&EPA
United SUtw
Environmental Protection
Agency
Office of
Pwticidw and Toxic Subcttnow
Wmhington OC 20460
December 1987
PmticidM
Guidance for the
Reregistration of
Pesticide Products
Containing
Phosphamidon
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PHOSPHAMIDON
(018201)
AS THE ACTIVE INGREDIENT
Case Number 157
CAS 13171-21-6 [(E-+(Z)-isomers]
CAS 23783-98-4 [(Z)-isomer]
CAS 297-99-4 [(E)-isomer]
December 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C.
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TABLE OF CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
C. Registration History
III. Agency Assessment 7
A. Summary Science Findings
B. Summary of Data Gaps
C. Preliminary Health Risk Assessment
D. Environmental Profile
E. Tolerance Reassessment
IV. Regulatory Position and Rationale 23
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Labeling
V. Products Subject to this Standard 33
VI. Reguirement for Submission of Generic Data 35
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI reguirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions uipon suspension or
cancellation
VII. Reguirement for Submission of Product-Specific Data . . 41
VIII. Requirement for Submission of Revised Labeling 42
IX. Instructions for Submission 42
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C (not applicable for this Standard)
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
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration system in an environment,
such as a terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
111
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OES Office of Endangered Species, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
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 the Federal insecticide,
Fungicide, and Rodenticide Act (FIFRA). The Standards are
applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Rach registrant of a product containing an active ingredient
subiect to this standard who wishes to continue to sell or
distribute that product must bring his product and lableing
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 produces in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess
the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criteria of
FIFRA. In its review, EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been required
when the product was initially registered or may be needed to
replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the
product is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^-, focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of a conclusion from available
data in its files pertaining to the pesticide active ingredient
(a.i.). However, during the review of these data, the Agency is
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M Street SW., Washington, DC 20460.
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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 mav 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 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 Canel 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 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.
EPA has authority under the Data Call-in (DCI) provision
of FIFRA section 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
Registration standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide. These data are
listed in Tables A, B, and c 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.
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Reqistrants are reminded that FIFRA section 6(a)(2)
requires them to submit factual information concerning possible
unreasonable adverse effects of a pesticide at any time that they
become aware of such information. You should notify the Agency
of anv 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 Aqency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered, by this Registration
Standard:
Common Name: Phosphamidon
Chemical Name: 2-chloro-3-(diethylamino)-l-methyl-3-
oxo-1-propenyl dimethyl phosphate
Other Chemical Nomenclature: dimethyl phosphate ester
2-chloro-N,N-diethyl-3-
hydroxycrotonamide;
2-chloro-2-diethylcarbamoyl-
1-methylvinyl dimethyl
phosphate;
0,0-dimethyl-0-(2-chloro-
2-diethylcarbamoyl-l-
methylvinyl) phosphate
Trade Names: Apamidon; C570; Ciba 570; Dimecron; Dixon;
Dimenox
Chemical Class: Organophosphate
Empirical Formula:
CAS Registry Nos.: 13171-21-6 [ (E)-+( Z)-isomers]
23783-98-4 [(Z)-isomer]
297-99-4 [(E)-isomer]
Shaughnessy No. : 018201
Physical/chemical properties of pure phosphamidon and
of the technical phosphamidon.
Color: Colorless (PAI*),'
Slightly amber oil (T*)
Physical State: Liquid (PAI)
Odor: odorless, faint, mild (PAI)
Melting Point: Liquid at room temperature
*PAI = Pure Active Ingredient, T = Technical
4
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Boiling Point: 160 °C, 1.5 mm (PAI)
Density: 1.2 at 20 °C (PAI)
Solubility: Miscible with water, alcohol,
and ketones. Highly soluble
in aromatic and chlorinated
hydrocarbons, esters and ethers.
Solubility in hexane is
3.23 g/100 g 25°C (PAI)
Vapor Pressure: 2.5 x 10~5 mm Hg at 20 °C (PAI)
Octanol/water partition Coefficient: Log P = 0.8 (PAI)
Stability in water:
Half-life at 2 ppm and 38 °C
is 70 hours at pH 9.1 and
> 300 hours at pH 1.1 (PAI).
Half-life (in days) of
phosohamidon in buffered
media (T):
PH
4
7
10
Temperature
23 °C 45 °C
74 6.6
13.8 2.1
2.2 0.14
B. Use Profile
Phosphamidon is a systemic organophosphate insecticide/
acaricide registered for use to control many insects, primarily
aphids, leafminers, and mites. Registered sites include a variety
of field, fruit and vegetable crops, with the predominate uses on
apples, potatoes, walnuts and tomatoes.
Usage information indicates that about two-thirds of
the phosphamidon used in the United States is applied to apples.
The second major use, approximately one-fifth, is on potatoes,
with walnuts third, and in decreasing volume, tomatoes, cauli-
flower, and broccoli. Other uses account for less than 0.3
percent individually.
Phosphamidon is marketed as an 8 Ib ai/gal SC/L
(soluble concentrate/liquid), and is formulated from a single
89.5% technical product. Phosphamidon is applied by ground
and aerial application.
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C. Registration History
Phosphamidon was first registered for use in the U.S.
in 1963 by Ciba-Geigy as a 89.5% technical product. It exists
as a mixture of 70% (Z) isomer (beta isomer) and 30% E (alpha
isomer). The Z isomer is the most active insecticidally.
There are nine federally registered products (1 technical and 8
end-use products), two Special Local Need [FIFRA §24(c)]
registrations, and five intrastate registrations containing
phosphamidon as a single active ingredient.
The Agency has classified all phosphamidon end-use
liquid formulations of 75% and greater and all dust formulations
1.5% and greater as Restricted Use pesticides, based on acute
dermal toxicity and residue effects on mammalian and avian
species. However, no dust formulation products are currently
registered.
The Agency has issued three Data Call-in Notices (DCIs)
under FIFRA §3(c)(2)(B) on phosphamidon. In September 1981, EPA
issued a combined DCI which was a result of the Agency's ongoing
DCI Program for chronic data (chronic feeding, reproduction, and
teratogenicity). The second DCI was issued in May 1984 for
environmental fate data (hydrolysis, photodegradation in water
and soil; aerobic soil metabolism, anaerobic aquatic metabolism,
mobility, field dissipation) and product chemistry data (water
solubility, octanol/water partition coefficient). The third DCI
was issued in February 1985 for foliar and soil dissipation data,
and dermal and inhalation exposure studies.
The registrant has submitted data in response to the
DCI Notices of September 1981 and May 1984. Soil dissipation
and foliar dislodgeable residue studies requested in the February,
1985 DCI have been submitted. The dermal and inhalation exposure
studies required under this DCI have been waived.
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III. AGENCY ASSESSMENT
A. SUMMARY SCIENCE FINDINGS
1. Toxicology
The following is a summary of scientific findings
based on the available toxicity data on phosphamidon:
Acute Effects
The Agency has no valid acute toxicity studies for
phosphamidon. All of the acute toxicity studies are therefore
required.
Subchronic Effects
The Agency has no valid subchronic studies for
phosphamidon. However, since a valid 2-year rat feeding study is
available, a subchronic oral toxicity study in a rodent species
is not required. A subchronic oral toxicity study in a nonrodent
species and a subchronic 21-day dermal study are required.
Chronic Effects
A 2-year rat feeding study showed toxic signs
of cholinesterase inhibition activity in serum and brain,
decreased body weights, erythrocyte counts, hemoglobin levels
and necrotic changes in the stomach and other organs. A NOEL for
chronic toxicity in rats was 1.0 ppm (O.'OS mg/kg/day) and the LEL
was 30 ppm (1.5 mg/kg/day). Studies on the toxic effects of
phosphamidon in nonrodent species are not available. A 1-year
feeding study in a nonrodent species is required.
Oncogenicity
The available oncogenicity studies for phosphamidon
include a rat oncogenic study (the 2-year rat feeding study
is considered to be an acceptable oncogenic study) and National
Cancer Institute (NCI) bioassays with rats and mice. The NCI
mouse and rat bioassays were not conducted in accordance with
the guideline requirements for an oncogenicity study and are
therefore not adequate to satisfy the mouse onocogenicity data
requirement. An oncogenicity study in the mouse is required.
Developmental Effects (Teratogenicity)
Sufficient data are available that allows the
Agency to conclude that phosphamidon did not demonstrate any
significant developmental toxic effects in the rat and rabbit.
No additional data are required.
Reproduction
Based upon a 2-generation rat reproduction study,
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the parental NOEL was shown to be 30 ppm (1.5 mg/kg/day) and the
reproductive/developmental NOEL as 5 ppm (0.25 mg/kg/day).
Additional data are not required.
Mutagenicity
No data are available to evaluate the mutagenic
potential of phosphamidon. Gene mutation, chromosomal aberration,
and direct DNA damage studies are required.
Metabolism
No data on the metabolic pathway of phosphamidon
are available. A metabolism study is required.
Worker Exposure
The use of phosphamidon poses risks to mixers,'
loaders, applicators, and .persons reentering treated fields.
Exposure may be by dermal, inhalation, and ocular routes of
entry. Federally registered end-use phosphamidon products do not
currently have any reentry restrictions or require protective
clothing. The Agency is specifying label language which requires
the use of protective clothing and imposes an interim 48-hour
reentry interval until required data are reviewed, evaluated and
the Agency announces any change in its position.
2. Ecological Effects
The following is a summary of scientific findings
based on the available ecological effects data on phosphamidon:
Avian Species
Phosphamidon is acutely and subacutely very highly
toxic to a variety of avian species and can be lethal to birds
through dermal exposure. Avian reproduction and field studies
are required to assess the effect on nontarget organisms. In
addition, available information indicate that delayed mortality
of birds occurs after applications of phosphamidon (in some cases
up to several weeks). Since available information suggests that
phosphamidon may have a relatively short 'half-life, it follows
that some degradate of phosphamidon may be a bird toxicant.
Acute and subacute studies on each major degradate of phosphamidon
are required.
Aquatic Organisms
Based upon the available fish and wildlife data,
technical phosphamidon is very highly toxic to both coldwater
and warmwater fish species, aquatic invertebrates, and mammals.
Additional data are required to assess the potential impact on
aquatic organisms.
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Nontarget Insects
Available data indicate that phosphamidon is highly
toxic to honey bees, predaceous mites, parasitic wasps, and
predaceous beetles. Additional data are not required under this
Standard.
Endangered Species Considerations
The Agency has evaluated the risk phosphamidon
poses to endangered species and the previously issued biological
opinions prepared by the Department of the Interior's Office of
Endangered Species (OES) for pesticides used on apples, citrus
and other fruits, vegetables, and cotton. Based on .the Agency's
evaluation, it appears that phosphamidon use on apples, citrus and
other fruits and vegetables, and cotton may result in sufficient
exposure to pose a potential hazard to certain endangered species
of mammals, birds, aquatic invertebrates, insects, reptiles,•
and plants (based on the loss of pollinators). Refer to PR Notice
87-5 for endangered species labeling for the use of phosphamidon
on cotton. Based on jeopardy opinions received for pesticides
having similar use patterns, assumptions of jeopardy have been
made for additional non-target species for various fruit and
vegetable uses of phosphamidon. Should the Office of Endangered
Species concur in an assumption of jeopardy, appropriate labeling
will be required.
3. Environmental Fate
Available environmental fate data on phosphamidon
are insufficient to fully assess the environmental fate of and
the exposure of humans and nontarget organisms to phosphamidon,
including the extent of groundwater contamination, phosphamidon
persistence in the environment, and the need for crop rotational
label restrictions.
4. Tolerance Reassessment
Because of extensive residue chemistry and
toxicology data gaps, the Agency cannot complete a tolerance
reassessment.
B. SUMMARY OF DATA GAPS:
The Agency has identified missing data necessary for
use in evaluating the human and environmental risks associated
with the use of phosphamidon. A summary of those data gaps is
given below. please note, this is only a summary and complete
details can be obtained by referring to the data tables in
Appendix I. These data must be developed and submitted in order
to maintain registrations of existing -products or to register any
new products containing phosphamidon.
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Toxicology
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye irritation
Primary Dermal Irritation
Dermal sensitization
Acute Delayed Neurotoxicity (Hen)
Subchronic 90-day feeding (nonrodent)*
Subchronic 21-Day Dermal
Chronic Toxicity (nonrodent)
Oncogenicity (mouse)
Mutagenicity (Gene Mutation, Chromosomal Aberration
and Direct DNA Damage and Repair Studies)
Metabolism (rats)
Environmental Fate/Exposure
Hydrolysis
Phot©degradation
In water
In soil
In air
Metabolism
Aerobic Soil
Anaerobic Soil
Mobility
Leaching and Adsorption/D-esorption
Laboratory Volatility
Field Volatility
Dissipation Studies - Field
Soil Dissipation
Confined Accumulation Study
Fish Accumulation Study
Reentry Protection
Foliar Dissipation
Spray Drift
Droplet Size Spectrum
Drift Field Evaluation
Ecological Effects
Acute Avian Oral Toxicity (Degradate)
Acute Avian Dietary Toxicity (Degradate)
Avian Reproduction
Avian Field Testing (Mammals, Birds)
Special Avian Testing (Dermal Toxicity)
Acute Toxicity to Estuarine and Marine Organisms
Fish Early Life stage and Aquatic Invertebrate
Life Cycle
Aquatic Residue Monitoring
* Not required if an acceptable chronic study is submitted,
10
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Residue Chemistry
Nature of Residues (Plants, Livestock) .....
•Residue Analytical Method (Plant, Animal) ^
Storage Stability
Magnitude of Residues (Field crop) ,.,
Product Chemistry
All product chemistry studies
C. PRELIMINARY HEALTH RISK ASSESSMENT
Numerous data gaps exist for phosphamidon and few ,>,....
definitive conclusions can be made pending receipt of additional
data. The following preliminary health risk assessment is -based
on the data available.
1. Acute Toxicity
There are no acute toxicology studies available lor..-
technical phosphamidon. Phosphamidon is an organophosphate :
insecticide whose primary mechanism of action is an inhibitioi^of.
cholinesterase activity. Technical phosphamidon is currently.,. :.
labeled as a Toxicity category I pesticide. A precautionary ..
statement on the label states that phosphamidon is "Rapi'dly ,. .
absorbed through skin". The lack of acute toxicity studies
precludes the Agency from determining at this time the atmte tQx'ic
effects or from refining further the toxicity category far this ~,.
product. Therefore, the currently assigned Toxicity category "i-., T,
will be retained until acute data for phosphamidon are receive^.-^
and evaluated.
2. Subchronic Toxicity
There are no subchronic feeding data p^er se:: a ^~:
available. However, these data requirements may be sati^fied^ 7^'."
with adeauate chronic feeding studies. Subchronic derma'i '*^,^-
(90-day) and subchronic inhalation studies are not required =^
at this time since the Agency has determined that the existing"" . •„
acceptable end-uses of phosphamidon should not result in repealed
human skin contact for extended periods or repeated inhalatiop . ^
exposure. The requirement for a subchronic neurotoxicity stu.dy.1"
is reserved pending the results of the required acute neuro- "srl:r
toxicity study. A subchronic dermal (21-day) study is requir^. ,
3. Chronic Toxicity
The only chronic feeding study available to the .:
Agency is a 2-year rat feeding study. In this study Sprague-%,? , ;
Dawley rats (60 animals/sex/dose level) were fed diets '
0, 1.0, 30.0, or 80.0 parts per million (ppm) of technical
qrade phosphamidon for a two (2) year period. The findings
11
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observed in the low-dose group (1.0 ppm) were generally similar
to those of the controls. In the mid-dose (30.0 ppm) and high-dose
(80.0 ppm) groups the statistically significant (p £ 0.05 to
0.01) findings included the inhibition of cholinesterase activity
in brain and serum, and toxic signs (muscle tremors, irritability)
associated with the cholinesterase inhibition activity decreased
body weights, erythrocyte counts, hemoglobin levels and hematocrit
values, and increased leucocyte and platelet counts: increased
number of animals with Howell-Jolly bodies in erythrocytes;
increased incidence of ulcerated, thickened, or swollen footpads
and hyperkeratotic dermatitis in the tail, accompanied by
degenerative changes in the draining lymph nodes and inflammation
at distal sites; increased incidence of hepatocellular degeneration/
necrosis, mucosal erosion and hyperplasia of the stomach (high-dose
males); peribronchial inflammatory infiltration/nodules and
pneumonitis (high-dose males): peribronchial'pneumonia (high'-dose
females); and increased iacidence of ophthalmologic findings
(cataracts, subcapsular opacity, and atrophy of the iris) in the
high-dose groups.
The No Observed Effect Level (NOEL) for chronic
toxicity in rats was 1.0 ppm (0.05 mg/kg/day) and the Lowest Effect
Level (LEL) was 30.0 ppm (1.5 mg/kg/day) for the cholinesterase
inhibiting effect.
Studies on the effects of phosphamidon on a nonrodent
"species are not available. A 1-year feeding study in a nonrodent
species is required.
;/4. Oncogenicity
The available oncogenicity studies for phosphamidon
include ajrat oncogenic study (the 2-year rat feeding study
presented"above under Chronic Toxicity is considered to be an
acceptable oncogenic study) and National Cancer Institute (NCI)
bioassays with rats and mice. The NCI mouse and rat bioassays
were not.conducted in accordance with the guideline requirements
for an oncogenicity study and are therefore not adequate to satisfy
the mouse onocogenicity data requirement. An oncogenicity study
in the mouse is required.
In the rat oncogenicity study,. Sprague-Dawley rats
were orally dosed at 0, 1.0, 30.0 or 80.0 ppm of technical grade
phosphamidon for 2 years. As discused above under Chronic
Toxicity, several toxic signs and mortality were observed and
it appeared that the maximum tolerated dose (MTD) was reached.
