OMB Control No. 2070-0057
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ALUMINUM TRIS(O-ETHYLPHOSPHONATE)
(REFERRED TO AS FOSETYL-AL) .
AS THE ACTIVE INGREDIENT
CASE NUMBER: 0646
CAS (DOCKET) NUMBER 39148-24-8
FEBRUARY, 1988
ENVIRONMENTAL PROTECTION AGENCY:
OFFICE OF PESTICIDE PR66RAMS'
WASHINGTON, D. C. 20460
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TABLE OF CONTENTS
Page
Glossary of Terms and Abbreviations iv
I . Tntroduct ion 1
IT. Chemical(s) Covered by this Standard 4
A. Description of Chemical
R. Mse Profile
C. History
III. Agency Assessment 5
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Renefits
E. Tolerance Reassessment
IV. Regulatory Position and Rationale 17
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 77
VI. Requirement for Submission of Generic Data 24
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
F. Testing protocols, standards for conducting
acceptable tests, guidance on evaluating and
reporting data.
F. Procedures for requesting a change in testing
protocol.
G« Procedures for requesting extensions of time
RJ PR Notice 86-5 and any other requirements
referenced or included within this Notice.
Existing stocks provision upon suspension
or cancellation
vii. Requirement for Submission of Product-Specific Data . 30
VIII. Requirement for Submission of Revised Labeling 31
IX. Instructions for Submission 31
A. Manufacturing use products containing the
subject pesticide as sole active ingredient
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Page
B. Manufacturing use products containing
the subject pesticide in combination with
other active ingredients
C. End use products containing the subject
pesticide as sole active ingredient
D. End use products containing the subject
active ingredient as one of multiple active
i ngred ients
E. Intrastate products containing the subject
pesticide either as sole active ingredient
or in combination with other active
ingred ients
?. Addresses
APPENDICES
I. DATA APPENDICES
Guide to Tables 35
Table A 37
Table R 58
Table C 62
II. LABELING APPENDICES fit
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements 7fi
Physical/Chemical Hazards Labeling Statements.... 85
Storage Instructions 86
Pesticide Disposal Instructions 87
Container Disposal Instructions.. BR
III. USB INDEX APPENDIX 8 9
— ^
IV. «T»6tfWi»tpnY APPENDICES 97
Guide to Bibliography 98
Bibliography. 100
V. FORMS APPENDICES 107
EPA Form 8580-1 FIFRA 53(c)(2)(B) Summary Sheet 108
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' /
Pa9e
EPA Form 8580-6 Certification of Attempt to 109
Enter Into an Agreement with
Other Registrants for Development
of Data
RPA Form R5R0-4 Product Specific Data Report 110
RPA Form 8 570-27 Formulator's Exemption Statement 113
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: (Acceptable Daily Intake) An acceptable daily intake
of pesticide residue based on a complete data base.
ai: Active Ingredient
CAS: Chemical Abstract Service (Number)
Core Classifications: A general guide to the acceptability of
data for the purpose of supporting
registration (invalid, supplementary,
minimum, or guideline).
Core Guideline: Studies which satisfy Agency data requirements.
Core Minimum: Studies which are acceptable to support registration
of pesticide products but were not necessarily done
according to Agency guidelines.
Core Supplementary: Studies in this category are scientifically
sound, thus the information may be useful.
However, the studies were performed under
conditions that deviated substantially from
recommended protocols. Studies do not meet
guideline requirements and thus do not support
registration of a product.
CSF: Confidential Statement of Formula
DNA: deoxyribonucleic acid
EEC: (Estimated Environmental Concentration) Estimated pesticide
concentration in the environment (terrestrial or aquatic
ecosystem).
EP: End-Use Product
EPA: The Environmental Protection Agency, also "the Agency"
Epicotyl - The growing point of the embryo, which gives rise to
the shoot, or aboveground part of the plant.
Fq' Refers to the generations in a multigeneration study.
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
HDT: Highest Dose Tested
Invalid: Studies which are deficient in some vital parameter
or those studies which have been judged not to be
scientifically sound or those studies whose
reliability is seriously questioned.
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Interim Tolerance - As per 40 CFR 180.319, interim tolerances
were formerly established for residues of various pesticides
while petitions for tolerances for negligible residues were pending.
Note that negligible residue tolerances are no longer established.
LC50: (median lethal concentration) a statistically derived
concentration of a substance that can be expected to cause
death in 50% of test animals, expressed as weight or volume
of test substance per volume of air or water (e.g., mg/L
or ppm).
LD50: (median lethal dose) a statistically derived single dose
that can be expected to cause death in 50% of animals when
administered by the route indicated, expressed as weight
of substance per unit weight of test animal (e.g., mg/kg).
LDT: Lowest Dose Tested
LEL: Lowest-Effect Level
MDT: Mid-Dose Tested
MOS: Margin of Safety - The calculation of a margin of safety
involves division of an appropriate NOEL by a worker's
estimated exposure. The result is a unitless figure which
gives an indication of how close a worker's internal dose
is in relation to the NOEL for laboratory animals.
MP: Manufacturing-Uee Product
MPI: Maximum Permissible Intake
MRID: Master Record Identification (Number) - EPA's system of
tracking studies used in support of registrations.
NPDES: National Pollution Discharge Elimination System
NOEL: No-Observed-Effect Level —the maximum dose used in a test
which produces no observed effects.
OPP: IK* Office of Pesticide Programs
OESt Office of Endangered Species, U.S. Fish and Wildlife Service
OM: Organic natter (used to describe soils)
PADI: Provisional Acceptable Daily Intake —an acceptable daily
intake of pesticide residue based on a limited data base.
PAI: Pure Active Ingredient
ppm: parts per million
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•s
RACs: Raw Agricultural Commodities
Technical: Active ingredient aa manufactured
TGAI: Technical Grade of the Active Ingredient
TMRC: Theoretical Maximum Residue Contribution --an estimate of
dietary exposure obtained by multiplying residue tolerance levels
for a given pesticide by the average daily per capita food
consumption figure, then adding the exposure figures for each
crop. TMRC is usually expressed in terms of milligrams of active
ingredient per kilogram body weight per day.
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1• INTRODUCTION
v This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued in
June 1983, the Agency described the available data supporting
the registration of the chemical and its assessment of those
data in terms of whether the pesticide met the "no unreasonable
adverse effects" standard of FIFRA. The Agency concluded
that additional data were necessary to fully evaluate the
pesticide, and, as part of the issuance of the Standard,
required that registrants supply those data. The Agency
also set out label requirements needed to ensure that products
containing the pesticide were adequate to protect public
health and the environment while the data were under develop-
ment.
The Agency has now received and reviewed the new data
and has updated and revised its scientific and regulatory
conclusions concerning the pesticide. The Registration
Standard contains the Agency's updated scientific assessment
of this pesticide and its currently registered uses. As part
of its review, the Agency has reassessed the tolerances for
the pesticide and determined whether they are adequate. The
tolerance reassessment is included in this Registration
Standard.
In the intervening period between the original standard
and this revision, the Agency has expanded its data requirements.
Consequently this Registration Standard may contain additional
data requirements not foreseen or required at the time of
initial issuance. Based on the new data, the Agency has
also reviewed the labeling requirements for the pesticide
and may be requiring label revisions.
In this review EPA identifies:
1. Studies that are acceptable to fulfill the data
requirements and support the currently registered uses of the
pesticide.
2. Additional studies necessary to support registration
or rarqgiatration. The additional studies may not have
been reguired whan the application was initially submitted or
when tlw product was initially registered, or may be needed to
replace studies that are now considered inadequate.
3. Labeling statements needed to ensure that the product
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is not misbranded and that the labeling is adequate to protect
human health and the environment.
The detailed 3cientific review, which is not contained
in this document, but is available upon request^-, focuses
on the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect human health and the environment.
EPA's reassessment results in the development of
regulatory positions, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory positions, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration:
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suipend (in the case of failure to submit data).
XH addition, in cases of registered pesticides for
which Ikasards to humans or the environment are identified, the
Agency may initiate a special review of the pesticide in
accordance with 40 CFR Part 154 to examine in depth the risks
and benefits of use of the pesticide. If the Agency determines
that the risks of the pesticide's use outweigh the benefits
of use, the Agency may propose additional regulatory actions,
such as cancellation of uses of the pesticide which have been
determined to cauae unreasonable adverse effects on the
environment.
^The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve its concerns about this pesticide.
These data are listed in Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements may result in the
issuance by EPA of a Notice of Intent to Suspend the affected
product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify the
Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as a product is registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of chemical
The following chemical is covered toy this Registration
Standard:
B.
Common name: Nonel
Chemical name: Aluminum tris(0
to hereafter as
CAS Number: 39148-24-8
OPP Shaughnessy Number: 123301
Empirical Formula: Al(HgC203P)3
Trade name: Aliette
Description of physical characteristics
ethylphosphonate)
fosetyl-Al)
(Referred
of chemical:
Fosetyl-Al is a white odorless powder that melts with
decomposition at temperatures greater than 200* Celsius.
The solubility of fosetyl-Al in water at 20* Celsius is
120 grams per liter. The chemical is stable under
normal storage conditions.
Uae Profile
Type of Pesticide
Pests Controlled:
Registered Uses:
Predominant Uses:
Mode of Activity:
Formulation Types
Systemic fungicide
Oomyceteous fungi causing damping-off
and rot of roots, stems and fruit.
Pineapples; Citrus; Ornamentals; Turf
Pineapples; Citrus; Ornamentals
Unknown
Registered:
Technical - 95 percent active ingredient
Formulation - 80 percent wettable powder
Methods of Applications
C. History
Dip treatment; Pre-plant soil
Incorporation; Foliar; Drench
Fosetyl-Al was first registered by the Agency in 1983
for use on pineapples* ornamentals and turf. The chemical
is sold under the trade name Aliette". It is known in
England as fosetyl-Al and in France as phosetyl-Al.
It has a discontinued common name of efosite-Al. The
uses of fosetyl-Al for foliar application to pineapple
and to citrus were added in 1985 and 1986, respectively.
1/ For the purpose of the standard, the name, fosetyl-Al, is
used rather than Aluminum tris(0-ethylphosphonate).
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III. AGENCY ASSESSMENT
A. Summary
The Agency has reviewed all data submitted to support the
registration of fosetyl-Al. Based on the review and evalua-
tion of these data, the Agency has reached the following
conclusions. A detailed discussion of the points summarized
below appears in Section B of this Chapter.
1. Fosetyl-Al poses a limited oncogenic risk to the general
population as a result of exposure through the diet and to
persons who may be exposed during the application of the chemical.
This is based on limited evidence of carcinogenicity in animal
data. The animal data indicates a statistically significant
increased incidence of urinary bladder tumors (adenomas and
carcinomas combined) in male rats administered fosetyl-Al at
the highest dose tested (40,000/30,000 ppm). There are no
human data on the effects of fosetyl-Al. Based on these data,
fosetyl-Al is classified as a Group C (possible human) carcinogen.
2. As stated in the Guidelines for Carcinogen Risk Assessment
(51 FR 33992) it may be necessary for the Agency to determine,
on a case-by-case basis, whether a Group C carcinogen is
suitable for quantitative risk assessment. In the case of
fosetyl-Al, the Agency has determined that a quantitative
oncogenic risk assessment is not appropriate. The available
data do not provide a suitable basis for numerical extrapolation
to humans for the following reasons;
a. The incidence of urinary bladder tumors was not a
strictly dose-related phenomenon. The response was observed
only in male rats at the highest dose tested (40,000/30,000 ppm).
b. The extremely high doses tested (40,000/30,000 ppm)
approached the level of 5% of the diet which could begin to
compromise the nutritional status of the experimental animals,
due to the dilution of essential nutrients. Moreover, the
Agency is now tentatively proposing that the maximum tolerated
dose for rata ahoyId not exceed 20,000 ppm in oncogenicity studies.
e. Stress produced by administering extremely high
doses of cheatcals to laboratory animals can enhance the
response to oncogenic viruses and perhaps other innate
carcinogens as well (Paynter, Standard Evaluation Procedure
for Evaluation of Oncogenicity Potential, June 1985, page 24).
High doses of fosetyl-Al (40,000/30,000 ppm) nay have produced
stress, allowing a second substance to produce the carcinogenic
response or facilitating a neoplastic process.
d. All mutagenicity tests on fosetyl-Al were negative.
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3. The review of fosetyl-Al is the second intensive evaluation
of the compound. A registration standard was developed in
1983 in conjunction with its initial registration. There are
no major data gaps. A draft revised Registration Standard
for fosetyl-Al was issued for public comment in December
1986. No comments were received on the draft Standard.
Since the issuance of the standard in 1983, the Agency has
published the data requirements for registration. Based on
these requirements, the Agency will require the following
data:
§158.125 Residue Chemistry
171-4 Storage Stability of Residues in Pineapples and
Citrus
Storage stability data for pineapples and citrus are
required reflecting sample storage time between harvest
and analysis. Recent information reviewed by the Agency
has indicated that fosetyl-Al is less stable than
previously characterized.
§158.140 Reentry Protection
132-1 Foliar Dissipation
Data are required to establish a reentry interval for
farmworkers and maintenance personnel on all crops that
require hand harvesting, pruning, and other high intensity
worker contact with treated foliage due to potential
eye irritation.
§158.150 Plant Protection
122-2 Aquatic Plant Growth
This study is required due to the persistence of
fosetyl-Al in water.
§158.155 Nontarget Insects
141-1 Honeybee Acute Contact LD50
This study is required because use on crops may result
in exposure of honeybees.
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B. Risk Assessment.
The Agency has conducted a thorough review of the scientific data
base for fosetyl-Al. The conclusions and requirements imposed as a
result of this review and evaluation are summarized in Section III-A.
A discussion of the results of the review of the data base is
presented below.
1. Acute and Subacute Toxicity. Adequate data are available to
determine the acute toxicity of fosetyl-Al. Based on the available
data, technical fosetyl-Al (purity 98.4%) is classified as a Toxicity
Category I chemical based on eye irritation. For the other exposure
routes fosetyl-Al is classified as a Toxicity Category III or IV
chemical.
Available data define the approximate LD^q values for oral and
dermal exposure and the LC50 for inhalation exposure. The LD50
for acute oral (rat) and dermal (rabbit) exposure are 5.4 g/kg
and >2g/kg, respectively, and the LC50 for inhalation (rat) is
>1.73 mg/1. A primary eye irritation study indicated the chemical
was irritating to the eye of the rabbit, with cornea involvement
persisting at 21 days in 2 of the 6 treated animals (eyes
not rinsed).
Data show that fosetyl-Al Is not a skin sensitizer. No
additional dermal sensitization data are needed.
Acute toxicity data are available on Aliette" (80% WP).
Acute oral (rat) and dermal (rabbit) toxicity LD50 values are
>5 g/kg and >2 g/kg, respectively. The acute inhalation toxicity
LC50 (rat) value is >2.67 g/1. Based on eye irritation data,
Aliette" is classified as a Toxicity Category III product. No
additional acute toxicity data are required.
2. Chronic Feeding/Oncogeniclty Studies.
Rat Oncogenicity Study - Fosetyl-Al was administered in
the diet to 80 Charles River CD-1 rats/sex/dose level at
doses of 0, 2000, 8000 and 40,000/30,000 (0, 100, 400, and
2000/1500 ng/kg body weight/day) for two years. The high
level was reduced to 30,000 ppm after 2 weeks, following
observations of staining of the abdominal fur and red coloration
of the urine at 40,000 ppm. No clinical signs were noted at
the 2000 and 8000 ppm levels and no NOEL for systemic
effects was established.
