&EPA
United State*
Environmental Protection
Agency
Office of
PMicidei end Toxic SubetanoM
Wachlngton OC 20460
November 1987
PerticidM
Guidance for the
Reregistration of
Pesticide Products
Containing PHOSALONE
as the Active Ingredient
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OMB Control No. 2U7U-UUb7
Expires ll/8y
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PHUSALONE
U977U1
AS THE ACTIVE INGREDIENT
CASE NUMBER 21 .
CAS NO. 23IU-17-U
November, Iyy7
.ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 2U46U
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TABLE OF CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard 3
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Toxicological Assessment
C. Ecological Assessment
D. Environmental Fate Assessment
E. Other Science Findings
F. Tolerance Reassessment
IV. Regulatory Position and Rationale 18
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 28
VI. Requirement for Submission of Generic Data ..30
A. What are generic data? . .
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 36
VIII. Requirement for Submission of Revised Labeling 37
IX. Instructions for Submission 37
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 41
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES 77
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 90
IV. BIBLIOGRAPHY APPENDICES . 113
Guide to Bibliography
Bibliography
V. FORMS APPENDICES .' 135
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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I. INTRODUCTION
This document is a revised Keyistcat ion standard tor
the subject chemical. IP. its original Standard, the Agency-
described the available data Supporting the registration ot
the chemical and its assessment ot those data in terms ot
whether the pesticide met the "no unreasonable adverse ettects"
standard ot the federal Insecticide, fungicide and Rodenticide
Act (t'lt'RA). The Agency concluded that additional data were
necessary to fully evaluate the pesticide and, in issuing the
Standard, required that registrants supply those data. The
Agency also set out label requirements needed to ensure that
products containing the pesticide were labeled adequately to
protect public health and the environment.
The Agency has now received and reviewed the new data
and has updated and revised its scientitic and regulatory
conclusions concerning the pesticide. The Registration
Standard contains the Agency's updated sceintitic assessment
ot this pesticide and its currently registered uses. As part
ot its review, the Agency has reassessed current tolerances
tor the pesticide and has determined whether they are adequate.
The tolerance reassessment is included in this Registration
Standard. The Agency's scientitic assessment is set out in
Section III ot this standard. EPA's regulatory conclusions
are set out. in section IV.
In the intervening period, the Agency has expanded its
data requirements, .and adopted more stringent standards tot-
data acceptability. Rereview ot some studies considered
acceptable at the time ot issuance ot the original Standard
reveals that the studies do not meet current standards. Thus
additional data requirements are identitied in the data
tables in Appendix I.
Based upon the new data, the Agency has also reviewed the
labeling requirements tor this pesticide chemical. New label
requirements are set out in Section IV.U., together with the
schedule tor accomplishing label revisions.
Each registrant who wishes to continue to sell and
distribute a product containing this pesticide must bring his
product into compliance with fIFRA, as instructed in this
revised Registration Standard.
Detailed scientitic reviews are not contained in this
document, but are available upon request-L . These reviews tocus
upon the pesticide active ingredient. The scientitic reviews
1 The scientitic reviews may be obtained trom the Intormation
Services -Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D..C. 2U46U.
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primarily discuss the Agency's evaluations ot data in its files
which pertain to the active ingredient. These reviews also
discuss potential hazards that may be associated with the
end-use products that contain the active ingredient. EPA will
apply the provisions ot this Registration Standard to end-use
products as necessary to protect man and the environment.
In Registration Standard documents, the Agency generally
prescribes steps tor registrants to take to maintain their
registrations in compliance with t'lt'RA. Depending upon the
regulatory position, these steps may include:
1. Submission ot data in support ot product registration;
2. Moditications ot product labels;
3. Moditications to the manufacturing process ot the
pesticide to reduce the levels ot impurities or contaminants;
4. Restriction ot the use ot the pesticide to certified
applicators or other specially trained individuals;
b. Modification ot the uses or formulation types; ot
6. specification ot packaging limitations.
It the registrants tail to comply with these requirements,
EPA may issue a Notice ot Intent to Cancel or a Notice ot Intent
to suspend (in the case ot failure to submit data) the pesticide
registration!s) .
If hazards to man or the environment are identified, the
Agency may initiate a special review, in accordance with 4U Cb'R
Part 154, to examine in depth the risks and benefits ot use ot
the active ingredient. It the Agency determines that the risks
ot the pesticide's use outweigh its benefits, EPA will propose
additional regulatory actions, such as cancellation ot the
uses ot the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
to t'lt'RA sec. 3(c)(2)(B) to require registrants to submit data
concerning the chemical, toxicoiogical, and environmental char-
acteristics and fate ot a pesticide. This document identities
data requirements that EPA believes to be necessary to resolve
its concerns about Phosalone. These requirements are listed
in the Tables A, b, and C in Appendix I. It any registrants
tail to comply with the DCI requirements enumerated in this
Registration Standard, EPA may issue a Notice ot Intent to
Suspend the affected product registrations.
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FIFRA sec. 6(a)(2) requires registrants to submit factual
information concerning possible unreasonable adverse effects
of a pesticide at any time that they become aware of such
information. Registrants must notify the Agency of any
information concerning the pesticide, including interim or
preliminary results of studies, suggesting possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
II . CHEMICAL COVERED BY THIS STANDARD
A. Description of chemical
The following pesticide chemical is covered by this revised
Registration Standard:
Common name: Phosalone (ANSI)
Chemical name (IUPAC): S-6-chloro-2,3-dihydro-2-
oxobenzoxazol-3-yl methyl l),0-diethyl phosphorodi thioate
Alternate Chemical Names: S-[(6-chloro-2-oxo-3(2H)benzoxa-
zolyl)methyl] 0 , (J-diethylphosphorod i th ioate ; 0,0-
diethylphosphorodithioate S ester with 6-chloro-3-
(mercaptomethyl)-2-benzoxazolinone; 0-U-diethyl-S-
[(6-chloro-2-oxobenzoxazolin-3-yl)methyl]phosphorodi-
thioate; S-[6-chloro-3-(me reaptomethyl)-2-benzoxazo-
linone] 0,0-diethylphosphorodithioate; 0,0-diethyl-S-
[6-chloro-3-(me reaptomethyl)-2-benzoxazoli nonej
phosphorodithioate.
CAS Number: 2310-17-0
OPP (Shaughnessy) Number: 097701
Empirical Formula: C]^2H 15C-1-N(->4PS2
Trade names: Azontene; Benzofos; RP11974; Rubitox; ana Zolone
Physical Characteristics of Chemical:
Technical Phosalone
Color: White
Physical State: Crystalline solid
Molecular Weight: 367.8
Melting Point: 45-75°C
. Solubility: At 20°C: 1.7 ppm in water; 20 g/100 ml in methanol
and ethanol; and 10 g/100 ml in acetone, benzene,
cyclohexanone, acetonitrile, xylene, toluene,
dioxane, 'Chloroform, and methyl chloride.
Vapor Pressure: _< 0.5 xlO~6 mmHg at 24°C and 16.4 xlO"6- at 60°C
. Density: 1.391 g/ml at 20°C
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B. Use Profile
Type of Pesticide:
Pests Controlled:
Registered Uses:
Predominant Uses:
Mode of Activity:
Method of Application:
Formulations:
basic Registrant:
Number ot Registrants:
End-Use Registrations:
Formulation
wettable Powder
Emulsifiable Concentrate
Insecticide and acaricide.
Insects and mites
Phosalone is registered on a variety ot
orchard crops, vegetables, roses,
and arborvitae.
Pecans and walnuts
Inhibits the enzyme acetyl cholinesterase
Foliar: ground, and aircraft.
94% Technical
25% Wettable powder
34.4% (31b/gal) Emulsitiabie Concentrate
17.2% (1.351b/gal) Emulsitiable Concentrate
Rhone-Poulenc, Inc.
3
Section 3 Section 24C Intrastate
1
3
16
5
Phosalone is registered for use on almonds, apricots,
apples, artichokes, cherries, grapefruit, lemons, oranges,
walnuts, grapes, nectarines, peaches, filberts, pears, pecans,
plums, prunes, potatoes, roses, and arborvitae.
About 80 percent of the phosalone used annually in the U.S.
is used on pecans. The 580-690 thousand base acres ot pecans
treated each year represents 80 to 90 percent of the total U.S.
pecan acreage. About 4 or 5 applications are made each year,
with the amount of active ingredient used per application
ranging from about 1/2 to 2 pounds active ingredient per acre.
An estimated 2.6 to 3.6 millon acre treatments are made each
year.
The use of phosalone on apples, grapes, walnuts, cherries,
and pears accounts for a large part of the remaining 20 percent
of the annual phosalone usage in the U.S.
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Ill. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all data currently supporting the
registration ot phosalone and has concluded that numerous data gaps
exist. Based on the available data, EPA has reached the tollowing
conclusions. The points summarized below are presented in further
detail, in the context of EPA's science findings and additional
data requirements, in Sections B through D.
1. Technical phosalone is a moderately acute toxic pesticide
tor oral and dermal routes of exposure, Toxicity Category II.
2. Phosalone may have an adverse impact on birds and aquatic
organisms resulting from all use patterns except ornamentals.
Aquatic and terrestial field studies are required to determine
the potential risks to these organisms. Restricted Use labeling
is required on an interim basis due to aquatic toxicity and
avian hazards.
3. Available laboratory data show that technical phosalone
is very highly toxic to fish and aquatic invertebrates.
4.. Preliminary data indicate that groundwater contamination
resulting from phosalone applications is unlikely, but the
Agency is unable to conduct a complete assessment due to data
gaps.
5. Phosalone meets the toxicity and exposure criteria defined
under the Pesticide Assessment Guidelines, Subdivision K, for
reentry. The Agency will retain the current 24 hour reentry
interval based on epidemiological and current agriculture uses.
The Agency has identified the data it believes are
necessary to fully evaluate the human and environmental risks
associated with the use ot phosalone. These data must be sub-
mitted in order to maintain registration of products or to
register new products containing phosalone. A summary of these
data gaps appears in Figure I. Please note that this is only
a summary and complete details can be obtained by referring.
to the tables in Appendix I.
The Agency has also determined that certain label restric-
tions and revisions are necessary. Refer to Section VI.D for
a description of the required revisions.
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FIGURE 1 -DATA GAP TABLE
TOXICOLOGY
Primary Eye Irritation
Dermal Sensitization
Acute Inhalation
Subchronic
Mutagenicity
Teratology
2-Generation Reproduction
De- al Absorption
G»-P a Metabolism
Oncogenicity
ENVIRONMENTAL FATE
Aged Leaching Study
Foliar Dissipation
Rotational Crop (Confined)
Spray Dritt
Soil Dissipation
ECOL
RESIDUE CHEMISTRY
Animal Metabolism
Plant Metabolism
Storage Stability
Residue Studies
PRODUCT CHEM
Product Chemistry
B. TQXICOLOGICAL ASSESSMENT
1. MANUFACTURING FORMULATION
Acute Toxicity
a. Acute oral LD50
Technical phosalone was administered in single oral doses
of 83, 100, 124, 150, 186, or 225 mg/kg. Signs ot toxicit^
included salivation, lacrimation, muscle tasciculation, convul-
sions, and respiratory dysfunction which preceded death. The
LD50 for male rats is 125 mg/kg (102-152) and tor female rats
is 90 mg/kg (68-119). Based on this study the product was
classifiea as moderately toxic and placed in Toxicity Category
II for this route of exposure.
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b. Acute dermal LD50
Technical phosalone was applied as an oil and alcohol
solution to depilated areas of skin to groups of rabbits and
rats. Rabbits were given 0.5 or 1.0 gm/kg, while rats received
100, 200, 600, or 800 mg/kg of phosalone. Signs.of toxicity
were characteristic of cholinesterase inhibition as described
for acute oral toxicity. Deaths occurred within tour days.
Dermal LDSO's were: for rabbits > 1000 mg/kg and tor rats
>390 mg/kg. These data demonstrate that technical phosalone
has a high degree of acute dermal toxicity, placing phosalone
in Toxicity Category II.
c. Acute inhalation LC50
Acute inhalation study requirements for the technical
material have been waived. The physical form of the technical
material is a waxy solid. Particle size data indicates that
93% of the particles analyzed were greater than 100 microns.
Particles less than 15 microns are considered to be within
the respirable range.
d. Neurotoxici ty
Technical phosalone did not produce org.anophosphate type
d.elayed neurotoxici ty in an acute delayed neurotoxici ty study-
in hens. ' •
e. Dermal irritation
Primary dermal irritation data demonstrate that technical
phosalone is a mild skin irritant, placing phosalone in
Toxicity Category IV.
No primary eye irritation or dermal sensitization study
is available. These studies are required tor the technical
material.
Subchronic Toxicity
No acceptable subchronic rat study is available,- however,
an adequate chronic feeding study in the rat is available and
was used to evaluate subchronic toxicity in the rat.
7.
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A partially acceptable subchronic study in dogs is avail-
able. Groups of dogs were fed diets containing 0, 10, or 25 ppm
phosalone toe 6 months, at which time two animals per sex were
sacrificed and the remainder placed on phosalone-free diets for
a further 4 weeks before being sacrificed. No effects on body
weights, food consumption, clinical signs of cholinesterase
inhibition, hematological parameters, or gross or microscopic
examinations were observed. The only effects noted were
depressions of plasma cholinesterase. Although actual compound
intakes were not calculated, these dietary levels corresponded
to approximately 0.25 and 0.625 mg/kg/day, respectively.
A subchronic feeding study is required in the dog to deter-
mine a NOEL (no-observed-etfect level) tor cholinesterase inhibi-
tion due to phosalone.
In a 21-day subchronic dermal exposure study, groups of
New Zealand rabbits were treated tor 3 weeks with concentrations
of technical phosalone providing 0.4, 2.0 and 10 mg/kg/day
applied to both intact and abraded dorsal skin sites. Cholines-
terase activity was decreased in treated females. Both
plasma and red blood cell values were variable, and the only
consistent doserelated depression recorded was in brain values
tor the high-dose females. The NOEL for this study was 2.0
mg/kg/day based upon brain cholinesterase inhibition of 10
mg/kg/d-ay in female rabbits..
Chronic Toxicity
In an acceptable two year feeding study, groups of rats
(30 per sex).were given diets containing 0, 25, 50 or 250 ppm
phosalone. A NOEL of 25 ppm was established in this study based
upon inhibition of erythrocyte cholinesterase at 50 and 250 ppm.
In a 2 year feeding study, groups ot beagle dogs (tour
per sex) were given diets containing 0, 100, 200, or 1000
ppm phosalone. At the highest dose, effects noted were
inhibition of red blood cell and brain cholinesterase activity,
decreased body weight, hypersensitivity, and generalized
muscular tasciculations. A NOEL was not established due to a
reduction in plasma cholinesterase values at the lowest
dietary level, 100 ppm.
Although requirements tor chronic data have been minimally
satisfied in the dog, additional data must be submitted to
establish detinitive no-etfeet-levels for cholinesterase inhibi-
tion in plasma, erythrocyte and tissues (preferably brain).
This requirement can be satisfied by a subchronic dog study.
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Oncogenici ty
The rat chronic study previously described above fails
to adequately assess the oncogenicity of phosalone. The
number of test animals used was insufficient to evaluate the
sensitivity of the assay.
A rat oncogenicity study is required.
A 104-week feeding oncogenicity study in CD-I mice was
reviewed and found to be partially acceptable. Fifty animals
per sex were used. The dietary doses given were U, 5, 50, and
100 ppm. Female mice demonstrated an increased incidence of
leiomyomas and leiomyosarcomas of the uterus and of the
Harderian gland adenomas.
Historical control data must be submitted for these tumor
types in female CD-I mice. Upon receipt of these data, the
'Agency will reevaluate this study.
Reproduction and Teratology Effects
Reproduction
An available three-generation reproduction study w.as
'reviewed and found, to be unacceptable because of serious
deficiencies. Specifically, there was no indication ot
minimal -toxicity at the highest dose and no rationale tor
dose selection, only two doses were tested, 25 and 50 ppm,
whereas at least three doses are currently considered acceptable,
At the lowest dose, no effects were noted.
A two-generation reproduction study in the rat is required.
Teratology
An available rabbit teratogenicity study was reviewed ana
found to be unacceptable. Groups ot 25 pregnant rabbits
received a daily oral gavage dose ot 0, 2, 6, or 18 mg/kg for
10 days during gestation. At no dose of phosalone administered
were there any maternal toxic effects noted, nor any evidence
ot induced fetotoxicity or developmental defects in contrast
to the postive control, thalidomide. Also lacking was any
evidence that a dose sufficiently high enough to affect
clinical, reproductive, or fetal parameters was used.
No data are available to assess teratological effects
in rats.
Teratology studies in both the rat and rabbit are required.
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Mutagenicity
Gene Mutation
A bacterial assay for reverse gene mutation with technical
phosalone was conducted using Salmonella typhimurium strains.
This study was unacceptable because positive controls were not
run concurrently with test strains.
Chromosomal Aberrations
A dominant lethal study was conducted in mice. Five groups
ot ten males each were given a single dose ot 0, 10, 30, or 75
mg/kg phosalone by gavage or an intraperitoneal dose ot 40 mg/kg
ot cyclophosphamiae (reference mutagen) . This study was unaccep-
table because no indication was given that the highest dose
tested produced any clinical or reproductive etfects.
In view ot the unacceptable mutagenicity assays described
above, the Agency is requiring the full minimum battery ot muta-
genicity assays with phosalone be submitted, consisting ot;
1. A mammalian in vitro point mutation test
2. A mammalian in vitro cytogenetics test
3. At least one testFor DNA damage/repair
Metabolism .
No valid metabolism study is available. This study is
required.
Dermal Absorption
A dermal absorption study was reviewed and tound to be
unacceptable. Radiolabeled phosalone, 13.9 mg, was applied
to the skin of a pig. Results of this study indicated that
phosalone does not appear to be absorbed percutaneously;
however, this study was deemed not acceptable because no data
were submitted to substantiate percent ot absorption measured.
2 . END USE FORMULATIONS
Phosalone EC
Available data indicate that the 34% EC tormulation ot
phosalone when tested tor primacy eye irritation in 9 New Zea-
land White rabbits, elicited corneal opacity persisting in 6/6
unwashed and in 2/3 washed treated eyes until day-7. other eye
effects reported were conjunctival pucke.ring (2/6 unwashed),
and a hard white residue around the eye ( 1/6 unwashed and
1/3 washed). All eyes were clear by day-10. Phosalone EC is
characterized as moderately irritating to the eye, placing it
in Toxicity Category II.
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Phosalor.e EC is characterized as being a highly acutely
toxic pesticide. LD50 values calculated at > 480 mg/kg tor
females and 488 mg/kg tor males place this product in Toxicity
Category II tor oral exposure.
Primary dermal irritation data demonstrate that phosalone
LC is. mildly irritating to the skin, Toxicity Category IV, ana
is viewed as being a weak dermal sensitizer.
Phosalone WP
Available data indicate that the 25% WP tormulation of
phosalone when tested for primary eye irritation in y New Zealand
White rabbits, elicted corneal opacity persisting in 6/6 unwashed
treated eyes until day-7. Slight conjunctival irritation was
exhibited in 2 of the washed treated eyes. All eyes were clear
by day-10. Phosalone WP is characterized as moderately irritating
to the eye.
Phosalone WP is characterized as being a highly acutely
toxic pesticide. LD50 values calculated at 48U mg/kg and 6UU
mg/kg for males only, place this product in Toxicity Category
II tor oral exposure.
Primary dermal irritation data demonstrate that phosalone
WP is mildly irritating to the skin, Toxicity Category IV, and
is viewed as being a weak dermal sensitizer'.
C. ECOLOGICAL ASSESSMENT
Aquatic Organism Toxicity
Acute toxicity data indicate that technical phosalone is
very highly toxic to warmwater fish (bluegill) with an LC50 of
50 ppb and is highly toxic to coldwater tish (rainbow trout)
with an LC50 of 630 ppb. Results of an aquatic invertebrate
study conducted with Daphnia magna demonstrated that technical
phosalone was very highly toxic to this species with an LC50
of 1.2 ppb.
