspecified; and (ii) geographic representation was poor. The following
additional data are required:
o Data depicting folpet residues of concern in or on tart cherries following multiple foliar applications at
1 Ib ai/100 gal spray suspension sprayed until runoff. Foliar applications should begin at first bloom and con-
tinue at 7- to 14-day intervals until the day of harvest. Tests should be conducted in MI (56%), UT (16%), and
NY (15%), which collectively accounted for 87% of the 1983 U.S. tart cherry production (Agricultural Statistics,
1984, p. 198). The registrant must propose a maximum number of applications per season or a maximum seasonal
use rate. The submitted data must reflect this proposed maximum. If aerial applications are envisioned,
studies reflecting this type of treatment will also be needed.
t/ A crop group tolerance is not appropriate at the present time for the following reason:
o Additional data are required to support the established tolerances for residues in or on blackberries,
cranberries, grapes, and strawberries.
u/ The available data are insufficient to support the established tolerance for residues of folpet in or on
blackberries because: (i) the single submitted test did not depict residues after a maximum seasonal regimen
permitted under the registered uses; and (ii) it was not specified whether the analytical method (RM-1) was
performed with a maceration or a surface extraction procedure; surface extraction of residues is not acceptable
for data collection. The following additional data are required:
o Data depicting folpet residues of concern in or on blackberries on the same day following the last of multiple
foliar applications of 2.5 Ib ai/A at 7-day intervals from the time berries have set until harvest. Tests must
be conducted in OR (75.9%) and CA (12.7%), States which collectively account for 88.6% of U.S. blackberry
production (1982 Census of Agriculture, Vol. 1, Part 51, U.S. Department of Commerce, p. 370-371). If aerial
applications are envisioned, studies reflecting this mode of treatment will also be needed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
vj The available data are insufficient to support the established tolerance for residues of folpet in or on blueberries
because: (i) data submitted concerning residues in or on blueberries following multiple foliar applications are
meager; and (ii) no method recovery data were submitted and analytical procedures (surface extraction or sample
maceration) were unspecified. The following additional data are required:
o Data depicting folpet residues of concern in or on blueberries following multiple foliar applications at 2.5 Ib
ai/A. Foliar applications should begin prior to the normal time of first infection and be repeated at 7-day
intervals until the day of harvest. Tests should be conducted in MI (41%) and NJ (34%), which collectively
account for 75% of U.S. blueberry production (1982 Census of Agriculture, Vol. 1, Part 51, U.S. Department of
Commerce, p. 371). If aerial applications are envisioned, studies reflecting this type of treatment will also
be needed.
w/ No residue data were submitted to support the established tolerance for residues of folpet in or on boysenberries.
However, since the registered use on blackberries is identical to that for boysenberries, the requested data for
blackberries will be translated to boysenberries.
x/ The available data are inadequate to support the established tolerance because: (i) none of the submitted data
depicted folpet residues at the PHI following a treatment regimen reflecting the maximum permitted seasonal use;
and (ii) it is not known whether samples were macerated or merely surface extracted for residue analysis. The
following additional data are required:
o Data depicting folpet residues of concern in or on cranberries following multiple foliar applications at
4.5 Ib ai/A beginning during bloom and continuing at 10- to 14-day intervals until 30 days prior to harvest.
Tests should be conducted in WI (42%) and MA (41%), which collectively provide 83% of the cranberries produced
in the U.S. (1982 Census of Agriculture, Vol. 1, Part 51, U.S. Department of Commerce). If aerial applications
are envisioned, studies reflecting this mode of treatment will also be needed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
of gooseberry production (Modern Fruit Science, 1976, p. 795; percentage figures unavailable). If aerial
applications are envisioned, studies reflecting this mode of treatment will also be needed.
bb/ The available data are insufficient to support the established tolerance for folpet residues in or on grapes
because: (i) geographic representation was inadequate; and (ii) the registrant did not specify whether samples
were macerated prior to analysis (data depicting only surface residues of grapes are not acceptable). Furthermore,
no data are available to determine if folpet residues concentrate in raisins, raisin waste, and in wet or dry
pomace processed from grapes bearing measurable weathered residues. The following data are required:
o Data depicting folpet residues of concern in or on grapes following multiple foliar applications of a WP
formulation at 2.5 Ib ai/A and (in a separate test) the 4% D MAI formulation at 3 Ib ai/A. Foliar applica-
tions should begin just before bloom, repeated just after bloom, and be repeated just after bloom at 7-day
intervals for three times until the day of harvest. Tests should be conducted in CA (89%) and NY (4%), which
>j collectively represent 93% of the 1983 U.S. grape-growing regions (Agricultural Statistics, 1983, p. 210). If
aerial applications are envisioned, studies reflecting this type of treatment will also be needed.
o Data depicting residues in wet and dry pomace, juice, raisins, and raisin waste processed from grapes bearing
measurable, weathered residues. If residues concentrate in any of these processed commodities, appropriate
food/feed additive tolerances must be proposed.
cc/ No data were submitted to support the established tolerance for residues of folpet in or on huckleberries.
However, since the registered use on blueberries is identical to that for huckleberries, the requested data for
blueberries will be translated to huckleberries.
dd/ No data were submitted to support the established tolerance for residues of folpet in or on loganberries.
However, since the registered use on blackberries is identical to that for loganberries, the requested data for
blueberries will be translated to loganberries.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOLPET
§158.125 Residue Chemistry (continued)
ee/ The available data are insufficient to support the established tolerance for residues of folpet in or on raspberries
because: (i) insufficient data are available to determine the maximum residue level resulting from registered
uses; and (ii) no method recovery data were submitted and analytical procedures (surface extraction or sample
maceration) were unspecified. However no additional data are required, since upon submission of the data required
for blackberries, these data will be translated to raspberries to evaluate the established tolerance.
f f/ The available data are inadequate to support the established tolerance because: (i) none of the submitted data
depicted folpet residues following a treatment regimen reflecting the maximum permitted seasonal use; and (ii) it
is not known whether samples were macerated or merely surface extracted for residue analysis. The following
additional data are required:
o Data depicting folpet residues of concern in or on strawberries following multiple foliar applications at 2 Ib
ai/A. Foliar applications should begin prior to bloom and be repeated at 7-day intervals until the day of
harvest. Tests should be conducted in CA (70%) and FL (12%), where 82% of 1983 U.S. strawberries were produced
(Agricultural Statistics, 1984, p. 227). If aerial applications are envisioned, studies reflecting this type
of treatment will also be needed.
gg/ No data were submitted to support the established tolerance for residues of folpet in or on avocados. The following
data are required:
o Data depicting folpet residues of concern in or on avocados following multiple foliar treatments with a WP
formulation at 1.5 Ib ai/100 gal spray suspension sprayed until the point of runoff. Foliar applications should
commence when bloom buds begin to swell and continue at 2- to 3-week intervals until the day of harvest. Tests
should be conducted in CA (86%) and FL (14%), which collectively produce 100% of U.S. avocados (1982, Census of
Agriculture, p. 360). If aerial applications are envisioned, studies reflecting this mode of treatment will
also be needed.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING -USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% TECHNICAL3 (EPA REG. NO. 239-1763; CHEVRON CHEMICAL CO.)
Data Requirement
Composition*3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials and Manufacturing Process
61-3 - Discussion of Formation of Im-
purities
Analysis and Certification of Product
Ingredients
t>2-l - Preliminary Analysis of Product
Samples
62-2 - Certification of Ingredient Lim-
its
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or Speci-
fic Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Partially
Partially
No
Partially
No
No
No
No
No
N/Ae
No
— d No
00104841 Yes
00034754, 00109055 Yes
Yes
Registration jacket Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
(6 months)
(6 months)
(6 months)
(6 months)
(6 months)
a The 88% technical serves as a manufacturing-use product.
b Cotposition: TGAI = technical grade of the active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d information obtained from desk references.
e Not required because the technical is a solid at room tesnperature.
-------
00
o
TABLE B
PROOJCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING -USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% TECHNICAL3 (EPA REG. NO. 239-1763; CHEVRON CHEMICAL CO.)
Data Requirement
Conpos itionk
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry (continued)
63-8
63-9
63-10
63-11
63-12
63-13
Other
64-1
- Solubility
- Vapor Pressure
- Dissociation
Constant
TGAI or PAI
PAI
PAI
No
N/Ad
No
Yes
No
Yes
(6 months)
(6 months)
- Octanol/Water Partition
Coefficient
-pH
- Stability
Requirement :
- Submittal of
samples
PAI
1GAI
TGAI
N/A
No
No
No
N/A
Yes
Yes
Yes
No
(6 months)
(6 months)
(6 months)
a The 88% technical serves as a nanufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Not required because the melting point of the pure form of the active ingredient is >30 C.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% TECHNICAL3 (EPA REG. NO. 476-2040; STAUFFER CHEMICAL CO.)
Data Requirement
Compos ition
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)<=
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials and Manufacturing Process
61-3 - Discussion of Formation of Im-
purities
M Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples
62-2 - Certification of Ingredient Lim-
its
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or Speci-
fic Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
No
No
No
Partially
No
No
No
No
No
N/Ae
No
~d No
Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
No
Yes (6 months)
a The 88% technical serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
e Not required because the technical is a solid at roan temperature.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING -USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% TECHNICAL3- (EPA REG. NO. 476-2040; STAUFFER CHEMICAL CO.)
Data Requirement
Compos it ion*3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry (continued)
63-8 - Solubility
oo 63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirement;
64-1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
No
N/Ad
No
No
No
No
N/A
Yes (6 months)
No
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
No
a The 88% technical serves as a manufacturing^use product.
k Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Not required because the melting point of the pure form of the active ingredient is >30 C.
-------
•I-AHI .P. B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MAtslUFACTURING-USE PRODUCTS CONTAINING POLPET
DATA REQUIREMENTS FOR FOLPET 88% TECHNICAL^ (EPA REG. NO. 32691-2; CAIHIO CHEMICALS, INC.)
Data Requirement
Composition*3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
CD
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure
of Ingredients TGAI
61-2 - Description of Beginning Mate-
rials and Manufacturing Process TGAI
61-3 - Discussion of Formation of Im-
purities TGAI
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples TGAI
62-2 - Certification of Ingredient Lim-
its TGAI
62-3 - Analytical Methods to Verify
Certified Limits TGAI
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, or Speci-
fic Gravity TGAI
Yes
Partially
No
No
Partially
No
No
No
No
No
N/Ae
No
~d No
Registration jacket Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
No
Yes (6 months)
a The 88% technical serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
e Not required because the technical is a solid at room temperature.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% TECHNICAL3 (EPA REG. NO. 32691-2; CALHIO CHEMICALS, INC.)
Data Requirement
Compos itionk
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry (continued)
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirement:
64-1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
No
N/Ad
No
No
No
No
N/A
Yes (6 months)
No
Yes (6 months)
Yes (6 nonths)
Yes (6 months)
Yes (6 months)
No
a The 88% technical serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
c Data must be submitted no later than the time specified fron the date of receipt of this Standard.
^ Not required because the melting point of the pure form of the active ingredient is >30 C.
-------
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 90% TECHNICAL^ (EPA REG. NO. 11678-18; MAKHTESHIM EEER SHEVA
CHEMICAL WORKS, LTD.)
Data Requirement
Composition.*3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
CD
Ul
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure
of Ingredients TGAI
61-2 - Description of Beginning Mate-
rials and Manufacturing Process TGAI
61-3 - Discussion of Formation of Im-
purities TGAI
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples TGAI
62-2 - Certification of Ingredient Lim-
its TGAI
62-3 - Analytical Methods to Verify
Certified Limits TGAI
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, or Speci-
fic Gravity TGAI
Yes
No
No
No
Partially
No
No
No
No
No
N/Ae
No
~d No
Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
No
Yes (6 months)
a The 90% technical serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
e Not required because the technical is a solid at room temperature.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 90% TECHNICAL3 (EPA REG. NO. 11678-18; MAKHTESHIM BEER SHEVA
CHEMICAL WORKS, LTD.)
Data Requirement
Composition*3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
00
158.120 Product Chemistry (continued)
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirement:
64-1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
No
N/Ad
No
No
No
No
N/A
Yes (6 months)
No
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
No
a The 90% technical serves as a manufacturing-use product.
k Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Not required because the melting point of the pure form of the active ingredient is >30 C.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 1.4% FORMULATION INTERMEDIATE3 (EPA REG. NO. 4816-276;
FAIRFIELD AMERICAN CORP.)