In the male rats, there was an increased incidence
of -transitional cell carcinoma in the bladder, adrenal cortical
adenoma, and hepatocellular carcinoma when the treated animals
Were-compared with the controls. In the female rats, there was
a dose-related increased incidence of granulosa-theca cell
12
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tumor in the ovary. The incidence* of these neoplasms was as
follows:
Phosohamidon (ppm)
Bladder: Transitional
cell carcinoma
Adrenal: Cortical
adenoma
Liver: Hepatocellular
carcinoma
Hepatocellular
adenoma
Combined
Ovary: Granulosa-theca
cell tumor
0
0
1/80
1/80
2/80
3/80
2/80
(1.
(1.
(2.
(3.
(2.
2)
2)
5)
7)
5)
1
.0
0
3/70
1/68
2/68
3/68
2/70
(4
(1
(2
(4
(2
.3)
.5)
.9)
.4)
.9)
30
1/68
3/70
5/70
3/70
8/70
3/70
.0
( 1
( 4
( 7
( 4
(11
( 4
.5)
.3)
.1)
.3)
.4)
.3)
80
3/77
5/79
5/80
2/80
7/80
5/80
.0
(3.9)
(6.3)
(6.2)
(2.5)
(8.7)
(6.2)
The Agency's preliminary statistical analysis (using
the Cochran-Armitage test, not adjusted for survival) indicated
that there was no statistical significance to the incidence of
adrenal cortical adenoma and ovarian granulosa-theca cell tumor.
However, significant trends were noted in hepatocellular carcinoma
and transitional cell carcinoma of the bladder.
Because of the low incidence of the above neoplasms
and the lack of a dose relationship in the case of some neoplasms,
the Agency concluded that the oncogenic potential of phosphamidon
could not be assessed adeauately without considering the historical
control data. Therefore, the Agency requested those data and they
are currently underqoing Agency review.
In the NCI bioassays Osborne-Mendel rats were fed
technical ohosphamidon in the diet for 80 weeks and then were
observed without phosphamidon administration for 30 or 31 weeks
before being sacrificed. B6CF1 mice were fed diets containing
phosphamidon as follows: low-dose males, 71 weeks on the phosphamidon
diet and 19 weeks observation without phosphamidon administration;
high-dose males, 62 weeks on the phosphamidon diet and 28 weeks
observation without phosphamidon administration; low-dose and
high-dose females, 80 weeks on the phosphamidon diet and 10 or 11
weeks observation without phosphamidon administration. The levels
of phosphamidon fed to each species were 0, 80, and 160 ppm. Fifty
males and fifty females per dose level were assigned to the treated
groups, but only 10 males and 10 females were in the control groups.
No hepatocellular carcinomas were observed in the
male rats in the NCI study. The incidence of cortical adenoma of
the adrenal in male rats in the low-dose group (6/49) was
significantly higher (p = 0.023) than that in the control group
* incidence = Number of neoplasms observed/number of tissues
examined and (percent).
13
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(0/8) but was not significant in the high-dose group (2/49).
Therefore, the occurrence of these tumors was not considered to
be related to the administration of the test chemical. Transitional
cell carcinoma of the bladder was observed only in one high-dose
male (1/47). Single incidences of ovarian granulose cell tumor
were observed in both the mid-dose (1/49) and high dose (1/49)
females. No tumors occurred at a higher incidence in mice dosed
with phosphamidon than in the controls.
Technical phosphamidon was not considered to be
oncogenic to Osborne-Mendel rats nor to B6C3F1 mice in the NCI
bioassay. However, the Agency considers these studies to be
inadequate to assess the oncogenic potential of phosphamidon.'
5. Developmental Effects (Teratogenicity)
The three available teratology studies (two in the
rat and one in the rabbit) satisfy the teratology data requirements
for phosphamidon.
In one rat study, phosphamidon was administered
orally at doses of 0, 1, 2, or 4 mg/kg. A developmental NOEL of
2 mg/kg was based on significantly increased incidences of runts
and fetuses with one or more malformations in the 4 mg/kg group
compared to the controls. Visceral malformations were not observed
in this study. The maternal NOEL was reported to be 1.0 mg/kg.
It was concluded that phosphamidon did not demonstrate significant
developmental toxic effects in this study. In the second rat
study, phosphamidon was administered orally at doses of 0, 0.5,
2, 4 or 6 mg/kg. A developmental NOEL 2.0 mg/kg and a maternal
NOEL of 0.5 mg/kg were reported. The developmental effects were
attributed to maternal toxicity. No significant developmental
toxic effects were observed in fetuses from treated dams.
In an acceptable rabbit (New Zealand strain) study,
the animals were treated with phosphamidon technical by gavage on
days 6 through 18 of gestation at doses of 0, 1, 3, or 10 mg/kg.
Phosphamidon had no effect on maternal survival, clinical signs,
fetotoxic effects and other parameters examined. However, rabbits
treated at rates of 0, 2, 4, 8, and 12 mg/kg in a range finding
study displayed maternal effects (death, hemorrhagic foci throughout
the stomach) at the 12 mg/kg treatment level. Maternal toxicity
was therefore established at the 10 mg/kg level, maternal NOEL
at 3 mg/kg, and maternal LEL of 10 mg/kg. At this dosing level
significantly reduced body weight gains during the treatment
period were observed when the treated animals were compared to
the controls. However, when body weights were corrected for
gravid uterine weights treated animals were not significantly
different from the controls. Fetal effects were not observed, and
a developmental NOEL of > 10 mg/kg (HOT) was established.
'Based on the data described above, it was concluded
that phosphamidon did not demonstrate any significant developmental
toxic effects to rats and rabbits.
14
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6. Reproductive Effects
The available 2-generation rat reproduction study
satisfies this data requirement. Additional data are not required.
In the 2-generation reproduction study in Charles
River rats fed technical phosphamidon at levels of 0, 5, 30,
or 50 ppm, the reproductive and developmental effects included
reduced pup survival; reduced pup weights- and reduced organ
weight (liver, kidney, and testes) to brain weight ratios in the
30 and 50 ppm groups; and prolonged precoital intervals, reduced
mating indices and reduced pregnancy rates and breeding intervals
at the 50 ppm level.
This study yielded a parental NOEL of 30 ppm
(1.5 mg/kg/day) and a parental LEL of 50 ppm (2.5 mg/kg/day).
The reproductive/developmental NOEL was 5 ppm (0.25 mg/kg/da'y) and
the LEL was 30 ppm (1.5 mg/kg/day).
7. Mutagenicity
No data are available to evaluate the mutagenic
potential of phosphamidon. Gene mutation, chromosomal aberration,
and direct DNA damage studies are required.
8. Metabolism
No data are available to evaluate the mammalian
metabolism of phosphamidon. A metabolism study in the rat is
required.
9. Worker Exposure
Mixers, loaders, applicators, and persons reentering
treated fields may be exposed to phosphamidon. Although acute
toxicity data are currently unavailable, all phosphamidon products
are currently classified as Toxicity Category I. Labeling for
both the manufacturing-use and end-use products state that the
product is "Rapidly absorbed through skin". Since exposure may
be by dermal, inhalation, and ocular routes of entry, the Agency
believes that appropriate protective clothing and reentry intervals
are necessary to reduce potential risks to workers exposed to
phosphamidon.
Reentry data are generally required to assess hazards
to farm workers resulting from reentry into pesticide treated
areas. To develop a chemical specific reentry interval, studies
on toxicity, residue dissipation, and human exposure are generally
needed. Monitoring data generated during exposure studies are
used to determine the quantity of pesticide residues to which
people may be exposed after application.
15
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In 1985 the Agency required the registrants of
phosphamidon products to submit appropriate reentry studies.
A foliar dissipation study in citrus and a soil dissipation
study in potatoes received by the Agency are currently under
review. Dermal and inhalation exposure studies are normally
optional for these use patterns and have not been submitted.
After the Agency's review and assessment of the submitted foliar
and soil dissipation studies, a chemical specific reentry interval
for all agricultural uses of phosphamidon will be established.
D. ENVIRONMENTAL PROFILE
1. Environmental. Fate
Available data reviewed by the Agency are not
sufficient to fulfill the data requirements. Therefore, the
the environmental fate of phosphamidon cannot be fully assessed.
The available data suggest that phosphamidon is
readily susceptable to hydrolysis. Reported (but unconfirmed)
results indicate that hydrolysis is pH dependent with half-lives
of 4 and 14-21 days at pH's of 9 and 5-7, respectively.
Phosphamidon appears to be relatively short lived
in aerobic soil. A half-life of < 3 days was reported for metabo-
lism in a silt loam soil. N,N-diethyl-2-chloroacetoacetamide
and N-ethyl-2-chloroacetamide were identified as the two major
nonvolatile degradates, but the characterization of degradates
has not been completed. Most of the l^C from 1-vinyl and carbonyl
portions was evolved as C02 (79.6% in 60 days).
Phosphamidon residues are considered to be highly
mobile in soil. However, the relative mobilities of the parent
compound and its degradates have not been adequately defined.
Freundlich absorption coefficients were determined to be 1.36
for several soils including muck soil. Both aged (32 day aerobic)
and unaged residues of l^c-phospamidon were readily leached
(20 inches of water) from 12-inch columns of loamy sand. More
than 78% of the residues from the unaged phosphamidon were
recovered from the leachate; 69-74% of the residues were leached
through the column in the aged study.
16
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Available data are not adequate to fully assess the
potential of phosphamidon to contaminate ground water. However,
available mobility data suggests that leaching of phosphamidon
residues is possible. Limited data also indicate that the parent
compound is rapidly dissipated under field conditions but the
fate of degradates is not fully understood. When the required
data are submitted, the potential of phosphamidon and its
degradates to contaminate ground water will be reassessed.
2. Spray Drift
There are no data available to assess the hazard
to nontarget organisms (fish and wildlife, domestic animals, and
humans) caused by drift from aerial applications of phosphamidon.
Droplet size spectrum and spray drift field evaluation studies
are required to assess this concern.
3. Ecological Characteristics
Avian Species
Technical phosphamidon is very highly acutely toxic
to birds as demonstrated by both acute and dietary studies.
Acute oral toxicity tests with birds resulted in
acute toxicity values ranging from 1.5 mg/kg (sharp-tailed grouse)
to 11.8 mg/kg (Chukar). Subacute dietary studies demonstrate
that there is a .range of toxicity from 24 ppm (bobwhite quail) to
712 ppm (mallard duck). Additional data are not required.
Avian dermal toxicity studies are not normally
required. However, available data indicate that phosphamidon
can be toxic to birds through contact with head, feet or through
contact with sprayed foliage. Data indicate that small doses
picked up from perches or applied to the feet of birds can be
lethal. Doses in the range of 200 mg/kg or more caused effects
in birds. Special tests are being required to determine the
dermal toxicity of phosphamidon to birds. This special testing
is being required for both technical phosphamidon, and an
end-use formulation of the highest percent active ingredient.
Avian reproduction studies for phosphamidon are not
available. Data are required to support uses of phosphamidon on
crops with multiple applications such as cauliflower, cotton and
apples. Therefore, an avian reproduction study with an upland
species and a waterfowl species are required. Pending the results
of these and/or other special studies on birds, special avian
reproduction studies testing anticholinesterase effects of
phosphamidon on bird parental behavior and bird productivity may
be required.
17
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There are no data available on the toxicity of
degradates of phosphamidon to birds. Because delayed mortality
is an indicated adverse effect of phosphamidon on birds, and
because substantial reduction of populations of songbirds have
occurred several weeks after phosphamidon applications to forests,
it is possible that degradation products of phosphamidon can
result in such effects. Therefore, these degradates must be
identified and tested.
Aquatic Species
Acute toxicity'tests with technical phosphamidon
indicate that phosphamidon is highly toxic to fish. The 96-hour
acute toxicity for rainbow trout is 7.8 ppm, and for the bluegill
sunfish 3.4 ppm. Additional data are not required.
Acute toxicity tests with freshwater invertebr'ates
indicate that phosphamidon is very highly acutely toxic to aquatic
invertebrates. The acute toxicity values ranged from 0.012 ppb for
Simocephalus (a daphnid species) to 15 ppb for Orconectes nais
(crayfish). Additional data are not required.
There are no acceptable data evaluating the toxicity
of technical phosphamidon to estuarine and marine organisms.
Phosphamidon may reach estuarine environments from its use on
citrus orchards. Since this use has the potential to result in
significant concentrations of phosphamidon in estuarine waters
and because the technical phosphamidon is demonstrated to be very
highly-toxic to aquatic invertebrates, aquatic organisms may be
impacted. Acute studies on the toxicity of phosphamidon to
estuarine and marine invertebrates are required.
Since aauatic invertebrate life-cycle data are not
available, no conclusions can be drawn regarding the chronic
effects of phosphamidon on aquatic invertebrates. An aquatic
invertebrate life cycle study is required to support the
agricultural use applications.
Wild Mammal Toxicity
There are no adequate data'with which to assess the
toxicity of phosphamidon to mammals. The only study available,
which suqgests a lethal dose of 18 mg/kg in the deer mouse,
indicates that phosphamidon may be highly toxic to wild mammals.
Although the Agencv can draw no conclusions regarding the potential
toxicity of phosphamidon to mammals, a wild mammal toxicity study
is not being required at this time. However, if the acute mammalian
studies required in the Toxicology Section indicate a rat acute
toxicity £ 5 mg/kg, then a wild mammal toxicity study will be
required.
18
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Endangered Species
The Agency has evaluated the hazard posed by
phosphamidon to endangered species based on jeopardy opinions
prepared by the U.S. Department of the Interior's Office of
Endangered Species (OES) for pesticides used on cotton, fruits,
and vegetables. A number of listed bird and mammal species were
identified as being jeopardized by the use of phosphamidon on
cotton (refer to PR Notice 87-5 for labeling). Based on jeopardy
opinions received for pesticides with similar use patterns,
assumptions of jeopardy were made for various species of birds,
mammals, aquatic invertebrates, insects and reptiles, and plants
(based on loss of pollinators) by the use of phosphamidon on
various fruits and vegetables. Should the Office of Endangered
Species concur in this assumption of jeopardy, the Agency will
specify that product labels include appropriate labeling. There
were no endangered species impacted from the use of phosphamidon
on sugarcane.
Non-target Insects
Data from honey bee acute contact toxicity studies
indicate that phosphamidon is highly toxic to honey bees when
bees are exposed to direct application or to dried residues on
foliage. Precautionary labeling is specified for all phosphamidon
products intended for outdoor applications. Additional data are
not required.
There is sufficient information to indicate that
phosphamidon, when used at standard field rates, is generally
highly toxic to predaceous mites, parasitic wasps, and predaceous
beetles. Study requirements for testing on predaceous and
parasitic insects are currently reserved.
4. Product Chemistry
Although product chemistry data may have been
submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide consistent with new data
requirements. Previously submitted data'must be updated as
appropriate.
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E. TOLERANCE REASSESSMENT
Tolerances (expressed as phosphamidon) for residues of
the insecticide phosphamidon (2-chloro-2-diethylcabamoyl-l-methyl-
vinyl dimethyl phosphate) including all of its related.
cholinesterase-inhibiting compounds have been established in or
on various raw agricultural commodities (40 CFR 180.239).
Tolerances (ppm)
Commodity
Apples
Broccoli
Cantaloupe
Cauliflower
Citrus
(Lemons,
oranges,
tangerines,
grapefruit)
Cottonseed
Cucumbers
Peppers
Potatoes
Tomatoes
Sugarcane
Walnuts
Watermelon
U.S. Canadian1
0
0
0
0
0
0
0.1
0.25
Mexican2
MRLs
International
Codex3
1
0
0
0
0
.0
.5
.25
.5
.75
1
0
0
0
.0
.5
.25
— —
.75
0
0
0
.'5
.2
. —
__
.4
0
0
0
0
0
0
0
0.25
0.1
0.05
0.1
0.1
Canadian tolerances have not been established for residues
of phosphamidon.
Mexican tolerances are expressed in terms of phosphamidon
per se.
The Codex Maximum Residue Limits (MRL) are expressed as
residues of phosphamidon and N-desethylphosphamidon
(E- and z-isomers of each).
20
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Residue Data
The metabolism of phosphamidon in plants and
animals is not adequately understood. Residues of [l^C]
phosphamidon were identified and quantitatively determined only
in immature bean plants. No edible livestock tissues (other
than milk) were analyzed for residues, and residues were not
characterized sufficiently in livestock. No poultry data were
submitted.
The available plant metabolism data indicate that
phosphamidon degrades rapidly when applied directly to the leaves
of very young "two-leaf stage" bean plants. After 4 days, only
4 to 7 percent of the applied phosphamidon (approximately 15 ppm)
was recovered. The predominant initial metabolite is the
acetylcholinesterase-inhibitor, desethylphosphamidon, which is
formed by enzymatic cleavage of an ethyl group. Desethylphos-
phamidon is subsequently rapidly metabolized in young bean plants.
The limited available ruminant metabolism data
indicate that phosphamidon is degraded rapidly in animals, with
most of the metabolic compounds being excreted in the urine.
Phosphamidon is hydrolyzed at the phosphate-vinyl bond, forming
dimethylphosphoric acid and alpha-chloroacetoacetic acid ethyl
and diethyl amides. An additional pathway involves deethylation
to form the N-unsubstituted amide of phosphamidon followed by
reductive dehalogenation of this compound to form the dechlbri-
nated, unsubstituted amide of phosphamidon.
Data gaps exist for plant and animal metabolism
and storage stability. On receipt and review of the data
required in these sections of the registration standard, the
conclusions stated below regarding the adequacy of established
tolerances are subject to change. Furthermore, since the data
required for individual commodities are dependent on the metabolism
data, the Agency recommends that metabolism data be obtained and
submitted prior to any required residue data.
If the metabolism of phosphamidon in ruminants or
poultry differs from that in rats, then data on the metabolism
of phosphamidon in swine will also be required.
Available data support the established tolerances
for residues of phosphamidon including all of its related
cholinesterase-inhibiting compounds (as currently known) in or
on the raw agricultural commodities (RACs) potatoes, tomatoes,
cucumbers, cottonseed, and sugarcane. Note, however, that these
tolerances, including the residue definition, will be reassessed
upon receipt of the requested plant metabolism studies.
Ultimately, the tolerance definition will be changed to list
specific metabolites.