The Agency's estimated environmental concentrations (EEC's)
resulting from runoff, drainage, ana dritt of a single maximum
application of phosalone would range from 15 to 138 ppb based
upon current use patterns. These estimated concentrations are
above the lower aquatic LC5U values discussed above.
Transportation of phosalone into aquatic environments could
lead to airect toxicity to fish as well as the loss to tish of
their prey base. The Agency is requiring simulated (e.g., meso-
cosm) , actual field testing, or field monitoring studies to
ascertain the potential impact of transported phosalone to
aquatic environments.
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Avian Toxicity
An acute oral avian study indicates that phosalone, when
administered orally in a single dose, is slightly or practically
nontoxic to birds. The LD50 value tor the mallard duck is
greater than 2150 my/kg.
Subacute dietary toxicity studies on mallard ducks and
bobwhite quail likewise support findings that phosalone is
slightly toxic to birds. The LC50 values calculated tor the
bobwhite quail and for the mallard duck are 2033 ppm and 1659
ppm respectively. A dietary NOEL was calculated tor mallards
to be 562 ppm and for bobwhite quail to be 1000 ppm.
Maximum application rates tor phosalone range tcom 1 Ib
ai/acre to 9 Ib ai/acre, depending upon the crop. Estimated
foliar residues immediately following a single application would
be 125 to 1350 ppm. All use patterns with application rates
at 3 Ib ai/acre and above would exceed one fifth, 332 ppm,
the subacute dietary LC50 value tor mallards calculated
above .
For both species tested, 50 percent mortality occurted
at 1780 ppm. The data suggest that acute effects in the
field are unlikely at maximum application rates or 4 Ib
ai/Acre and below, which would include.ail current use patterns
except tor cherries .and citrus. A potential .tor acute field
effects may exist tor cherries (maximum applicat-ion rate y Ib
ai/Acre) and citrus (maximum application rate 9 Ib ai/Acre).
A field study in citrus to characterize this effect is required.
There are no adequate data for assessing the potential
hazards of repeated applications or the likelihood of chronic
effects. Information is also needed on minimum intervals
between repeat applications and experimental data on the effects
of phosalone on avian reproduction. After evaluation of these
data, field studies in crops other than citrus may be required.
Endangered Species
There are sufficient data to indicate that the current
registered uses of phosalone may affect endangered species.
In aquatic environments, all maximum application rates for
various uses are expected to result in EEC's above the inverte-
brate LC50 value and above 1/20 the fish LC50 values tor the
tested species. In terrestrial environments, the EEC's tor
cherries and citrus applications exceed the NOEL tor mallards
(562 ppm) and for bobwhite quail (1000 ppm). Concerns are reduced
tor other uses but are not eliminated because some terrestrial
endangered wildlife species could be more sensitive than those
that were tested.
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Hazards'to Non-Target Insect-Pollinators
Available data indicate that phosalone is moderately toxic
to honey bees, Apis mellifera, by direct spray contact. Residual
contact for wild bees was studied with the leatcutter bee,
Megachile paci fica, ana the alkali bee, Nornia melanderi. This
study demonstrated that phosalone has a low residual toxicity.
D. ENVIRONMENTAL FATE ASSESSMENT
Environmental Characteristics
Phosalone is stable at pH 5 and 7, but is hydrolyzed at
a pH ot 9 with a half-life of 9 days. Artificial light
accelerated degradation in buffeted solution at a pH ot 5 and
in soil. Aerobic soil metabolism studies demonstrated halt-lite
values of 1-7 days. Field dissipation studies showed halt-life
values ot 1-9 weeks. Phosalone was essentially immobile in a
soil column test. . Based upon this preliminary data phosalone
appears unlikely to contaminate ground water. It exhibited
moderate accumulation in the bluegill sunfish, with rapid
dissipation in untreated waters.
Exposure Incidents
Phosalone is an acetylcholinesterase inhibiting pesticide
whi'ch may present a hazard to persons reentering treated fields.
The Agency has received a number ot poisoning incidents
that suggest that phosalone can cause adverse effects to persons
entering treated fields and to persons involved in the preparation
and application of this pesticide. This evidence is based on
poisoning episodes cited in the Pesticide Information Monitoring
System (PIMS) and reports received from the California Department
of Food and Agriculture (CDFA).
The Pesticide Information Monitoring System lists 12 incidents
involving phosalone. However, eleven of these incidents could
not conclusively implicate phosalone, because ot improper use
of equipment and failure to follow recommended safety regulations.
The one valid incident involved an tieldworker stripping grape
leaves that had been sprayed with phosalone. He was hospitalized
for one day then released.
The California Department of Food and Agriculture (CDFA)
lists 4 incidents involving phosalone; three applicator poisoning
and one fieldworker. No deaths or hospitalizations were reported.
In September 1987, the Agency received notification from
CDFA and from the producer of phosalone of several incidents
involving fieldworker illnesses during harvesting of grapes.
The producer reported that, in three incidents in California
vineyards, 37 workers exhibited symptoms of organophosphate
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poisoning, and that a total of 15 workers were hospitalized.
These poisoning incidents occurred in three ditterent vineyards
in California, according to the report. Preliminary residue
analysis indicated that phosalone levels on foliage ranged
up to 95 ppm and residues of its oxygen analog on foliage
ranged from 6 ppm to 32 ppm. Residues in leaf debris on the
ground were considerably higher (up to 580 ppm phosalone and
75 ppm oxygen analog). Analysis also indicated the presence
of residues of other pesticides. These incidents are still
under investigation by the State of California and the producer
of phosalone.
fcl. OTHER SCIENCE FINDINGS
Phosalone Metabolites
Phosalone-Oxon
An acute oral LD50 stud^ conducted on the oxygen-analog
of phosalone, a known plant and animal metabolite, demonstrated
that the oxon was more acutely toxic than its parent. The LD5U
values were 36 mg/kg tor males and 20 mg/kg tor females, which
place this metabolite in Toxicity Category I tor oral exposure.
Phosalone-Sultone . .
. A study describing the subchronic effects o.t phosalone-
sultone 6-chlorobenzoxazolone in rat, was reviewed and tound
to be unacceptable. Phosalone-sultone was ted at dietary
concentrations equivalent to 0, 5, 15, and 45 mg/kg/day.
This study was unacceptable because ot no clear toxic ettects
were shown and there was incomplete reporting ot the doses
administered and statistical results. No further testing is
required, pending evaluation ot plant and animal metabolism
data.
Emergency Treatment
Current product labeling recommends the use ot atropine
in conjunction with 2-PAM.
In a study to determine the effectiveness, ot cholinesterase
reactivators as antidotes against a lethal dose ot phosalone,
?2S (l-methylpyrid^l-2-aldoxime methyl sultate), an analog ot.
2-PAM, was found to be more effective than atropine when
tested. A combination ot the two (10 or 20 mg/kg atropine
plus 25 or 50 mg/kg P2S) was the most effective treatment.
Rotational Crop
A confined rotational crop study performed under greenhouse
conditions using 14c-phosalone in loam soil was reviewed and
14
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found to be partially acceptable. The study demonstrated
that phosalone and/ or its metabolites can accumulate in
radishes, beans, potatoes, and wheat planted 5.3 to 7.8 months
after soil treatment with phosalone at 3 kg ai/ha.
This study failed to identify residues detected and did not
evaluate multiple applications; for potatoes up to 20 Ib/acre
and for artichokes up to 12 Ib/acre can be applied per season.
F. TOLERANCE REASSESSMENT
1. Tolerances Issued
Tolerances have been established for phosalone on a
variety of raw agricultural commodities, in meat, fat and
meat byproducts (40 CFR 180.263),in processed food (21 CFR
193.340), and in feed (21 CFR 561.300).
2. Residue Data
The residue data reviewed in support of these phosalone
tolerances are:
a. Data on the nature of the residue in both plants
and animals, including identification of major metabolites
and degradates of phosalone.
The nature'of the residue in plants is not completely
understood. Plant studies reviewed in the initial regis-
tration standard either failed to (i) use radiolabeled phosalone;
(ii) provide a l^c-balance; or (iii) identify residues in the
raw agricultural commodity. Data on plant metabolites are
unacceptable because the percentage of characterized metabolites
was below accepted standards. Identified metabolites included
phosalone, its oxygen-analog, 6-chloro-2-oxobenzoxazoline, and
a conjugated glycoside.
The metabolism of phosalone in animals also is not fully
characterized. The sole available ruminant metabolism study
failed to quantify or characterize 14C-residues in tissues.
A goat metabolism study submitted subsequent to issuance of
the 1981 registration standard was found to be unacceptable,
because greater than 40% of the l^C-activity in milk and in
tissues was uncharacterized by TLC and GLC methods.
Metabolism studies in both plants and animals are
required.
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Tolerance (ppm)
Commodity U.S. Canadian Codex
Almond, hulls 50.0
Apples 10.0 5 5
Dried apple pomace 85.0
Apricots 15.0 4 ' -
Dried apricots - 1.2
Artichokes 25.0 15
Cattle, fat 0.25
Cattle, meat 0.25
Cattle, mbyp 0.25
Cherries 15.0 6 10
Citrus fruits 3.0 1.5 1
Citrus pulp 12.0
Goats, fat 0.25
Goats, meat 0.25
Goats, mbyp 0.25
Grapes 10.0 5 5
Dried grape pomace 45.0
Hogs, fat 0.25
Hogs, meat 0.25
Hogs, mbyp 0.25
Horses, fat 0.25
Horses, meat - 0.25
Horses, mbyp 0.25 . -
Nectarines . 15.0
Nuts 0.1 - . . -
Peaches 15.0 4 5
Pears 10.0 2 2
Plums (fresh prunes)15.0 55
Dried prunes 40.0
Potatoes O.l(N) 0.1 0.1
Raisins 20.0
Sheep, fat 0.25 . - 0.5
Sheep, meat 0.25 - 0.05
Sheep, mbyp 0.25
Tea 8.00
a-shell-free
No Mexican tolerances for phosalone have been established.
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Tolerances for residues in or on animal.and plant commodi-
ties are currently expressed in terms of phosalone per se.
On receipt of the required data the adequacy of this tolerance
expression will be reevaluated. If metabolites are found to
be of toxicological concern, the metabolite may be included
in the tolerance.
b. Adequate GLC methods (nos. 54A and 54C) are available
for data collection and enforcement of established tolerances
for phosalone residues in or on raw agricultural commodities and
animal tissues. Method no. 54A has previously been determined,
in the initial registration standard, to be adequate for data
collection and enforcement and is listed in the PAM Vol. II as
enforcement method I.
Both methods have undergone successful method tryouts.
Modifications of method no. 54A permit detection of phosalone
and its o-analog in plant tissue by GLC with electron capture
detection.
Phosalone is recovered by all four multiresidue method
protocols published by NTIS under order No. PB203734/AS.
c. Storage stability data demonstrate that phosalone and
its O-analog are stable in frozen plant tissue for up to
three years.
Storage stability data are required to evaluate the stability
of phosalone and its metabolites in animal tissues.
If, upon receipt of the required metabolism data, the Agency
determines the need to regulate metabolites of phosalone,
additional data on the storage stability of the metabolites
may be required.
d. Data on the magnitudes and levels of residues of phosalone
are sufficient to determine the adequacy of the established
tolerance for residues of phosalone in or on potatoes, citrus,
apples, pears, apricots, cherries, nectarines, peaches, plums
(fresh prunes), dried prunes, grapes, raisins, artichokes,
and the fat, meat, and meat by-products of cattle, goats,
hogs, horses, and sheep.
Additional data are required to assess the need for food/
feed additive tolerances for the following processed products
from raw agricultural commodities bearing measurable, weathered
residues: potato granules and flakes, chips, and wet and dry
peels; and raisin waste and grape juice.
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3. Toxicology
The Agency has established a Provisional Acceptable Daily
Intake (PADI) at 0.0025 mg/kg/day based on a 6-month dog
feeding study in which plasma cholinesterase activity was
depressed. Because a NOEL was not established in this study
a 100-fold uncertainty factor has been used rather than the
10-fold factor normally applied for cholinesterase inhibition.
The anticipated residue contribution (ARC) to the human
diet was calculated based upon anticipated residues obtained
from field residue data, processing data, and percent of crop
treated data.
The ARC for the United States population is 0.001238
mg/kg/day which occupies 49.5% of the PADI. The two highest
calculated exposures based on tolerances and anticipated res-
idues were for non-nursing infants (0.003545 mg/kg/day, 141.8%
of the PADI) and for and children under the age of six
(0.002768 mg/kg/day, 110.7% of the PADI).
The PADI will be reassessed upon receipt and evaluation
of toxicology data enumerated in this standard.
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaulation of all available data and
other relevant information on phosalone, the Agency has made
the following determinations.
1. Special Review.
The Agency is. not placing phosalone into Special Review
at this time. The Agency has insufficient information to
determine whether the criteria of 40 CFR 154.7 are exceeded
for phosalone use patterns. The avian and aquatic field
studies are required to determine actual residue levels in
the aquatic environment and to assess potential risks to
aquatic and avian species.
Rationale; Laboratory data, theoretical calculations and model-
ing indicate that phosalone use patterns could result in residue
levels that would exceed risk criteria for mortality to non-
target fish, birds, mammals, and aquatic invertebrates. The
aquatic and terrestial field studies that are. required will
allow the Agency to assess the potential risks.
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2. Restricted Use.
The Agency is classifying phosalone products as restricted
use pesticides except for products packaged and labeled solely
for use around the home.
Products containing phosalone for use on cherries and citrus .
are restricted due to avian hazards. All use patterns are
restricted due to aquatic toxicity. Use is restricted to
certified applicators or persons under their direct supervision.
Limiting the use to certified applicators will ensure applications
by persons knowledgeable of the hazards to wildlife, thereby
reducing the potential for adverse effects.
Rationale: Pesticide products may be classified as restricted
use if the product, without such restrictions, "may generally
cause unreasonable adverse effects on the environment", which
can reasonably be prevented by classification for restricted
use.
Phosalone is highly toxic to aquatic organisms; for Daphnia
magna the LC50 is 1.2 ppb. The estimated environmental concen-
tration ranges from 15 to 138 ppb for various uses of phosalone,
which far exceeds the lower LC50 value calculated for aquatic
invertebrates.
Phosalone applied at a single maximum application on either
cherries or citrus would exceed not only 1/5 the LC50 value
for mallards, but would also exceed the dietary NOEL for both.
mallards and bobwhite quail.
The application rates and the area generally treated by
the individual homeowner in relation to application rates and
area treated by an agricultural user are not expected to
cause adverse effects on the environment.
3. Aquatic and Avian Field Testing
The Agency is requiring simulated or actual aquatic field
testing unless aquatic residue monitoring studies are conducted
and demonstrate that phosalone and its oxygen-analog do not
occur in aquatic environments near use sites at concentrations
above 0.6 ppb.
Field studies are required for citrus application to
evaluate acute hazard to avian and terrestrial mammalian
species.
Rationale; These studies are needed to assess risks to these
species to determine whether additional regulatory action is
warranted.
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4. Reentry Interval
The Agency will retain as an interim measure the 24-hour
reentry interval required by 40 CFR 170.3, and confirmed by
the 1981 Registration Standard. In light of the reported
California poisoning incidents, the Agency will accelerate
the submission of reentry data on foliar dissipation of
residues, and will give such data priority review upon receipt.
Based on these data, the registrant must propose a reentry
interval, in accordance with Subdivision K Guidelines.
Rationale: Phosalone is a moderately toxic pesticide at the
high end of Tox Category II for dermal and oral toxicity.
Its uses would involve substantial exposure to fieldworkers.
The Agency has received incident data indicating that residues
of this pesticide can cause adverse effects to persons entering
treated sites. This evidence is based on number of poisoning
episodes documented in the Pesticide Information Monitoring
System (12) and by reports received from the California
Department of Food and Agriculture (4).
The Agency is seriously concerned about the recent field-
worker poisonings in California, which may be attributable to
phosalone treatment of grapes. Although the incidents are still
under investigation by the California Department of Food and
Agriculture and the producer of phosalone, EPA believes it prudent
to obtain and review relevant data concerning foliar dissipation
as quickly as possible, so that if revisions to the reentry
interval or other protective measures are warranted, they can
be implemented as soon as possible.
5. Protective Clothing and Equipment
The Agency will require that labels bear statements
requiring the use of protective clothing for pesticide
handlers and workers reentering treated fields. In addition,
the use of human flaggers during aerial application is
prohibited, unless they are in an enclosed vehicle such as
a pickup truck or a tractor with a completely enclosed cab.
Rationale; Because of the acute toxicity of phosalone
and the poisoning incidents cited, specific protective clothing
and equipment are required to minimize exposure of field
workers, applicators, and flaggers.
6. Significant New Food Uses
The Agency will not approve significant new food uses3 of
phosalone until the required toxicity data have been submitted
and evaluated.
3/ Significant new uses as defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will consider
as significant an increase in the Theoretical Maximum Residue
Contribution of greater than one percent.
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Rationale; The residue chemistry and toxicology data
bases for phosalone are not complete. Animal and plant
metabolism data are required as well as data on various
commodities. The required toxicology data include subchronic
feeding, chronic feeding, oncogenicity, teratology, 2-generation
reproduction, mutagenicity and metabolism testing. (Refer to
Appendix I, for a listing of required residue chemistry and
toxicology data).
7. Endangered Species Concerns
The Agency will not require endangered species labeling
for phosalone at this time. However, the Agency has referred
phosalone to the Fish and Wildlife Service to determine
if endangered species may be in jeopardy.
Rationale: There are sufficient data to indicate that
the current use patterns of phosalone may affect endangered
species.
An analysis of pesticides with similar uses to phosalone
revealed that a number of endangered species were found to be
in jeopardy.
In the aquatic environments ', all maximum application rates
for the various uses are expected to result in EEC's above the
aquatic invertebrate LC50 and above.l/20th the fish LC50 for
tested species. These levels indicate potential hazard to
fish, aquatic invertebrates, and endangered species.
In the terrestial environments, all uses except ornamen-
tals may result in EEC's that exceed 1/10 the dietary LC50
for mallards. Application rates for citrus in California and
in Arizona may have EEC's that approach the actual mallard
LC50.
8. Rotational Crop Restriction
The Agency is imposing a 6 month rotational crop
restriction for small grain crops and a 12 month rotational
crop restriction for root crops and leafy vegetables. If
the rotational crop studies for small grains and root crops,
which were only partially acceptable, are repeated, these
restrictions may be modified.
Rationale; The rotational crop restrictions are required
because unidentified residues were detected in a .confined
rotational crop study at up to 7.8 months rotational intervals
following a single maximum application. Multiple applications
of phosalone were not evaluated. The Agency believes it is
prudent to impose the above restrictions until the results of
an additional crop rotational study is evaluated.
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9. Groundwater Contamination
Preliminary data indicate that phosalone is unlikely
to leach through the soil. The Agency is requiring environ-
mental fate studies to fully characterize phosalone's fate in
the environment.
Rationale; A leaching study (unaged portion only)
indicates that phosalone was relatively immobile in sandy
loam, clay loam, and slit loam. Aerobic metabolism studies
demonstrated half-life values of 1-7 days. However the
available data are insufficient to fully characterize the
leaching potential of phosalone. Additional studies are
required.
The Agency has become increasingly concerned about
the presence of pesticide chemicals in ground waters of
the United States. Although phosalone was not included
in the Special Data Call In Notice the Agency issued on
March 31, 1984, the Agency is concerned over the potential
of phosalone to leach. The data required under this Guidance
Document will allow the Agency to characterize the potential
of phosalone to contaminate ground water.
10. Tolerance Reassessment. Based on its review of
currently available data, the Agency has concluded that:
a. Tolerances for the following commodities are.adequately
supported: potatoes, citrus, apples, pears, apricots, cherries,
nectarines, peaches, plums (fresh prunes), dried prunes,
grapes, raisins, artichokes, tree nuts, 'almond hulls, and the
fat, meat, and meat byproducts of cattle, goats, hogs, horses,
and sheep.
. b. Additional data are required to assess the need for
food/feed additive tolerances for the following products
processed from raw agricultural commodities bearing measurable,
weathered residues: potato granules or flakes, chips, wet and
dry peels; raisin waste; and grape juice. If residues are
found to concentrate in these processed foods/feeds, food or
feed additive tolerances will be required.
c. The nature of the residue in both plants and animals
is not completely understood. If, on receipt of the required
metabolism data, the Agency determines that residues of con-
cern in addition to the parent phosalone require regulation,
additional methods for data collection and enforcement will
be needed. Moreover, additional residue data on crops may be
required to measure the level of new metabolites of concern.