Data Requirement
Does EPA
Have Data to
Satisfy This
Composition13 Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)C
CD
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients MP
61-2 - Description of Beginning Mate-
rials and Manufacturing Process MP
61-3 - Discussion of Formation of Im-
purities MP
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples MP
62-2 - Certification of Ingredient Lim-
its MP
62-3 - Analytical Methods to Verify
Certified Limits MP
Other Requirements;
64-1 - Submittal of Samples N/A
Yes —d No
No Yes (6 months)
No Yes (6 months)
No Yes (12 norths)
Partially Registration jacket Yes (12 months)
No Yes (12 months)
N/A No
a The 1.4% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
G Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING POLPET
DATA REQUIREMENTS FOR FOLPET 1.4% FORMULATION INTERMEDIATED (EPA REG. NO. 1021-1042;
MCLAUGHLIN GORMLEY KING CO. )
Data Requirement
Compos itionb
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
00
03
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure
of Ingredients MP
61-2 - Description of Beginning Mate-
rials and Manufacturing Process MP
61-3 - Discussion of Formation of Im-
purities MP
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples MP
62-2 - Certification of Ingredient Lim-
its MP
62-3 - Analytical Methods to Verify
Certified Limits MP
Other Requirements:
64-1 - Submittal of Samples N/A
Yes
No
No
No
Partially
No
N/A
—d No
Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
No
a The 1.4% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
^ Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 1.4% FORMULATION INTERMEDIATE3 (EPA REG. NO. 4816-265;
FAIRFIELO AMERICAN CORP.)
Data Requirement
Campositionb
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
VC'
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure
of Ingredients MP
61-2 - Description of Beginning Mate-
rials and Manufacturing Process MP
61-3 - Discussion of Formation of Im-
purities MP
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples MP
62-2 - Certification of Ingredient Lim-
its MP
62-3 - Analytical Methods to Verify
Certified Limits MP
Other Requirements;
64-1 - Sutamittal of Samples N/A
Yes —d No
No Yes (6 months)
No Yes (6 months)
No Yes (12 months)
Partially Registration jacket Yes (12 months)
No Yes (12 months)
N/A No
a The 1.4% formulation intermediate serves as a manufacturing-use product.
t> Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING POLPET
DATA REQUIREMENTS FOR FOLPET 2% FORMULATION INTERMEDIATE3 (EPA REG. NO. 1021-943;
MCLAUGHLIN GORMLEY KING CO. )
Data Requirement
Does EPA
Have Data to
Satisfy This
Compos iti on*3 Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients MP
61-2 - Description of Beginning Mate-
rials and Manufacturing Process MP
61-3 - Discussion of Formation of Im-
purities MP
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples MP
62-2 - Certification of Ingredient Lim-
its MP
62-3 - Analytical Methods to Verify
Certified Limits MP
Other Requirements:
64-1 - Submittal of Samples N/A
Yes
No
No
No
Partially
No
N/A
~d No
Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
No
a The 2% formulation intermediate serves as a manufacturing-use product.
k Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 2% FORMULATION INTERMEDIATE3 (EPA REG. NO. 1021-761;
MCLAUGHLIN GORMLEY KING CO. )
Data Requirement
Composition^
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition :
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
~d No
Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months )
(6 months)
(12 months)
(12 months)
(12 months)
a The 2% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
VO
to
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 2% FORMULATION INTERMEDIATE3 (EPA REG. NO. 1021-987;
MCLAUGHLIN GORMLEY KING CO.)
Data Requirement
Composition*3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
~d No
Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 2% formulation intermediate serves as a manufacturing-use product.
k Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANIJFACTURIN3-USE PRODUCTS CONTAINING POLPET
DATA REQUIREMENTS FOR POLPET 37.5% FORMULATION INTERMEDIATES (EPA REG. NO. 1021-1017;
MCLAUGHLIN GORMLEY KING CO. )
Data Requirement
Conpos itionk
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Conpos it ion:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
— d No
Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 37.5% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MA1SWFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 50% FORMULATION INTERMEDIATE3 (EPA REG. NO. 11678-29;
MAKHTESHIM BEER SHEVA CHEMICAL W3RKS, LTD. )
Data Requirement
Compositionk
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)C
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
~d No
Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 50% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
'TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANL/FACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 50% FORMULATION INTERMEDIATEa (EPA REG. NO. 239-2489;
CHEVRON CHEMICAL CO.)
Data Requirement
Composition^3
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Produot Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
Liinits
62-3 - Analytical Methods to Verify
Certified Liinits
Other Requirements:
64-1 - Sutmittal of Samples
MP
MP
MP
MP
MP
MP
N/A
Yes
Partially
No
No
Partially
No
N/A
~d No
00104841 Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 50% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-Use PODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 50% FORMULATION INTEPMEDIATEa (EPA REG. NO. 34688-8;
INTERSTAB CHEMICALS, INC.)
Data Requirement
Compos it ion*5
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
— d NO
Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 50% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 75% FORMULATION INTERMEDIATED (EPA REE. NO. 239-1352;
CHEVRON CHEMICAL CO.)
Data Requirement
Compositionk
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry-
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
Partially
No
No
Partially
No
N/A
— d No
00104841 Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 75% formulation intermediate serves as a manufacturing-use product.
t> Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
00
TABLE B
PRODUCT SPECIFIC DATA REQUREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 80% FORMULATION INTERMEDIATE3 (EPA REG. NO. 11678-28;
MAKHTESHIM BEER SHEVA CHEMICAL WORKS, LTD. )
Data Requirement
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
Composition13
MP
MP
MP
MP
MP
MP
N/A
Does EPA
Have Data to
Satisfy This
Requirement?
Yes
No
No
No
Partially
No
N/A
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)c
— d No
Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
No
a The 80% formulation intermediate serves as a manufacturing-use product.
k Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
^ Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% FORMULATION INTEEMEDIATEa (EPA REG. NO. 5383-54;
TROY CHEMICAL CO.)
Data Requirement
Compositionb
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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 Lim'
Other Requirements:
64-1 - Submittal of Samples
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
— d No
Yes
Yes
Yes
Registration jacket Yes
Yes
No
(6 months)
(6 months)
(12 months)
(12 months)
(12 months)
a The 88% formulation intermediate serves as a manufacturing-use product.
t> Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of this Standard.
d Information obtained from desk references.
-------
o
o
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
DATA REQUIREMENTS FOR FOLPET 88% FORMULATION INTERMEDIATED1 (EPA REG. NO. 1100-70;
TENNECO CHEMICALS)
Data Requirement
Does EPA
Have Data to
Satisfy This
Composition^ Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)c
158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials 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
MP
MP
MP
MP
MP
MP
N/A
Yes
No
No
No
Partially
No
N/A
— d No
Yes (6 months)
Yes (6 months)
Yes (12 months)
Registration jacket Yes (12 months)
Yes (12 months)
No
a The 88% formulation intermediate serves as a manufacturing-use product.
b Composition: MP = Manufacturing-use product.
c Data must be submitted no later than the time specified from the date of receipt of tliis Standard.
d Information obtained from desk references.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOLPET
ACUTE TOXICOLOGY DATA FOR EACH MANUFACTURING-JUSE PRODUCT CONTAINING FOLPET
Data Requirement
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
o 81-3 - Acute Inhalation - Rat
81-4 - Primary Eye Irritation
81-5 - Primary Dermal
81-6 - Dermal Sensitization
Test I/
Substance
MP
MP
MP
MP
MP
MP
Does EPA Have Data
To Satisfy This
Requirement ? (Yes ,
No or Partially)
Yes
Yes
No
Yes
Yes
Yes
B ibliographic
Citation
Must Additional
Data Be
Submitted? (Time)
00144057, 00137695 No
00141728
00160444
00160430
00160431
No
Yes (9
No
No
No
months)
I/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than the time specified from the date of receipt of this Standard.
-------
APPENDIX II
LABELING APPENDICES
102
-------
SUMMARY-1
LABEL CONTENTS
40 CPR 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 CPR I62.10(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 CPR I62.10(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 CPR I62.10(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 I62.10(g)]
103
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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)(!)(!)]
Item 70. 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)(1)]
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)(ill)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I62.10(h)(l)(lll)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 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 CPR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CPR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - PLAMMABILITY
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 - PIPRA 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 I62.11(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 l-abel 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
CPR
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label, uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
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SUMMARY-5
Item IDA. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CPR 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-6
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gal Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center 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.
o
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SUMMARY-7
ITEM
7C
7D
-j
D
Q
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
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OP 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 I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
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
OP 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/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is :
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Chapter 1—Environmental Protection Agency
$162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section?
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
111
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly .implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act^nd these regulations;
112
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "nonipjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to S 162.6(b){4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***„" or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the netC content statement
shall be in terms of liquid measure at 68°F .(20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e. , *'l pound 10 ounces" rather than
"26 ounces."
113
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned .to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement. ~
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front'panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text'of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
/•^ f S~\ ^VtA^-^A..^ *"
of other text.
114
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name ma'y 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 proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]«™
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are giyen below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below;
115
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Hazard Indicators
Oral LD50
Inhalation LC
Dermal LD
50
Eye effects
Skin effects
1
Up to and
Including
50 mg/kg
Up to and
tnclud Ing
.2 mg/llter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive
Toxlclty <
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/llter
From 200
thru 2000
Cornea! opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
rateqorles
III
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
No cornea 1 opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/ liter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.—(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red .on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel'
the signal word
(C) Toxicity
"Warning.
Category
III
criteria of Toxicity Category
the signal word "Caution,."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide
III shall bear
All pesticide
IV shall bear
products meeting the
on the front panel
products meeting the
on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except whe,n the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
{iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the- front panel except as described
in paragraph (h)(1)(iii)(A) of this-section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 10 to 15 .........
Over 30
Poir
Required
signal .word ,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
117
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautianary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxic I ty
category
Precautionary statements by toxictty category
Oral. Inhalation, or dermal toxicIty
Skin and eye local effects
III . .
IV
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin). Do not breathe
vapor Idust] or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
required.).
May be fatal If swallowed (Inhaled or
absorbed through the skin). Do not breathe
vapors Idust or spray mist). Do not get In)
eyes, on skin, or on clothing. (Appropriate)
first aid statements required.).
Harmful If swallowed I Inhaled or absorbed
through the skin). Avoid breathing vapors
Idust or spray mist]. Avoid contact with
skin (eyes or clothing). (Appropriate
first aid statement required.).
(No precautionary statements required.1,
Corrosive, causes eye and skin damage (or
skin Irritation). Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
Causes eye land skin] Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
I No precautionary statements required.).
(ii)
target organisms
Environmental hazards.
Where a hazard exists to non-
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
118
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or. less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC5Q of 1 ppm or less,, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary LC5Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive .characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURSZED CONTAINERS
Fiash point at or b®low 20*F; If there fs 9
flashback at any valve opening.
Flash point above 20*F and not over 80*F or It
the flame extension Is wore than 18 in. long
at a distance of 6 In. from the flame.
Extremely flammable. Contents under pressure.
Keep away frow fire, sparks, and heated
surfecas« Do not puncture or Incinerate
contatnar. Exposure to Temperatures above
150*F way cause bursting.
Flammable. Contents under pressure. Keep away
from heat ^sparks, and open flame. Do not
puncture <>r incinerate container. Exposure to
temperatures abova 130*F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame* Do not puncturfe or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
119
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(i) Directions for Use—(1) General requirements—(i ) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
( i i i ) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(JJ The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(2) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(I) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(_3) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(JL) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
120
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(2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(_3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use" :
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically 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
applicator who is physically present.
121
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(F) Other.pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s)classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978]
-------
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°P; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
123
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs,
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
124
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products-, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes (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 rlnsate 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 CPR 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 rlnsate 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."