The study demonstrated a statistically significant elevated
incidence of urinary bladder tumors (adenomas and carcinomas
combined) at the highest dose level tested (40,000/30,000
ppm) In male Charles River CD-1 rats. The tumors were mainly
seen In surviving males at the time of terminal sacrifice.
The original pathological diagnosis of these tumors was
independently confirmed by a second consulting pathologist,
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who also reported an elevated incidence of urinary bladder
hyperplasia in male rats at the high dose level (Table 1).
No elevated incidence of urinary bladder tumors was observed
in female rats.
The original diagnosis of adrenal medullary tumors (pheochromo-
cytomas) indicated there was a statistically significant
increase in pheochromocytomas (adenomas plus carcinomas
combined) in male rats at the mid (8000 ppm) and high
(40,000/30,000) dose levels (Table 1; pathologist No.l). The
elevated pheochromocytoma incidence was primarily due to an
increase in the adenomas; no elevated incidence of adrenal
medullary hyperplasia was observed. Furthermore, when all 3
adrenal medullary lesions were combined (i.e., adenomas,
carcinomas and hyperplasia), no significant dose-related
effects were reported by pathologist No. 1.
This diagnosis was not confirmed by two other consulting
pathologists who reread the male rat adrenal gland slides
(Table 1? pathologists No. 2 and No. 3). Neither consulting
pathologist found significant dose-related increases in the
incidence of pheochromocytomas (adenomas plus carcinomas
combined) in male rats treated with fosetyl-Al. None of the
three pathologists reported increased incidences of combined
of adrenal medullary lesions (i.e., adenomas, carcinomas, and
hyperplasia). The Agency attributed the differences in the
pathological diagnosis of pheochromocytommas among the three
pathologists to the fact that a high degree of variability
exists in the interpretation of adrenal medullary neoplasia
versus adrenal medullary hyperplasia.
Pathologist No. 3, a known authority in the field of endocrine
pathology, was requested by the Agency to read all of the
slides blindly. Based on this reading of the slides and wide
variability in the interpretation of adrenal medullary
neoplasia versus hyperplasia, the Agency concluded that
fosetyl-Al did not produce an increased incidence of pheochromo-
cytomas in the high dose male rats. No elevated incidence of
adrenal gland tuaor9 was observed in female rats.
Rat Oncogenicity Study with Monosodium Phosphite (a metabo-
lite of roeetyl-Al) -Monosodium phosphite, the urinary
metabolite of £osetyl-Al in the rat, was administered in the
diet to 60 Charles River CD-I rats/sex/dose level at doses
of 0, 2,000, 8,000, and 32,000 ppm (0, 100, 400, and 1600
mg/kg body weight/day) for 117 weeks. The dose levels tested
in this study were equivalent to those employed in the chronic
oncogenicity study of fosetyl-Al described above. No evidence
of an oncogenic response in the urinary bladder, the adrenal
medulla, or at any other site was observed in this study.
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TABLE 1
Pathology Diagnoses of Urinary Bladder and Adrenal Medullary
Tumors in Oncogenicity Feeding Study of fosetyl-Al in Male
Charles River CD Bats
Tumor Site Reviewing^/
and Type Pathologist
0
Cto6e (ppm)
2,000 3,000
40,000/
30,000
Urinary Bladder:
Adenona 1
3
0/00(0%)
1/80(1%)
1/78(1%)
1/78(1%)
1/79(1%)
1/79(1%)
8/80(10%)
5/80(6%)
Carcinoma 1
2/80(2.5%)
2/80(2.5%)
0/78(0%)
2/78(2.5%)
0/79(0%)
1/79(1%)
7/80(9%)
16/80(20%)
Adenoma + Carcinoma 1
Combined 3
2/80(2.5%)
3/80(4%)
1/78(1%)
3/78(4%)
1/79(1%)
2/79(2.5%)
15/80(19%)*
21/80(26%)
Hyperplasia 1
3
NA
5/78(6%)
MA
7/78(9%)
NA
5/80(6%)
NA
29/79(37%)
Adrenal Medulla:
Adenoma 1
Carcinoma 1
5/80(6%)
1/80(1%)
7/78(9%)
0/78(0%)
15/79(19%)
1/79(1%)
16/80(20%)
2/80(2.5%)
Adenoma + Carcinoma 1
Combined 2
3
6/80(7%)
17/80(21%)
6/80(7%)
7/78(9%)
15/78(19%)
5/78(6%)
16/79(20%)*
19/79(24%)
10/79(13%)
18/80(22%)*
21/80(26%)
6/80(7%)
Hyperplasia 1
2
3
16/80(20%)
5/80(6%)
15/80(19%)
11/78(14%)
3/78(4%)
14/78(18%)
10/79(13%)
5/79(6%)
13/79(13%)
9/80(11%)
4/80(5%)
16/80(20%)
Adenoma + Carcinoma 1
+ Hyperplasia 2
(Combined) 3
22/00(27%)
22/80(27%)
21/80(26%)
18/78(23%)
18/78(23%)
19/78(24%)
26/79(33%)
24/79(30%)
23/79(29%)
27/80(34%)
25/80(31%) .
22/80(27%)
1 ¦ Or. R. M. Kovat<±i (Original Pathology Report"]"
2 - Or. W- R. Richter (Consultant; Examined Limited Slides)
3 3 Dp' S. W. Thcapsan (Consultant; Examined All Slides Blindly)
p< 0.05 aonpared to controls (Notes Statistical evaluation of data was presente
only for the diagnosis provided by pathologist No. 1).
NA = Information Not Available
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The highest dose of monosodium phosphite tested in the study
was associated with the following sign9 of toxicity: (a), a
significant ( p< 0.05) reduction in mean body weight gain in
male rats (-13.8%) and female rats (-9.4%) (throughout the
study this effect appeared to be compound related for the
males since weight gain was also reduced in low dose males
(-9.5%) and in mid dose males (-15.4%) at the end of the
study); (b). a reduction in the efficiency of food utilization
in male rats (this effect, which also occurred in the mid
dose males, may have been related to the reduced rate of
weight gain seen in male rats); (c). soft stools in male rats;
(d). a slight reduction in urine pH (acidification) in male
rats, and (e). significant (p<0.05) increases in relative
weights of the liver (male rats), kidneys (male and female
rats), and the heart (male and female rats). It was concluded
that, although most of these changes would not satisfy the
usual criteria for meeting a maximum tolerated dose (MTD)
level, the high dose level of 32,000 ppm (3% of the diet) was
approaching a level that affected nutrition.
Mouse Oncogenicity - Fosetyl-Al was administered in the diet
to 60 Charles River CD-I mice/sex/dose level at doses of 0,
2,500, 10,000, and 20,000/30,000 ppm ( 0, 357, 1,430, 2,857/
4,286 mg/kg body weight/day) for 2 years. The high dose level
was increased from 20,000 ppm to 30,000 ppm at study week 19
because of the absence of any observable effect in the early
part of the study. No evidence of an oncogenic response was
observed with fosetyl-Al, and no other toxicological changes
were seen.
The highest dose of fosetyl-Al tested in this study (i.e.,
20,000/30,000 ppm) did not approximate a MTD level. The
registrant apparently set the dose levels in this study on
the basis of those used in the chronic rat oncogenicity study,
since no subchronic toxicity tests were performed in nice to
estimate the MTD level. The initial dose levels used in the
mouse study were extremely high and were increased at week 19
o£ the study. The animals received a high enough dose
throughout the study to demonstrate any toxic effects. The
Agency does not believe that additional oncogenicity testing
in Die* would increase an understanding o£ the chemical's
toxicity since the high dose level of 20,000/30,000 ppm (2%
of the diet) was approaching a level that affected nutrition.
Two Year Dog Feeding Study - Fosetyl-Al was administered in
the diet to 6 dogs/sex/dose level at doses of 0, 10,000.
20,000, and 40,000 ppm (0, 250, 500, and 1,000 mg/kg body
weight). The no-observed-effect-level (NOEL) was 10,000
ppm. The lowest effect level (LEL) was 20,000 ppm based on
testicular changes (i.e. presence of spermatocytic and/or
spermatidic giant cells in the lumen o£ the seminiferous
tubules) in 2/6 males? this effect was also observed for 6/6
high dose male dogs. Other changes that were seen only at
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the high close level consisted of a reduction in total serum
proteins in male dogs throughout the study and a reduced BUN
in female dogs at several study intervals. Mo other toxicologica1
or histopathologica1 effects were observed.
The Agency has concluded that the data available constitutes
limited evidence of oncogenicity under the RPA Guidelines for
Carcinogen sisk Assessment (September 24, 1996, 51 FR 33992).
Therefore, fosetyl-Al is classified as a Group C carcinogen
(limited evidence of carcinogenicity in animals). The Agency
has determined that a quantitative oncogenic risk assessment
is not appropriate. The classification and the decision on
not to perform a quantitative risk assessment are based on
the following:
a. The oncogenic response observed with fosetyl-Al were
confined solely to the high dose males at one site (urinary
bladder) in Charles River CD-I rats. The tumors were mainly
seen in surviving animals at the time of terminal sacrifice.
Moreover, the unusually high dose at which oncogenic effects
were observed (40,(100/30,000 ppm) approached a level in the
diet at which the nutritional status of the experimental
animals may begin to be compromised.
b. Fosetyl-Al was not oncogenic when administered in the
diet to Charles River CD-I mice at dose levels ranging from
2,500 to 30,000 ppm.
c. Stress produced by administering extremely high doses of
chemicals to laboratory animals can enhance the response to
oncogenic viruses and perhaps other innate carcinogens as
well (Paynter, Standard Evaluation Procedure for Evaluation
of Oncogenicity Potential, June 1965, page 24). High doses
of fosetyl-Al (40,ono/30,000 ppm) may have produced stress,
allowing a second substance to produce the carcinogenic
response or facilitating a neoplastic process.
c. Hie urinary metabolite of fosetyl-Al, monosodium phosphite,
was not oncogenic when administered in the diet to Charles
River CT>— 1 rats at dose levels ranging from 2,000 to 32 ,000 ppm,
d. No adverse effects on the urinary bladder or the adrenal
gland were produced by fosetyl-Al in a 2-year chronic toxicity
study performed in Beagle dogs at dose leveLs ranging from 10,000
to 40,000 ppm.
e. Fosetyl-Al was not mutagenic in eight genotoxicity assays.
1 1
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3. Reproduction Study - A three generation rat reproduction
study was carried out at doses of 0, 6,000, 12,000, and
24,000 ppm (0, 300, 600, and 1,200 mg/kg body weight). There
was no evidence of an adverse effect on fertility or reproduction
at any dosage. Similarly there was no indication of an
adverse effect on j_n utero or on the development of young,
Parental animals were adversely affected at the highest
concentration (24,000 ppm) and to a lesser extent at 12,000
ppm but not at 6,000 ppm. At 24,000 ppm the most noteworthy
effects were:
(a). Lower body weight gain for males of all generations,
and females of the Fl** and F2R generation; the more marked
deviations of the FlP and F2R generations were associated
with both higher ingestions of material and lower weight at
weaning, (b). For all generations a specific effect on the
pattern of maternal weight changes during lactation leading
to slower mean pup weight gain and lower litter and mean pup
weights in mid- and late lactation, (c). A high incidence of
animals showing pathological changes in the urinary tract,
particularly for the FlP and F2R generations. These pathological
changes in the urinary tract were associated with an increased
incidence of male but not female deaths for the FIB and F2B
generations, (d). Correlating with urinary tract changes
observed in adults, the more detailed microscopic examination
at weaning of 10 male and 10 female per group (F3R generation)
revealed crystalline or calcareous deposits in the lumen of
the urinary bladder of most animals. The presence of these
deposits was frequently associated with minimal hyperplasia/
hypertrophy of transitional epithelium and sometimes also
with papillary projections and/or desquamation of epithelial
cells. These epithelial abnormalities are most likely reactive
to the presence of crystalline, calcareous deposits in the
bladder.
Similarly, at 12,000 ppm the following less marked effects
were observed! lower overall weight gains of the F2R
generation, lower litter and mean pup weight in late lactation,
and urinary tract changes in some adults and 10* weanling
males of the P3B generation. The NOEL in this study is
considered to be 6,000 ppm in adult and young rats (300 mg/kg
and 600 ragAg» respectively).
4. Teratogenicity Studies - Fosetyl-Al did not induce any
embryotoxic, fetotoxic, or teratogenic effects when orally
administered to pregnant New Zealand White rabbits at dose
levels of 125, 250 and 500 mg/kg body weight/day. The maximum
tolerated dose was 250 mgAg body weight/day based on significantly
lower weight gain in pregnant dams.
Fosetyl-Al was orally administered to rats at levels of 0,
500, 1 ,000, and 4,000 mgAg body weight. The treatment with
fosetyl-Al caused maternal toxicity at the highest dose
tested (4,000 mg/kg body weight/day). As a result of maternal
P
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toxicity effect at this dose level, litter and mean fetal
weights were reduced, total resorptions were increased and
delayed ossification of fetuses were observed. Five of 20
pregnant dams died at the high dose. The NORL for this study
is considered 1,000 mg/kg body weight/day.
5. Mutagenicity Studies - Fight mutagenicity tests were
performed with fosetyl-Al. All were acceptable to the Agency
and all were negative for mutagenic effects. TViese included
two Ames tests using typh imu r i um (strains TA QR, TA 1 535 ,
TA 1537, and TA 153R), two phage induction tests using F.
coli, two micronucleus tests in Swiss nice and CD-I mice (no
increase in the percentage of polychromatic erythrocytes
with micronuclei was observed), one DNA repair test using E.
coli, and one Saccharomyces cereviscae yeast assay.
f>. Metabolism Studies - Two studies were conducted in Sprague-
Dawley (SD) rats with orally administered fosetyl-Al
(250 mg/kg body weight/day X 7 days). The compound was rapidly
metabolized to give mainly CO2 (60%) which was recovered
from exhaled air. The second major route of excretion was
via the urine (approximately 26%) which contained some unchanged
parent compound plus a larger amount of phosphite (phosphorus
acid) as a metabolite, but no phosphate. Only minor amounts
(3-4*) of administered radioactivity were found in feces
and this consisted mainly of the phosphite metabolite. Two
additional studies were conducted in SD rats with the P^2
labeled phosphite metabolite (111 mg/kg body weight/day X 7
days). Ttie phosphite was excreted unchanged in both the
urine (59-65%) and the feces (30-32%). No unusual localization
of either fosetyl-Al or the metabolite in tissues was observed.
Prom the above results it appears that fosetyl-Al is essential-
ly completely absorbed after oral ingestion and extensively
hydrolyzed to phosphite and acetate to CO2 and then excreted
in expired air. Tie phosphite is excreted (along with some
unchanged parent compound) directly into the urine without
further oxidation to phosphate.
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7. Other Scientific Findings.
Environmental Fate - The environmental fate of fosetyl-Al
is sufficiently understood to conclude that no accumulation
of the chemical will result and because of rapid degradation,
it will not pose a potential a ground water contamination hazard.
Posetyl-Al degrades in the environment through the hydrolysis
of the ethyl ester bond with subsequent degradation of the
ethanol into carbon dioxide. The phosphorous acid metabolite
is expected to form precipitates with aluminum, calcium, or
iron in the soil. The half-life of fosetyl-Al under aerobic
conditions in soil is approximately 1.5 hours. The intermediate
metabolites in qrapes, pineapples and the rat are ethanol and
phosphorous acid.