22
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d. Crop group tolerances may be established for the Pome
Fruit Group at 10 ppm and for the Stone Fruit Group at 15
ppm.
11. Immediate Review of Studies
The Agency has identified certain data that will receive
priority review when submitted.
Rationale; Certain data are essential to the Agency's
assessment of phosalone. A review of these data may indicate
the need for further studies which should be initiated as soon
as possible (e.g. tiered studies). The following studies have
been identified to receive priority review as soon as they
are received by the Agency:
§158.125-Residue Chemistry - Plant Metabolism
- Livestock Metabolism
- Storage Stability Data
(5158.130-Environmental Fate- Foliar Dissipation
- Aged Leaching Study
§ 158.135-Toxicology - Subchronic 90-Day Feeding (Dog)
- Oncogenicity
- Mutagenicity
§158 .140-Reentry Protection- Foliar Dissipa-tion
S158.145-Wildlife and - Terrestial field studies
Aquatic Organims - Aquatic field studies
- Avian Reproduction
11. Continuation of Registration
While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing phosalone may be sold, distributed, formulated and
used, subject to the terms and conditions specified in this
Standard. Registrants must provide or agree to develop addi-
tional data, as specified in the Data Appendices, in order to
maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data are
missing or inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated,
after which the Agency will determine if additional regulatory
changes are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain Phosalone and bear required labeling,
and conform to the product composition, acute toxicity limits,
and use patterns requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard, manu-
facting-use products (MPs) must contain phosalone as the sole
active ingredient. Each MP formulation proposed for registration
must be fully described with an appropriate certification of limits
stating maximum and minimum amounts of the active ingredient
and inert ingredients which are present in products, as well as
impurties found at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade,
manufacture-use products, and end-use products containing
phosalone provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category in
which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products must be labeled for formulation into other manufact-
uring-use proudcts or into end-use products bearing federally
registered uses. Appendix III list all federally registered
uses as well as as approved maximum application rates and
frequencies.
D. LABELING
All manufacturing-use products and end-use products, must
bear appropriate labeling as specified in 40 CFR 162.10, PR
Notices 83-2, 83-3, and below. Appendix II contains information
on label requirements.
No pesticide product containing phosalone may be released for
shipment by the registrant after November 30, 1988, unless the
product bears an amended label which complies with the require-
ments of FIFRA, as specified in this Standard.
No pesticide product containing phosalone may be distributed,
sold, offered for sale, held for sale, shipped, delivered for
shipment, or received and (having been so received) delivered or
offered to be delivered by any person after November 30, 1989,
unless the product bears an amended label which complies with the
requirements of FIFRA, as specified in this Standard.
24
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ALL PRODUCTS
1. Ingredients Statement
Registrants of all phosalone products are required to revise
their labels to the following format:
ACTIVE INGREDIENT:
Phosalone [S-6-chloro-2,3-dihydro-2-oxobenzoxazol-3-yl methyl
0,0-diethyl phosphorodithioate] %
INERT INGREDIENTS: %
MANUFACTURING-USE PRODUCTS
1. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for uses
accepted by the U.S. Environmental Protection Agency. Labeling
must specify sites for those use patterns listed under Use
Patterns as Appendix III. No uses may be included on any
label where the registrant fails to agree to comply with the
data requirements in TABLE A for that pattern of use.
2. Environmental Hazard Statements .
The following revised environmental hazard statement must
appear on all manufacturing product labels:
"This pesticide is toxic to fish. Do not discharge effluent
containing this pesticide into lakes, streams, ponds, estuaries,
oceans, wetlands, or public waters unless this product is speci-
fically identified and addressed in an NPDES permit. Do not
discharge effluent containing phosalone to sewer systems
without previously notifying the sewage treatment plant
authority. For guidance contact your State Water Board or
Regional Office of the EPA".
3. Precautionary Statements
The following revised precautionary statement must
appear on all manufacturing product labels:
"HAZARDS TO HUMANS AND DOMESTIC ANIMALS
WARNING
"May be fatal if swallowed or absorbed through the skin.
Causes eye irritation. May cause allergic skin reactions in
some individuals. Do not get into eyes, on skin or on clothing.
Wear protective clothing, chemical resistant gloves, and goggles.
or faceshield. Avoid breathing fumes or spray mist".
•H:
25
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END-USE PRODUCT LABELING
1. Restricted Use Statement
The following restricted use statement must appear on
the front panel of all products not intended for or packaged
for use around the home.
"RESTRICTED USE PESTICIDE
Due to Aquatic Toxicity and Avian Hazard
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. Environmental Hazard Statements
The following revised environmental hazard statement
must appear on all end-use product labels:
"This pesticide is toxic to fish. Drift and runoff may
be hazardous to aquatic organisms in neighboring areas.
Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water by
cleaning of equipment or disposal of wastes".
3. Bee Caution Statements
The following revised bee hazard statement must appear
on all end-use product labels:
"This pesticide is toxic to bees exposed to direct
treatment. Do not apply this product while bees are
actively visting the treatment area".
4. Reentry Statement
The following statement must appear on the labeling of
all agricultural end-use products:
"Do not enter treated areas for 24 hours after applica-
tion unless the protective clothing specified is worn"
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5. Protective Clothing and Equipment
The following statements must appear on the label of all
end-use products:
"USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE CLOTHING
AND EQUIPMENT DURING MIXING/LOADING, APPLICATION, REPAIR
AND CLEANING OF MIXING, LOADING, AND APPLICATION EQUIPMENT,
DISPOSAL OF THE PESTICIDE, AND EARLY REENTRY INTO TREATED
AREAS: Protective suit of one or two pieces covering all
parts of the body except head, hands, and feet; chemical
resistant gloves; chemical resistant shoes, shoe covering,
or boots; and goggles or face shield. Wear a chemical
resistant hood or wide-brimmed hat during airblast applica-
tion or when overhead exposure will occur".
IF MIXING/LOADING IS PERFORMED USING A CLOSED SYSTEM,
THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT MAY BE
WORN AS AN ALTERNATIVE: Long-sleeved shirt and long-
legged pants; chemical resistant gloves; chemical
resistant apron; shoes and socks. Goggles or face shield
must be worn if the system is under pressure.
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
long-legged pants; shoes and socks. Chemical resistant
gloves must be available in the cab or cockpit and must
be worn when exiting. This clothing is inadequate to
protect you during equipment repair or cleaning, reentry,
or pesticide disposal work. During equipment repair or
cleaning, reentry, or pesticide disposal work, full
protective clothing must 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.
AFTER WORK: Before removing gloves, wash them with soap
and water. Take off all work clothes and shoes. Shower
using soap and water. Wear clean clothes. Do not reuse
contaminated clothing. Personal clothing worn during
work must be laundered separately form household articles.
Store protective clothing separately from personal clothing,
Clean or launder protective clothing after each use. Cloth-
ing that becomes heavily contaminated or drenched must be
destroyed according to state and local regulations. HEAVILY
CONTAMINATED OR DRENCHED CLOTHING CANNOT BE ADEQUATELY
DECONTAMINATED.
DURING AERIAL APPLICATION, HUMAN FLAGGERS MUST BE IN
TOTALLY ENCLOSED VEHICLE.
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6. Rotational Crop Statement
The following revised rotational crop statements must appear
on all end-use product labels:
11 Do not rotate any leafy or root crop vegetable on soil
treated with phosalone for at least 12 months".
" Do not rotate any small grain crops on soil treated
with phosalone for at least 6 months".
7. Precautionary Statements
The following revised precautionary statement must appear
on all end-use products labels:
"HAZARDS TO HUMANS AND DOMESTIC ANIMALS
WARNING
"May be fatal if swallowed or absorbed through the skin.
Causes eye irritation. May cause allergic skin reactions in
some individuals. Do not get into eyes, on skin or on clothing.
Wear protective clothing, chemical resistant gloves, and goggles.
Avoid breathing fumes or spray mist".
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing the pesticide 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:
4/ 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
fonnulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products.
28
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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 B4
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.
B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product. .
2. If eligible for the formulator's exemption , the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
5/ 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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4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
2. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3. 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.6
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
6/ Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
30
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who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a formulator's exemp-
tion, you may qualify for one if you change your source of
supply to a registered source that does hot 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 registra-
tion 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 regis-
tration 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
31
-------
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
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
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 con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
32
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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 registra-
tion for non-compliance with the PCI. EPA has determined
that, as a general policy, it will not suspend the registra-
tion of a product when the registrant has in good faith
sought and continues to seek to enter into a data development
/cost sharing program, but the other registrants developing
the data have refused to accept its offer. [If your offer
is accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[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) (ii'i) .
The remainder of your offer may not in any way attempt to
limit this'commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI., then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data,
33
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4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your productfs) 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 conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
34
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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.
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 timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
35
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H. PR Notice 86-5 and Any Other Requirements Referenced or
Included within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their"sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
36
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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.
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
7/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.)
37
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Form 8580-1), with appropriate attachments.7
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.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A. you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
38
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d. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
2. Within the time frames set forth in Table A. you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula "(EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies' of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
39
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D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
F. Addresses
The required information must be submitted to the following
address:
Dennis H. Edwards (PM 12)
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 Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
40
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DATA APPENDICES
41
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285.Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
42
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
accordance with data compensation requirements of
t 152, Subpart E.
in
Part
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 onione of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation .
5. Bibliographic citation (Column 5). If the Agency has.
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to'the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 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.
43
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TABLE A
GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF PHOSALONE
Data Reauirement
Test
Substance
Use
Patterns
Does EPA
Have Data?l
Bibliographic
Citation1
Must Additional
Data Be
Submitted?
Time Frame
For
Submission
158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis of TGAI
product Samples
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
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:
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes/2
Yes/3
Yes/4
Yes/5
Yes/5
Yes/5
Yes/5,6
Yes/5,7
Yes/5
Yes/5
Yes/5
Yes/5
Yes/5,8
Yes/5,9
Yes/5
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
64-1- Submittal of samples
TGAI or PAI
All
NO
N/A
NO
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TABLE A
GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF PHOSALONE
S158.120 Product Chemistry-Continued
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier of each beginning material must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
3/ 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.
4/ 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.
<~n 5/ Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
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.
6/ Data needed if the technical chemical is a solid at room temperature.
7/ Data needed if the technical chemical is a liquid at room temperature.
8/ Required if the technical chemical is organic and non-polar.
9/ Required if the test substance is dispersible with water.
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TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSALONE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry
171-4 - Nature of Residue
(Metabolism)
- Plants
PAIRA
Partially
- Livestock
171-4 - Residue Analytical
Methods
- Plant and Animal
Residues
PAIRA & Plant
Metabolites Partially
TGAI &
Metabolites
Yes
ON
171-4-Storage stability data
PAI and
Metabolites
Partially
00006386, 00006675
00062878, 00062879
05013895, 05014688
00006125, 00006791
05016356.
00006715, 00006974
00064523.
05016979,
00006703,
00006762,
00053758,
40259201,
00006700,
00086695,
00064522,
00064525,
00064530,
00006383,
00144442,
05003635,
05007745,
05009309,
05016979.
00006979
00006129
00006105
00006083
00006678
00006701
00062880
00064524
00064528
00064634
00109468
00159274
05007744
05008190
05016356
00062881, 00006968
05014548, 00006698
00006113.
Yes/1
18 Months
Yes/2
No/3
18 Months
Yes/4,5
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS K)k PHOSAlJONE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
$158.125 Residue Chemistry
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Field Trials
- Root and Tuber
Vegetables Group
o Potatoes
- Citrus Fruit Group
-^ -Pome Fruit Group
o Apples
TEP
TEP
Partially
Yes
TEP
Yes
o Pears
TEP
Yes
00006395, 00005576.
00006511, 00057510
00057511.
00006707, 00006388
00006783, 00006711
00o060b4, 00006712
00086695.
00006714, 00006392,
Yes/6, 11
No/11
No/11
No/11
18 Months
-Stone Fruit Group
o Apricots
o Cherries
TEP
TEP
Yes
Yes
00006194, 00006195, No/11
00006196, 00006197,
00006198, 00006483.
00006194, 00006195, No/11
00006196, 00006197,
00006198, 00006389,
00006484.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSALONE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry
171-4 - Magnitude of the Residue-
Residue Studies for Each
Pood Use
- Crop Field Trials
-Stone Fruit Group (continued)
o Nectarines TEP
CO
o Peaches TEP
o Plums
(fresh prunes) TEP
-Small Fruits and Berries
Group
o Grapes TEP
o Tree Nuts Group TEP
Yes
Yes
Yes
Partially
Yes
00006194, 00006195, No/11
00006196, 00006197,
00006198, 00006485.
00006194, 00006195, No/11
00006196, 00006197,
00006198, 00006391,
00006486, 00035788.
00006194, 00006195, No/11
00006196, 00006197,
00006198, 00006487,
00006769.
00006390, 00006480, Yes/7,11
00006707, 00006708,
00006713.
00006358, 00006511, No/11
00098485.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry- contined
171-4-Magnitude of the Residue-
Residue Studies for Each
Food Use
-Crop Field Trials
-Miscellaneous Commodities
o Artichokes
o Tea
TEP
TEP
Yes
Partially
00006964, 00057508
00034721.
00006209, 00006210
00006735.
No/11
Yes/8, 11
18 Months
-Meat/ Milk/
\O Poultry/ Eggs TGAI or Yes 00064524,
Plant Metabolite 00006972,
00006974,
00006971,
00006761,
00006120,
00006717,
00006978
00006973
00006975
00006071
00006792
00006123
00006073.
No/9, 10
I/ The uptake, distribution and metabolism of phosalone must be studied in almonds, apples, and potatoes following
multiple foliar treatments with ^4C-ring-labeled phosalone at rates sufficiently high to permit complete
characterization of ^^C-residues in mature almond hulls and nutmeats, apples, and potato tubers. Samples must
be collected at the minimum permissible interval after the last treatment in accordance with registered uses
(0-day-potatoes; 14 days-apples; 60 days-almonds). Almond samples should also be collected immediately after
the last treatment and after 30 days to adequately represent registered uses on other tree nut crops (filberts,
pecans and walnuts). Representative samples from these tests must also be analyzed by enforcement methods
currently in use to ascertain that the methods are capable of adequately recovering and quantifying all
residues of concern.
-------
TABLE A
GENERIC DATA RhXJUiRJ'MENTS FDR PHOSALONE
§158.125 Residue Chemistry-Centinued
2/ Metabolism studies using ruminants and poultry must be submitted. Animals must be dosed for 3 days with
l^c-ring-labeled phosalone at a level sufficiently high to permit complete identification and quantification
of 14 C-residues. Milk and eggs must be collected twice daily during the dosing period. Animals must be
sacrificed within 24 hours of the final dose. The distribution and characterization of residues must be
determined in milk, eggs, liver, kidney, muscle and fat. Samples from these studies must also be analyzed
using enforcement methods currently in use to ascertain that the methods are capable of adequately recovering
and quantifying all residues of concern. [It should be noted that if metabolism in ruminants or poultry is
found to differ significantly from that in rats, additional metabolism data for swine may be required.]
3/ No additional data are required at present. It should be noted, however, that if the requested metabolism
studies indicate the need to collect data for or regulate metabolites of phosalone, additional methods for data
collection and/or enforcement may be required.
4/ Samples of fat, muscle, liver, milk, and eggs must be fortified with phosalone, sampled and analyzed immediate-
ly, stored frozen for the time periods equivalent to those used in all previously-submitted feeding studies,
and reanalyzed.
5/ If, on receipt of the required metabolism data, the Agency determines the need to collect data for or regulate
metabolites of phosalone, additonal storage stability data may be required.
6/ Data must be submitted depicting residues in granules or flakes, chips, and wet and dry potato peel processed
from potatoes bearing measurable, weathered residues. If residues concentrate in any of these processed
commodities, appropriate food/feed additive tolerances must be proposed. It may be necessary to use exaggerated
rates to obtain measurable residues in the raw agricultural commodity.
7/ Data depicting residues in raisin waste and juice processed from grapes bearing measurable, weathered residues.
If residues concentrate in either of these processed commodities, appropriate food/feed additive tolerances must
be proposed.
8/ The registrant must submit copies of labels for all phosalone formulations (accompanied by English translations)
that are used on tea in tea-producing countries that export to the United States.
O
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSADONE
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Fiame
fot
Submission
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
CJl
rv>
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Aged leaching
study
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
A,B
A,B
A,B
Yes
00006067
Yes
05009356, 00006666
05008305, 00006664
00006770, 00006649
00006385, 00006791
Partially 00006663
No
A,B
A
A
Yes
Yes
No
00006665
00006666
No
No
No/1
No
A
A
A
•Partially 05009356
No
No
No/ 2
No/1
No/1
Yes/3
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSALONE
Data Requirement
§158.130 Environmental Fate -
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Test
Substance
Continued
TEP
TEP
TEP
TEP
TEP
TEP
Use Does EPA Bibliographic
Patterns Have Data? Citation
A No
A No
A,B Yes 00137036
A,B No
A,B No
A,B No
Must Additional
Data be
Submitted?
No/4
No
No
No/1
No/1
No/ 5
Time Ftame
fot
Submission
Tank Mixes
164-5 - Soil, Lonq-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irriqated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Tarqet
Orqanisms
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
No
Partially 00006664
No
A
A,B
A,B
.No
Yes
No
No/6
Yes/7
Reserved/8
No/1
00115113, 00115114 No
00164511
No/1
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
§158.130 Environmental Fate - Continued
I/ Not required based on the use pattern of phosalone.
2/ Data which will be obtained from the leaching study (163-1) will be used to supplement existing data on aerobic soil
metabolism.
3/ A column leaching study on aged phosalone is required. The column should be leached with 1/2 inch water (preferably
0.01 - 0.02 N calcium chloride solution) per day for a minimum of 45 days. Adequate identification of leached
residues in soil and eluate is required. Leaching study conducted on unaged phosalone was acceptable.
4/ This study is not required because of the low vapor pressure of phosalone (<0.5 x 10~6 mm Hg at 24°C).
5/ Tank mix data requirements are not being imposed.
6/ A long term soil study is not required because of the rapid dissipation rate of phosalone.
7/ Confined rotational crop study on leafy vegetables is requited.
8/ Reserved pending results of confined crop rotational study.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
Date
§158.
Requirement
135 Toxicology
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic Must Additional Time Frame
Citation Data be for
Submitted Submission
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Delayed
Neurotoxicity - Hen
TGAI
TGA1
TGAI
TGAI
A,B
A,B
A,B
A,B
Yes
Yes
No
Yes
00006716, 05007746 No
00006643
05007746, 00006643 No
No/1
00137037, 00137038 No
SUBCHRONIC TESTING:
82-1
LTI
LTI
82-2
82-3
82-4
82-5
- 90-Day Feeding:
- Rodent, and
- Non- rodent (Dog)
- 21-Day Dermal - Rabbit
- 90-Day Dermal - Rabbit
— 90-Day Inhalation:
- Rat
- 90-Day Neurotoxicity:
- Hen
-Mammal
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
No
Partially
.Yes
No
No
NO-
NO
No/2
00006684 Yes/3
00115115 No
No/4
No/5
No/6
No/6
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
Data
§158.
Requirement Test
Substance
135 Toxicology - Continued
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
CHRONIC TESTING:
83-1
83-2
83-3
cn
ON
83-4
- Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
- Oncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
- Teratogenicity - TGAI
2 species:
- Rat
- Rabbit
- Reproduction - Rat TGAI
2-generation
A,B Yes 00006202
A,B Partially 00006203
A,B No
A,B Partially 00065653
A,B No
A,B No
A,B No
No
Reserved/ 7
Yes/8
Yes/8,9
Yes
Yes
Yes
•— •
50 Months
50 Months
15 Months
15 Months
39 Months
MOTAGENICITY TESTING
84-2
84-2
- Gene Mutation (Ames Test) TGAI
- Structural Chromosomal TGAI
A,B No
A,B No
Yes/ 10
Yes/ 10
9 Months
12 Months
Aberration
84-4 - Other Genotoxic Effects
TGAI
A,B
No
Yes/10
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
Data
§158
Requirement Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
.135 Toxicoloqy - Continued
Must Additional
Data be
Submitted?