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Insufficient data are available to evaluate the
adeauacy of the established tolerances for residues in or on
broccoli, peppers, cantaloupe, watermelon, apples, oranges,
and walnuts.
•
Although insufficient data are available to
assess the established tolerances for residues of phosphamidon
in or on cauliflower, grapefruit, lemons, and tangerines, no
data are reauired for these commodities because data requested
for crops listed in the previous paragraph will be translated
to assess the tolerances. Translated data may not be used to
support a crop group tolerance.
Processing studies are required for potatoes,
oranges, apples, tomatoes, cottonseed, and sugarcane.
Insufficient data are available for residues of
phosphamidon in (i) milk; (ii) fat, meat, and meat byproducts
of cattle, goats, hogs, and sheep; or (iii) eggs, fat, meat,
and meat byproducts of poultry. There are no established or
proposed direct animal treatment uses for phosphamidon. Maximum
livestock dietary intake figures were not calculated because
there are numerous deficiencies in the residue data for the
various feed items as well as animal and plant metabolism data.
Upon receipt of these data, the need for, and the nature of the
tolerances for phosphamidon residues in livestock will be
reassessed; then the available data regarding magnitude of the
residues in livestock will be evaluated as to its adequacy to
support tolerances for residues in animal commodities.
No Canadian or Mexican tolerance or codex maximum
residue limit (MRL) exists for residues of phosphamidon in
animal products. Therefore, no compatibility questions exist
with respect to the codex MPL.
The Codex MRLs and U.S. tolerances for phosphamidon
residues in or on various commodities are expressed in different
terms. A decision on revision of the U.S. tolerance definition
is dependent upon additional plant and animal metabolism data.
Reports of regulatory incidents concerning
phosphamidon have been received from the Food and Drug Adminis-
tration (FDA); no illegal residues were detected in surveillance
monitoring samples. Phosphamidon is not included in the United
States Department of Agriculture's (USDA) National Residue
Program.
22
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Dietary Exposure
The No Observed Effect Level (NOEL) of 1 ppm
(0.05 mg/kg/day) is based on the inhibition of serum and brain
ChE activity from a 2-year feeding study in the rat. Because of
the extensive residue chemistry and toxicology data gaps, the
Agency cannot complete the dietary exposure reassessments. The
tolerances and dietary exposure will be reassessed when the
required data are submitted and evaluated.
IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions
Based on review and evaluation of all available data on
phosphamidon, the Agency has made the following determinations?
1. No referral to Special Review is being made concerning
the potential hazards to wildlife and aquatic organisms at this
time.
Rationale: The Agency is concerned over the potential
adverse impact of phosphamidon on birds, mammals and aquatic
organisms resulting from the agricultural uses of phosphamidon.
Available data indicate that phosphamidon is acutely to highly
acutely toxic to various avian, mammalian and aquatic species.
However, additional data on both technical phosphamidon and the
degradate(s) are needed before the Agency can complete a full
assessment of this concern. In the interim, as noted in this
standard, the Agency is specifying precautionary label language
to address this concern.
2. The Agency's position is that, in order for products
to remain in compliance with FIFRA, product labels must contain
language imposing a 48-hour reentry interval and requiring the
use of protective clothing for all end-use products containing
phosphamidon. Protective clothing and reentry statements are
specified in Section IV.D.
Rationale; Phosphamidon is registered for use on a
variety of agricultural sites all of which may involve hand
labor, and may pose potential dermal exposure risks to workers.
All phosphamidon products are currently classified in Toxicity
Category I, bear a statement that they are rapidly absorbed
through the skin, and are cholinesterase inhibitors. Current
labeling does not provide a reentry interval and protective
clothing is not specified. Both California and Texas have
established reentry intervals of 14 days and 2 days, respectively.
Foliar dissipation data for citrus and soil dissipation data for
potatoes are currently under review in the Agency. After these
data have been reviewed and evaluated, product specific reentry
23
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intervals for all agricultural uses will be determined. It is
the Agency's position that a 48-hour interim reentry interval is
required until these data have been evaluated and the Agency has
announced any change in its position. Likewise, appropriate
protective clothing is also needed to reduce exposure risks.
3. The Restricted Use classification for all uses of
phosphamidon liquid formulations (75% and greater) and dust
formulations (1.5% and greater) under FIFRA §162.31 will remain
in effect. In addition, a statement identifying the reasons for
the restriction are to appear on the label as specified in
Section IV.D. It is the Agency's position that affected products
must bear appropriate restricted use labeling in order to remain
in compliance with FIFRA.
Rationale; All uses of phosphamidon, whether liquid
or dust formulations, were classified for restricted use based on
the acute dermal toxicity, and residue effects on avian and
mammalian species. Although there are numerous toxicology and
ecological effects data gaps, available data are sufficient to
show that these effects are of continuing concern. In order that
the public and/or the user be aware of the reasons for the
restricted use classification, a statement identifying the reasons
for the restriction are to appear on the label as specified in
Section IV.D.
4. No tolerances or significant new food uses will be
granted until the Agency has received data sufficient to evaluate
the dietary exposure to phosphamidon.
Rationale; Available residue chemistry and toxicology
data for phosphamidon are not sufficient to reassess existing
tolerances. Plant and animal metabolism data and residue data on
various commodities are required. The pertinent toxicology data
requirements include: chronic feeding, oncogenicity, mutagenicity
and metabolism (refer to Table A for specific residue chemistry
and additional toxicology data requirements). Until these data
are submitted and reviewed, the Agency cannot perform a tolerance
reassessment.
5. In order to meet the statutory standard for continued
registration, the Agency has determined that phosphamidon products
must bear revised and updated labeling for hazards to nontarget
organisms.
Rationale; Available data show that phosphamidon is
highly toxic to birds, wild mammals, and toxic to aquatic organisms,
Other data indicate that phosphamidon is moderately to highly toxic
to the honey bee. Precautionary,label statements relative to the
potential risks posed by phosphamidon to nontarget organisms will
provide useful information to promote practices to limit such
exposure of nontarget species to this pesticide.
24
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6. The Agency has identified certain data that will
receive immediate review when submitted.
Rationale; Certain data are essential to the Agency's
a-ssessment of this pesticide and its uses and/or may trigger the
need for further studies which should be initiated as soon as
possible. The following studies have been identified to receive
priority review as soon as they are received by the Agency:
§158.125 - Residue Chemistry
171-4 - Residue Analytical Method
171-4 - Nature of Residues (Metabolism)
171-4 - Magnitude of the Residues in Plants
(field and processing studies on
apples, oranges, potatoes and
tomatoes)
§158.130 - Environmental Fate
161-1 - Hydrolysis
161-2 - Photodegradation - in water
161-3 - Photodegradation - in soil
161-4 - Photodegradation - in air
163-1 - Leaching and Adsorption/Desorption
163-2 - Volatility (Lab)
164-1 - Field Dissipation - Soil
165-1 - Confined Rotational Crop
.§158.135 - Toxicology
81-1 - Acute Oral
81-2 - Acute Dermal
81-3 - Acute inhalation
81-4 - Eye Irritation
81-5 - Dermal Irritation
81-6 - Dermal Sensitization
81-7 - Acute Delayed Neurotoxicity (Hen)
83-2 - Oncogenicity - mouse
85-1 - General Metabolism
§158.142 - Spray Drift
201-1 - Droplet Size Spectrum
202-1 - Drift Field Evaluation
25
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§158.145 - Wildlife and Aquatic Organisms
71-1 - Avian Acute Oral (Degradate)
71-2 - Avian Subacute Dietary (Degradate)
71-4 - Avian Reproduction
71-5 - Field Testing (Mammals, Birds)
70-1 - Special Avian Testing (Dermal)
72-3 - Acute Toxicity to Estuarine and
Marine Organisms
72-4 - Aquatic Invertebrate Life Cycle
70-1 - Special Testing - Aquatic Residue
Monitoring
7. While the data gaps are being filled, currently
registered manufacturing-use products (MP's) and end-use products
(EP's) containing phosphamidon may be sold, distributed, formulated
and used subject to the terms and conditions specified in this
Standard. The Agency has elected not to consider registration of
any significant new uses while data gaps are being filled and
data evaluated. Registrants must provide or agree to develop and
provide additional data, as specified in the Data Appendices in
order to maintain existing registrations.
Rationale; Under FIFRA, the Agency may elect not to
cancel or withhold registration even though data are missing or
are inadequate [see FIFRA section 3(c)(2)(B) and 3(c)(7)].
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory changes
are necessary.
26
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B. Criteria for Registration
To be registered or reregistered under this Standard,
manufacturing-use and end-use products must contain phosphamidon
as the sole active ingredient, bear required labeling, and conform
to the product composition, acute toxicity limits, and use pattern
requirements listed in this document.
C. Acceptable Ranges and Limits
1. Product Composition Standard
To conform to this Standard, manufacturing-use and
end-use products must contain phosphamidon. Each formulation
proposed for registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts of
the active and intentionally added inert ingredients present in
the product, as well as impurities found at levels greater than
0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical
grade, manufacturing-use or end-use products containing phosphamidon,
provided the product is supported by appropriate acute toxicity
data and the labeling for the product bears appropriate precautionary
statements for the toxicity category in which the product is placed.
Phosphamidon manufacturing-use and end-use products are currently
in Toxicity Category I and the appropriate signal word is DANGER.
3. Use Patterns
To be registered under this Standard, manufacturing-
use products must be labeled for formulation into other manufacturing-
use products or into end-use products bearing federally registered
uses. End-use products must bear federally registered uses.
Appendix III (Use Index) lists all federally registered uses as
well as approved maximum application rates and frequencies.
27
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The use patterns currently registered for phosphamidon
are as follows:
Terrestrial - Food Crop: apple; apple (nonbearing) ;
broccoli; cantaloupe; cauliflower? cotton; cucumber-
grapefruit; lemon; orange; peppers; potato; sugarcane;
tangerine l/; tomato; walnut- watermelon.
D. Labeling
All products must bear appropriate labeling as
specified in 40 CFR 162.10, PR Notices 83-2, 83-3, 87-5, and
below. Appendix II contains further information on label
requirements.
In order to remain in compliance with FIFRA, pe'sticide
products containing phosphamidon as the active ingredient may not
be released for shipment by the registrant after January 31, 1989
unless the product bears amended labeling that complies with the
specifications of this Standard.
In order to remain in compliance with FIFRA, pesticide
products containing phosphamidon as the active ingredient may not
be distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having been so received)
delivered or offered to be delivered by any person after January
31, 1990 unless the product bears amended labeling that complies
with the specifications of this Standard.
In addition to the above, in order to remain in
compliance.with FIFRA, the following information must appear on
the labeling of all manufacturing-use and end-use products .
Ingredient Statement
The ingredient statement for all phosphamidon
products must list the active ingredient as:
ACTIVE INGREDIENT:
Phosphamidon: 2-chloro-'3- (diethylamino)-
l-methyl-3-oxo-l-propenyl dimethyl
phosphate %
!/This use is currently registered as a Special Local Need
registration under 24(c) of FIFRA.
28
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1. Manufacturing-Use Product Labeling
a. Use Pattern Statements
In order to remain in compliance with FIFRA, all
manufacturing-use phosphamidon products must state that they are
intended for formulation into other manufacturing-use or end-use
products for acceptable use patterns. Labeling must specify
sites, which are listed in Use Patterns, Appendix III. However,
no use may be included on the label where the registrant fails to
agree to comply with the data requirements in Table A for that
u.se pattern.
b. Environmental Hazards Statement
In order to remain in compliance with FIFRA, the
following revised environmental hazard statement must appear' on
all manufacturing-use product labels:
"This pesticide is toxic to aquatic invertebrates.
Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans or
public waters unless this product is specifically
identified and addressed in an NPDES permit. Do
not discharge effluent containing this product
into sewer systems without previously notifying
the sewage treatment plant authority. For guidance
contact your State Water board or Regional Office
of the Environmental Protection Agency."
c. Protective Clothing, Equipment and Work Safety
Statements
In order to remain in compliance with FIFRA, the
following protective clothing, equipment and work safety statements
must appear on all manufacturing-use product labels:
"USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE
CLOTHING AND EQUIPMENT DURING MIXING/LOADING,
OR DISPOSAL OF THE PESTICIDE: Protective suit of
one or two pieces covering all parts of the body
except head, hands, and feet; chemical-resistant
gloves; chemical-resistant shoes (or chemical-
resistant shoe coverings or chemical-resistant
boots). In addition, mixer/loaders must wear a
chemical-resistant apron. During equipment
repair and cleaning, the protective suit need not
be worn.
IMPORTANT: If pesticide comes in contact with
skin, wash off with soap and water. Always wash
hands, face, and arms with soap and water before
smoking, eating, drinking, or toileting.
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AFTER WORK: Before removing gloves, wash them
with soap and water. Take off all work clothes
and shoes. Shower using soap and water. Wear
only clean clothes when leaving job — do not wear
contaminated clothing. Personal and protective
clothing worn during work must be laundered
separately from household articles. Store
protective clothing separately from personal
clothing. Clean or launder protective clothing
after each use. Protective clothing and equipment
that becomes heavily contaminated or drenched
must be destroyed according to State and local
regulations. HEAVILY CONTAMINATED OR DRENCHED
CLOTHING CANNOT BE DECONTAMINATED."
2. End-Use Product Labeling
In order to remain in compliance with FIFRA, all
end-use products containing phosphamidon as an active ingredient,
must bear the following labeling statements:
a. Restricted Use Statement
In order to remain in compliance with FIFRA, the
following statement must appear on the front panel of all end-use
products containing phosphamidon:
"RESTRICTED USE PESTICIDE
Due to Acute Dermal Toxicity to Humans
and
Residue Effects on Avian and Mammalian Species
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."
b. Environmental Hazards Statements
In order to remain in compliance with FIFRA, the
following environmental hazard statement must appear on the label
of all end-use products:
"This pesticide is toxic to aquatic invertebrates
and wildlife. Do not apply directly to water or
wetlands (including swamps, marshes, bogs, and
potholes). Runoff and drift from treated areas
may be hazardous to aquatic organisms in adjacent
aquatic sites. Do not contaminate water by
cleaning of equipment or disposal of wastes."
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c. Protective Clothing, Equipment and Work Safety
Statements
In order to remain in compliance with FIFRA, the
following protective clothing, equipment and work safety statements
must appear on the labeling of all end-use products containing
phosphamidon:
"USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE
CLOTHING AND EQUIPMENT DURING MIXING/LOADING,
APPLICATION, DISPOSAL OF THE PESTICIDE, AND
EARLY REENTRY INTO TREATED AREAS: Protective
suit of one or two pieces covering all parts of
the body except head, hand, and feet; chemical-
resistant gloves; chemical-resistant boots). In
addition, mixer/ loaders must wear a chemical-
resistant apron. During equipment repair and
cleaning, the protective suit need not be worn.
If overhead exposure is likely, such as when
flagging during aerial application, a hood or
wide-brimmed hat must be. worn.
(The following label statement concerning application
using an enclosed cab or cockpit is optional:
IF APPLICATION IS PERFORMED USING AN ENCLOSED
CAB OR COCKPIT, THE FOLLOWING PROTECTIVE CLOTHING
AND EQUIPMENT MAY BE WORN AS AN ALTERNATIVE:
Long-sleeved shirt and longlegged pants; shoes
and socks. Chemical-resistant gloves must be
available in the cab or cockpit and must be worn
during entry to and exit from the application
vehicle. All other protective clothing and
equipment required for use during application
must be available in the cab and must be worn
when exiting the cab into treated areas. When
used for this purpose, contaminated clothing may
not be brought back into the cab unless in an
enclosure such as a plastic bag.)
IMPORTANT! If pesticide comes in contact with
skin, wash off with soap and water. Always wash
hands, face, and arms with soap and water before
smoking, eating, drinking, or toileting.
AFTER WORK: Before removing gloves, wash them
with soap and water. Take off all work clothes
and shoes. Shower using soap and water. Wear
only clean clothes when leaving job — do not
wear contaminated clothing. Personal and
protective clothing worn during work must be
laundered separately from household articles.
Store protective clothing separately from personal
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clothing. Clean or launder protective clothing
after each use. Protective clothing and equipment
that becomes heavily contaminated or drenched
must be destroyed according to State and local
regulations. HEAVILY CONTAMINATED OR DRENCHED
CLOTHING CANNOT BE ADEQUATELY DECONTAMINATED."
d. Bee Precautionary Statements
In order to remain in compliance with FIFRA, the
following bee precautionary statement must appear on the label of
all end-use products containing phosphamidon:
"This pesticide is highly toxic to bees exposed to
direct treatment or residues on blooming crops or
weeds. Do not apply this pesticide or allow it to
drift to blooming crops or weeds if bees are'
visiting the treatment areas."
e. Reentry Interval and Protective Clothing for Early
Reentry Statements
In order to remain in compliance with FIFRA, the
following statements must appear on the labeling of all end-use
products containing phosphamidon:
Reentry Interval
"Reentry into treated areas is prohibited for 48
hours after the end of application, unless the
protective clothing specified on this label for
early reentry is worn."
Protective Clothing for Early Reentry
"FOR EARLY REENTRY INTO TREATED AREAS: Use
protective suit of one or two pieces covering
all parts of the body except head, hands, and
feet; chemical-resistant gloves; chemical-
resistant shoes (or chemical-resistant shoe
coverings or chemical-re'sistant boots)."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of-the pesticides
identified in section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing-use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases? it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing-use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The labeling requirements specified for manufacturing-
use products in Section IV.
3. 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 exemption3, the
data requirements listed in Table C (if included).
3. If not eligible for the formulator's exemption,
the data requirements listed in Table A and the data require-
ments listed in Table C (if included).
4. The labeling requirements specified for end-use
products in Section IV.
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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D. End-use products containing this pesticide as one of
multiple active ingredients are subject to:
1. The restrictions (if any) upon use, composition,
or packaging listed in Section IV if they pertain to the
end-use product.
2. If not eligible for the formulator's exemption,
the data requirements listed in Table A and Table C (if
included).
3. If eligible for the formulator's exemption, the
data requirements listed in Table C (if included).