Ecological Effects. Fosetyl-A.1 is not expected to pose a
significant hazard to terrestrial or aquatic organisms. The
toxicity of fosetyl-Al ranges from slightly toxic to practically
non-toxic. rre
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D.
Tolerance Reassessment.
Tolerances have been established in 40 CFR 180.415 for residues
of fosetyl-Al in or on citrus, pineapple, and pineapple
forage at 0.1 ppm. There are no Codex tolerances for fosetyl-Al.
EPA has evaluated the residue and toxicology data supporting
tolerances, and has made the following regulatory determinations:
1. The data submitted have been judged adequate to
support the existing tolerances. The established
tolerances are set at the appropriate levels and no
new tolerances are required to cover the existing uses
for the registered product. The established tolerances
have an adequate margin of safety to protect the
public health.
2. An oncogenicity study in mice was conducted in which
no oncogenic effects were induced at any dose level
under the conditions of the study (the highest dose
tested was 2,857/4,286 mg/kg body weight/day).
3. A rat chronic feeding/oncogenicity study was conducted
in which a NOEL for systemic effects wag not demonstrated.
A statistically significant increase in the incidence
of urinary bladder tumors was noted at the highest dose
tested (40,000/30,000 ppm). The incidence of these tumors
was not a strictly dose-related phenomenon since the
response was only at the highest dose tested. These high
doses could begin to compromise the nutritional status
of the experimental animals and also produce stress which
could enhance the response to oncogenic viruses.
4. A dog feeding study demonstrated a NOEL of 250 mg/kg
body weight/day.
5. A reproduction study in rats demonstrated a NOEL of
300 mg/kg body weight/day.
6. A teratology study in rabbit9 showed no teratogenic effects
and a NOEL of 500 mg/kg/day based on maternal toxicity.
7. A teratology study in rats demonstrated no teratogenic
effects and a NOEL of 1,000 mg/kg/day based on maternal
toxicity.
15
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8. Ames mutagenicity assays, E. Coli phage induction tests,
micronucleaus tests in mice, DNA repair tests using E. Coli,
and Saccharomyces cervisiae yeast assay were all negative"for
mutagenic effects.
9. There are two analytical methods acceptable for determin-
ing the levels of residues of fosetyl-Al in plants. A gas
chromatography method for pineapples with an analytical
sensitivity of 0.1 ppm and a phosphorous specific flame
photometric gas chromatography method for citrus with an
analytical sensitivity of 0.02 ppm. Harvested citrus fruit
were stored at 0° Fahrenheit for two months prior to analyses.
This time period is not considered unduly long; however, no
storage stability data were submitted to show fosetyl-Al was
stable under these conditions. The Agency is requiring these
data to be submitted.
10. Radiolabeled studies on the uptake, translocation and
metabolism of fosetyl-Al in plants show that the chemical
proceeds through hydrolytic cleavage of the ethyl ester,
with phosphorous acid and probably ethanol as the major
plant metabolites.
11. Adequate data on the nature of the residues in both
plants and animals, including identification of major metabolites
and degradates of fosetyl-Al are available. The major residues
were fosetyl-Al, phosphorous acid, and ethanol. The tolerances
are established for the parent only, that is, fosetyl-Al.
12. No poultry or livestock studies have been required because
measurable residues of fosetyl-Al are expected to occur in
or on the feed commodities, pineapple bran and forage, and
citrus pulp and molasses.
13. Residues of fosetyl-Al in pineapples, pineapple forage
and citrus are not likely to exceed the 0.1 ppm level and no
residues are detected in the processed fractions of pineapple
or citrus.
The Agency has determined the two year feeding study with
dogs is the study of choice to establish the acceptable
daily intake (ADI) because the dog was the most sensitive
species for which data on fosetyl-Al are available.
The NOEL in this study was 10,000 ppm (250 mg/kg body weight/day).
Using a safety factor of 100, the ADI is set at 2.5 mg/kg/day.
This is equivalent to a maximum permissible intake (MPI) of
150.0 mg/day for a 60 kg person. The theoretical maximum
residue contribution (TMRC) for fosetyl-Al based on the
established tolerances for pineapples and citrus and a daily
food intake of 1.5 kg is 0.00617 mg/kg. This represents
0.004 percent of the MPI.
16
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1
IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationales
1. None of the risk criteria listed in 40 CFR 154.7 for
initiating a Special Review have been met. Therefore, fosetyl-
A1 is not being placed in Special Review at this time.
Rationale: After consideration of available toxicology data,
the Agency has determined that no reason exists for placement
of fosetyl-Al in Special Review at this time. Fosetyl-Al has
been classified as a Group C carcinogen (limited evidence of
carcinogenicity in animals) and appears to pose minimal risk
of causing cancer in humans. The oncogenic responses observed
with fosetvl-Al were confined solely to the hiqh dose (40,000/
30,000 ppm) males at one site (urinary bladder) in one species
(rat). Oncogenicity testing in mice, oncogenicity testing on
the major metabolite of fosetyl-Al, and mutagenicity assays
were all negative for oncogenic effects.
2. An interim 24-hour reentry interval is being imposed for
all fosetyl-Al products with crop uses.
Rationale: Due to the potential for eye irritation resulting
from exposure to foliar residues of fosetyl-Al, this interval
is needed to protect farmworkers reentering treated areas.
Unprotected persons (i.e., workers not wearing protective
clothing) will be prohibited from entering sites for a 24-hr.
period. Although the formulated end use product is classified
as Toxicity Category III, technical fosetyl-Al is in Toxicity
Category I. Reentry intervals are established based on the
toxicity of the technical material because the concern is with
exposure to the active ingredient. A 24-hour reentry interval
is imposed for sites as an interim measure since exposure
data requirements under 40 CFR Section 158.140 have not been
submitted. These data are required under this Standard.
Once these data are received and evaluated, the reentry
interval will be reassessed.
3. The Agency ia not requiring an endangered species statement
on registered products containing fosetyl-Al.
Rationale! Fosetyl-Al demonstrated a very low toxicity to
terrestrial animals and the residues are not expected to
accumulate in the environment. Minimal exposure is anticipated
for endangered aquatic species. The chemical degrades in the
environment through the hydrolysis of the ethyl ester bond
with subsequent degradation of the ethanol into carbon dioxide.
The phosphorus acid metabolite is expected to form precipitates
with aluminum, calcium, or iron in the soil. The aerobic
half-life of fosetyl-Al in soil with air present is approximately
1.5 hours. The intermediate metabolites in grapes, pineapples,
and the rat are ethanol and phosphorus acid.
17
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U. It is the Agency's position that, in order to remain in
compliance with FIFRA, a restriction prohibiting livestock
from grazing in treated citrus groves is imposed.
Rationale: Although no detectable (<0.1 pprc) residues are
expected to occur in or on pineapples, citrus, or pineapple
forage, there may be higher residues on the grass in treated
citrus groves; if these residues are consumed they might be
detectable in livestock and the resulting food would be
considered adulterated.
B. Criteria for Registration
To be registered or reregistered under this Standard, products
must contain fosetyl-Al as the sole active ingredient, bear
required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in
this section.
C. Acceptable Ranges and Limits
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain fosetyl-Al
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 impurities found at greater
than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and end-use products containing fosetyl-Al provided that the
product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The Use Index lists
all registered uses, as well as approved maximum application
rates and frequencies.
18
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® Terrestrial, food uses on:
pineapple crowns (seed pieces) and citrus
° Terrestrial, non-food uses on:
ornamentals (including alaonena, azalea, bougainvilla,
boxwood, hibiscus, Japanese andromeda, Japanese
holly, juniper, leatherleaf fern, Monterey pine,
Pittosporium, pothos , rhododendron, and Schefflera) ,
ornamental turf, and non-bearing citrus.
° Domestic, outdoor uses on:
ornamentals (as specified above).
° Greenhouse, non-food uses on:
ornamentals (as specified above).
D. Required Labeling
End-use or manufacturing-use pesticide products containing
fosetyl-Al may not be released for shipment by a registrant
or producer of that product after March 30, 1989 unless
the product bears amended labeling which complies with
this Registration Standard.
End-use or manufacturing-use pesticide products containing
fosetyl-Al may not be distributed, sold, offered for sale,
held for sale, shipped, delivered for shipment, or received
and (having been so received) delivered or offered to be
delivered by any person after March 30, 1990 unless the
product bears amended labeling which complies with this
Registration Standard. After review of da£a to be submitted
under this standard, the Agency may impose additional
labeling requirements.
1 . All Products. All products are to bear appropriate
labeling as specified in 40 CFR 162.10. Specific information
regarding label requirements is included in Appendix II.
Fosetyl-Al is not designated as an acute or toxic hazardous
waste under the Resource Conservation and Recovery Act (RCRA).
The label is to 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."
•>i: 19
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The lab els of all products are to bear the ap propr iate container
disposal statement (see Appendix III).
2. Manufacturing Use Products. Labels of all MPs are to
bear the statement:
"For formulation into end-use fungicide products
intended only for use on citrus, pineapples,
ornamentals, and turf."
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans,
or public waters unless this product is specifically
identified and addressed in an NPDES permit. Do
not discharge effluent containing this product
to sewer systems without previously notifying
the sewage treatment plant authority. For
guidance contact your State Water Board or
Regional Office of the EPA."
"Pesticide Handlers: During mixing, loading, or
formulating of this product, wear long pants (or
coveralls), long sleeved shirt, shoes, socks, goggles
or face shield, and chemical/water resistant gloves."
3. End-Use Products
a. Labels of all formulated end-use products (EP's)
are to bear the statements reflecting the acute
toxicity of the formulated product.
b. All End-Use products are to bear the following
statement:
"Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes). Do not
contaminate water when disposing of equipment
washwaters."
c. EP products labeled for use on citrus and pine-
apples are to bear the following statement:
"Do not enter into treated areas until sprays have
dried. After sprays have dried, do not enter treated
areas until the 24-hour reentry interval has expired.
During early reentry into treated areas to perform
hand labor tasks, wear long pants (or coveralls),
long-sleeved shirt, shoes, socks; chemical/water-
resistant gloves; goggles or face shield."
20
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d. EP products labeled for use on cicrus are to bear
the following statement:
"Note - Do not graze or feed forage
from treated groves to livestock."
21
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
f o 11 ow s :
A.- Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables-
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
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 require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient {Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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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.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data7
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
^ Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
OA
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each qf 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 coat 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
25
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EPA with documentary evidence that an agreement-has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b- The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. Clf 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 8500-6, enclosed).
2. Provide us with a copy of your offer to the other
ou reauest tnac cnot suspend your reqisiraiion
26
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registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c ) (2 ) (B ) (iii ) .
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may 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
dat a.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request la denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
27
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tels 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
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
28
-------
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe'
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
Th» Agency has determined that if a registration is
suspend^ for failure to respond to a DCI request under
FIFRA nc. 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
29
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII# requirement for SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-9pecific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard? if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.l. (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.
30
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). in
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR
152.80-152.99.
5 if on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or 9hould 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.)
; ^1
-------
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 inqredientB.
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. Fornulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of 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 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.
32
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3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption- If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments* (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 z 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. 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
33
-------
of the front panel of the label, and the intended type
9izes of the text. End use product labeling-must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Addresses
The required information must be submitted to the following
address:
Lois Rossi
Product Manager 21
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.
34
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TGUIDE-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information •
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI ¦ Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP - Typical end use formulation
MP ¦ Manufacturing use product
EP ¦ End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are th« 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.
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-r
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 b««n waived or reserved. Any such unusual situations
will b« 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.
36
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TABLE A
GQIERIC DftTA REQUIRQffiNTS FOR TOSLTYL-AL
Data Requirement
Teat !/
Substance
Use 2/
Patterns
Does EPA Bibliographic Must Additional Time Frame-*/
Have Data?^/ Citation"*/ Data be for
Submitted? Submission
§158.120 Product Chemistry^/
Product Identity
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Inpurities
Analysis and Certification of
Product ingredients
62-1 - Preliminary Analysis
Riysical and Chemical
Characteristics
63-2 - Color
63-3 - Riysical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
TGAI
TGAI
TCAI
TGAI
TGAI
All
All
All
All
All
All
All
All
YES
YES
YES
YES
YES
YES
YES
N/A
00098326
00098326
00098326
00098325
00098325
00098325
00098325
NO
NO
NO
NO
NO
NO
NO
37
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TABLE A
GENERIC DATA REQUIRQU-NTS TOR TOSETYL-AL
Data Requirement
Test*-/
Substance
Use 2/
Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data?^/ Citation^' Data be for-*/
Submi Lted?
§158.120 Product Chemistry (Continued)5/
Riysical and Chemical Characteristics
(Continued) ~"
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
All
YES
CXK)98326 NO
63-8 - Solubility
TGAI or PAI
All
YES
00098325
NO
63-9 - Vapor Pressure
PAI
All
N/A
63-10 - Dissociation constant
PAI
All
YES
00098325
NO
63-11 - Octanol/water partition
PAI
All
YES
00098325
NO
coefficient
63-12 - pH
TGAI
All
YES
00098325
NO
63-13 - Storage Stability
TGAI
All
YES
00098325
YES
Other Requirements:
64- 1 - Submittal of sanples
TGAI, PAI
All
YES
00098325
NO
15 months
38
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TABLE A
GENERIC DATA REQUIREMENTS POR POSETYIj-AL
FOOTNOTES:
1/ Composition: TCAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient,
radiolabelled; PAI = Pure active ingredient; TCP = Typical end-use product.
2/ Hie use patterns are aodad as follows: A = Terrestrial, Food Crcp; B = Terrestrial, Non-Food;
C = Aquatic, Flood Crop; D - Aquatic; Non-Food; E = Greenhouse, Pood Crop; F = Greenhouse, Nori-Food;
G = Forestry; H - Dcnestic Outdoor; I = Indoor.
3/ Data out be submitted within the indicated timeframes which begin upon receipt of the Guidance Docunent.
4/ Althouc£i prodLct chemistry data Bay have been submitted in past, the Agency has determined that these
mist be resubmitted for each pesticide registration. Bibliographic citations listed in the tables would
not apply to new registrations.
5/ Althoucfi product chemistry data may been submitted in the past, the Agency has determined that these data
aust be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data mat be updated. Iherefore bibliographic citations for the old data are not applicable.
- ' 39
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TABLE A
GQiERIC DATA REQUIREMENTS FOR FOSETYL-AL
Data Requi rement
§158.125 Residue Cheniatry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal residues
Test 1/
Substance
TGfcl
PAIRA
PAIRA U Plant
Metabolites
TCAI &
Metabolites
TCAI &
Metabolites
171-4 - Magnitude of the Residue—
Residue Studies for Each
Food Use
o Crop 1 Pineapples
— Crap field trials
TEP
Does EPA
Have Data?