Time Frame
for
Submission
SPECIAL TESTING
85-1
85-3
- General Metabolism PAI or PAIRA A,B No
- Dermal Absorption TGAI A,B No
Yes
Yes
24 Months
I/ Not required based on particle size analysis.
2/ Although an adequate subchronic rodent study is not available, this study will not be required since an
adequate chronic rodent study is available.
3/ A special subchronic study is required in the dog to determine a NOEL for cholinesterase inhibition,
since a NOEL was hot determined for this effect in any dog study.
4/ Due to the present use patterns of phosalone and the adequacy of the 21-day dermal study a 90-day study
is not required at this time.
5/ Because of its physical characteristics, no significant inhalation hazard is anticipated from the
manufacture and use of phosalone.
6/ This study is not required because acute neurotoxicity study was negative.
-------
TABLE A
GENERIC DATA REQUIREMEtfrS FOR PHOSALQNE
§158.135 Toxicology - Continued
7/ This study did not establish definitive no-effect-levels for cholinesterase inhibition in plasma, erythrocyte,
and brain tissue.
A special subchronic dog feeding study is required in lieu of a new chronic dog feeding study. This study must
establish definitive no-effect levels for cholinesterase inhibition in three coiri:>artjnents—plasma, erythrocyte,
and brain tissue. A new chronic study is deferred pending the results of the subchronic study.
8/ Registrants who conduct chronic feeding and/or oncogenicity studies should inform the Agency in writing of the
dosage levels planned and their reasons for believing that the highest dose approaches or equals the Maximum
Tolerated Dose observed in subchronic or range finding studies, and must also consult with the Agency to
determine that the appropriate dosage levels are being used in the chronic feeding and/or oncogenicity studies.
If EPA subsequently determines that the study was conducted using a dosage rate that was too low to assess
long-term effects, the study may be deemed not to satisfy the data requirement.
9/ Historical control data are required on the incidence of leiomyomas and leiomyosaroomas of the uterus and
Harderian gland adenomas in female CD-I mice.
10/ The full minimum battery of mutagenicity assays is required to be submitted. These consist of mammalian
in vitro point nutation, a mammalian in vitro cybernetics test and at least one test for DMA damage/repair.
CO
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSALONE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Fiame
for
Submission
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
TEP
TEP
TEP
TEP
TEP
TEP
ABEF
A
ABEF
ABEF
A,B
A,B
Partially
No
No
No
No
No
05005243, 05003635
05001343, 05007744
05007745, 05008190
05021646.
Yes/I
Yes/2
No/3
No/3
Yes
Yes
15 Months
27 Months
12 Months
12 Months
I/ This study must be conducted in accordance with Subdivision K of the Pesticide Assessment Guidelines. Specifically,
the study must be conducted in California, under hot, dry conditions representative of worst case exposures.
Testinq mast be done on qrapes, and residues must be analyzed for phosalone, its oxygen analog and other
toxic deqradates, at intervals of 1, 2, 5, 7, 14, 21, 28, 35, 60 and 90 days after last treatment.
Soil dissipation data are required only for uses where workers will be exposed directly to substantial quantities
of soil durinq their work activity, for example use on potatoes where hand harvesting will be performed.
3/ Human exposure monitoring data may be submitted at the registrant's option. If dermal exposure data are submitted,
inhalation exposure data must also be submitted.
-------
TABLE A
GENERIC CATA REQUIREMENTS FDR PHOSALONE
Data
§158.
Requirement Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
,145 Wildlife and
Must Additionl Time Frame
Data be for
Submitted? Submission
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
71-5
- Acute Avian Oral Toxicity TGAI A,B Partially 00115116
- Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and A,B Yes 00115117
-Waterfowl A,B Yes 00115118
- Wild Mammal Toxicity TGAI A,B No
- Avian Reproduction TGAI
- Upland Game Bird, and A,B No
- Waterfowl A,B No
- Simulated TEP A,B No
Field Testing for
Birds and Mammals
- Actual Field TEP A,B No
Testing for Birds
Mammals
No/1
No
No
No/2
Yes
Yes
No
Yes/ 3
24 Months
24 Months
6 Months
[protocol]
30 Months
(citrus)
ON
O
Reserved/4
-------
TABLE A
GENtlRIC DATA REQUIREMENTS FOR PHOSALONE
Data
§158
Requirement
.145 Wildlife and
Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1
72-2
72-3
ON
72-4
- Freshwater Fish Toxicity
- Coldwater Fish Species,
and
- Warmwater Fish Species
- Acute Toxicity to
Freshwater Invertebrates
- Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Oyster
- Shrimp
- Fish Early Life Stage,
and
- Aquatic Invertebrate
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
. Yes 00115119
Yes 40094602
Yes 00115120
Yes 40094602
Yes 00115121
,No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes/5
Yes/6
Reserved/7
Yes/6
Reserved/7
Yes/6
Reserved/7
Yes/8
Yes/8
9 Months
12 Months
12 Months
12 Months
15 Months
15 Months
Life-Cycle
72-5 - Fish - Life-Cycle
TGAI
A,B
No
Reserved/9
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
(5158.145 Wildlife and
Aquatic Organisms - Continued
12-6 - Aouatic Organism
Accumulation
TGAI, PAI OR
Degradation
Product
- Fish
72-7 - Simulated Field Testing TEP
- Aquatic Organisms
Actual Field Testing TEP
-Aquatic Organisms
Aquatic Residue TEP
Monitoring Study
A,B
A,B
A,B
A,B
Yes/10 00164511
No
No
No
NO
Yes/11
Yes/11
Yes/11
6 Months
[protocol]
48 Months
6 Months
[protocol]
48 Months
6 Months
[protocol]
24 Months
ON
fX)
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSALONE
§158.145 Wildlife and Aquatic Organisms - Continued
I/ This study was not fully acceptable. However, the slight toxicity demonstrated and other avian data reviewed do
not indicate a need for repeating this study.
2/ No requirement currently exists.
3/ Actual field testing with birds and mammals is required as per 40 CFR 158.145, to support the use of
end-use products containing phosalone on citrus in California and Arizona. The design of the field study must
include appropriate methods, such as thorough carcass searching, to determine whether there is pesticide-induced
mortality and, if so, the extent of mortality. A protocol for conducting the field study should be submitted
to the Agency for review and approval prior to the initiation of the study. A Guidance Document is available
from the Agency, which outlines an acceptable approach to these studies. The Agency encourages registrants
to consult with EEB staff for assistance as needed.
4/ Actual field testing with birds and mammals is required, as per 40 CFR 158.145, to support the use of
phosalone products on any crops where the estimated environmental concentrations (EEC'S) exceed the effect
levels, if any, that are determined for the more sensitive species in the required avian reproduction
tests. Unless actual residue and residue decline data that are applicable to wildlife food sources (e.g., c
foliar and insect residues) are submitted, EEC's will be estimated based on initial residues from the RF.R
nomograph, the minimum spray interval for the particular use, and the maximum half-life for foliar dissipation.
C^ The Agency will determine which crops need to be tested after receipt and evaluation of avian reproduction
L^ study.
The design of the field studies must include appropriate techniques to determine the potential field effects
on reproduction and populations of birds and mammals in a multiple year study. Protocols for conducting
field studies should be submitted to the Agency for review and approval prior to the initiation of the
studies. A Guidance Document is available from the Agency, which outlines an acceptable approach to these
studies. The Agency encourages registrants to consult with EEB staff for assistance, as needed.
5/ Required to support all crop uses because EEC's on technical phosalone exceed the aquatic invertebrate LC50.
6/ Required to support use on citrus because of potential exposure of estuarine/marine environments through
runoff, drainage, and drift.
7/ Reserved pending the results of acute toxicity testing with technical phosalone on marine/estuarine organisms.
Required if such testing results in LC50 value(s) that is (are) below the EEC in estuarine/marine environments.
8/ Required to support all crop uses because the acute toxicity of technical phosalone is less than 1 mg/L
and because the EEC in water is greater than 0.01 times the acute LC50.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PHOSALONE
§158.145 Wildlife and Aquatic Organisms - Continued
9/ Reserved pending the results of fish early life stage and aquatic invertebrate life-cycle tests.
10/ Data submitted under §158.130 guideline series 165.4, accumulation in fish, satisfies this requirement.
ll/ Simulated or actual field testing with aquatic organisms is required unless aquatic residue monitoring
studies are conducted and demonstrate that phosalone and phosalone-oxon do not occur in aquatic environ-
ments near use sites at concentrations above 0.6 ppb. If aquatic residue studies are conducted, they must
include pecans as a high use crop and citrus (AZ/CA) or cherries as a high rate crop, with residue studies
on other crops reserved pending the results. For each use pattern, multiple independent sites are to be
monitored. Each site is to be located in an area where there is a maximum potential exposure due to soil
type, proximity to aquatic habitats, and percentage of the local area crop treated with phosalone. Residues
must be monitored in receiving water and should be monitored in runoff or drainage water, if feasible.
Protocols should be submitted to the Agency for review and approval prior to the initiation of the monitor-
ing studies.
If aquatic residue monitoring studies are not conducted, or show aquatic concentrations greater than 0.6
ppb, then mesocosm studies are preferred and would support all use patterns. Alternatively, full field
studies may be conducted in pecans and walnuts to support these uses. Additional full field studies for
other use patterns are reserved, pending an evaluation of the results for pecans and walnuts and an
analysis of their applicability to support other crop uses. For either mesocosm or full field studies the
study design must include appropriate techniques to determine acute mortality and effects on productivity
and diversity of fish and aquatic invertebrates. Protocols for conducting residue monitoring, mesocosm,
or full field studies should be submitted to the Agency for review and approval prior to the initiation of
the study. A Guidance Document is available from the Agency, which outlines an acceptable approach to
mesocosm studies. This document also provides relevant, although general, guidance for full field studies,
which, if selected in place of mesocosm studies, must include multiple treated ponds and control ponds.
The Agency encourages registrants to consult with FTTO staff for assistance as needed.
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PHOSALONE
Data
§158.
121-1
Requirement Test Use . Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for -
Submitted? Submission
150 Plant Protection
- TARGET AREA EP All No
PHYTOTOXICITY
NO/1
NONTARGET AREA PHYTOTOXICITY
122-1
ON 122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI All No
Seedling Emergence
- vegetative Vigor TGAI All No
- Aquatic Plant Growth TGAI All No
TIER II
- Seed Germination/ TGAI All No
Seedling Emergence
- Vegetative Vigor TGAI All ' No
- Aquatic Plant Growth TGAI All ' No
TIER III
- Terrestrial Field TEP All No
- Aquatic Field TEP All No
NO/1
NO/1
NO/1
NO/1
NO/1
NO/1
NO/1
NO/1
I/ Not required for insecticides and acaricides.
-------
. TABLE A
GLNER1C DATA REQUIREMENTS FOR PHOSALDNE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be tor
Submitted? Submission
ON
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATC
143-3 AND PARASITES
TGA1
TEP
A, B
A, B
Yes
Yes
00006653, 00006054
00006793, 00139544
00006793
TEP
A, B
No
No
No
Reserved/1
No/2
Reserved/3
Reserved/3
Reserved/3
Reserved/3
-------
TABLE A
GENERIC DATA REQUIRLMhtsTTS FOR PHOSALONE
§158.155 Nontarget Insect- Continued
I/ Reserved pending development of methodology.
2/ As data from the acute and residual test indicated low to moderate toxicity, no further testing is required.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
ON
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSALONE
Data Reauirement
Test
Substance
Use
Pattern
Does
Have
EPA Bibliographic Must Additional Time Frame
Data?l citation-1- Data Be For
Submitted? Submission
158.120 Product Chemistry
CO
Product Identity and Composition
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
All
All
All
No
No
NO
N/A
N/A
N/A
Yes/2
Yes/3
Yes/4
6 Months
6 Months
6 Months
Ingredients
62-1
62-2
62-3
- Preliminary Analysis
- Certification of Limits
- Analytical Methods to Verify
Certified Limits
MP
MP
MP
All
All
All
NO
NO
NO
N/A
N/A
N/A
Yes/5
Yes/6
Yes/7
12 Months
12 Months
12 Months
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
- Color
- Physical State
- Odor
- Density, Bulk Density, or
MP
MP
MP
MP
All
All
All
All
NO
NO
NO
NO
N/A
N/A
N/A
N/A
Yes/8
Yes/8
Yes/8
Yes/8
6 Months
6 Months
6 Months
6 Months
Specific Gravity
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSALONE
Data Reauirement
Test
Substance
Use
Patterns
Does EPA
Have Data?3
Bibliographic
Citation3
Must Additional
Data Be
Submitted
Time Frame
For
Submission
ON
158.120 Product Chemistry (continued)
63-12 - DH MP
63-14 - Oxidizinq or Reducing Action MP
63-15 - Flammability MP
63-16 - Explodability MP
63-17 - Storage Stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP
63-20 - Corrosion Characteristics MP
Other Requirements;
" \ ' Y " :
t64-1 - Submittal of samples MP
All
All
All
All
All
All
All
All
All
NO
NO
NO
NO
NO
NO
NO
NO
NO
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes/8,9
Yes/8,10
Yes/8,11
Yes/8,12
Yes/8
Yes/8,13
Yes/8,14
Yes/8
No
6 months
6 months
6 months
6 months
15 months
6 months
6 months
15 months
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted, in addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and
purpose of the active ingredient and each intentionally added inert must be provided. For the active ingredient,
the following must also be provided; the product name, trade name, and common name; the molecular, structural,
and empirical formulas; the molecular weight or weight range; and any experimental or internally assigned company
code numbers.
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, eauipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, the name
and address of the manufacturer, producer, or supplier of each beginning material must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
4/ A detailed discussion of all impurities that are or may be present at X).l%, based on knowledge of the begin-
ning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and aftej: production must be submitted.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSALONE
5158.120 Product Chemistry-Continued
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
6/ upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at X).l% (w/w) and each "toxicologically significant" impurity present at <0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and
precision data have been provided. Limits for impurities not associated with the active ingredient need be
provided only if they are considered to be of toxicological significance, regardless of the concentration at
which they are present. Certifications must be submitted on EPA Form 8570 Rev. 2-85.
7/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which certified limits are required. Each method must be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement
of certified limits.
8/ Physicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing
action, flammability, explodability, storage stability, viscosity, miscibility, and corrosion characteristics)
as required in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D
must be submitted.
9/ Required if the test substance is dispersible with water.
10/ Required if the product contains an oxidizing or reducing agent.
ll/ Required if the product contains combustible liquids.
12/ Required if the product is potentially explosive.
13/ Required if the product is a liquid.
14/ Required if the product is a liquid and is to be diluted with petroleum solvents.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PHOSALONE
Data
§158.
Requirement Test
Substance
135 Toxicology
Use Does EPA Bibliographic Must Additional
Pattern Have Data? Citation Data be
Submitted?
Time Frame
for
Submission
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP
- Acute Dermal Toxicity MP
- Rabbit
- Acute Inhalation Toxicity MP
- Rat
- Primary Eye MP
Irritation - Rabbit
- Primary Dermal MP
Irritation - Rabbit
- Dermal Sensitization - MP
Guinea Pig
A,B Yes 00006716, 05007746 No
00006643
A,B Yes 05007746, 00006643 No
A,B No No/1
A, B No Yes/2
A,B, Yes 00101506 No
A,B "No Yes/3
9 Months
9 Months
I/ Waived based on particle size analysis. Analysis showed that particle size distribution was not within
the respirable range.
2/ Previously accepted study was rereviewed and found to be unacceptable, because it does not allow for an
assessment of reversibilty of effects, and does not meet current guidelines.
3/ A recently submitted dermal sensitization study was considered to be inadequate.
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS' FOR END USE PRODUCTS CONTAINING PHOSALONE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data?1 Citation1
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and EP
Disclosure of
Ingredients
61-2 - Description of Beginning EP
Materials and
Manufacturing Process
61-3 - Discussion of Formation EP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis EP
62-2 - Certification of Limits EP
62-3 - Analytical Methods to Verify EP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color EP
63-3 - Physical State EP
63-4 - Odor EP
All
All
All
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes/2
Yes
Yes
Yes
Yes
Yes
6 months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END USE PRODUCTS CONTAINING PHOSALONE
Data Requirement Test
Substance
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flanmability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements:
64- 1 - Submittal of samples
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Use Does EPA
Pattern Have Data?1
All
All
All
All
All
All
All
All
All
All
Bibliographic
Citation1
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No3
Time Frame
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS frXDR END USE PRODUCTS CONTAINING PHOSALONE
§ 158.120 Product Chemistry - continued
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each manufacturing use product. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ Required if source of any active ingredient in end use product is an unregistered pesticide. Five or more represen-
tative samples must be analyzed for the amount of active ingredient and each impurity for which a certified limit
is required. Complete validation data (accuracy,. poioLsLou) mist l?e submitted for each analytical method used.
3/ Samples of the product are required only if the Agency specifically requests them.
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS
CONTAINING PHOSALONE AS AN EMJLSIFIABLE CONCENTRATE
Data
§158.
Requirement Test
Substance
135 Toxicology
Use . Does EPA Bibliographic
Pattern . Have Data? Citation
Mast Additional Time Frame
Data be for
Submitted? Submission
ACUTE TESTING
81-1
81-2
8.1-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat EC
- Acute Dermal Toxicity EC
- Rabbit
- Acute Inhalation Toxicity EC
- Rat
- Primary Eye EC
Irritation - Rabbit
- Primary Dermal EC
Irritation - Rabbit
- Dermal Sensitization - EC
Guinea Pig
A,B Yes 00137882
A, B Yes 00006689
A,B No
A,B Yes 00101511
A,R, Yes 00101512
A,B No . 00101513
No
No
Yes /I 9 Months
No
No
No
I/ Previously submitted study is unacceptable, because the duration of exposure was inadequate
to evaluate this route of exposure.
-------
TABLE C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR EMD-USE PRODUCTS
CONTAINING PHOSADDNE AS A WETTABLE POWDER
Data
§158.
Requirement Test . Use Does EPA Bibliographic Must Additional
Substance Pattern Ha've Data? Citation Data be
Submitted?
135 Toxicology
Tiire Frame
for
Submission
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat WP A,B. Yes 00137881 No
- Acute Dermal Toxicity WP A,B Yes 05007746, 00006643 No
- Rabbit
- Acute Inhalation Toxicity WP A, B No Yes/1
- Rat
- Primary Eye WP A,B Yes 00101508 No
Irritation - Rabbit
- Primary Dermal WP A,B, Yes 00101509 No
Irritation - Rabbit
- Dermal Sensitization - WP A,B • Mo 00101510 No
Guinea Pig
.
t
9 Months
I/ Previously submitted study is unacceptable, because the duration of exposure was inadequate
to evaluate this route of exposure.
ON
-------
LABELING APPENDICES
77
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. L40 CFR 162.10(d)j
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)j
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.
L40 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)j
78
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point b 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. L40 CFR 162 .10(h) (1)(ii)j
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. L4Q CFR 162.10 (h)(l)(i)J
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. L40 CFR 162.10(h)(1)(i)J
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
L40 CFR 162.10(h)(l)(iii)J
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. l_40 CFR 162.10(h ) (2 ) ] .
79
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHtM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations ana
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all" pesticide formulations/uses be classified
for either general or restricted use. 'Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
80
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 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 it specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. It the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
8
-------
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, ana
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 ot
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. .
L40 CFR 162.10J
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
82
-------
SUMMARY-6
LAHhl .ING RETIREMENTS OF THE F1FRA, AS AMENDED
OO
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 /ga 1 Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
^REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel .
Front panel
PREFERRED
Center front
panel
Bottom tront
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
CO
-£>.
7E
8
8A.
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
'
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Envi ronmental
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, 11, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
1, II, and III
All products
PLACEMENT
REQUIRED
Front panel
Category 1:
Front panel
unless reter-
ral statement
is used.
Others:
Grouped with
side panel
precaut ionary
statements.
Front panel
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
HA, tiB, and BC; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-b
ITEM
8C
9A
9B
1UA
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED .
