united sum
Enviranmwnai Protection
Aocncy
Pwtickta «nd Toxic Submncw
Wa^iinqton OC 20460
March 1987
PacticidM
Guidance for the
Reregistration of
Pesticide Products
Containing Vendex
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
FENBUTATIN-OXIDE
(TRADE NAME - VENDEX)
SHAUGHNESSY NO. 104601
MAR 3 I 1987
AS THE ACTIVE INGREDIENT
CAS NO. 13356-08-6
CASE NUMBER 0245
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment 6
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 18
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 28
VI. Requirement for Submission^of Generic Data 30
A. What are generic data?' •>>•>• •
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 35
VIII. Requirement for Submission of Revised Labeling 36
IX. Instructions for Submission 37
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
Table C
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
,. • Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Formulator's Exemption Statement
11
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance .with.. FIFRA,..as ..instructed...by. this.' St.andardA..._
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
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2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request-'-, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active - ingredient-. -:..Howe-v.er.,<,,during,»th.e^r.ev.iew of,^these.v,da,ta.-.,
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
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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steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in. cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
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
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necessary to resolve'our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. 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 their products are registered by the Agency.
II. CHEMICAL(S) COVERED BY THIS STANDARD
A. Description of chemical(s)
The following chemical is covered by this Registration
Standard:
Common name: Fenbutatin-oxide
Chemical name: Bis [tris(2-methyl-2-phenylpropyl)tin] oxide
or hexakis (2-methyl-2-phenylpropyl)-
distannoxane
CAS Number : 13356-08-6
OPP (Shaughnessy) Numbers: 104601
Empirical Formula: CgoH78OSn2
Trade and Vendex, Fenbutatin oxyde, SD 14114, Torque,
other names: Neostanox, Osadan and Hexakis
Description of physical characteristics of chemical:
Technical Fenbutatin-oxide
Color: White
Odor: Odorless
Physical State: Crystalline solid
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Melting point: 145°C
Solubility: Insoluble in water and slightly soluble in
aromatic sovents
Molecular Weight: 1053
B. Use Profile
Type of Pesticide: Organotin acaricide, refer to Pesticide
Index (Appendix III).
Predominant Use(s): Oranges, grapefruit, pears, apples, grapes,
almonds, cherries, strawberries and
ornamentals
Mode of Activity: It is suspected that fenbutatin-oxide
inhibits adenosine triphosphate (ATP) enzymes.
Methods of Application: Foliar application by ground equipment
only
Fenbutatin-oxide is the common name for hexakis (2-methyl-
2-phenylpropyl) distannoxane and this common name will be
used through out this Guidance Document. Fenbutatin-bxide
is a non-systemic organotin acaricide that has been marketed
in the United States for 12 years and is used to control more
than 20 different types of mites on about 17 sites. All
fenbutatin-oxide registrations were recently transferred from
Shell Chemical to E.I. du Pont de Nemours and Company.
There are 3 registered products with the following formulations:
Technical (97%)
Wettable Powder (50%)
Flowable Concentrate (4 Ib/gal)
Fenbutatin-oxide is used on a variety of use sites which
include:'almonds, apple, cherry, citrus fruits, eggplant,
grapes, papaya, peach, pear, pecan, plum, prune, strawberry,
walnut and ornamentals. Recommended application rates range
from 0.5 pounds active ingredient (a.i.) per acre to 2.0
pounds a.i. per acre.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed data submitted to support the
registration of fenbutatin-oxide and concluded that numerous
data gaps exist for fenbutatin-oxide. However, based on
available data the Agency has reached the following conclusions.
(A detailed discussion of the points summarized below appears
in Section B.)
1. A primary eye irritation study demonstrat.es that technical
fenbutation-oxide is a severe eye irritant and is therefore
classified as a Toxicity I chemical based on eye effects only.
. The Agency .believes^, that the. p.r;e,cau,ti£mar,y.,.s.ta,temeji.ts_iCQncerning,..,
these eye effects presently on-fenbutatin-oxide labels are
adequate to protect the public.
2. Available data demonstrate that the use of fenbutatin-oxide
in citrus groves may present a chronic hazard to nesting and
foraging birds and an acute hazard to freshwater and estuarine
aquatic organisms. Until the required data are developed
and submitted, hazards can be reduced through labeling statements,
(Refer to Section IV A for a description of the required data).
The. Agency has identified the data it feels is necessary
to fully evaluate the human and environmental risks associated
with the use of fenbutatin-oxide. These data must be developed
in order to maintain registrations, of. products or .to register
new products containing fenbutatin-oxide. A summary of these
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data gaps appears in Figure I. Please note that this is only
a summary and complete details can be obtained by referring
to the tables in Appendix I.
The Agency has also determined that certain label re-
strictions and revisions are necessary. Please refer to
Section VI.D. for a description of the required labeling
revisions.
Figure 1- DATA GAP TABLE
Toxicology
Acute Oral (Rat)
Acute Inhalation (Rat)
90 Day Feeding (Non-rodent)
21 Day Dermal Toxicity
Chronic Toxicity (Non-rodent)
Oncogenicity (Mouse)
Mutagenicity
General Metabolism Testing"
2-Generation Reproduction
Environmental Fate
Leaching
Hydrolysis
Photodegradation (In water)
Photodegradation (On soil)
Aerobic and Anaerobic Soil
Soil Metabolism Studies
Volatility (Lab)
'Soil Dissipation"*-' '* '"
Rotational Crops (Confined)
Accumulation in Fish
Re-entry
Foliar Dissipation
Product Chemistry/Residue Chemistry
Product Chemistry
Animal Metabolism
Storage Stability
Residue Studies
Ecological Effects
Avian Subacute Dietary Toxicity
Avian Reproduction
Freshwater Fish Toxicity
Acute Toxicity to Freshwater Invertebrates and
Fish Early Life Stage and Aguatic Invertebrate
Aguatic Organism Accumulation Testing
Simulated or Actual Field Testing for Aguatic Organisms
Marine Organisms
Life Cycle
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8
B. PRELIMINARY RISK ASSESSMENT
The Agency has reviewed fenbutatin-oxide data in the areas
of acute toxicity, chronic toxicity, oncogenicity, reproductive
effects, mutagenicity, environmental fate and exposure, and
ecological effects. Numerous data gaps exist. The following
assessment is based on available data and is subject to change
when the results of the required studies are available for
Agency review. (Refer to Section C for a detailed discussion
of other science findings not covered in the Preliminary
Risk Assessment Section).
1. Toxicology
a. Eye Irritation
Six male Albino rabbits were administered 100 mg of
undiluted technical fenbutatin-oxide in the conjuctival sac
of the treated eye. All animals showed damage to the cornea,
iris and conjunctiva up to 14 days post treatment. Based
upon this primary eye irritation study, technical fenbutatin-
oxide is characterized as a severe eye irritant and is clas-
sified as a Toxicity Category I chemical because of eye
effects.
2. Ecological Effects
Birds
An acute oral avian toxicity study indicates that
fenbutatin-oxide, when administered orally in a single dose,
is practically nontoxic to birds. "The LD5Q value for-'Bobwhite-
Quail is 2510 mg/kg.
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A subacute dietary toxicity study on Mallard ducks
likewise supports a finding indicating that fenbutatin-oxide
is nontoxic to birds. The LC^Q value for Mallard ducks is
greater than 5620 parts per million (ppm). (A subacute dietary
toxicity study using Bobwhite Quail must be repeated because
the administered dose was not sufficient to calculate a
reliable LCso value).