125
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PEST/DIS-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA # and CAS #
[40 CPR 261.33le;j '
Acrolein P003 107-13-1
Aldicarb P070 116-06-3
Aldrln P004 309-00-2
Allyl alcohol P005 107-18-6
Aluminum phosphide P006 1302-45-0
4-Amlnopyridine (Avitrol) P008 504-24-5
Arsenic acid P010 7778-39-4
Arsenic pentoxide P011 1303-28-2
Arsenic trioxide P012 1327-53-3
Calcium cyanide P021 592-01-8
Carbon disulfide P022 75-15-0
p-Chloroaniline P024 106-47-8
Cyanides (soluble cyanide salts P030
not otherwise specified)
Cyanogen chloride P031 506-77-4
Dieldrin P037 60-57-1
0,0-Diethyl S-[2-ethylthio)ethyl] P039 298-04-4
phosphorodithioate (disulfoton)
0,0-Diethyl 0-pyrazinyl P040 297-97-2
phosphorothioate (Zinophos®)
Dimethoate P044 60-51-5
0,0-Dimethyl 0-p-nitrophenyl P071 298-00-0
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts P047 534-52-1
4,6-Dinitro-o-cyclohexylphenol P034 131-89-5
Dinoseb P020 88-85-7
Endosulfan P050 115-29-7
Endothall P088 129-67-9
Endrin P051 72-20-8
Pamphur P097 52-85-7
Fluoroacetamide P057 640-19-7
Heptachlor P059 76-48-8
Hexachlorohexahydro-exo.exo- P069 465-73-6
dimethanonaphthalene (Isodrin)
Hydrocyanic acid P063 74-90-8
Methomyl P066 16752-77-5
alpha-Naphthylthiourea (ANTU) P072 86-88-41
Nicotine and salts P075 54-11-5
Octamethylpyrophosphoramide P085 152-16-9
(OMPA, schradan)
Parathion P089 56-38-2
Phenylmercuric acetate (PMA) P092 62-38-4
Phorate P094 298-02-2
Potassium cyanide P098 151-50-8
Propargyl alcohol P102 107-19-7
Sodium azide P105 26628-22-8
Sodium cyanide P106 143-33-9
Sodium fluoroacetate P058 62-74-8
126
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PEST/DIS-3
Strychnine and salts P108
0,0,0,0-Tetraethyl P109
dlthiopyrophosphafre (sulfotepp)
Tetraethyl pyrophosphate Pill
Thallium sulfate P115
Thiofanox P045
Toxaphene P123
Warfarin (>0.3%) P001
Zinc phosphide (>105£) P122
57-24-9
60-41-3
3689-24-5
107-49-3
7446-18-6
39196-18-4
8001-35-2
81-81-2
1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED PROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
[40 CPR 261.31]
2-Chloroethyl 2-(2, 4, 6-trichloro-
phenoxy) ethyl ether
Dehydroabletylammonlum
pentachlorophenoxlde
Erbon
0-ethyl 0-(2,4,5-trlchlorophenyl)
ethylphosphonothloate
2,2'-Methylenebls
(3,4, 6-trlchlorophenol )
(Hexachlorophene)
— Potassium salt of
— Sodium salt of
— Dlsodlum salt of
Pentachlorophenol
— Potassium salt of
—Sodium salt of
— Zinc salt of
— Zinc salt of N-alkyl
_
— Pentachlorophenyl laurate
Potassium trlchlorophenate (2,4,6)
Potassium trlchlorophenate (2,4,5)
Sllvex
— 2-Butoxyethyl ester
— Butoxypolypropoxypropyl ester
— Butoxypropyl ester
— Dlethanolamlne salt
— Dllsopropanolamlne salt
— Dlmethylamlne salt
— Dlpropylene glycol Isobutyl
ether ester
— Ethanolamine salt
— 2-Ethylhexyl ester
— Isooctyl ester
P027 5324-22-1
F027 35109-57-0
P027 136-25-4
F027 327-98-0
P027 70-30-4
P027 67923-62-0
P027 3247-34-5
P027 5736-15-2
F027 87-86-5
P027 7778-73-6
F027 131-52-2
F027 2917-32-0
F027
P027 3772-94-9
P027 2591-21-1
P027 35471-43-3
P027 93-72-1
F027 19398-13-1
F027 53404-07-2
F027 25537-26-2
F027 51170-59-3
F027 53404-09-4
F027 55617-85-1
F027 53535-26-5
F027 7374-47-2
F027 53404-76-5
F027 53404-14-1
127
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PEST/DIS-5
—Isopropyl ester P027 93-78-7
—Propylene glycol Isobutyl P027 53^66-86-7
ether ester
—Trlpropylene glycol isobutyl P027 53535-32-3
ether ester
4-(2,4,5-Trichlorophenoxy)butyric P027 93-80-1
acid [2,4,5-TB]
2-(2,4,5-Trlchlorophenoxy)ethyl P027 69633-04-1
hydrogen sulfate [2,4,5-TES]
l,4?,5'-Trichloro-2'-(2,it,5- P027 69^62-1^1-2
trlchlorophenoxy)
methanesulfonanlllde [Edolan U]
128
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PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "P" LIST (with
[40 CFR 261.33(f)J
Acetone
Acrylonitrile*
Amitrole
Benzene*
Bis(2-ethylhexyl)phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
(chloroacetaldehyde)
Chlordane, technical*
Chlorobenzene*
4-Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresyllc acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1, 3> 4-metheno-
2H-cyclobuta[c,d]-pentalen-2-one
(Kepone, chlordecone)
l,2-Dibromo-3-chloropropane (DBCP)
Dlbutyl phthalate
S-2,3-(Dlchloroallyl diisopropyl-
thlocarbamate) (dlallate, Avadex)
o-Dlchlorobenzene*
p-Dl chlorobenzene*
Dlchlorodlfluorome thane
(Freon 12®)
3,5-Dlchloro-N-(l,l-dimethyl-2-
propynyl) benzamlde
(pronaralde, Kerb®)
Dlchloro dlphenyl dlchloroethane
(ODD)
Dlchloro dlphenyl trlchloroethane
(DDT)
Dichloroethyl ether
2, 4-Dlchlorophenoxyacetic,
salts and esters (2,4-D)*
1 , 2-Dlchloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Eplchlorohydrln
(l-chloro-2, 3-epoxypropane)
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
(chlorobenzllate)
RCRA #,
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 #
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
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
129
-------
PEST/DIS-7
Ethylene dibromide (EDB) U06? 106-93-4
Ethylene dichlorid.e* U077 107-06-2
Ethylene oxide U115 75-21-8
Formaldehyde U122 50-00-0
Furfural U125 98-01-1
Hexachlorobenzene* U127 118-74-1
Hexachlorocyclopentadiene U130 77-47-4
Hexachloroethane* U131 67-72-1
Hydrofluoric acid U134 7664-39-3
Isobutyl alcohol* U140 78-83-1
Lead acetate U144 301-04-2
Llndane* U129 58-89-9
Maleic hydrazide U148 123-33-1
Mercury U151 7439-97-6
Methoxychlor* U247 72-43-5
Methyl alcohol (methanol) U154 67-56-1
Methyl bromide U029 74-83-9
Methyl chloride U045 74-87-3
2,2'-Methylenebis U132 70-30-4
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31J
Methylene chloride* U080 75-09-2
Methyl ethyl ketone* U159 78-93-3
4-Methyl-2-pentanone U161 108-10-1
(methyl isobutyl ketone)
Naphthalene U165 91-20-3
Nitrobenzene* U169 98-95-3
p-Nitrophenol U170 100-02-7
Pentachloroethane U184 76-01-7
Pentachloronitrobenzene (PCNB) U185 82-68-8
Pentachlorophenol* U242 87-86-5
[acute waste per 261.3U
Phenol* U188 108-95-2
Pyridine* U196 110-86-1
Resorcinol U201 108-46-3
Safrole U203 94-59-7
Selenium disulfide U205 7488-56-4
Silvex {acute waste per 261.31] U233 93-72-1
1,1,2,2-Tetrachloroethane* U209 79-34-5
Tetrachloroethylene* U210 127-18-4
2,3,4,6-Tetrachlorophenol* U212
[acute waste per 261.31]
Thiram U244 137-26-8
Toluene* U220 108-88-3
1,1,1-Trichloroethane* U226 71-55-6
(methyl chloroform)
Trichloroethylene* U228 79-01-6
Trichloromonofluoromethane U121 75-69-4
(Freon 11®)
2,4,5-Trlchlorophenol* U230 95-95-4
[acute waste per 261.31]
2,4,6-Trichlorophenol* U231 88-06-2
[acute waste per 261.31]
130
-------
PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)« .
[acute waste- per. 261. 3U «i-fti_?
Warfarin «0.3*> ^ 1330-20-7
phosphide «10?) U249 1314-8^-7
83 ACTIVES
131
-------
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:
Statement
Metal
containers
(non-aerosol )
Plactic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reusedl, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
}J Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
132
-------
APPENDIX III
USE INDEX APPENDICES
133
-------
EPA Index to Pesticide Chemicals
FOLPET
Auxiliary Documentation
Reg. No. 334-256 has been sent to PCB for cancellation.
Reg. No. 19753-2 has been voluntarily cancelled and sent to PCB.
Reg. No. 3090-90 has captan as the active ingredient, not folpet. It is
currently on the folpet GFD.
Reg. No. 239-1029 (75% WP) has insecticide tank mixes (ORTHENE or ISOTOX)
and a foliar feeding mix.
Reg. No. 4-186 has house plant uses that were determined to be for sites
validated for the other active ingredients.
Reg. No. 5383-54 has a 'laquers1 claim, but specific directions for paint
only.
Reg. No. 1100-78 has a "caulking1 claim, but specific directions for paint
only.
Reg. No. 43-70 (creosote paint) does not give specific sites.
The directions for strawberry to apply "until after harvest" is on most
labels, but not in the compendium.
Flowering Crabapple/Scab (on 8590-343) is not in the compendium but has
been entered on the strength of the Ag Crops claim.
134
Issued: 4-09-85
-------
EPA Compendium of Acceptable Uses
FOLPET
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP 2
(Agricultural Crops) 2
Apple2
Avocado 3
Blackberry 3
Blueberry 4
Boysenberry 3
Celery 4
Cherry (sour) 4
Citrus Fruits (grapefruit, kumquat, lemon, lime, orange,
tangelo, tangerine) 5
Crabapple 2
Cranberry 5
Cucumber 5
Currant 6
Dewberry 3
Garlic 7
Gooseberry 6
Grapes 7
Huckleberry 4
Leek 7
Lettuce 8
Loganberry 3
Melons (cantaloupe, honeydew melons, muskmelons, water-
melons) 8
Onion 7
Pumpkin 8
Raspberry 3
Shallot, Onions 7
Squash, Summer 8
Squash, Winter 8
Strawberry 9
Tomato 10
TERRESTRIAL NON-FOOD CROP 10
(Ornamental Plants and Forest Trees) 10
Aster 10
Azalea (cuttings) 11
Bluegrass (in nonpasture sites) 11
Carnation 12
Chrysanthemum 12
Flowering Crabapple 13
Gladiolus 13
Iris I*
Lilac 14
Marigold 15
Ornamental Flowering Plants 15
Phlox 10
Rose 16
Issued: 4-09-85 11-081601-i
Provisional Update: 11-07-86
135
-------
EPA Compendium of Acceptable Uses
FOLPET
TABLE OF CONTENTS
Site Name Page
Snapdragon 17
Zinnia 15
GREENHOUSE NON-FOOD CROP 18
(Ornamental Plants and Forest Trees) 18
Poinsettia 18
DOMESTIC OUTDOOR 18
(Wood or Wood Structure Protection Treatments) 18
Wood Protection Treatment of Existing Buildings or Parts
of Buildings 19
Wood Protection Treatment of Finished Wood Products and/or
Components of Buildings 19
Wood Protection Treatments Hade to Wooden Aquatic Struc-
tures and Items 20
Wood Protection Treatments Made to Wooden Containers and
Other Items Used for Growing Plants 20
INDOOR 21
(Ornamental Plants) 21
Ornamental Plants (houseplants) 21
(Wood or Wood Structure Protection Treatments) 21
Wood Protection Treatment of Existing Buildings or Parts
of Buildings 21
Wood Protection Treatment of Finished Wood Products and/or
Components of Buildings 21
(Commercial and Industrial Uses) 21
Naugahyde 21
Paints (for preservation of applied paint films) 22
Issued: 4-09-85
136
-------
EPA Compendium of Acceptable Uses
c081601 FOLPET*
TYPE PESTICIDE: Fungicide
FORMULATIONS:
Tech (88%, 90%)
FI (1.4%, 2%, 37.5%, 50%, 75%, 80%, 88%)
D (4%, 5%, 7.5%, 35%, 88%)
WP (14.5%, 25%, 42%, 50%, 60%, 75%)
WP/D (5%, 6.5%, 7.5%, 8.82%)
Impr (0.0616%, 0.1056%, 0.2288%)
F1C (1.17 Ib/gal or 13%, 4.29 Ib/gal or 44%)
RTU (0.27%, 0.3%, 0.4%, 0.44%, 0.45%, 0.47%, 0.48%, 0.49%, 0.5%, 0.5275%,
0.53%, 0.66%, 0.7%, 0.8%, 1%)
PrL (0.5%, 0.7%, 0.75%)
PrD (4%)
GENERAL WARNINGS AM) LIMITATIONS; Folpet is compatible with most commonly
used insecticides, adjuvants, and fungicides. Folpet is not compatible
with strongly alkaline materials such as hydrated lime (fungicidal activi-
ty is reduced). Do not use in combination with or closely following oil
sprays. Do not combine wettable powders with emulsifiable concentrates
in the same spray tank unless previous use of the materials being combined
has proven them to be physically compatible. Observe all warnings and
limitations for other active ingredients on multiple active ingredient
labels.
Mixers, loaders, and applicators, when mixing, loading, and applying, must
wear mid-forearm to elbow-length natural or synthetic rubber, vinyl, or
plastic gloves impermeable to folpet, boots or overshoes, one-piece over-
alls which have long sleeves and long pants, face shield or goggles, and
a hat or other appropriate head covering. Applicator's protection may
also be obtained by use of an enclosed tractor cab with a properly filter-
ed air supply. Fieldworkers and harvesters must wear natural or synthetic
rubber, vinyl, or plastic gloves impermeable to folpet residues. Leather
or fabric gloves are not acceptable. If the folpet formulation is a liq-
uid, a chemical-resistant apron must be worn when mixing and loading the
chemical. If the formulation is a dust, granular, or wettable powder, a
dust mask must be worn when mixing and loading the chemical. Clothing
worn while loading, mixing, and applying this product must be laundered
separately from other clothing before reuse. Clothing that may have been
drenched or heavily contaminated must be disposed of in accordance with
State and local regulations.
Homeowners must wear natural or synthetic rubber, vinyl, or plastic gloves
impermeable to folpet when using indoors or outdoors. They must also wear
long pants and long-sleeved shirt and apply, if a spray, with the wind to
their back. Nondisposable gloves must be washed thoroughly with soap and
water before removing. Clothing worn while handling folpet must be laun-
dered separately from other clothing before reusing.