Bibliographic
Citation
YES
YES
YES
00098326
00139527
00148619
00103249
00103250
00148290
Not applicable
YES 00148619
00147569
Not applicable
Must Additional Time Frame
Data be for 2'
Submitted? Submission
YES
00139527^/
00148619
00103250
NO
NO
NO
NO
YES
12 months
— Processed Food/Feed
— Meat/Milk/
Poultry/Eggs
EP
TCAI or Plant
Metabolites
Not applicable
Not applicable
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POSETYL-AL
Data Requirement
Teat 1/
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for2/
Submission
$158,125 Residue Chemistry - Continued
171-4 - Ktagnitude of the Residue -
Residue Studies
o Crop 2, Citrus
— Crop Field Trials
— Processed Food/Feed
— Meat/Mi lk/
Poultry/Eggs
- Potable Water
- Fish
- Irrigated Crops
- Food Handling
171-13 - Submittal of Analytical
Reference Standards
TCP
EP
TGAI or Plant
Metabolites
EP
EP
EP
EP
PAIRA
YES 00148290V
Not applicable
Not applicable
YES
12 months
YES
NO
41
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table a
GENERIC DATA RBQUIREMHfTS POR POSCTYL-AL
FOOTNOTES:
1/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient,
radiolabelled; TEP = Typical end-use product; EP = End-use product.
2/ Data must be submitted within the indicated timeframes which begin upon receipt of the Guidance Document.
3/ The Agency ia requesting a study on the stability of fosetyl^Al during storage. This study was not
required for the purpose of establishing tolerances; however, the Agency wishes to confirm the stability
of fosetyl^Al.
42
i
i
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- -jLE a
GENERIC DATA REQUIREMENTS FOR POSETYL-AL
Data Requirement
Test*/
Substance
Use 2/
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Mist Additional
Data be
Submitted?
Time Frame
for 3/
Submission
§156-130 Environmental Fate
DEGRADATION STUDIES-LAB i
161-1 - Hydrolysis
TGAI
or
PAIRA
B.F.H
YES
00098370
NO
Rtotodegradat i on
161-2 - In water
TCAI
or
PAIRA
B
YES
00098371
NO
161-3 - On soil
TGAI
or
PAIRA
N/A
YES
00098371
NO
161-4 - In Air
TCAI
or
PAIRA
n/a
YES
00098371
NO
METABOLISM OTUDIES-IAB:
162-1 - Aerobic Soil
TGAI
or
PAIRA
B.F
YES
00106018
00098372
NO
162-2 - Anaerobic Soil
TGAI
or
PAIRA
N/A
N3V
NO
162-3 - Anaerobic Aquatic
TGAI
or
PAIRA
JJ/A
YES
00147361
NO
162-4 - Aerobic Aquatic
TGAI
or
PAIRA
N/A
NOV
NO
MOBILITY SIUDIES:
163-1 - Leactiing and
Adsorpt ion/Desorpt ion
TGAI
or
PAIRA
B.F.H
F,H
YES
YES
00098375
00106019
NO
NO
163-2 - Volatility (lab)
TEP
F
NO
NO
163-3 - Volatility (Field)
TEP
F
Nofy
NO
43
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TVw _ A
GENERIC DATA REQUIREMENTS FOR EOSETYLr-AL
Data Requirement
Test^/ Use^/ Does EPA Bibliographic
Substance Patterns Have Data? Citation
$158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELDi
164-1 - Soil
164-2 - fejuatic (Sediment)
164-3 - Forestry
164-4 - Coabi nation and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
TEP
TEP
TEP
TEP
TEP
PAIRA
TCP
TCP
TGAI or PAIRA
TCP
B,H
N/A
N/A
N/A
N/A
N/A
N/A
N/A
B
N/A
toV
ndV
MOV
NO
NO?/
N0^/
NO®/
M0V
NOV
NOpJ
Must Additional Time Frame
Data be for-*'
Submitted? Submission
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
44
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•BLE A
GENERIC DATA RBQUIKtMaTTS R3H FOSE7IYL-AL
Data Requiresent
Test1/ Use2/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
§156.140 Reentry Protection
132-1 - Foliar Dissipation TCP
132-1 - Soil Dissipation TEP
133-3 - Denial Exposure TEP
133-4 - Inhalation Exposure TEP
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TCP
201-1 - Drift Field Evaluation TCP
A
A
A
A
NO
ND
NO
t»
NO
ND
Mist Additional
Data be
Submitted?
YES10/
NO
NO^j/
NOW
NO
NO
Time Fr,
for-'
:r
Submission
12 months
45
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TA. . A
GENERIC QATA REQUIRfcMQJTS FOR POSETYL-AL
FOOTNOTES:
1/ Composition*. TCAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient
radio Label led; TCP = Typical end-use product.
2/ The use patterns are ooded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food;
C = Aquatic, Pood Crqp; D - Aquatic; Hoi-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G = Forestry; H = Domestic Outdoor; I = Indoor.
3/ Data Bust be submitted within the indicated timeframes which begin upon receipt of the Guidance Document
4/ 1fte anaerobic aquatic stud/ satisfies the anaerobic soil requirerent.
5/ Use pattern does not require this study.
6/ Active ingredient is a mineral salt—volatility studies not required.
7/ Not required because of extremely short half-life.
8/ TVie crqp use on pineapple and citrus doesn't require crop rotation data— pineapple and citrus not
rotated crops.
9/ Not required because of low octanol/water coefficient and short 1/2-life.
10/ A 24-hour interim re-entry interval is inposed for farm workers and neintenance personnel until
acceptable re-entry data are received by the Agency. TTie interim interval is inposed on all crcps
that require hand harvesting, pruning, and other high intensity worker contact with treated foliage.
11/ Not required if acceptable foliar dissipation data are submitted.
46
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TABLE A
GENERIC DATA REQUIREMENTS FOR F06EHYL-AL
Date Requirement
Test*/ Uae^/ Does EFA Bibliographic Must Additional Time Fram
Substance Patterns Have Data? Citation Data be for^/
Submitted Submission
$158.135 Toxieulogy
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dernal Toxicity
- Rabbit
81-3 - Acute Inhalation Toxicity
- Rat
81-7 - Delayed
Neurotoxicity - Hen
SUBCHRPNIC TESTING:
82-1 - 90-Day Feeding:
- Rodent, and
- Nan-rodent (Dog)
82-2 - 21-Day Denial - Rabbit
82-3 - 90-0ay Der»l - Rabbit
82-4 - 90-Day Inhalation:
- Rat
82-5 - 90-Day Neurotoxicity:
- Hen
- Manual
TGAI
TCAI
TGAI
TGAI
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,F,H YES
A,B,F,H YES
A,B,F,H YES
Not applicable
A,B.F,H YES
A, B,F,H YES
Not applicable
Not applicable
Not applicable
Not applicable
00098330
00098331
00098332
00098336
00098337
00098338
NO*/
NO
NO
NO5/
NO
• i 47
-------
TABLE A
GENERIC DATA REQUXWMEOTS FOR TOSEFYL-AL
Data Requirement
Test*/ UseV Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for3'
Submitted? Submission
$156.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - TCAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogenicity - TCAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generatian
MLTTAGPnCITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromoeomal TGAI
Aberration
84-4 - Other Genotoxic Effects TGAI
A,B,F,H YES
A,B,F,H YES
A,B,F,H YES
A,B,F,H YES
A.B.F.H YES
A,B,F.H YES
A,B,F,H YES
00098339
00098353V
00098340
00098339
00098352**/
00098353
00098347
00114091
00098348
00098343
00098345
00098343
00098345
NO
NO
NO
NO
NO
to
NO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POSETtfL-AL
Data Requirement
Test1/ Use2/ Does EPA
Substance Pattern Have Data?
Bibliographic
Citation
$158-135 Toxicology - Continued
¦ ¦ ¦ ¦ -ii i ¦ .
SPECIAL TEST IMG
Must Additional
Data be
Submitted?
Time Frame
farV
Submission
PAI or PAIRA
Choice
Choice
A.B.F.H YES
Not applicable
Not applicable
00090358
NO
85-1 - General Metabolism
85-2 - Dernal Penetration
86-1 - Domestic Animal
Safety
FOOTNOTES:
1/ Composition: TCAI = Technical Grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient, radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.
2/ The use patterns are ooded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = fe^uatic, Food
Crop; D = Aquatic, Ncn-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic,
Outdoor; I = Indoor-
3/ Data aost be submitted within the indicated time frames Which begin upon receipt of the Guidance Document.
4/ Ttie rabbit oral ID50 is used to fulfill this requirement because it is the most sensitive species for oral
toxicity.
5/ The 90-day feeding studies requirements are superceded by the chronic feeding studies listed in 83-1.
6/ Study was conducted with phosphorous acid metabolite.
49
-------
1. xA
GfcNERIC DATA REQUIRtMEUTS FOR TOSETYL-A1
Data Requirement
Test1/ Use2/ Does EPA
Substance Pattern Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Time Frane
for 3/
Submission
§158.145 Wildlife and
Aquatic Organisms
AVIAN AMD MAH4ALJAN TESTIMQ
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Subacute Dietary TGAI
Toxicity
- Upland Gane Bird, and
- Mater Cowl
71-3 - Wild Manual Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Gane Bird, and
- Vtaterfcwl
71-5 - Siuulated Field Testing TEP
- ttamals, and
- Birds
- Actual Field Testing TEP
- Manuals, and
A,B,F,H YES
A,B,F,H YES
A, B
A, B
A, B
A.B
NO
NO
NO
NO
0009B360
00098362
00098363
NO
NO
N0^/
NO5/
NO
NO
- Birds
50
-------
TAi..A
GfcUERlC DATA RBQUI REMtMS FOR tXJSE7I*YL-AL
Data Requirement
Teat1/ Use2/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
§158-145 Wildlife and
Aquatic Organ!bum - Continued
AQUATIC ORGAN 134 TESTING
72-1 - Frestwater Fish Toxicity TGAI
- Colcbater Fish Species,
and
- Vfernwater Fish Species
72-2 - Acute Tbxicity to
Frestwater Invertebrates
72-3 - Acute Toxicity to
Eatuarine and Marine
Organisms
- Fish
- Mollusk
- Shrinp
72-4 - FiBh Early Life Stage,
and
- Aquatic Invertebrate
Life-Cycle
72-5 - Fish - Life-Cycle
TGAI
TGAI
TGAI
A,B,F,H YES
A,B.F,H YES
[A,B]6/ YES
TGAI
Not applicable
Not applicable
00119526
00126944
01128943
00147360
00147359
00098368
Must Additional
Data be
Submitted?
Time Frame
for-'/
Submission
NO
NO
NO
51
-------
TABLE A
GENERIC DATA RBQUIRtMEUTS TOR FOSETYL-AL
Data Requirement Test*/ Use2/ Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for3/
Submitted? Submission
§158.145 Wildlife ara3
Afuatic Organism - Continued
72-6 - JWjuatic Organion
AoaunuLatian
- Grustaoean
- Fish
- Insect Nynph
- Mollusk
72-7 - Simulated Field Testing
- Aquatic Organisms
- Actual Field Testing
-Aquatic Organisms
TQAI, PAI OR
Degradation
Product
Not applicable
TCP
Not applicable
52
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POSETYL-AL
FOOTNOTES:
1/ Conpoeition: TGAI » Technical grade of the active ingredient; PAJRA = Pure active ingredient,
radiolabelled; TEP » Typical end-use product.
2/ Hie use patterns are nodal as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food;
C = Aquatic, Rood Crop; D ¦ Aquatic; Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G « Forestry; H - Droastlc Outdoor; 1 = Indoor.
3/ Data mist be submitted within the indicated timeframes which begin upon receipt of the Guidance Document.
4/ TYiere is no requirement since the nam&lian toxicity data indicate that the chemical will po6e a low
potential risk to wild aninals.
5/ These data are not required for the uses oovered by the standard based on the short half-life of fosetyl-Al
under aerobic conditions and the octanol/water partition coefficient that indicate persistence arid accumulation
is not expected. These data nay be required for additional uses.
6/ Required to support the citrus and turf uses.
53
-------
i.uiLE A
GENERIC DATA REQUIREMENTS FOR P06ETYL-AL
Data Requiresent
Test*/
Substance
Use^/ Does EPA
Pattern Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
torV
Submission
§158.150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITy
NOWTARGET AREA PHYTOTOXlCm
Tiro 1
122-1 - Seed Germination/
Seedling Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER 11
123-1 - Seed Germination/
Seedling Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER III
124-1 - Terrestrial Field
124-2 - fcjuatic Field
EP
B
tO
NO
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
B
B
B
B
B
B
B
MD
to
tO
to
to
NO
to
to
NO
NO
yes4/
NO
NO
ReservedV
NO
Reserved6/
9 months
54
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FOSETYL-AL
footnotes:
1/ Composition: TGAI - Technical grade of the active ingredient; PA.I = Pure active ingredient;
PWRA = Pure active ingredient, radiolabelled; TEP - Typical end-use product;
EP = Ehd-use prockict. ;
2/ TYie use patterns are ooded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food;
C = Aquatic, Ftood Crop; D ¦ Aquatic; Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G - Forestry; H - Downs tic Outdoor; I = Indoor.
3/ Data mat be submitted within the indicated timeframes which begin upon receipt of the
Guidance Docunent.
4/ Required due to the persistence in water (hydrolysis degradation less than 10% after one month).
5/ Reserved based on the results of Section 122.2-Aquatic Plant Growth (Tier I).
6/ Reserved based on the results of section 123.2-Aquatic Plant Growth (Tier II).
55
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POSETYLr-AL
Data Requirement
Test1/ Use^/ Does ERA Bibliographic
Substance Pattern Have Data? Citation
§158.155 Montarget Ipm*^ '
HONTASGET 1MSBCT TE8TIMG -
POLLINATORS i
141-1 - Honey bee acute
aontact toxicity TGAI
141-2 - Honey bee - toxicity TO5
of residues on
foliage
141-4 - Hcney bee subacute (Reserved)
feeding study
141-5 - Field testing for TEJ»
pollinators
HCHTABGgr IHSBCT TEgTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to (Reserved)
aquatic insects
142-1 - Aquatic insect (Reserved)
life-cycle study
142-3 - Simulated or actual (Reserved)
field testing for
aquatic insects
143-1 - NCWTAfCET INSECT (Reserved)
fhn. TESTING - PRHMORS
143-3 wuasrng
Must Additional
Data be
Submitted?
Time Frame
for3/
Submission
A,B,H
A, B,H
NO
NO
A, B,H
NO
56
YES
Reserved'*/
9 Months
Reserved4/
-------
TABLE A
GENERIC DATA REQUIREMENTS POR FOSCTYL^AL
poornores:
1/ Ccxpoeitian: TCAI * Technical grade of the active ingredient; TEP - Typical end-uae product.
2/ TTie use patterns are follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C - Aquatic,
Pood Crap; D 3 Aquatic, Mta-Pood; E = Greenhouse, Flood Crop; F - Greenhouse, Non-Food: G = Forestry;
H - Domestic Outdoor; I - Indoor.
3/ Data mat be 8Ul*i t ted within the iivlicated tine frames which begin upon receipt of the Guidance Document.
4/ Requirement is reserved receipt of data from the acute contact study (141-1).
57
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACWRHKMiSE PRODUCTS CONTAINING FOSETYL-AL
Data Requirement
Test*/ Use^/ Does EPA Bibliographic
Suhetance Pattern Have Data? Citation
$158.120 Product Chfljtjjf
Product Identity!
Must Additional
Data be
Submitted?