Aquatic Organisms
Preliminary freshwater invertebrate acute toxicity
data indicate that fenbutatin-oxide is highly toxic to fresh-
water invertebrates. This study was classified as supplemental
data-and must be repeated because the test water was not
properly characterized and only 3 dose levels, rather than
5 levels, were used. The tentative LD5Q value for Daphnia
magnia is 0.04 ppm.
Acute toxicity data on Rainbow trout and Bluegill sunfish
indicate that fenbutatin-oxide is highly toxic to freshwater
fish. The LCso value for Rainbow trout is 0.0017 ppm. The
LCso value for Bluegill sunfish is 0.0048 ppm.
Wildlife Exposure and Hazard
The "highest application rates for fenbutatin-oxide are
applied to citrus crops in Florida at a rate of 2 Ibs active
ingredient per acre. Use directions allow for up to 4 total
applications to citrus with each application being 2 to 3
weeks apart.
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10
The Agency is carefully evaluating f enbutatin-oxide
use on citrus for the following reasons:
a. Repetitive applications could result in an ac-
cumulation of parent f enbutatin-oxide and metabolites that,
because of the persistent nature of the pesticide, may present
a chronic hazard to birds foraging in soils and nesting in
citrus groves.
b. Although run-off does not appear to present a risk
to aquatic species, spray drift resulting from application
of fenbutatin-oxide to citrus groves may pose an acute toxicity
hazard to freshwater and estuarine species.
..... The -Agency- i-S'^
aquatic and avian toxicity testing, chronic toxicity testing
as well as aquatic field monitoring studies be conducted
before the wildlife risk assessment can be completed. (Refer
to Appendix I for a complete listing of required data).
C. OTHER SCIENCE FINDINGS
1 . Acute and Subchronic Toxicity
Available dermal toxicity data demonstrate that fenbutatin-
oxide exhibits low toxicity to mammals by dermal route of
exposure* The acute dermal toxicity to rabbits is greater
than 2,000 mq/kg.
Data are sufficient to indicate that fenbutatin-oxide is
not a dermal sensitizer* Primary dermal' irritation data. ,
demonstrate that fenbutatin-oxide is a mild skin irritant.
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No valid acute oral toxicity, acute inhalation, 90 day
feeding (non-rodent) or subchronic dermal toxicity studies.
are available. These data are required.
2. Chronic Toxicity
Rat
An acceptable 2 year rat feeding study, where 72 male
and 72 female Carworth rats were administered fenbutatin-oxide
in dietary doses of 50, 100, 300 and 600 ppm for 104 weeks,
demonstrated that fenbutatin-oxide was not oncogenic under test
conditions. One hundred forty-four animals of each sex were
used as controls. A systemic No Observed Effect Level (NOEL)
of 100 ppm (or 5 mg/kg) was established based on decreased leuco-
cytes in female rats and reduced body weight in both sexes
receiving dosages greater than 300 ppm.
Non-rodent
A 2 year dog feeding study^was reviewed and found to be
supplemental because of reporting deficiencies. The study may
be upgraded when the required information listed in Appendix I
is submitted and reviewed.
In this study, male and female dogs (4 animals per sex
per dose) were administered fenbutatin-oxide in gelatin
capsules "containing 2.5, 5, 15, 30 and 60 mg/kg. The control
group consisted of 8 animals per sex.
These preliminary data indicate that the NOEL is considered
to be 5 mg/kg/day with a lowest effect level of 15 mg/kg/day
based on clinical observations of vomiting and diarrhea.
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3. Oncogenicity
Rat
The rat chronic/oncogenicity study previously described
in Section C2 adequately assesses the oncogenicity of fenbutatin-
oxide. No oncogenic effects were demonstrated at doses up to
600 ppm, the highest level tested).
Mouse
An 18 month feeding/oncogenicity study was reviewed and
found to be supplemental because of reporting deficiencies.
The study may be upgraded when the required information
listed in Appendix I is submitted and reviewed. Sixty male
and sixty female Carworth mice were fed diets containing 5,
100, 300, 600 ppm of fenbutatin-oxide. A control group of
120 male and 120 female mice received an untreated diet.
Preliminary data indicate that the NOEL is 100 ppm
based on decreased body weight. No oncogenic effects were
reported at the highest dose tested.
4. Reproductive and Teratogenic Effects
Reproduction
There are no valid reproduction studies available to
\
assess reproductive effects from fenbutatin-oxide exposure.
This study is required.
Teratology
Rat
An acceptable rat teratology study demonstrates that
fenbutatin-oxide is not teratogenic in the rat. The NOEL for
this study is 60 mg/kg, the highest dose tested.
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One hundred ''thirty s ix fema 1'e ""Wfsfcar:'~*ra'ts -were" adm'rrf- - *"~-' —
istered fenbutatin-oxide by gavage at doses of 15, 30 or 60
mg/kg from 6 through 15 days of pregnancy. Fifteen female
rats were administered aspirin which served as the positive
control.
Rabbit
• ———
A rabbit teratology study was reviewed and found to be
acceptable. Female New Zealand White rabbits were administered
fenbutatin-oxide in gelatin capsules at doses of 1, 5, and 10
mg/kg on days 6-18 of gestation. Thalidomide was given as the
positive control. The NOEL for this study as 5 mg/kg.
5. Mutagenicity and Metabolism
There are "no"valid- mat-a-ge-nicity-->or~me-tabol-isTn~studtesr »"~»—
available. These studies must be conducted and submitted to
the Agency.
6. Environmental Fate ;
The available data are insufficient to fully assess the
environmental fate of fenbutatin-oxide. Refer to Appendix I for
a listing of required data.
D. Tolerance Assessment
1. Tolerances issued
Tolerances have been established for residues of fen-
butatin-oxide in a variety of raw agricultural commodities
including meat, fat and meat by products (refer to 40 CFR-:
180.362 for listing of tolerances), and in processed food (21
CRF 193.236) and feed (21 CFR 561.255).
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Commodity
Almonds
Almonds, hulls
Apples
Cattle ,f at
Cattle, meat
by product
Cattle, meat
Cherries, sour
Cherries, sweet
Citrus fruits
Cucumber
Eggplant
Eggs
Goats, fat
Goats, meat by
product
Goats, meat
Grapes
Hogs, fat
Hogs, meat by
products
Hogs, meat
Horses, fat
Horses, meat" by
product
Horses, meat
milk fat
Papayas
Pecans
Peaches
Pears
Plums
Poultry, fat
Poultry, meat by
products
Poultry , meat
Prunes
Sheep, fat
Sheep, meat by
products
Sheep ,meat
Strawberries
Walnuts
Apple pomace, dried
Citrus pulp, dried
Grape pomace, dried
Raisin waste
Prunes, dried
Raisins
Tolerance- '(ppnr)-"
U.S. Canadian Mexican
0.5
80.0
15.0 3.0
0.5
0.5
0.5
6.0
6.0
2.0 2.0
4.0 0.5
6.0
0.1 -
0.5
0.5
0.5
5.0
0.5
0.5
0.5
0.5 . -
- 0.5 ' " "- '
0.5
0.1
2.0
0.5
10.0
15.0
4.0
0.1
0.1
0.1
4.0
0.5
0.5
0.5
10.0
0.5
20.0
7.0 -
100 - •
20.0
8.0
20.0 -
• - ~(-MRL)
Codex
—
-
5.0
-
-
0.02
5.0
5.0
5.0
1.0
1.0
-
-
-
—
5.0
-
—
—
-
-
-
-
-
-
7.0
3.0
-
-
—
-
-
-
—
—
-
-
—
—
—
-
-
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15
2. Resrdue -Da ta"" -ra-'
The residue data reviewed in support of these fenbutatin-
oxide tolerances are:
a. Data on the nature of the residue in both plants and
animals, including identification of major metabolites and
degradates of fenbutatin-oxide.