4. The labeling requirements specified for end-use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of
a particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. who must submit generic data? '
.All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant.
who supplies the active ingredient in his product is complying
with the data request.
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration standard.
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If you are granted a generic data exemption, you rely
on the efforts of other persons to provide the Agency with
the required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a 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:
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1. You will submit the data yourself.
2. You have entered into an agreement with one or
more reqist-rants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are
generating or submitting requested data as a task force or
consortium, a representative of the group should request a
Joint Data Submitter Number from the Registration Support and
Emergency Response Branch, Registration Division. The request
must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom
EPA will correspond concerning the data;
c. Identity of the Registration standard
containing the data requirement;
d. A list of the products affected (from all
members of the consortium); and
e. Identification of the specific data that
the consortium 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 Center into a data development/cost
sharina 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.]
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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
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the
other registrant and proof of the other registrant's receipt
of your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
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 aualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by
this Notice in a timely manner. If the other registrant
fails to develop the data or for some other reason would be
subject to suspension, your registration as well as that of
the other registrant will normally be subject to initiation
of suspension proceedings, unless you commit to submit and
submit the required data in the specified timeframe. In such
cases, the Agency generally will not grant a time extension
for submitting the data.
4. You request a waiver of the data requirement.
If you believe that a data requirement does not (or should
not) apply to your product or its uses, you must provide EPA
with a statement of the reasons why you believe this is so.
Your statement must address the specific composition or use
factors that lead you to believe that a requirement does not
apply. Since the Agency has carefully considered the composition
and uses of pesticide products in determining that a data
requirement applies, EPA does not anticipate that many waivers
will be aranted. A request for waiver does not extend the
timeframes for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
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5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
recruired to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the
registration of your product(s) for which the data are needed.
E. Testing Protocols/ Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be con-
ducted 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 unapproved protocols. A request for
protocol approval will not extend the timeframe for submission
of the data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
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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
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 time-
frame 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
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and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision
is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale
or distribution; and
2. Demonstration that such a provision would be
consistent with the provisions of FIFRA.
Vir. 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 tha.t product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6. (cancellation of registration.).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA reauires 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 vou fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing-Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet"
(EPA Form 8580-1), with appropriate attachments.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)(l)(D). Refer to
40 CFR 152.80-152.99.
15 If on the Summary Sheet, you commit to develop, the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration/Amend-
ment (EPA Form 8570-1).
b. Two copies of any required product-specific
data (See Table B).
c. Product Specific Data Report (EPA Form 8580-4).
d. Three copies of draft labeling, as specified
in Chapter IV.D. Required Labeling, including
the container label and any associated
supplemental labeling. Labeling should be
either typewritten text on 8-1/2 x 11 inch'
paper or a mockup of the labeling suitable
for storage in 8-1/2 x 11 files. The draft
label must indicate the intended colors of
the final label, clear indication of the
front panel of the label, and the intended
type sizes of the text.
3. Within the times set forth in Table A, you must
submit to the Registration Division .all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing-Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachmentsS (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. Application for Pesticide Registration/Amend-
ment (EPA Form 8570-1).
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b. Three copies of draft labeling, as specified
in Chapter IV.D. Required Labeling, including
the container label and any associated
supplemental labeling. Labeling should be
either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable
for storage in 8-1/2 x 11 files. The draft
label must indicate the intended colors of
the final label, clear indication of the
front panel of the label, and the intended
type sizes of the text.
3. Within the time frames set forth in Table A, you
must submit to the Registration Division all generic data,
unless you are eligible for the formulator's exemption. If
for any reason any test is delayed or aborted so that the
schedule cannot be met, immediately notify the Product Manager
and the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End-Use Products containing the subject pesticide as,
sole active ingredient.
- 1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA
Form 8570-4).
c. Formulator's Exemption Statement (EPA
Form 8570-27), if applicable.
2. within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if
recruired by Table C (if included).
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, as specified
in chapter IV.D. Required 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
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the final label, clear indication of the front
panel of the label, and the intended type sizes
of the text.
3. Within the time frames set forth in Table A, you
must submit to the Registration Division all generic data,
unless you are eligible for the formulator's exemption. If
for any reason any test is delayed or aborted so that the
schedule cannot be met, immediately notify the Product Manager
and the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
D. End-Use Products containing the subject pesticide in
combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA
Form 8570-4).
c. Formulator's Exemption- Statement (EPA Form
8570-27), if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if
required by Table C (if included).
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data,
c. Three copies of draft labeling, as specified
in Chapter IV.D. Required 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.
45
-------
E. Intrastate Products containing the subject pesticide
either as sole active ingredient or in combination with other
active ingredients.
1. These products are being called in for full Federal
registration. Producers of these products are being sent a
letter instructing them how to submit an application for
registration.
2. In addition, within 9 months from receipt of this
document, you must submit to the Product Manager, three copies
of draft labeling, as specified in Chapter IV.D. Required
Labeling, including the container label and any associated
supplemental labeling must be submitted. 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.
F. Addresses
The required information must be submitted to the following
address:
William H. Miller (PM 16)
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 Divison
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
46
-------
I. DATA APPENDICES
47
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use productv
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format: •» - ' . ;
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product %
Any other test substances, such as metabolites, will be
'specifically named in Column 2 or in footnotos 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 a 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
r " 48
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by-
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
•
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two»required species
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to •
the table will usually say so. -
NO - EPA either possesses no data which are sufficient
.to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the .Agency has
acceptable data in its files, this column l^ists the identifying
number of-each .study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
(his 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.
" r 49
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Test
Data Requirement Substance
§158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning TGAI
Materials and Manufac-
turing Process
61-3 - Discussion of Formation TGAI
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
of Product Samples.
Physical and chemical Characteristics
Timeframe
Use Does EPA Bibliographic Must Additional for
Patterns Have Data? Citation Data Be Submitted? Submission2/
4/
All I/ I/ Yes 6 Months
5/
All I/ I/ Yes 6 Months
6/
All I/ I/ Yes 12 Months
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
All
All
All
All
All
I/
I/
i/
i/
Yes
Yes
y
I/
3
7/
Yes
Yes
i/
ZA1/
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
.GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
§158.120 Product Chemistry (cont1
Physical and Chemical
Characteristics (cont'd)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
Test
Substance
d)
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
Use Does EPA
Patterns Have Data?
All I/
All I/
All I/
All I/
All I/
All I/
All I/.
Bibliographic Must Additional
Citation Data Be Submitted?
7/
I/ Yes
. 7/
I/ Yes
7/
I/ Yes
Z/
V Yes
*7 / "1 A /
// • iU/
I/ Yes"
I/ Yes~
7/
I/ Yes
f?:ll
Timeframe
for
Submission2/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
64-1 - Submittal of Samples
TGAI, PAI
All
I/
Reserved
0 -1 3
?! cxj
C'J
Co
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.120 Product Chemistry Footnotes
I/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been imposed and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration standard, unless
otherwise indicated.
3/ If samples are needed, the Agency will reouest them. If required, samples will be due within 6 months after
notification of requirement by the Agency.
£/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate a'nd the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
5/ A detailed discussion of .all impurities that are or may be present at X).l%, based on knowledge of the begin-
ning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy* precision) must be submitted for each
analytical method used.
7/ Physiochemical characterisitics (color, physical state, odor, melting point, boiling point, specific gravity,
pH, solubility, vapor pressure, dissociation constant, K^, ph, and stability), as required in 40 CFR 158.120
and more fully described in the Pesticide Assessment Guidelines, Subdivision D must be submitted.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.120 Product Chemistry - Footnotes (cont'd)
Q/ Data needed if the technical chemical is a solid at room temperature.
9/ Data needed if the technical chemical is a liquid at room temperature.
10/ Required if the technical chemical is organic and non-polar.
ll/ Required if the test substance is dispersible with water.
Ln
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
Test
SubstanceV
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Timeframe
for
Submission2/
S158.125 Residue Chemistry
171-2 - Chemical Identity^/
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism)
- Plants
PAIRA
(See Index)
Partially
00056937,
00083464,
00101264,
00151145,
00136247,
00090389,
40299301
Yes4/
YesV
18 Months
18 Months
- Livestock
171-4 - Residue Analytical
Method
- Plant Residues
PAIRA
Partially
TGAI and Partially
Metabolites
00083474,
00083475,
00090332,
00151145,
40299501
00083482,
00090331,
00090388,
00101271,
Yes6/
Yes?/
18 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
Test
Substance^/
Does EPA
Have Data?
Must Additional
Bibliographic Data Be
Citation Submitted?
Timeframe
for
Submission^/
§158.125 Residue Chemistry (cont'd)
171-4 - Residue Analytical
Method (cont'd)
- Plant Residues (cont'd)
cn
- Animal Residues
171-4 - Storage Stability Data
171-4 - Maqnitude of the Residue
- Croo Field Trials
- Root and Tuber
Vegetables Group
0 Potatoes
TGAI and
Metabolites
PAI
No
Partially
EP
Partially
00101284,
00101292,
00101302,
00101308,
00101310,
00101315,
00136262,
00155166
00090332,
00101314
00090331,
00101271,
00101285,
00101306
Reserved^/
YesV10/
18 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
cn
Test Does EPA
Data Requirement Substance1/ Have Data?
§158.125 Residue Chemistry (cont'd)
171-4 - Maqnitude of the Residue
- Crop Field Trials (cont'd)
- Brassica Leafy
Veqetables Group
0 Broccoli EP Partially
0 Cauliflower EP Partially
- Fruitinq Vegetables
(Except Cucurbits)
Group
0 Peppers EP Partially
0 Tomatoes EP Partially
- Cucurbit Veqetables
1 Group
0 Cucumbers EP Yes
0 Melons EP Partially
Must Additional
Bibliographic Data Be
Citation Submitted?
00083482, YesiV
00101271
00101271 Yes^/
00090331 Yes^V
00090331, Yes15/
00101271
00090331, No
00101271
00090331, Yes16/
00101271
Timeframe
for
Submission^/
18 Months
18 Months
18 Months
24 Months
—
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAHIDON
ui
Test
Data Requirement Substance!/
§158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residue
- Crop Field Trials (cont'd)
- Citrus Fruits Group
0 Grapefruit EP
0 Lemons EP
0 Oranges EP
0 Tangerines EP
- Pome Fruits
0 Apples EP
Does EPA
Have Data?
Partially
Partially
Partially
Partially
Partially
Bibliographic
Citation
00090388,
00101271
00101271,
00101302
00083482,
00101271
00101271
00083482,
00090389,
00101271
Must Additional
Data Be
Submitted?
Yes£V
Yesl7/
18/
Yes
Yes^V
YesH/
20/
Yes
Yes21/
Timeframe
for
Submission2/
18 Months
18 Months
18 Months
24 Months
18 Months
18 Months
24 Months
Tree Nuts
0 walnuts
EP
No
Yes22/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Test Does EPA Bibliographic
Data Requirement Substance1/ Have Data? Citation
§158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residue
- Crop Field Trials (cont'd)
- Miscellaneous
Commodities
0 Cottonseed EP Partially 00101319,
00101276
0 Sugarcane EP Partially 00101276
0 Meat/Milk/ EP Partially 00101266
' Poultry/Eggs
1 'i
cn
oo
Must Additional
Data Be
Submitted?
Yes23/
Yes24/
Reserved^/
Timeframe
for
Submission2/
24 Months
24 Months
....
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.125 Residue Chemistry - Footnotes
VTest Substance: TGAI = Technical Grade of the Active Ingredient; PAIRA = Pure Active Ingredient, Radiolabeled;
EP = End-Use Product.
Z/Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
VRefer to Product Chemistry Data Requirement tables (A,B).
£/The maximum number of applications and/or seasonal application rate must be specified on the product labels for
apple, broccoli, cauliflower, cantaloupe, cucumber, watermelon, grapefruit, lemon, orange, tangerine, pepper,
potato, sugarcane, tomato, and walnut.
.5/Data describing the distribution and metabolism of vinyl or carbonyl-labeled [14C]phosphamidon in mature, foliar-
treated apples, potatoes, and broccoli. Foliar application rates should be large enough to permit 14c_residue
identification in appropriate parts of the mature plants. Upon receipt of acceptable metabolism data and validated
residue data, the tolerance definition will be changed to list specific metabolites. Representative samples from
, the above-described test must also be analyzed using accepted enforcement methods to ascertain that these methods
> will determine all possible metabolites of concern.
6/Studies on the metabolism of vinyl or carbonyl-labeled [14c]phosphamidon in ruminants and poultry. Animals must be
dosed for a minimum of 3 days at a level sufficient to make identification and Quantification of residues possible.
Milk and eqgs must be collected for analysis twice daily during the dosing period, and animals must be sacrificed
within 24 hours after administration of the final dose. The distribution and identity of residues must be
determined in milk, liver, kidney, muscle, and fat of ruminants, and in eggs, liver, kidney, muscle, and fat of
poultry. Samples from the requested animal metabolism studies must also be analyzed using current enforcement
methods to determine the usefulness of these methods for analysis of animal commodities.
I/All residues of concern, as determined from the requested metabolism studies, must be subjected to FDA
Multiresidue Protocols I, II, III, and IV as required at 40 CFR 158.125(b)(15). Protocols are available from
NTIS under Order No. PB 203734/AS. If the requested data regarding the nature of the residue in plants reveal
additional metabolites of toxicological concern, additional analytical methods for data collection and
enforcement may be required.
8/Should the required animal metabolism data indicate that registered uses may result in phosphamidon residues
of concern in animal feed items, then analytical methods for residues in animal commodities suitable for data
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.125 Residue Chemistry - Footnotes (cont'd)
collection and enforcement will be required. Footnote 7, regarding FDA Multiresidue Protocols, will apply to
any metabolites of concern that are unique to livestock.
9/To support crop residue data, storage stability studies must be conducted on either weathered samples or
fortified frozen samples of a least one representative crop from each crop grouping (40 CFR 180.34) on which
registered uses of the active ingredient exist. Guidance on the conduct of these studies is provided in
Subdivision 0, Addendum 2 (NTIS No. PB86-248192). Analyses of each crop must be conducted over a time period
that includes the time interval that the raw agricultural commodity is held in frozen storage prior to the
crop residue analysis. To support residue data on processed commodities, fortified storage stability data
are reauired for all processing studies submitted to the Agency. Analyses must be conducted over a time
period that includes the frozen storage of the raw agricultural commodity prior to processing and each
processed commodity prior to the residue analysis. One of the following two approaches must be taken:
a. Storage stability data using weathered samples. Data are required for crop samples field treated with a
typical end-use product which are frozen immediately upon harvesting. The integrity of the samples must
be maintained by freezing. The samples must be analyzed for the active ingredient and each metabolite of
s concern on the day they arrive at the analytical laboratory, and then stored frozen and analyzed periodically
for the active ingredient and each metabolite of concern.
b. Storage stability data using fortified samples. Data are required on the active ingredient and metabolites
in which a group of untreated samples of raw agricultural commodities and processed crops are fortified
(spiked) with the pure active ingredient and other groups are fortified individually with each additional
metabolite, immediately after fortification, the samples fortified with the active ingredient must be
analyzed and samples fortified with other metabolites must be analyzed for only the metabolite with which
the sample was fortified, sample integrity must be maintained by freezing, and analyses for active
ingredient and metabolites must be conducted periodically.
^0_/Storage intervals and conditions must be reported for the samples used to generate residue data submitted
in support of the established tolerances (i.e., data reviewed as part of this Registration Standard) for
phosphamidon residues in or on plant commodities. Data must also be provided which depict the decline in residues
during the storage intervals and under the conditions reported if different from the above (see Footnote 9).
In laboratory tests using fortified samples, the pure active ingredient and pure metabolites must be used. However,
if field-weathered samples are used, the test substance must be a typical end-use product.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
S158.125 Residue Chemistry - Footnotes (cont'd)
11/Residues must be determined in granules, chips, wet peel, and dry peel processed from potatoes bearing
weathered residues. The fate of residues in baked whole potatoes, in baked and fried peeled potatoes and
in dehydrated potatoes must be determined as well to ascertain effects of cooking on phosphamidon residues.
It may be necessary to use exaggerated rates to obtain measurable residues in the raw agricultural commodity
(RAC). If residues concentrate in any of these processed products, appropriate food/feed additive tolerances
must be proposed.
j.2/Data depicting phqsphamidon residues of concern in or on broccoli harvested 3 days after the last of multiple
foliar applications (with 10-14 day intervals) utilizing an SC/L formulation at 1 Ib ai/A. Tests must be
conducted in CA, which produced 92% of the 1984 U.S. broccoli crop (Agricultural Statistics 1985, p. 150).
jJ/The requested data for broccoli (refer to footnote 12) will be used to complete the data requirements for
cauliflower.
ON J.4/Residue data reflecting multiple aerial and ground applications of the 8 Ib/gal SC/L at 1 Ib ai/A harvested
—' 6 days posttreatment. Tests must be conducted in FL and TX. All residues of concern must be determined using
validated methods.
15_/0ata depicting phosphamidon residues of concern in dry pomace, whole cooked tomatoes, puree, paste, catsup, and
(raw and cooked) iuice processed from tomatoes bearing measurable weathered residues. It- may be necessary to use
exaggerated rates to obtain measurable residues in or on the RAC. If residues concentrate in any of these processed
products, appropriate food/feed additive tolerances must be proposed.
16/Determination of all residues of concern 1 day following the last of several foliar applications of the
8 Ib/gal SC/L at 0.5 Ib ai/A. Validated methods are to be used. Cantaloupes are to be treated in AZ, CA,
and TX, and watermelon in FL.
J/7/The requested data for oranges (refer to footnote 18) will be used to complete the data requirements for
grapefruit, lemons, and tangerines.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
S158.125 Residue Chemistry - Footnotes (cont'd)
18/Depiction of residues of concern in or on oranges harvested 15 days after the last of multiple applications
with aerial equipment of the 8 Ib/qal SC/L formulation at 0.75 Ib ai/A in 10 to 20 gal water/A. Tests must
be conducted in CA (29%) and FL (69%); these States collectively account for ca. 98 percent of U.S. orange
production (Agricultural Statistics 1985, p. 198).