Folpet is toxic to fish. Cranberries excluded, do not apply directly to
water or wetlands (swamps, bogs, marshes, and potholes). Drift and run-
off from treated areas may be hazardous to aquatic organisms in neighbor-
ing areas. Do not contaminate water by cleaning of equipment or disposal
*N-((trichloromethyl)thio)phthalimide
Issued: 4-09-85 11-081601-1
Provisional Update: 11-07-86
137
-------
EPA Compendium of Acceptable Uses
FOLPET
GENERAL WARNINGS AND LIMITATIONS (continued)
of wastes. Refer to labeling for appropriate Endangered Species Limita-
tions.
Dosage rates are given in active ingredient.
Definition of Terms:
*Tablespoons actual: A hypothetical quantity computed by multiplying the
number (or equivalent number) of tablespoons of product by the concentra-
tion of folpet in the formulation.
MAI - multiple active ingredient(s)
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
TERRESTRIAL FOOD CROP
/04001AA
/04002AA
FEAJVAG
FIADGAP
FIBFPCH
FMAVPCH
FMAIMCO
FMADSAH
General Warnings and Limitations; Do not rotate a foliar treated crop
with crops other than those with registered folpet uses, excluding seed
piece and plant propagule treatments. Do not allow persons to enter
treated areas within 4 days following application unless protective cloth-
ing specified for applicators is worn. Reentry information must be posted
conspicuously at the site of application.
(Agricultural Crops)
Apple
Crabapple
Apple scab
(Venturia)
Bitter rot
(Glomerella)
Black rot of fruit
and frogeye leaf
spot
(Physalospora)
Brook's fruit spot
(Mycosphaerella)
Flyspeck
(Schizothyrium)
0.75-1.0 lb/
100 gal
[up to 800
gal/A]
(50%, 75% WP)
or
1 tbls actu-
al/gal
(75% WP)
or
25 ppm
No preharvest Interval through 8.0
pounds per acre.
In eastern states, russeting may
occur on sensitive varieties such
as Golden Delicious, Red Delicious,
and Stayman Winesap when applied
just before bloom to 30 days after
petal fall. In western states, do
not apply between bloom and July 1
to avoid injury.
Delayed dormant and foliar applica-
tion. Apply at delayed dormant.
Repeat at 14 day Intervals through
cover sprays.
OR MAI
Formulated with dicofol, carbaryl,
and malathion.
Issued: 4-09-85
11-081601-2
138
-------
Site and Pest
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
FMBCAAX
FCAFGAL
FICRBAT
/28000AA
FEAJSCB
/01002AA
/01003AA
/01004AA
/01005AA
/01006AA
FIBFQBB
FHACBAW
FBBDDBC
Apple cluster (continued)
Pest list continued from previous page.
—OR MAI—
Leaf spot
(Alternaria)
Sooty blotch
(Gloeodes)
White rot
(Botryosphaeria)
Avocado
Scab (spot anthrac- 1.5 lb/100
nose) (Sphaceloma) gal
Blackberry
Boysenberry
Dewberry
Loganberry
Raspberry
0.145 lb/20
gal
or
0.435 tbls
actual*/gal
(14.5% WP)
25 ppm
No preharvest interval through 18.0
pounds per acre.
Foliar application. Apply when the
bloom buds begin to swell in very
[up to 1,000 susceptible varieties, or during
gal/A] late bloom when some fruit has set
(50%, 75% WP) in the slight and moderately sus-
ceptible varieties. Repeat at 2 to
3 week intervals as needed.
25 ppm
No preharvest interval through 2.5
pounds per acre.
Fruit rot
Gray mold
(Botrytis)
Spur blight
(Didymella)
1.0 lb/100
gal
[250 gal/A]
(25%, 50%,
75% WP)
or
0.625-1 tbls
actual*/gal
(25%, 75% WP)
—OR MAI—
0.145 lb/20
gal
or
0.435 tbls
actual*/gal
(14.5% WP)
Foliar application. Apply when
berries have set. Repeat at 7 day
intervals until harvest.
OR MAI
Formulated with dicofol, carbaryl,
and malathioru
Issued: 4-09-85
II-081601-3
139
-------
/01009AA
/01015AA
FHACBAW
FMBCGAN
FFACMBT
/28003AA
FBAMCBM
FBASSBL
/05002AA
FBADMCB
FIALMCB
FMBCCDJ
Site and Pest
Blueberry
Huckleberry
Gray mold
(Botrytis)
Leaf spot
(anthracnose)
(Gloeosporium)
Powdery mildew
(Microsphaera)
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
Early blight
(Cercospora)
Late blight
(Septoria)
Cherry (sour)
Brown rot blossom
and twig blight
(Monilinia)
Brown rot of fruit
(Monilinia)
Cherry leaf spot
(Coccomyces)
25 ppm
No preharvest interval through 2.5
pounds per acre.
Foliar application. Apply before
first infection. Repeat at 7 day
intervals until harvest.
1.0 lb/100
gal
[250 gal/A]
(25%, 50%,
75% WP)
or
0.625-1 tbls
actual*/gal
(25%, 75% WP)
See Blackberry cluster.
50 ppm
7 day preharvest interval through
2.0 pounds per acre.
1.0-2.0 Ib/A Foliar application. Apply after
(50%, 75% WP) plants are established in the field.
or Repeat at 7 day intervals.
1 tbls actu-
al*/gal
(75% WP)
50 ppm
No preharvest interval through 6.0
pounds per acre.
Do not use on sweet cherries as
foliage injury may occur.
0.5-1.0 lb/
100 gal
(50%, 75% WP)
or
1 tbls actu-
al/gal
(75% WP)
—OR MAI--
0.145 lb/20
gal
or
0.435 tbls
actual*/gal
(14.5% WP)
Delayed dormant, foliar, and post-'
harvest application. For brown rot,
apply in delayed dormant, popcorn,
and bloom stages and at 7 to 14 day
intervals. Repeat as needed. For
leaf spot, apply in cover period at
7 to 14 day intervals as needed.
Repeat once or twice as a posthar-
vest foliar application.
OR MAI
Formulated with dicofol, carbaryl,
and mala t hi on.
Issued: 4-09-85
11-081601-4
140
-------
Site and Pest
/02000AA
FMAYMCO
FIBLDAP
FAABEAH
/01010AA
FICJQBB
/10010AA
FAAACDP
FFABPEA
FIBFPES
FIBFRAM
FFACEBJ
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Fommlation(s)
Citrus Fruits (grapefruit, kum-
quat, lemon, lime, orange, tan-
gelo, tangerine)
15 ppm
No preharvest interval through 20.0
pounds per acre.
Greasy spot
(Mycosphaerella)
Melanose
(Diaporthe)
Scab (spot anthrac-
nose) (Elsinoe)
Crabapple
Cranberry
Storage rots
Cucumber
1.0-2.0 lb/ Foliar application. For greasy
100 gal spot, apply 1.0 pound per 100 gal-
(50%, 75% WP) Ions with a suitable sticker. Apply
or in August and September, 3 to 10
0.6-1.125 weeks after first growth. For mela-
tbls actu- nose, apply 1.0 to 2.0 pounds per
al*/gal 100 gallons. Apply 1 week after
(75% WP) bloom and complete as soon as possi-
ble. For scab, apply 1.0 pound per
100 gallons. Apply in dormant and
two-thirds petal fall stages, 2
weeks later, and on fall flush in
August and September.
See Apple cluster.
25 ppm
30 day preharvest interval through
9.0 pounds per acre.
Water from cranberry bogs (in which
cranberry plants has been treated
with folpet) must not be used for
irrigation of crops other than those
with registered folpet uses.
4.5 Ib/A Foliar application. Apply during
(50%, 75% WP) bloom. Repeat at 10 to 14 day in-
tervals.
15 ppm
No preharvest interval through 4.0
pounds per acre.
Anthracnose
(Colletotrichum)
Downy mildew
(Pseudoperono-
spora)
Fruit rot (Pythium)
Fruit rot
(Rhizoctonia)
Powdery mildew
(Erysiphe)
Issued: 4-09-85
1.0-2.0 lb/
100 gal
[200 gal/A]
(25%, 50%,
75% WP)
or
1.875-2.5
tbls aetu-
al*/gal
[fruit rots]
(25% WP)
or
Foliar application. For fruit rots,
apply 3.0 to 4.0 pounds per acre as
a directed spray at the soil in the
row. Apply when plants begin to
run. For the other diseases, apply
1.0 to 2.0 pounds per acre with a
suitable sticker. Apply at first
true leaf stage. Repeat at 5 to 10
day intervals depending upon disease
pressure until harvest.
OR MAI
Formulated with dinocap; or dicofol,
carbaryl, and malathion.
11-081601-5
141
-------
Site and Pest
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formula t ion(s)
Cucumber (continued)
/ 01OUAA
/01013AA
FMBCQBB
Currant
Gooseberry
Leaf spots
0.625-1.25
tbls actu-
al/gal
(25% WP)
or
1.125 tbls
actual*/gal
[2 qt/100
ft of row]
(75% WP)
—OR MAI—
0.145 lb/20
gal
or
0.435 tbls
actual*/gal
(14.5% WP)
or
0.105 lb/8-16
gal
[200 gal /A]
or
0.42-0.84
tbls actu-
al*/gal
(42% WP)
25 ppm
No preharvest interval through 3.0
pounds per acre.
2.0 lb/100
Dewberry
Foliar application. Apply before
infection or before bloom. Repeat
[150 gal /A] at 7 to 10 day intervals in the
(50%, 75% WP) post-bloom period.
or
1.25 tbls
actual*/gal
(25% WP)
or
2 tbls actu-
al/gal
(75% WP)
See Blackberry cluster.
Issued: 4-09-85
11-081601-6
142
-------
/14007AA
/14010AA
/14011AA
/14017AA
FFABPAU
FCAEAAX
/01014AA
FIBFGBC
FFABPCV
FDAMQBB
FFACUAB
Site and Pest
Garlic
Leek
Onion
Shallot, Onions
Downy mildew
(Peronospora)
Purple blotch
(Alternaria)
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
15 ppm (garlic, onions (dry bulb))
50 ppm (leek, onions (green), shal-
lots)
No preharvest interval through 4.0
pounds per acre.
2.0 lb/100 Foliar application. Apply before
gal infection. Repeat at 7 day inter-
[200 gal/A] vals until tops begin to dry before
(50%, 75% WP) harvest.
or
1.125 tbls
actual*/gal
[1 qt/100
ft of row]
(75% WP)
or
1.25-2 tbls
actual*/gal
(25%, 75% WP)
See Currant cluster.
25 ppm
No preharvest interval through 3.0
pounds per acre.
During periods of extended hot, dry
weather, foliage injury may occur.
Black rot
(Guignardia)
Downy mildew
(Plasmopara)
Dead-arm
Powdery mildew
(Uncinula)
1.0 lb/100
gal
(25%, 50% WP)
or
0.625-1 tbls
actual*/gal
(25%, 75% WP)
—OR MAI—
3.0 Ib/A
or
0.07 lb/1,000
sq.ft
(4% D)
or
Delayed dormant and foliar applica-
tion. For black rot and downy mil-
dew, apply 250 to 300 gallons per
acre. Apply just before bloom. Re-
peat just after bloom and at 7 to
10 day intervals for 1 to 3 more
applications. For dead-arm in east-
ern states, apply when new growth
is 1 to 2 inches long. Repeat when
4 to 10 inches long. In western
states, apply at bud break. Repeat
2 weeks later or when new growth is
4 to 8 inches long. For powdery
mildew, apply 2 to 3 weeks after
bloom. Repeat at 2 week intervals.
OR MAI
Formulated with dinocap; or car-
baryl.
Issued: 4-09-85
II-081601-7
143
-------
/13020AA
FFABBBA
/10001AA
/10011AA
/10013AA
/1001 AM
FAAACDP
FFABPEA
FFACEBJ
Site and Pest
Grapes (continued)
Huckleberry
Leek
Lettuce
Downy mildew
(Bremla)
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.16 lb/16
gal
[up to 300
gal/A]
or
0.63 tbls
actual*/gal
(42% WP)
See Blueberry cluster.
See Garlic cluster.
50 ppm
No preharvest interval through 2.0
pounds per acre.
Loganberry
1.0 lb/100
gal
[up to 200
gal/A]
(50%, 75% WP)
or
0.625-1 tbls
actual*/gal
(25%, 75% WP)
Foliar application. Apply when
plants are established in field.
Repeat at 7 day intervals until
harvest.
Melons (cantaloupe, honeydew mel-
ons, muskmelons, watermelons)
Pumpkin
Squash, Summer
Squash, Winter
Anthracnose
(Colletotrichum)
Downy mildew
(Pseudoperono-
spora)
Powdery mildew
(Erysiphe)
1.0-2.0 lb/
100 gal
[up to 200
gal/A de-
pending on
vine size]
(50%, 75% WP)
or
0.625-2 tbls
actual*/gal
(25%, 75% WP)
See Blackberry cluster.
15 ppm
No preharvest interval through 4.0
pounds per acre.
Foliar application. Apply when
first true leaves appear. Repeat
weekly until harvest.