The nature of the residue of fenbutatin-oxide in animals
is not adequately understood because: (1) insufficient residue
levels were present in milk and meat of dairy cows for charac-
terization/ (2) residues in laying hens were not properly
characterized due to problems with analytical methodology,
and (3) no material balance information was provided for
residues recovered from laying hens. The limited data do
show that up to 82% of fenbutatin-oxide residues were recovered
from the feces of dairy cattle that were fed diets containing
radiolabeled fenbutatin-oxide. No detectable fenbutatin-oxide
residues or metabolites were detected in milk, fat or muscle
of cattle and less than one percent of the total administered
dose occured in the lungs, liver, kidneys and urine combined.
Characterization of residues in the liver and kidney revealed
the presence of fenbutatin-oxide per se, dihydroxy-bis(2-methyl-
2-phenylpropyl) stannane and inorganic tin.
A fe'nbutatin-oxide hen feeding study indicated that
fenbutatin-oxide residues were found in egg yolks, liver
and kidney. Due to problems with analytical methodology
and residue recovery, however, a new study must be conducted
and submitted.
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16
The metabolism of fenbutatin-oxide in plants is adequately
understood and no additional data are required. Available
data demonstrate that fenbutatin-oxide residues (fenbutatin-
oxide, dihydroxy-bis-(2-methyl-2-phenylpropyl) stannane,
2-methyl-2phenylpropyl stannonic acid and other organic and
inorganic compounds) were detected in treated leaves and
fruit of apples and oranges.
Tolerances of fenbutatin-oxide are currently expressed
as the combined residues of hexikis (2-methyl-2-phenylpropyl)-
distannoxane and its organotin metabolites. Upon receipt of
the required animal data, the tolerance expression will be
re-evaluated.
..., —b ~ --Adequate •ga^s'-rrqurd-'^ftrcmat'ograpfric -(GLC) methods-
utilizing either a tin-specific flame photometric detector
or mass selective detector are available for collection of
data pertaining to residues of fenbutatin-oxide and its
organotin metabolites. A method trial for two procedures is
needed for the determination of fenbutatin-oxide and its
metabolites. Data for residues of fenbutatin-oxide and its
organotin metabolites in or on crop samples must be analyzed
using the multiresidue methods published in PAM, Vol. I.
c. Storage stability data demonstrate that the metabolites
"dihydrbxy-bis ^-me^hYl-^'-ph-efiypr'opyt^s-tannane-^and 2-met-hyl—-"-•'
2-phenylpropyl stannonic acid were stable in frozen chicken
tissue and egg samples stored at -10°F for up to four months.
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17..
order to evaluate the adequacy of numerous established
tolerances.
d. Data on the magnitude and levels of residues of
fenbutatin-oxide are sufficient to determine the adequacy
of the established tolerances for residues of fenbutatin-oxide
in or on almonds, almond hulls, apples, cherries (sweet and
sour), citrus fruits, eggplant, grapes, papayas, peaches,
pears, pecans, plums, raspberries, strawberries and walnuts.
There are not sufficient data available to ascertain the
adequacy of the established tolerances for residues of fen-
butatin-oxide in or on cucumbers. Processing studies are
required for apples, citrus fruits, grapes and plums.
-•- Because ^'''ttpe^TTUmeTOu^-xesidue'-^tie^
the Agency cannot conduct a tolerance reassessment until
the required data are received and reviewed.
2. Toxicology
A 2 year rat feeding study, originally used to support
the previously established tolerances for residues of fenbuta-
tin-oxide, has been re-evaluated and found to be acceptable
to continue supporting the existing tolerances. Based upon a
No Observed Effect Level (NOEL) of 100 ppm for systemic
effects, and using a 100 fold safety factor, the Acceptable
Daily Intake (ADI) was calculated to be 0.05 mg/kg/day. (An
ADI rather than a PADI, or provisional ADI, was used because
available data, deemed to be supplemental due ,,to reporting
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18
deficiencies, demonstrate that the no effect level of 100 ppm
"i s ~ not ' l:l*ke"ly to' "cif a:htre%>^
The MPI (Maximum Permissible Intake), for a 60 kg individual
was found to be 3.0 mg/kg/day. The Theoretical Maximum Residue
Contribution (TMRC) for all published tolerances was calculated
to be 0.0357 mg/kg/day for a 1.5 kg diet. The TMRC utilized
71.4% of the ADI.
Because of the extensive residue chemistry and toxicology
data gaps, the Agency cannot conduct a full tolerance reassess-
ment. The tolerances will be reassessed when the required
data are received and reviewed.
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
...... Based" on a rfeviW'-'aivdrevaM^t^TiFXJf^a^
and other relevant information on fenbutatin-oxide, the
Agency has made the following determinations:
1. The Agency is requiring the submission of acute aquatic
toxicity data and aquatic field monitoring data on the end
use formulations and aquatic life stage data and avian
reproduction data on the technical formulation.
Rationale
Based on acute toxicity data, use pattern, and modeling
information, the use of fenbutatin-oxide in citrus groves may
present a chronic hazard to nesting and foraging birds and an
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9
acute hazard to freshwater and estuarine aquatic organisms.
Upon receipt of the required data, the Aqency will complete
the hazard assessment.
2. The Agency is imposing a 24 hour reentry interval and is
requiring that protective clothing statements for all
fenbutatin-oxide products be revised to include labeling
language for early reentry into treated fields.
(Refer to Section IV D for specific labeling requirements).
Rationale
As required in PR Notice 83-2, fenbutatin-oxide product
labels currently prohibit workers from reentering treated
fields without protective clothing unless sprays have dried.
However, because of a few California incidence reports and
the fact that this chemical is acutely toxic due to adverse
eye effects, the Agency is imposing an interim 24 hour reentry
interval in an effort to further reduce exposure. It may be
noted that both California and Texas have established 24 hour
reentry intervals. This interim reentry interval will be retained
until the required reentry data are received and evaluated.
Technical fenbutatin-oxide is characterized as a severe
eye irritant and is classified as a Toxicity Category I
chemical because of eye effects. The Agency is requiring
that these statements be modified and upgraded to further
protect persons involved in early reentry into treated fields.
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20
3. No significant new food uses* will be granted until the
Agency has received sufficient data to evaluate the dietary
exposure to fenbutatin-oxide.
Rationale
The Residue Chemistry and Toxicology data bases for
fenbutatin-oxide are not sufficient to assess the existing
tolerances. Animal metabolism and residue data including
processing studies as well as data on various commodities
are required. The required toxicology data include: chronic
feeding/ oncogenicity, 2-generation reproduction, mutagenicity
and metabolism testing. (Refer to Appendix I, for a listing
of required residue chemistry and toxicology data).
4. The Agency will not require endangered species labeling
at this time.
Rationale
Since 1982, cotton, corn, small grains, sorghum, soybeans,
rangeland, forest and mosquito larvicide uses have been
reviewed under a cluster approach to determine the endangered
species impacted by certain pesticide uses. Fenbutatin-oxide,
* Significant new use us defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will
consider as significant an increase in the Theoretical
Maximum Residue Contribution of greater than one percent.