19/All residues of concern must be determined in dried pulp, molasses, oil, and fresh and canned raw and cooked
iuice processed from oranges bearing measurable weathered residues. Exaggerated rates may be necessary to
obtain measurable residues in the RAC. If residues concentrate in any processed product, then appropriate
food/feed additive tolerances must be proposed.
2P_/Depiction of residues of concern of phosphamidon in or on apples harvested 30 days after the last of multiple
foliar applications (at 7-day intervals) of the 8 Ib/gal SC/L formulation with ground equipment at 2 Ib ai/A
in ROO gal of spray solution/A. Tests must be conducted in CA (6%), MI (9%), NY (12%), and WA (36%), States
i which collectively accounted for ca. 63 percent of U.S. 1984 apple production (Agricultural Statistics
1985, p. 242). Tests are also required depicting the same residues in or on apples 30 days after the last
* of multiple applications (at 14-day intervals) of the 8 Ib/gal SC/L formulation with aerial equipment at
1.5 Ib ai/A in 3 to 10 gal spray solution/A. These tests must be conducted in WA, the only State in which
O^ aerial applications are registered.
21/Depiction of residues of concern of phosphamidon in apple pomace, cooked apples (canned, including applesauce,
and baked), dried apples, and fresh and canned raw and cooked apple juice processed from apples bearing measurable
weathered residues. If residues in pomace or juice are found to occur at higher concentrations than in the RAC,
then appropriate food/feed additive tolerances will be required.
22/Depiction of residues of concern of phosphamidon in or on walnuts 7 days after the last of multiple foliar
applications of the 8 Ib/gal SC/L formulation at 1 Ib ai/A at 10-day intervals using ground equipment.
Tests must be conducted in CA since this State produced virtually all of the 1982 U.S. English walnut crop
(1982 Census of Agriculture, p. 368).
23/Depiction of residues of concern of phosphamidon in meal, hulls, soapstock, crude oil, and refined oil
processed from cottonseed bearing measurable weathered residues (exaggerated rates may be necessary to
obtain such residues). If residue concentrations in any of these processed commodities exceed the residue
concentration of the RAC, then the registrant must propose appropriate food/feed additive tolerances.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158,125 Residue Chemistry - Footnotes (cont'd)
24/Data depicting residues in molasses and refined sugar processed from sugarcane treated at exaggerated rates.
If residues are found to concentrate in these processed commodities, then the registrant must propose
appropriate food/feed additive tolerances.
_25/Should the reauested animal metabolism studies indicate that residues of concern may occur in animal
commodities as a result of registered uses, then tolerances will need to be proposed along with supporting
residue data for edible tissues of ruminants and poultry.
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
ON
Data Requirement
Use
Composition1/ Pattern2/
Bibliographic
Does EPA Citation
Have Data? (MRID)
Timeframe
Must Additional Data for 3/
Be Submitted? Submission
§158.130 Environmental Fate
Degradation Studies-Lab
161-1
- Hydrolysis
TGAI or
PAIRA
A
NO
Yes
9 Months
Photodearadation
161-2
161-3
161-4
- In Water
- On Soil
- In Air
TGAI or
TGAI or
TGAI or
PAIRA
PAIRA
PAIRA
A
A
A
NO
No
NO
Yes
Yes
4/
Yes
9 Months
9 Months
9 Months
Metabolism Studies-Lab
162-1
162-2
162-3
162-4
- Aerobic Soil
- Anaerobic Soil
- Anaerobic Aquatic
- Aerobic Aquatic
-TGAI or
TGAI or
TGAI or
TGAI or
PAIRA
PAIRA
PAIRA
PAIRA
A
A
N/A
N/A
NO
NO
NO
NO
Yes
Yes
5/
NO
5/
NO
27 Months
27 Months
—
—
Mobility Studies
163-1 - Leaching and
Adsorption/
Desorption
TGAI Or PAIRA
Partially 00153162
6/
Yes
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
§158.130 Environmental Fate
Mobility Studies (cont'd)
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Dissipation Studies-Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
ON
c-n 164-4 - Combination and
Tank Mixes
165-5 - Soil, Long-Term
Accumulation Studies
Use
Composition!/ Pattern2/
(cont'd)
TEP
TEP
TEP
TEP
TEP
TEP
TEP
A
A
A
N/A
N/A
N/A
A
Bibliographic
Does EPA Citation
Have Data? (MRID)
NO
No
NO
No
NO
NO
NO
Must Additional Data
Be Submitted?
Yes
y
Reserved
Yes
v
NO
8/
NO
I/
NO
Reserved
Timeframe
for 3/
Submission
12 Months
—
27 Months
—
—
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
PAIRA
TEP
NO
NO
Yes
Reserved"
ll/
39 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
Use
Composition!/ Pattern2/
Bibliographic Timeframe
Does EPA Citation Must Additional Data for 3/
Have Data? (MRID) Be Submitted? Submission
§158.130 Environmental Fate (cont)
Accumulation Studies (cont)
65-3 - irriaated crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
TEP
TGAI or
PAIRA
N/A
A
NO
NO
TEP
N/A
NO
12/
NO
Yes
Reserved"
13/
12 Months
ON
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.130 Environmental Fate - Footnotes
^/Composition: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-use product.
2/The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; c = Aquatic, Food
Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F.= Greenhouse, Nonfood; G = Forestry; H = Domestic,
outdoor; I = indoor; N/A = Not Applicable.
VDue dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
jl/Required because of the highly toxic (Toxicity category I, oral and dermal) nature of the chemical and the
necessity to determine photoproduct toxicities and half-lives.
jj/There are no acruatic uses currently registered for phosphamidon.
j5/Data reauirement partially satisfied; additional data required on mobility of unaged parent in two silt loam
soils and aged parent in one clay soil.
7/Field volatility requirement conditional on results of the laboratory study—field volatility requirement
reserved until acceptable laboratory data are received. If required, the study will be due within 15 months
after notification of requirement by the Agency.
£/There are no forestry uses currently registered for phosphamidon.
!
9/Combination and tank mixes are not being addressed in this standard.
10/Long-term field dissipation studies are conditional on results of the field dissipation study. The long-term
field dissipation requirement is reserved until acceptable confined data are received. If required, the study
will be due within 50 months after notification of requirement by the Agency.
U/Field crop rotation data are conditional on results of the confined study; the field crop rotation requirement
is reserved until acceptable confined data are received. If required, the-study will be due within 50 months
after notification of requirement by the Agency.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOP. PHOSPHAMIDON
S158.130 Environmental Fate - Footnotes (cont'd)
study is not required because the pesticide is not applied to or around water that is likely to be used
for irrigation or other growing agricultural crops.
]J/This study may be required if significant concentrations of the active ingredient and or/its degradates are likely
to occur in aquatic environment and may accumulate in aquatic organisms. See foot note 15/ under § 158.145 data
requirements. If required, the study will be due within 12 months after notification of requirement by the
Agency.
ON
OO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Use
Data Requirement Composition!/ Pattern2/
Bibliographic
Does EPA Citation
Have Data? (MRID)
Timeframe
Must Additional Data for 3/
Be Submitted? Submission
§158.135 Toxicology
Acute Testinq
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
CN 81-7 -
vO
Acute Oral - Rat
Acute Dermal
Acute Inhalation - Rat
Eye irritation - Rabbit
Dermal Irritation -
Rabbit
Dermal Sensitization -
Guinea Pig
Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
No
NO
NO
NO
NO
NO
NO
Yes
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
12 Months
Subchronic Testinq
82-1
82-2 -
82-3 -
- 90-Day Feedinq -
- Rodent
- Nonrodent
21-Day Dermal
90-Day Dermal
TGAI
TGAI
TGAI
TGAI
A
A
A
A
NO
NO
NO
NO -
No4/
Yes
Yes
NO5/
18 Months
12 Months
__
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Bibliographic Timeframe
Use Does EPA Citation Must Additional Data for 3/
Data Requirement Composition1/ Pattern2/ Have Data? (MRID) Be Submitted? Submission
§158.135 Toxicoloqy (cont'd)
Subchronic Testinq (cont'd)
82-4 - 90-Dav Inhalation
82-5 - 90-Day Neurotoxicity
Chronic Testinq '
83-1 - Chronic Toxicity -
- Rodent
- Non rodent
83-2 - Oncoqenicity Study -
• - Rat
O
- Mouse
83-3 - Teratoqenicity -
- Rat
- Rabbit
83-4 - Reproduction
Mutaqenicity Testinq
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
A
A
A
A
NO
NO
Yes 00157159
NO
Partially 00157159, 40299302
NO
Yes 00146424, 00146418,
00146419
.Yes 00146422, 00146423
Yes 00146420
-
NO
NO
NO6/
Reserved7/
NO
Yes
No8/
Yes9/
NO
No
No
Yes
Yes
—
—
—
50 Months
—
50 Months
—
—
—
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
Use
Composition1/ Pattern2/
Bibliographic Timeframe
Does EPA Citation Must Additional Data for 3/
Have Data? (MRID) Be Submitted? Submission
§158.135 Toxicology (cont'd)
Hutagenicity Testing (cont'd)
84-2 - Other Mechanisms of
Mutagenicity
Special Testing
85-1 - General Metabolism
85-2 - Domestic Animal
Safety
TGAI
PAI or PAIRA
Choice
A
A
NO
NO
NO
Yes
Yes
NOW
9 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
S158.135 Toxicology - Footnotes
^Composition: TGAI = Technical Grade Active Ingredient; PAI = Pure Active Ingredient, Radiolabeled; .
Choice = choice of Several Test Substances Determined on a case-by-case Basis.
2/The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; c = Aquatic,
Pood Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic,
Outdoor; I = Indoor; IP = Industrial Preservative.
Voue dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
^/A 2-year rat feeding study is available and a 90-day feeding study is therefore not required.
5/This study is not needed because the existing acceptable end-uses should not result in repeated human skin
contact for extended periods.
6!/This study is not required because the existing acceptable end-uses should not result in repeated inhalation
exposure.
-vj 2/90-day neurotoxicity testing is reserved pending results of acute delayed neurotoxicity testing. If required,
IX) the study will be due within 15 months after notification of requirement by the Agency.
8/Historical control data requested for one study (MRID No. 00157159) are currently under review.
'9/Only a National Cancer Institute bioassay is available, which is inadequate. Data for a full study must therefore
be submitted no later than 50 months after the publication of this standard.
10/Not required for this use pattern.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Bibliographic Timeframe
Use Does EPA Citation Must Additional Data for 3/
Data Requirement Composition1/ Pattern2/ Have Data? (MRID) Be Submitted? Submission
S158.
132-1
132-2
133-3
133-4
i
140 Reentry Protection
- Foliar Dissipation TEP A Yes 40270102
- Soil Dissipation TEP A Yes 40270101
- Dermal Exposure TEP A No
- Inhalation Exposure TEP A No -
4/
NO
5/
NO
6/
NO
7/
NO
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEP
201-1 - Drift Field Evaluation TEP
No
No
8/
Yes
8/
Yes
24 Months
24 Months
Uvl
-------
§158.140 Reentry Protection - Footnotes
i
I/Composition: TGAI - Technical Grade of the Active Ingredient; PAIRA - pure Active Ingredient, Radiolabeled;
TEP - Typical End-Use Product.
2/The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; c = Aquatic, Food
Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic,
outdoor; I = Indoor; N/A = Not Applicable.
VDue dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
4/For the agricultural crop use, a 48-hour interim reentry interval is established. Foliar dissipation studies
have been received by the Agency and are under review.
5/For the agricultural crop use, a 48-hour interim reentry interval is established. Soil dissipation data are required
for potatoes and peanuts. The Agency received a request for waiver of data and the waiver request has been granted
for all crops except potatoes. The soil dissipation study was received by the Agency and is under review.
6/This study is not required due to current use patterns of phosphamidon. However, the registrant may submit this
study at his option.
I/If, the registrant submits the dermal exposure study, the inhalation study must be submitted along with the dermal
exposure study. , .
§158.142 Spray Drift - Footnotes
8/Spray Drift Data Requirements; The Agency is requiring Droplet Spectrum and spray Drift Evaluation tests due to
the toxicity of the chemical, its methods of application (aerial and ground), and the likely exposure of off-site
people and wildlife to the pesticide. The droplet spectrum study is to be performed to reflect the nozzle and
other equipment types to be used in the application of phosphamidon for terrestrial food uses. The spray drift
field evaluation is to be performed to reflect the application equipment, use pattern, and typical locations of
use, which includes different weather factors, in the application of phosphamidon for the present uses.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Use
Data Requirement Composition1/ Pattern2/
S158.145 Wildlife and Aquatic
' Organisms
Avian And Mammalian Testinq
71-1 - Avian Acute Oral
Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Waterfowl
- upland game bird
71-3 - Wild Mammal Toxicity
•xl . .
Ln
71-4 - Avian Reproduction
- waterfowl
- Upland game bird
TGAI
Degradate
TGAI
Degradate
TGAI
Degradate
TGAI
Degradate
TGAI
Degradate
TGAI
Degradate
A
A
A
A
A
A
A
A
A
A
A
A
Bibliographic
Does EPA Citation
Have Data? (MRID)
Yes 00160000
NO.
Yes 00022923
NO
Yes 00022923
NO
NO
NO
NO
No
NO
NO
Timeframe
Must Additional Data for 3/
Be Submitted? Submission
NO
Yes4/
NO
Yes4/
NO
Yes4/
Reserved5/
Reserved^/
Yes7/
Reserved^/
Yes7/
Reserved^/
9 Months
9 Months
9 Months
—
24 Months
24 Months
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
- Preliminary field
study
- Definitive field
study
TEP
TEP
A NO
(Orchard Uses,
Apple, Citrus)
A No
(Orchard Uses,
Apple, Citrus)
YesV
Reserved^/
24 Months
-------
ON
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Use Does EPA
Data Requirement Composition1/ Pattern2/ Have Data?
§158.145 Wildlife and Aquatic
Organisms (cont'd)
Avian And Mammalian Testinq
(cont'd)
10/
70-1 - Special Testinq
- Dermal Toxicity
- Upland Game Bird TGAI A No
TEP A No
Major
Degradate(s) A No
- Outdoor (penned or TEP A No
Bibliographic Timeframe
Citation Must Additional Data for 3/
(MRID) Be Submitted? Submission
YesJ-Oa/ 6 Months -
(Acceptable
Protocol )
Yes^b/ 6 Months -
( Acceptable
Protocol )
Yes^P_£/ 6 Months -
(Acceptable
Protocol )
Reserved10*3/
nest box) reproduction
study
Aquatic Organisms Testinq
72-1 - Freshwater Fish Toxicity
- Warmwater TGAI
Yes
40094602
No
- Coldwater
TGAI
Yes
40094602
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
Use
Composition1/ Pattern2/
Bibliographic Timeframe
Does EPA Citation Must Additional Data for V
Have Data? (MRID) Be Submitted? Submission
§158.145 Wildlife and Aquatic
Organisms (cont'd)
Aquatic Organisms Testing
(cont'd)
72-2 - Acute Toxicity to Fresh-
water Invertebrates
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
TGAI
TGAI
72-4 - Fish and Early Life Stage TGAI
and Aquatic Invertebrate
Life Cycle
72-5 - Fish Life Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing-
Aquatic Organisms
70-1 - Special Testing
- Aquatic Residue
Monitoring
TGAI
TGAI
TEP
TEP
A
A
Yes
NO
NO
NO
NO
NO
NO
40094602
NO
Yes11/
Yes12/
NO
Reserved13/
Reserved1**/
Yes15/
12 Months
15 Months
6 Months-
(Acceptable
Protocol)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.145 Wildlife and Aquatic Organisms - Footnotes
1/TGAl = Technical Grade of the Active Ingredient; TEP - Typical End-use Product; Degradate = Major Degradates of
Phosphamidon as Determined by the Exposure Assessment Branch.
2/The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; c = Aquatic, Food
Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic,
outdoor; I = Indoor.
3/Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated. .
4/Required because a series of laboratory and field data indicated that delayed mortality of birds occurs after
applications of phosphamidon (in some cases up to several weeks). Since the available information suggests that
phosphamidon may have a relatively short half-life, it is possible that some degradate is toxic to birds. One oral
acute toxicity study with either an upland species or a waterfowl, plus two subacute dietary toxicity studies, one
with an upland species and one with a waterfowl, using each major degradate of phosphamidon must be performed.
5/If the mammalian studies required in Table A (Toxicology) indicate a rat acute oral toxicity £ 5 mg/kg, a wild mammal
toxicity study will be required. If required, study will be due 24 months after notification of requirement by
the Agency.
6/Reserved pending receipt of mammal acute toxicity data required in Table A (Toxicology) and avian toxicity
data for degradates required under 71-1. If required, study will be due within 24 months after notification
of requirement by the Agency.
7/Required because some'uses of phosphamidon involve multiple applications.
i
8/Reserved pending receipt of avian acute and dietary toxicity studies with degradates. if required, study will be
due within 24 months after notification of requirement by the Agency.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.145 Wildlife and Aquatic Organisms - Footnotes (cont'd)
9/Terrestrial Field Studies
The use of phosphamidon for forestry has been determined to cause avian mortality and significant population
reduction of birds. Certain adverse effects on mammals were also indicated as potentially possible. However, the
available forestry field study data are inappropriate to simulate the exposure of nontarget organisms to orchard
uses of phosphamidon. Therefore, additional field studies are required on orchard uses. The folloiwng information
indicates the types of terrestrial field studies required for each use site. The types of terrestrial field studies
are defined as follows:
a. Preliminary field study, which is a multisite, multilocation screening study to detect acute effects to
mammals/birds. Multisite means several (8) treatment and sampling areas within each location. Location
refers to geographically or ecologically distinct portions of the range where phosphamidon is applied for
each particular use site (e.g., apple orchards or citrus orchards). The result of these preliminary screening
studies will be used to determine the need for definitive avian/mammalian studies. The EEB has guidance for
developing such studies. However, in the case of phosphamidon, the delayed response of birds/mammals requires
additional guidance on the conduct of such studies. Protocols for conducting these field studies should be
submitted to the Agency within 6 months of receipt of this Standard, for review and comment prior to the
initiation of the study. A Guidance Document is available from the Agency, which outlines an acceptable
approach to these studies. Consultation with the Agency is strongly advised prior to conducting such studies.