Issued: 4-09-85
II-081601-8
144
-------
/01016AA
FEBFQBB
FMBCMCO
EPA Compendium of Acceptable Uses
FOLPET
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Melons (cantaloupe, honeydew melons, muskmelons, watermelons) (con-
tinued)
Onion
Pumpkin
Raspberry
Shallot, Onions
Squash, Summer
Squash, Winter
Strawberry
Fruit rot
Leaf spot
(Mycosphaerella)
MAI:
melons -
0.145 lb/20
gal
or
0.435 tbls
actual*/gal
(14.5% WP)
MAI:
summer
squash -
0.105 lb/8-
16 gal
[200 gal/A]
or
0.42-0.84
tbls actu-
al/gal
(42% WP)
Foliar application.
Formulated with dicofol, carbaryl,
and malathion.
Foliar application.
Formulated with dinocap.
1.0 lb/100
gal
[up to 200
gal/A]
(50%, 75% WP)
or
1 tbls actu-
al*/gal
(75% WP)
See Garlic cluster.
See Melons cluster.
See Blackberry cluster.
See Garlic cluster.
See Melons cluster.
See Melons cluster.
25 ppm
No preharvest interval through 2.0
pounds per acre.
Delayed dormant, foliar, and post-
harvest application. Apply before
bloom. Repeat at 7 day intervals
until after harvest.
Issued: 4-09-85
11-081601-9
145
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/11005AA
FAAAGAP
Site and Pest
Tomato
Anthracnose
(Glomerella)
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
25 ppm
No preharvest interval through 4.0
pounds per acre.
2.0 lb/100
gal
[up to 200
gal/A]
(50%, 75% WP)
or
1.125 tbls
actual*/gal
[2 qt/100
ft of row]
(75% WP)
or
1-2 tbls
actual*/gal
(25%, 75% WP)
Foliar application. Apply during
bloom. Repeat at 7 to 10 day inter-
vals through harvest.
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
General Warnings and Limitations; Apply as specified except more fre-
quently during periods of rapid new growth and severe infection under
conditions of recurring rains or high humidity. Dust, pressurized liq-
uid, and pressurized dust formulations for which a dose rate is not spe-
cified should be applied lightly, covering both upper and lower leaf
surfaces. All wettable powder/dust formulations may be applied at the
dilution given or as a dust in the manner previously described.
/31026AA
/31156AA
FFACEBJ
Powdery mildew
(Erysiphe)
1.0 lb/100
gal
or
0.625-1.125
tbls actu-
al*/gal
(25%, 50%,
75% WP)
or
0.15 oz/gal
(1.17 Ib/gal
or 13% F1C)
or
Foliar application. Apply before
disease appears. Repeat at 7 to 10
day intervals.
OR MAI
Formulated with dinocap; dicofol and
carbaryl; dicofol and malathion;
methoxychlor and malathion; methoxy-
chlor and oxydemeton-methyl; carba-
ryl and malathion; diazlnon and sul-
fur; dicofol, carbaryl, and malathi-
on; diazlnon, piperonyl butoxide,
and pyrethrins; or carbaryl, petro-
leum distillate, piperonyl butoxide,
pyrethrins, and rotenone.
Issued: 4-09-85
11-081601-10
146
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Site and
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
Aster cluster (continued)
—OR MAI—
0.05-0.098
lb/10 gal
or
0.3-0.75 tbls
actual*/gal
(14.5%, 42%
WP)
(5%, 7.5%
WP/D)
or
(5%, 7.5% D)
(0.5%, 0.7%
PrL)
or
0.75 oz/625
sq.ft
(7.5% D)
/34022AA
FKAAQBB
FKAACFO
Azalea (cuttings)
Damping-off
Damping-off
(Cylindrocladium)
/33019AA
FBATHAM
0.75 lb/100
gal
(50%, 75% WP)
or
0.5-1.5 tbls
actual*/gal
(25%, 75% WP)
or
0.15 oz/gal
(1.17 Ib/gal
or 13% F1C)
—OR MAI—
0.63 tbls
actual*/gal
(42% WP)
Bluegrass (in nonpasture sites)
Cuttings treatment. Soak cuttings
for 15 to 30 minutes before placing
in rooting media.
OR MAI
Formulated with dinocap.
Do not graze in treated areas. Do
not feed clippings to livestock.
Melting-out 3.0 oz/5 gal/ Foliar application. Apply before
(Helminthosporium) 1,000 sq.ft disease is expected to appear. Re-
(50%, 75% WP) peat at 7 day intervals as needed.
Issued: 4-09-85
11-081601-11
147
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Site and Pest
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
/31057AA
FBATAAX
FJAAUAH
Carnation
Altemaria blight
(leaf spot)
Carnation rust
(Uromyces)
/31065AA
FMBCSBL
FFACEBJ
Chrysanthemum
Leaf spot
(Septoria)
Powdery mildew
(Erysiphe)
0.5-1.25 lb/
100 gal
or
0.5-1.125
tbls actu-
al/gal
(25%, 50%,
75% UP)
or
0.15 02/gal
(1.17 Ib/gal
or 13% F1C)
—OR MAI—
0.05-0.098
lb/10 gal
or
0.3-0.75 tbls
actual*/gal
(14.5%, 42%
WP)
(5%, 6.5%,
7.5% WP/D)
or
(5%, 7.5% D)
(0.5%, 0.7%
PrL)
(4% PrD)
0.94-1.25 lb/
100 gal
or
0.625-1.125
tbls actu-
al*/gal
(25%, 50%,
75% WP)
or
0.15 oz/gal
(1.17 Ib/gal
or 13% F1C)
or
Foliar application. Apply 2 weeks
after planting. Repeat at 7 to 10
day intervals as needed.
OR MAI
Formulated with dinocap; dicofol and
carbaryl; dicofol and malathion;
methoxychlor and malathion; methoxy-
chlor and oxydemeton-methyl; carba-
ryl and malathion; diazinon and sul-
fur; dicofol, carbaryl, and malathi-
on; diazinon, piperonyl butoxide,
and pyrethrins; dicofol, carbaryl,
aromatic petroleum derivative sol-
vent, methylated naphthalenes, and
lindane; dicofol, carbaryl, aromatic
petroleum derivative solvent, meth-
ylated naphthalenes, and malathion;
or carbaryl, petroleum distillate,
piperonyl butoxide, pyrethrins, and
rotenone.
Foliar application. Apply immedi-
ately after planting. Repeat at 7
to 10 day intervals.
OR MAI
Formulated with dinocap; lindane and
dicofol; dicofol and carbaryl; dico-
fol and malathion; methoxychlor and
malathion; methoxychlor and oxydeme-
ton-methyl; carbaryl and malathion;
diazinon and sulfur; dicofol, car-
baryl, and malathion; dinocap, car-
baryl, and rotenone; diazinon,
piperonyl butoxide, and pyrethrins;
dicofol, carbaryl, aromatic petro-
leum derivative solvent, methylated
Issued: 4-09-85
11-081601-12
148
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Site and Pest
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
Chrysanthemum (continued)
/35056AA
FEAJVAG
Flowering Crabapple
Scab (Venturia)
/31111AA
FIAPQBB
FKAAQBB
Gladiolus
Corm rot
Damping-off
naphthalenes, and lindane; dicofol,
carbaryl, aromatic petroleum deriva-
tive solvent, methylated naphtha-
lenes, and malathion; or carbaryl,
petroleum distillate, piperonyl
butoxide, pyrethrins, and rotenone.
—OR MAI—
0.05-0.098
lb/10 gal
or
0.3-0.75 tbls
actual*/gal
(14.5%, 42%
WP)
(5%, 6.5%,
7.5%, 8.82%
WP/D)
or
(5%, 7.5% D)
(0.5%, 0.7%
PrL)
(4% PrD)
or
0.75 oz/625
sq.ft
(7.5% D)
MAI: Delayed dormant and foliar applica-
1.2 oz/mature tion. Apply when leaves first ap-
tree pear. Repeat at weekly intervals
(7.5% D) until 30 days after petal fall.
Formulated with dicofol and carba-
ryl.
2.5 tbls Corm treatment. Apply to conns as
actual*/gal a preplanting soak for 20 to 30
(50%, 75% WP) minutes. Keep mixture stirred.
or Drain and plant immediately.
7.5 tbls
actual*/gal
(75% WP)
Issued: 4-09-85
11-081601-13
149
-------
/31126M
FMBCDBD
Site and Pest
Iris
Leaf spot
(Didymellina)
/34089AA
FFACMBT
Lilac
Powdery mildew
(Microsphaera)
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.94-1.25 lb/
100 gal
or
0.625-1.125
tbls actu-
al*/gal
(25%, 50%,
75% WP)
—OR MAI—
0.05-0.06
lb/10 gal
or
0.3-0.4 tbls
actual*/gal
(5%, 7.5%
WP/D)
or
(5% D)
(0.5%, 0.7%
PrL)
(4% PrD)
or
0.75 oz/625
sq.ft
(7.5% D)
(0.7% PrL)
Foliar application. Apply when
plants emerge. Repeat at 7 to 10
day intervals.
OR MAI
Formulated with dicofol and carba-
ryl; dicofol and malathion; methoxy-
chlor and oxydemeton-methyl; carba-
ryl and malathion; dicofol, carba-
ryl, and malathion; dlazinon, piper-
onyl butoxide, and pyrethrins; or
carbaryl, petroleum distillate,
piperonyl butoxide, pyrethrins, and
rotenone.
Foliar application. Apply before
disease appears, or at first signs
of disease.
Formulated with carbaryl, petroleum
distillate, piperonyl butoxide,
pyrethrins, and rotenone.
Issued: 4-09-85
11-081601-14
150
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/31137AA
/31213M
FMBCAAX
Site and Pest
Marigold
Zinnia
Leaf spot
(Alternaria)
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance. Use, Limitations
Formulation (s)" ~
1.0-1.25 lb/
100 gal
or
0.625-1.125
tbls actu-
al*/gal
(25%, 50%,
75% WP)
or
0.15 oz/gal
(1.17 Ib/gal
or 13% F1C)
—OR MAI—
0.05-0.098
lb/10 gal
or
0.3-0.75 tbls
actual*/gal
(14.5%, 42%
WP)
(5%, 6.5%,
7.5% WP/D)
or
(5%, 7.5% D)
(0.5%, 0.7%,
0.75% PrL)
(4% PrD)
Foliar application. Apply when
plants emerge. Repeat at 3 to 7 day
intervals.
OR MAI
Formulated with dinocap; dicofol and
carbaryl; dicofol and malathion;
methoxychlor and malathion; methoxy-
chlor and oxydemeton-methyl; carba-
ryl and malathion; diazinon and sul-
fur; resmethrin and acephate; dico-
fol, carbaryl, and malathion; diazi-
non, piperonyl butoxide, and pyre-
thrins; or carbaryl, petroleum dis-
tillate, piperonyl butoxide, pyre-
thrins, and rotenone.
/31003AA
FMBCQBB
FFACQBB
Ornamental Flowering Plants
MAI:
Leaf spots
Powdery mildew
(5% D)
(0.7% PrL)
Foliar application. Apply as a pre-
ventative when leaves appear. Re-
peat at 7 to 10 day intervals. Dust
should be reapplied after sprinkler
or overhead irrigation or rainfall.
Formulated with dicofol, carbaryl,
or malathion; carbaryl, piperonyl
butoxide, pyrethrins, and rotenone;
or carbaryl, petroleum distillate,
piperonyl butoxide, pyrethrins, and
rotenone.
Issued: 4-09-85
11-081601-15
151
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Site and Pest
/34120AA Rose
FMAEDBS Black spot
(Dlplocarpon)
FFACQBB Powdery mildew
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
Do not use wetting agents as injury
may result.
0.5-1.25 lb/
100 gal
or
0.5-1 tbls
actual*/gal
(25%, 50%,
75% WP)
or
0.15 oz/gal
(1.17 Ib/gal
or 13% F1C)
—OR MAI—
0.05-0.98
lb/10 gal
or
0.3-0.75 tbls
actual*/gal
(14.5%, 425J
WP)
(5%, 6.5%,
7.5%, 8.82%
WP/D)
or
(5%, 7.5% D)
(0.5%, 0.7%,
0.75% PrL)
(4% PrD)
or
1.2-1.6 Ib/A
or
0.48-0.64 oz/
1,000 sq.ft
(4% D)
or
0.75 oz/625
sq.ft
(7.5% D)
Foliar application. Apply when
first leaves unfold. Repeat at 7
to 10 day intervals throughout the
season.
OR MAI
Formulated with dinocap; carbaryl;
malathion; lindane and dicofol;
dicofol and carbaryl; dicofol and
malathion; methoxychlor and mala-
thion; methoxychlor and oxydemeton-
methyl; carbaryl and malathion;
diazlnon and sulfur; resmethrin and
acephate; dicofol, carbaryl, and
malathion; dicofol, carbaryl, and
sulfur; dinocap, carbaryl, and rote-
none; diazinon, piperonyl butoxide,
and pyrethrins; carbaryl, piperonyl
butoxide, pyrethrins, and rotenone;
dicofol, carbaryl, aromatic petro-
leum derivative solvent, methylated
naphthalenes, and lindane; dicofol,
carbaryl, aromatic petroleum deriva-
tive solvent, methylated naphtha-
lenes, and malathion; carbaryl,
petroleum distillate, piperonyl
butoxide, pyrethrins, and rotenone;
or methoxychlor, dinocap, N-octyl
bicycloheptene dicarboximide, petro-
leum distillate, pyrethrins, and
rotenone.