None
Top center
of front
panel
Immediately
following.
heading of
directions
for use
In the
directions
for use
In the
direct ions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
tor 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
PESTICIDt," 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/D1S tor further
information and required statements.
May be in metric as well as U.S. units
cc
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
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.
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.
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.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
86
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to.
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
87
-------
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 11 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 tor
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."
88
-------
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)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Non-aerosol products |
(bags) I
Do not reuse bag. Discard bag in trash,
Aerosol products
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
j containers
|(non-aerosol)
Triple rinse (or equivalent). Then otfer |
for recycling or reconditioning, or puncture)
and dispose of in a sanitary landfill, or byj
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
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.
89
-------
USE INDEX APPENDIX
90
-------
EPA Compendium of Acceptable Uses
PHOSALONE
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP 3
(Agricultural Crops) 3
TERRESTRIAL NONFOOD CROP 16
(Ornamental Woody Shrubs and Vines) 16
(Ornamental Trees) 16
Almond 3
Apple 4
Apricot 6
Arborvitae 16
Artichoke 7
Cherry 8
Filberts 8
Grapefruit 9
Grapes 10
Hazelnuts 8
Lemon 9
Nectarine 6
Orange 9
Peach 6
Pear 12
Pecan . 13
Plum 14
Potato . 15
Prune 14
Rose 16
Walnuts (English) 15
91
Issued: 2-11-86 III-097701-i
Provisional Update: 7-27-87
-------
EPft Compendium of Bcceptable Uses
C097701 PHOSBLONE*
TYPE PESTICIDE; Insecticide, Rcaricide
FDRMULflTIONS;
Tech (9474)
WP <25X>
EC (1.35 Ib/gal, 3 Ib/gal)
GENERAL WARNINGS flND LIMITATIONS; Phosalone is classified as a
RESTRICTED USE PESTICIDE due to aquatic and avian toxicity for all
commercial agricultural products. Phosalone is toxic to fish.
Drift and runoff may be hazardous to aquatic organisms in neighboi—
ing areas. Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate water by cleaning
of equipment or disposal of wastes. Phosalone causes eye irrita-
tion and may cause allergic skin reactions; do not get in eyes, on
skin or on clothing.
Protective Clothing and Equipment!
Opply phosalone only when wearing the following protective clothing
and equipment during mixing/loading, application, repair and clean-
ing 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, hands,
and feet; chemical resistant gloves; chemical resistant shoes, shoe
covering, or boots; and goggles or face shield. If mixing/loading
i.s performed using a closed system, the following protective cloth-
ing and equipment may be worn as an alternative: Long-sleeved
shirt and long-legged pants; chemical resistant gloves; chemical
resistant apron; shoes and socks. Goggles or face shield must be
worn if the system is under pressure. 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 long-legged pants; shoes and socks. Chemical resistant gloves
must be available in the cab or cockpit and must be worn when exit-
ing. This clothing is inadequate to protect during equipment re-
pair or cleaning, reentry, or pesticide disposal work. If pesti-
cide comes in contact with skin, wash off with soap and water. ftl-
ways wash hands, face, and arms with soap and water before smoking,
eating, drinking, or toileting. Before removing gloves, wash them
with soap and water. Take off all work clothes and shoes. Shower
using soap and water. Wear clean clothes. Do not reuse contaminat-
ed clothing. Personal clothing worn during work must be laundered
separately from household articles. Store protective clothing sepa-
rately from personal clothing. Clean or launder protective cloth-
ing after each use. Clothing that becomes heavily contaminated or
drenched must be destroyed according to state and local regula-
tions. Heavily contaminated or drenched clothing cannot be ade-
quately decontaminated. During aerial application, human flaggers
must be in totally enclosed vehicle.
*0, 0-diethyl S-C(6-chloro-2-oxobenzoxazolin-3-y1)methyID phosphoro-
dithioate
Issued: 2-11-86 III-037701-1 ?• *'
Provisional Update: 7-27-87
-------
EPfi Compendium of Occeptable Uses
PHOSftLONE
GENERflL WARNINGS flND LIMITOTIONS (continued)
Bee Caution;
Phosalone is toxic to bees exposed to direct treatment or residues
on blooming crops or weeds. Do not apply this product if bees are
visiting the treatment area.
Reentry;
Do not enter treated areas for 24 hours after application unless
protective clothing is worn.
Agricultural Crop Tolerances (other than those listed in the text):
Brazil nuts O.05 (N) ppm
Butternuts 0.05 (N) ppm
Cashews 0.05 (N) ppm
Chestnuts 0.05 (N) ppm
Hickory nuts 0.05 (N) ppm
Macadamia nuts (Bush nuts) 0.05 (N) ppm
Tea, dried 8.0 ppm
Dairy. Livestock, and Poultry Tolerances;
Cattle (fat, meat, mbyp) 0.25 ppm
Goats, (fat, meat, rnbyp) 0.25 ppm
Hogs (fat, meat, mbyp) 0.25 ppm
Horses (fat, meat, mbyp) 0.25 ppm
Sheep (fat, meat, mbyp) 0.25 ppm
Definition of Terms;
Claims for pest control limited to suppression of population are in-
dicated by an entirely parenthesized pest name.
Issued; 2-11-86 111-097701-2
93
-------
Site and Pest
EPA Compendium of Acceptable Uses
PHOSALONE
Dosages and Tolerance. Use. Limitations
Forrnulat ion (s)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Do not rotate any leafy or
root crop vegetable on soil treated with phosalone for at least
12 months. Do not rotate any small grain crops on soil treated
with phosalone for at least 6 months. The 25 percent wettable
powder and the 3 pound per gallon emulsifiable concentrate prod-
ucts are for agricultural or commercial use, and are suitable for
use in power operated ground sprayers, including concentrate
sprayers and by aircraft. The 1.35 pound per gallon emulsifiable
concentrate products may be applied using hand held pressure
sprayers or small power sprayers. The use of surfactants (wet-
ting agents) are not recommended. Crop injury resulting from
adverse environmental conditions may be aggravated by emulsifia-
ble products. Do not allow livestock to graze on cover crops in
treated orchards or nut groves. Do not feed treated cover crops
to 1ivestock.
/030O1AA
Almond
O.1 (N) ppm (almonds)
50 ppm (hulls)
60 day preharvest interval.
Do not apply more than 6 pounds
per acre per season. Do not ap-
ply more than once during the
fruiting season and do not exceed
3 pounds per acre. Apply a mini-
mum of 2 pounds per acre per ap-
plication. Cover sprays applied
as concentrate sprays, dilute
(AOO to 6OO gallons per acre) or
with suitable pressure sprayers
(hand held tank or small power
sprayers).
CA (24-C) CA80O158. Aerial appli-
cation, apply in minimum of 20
gallons of water per acre.
CA reentry 7 days.
ITAMABA
Peach twig
bore*"
0.5-0.75 lb/ Foliar application.
100 gal
or
2-3 Ib/A
(2554 WP)
(3 Ib/gal EC)
or
2.4-3.2 g/gal
(1.35 Ib/gal
EC)
Issued: 2-11-86
III-O977O1-3
94
-------
EPft Compendium of acceptable Uses
PHOSftLONE
Site and Pest
Dosages and Tolerance.
Formulat ion(s)
Use, Limitations
fllmond (continued)
ILPVftCO
Brown mite
ILflVBOP
ILflVBEA
Pacific spider
mite
Twospotted
spider mite
/04001AQ
Apple
IRACAftft
ITBUCSO
Rphids
Codling
moth
O.5-0.75 lb/
gal
or
2-3 Ib/ft
(3 Ib/gal EC)
or
2.4-3.2 g/gal
(1.35 Ib/gal
EC)
0.5 lb/100
gal
or
2-3 lb/«
(3 Ib/gal EC)
or
2.4 g/gal
(1.3S Ib/gal
EC)
Foliar application. Do not apply
in areas of phosphate resistance.
Foliar application. Do not apply
in areas of phosphate resistance.
10 ppm (apples)
85. ppm (dried apple pomace)
14 day preharvest interval.
Do not apply more than 17.5
pounds per acre per season. Sone
russet ing of golden delicious and
other yellow varieties may occur
in some areas. Use low rates for
preventative applications and
high rates for severe infesta-
tions. Time applications to lo-
cal pest control programs. Cover
sprays are applied as concentrate
sprays, dilute (40O to BOO gal-
lons per acre) or with suitable
pressure sprayers (hand held tank
or small power sprayers).
0.25-0.5 lb/ Foliar application.
100 gal
or
1-2 Ib/ft
<25* WP)
(3 Ib/gal EC)
or
1.2-2.4 g/gal
<1.35 Ib/gal
EC)
Issued: 2-11-86
111-097701-4
95
-------
INPSftVfl
ILRVBEft
ITBUPPP
ILPVPSP
ITBCBSP
Site and Pest
IOBMPQP
EPft Compendium of Acceptable Uses
PHOSflLONE
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
Ppple (continued)
PI urn curcul io
Twospotted
spider mite
0.5-1 lb/100 Foliar application.
gal
or
2-4 Ib/P
(25* WP)
(3 Ib/gal EC)
or
2-4.2 g/gal
(1.35 Ib/gal
EC)
0.5-1 lb/100 Foliar application. Do not apply
gal in areas of phosphate resistance.
or
2-4 Ib/P
(3 Ib/gal EC)
or
2-4.2 g/gal
(1.35 Ib/gal
EC)
Redbanaed leaf- 0.375-1 lb/
roller
European red
mite
Foliar application. Do not apply
in areas of phosphate resistant
mites.
1OO gal
or
1.5-4 Ib/P
(3 Ib/gal EC)
or
1.6-4.2 g/gal
(1.35 Ib/gal
EC)
Green fruitworm 0.375 Ib/lOO Foliar application.
gal
or
1.5 Ib/P
(3 Ib/gal EC)
or
1.6 g/gal
(1.35 Ib/gal
EC)
Apple maggot
O.5—1 Ib/lOO Foliar application.
gal
or
2-4 Ib/ft
(25% WP)
(3 Ib/gal EC)
or
96
Issued: 2-11-86
III-O97701-5
-------
Site and Pest
EPft Compendium of Acceptable Uses
PHOSftLONE
Dosages and Tolerance. Use, Limitations
Formulat ion(s)
Apple (continued)
2. 4-4
<1. 35
EC)
g/gal
Ib/gal
ILAJAKA
Apple rust mite
0.56-1 lb/
100 gal
or
2.1-4 Ib/A
<3 Ib/gal EC)
or
2.4-4 g/gal
(1.35 Ib/gal
EC)
Foliar application.
tained when used in
program.
Control ob-
a seasonal
/05001AA
/05003AA
/05004AA
Apricot
Nectarine
Peach
ITAMABA
ITBUCJA
Peach twig
borer
Oriental fruit
moth
0.5 lb/100
gal
or
2 Ib/A
(25* WP)
(3 Ib/gal EC)
or
2-2.4 g/gal
(1.35 Ib/gal
EC)
IRACAAA
Aphids
O. 25-0. 5
1OO gal
or
15 pprn (apricot, nectarine,
peach)
7 day preharvest interval.
flpply in seasonal program as re-
quired, but do not apply more
than 12 pounds per 20 pounds emul-
sifiable concentrate per acre per
season. Cover sprays are applied
as concentrate sprays, dilute
sprays (400 gallons per acre) or
with suitable power sprayers
(hand held tank or small power
sprayers).
CO (24-C) Cfi800158. fierial appli-
cation, apply in minimum of 20
gallons of water per acre.
Cfi reentry 7 days.
Foliar application.
lb/ Foliar application.
97
Issued: 2-11-86
111-097701-6
-------
Site and Pest
EPA Compendium of Acceptable Uses
PHOSALONE
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
Apricot cluster (continued)
1-2 Ib/A
(25* WP)
(3 Ib/gal EC)
or
1.2-2.4 g/gal
(1.35 Ib/gal
EC)
ILAAABA
ILAVASA
ILAVBEA
IL.AVACA
1RAFAAA
INASAVA
/13018AA
IClflBAMfl
ITBLfiftR
Mites
European red
mite
Twospotted
spider mite
Brown almond
mite
Leafhoppers
PIum curculio
Art ichoke
fiphids
Chrysanthemum
leafminer
Plume moths
0.75—1 lb/100 Foliar application. Do not apply
gal in areas of phosphate resistance.
or
3-4 Ib/A
(3 Ib/gal EC)
or
3. 2-4. 2 g/gal
(1.35 Ib/gal
EC)
0.5-1 lb/100 Foliar application.
gal
or
2-4 Ib/A
(25* WP) .
(3 Ib/gal EC)
or
2-4.2 g/gal
(1.35 Ib/gal
EC)
25 ppm
7 day preharvest interval.
Do not apply more than 12 pounds
per acre per season. Apply by
air (5 to 10 gallons) or ground
equipment (50 to 1OO gallons).
Apply in seasonal program as re-
quired.
2 Ib/ft
(3 Ib/gal EC)
Foliar application.
1-2 Ib/fi Foliar application.
(3 Ib/gal EC)
Issued: 2-11-86
98
111-097701-7
-------
/05002AP
Site arid Pest
Cherry
EPfl Compendium of Acceptable Uses
PHOSflLONE
Dosages and Tolerance. Use. Limitations
Formal at ion(s)
15 ppm
7 day preharvest interval.
fipply in seasonal program as re-
quired, but do not exceed 12
pounds wettable powder or 20
pounds emulsifiable concentrate
per acre. Cover sprays are ap-
plied as concentrate or dilute
(BOO to BOO gallons per acre).
CA (24-C) CP800158. Aerial appli-
cation, apply in minimum of 20
gallons of water per acre.
CA reentry 7 days.
ITBUAGA
Fruittree leaf- 0.375-1 lb/ Foliar application.
roller
100 gal
or
3-8 Ib/A
(25* WP)
<3 Ib/gal
EC)
IOBMALA
Cherry
fly
fruit
0.5 lb/100
gal
or
4 lb/0 '
(25* UP)
(3 Ib/gal EC)
/03OO5AO
Fi1berts (Hazelnuts)
IRACCPfl
ITBUBIO
ITBUCUfl
Filbert aphid
Filbert leaf-
roller
Fi1bertworm
0. 375-0.56
Ib/lOO gal
or
1.5-3 Ib/ft
(3 Ib/gal EC)
Foliar application.
0.5 (N) ppm (filberts (hazel-
nuts) )
Full cover spray applying a mini-
mum of 1.5 pounds per acre.
Use limited to OR and UIA.
Foliar application.
99
Issued: 2-11-86
III-O97701-8
-------
/02000AA
/02004AA
/02006AA
Site and Pest
Grapefruit
Lemon
Orange
EPA Compendium of Acceptable Uses
PHOSALONE
Dosages and Tolerance. Use,
Formulat ion(s)
Limit at ions
ILAVARA
Citrus red miti
ITBHADA
Orange dog
IMOCAOA
Citrus thrips
IRABAAA
Whiteflies
0.25-0.375
lb/100 gal
or
5-9 Ib/A
<3 Ib/gal EC)
0.25 lb/100
gal
or
1.5-3 Ib/A
(3 Ib/gal EC)
or
1.2 g/gal
<1.35 Ib/gal
EC)
O.5 Ib/lOO
gal
or
2-3 Ib/gal
(3 Ib/gal EC)
or
2.4 g/gal
(1.35 Ib/gal
EC)
O.5 Ib/lOO
gal
or
3-4.5 Ib/A
(3 Ib/gal EC)
or
2.4 g/gal
(1.35 Ib/gal
EC)
3 ppm (citrus fruit)
12 ppm (dried citrus pulp)
14 day preharvest interval.
Do not make more than 1 applica-
tion every 30 days. Do not make
more than 2 applications per sea-
son. Do not apply more than 25
pounds per acre per season. Ap-
ply as a complete cover spray.
Use limited to CA and AZ.
Foliar application. Apply a mini-
mum of 5 pounds per acre to ma-
ture trees.
Foliar application.
Foliar application.
Foliar application.
Issued: 2-11-86
100
II1-097701-9
-------
EPO Compendium of Acceptable Uses
PHOSOLONE
Site and Pest
Dosages and
Formulat ion (>
/01O140O Grapes
IROFOOO
Grape leaf-
hopper
1-2 lb/100
gal
or
2-4 Ib/fi
(25* WP)
Tolerance. Use. Limitations
10 ppm (raisins)
20 ppm
45 ppm (dried grape pomace)
14 day preharvest interval.
Do not apply more than 8 pounds
per season. Apply minimum rates
for preventative applications and
high rates for severe infesta-
tions. Use only concentrate ap-
plications to grapes intended for
packing or canning. Otherwise ap-
ply as concentrate or dilute ap-
plications (100 to 200 gallons
per acre) or with suitable pres-
sure sprayer (hand held tank or
small power sprayer). Time appli-
cations to local pest control pro-
grams, repeat as needed.
CO (24-C) C0800158. Oerial appli-
cation, apply in minimum of 20
gallons of water per acre.
CO reentry 7 days.
Use limited to CO.
Foliar application. On varieties
where residue of spray powder is
objectionable do not apply after
"buckshot" stage of berry develop-
ment.
IROFOOO
Leafhoppers
0.75-1.5 lb/ Foliar application.
1OO gal
or
1.5-3 lb/0
(3 Ib/gal EC)
or
3. 2-6. 4 g/gal
(1.35 Ib/gal
EC)
ILOOOBO
Mites
1-2 Ib/lOO
gal
or
2-4 Ib/O
(3 Ib/gal EC)
or
4.2 g/gal
(1.35 Ib/gal
EC)
Foliar application.
101
Issued: 2-11-66
111-097701-10
-------
Site and Pest
ITBUCWP
ITBUBCfl
EPP Compendium of Pc.-ceptable Uses
PHOSftLONE
Dosages and Tolerance. Use. Limitations
Formu1 at ion(s)
Grapes (continued)
Grape berry
moth
0.75.1.5 lb/ Foliar application.
100 gal
or
0. 75-2. 25
Ib/P
(3 Ib/gal EC)
or
3. 2-6. 4 g/gal
(1.35 Ib/gal
EC)
Grape phyllox- 0.5-0.75 lb/ Foliar application.
era
Omnivorous
leafroller
Lemon
Nectarine
Orange
Peach
100 gal
or
1-1.5 Ib/P
(3 Ib/gal EC)
or
2.4-3.2 g/gal
(1.35 Ib/gal
EC)
1-2 lb/100
gal
or
2-4 Ib/P
(3 Ib/gal EC)
Foliar application. Ground equip-
ment only.
See Grapefruit cluster.
See Ppricot cluster.
See Grapefruit cluster.
See Ppricot cluster.
Issued: 2-11-86
111-097701-11
102
-------
EPA Compendium of Acceptable Uses
PHOSftLONE
/04003AA
Site and Pest
Pear
I RAXALA
Pear psylla
Dosages and Tolerance.
Formal at ion(s)
Use. Limitations
10 ppni
14 day preharvest interval.
Do not apply more than 17.5
pounds per acre per season. Use
low rates for preventative appli-
cations and high rates for severe
infestations. Time applications
to local pest control programs.
Cover sprays are applied as con-
centrate sprays, dilute (400 to
600 gallons per acre) or with
suitable pressure sprayers (hand
held or small power sprayers).
1.25 lb/100 Foliar application.
gal
or
3 Ib/A
(25* WP)
or
O.75 lb/100
gal
or
3 Ib/A -
(3 Ib/gal EC)
or
3.2 g/gal
(1.35 Ib/gal
EC)
IRACAAA
ITBUCSA
ILAVASA
ITBCBSA
INASAVA
ITBVAPA
ILAVBEA
Aphids
Codling moth
European red
mite
Green fruitworm
Plum curculio
Redbanded leaf-
roller
Twospotted
spider mite
Refer to these pests under Apple for rates of
application and use limitations.
Issued: 2-11-86
111-097701-12
103
-------
EPft Compendium of Occeptable Uses
PHOSRLONE
/03008P.P
Site and Pest
Pecan
Dosages and Tolerance.
Formulat ion(s)
Use, Limitations
IROCRFfl
IRBCDSP.
