xvEPA
United State*
Environmental Protection
Agency
Off ice of
Pesticides and Toxic Substance*
Washington OC 20460
Pesticides
June 1987
Guidance for the
Reregistration of
Pesticide Products
Containing
Diphenamid
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
DIPHENAMID
AS THE ACTIVE INGREDIENT
CHEMICAL CODE: 036601
CAS NUMBER: 957-51-7
CASE NUMBER: 0269
June 24, 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Cheraical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Risk Concerns
C. Other Science Findings
D. Tolerance Reassessment
E. Summary of Label Changes and Data Gaps
IV. Regulatory Position and Rationale 12
A. Regulatory Positions 12
B. Criteria for Registration 15
C. Acceptable Ranges and Limits 15
D. Required Labeling 16
V. Products Subject to this Standard 18
VI. Requirement for Submission of Generic Data 20
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product Specific Data. 26
VIII. Requirement for Submission of Revised Labeling ... 27
IX. Instructions for Submission. 27
A. Manufacturing use products (Sole Active) ... 27
B. Manufacturing use products (Multiple Active) . 28
C. End use products 29
D. Intrastate products 29
E. Addresses . . . . . 30
Glossary of Terms & Acronyms iii
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
1. The Agency: U.S Environmental Protection Agency/EPA
2. ADI: Acceptable daily intake (mg/kg/day) of a pesticide by an
individual weighing 60 kilograms
3. A.I.: Pes.ticide active ingredient
4 CAS: Chemical Abstract Society (number)
5 CSF: Confidential Statement of Formula
6. DCI: Data Call-in Notice
7. EPs: End-Use pesticide products
8. EUP: Experimental Use Permit
9. FIFRA: Federal Insecticide, Fungicide, Rodenticide Act (As amended)
10. LC50: (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).
11. LD5Q: (median lethal dose) a statistically derived single
dose that can be expected to cause death in 50% of animals
when administered by the route indicated, expressed as
weight of substance per unit weight of test animal
(e.g., mg/kg).
12. LEL: Lowest Effect Level
13. MBYP: Meat byproducts of cattle, goats, hogs, horses and sheep.
14. MPs: Manufacturing-Use pesticide products
15. MPI: Maximum permitted intake of a pesticide in XX rag/day for a
60 kg individual.
16. NOEL: No Observed Effect Level
17. NPDES Permit: National Pollutant Discharge Elimination System
18. MRID: Master Record Indentification (number) - EPA's system
of tracking studies used in support of registrations.
iii
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19. OES: Office of Endangered Species, U.S. Dept. of the Interior
20. PADI: a provisional/temporary ADI
21. RAC's: Raw agricultural commodities
22. Technical: Technical grade of the active ingredient
23. 40 CFR: Title 40, Code of Federal Regulations
24. TMRC: Theoretical Maximum Residue Contribution for a pesticide in
- the daily diet is based on the total tolerances in addition
to a daily food intake of X.X kg = X.X rag/kg.
iv
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I. INTRODUCTION
The Registration Standards Program
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 FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
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
scientific reviews may be requested from: In-formation Services
Section (TS-768C), Office of Pesticide Programs, U.S. Environmental
Protection Agency, Room 236, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, Virginia 22202 (telephone (703) 557-4453).
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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
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 Gancel 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 our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide. This Regis-
tration Standard lists the data that EPA believes are necessary to
resolve our concerns about this pesticide. These data are listed in
Table A in Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration 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. You should notify the Agency of any
information, including interim or preliminary results of studies,
if those results suggest possible adverse effects on man or the
environment. This requirement continues as long as your products
are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
Description of chemical
The following chemical is covered by this Registration
Standard:
Common name:
Chemical name:
CAS Number:
OPP (Shaughnessy) Number
Empirical Formula:
Trade Names:
Chemical Family:
Pesticide Type:
Year of Initial
Registration:
Registrants of Technical
Products:
Diphenamid
N,N-d imethyldiphenylacetamid e
957-51-7
036601
C16H17NO
Difenamid, Dymid, Enide®,
A-831010, L-34-314
Acetamide
Herbicide
1964
Nor-Am Chemical Co.
Description of physical characteristics of chemical:
Diphenamid is a white to off white granular solid with a sweet
aromatic odor at room temperature, its melting point is 133.8-
135.4° C, and its molecular weight is 239.3. Its solubility
in water is 0.26 g/liter at 25°C.
B. Use Profile
Type of pesticide:
Pests controlled:
Registered Uses:
Predominant uses:
Mode of activity:
Single active
ingredient (a.i.)
Formulations:
Methods of application;
Application Rates:
Selective preemergent herbicide,
Annual grasses, broadleaf weeds
Field, bush, vine & vegetable crops,
fruit, citrus fruit, cotton, green-
house & ornamental plants, and turf,
Tomatoes, tobacco, sweet potatoes
potatoes, caneberries & peppers,
Inhibition of terminal leaf and root
growth or seed germination,
97% technical,
90%, 80% & 50% (a.i.) wettable powder;
5% & 1.42% (a.i.) granular; 42.5% &
15.4% (a.i.) flowable concentrates,
Primarily applied as broadcast or
banded spray by ground or aerial
equipment,
Terrestrial food crops: 2.0 to 9.0 Ib.
a.i. per acre,
Terrestrial non-food crops: 2.0 to
6.0 Ib. a.i. per acre, ornamentals:
0.50 to 1.25 Ib. a.i. per acre.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all of the data submitted to support the
registration of diphenamid, as well as open literature infor-
mation relevant to this compound. Based on the review of these
data, the -Agency has reached the following conclusions.
Diphenamid related effects include increased liver weights and
slight histological changes in a chronic toxicity study in dogs.
Except for mild liver reactions in weanlings, this chemical
does not induce reproductive effects in rats. This pesticide
has shown low acute oral and dermal toxicity in test animals
and it is not an eye irritant. It is low in avian toxicity and
slightly to moderately toxic to fish and aquatic invertebrates.
Although the present data base for diphenamid does not indicate
major toxicological concerns, there are toxicology data gaps:
including acute inhalation toxicity, primary dermal irritation,
dermal sensitization, subchronic dermal toxicity (21-day),
chronic toxicity (rat), oncogenicity in two species, teratology
in two species, mutagenicity and general metabolism studies.
In addition, the environmental fate, product chemistry, and the
metabolism in food crops, in ruminants and poultry for this
compound have not been characterized.
B. TOXICOLOGY
1 . In a 2-year dog feeding study, males and females were
offered diets containing .0, 120, 400, and 1200 ppm technical
diphenamid in the diet for 103 weeks. The only compound-
related effects included slightly increased liver weights
and slightly increased portal macrophages and/or fibroblasts
in the livers of the dogs in the 400 and 1200 ppm dose group.
The no-observed-effect level (NOEL) was determined to be 120
ppm (3 mg/kg/day) in the diet.
Available data are sufficient to satisfy the data requirements
for chronic toxicity study in the nonrodent (dog) only.
2. A rat feeding study was not adequate to assess chronic toxi-
city or oncogenicity. A chronic toxicity study and onco-
genicity study in rats are required. Also, a second species
oncogenicity study (mouse) is ongoing and is expected to be
completed in .June 1988.
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3. Technical diphenamid was fed at dosage levels of 0, 10, and
30 rag/kg/day to rats of both sexes in a three generation
reproduction study. The only compound-related effects
observed were mild liver reactions in the weanlings of the
F3 generation from the high dose group (30 mg/kg/day).
Therefore, the NOEL for fetal effects was determined to be
10 mg/kg/day (200 ppm). Since the data demonstrated absence
• of reproduction performance effects in treated animals at
all the dose levels, the NOEL for reproductive effects was
determined to be greater than 600 ppm (30 mg/kg/day) in the
diet. Sufficient data are available to satisfy the data
requirements for a reproduction study in the rat.
4. No teratology studies are available for technical diphenamid.
Teratology studies in -the rat and the rabbit are required.
5. Diphenamid technical exhibited low acute oral toxicity [Cate-
gory III: 1,373 mg/kg (rats, both sexes)], low acute dermal
toxicity [Category HI: >6,320 mg/kg (rabbits, both sexes)]
to mammals. It was not an eye irritant in the primary eye
irritation study:[Category IV - No irritation with 0.1 ml
solution (rabbits)].
C. OTHER SCIENCE FINDINGS
1. Human Exposure . -
Major routes of exposure: Applicators (mixer/loader) handling
this pesticide would be exposed primarily through skin contact
and inhalation.
2. Physiological & Biochemical Chracteristics:
Translocation: Diphenamid is absorbed by the roots and trans-
located through the roots, stem, and leaves.
Mechanism of pesticidal action: It inhibits growth in terminal
leaves and roots.
Metabolism & Persistence in Plants & Animals: The available
data are inadequate to evaluate the persistence of diphenamid
in plants and animals.
3. Environmental Fate
The Agency does not have sufficient data to fully assess the
environmental fate of diphenamid.
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a. Ground Water
A ground water Data Call-in Notice was issued for
diphenamid. The data received were insufficient to fully
assess the leaching potential of parent compound and
metabolites in a variety of soils. However, available
studies indicate that this compound is mobile in a silty
clay loam soil, and is relatively stable to hydrolysis and
may leach to ground water supplies.
b. Degradation
The Agency does not have sufficient data to fully assess
the degradation of diphenaraid.
c. Forestry Uses
Since the registrant has voluntarily deleted the forestry
use pattern for diphenamid products, an anaerobic aquatic
metabolism and a forestry dissipation study which would
have been required under forestry uses will not be required
in this Standard.
4. Ecological Effects
There is sufficient information to characterize technical
diphenamid as slightly toxic to freshwater invertebrates:
Daphnia magna (LC5Q of 58.0 ppm). There is sufficient infor-
mation to characterize formulated diphenamid as having very
low toxicity on avian dietary basis: Bobwhite quail (LC^Q of
18,000 and Mallard duck (LC5p of 30,000 ppm). However, an
avian single-dose oral toxicity study and an avian dietary
toxicity study in two species using technical diphenamid are
required. There is sufficient information to characterize
formulated diphenamid as being slightly toxic to warmwater
fish: Bluegill (LC5Q of 32.0 ppm) and moderately toxic to
coldwater fish: Rainbow trout (1,050 of 1.2 ppm). However, a
freshwater fish toxicity study in two species using technical
diphenaraid is required. In an acute contact study, diphenamid
was shown to be very low in toxicity to honey bees.
Hazard assessments were conducted for terrestrial and aquatic
organisms in which hypothetical environmental concentrations
were compared to lethal concentrations (LC5o) and lethal
dosages (1059) of the pesticide. Acute concerns were not
triggered for mammals, birds, or fish.
Since the registrant has voluntarily deleted the forestry use
pattern for diphenamid products, endangered species labeling
which would have been required under forestry uses will not
be required in this Standard.
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D. TOLERANCE REASSESSMENT
According to 40 CFR 180.230, tolerances, for diphenaraid have been
approved for the raw agricultural commodities (RAC's) listed
below.
Crop Tolerance(ppm)
Apples 0.10
Cattle, fat 0.05
Cattle, meat 0.05
Cattle, mbyp 0.05
Cottonseed 0.10
Cotton forage 0.20
Fruiting vegetables 0.10
Goat, fat 0.05
Goat, meat 0.05
Goat, mbyp 0.05
Hogs, fat 0.05
Hogs, meat 0.05
Hogs, mbyp 0.05
Horses, fat 0.05
Horses, meat 0.05
Horses, mbyp 0.05
Milk 0.01
Okra 0.10
Peaches 0.10
Peanuts 0.10
Peanut, hay & forage 2.00
Peanut hulls 0.50
Potatoes 1.00
Raspberries 1.00
Sheep, fat 0.05
Sheep, meat 0.05
Sheep, mbyp 0.05
Strawberries 1.00
Soybeans 0.10
Soybean, hay & forage 0.50
Sweet potatoes 0.10
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The Provisional Acceptable Daily Intake (PADI) for diphenamid is
based on the 103 week dog feeding study with a NOEL of 120 ppm
(3 rag/kg/day). Other toxicology data considered in suport of these
tolerances include a 3-generation rat reproduction study indicating
that reproductive performance was not affected at dietary intake up
to and including 30 mg/kg/day. Utilizing a safety factor of 100,
the PADI was calculated to be .03 mg/kg/day.
The Agency examined the dietary burden of diphenamid using the
Tolerance Assessment System (TAS), a dietary exposure data base.
TAS allows the Agency, using either known residue levels or
tolerance levels in raw agricultural commodities to determine
the average and range of exposure to pesticide residues for the
general population and twenty two subpopulations based on known
patterns of food consumption. The theoretical dietary exposure
expressed as a percentage of PADI utilized by the Theoretical
Maximum Residue Contribution (TMRC) ranged from 3.8% to 11.8%
of the PADI for various subgroups with 5.6% being the U.S.
population average.
Additional data are required for plant and animal metabolism,
analytical methods, and storage stability. Processing studies
are required for potatoes, soybeans, tomatoes, apples, cotton-
seed and peanuts. Since the data required for individual commo-
dities .are dependent on .metabolism data, the Agency recommends
that metabolism data be obtained and submitted prior to any
required residue data.
There is a Canadian tolerance of 1.0 ppm for diphenamid residues
in or on strawberries, but no Canadian tolerances exist for
residues of diphenamid on the other raw agicultural commodities
listed in 40 CFR 180.230. There are no Mexican tolerances or
Codex Maximum Residue Levels for residues of diphenaraid on the
raw agicultural commodities listed in 40 CFR 180.230. •
Existing tolerances for soybean hay and forage; and peanut hay
are adequately supported by data. Therefore, a proposal to
remove the grazing and feeding restrictions currently in effect
for diphenamid products in soybeans and peanuts would be approved
by the Agency.