Issued: 4-09-85
11-081601-16
152
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Site and Pest
EPA Compendium of Acceptable Dees
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
/31184AA Snapdragon
FAAACDP Anthracnose
(Colletotrichum)
FFACOAB Powdery mildew
(Oidium)
FJAAPEJ Rust (Puccinia)
1.0-1.25 lb/
100 gal
or
0.625-1.125
tbls actu-
al*/gal
(25%, 50%,
75% WP)
or
0.15 oz/gal
(1.17 Ib/gal
or 13% FIG)
—OR MAI—
0.05-0.098
lb/10 gal
or
0.3-0.75 tbls
actual*/gal
(14.5%, 42%
WP)
(5%, 7.5%,
8.82% WP/D)
or
(5%, 7.5% D)
(0.5%, 0.7%
PrL)
(4% PrD)
Foliar application. Apply when
plants emerge. Repeat at 3 to 7 day
intervals.
OR MAI
Formulated with dinocap; lindane and
dicofol; dicofol and carbaryl; dico-
fol and malathion; methoxychlor and
malathion; methoxychlor and oxydeme-
ton-methyl; carbaryl and malathion;
diazinon and sulfur; dicofol, car-
baryl, and malathion; diazinon,
piperonyl butoxide, and pyrethrins;
or carbaryl, petroleum distillate,
piperonyl butoxide, pyrethrins, and
rotenone.
Issued: 4-09-85
11-081601-17
153
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EPA Compendium of Acceptable Uses
FOLPET
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
GREENHOUSE NON-FOOD CROP
General Warnings and Limitations; Only the applicator is permitted to be
in the greenhouse during soil application of folpet. Greenhouse vents
must be open during application and for at least 1 hour after application.
Workers planting in folpet-treated soil in greenhouses must wear gloves
impermeable to folpet.
(Ornamental Plants and Forest Trees)
/31159CA Poinsettia
FICBPES Pythium root rot 1.0-1.25 Soil treatment. Add a suitable
lb/100 gal spreader. Use 1 pint of suspension
(25%, 50%, per 8 inch pan. Apply at time of
75% WP) panning. Repeat 10 days later.
or
0.625 tbls
actual*/gal
(25% WP)
DOMESTIC OUTDOOR
(Wood or Wood Structure Protection Treatments)
General Warnings and Limitations; The active ingredient is formulated
into 3 types of products: clear wood preservatives, solid color oil
stains, and semi-transparent oil stains. With noted exceptions, the
formulations should be applied to exterior wood with no soil contact.
Depending upon the type of product used, application can be made to new
or bare wood or over previously stained, unsealed wood. Do not apply
over painted surfaces. Most formulations do not recommend thinning.
All wood to be treated should be clean and dry, and free from wax, oil,
grease, chalk and mildew. Remove mildew by scrubbing with a solution
of non-ammoniated detergent, household bleach, and water. Do not apply
when temperature is below 40 F (4.4 C).
Issued: 4-09-85 11-081601-18
154
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Site and Pest
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulatlon(s)
/64000NB
/64003NB
FYABQBB
Wood Protection Treatment of
Existing Buildings or Parts of
Buildings
Wood Protection Treatment of
Finished Wood Products and/or
Components of Buildings
Mildew
MAI:
(0.27%, 0.
0.44%,
0.45%,
0.47%,
0.48%, 0.
0.53%,
0.66%, 0.
1% RTU)
7%
MAI:
(0.49% RTU)
Apply to siding, shakes, shingles,
fencing, trim, decks, porches, out-
door furniture, beams, roofs, sills,
or structural lumber.
Wood protection treatment. Apply
by brush, spray, roller, or pad.
When dipping is recommended, dip
siding for 3 minutes and millwork
for 5 minutes. Coverage for 1 gal-
lon ranges from 100 square for rough
or porous surfaces to 400 square
feet for smooth surfaces. General-
ly, 2 coats may be applied. Indivi-
dual product densities vary depend-
ing upon pigment and vehicle combi-
nations for different color stains.
The range between products varies
from 0.019 to 0.059 pound active in-
gredient per gallon (the 1 percent
formulation has 0.072 to 0.11 pound
active ingredient per gallon).
Formulated with bis(tributyltin)
oxide; zinc naphthenate; or 3-iodo-
2-propynyl butylcarbamate.
Wood protection treatment. Mix for-
mulation 1:1 with an appropriate oil
base solid color stain.
Formulated with bis(tributyltin)
oxide.
MAI: Wood protection treatment. Coverage
— for 1 gallon ranges from 300 to 600
(0.5%, 0.8% square feet depending upon surface
RTU) texture.
Formulated with bis(tributyltin)
oxide.
MAI: Wood protection treatment. To ap-
— ply, saturate surface, soak for 30
(0.5275% RTU) minutes, re-saturate, soak for 15
minutes then wipe dry. On rough-
sawn surfaces, saturate with a roll-
er, and remove with a dry roller.
Formulated with bis(tributyltin)
oxide.
Issued: 4-09-85
11-081601-19
155
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EPA Compendium of Acceptable Uses
FOLPET
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
Wood Protection Treatment of Existing Buildings or Parts of Buildings
(continued)
MAI:
(0.4% RTU)
/64000NA
/64003NA
FYABQBB
/640060A
FYABQBB
(wood protection treatment for
wood with ground contact)
Mildew MAI:
(0.3% RTU)
Wood Protection Treatments Made
to Wooden Aquatic Structures and
Items
Mildew
MAI:
(0.5% RTU)
/64004NA
FYABQBB
Wood Protection Treatments Made
to Wooden Containers and Other
Items Used for Growing Plants
Mildew
MAI:
(0.5%, 0.
RTU)
Wood protection treatment. Apply
by brush or spray. Coverage for 1
gallon is 400 square feet for 2
coats on smooth surfaces. (NOTE:
No specific sites are listed on
Registration Number 000043-00070).
Formulated with creosote oil.
Wood protection treatment. Apply
clear wood preservative as a dip.
Do not apply over pressure or dip
treated wood.
Formulated with bis(tributyltin)
oxide.
Wood protection treatment. Apply
to marina and dock slip wood and
swimming pool walk wood. Coverage
for 1 gallon Is 200 square feet for
smooth wood.
Formulated with bis(tributyltin)
oxide.
Wood protection treatment. Apply
to trellises or window boxes.
Formulated with bis(tributyltin)
oxide.
Issued: 4-09-85
11-081601-20
156
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/32000FA
FMAEDBS
FMBCAAX
FMBCSBL
FFACQBB
FJAAUAH
/64000NB
/64003NB
FYABQBB
Site and Pest
INDOOR
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
/810150A
FYABQBB
(Ornamental Plants)
Ornamental Plants (houseplants)
Blackspot
(Diplocarpon)
Leaf spot
(Alternaria)
Leaf spot
(Septoria)
Powdery mildew
Rust (Uromyces)
(Wood or Wood Structure Protection Treatments)
(0.5% PrL)
Foliar application to houseplants.
Apply before diseases appear.
Formulated with dicofol, carbaryl,
and malathion.
Wood Protection Treatment of
Existing Buildings or Parts of
Buildings
Wood Protection Treatment of
Finished Wood Products and/or
Components of Buildings
Mildew
MAI:
(0.5% RTU)
(Commercial and Industrial Uses)
Naugahyde
Mildew
(0.0616%
Impr)
(0.1056%
Impr)
(0.2288%
Impr)
See General Warnings and Limitations
for DOMESTIC OUTDOOR, (Wood or Wood
Structure Protection Treatments).
Wood protection treatment. May be
applied to interior or exterior
wood. Coverage for 1 gallon is 400
square feet for smooth surfaces.
Formulated with 3-iodo-2-propynyl
butylcarbamide.
Preservative incorporation. Incor-
porated in naugahyde vinyl uphol-
stery.
Preservative incorporation. Incor-
porated in naugahyde vinyl wall
covering.
Preservative incorporation. Incor-
porated in naugahyde gymnasium mat
material.
Issued: 4-09-85
11-081601-21
157
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Site and Pest
EPA Compendium of Acceptable Uses
FOLPET
Dosages and Tolerance, Use, Limitations
Formulation(s)
/810190A
Paints (for preservation of
applied paint films)
FYABQBB
Mildew
0.44-1.76%
a.i. based
on total
weight of
paint
(88% D)
0.44-1.32%
a.i. based
on total
weight of
paint
(4.29 Ib/gal
or 44% F1C)
For use in interior or exterior oil
or alkyd paint formulations. Do not
use in aqueous systems. Lead driers
and pigments should be avoided in
paint systems containing folpet.
Iron is also potentially reactive,
and paint formulations using pig-
ments known to contain iron impuri-
ties should be carefully tested for
color stability. The dosage level
will depend upon the nature of the
vehicle, the exposure conditions,
nature of the substrate, and the
amount of zinc oxide in the paint.
Preservative incorporation. The
formulation is best incorporated in
the pigment grind, prior to let-
down.
Preservative incorporation. The
formulation should be added during
the dispersion phase of manufacture;
however, it can be added in the let-
down.
Issued: 4-09-85
11-081601-22
158
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EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation
&088.0001 88% technical chemical
±oipet (081601)
000239-01763 000476-02040 032691-00002
&090.0001 90% technical chemical
folpet (081601)
011678-00018
&201.4002 1.4% formulation intermediate
folpet (081601), carbaryl (056801), piperonyl butoxide, technical
(067501), pyrethrins (069001) plus rotenone (and other cube resins)
(071003)
004816-00276
folpet (081601), carbaryl (056801), petroleum distillate (063503),
piperonyl butoxide, technical (067501), pyrethrins (069001) plus rote-
none (and other cube resins) (071003)
001021-01042 004816-00265
&202.0002 2% formulation intermediate
folpet (081601), methoxychlor, technical (034001), 2,4-dinitro-6-octyl*
phenyl crotonate 2,6-dinitro-4-octyl* phenyl crotonate nitrooctyl-
phenols (principally dinitro) *a mixture of 1-methylhelptyl, 1-ethyl-
hexyl and 1-propylpentyl (036001), petroleum distillate (063503),
piperonyl butoxide, technical (067501) plus pyrethrins (C69001)
001021-00943 001021-00987
folpet (081601), methoxychlor, technical (034001), 2,4-dinitro-6-octyl*
phenyl crotonate 2,6-dinitro-4-octyl* phenyl crotonate nitrooctyl-
phenols (principally dinitro) *a mixture of 1-methylhelptyl, 1-ethyl-
hexyl and 1-propylpentyl (036001), N-octyl bicycloheptene dicarboximide
(057001), petroleum distillate (063503), pyrethrins (069001) plus rote-
none (and other cube resins) (071003)
001021-00761
&037.5002 37.5% formulation intermediate
folpet (081601), petroleum distillate (063503) plus pyrethrins (069001)
001021-01017
&050.0002 50% formulation intermediate
folpet (081601)
000239-02489 011678-00029 034688-00008
&075.0002 75% formulation intermediate
folpet (081601)
000239-01352
&080.0002 80% formulation intermediate
folpet (081601)~~
011678-00028
Issued: 4-09-85 11-081601-23
159
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& 088.0002
EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation (continued)
88% formulation Intermediate
folpet (081601)
001100-00070 005383-00054#
//also used as a dust
&004.0003 4% dust
folpet (081601) plus carbaryl (056801)
008590-00183
&005.0003 5% dust
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
plus malathion (057701)
000070-00140
folpet (081601), carbaryl (056801) plus malathion (057701)
005535-00066
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501),
carbaryl (056801) plus malathion (057701)
000016-00049 000239-02346 000572-00055 005887-00004
049585-00001
folpet (081601), 2,4-dinitro-6-octyl* phenyl crotonate 2,6-dinitro-4-
octyl* phenyl crotonate nitrooctylphenols (principally dinitro) *a mix-
ture of 1-methylhelptyl, 1-ethylhexyl and 1-propylpentyl (036001), car-
baryl (056801) plus rotenone (and other cube resins) (071003)
000869-00136
&007.5003 7.5% dust
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
plus carbaryl (056801)
008590-00343
folpet (081601), methoxychlor, technical (034001) plus malathion
(057701)
000471-00008
folpet (081601), 0,0-diethyl 0-(2-isopropyl-6-methyl-4-pyrimidinyl)-
phosphorothioate (057801) plus sulfur (077501)
007001-00317
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501),
carbaryl (056801) plus sulfur (077501)
007401-00158
&035.0003 35% dust
folpet (081601)
019753-00002*
*see auxiliary documentation
Issued: 4-09-85
11-081601-24
160
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EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation (continued)
&088.0003 88% dust
folpet (081601)
005383-00054//