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however, is not registered for the above listed uses and
therefore, does not .fall under this cluster analysis for
endangered species.
An analysis of pesticides with similar uses to fenbutatin-
oxide revealed that a number of endangered species were found
to be in jeopardy but based on modeling (exposure concentrations
in this model did not exceed the endangered species trigger),
use information and available toxfcity data, fenbutatin-oxide
does not appear to pose a threat to endangered species.
Future analysis of uses that have not been reviewed in the
cluster project may necessitate the need for endangered species
labeling.-- ~ - • ....
5. The Agency has identified certain data that will receive
immediate review when submitted.
Rationale
Certain data are deemed essential to the Agency's assess-
ment of this pesticide and a review of these data may trigger
the need for further studies which should be initiated as
soon as possible (e.g. tier studies). The following studies
have been identified to receive priority review as soon as
they are received by the Agency:
158.140 Environemntal Fate
132-1 Foliar Dissipation (Re-entry)
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158.145 Ecological Effects
72-4 Fish Early Life Stage and Aquatic Invertebrate Life Cycle
72-3 Acute Toxicity- Aquatic Estuarine and Marine Organism
72-7 Field Testing for Aquatic Organism
6. The tolerance regulation must be revised to separately list
fenbutatin-oxide and its organotin metabolites.
Rationale
At present all established tolerances are expressed as the
combined residues of the parent compound and its organotin
metabolites calculated as the parent compound. The Agency is
requiring that the fenbutatin-oxide organotin metabolites be
listed separately in the tolerance regulation so that established
tolerances can be made compatible.with the Maximum Residue. . .
Limits (MRL's) established by the Codex Alimentarius Commission,
an organization set up in the United Nations designed to
facilitate international trade.
7. While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing fenbutatin-oxide as the sole active ingredient may
be sold, distributed, formulated and used, subject to the
terms and conditions specified in this Standard. Registrants
must provide or agree to develop additional data, as specified
in the Data Appendices,.an,.order to maintain existing registra-
tions.
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No pesticide product containing fenbutatin-oxide may
be distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having so received)
delivered or offered to be delivered by any person after
24 months from receipt of this document unless the product
bears an amended label which complies with the requirements
of this Standard.
In addition to the above, the following information must
appear on the labeling:
1. Ingredient Statement
The ingredient statement for all fenbutatin-oxide
products must list the active ingredient as:
ACTIVE INGREDIENTS:
Fenbutatin-oxide (Hexakis(2-methyl-2-
phenylpropyl) distannoxane. . . . %
INERT INGREDIENTS:
2. All products must have a statement of practical
treatment and in the following format:
If in eyes: Immediately flush eyes with plenty of
water. Call a physician.
If inhaled: Remove from exposure and have patient lie
down and keep quiet. If patient is not
breathing, start artificial respiration
immediately. Never give anything to an
unconscious person.
If on skin: Wash skin with plenty of soap and water.
If swallowed: Do not induce vomiting. Call a physician,
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Manufacturing Use Product Labeling
1. Use Pattern Statements
All manufacturing use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites, which are listed
in the Index in Appendix III. However, no use may be
included on the label where the registrant fails to agree to
comply with the data requirements in Table A for that use
pattern.
2. Precautionary Statements
Labels for manufacturing-use and end-use products must
bear statements reflecting the compound's acute human toxicity.
Fenbutatin-oxide is classified in Toxicology Category I on
the basis of eye irritation only. All the precautionary labeling
language that is currently on fenbutatin-oxide labels is to be
retained.
3. Environmental Hazards Statement
The following revised environmental hazard statement must
appear on all manufacturing use product labels:
"This pesticide is toxic to fish. Do not discharge
effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water unless
this product is specifically identified and addressed
in an NPDES permit. Do not discharge effluent containing
this product into sewer systems without previously
notifying the sewer treatment plant authority. For
guidance contact your State Water Board or Regional
office of the EPA."
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End Use Product Labeling
a. Environmental Hazards Statement;
"This product is toxic to fish. Do not apply directly to
water or wetlands (swamps, bogs, marshes, and potholes).
Drift and runoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not
contaminate water by cleaning of equipment or disposal
of wastes."
b. Reentry Statement;
"Do not enter treated fields within 24 hours of
application unless long pants and long-sleeved shirt
(or coveralls); chemical resistant gloves; shoes;
and goggles or a face shield are worn."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all'
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption3, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
.ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in. Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.'*
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data/ and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are 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
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
c- What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
.Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt.of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be.
submitting the data that you may rely upon its submission.
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:
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a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
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4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
If you will generate the required- data and plan to use
test procedures which deviate from (or are not specified in)
either 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
and await EPA approval, 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.
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a -time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the 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
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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 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. Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a new or modified protocol
before the "study can be begun.
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.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product/ and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing FENBUTATIN-
OXIDE 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. Foonulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present,.arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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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 FENBUTATIN-QXIDE
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
t
•
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing FENBUTATIN-OXIDE as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. .Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
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c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
E. Addresses
The required information must be submitted to the following
address:
Dennis Edwards (PM-12)
Registration Division (TS-767)
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.
F. Intrastate Products containing FENBUTATIN-QXIDE either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
G. Address
The required information for intrastate products only must be
submitted to the following address:
Stuart McArthur
Registration Support and Emergency Response Branch (TSr767)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
'test protocols set out in the Pesticide Assessment Guidelines/
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists "the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B — Terrestrial, non-food
C- = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table,
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the. data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-In letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test
; Substance
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
Physical and Chemical
Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boilina Point TGAI
Use
Patterns
All
All
All
All
All
All
All
All
Does EPA Bibliographic
Have Data? Citation
V
No
No
No
No
No
No
No
No
Must Additional
Data be
Submitted? 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Time Frame
for
Submission
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Use
Substance Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
I/ Submitted? 2/ Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- pH
- Storage Stability
TGAI All
TGAI or PAI All
PAI All
PAI All
PAI All
TGAI All
TGAI All
No
No
No
No
No
No
No
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must be
resubmitted. New requirements have been introduced and previously submitted data must be updated. Therefore biblio-
graphic citations for the old data are not applicable.
2/ Generic data are required for the following technical formulation : EPA REG. NO. 201-367.