Reported Pesticide Incidences
The Pesticide Incident Monitoring System (PIMS.) does not have
any incident involving diphenamid at this time. Based upon data
from California, five incidences indicating skin or eye irritation
occurred from 1981 through 1985. Although four of the incidences
involved applicators and one involved a non applicator, none of
these cases required hospitalization.
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E. SUMMARY OF LABEL CHANGES AND DATA GAPS
The Agency has determined that label revisions must be made
in the following areas (See Section D, Part IV).
0 Environmental Precautions
0 Ecological Effects
The Agency has identified data necessary to evaluate the envi-
ronmental and human risks associated with the use of diphenamid.
These data must be developed in order to maintain registrations
of products or register new products containing diphenamid.
The following table summarizes the data gaps, including product
chemistry information. Please note that this is only a summary
and details can be obtained by referring to Table A.
Summary of Data Gaps - Diphenamid
158.120 Product Chemistry
All of the Product Chemistry data are required.
158.125 Residue Chemistry:
171-4 Nature of Residue (Plant & Animal Metabolism)
171-4 Residue Analytical Methods
171-4 Storage Stability
171-4 Residue Studies on Crops
171-4 Residue Studies on Processed Food/Feed
Commodities
158.135 Toxicology:
81-3 Acute Inhalation Toxicity (Rat)
81-5 Primary Dermal Irritation (Rabbit)
81-6 Dermal Sensitization (Guinea pig)
82-2 Subchronic Dermal (21-day)
83-1 Chronic Toxicity (Rat)
83-2 Oncogencity (Two species)
83-3 Teratogenicity (Two species)
84-2 Mutagenicity
85-1 Metabolism
158.130 Environmental Fate
161-2 Photodegradation in Water
161-3 Photodegradation in Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
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158.130 Environmental Face
163-1 Mobility Studies-Leaching & Adsorption/
Desorption
163-2 Mobility Studies-Volatility (Lab)
164-1 Soil Dissipation
165-1 Rotational Crops (Confined)
165-4 Accumulation in Fish
158.145 Wildlife and Aquatic Organisms
71-1 Avian Acute Oral Toxicity
71-2 Avian Dietary Toxicity
(Two species)
72-1 Freshwater Fish Acute Toxicity
(Two species)
122-2 Aquatic Plant Growth
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions
Based on a review and evaluation of all available data and other
relevant information on the herbicide diphenamid, the Agency has
reached the following determinations.
1. The Agency will not place diphenamid in Special Review.
Rationale: Diphenamid does not exceed the risk criteria for
adverse effects in 40 CFR, Section 154.7.
Available data indicate that Diphenamid does not pose a risk
of serious acute injury to humans, avian species and aquatic
organisms. In a chronic toxicity study of diphenamid in dogs,
data indicated no adverse chronic liver effects at the 400 ppra
(10 mg/kg/day) dosage level. Except for mild liver reactions
in weanlings in the third generation of a reproduction study
in rats, this compound does not induce reproductive effects
in rats.
2. The Agency has determined that certain toxicological studies
are required to support the reregistration of diphenamid
-products.
Rationale: The Agency does not have the following data on
diphenamid which are required to meet Agency guidelines for •
toxicological testing necessary to support its registration:
acute inhalation toxicity, primary dermal irritation, dermal
sensitization, subchronic dermal (21-day), chronic toxicity
in rats, oncogenicity in two species, teratology in two
species, mutagenicity and and metabolism studies.
3. The Agency has determined that present precautionary statements
for persons handling or applying diphenamid products are
sufficient for the labels of manufacturing-use and end-use
products.
Rationale: Available data indicate that diphenamid causes low
acute oral (Category III) and acute dermal (Category III)
toxicity in test animals and it is not an eye irritant (Cate-
gory IV). The labeling of these products contains statements
that provide precautionary measures to ensure safe handling
of the pesticide products and provides the user with first
aid instructions.
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4. The Agency will require certain environmental fate data.
Rationale: The Agency does not have the following environmental
fate data necessary to support the reregistration of diphena-
mid: photodegradation in water and soil, mobility (leaching &
adsorption/desorption) mobility [volatility (lab)], soil
dissipation, rotational crops (confined) and accumulation in
fish studies.
5. The Agency has determined that certain groundwater data are
required.
Rationale: The Agency evaluated the data submitted in response
to the May 1984, Ground Water Data Call-in for Diphenamid,
and found them to be inadequate to fully assess the potential
of diphenamid to reach ground water supplies.
However, available data indicate that diphenamid is mobile in
a silty clay-loam soil, and relatively stable to hydrolysis,
and may leach to ground water.
The necessary environmental fate data (aerobic and anaerobic
metabolism studies) are being repeated at the present time.
The Agency expects to receive these data by July 1987. Until
these data are received and found acceptable by the Agency,
data gaps for ground water exist.
6. The Agency has determined that reentry data are not required
for diphenamid at this time.
Rationale: The low acute toxicity of this chemical does not war-
rant significant concern about exposure of workers reentering
treated areas, according to the criteria in 40 CFR Part 158.140,
Diphenamid has been determined to be low in acute oral, and
dermal toxicity, and it is not an eye irritant.
7. The Agency has determined that certain residue chemistry data
are required.
Rationale: The Agency does not have the following residue chemis-
try data necessary to support the reregistration of diphenamid:
plant and animal metabolism, analytical methods, storage
stability, and processing studies for potatoes, soybeans,
tomatoes, apples, cottonseed and peanuts.
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8. The Agency has determined that grazing and feeding restrictions
for soybean hay and forage, and peanut hay are not required
for diphenamid products.
Rationale: Existing tolerances for soybean hay and forage; and
peanut hay are adequately supported by residue chemistry data.
Therefore, EPA will approve removing the grazing and feeding
restrictions currently in effect for soybeans and peanuts if
the registrants propose it.
9. The Agency has determined that endangered species labeling is
not required in this standard.
Rationale: The registrant has voluntarily deleted the forestry
use pattern for diphenamid products. Therefore, endangered
species labeling which would have been required under forestry
uses will not be required in this standard.
10. The available data indicate that this pesticide, when applied
at recommended rates, does not present unreasonable hazards to
birds.
Rationale: Existing studies on a formulation of this chemical
indicate that its dietary toxicity to avian species is very
low.
11. While the data gaps are being filled, currently registered MPs
• and EPs containing diphenamid as the sole active ingredient
may be sold, distributed, formulated and used in the United
States, subject to the terms and conditions specified in this
Standard. Registrants must provide and agree to develop
additional data, as specified in the Data Appendices of this
guidance document, in order to maintain existing registrations.
Rationale: Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing
or inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7)).
Issuance of this standard provides a mechanism for identifying
data needs. These data will be evaluated, after which the
Agency will determine if additional regulatory changes are
necessary.
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B. Criteria for Registration
To be registered or reregistered under this Standard, manufacturing-
use products must contain diphenamid 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 covered under this Standard, manufacturing-use products (MPs)
must contain diphenamid as the sole active ingredient. Each iMP
formulation proposed for registration must be fully described with
an appropriate certification of limits, stating maximum and minimum
amounts of the active ingredient which may be present in products.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and MP
products containing diphenamid, 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
containing diphenamid must be labeled for formulation into end-use
products only for the commodities listed below. The EPA Index to
Pesticide Chemicals for Diphenamid lists all registered uses, as
well as approved maximum application rates and frequencies.
0 Terrestrial food uses on apples, cotton, peaches, black and red
raspberries, okra, peanuts, peppers, potatoes, soybeans, straw-
berries, sweet potatoes, tomatoes, on non-bearing blackberry,
blueberry, cherry, lime, orange, and raspberry plants.
0 Terrestrial nonfood uses on tobacco, ornamental plants, nursery
seed crops, hardwood, tobacco seedbeds, and turf.
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D. Required Labeling
All manufacturing-use and end-use diphenaraid products must bear
appropriate labeling as specified in 40 CFR 162.10,- and below.
Appendix II contains information on label requirements.
No pesticide products containing diphenamid may be released for
shipment by a registrant or producer of that product after July 30,
1988, unless the product bears an amended label which complies with
the requirements of this Standard.
No pesticide products containing diphenamid 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 July 30, 1989, unless
the product bears an amended label which complies with the require-
ments of this Standard.
In addition to the above, the following information must appear on
the labeling:
1. Ingredient Statement
The ingredient statement for all manufacturing-use products contain-
ing diphenamid products must list the active ingredient in the
following manner (example):
Diphenamid (N,N-dimethyldiphenylacetamide) %" ;
2. Use Pattern Statements
All manufacturing-use products containing diphenamid must state
that they are intended for formulation into end-use products for
only the aforementioned use patterns. Labeling must specify sites
which are listed in Use Patterns, Section C.3. However, no use may
be included on the label where the registrant fails to comply with
the data requirements listed in Table A for that use pattern.
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3. Precautionary Statements
a. Manufacturing-Use Product Statements
All diphenamid products intended for formulation into
end-use products must bear the following statements:
"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 NPUES permit. Do not discharge effluent
containing this product into sewer systems without
previously notifying the sewage treatment plant authority.
For guidance contact your State Water Board or Regional
Office of the EPA."
b. End-Use Product Statements
The following precautionary statements must appear on the
following diphenamid EP labels:
1. (Non-granular)
" Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water by
cleaning of equipment or disposal of wastes."
2. (Granular)
" Cover, incorporate or collect granules spilled on the
soil surface. Do not contaminate water by cleaning of
equipment or disposal of wastes."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All produces 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
formulator1s 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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1,9
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 formulator1s 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.^
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 submi-c
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 tiraeframe. 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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21
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 157
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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22
The Agency will also require adequate assurance chat 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 terras 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 request that EPA not suspend your registration
for non-compliance with the PCI.EPA has determined that,
as a general policy,it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
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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23
[Your company name] offers co 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 timefrarae. 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 that EPA amend your registration by deleting
the uses for which the data are needed.You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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24
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 for 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 unapprbved protocols. A request for protocol
approval will not extend the timefrarae 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 time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
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25
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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26
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.1. (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 Diphenamid 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.5
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)(1)(D). Refer to 40 CFR
152.80-152.99.
5 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 submTttothe 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 forniulator'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 Dlphenamid in combi-
nation 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
attachments^ (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 the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the forraulator'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.
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C. End Use Products containing Diphenamid as the sole active
ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3£c)(2)(B) Summary Sheet, with
appropriate attachments^ (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).
D. Intrastate Products containing Diphenamid either as sole
active ingredient or in combination with other active
ingredients.
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.
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E. Addresses
The required information must be submitted to the following
address:
Robert J. Taylor (PM-25)
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 Compliance
Monitoring is:
Laboratory Data Integrity Assurance Division
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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TGUIDE-1 3 1
GUIDE TO TABLES
Tables A and B 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.
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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W 4—
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Pirt 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Itaster 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
columnindicates 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.
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TA1M.K A
GENERIC DATA REQUIREMENTS TOR DIPHENAMID 97% TECHNICAL3 (EPA REG. NO. 45639-127)
DRAFT
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
Physical and Chemical Characteristics
•••« 63-2 - Color
63-3 - Physical State
^ 63-4 - Odor
Osl
63-5 - Melting Point
63-6 - Boiling Point
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
All
All
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
No
Bibliographic
Citation1
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Addtl
Data be
Submitted?
Yes 21
Yes 3/
Yes 4/
Yes J>/
Yes 6/
Yes TJ
Yes 8/
Yes 8/
Yes 8/
Yes 8/
Yes 8/
Time Frame
for
Submission
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
All
No
N/A
Yes 8/
6-Months
-------
TAHLK A
GFNFR1C LttTA RtiQUIKblflWrs FOR DIPHKNAMID, 97% TI-'.CHNICAl.a (HPA RF.G. NO. 45639-127)
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation^
Other Requirement:
64-1- Submittat of samples
N/A
No
Mist Addtl Time Frame
Data be for
Submitted? Submission
§158.120 Product Chemistry (Continued)
63-8
63-9
63-10
63-11
63-12
63-13
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- PH
- Stability
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Yes 8/
Yes JB/
Yes 8/
Yes 8/
Yes &/
Yes 8/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
No 9/
ON)
-------
TABLE A
GENERIC CftTA REQUIREMENTS FOR DIPHENAMID, 97% TECHNICAL3 (EPA REG. NO. 45639-127 )
§158.120 Product Chemistry (Continued)
a The 97% technical serves as a manufacturing-use product.
J/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
~~ certain data must be resubrnitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. The bibliographic citations for old data are not applicable.
2/ The name of each impurity present at >0.1% must be reported.
y Complete information must be provided regarding the nature of the process (batch or continuous) , the
relative amounts of beginning materials and the order in which they are added, a flow chart with chemical
equations for each intended reaction, equipment used to produce the product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used.
4/ A detailed discussion of all impurities that are or may be present at X).1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
_5/ Five or more representative samples must be analyzed for the anount of active ingredient and toxicologically signi-
ficant inerts. Complete validation data (accuracy, precision) must be submitted for each analytical method used.
In addition, all nitrosamines must be identified and quantified in six samples; two samples of each must be
analyzed shortly after production, 3 months after production, and 6 months after production.
6/ Upper and lower limits for diphenamid must be provided, certified, and validated by sample analysis using ana-
lytical procedures for which accuracy and precision data have been provided. Upper limits for each impurity
present at X). 1% (w/w) , and for each "toxicologically significant" impurity present at <0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and precision
data have been provided. Certifications must be submitted on EPA Form 8570-4, Rev. 2-85.
TJ Analytical methods must be provided to determine the active ingredient and each toxicologically significant
impurity for vfaich a certified limit is required. Each method must be accompanied by validation studies
indicating its accuracy and precision. These methods must be suitable for enforcement of certified limits.
8/ All physicochemical characteristics of the 97%T (EPA Reg. No. 45639-127) (i.e. , color, physical state, odor,
melting point, specific gravity, solubility, vapor pressure, pH, and stability) or the pure active ingredient
(Row), as required in 49 FR 42890 (Sec. 158-120) and more fully described in the Pesticide Assessment Guideline
Subdivision D, must be submitted.