#also used as a formulation intermediate
&014.5006
&025.0006
&042.0006
&050.0006
&060.0006
&075.0006
&005.0007
&006.5007
14.5% wettable powder
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501),
carbaryl (056801) plus malathion (057701)
001159-00197 051400-00001*
*currently unavailable for review
25% wettable powder
folpet (081601)
004931-00102
42% wettable powder
folpet (081601) plus 2,4-dinitro-6-octyl* phenyl crotonate 2,6-dinitro-
4-octyl* phenyl crotonate nitrooctylphenols (principally dinitro) *a
mixture of l^methylhelptyl, 1-ethylhexyl and 1-propylpentyl (036001)
000869-00065
50% wettable powder
folpet (081601)
000004-00181 000072-00524
000476-01609 000477-00237
008590-00215
000239-01102
000477-00275
000279-01508
002124-00480
60% wettable powder
folpet (081601),"cadmium carbonate (012901) plus thiram (079801)
000334-00256*
*see auxiliary documentation
75% wettable powder
folpet (081601)
000239-01029 000476-01294
002125-00027 008590-00560
000557-01848
033955-00517
001159-00122
5% wettable powder/dust
folpet (081601), carbaryl (056801) plus malathion (057701)
001159-00147 005535-00051
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501),
carbaryl (056801) plus malathion (057701)
000904-00130 002125-00054
6.5% wettable powder/dust
folpet (081601), aromatic petroleum derivative solvent (006501), lindane
(gamma isomer of benzene hexachloride) (009001), l.l-bis(chlorophenyl)-
2,2,2-trichloroethanol (010501), methylated naphthalenes (054002) plus
carbaryl (056801)
000004-00103
Issued: 4-09-85
11-081601-25
161
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EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation (continued)
6.5% wettable powder/dust (continued)
folpet (081601), aromatic petroleum derivative solvent (006501), 1,1-
bis(chlorophenyl)-2,2,2-trichloroethanol (010501), methylated naphtha-
lenes (054002), carbaryl (056801) plus malathion (057701)
000004-00185
&007.5007 7.5% wettable powder/dust
—folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
plus carbaryl (056801)
004636-00004
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
carbaryl (056801) plus sulfur (077501)
007401-00014
folpet (081601), methoxychlor, technical (034001) plus malathion
(057701)
000407-00279
&008.8207 8.82% wettable powder/dust
folpet (081601), lindane (gamma isomer of benzene hexachloride) (009001)
plus l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
010051-00013
&000.0610 0.0616% impregnated materials
folpet (081601)
007874-00004
&000.1110 0.1056% impregnated materials
folpet (081601)
007874-00005
&000.2310 0.2288% impregnated materials
folpet (081601)
007874-00006
&213.0014 13% (1.17 Ib/gal) flowable concentrate
folpet (081601)
007401-00231
&244.0014 44% (4.29 Ib/gal) flowable concentrate
folpet (081601)
001100-00078
&200.2716 0.27% liquid-ready to use
folpet (081601) plus zinc naphthenate (088301)
008177-00031
Issued: 4-09-85
11-081601-26
162
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EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation (continued)
&200.3016 0.3% liquid-ready to use
folpet (081601) plus bis(tributyltln) oxide (083001)
008177-00032 008177-00036
&200.4016 0.4% liquid-ready to use
folpet (081601) plus creosote oil (025003)
000043-00070
&200.4416 0.44% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
000518-00068
&200.4516 0.45% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
016164-00008
&200.4716 0.47% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
016164-00010
&200.4816 0.48% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
016164-00011
&200.4916 0.49% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
016164-00009
&200.5016 0.5% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
000043-00073 000043-00103 000043-00104 000748-00249
001386-00607 001609-00014 001609-00015 007313-00005
007313-00006 007313-00008 010856-00007 016164-00012
folpet (081601) plus 3-iodo-2-propynyl butylcarbamate (107801)
039702-00001
&200.5316 0.5275% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
011234-00004
&200.5316 0.53% liquid-ready to use
folpet (081601) plus 3-iodo-2-propynyl butylcarbamate (107801)
032259-00005 032259-00006 032259-00007 032259-00008
&200.6616 0.66% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
000577-00538 000577-00539
Issued: 4-09-85
11-081601-27
163
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EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation (continued)
&200.7016 0.7% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
004664-00020 042768-00003
&200.8016 0.8% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
000748-00250
&201.0016 1% liquid-ready to use
folpet (081601) plus bis(tributyltin) oxide (083001)
010856-00005
&200.5019 0.5% pressurized liquid
folpet (081601) plus malathion (057701)
008222-00016
folpet (081601), methoxychlor, technical (034001) plus S-[2-(ethylsul-
finyl)ethyl] 0,0-dimethyl phosphorothioate (058702)
007401-00182
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
carbaryl (056801) plus malathion (057701)
000004-00186
folpet (081601), 0,0-diethyl 0-(2-isopropyl-6-methyl-4-pyrimidinyl)-
phosphorothioate (057801), piperonyl butoxide, technical (067501) plus
pyrethrins (069001)
000100-00539
folpet (081601), methoxychlor, technical (034001), 2,4-dinitro-6-octyl*
phenyl crotonate 2,6-dinitro-4-octyl* phenyl crotonate nitrooctyl-
phenols (principally dinitro) *a mixture of 1-methylhelptyl, 1-ethyl-
hexyl and 1-propylpentyl (036001), N-octyl bicycloheptene dicarboximide
(057001), petroleum distillate (063503), pyrethrins (069001) plus rote-
none (and other cube resins) (071003)
000538-00049**
**suspended
&200.7019 0.77, pressurized liquid
folpet (081601), carbaryl (056801), piperonyl butoxide, technical
(067501), pyrethrins (069001) plus rotenone (and other cube resins)
(071003)
000538-00105**
**suspended
Issued: 4-09-85
11-081601-28
164
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EPA Compendium of Acceptable Uses
FOLPET
Listing of Registered Pesticide Products by Formulation (continued)
0.7% pressurized liquid (continued)
folpet (081601), carbaryl (056801), petroleum distillate (063503),
piperonyl butoxide, technical (067501), pyrethrins (069001) plus rote-
none (and other cube resins) (071003)
000239-02352 000334-00239 000407-00331 002059-00027**
004816-00348 004822-00029 005605-00128 008590-00250
009444-00050 009852-00039 010631-00003** 010807-00036*
011525-00020
*currently unavailable for review
**suspended
&200.7519 0.75% pressurized liquid
folpet (081601), resmethrin (097801) plus acephate (103301)
000239-02439
&004.0020 4% pressurized dust
folpet (081601), l,l-bis(chlorophenyl)-2,2,2-trichloroethanol (010501)
carbaryl (056801) plus malathion (057701)
000239-02415
Issued: 4-09-85 11-081601-29
165
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Listing of
Chemical
Code
009001
010501
034001
036001
057801
057802
067501
071003
EPA Compendium of Acceptable Uses
FOLPET
Appendix A
Common Chemical Names Used on the Entry
Common Name
(source)
lindane
dicofol
methoxychlor
dinocap (ISO)
diazinon (ISO)
oxydemeton-methyl
(ISO)
piperonyl butoxide
rotenone
EPA Acceptable
Common/Chemical Name
lindane (gamma isomer of benzene hexachloride)
l,l-bis(chlorophenyl)-2,2,2-trichloroethanol
methoxychlor, technical
2,4-dinitro-6-octyl*phenyl crotonate
2,6-dinit ro-4-octyl*phenyl crotonate
nitrooctylphenols (principally dinitro) *a
mixture of 1-methylheptyl, 1-ethylhexyl and
1-propylpentyl
0,0-diethyl 0-(2-isopropyl-6-methyl-4-pyrimi-
dinyl) phosphorothioate
S-[2-(ethylsulfinyl)ethyl] 0,0-dimethyl phos-
phorothioate
piperonyl butoxide, technical
rotenone (and other cube resins)
Issaed: 4-09-85
11-081601-30
166
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APPENDIX IV
BIBLIOGRAPHY APPENDICES
167
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has- attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
168
-------
BIBGUluc, ~
a. Author. Whenever the AgencynciSJiao confidently
one, the Agency Ixas chosen to sW#iaiflpersonal autnu...
When no individual was identifi^d^sfctiheo^geinidyJKfls
shown an identifiable laboratoryswteffea*ting 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 tobfc&itt&^ildkRili^1
from the document. When a four-digit ate^e^ is followed
by a question mark, the bibliographer S&dCi&ed 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, 12345&-Z; and the 27th, 123456-AA.
169
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OMlCEoOF PESTICIDE PROGRAMS
Ieno8:ieqRKI«<»«TION STANDARD BIBLIOGRAPHY
toee/Coatfttlerb* to be Part of the Data Base Supporting
gn i 3 iftagi stations Under the Folpet Standard
nworts aeri
MRID CITATION
ertipib iuc5 ss sr .
OOflM7^&rfci$ial*ia^RJt?ed by Thermo Electron Corp., submitted by Chevron Chemical
aieb srl.f0n>9 Richmond, Calif,; CDL:242874-A)
s, 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.)
00053326 Chevron Chemical Company (1957) Residue Status. (Unpublished study
received Feb 11, 1958 under unknown admin, no.; CDL:119325-C)
00053865 Avens, A.M.; Davis, D.L. (1959) Residue Study—Grapes, Juice,
Wine. (Compilation; unpublished study received Jan 19, 1959
under 239-1102; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:119328-A)
00054015 California Spray Chemical Corporation (1960) The Analysis of Resi-
dues of Captan and Phaltan. Method RM-1 dated Apr 4, 1960.
(Unpublished study received Jul 14, 1972 under 2E1215; submitted
by Interregional Research Project No. 4, New Brunswick, N.J.;
CDL-.091043-A)
00070507 Boudreau, P.; Forbis, A.D.; Cranor, W.; et al . (1980) Static Acute
Toxicity of Phaltan Technical (SX-946) to Daphnia magna: ABC
Report # 26632. (Unpublished study received Jan 14, 1981 under
239-1763; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, Calif.; COL:
244442-A)
00074008 LeBlanc, G.A. (1977) Acute Toxicity of Fungitrol 11-50: Dis-
persion to the Water Flea (Daphnia magna). (Unpublished
study received Mar 7, 1978 under 1100-70; prepared by EG & G,
Bionomics, submitted by Tenneco Chemicals, Inc., Piscataway,
N.J.; CDL:232998-J)
00074009 Buccafusco, R.J. (1977) Acute Toxicity of Fungitrol 11-50:
Dispersion to Rainbow Trout (Salmo gairdneri). (Unpublished
study received Mar 7, 1978 under 1100-70; prepared by EG & G,
Bionomics, submitted by Tenneco Chemicals, Inc., Piscataway
N.J.; CDL.-232998-K)
170
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Folpet Standard
MRID CITATION
00074010 Buccafusco, R.J. (1977) Acute Toxicity of Fungitrol 11-50%
Dispersion to Bluegill (Lepomis macrochirus). (Unpublished
study received Mar 7, 1978 under 1100-70; prepared by EG & G,
Bionomics, submitted by Tenneco Chemicals, Inc., Piscataway,
N.J.; CDL:232998-L)
00083390 Californai Spray-Chemical Corporation (1960) Residues of Phaltan
in Oranges and Grapefruit. (Compilation; unpublished study
received Dec 27, 1960 under PP0283; CDL:090305-A)
00083392 California Spray-Chemical Corporation (1960) Residues of Phaltan
in Cranberries. (Compilation; unpublished study received Dec
27, 1960 under PP0283; CDL:090305-C)
00083393 California Chemical Company (1961) The Determination of and Differ-
entiation between Residues of Phaltan and Captan: File 740.10.
Residue method RM-1A dated Jan 31, 1961. (Unpublished study
received on unknown date under PP0283; CDL:090305-D)
00083400 California Chemical Company (1961) The Differentiation between
Residues of Phaltan and Captan--a Modified Cleanup Procedure:
File 740.10. Residue method RM-1B dated Aug 8, 1961. (Unpub-
lished study received on unknown date under PP0283; CDL:
090305-K)
00083401 Heuberger, J.W.; Davis, D.L. (1961) Spray Residue: Phaltan--
Apples. (Unpublished study received on unknown date under
PP0283; prepared in cooperation with Univ. of Delaware, Dept. of
Plant Pathology, submitted by California Spray-Chemical Corp.,
Richmond, Calif.; CDL:090305-L)