61-1 - Product identity and
Disclosure of
Ingredients
MP
All
YES
00098325
NO
61-2 - Description of Beginning
Materials and
Mamfacturing Process
W
All
YES
00098325
NO
61-3 - Discussion of Formation
of Impurities
MP
All
YES
00098325
NO
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
MP
All
YES
00098325
NO
62-2 - Certification of Limits
M»
All
YES
00098325
NO
62-3 - Analytical Methods to Verify
Certified Limit
MP
All
YES
00098327
NO
and Cheaical Characteristics
63-2 - Color
MP
All
YES
00098325
NO
63-3 - Riysical State
MP
All
YES
00098325
NO
63-4 - Odor
MP
All
YES
I
00098325
NO
Time Frame
for3/
Submission
58
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING FOSETYL-AI,
Data Requirement
Test*/ Use^/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Tine Frame
for-'/
Submission
§158.120 Product Chesdfgy/tOontinued)
Riysioal arei Qwaloal Characteristics
(Continued) ~
63-7 - Density, Bulk Density, or
Specific Gravity
All
YES
00098325
NO
63-12 - pH
MP
All
YES
00098325
NO
63-14 - Oxidizing or Reducing
Action
MP
All
YES
00098325
NO
63-15 - Flaanability
MP
All
YES
00098328
NO
63-16 - Eapiodability
MP
All
YES
00098320
NO
63-17 - Storage Stability
MP
All
YES
00098325
YES
63-18 - Visaoeity
MP
All
Not
applicable
63-19 - Miscibility
MP
All
Not
applicable
63-20 - Corrosion Characteristics
MP
All
YES
00098325
NO
Other Requirementsi
64- 1 - Submittal of saiples
MP
All
YES
00098325
NO
6 months
59
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MMttJFACTURING-USE PRODUCTS CONTAINING POSETYL-AL
POOmOTES:
1/ Composition: TCAI - Tactinio&l grade of the active ingredient; TEP = Typical end-use product.
MP = Manufacturing-use product.
2/ Hie use patterns are as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic,
Pood Crop; D - Aquatic, Man-Pood; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food: G = Forestry
H * Denes tic Outdoor; 1 " Indoor.
3/ Data mst be si±nitted within the indicated tinefranes which begin upon receipt of the Guidance Document.
60
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOSCTYI<-AL
Data Requirement
Test^/ Uae^/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be forV
Submitted? Submission
§156.135 Toacioology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dernal Toxicity
- Rabbit
81-3 - Acute Inhalation Toxicity
- Rat
01-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbit
81-6 - Dernal Sensitization -
Guinea Pig
MP A,B,F,H YES
MP A,B,F,H YES
MP A, B,F,H YES
MP A.B.F.H YES
MP A,B,F,H YES
MP A,B,F,H YES
00098330
00098331
00098332
00098333
00098334
00098335
NO
NO
NO
NO
NO
NO
1/ Conpoeiticm: TGAI = Tecivucal grade of the active ingredient; TEP - Typical end-use product.
MP 3 Manufacturing-use product.
2/ The use oatterns are coded as follows: A = Terrestrial, Food Crop; B - Terrestrial, Non-Food; C = Aquatic. Food Crop;
D = Aquatic, Non-Food; E - Greenhouse, Food Crop; F = Greenhcuse. Non-Food: G = Forestry; H = Domestic Outdoo .
I - Indoor.
3/ Data «u.t be .fitted within the indicated tioefraaea Whidi begin upon receipt of the Guidance Doourent.
61
-------
tabu: c
PRODUCT SPECIFIC EftTA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING FOSETYL-AL
Data Requirement
Teat1/ Use2/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be for^/
Submitted? Subnisaian
§158.120 Product Chemistry
Product Identity:
61-1 - Prockict Identity and
Disclosure of
Ingredients
EP
All
Partially
Reg.Jacket
(359-706)
YES*/
6
months
61-2 - Description of Beginning
Materials and
Manufacturing Process
EP
All
NO
YES5/
6
months
61-3 _ Discussion of Formation
of Impurities
EP
All
NO
YES6/
6
months
Analysis arei Certification of Product
Ingredients
NO?/
62-1 - Preliminary Analysis
EP
All
62-2 - Certification of Limits
EP
All
NO
YES8/
12
months
62-3 - Analytical Methods to Verify
Certified Limit
EP
All
YES9/
12
months
Rrvsical and Chesical Characteristics
63-2 - Color
EP
All
YES
00090325
NO
63-3 - Riysical State
EP
All
YES
00098325
NO
63-4 - Odor
EP
All
YES
00098325
NO
62
cl
-------
TAi-ii .f. C
PRODUCT SPECIFIC UATA REQUIREMENTS TOR EMMJSE PRODUCTS OOOTAJNING EOSEHYL-AL
Data Requirement
Test1/ Use^/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for3/
SubmiBBion
§158.120 Product Chemistry (Continued)
Biysical and Chemical Characteristics
(Continued)
63-7 - Density, BulX Density, or
EP
All
YES
00098325
NO
Specific Gravity
63-12 - pH
EP
All
Partially
00098325
YES10/ **/
6 months
63-14 - Oxidizing or Reducing
EP
All
NO
00098325
MJ1(V 12/
Action
63-15 - Flamnability
EP
All
NO
YES*0/ 1-*/
6 months
63-16 - Explodabiiity
EP
All
NO
YES10/ 14/
6 months
63-17 - Storage Stability
EP
All
NO
YES10/
15 months
63-1B - Viscosity
EP
All
NO
YES10/ 15/
6 months
63-19 - Miscibility
EP
All
NO
YES10/ 1^/
6 nunths
—
63-20 - Corrosion Characteristics
EP
All
NO
YES10/
15 months
63-21 - Dielectric Breakdown Voltage
EP
All
NO
YEglO/ 17/
6 months
Other Requirements:
64- 1 - Submittal of aanplea
EP
All
Not Applicable
NO
63
-------
Tt Z
PRODUCT SPECIFIC DATA REQUIREMENTS POk rXlD USE PRODUCTS CONTAINING FOStTYL-AL
FOOTNOTES:
1/ q» = End-Use Product
2/ the use patterns are coded as follows: A = Terrestrial, Food Crqp; B = Terrestrial, Non-Food; C = Aquatic, Food
Crqp; D = Aquatic, Non-Food; E = Greenhouse, Food Crap; F = Greenhouse, Non-Food: G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Data Bust be submit tad within the indicated timeframes which begin upon receipt of the Guidance Docuuent.
4/ The chemical name, ncadnal concentration, Chemical Abstracts Service (CAS) Registry Number, and purpose of the
active ingredient and aabh intentionally added inert ingredient mist be provided. For the active ingredient,
the following oust also bo provided: the product name, trade name, and common name; the nolecular, structural,
and eipirical for aulas; the nolecular weight or weicpit range; and any experimental or internally assigned
ooqpany code mutters.
5/ Complete information nist be provided regarding the nature of the process (batch or continuous), the relative
anounts of beginning Materials and the order in which they are added, a statement of whether the process for
producing the product involves intended chemical reactions, equipment used to produce the final product,
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 nanufacture each product.
6/ A detailed discussion of all impurities that are or may be present at >0.1%, based on knowledge of the
beginning materials, chemical reactions (intended and side), if any, in the manufacturing process, and any
contamination during and after production mist be submitted.
7/ Five or more representative sanples mist be analyzed for the amount of active ingredient and each impurity
for which a oertified limit is required. Oonplete validation data (accuracy, precision) nust be submitted
for each analytical method used. A preliminary analysis of end-use products nust produced by an integrated
fornilation system are required on a case-by-case basis only.
8/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
iipurity present at >0.1% (w/w) and each "toxicologically siyjificant" i iipurity present at <0.1% (w/w) must be
provided and oertified. A statement regaurding the accuracy and precision of the stated limits should also be
provided. Limits for iopurities not associated with the active ingredient need be provided only if they are
considered to be of toxioological significance, regardless of the concentration at which they are present.
Certifications Bust be submitted on EPA Form 8570-4 (Rev. 2-85).
9/ Analytical vthocte mist be provided to determine the active ingredient, toxicologically significant inpurity,
or intentionally inert for which certified limits are required. Each method nust be accompanied ty
validation studies indicating its accuracy and precision. These methods must be suitable for enforcement
of oertified limits. . .
10/ Physioochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing
action, flaanability, explodability, storage stability, visoosity, miscibility, corrosion characteristics,
and dielectric breakdown voltage) as required in 40 CI'R Part 158.120 and more fully described in the
Pesticide Assessment Guidelines, Subdivision D oust be submitted.
64
-------
TAi-... C
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS OOOTAINING POSETYIr-
POOTHOTES:
11/ Required if the test substance is dispersible with water.
12/ Required if the product contains an oxidizing or reducing agent.
13/ Required if the prockict contains combustible liquids.
14/ Required if the product is potentially explosive.
15/ Required if the pcoAict ia a liquid.
16/ Required if the proAlCt 1b a liquid and is to be diluted with petroleum solvents.
17/ Required if the product 1b a non-oonductant liquid and is intended for use in or around
electrical equipnent.
65
-------
TABU. ,
PRODUCT SPECIFIC DATA REQUIREMENTS FOR EMMJSE PRODUCTS CONTAINING POSETYL-AL
Data Requirement
TeBt^-/ Use^/ Does EPA Bibliographic
Substance Pattern Have Data? Citation
§156.135 Toxicology
ACUTE TESTING
Must Additional
Data be
Submitted?
Time Frame
for-^7
Submission
81-1 - Acute Oral Toxicity - Rat EP All
81-2 - Acute Dermal Toxicity EP All
- Rabbit
YES
YES
00122781
00122782
NO
NO
81-3 - Acute Inhalation Toxicity
- Rat
EP
All
YES
00122783
HO
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Deroal
Irritation - Rabbit
81-6 - Dermal Sensitization
Guinea Pig
EP
EP
EP
All
All
All
YES
YES
NO
40131101
00122785
NO
NO
YES
6 months
1/ Ccsfxniticn: EP = End-use product-
2/ The use nattem are coded as follows A - Terrestrial, Food crqp; B - Terrestrial, Non-Food; c - Food
ttZpTl HSSSc. Non-Food; E - Gr«ri>ouae, Food Crcp; F = Greenhouse. Non-Food: G = Forestry; H - Domest.c
Outdoor; I = Indoor.
3/ Data aost be submitted within the indicated timeframes which begin upon receipt of the Gudance Document-
-------
APPENDIX IX
LABELING
67
-------
SUMMARY-1
LABEL CONTENTS
40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CPR 162.10(d)]
Item . 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
labex 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.
[JJ0 CPR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." la the final' estab-
lishment at which the product was produced, and may appear
In any suitable location on the label or Immediate container.
It oust also appear on the wrapper or outalde container of
the package If the EPA establishment number or. the Immediate
container cannot be clearly read through such wrapper or container.
[10 CPR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An Ingredients statement
Is required or. 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 la immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It muat not be
placed lr. the body of other text. [10 CPR 162.10(g)]
68
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SUMMARX-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
or. Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Miniaun Type Size
All Capitals
6 point
10 point
12 point
14 point
Id point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
. 6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(H)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) Is required on.the front panel Immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(1)(1)]
Item 7C. SKULL & CR0SSB0NES 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 lr. red on a background of distinctly contrasting color and
the skull and crossbones shall appear In Immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(1)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products In toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(ill)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or uack) Panel for Additional Precautionary Statements" Is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I62.10(h)(l)(lll)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements Hated below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location la at the top of the aide or back
panel preceding the directions for use, and It la preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
69
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required Indicating the particular hazard, the
route(s) of exposure ar.d the precautions to be taken to avoid
accident. Injury or damage. [40 CFR 162.10(h)(2)(1)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, Injury, or damage. [40 CPR 162.10(h)(2)(H)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flaomablllty of a product
are required to appear on the label If It neets the criteria
In the PHYS/CHEM Labeling Appendix. The requirement Is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word Is
used In conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use nay be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that nay be Imposed by regulation).
In the Registration Standard, the Agency has (1) Indicated
certain formulatlons/uses are to be restricted (Section IV
Indicates why the product has beer, 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 (aee 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 rereglstratlor.. 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.
i
70
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SUMMARY-ft
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
CPR 162.10(h) (1 Kiv)
b. Directly below this statement on the front panel,
a summary statement of the tenia of restriction must
appear (Including the reasons for restriction If specified
lr. Section I). If use Is restricted to certified applicators,
the following statement Is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may Include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "apllt" 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
rereglstratlon, each containing all forma and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be asalgned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It Is a violation of Federal law to use
thla product In a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for uae, directly beneath the heading of that section.
71
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, It oust be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS POR USE - Directions for use must
be stated In terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions oust be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[10 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed natter which Is
referred to on the label or which is to accoop&ny 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.
/
72
-------
SUM4ARY-6
LABELING REQUIREMENTS OP TTE PIFRA, AS AMENDED
LABEL EEEHEMT
APPLICABILITY
-------
SUW1ARY-7
ITCH
7 C
LABEL ELSQfT
Skull a croes-
bonea and word
POISON (In red)
APPLICABILITY
CP nSQUIHEMSHT
All products
Mhlch are Cat-
egory I baaed
cn oral, der-
mal , or Inhala-
tion toxicity
placbbjt
required
Front panel
ON LABEL
prETCTJSJJ
both in close
proximity to
signal word
COMMENTS
7D
uUH!fl£l)t of
Practical
Treatment or
Plrat Aid
All producta
in Categories
I, 11, and III
Category I:
front panel
wless refer-
ral statement
Is used.
Others:
Grouped with
aide panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
atatenenta
All products
None
¦ Ttop or side
of back panel
preceding
directions
for use
Must be grouped inder the headings In
8A, 88, and 8C; preferably blocked.
OA
Hazards to
| hunans and
domestic
anlmla
All producta
In Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
BB
Envlrormental
i hazards
All products
None
Same as above
fcnvlrormental hazards Include bee
caution where applicable.
74
-------
SWtMRY-8
rre*
LABEL HflOir
ARWCXBICm—
QP REQUIREMENT
PLACEJEM
ror
OTE
L
OOWENTS
yc
R\jmlcal or
chenlcal
hazards
All pressurized
products, others
tilth flash
points under
150*F
None
Stmts as above
Refer to Appendix II guide
PHYS/CHEM
9A
Restricted
block
All restricted
products
"Rap center
of front
panel
Preferably
blocked
Includes a statement of the terms of
reatrlctlon. The words "RESmiCTED U
RLSriCIDE" must be same type size aa
signal word.
9B
Misuse
statement
All products
limed lately
following
heading of
directions
for use
Required statement la:
"It Is a violation of Federal law
to use this product In a manner
Inconsistent with Its labeling."
10A
Reentry
statement
FH Notice 83-2
or aa determined
by the Agency
In the
directions
for use
I
a
a
rimed
fter
tste
lately
misuse
ment
10B
Storage and
disposal block
*
All products
In the
directions
Tor use
Inmedlately
before
specific
directions
for use or
at the end or
directions
for use
Must be set apart and clearly distin-
guishable from fron other directions
for use.
Refer to Appendix II guides STOR,
OOMT/DIS, and PEST/DIS for further
Information and required statements.
IOC
Direction#
for um
All products
None
None
May be in metric as well aa U.S. unit
75
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5 162.10 Labeling requirement*.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following;
The name, brand, or trademark
under which the product la sold as pre-
scribed in paragraph Cb) of this sec-
tion:
(11) The name and address of the
producer, registrant, or person for
whom produced as prescribed In para-
graph (c) of this section:
(ill) The net contents as prescribed
In paragraph (d) of this section:
(lv) The product registration
number as prescribed In paragraph (e)
of this section:
76
-------
Environmental Protection Agency
§ 162.10
(v) The producing establishment
number as prescribed In paragraph (f)
of this section:
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vjj) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pre-
scribed in paragraph (1) of this section;
and
(be) The use classiflcatlon(s) as pre-
scribed In paragraph (J) of this section.