-------
TABLE A
GEMERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
158.125 Residue Chemistry
171-4 Nature of the residue
(Metabolism)
- Plants PAIRA
- Livestock PAIRA
Yes
Partially
00113018
00113018
00113020
00113078
00113029
NoV
Yes2/
18 Months
171-4 Residue analytical
methods
- Plant and Animal
Residues
TGAI &
Metabolites
Partially
00026038
00030349
00045869
00045870
00069881
00070506
00077245
00093721
00105161
00105203
00105204
00109280
Yes3/
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
)ata Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
158.125 Residue Chemistry
171-4 Residue analytical
method
(Continued)
- Plant and Animal
Residues
171-4 Storage stability data
171-4 Magnitude of the Residue
- Crop field trials
- Fruiting Vegetables ^/
(except Cucurbits)
Group
o Eggplant
TEP &
Metabolites
00112902
00113018
00113063
00113078
00143694
00145444
00146038
00148257
00148733
00130837
Partially 00113063
00113078
00146038
TEP
Yes
00130837
U1
Yes
15 Months
No
- Cucurbit Vegetables
Group
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
lata Requirement Test Substance
171-4 Magnitude of the Residue
- Crop field trials
(continued)
o Cucumbers TEP
- Citrus Fruits Group TEP
- Pome Fruits Group 11/
o Apples TEP
o Pears TEP
- Stone Fruits 13/
Group
o Cherries (sweet TEP
and sour)
o Peaches . TEP
o Plums (fresh TEP
r»t-iin*><5 \
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
Partially 00146038 YesjV
Partially 00030349 Yes10/
00093721
00105204
00113018
Partially 00030349 Yes12/
'00105204
00113018
Yes 00030349 No
00093721
00105204
00113018
Yes 00026038 No
00112902
Yes 00026038 No
00148257
Partially 00026038 Yes14/
00112902
Time Frame
for
Submission
18 Months
24 Months
24 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test Substance
171-4 Magnitude of the Residue
- Crop field trials
(continued)
- Small Fruits and 15/
Berries Group
o Grapes TEP
o Raspberries TEP
o Strawberries TEP
- Tree Nuts Group *V
o Almonds TEP
o Pecans TEP
o Walnuts . TEP
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
Partially 00077245 Yes16/
00105203
00113078
Yes 00145444 No
Yes 00069881 No
00071183
00148257
00148733
Yes 00109280 No
00113078
Yes 00105161 No
00109280
00113063
Yes 00105161 No
00109280
Time Frame
for
Submission
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
171-4 Magnitude of the Residue
- Crop field trials
(continued)
- Miscellaneous Commodities
o Avocados 17/
o Papayas EP
- Meat/failk/poultry/eggs
Yes
Partially
00045869
00113078
No
reserved
OO
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FENBUTATIN-OXIDE
§158.125 Residue Chemistry - Continued
I/ The present tolerance regulation should be modified to specifically name fenbutatin-oxide and its metab-
olites dihydroxybis(2-methyl-2-phenyl-propyl) stannane, 2-methyl-2-phenyl-propyl stannonic acid and
possibly inorganic tin.
2/ Metabolism studies in ruminants and poultry fed technical grade [H^Sn] fenbutatin-oxide, which must be
complety characterized (including impurities) and representative of the technical fenbutatin-oxide
currently used in commercial formulations. Animals must by dosed for at least three days with concentrations
in the diet which will result in sufficient residues in tissues, milk, and eggs for characterization. Milk
and eggs must be collected for analysis twice daily, and animals must be sacrificed within 24 hours of
the final dosing. The distribution and identity of H^Sn-residues must be determined and guantified in
the milk, muscle, fat, kidney, and liver of ruminants, 'and in the eggs, muscle, fat, kidneys, and liver of
poultry. At such time as these studies are completed and submitted the present tolerance regulation should
be modified to specifically name fenbutatin-oxide and any metabolites of concern.
3/ Residues of fenbutatin-oxide and its organotin metabolites in or on crop samples must be subjected to
analysis by the multiresidue methods published in PAM, Vol. I. Protocols for methods I, II, III, and IV are
available from the National Technical Information Service under Order No. PB86 203734/AS. Also, \O
since the present tolerance regulation is to be modified to specifically name fenbutatin-oxide and metabolites
of concern, if Toxicology Branch deems that each metabolite must be guantitated separately, then methodology
for plant and animal commodities including validation data and a method trial will be needed.
<.' •
4/ The storage intervals and conditions of storage of all samples used to evaluate all established
tolerances for residues of fenbutatin-oxide and its organotin metabolites must be submitted. These data must
be accompanied by data depicting the percent decline in residues at the time and under the conditions
specified for each test. On receipt of these data, the adeguacy of the aforementioned tolerances will be
reevaluated.
i
5/ All residue data requested in this Standard must be accompanied by data on the conditions and intervals
of sample storage. Fortification recovery data must aiso be included which depict the stability of
residues of fenbutatin-oxide and its organotin metabolites in appropriate sample substances under the con-
ditions and for the time intervals used in the tests. •
• \ • ,
6/ Use directions must be proposed, and appropriate supporting residue data submitted for the representative
group members tomatoes and peppers.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
158.125 .Residue Chemistry - Continued
7/ Use directions must be proposed, and appropriate supporting residue data must be submitted for
melons (cantaloupe or muskmelon) and summer squash.
8/ Appropriate supporting residue data collected using an adequate analytical method must be submitted
for cucumbers.
9/ The registrant must propose use directions for fenbutatin-oxide on cucumbers and provide appropriate
supporting residue data (collected using an adequate analytical method). Residue data must reflect the
combined residues of fenbutatin-oxide and its organotin metabolites calculated as fenbutatin-oxide
in or on cucumbers.
10/ Data reflecting the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
fenbutatin-oxide) in dried citrus pulp, wet pulp, molasses, juice, and oil processed from citrus fruit
bearing weathered residues. Exaggerated rates may be necessary to achieve these residues in or on the fruits.
If residues are found to concentrate in dried citrus pu,lp the established food additive tolerance may need to
be amended. Ifj residues are found to concentrate in we,t citrus pulp, molasses, juice, or oil, appropriate
food/feed additive tolerances must be proposed.
ll/ The available data are sufficient to determine that a crop group tolerance is appropriate at the
present time. < >
i
12/ Data depicting ,the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
fenbutatin-oxide) in dried apple pomace and juice processed from apples bearing measurable weathered residues.
Exaggerated rates may be necessary to achieve these residues in or on the fruits. If residues are found to
concentrate in dried apple pomace the established food .additive tolerance may need to be amended. If residues
are found to cqncentrate in juice, an appropriate food additive tolerance must be proposed.
13/ Conclusions may not be made at the present time because available data in support of the proposed crop
group tolerance are currently under review.
i.
14/ Tests reflecting the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
fenbutatin-oxide in prunes processed from plums (fresh !prunes) bearing measurable weathered residues. Ex-
aggerated rates may be necessary to achieve these residues in or on the fruits. If residues are found to
concentrate, then the established food additive tolerance may need to be amended.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
§158.125 Residue Chemistry - Continued
15/ Proposed use directions roust be submitted along with appropriate supporting residue data for blackberry
(Rubus spp.), blueberry, and cranberry.
16/ Data depicting the combined residues of fenbutatin-oxide and its organotin metabolites (calculated as
fenbutatin-oxide in raisins, raisin waste, dried grape pomace, and grape juice processed from grapes bearing
measurable weathered residues. If residues are found to concentrate in raisins, raisin waste, or dried grape
pomace, the established food/feed additive tolerances may need to be amended. If residues concentrate
in juice, an appropriate food additive tolerance must be proposed.
17/ Conclusions may not be made at the present time because available data in support of the proposed
tolerance for the combined residues of fenbutatin-oxide and its organotin metabolites calculated as
fenbutatin-oxide in or on avocados are currently under review.
18/ On receipt of the data requested in £/ above, the appropriate nature of tolerances for residues in animal
products will be determined and, with consideration for any newly found metabolites of toxicological
concern, the adequacy of the available data regarding ;the magnitude of residues in fat, meat, and meat
by-products will be determined.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test Use Does EPA Bibliographic
:' Substance Patterns Have Data? Citation
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1\- Hydrolysis TGAI or PAIRA A,B,F No
Photodeqrada t ion
161-2 - In water TGAI or PAIRA A,B No
161-3 - On soil TGAI or PAIRA A No
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA A,B,F No
162-2 - Anaerobic Soil TGAI or PAIRA A No
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA A,B,F Partial 00071228
Adsorp t ion /Desorp t ion
163-2 - Volatility (Lab) TEP A,F No
163-3 - Volatility (Field) TEP A,F No
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Yes.