9/ The compound does not require submission of samples at this time.
-------
TAKI.K A
GF-NliRIC LV\TA RB^UIRFMENTS FDR DIHHENAMID
Data Requirement
Test
Substance
Does FPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
§158.125 Residue Chemistry
171-4 - Nature of Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal Residues
PAIRA
PAIRA & Plant
Metabolites
TGAI &
Metabolites
TGAI
Partially
No
Partially
No
00093608. 00114601
00093609. 00114613
40200701
00035605. 00114570
00043703. 00114586
00106180. 00114590
Yes 1/2/ 18 Months
Yes 3/4/
Yes 5/6/
Yes 5/6/
18 Months
15 Months
15 Months
171-4 - Storage Stability Data PAI
171-4 - Magnitude of the Residue -
Residue Studies
a. Root & Tuber Vegetables 9/
'•3 ° Potatoes
_ — Crop Field Trials TfcP
-- Processed Food/Feed KP
ON
Partially 00035601,00093614 Yes 7/87 15 Months
00035602. 00114577
00035603.. 00114585
Partially
No
00114577. 00114601
00114588,
Yes _K)/
Yes 11/
18 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR DIPHENAMID
Data Requirement
Test
Subs tance
Does EPA Bibliographic
Have Data? Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies
0 Sweet Potatoes
— Crop Field Trials TEP
b. Legume Vegetables 12/
0 Soybeans
— Crop Field Trials TEP
-- Processed Food/Feed EP
c. Fruiting Vegetables
(Except Cucurbits)
0 Peppers
-- Crop Field Trials TEP
0 Tomatoes
-- Crop Field Trials TEP
— Processed Food/Feed EP
d. Pome Fruits 16/
0 Apples
— Crop Field Trials TEP
-- Processed Food/Feed EP
Yes
Yes
No
Partially
Yes
No
00035596, 00073539
00035649
00035643, 00114566
00114585
00105710, 00114601
00106180, 00138452
00114570
Partially 00035607, 00035612
No
No
No
Yes 13/
Yes 14/
No
Yes 15/
Yes \TJ
Yes 18/
24 Months
18 Months
24 Months
18 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DIPHENAMID
Data Requirement
Test
Subs tance
Does EPA Bibliographic
Have Data? Citation
Mist Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies
e. Stone Fruits 19/
0 Peaches
— Crop Field Trials TEP
f. Small Fruits & Berries 20/
0 Raspberries
— Crop Field Trials TEP
0 Strawberries
-- Crop Field Trials TEP
g. Miscellaneous Commodities
Cottonseed
-- Crop Field Trials TEP
— Processed Food/Feed EP
0 Okra
— Crop Field Trials TEP
Peanuts
-- Crop Field Trials TEP
CM
OO
-- Processed Food/Feed EP
Tobacco
— Crop Field Trials TEP
-- Processed |?p
Yes
Yes
Yes
No
Yes
Yes
No
No
No
00035610.
Partially 00029335. 00114602
00093614, 00114594
00035608
00035609, 00114600
00026700, 00035611
00031791, 00035647
00035595,
No
Yes _21_/
No
No
Yes 22/
No
No
Yes 23/
Yes 24/
Yes 25/
18 Months
24 Months
24 Months
18 Months
24 Months
-------
TABLE A
GENERIC DATA RHQUIREMENTS -FDR DIPHENAMID
Data Requiranent
Test
Subs tance
Does EPA
Have Data?
Bibliographic
Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry - Continued
171-4 - Magnitude of the Residue -
Residue Studies
d. Meat/Milk/
Poultry/Eggs
- Potable Water
- Fish
- Irrigated Crops
- Food Handling
TGAI or Plant
Metabolites
TEP
TEP
TEP
TEP
Partially 00114586
No
No
No
No
Reserved 26/
No 22J
No 27 /
No _27/_
No 27/
-------
TABLE A
GENERIC DATA RtQUIRtMENTS TOR DIPHENAMID
§158.125 Residue Chemistry - Continued
I/ Data must be submitted depicting the uptake, distribution, and metabolism of ring-labeled [I^Cjdiphenamid (or
~ carbon labeled [ I^C]diphenamid) in potatoes following preemergence or layby applications, and in tomatoes
following broadcast or band treatment one month after direct seeding or transplanting at a rate sufficiently
high to permit complete ^-residue identification. Plants must be harvested for residue characterization at
regular intervals until maturity.
2J Representative samples from the requested plant metabolism studies must also be analyzed using accepted
~ enforcement methods to ascertain that these methods will determine all possible metabolites of concern.
3/ Metabolism studies must be submitted utilizing ruminants and poultry. Animals must be dosed for three days
~~ with ring-labeled [ 1/tC]diphenaroid 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 sacrified
within 24 hours of the final dose. The distribution and characterization of residues must be determined in
milk, eggs, liver, kidney, muscle, and fat.
kj Representative samples from the requested animal metabolism studies must also be analyzed using accepted
enforcement methods to ascertain that these methods will determine all possible metabolites of concern.
_5/ Residues of MM in or on crop samples must be subjected to analysis by multiresidue protocols.
Protocols for Methods I, II, III, and IV are available from National Technical Information Service
under Order No. PB 203734/AS.
6/ Additional methods, validation data, and residue data (for representative commodities) may be required
if the metabolism studies requested in footnotes 4 and 6 indicate that additional metabolites may
constitute residues of toxicological concern in plants or animals.
' T_l The storage intervals and conditions of storage of samples used to support all established
tolerances for residues of diphenamid including its desmethyl metabolite must be submitted.
These data must be accompanied by data depicting the percent decline in residues at the time and
^ under the conditions specified. On receipt of these data, the adequacy of the aforementioned
tolerances will be reevaluated.
&/ All residue data requested in this Standard must be accompanied by data regarding storage intervals
and conditions of sample storage. These data must be accompanied by fortification recovery data
depicting the stability of diphenamid residues of concern in appropriate sample substances under
the conditions for the time intervals specified.
-------
D1PMJNAM1I)
§158.125 Residue Chemistry - Continued
9/ If the registrant socks a crop group tolerance, tolerances and use directions must he proposed, and
~ supporting residue data submitted for additional representative group members (carrot, radish, and sugar
beet).
10/ Data must be submitted depicting residues of concern in or on potatoes harvested 50 days following preemergence
~~ broadcast application (in at least 30 gal water/A) , and, in separate tests, layby application of the 50 or 90%
WP formulation at 6 Ib ai/A. Tests must be conducted in ID(24%), ME(6%) , and WA(16%), states which are repre-
sentative of the major U.S. potato production regions (Agricultural Statistics, 1985, p. 164).
11/ Data must be submitted depicting diphenamid residues of concern in or on granules, dried peels and dried
chips processed from potatoes bearing measurable weathered residues. It may be necessary to use exaggerated
rates to achieve such residues. If residues are found to concentrate in any processed product, appropriate
food/feed additive tolerances must be proposed.
]2/ If the registrant seeks a crop group tolerance, use directions must be proposed, and appropriate supporting
residue data submitted for the additional representative group members beans (succulent and dry) and peas.
13/ Data must be submitted depicting diphenamid residues of concern in hulls, crude oil, refined oil, meal, and
soap stock processed from soybeans bearing measurable, weathered residues. In may be necessary to use
exaggerated rates to obtain such residues. If residues are found to concentrate upon processing,
then appropriate food/feed additive tolerances must be proposed.
14/ If the registrant seeks a crop group tolerance, additional data are required depicting diphenamid
residues of concern in or on peppers treated within one month following direct seeding or transplanting
with a single broadcast application of a WP or FlC (4 Ib/gal) formulation at 5 Ib ai/A. Tests must
be conducted in CA(18%), FL(23%) , and TX(16%) which represent the major U.S. sweet pepper growing
regions (1982 Census of Agriculture, pp. 349-350).
15/ Data must be submitted depicting diphenamid residues of concern in or on catsup, juice, puree, and dry poinace
k. processed from tomatoes bearing measurable weathered residues. Exaggerated application rates
may be necessary, to achieve such residue levels. If residues are found to concentrate in any
processed product, appropriate food/feed additive tolerances must be proposed.
If the registrant desires a crop group tolerance, use directions must be proposed, and appropriate supporting
residue data submitted for the representative group member pears.
_T7/ Data must be submitted depicting diphenamid residues of concern in or on apples harvested 90 days following
one directed spray soil application of a WP formulation at 6 Ib ai/A. Tests must be conducted in MI(9%), 7
NY(12%), WA(36%), and VA(6%) (state percent of total U.S. production given parenthetically data from
Agricultural Statistics. 1985, p. 196).
-------
§158.125 Residue Chemistry - Continued
187 Data must be submitted depicting diphenamid residues of concern in apple juice and dry pomace processed from
~~ apples bearing measurable weathered residues (exaggerated application rates may be necessary to achieve
such residues). If residues are found to concentrate in either commodity, then appropriate
food/ feed additive tolerances must be proposed.
19/ If the registrant seeks a crop group tolerance, use directions must be proposed, and appropriate
— supporting residue data submitted for the additional representative group members cherries and plums.
20/ If the registrant seeks a crop group tolerance, use directions must be proposed, and appropriate
supporting residue data submitted for additional representative group members (blueberries, cran-
berries, and grapes).
217 Data depicting diphenamid residues of concern in or on raspberries harvested 60 days following one directed
spray soil application of a WP formulation at 6 Ib ai/A must be submitted. Field trials must be conducted in
MI(3%) and WA(44%) (state percentages of U.S. raspberry acreage appear parenthetically)
(1982 Census of Agriculture. Vol. 1, Pt. 51, p. 372).
22/ Data must be submitted depicting diphenamid residues of concern in hulls, meal, crude oil, refined oil, and
soapstock processed from cottonseed bearing measurable, weathered residues. It may be necessary to use
exaggerated rates to obtain such residues. If residues are found to concentrate upon processing then appro-
priate food/feed additive tolerances must be proposed.
237 Data must be submitted depicting diphenamid residues of concern in meal, crude oil, refined oil, and soap-
stock processed from peanuts bearing measurable, weathered residues (exaggerated rates may be necessary
to achieve such residues). If residues concentrate in these processed commodities, appropriate
food/ feed additive tolerances must be proposed.
247 Data must be submitted depicting diphenamid residues of concern in or on green, freshly harvested tobacco
receiving the following full-season treatment schedules in separate tests: one broadcast soil application 7
days after transplanting of a WP formulation at 6 Ib ai/A followed by one soil band application at layby after
the last cultivation of a WP formulation at 2 Ib ai/A; and (ii) the same applications except at 2 and 6 Ib
ai/A, respectively. Applications must be made by ground equipment.
25/ If residues in freshly harvested green tobacco exceed 0.1 ppm, data depicting residues in or on dried or cured
tobacco will be required. If residues in or on dried or cured tobacco exceed 0.1 ppm, pyrolysis products
derived fron the active ingredient must be characterized and the level of residue in smoke must be quantified.
(Ring-labeled [ l^C] diphenamid must be used for identification of pyrolysis products.)
f\O
and
26 / The nature of the residue in animals is not adequately understood and outstanding data gaps exist for many
processed feed items. Upon receipt of the data requested in the sections "Nature of the Residue in Animals"
and "Magnitude of the Residue in Animals", the established tolerances will be assessed, and the adequacy of the
available data regarding the magnitude of residues will be determined with consideration for any additional
residues of Lexicological concern.
27/ The Guidelines and use patterns indicate that these data are not required.
-------
TABLE A
GENERIC WTA KEQUIREMENTS TOR DIPHENAMID
Data Requiranent
§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:
163-1 - Leaching &
Adsorption/
Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B
TEP A
TEP A
Yes 001 57344
No
No
No
No
No
No
No
*
No
No
No
Must Addtl Time Frame
Data be for
Submitted? Submission
No
Yes 9 Months
Yes 9 Months
Reserved 1 /
Yes July 1987 _2/
Yes July 1987 2J
No y
No V
Yes 12 Months
Yes 12 Months
Reserved 4/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIPHENAMID
l>it:a Requiranent
Test
Substance
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
Must Addtl Time Frame
Data be for
Submitted? Submission
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
1 64-3 - Forestry
1 64-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
TEP
TEP
TEP
- -
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
A,B
A
A
A,B
A
A
A
N/A
A
N/A
No
No
No
No
No
No
No
No
No
No
^
Yes 27 Months
Noj>/ ~
No_3/
No 6/
Reserved 7/
Yes 39 Months
Reserved jj/
No_5/
Yes 12 Months
No _5 /
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DIPHENAMID
l>> ta Requi r emen t
§158.140 Reentry Protection
132-1 - Foliar Dissipation
1 32-1 - Soil Dissipation
1 33-3 - Dermal Exposure
1 33-4 .- Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use
Pattern
A,B
A
' A.B
A,B
A
A
Does EPA Bibliographic
. Have Data? Citation
No
No
No
No
No
No
Must Addtl Time Frame
Data be for
Submitted? Submission
Reserved 9/
Reserved 9/
Reserved 9/
Reserved 9/ LO
Reserved 9/
Reserved 9/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIPHENAMID
§158.130 Environmental Fate - Continued
J_/ Photodegradatton test in air is reserved pending results of the laboratory volatility studies.
2J The registrant requested on 2/11/87 an extension of time from March 1987 to July 1987 to complete the following
soil metabolism tests: 162-1 and 162-2. The Agency has granted the extension of time for these soil metabolism
tests.
JJ/ The Agency has waived the data requirements for (a) anaerobic aquatic study [162-3] and (b) forestry dissipation
study [164-3] which were required in the Ground Water Data Call-in Notice of 6/26/84. This decision has taken into
consideration that the registrant has revised all forestry uses to ornamental uses for diphenanid products.
_4/ Field volatility study is reserved pending results of the laboratory studies.
J>/ The Guidelines and use patterns indicate that these data are not required.