(2) Prominence and legibility, (1) Ail
words, statements, graphic representa-
tions, designs or other Information re-
quired on the libeling bjr the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness
-------
§ 162.10
40 CFR Ch. I (7-1-65 Edition)
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
cviii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients. Including
statements such as "safe." "nonpolson-
ous." "nonlnjurious." "harmless" or
"nontoxic to ^humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed, labeling. (I) Except
as provided in paragraph (aXfl)Ol) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(11) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum libels.
Such reproductions most be of micro-
film reproduction quality.
-------
Environmental Projection Agency
§ 162.10
or endorsement' of the product by the
Agency.
CfJ Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est."", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
Ingredient statement—<1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ents; and If the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active Ingredi-
ents** and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement Is a
complete analysts of the pesticide, the
term "analysis" shall not be used aa a
heading for the Ingredient statement.
(2) Position of ingredient statement
(1) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there is aa outside con-
tainer or wrapper through which the
ingredient "*¦***'i>jh^ cannot be clearly
read, the pit imiffr
also appear on soch outride container
or wrapper. If Hie 4m or form of the
package ftiflrff It twpw*H*«Ku |0
place the Ingredient statement on Mm*
front p*"*1 of label. pemMoo
may be muted for the ingredient
statement to appear elsewhere.
(11) The text of fafHIHtt state-
ment must ran parallel wftb other
text on the panel oh which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25
-------
§162.10 ' " " 46 M Ou t (7-1-45 Edition)
(h) Warnings and precautionary type size, and prominence are riven
statements. Required warnings and below.
precautionary statements concerning (1) Required front panel statements.
the general areas of toxicologic*! With the exception of the child .
hazard including hazard to children, hazard warning statement, the text re- <
environmental hazard, and physical or quired on the front panel of the label -
chemical hazard fall into two groups; is determined by the Toxicity Catego :
those required on the front panel of ry of the pesticide. The category is as-
the labeling: and Chose which may signed on the basis of the highest
appear elsewhere. Specific require- hazard shown by any of the indicators
merits concerning content, placement, in the table below:
Tcsdc*y oMgom
1
¦
m
fV
Oral 10.
1 Cm
0«ll«< LDm ¦
Up la tatotfng 90
ur* 9* 2
mg/ltar.
1* id wd hdtoenj 300
mp*0.
Corn** commi
apad* m nwrabto
«M) 7 d^fi.
Cawp—w
Fmm 90 *m 900
From J nv 2
fienMttvSdd
CofflMi flpviy
DMnth*Mi7
daycMMton
fifing tar 7 day.
SMtMrionan
tain.
From 500 im 9000 mg/
*9-
from a in 20 mg/Mar.
From 1000 M 20.000_
No comari
friMifciw iMnfeii
¦**1 7 day*.
tiodantfa fcWfan * 75
hon.
OraaMr f*n 5O0Q mg/
kg.-
Omm nw 20 mQ/ttm.
<3m*r 20000.
NplnMbv.
Ifld or HkitiKi m
73 hows.
(1) Human hazard signal toord—(A)
Toxicity Category /. All pesticide prod-
ucts mating the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral* Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the sloill and
crossbones 'pf*" in immediate
proximity to the word "poison."
(B) Toxicity Category TL All pesti-
cide products meeting the attaris of
Toxicity Category n ahaQ bear on the
front r"1*1 the signal voitf "Wan*
Ing."
(C) Toxicity nsfeyiiy UL AR pesti-
cide products moetfcig the criteria of
Toxicity Catsfoiy HZ shall beer on
the front panel the signal word "Can-
tion."
CD) Toxicity CUapor? IV. AD pesti-
cide products meiitlin the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Oaotkn."
(X) Um of signal writ. Use of any
signal voriti) associated with a *»*!*¦¦¦
Toxicity Category is not permitted
exoept when the Agency determines
that such labeling Is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more ***** one human hazard
signal word appear on the front panel
of a label.
(11) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood, of contact with
children during distribution, market-
ing. storage or use is demonstrated by
th« applicant to be extremely remote,
or if the n&turs of the peitldde is such
that it is approved far-use on Infanta
I, may
tor waive this reoulretnenL
(ill) Statement of practical treat-
ment—4A3 Toxicity Category L A
statement of practical treatment (first
aid or other) shall appear on the front
panel of of an pesticides fail-
ing into Toxfctty Category I on tlio
bttria of oral* inhalation or dorsal tw*
Jetty. no Agenry nay* however,
permit reasonable variations tn the
planamsnt, of the sfitwnmt of pnctt-
as "See fstement of practical treat-
ment on bade panel" appears on the
80
-------
Environmental Protection Agency
§ 162.10
front panel near the word "Poison"
and the skull and cross bones.
(B) Other toxicity categories. The
statement of practical treatment Ls not
required on the front panel except as
described In paragraph (hXlXiiD(A) of
this section. The applicant may. how-
ever, Include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label In
accord with paragraph (hX2) of this
section Lf they do not appear on the
front paneL
of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modi/led or ex-
panded to reflect specific hazards.
(U) Environmental hazard*. Where a
hazard exists to non target organisms
excluding huznass and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
haard ***** tbi appropriate praam*
ttoas to avoid potenflil accident,
injury or damage. Examples of the
hazard statements and the drcum-
81
-------
§ 162.10
40 CFR Ch. I (7-1 -83 Edition)
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCH of 1 ppm or less,
the statement "This Pesticide Is Toxic
to Fish" is required.
(C) If a pesticide Intended for out-
door use contains an active Ingredient
with an avian acute oraJ LD„ of 100
mg/kg or less, or a subacute dietary
LC*. of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" Is
required.
(DJ If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabrU-
Ity or explosive characteristics of the
pesticide are required as follows:
Run port
RaqUrad mi
(AJ PwnmiMiTtn Catrxmmn
Fla*i port or Mow 20" F; i am m a float*xdi ai
any ntirm ooarane.
Rain port atewa 20* F and not ovar ao* F or 1 tho
Homo mammon la mora tun it in long at a donnca
at Bin fcom ra ten*.
aj ootor praaaunad coruinar*
Exnmoty lammabta. Conuna proaaura. away (ram
fra. aparfca. and haatad aurfacaa. Oo not pux&ra or Incinaraia
oontaaiar. Ejpoau* to lamperaame ate*a 130* f may cauoo
bunting,
Ramnatta. Contano mdv praaara. Kaop away tan haat
apaiHa. and opai flama. 0o not puncM or Indnanrti comainar.
Eqmra lo tamparaaaaa ate* 130* F may cauaa butting.
Conttnts mlor praaatra. Oo not uaa or nor* near haal or opon
flam. Oo not puncttm or inonarata oontanr. Expoto
tamparaBaaa abwe 130* F may cauaa burstog.
(B) NONPMXWMZSS C0NTAB«U
ai ~ an* c
Exnmdy ftammrtio. Ka^ away (rom fir*. aparfca. and fwatad
naiiaiiaflta Kaap away torn haal and opan Aama.
Oo not la* or aora naar nam or opan llama.
(I) Directions for U*e—<1) General
reen*iTcmer*ii—;i) Adequacy and clar-
ity of direction*. Directions for use
must be stated In terns which can be
easily read and understood by the av-
erage person likely to use or to soper-
vise the use of the pffitldde. When fol-
lowed, directions most be adequate to
protect the pofciJc front fraud and
from personal Injury and to prevent
iinneriiThin adverse ifftiia on the
environment.
(11J Placement of direction* for mie.
Direction* may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pftldde product
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter la securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag!
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections In the enclosed circular:*" *****
(C) Ttie determines
that It Is not nsea—aiy for sodi direc-
tions to appear oa the labeL
(111) Exception* to rwtrment for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are Intended
82
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Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products In
their regular manufacturing processes,
provided that:
(J) The label clearly shows that the
product Is intended for use only In
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es:
(J) The product will not come into
the hands of the general public except
after incorporailonjnto finished prod-
ucts: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists. provided that:
(J) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment; and
The target pesus) associated
with each site.
(v) The dosage rate associated ^Ith
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlli) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(lx) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the hading "Storage
and Disposal." This heading must be
set In type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table In S l«110(hXlXlv»
-------
(C) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22, 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (J) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth In
this subsection, and shall be marketed
as separate products. with differen
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use Front panel statement of restrict'
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in f 162.LO(hXlXiv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make ft unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use Is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation,
(k) Advertising. [Reserved]
(40 FR 28208. July 3. 1975: 40 FR 32329,
Aug. 1. 1973; 40 FR 36371, Aug. 21. 1975. as
amended at 43 FR 5786. Feb. 9, 19781
84
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
B.
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.
C. All Other Pressurized
Containers
Required Label' Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Xeep 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 r.ot
puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
B. Plaahpoint above 20°P
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.
85
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
Instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage Instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container In storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
Including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. Qensral storage instructions for household products should
emphasise storage in original container and placement in
locked storage areas.
4
86
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
Ibe 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 ar« Acute Hazardous
Wastes or are assigned to Ibxlclty Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
Inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rlnsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Brvlronnental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. labels of all products, except those Intended for daoestlc 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 rtlnposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rlnsate Is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Ehvlronnent&l Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for dcnestic
use, oust bear the following pesticide disposal statement:
"Wastes resulting from the use of this product nay be disposed of or.
site or at an approved waste disposal facility."
5. Products Intended for domestic use only oust bear the following
disposal statement: "Securely wrap original container In several layers
of newspaper and discard In trash."
/
87
-------
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
Pi
Hon -aerosol products
(bottles, cans, jars)
Statement
bo not reuse container (bottle, car., Jar).
Rinse thoroughly before discarding In trash.
Do not reuse bag.Discard bag In trash.
Non-aerosol products
(bar.s)
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
containers
(non-aerosol)
Triple rinse (or equivalent). Then ofTer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then ofrer
for recycling or reconditioning, or puncture
and dispose of In a sanitary landfill, or
Incineration, or, If allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue Into application
equipment. Then dispose of liner In a
sanitary landfill or by Incineration If
allowed by state and local authorities.
If drum Is contaminated and cannot be
reused!, dispose of In the same manner.
Paper and
plastic bags
Completely empty bag Into application
equipment. Then dispose of empty bag In
a sanitary landfill or by Incineration,
or, If allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
1/ Manufacturer may replace this phrase with one Indicating
~~ whether and how fiber drum may be reused.
/
88
-------
APPENDIX II
USE INDEX
89
-------
EPA Index to Pesticide Chanicals
_ j. 23301
ALUMINUM TRIS (O-ETHYL PHOSPHONATE)*
TYPE PESTICIDE; Fungicide
FORMULATIONS;
Tech (95%)
WP (80%)
GENERAL WARNINGS AND LIMITATICNS; Wbrkers should wear full protective
clothing (long pants, long sleeve shirt and water resistant gloves)
when applying this product or during the mixing and loading operations.
Do not apply this product in such a manner as to directly or through drift
expose workers or other persons. Hie area being treated nust be vacated
by unprotected persons. Do not enter treated areas without protective
clothing until spray is dried.
Do not mix with any sticker, extender or wetting agent.
Dosage rates are given in active ingredient.
Definition of Terms:
N.F. - Non-food use.
Site and Pest
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
TERRESTRIAL POOD CROP
(Agricultural Crops)
/02000AA Citrus (Non-bearing)
/02000DA (for trees that will not produce
marketable fruit for 12 months
after the last application)
N. P.
Nay be used in all areas except
California.
Do not exceed 4 applications per
year and 100 gallons per acre per
application.
Do not allow livestock to graze in
treated citrus groves.
FICEPOJ
FICBPCN
Phytophthora foot rot 4.0 lb/ Fbliar treatment. Apply as a
Phytcphthora coot rot 100 gal spray to run-off at each leaf
(80% UP) flush. Nursery trees, resets*
and new plantings should be
treated at time of planting.
•fosetyl-Al
•Aliett^
Issued: 03-14-86
I1-123501-1
Provisional Update: 10-15-86
90
-------
Site and Pest
EPA Index to Pesticide Chsnicals
ALUMINUM TRIS (O-ETHYL PHOSPHONATE)
Dosages and Tolerances, Use, Limitations
Fonnulation(s)
/02000AA
Citrus (continued)
Citrus
FICEPQ4
FICBPOl
/06013AA
/06013DA
IBIPJN
Phytophthora foot rot 4.0 lb/
Phytophthora root rot 100 gal
(80% WP)
Pineapple
Heart rot
(Phytcphthora
parasitica)
2.0 lb/
100 gal/A1
(80% WP)
1.0 lb/
100 gal
(80% HP)
0.1 ppn.
Do not apply within 90 days of
harvest.
Do not exceed 4 applications per
year and 1500 gallons per acre
per application.
Do not allow livestock to graze in
treated citrus groves.
Ebliar treatment. Apply as a
spray to run-off at each leaf
flush (i.e., March, May, July
and September).
0.1 ppn for pineapple
0.1 ppn for pineapple fodder
0.1 ppn for pineapple forage
Do not apply within 9 months of
harvest.
Dip treatment. Apply as a pre-
plant'dip to pineapple slips
(seed-pieces) immediately prior
to planting.
foliar treatment. Use up to 300
gallons per acre. A maximum of
4 sprays per year may be applied
at 3 month intervals. Apply to
established plants, when aggravat-
ing enviromental conditions (i.e.
excessive rainfall) occur or are
anticipated.
1 100 gallons is intended to treat the number of slips required to
plant one acre.
Issued: 03-14-86 II-123301-2
Provisional Update: 10-15-86
91
-------
EPA Index to Pesticide Gienicals
ALUMINLM TRIS (O-ETHYL PHOSPHCNATE)
Site and Pest
Dosages and Tolerances, Use, Limitations
Fonnulation(s)
/33007AA
/33008AA
FBAAPES
/34022AA
/34022QA
/34031AA
/34031DA
/34078AA
/34078CA
/3408QAA
/34080DA
/35073AA
/35073DA
/35196AA
/35196EA
/34113AA
/341130ft
/31175AA
/31175CA
/34118AA
/34118CA
TERRESTRIAL NCN-POOD CROP
(Lawns and turf (including ground cover))
Golf Course.Turf (golf fairways,
greens and tees)
Ornamental Turf (sod fam)
Pythiun blight
3.2-6.4 oz/
1,000 sq ft
(80% WP)
Do not graze animals on treated
turf* Do not feed clippings fran
treated turf to livestock or
poultry. Do not mow and/or water
areas until foliage is completely
dry. Maintain agitation during
spray operation.
Ft)liar application. Apply as a
foliar spray , using 1 to 5 gal-
lons of water per 1000 square
feet. The lower rate is applied
using a 14 day interval between
applications and the hi^ier rate
using a 21 day interval. Begin
preventive application tton con-
ditions first favor disease devel-
opment.
(Ornamental Plant* and Forest Trees)
Azalea (Rhododendron spp.)
Boxwood (Buxua sanperv Irene)
Japanese Androneda (Plerls iapcrica)
Japanese Holly (111 crenata)
Juniper (Juniperus spp.)
Monterey Pine ( Plnus radiate)
Pittoapoma (Pittoeccran spp.)
Schefflera (Schefflera spp.)
Rhododendron (Rhododendron spp.)
Issued: 03-14-86
Provisional Update: 10-15-86
II-l23301-3
9?