Yes
Yes/1
Yes
Yes/2
Time Frame
for
Submission
9 Months
9 Months
9 Months
27 Months
27 Months
12 Months
12 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test
Substance
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
i
Must Additional
Data be
Submitted?
Time Frame
for
Submission
158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-4 - In Fish
165-5 - In Aquatic Non-Target
TEP
TEP
PAIRA
TEP
TGAI or PAIRA
TEP
A,B
A
A
A
A,B
N/A
No
No
No
No
No
No
Yes
Reserved/3
Yes
Reserved/4
Yes
Reserved/5
27 Months
39 Months
12 Months
U1
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
§158.130 Environmental Fate - Continued
I/ A study is required on the mobility of aged fenbutatin-oxide residues in sandy loam soil.
2/ Study reserved pending receipt and review of required laboratory volatility data.
3/ Study reserved pending receipt and review of required field dissipation data.
4/ Study reserved pending receipt and review of required confined crop rotation study.
No interim crop rotation label restriction is being imposed because of the data gap. Rotation crop uptake data
are being required in this registration standard. When acceptable uptake data are received, the Agency will
assess crop residue uptake and apply appropriate regulatory safeguards.
5/ Study reserved pending receipt and review of required fish accumulation study.
Ln
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Date Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Data be
Submitted
Time Frame
for
Submission
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat TGAI
81-2 - Acute Dermal Toxicity TGAI
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI
- Rat
81-7 - Delayed TGAI
Neurotoxicity - Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding; TGAI
- Rodent, and
- Non-rodent (Dog)
82-2 - 21-Day Dermal - Rabbit TGAI
A
A
A
A
A
No
Yes
No
No
Yes
No
No'
00112990
00037582
Yes
No
Yes
No/1
No/2
Yes/3
Yes
9 Months
9 Months
U~
12 Months
82-5 - 90-Day Neurotoxicity:
- Hen
-Mammal
TGAI
A
A
No
No
No/1
No/1
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBuTATIN-OXIDE
Data Requirement Test
Substance
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogenicity - TGAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
R4-? - Structural Chromosomal TGAI
Use
Patterns
A
A
A
A
A
A
A
A
A
Does EPA Bibliographic
Have Data? Citation
Yes 00037582
00113001
Partial 00037583
Yes 00037582
00113001
Partial 00037581
Yes 00072693
Yes 00079319
No
No
No
Must Additional
Data be
Submitted?
No
Yes/4
No
Yes/5
No
No
Yes
Yes
Yes
Time Frame
Eor
Submission
50 Months
50 Months
39 Months
9 Months
12 Months
Aberration
84-4 - Other Genotoxic Effects TGAI
No
Yes
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology - Continued
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
No
Yes
24 Months
I/ Because fenbutatin-oxide is not an organophosphate chemical and available data indicate that there are no neuro-
toxicological problems associated with this chemical, data are not needed at this time.
2/ There are adequate chronic toxicity data to satisfy this data requirement.
3/ These studies will not be necessary if adeuquate chronic toxicity studies are submitted.
4/ This study may be upgraded to an acceptable level with the submission of the following data:
a. The composition of the test material used in this doq study and the composition of the technical material
currently marketed and registered product.
b. An explanation for carrying out this experiment in two time periods, six weeks apart.
-------
n58.135 Toxicology - Continued
4/ continued-
c. Raw data and;summary tables on urinalysis.
t '
d. Individual animal data on macroscopic and microscopic lesions with the data presented in parallel
columns on the same page for the same animal.
e. Listing of all tissues examined grossly and micrscopically with a description of all gross lesions
observed and/ or examined.
f. Summary tables for the incidence of macroscopic and microscopic lesions.
If this information is no longer available a new study must be submitted.
5/ This study may be upgraded with the submission of the following data:
i
a. Analysis of feed administered to treated animals for test material content.
b. Measurement of food consumption.
i CO
c. Necropsy information.
} \
d. Adeguate number of tissues subjected to microscopic examination.
I
e. Summary of incidence table of neoplastic and non-neoplastic pathology based upon number of tissues examined
by sex and dpse.
f. Identification of tissues examined histologiclally and organ weight.
If this information is no longer available, a new study must be submitted.
i
! i
i
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement ' ; Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP A No
132-1 - Soil Dissipation TEP A No
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEP N/A No
f
201-1 - Drift Field Evaluation TEP N/A No
Must Additional
Data be
Submitted?
Yes
No/1
No/2
No/2
Time Frame
for
Submission
27 Months
(
>
un
I/ Soil dissipation data not required if acceptable foliar data are submitted.
2/ Because this chemical is applied by ground application, only, there are no spray drift requirements.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement Test
; Substance
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mammals, and
- Birds
Use
Pattern
A,B/1
A,B/1
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA Bibliographic
Have Data? Citation
Yes 00113073
No
Yes 00113074
No
No . -
No
No
No
No
No
Must Additional
Data be
Submitted?
No
Yes
No
No/2
Yes/3
Yes/3
Reserved/4
Reserved/4
Reserved/4
Reserved/4
Time Frame
for
Submission
9 Months
ON
O
24 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data
§158.
Requirement
145 Wildlife and
Test Use
Substance Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1
72-2
72-3
- Freshwater Fish Toxicity
- Coldwater Fish Species,
and :
-Coldwater Fish; Species
i
- Warmwater Fish Species
- Warmwater Fish Species
f
- Acute Toxicity to
Freshwater Invertebrates
- Acute Toxicity to
Estuarine and Marine
Organisms/6
- Fish :
- Mollusk ;
- Shrimp
TGAI
A,B/1
TEP A
(41b/gal FC)
TGAI A,B
TEP A
(41b/gal FC) •
TGAI A,B/1
TEP A
(41b/gal FC)
TGAI
A,B
A,B
A,B
Yes 00113075
No
Yes 00113076
No
No .
No
No
No
No
No
Yes/5
No
Yes/5
Yes
Reserved/5
Yes
Yes
Yes
9 Months
•
9 Months
9 Months
12 Months
12 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
§158.145 Wildlife and
Aquatic Organisms -
- Acute Toxicity to
Estuarine and Marine
Organisms/6
- Fish
- Mollusk
- Shrimp
72-4 - Fish Early Life Stage
- Freshwater
- Estuarine
and
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Continued
TEP
(41b/gal FC)
A No
A No .
A No
TGAI
TGAI A,B No
TGAI A,B No
Must Additional
Data be
Submitted?
Reserved/7
Reserved/7
Reserved/7
Yes/8
Reserved/9
Time Frame
for
Submission
15 Months
- Aquatic Invertebrate
Life-Cycle
- Freshwater
-Estuarine
TGAI A,B No
TGAI A,B No
Yes/8
Reserved/9
15 Months
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
72-5 - Fish - Life-Cycle
TGAI
A,B
No
Reserved/10
72-6 - Aquatic Orqanism
Accumulation
72-7 - Simulated or Actual
Field Testinq
- Aquatic Orqanisms
TGAI, PAI OR
Deqradation
TEP
A,B
No
No
Yes
Yes/11
12 Months
15 Months
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBLTTATIN-OXIDE
§158.145 Wildlife and Aquatic Organisms - Continued
I/ These data are required in order to support the manufacturing use product.