6/ The data requirements for combination and tank mixes are not being imposed in this Standard.
TJ Soil long terra study is reserved pending results of acceptable aerobic soil metabolism and field dissipation
studies.
8/ Rotational crop field study is reserved pending results of an acceptable confined rotational crop study.
9/ Reentry and spray drift data may be required if the results of the toxicity tests being required under this
Standard indicate that a significant chronic toxicity hazard may exist.
ON
-------
TABLK A
CKNERIC DATA REQUIREMENTS FDR DIPHENAMID
D;ite
SI 58.
ACUTE
81-1
81-2
81-3
81-4
81-5
81-6
Requirement
135 Toxicology
TESTING:
- Acute Oral Toxicity
- Acute Dermal Toxicity
- Acute Inhalation
Toxicity
- Primary Eye Irritation
- Primary Dermal
- Dermal Sensitization
Tost
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,
A,
A,
A,
A,
A,
1
Does EPA Bibliographic
Have Data? Citation
*
Yes 00114560
Yes 00114575
No
Yes 00077881
No
No
Must Addtl
Data be
Submitted
No
No
Yes
No
Yes
Yes
Time Frame
for
Submission
9 Months
1^.
-3-
9 Months
9 Months
81-7 - Acute Delayed
NeurotoxLcity - Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding -
Rodent
Nonrodent (dog)
82-2 - 21-Day Dermal
TGAI
TGAI
TGAI
A,
A,
No
No
No
No 1/
No A/
Yes
12 Months
-------
TABLE A
GENERIC DATA RBQUIRKMENTS FOR DIPHENAM1D
Data Requirement
§158.135 Toxicology - Continued
SUBCHRONIC TESTING :
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxi city-
Hen
CHRONIC TESTING:
83-1 - Chronic Toxicity -
Rodent (rat)
Nonrodent (dog)
83-2 - Oncogenicity -
Rat
Mouse
83-3 - Teratogenicity -
Kat
Rabbit
83-4 - Reproduction -
2 - PPPPrP f- i rtrt
Test
Subs tance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,
A,
A.
A,
A,
A,
A,
A,
A,
A.
Does EPA Bibliographic
Have Data? Citation
•
No
No
No
No
Yes 00076382
No
No
No
No
Yes 00076383
Must Addtl
Data be
Submitted?
No 21
Reserved 5/
No \J
Yes
No
Yes
Yes
Yes
Yes
No
Time Frame
for
Submission
50 Months
50 Months
June 1988
15 Months
15 Months
OO
-------
TABLE A
GENERIC Q\TA REQUIREMENTS FOR DIPHENAMID
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Adcltl Time Frame
Data be for
Submitted? Submission
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
84-2 - Gene nutation
(Ames Test)
84-2 - Other Genotoxic
Effects
TGAI
84-2 - Structural Chromosomal TGAI
Aberration
TGAI
A,
A.
A,
No
No
No
Yes
Yes
Yes
9 Months
12 Months
12 Months
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal
Safety
PAI or
PAIRA
Choice
A,
A,
Partially 00077893, 00093606 Yes
»
No No 3/
24 Months
-------
TAIil.K A
t.'KNKRLC DATA KMQU IRAKI'S TOR DIPHENAMID
§158.135 Toxicology - Continued
i
I/ Because diphenamid is not structurally related to the known family of neurotoxins, organophosphates, this
~ neurotoxicity study is not required.
2/ This study is not needed because the existing acceptable end-uses should not result in repeated human skin
~~ contact for extended periods.
3/ Use patterns in conjunction with the Guidelines indicate that these data are not required.
kj This study is not necessary since an adequate chronic feeding dog study is available.
_5/ A subchronic inhalation study is required for use on tobacco if residues occur in dried tobacco.
en
o
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIPHENAMID
Data Requirement Test Use
Substance Pattern
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDjO TGAI A,B
71-2 - Avian Dietary 1^50
a. Waterfowl TGAI A,B
b. Upland game bird TGAI A.B
71-3 - Wild Mammal
Toxicity TGAI A,B
71-4 - Avian Reproduction
a. Waterfowl TGAI A,B
b. Upland game bird TGAI A,B
71-5 - Simulated Field Testing
- Mammals, and TEP A B
- Birds
Actual Field Testing
- Mammals , and TEP A B
- Birds
AQUATIC ORGANISM TESTING
72-1 - Acute Toxicity,
Freshwater Fish
• a. Warmwater TGAI A(B
b. Coldwater TGAI A,B
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
No
No
No
No
•
Must Adcltl Time Frame
Data be for
Submitted? Submission
Yes 9 Months
Yes 9 Months
Yes 9 Months
No \J
No 21
No 21
No J/ 21
No \J 21
Yes 9 Months
Yes 9 Months
-------
TABLK A
CKNKKIC LV\TA REglJIRFMKNTS FOR DlPHENATflD
Data Requirenent
§158.145 Wildlife and
Aquatic Organisms
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Adcltl
Data be
Submitted?
Time Frame
for
Submission
AQUATIC ORGANISM TESTING
72-2 - Acute LC5o Freshwater TGAI
Invertebrates
72-3 - Acute LC^Q Estuarine TGAI
and Harine Organisms
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life- TGAI
Cycle
72-5 - Fish full Life-cyle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated Field TEP
Testing
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
A,B
A,B
A,B
A,B
Yes
No
00138963
No
TGAI
TGAI. PAI,
Degradation
Product
A,B
A.B
No
No
No
No
No 3/
No 3/
No J}/
No 3/
No 3/
01
ro
-------
TABLF. A
GKNERIG DATA REQUIREMENTS FOR DIPHENAMID
Data Requiranent
§158.
121-1
150 Plant Protection
- Target Area Phytotoxicity
Test Use Does F.PA Bibliographic Must Addtl Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
TGAI A.B No -
No . 4/
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER 11
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI A.B No
TGAI A.B No
TGAI A,B No
TGAI A.B No
TGAI A,B No
TGAI A.B No
TGAI A.B No '
TGAI A.B No
No 4/
No 4/
Yes J>/ 9 Months
No 4/
No 4Y
No 4/
No 4/
No 4/
-------
TAHI.K A
(JKNKKIC DATA RRQUIRHMKNTS R)H DIPHIilNAMID
§158.145 Wildlife and Aquatic Organisms - Continued
J_/ Surrogate data indicate that diphenamid is Low in toxicity to mammals, therefore the study is not required.
27 Data on a formulated product indicate that diphenamid is very low in toxicity to waterfowl and upland gamebirds,
therefore, the studies are not required.
3/ Data on formulated products and surrogate data indicate that these studies are not required.
4/ Phytotoxicity testing can be required on a case-by-case basis to support, among others, end-use products that may
pose hazard to endangered or threatened plant species.
5/ Required for large acreage herbicide use with the potential for runoff into aquatic systans.
c_n
-------
Data Requirenent
TABLK A
CKNKRIC Ii\TA RhQIJIRWIKNTS K>R DIIUENAMID
Test
Substance
Use
Pattern
Does EPA
Have Data?
Biblipgraphic
Citation
Must Addtl
Data be
Submitted?
Time Frame
for
Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
1 NONTARGET INSECT TESTING -
« AQUATIC INSECTS:
l 142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
NONTARGET INSECT TESTING
143-1 - Predators and
thru
143-3 - Parasites
TGAI A
TEP A
(Reserved) 21
TEP A
(Reserved) _3/
(Reserved) 3/
(Reserved) 3/
(Reserved) 3/
Yes
No
00018842
No
No 1/
No
No I/
-------
TABLE A
GKNKRIC DATA RBQUIREMENTS FDR DIPHF.NAMID
\J Data tram the acute contact study show low toxicity'to honey bees. Therefore, no further testing is required,
2J Data requirements are reserved pending development of test methodology.
y Data requirements are reserved pending an Agency decision as to whether the data requirement should be
established.
O\
-------
TABLK H-l
PRODUCT SPKC1FLC IttTA KII}UIKKMKNTS WR IHPIIFNAMID 95% Fla (KPA RF,G.NO. 45639-120)
PRODUCT SPKC1F1C DATA RI/
Yes 6/
Yes 11
Time Frame
for
Submission
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
Other Requirements:
64-1 - Submittal of Samples
N/A
No
N/A
No 8/
CJl
-------
TAHJJ-: B-1
PRODUCT SPECIFIC DATA KBJIIL KIM-MS TOR DIPHENAMID 95% FIa & 90% FIb (EPA REG.NOS. 45639-108 and 120)
§158.120 Product Chemistry (Continued)
a The 95% formulation intermediate (FI) serves as a manufacturing-use product.
b The 90% formulation intermediate (FI) serves as a manufacturing-use product.
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
~ certain data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. The bibliographic citations for old data are not applicable.
2f The chemical name and CAS Registry no. of each intentionally added inert must be submitted, along with the
~ identity (e.g., EPA Reg. No.).
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative amounts
~ of beginning materials and the order in which they are added, a flow chart with chemical equations for each intended
reaction, equipment used to produce the product, reaction conditions, the duration of each step of the process,
purification procedures, and quality control measures. In addition, the name and address of the manufacturer,
producer or supplier of each beginning material must be provided along with information regarding the properties of
each beginning material used.
4_/ A detailed discussion of all impurities that are or may be present at X).1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
_5/ Five or more representative samples must be analyzed for the amount of active ingredient and toxicologi-
cally significant inerts. Complete validation data (accuracy, precision) must be submitted for each
analytical method used. In addition, all nitrosamines must be identified and quantified in six samples;
two samples each must be analyzed shortly after production, 3 months after production, and 6 months
after production.
y Upper and lower limits for diphenamid must be provided, certified, and validated by sample analysis using analytical
procedures for which accuracy and precision data have been provided. Upper and lower limits for each intentionally
added inert must be provided, certified, and validated by sample analysis using analytical procedures for which
accuracy and precision data have been provided. Upper limits for each impurity present at X).1% (w/w) , and for each
"toxicologically significant" impurity present at <0.1% (w/w) must be provided, certified, and validated by sample
analysis using analytical procedures for which accuracy and precision data have been provided.
Certifications must be submitted on EPA Form 8570-4, Rev. 2-85.
]_l Analytical methods must be provided to determine the active ingredient and each toxicologically significant impurity
and intentionally added inert for which a certified limit is required. Each method must be accompanied by validation
studies indicating its accuracy and precision. These methods must be suitable for enforcement of certified limits.
S/ The compound does not require submission of samples at this time.
Ul
OO
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TABLE B
PROUULT SPKCIKIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING DIFHENAMID
Data
§158.
ACUTE
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Requirement
135 Toxicology
TESTING:
- Acute Oral Toxicity
- Acute Dermal Toxicity
- Acute Inhalation
Toxicity
- Primary Eye Irritation
- Primary Dermal
- Dermal Sens itizat ion
- Acute Delayed
Neurotoxicity - Hen
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Pattern
A,
A.
A.
A,
A.
A,
A,
Does EPA Bibliographic
Have Data? Citation
Yes . 00114560
Yes 00114575
No
Yes 00077881
No
No
No
Must Addtl
Data be
Submitted?
No
No
Yes
No
Yes
Yes
No \J
Time Frame
for
Submission
9 Months
9 Months
9 Months
I/ Diphenamid is not an brganophosphate and available data do not indicate a neurotoxicological problem.
LH
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SUMMARY-1
LABEL CONTENTS
40 -CFR 162.10 requires that certain specific Labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
60
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
• Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point . 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word '(DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. ~ SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - 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)].
61
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application mxist
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
62
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SUMMARY -4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 1b2.1
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.
63
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 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.
64
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SUMMARY-6
LABELING REQUIKQ1ENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product nane
Company nane
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
pr ecaut ionary
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
r ' 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
Mast 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 statement:;
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
ON
U1
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull ft cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/ back panel
precatitionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
vhich 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
pr ec aut ionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
• signal word
Front panel
for all.
Top or side
of back panel
* preceding
directions
- for use
Same as above
Same as above
COMMENTS
•
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
ON
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
s tatement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Iramed lately
before
' specific
directions
for use or
at the end of
directions
• for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statanent of the terms of
restriction. The words "RESTRICTED USl-l
PESTICIDE" must be same type size as
signal word.
Required statanent is:
"It is a violation of Federal law
to use this product in a mariner
inconsistent with its labeling."
Mast 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 statenents.
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
68
-------
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 and these regulations;
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited 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 § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
70
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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
of other text.
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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 may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or 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 po'sition o'n 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 given 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:
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Hazard Indicators
Oral LD5o
Inhalation 1C
Dermal LD
50
Eye effects
Skin effects
1
Up to and
Including
50 mg/kg
Up to and
Including
.2 mg/l Iter
Up to and
tnclud Ing
200 mg/kg
Corrosive;
cornea) opacity
not reversible
within 7 days
Corrosive
Toxlclty <
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Corneal opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor les
1 1 1
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/l Iter
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
the basis of its oral, inhalation or dermal toxicity (as di
or
the
on
istinct
word "Poison" shall appear
contrasting color and the
the basis of its oral,
from skin and eye local effects) unc WWLU r-vjjL=>i_m auaxj. appeal
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
Toxicity Category II. All pesticide products meeting the
a of Toxicitv Cateaorv II shall bear on the front panel*'
(B) _
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity^Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide
III shall bear
All pesticide
IV shall bear
products meeting the
on the front panel
products meeting the
on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described"
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
.or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxlcl.ty
category
Precautionary statements by toxictty category
Oral, Inhalation, or dermal toxicIty
Skin and eye local effects
II .
Ill .
IV . . .
Fatal (poisonous) If swallowed [Inhaled or
absorbed through skin). Do not breathe
vapor [dust] or spray mist]. Do not get
In eyes, on skin, or on clothing IFront
panel statement of practical treatment
required.].'
May be fatal If swallowed I Inhaled or
absorbed through the skin). Do not breathe
vapors Idust or spray mist]. Do not get In
eyes, on skin, or on clothing. tApproprlate
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 I eyes or clothing]. (Appropriate
first aid statement required.].