-------
EPA Index to Pesticide Qianicals
Site and Pest
ALUMINUM TRIS (OETHYLTfflOSPHONATE)
Dosages and Tolerances, Use, Limitations
Fonnulation(s)
(Ornanental Plants and Forest Trees) (continued)
FICBPCN
/31014AA
/34022AA
/34030AA
/34031AA
/34069AA
/35073AA
/39010AA
/34113AA
/34116AA
/34118AA
FKAZPCN
FKAZPES
Phytophthora root rot
(Phytophthora sp.)
5.2-10.4 oz/ Soil incorporation. Incorpor-
yd3
(804 WP)
0.8-1.6 lb/
1000 sq ft
(80% WP)
ate into the potting mixture
as it is being prepared.
Under severe disease condit-
ions the higher rate should
be used.
Drench application. Apply in
62.5 to 187.5 gallons per 1000
square feet (0.5 to 1.5 pints
per square foot). May be used
in conjunction with soil incor-
poration. Begin application at
potting or prior to anticipated
disease development. Continue
application (monthly) as long
as conditions are favorable
for disease development.
Under severe disease conditions
the higher rate should be used.
Aglaonana (Aqlaonana spp.)
Azalea (Rhododendron spp.)
Bougainvillea (Bougainvillea spp.)
Boxwood (Buxus sanpervlrens)
Hibiscus (Hibiscus spp.)
Juniper (Juniperus spp.)
Leatherlif fern ("ftinohra adaintiformis)
Pittosporvia (Pittoapomn spp.)
Pathos (ftothoe sppT)
Bhododtdron (Hhododsodron spp.)
May be used in all areas
except California.
Riytcphthora (disease
ccnplex)
IVthi.ua (disease
canplex)
2.0-4.0 lb/
100 gal
(80% HP)
Foliar application. Begin
application at potting or prior
to anticipated disease develop-
ment. Spray foliage and plant
parts until wet. Continue at
monthly intervals as long as
conditions are favorable for
disease development.
Under severe disease conditions,
the higher rate should be used.
Issuedt 03*14-86
II-123301-4
Provisional Update: 10-15-86
-------
EPA Index to Pesticide Chenicals
Site and Pest
ALUMINUM TRIS (O-ETHYL PHOSPHORATE)
Dosages and Tolerances, Use, Limitations
Focmulation(s)
(Omanental Plants and Forest Trees) (continued)
GREENHOUSE NON-POOD CROP
/31014CA Aqlaonana (Aqlaonana spp.)
/34022CA Azalea (Rhododendron spp.)
/34030CA Bouqainvillea (Bougainvillea spp.)
/34031CA Boxwood (Buxus sempervirens)
/34069CA Hibiscus (Hibiscus spp.)
/34078CA Japanese Andrtmeda (Pieris japonlca)
/34080CA Japanese Holly (Ilex crenata)
/35073CA Juniper (Juniperus spp.)
/39010CA Leatherleaf fern (Rumohra adaintifotmis) '
/35196CA Monterey Pine ( Pinus radiata)
/34113CA Pittosporim (Pittosporan spp.)
/34116CA Pothos (Pothoe spp.)
/34118CA Rhododendron (Rhododendron spp.)
/31175CA Schefflera (Sche^frlera spp.)
Refer to:
TERRESTRIAL NOH-POOD OCT (Ornamental Plants
and Forest Trees), for xnonental plant and
forest tree pest, use and limitation infor-
mation.
Issued: 03-14-86
Provisional Update: 10-15-86
I1-123301-5
94
-------
EPA Index to Pesticide Chmicala
ALUMINUM TRIS (O-FTHYL FHDSFUQNATE)
Listing of Registered Pesticide Pro&jcts by Formulation
&095.0001 95% technical chemical
aluminum tris (o-ethyl phoaphonate) (123301)
000359-00705
$080.0006 801 wettable powder
aluminum tris (o-ethyl phosphonate) (123301)
000359-00706
Issued: 03-14-86 11-123301- 6
Provisional Update! 10-15-66
95
-------
EPA Index to Pesticide Chemicals ^
<
ALUMINUM TRIS (O-ETHYL FHOSPHONATE)f
Auxiliary Docunentation
SLN [24 (c)] registration # FL85000300 is currently on the books
as a valid "special local need" registration for the state of
Florida. A review of this registration jacket indicates that its
use pattern has been superceded by the May 13, 1985 ppdate of the
parent product, *000359-00706, a regular section 3 registration.
Consequently there was no need to address this SLN registration
in this index entry.
Signed:
J. Dean Hansen
Plant Pathologist
08 April 1986
96
-------
APPENDIX IV
BIBLIOGRAPHY
97
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary source^ for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review nay be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA* by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
98
-------
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.
99
-------
APPENDIX IV
Registration Standards Case 0646; Foaetyl-ftl
BIBLIOGRAPH? OF STUDIES CONSIDERED IN SUPPORT OF REGISTRATION UNDER THE STANEARD
All studies in this bibliography are usable only with the permission of their
submitter—Hhcne-Foulenc—under the provisions of FIFRA §3(c)(1)(D)(i), for the
ten-year period beginning with the date of first product registration under this
standard.
MRJD
00098325
00098326
00098327
00098328
00098330
00098331
CITATION
Rhcne-Poulenc Chemical Company (1981) Product Chemistry:
[Fosetyl-Al]. Includes method LS 74.783 dated Jul 7,
I960, method dated May 7, 1981 and undated method R£-
18-81. (Conpilation; unpublished study received Apr 5,
1982 under 359-705; CDL:247159-A)
Bertrand, A. (1981) Fosetyl-Al: Conpoeition of the Technical
Grade Industrial Product (Analysis of 5 Typical Batches):
Ref: AG/CRLD/An AB/SV 164. Includes method P-286-06-80
and method P.306.03.81. (Unpublished study received
Apr 5, 1982 under 359-705: prepared by Rhone-Poulenc
Agrochimie, France, submitted by Rhcne-Poulenc Chemical
Co., Monmouth Junction, N.J.; CDL:247159-B)
Jfocne-Poulenc Agrochimie (1980) Fosetyl-Al or Ca (O-ethyl
Hrosphonate Salts of Aluminium or Calcium) Lodometric
Determination in the Technical aoupounds and fornulations.
Method P-286-06-80 Dated Jul 17, 1980. (Translation;
unpublished study received Apr 5, 1982 under 35^-705;
Submitted by Rhcne-Poulenc Chemical Co., Mcruncuth Junction,
N.J.; CCLs 247159-C)
Rhorie-Boulenc Agroc±iimie (19??) Foeetyl-Al Technical
Stability to Heat, Inflammability Exploeivity: AG/RD/DAFG0IRE
SRPH JD/NC/177. (Unpublished study received Apr 5, 1982
under 359-705; submitted by ffrcne-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:247159-D)
Paequet, J.; M&zuret, A.; Maratrat, ?; et al. (1977) LS 74-
783 (Aluminium Ethyl Phosphite; 32 545 R.P., Aluminium
Salt): Acute toxicity in the Rat and Rabbit: R.P./R.D./C.N.G.
No. 19 143-E. (Translation; unpublished study received
Apr 5, 1982 under 359-705; prepared by Rhone-Poulenc,
France, submitted by ttvcne-Foulenc Chemical Co., Monmouth
Junction, N.J.; CEL:247160-B)
Paaquet, J.? Mazuret, A.; Kalifat, R.; et al. (1981) Fosetyl-
Al (32 545 R.P., Aluminium Salt): Acute Percutaneous
Toxicity in the Rabbit: Reference C.R. Vitry/C.N.G. No.
21 162-E. (Translation; unpublished study received Apr
5, 1982 under 359-705; prepared by Rhcne-Poulenc Industries,
France, submitted by Rhone-Poulenc Chemical Co.. Monmouth
Junction, N.J.; CDL:247160-C)
1 nn
-------
Fosetyl-AI Bibliography page 2
MRID
CITATION
00098332 Cocobs, D.W.; Clark, G.C. (1977) Acute Inhalation Toxicity
in Rats: Four Hour Exposure to the Dust of LS 74.783
(Technical): RNP 79/77546. (Unpublished study received
Apr 5, 1982 under 359-705; prepared by Huntingdon Research
Centre, England, submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:247160-D)
00098333 Pasquet, J.; Mazuret, A.; Maratrat, ?; et al. (1981) Fosetyl-Al
(32 545 R.P., Aluminium salt): Prinary Eye Irritation in
the Rabbit: Reference C.R. Vitry/C.N.G. No. 21 163-E.
(Translation; unpublished study received Apr 5, 1982
under 359-705; prepared by Rhone-Poulenc Industries,
France, submitted by Rhone-Poulenc Chemical Co., Monmouth
Junction, N.J.; CDL:247160-E)
00098334 Pasquet, J.? Mazuret, A.? Maratrat, ?; et al (1981) Fosetyl-Al
(32 545 R.P., Aluminium Salt): Prinary Sfcin Irritation in
the Rabbit: reference C.R. Vitry/C.N.G. No. 21 164-E.
(Translation? unpublished study received Apr 5, 1982
under 359-705; prepared by Rhone-Poulenc Industries,
France, submitted by Rhone-Poulenc Chemical Co., Monmouth
Junction, N.J.; CDL:247160-F)
00098335 Elliott, P.H.; Seaber, J.A. (1979) Screening Test for Delayed
Contact Hypersensitivity with Fosetyl-Al (LS 74-783) in
the Albino Guinea Pig: 79443D/RNP/168. (Unpublished
study received Apr 5, 1982 under 359-705; prepared by
Huntingdon Research Centre, England, submitted by
Rhcne-Boulenc Chemical Co., Mcmnouth Junction, N.J.; CDL:
247160-G)
00098336 Coquet, B.; Guyot, D.; Galland, L.; et al. (1977) LS 74783:
3 Month Oral Toxicity Study in the Rat: IFFEB R 770359.
(Translation; unpublished study received Apr 5, 1982
under 359-705; prepared by Institut Francais de Recherches
et Esoais Biologiques, France, submitted by Rhone-Pou lenc
Chemical Co., Monmouth Junction, N.J.; CLD:247161-A)
00098337 Coquet, B.; Clair, M. (1977) LS 74783 (Aluminium Ethylptoephite):
3 Month Oral Toxicity Study in the Dogs IFREB-R 712110.
A translation of: LS 74783 (Ethylphooptaite D'Aluminium):
Taxi cite a Terme (3 mois) Par Voie orale Chez le Chi en:
1FKEB-R 709235. (Unpublished study received Apr 5, 1982
under 359-705; prepared by Institut Francais de Recherches
et Essais Biologiques, France, submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:247161-B)
00098338 Kynoch, S.R.; Lloyd, G.K.; Mallard, J.R.; et al. (1979) The
Effect of Repeated Applications of LS 74783 Technical to
the Skin of Rabbits for Twenty-one Days: RNP/123/79314.
(Unpublished study received Apr 5, 1902 under 359-705;
prepared by Huntingdon Research Centre, England, submitted
by Rhone-Poulenc Qiemical Co., Mcmnouth, N.J.; CDL:247161-C)
101
-------
Fosetyl-Al Bibliography page 3
MRID
CITATION
00098339 Spicer, E.J.F.; Trumbull, R.R.; Blanchard, G.L.; et al. (1981)
Chronic Toxicity (2 Year) and Carcinogenicity Study in Rats:
IRDC Study No. 347-016. (Unpublished study received Apr 5,
1982 under 359-705; prepared by International Research and
Development Corp., submitted by Khone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:247162-66)
00098340 Spicer, E.J.F.; Phillips, L.M. ; Richter, W.R.; et al. (1981)
Two-year Dietary Toxicity Study in Dogs: IRDC Study No-
347-023. (Unpublished study received Apr 5, 1982 under
359-705; prepared by International Research and Development
Corp., submitted by Khone-Poulenc Chemical Co., Monmouth
Junction, N.J.; CDL:247167-A)
00098343 Bouanchaud, D.H.; Cartier, J.R.; Vessieres, ? (1981) Foeetyl-al
(32 545 R.P., Aluminum Salt): Supplementary Studies of
Mutagenesis in Microorganisms: C.R. Vitry/C.N.G. No. 21
212. (Unpublished study received Apr 5, 1982 under 359-705;
prepared by Rhcne-Poulenc Industries, France, submitted
by Rhcne-Poulenc Chemical Co., Mcnmouth Junction, N.J.;
CDL: 247173-B)
00098345 Cordier, A.; Fournier, E.; Viziere, ? (1981) Fosetyl-al (32
Sys R.P., aluminium Salt): Micrcnucleus Test in the
Mouse the Oral Route: Reference C.R. Vitry/C.N.G. No.
21 186-E. (Translation, unpublished study received Apr
5, 1982 under 359-705; prepared by Rtane-Poulenc Industries,
France, submitted by Rhone-Poulenc Chemical Co., Mcnmouth
Junction, N.J.; CDL: 247173-D)
00098347 Paaquet, J.; Le Bail, R. ,; Cegeral, ? (1976) Compound LS
74-783; Oral Teratogenicity Study in the Rabbit: Report
R.P./R.D./C.N.G. No. 18917-F. (Translation; unpublished
study received Apr 5, 1982 under 359-705; prepared by
Rhcne-Poulenc, France, submitted by Rhcne-Poulenc Chemical
Co., Mcruoouth Junction, N.J.; CEL:247174-A)
00098348 Palmer, A.K.; Bottomley, A.M.; Barton, S.J.; et al. (1981)
Effect of LS 74-783 on Reproductive Function of Multiple
Generations in the Rat: RNP/89/80745. (Unpublished study
received Apr 5, 1982 under 359-705; prepared by Huntingdon
Research Centre, England, submitted by Rhone-Poulenc
Chesdcal Co., Monmouth Junction, N.J.; CEL:247174-C)
00098352 Spicar, E.J.F.; Phillips, L.M.; Ri<±iter, W.R.; et al. (1981)
Life-time Chronic Toxicity and Carcinogenicity Study in
Rats: IRDC Study No. 347-022. (Unpublished study received
Apr 5, 1962 under 359-705 prepared by International Research
and Development Corp., Submitted by Rhcne-Poulenc Chemical
Co., Monmouth Junction, N.J.; CEL:247176-82)
102
-------
Fosetyl-AI Bibliography page 4
MRID
00098353
00098358
00098360
00098362
00098363
00098368
00098370
CITATION
Spicer, E.J.F.; Phillips, L.M.; Richter, W.R.; et al. (1981)
24-month Carcinogenicity Study in Mice: IRDC Study No. 347-021.