ITBUCQft
ITBMODA
IRPEADA
INP.SBBP
IROVOHfl
Pecan aphid
(Monel1ia sp. )
Black pecan
aphid
Hickory suck-
worm
Pecan nut case-
bearer
Pecan spittle-
bug
Pecan weevi1
(Pecan phyllox-
era)
0.5 Ib/lOO
gal
or
1-2 lb/0
<3 Ib/gal EC)
or
2-2.4 g/gal
(1.35 Ib/gal
EC)
0.05 (N) ppm
Do not apply after shuck split.
Do not apply more than 20 pounds
per acre per season. Do not tank
mix with disulfoton. Cover
sprays are applied by aircraft (5
to 10 gallons per acre), concen-
trate sprayers, dilute sprayers
(200 to 400 gallons per acre) or
with suitable pressure sprayers
(hand held tank or small power
sprayers). Opply in seasonal pro-
grams as required. fierial appli-
cation may result in reduced con-
trol due to poorer coverage.
Foliar application.
104
Issued: 2-11-86
111-097701-13
-------
EPft Compendium of ftcceptable Uses
PHOSflLONE
/0500500
/05006««
Site and Pest
Plum
Prune
Dosages and
Formal at ion (•
Tolerance. Use. Limitations
i)
IRACfifift
ILftVBCfl
ILftVfiSft
IRPFOOft
ILAftftBft
ITBUCJft
ITRMftBfl
INOSfiVO
ILflVBEfi
Pphids
Brown almond
mite
European red
mite
Leafhoppers
Mites
Oriental fruit
moth
Peach twig
borer
Plum curculio
Twospotted
spider mite
15 ppm (plums/fresh prunes)
40 ppm (dried prunes)
7 day preharvest interval.
flpply in seasonal programs as re-
quired but do not apply more than
12 pounds wettable powder or 20
pounds emulsifiable concentrate
per acre per season. Cover
sprays are applied as concentrate
sprays, dilute sprays (400 gal-
lons per acre) or with suitable
pressure sprayers (hand held tank
or small power sprayers).
Cft (24-C) CfteOOlSS. Rerial appli-
cation, apply in a minimum of 20
gallons of water per acre.
Cfl reentry 7 days.
Refer to individual pests under fipricot cluster
for use and limitation information.
Issued: 2-11-86
III-O97701-14
105
-------
/140130ft
Site and Pest
Potato
EPft Compendium of ftcceptable Uses
PHOSflLONE
Dosages and Tolerance, Use. Limitations
Formulat ion(s)
0. 1 (N) ppm
Do not exceed £0 pounds per acre
per season. Do not forage or
feed vines to livestock. Do not
use on sweet potatoes. Do not
tank mix with disulfoton. flpply
by air (5 gallons per acre) or
ground equipment (60 to 150 gal-
lons per acre). Rpply in season-
al program as required.
INftMCFft
X RftCftSft
IRftCCUft
IRftCCHft
IRflFftJft
ITftMftPft
ITBMCCft
/O3OO9ftft
Colorado potato
beetle
(Buckthorn
aphid)
(Green peach
aphid)
(Potato aphid)
(Potato leaf-
hopper)
(Potato tubei—
worm)
European corn
borer
Prune
Walnuts (English)
0.5-1.5 Ib/ft
(3 Ib/gal EC)
Foliar application.
1 Ib/ft
(3 Ib/gal
EC)
IRftCBHft
Walnut aphid
O. £5-0. 5 lb/
100 gal
or
0.75-1.5 Ib/fl
(£5% WP)
(3 Ib/gal EC)
Foliar application.
See Plum cluster.
O.O5 (N) ppm
Do not apply more than £0 pounds
per acre per season. Do not ap-
ply after the husks have split.
ftpply a minimum of 1 pound per
acre by air blast equipment. ftp-
ply complete cover spray (300 to
600 gallons per acre). ftpply in
seasonal programs as necessary.
Cft (£4-C) CftSOOlSB. fterial appli-
cation, apply in minimum of £O
gallons of water per acre.
Cft reentry 7 days.
Foliar application.
106
Issued
£-11-86
111-097701-15
-------
ILAVBEA
Site and Pest
EPA Compendium of Acceptable Uses
PHOSPLONE
Dosages and Tolerance. Use. Limitations
Formulat ion(s)
Walnuts (English) (continued)
ITBUCSA Codling moth 0.5-0.75 lb/ Foliar application.
100 gal
or
2.25 Ib/A
(25* WP)
(3 Ib/gal EC)
0.5—0.75 lb/ Foliar application. Do not apply
100 gal in areas of phosphate resistance.
or
2-3 Ib/A
(3 Ib/gal EC)
IOBMAMA Walnut husk fly 0.5-0.75 lb/ Foliar application. Apply before
100 gal larval feeding causes the husks
or to darken or shortly after ovi-
2.25 Ib/A position.
(3 Ib/gal EC)
Twospotted
spider mite
/3412OAA
IRACCKA
/35O21AA
TERRESTRIAL NONFOOD CROP
(Ornamental Woody Shrubs and Vines)
Rose
Rose aphid
O. 5-1 Ib/lOO Foliar application. Apply as
gal cover spray (spray to Met) when
(3 Ib/gal EC) pest present and repeat as neces-
sary. Slight injury to leaves
may occur.
(Ornamental Trees)
Arborvitae
Spruce spider
mite
O. 5-1 Ib/lOO Foliar application. Apply as
gal cover spray (spray to wet) when
(3 Ib/gal EC) pest is present and repeat as
necessary.
Issued: 2-11-86
107
111-097701-16
-------
EPft Compendium of flcceptable Uses
PHOSRLONE
Site and Pest Dosages and Tolerance. Use. Limitations
Formu1 at ion(s)
flERIflL. MOTHPROOFING OND TQNK NIX PPPLICflTIDNS
9O01500 Perial ftpplication
— Refer to
TERRESTRIAL FOOD CROP
(ftqricultural Crops)
Pll sites
108
Issued: £-11-86 111-097701-17
-------
EPft Compendium of Pcceptable Uses
PHOSALONE
Listing of Registered Pesticide Products by Formulation
&094.00O1 94* technical chemical
phosalone (097701)
000359-00632
4025.OOO6 25* wettable powder
phosalone (097701)
000359-00626
&101.3512 1.35 Ib/oal emulsifiable concentrate
phosalone (097701)
010370-00162
phosalone (097701) plus aromatic petroleum derivative solvent
(006501)
034911-00026
&103.0012 3 Ib/qal emulsifiable concentrate
phosalone (097701)
000359-00620
(000359-00620) CP800158
9999999 State Label Registrations
AL Reg. No.
000359-05112
AR Reg. No.
000359-05114
PZ Reg. No.
000359-05113 ,
CA Reg. No.
OOO359-05103 000359-05108
FL Reg. No.
OO0359-05115
GO Reg. No.
OOO359-05116
HI Reg. No.
OO0359-05106
LA Reg. No.
OOO359-05117
Issued: 2-11-86 111-097701-18
-------
EPft Compendium of Acceptable Uses
PHOSftLONE
Listing of Registered Pesticide Products by Formulation (continues)
MS Reg. No.
000359-05118
NM Reg. No.
000359-05119
NY Reg. No.
000359-05110
OK Reg. No.
000359-05120
OR Reg. No.
000359-05104
PA Reg. No.
000359-05109
SC Reg. No.
OO0359-O5121
TX Reg. No.
000359-05111
Wft Reg. No.
000359-05105
038655-10415
000359-05107
OO0359-O5122
110
Issued: 2-11-86
111-097701-19
-------
EPft Compendium of Pcceptable Uses
PHOSPLONE
Appendix fi-1
Listing of Pctive Ingredient(s) Found in Combination with the
Report Chemical
Chemical Common Name EPft Acceptable
Code (source) Common/Chemical Name
O06501 aromatic petroleum derivative —
solvent
— Use Common Name
1 11
Issued: 2-11-86 111-097701-20
-------
EPO Compendium of Acceptable Uses
PHOSflLONE
Auxiliary Documentation
None.
1 12
Issued: 2-11-86 III-0377Ol-a
-------
BIBLIOGRAPHY APPENDICES
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
114
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received." • .
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
1 15
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006067 Laurent, ?; Buys, ?; Aublet, ?; Bottreau, ? (1975) Phosalone:
Solubility and Stability in Water: R.P./R.D./C.N.G.—^
No. 2793. (English translation; unpublished study received Sep
29, 1975 under 359-620; prepared by Societe des Usines Chimiques
Phone-Poulenc, submitted by Rhone-Poulenc, Inc., Monmcuth
Junction, N.J.; CDL:094857-A)
00006071 Totnan, L.C.; Inuning, R.J.; Woodard, G. (1967) Phosalone: Analysis
of Compound Residue in Tissues of Beef Cattle and Sheep. (Un-
published study received Oct 16, 1967 under 9F0759; prepared by
Woodard Research Corp., submitted by Rhodia, Inc., New Bruns-
wick, N.J.; CDL:093071-E)
00006073 Totman, L.C.; Greenstein, E.T.; Woodard, M.W.; Woodward, G. (1967)
Phosalone: Analysis of Residue in Milk of Dairy Cattle. (Unpub-
lished study received Oct 16, 1967 under 9F0759; prepared by
Woodard Research Corp., submitted by Rhodia, Inc., New Bruns-
wick, N.J.; CDL:093071-I)
00006083 Guardigli, A.; Melkesian, B. (1968) Detection of Metabolites in
Grapes Sprayed with Excessive Amounts of Phosalone (PA-68-30)..
(Unpublished study received Sep 12, 1968 under 9F0759; submitted
by Rhodia, Inc., New Brunswick, N.J.; CDL:091306-AC)
00006084 Guardigli, A.; Rock, G. (1968) Detection of the Oxygen Analog (RP
12244) in Apples (AT-68-10). (Unpublished study received Sep
12, 1968 under 9F0759; prepared in cooperation with North Caro-
lina State Univ., submitted by Rhodia, Inc., New Brunswick,
N.J.; CDL:091306-AD)
00006105 Guardigli, A. (1973) Electron Capture Gas Liquid Chromatography
Determination of Phosalone and Its Oxygen Analog in the Milk
and Tissues of Dairy Cattle. Revised Method 54-C dated Apr
1973. (Unpublished study received May 15, 1973 under 2F1193;
submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:093518-AC)
00006113 Rhodia, Incorporated (19??) Technical Data Bulletin: Zolone: In-
secticide annd Miticide. (Unpublished study received Mar 4, 1976
under 6F1753; CDL:095979-0)
00006120 Rhodia, Incorporated (19??) Phosalone in Dairy Cattle Tissue: Sum-
mary. (Unpublished study received May 6, 1970 under OF0983;
CDL:093292-G)
1 16
-------
. OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006123 Rhodia, Incorporated (1967) Summary: Analysis of Phosalone (RP
11974) Residue in Tissues of Beef Cattle and Sheep. (Unpub-
lished study received May 6, 1970 under OF0983; CDL:093292-J)
00006125 Ambrosi, D.; Desmoras, J.; Savary, M. (1974) Phosalone: Transloca-
tion Study in Potato Plants Using 14C-Labelled Phosalone:
S.U.C.R.P.—D.S.Ph. No. 17416. (Unpublished study received Feb
12, 1974 under 4E1468; prepared by Societe des Usines Chimiques
Rhone-Poulenc, submitted by Interregional Research Project
No. 4, New Brunswick, N.J.; CDL:093909-C)
00006129 Guardigli, A. (1%7) Analytical Procedure for Phosalone Residue
Determination in Milk and Animal Tissues by Electron Capture
Chromatography. Method no. 54-C dated Aug 14, 1967. (Unpub-
lished study received Oct 17, 1967 under 7G0575; prepared by
Rhodia, Inc., submitted by Chipman Chemical Co., Inc., Burlin-
game, Calif.; CDL:090733-B)
00006194 Rhodia, Incorporated (1970) Apricots: Phosalone. (Unpublished
study received Mar 26, 1971 under 1F1155; CDL:093475-A)
00006195 Rhodia, Incorporated (1970) Cherries: Phosalone. (Unpublished
study received Mar 26, 1971 under 1F1155; CDL:093475-B)
00006196 Rhodia, Incorporated (1970) Nectarines: Phosalone. (Unpublished
study received Mar 26, 1971 under 1F1155; CDL:093475-C)
00006197 Rhodia, Incorporated (1970) Peaches: Phosalone. (Unpublished
study received Mar 26, 1971 under 1F1155; CDL:093475-D)
00006198 Rhodia, Incorporated (1970) Prunes: Phosalone. (Unpublished
study received Mar 26, 1971 under 1F1155; CDL:093475-E)
00006202 Wcodard, M.W.; Howard, D.J.; Donoso, J.; Wcodard, G. (1967) Phosa-
lone: Safety Evaluation by Repeated Oral Administration to Rats
for 103-104 Weeks. (Unpublished study received Oct 17, 1967 .
under 7G0575; prepared by Wcodard Research Corp., submitted by
Chipman Chemical 2Co., Inc., Burlingame, Calif.; CDL:090730-A)
00006203 Donoso, J.; Wcodard, M.W.; Woodard, G. (1967) Phosalone: Safety
Evaluation by Repeated Oral Administration to Dogs for 107
Weeks. (Unpublished study received Oct 17, 1967 under 7G0575;
prepared by Wcodard Research Corp., submitted by Chipman Chemi-
cal Co. , Inc., Burlingame, Calif.; CDL:090731-A)
117
-------
OFFICE OF PESTICIDE PROGRAMS
.REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006209 Desmoras, J.; Buys, M.; Laurent, L. (1973) Phosalone Residues in
Tea: S.U.C.R.P.—D.S.Ph./D.S.An.Nord NO. 17389. (Unpublished
study received on unknown date under 3H5038; prepared by Societe
des Usines Chimiques Khone-Poulenc, submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:221773-A)
00006210 Rhodia, Incorporated (1971) Phosalone—Tea: Phosalone Residue Stud-
ies. (Unpublished study including letters dated Jul 19, 1972
from J. Metivier and P. Petrinko to Tea Research Association and
Aug 1, 1972 from B. Banerjec to Societe des Usines Chimiques
Rhone-Poulenc, received Jun 8, 1973 under 3H5038; prepared in
cooperation with Tea Research Association and United Planters
Association of Southern India; CDL:221773-B)
00006358 Guardigli, A.; Martwinski, P. (1970) Results of Almond Residue
Tests: Part D. (Unpublished study including field test project
nos. PAW 69-5, PAW 69-6, PAW 69-9, PAW 69-13, PAW 69-18 and
PAW 68-18, received Jun 26, 1972 under OF0983; submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:091691-J)
00006383 Guardigli, A. (1964) Chemical Determination of R-P-11974 (Phosa-
lone) for Crop Residues. Method no. 54 dated Oct 2, 1964. (Un-
published study received Feb 2, 1967 under 7G0575; submitted by
Chipman Chemical Co., Inc., Burlingame, Calif.; CDL:090727-A)
00006385 Desmoras, J.; Laurent, M.; Metivier, J.; Sauli, M.; Terlain,
B. (1966) Phosalone: Study on the Degradation of Phosalone
(11974 R.P.) in Soil: R.P.—D.S.Ph. No. 11423. (Unpublished
study received Feb 2, 1967 under 7G0575; prepared by Societe
des Usines Chimiques Rhone-Poulenc, submitted by Chipman Chem-
ical Co., Inc., Burlingame, Calif.; CDL:090727-D)
00006386 Desmoras, J.; Laurent, M.; Terlain, B.; Aublet, J.C.; Sasmayoux,
J.C.; Savary, M. (1966) Study of the Metabolism of Phosalone
(11974 R.P.) in Plants: R.P.—D.S.Ph. No. 11686. (Unpublished
study received Feb 2, 1967 under 7G0575; prepared by Societe des
Usines Chimiques Rhone-Poulenc, submitted by Chipman Chemical
Co., Inc., Burlingame, Calif.; CDL:090727-E)
00006388 Guardigli, A. (1965) Residue Summary Sheet: Phosalone. (Unpub-
lished study including project nos. BB 10-64-12, BB 12-64-20,
BB 64-26, BB 65-18, BB 65-27, BB 65-47, BB 65-49, BB 65-127,
C 64-12, C 65-17, C 65-30 and Port 65-47, received Feb 2, 1967
under 7G0575; prepared by Rhodia, Inc., submitted by Chipman
Chemical Co., Inc., Burlingame, Calif.; CDL:090727-G)
118
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006389 Guardigli, A. (1964) Laboratory Analytical Data Sheet for Residues
of R.P. 11974: Phosalone. (Unpublished study received Feb 2,
1967 under 7G0575; prepared by Rhodia, Inc., submitted by Chip-
nan Chemical Co. , Inc., Burlingame, Calif.; CDL:090727-H)
00006390 Guardigli, A. (1966) Residue Summary Sheet: Phosalone. (Unpub-
lished study including project nos. C-64-12 and BB-65-63, re-
ceived Feb 2, 1967 under 7G0575; prepared by Rhodia, Inc., sub-
mitted by Chipman Chemical Co., Inc., Burlingame, Calif.; CDL:
090727-1)
00006391 Guardigli, A. (1966) Laboratory Analytical Data Sheet for Residues:
Field Test Project No. BB 66-126. (Unpublished study received
Feb 2, 1967 under 7G0575; prepared by Rhodia, Inc., submitted by
Chipman Chemical Co., Inc., Burlingame, Calif.; CDL:090727-J)
00006392 Guardigli, A. (1966) Residue Summary Sheet: Phosalone. (Unpub-
lished study including project nos. BB 64-26, BB 65-125, C 64-
12, C 65-27, Port 65-66 and Port 66-12, received Feb 2, 1967
under 7G0575; prepared by Rhodia, Inc., submitted by Chipman
Chemical Co., Inc., Burlingame, Calif.; CDL:090727-K)
00006395 Guardigli, A. (1966) Residue Summary Sheet: Phosalone. (Unpub-
lished study including project nos. C 64-16, C 65-44, BB 65-42
and BB 65-51, received Feb 2, 1967 under 7G0575; prepared by
Rhodia, Inc., submitted by Chipman Chemical Co., Inc., Burlin-
game, Calif.; CDL:090727-0)
00006480 Guardigli, A.; MartwinsXi, P. (1971) Residue Data: Zolone. (Un-
published study including field test project nos. BB 65-63, BB
68-91, PA 68-46, PA 70-25/25A, PA 70-26, PA 70-27/27A and PAW
70-29, received Nov 18, 1971 under 359-626; prepared by Rhodia,
Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J.;
CDL:003175-X)
00006483 Henckler, P.M.; Dennis, S. (1973) Residue Summary: Apricots. (Un-
published study including residue final report nos. 170473-042
and 170473-053, received Mar 29, 1974 under 359-620; prepared by
Rhodia, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junc-
tion, N.J.; CDL:028124-C)
00006484 Henckler, P.M.; Dennis, S.; Collins, R. (1973) Residue Summary:
Cherries. (Unpublished study including residue final report
nos. 170473-041 (A), 170473-041 (B) and 213673-013, received Mar
29, 1974 under 359-620; prepared by Rhodia, Inc., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, N.J.; CDL:028124-D)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006485 Henckler, P.M.; Rice, R. (1973) Residue Summary: Nectarines: Pro-
ject No. 180473-032. (Unpublished study received Mar 29, 1974
under 359-620; prepared by Rhodia, Inc. in cooperation with
Univ. of California, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, N.J.; CDL:028124-E)
00006486 Henckler, P.M.; Taylor, J.C.; Corner, G.; Dennis, S. (1973) Residue
Summary: Peaches. (Unpublished study including residue final
report nos. ARK 72-77, 123973-023 and 170473-072, received Mar
29, 1974 under 359-620; prepared by Rhodia, Inc. in cooperation
with Louisiana State Univ. and Clemson Univ., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, N.J.; CDL:028124-F)
00006487 Henckler, P.M.; Rice, R. (1973) Residue Summary: Plums: Project
No. 180473-033. (Unpublished study received Mar 29, 1974 under
359-620; prepared by Rhodia, Inc. in cooperation with Univ. of
California, submitted by Rhone-Poulenc, Inc., Monmouth Junction,
N.J.; CDL:028124-G)
00006511 Guardigli, A.; Martwinski, P. (1970) Results of Residue Tests.
(Unpublished study, including report nos. AT 69-14, AT 69-20, AT
69-22, AT 69-47, PA 67-45, PA 68-50, PA 69-29, PAS 67-77, PAW
69-2 and PAW 69-7, received Mar 12, 1970 under OF0948; submitted
by Rhodia, Inc., New Brunswick, N.J.; CDL:091617-B)
00006576 Guardigli, A.; Martwinski, P. (1972) Phosalone—Potato Petition:
Residue Summary—Potatoes. (Unpublished study including field
test project nos. AT 71-15, BB 68-87, BB 68-94, BB 69-60, C 66-
41, CH 71-61, CH 71-84, CH 71-103, FW 71-52 and Port 71-30,
received May 25, 1973 under 3F1337; submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:093575-E)
00006643 Dubost, P.; Fournel, J.; Ganter, P.; Julou, L.; Koenig, F.; Myon,
J.; Bredenbac, J.; Lemoine, F. (1964) Acute Toxicity, Local Tol-
erance, Anticholinesterase Activity and Chronic Toxicity in Rats
and Dogs: R.P.—D.S.Ph. 9203. (English translation; unpublished
study received 1965 under 359-EX-46; prepared by Societe des
Usines Chimiques Rhone-Poulenc, submitted by Rhone-Poulenc,
Inc., Monmouth Junction, N.J.; CDL:123396-D)
00006649 Desmoras, J.; Laurent, M. (1964) Insecticides: R.P. 11974—Para-
thion (R.P. 3470): Study.of Breakdown in the Soil: R.P.—
D.S.Ph./D.R.An. No. 9188. (English translation; unpublished
study received 1965 under 359-EX-46; prepared by Societe des
Usines Chimiques Rhone-Poulenc, submitted by Rhone-Poulenc,
Inc., Monmouth Junction, N.J.; CDL:123396-J)
120
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006653 Atkins, E.L., Jr.; Anderson, L.D.; Nakakihara, H.; Greywood, E.A.