00083402 Goode, J.P.; Pack, D.E. (1961) Spray Residue: Phaltan--Lettuce.
(Unpublished study received on unknown date under PP0283;
submitted by California Spray-Chemical Corp., Richmond, Calif.;
CDL:090305-M)
00090170 California Spray Chemical Corporation (I960) Results of Tests
on Amount of Residue Remaining and Description of Analytical
Methods Used: Phaltan. Includes method RM-1 dated Apr 4,
1960. (Compilation; unpublished study received Feb 20, 1961
under PP0283; CDL:090306-C)
171
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Folpet Standard
MRID CITATION
00098004 Fink, R.; Beavers, J.B.; Joiner, 6.; et al. (1982) Final Report:
One-generation Reproduction Study--Bobwhite Quail: Phaltan
Technical (SX-1111): Project No. 162-133. (Unpublished study
received Mar 29, 1982 under 239-1763; prepared by Wildlife
International Ltd. and John's Hopkins Univ., Dept. of Biostatis-
tics, submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
247113-B)
00098005 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1982) Final Report:
One-generation Reproduction Study—Mallard Duck: Phaltan Tech-
nical (SX-1111): Project No. 162-134. (Unpublished study re-
ceived Mar 29, 1982 under 239-1763; prepared by Wildlife Inter-
national Ltd. and John's Hopkins Univ., Dept. of Biostatistics,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
247113-C)
00098759 Office of the Commissioner (1961) Residues of Captan in Citrus
and Other Crops. (Compilation; unpublished study received
Oct 2, 1967 under 9E0755; CDL:091304-F)
00104841 California Chemical Co. (1960) Name, Chemical Identity and Compo-
sition of the Pesticide Chemical: Phaltan. (Unpublished
study received Dec 19, 1960 under PP0283; CDL:092561-B)
00109055 Tenneco Chemicals, Inc. (1978) Product Chemistry Data: Fungitrol
11-50 Dispersion. (Compilation; unpublished study received
Jan 29, 1979 under 1100-78; CDL:236874-A)
00112793 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report:
Acute Oral LD50—Bobwhite Quail: Phaltan Technical (SX-1111):
Project No. 162-149. (Unpublished study received Jul 19, 1982
under 239-1763; prepared by Wildlife International Ltd.,
submitted by Chevron Chemical Co., Richmond, CA; CDL:247887-A)
00112794 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report:
Eight-day Dietary LC50--8obwhite Quail: Phaltan Technical
(SX-1111): Project No. 162-147. (Unpublished study received
Jul 19, 1982 under 239-1763; prepared by Wildlife International
Ltd., submitted by Chevron Chemical Co., Richmond, CA; CDL:
247887-B)
00112795 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report:
Eight-day Dietary LC50--Mallard Duck: Phaltan Technical (SX-
1111): Project No. 162-148. (Unpublished study received Jul
19, 1982 under 239-1763; prepared by Wildlife International
Ltd., submitted by Chevron Chemical Co., Richmond, CA- CDL-
247887-C)
172
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Folpet Standard
MRID CITATION
00115198 Tucker, R.; Crabtree, D. (1970) Handbook of Toxicity of Pesticides
to Wildlife. By U.S. Fish and Wildlife Service, Denver Wildlife
Research Center. Washington, DC: USFWS. (Resource publication
no. 84; available from: Superintendent of Documents, U.S.
Government Printing Office, Washington, DC 20402; published
study; CDL:228345-M)
00115269 Reno, F.; Burdock, G.; Serota, D.; et al. (1981) Subchronic Toxic-
ity Study in Rats: Phaltan: Project No. 2107-100. Final rept.
(Unpublished study received Oct 7, 1982 under 239-1763; prepared
by Hazleton Laboratories America, Inc., submitted by Chevron
Chemical Co., Richmond, CA; CDL:248511-A; 248510)
00125718 Wong, Z.; Eisenlord, G.; MacGregor, J.; et al. (1982) Lifetime On-
cogenic Feeding Study of Phaltan Technical (SX-946) in CD-I (ICR
Derived) Mice: SOCAL 1331. (Unpublished study received Feb 1,
1983 under 239-1763; submitted by Chevron Chemical Co., Rich-
mond, CA; CDL:249485-A; 249486; 249487; 249488; 249489; 249490;
249491; 249492)
00132456 Hoberman, C.; Christian, M.; Sica, E.; et al. (1983) Pilot Tera-
tology Study in Rats with Folpet Technical: Argus Project 303-
001P. Final rept. (Unpublished study received Oct 24, 1983
under 239-1763; prepared by Argus Research Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, CA; CDL:251659-A)
00132457 Hoberman, A.; Christian, M.; Sica, E.; et al. (1983) Teratology
Study in Rats with Folpet Technical: Argus Research Laboratories
Study No. 303-001. Final rept. (Unpublished study received
Oct 24, 1983 under 239-1763; prepared by Argus Research Labora-
tories, Inc., submitted by Chevron Chemical Co., Richmond, CA;
CDL:251659-B)
00132582 Simmon, V.; Mitchell, A.; Jorgenson, T. (1977) Evaluation of Se-
lected Pesticides as Chemical Mutagens: In vitro and in vivo
Studies. By Stanford Research Institute. Research Triangle
Park, NC: Health Effects Research Laboratory. (Environmental
health effects research series; EPA-600/1-77-028; contract
no. 68-01-2458; available from: National Technical Information
Service, Springfield, VA 22161; also in unpublished submission
received Nov 28, 1980 under unknown admin, no.; submitted by
Stauffer Chemical Co., Richmond, CA; CDL:251563-H)
173
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Folpet Standard
MRID CITATION
00137695 Dickhaus, S. ; Heisler, E. (1983) Acute Toxicological Study of Fol-
pet after Oral Application to the Mouse: E.H./P. 1-1-112-83.
(Unpublished study received Feb 22, 1984 under 11678-18; pre-
pared by Pharrtatox Forschung und Beratung GnibH, W. Ger., submit-
ted by Makhteshim Beer Sheva Chemical Works Ltd., New York, NY;
CDL:252593-A)
00141728 Korenaga, G. (1982) The Acute Dermal Toxicity of Chevron Folpet
Technical (SX-1346) in Adult Male and Female Rabbits: S-2152.
Unpublished study prepared by Chevron Environmental Health Cen-
ter. 10 p.
00144057 Korenaga, G. (1983) The Acute Oral Toxicity of Chevron Folpet Tech-
nical (SX-1346) in Adult Male and Female Rats: S-2151. Unpub-
lished study prepared by Chevron Environmental Health Center.
14 p.
00143567 Valencia, R. (1981) Mutagenesis Screening of Pesticides Drosophila.
Prepared by Warf Institute, Inc. for the Environmental Protect-
ion Agency; available from National Technical Information Ser-
vice. 80 p. EPA 600/1/-81/017.
00148625 Moore, M. (1985) Evaluation of Chevron Folpet Technical in the
Mouse Somatic Cell Mutation Assay: Final Report: Project No.
20994. Unpublished study prepared by Litton Bionetics, Inc.
117 p.
00149567 Moore, M. (1985) Evaluation of Chevron Folpet Technical in the Mouse
Somatic Cell Mutation Assay: Final Report: Project No. 20994.
Unpublished study prepared by Litton Bionetics, Inc. 156 p.
00151075 Rubin, Y. (1985) Folpan: Oncogenicity Study in the Mouse: LSRI
Report No. MAK/015/FOL. Unpublished study prepared by Life
Science Research Israel Ltd. 1109 p.
00151489 Hardy, L. (1985) Two Generation (Two Litter) Reproduction Study in
Rats with Chevron Folpet Technical: SOCAL 2140. Unpublished
study prepared by Chevron Environmental Health Center. 3527 p.
00151560 Cox, R. (1985) Combined Chronic Oral Toxicity/Oncogenicity Study
in Rats: Chevron Folpet Technical (SX-1388): Final Report: Proj-
ect No. 2107-109. Unpublished study prepared by Hazleton Labo-
ratories America, Inc. 3015 p.
00153085 Carver, J. (1985) Response by the Chevron Environmental Health
Center, Inc. to Comments from the U.S. Environmental Protection
Agency on the in vivo Cytogenetics Study in Rats: Folpet
Technical, SX-1388 (MRI-225-CC-83-21) and Reverse Mutation in
Salmonella (S-1262). Unpublished study prepared by Chevron
Chemical Co. 64 p.
174
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Folpet Standard
MRJD CITATION
00160393 Chevron Chemical Co. (1983) Phalatan (Folpet): Residue Tolerance
Petition: Kiwi. Unpublished conpilation. 30 p.
00160430 Bullock, C. (1982) The Four-hour Skin Irritation Potential of
Phalatan Tehnical (PN 2623): SOCAL 1908. Unpublished study
prepared by Chevron, Environmental Health & Toxicology. 8 p.
00160431 Cavalli, R.; Hallesy, D. (1969) Skin Sensitization Potential of
Difolatan II: SOCO 63/11:69. Unpublished study prepared by
Standard Oil Co. of California, Industrial Hygiene & Toxicology.
12 p.
00160432 Feussner, E. (1984) Teratology Study in Rabbits with Folpet Techni-
cal: Final Report: Project No. 303-002. Unpublished study pre-
pared by Argus Research Laboratories, Inc. 126 p.
00160435 Bullock, C. (1978) S-1261: The Potential of Technical Phalatan
(Calhio) and Technical Phalatan (Port de Bouc) To Mutane TA 100,
a Histidine-deficient Strain of Salmonella typhinurium: SOCAL
1216/32:75. Unpublished study prepared by Standard Oil Co. of
California. 5 p.
00160444 Bullock, C. (1982) The Eye Irritation Potential of Phalatan Techni-
cal (PN 2623): SOCAL 1907. Unpublished study prepared by Chev-
ron, Environmental Health & Toxicology. 11 p.
00160473 McCann, J. (1969) [Toxicity of Ortho Phaltan 50 Wettable to Rainbow
Trout]: Test Number 198. Unpublished study prepared by U.S.
Environmental Protection Agency, Animal Biology Laboratory. 9
P-
00160475 McCann, J. (1969) [Toxicity of Phaltan Containing 75% Folpet to
Rainbow Trout]: Test Number 193. Unpublished study prepared by
U.S. Environmental Protection Agency, Animal Biology Laboratory.
12 p.
00161315 Daly, I. (1986) A One-year Subchronic Oral Toxicity Study in Dogs
with Folpet Technical: Final Rept.: Project No. 82-2677. Unpub-
lished study prepared by Bio/dynamics Inc. 931 p.
40199101 Shah, P.; Fisher, H.; Sumler, M.; et al (1987) Comparison of the
Penetration of 14 Pesticides Through the Skin of Young and Adult
Rats. Journal of Toxicology and Environmental Health: (In press).
14 p.
175
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Folpet Standard
GS_ CITATION
GS0630-001 Jotz, M.; Rundle, D.; Mitchell, A. (1980) An Evaluation of the
Mutagenic Potential of Folpet Enploying the L5178Y TK+/-
Mouse Lynphoma Assay: Final Report: Contract No. 68-02-2947:
Project No. LSU-7558. Unpublished study prepared by SRI
International. 17 p.
GS0144-012 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. USDI Publication
137, Washington, D.C.
-U.S. GOVERNMENT PRINTING OFFICE: 1987-761-002/60640
176
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APPENDIX V
FORMS APPENDICES
177
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OMB Approvtl No. 2OOOO46a
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With retpect to tilt requirement to wbmit "generic" data imooted by thi FIFRA action 3(C)(2)(B) nctici contained in (he refi.-rjrn.ej
Guidanci Document, I am responding in tha following manner
O 1. I will admit data in a timtly manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Grouo, OECO
Chemicals Testing Programme, I enclose the protocols that I will use:
O 2. I have entered into in agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
O 2. I enclose a completed "Certification of Anempt to Enter Into an Agreement with Other Registrants (or Development of Data" with
respect to the following data requirements:
D 4. I request that you emend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancttiition o< the registration of this product. (This option is not available to applicants for new products.)
«GISTBANrS AUTHORIZED REPRESENTATIVE
EPA Form K80-1 (1042)
SIGNATURE
DATE
178
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OMB Approval No.
•04-59
(To
ify ALL fourrtfmt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I «m duly (uftiorized to repr«*nt the following firm(i) who are subject to th« require-
ment* of » Notice under FIFRA Section 3(c)(2)(B) contained in c Guidance Document
to submit data concerning the active ingredient:
GUIDANCE OOCUMSKT OATS "
ACTIVE INGBCOIENT
NAME Of FIRM
es»A COMPANV
(This firm or group of firms it referred to below as "my firm".)
2 My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into tuch tn agreement. Copies of thf offers are attached That otter was irrevocable and included an offer to be
Bound by an arbitration decision under FIFRA Section 3(c)l2)(8)(iii) if final agreement on all terms could not be reached otherwise. This oHer was made
to trie following firm(s) on the following dite(s).
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration)*) of my firm's product(s). if any o< the firms named in paragraph (31 above
have agreed to submit the data listed in paragraph (2J above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration^) under FIFRA Section 3(cH2H8). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TVPEO NAME
SIGNATURE
DATE
EPA Form BS804
179
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-H
63-12
Name of Test
-=-. _
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
130
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
til-4
81-5
«l-6
Name of Test
Stability
Oxidizing/reducing
reaction
Plamnability
Explodabllity
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute Inhalation,
toxicity j rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensltlza-
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
181
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OMB Approval wo.
Expiration Date 5/31/86
"GENERIC" DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the
product identified above, I certify that:
(1) I have read and am familiar with the terms of the
Notice from EPA dated concerning a requirement for
submission of "generic" data on the active ingredient named
under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration
of our product, despite our lack of intent to submit the generic
data in question, on the grounds that the product contains the
active ingredient solely as the result of the incorporation
into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and
which is purchased by us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for
the above identified product is attached to this statement.
That formula statement indicates, by company name, registration
number, and product name, the source of the subject active in-
gredient in my firm's product,
OR
The CSF dated on file with EPA is complete, current and
accurate and contains the information requested on the current
CSF Form No. 8570-4. The registered source(s) of the above named
active ingredient in my product(s) is/are
and their registration number(s) is/are .
My firm will apply for an amendment to the registration prior
to changing the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if
at any time any portion of this Statement is no longer true, or
if my firm fails to comply with the undertakings made in this
Statement, my firm's product's registration may be suspended
with FIFRA Section 3(c)(2)(B).
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
182
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