If the terrestrial studies on the orchard uses of phosphamidon indicate a hazard to wildlife then the Agency
is reserving the option to require other terrestrial 'field studies. If any of the orchard use patterns are
cancelled, then preliminary field studies are still required for those use patterns where the estimated
environmental concentration (EECs) exceed levels of the most sensitive species of mammalian and avian wildlife.
The preliminary field study is due within 24 months after receipt of the Registration Standard.
b. Definitive field study, which is a multiyear, multilocation study to quantify the effects of the particular
use on, in this case, exposed birds and possibly mammal species. This would involve studying several species
with various censusing and population measuring techniques for several years to determine the extent of
effects that have already been demonstrated in preliminary type studies and incident reports. This study is
reserved pending results of the preliminary field study. The definitive field study will be required where
the preliminary field study has identified potential field effects on populations of birds and mammals.
A Guidance Document is available from the Agency, which outlines an. acceptable approach to these studies.
Consultation with the Agency is strongly advised prior to conducting such studies. The definitive field study
will be due within 48 months after notification by the Agency that the study is required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.145 Wildlife and Aquatic Organisms - Footnotes (cont'd)
9/Terrestrial Field studies (cont'd)
Site Category Use site use Type of Field Study Required
A Terrestrial
Food
Apples Aphids and Preliminary mammalian study.
leafhoppers Definitive avian study.
Citrus
FL Aphids and Preliminary mammalian study.
thrips Definitive avian study.
CA Aphids and Preliminary mammalian study.
thrips Definitive avian study.
CO
° AZ Aphids and Preliminary mammalian study.
thrips Definitive avian study.
(tangerines)
j-0/Because phosphamidon has been demonstrated to result in adverse effects on birds, including mortality (abrupt and
delayed), illness (abrupt and delayed), abnormal behavior (singing and territorial occupation reduced), and
because available data indicate that phosphamidon may have a relatively short half-life, it is possible that the
parent compound or major degradate(s), or both, can be acutely toxic to, or could adversely affect the mating,
nesting, or other nurturing behavior of parent birds. Effects on avian productivity could occur regardless of
potential physiologic effects on oogenesis, spermatogenesis, fertilization, or development of eggs and young, which
are typically studied by a Guidelines (71-4) avian reproduction study. Such a study would therefore be inadequate
to investigate all of the potential effects of phosphamidon on avian productivity. -The following studies are
required as special tests:
a. Dermal toxicity study with upland game bird using TGAI; acceptable protocols must be submitted within 6 months
of receipt of this Standard. The study is due within 12 months after notification by EPA that the protocol
is acceptable.
b. Dermal toxicity study with upland game bird using TEP; acceptable protocols must be submitted within 6 months
of receipt of this standard. The study is due within 12 months after notification by EPA that the protocol
is acceptable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
S158.145 Wildlife and Aquatic Organisms - Footnotes (cont'd)
10/(cont'd)
c. Dermal toxicity study with upland game bird using major degradate(s); acceptable protocols must be submitted
within 6 months of receipt of this Standard. The study is due within 12 months after notification by EPA
that the protocol is acceptable.
d. The following study is reserved pending results of the other special studies: Outdoor (penned or nest box)
reproduction study of the potential effects of phosphamidon on parental birds and avian productivity, and which
investigates mating, nesting, brood rearing, and productivity of waterfowl or. passerine species, using TEP.
If required, acceptable protocols must be submitted within 6 months after notification of requirement by the
Agency. The due date for the study will be determined based upon the date of notification of the acceptability
of the protocol by the Agency, and the complexity and scope of the study.
> J.l/Required because use on citrus orchards has the potential to result in significant concentrations of phosphamidon
in estuarine waters when used as directed, and because TGAI is demonstrated to be very highly toxicfto aquatic
invertebrates. Testing requirements are:
a. A 96-hour LC5Q on a marine or estuarine shrimp species.
b. Either a 48-hour EC5Q 'study on oyster embryolarvae O£ a 96-hour £€59 oystershell deposition study.
JL2/Life-cycle study of aauatic invertebrate is required.
IJ/Reserved pending receipt and evaluation of environmental chemistry and fate data required by EAB. If required,
study will be due within 12 months after notification of requirement by the Agency.
L4/Reserved pending receipt and evaluation of acute and life-cycle testing under this subpart, environmental chemistry
and fate data requirement by EAB, and special testing for aquatic organisms required under 70-1. Concern is for
toxicity to aauatic invertebrates, which through potential perturbations of aquatic food chains could result in
adverse effects on finfish. If required, study will be due within 24 to 48 months after notification of
requirement by the Agency. The specific due date and length of the study is determined by the scope and complexity
of the study.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
§158.145 Wildlife and Aquatic Organisms -7 Footnotes (cont'd)
JLS/Aquatic residue monitoring data are required to determine the extent of exposure of aquatic organisms and to
determine need for further testing requirements. Residue monitoring must be conducted in watersheds where apples
have been treated with phosphamidon in these apple-producing regions: pacific Northwest, North Central, and Eastern.
At least five sampling sites (farm ponds) should be treated with PPD in each region, water and hydrosoils (top 0.5
inch only) must be sampled, in duplicate, at 0, 1, 2, 4, and 8 days after treatment, and at 0, 1, 2, 4, and 8 days
after the first major rainfall (1 inch or above). Acceptable protocols must be submitted within 6 months of receipt
of this Standard. . The study is due within 12 months after notification by the Agency that the protocol is
acceptable.
CD
ho
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSPHAMIDON
Data Requirement
Use
Composition1/ Pattern2/
Bibliographic Timeframe
Does EPA Citation Must Additional Data for V
Have Data? (MRID) Be Submitted? Submission
§158.155 Nontarget Insects
141-1 - Honeybee Acute Contact TGAI
Toxicity
141-2 - Honeybee - Toxicity of
Residues on Foliage
141-4 - Honeybee Subacute
Feeding Study
141-5 - Field Testing for
Pollinators
TEP
Reserved V -
TEP
Yes
00036935
No
Yes 00037799, 00060625, No
00060628
No
I/Composition: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-Use Product.
2/The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; c = Aquatic, Food
Croo; D = Aouatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic,
outdoor; I = indoor; N/A = Not Applicable.
3/Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
^/Reserved pendinq development of test methodology.
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSPHAMIDON
CO
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data?
Bibliographic Must Additional
Citation Data Be Submitted?
Timeframe
for
Submission2/
§158.120 Product Chemistry (cont'd)
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
- Color
- Physical State
- Odor
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizinq or Reducing
Action
- Flammability
- Exolodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
All
All
I/
I/
!/
I/
I/
I/
I/
!/
!/
!/
!/
i/
!/
!/
V
IJ
!/
i/
I/
I/
!/
V
I/
i/-
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
Characteristics
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSPHAMIDON
Data Requirement
§158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity
and Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and Manufac-
turing 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
Test Use Does EPA
Substance Patterns Have Data?
MP All I/
MP All I/
MP All I/
MP All I/
MP All I/
MP All I/
Bibliographic Must Additional
Citation Data Be Submitted?
I/ Yes
I/ Yes
I/ Yes
I/ Yes
I/ Yes
I/ Yes
Timeframe
for
Submission2/
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
to Verify Certified
Limits
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSPHAMIDON
Test use Does EPA Bibliographic Must Additional for
Data Requirement Substance Patterns Have Data? Citation Data Be Submitted? Submission2/
§158.120 Product Chemistry (cont'd)
Other Requirements;
I/
64-1 - submittal of Samples MP All — — Reserved
I/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration standard, unless
otherwise indicated.
i
3/ If samples are needed, the Agency will request them. If required, the samples will be due within 6 months after
notification of requirement by the Agency.
00
ON
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSPHAMIDON
Use
Data Reouirement Composition!/ Pattern
Bibliographic
Does EPA Citation
Have Data? (MRID)
Must Additional Data
Be Submitted?
Timeframe
f or2/
Submission
§158.135 Toxicology
Acute Testinq
81-1
81-2
81-3
81-4
81-5
3 81-6
•4
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
Rabbit
- Dermal Sensitization -
Guinea Piq
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
v
I/
I/
v
I/
!/
4/
Yes
4/
Yes
4/
Yes
4/
Yes
I/
Yes
4/
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/ Composition: MP = Manufacturing-Use Product.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration standard, unless
otherwise indicated.
V Although product specific toxicity data may have been submitted in the past, the Agency has determined that these
data must be resubmitted for each manufacturing-use product.
4/ If the MP is a technical grade active ingredient, refer to the Toxicology Table A for data requirements which may
have been satisfied.
-------
•II. LABELING APPENDICES
88
-------
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
reauired 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 content's 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)1
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)]
89
-------
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 s.quare 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
reauired 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)].
90
-------
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 RC. 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 whv the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).'
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
91
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label reauirements 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 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I)'. If use is restricted to certified appl'icators,
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
rereqistration, 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.
92
-------
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 162.101
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the labe.1 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.
93
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
A.H products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. NO.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
•
-------
SUMMARY-7
ITEM
7C
7D
M3
U1 7E
8
RA
RB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and ill
All products
where pre-
cautionary
labeling
appears on
other than
front jDanel .
All products
All products
in Categories
I, II, and in
All products
PLACEMENT
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
i
None
None
None
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
IrtA
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMEN
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
r ON LABEL
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
Ox
-------
\o
STATEMENTS
HAJW03 ?0 HUMANS
II OOMEMC ANIWAISI
OANOM
on
u«
RE ENTRY STATEMENT
|» A*o4e*>ta)
STORAGE AND
DISPOSAL
CWir-OSAl
cnew>
RESTRICTED USE
; f PESTICIDE
for rttll) nit t« intf ult o«lr br Cirtiricd Ippllciteri
or firioxl under (K«lr dlrict luptrvltloi I'd only for
thoit 0\ft co«iri4 by lh» C«rlHlfd Appllcitorl Cirtlfl-
Cltltn. .' •
PRODUCT
NAME
AtTVf MQREDCNT
attar nrtnrr>*wTS
TOTAL
Tlft] PRODUCT CONTAMS
%
«
10006%
«H OAUON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
STATEUtNl Of
TREATMENT
r SWAUOWEO:
r NMAiJo=s
r ON SKN —
r NEVIS =
SEE SC< PAMEl FOR AromOHAL t>«>f CAUTDNAAT STATEUtNIS
MO
IP*
NET coMttNis:
©
CROP
c«o^
CROT;
OttP:
WAMUMTV ST»Tf MINT
-------
D"MCIO"S fOn DSC
'9,^A nmiAi
3»a
m tmdurl W i mmr rmu uLU
OD
I0cj»
"I CNIOT S">C".'INI
STORAGE AND
lll.M-OS*!
Cine
PRODUCT
NAME
• Cirvt »ir>nioi|Nl
»il ni ricnioilxis
>OUI
luis rnotitici
IOOIKH
tv rinciMiOM
^L^
KEEP OUT OF REACH OF CMILOREN
CAUTION
mwNf JI»M
x~\i inw»f 51
(5>.»..m,S
Nil
00
^ •«
G«
v-<
a©
J^
COW
cnof
CHOP
cnon
CHOP'
-------
§162.8
p) Conditional registration. Any ap/
.tlon for which a review of scler/-
data Is needed, other than an
Ion which the Agency de
may be considered for uncondi-
tional registration under paragraph
(d) of this section, will be treated afc an
application for conditional registration
under FIFRA sec. 3(c)<7) and will be
reviewed and acted upon as set/ forth
in {§ 162U60 through 162.177.
—- (f) Derkal of registration, "tfhe Ad-
mlnistratdr shall deny an application
reviewed under paragraph (an of this
section if any of the requirements of
paragraph \d)(2) of this section are
not met, or\if there are insufficient
data to make\ the required/determina-
tions.
(1) Notification. Promptly after
making a determination fib deny a reg-
istration, the \ Administrator shall
notify the applicant by Certified letter
of the denial of YegistrAtion and shall
pns and factual basis
fiorj and the condi-
lust be satisfied
set forth the re
for the determln
tions, if any, whi
in order for the rei
proved.
(2) Opportunity ft
cant (i) The app,
days from the d
certified letter
corrective actioi
(ii) The applicant m
Administrator it with
tion. The Adn&lnstrator
discretion, deriy any peti
drawal and pqbceed to iss
ration to be ap-
remedy by appli-
t will have 30
receipt of the
the specified
petition the
i his applica-
may, in his
n for with-
a notice of
denial in accordance wlth\ paragraph
(f)(3) of this/section.
(3) FEDER/L REGISTER publication. It
the applicant fails to remedi the defi-
ciency of his registration application,
the Administrator shall nromptly
issue in the FEDERAL REGISTER^ notice
of deniu of registration. SucH, notice
shall sef forth the reasons and Tactual
basis ffir the denial and shall cbntaln
e and address of the appfi
duct name, the name ano\per-
e by weight of each active L
in the product, the proposed bat-
of use, and the proposed clasajfl-
cayon.
) Hearing rights. Within 30. da\
following publication of the denial
e FEDERAL REGISTER, the applicant i
interested party with the written
40 CFR Ch. I (7-1-86 Edition)
authorization of the applicant may re
quest a hearing pursuant to sectioi.
6Cb) of the Act and Part 164 of tliis
chVpter. If no hearing is timely/re-
queued, the denial shall become e/fec-
tive ut the end of the 30 days. /
<.e)\f>isposition of material submit-
ted with the application. The te/t data
and other information submitted with
an application shall become a/part of
the official file of the Agency for that
application or registration. Except as
provided by section 10 of the Act,
within 30 dkys after the registration of
a pesticide, the data calleQ for in the
registration Statement t/gether with
such other scientific information as
the Administrator deejfcs relevant to
his decision srkll be /made available
for public Inspection.
(48 FR 34004, July 2$. 1/83]
§ 162.8 Data to be finished by applicant.
(a) An applicanyf\r registration, re-
registration, or amendment of a regis-
tration under FIFRA W. 3(c)(5) shall
furnish data As required by the
Agency to determine Whether his ap-
plication may/be approved under this
Part. / \
(b) An,applicant shall \ubmit with
his application any factual Informa-
tion regarding adverse effeVts of the
pesticide en the environment or man
that: - / \
(1) Ha/ been obtained by hiift or has
come to/his attention; and
(2) Insofar as he is aware, has not
previously been submitted to\ the
Agency.
Sucn Information shall include, \ut
shall not be limited to, published \>r
unpublished laboratory studies and
extent experience.
/48 FR 3400S, July 26.1983]
§ 162.10 Labeling requirements.
(a) General—<1> Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(I) The name, brand, or trademark
under which the product is sold as pre-
Environmental Protection Agency
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, reglstrapt. or person for
whom produced as prescribed in para-
graph (c) of this section;
(ill) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed In paragraph (f)
of this section;
(vl) An ingredient statement as pre-
scribed In paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
' scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed In paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(I) General.
The label shall appear on or be secure-
ly attached to the immediate contain-
§ 162.10
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(11) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile, or stationary, which
remain in the custody of the user..a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
i 162.15. is mlsbranded if its labeling is
false or misleading in any particular
Including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(Hi) A false or misleading statement
about the value of the product for
-------
§ 162.10
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly Implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
Ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other Ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(vlil) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(Ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpolson-
ous." "nonlnjurious." "harmless" or
"nontoxic to humans and pets" with
. or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
. product, Including but not limited to:
(A) "Contains all natural Ingredl-
O ents";
O
-------
§ 162.10
the label: "Not for sale or use after
[date]."
(11) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert 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 lexicological
hazard Including hazard to children,
environmental hazard, and physical or
40 CFR Ch. I (7-1-86 Edition)
chemical hazard fall lt)to two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and promlpence are given-
below. r
(1) Required front fanel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard indicators
Oral L0«
Inhalation LC»
Dermal LD.
Eye effects
SWn etfecta
Toxicity categories
1
Up to and Including SO
mg/kg.
Up to and including .2
mg/liter.
Up to and including 200
mg/kg.
Corrosive; cornea!
opacity not reversible
within 7 days.
II
From 50 thru 500 mg/kg..
From .2 thru 2 rug/liter
From 200 thru 2000
Cornea) opacity
reversible within 7
days; Irritation
persisting lor 7 days.
Severe Irritation at 72
hours.
Ill
From £00 thru 5000 mg/
kg.
From 2. thru 20 mg/liter...
From 2,000 thru 20,000....
No corneal opacity.
Irritation reversible
within 7 days.
Moderate Irritation at 72
hours.
IV
Greater than 5000 mg/
kg.
Greater than 20 mg/liter.
Greater than 20,000.
No irritation.
Mild or slight irritation at
72 hours.
(i) Human hazard, signal word—(.A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category. I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
. Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher •
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
Ing, storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(Hi) Statement of practical treat-
ment—(A.) Toxicity Category I. A
Environmental Protection Agency
statement of practical treatment (first
aid or other) shaft appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I .on the
basis of oral, Inhalation or dermal tox-
icity. The Agency may. however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXlilXA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
' practical treatment ,are, however, re-
quired elsewhere -on the label in
accord with paragraph
-------
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD>0 of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC» of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LD» of 100
nig/kg or less, or a subacute dietary
LCw of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(O) If either accident history or field
studies demonstrate that use of the
40 CFR Ch. I (7-1-86 Edition)
pesticide may relult in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or 'for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes.
ponds or streams. Oo not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flashpoint
Required text
(A) PRESSURIZED CONTAINERS
Flash point «t or below W.F; H there It • flashback it
tny vsh/e opening.
Flash paint above 20' F and not over 80* F or if the
^ Ham* extension is more than 18 In long at a distance
~—* of 8 In from the flam*.
£—5 Al other pressurized containers
IV)
Extremely flammable. Contents under pressure. Keep sway 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 sway from heat.
sparks, snd open name. Oo not puncture or Incinerate container.
Exposure to temperatures above 130* F may cause bursting.
Contents under pressure. Oo not use or store near heat or open
flame. Oo not punctur* or Incinerate container. Exposure to
temperatures above 130* F may cause bursting.