(1970) Toxicity of Pesticides and Other Agricultural Chemicals
to Honey Bees: Laboratory Studies. Rev. By Univ. of Califor-
nia, Dept. of Entomology. Riverside, Calif.: U.C. (Agricul-
tural Extension M-16; also in unpublished submission received
Nov 17, 1975 under 359-620; submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, N.J.; CDL:223344-B)
00006654 Atkins, E.L., Jr.; Anderson, L.D. (1967) Toxicity of Pesticides and
Other Agricultural Chemicals to Honey Bees: Laboratory Studies.
Rev. By Univ. of California, Dept of Entomology. Riverside,
Calif.: U.C. (Agricultural Extension M-16; also in unpublished
submission received Nov 17, 1975 under 359-620; submitted by
Rhone-Poulenc, Inc., Monmouth Junction, N.J.; CDL:223344-D)
00006663 Ambrosi, D.; Desmoras, J.; Huguet, ?; Lingart, ?; Savary, ? (1976)
Herbicides: Phosalone: Studies on Leaching in Different Soils:
R.P./R.D./C.N.G. No. 18752. (Unpublished study received May 10,
. 1977 under 359-620; prepared by Societe des Usines Chimiques
Rhone-Poulenc, submitted by Rhone-Poulenc, Inc., Monmouth Junc-
tion, N.J.; CDL:229759-C)
00006664 Ambrosi, D.; Desnoras, J.; Blanchard, ?; Leteve, ?; Savary, ?
(1977) Insecticides: Phosalone: Study on Persistence of 14C-
labelled Phosalone in Soil: Rotational Crops: R.P./R.D./
C.N.G. No. 19040. (Unpublished study received May 10, 1977
under 359-620; prepared by Societe des Usines Chimiques Rhone-
Poulenc, submitted by Rhone-Poulenc, Inc., Monmouth Junction,
N.J.; CDL:229759-D)
00006665 Laurent, M.; Buys, M.; Chabassol, Y.; Sauli, M.; Brunie, B.; Ray-
naud, L.; DePaire, H.; Snozzi, C.; Kretz, M.; Bisch, D. (1977)
Phosalone (11974 R.P.): Photodegradation in the Water-Dissolved
State: R.P./R.D./C.N.G.-An—Report No. 3131. (Unpublished study
received May 10, 1977 under 359-620; prepared by Societe des
Usines Chimiques Rhone-Poulenc, submitted by Rhone-Poulenc,
Inc., Monmouth Junction, N.J.; CDL:229759-E)
00006666 Ambrosi, D.; Desnoras, J.; Blanchard, ?; Savary, ? (1977) Phosa-
lone: Photodegradation in Soil: R.P./R.D./C.N.G. No. 19046. In-
cludes undated method. (Unpublished study received May 10, 1977
under 359-620; prepared by Societe des Usines Chimiques Rhone-
Poulenc, submitted by Rhone-Poulenc, Inc., Monmouth Junction,
N.J.; CDL:229759-F)
121
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRJD CITATION
00006675 Societe des Usines Chimiques Rhone-Poulenc (1968) 20650 R.P.: The
Final Metabolite of Phosalone in Plants: Synthesis, Identifica-
tion, Toxicity, Possible Presence in Plants: R.P.—
D.S.Ph. No. 12645. Includes method dated Feb 20, 1968. (Unpub-
lished study received Jun 14, 1968 under 8F0668; submitted by
Chipnan Chemical Co., Inc., Burlingame, Calif.; CDL:091170-C)
00006678 Guardigli, A.; Taschenberg, E.F.; Stafford, E.M. (1967) Laboratory
Analytical Data Sheet for Residues: Field Test Project No. BB
67-100. (Unpublished study including field test project no. PA
67-25, received Jun 14, 1968 under 8F0668; prepared by Rhodia,
Inc., submitted by Chipman Chemical Co., Inc., Burlingame,
Calif.; CDL:091170-F)
00006684 Fcurnel, J.; Ganter, P.; Julou, L.; Populaire, P.; Myon, J.;
Pascal, S.; Pasquet, J. (1966) Phosalone (11974 R.P.): Toxicity
after 6 Months Administration to Dogs: R.P.--D.S.Ph. No. 11410.
(Unpublished study received Dec 12, 1966 under 7G0575; prepared
by Societe des Usines Chimiques Rhone-Poulenc, submitted by
Chipnan Chemical Co., Inc., Burlingame, Calif.; CDL:090728-C)
00006689 Horn, H.J.; Wbodard, M.W.; Woodard, G. (1965) Phosalone R.P. 11974:
Acute Dermal Toxicity for Rabbits. (Unpublished study received
December 15, 1966 under 7G0575; prepared by Woodard
Research Corp., submitted by Chipnan Chemical Co., Inc.,
Burlingame, Calif.; CDL:090729-D)
00006698 Laurent, M.; Terlain, B.; Vertalier, S. (1965) Phosalone
(RP 11974): Stability of the Bulk Product; (Control 64-R-1921):
R.P.—D.S.An. Nord—No. 151. Includes two methods dated Dec 3,
1964. (English translation; unpublished study received Dec 15,
1966 under 7G0575; prepared by Societe des Usines Chimiques
Rhone-Poulenc, submitted by Chipman Chemical Co., Inc., Bur-
lingame, Calif.; CDL:090729-N)
00006700 Laurent, M.; Aublet, J.C.; Sasmayoux, J.C. (1967) Phosalone: Method
of Determination of Phosalone Residues in Plants by Gas-Liquid
Chromatography: R.P.—D.S.Ph. No. 11791. Method dated Feb 3,
1967. (Unpublished study received Jun 14, 1968 under 8F0668;
prepared by Societe des Usines Chimiques Rhone-Poulenc, sub-
mitted by Chipiran Chemical Co., Inc., Burlingame, Calif.; CDL: .
091171-A)
122
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00006701 Societe des Usines Chimiques Rhone-Poulenc (1968) Phosalone: Iden-
tification of Phosalone in Plant Extracts: R.P.-D.S.Ph. No.
12642. Includes two methods dated Feb 20, 1968. (Unpublished
study including R.P.—D.S.Ph. No. 13021, received Jun 14,
1968 under 8F0668; submitted by Chipman Chemical Co., Inc.,
Burlingame, Calif.; CDL:091171-B)
00006703 Guardigli, A. (1968) Determination of RP 11974 (Phosalone) for Crop
Residue by Electron Capture Chromatography. Rev. Method no.
54-A dated Mar 20, 1968. (Unpublished study received Jun 14,
1968 under 8F0668; prepared by Rhodia, Inc., submitted by Chip-
man Chemical Co., Inc., Burlingame, Calif.; CDL:091171-D)
00006707 Desmoras, J.; Laurent, M.; Aublet, ?; Sasmayoux, ?; Savary, ?
(1968) Phosalone: Determination of Phosalone, 12244 R.P. and
20650 R.P. in Fruit from the U.S.A.: R.P.—D.S.Ph./D.S.An.Nord
No. 12850. (Unpublished study received Jun 14, 1968 under
8F0668; prepared by Societe des Usines Chimiques Rhone-Poulenc,
submitted by Chipman Chemical Co., Inc., Burlingame, Calif.; •
CDL:091171-I)
00006708 Laurent, M.; Buys, M.; Sasmayoux, J.C. (1968) Phosalone: G.L.C. De-
termination of Phosalone and 12244 R.p. in Apples and in Grape
Extracts from the U.S.A.: D.S.Ph./D.S.An.Nord No. 12864. (Un-
published study received Jun 14, 1968 under 8F0668; prepared by
Societe des Usines Chimiques Rhone-Poulenc, submitted by Chip-
nan Chemical Co., Inc., Burlingame, Calif.; CDL:091171-J)
00006711 Guardigli, A. (1968) Results of Tests on the Amount of Residue Re-
maining. (Unpublished study including letters dated Dec 9,
1964, Jan 21, 1965 and Oct 1, 1965 from L. Farber to L. Reed
and field test nos. BB-10-64-12, BB-64-10, BB-64-26, BB-65-47,
BB-65-49, BB-65-127, C-64-12, C-65-17; C-65-30, C-66-32,
C-66-33, PA-66-32, PA-67-58 and Port-65-47, received Jun 14,
1968 under 8F0668; prepared by Rhodia, Inc., submitted by Chip-
man Chemical Co. , Inc., Burlingame, Calif.; CDL:091171-N)
00006712 Rhodia, Incorporated (1967) Field and Analytical Data: Phosalone
Residue in Apples—Ontario, Canada—1967. (Unpublished study
received Jun 14, 1968 under 8F0668; submitted by Chipman Chemi-
cal Co., Inc., Burlingame, Calif.; CDL:091171-X)
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 Phosalone Standard
MRID CITATION
00006713 Guardigli, A. (1967) Laboratory Raw Analytical Data. (Unpublished
study including letter dated Mar 2, 1965 from L. Farber to L.
Reed and field test project nos. BB-65-63, BB-67-100, C 64-12,
and PA 67-28, received Jun 14, 1968 under 8F0668; prepared by
Rhodia, Inc., submitted by Chipman Chemical Co., Inc.,
Burlingame, Calif.; CDL:091171-Z)
00006714 Guardigli, A. (1966) Laboratory Raw Analytical Data. (Unpublished
study including letter dated Feb 9, 1965 from L. Farber to L.
Reed and test nos. BB-64-26, BB-65-125, C-64-12, C-65-27, Port-
65-66 and Port 66-12, received Jun 14, 1968 under 8F0668; pre-
pared by Rhodia, Inc., submitted by Chipman Chemical Co., Inc.,
Burlingame, Calif.; CDL:091171-AD)
00006715 Desmoras, J.; Fournel, J.; Bredenbach, ?; Savary, ? (1968) Studies
on Degradation of Phosalone in Mammals: R.P.—D.S.Ph. No. 12667.
(Unpublished study received Jun 14, 1968 under 8F0668; prepared
by Societe des Usines Chimiques Rhone-Poulenc, submitted by
Chipman Chemical Co., Inc., Burlingame, Calif.; CDL:091171-AK)
00006716 Fournel, J.; Julou, L.; Pasquet, J.; Bredenbac, J. (1968) 12244
R.P.: Acute Toxicity in Mice and Rats and in Vivo Anti-Choli-
nesterase Activity in Rats: R.P.—D.S.Ph. No. 12663. (Unpub-
lished study received Jun 14, 1968 under 8F0668; prepared by
Societe des Usines Chimiques Rhone-Poulenc, submitted by Chip-
man Chemical Co. , Inc., Burlingame, Calif.; CDL:091171-AL)
00006717 Rhodia, Incorporated (1967) Phosalone Feeding Test. (Unpublished
study received Jun 14, 1968 under 8F0668; prepared in coopera-
tion with Woodard Research Corp., submitted by Chipman Chemical
Co., Inc., Burlingame, Calif.; CDL:091171-AM)
00006735 Crouch, R.V. (1970) Phosalone (11974 R.P.): Residue Studies on Tea
(Green Leaf): Pakistan 1969: Report No. RG/758. (Unpublished
study received Jun 8, 1973 under 3H5038; prepared by May &
Baker, Ltd., submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:221773-H)
00006761 Posner, S. (1971) Cow-Feeding Study with Phosalone (Technical)
Insecticide (Dairy Cattle)—Biological Phase. (Unpublished
study including project no. 49-181, received Jun 26, 1972 under
OF0983; prepared in cooperation with Biometric Testing, Inc.,
submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:091691-C)
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 Phosalone Standard
MRID CITATION
00006762 Guardigli, A. (1971) Method of Analysis of Phosalone and Its Oxygen
Analog (RP 12244) in Animal Tissues by TIC. Method no. 54-C1
dated Jun 1, 1971. (Unpublished study received Jun 26, 1972
under OF0983; submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:091691-1)
00006769 Guardigli, A. (1964) Laboratory Analytical Data Sheet for Residues:
Field Test Project No. BB 64-26. (Unpublished study received
Feb 2, 1967 under 7G0575; prepared by Rhodia, Inc., submitted
by Chipnan Chemical Co., Inc., Burlingame, Calif.; CDL:090727-L)
00006770 Desmoras, J.; Ambrosi, D.; Savary, ? (1975) Phosalone: Degradation
in Sterile and Non-Sterile Soil Using 14C-Labelled Phosalone:
R.P./R.D./Biol—No. 22. (Unpublished study received Mar 24,
1975 under 3F1337; prepared by Societe des Usines Chimiques
Rhone-Poulenc, submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:093574-J)
00006783 Guardigli, A.; Martwinski, P. (1969) Phosalone Residues on Apples
Treated with Zolone 25% Wettable Powder at Several Application
Rates. (Unpublished study including field test project nos. AT
69.16-AT 69.17, BB 68-66, BB 69.7-BB 69.9, Port 68-12 and Port
69-56, received Dec 22, 1969 under 359-626; prepared by Rhodia,
Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J.;
CDL-.003174-W)
00006791 Desmoras, J.; Laurent, M.; Sauli, M.; Terlain, B. (1968) Metabolism
study of Phosalone in plants and soils. Phytiatrie-Phytopharma-
cie 4(? ):263-275. (Presented at the VI International Congress
for the Protection of Plants, Vienna, 8-30-67 to 9-6-67;
also in unpublished submission received Jun 13, 1974 under 359-
620; submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J.;
CDL:12035l-C)
00006792 Posner, S. (1971) Cow-Feeding Study with Phosalone (Technical)
Insecticide (Dairy Cattle)—Biological Phase. (Unpublished
study including letter dated Jul 26, 1971 from L.C. Brown to
Lee E. TerBush, received Jun 13, 1974 under 359-620; prepared by
Biometric Testing, Inc. for Rhodia, Inc., submitted by Rhone-
Poulenc, Inc., Monmouth Junction, N.J.; CDL:120351-T)
00006793 Smyth, E.P.; Johansen, C. (19??) Report No. Port 68-67. (Unpub-
lished study received Jun 13, 1974 under 359-620; prepared in
cooperation with Washington State Univ., submitted by Rhone-
Poulenc, Inc., Monmouth Junction, N.J.; CDL:120351-X)
125
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGR/ HY
Citations Considered to be Part of the Data ase Supporting
Registrations Under the Phosalone £ .andard
MRID
CITATION
OC 06964 Henckler, P. (1973) Project Number 170473- >08. (Unpublished study
including letter dated Nov 6, 1973 froi D.I. Wang to C.C. Comp-
ton, received Oct 18, 1973 under 3E140: prepared by Rhodia,
Inc., submitted by Interregional Resea: :h Project No. 4, New
Brunswick, N.J.; CDL:098195-A)
OC O6968 Desmoras, J.? Laurent, M.; Buys, M. (19??
397, In Analytical Methods for Pestici<
lators—Ttiin Layer and Liquid Chromato
Pesticides of International Importance
G. Zweig. New York: Academic Press.
mission received Mar 4, 1976 under 6F1
Inc., Momrcuth Junction, N.J.; CDL:098
Phosalone. Pages 385-
js and Plant Growth Regu-
raphy and Analyses of
Volume VII. Edited by
(Also in unpublished sub-
53; submitted by Rhodia,
38-1)
0( X36971 Guardigli, A. (1973) Residue Studies in t" 2 Milk and Tissues of
Dairy Cows Fed Phosalone. (Unpublishe study received Mar 4,
1976 under 6F1753; submitted by Rhodia Inc., Monmouth Junction,
N.J.; CDL:098088-L)
0< 306972 Craine, E.M. (1974) Disposition of Phosal ne-14C in a Lactating
Cow: Research Report No.. EMC 74:17. ( npublished study received
Mar 4, 1976 under 6F1753; submitted by Rhodia, Inc., Monmouth
Junction, N.J.; CDL:098088-M)
Oi 306973 Craine, E.M. (1974) Disposition of Phosal ne-14C in a Lactating
Cow: Research Report No. EMC 74:84. ( npublished study received
Mar 4, 1976 under 6F1753; submitted by Rhodia, Inc., Monmouth
Junction, N.J.; CDL:098088-N)
0' 006974 Craine, E.M. (1975) The Metabolism of Phc alone-14C in Dairy Cows:
Research Report No. EMC 75:51. (Unpuk .ished study received Mar
4, 1976 under 6F1753; submitted by Rhc iia, Inc., Monmouth Junc-
tion, N.J.; CDL:098088-O)
0 006975 Craine, E.M. (1974) The Disposition of PV salone-14C Applied to the
Skin of a Pig: Research Report No. EMC 74:30. (Unpublished
study received Mar 4, 1976 under 6F17E i; submitted by Rhodia,
Inc., Monmouth Junction, N.J.; CDL:09E )88-P)
0 006978 Collins, R.F.; Roxburgh, J. (1967) Phosa! >ne (11,974 R.P.): Studies
of Levels in the Skin and Edible Tissi ;s of Sheep: Gas-Liquid-
Chromatography (G.L.C.) Determinations: BIOCHEM/353. (Unpub-
lished study received Mar 4, 1976 undt : 6F1753; prepared by May
& Baker, Ltd., submitted by Rhodia, Ir :., Monmouth Junction,
N.J.; CDL:098088-V)
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 Phosalone Standard
MRID CITATION
00006979 Dorough, H.W.; Randolph, N.M. (1967) Dissipation of Zolone insecti-
cide from treated alfalfa. Journal of Economic Entomology 60
(l):285-286. (Also in unpublished study received Mar 4, 1976
under 6F1753; submitted by Rhodia, Inc., Monmouth Junction,
N.J.; CDL:098088-X)
00034721 Henckler, P.; Dennis, S.; Torre, C. (1973) Residue: Zolone EC
Artichoke: Project no. 170473-008. (Unpublished study received
on unknown date under 3E1401; prepared by Rhodia, Inc.,
submitted by Interregional Research Project No. 4; CDL 093752-A)
00035788 Anon. (19??) Peaches. (Unpublished study received on unknown date
under unknown admin, no.; submitted by ?; CDL:118507-A)
00053758 Guardigli, A. (1968) Quantitative Determination of Phosalone by
GLC and Semi-quantitative Determination of RP 12244 (Phosalone
Oxygen Analog) in Crop Extracts by Thin Layer Chromatography.
Rhodia analytical method no. 54-D dated Aug 30, 1968. (Rhodia,
Inc., unpublished study) .