2/ Acute toxicity data indicate that this study is not required.
3/ Because the use directions for this product indicate the need for repeat applications, these data are required.
4/ This requirement is reserved pending receipt for avian reproduction data and additional environmental fate data.
5/ This data requirement is required to support the citrus use. >'
6/ This data requirement is required to support the citrus use. (Citrus is grown in coastal counties in excess of
300,000 acres). < '
7/ Reserved pending the outcome of acute studies on the tehcnica^l material and monitoring data.
8/ This data requirement is required to support the orchard uses.
9/ This requirement is reserved pending the outcome of the chronic studies on freshwater organisms, and on acute
estuarine organism testing on the technical and the monitoring data.
10/ This requirement is reserved pending the outcome of required ;chronic studies on freshwater and estuarine organisms
and monitoring data.
ll/ Aquatic residue monitoring studies on fenbutatin-oxide and its major metabolities are required to determine
exposure levels (acute and chronic) in Florida citrus groves 'and adjacent waters. Monitorinq of these sites
is necessary due to the demonstrated aquatic toxicity and persistnace of fenbutatin-oxide. Based on use
information, pesticide history and topoqraphy, you must develop an acceptable protocol to sample a representative
number of citrus use'sites (at least 5). A protocol must bessubmitted within 3 months of receipt of this
guidance document. Monitoring efforts should focus on citrus production sites with a history of fenbutatin-oxide
use and having extensive adjacent water bodies and canals (freshwater and estuarine). Residue monitoring
studies must incorporate the following design characteristics:
A. Sampling shall include grove soil and adjacent waters:' water column, sediment, benthic invertebrates
and endemic fish (particularly bottom feeders). -.'
B. Analytical methodology used to measure residuses must be described.
C. Sampling stations must be described on U.S.G.S. topographicbathymetric 7.5 minute series maps.
D. Soil and sediment characteristics of the sites being monitored must be specified.
E. Samples should be taken before, during and following applications of the pesticide and should include control
sites. '
F. Sampling should be done at regular intervals for a long enough period of time to account for such things as
seasonal and use variations. •
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY.
>JQNTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
L23-1 - Seed Germination/
Seedling Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER III 'I
124-1 - Terrestrial Field
L24-2 - Aquatic Field
EP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
V:
V
V
V
V
V
V
V
V
ON
un
I/ These data are not required in accordance with §158.150.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBUTATIN-OXIDE
Data Requirement
§158.155 Nontarget Insect'
NONTARGET INSECT TESTING -
POLLINATORS:
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage -
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators ,
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES;
TGAI A,B
TEP A,B
(Reserved)I/
TEP A,B
Yes
Yes
00036935
00088398
No
No
No
No/2
ON
(Reserved)3/
(Reserved)3/
(Reserved)3/
(Reserved)3/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENBuTATIN-OXIDB
Data Requirement
i •
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.155 Nontarqet Insect •
I/ Reserved pending development of methodology.
2/ As data from the acute and residual test indicate low toxicity, no further testing is required.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
ON
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENBUTATIN-OXIDE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
V
Bibliographic
Citation
Must Additional Time Frame
Data be Cor '
Submitted? Submission
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and !
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color . MP
63-3 - Physical State < MP
63-4 - Odor - MP
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
6 Months
6 Months
ON
6 Months °°
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
: TABLE B '
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENBUTATIN-OXIDE
Data Requirement .; Test
; Substance
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued) ,
63-7 - Density, Bulk Density, or
Specific Gravity^
63-12 - pH ';
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability (
63-16 - Explodability '•
63-17 - Storage Stability
63-18 - Viscosity •
63-19 - Miscibility
63-20 - Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
Use
Pattern
All
All
All
All
All
All
All
All
All
Does EPA Bibliographic
Have Data? Citation
V
!
No
No
No
No
No
No
No
No
No ;
Must Additional
Data be
Submitted? 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Yes 2/
Time Frame
for
Submission
7 Months
7 Months
7 Months
O\
VO
7 Months
7 Months
16 Months
7 Months
7 Months
7 Months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubmitted for each manufacturing use product. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ Product Specific data are required for the following formulation: EPA REG. NO. 201-367.
-------
TABLE B
PRODUCT 5PECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENBUTATIN-OXIDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? I/ Submission
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat MP All
81-2 - Acute Dermal Toxicity MP All
- Rabbit
81-3 - Acute Inhalation Toxicity MP All
- Rat 3
81-4 - Primary Eye MP All
Irritation - Rabbit
81-5 - Primary Dermal MP All
Irritation - Rabbit
i
81-6 - Dermal Sensitization - MP All
Guinea Pig
No -
Yes
No -
Yes;
Yes
Yes
00112990
00112990
00112990
00112990
Yes I/
No
Yes I/
No
No
No
9 Months
9 Months
O
I/ Product Specific data are required for the following formulation: EPA REG. NO. 201-367.
-------
71
SUMMARY-1
LABEL CONTENTS - '
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned.to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel 'to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR'162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
-------
72
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1) (ii)]
Item 7B. SIGNAL WORD, -. The signal word.'(DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i ) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side -
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all .
required, precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.I0(h)(2)].
-------
73
SUMMARY-3
Item 8A. "HAZARD TO HUMANS-AND D0M€-ST-I-G-ANI.MAL&, -n:W.here-.a^t t
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h) (2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either-- general-- o-JTrce starlet e.d: us,e.^-:.Px&&U-G£^-J&£^i£J--gd*.--~.,v*.: ,
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted.to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your, application., your^prppjos^ed.. class i-
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.
-------
74
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary .
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
I tern' 9B. ' 'M'l SUSE'-STATEMENT'—•"•ft-rr ••p'ro'du-c ts~mus t-be-ar- the «
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
75
SUMMARY-5
Item rOA. -REENTRY-'^STATEMENT ---^rf• a'"reenftry^rrrtBrva-r «••—- —
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name .
Company name
and address
Net contents
\
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement :
Front panel
precautionary
statements
Keep Out of Reach
of 'Children
(Child hazard
warning)
Signal word .
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
O\
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT'
Skull & cross-
bones and word
POISON (in red)
T
i
j
Statement of ^
Practical
Treatment or
First Aid
Referral ;
statement
Side/back panel
precautionary
statements
!<
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
: PREFERRED
Both in close
( proximity to
- signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
-xj
~^J
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
i ;
Must be preceded by appropriate signal '
word.
i
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical ' .
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use >
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
. blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
->x
ex
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
79
Chapter I—Environmental Protection Agency
obtained the data from anothe
(Identify); applicant copied daf
, a publication: applicant obt
spy of the data from EPA).
\) The applicant shall submit
ppUcatioii a statement that
i evaluation of the proper
and safety of the lom\
product, may not consic
supportlnc the appl
«following data:
,e data the applicant fcs sub-
cacy.
end
data
except
(1)
mitted tk EPA under
thissectli
(2) Other data
safety of the product's
ents, rather than to the
end-use proHuct; and
(3) Existing tolerances.
regulations. \exemptl
clearances Issued unde:
Pood, Drue, and Conn
(e) If the applicant
Item of data he\ su
section was ten1
pense of) anoth
ly submitted the
predecessor. USD.
ary 1. 1970, to su;
for registration.
permit, or amei
use to an
&h (b) of
to the
(re Ingredl-
lety of the
Food additive
and other
the Federal
[cAct.
ws that any
ted under this
y (or at the ex-
who original-
to EPA (or Its
on or after Janu-
an application
•xperimental use
nt adding a new
tlon. or for
reregistration (tfnlesfc the applicant
and the original dataXsubmltter have
reached written agreement on the
amount and UK terms )pf payment of
any compensation thatXmay be pay-
able under FXFHA section
a(cXlXDXil)/with regaroX to approval
of the application), the applicant shall
submit to EPA a statement that he
has furnisaed to each sacn. Identified
ipllcant's.