(B) NONPMESSURIZED CONTAINER*
At or below 20'F..
Above »• F and not over W F
Above 80'F and not over 1 SO'F.
Extremely flammable. Keep (way from fire, sparka, and healed
surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heal or open flame.
(i) Directions for Use—(1) General
requirements—(it Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
(li) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that It Is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
Erwlronmental Protection Agency
tions for use may be omitted from la-
beling of pesticide^ which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing-processes,
provided that:
(7) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate Information such as
technical data sheets or bulletins, Is
available to the trade specifying the
type of product Involved and its
proper use in manufacturing process-
es;
(3) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
§ 162.10
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; ai)d
(tf) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall Include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.10(J) immedi-
ately under the heading "Directions
for Use."
(11) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with Its labeling."
(ill) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(Iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vli) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in S 162.10(h)(l)(iv))
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
-------
§162.11
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22.1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
~~* rections only for general use(s) and
ID the other bearing directions for re-
j^ stricted use(s) excep: that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of {162.10(j)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
40 CFR Ch. I (7-1-86 Edition)
siflcation on the front panel as de-
scribed below: '
(1) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard Signal words (see
table in 5162.10(h)(lMiv)), and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make It unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use Is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 FR 28268, July 3. 1975: 40 FR 32329,
Aug. 1, 1975; 40 FR 36571. Aug. 21, 1975, as
amended at 43 FR 5786. Feb. 9.19781
lyl62.11 Criteria for determinations of ur
.reasonable adverse effects.
(a\(b) [Reserved]
(c) else classification—ID Clasdifica-
tion criteria for new registrations.
Except as\provlded in paragraph (c)(4)
of this section, a specific xise(s) of a
pesticide product not previously regis-
tered shall be sJassified/or general use
if each of the^applicXble criteria set
forth in paragrabh/CcXlXl) through
(Hi) of this sectlorWs met. Otherwise,
the product use(/) Shall be classified
for restricted use unless a review of
the labeling/pursuantNto paragraph
(c)(3) of thl^sectlon Indicates that the
product use may be classified for gen-
eral use/or the benefits from unre-,
strlctecKuse of the pesticide outweigh
the risks of unrestricted use V the
pesticide. Each of the separate criteria
it forth below must be appliedXr
product use(s) to be classifie
Environmental Protection Agency
i^nless the formulation, packaging,
Method of use oj»the product can re
lably be expected to .eliminate the
ro\ite of exposure. New data submitted
to support classification must conform
to uie specifications of the Regiytra-
tion\Guidelines.
(i)YDomestic applications. A pesti-
cide nse(s) intended for domestic ap-
plicatron will be a candidate for/gener-
al useXclassification if the pesticide
formulation:
(A) Hsrc an acute dermal LD^t greater
than 2,000 mg/kg;
(B) Has an inhalation IX/» greater
than 2 mgVliter;
(C) Causes no corneal Opacity, or
causes eye \rritatlon reversible within
7 days or les
(D) Cause A no more tr/an moderate
skin irritationwithin 72 Hours;
(E) Has anVcute ora/l LDW greater
than 1.5 g/kgvor the formulation as
diluted for use; and
(F) Causes, unner conditions of label
use or widespread ana commonly rec-
ognized practice of use, only minor or
no discernible subacnte, chronic, or de-
layed effects on man or other nontar-
get organisms frorAsingle or multiple
exposures to the product Ingredient(s),
their metabollte/s),\ or degradation
product(s).
(ii) NondomesAc applications. A pes-
ticide use(s) Intended for nondomestic
application wll/be a candidate for gen-
eral use classification l\the pesticide
formulation:
(A) Has an Acute derma\LD» greater
than 200 mg/kg;
(B) Has art acute dermal LDM greater
than 16 g/ug for the formulation as di-
luted for use as a mist or spray;
(C) Has; an inhalation LD\0 greater
than 0.2 mg/liter;
(D) Is/not corrosive to th eye or
causes / corneal opacity reversible
withlnA days:
(E) jfs not corrosive to the sk\n and
cause/ no more than severe skin \rrita-
tion within 72 hours; and
(F/ Causes under conditions of label
use/or widespread and commonly rec-
ognized practice of use. only minonor
nodiscernible subacute, chronic, or ae-
toxic effects on man or othVr
antarget organisms from single
lultlple exposures to the product
§162.11
agredlent(s). their their metabolite^
o\ degradation product(s).
Jli) Outdoor applications. A
doe use(s) intended for outdoor at;
cation will be a candidate for ger
use classification if it meets the
cable, set of criteria set forth
atelyvabove for either domestic <
domestic application, as apprq
and If \he pesticide:
(A) Occurs as a residue immediately
following application in or on/the feed
of a mammalian species representative
of the species likely to be exposed to
such feedun amounts equivalent to the
average dally intake of sucn represent-
ative species, at levels lessAhan Vfe the
acute oral £lpu, measured in mammali-
an test animals as specified in the Reg-
istration Guidelines.
(B) Occurs Vs a. resldufe immediately
following application In/or on the feed
of an avian snecies representative of
the species lUoely to/be exposed to
such feed in amounts Equivalent to the
average daily Intake
atlve species, at lW
subacute dietary
avian test anim
Registration Guid
(C) Results In a
concentration folio1
tion to a 6-lncr/ la;
than Via the aci
ganlsms represfentatl1
nlsms likely tox>e expo;
In test animals as s;
lelines.
feticide cai
ft such represent-
; less than V4 the
measured in
specified in the
under con-
turn calculated
g direct applica-
r of water less
for aquatic or-
of the orga-
as measured
In the Reg-
istration Gul
-------
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.
c.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable, contents under
pressure. Keep away -from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
104
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are reauired 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.
105
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous, improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
106
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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
(baqs)
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)
^/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
107
-------
III. USE INDEX APPENDIX
108
-------
EPA Compendium of Acceptable Uses
PHOSPHANIDON
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP 2
(Agricultural Crops) - £
Apple 2
Apple (nonbearing) 3
Broccoli 4
Cantaloupe 4
Cauliflower 4
Cotton 5
Cucumber 4
Grapefruit 7
Lemon 7
Orange , 7
Peppers 7
Potato 8
Sugarcane 8
Tangerine (AZ and CA only) 7
Tomato 8
Walnut 9
Watermelon 4
Issued: 2-11-86 III-O182Ol-i
Provisional Update: 11-18-87 109
-------
EPA Compendium of Acceptable Uses
cO18201 - PHOSPHAMIDON*
TYPE PESTICIDE; Insecticide, Acaricide
FORMULATIONS;
Tech (89.5S)
SC/L (8 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; Phosphamidon is classified as a
RESTRICTED USE PESTICIDE (due to acute dermal toxicity to humans
and residue effects on avian and mammalian species). Phosphamidon
has some endangered species restrictions. Refer to product label-
ing for use restrictions to protect endangered species.
Phosphamidon is toxic to aquatic invertebrates and highly toxic to
wildlife. Harming or killing wildlife protected by wildlife con-
servation laws, such as the Migratory Bird Treaty Act or similar
statutes, may result in civil penalties. Do not apply directly to
water or wetlands (including swamps, marshes, bogs, and potholes). .
Runoff and drift from treated areas may be hazardous to a'quatic
organisms in adjacent aquatic sites. Do not contaminate water by
cleaning of equipment or disposal of wastes.
Protective Clothing. Equipment and Ulork Safety; Use only when wear-
ing the following protective clothing and equipment during mixing/
loading, application, repair and cleaning of mixing, loading, and
application equipment, disposal of the pesticide, and early reentry
into treated areas: Protective suit of 1 or 2 pieces covering all
parts of the body except head, hand, and feet; chemical-resistant
gloves; chemical resistant boots. In addition, mixer/loaders must
wear a chemical-resistant apron. During equipment repair and clean-
ing, the protective suit need not be worn. If overhead exposure is
likely, such as when flagging during aerral application, a hood or
wide-brimmed hat must be worn.
If application is performed using an enclosed cab or cockpit, the
following protective clothing and equipment may be worn as an al-
ternative; Long—sleeved shirt and long-legged pants; shoes and
socks. Chemical-resistant gloves must be available in the cab or
cockpit and must be worn during entry to and exit from the applica-
tion vehicle. All other protective clothing and equipment required
for use during application must be available in the cab and must be
worn when exiting the cab into treated areas. When used for this
purpose, contaminated clothing may not be brought back into the cab
unless in an enclosure such as a plastic bag.
If pesticide comes in contact with skin, wash off with soap and
water. Always wash hands, face, and arms with soap and water be-
fore smoking, eating, drinking, or toileting.
After work: Before removing gloves, wash' them" wrth soap and water.
Take off all work clothes and shoes. Shower using soap and water.
Wear only clean clothes when leaving job—do not wear contaminated
clothing. Personal clothing worn during work must be laundered
separately from protective clothing and household articles. Store
protective clothing separately from personal clothing. Clean or
*£-chloro-2—diethylcarbamoyl-1-methylvinyl dimethyl phosphate
£—chloro-N, N—diethyl-3—hydroxycrotonamide, ester with dimethyl
phosphate
Dimecron
Issued: £-11-86 III-018£01-1 1 * n
Provisional Update: 11-18-87 M U
-------
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
GENERAL WARNINGS AND LIMITATIONS (continued)
launder protective clothing after each use. Protective clothing
and equipment that becomes heavily contaminated or drenched must be
destroyed according to State and local regulations. Heavily contam-
inated or drenched clothing cannot be adequately decontaminated.
Reentry Interval; Reentry into treated areas is prohibited for 48
hours after the end of application, unless the protective clothing
specified above for early reentry is worn.
Protective Clothing for Early Reentry; For early reentry into
treated areas: Use protective suit of 1 or 2 pieces covering all
parts of the body except head, hands, and feet; chemical-resistant
gloves; chemical-resistant shoes (or chemical-resistant shoe cover-
ings or chemical—resistant boots).
Bee Caution;
Phosphamidon is highly toxic to bees exposed to direct treatment or
residues on blooming crops or weeds. Do not apply phosptvarnidon or
allow it to drift to blooming crops or weeds if bees are visiting
the treatment area.
Site and Pest
Dosages and Tolerance.
Formulat ion(s)
Use
Lirnitat ions
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Do not allow phosphamidon
sprays to drift on to maple trees, peaches, plums, cherry as
phytotoxicity may occur. Unless otherwise specified, apply
phosphamidon in the following quantities of water per acre:
Ground Equipment
Vegetable and Field Crops
Deciduous Fruit Crops
Young Fruit Plantings
Aircraft (where specified)
Field Crops
Orchard Crops
/04001AA
Apple
IRACAAA
Aphids
Issued: 2-11-86
0.167 Ib/lOO
gal water
Cup to 800
gal/A3
(8 Ib/gal
SC/L)
III-018201-2
3O to 250 gallons
60 to 800 gallons
minimum of 15 gallons
. 3 to 1O gallons
1O to 20 gallons
1 ppm
3O day preharvest interval
through 2.0 pounds per acre for
foliar application.
Fo1iar app1icat ion.
Ill
-------
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
Site and Pest
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
Apple (continued)
ITBUCSA
IRACCUA
IRAFAAA
IMAAAGA
IRACBQA
ILAVASA
INBUAGA
IRACCUA
IRACBQA
IRAKBYA
IRACAUA
IRAFAAA
IRACBQA
Codling moth
(first brood)
Green peach
aphid
Leafhoppers
Leafminers
Rosy apple
aphid
European red
mite
Fruittree
leafroller
Green peach
aphid
Rosy apple
aphid
San Jose scale
Apple aphid
Leafhoppers
Rosy apple
aphid
0.25 Ib/lOO
gal water
Cup to 800
gal/ft:
(8 Ib/gal
SC/L)
0.£5 lb/100
gal water
Cup to 800
gal/AD
(8 Ib/gal
SC/L)
CSLN3
0.75-1.5
(8 Ib/gal
SC/L)
/0400IDA
Apple (nonbearing)
Foliar application. For cod 1 ing
moth, apply at petal fall and
every 1O to 14 days thereafter
until control is achieved. For
other pests apply as a preblossorn
cover spray and repeat at 7 to 10
day intervals (14 to 121 day inter-
vals in western states).
Early delayed-dormant applica-
tion. For areas other than west-
ern states, combine 2 gallons of
a heavy, 70 sec., oil with the
spray mixture. For the western
states, combine 1.5 gallons of a
very heavy, 140 sec., oil with
the spray mixture. Do not com-
bine phosphamidon oil sprays with
captan, folpet or sulfur.
Use limited to WA in conjunction
Ib/A with SLN-WA-820047 and SLN-WA-
820056.
Foliar application. Apply only
by aircraft in 3 to 1O gallons of
water per acre. May be applied
by either Becornist dispensers or
standard boom applicators. Do
not apply under slow drying condi-
tions or to trees under high mois-
ture stress. Apply at 14 to 21
day intervals as needed.
1 ppm
Do not apply to bearing apple
trees.
IRACAUA
IRAFAAA
IRACBQA
Apple aphid
Leafhoppers
Rosy apple
aphid
0.25 Ib/lOO Foliar application to nonbearing
gal water/A trees. Do not apply to trees un-
(8 Ib/gal der moisture stress. Apply when
SC/L) pests first appear and repeat at
14 to 21 day intervals.
Issued: 2-11-86
III-O1S201-3
112
-------
*/13Q08Afl
I RACAAA
ITBJAHA
/lOOOSfift
/10010AA
/I0008Aft
IRACAAA
IRAFAAA
IMAAAGA
/10002AP
IQAMBDA
ILAVAAA
IMOAAAA
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
Site and Pest
Broccoli
Caul iflower
Aphids
Imported cab-
bageworm
Cantaloupe
Cucumber
Watermelon
Dosages and Tolerance. Use.
Formu1at i on(s)
Limitat ions
0.5-1 Ib/A
(8 Ib/gal
SC/L)
Aphids
Leafhoppers
Leafminers
(Cantaloupe)
Fleahoppers
Spider mites
Thrips
Caul iflower
0. 5 ppm
3 day preharvest interval through
1 pound per acre for foliar appli-
cat ion.
Foliar application. For aohids.
apply at 10 to 14 day intervals
to prevent buildup of damaging
populat ions.
O.25 ppm (cantaloupe, watermelon)
0.5 ppm (cucumber)
1 day preharvest interval through
0.5 pound per acre for foliar ap-
plication (cantaloupe, water-
rne Ion).
3 day preharvest interval through
0.5 pound per acre for foliar ap-
plication (cucumber).
0. £5-0. 5 Ib/A Foliar application. For cucurn-
(8 Ib/gal ber, apply in 100 gallons of
SC/L) water per acre.
0. 125-0. £5
Ib/A
(8 Ib/gal
SC/L)
Foliar application.
See Broccoli cluster.
Issued: 2-11-86
III-O182O1-4
113
-------
/28O07AA
Site and Pest
Cotton
EPA Compendium of Acceptable Uses
PHOSPHftMIDON
Dosages and Tolerance. Use. Limitations
Formulation(s)
0. 1 pprn (cottonseed)
30 day preharvest interval
through 0.5 pound per acre for
foliar application.
Do not make more than 3 applica-
tions per season.
Do not allow livestock to graze
treated fields.
Use limited to AZ, PR, CA, PL,
KY, MS, NC, TN, and VA.
The use of phospharnidoh on cotton
after February 1, 1988 has some
endangered species restrictions.
Before using phosphamidon in the
counties listed below, the appli-
cator must obtain the Pesticide
Use Bulletin for Protection of
Endangered Species for the county
in which phosphamidon is to be
used. The bulletin is available
from your County Extension Agent,
State Fish and Game Office, or
the applicator's pesticide deal-
er. Use of phosphamidon in a
manner inconsistent with the Pes-
ticide Use Bulletin for Protec-
tion of Endangered Species is a
violation of Federal laws:
Alabama — Colbert, Green, Jack-
son, Lamar, Lauderdale, Lime-
stone, Madison, Marshall, Mor-
gan, Pickens, and Sumter
Arkansas - Clay, Clark, Cross,
Lawrence, Lee, Poinsette, Ran-
dolph, Sharp, and St. Francis
California - Butte, Colusa,
Glenn, Kern, Merced, Sacramen-
to, Solano, Sutter, Tehema, and
Yolo
Florida — Broward, Dade, Blades,
and Palm Beach
Kentucky - Ballard, Butler,. Ed-
mundson, Green, Hart, Jackson,
Laurel, Livingston, Marshall,
McCracken, McCreary, Pulaski,
Rockcastle, Taylor, Warren, and
Wayne
Mississippi — Itawarnba, Lowndes,
Monroe, and Noxubee
Issued: 2-11-86
II1-018201-5
114
-------
r*. v*
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
Site and Pest
Dosages and Tolerance. Use. Limitations
Formu1at i on(s)
Cotton (continued)
IRACAAA
IQAMBDA
ILAVAAA
IMOAAAA
IRACAAA
INAMADA
IRAFAAA
IQAMARA
Aphids
Fleahoppers
Spider mites
Thrips
Aphids
Flea beetles
Leafhoppers
Lygus bugs
Cucumber
0.188 Ib/A
(8 Ib/gal
SC/L)
O.£5 Ib/A
(8 Ib/gal
SC/L)
0.5 Ib/A
(8 Ib/gal
SC/L)
North Carolina -' Edgecombe, Nash,
and Pitt
Tennessee - Bedford, Blount,
Claiborne, Oecatur, Franklin,
Hancock, Hardin, Hickman, Knox,
Lincoln, Loudon, Marshall,
Maury, Meigs, Monroe, Rhea,
Roane, Scott, Sequatchie,
Smith, Sullivan, and Wayne
Virginia - Lee, Russell, Scott,
Smyth, Tazewell, Washington,
and Wise
Foliar application for early sea-
son control <£ to 10 leaf stage).
Apply by ground equipment begin-
ning at the second true leaf
stage.
Foliar application for mid to
late season control. Apply in 1
to 5 gallons of water per acre by
aircraft or in sufficient water
for thorough coverage by ground
equipment.
See Cantaloupe cluster.