(Unpublished study received Apr 5, 1982 under 359-705;
prepared by International Research and Development Corp.,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:247168-71)
Caillard, C.G.; Deregnaucourt, J.; Garret, C,; et al. (1980)
Monoethylphosphonic Acid, Aluminium Salt (LS 74 783 = 32
545 R.P., Aluminium Salt): Effects in a Number of Pharmaco-
logical Tests: R. P./R.D./C-N.G. No. 20 680-E. (Translation;
unpublished study received Apr 5, 1982 under 359-705;
prepared by Rhone-Poulenc, France, submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:247183-E)
Roberts, N.L.; Phillips, C.N.K. (1981) The Acute Oral Toxicity
(LD50) of LS 74.783 to the Bobwhite Quail: RNP 189
WL/81148. Final report. (Unpublished study received Apr 5,
1982 under 359-705; prepared by Huntingdon Research
Centre, England, submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:247184-B)
Roberts, N.L. ; Efaillips, C.N.K. ; Almond, R.H. (1982) The
Subacute Dietary Toxicity (LC50) °* ^ 74.783 to the Bobwhite
Quail: WJP 190 WL/81699. Final report. (Unpublished study
received Apr 5, 1982 under 359-705; prepared by Huntingdon
Research Centre, England, submitted by Rhone-Poulenc
Oiemical Co., Mcrunouth Junction, N.J.; CEL:247184-D)
Roberts, N.L.; Etaillipe, C.N.K.; Almond, R.H. (1981) The
Subacute Dietary Toxicity (LC50) of LS 74.783 to the
Mallard Dude: RNP 191 WL/81716. Final report. (Unpub- •
lished study received Apr 5, 1982 under 359-705; prepared by
Huntingdon Research Centre, England, 3ufcmitted by Rhone-
Poulenc Qvemical Co., Monmouth Junction, N.J.; CDL:247184-E)
Rhoderick, J.C.; Spare, W.C.; Hutchinson, C. (1981) The
Acute Toxicity of Aluminum-ethyl-phoaphonate to Grass
Shriap, Pal»«**Tnetes pugio: Project No. 331-2. (Unpublished
study received Apr 5, 1982 under 359-705? prepared by
Biospherics, Inc., submitted by Rhone-Poulenc Chemical Co.,
Mcraaouth Junction, N.J.; CDL:247184-J)
Buys, M.; Bertrand,; Giraud, J.P. (1961) Foeetyl-al (Aluminium
Tris-O-ethylphoephcnate) Hydrolysis Study: Ref. AG/CRL£)/An/
AB/MB/JPG/CB/613.81. (Unpublished study received Apr 5,
1982 under 359-705; prepared by Rhcne-Poulenc Agrochemie
S.A., France, submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CEL:247185-B)
103
-------
MRID
CITATION
Fosetyl-Al Bibliography page 5
00098371 Bertrand, A. (1981) Fosetyl-al: UV Absorption Characteristics:
Ref. No. AG/CRLD/An/AB/DB/324/81. (Unpublished study
received Apr 5. 1982 under 359-705; prepared by Rhone-
Poulenc Agrochimie; France, submitted byRhsne-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:247185-C)
00098372 Hascoet, M.• Jamet, P. (1978) Aluminium Ethylptosphite
Degradation in the Soil. (Translation; France, Ministere
de 1'Agriculture, Institut National de la Recherche
Agronomique, Laboratoire de Phytopharmacie; unpublished
study; received Apr 5, 1982 under 359-705; submitted by
Rhcne-Poulenc Chemical Co., Monmouth Junction, N.J.,
CDL:247185-D)
00098375 Buys, M.; Giraud, J.P. (1982) Fosetyl-al (Aluminum Tris-o-ethyl-
phosphcnate) Soil Leaching Studies: Rfif. AG/CRLD/An/AB/MB/JPG/
CB/025.82. (Unpublished study received Apr 5, 1982 under 359-
705; prepared by Rhone-Poulenc Agrochimie, France, submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J. ;
CEL:247185-G)
00103249 Brockelsby, C.; Catchpole, A.; Crourii, R. (1977) Fungicides: Alu-
minum Ethyl Phosphite (L£ 74.783 or Aliette): Studies with the
14C-Tshelled Conpcund in Vines: AR/1257. (Unpublished study re-
ceived Jun 6, 1982 under 359-706; prepared by May & Baker Ltd.,
Eng., submitted by Rhone-Poulenc, Inc., Mcnmouth Junction, N. J.;
CDL:247647-B)
00103250 Laurent, M.; Chabassol, Y. (1982) Fosetyl-Al (32 545 R.P., Alumin-
ium Salt): Pineapple Metabolism Study: Report C.R. Vitry/CNG-An
No. 4412-E. (Translation; unpublished study received Jun 8,
1962 under 359-706; submitted by Rhone-Poulenc, Inc., Mcnmouth
Junction, N.J.; CEL:247647-C)
00106018 Buys, M.; Giraud, J.; Alix, M.; et al. (1982) Fosetyl-Al (Aluminum
Tria-o-ethylphosphcnate): Soil Metabolism Study: Refl AG/CRLD/
AH/262.82. (Unpublished study received Jul 13/ 1962 under 359-
705; prepared by Rhone-Poulenc Agrochimie S.A., Ft., submitted
by Rhone-Poulenc, Inc., Mcnmouth, N.J.; CDL:247820-A)
00106019 Bertrand, A.; Buys, M. (1982) Foeetyl-Al—Soi1 Sorption Studies:
Ref. AG/CRLD/AN/163.82. (Urpublished study received Jul 13,
1982 under 359-705; prepared by Rhone-Poulenc Agrochimie S.A.,
Fr., submitted by Rhone-Poulenc, Inc., Mcnmouth Junction, N.J. ;
CCL:247820-B)
104
-------
Fosetyl-AI Bibliography page 6
MRID
00114091
00119526
00122701
00122782
00122783
00122785
00128944
CITATION
Palmer, A.K., James, R.W. (1977) Effect of LS74—783 on Pregnancy
of the Rat: RNP/33/76939. (Unpublished study received Apr 5,
1982 under 359-705; prepared by Huntingdon Research Centre,
England; submitted by Rhone-Poulenc Chemical Co., Mcnraouth
Junction, N.J.: CDL:247174-B)
Biospherics, Inc. (1982) Hie Acute Toxicity of Fosetyl-Al
to the Bluegill Sunfish (Lepomis macrodiirus): Project
No. 82-E-380-B. (Unpublished study received Oct 28, 1982
under 359-705; submitted by Rhone-Poulenc Chemical Co-/
Monmouth Junction, N.J.; CDL:248674-A)
Paaquet, J.; Mazuret, A.; Gaildrat, P.; et al. (1981) Foeetyl-
A1 (32 545 R.P., Aluminium Salt); Aliette WP 80% (Wettable
Powder Containing 80% Fosetyl-AI); Acute Oral Toxicity
in the Rat: Reference C.R. Vitry/C.N.G. no. 21 165-E.
(Translation; unpublished study received Apr 5, 1982 under
359-706; prepared by Centre Nicolas Grillet, Fr.,
submitted by Rhone-Poulenc, Inc., Monmouth Junction,
NJ; CDL:247186-B).
Paaquet, J.; Mazuret, A.; Gaildrat, P.; et al. (1981) Faeetyl-
A1 (32 545 R.P., Aluminium Salt); Aliette WP 80% (Wettable
Pcwder Containing 80% Foeetyl-Al); Acute Percutaneous
Toxicity in the Rabbit: Reference C.R. Vitry/C.N.G. rvo. 21
166-E. (Translation; unpublished study received Apr 5, 1982
under 359-706; prepared by Centre Nioolas Grillet, Fr.,
submitted by Rhone-Poulenc, Inc., Monmouth Junction, JU;
CDL:247186-C).
Cwen, P.; Blackett, N. (1981) Aliette (80% Fosetyl-AI):
Acute Inhalation Toxicity Study — LC50 in Rats (4 Hours
Exposure): Report No. 2771-198/1. (Unpublished study
received Apr 5, 1962 under 359-706; prepared ty Hazleton
Laboratories Europe, Ltd., Eng., submitted by Rhone-
Poulenc, Inc., Mcnmouth Junction, NJ; CEL:247186-D).
Paaquet, J.; Mazuret, A.; Gaildrat, P.; et al. (1981) Fosetyl-
AI (32 545 R.P., Aluminium Salt); Aliette WP 80% (Wettable
Powder Containing 80% Fosetyl-AI); Primary Skin Irritation
in the Rabbit: Reference C.R. Vitry/C.N.G. no. 21
160-E of 2.11.81. (Translation; unpublished study received Apr
5, 1982 under 359-706; prepared by Centre Nioolas Grillet, Fr.,
submitted by Rhcne-Poulenc, Inc., Mcronouth Junction, NJ;
CDL:247186-F).
Canzelmann, P.; Brady, S. (1983) Acute Toxicity Bioassay Testing
Fosetyl-AI on Rainbow Trout: GSRI Project No. 413-B45-41.
(Ur(>ublished study received June 17, 1983 under 359-705; prepared
by Gulf South Research Institute, submitted by Rhone-Poulenc,
Inc., Monmouth Junction, NJ; CDL:250499-B)
1 r\ <~
-------
Fosetyl-Al Bibliography Page 7
MRID
00128943
00139527
00147359
00147360
00147361
00147569
00148290
00148619
40131101
CITATION
Spare, W. r Gottfried, G. (1983) "The Actue Toxicity of Fosetyl-Al
to Daphnia nagna Straus: Biospherics Project No. 82-E-380EMR.
(Unpublished study received June 17, 1983 urvder 359-705; prepared
by Biospherics, Inc., submitted by Rhone-Pou1enc, Inc., Monmouth
Junction, NJ; CDL:250499-A)
Rhcne-Poulenc, Inc. (1983) Residue data in/on pineapple resulting
from Aliette dip and/or foliar treatments, (compilation
unpublished study received May 12, 1983 under 2F2702; CDL:071491-
A:071592)
ward, G. (19 85) Acute Toxicity of Fosetyl-Al to Embryos and Larvae
of the Eastern Oyster (Crassostrea virginica): ESE No. 85-314-
0200-2130. Unpublished study prepared by Environmental Science
and Engineering, Inc. 17 p.
Suprenant, D. (1985) Acute Toxicity of Fosetyl-Al to Sheepshead
Minnow (Cyprinodon variegatus): Bionomics Report #BW-85-5-1777.
Unpublished study prepared by Springbom Bionomics, Inc. 55 p.
Chabassol, Y. (1984) Fosetyl-Al: Anaerobic Aquatic Metabolism Study:
Ref. No. AC/CRLC/An/241.84. Unpublished study prepared by Rhcne-
Poulenc Agrochimie, Lyon, France.
Rhcne-Poulenc, Inc. (1984) [Residue Data of Aliette], Unpublished
study. 56 p.
Rhcne-Poulenc, Inc. (1985) Residue of fosetyl-Al in citrus fruits.
Unpublished oonpilation- 273 p.
Hylin, J. and K. Yanagihara. (1985) Residue data in/on pineapple
resulting from Aliette dip and/or foliar treatments. Unpublished
study prepared by University of Hawaii. 315 p.
Auletta, C.; Hogan, G.; Lamb, C. (1982) Eye Irritation Study
of Rabbits with Aliette 80 WP: Lab Project ID:
4090-82. Unpublished study prepared by Bio/dynamics, Inc.
17 p.
106
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APPENDIX V
FORMS
107
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FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUES
With rap act to tha raquiramiM to Mbmh "generic" data impoMd by tha FIFRA action 3(C)(2)(B) no tic* contained in tha rafwancad
Guidanca Documant, 1 am responding in tha following mannar.
~ 1. I will ubmit data in a drnaly mamar to attafy tha following raquirvnanu. H tha tan procadur* I will ua daviata from (or va not
ipacifiad in) tiit Ragimr'on CukWio« or tha Protocols containad in thi Raporvof Eiptrt Group* to tha Chamicaii Group. OECO
Cham call Taating Programme I andosa tha protocols that I will us:
G1 I hava antarad into on ywiin witti ona or mora othar ragntranti undar F1FRA action 3
-------
SHSJ^SS!JiSiJSS2£SSSJm£E£SkJ£i2L22l
f To Qualify, canity ALL four rtwrngj
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly autftorixod to represent the following firm(i) who art ubfect to the require-
ment! of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Docunent
to (ubmit data concerning The active ingredient:
ouidanci oocumcnt oati
ACTIVt INOMEOltNT
MAMK OF FIRM
¦PA COMPANY NIMMIR
(Thit firm or proup of firmi n referred to below *» "my firm".)
2. My Ann it willing to develop and ubmit the dau at required by that Notice, if Decenary. However, my firm would prefer to enter
into an agreement with one or more other regirtrinu to develop jointly, or to there in the coct of developing, the following required
itemiordeta:
My fin* tM offarad in wrttmi t» emtf lute aidi ait agwemant Copies sf the offan a
Bound fry an arMtmton dociaoa under FIFRA Section 3
-------
PRODUCT SPEC EPIC DATA REPORT
EPA Reg. No. Date
Guidance Document Tor
Registration
Guideline No.
Name of Test
Ttest not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Chly)
Accession Numbers
Assigned
citing KRID
Ntnber or
EPA Accession
Rmber
Submit-
ting
Data
(At-
tached)
$158,120
FflQDUCT
CHEMISTRY
61-1
Identity of
Ingredients
61-2
Statement of
ccnuoaitlor.
61-3
Discussion of
formation of
ingredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcement
limits
63-2
Color
65-3
Rwalcal stat*
63-5
Odor
63-5
Melting point
63-6
Boiling point
63-/
Density, bulk-
density, or
specific gravity
63-tt
Solubility
53~9
Vapor pressure
63-10 -
Dissociation
oontant
63-11
Octanol/water
partition
coefficient
63-12
pH
i
no
-------
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
be lew)
1 an canplying
data requlreme
Citing MR®
Number or
EPA Accession
timber
with
nts by
^Sit-
ting
Data
(At-
tached)
(For EPA Use Cfcly)
Accession Nusbers
Assigned
63-13
Stability
63-11*
Oxidizing/reducing
reaction
63-15
Flasmablllty
6§-16
Explodability
63-17
Storage stability
63—18
Vlacoeity
b2"1?
tttscibillty
. 63-20
Corroaion
characteristics
63-21
Dielectric break-
down voltage
§158.135
TOXICOLOGY
-
81-1
Acute oral
toxicity, rat
81-2
Acute dermal
toxicity, rabbit
81-3
Acute inhalation,
toxicity, rat
81-4
Primary eye
irrltaticr., rabbit
81-5
Primary dermal
irrltaticr.
81-6
Deraal sensitiza-
tion
/
1 12
-------
CKB Approval No. 2070-0057
Expiration Date H/30/89
GDffiEIC DATA EXEMPTION STATEMENT
EPA Product Registration NLmber: _____________
Registrant'3 Name and Address:
As ar. authorised representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terns of the Notice from EPA dated
concerning a requirement for submission of "generic" data crj the
active ingredient ____________ named wder 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 frao another producer.
(3) At. accurate Confider.tal 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
Ihe CSF dated on file with EPA Is complete, current and accurate and
contains the information requested on the current CSF Pom No. 8570-4, The
registered source(s) of the above named active ingredient in my product(s) ls/are
________________________ and their registration nunber(s) ls/are ___________ •
My firm will apply for an amendDent to the registration prior to changing
the source of the active Ingredient in our product.
(4) 1 understand, and agree on behalf of ny firm, that If at any time any
portion of this Statement 1a no longer true, or if my fin fails to ocmply with
the undertakings made lr. this Statement, my firm's pro&jct's registration ny be
suspended under FIFRA Section 3(e)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persona to provide the
Agency with the required generic data. If the registrant (a) have ccDdtted
to generate and autnlt the required data fall to take appropriate steps to meet
requirements or are no longer In compliance with this Nbtles'a data requlrosrts,
the Agency will consider that both they and my flra are not in ©alliance and
will normally initiate proceedings to suspend the registrations of tag firm's
product(s) and their product(s), wless my firm coonits to submit and submits
the required data lr the specified tine frame. I mderetand that, In such cases,
the Agency generally will not grant a tins extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated: /
T5p53T
EPA Form 8570-27
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4 ^
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