I No precautionary statements required.!.
Corrosive, causes eye and skin damage lor
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.
lApproprlate first aid statement required.)
Causes eye land skin] Irritation. Do not
get In ayes, 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.
(No precautionary statements required.].
«
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
75
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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 LC$Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are.
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flesh point above 20*F and not over 80*F or If
the flame extension Is more than 18 In. long
at a distance of 6 In. from the flame.
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 open flame. Do not
puncture or Incinerate container. Exposure to
temperatures above 130*F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame. Do not 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.
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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:
(_!) 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:
(JJ 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:
(\) 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 ;
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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
(_4) 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.
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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]
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
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.
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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.
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type,listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^ , dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
J_/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
82
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or Toxicity
Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a. viola-
tion of Federal Law. If these wastes cannot be disposed
of by use according to label instructions, contact your
State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance." • "
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR
261, Subpart C for a hazardous waste must bear the following
pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according
to label instructions, contact your State Pesticide or Environ-
mental 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 state-
ment :
"Wastes resulting from the use of this product may be dis-
posed of on site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the follow-
ing disposal statement:
"Securely wrap original container in several layers of
newspaper and discard in trash."
83
-------
tip ft Compendium of Acceptable Uses
DIPHENflMID
TABLE OF CONTENTS
Site Name Page
TERRESTRIftL FOOD CROP 3
(Agricultural Crops) 3
TERRESTRIAL NONFOOD CROP 9
(Agricultural Crops) 9
(Ornamental Plants and Forest Trees) 10
African Daisy 10
fileppo Pine 11
Algerian Ivy (ground cover) 14
ftlyssurn 10
ftpple 3
ftpple (ornamental) 11
ftrborvitae 1 1
fish 11
ftster 10
Azalea 11
Baby's Breath 10
Baby's Tears (ground cover) 14
Bald Cypress 11
Barberry 11
Beauty Bush 11
Beech 11
Begonia " • , • 10
Bermudagrass 14
Big Blue Lily Turf 14
Birch 11
Black Locust 11
Black Raspberry 4
Black Walnut 11
Blackberry (non-bearing) 3
Blackgurn 11
Blueberry (non-bearing) 3
Bottlebush 11
Boxwood 11
Bugleweed (ground cover) 14
Butterfly Orchid 10
California Fan Palm 11
California Poppy 10
California Privet 11
Cajeput Tree 11
Camellia 11
Carob • 11
Carolina Cherry Laurel 11
Ceanothus 11
Ceanothus (ground cover) 14
Cherry (non-bearing) 3
Cherry Laurel 11
Chestnut 11
Chinese Chestnut 11
Chrysanthemum 10
Issued: 4-01-66 I-03£601-i
Provisional Update: 4-29-87
84
-------
DIPHENOMID
TftBLE OF CONTENTS
Site Name Pane
Cinquefoil (ground cover)
Cosmos
Cotoneaster
Cotton
Cott onwood
Crabapple (ornamental)
Crearn Carpet
Crown-of -Thorns
Cupaniopsis anacard i ops is
Cypress
Dan 1 ias
Dent si a
Dichondra
Dogwood
Dwarf Coyotebrush (ground cover)
Elaeagnus
English Ivy (ground cover)
Eucalyptus
Euonyrnus
Fern Podocarpus
Fetter-Bush
Feverfew
Ficus
Fir
Fi ret horn
Flowering fllmond
Flowering Currant
Forsyth ia
Gazania (ground cover)
Gerani urn
Har lands Boxwood
Hawaiian Tree Fern
Heath
Heavenly Bamboo
Hel iotrope
Hemlock
Holly
Honey locust
Honeysuckle
Hydrangea
Ice Plant (ground cover)
India Hawthorn
Indian Laurel
Jacaranda acuti folia
Japanese Black Pine
Japanese Holly
Japanese Snowball
Japanese Yew
Juni per
Juniper (ground cover)
14
10
1 1
4
11
': 1
11
1 1
11
15
10
1 1
16
11
14
1 1
14
11
1£
i£
1£
10
IS
15
It-
IE1
1£
1£
14
10
1£
1£
1£
1£
10
IS, 15
IS
1£
IS
IS
14
IS
10
IS
IS
IS
IS
IS
IS
14
Issued: 4-01-86 I-036601-ii
Provisional Update: 4-S9-S7
-------
compendium of Acceptable Uses
DIPHENfiMID
7 A B LE OF CDN7EN7S
Site Name
Pane
Larch
Larkspur
Laurel
Li gust r urn
Lilac
Li ly-of-the-Ni le
Lirne (non-bear ing )
Lobel ia
London Plane
Loosest ri fe
Mahonia
Maple
Mar i gold
Mirror Plant
Mock Orange
Monterey Pine
Moreton Bay Fig
Mount a i n-Laure 1
Mugho Pine
Mult if lor a Rose
Norway Maple
Oak
Okra
Oleander
0 1 i ve ( ornament a 1 )
Orange (non-bearing")
Oriental flrborvitae
Ornamental Evergreen Pear
Peach
Peach ( ornament a 1 )
Peanuts
Pear (ornamental)
Pecan (ornamental)
Peonies
Peppers
Periwinkle (ground cover)
Petunias
Ph i lodendron
Phlox
Pin Oak
Pine
Pineapple Buava
Pink Indian Hawthorn
Pittosporurn
P 1 urn ( ornament a 1 )
Potato
Raspberry (non-bearing)
Red Maple
Red Oak
Red Raspberry
15
10
i£
1£
i£
10
3
10
1£
10
1£
1£
10
1£
1£
1£
IS
IE-
IE
1£
1£
1£
4
' 1£
IS
3
1£
1£
3
1£
4
1£
1£
10
5
14
1O
10
10
IS
13,
13
13
13
13
c-
wJ
3
13
13
4
Issued: 4-01-86
Provisional Update:
I-O36601-i i i
4-£9-S7
86
-------
Compendium of ftcceotabie Uses
DIPHENfiMID
TflBLE OF CONTENTS
Site Name [ Pane
Redbud 13
Redcedar 13
Rhododendron 13
Rose 13
Sakaki 13
Salvia 10
Sandankwa Viburnum 13
Sasanqua Camellia 13
Scarlet Oak 13
Scotch Heather 13
Shasta Daisy 10
Shore Juniper 13
Shrub-ftlthea 13
Silver Maple 13
Snapdragon 10
Soybeans 6
Spineless Yucca 13
Spirea 13
Spruce 15
St. Johnswort 13
Star Jasmine 13
Stocks 1O
Stonecrop (ground cover) 14
Strawberry 6
Strawberry (ornamental) (ground cover) . 14
Sugar Maple 13
Sweet Potato 6
Sweet William 10
Sweet g urn 13
Sycamore 13
Tobacco 9
Tobira 13
Tomato • 7
Tuliptree 13
Verbena 1O
Viburnum 13
Victoria—Box 13
Weigela 13
Wei gela (bristol ruby) 13
White fish 13
White Birch 13
White Cedar 13
Willow 13
Yellow Foxglove 10
Yew 13
Yew Podocarpus 13
Z i nn i a 10
Issued: 4-01-86 1-036601-iv
Provisional Update: 4-29-87 87
-------
Uornpend i urn of Acceptable Uses
DIPHENfiMID*
TYPE PESTICIDE: Herbicide
FORMULATIONS:
Tech (97-/.)
FI (90-/., 95%)
G ( 1. 4£'/i, £. 3"/-, £.
WP (5054, SO'/., 9054)
EC (18.3%)
F1C (1.39 Ib/gal or
GENERfii_ WARNINGS AND
65*, 3. 44*,
15. 4* a. i . ,
LIMITATIONS
5. 554,
A Ib/gal or 4£. 5'/. a. i.)
i ft selective preemergence herbi-
cide used to control broad leaf weeds and grasses in agricultural
and noncrop areas. Pi light rainfall or irrigation following appli-
cation will improve weed control. Incorporation may be necessary
under dry soil conditions. Do not apply directly to water or wet-
lands (swarnps, bogs, marshes, and potholes). Do not apply to lakes,
ponds, or streams. Cover, incorporate or collect granules spilled
on the soil surface. Do not contaminate water sources by cleaning
of equipment or disposal of wastes. Crops other than those regis-
tered for this product should not be planted in treated soil for 6
months after the last treatment. Do not use product in direct com-
bination with fertilisers, insecticides, fungicides, or with other
herbicides except as specifically recommended.
Livestock Tolerances:
Cattle, fat
Cattle, meat
Cattle, rnbyp
Goats, fat
Goats, meat
Goats, rnbyp
Hogs, fat
Hogs, meat
Hogs, rnbyp
Horses, fat
Horses, meat
Horses, rnbyp
Milk
Sheep, fat
Sheep, meat
Sheep, rnbyp
0. 05
0. 05
. 0. 05
0. 05
0.05
0.05
0. 05
0. 05
0.05
0. 05
0. 05
0. 05
0.01
0.05
0.05
0. 05
(N>
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
pprn
pprn
p.pm
ppm
ppm
pprn
ppm
ppm
ppm
ppm
ppm
pprn
ppm
pprn
ppm
ppm
TIME REQUIRED FDR CONTROL; Not located.
PHYTQTOXICITY TO TARGET WEEDS; Not located.
PHYTDTOXICITY TO CROPS; Not located.
MODE OF ACTION; Inhibits seed germination or early seedling growth
and root elongation by affecting the uptake of inorganic ions and
influencing the distribution of calcium.
*N, N-dirnethyl-£, £-d iphenylacet amide
Issued: 4-01-86 1-036601-1
Provisional Update: 4-E9-87
-------
Uornperid i urn of flcceotabie Uses
DIPHENPMID
PftZfiOBB
PBF.CiEBPi
PPZPi^Bft
BROADLEfiF WEEDS CONTROLLED!
PBFBOBB Brassbuttons
PfiDftBBfi Car pet weed
Chickweed
Common chickweed
Common ragweed
Corn spurry
Cudweed
Even ing or irnrose
Field pep per weed
PBZftBftfi Filaree
PEMQEBB Florida pus ley
PBFCXftP Groundsel
PftZSKBfl Knawel
PEOOGAC Knot weed
Larnbsquarters
Mallow
PPlZfiDBC Mouseear chickweed
PDPRBftft Oxalis
PfiZftlftft Pearl wort
PfififtflBI Pigweed
PPftftfiBP Purslane
PEflftHBB Red sorrel
PftFftCBI Redroot pigweed
PBKftHBft . Shepherdspurse
PEfiftBRD Smart weed
PRFfiQBJ Spiny amaranth
PBVfiGBK Spotted spurge
PZflftftGJ Spurweed
PftZftCBft Thyme leaf sandwort
PCDBYBJ White clover
GRflSSES flND OTHER MONQCOTS CONTROLLED!
PCftCKBfl finnual bluegrass
PCfififtftB flnnual grasses
PBMPDBO ftnnual sedge
PCftBHBB Barnyardgrass
PCfiftDflA Bent grass
PCOftZBA Berrnudagrass
PCfiCKfift Biuegrass
PCOftTBK Cheat
PCRBMflC Coarse fescue
SCQBRBQ Common velvet grass
PCfiBFftfi Crabgrass
PCfiBCBfi Crowfoot grass
PCftCEBD Fall panic urn
PCftCUftfl Foxtail
PCftBSBC Foxtail barley
PCftCUBft Giant foxtail
PCABIBfi Goosegrass
PCflCWBC Johnsongrass (from seed)
Issued: 4-O1-86
I-03660i-£
89
-------
iiPfl Compendium of Hcceptabie uses
'DIPHENRMID
GRftSSES fljxiDOTHER MQNOCQTS CONTROLLED (cont i nu e c)
PCfiCFBD Knotgrass
PCfiBFE
-------
/OiOiSAfi
/£300500
/I501500
/£300700
EPfi Cornpenc i urn of ficceDtabie Uses
DIPHENftttlD
Site, Dosage ana •• Tolerance, use, Limitations
Forrnulat ion
(ib a. i. /ft)
SIackberry (non-bearing) cluster (continued)
4-6
(SO'/-, 90% WP)
Black Raspberry
Red Raspberry
£-6
(50V., 90'/. WP)
(4 Ib/gal F1C)
Cotton
3-4
(SO'/-, 90'/. WP)
(4 Ib/gal F1C)
Okra
3-5
(SO-/., 90'/. WP)
(4 Ib/gal FiC)
Peach
Peanuts
4-6
(5O-/C, 90'/. WP)
(4 Ib/gal FIC)
£-3
(SO-/., 90'/. WP)
(4 Ib/gal FIC)
Broadcast. ftppiy in the fail or spring
before weeds emerge. ftpply in 10 gallons
of water.
i. 0 pprn
60 day preharvest interval.
1£ month preharvest interval for red rasp-
berry.
Do not use more tnan 6 pounds active in-
gredient during a growing season.
Directed spray to the soil. ftpply after
planting but before weeds germinate.
Apply prior to weed emergence in estab-
lished plantings or immediately following
a cult ivat ion.
0. £ pprn (cotton, forage)
0.1
-------
Site, Dosage and
Form ill at i on
(ib a. i. /ft)
Compendium of flcceotabie Uses
DIPHENftMID
Tolerance, Use, Limitations
Peanuts (continued)
//110030ft
/14013flft
(50-/.. 90% WP)
(4 Ib/gai FiC)
Peppers
(50'/., SO'/., SO'/. WP)
(4 Ib/oal FIC)
ESLN:
5
(50'/., 90S WP)
Potato
4-6
<50'/., 90'/. WP)
(4 Ib/gal FIC)
CSLN3
&
(SOS, 90'/. WP)
Red Raspberry
Layby application following last culti-
vation. Will not control established
weeds. Do not use if more than £ pounds
active ingredient per acre were appiiec at
planting or cracking stages.