Issued: 2-11-86
III-O18201-6
115
-------
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
Site and Pest
Dosages and Tolerance.
Formulation(s)
Use. Limitations
/02OO2A«
/02004AA
/0201OOP
/02008Aft
Grapefruit
Lemon
Orange
Tangerine (AZ and CA only)
IRACAAA
IMOAAAA
Aphids
Thrips
0. £5-0. 5 lb/
100 gal
water
C40O-3,000
gal/ft]
Cground
equipment -
dilute
sprays]
or
1.25-2.5 Ib/A
[ground
equipment -
concentrate
sprays]
or
O.5-0.75 Ib/A
Cin 10-20
gal water/A]
[aircraft]
(8 Ib/gal
SC/L)
0.75 ppm
15 day preharvest interval
through 2.5 pounds per acre
(ground equipment - concentrate
sprays) or 0.75 pound per acre
(aircraft) or O.5 pound per 1OO
gallons of water (ground equip-
ment - dilute sprays) (400 to
3,000 gallons per acre) for
foliar application.
Foliar application. Apply during
periods of aphid and thrips at-
tack on new flush growth and re-
peat as needed.
/11003AA
IRACAAA
IMAAAGA
IRABAAA
ITBMCCA
Lemon
Orange
Peppers
Aphids
Leafminers
Whiteflies
European corn
borer
O.5 Ib/A
(8 Ib/gal
SC/L)
1 Ib/A
(8 Ib/gal
SC/L)
See Grapefruit cluster.
See Grapefruit cluster.
O. 5 ppm
6 day preharvest interval through
1 pound per acre for foliar appli-
cation.
Foliar application. Apply when
pests first appear.
Foliar application. Apply when
pest infestation is expected.
Issued: 2-11-86
II1-018201-7
-------
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
Site and Pest
Dosages and
Formulat ion (•
Tolerance. Use. Limitations
/14O13AA
Potato
IRACAAA
INAMCFA
INAMADA
IRAFAAA
IMAAAGA
IQAQAAA
Aphids 0.5 Ib/A
Colorado potato (8 Ib/gal
beetle SC/L)
Flea beetles
Leafhoppers
Leafminers
St inkbugs
0. 1 ppm
14 day preharvest interval
through 1 pound per acre for
foliar application.
Foliar application. Apply in 1
to 5 gallons of water per acre by
aircraft or in sufficient water
for thorough coverage by ground
equipment. Apply prior to row
closing or at first sign of leaf-
mining and repeat at 10 to 12 day
intervals as needed.
ITAMAPA
Potato tuber-
worm
0.5-1 Ib/A
(8 Ib/gal
SC/L)
Foliar application. Apply in 1O
gallons of water per acre by aii —
craft or in sufficient water for
thorough coverage by ground equip-
ment. Apply prior to row closing
and repeat at 1O to 1£ day inter-
vals as needed.
/25O03A«
Sugarcane
IRACDOA
/11O05AP
*I RACAAA
INAMCFA
INAMADA
IMABACA
IQAQAAA
IRABAAA
Yellow sugar-
cane aphid
Tangerine
Tomato
Aphids
Colorado potato
beetle
Flea beetles
Leafminers
Stink bugs
Whiteflies
O.1 ppm
9O day preharvest interval
through 0.5 pound per acre for
foliar application. Do not allow
livestock to graze on treated
immature sugarcane fields.
0.5 Ib/A Use limited to FL and PR.
(8 Ib/gal Foliar application. Apply by air-
SC/L) craft in 4 gallons of water per
acre.
See Grapefruit cluster.
0.1 ppm
1O day preharvest interval
through 0.5 pound per acre for
foliar application.
0.5 Ib/A Foliar application. Apply in 1
(8 Ib/gal to 5 gallons of water per acre by
SC/L) aircraft or in sufficient water
for thorough coverage by ground
equipment.
Issued: £-11-86
II1-018201-8
1 17
-------
Site and Pest
/03OO9AA Walnut
EPA Compendium of Acceptable Uses
PHOSPHAMIDON
Dosages and Tolerance. Use. Limitations
Formu1at i on(s)
0.1 ppm
7 day preharvest interval through
1 pound per acre for foliar appli-
cet ion.
IRACAAA
ITBUCSA
Aphids
Codling moth
IOBMAMA
Walnut husk
fly
Watermelon
1 Ib/A Foliar application. Apply in 10
<8 Ib/gal to 2O gallons of water per acre
SC/L) by aircraft or in 400 gallons of
water per acre by ground equip-
ment. For codling moth apply at
petal fall and repeat at 10 to 14
day intervals as needed.
1 Ib/A Foliar application. Apply in 10
<8 Ib/gal to SO gallons of water per acre
SC/L) by aircraft or in £00 to 300 gal-
lons of water per acre by ground
equipment. Apply after first egg
"stings" occur on husks.
See Cantaloupe cluster.
Issued: £-11-86
III-018£01-9
118
-------
EPA Compendium of Acceptable Uses
PHOSPHOMIDON
Listing of Registered Pesticide Products by Formulation
&089.50O1 89.5% technical chemical
4 phosphamidon (018S01)
OOO10O-00545
&108.0O15 8 Ib/oal soluble concentrate/1iguid
phosphamidon (018201)
O00279-02114 000400-O0386 001526-00431 002935-00359
O070O1-00104 010163-00045 011656-00010 034704-00091
9999999 State Label Registrations
ftZ Reg. No.
010026-05672
Cft Reg. No.
010993-05223
035296-05788
011656-05738
011017^-08193 011159-07333
011656-05681
Special Local Need <24 Registrations
SLN-Wfi-820047 SLN-Wfl-820056*
•"•cancellation in progress
Issued: 2-11-86
111-018201-10
119
-------
IV. BIBLIOGRAPHY APPENDICES
120
-------
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 SPA
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 corresoonds closelv 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.
121
-------
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
122
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosphamidon Standard
MRID CITATION -
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity
of Pesticides and Other Agricultural Chemicals to Honey
Bees: Laboratory Studies. By University of California
Dept. of Entomology. ?: UC, Cooperative Extension,
Leaflet 2287; published study)
00037799 Johansen, C. 1961. Bee poisoning investigations, 1961. Report
No. 8577. (Unpublished study received Mar 26, 1975 under
3125-EX-119; prepared by Washington State Univ., submitted
by Mobay Chemical Corp., Kansas City, MO.; CDL: 094390-1)
00056937 Anliker, R.; Beriger, E.; Geiger, M.; et al. (1961) The Synthesis
of Phosphamidon and Its Breakdown in Plants. A translation of:
Ueber die Synthese von Phosphamidon und Seinen Abbau in Pflan-
zen. (Unpublished study received Dec 15, 1964 under 201-157;
prepared by Ciba, Ltd., Switzerland, submitted by Shell Chemi-
cal Co., Washington, D.C.; CDL:100375-0)
00060625 Johansen, C., and R. Hutt. 1962. Bee poisoning investigations,
1962. Report No. 10617. (Unpublished study received Mar 27,
1974 under 4F1485; prepared by Washington State Univ., sub-
mitted by Chemagro Corp., Kansas City, MO.; CDL: 092011-E)
00060628 Johansen, C.A., and J. Eves. 1965. Bee poisoning investigations,
1965. Report No. G-1705; Report No. 17338. (Unpublished study,
including letter dated Jun 12, 1973 from C.A. Johansen to A.D.
Cohick, received Mar 27, 1974 under 4F1485; prepared by Wash-
ington State Univ., Dept. of Entomology, submitted by Chemagro
Corp., Kansas City MO.; CDL: 092011-1)
00083464 Anliker, R.; Beriger, E.; Geiger, M.; et al. (19??) The Synthesis
of Phosphamidon and Its Breakdown in Plants. Basle, Switzer-
land: Ciba, Limited. A translation of: Uber die Synthese von
Phosphamidon und seinen Abbau in pflanzen. Helvita Chimica
Acta XLIV(VI):1622-1645. (Also in unpublished submission, in-
cluding German text, received Feb 23, 1961 under PP0300, sub-
mitted by California Chemical Co., Richmond, Calif.; CDL:
090339-C)
123
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosphamidon Standard
MRID CITATION
00083474 Graham, O.H. (1961) Letter sent to T. Walter Reed dated Dec 8,
1961 Phosphamidon residues in the muscle and fat of a calf..
(U.S. Agricultural Research Service, Entomology Research Div.,
Livestock Insects Investigations; unpublished study; CDL:
090339-N)
00083475 Chamberlain, ?; Hamilton, ?; Hicks, ? (19??) Studies of Irradia-
tion and Radioactive Insecticides on Flies and Other Anthro-
pods Affecting Man and Animals: Studies on the Metabolism of
C14-Labeled Phosphamidon Given Orally to a Steer. (Unpub-
lished study received Feb 23, 1961 under PP0300; submitted by
California Chemical Co., Richmond, Calif.; CDL:090339-0)
00083482 California Chemical Company (1961) Summary of Typical Phosphamidon
Residue Data in This Petition. (Compilation; unpublished
study received on unknown date under PP0300; CDL:090339-X)
00090331 California Chemical Company (1960) Phosphamidon: Results of Tests
on the Amount of Residue Remaining Including a Description of
the Analytical Method Used. Includes method RM-4 dated Aug
1959. (Compilation; unpublished study received Apr 18, 1962
under PP0300; CDL:090341-G)
00090332 California Chemical Company (1960) Phosphamidon: Milk Residue
Study. (Compilation; unpublished study received Apr 18, 1962
under PP0300; CDL:090341-H)
00090388 California Chemical Company (1963) Summary: Phosphamidon. (Com-
pilation; unpublished study received Feb 14, 1965 under 5G0438;
CDL:090476-C)
00090389 Pack, D.E. (1964) The Appearance and Decay of gamma-Chlorophos-
phamidon in Crops Sprayed with Phosphamidon: File 721.101. (Un-
published study received Feb 14, 1965 under 5G0438; submitted by
California Chemical Co., Richmond, Calif.; CDL:090476-D)
00101264 Ciba Ltd. (1964) Metabolism of Phosphamidon in Plants; Identifica-
tion of Desmethylphosphamidon in Plant Extracts. (Unpublished
study received NOV 1, 1966 under 7F0546; submitted by chevron
Chemical Co., Richmond, CA; CDL:090673-U)
00101266 Ciba Ltd. (19??) Phosphamidon in Tissues and Organs of Two Oxen
Given a Diet Containing 20 ppm of Active Compound. (Unpublished
study received NOV 1, 1966 under 7F0546; submitted by Chevron
Chemical Co., Richmond, CA; CDL:090673-W)
124
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosphamidon Standard
MRID CITATION
00101271 Chevron Chemical Co. (1965) Summary: Phosphamidon Residue Toler-
ance Petition. (Compilation; unpublished study received Nov 1,
1966 under 7F0546; CDL:090674-A)
00101276 Chevron Chemical Co. (1969) Summary: Phosphamidon Residue Tolerance
Petition. (Compilation; unpublished study received Apr I, 1970
under OF0974; CDL:091676-B)
00101284 California Chemical Co. (1964) Method for the Estimation of Des-
methylphosphamidon Residues: Method RM-4D. (Unpublished study
received Feb 23, 1965 under 5G0438; CDL:092727-F)
00101285 Ospenson, J. (1967) Desethyl Phosphamidon Residues: File
No. 741.10. (Unpublished study received Apr 17, 1970 under
7F0546; submitted by Chevron Chemical Co., Richmond, CA; CDL:
092834-D)
00101292 .California Spray Chemical Corp. (1961?) Analysis of Phosphamidon
Residues. (Unpublished study received on unknown date under
PP0300; CDL:098432-G)
00101302 Chevron Chemical Co. (1961) Residue Data for Phosphamidon in
Lemons and Grapefruit. (Compilation; unpublished study re-
ceived Dec 22, 1964 under 239-1865; CDL:101206-A)
00101306 Chevron Chemical Co. (1960) Residue Data for Phosphamidon in Po-
tatoes. (Compilation; unpublished study received Mar 28, 1960
under unknown admin, no.; CDL:119573-B)
00101308 Chevron Chemical Co. (19??) The Analysis of Phosphamidon Residues.
(Unpublished study received Mar 28, 1960 under unknown admin.
no.; CDL:119574-A)
00101310 Univ. of Maryland (19??) Phosphamidon Residue Analysis Method.
(Unpublished study received Mar 28; 1960 under unknown admin.
no.; submitted by Chevron Chemical Co., Richmond, CA; CDL:
119574-C)
00101314 Anliker, R. (1959?) Degradation of Phosphamidon in Plants and Its
Residues in Foods and Feeds. (Unpublished study received Mar
28, 1960 under unknown admin, no.; prepared by Ciba Ltd., sub-
mitted by Chevron Chemical Co., Richmond, CA; CDL:119575-C)
00101315 Chevron Chemical Co. (1964) Residue Data for Phosphamidon in
Eggplant, (compilation; unpublished study received Apr 22,
1964 under unknown admin, no.; CDL:119583-A)
125
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosphamidon Standard
MRID CITATION
00101319 Davis, D.; White, A. (1960) Spray Residue: Phosphamidon. (Un-
published study received Mar 12, 1962 under 239-1506; prepared
in cooperation with Ciba, Ltd., Switz., submitted by Chevron
Chemical Co., Richmond, CA; CDL:119650-A)
00136247 Anliker, R. (1962) Letter sent to L. Gardner dated May 17, 1962:
Phosphamidon, cis-trans isomerism. (Unpublished study received
Nov 1, 1966 under 7F0546; prepared by Ciba Ltd., Switz., sub-
mitted by Chevron Chemical Co., Richmond, CA; CDL:090673-S)
00136262 Chevron Chemical Co. (1963) Phosphamidon Metabolite Residue Study
Summary. (Compilation; unpublished study received Apr 17, 1964
under unknown admin, no.; CDL:119578-A)
00146418 Holson, J. (1985) Teratology Study of Phosphamidon Technical in
Rats: Project No. 283005. Unpublished study prepared by Science
Applications, Inc. 274 p.
00146419 Holson, J. (1985) Teratology.Study of Phosphamidon Technical in
Rats: Project No. 284001. Unpublished study prepared by Science
Applications, Inc. 300 p.
00146420 Holson, J. (1985) Two-generation Reproduction Study of Phosphamidon
Technical in Albino Rats: Project No. 282016. Unpublished study
prepared by Science Applications, Inc. 1256 p.
00146422 Holson, J. (1985) Teratology Study (Seg II) in Albino Rabbits with
Phosphamidon: (Dose Range-Finding Study): Project No. 283006.
Unpublished study prepared by Science Applications, Inc. 76 p.
00146423 Holson, J. (1985) Teratology Study (Seg II) in Albino Rabbits with
Phosphamidon: Project No. 283007. Unpublished study prepared by
Science Applications, Inc. 215 p.
00146424 Holson, J. (1985) Teratology Study (Seg II) in Albino Rats with
Phosphamidon: (Dose Range-finding Study): Project No. 283004.
Unpublished study prepared by Science Applications, Inc. 77 p.
00151145 Geissbuehler, H.; Voss, G.; Anliker, R. (1971) The metabolism of
Phosphamidon in plants and animals. Residue Review 37:39-60.
00153162 Warren, J.; Connor, S. (1985) Leaching Characteristics of Parent
Phosphamidon: Final Report #32451. Unpublished study prepared
by Analytical Bio-chemistry Laboratories, Inc. 37 p.
126
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosphamidon Standard
MRID CITATION
00155166 Westberg, G. (1985?) Determination of Phosphamidon Residues in
Hops. [Method]. Unpublished study prepared by Morse Laborator-
ies, Inc. 3 p.
00157159 Wingard, B. (1986) Twenty Four Month Combined Chronic Oral Toxicity
and Oncogenicity in Rats Utilizing Phosphamidon: Final Report:
Study No. 410/1056. Unpublished study prepared by American Bio-
genics Corp. 4731 p.
00160000 Hudson, P.? Tucker, R.; Haegele, M. (1984) Handbook of toxicity of
pesticides to wildlife: Second edition. US Fish and Wildlife
Service: Resource Publication 153. 91 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40270101 Breslin, J. (1987) Phosphamidon 8E: Dislodgeable Residues on
Potatoes (Leaves and Soil): Lab Study No. 1Q8-253. Unpublished
study prepared by Wildlife Intenational Ltd. 43 p.
40270102 Breslin, J. (1987) Phosphamidon 8E: Dissipation of Dislodgeable
Residues on Citrus (Leaves and Soil): Lab Project ID: 108-254.
Unpublished study prepared by Wildlife International Ltd.
40 p.
40299301 Menzer, R.; Ditman, L. (1963) Effect of environmental factors on
Phosphamidon deqradation. Agricultural and Food Chemistry
11(2):170-173.
40299302 National Cancer Institute (1979) Bioassay of phosphamidon for pos-
sible carcinogenicity. U.S. Department of Health, Education,
and welfare v. 16:1-98. DHEW publication no. (NIH) 79-816.
40299501 demons, G. (1968) Oxidative Metabolism of Phosphamidon in Animals.
Master of Science Thesis. Located in subject file. 2 p.
127
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V. FORMS APPENDICES
128
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OMB Approval No. 2070-0057
Expires 11/30/89
PA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANTS 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. OECO
Chemicals Testing Programme, I enclose the protocols that I will use:
O 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(CH2)(BHii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 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:
D 4. I request that you emend my registration by deleting the following uses (this option is not available to applicants for new products):
O 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA Form 8680-1
SIGNATURE
DATE
129
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OMB Approval No.
Expires 11/30/89
2070-0057
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items) FOR DE VE LOPMENT 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)(6) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
-
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
(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 enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
/
3. My firm has offered in writing to enter into 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 8S80-6
130
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OMB ApprovaI No.
2070-0057
Expi res I I/30/89
EPA Req. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-^
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 j»int
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
. . • ••
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
•
. • •
...•••
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
- -
• • ..
.
EPA Form 8580-4-
1,3-1
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
/
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flairanability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
i
(For EPA Use Only) *
Accession Numbers
Assigned
•
132
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OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number (s) is/are .
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B),
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated: •
(Typed)
133
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