00057508 Societe des Usines Chimiques Rhone-Poulenc (1973) Phosalone: Chro-
matography Test: Identification of Impurities: S.U.C.R.P.—
Document D.S.An. Nord No. 2340. A translation of: Phosalone Ex-
amen Chromatographique Identification des Impuretes. (Unpub-
lished study)
00057510 Rhodia, Incorporated (1969) Residues of Phosalone in Lemons: PA
66-73. (Compilation; unpublished study, including PA 66-63)
00057511 Rhodia, Incorporated (1968) Residues of Phosalone in Oranges:
PAS 66-57. (Compilation; unpublished study, including PA 69-19)
00062878 Hutsell, T.C.; Mulkey, N.S.; Wargo, J.P., Jr.; et al. (1978) Re-
search Report: 14C-Phosalone Sorghum Metabolism Study: ADC
Project No. 299. (Unpublished study received Dec 4, 1980 under
359-620; prepared by Analytical Development Corp., submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:
099782-A)
00062879 Penner, D. (1977) Sorghum Metabolism Study with 14C-Phosalone:
Report on: I. Growing, Treatment, and Harvest of the Sorghum;
II. 14C-Phosalone Translocation Study. (Unpublished study re-
ceived Dec 4, 1980 under 359-620; prepared by Michigan State
Univ., Dept. of Crop and Soil Sciences, submitted by Rhone-
Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:099782-B)
127
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00062880 Wargo, J.P., Jr.; Tessier, J.F.; Kruplak, J.F.; et al. (1980)
Validation of Methods 54A and 144 for the Determination of
Phosalone and Metabolites in Raw Agricultural Commodities: ADC
Project # 460. (Unpublished study received Dec 4, 1980 under
359-620; prepared by Analytical Development Corp., submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:
099782-C)
00062881 Rhone-Poulenc Chemical Company (1978) Freezer Storage Stability
Test on Alfalfa. (Unpublished study received Dec 4, 1980 under
359-620; CDL:099782-D)
00064522 Buys, M.; Guardigli, A. (1980) Validated Enforcement Methodology
for Animal Substrates: PDD Report No. 80/016. MetbOJ no. 155
dated Oct 1980. (Unpublished study received Dec 4, 1980 under
359-620; prepared in cooperation with Analytical Development
Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junc-
tion, N.J.; CDL:099784-A)
00064523 Witkonton, S. (1980) Research Report: Validation of Analytical
Methods for the Determination of Phosalone and Its Metabolites
in Milk and Animal Tissues: ADC Project # 496. (Unpublished
study received Dec 4, 1980 under 359-620; prepared by Analytical
Development Corp., submitted by Rhone-Poulenc Chemical Co., Mon-
mouth Junction, N.J.; CDL:099784-B)
00064524 Craig, L.D.; Langknecht, J.C.; Adams, L.; et al. (1980) Research
Report: Residue Determination of Phosalone and Its Oxygen Analog
in the Milk and Tissues of Dairy Cattle by Electron Capture Gas
Chromatography: ADC Project # 475-D. Includes method dated May
16, 1980. (Unpublished study, including ADC project #s 475-A&B
and 475-C, received Dec 4, 1980 under 359-620; prepared by Ana-
lytical Development Corp., submitted by Rhone-Poulenc Chemical
Co., Monmouth Junction, N.J.; CDL:099785-A)
00064525 Fox, S.E.; Langknecht, J.C.; Busemeyer, F.; et al. (1980) Research
Report: Residue Determination of Phosalone and Its Oxyon Analog
in the Eggs and Tissues of Chickens: ADC Project # 507. (Unpub-
lished study received Dec 4, 1980 under 359-620; prepared by
Analytical Development Corp., submitted by Rhone-Poulenc Chemi-
cal Co., Monmouth Junction, N.J.; CDL:099785-B)
00064528 Fox, S.E.; Herrera, R. (1980) Research Report: Residue Determina-
tion of Metabolites Containing the Chlorobenzoxazole Moiety in
Tissues and Eggs from Laying Hens Fed Phosalone: ADC Project #
507-A. (Unpublished study received Dec 4, 1980 under 359-620;
prepared by Analytical Development Corp., submitted by Rhone-
Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:099785-E)
128
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRJD CITATION
00064530 Breault, G.O.; Fox, S.E. (1980) Confirmation of Phosalone in Chick-
en Tissues by Gas Chromatography/Mass Spectrometry. (Unpub-
lished study received Dec 4, 1980 under 359-620; prepared by An-
alytical Development Corp., submitted by Rhone-Poulenc Chemical
Co., Monmouth Junction, N.J.; CDL:099785-G)
00064634 Chow, W.; Eng, S.; Piznik, M. (1980) Validated Enforcement Method-
ology for Plant Substrates: Electron Capture Gas Liquid Chro-
matography Determination of Phosalone and Its Oxygen Analog and
Thin Layer Chromatography Determination of the Aglycone and
Glycoside Benzoxazolone Moieties in/on Raw Agricultural Com-
modities: PDD Report No. 80/013. Rhone-Poulenc analytical
method no. 153 dated Sep 1980. (Unpublished study received Dec
4, 1980 under 359-620; submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:099783-A)
00065653 Spicer, E.J.F.; Geil, R.G.; Marshall, P.; et al. (1980) Lifetime
Oncogenicity Study in Mice: IRDC No. 347-009. (Unpublished
study received Dec 4, 1980 under 359-620; prepared by Inter-
national Research and Development Corp., submitted by Rhone-
Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:099788-A.)
00086695 Pennwalt Corporation (1968) Residue Chemistry: Introduction: Penn-
cap-M. (Unpublished study received Oct 28, 1981 under
4581-292; CDL:246182-A)
00098485 Guyton, C.L.; Chow, W.; Eng, S.; et al. (1982) Phosalone Residue
Data on Almond Hulls and Nut Meat at 30 Days Pre-harvest Inter-
val: PDD No. 821028. (Unpublished study received Apr 12, 1982
under 359-620; submitted by Rhone-Poulenc Chemical Co., Mon-
mouth Junction, N.J.; CDL:247231-A)
00101506 Abbott, L.; Valerio, J.; Kingery, A.F. (1982) Primary Skin irri-
tation Study in Albino Rabbits with Phosalone Technical: WIL-
81367. (Unpublished study received Apr 16, 1982 under 359-626;
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:247283-A)
00101508 Valerio, J.; Kingery, A.F. (1982) Acute Eye Irritation Study in
Albino Rabbits with Zolone WP: WIL-81259. (Unpublished study
received Apr 16, 1982 under 359-626; submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:247284-A)
00101509 Valerio, J.; Kingery, A.F. (1982) Primary Skin Irritation Study
in Albino Rabbits with Zolone WP: WIL-81259. (Unpublished
study received Apr 16, 1982 under 359-626; submitted by Rhone-
Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247284-B)
129
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00101510 Abbott, L.; Valerio, J.; Kingery, A.F. (1982) Delayed Contact
Hypersensitivity Study in Guinea Pigs with Zolone WP: WIL-
81369. (Unpublished study received Apr 16, 1982 under 359-626;
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:247284-C)
00101511 Abbott, L.; Valerio, J.; Kingery, A.F. (1982) Acute Eye Irritation
Study in Albino Rabbits with Zolone EC: WIL-81366. (Unpub-
lished study received Apr 16, 1982 under 359-626; submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:
247285-A)
00101512 Winbigler, J.C.; Kiggins, E.M.; Hastings, S.E.; et al. (1977) Re-
peat Acute Primary Dermal Irritation Study with Zolone E.G. in
Rabbits: Report No. JCW 77:13. (Unpublished study received Apr
16, 1982 under 359-626; submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:247285-B)
00101513 Abbott, L.; Valerio, J.; Kingery, A.F. (1982) Delayed Contact
Hypersensitivity Study in Guinea Pigs with Zolone EC: WIL-
81368. (Unpublished study received Apr 16, 1982 under 359-
626; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:247285-C)
00109468 Interregional Research Project No. 4 (1982) The Results of Tests
on the Amount of Phosalone Residues Remaining in or on Carrots
Including a Description of the Analytical Method Used. (Com-
pilation; unpublished study received Aug 5, 1982 under 2E2741;
CDL:071030-A)
00115113 Kuc, W. (1979) 14C-Phosalone—Bluegill Sunfish ... Bioconcentration
Study: UCES Project No. 11507-14. (Unpublished study received
Sep 20, 1982 under 359-632; prepared by Union Carbide Corp.,
submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:
248345-A)
00115114 Doebbler, G. (1979) Bioconcentration of Phosalone by Bluegills—
Extraction and Characterization of Metabolites in Tissue and
Water: UCES Project No. 11507-53. (Unpublished study received
Sep 20, 1982 under 359-632; prepared by Union Carbide Corp. En-
vironmental Services, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL:248345-B)
130
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00115115 Kynooh, S.; Lloyd, G.; Mallard, J.; et al. (1979) The Effect of
Repeated Applications of Phosalone 11974 RP to the Skin of Rab-
bits for Twenty-one Days: RNP125/79335. (Unpublished study
received Sep 20, 1982 under 359-632; prepared by Huntingdon
Research Centre, Eng., submitted by Rhone-Poulenc, Inc., Mon-
mouth Junction, NJ; CDL:248346-A)
00115116 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Acute Oral LD50—
Mallard Duck: Phosalone Technical: Project No. 171-106. Final
rept. (Unpublished study received Sep 20, 1982 under 359-632;
prepared by Wildlife International, Ltd., submitted by Rhone-
Poulenc, Inc., Monmouth Junction, NJ; CDL:248347-A)
00115117 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Eight-day Dietary
LC50—Bobwhite Quail: Prosalone Technical: Project No. 171-104.
Final rept. (Unpublished study received Sep 20, 1982 under 359-
632; prepared by Wildlife International, Ltd., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:248347-B)
00115118 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) Eight-day Dietary
LC50—Mallard Duck: Phosalone Technical: Project No. 171-105.
Final rept. (Unpublished study received Sep 20, 1982 under 359-
632; prepared by Wildlife International, Ltd., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:248347-C)
00115119 Rhoderick, J. (1982) The Acute Toxicity of Phosalone to Rainbow
Trout ...: Project No. 82-E-077-R. Final rept. (Unpublished
study received Sep 20, 1982 under 359-632; prepared by Biospher-
ics, Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ; CDL:248347-D)
00115120 Orza, A. (1979) The Acute Toxicity of Phosalone Technical (Lot #78-
193-00) to the Bluegill Sunfish ...: UCES Proj. No. 11507-14-O1.
(Unpublished study received Sep 20, 1982 under 359-632; prepared
by Union Carbide Corp., submitted by Rhone-Poulenc, Inc.,
Monmouth Junction, NJ; CDL:248347-E)
00115121 Graney, R. (1982) The Acute Toxicity of Phosalone to Daphnia magna
Straus: Project No. 82-E-077-D. Final rept. (Unpublished study
received Sep 20, 1982 under 359-632; prepared by Biospherics,
Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ;
CDL:248347-F)
00137036 Guyton, C.; Chow, W. (1983) Soil Dissipation Study of Phosalone:
ASD Report No. 83/061; Lab Ref. No. 83/BHL/904/AG. (Unpublished
study received Dec 27, 1983 under 359-632; submitted by Rhone-
Poulenc, Inc., Monmouth Junction, NJ; CDL:252077-A)
131
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
00137037 Morris, J. (1983) Acute Oral LD50 in Hens with Phosalone: GSRI
Project No. 411-B50-40. (Unpublished study received Dec 27,
1983 under 359-632; prepared by Gulf South Research Institute,
submitted by Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:
252078-A)
00137038 Morris, J. (1983) Acute Delayed Neurotoxicity Study in Hens with
Phosalone: GSRI Project No. 411-B51-40. (Unpublished study re-
ceived Dec 27, 1983 under 359-632; prepared by Gulf South Re-
search Institute, submitted by Rhone-Poulenc, Inc., Monmouth
Junction, NJ; CDL:252078-B)
00137881 Williamson, H.; McDuffie, W.; Teeters, W. (1973) Zolone WP: Rat
Oral: ID No. 91855. (Prepared by U.S. Environmental Protection
Agency, Pharmacology Laboratory).
00137882 Williamson, H.; McDuffie, W.; Jasper, R. (1972) (Rhodia Zolone EC:
Rat): ID No. 100897. .(Prepared by U.S. Environmental Protection
Agency, Pharmacology Laboratory).
00139544 Atkins, E.; Greywcod, E.; Macdonald, R.; (1973) Toxicity of Pesti-
cides and Other Agricultural Chemicals to Honey Bees: Laboratory
studies. Riverside, CA: Univ. of California. (M/16; also In
unpublished submission received Dec 15, 1983 under 239-2460;
submitted by Chevron Chemical Co., Richmond, CA; CDL:252084-A)
00144442 McEwen, F.; Ritcey , G.; Braun, H.; et al. (1980) Foliar pesticide
residues in relation to worker re-entry. Pestic. Sci. 11:643-
650.
00159274 Singh, B.; Dhaliwal, G.; Kalra, R. (1980) Residues of quinalphos
and phosalone in tomato. Bull. Environm. Contain. Toxicol. 24:
423-426.
00164511 Forbis, A.; Schoen, L.; Stuerman, L. (1986) Uptake, Depuration and
Bioconcentration of [Carbon 14]-phosalone by Bluegill Sunfish
(Lepomis macrochirus): ABC Final Report #34283. Unpublished
study prepared by Analytical Bio-Chemistry Laboratories, Inc.
74 p.
05001343 Winterlin, W.; Kilgore, W.; Mourer, C.; Mull, R.; Walker, G.;
Knaak, J.; Maddy, K. (1978) Dislodgable residues of dialifor
and phosalone and their oxygen analogs following a reported
worker-injury incident in the San Joaquin Valley, California.
Bulletin of Environmental Contamination and Toxicology
20(2):255-260.
132
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
05003635 Knaak, J.B.; Peoples, S.A.; Jackson, T.J.; Fredrickson, A.S.;
Enos, R.; Maddy, K.T.; Blair Bailey, J.; Duesch, M.E.; Gunther,
F.A.; Winterlin, W.L. (1978) Reentry problems involving the use
of dialifor on grapes in the San Joaquin Valley of California.
Archives of Environmental Contamination and Toxicology
7(4):465-481.
05005243 Popendorf, W.J.; Spear, R.C.; Leffingwell, J.T.; Yager, J.; Kahn,
E. (1979) Harvester exposure to Zolone (phosalone) residues in
peach orchards. Journal of Occupational Medicine
21(3):189-194.
05007744 Leffingwell, J.T.; Turner, E.R.; Futagaki, S.; Spear, R.C. (1977)
A field survey of dislodgeable Zolone residues in twelve
commercially treated vineyards. Bulletin of Environmental
Contamination and Toxicology 18(2):219-226.
05007745 Leffingwell, J.T.; Spear, R.C.; Jenkins, D. (1975) The persistence
of ethion and Zolone residues on grape foliage in the Central
Valley of California. Archives of Environmental Contamination
and Toxicology 3(l):40-54. .
05007746 Pasquet, J.; Mazuret, A.; Fournel, J.; Koenig, F.H. (1976) Acute
oral and percutaneous toxicity of phosalone in the rat, in
comparison with azinphosmethyl and parathion. Toxicology and
Applied Pharmacology 37(l):85-92.
05008190 Knaak, J.B.; Maddy, K.T.; Gallo, M.A.; Lillie, D.T.; Craine, E.M.;
Serat, W.F. (1978) Worker reentry study involving phosalone
application to citrus groves. Toxicology and Applied
Pharmacology 46(2):363-374.
05008305 Ambrosi, D.; Isensee, A.R.; Macchia, J.A. (1978) Distribution of
oxadiazon and phosalone in an aquatic model ecosystem. Journal
of Agricultural and Food Chemistry 26(l):50-53.
05009309 Winterlin, W.; Mourer, C.? Bailey, J.B. (1974) Degradation of four
organophosphate insecticides in grape tissues. Pesticides
Monitoring Journal 8(1):59-65.
05009356 Ambrosi, D.; Kearney, P.C.; Macchia, J.A. (1977) Persistence and
metabolism of phosalone in soil. Journal of Agricultural and
Food Chemistry 25(2):342-347.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY .
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Phosalone Standard
MRID CITATION
05013895 FAO Working Party of Experts on Pesticide Residues (1973) Phosa-
lone. Pages 493-520, In 1972 Evaluations of Some Pesticide
Residues in Food. By the Joint Meeting of the FAO Working
Party of Experts on Pesticide Residues and the WHO Expert
Committee on Pesticide Residues. Geneva, Switzerland: World
r/ Health Organization. (WHO pesticide residues series no. 2)
05014548 Klisenko, M.A.; Pis'mennaya, M.V. (1973) Vliyanie UF-sveta na
stabil'nost' dialkilditiofosfororganicheskii pestitsidov The
effect of ultraviolet light on the stability of
dialkyldithioorganophosphorus pesticides Khimiya v Sel'skom
Khozyaistve. Chemistry in Agriculture. 11(12):916-918.
05014688 Kovaleva, E.S.; Talanov, G.A. (1977) Absorptsiya TKhM-3 i fozalona
iz pochvy i ikh migratsiya v rasteniya Trichlorometaphos-3
and phosalone absorption from the soil and their migration into
plants Gigiena i Sanitariya. Hygiene and Sanitation.
42(12):87-88.
05016356 Nalbandyan, R.A. (1975) 0 vpzmozhnosti proniknoveniya nekotorykh .
pestitsidov v yagody vinograda The possibility of
penetration of some pesticides into grapes Vinodelie i
Vinogradarstvo SSSR. Winemaking and Viticulture in the USSR.
(6):42-43.
05016979 Desnoras, J. (1965) Dosage biologique de la phosalone ou 11 974
R.P.: application a 1'etude de la degradation de la phosalone
dans les plantes et le sol Biological determination of
phosalone or 11,974 R.P.: application to the study of
degradation of phosalone in plants and in the soil
Mededelingen van de Landbouwhogeschool en de Opzoekingsstations
van de Staat te Gent. Communications of the Agricultural
University and the State Research Station of Ghent.
29(3):1221-1234.
05021646 Knaak, J.B.; Schlocker, P.; Ackerman, C.R.; Seiber, J.N. (1980)
Reentry research: establishment of safe pesticide levels on
foliage. Bulletin of Environmental Contamination and
Toxicology 24(5):796-804.
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.
40259201 Guardigli, A.; Chow, W.; Martwinski, M. (1971) Determination of
Phosalone and Its Oxygen Analog in Citrus Crops. J. Agr. Food
Chem. (19:4) 742-744.
134
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FORMS APPENDICES
135
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OMB Approval No. 2070-0057
Expires 11/30/89
F1FHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
Witt) respect to tne requirement to submit "generic" diti imposed by the FIFRA section 3(C)(2)(B) notice contained in ih? rrltrenced
Guidance Document. I am responding in the following manner
CD 1. I will submit data in a timely manner to atuty the following requirements. It the test procedures I will use deviate from (or are a )i
specified in) the Registration Guidelines of the Protocols contained in the Reports of Expert Groups to the Chemicals Gioup. OECO
Chemicals Tasting Programme. I endow the protocols thai I will use:
O 2. I have entered into an agreement with on* or mora other registrant! und«r FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirement!. The testx, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 3. I enclose a completed "Cert H lot ion of Attempt to Enter Into an Agreement with Other Registrants for Development ol Data" with
respect to the following data requirements:
O 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
O S. I request voluntary cancellation of the registration of thh product (This option is not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA Form 8S80-1
SIGNATURE
DATE
136
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OMB A-pproval No. 2070-0057
Expires 11/30/89
(To qualify, certify ALL four itomt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following (irm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
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 »n 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 writirx) to enter into such in 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)(2H8)(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);) 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 S58O-6
137
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Date
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(Test not|
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Registration
Guideline No.
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PRODUCT
CHEMISTRY
61-1
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Discussion of
formation of
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• Preliminary
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for enforcement
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Color
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Solubility j
Vapor pressure
Dissociation
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Octariol/water
partition
coefficient
PH
for my
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listed
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(check
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data requirements by
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Number or
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Name of Test
Stability
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Flammability
Explodability
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Viscosity
Miscibility j
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
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Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
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EPA Form 8580-4
139
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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
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(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 reouired generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
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the Agency will consider that both they and my firm are not in compliance and
will normallv initiate proceedings to suspend the registrations of my firm's
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the required data in the specified time frame. I understand that, in such cases,
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Registrant's authorized representative:
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EPA Form 8570-27
(Typed)
140
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