0.1 (N) ppm (fruiting vegetables)
Do not graze treated areas.
General Information; Before treatment,
work all weed growth into soil.
Direct seeding treatment. apply in £0 to
50 gallons of water per acre.
OR
Broadcast application to transplants or
within 1 month after transplanting.
SLN - Use limited to Cft.
Preplant application. ftpply by air once
per season.
1.0 ppm
5O day preharvest interval.
General Information! finy tillage opera-
tion such as dragging-off, hilling, etc.,
that brings untreated soil to the surface
will result in poor weed control. Howev-
er, shallow cultivation (0.5 to £ inches)
after application will not reduce effec—
t iveness.
Preernergence. Broadcast. ftppiy in at
least 30 gallons of water per acre.
OR
Layby application. Directed spray to base
of plants.
SLN - Use limited to Cft.
Preplant application." ftpply by air once
per season.
See Black Raspberry cluster.
Issued: 4-O1-8&
1-036601-5
92
-------
/£SO£3flFi
Site. Dos5.ce ano
Forriiul at :. or;
( i b a. i . / ft)
Soybeans
EPft 'jornpenc i urn of Acceptaoie uses
DIPHENfiMID
Tolerance, Use, Lim i tat i on s
(50%, so/. WP>
(4 ib/gal F1C)
(4 Ib/oai FiC)
0. Zi ppm (soybean, forage, hay)
0. 1 (N) pprn (soybean)
Do not plant food crops other than soy-
beans within 6 months after treatment.
At olantinq. Broaacast.
Pit olanting. Broadcast or band.
Tank mix with linuron or ch lororooharn.
/Oi016Dft
Strawberrv
/140180ft
4-6
' (50%, 90% WP)
(4 Ib/gal FIC)
4-6
(50'/.,- 90% WP)
(4 Ib/gal FIC)
Sweet Potato
4-6
(50%, 90% WP)
(4 Ib/gal FIC)
£-6
(50%. 90% WP)
(4 Ib/gal FIC)
i. 0 pprn
60 day preharvest interval.
General I nf orrnat ion: Do not use on the
herbicide sensitive variety Shasta. A
temporary delay in rooting of Daughter
plants may occur but will not affect
yield.
Posttransplant application. Apply £ to 6
weeks after planting but before new fo-
liage has appeared. Use tne lower dosage
on light mineral soils and the higher dos-
age on medium/fine mineral soils. Apply
in 30 to 50 gallons of water.
Dormant application to established oiant-
ings. May be applied to serni-dormant
plantings or after bed renovation. Addi-
tional applications may be made at inter-
vals of 6 months or more.
0.1 (N) pprn
Post plant application to soil after covei—
ing sweet potatoes. Broadcast or band.
May be tank mixed with chloramben or orysa-
lin for preemergent weed treatment.
Post trans plant. Broadcast or oand.
be tank mixed with chloramben or oryzalin
for preemergent weed treatment.
Issued: 4-01-86
1-036601-6
93
-------
tPft Compendium of Receptacle Uses
DIPHENHM1D
/11005 A A
Site, Dosage and
Formu1 at i on
(Ib a. i. /A)
Tomato
4-6
(50%, SO'/., SO'/.
(4 Ib/gal F1C)
£-4
(50-/., BO'/-, 90'/.
(4 Ib/gal F1C)
4-6
(50%, 90%
(4 Ib/gal
WP)
F1C)
4-6
(SO'/. WP)
(4 Ib/gal
F1C)
tolerance. Use, Limitations
0.1 (N) pprn (vegetable, fruiting)
General Information; Following initial
watering, beds should be keot at the op-
timum moisture level for seed germination
and emergence. Allowing the seedbed to
dry out reduces the level of herbicide
effectiveness as well as the stand ana
vigor of the tomato plants. Do not use on
soils with over 10 percent organic matter
or on soils with a salt problem.
Broadcast or band treatment. Apply 1 week
WP) before to 1 month after direct seeding or
transplant ing.
Broadcast or band treatment. Apply 1 week
WP) before to 1 month after direct seeding or
transplanting. May be tank mixed with tri-
fluralin, pebulate, or naproparnide. Do
not tank mix with trifluralin or pebulate
for use on direct seeded tomatoes except
in CA.
Use limited to CA. Prep1ant application
to fields to be planted in with direct
seeded tomatoes. Broadcast. Apply to pre-
pared beds and incorporate into the soil
(1 to £ inches) with a power driven til-
ler. Do not apply earlier than 14 days
before seeding. Immediately following in-
corporation and seeding, the beds should
be thoroughly wet by furrow irrigation.
OR
Use limited to CA. Preplant application
to fields to be planted with direct seeded
tomatoes. Broadcast with disk incorpora-
tion. Apply in at least 30 gallons of wa-
ter per acre. Following application the
field should be double-disked with the sec-
ond disk at right angles to the first to
uniformly incorporate into the soil to a
depth of 3 to 4 inches. Following bedding
and seeding the beds should be thoroughly
wet using furrow irrigation.
Issued: 4-01-86
1-036601-7
94
-------
i=.PA CC'fnpenal urn of Acceptable Uses
DIPHENAMID
Si_te_,_ jDosage and
Forrnu 1 at i on
(I'c a. i . / A)
Tomato (continued)
4-6
(SO'/- WP5
(4 ib/gai FiC)
6
ooy. WP)
(4 Ib/oal FIC)
4-6
(SO*, 90% WP)
(4 Ib/nal FIC)
LSLND
4-6
<50'/., 90'/. WP)
i.olerance. Use, uirnitat: ions
Use limited to CA. Preplant application.
Broadcast to cirect-seeded tomatoes.
Apniy in 30 to 50 gallons of water per
acre. Incorporate into the soil to a
death of £ to 3 incnes. Do not use the
trifluralin tank mix on soils containing
more than 5 percent organic matter, or
soils with a salt problem. Tank mix with
trifluraiin or peculate.
Use limited to CA. Broadcast application
to fields prepared in the fail for early
spring planting of direct seeded tomatoes.
Apply prior to the start of the winter-
rainy season (October or November). Do
not incorporate into the soil rnecnanicai —
ly. Tomatoes may be planted through March
1 in the treated fields. Do not use a
fall application on fields to be planted
after March 1.
Use limited to Cft. Broadcast application
at planting or immediately after without
soil incorporation. After application, i
to £ inches of water should be applied by
sprinkler irrigation.
SLN - Use limited to CA.
Prep1ant application. Apply once per sea-
son in at least 3O gallons of water per
acre. Tank mix with naDrooarnide.
Issued: 4-01-86
1-036601-8
95
-------
bpft Corriosndi urn of ftcceotable Uses
DIPHENflMID
Si-e, Dosase and
Forrnulat ion
(Ib a. i. /ft)
'oierance, Use. Lirnita-c ions
TERRESTRIAL NONFOOD CROP
(ftor icu_l t iiral Crops,)
/£600>ififi
i ooacco
4-6
(5054, 80%, 90S WP)
(4 Ib/gal F1O
£-4
(4 Ib/oal F1C)
£-4
(50'/., SO'/., 90S WP)
Do not graze treatea areas.
General .In/format ion: Rainfall or overneaa
irrination within a week of treatment will
enhance herbicidal effectiveness. When ap-
plied more than £ days after transplanting
tillage is required before or at time of
treatment to destroy germinating weed
seeds. Small grain cover crops planted in
the fall following treatment may be in-
jured. When these crops are to be grown,
a band treatment to tobacco is recommend-
ed. Do not use more than a total of 8
pounds active ingredient per acre per sea-
son.
Broadcast application to seedbeds. flpply
at seeding to control white clover. Use
the lower dosage on coarse soils and the
higher dosage on medium/fine soils. May
be tank mixed with rnetalaxyl.
Broadcast. ftpply from 0 to 7 days before
transplanting or up to 7 days after trans-
planting. Incorporate into the top £ inch-
es of soil. ftpply in £0 to 4O gallons of
water per acre. May be tank mixed with
trichlorfon.
OR
Broadcast or band treatment at layby fol-
lowing last cultivation, usually 4 to 6
weeks after transplanting. If application
was used before or after transplanting ap-
ply £ to 4 pounds active ingredient per
acre. May be tank mixed with pebulate.
Pretransplant. ftppiy up to 7 days before
transplanting. Tank mix with trichiorfon,
isopropalin, pendirnethal in, or pebuiate.
Band treatment at layby. ftppiy to row mid-
dles following last cultivation. Do not
spray tobacco leaves as injury may occur.
Tank mix with oryzalin.
Issued: 4-01-86
1-036601-9
96
-------
±. ;-' H LJ '_< r
Site, Dosage and
Formal at ion
(1 b a. i. /ft)
YiDendiuffi of ficceptaole Uses
DIPHENflMID
i o
olerance. Use, Limitations
Tobacco (continued)
4-6
80%, 90'/.
4-6
(5054,
90'/. WP)
Band treatment at layby. Apply to row
middies following last cultivation. Do
not spray tobacco leaves as injury may
occur. Tank mix with metaiaxyl.
SLN - Use limited to i\iC, SC and VA.
Broadcast. Apply before transplanting, af-
ter transplanting, or at layby to suppress
common ragweed. Use the lower dosage on
coarse mineral soils and the higher dosage
on medium/fine mineral soils.
(Ornamental Plants and Forest Trees)
/3100IDA flfrican Daisy
/31017DP filyssum
/310£6Dft Qst er
/310£8Dfl Baby's Breath
/31034Dfl Begonia
/31045DB Butterfly Orchid
731051 DP) California Poppy
/31065DR Chrysanthemum
/31077DO Cosmos
/31084Dfi Pah 1 i a_s
/311OODfl Feverfew
/31i08Dfl Geranium
/31413DR Heliotrope
/3i£87Dfi Indian Laurel
/311S9DPI Larkspur
/314110ft Lily-pf-the-Nile
/31133DPI Lobel ia
/3141£Dfi Loosestrife
/31137DP) Marigold
/31151DA Peonies
/31154DA Petunias
/31155DO Philodendron
/31156DA Phlox
/31171Dft Salyia
/31iSODfl Shasta Daisy
/31184DA Snapdraoon
/311SeDft Stocks
/31198DA Sweet William
/31i£O6Dfl Verbena
/31410DO Yellow Foxglove
/31£13Dft Zinnia
Issued: 4-O1-86
1-036601-10
97
-------
EPft Compendium of ficceptabie Uses
DIPHENftPlID
/353£4Dfl
/350940ft
/350£lDfl
/350££Dft
/340££Dft
/350£5Dft
/340£5Dft
/340£8Dfl
/350£7Dft
/350£8Dft
/350300ft
/350310ft
/35O3£Dft
/34£6£Dft
/340310ft
/353590ft
/340350ft
/35460DA
/340360ft
/35£73Dft
/353840ft
/34158DA
/340400ft
/350390ft
/35£35Dft
/340450ft
/35133DA
/35056DA
/349840ft
/343600ft
/354740ft
/34O50DR
/350430ft
/340510ft
/350500ft
Site. Dosage
Forrnulat ion
-------
EPP CornneriGiu.nl of Pcceprable Uses
DIPHENifiMID
To lerance
/34053DA
/35360DA
/34056DA
/340570ft
/34058DA
/3505£DA
/34060DA
/3406£DA
/34£46DA
/3536£DA
/34067DA
/341000ft
/350680ft
/340700ft
/350700ft
/3407£Dft
/340730ft
/340750ft
/354580ft
/351850ft
/340800ft
/341900ft
/3507£Dft
/350730ft
/34£15Dft
/340880ft
/340890ft
/35i9£Dfl
/340900ft
/35083DA
/344160ft
/340940ft
/351-96Dft
/353610ft
/340970ft
/350860ft
/340980ft
/350890ft
/350930ft
/3410£DA
/35367DA
/35£540A
/353100ft
/350580ft
/350590ft
/353530ft
/35£55Dft
Site, Dosage arid
Formal at ion
(Ib a. i. /ft)
Aleppo Pine cluster (continued)
Euonyrnus
Fern Podccarsus
Fett er-B-.ish
Ficus
Firsthorn
Flowering A1 mor;d
Flowering Currant
Forsythia
har 1 andsT Bpxujppg
Hawaiian Tree Fern
Heath
Heavenly Bamboo
Hemlock
Hoi ly
Honeylocust
Honeysuckle
Hydrangea
India Hawthorn
Jacaranda acutifolia
Japanese B1ack Pine
Japanese Holly
Japanese Snowball
Japanese Yew
Juni per
Laurel
Li gustrum
Li lac
London Plane
Mahonia
Maple
Mirror Plant
flock Orange
Mont e r e y P_ i n e
ftloreton Bay Fig
Mount a i n-Laure1
Mugho Pine
Multiflora Rose
Norway friaple
Dak
Oleander
01ive (ornament a1)
Oriental ftrboryitae
Ornament a1 Evergreen
se.
_ i rr.it at ions
Pear
Peacn (ornament a1)
Pear (ornamental)
Pecan (ornament a1)
Pin Oak
Issued: 4-01-86
1-036501-1£
99
-------
EPft Compendium of Hccep^;able Uses
DI?~!lNAr<:ID
Sits. Dosace and
rprrnul at ion
( 1 b a. i . / ft)
"!>'! grange. USB., • ..irn i va':; ions
ftleopo Pine cluster (continued)
/350980ft
/ 3 4 1 1 £ D ft
/ 3 4 4- £ 8 D ft
/ 3 4 i i 3 D A
/350600ft
/35£04Dft
/35105DA
/35103Dft
/ 3 5 1 0 4 D ft
/345550ft
/341£ODft
/34£08Dft
/341££Dft
/341£4Dft
/35£06Dft
/340680ft
/35£09Dft
/34£09Dft
>"35£liDft
/353640ft
/341300ft
/341£lDft
/3413£Dft
/351 170ft
/351180ft
/35119DA
/342190ft
/351£ODfl
/341370ft
/344150ft
/341400ft
/34££4Dft
/35££7Dft
/35£48Dft
/351£5Dft
/351£8Dft
/351300ft
/35£53Dft
Pine
P in e a p o 1 e G a a y a
P i nn I ncJ i an Ha wt horn
Pit •bCjS_gor_iJifj'i
PI urn
Red...
(ornamental)
Red Dak
Reel bud
Red cedar
R h o d o d en a r o n
Rose
SaK.aki.
Santiankwa Viburnum
Sasanq ua Came Ilia
Scarlet Oak
Scotch Heather
Shore Juniper
Shrub-ftlthea
Silver Maple
Spineless Yucca
S'pirea
St. Johnswort
Star Jasmine
Sugar Maple
Sweetqurn
Sycamore
Tobira
Tul iptree
Viburnum
Victoria-Sox
Heiqela
Uiei qela (bristol ruby)
White ftsh
Ujhite Birch
Whit_e Cedar
Willow
Yew
Yew Podpca_rpJ-_LS
4-8
(50%, 90'/. WP)
(1.39 Ib/oal F1C)
Broadcast. flpoly in the fall or serin;! be-
fore weeds emerge. May ae dilutee in 10
gallons of water.
Issued: 4-O1-86
I-0366O1-13
100
-------
cPA Lorn pencil am of Acceptable L'sss
DIPHENAtfID
Site, Dosage arid
Formalat ion
(Ib a. i. /ft)
/33053AA ft1 peri an Ivy (ground
cover)
33059flft Baby1s Tears (ground
cover)
/33086ftA Bio Blue Lily Turf
(ground cover)
/33110AA Bugleweed (ground
cover)
/33060ftfl Ceanothus (ground
cover)
/33061ft!-) Cinauefoi 1 (around
cover)
/33130ftft Dwarf Coyotebrush
(ground covsr)
/33030ftft Enq1ish Ivy (ground
cover)
/33i£BAA Gasania (ground cover)
/331£4AA Ice Plant (ground
cover)
/331£7AA Juni per (ground cover)
/33O44Aft Per JVM ink le (ground
cover)
/331£5flfl Stonecrop (ground
cover)
/33106ftfl Strawberry (ornament-
al) (ground cover)
0. 5-£. 0 Ib a. i. /
5, 000 sq.ft
(50%, 8094, 90% WP)
(1.39, 4 Ib/gal
F1C)
Tolerance, Use, -.1,"nit-at ions
Broadcast application to new and
established plantings. For new plantings,
apply after cuttings have rooted (usually
1 month after planting). For established
plantings, apply in the fall, early win-
ter, or spring before weeds emerge. Re-
neat treatment in 6 months.
1. £5 Ib a. i. /5, 000
sq. ft
(£. 3'/. G)
/ 33017 Aft Berrnudaqrass
0. 5 Ib a. i. /5, 000
sq. ft
(50'/., 90'/. WP)
(4 Ib/gal F1C)
Preplant application. Broadcast. Do no'
use where plants are to be grown from
seed.
Formulated with carbaryl.
Broadcast. Apply to established berrnucia-
grass. Apply in the fall to control annu-
al blueqrass and in the spring to control
crabqrass. Make early spring applications
while berrnudagrass is still dormant.
Issued: 4-01-86
1-036601-14
101
-------
/3504£DA
/35051BA
/350680ft
/35074DR
/35098DA
/35il6Dfi
Site, Dosage and
Forrnul at ion
(Ib a. i. /ft)
Cypress
Fir
Hemlock
Larch
Pi ne
Sorace
Lornpend i urn of Hcceptable Uses
DIPHENftMID
Tolerance?, Use, Lirni t at ions
£-10
(50%, 90* WP)
(4 Ib/gal F1C)
Senera 1 In format i on: ihese sites iriciuae:
Baldcypress, Balsam-Fir, Douglas—Fir,
Frasier Fir, Grand Fir, Noble Fir, Red
Fir, White Fir, Rocky Mountain Douglas-
Fir, Eastern Hemlock, Western Hemlocx,
Japanese Larch, Western Larch, Austrian
Pine, Loblolly Pine, Lodgepoie Pine,
Long leaf Pine, Monterey Pine, Ponderosa
Pine, Scotch Pine, Short leaf Pine, Slash
Pine, Sugar Pine, White Pine, Enc iernann
Spruce, Norway Spruce, and White Spruce?.
If application is made 1 day before or
within £ days after seeding a second 10
pound active ingredient per acre treatment
may be applied & weeks after seeding. For
cypress and spruce apply after seedlings
are 1 month old. Use only post plant in- ap-
plications on ftustrian Pine.
Broadcast application to nursery seedbeds.
Apply 1 day prior to seeding to within i
month after seeding and mulching. ftpply
0.5 to 0.75 inch of water by overhead
sprinkler irrigation. Work all weed
growth into soil before application.
Issued: 4-01-86
1-036601-15
102
-------
=.PH Lorn penc i urn of fie ce p~ a31 s Lses
DIPHENfiMID -
Site, Dosage and
Form LI 1 at ion
(Ib a. i. /ft)
/330£Sftft Dichondra
1. £ Ib a. i. /5, 000
sq. ft
(1. 4£'/. G)
(SO'/., 80%, 30V. WP)
(1.33, 4 Ib/gal
FIC)
CMfilli
1 Ib a. i. /5,000
sq. ft
(3.4V/. G>
CMfilJ
1. 00-1. £5 Ib a. i. /
5, 000 sq.ft
(£. 3'/., £.
6)
CMflID
1 Ib a. i. /5, 000
sq. ft
(3.5-/. G)
tolerance. Use, •_r.rnitat ions
General Information: Do not use on grass
lawns. ftpply when foliage is cry.
Preplant application to seedbeds or broad-
cast treatment to established dichondra.
For preolant treatment preaare seed DSC and
rake in 0.5 inch deep before seeding. A
second application may be made in 6
months. For established dichondra. apply
in the spring before weeds germinate and
again in the fall. Repeat application
every 4 months. May be dilutee witn £ to
10 gallons of water.
May be formulated with rnonuron.
Preplant application to seedbeds or broad-
cast treatment to established dichondra.
ftpply throughout the year.
Formulated with one or a combination of
the following: neburon, rnonuron. and car-
baryl.
Use limited to Cft. Posternergence. Broad-
cast, ftpply in winter, spring or fall to
established dichondra. Make £ applica-
tions, 6 to S weeks apart, to control
emerged weeds. To control spurge and crab-
grass both applications must be rnace be-
fore mid-March in southern Cft, late March
in the Interior Valley, and before mid—
ftpril in northern Cft. Do not apply to new-
ly seeded dichondra and do not plant di-
chondra seed sooner than £ months after ap-
plicat ion.
Formulated with neburon, rnonuron, and chlo-
ropyri fos.
Issued: 4-01-86
1-036601-16
103
-------
irPfl Compendium of flcceptaoie Uses
DIPHENflMID
Site, Dosage arid Tolerance, Use, Li mi's at ions
Formulat ion
(Ib a. i. ,'P)
aERIPL flND TflNK KIX ftp PL. I CATIONS
900l500 fierial Application
— Refer to
TERRESTRIAL FDDD CROP
(flgricult ural Crops)
Peppers, Potatoes, Tomatoes
'3900300 Tank friix
— Refer to
TERRESTRIAL FOOD CROP
(flqricultural Crops)
Peanut, Soybean, Sweet Potatoes, Tomatoes,
Tobacco
104
Issued: 4-01-86 1-036601-17
-------
iiPH Cornoend i urn of Acceptable uses
DIPHENAMID
Listing of Registered Pesticide Products by Formalat ion
&097. OOOi 97'/- technical chemical
di phenarnid (036601)
045639-001£7*
*jacket currently unavailable for review
&090. 000£ 90'/. formulation intermediate
diDhenarnid (036601)
045639-00106
&095. 00OS 95'/. f orrnu 1 at i on i nt errned i at e
di phenarnid (036601)
045639-00 IE'0
&-OOi.4£04 1.4S'/. granular
di phenarnid (036601)
000557-01740
&00£. 3004 £. 3'/- Granular
di phenarnid (036601) plus carbaryl (056801)
01094^-00004
di phenarnid (036601), rnonuron (035501) plus carbaryl (056801)
01094£-OOOO3
&00£. 6504 £. 65'/- granular
di phenarnid (036601) plus carbaryl (056801)
000538-00031*+
•frjacket currently unavailable for review
-i-suspended
&003.4404 3.44% granular
d i ph enarri i d (036601) plus nion uron (035501)
003£34-0003£
&003.5004 3.5% granular
di phenarnid (036601), neburon (01S001), rnonuron (0355O1 ) plus
chloropyrifos (059101)
OO0538-OO1££
&005. 0004 5'/. granular
di phenarnid (036601)
(011440-00001) NC80003£*
*jacket currently unavailable for review
&005. 3004 5. 3'/. granular
di phenarnid (036601), neburon (012001) plus carbaryl (056801)
000538-0004£
Issued: 4-01-86 1-036601-18
105
-------
EPA Compendium of Acceptable Uses
DI PHENAiyilD
Listing of Registered Pesticide Products by Formulation (continues)
&£5O. 0006 SO'/- wet table powder
diphenarnid (036601)
000070-OOS3S 000 i9£-00139 000££6-00££6 000264-00353
00£393-00345 00£393-0043B 045633-00107 045639-00 i :• i
(045639-00107) CA7S0050*? CA7S0056 CS790107 NCB00005*
N C 6 0 0 0 0 6 *f S C S 0 0 0 0 i *f S C 6 0 0 0 0 £ & V A 6 0 0 0 0 6
Vft300010
wdouble parent iaoei
&£80. 0006 SO'/, wet table powder
diphenarnid (036601)
00£393-00346 0£34B6-00049*
*see auxiliary documentation
&£90.0006 90% wettable .powder
d i pheriarnid (036601)
000070-00£37 000££6-00£45 045639-00131 045639-00133
(045639-00131) C07B0050* CA7901BO NCSOOOOSfc iNiCB00006i*
SCBOOO01S SC80000£# VflS00009 VflSOOOll
#double parent label
&£lfl. 301£ IB. 3'A emulsif iable concentrate
diphenarnid (036601) plus dinoseb, triethanolarnine salt (037506)
045639-0011B*
*jacket currently unavailable for review
&•£ 15. 4014 15.4'/. (1.39 1 b/ga_l)_ f lowable concentrate
diphenarnid (036601)
00019£-00140 045639-00117
&£4£. 5014 4£. 5'X (4 1 b/qal) f lowable concentrate
diphenarnid (036601)
n01Bl£-00£B£
9999999 State Label Registrations
Cfi Reg. No.
007001-07762 007159-OB£79 011093-07367 011149-0467£
NY Reg. No.
038655-10441 03B655-10444
Issued: 4-01-B6 1-036601-19
106
-------
tPA l_-ornpentii urn of Acceptable uses
DIPHENftMID
Appendix ft—1
Listing of Active Ingredient(s) Found in Combination with the
Report Chemical
EPA Acceptable
Common/Chemica 1 Name
Chemical
Code
056301
053101
035501
01 £001
Common Name
(source)
carbary 1
ch loropyr i f os
rnonuron
neburon
— Use Common Name
Issued: 4-01-86 I-036601-SO
-------
C.PH Compendium of Acceptable Uses
DIPHENAMID
Appendix ft—£
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chern i ca 1 Common Name
Code (source)
029901
OIS301
037505
0375O6
100201
035506
113501
103001
104201
O41403
108501
098901
036101
ch lorarnben
ch iorpropharn
d inoseb
dinoseb, triethanolarnine salt
isopropal in
1inuron
rnetalaxy 1
napropamide
crysal in
pebulate
pend imethalin
trichlorfon
tri fluralin
EPA Acceptable
Common/Chemical Narne
isopropyl N-<3-
ch loropheny 1 ) carbarn-
ate
IM, N-diethyl-£-(l-
napthalenyloxy) pro-
pi onarnide
S-propyl
buty lethy 1 th iocarbarna
te
1,£—ben z i sot h i a z o1i n-
3—one
— Use Common Name
Issued: 4-O1-86
I-036601-21
108
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further 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.
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.
109
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a. last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
wich'no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In sone 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 s.tudy
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
110
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diphenamid Standard
MRID CITATION
00018842 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-
7501. (Unpublished study received May 8, 1971 under 1F1174;
prepared by Univ. of California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-B)
00026700 Holifield, E.; Barrow, K.; Clark, R.C.; et al. (1974) Residue:
Enide 50W. (Unpublished study received Aug 1, 1974 under
1023-23; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:
005407-C)
00029335 Upjohn Company (1966) Summary: Residue Analysis. (Unpublished
study received Mar 3, 1966 under 1023-23; CDL:005473-A)
00031791 Stephenson, J.E.; Deloatch, F.; Majett, G.B. (1975) Summary of
Residue Data for the Sequential Application of Vernam + Enide
+ Dinitro on Peanuts. (Unpublished study received Aug 11, 1976
under 476-2155; prepared in cooperation with Morse Laboratories,
Inc., submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:225431-B)
00035595 Holifield, E.L.; Hogan, W.H.; Stone, W.J.H.; et al. (1970) Residue
Determination for Oiphenamid and Desmethyldiphenamid on Peanut
Hulls: Report No. 119-9760-17. (Unpublished study including re-
port nos. 119-9760-18, 119-9760-19, 119-9760-24..., received
Jun 12, 1970 under OF0933; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:091591-E)
00035596 Hogan, W.H.; Stone, W.J.H.; Holifield, E.L.; et al. (1970) Residue
Determination for Diphenamid and Desmethyldiphenamid on Sweet
Potatoes: Report No. 119-9760-14. (Unpublished study including
report nos. 119-9760-15, 119-9760-20, 119-9760-21..., received
Jun 12, 1970 under OF0933; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:091591-F)
00035601 Upjohn Company (1964) Stability of Diphenamid in Frozen Produce.
(Unpublished study received Jun 12, 1970 under OF0933; CDL:
091592-E)
00035602 Upjohn Company (1963) Stability of Diphenamid in Frozen Macerated
Peanut. (Unpublished study received Jun 12, 1970 under OF0933;
CDL:091592-F)
00035603 Upjohn Company (1963) Stability of Diphenamid in Frozen Macerated
Sweet Potato. (Unpublished study received Jun 12, 1970 under
OF0933; CDL:091592-G)
111
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diphenamid Standard
MRID CITATION
00035605 Staten, F.W.; Cox, B.L. (1968) A Modified Method for the Residue
Analysis of Diphenamid and Desmethyl diphenamid in Green Forage
Crops: Report No. 116-9760-41. Method dated Sep 12, 1968. (Un-
published study received Jun 12, 1970 under OF0933; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:0391592-J)
00035607 Wardowski, W.F.; Niedbalski, J.F. (1969) Residue Determination for
Diphenamid on Apples: Report No. 112-9760-9. (Unpublished study
including report no. 112-9760-24, received Jun 12, 1970 under
OF0933; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:091592-L)
00035608 Holifield, E.L. (1969) Residue Data for Diphenamid on Cotton and
Cottonseed. (Unpublished study including report nos. 112-9760-
28, 112-9760-49, 112-9760-48..., received Jun 12, 1970 under
OF0933; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:091592-M)
00035609 Holifield, F..L. (1959) Residue Data for Diphenamid on Okra. (Un-
published study including report no. 112-9760-50, received Jun
12, 1970 under OF0933; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:091592-N)
00035610 Hogan, W.H.; Bowers, R.C. (1969) Residue Data for Diphenamid and
Desmethyldiphenamid on Peaches: Report No. 112-9760-35. (Un-
published study including report no. 112-9760-34, received Jun
12, 1970 under OF0933; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:091592-0)
00035611 Staten, F.W.; Hogan, W.H.; Holifield, E.L.; et al. (1969) Residue
Data for Diphenamid on Peanuts. (Unpublished study including
report nos. 112-9760-40, 112-9760-41, 112-9760-39..., received
Jun 12, 1970 under OF0933; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:091592-P)
00035612 Wardowski, W.F. (1969) Residue Determination for Diphenamid on Ap-
ples: Report No. 112-9760-10. (Unpublished study received Jun
12, 1970 under OF0933; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:091592-Q)
00035647 Holifield, E.L.; Niedbalski, J.F.; Hogan, W.H.; et al. (1968) Res-
idue Determination for Diphenamid, DNBP and Desmethyl diphenamid
on Peanuts: Report No. 116-9760-36. Includes method dated Mar
2, 1964. (Unpublished study including report nos. 116-9760-30,
116-9760-28, 116-9760-44..., received Jun 13, 1970 under OF0933;
submitted by Upjohn Co., Kalamazoo, Mich.; CDL:091593-A)
112
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diphenamid Standard
MRID CITATION
00035648 Wardowski, W.F.; Holifield, E.L.; Niedbalski, J.F.; et al. (1969)
Residue Determination for Diphenamid on Soybeans: Report
No. 112-9760-32. (Unpublished study including report nos. 112-
9760-17, 112-9760-2, 112-9760-5..., received Jun 13, 1970 under
OF0933; submitted by Upjohn Co., Kalamazoo, Mich.; CDL-.091593-B)
00035649 Chambers, E.E.; Staten, F.W.; Holifield, E. (1968) Residue Study--
Sweet Potatoes. (Unpublished study including report no. 112-
9760-1, received Jun 13, 1970 under OF0933; submitted by Upjohn
Co., Kalamazoo, Mich.; COL-.091593-C)
00043703 Boyack, G.A.; Lemin, A.J.; Staten, F.W.; et al. (1966) Determina-
tion of N,N-Dimethyl-2,2-diphenyl acetamide (Diphenamid) in plant
tissues using gas-liquid chromatography. Journal of Agricultur-
al and Food Chemistry 14(3):312-314. (Also in unpublished sub-
mission received Feb 21, 1968 under 8F0708; submitted by Upjohn
Co., Kalamazoo, Mich.; CDL:093015-A)
00053607 Schulz, J.E.'(1968) Cataractogenic Studies .(Leghorn Chickens).
(Unpublished study received on unknown date under unknown admin.
no.; submitted by ?; CDL-.105547-B)
00073539 Upjohn Company (1968) Residues: Enide SOW in Sweet Potato Plants.
(Compilation; unpublished study received Nov 1, 1965 under
1023-23; CDL:024408-C)
00075382 Woodard, M.W.; Woodard, G.; Cronin, M.T.I. (1966) Diphenamid Safety
Evaluation by Dietary Feeding to Dogs for 103 Weeks. Final
rept. (Unpublished study received Jan 29, 1967 under 7F0585;
prepared by Woodard Research Corp., submitted by Upjohn Co.,
Kalamazoo, Mich.; CDL:090749-D)
00076383 Woodard, M.W.; Woodard, G.; Cronin, M.T.I. (1966) Diphenamid:
Three-generation Reproduction Study in Rats. (Unpublished study
received Jan 29, 1967 under 750585; prepared by Woodard Research
Corp., submitted by Upjohn Co., Kalamazoo, Mich.; CDL:090749-E)
00077881 Johnston, R.L.; Schwikert, R.S.; Ceru, J.G. (1960) .Letter sent to
E.S. Feenstra dated Nov 10, 1960: U-4513 (acetamide, N,N-di-
methyl-2,2-dipheny1-) powder and 0.1% suspension. (Unpublished
study received Nov 8, 1965 under unknown admin, no.; submitted
by Upjohn Co., Kalamazoo, Mich.; CDL:109751-C)
00077893 Eberts, F.S.; Weeks, R.C.; Vliek, R.W. (1964) Letter sent to A.A.
Forist dated Feb 21, 1964: Metabolism of C14-labeled Enide in
the rat. (Unpublished study received Nov 8, 1965 under unknown
admin, no.; submitted by Upjohn Co., Kalamazoo, Mich.; CDL:
109751-P)
113
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diphenamid Standard
MRID CITATION
00083606 DuBois, K.P.; Kinoshita, F. (1965) The Acute Toxicity of Bayer
37289 in Combination with Other Anticholinesterase Agents to
Adult, Female Rats: Submitter 15983. (Unpublished study re-
ceived Apr 7, 1970 under OF0869; prepared by Univ. of Chicago,
Dept. of Pharmacology, submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:091498-U)
00093606 Upjohn Company (1967) Metabolism of Diphenamid: Summary, and Dis-
cussion. Summary of studies 090751-C through 090741-1. (Un-
published study received on unknown date under 7F0585; CDL:
090751-A)
00093608 Lemin, A.J. (1966) Absorption, translocation, and metabolism of
diphenamid-l-C14 by tomato seedlings. Journal of Agricultural
and Food Chemistry 14(2):109-111. (Also in unpublished sub-
mission received Jan 29, 1967 under 7F0585; submitted by Upjohn
Co., Kalamazoo, Mich.; CDL:090751-D)
00093609 Go.lab, T.; Herberg, R.J.; Parka, S.J.; et al. (1966) The metabolism
of carbon-14 diphenann'd in strawberry plants. Journal of
Agricultural and Food Chemistry 14(6):592-596. (Also in un-
published submission received Jan 29, 1967 under 7F0585; sub-
mitted by Upjohn Co., Kalamazoo, Mich.; CDL-.090751-F)
00093614 Upjohn Company (1967) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method
Used: Diphenamid in Strawberries. (Compilation; unpublished
study received on unknown date under 7F0585; CDL:090750-B)
00105710 Johnson, W.; Griggs; Turner (1975) Residue Data on Trifluralin and
Diphenamid When Trefmid Plus Dymid Is Preplant Soil Incorporated
for Weed Control in Direct-seeded Tomatoes. (Unpublished study
received Apr 28, 1975 under 1471-68; submitted by Elanco Prod-
ucts Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:
101101-A)
00106180 Mobay Chemical Corp. (1976) Addition No. 1 to Brochure Entitled:
Sencor: Residue Chemistry on Tomatoes: Document No. AS76-549.
(Compilation; unpublished study received May 6,-1976 under
6F1783; CDL:095907-A)
00114560 Johnston, R.; Ceru, J. (1963) Study: N,N, Dimethyl-2,2-diphenyl-
acetamide Toxicity to Rats: U-4513. (Unpublished study
received Feb 8, 1963 under 1023-23; submitted by Upjohn Co.,
Kalamazoo, MI; CDL:005458-B)
114
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diphenamid Standard
MRID CITATION
00114566 Upjohn Co. (1965) Study: Diphenamid Residue on Specified Crops.
(Compilation; unpublished study received Mar 8, 1965 under 1023-
23; CDL-.005471-A)
00114570 Upjohn Co. (1969) Residues of Diphenamid in Potatoes and Other
Crops. (Compilation; unpublished study received Dec 12, 1969
under 1023-23; CDL:005478-B)
00114575 Upjohn Co. (1967) Toxicity of Enide to Mice and Other Subjects.
(Compilation; unpublished study received May 16, 1968 under
1023-45; CDL:005487-G)
00114577 Upjohn Co. (1969) Residues: Summary and Discussion: Enide.
(Compilation; unpublished study received Jan 8, 1969 under
1023-45; CDL:005489-H)
00114585 Upjohn Co. (1965) Summary of Analyses for Diphenamid Residue.
(Compilation; unpublished study received Jul 1, 1967 under
8F0627; CDL:090820-A)
00114586 Upjohn Co. (1968) Residues of Diphenamid in Cattle, Milk and
Other Products. (Compilation; unpublished study received
Jul 22, 1968 under 8F0708; CDL:091227-A)
00114588 Upjohn Co. (1958) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method
Used: Diphenamid. (Compilation; unpublished study received
Jul 22, 1968 under 8F0708; CDL:091227-C)
00114590 Elanco Products Co. (1968) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method Used: Diphenamid. (Compilation; unpublished study
received Oct 30, 1968 under 8F0717; CDL:091240-A)
00114594 Upjohn Co. (1967) Diphenamid Residue Analyses in Various Crops.
(Compilation; unpublished study received Aug 15, 1967 under
7F0585; CDL:092873-B)
00114600 Upjohn Co. (1965) Requests for Registration of Enide (Diphenamid):
Book II. (Compilation; unpublished study received Feb 10, 1965
under 1023-23; CDL:101552-A)
00114601 Upjohn Co. (1964) Supplement: Residue Determinations: Request for
Registration of Enide (Diphenamid). (Compilation; unpublished
study received Jan 20, 1964 under 1023-23; CDL:101553-A)
115
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diphenamid Standard
MRID CITATION
00114602 Upjohn Co. (1966) Residues of Diphenamid in Raspberries. (Com-
pilation; unpublished study received May 17, 1966 under 1023-23
CDL:101562-A)
00114613 Crabtree, R. (19??) To Establish a Technique for Handling Radio-
active Diphenamid in the Growth Room: Experiment G33:54. (Un-
published study received on unknown date under unknown admin.
no.; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, IN; CDL:120270-E)
00133452 Staten, F. (1963) Determination of N,N-dimethyl-2,2-dipheny1-
acetamide in Tomato Using Gas Liquid Chromatography. (Unpub-
lished study received Mar 7, 1963 under unknown admin, no.;
submitted by Upjohn Co., Beaver Falls, PA; CDL:120231-A)
00138963 Johnson, W.; Finley, M. (1930) Handbook of Acute Toxicity of Chem-
cals to Fish and Aquatic Invertebrates. By U.S. Fish and Wild-
life Service. Washington, D.C.: USFWS. Resource publication
137,
00157344 Repenthin, W. (1986) Hydrolysis of N,N-dimethyl-2,2-diphenyl- .
acetamide (Diphenamid) at pH 1 and 13 at 25[Degrees]C and at pH
5,7 and 9 at 49[Degrees]C: Bericht Nr. APC 06/85. Unpublished
study Schering AG. 20 p.
40200701 Schultz, D.; Tweedy, G. (1972) The Effect of Light and Humidity
on Absorption and Degradation of Diphenamid in Tomatoes.
J. Agr. FoodChem., (20:1) 10-13.
116
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OMB Approval No. 2000-0453 (Expires 12-31-83)
FIFKA SECTION 3(C)(2){B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
CD 1. I will submit data in a timely 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 Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into an 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
G 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
117
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OMB Approval No. 2000-0468 (Expires: 12-3 1-83.
8'
CERTIFICATION OF ATTEMPT TO ENTER i
INTO AN AGREEMENT WITH OTHER REGISTRANTS i
(To qualify, certify ALL four items) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent .the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
i
'
.
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to erne: jj
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required j
items or data: •
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(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(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) 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(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8580-6 (11X82)
118
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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
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
.ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
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 comp lying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRI-D Numbers
Assigned
119
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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
§138.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corros ion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicityj rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
•
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
_
120
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CMB Approval No. 2000-0468
Expiration [fete 5/31/86
ATTACHMENT D
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Nunber:
Registrant's Name: .
and Address:
As an authorized representative of the registrant of the product
identified above, I certify that:
»
(1)1 have read and am familiar with the terms of the Notice fron EPA
dated concerning a requirement for submission of generic data
on the active Ingredient naned under PIPRA sec. 3(c)(2)(B).
(2) Hy 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 PIPRA sec. 3,
and which is purchased by us frcm another producer.
v
(3) An accurate Confidential Statement of Formula (CSF) for the
above Identified product Is attached to this statement. That formula
statement Indicates, by company name, registration number, and product
name, the source of the subject active Ingredient In my firm's product,
OR
The CSP 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
Viy 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 falls
to comply with the undertakings made in this Statement, my firm's product's
registration may be suspended under PIPRA sec. 3(c)(2)(B).
Registrant's authorized representative:
Signature
Dated: • •
(Typed;
121
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