Inclurt-
(1) A nfttfleation of the
intent to Apply for registraUc
tag the imposed product i
(2) An7 offer to pay the
. with regard to the:
of the/ application, to the
by FIFRA sections
CX2XDK
An Identification of the
>ta to which the offer applies:
Ay< offer to commence negoX
to ascertain the amount
of ronnTpnsi tttm to be paid: a^d
'(S) The applicant's name,
telephone number.
§ 162.10
If the applicant's product cof
any active Ingredient other
that are present solely
incorporation into the product.
formulation, of one or/more
:red pesticide ppducts
tr.
comply
ve ingre-
'shall eon-
t for pur-
of
d
other
purchased from another
then theXappllcant shall
with I iete-3 as to such
dient. andVhe appllcatloi
tain an acknowledgment
poses of
application re)
Ing registratiot
section
les on (i
.should
tcXIXD) the
any result-
regarded
the/Administrator's
le/ollowing data:
or specifically
t in support of
of data in the
if it were based
consideration of)
(1) All data su
cited by the
the registration;
(2) Each oth<
Agency's files wj
<1) Concerns me properties or effects
of any such active Ingredient: and
(U) Is one/of the typesNof data that
EPA would/equire to be submitted for
scientific seview by EPA lf\Lhe appli-
cant sourfht the initial
under BTFRA Section 3(ctf6) of a
'with composition andVintend-
ed use/ identical to those proposed for
the applicant's product, undek the
requirements in effect on\the
EPA approves the applicant's
it application.
, I.«. and » of RPRA. u i
(44 FR179M, May 11.11781
lltt.lt LabtUag nqminmrau.
(a) General—(1) Content* of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Art and the recu*
lations in this Part. The contents of a
label must show clearly aad promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed la paragraph (b) of this sec-
tion:
(U) The name aad address of the
producer, registrant, or person for
whom produced as-prescribed m para-
graph (c) of this section:
(ill) The net contents as prescribed
ta paragraph (d) of this section:
-------
I
11*2.10
(Iv) The product registration
number as prescribed In paragraph (e)
of IhU McUon;
(v) The producing establishment
number u prescribed In paragraph (0
of this section:
(vl) An Ingredient statement as pre-
scribed In paragraph (g) of this sec-
tion; I
(vll) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section;
(vlll) The directions for use as pre-
scribed In paragraph (I) of this section;
and
llx> The use classlflcatlon(s) as pre-
scribed In paragraph (j) of this section.
<» Prominence and leoibUit* (I) All
word*, statements, graphic representa-
tions, designs or other Information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be \ placed with such
consplcuousneas (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed In such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(II) All required label text must:
(A) Be set In 0-polnt or larger type:
(B)' Appear on a 'clear contrasting
background: and
(C) Mot be obscured or crowded.
(1) tanffMocw to oe'iuea. All required
label'or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as Is considered necessary to
protect the public.;When additional
text In another language Is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label-in General
The label shall appear on or be secure-
ly attached to the Immediate contain-
er of the pesticide;product, for pur-
poses of this Section, and the mls-
brandlng provisions of the Act. "se-
curely attached" shall mean that a
SabeJ can reasonably be expected to
remain affixed during the foreseeable
rmwuibwui tnd oerlod of use. If the Im-
Till. 40-frotoctlon of fnvlr.nm.nl
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, If It Is a part of the package as
customarily distributed or sold.
(II) Tttn* can and other bulk con-
tainer*— 4A) Trantportallon. While a
pesticide product Is In transit, the ap-
propriate provisions of 49 CFR Parts
110-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling. marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirement*. In addition, when tuty
regUtered pesticide product Is trans-
ported In a tank car. tank truck or
other mobile or portable bulk contain-
er. a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B> Storage. When pesticide prod-
ucts are stored In bulk containers.
whether mobile or stationary, which
remain In the custody of the user, a
copy of UM label of labeling. Including
all appropriate directions for use. shall
be securely attached to UM container
In the immediate vicinity of the dis-
charge control valve.
(B) faltt or mitleadino statement*.
Pursuant to section atqMiXA) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
1 101.15. to mlsbranded If IU labeling la
false or misleading In any particular
Including both pestlddal and non-pee-
Uddal claims. Examples of statements
or representations In the labeling
which constitute mUbrandlng Include:
(I) A false or misleading statement
concerning the composition of the
product:
(II) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
• device;
(hr» A false or misleading comparison
with other pesticides or devices;
<? Any olatement directs? C7 8nd5-
rectly Implying that the pesticide or
• . ._... ----- • ». —
Chopt.r
Protection A8*ncy
(conrInued) :
( 1*1.10
any agency of the Federal Govern-
ment;
(vl) The name of a pesticide which
contain* two or more principal active
Ingredients If the name suggests one
or more but not all mich principal
active. Ingredient* even though the
names of the other Ingredients .are
Hlated elaewhere. In the labeling:
(vll) A true iitatement u»ed In mich a
way as to give a fal*e or mUlradlng Im-
prrtnlon to the purchaser;
(vlll) Label disclaimer* which negate
•or detract from labeling statement* re-
quired under thr Act and these regula-
tions:
(lx> Claims an to the Mfcty of the
protlrldc or IU Ingredient*. Including
statement* such as "safe." "nonpolson-
ou»." "nonlnjurloiiii." "harmleiw" or
"nontoilc to humans and pet*" with
or without auch a qualifying phrase M
"when uned an directed"; and
(x> Non-numerical and/or compara-
tive statement* on the safely of the
product. Including but not limited to:
"Contains all natural Ingredi-
ents";
(B) "Among the leant toxic chemi-
cals known"
(C> "Pollution approved"
(«> Final printed labeling. (I) Except
as provided In paragraph (aX6)(ll) 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 text* have been provision-
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
No name, brand, or-trademark
may appear on the label which:
(I) Is false or misleading, or
(II) Has not been approved by the
Administrator through registration or
supplemental registration as an addl-
(c) Name and addr.es* of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall he con-
sidered as the name and addres* of the
producer. If the registrant's name ap-
pear* on the label and the reglnlrant I*
not the producer, or If the name of the
pe.raon for whom the pesticide w,a*
produced appears on the label. II. must
be qualified by appropriate wordlps;
such an "Packed for * * V "Dlstrlbut-
ed by * • V or "Sold by In nrtow
that the name Is not thai of I lie pro-
ducer. /
(d) Net toefoftf or mrtimrr o/ con-
tent*. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other material* and Nhall/be
the average content unlraa explicitly'
stated a* a minimum quantity.
(3) If the pentlclde I* a liquid, the
net content statement Khali be:.In
terms of liquid measure at 48* P
and shall be exprensed In conventional
American units of fluid ounce*, pint*.
quart*, and gallons.
()) If the peMlclde Is solid or nemlso-
lid. 'viscous or pressurized, or I* a mix-
ture of liquid and solid, the net con-
tent statement shall be In term* |of
weight expressed a* avoirdupois
pounds and ounces. ,;.
(4) In all cases, net content *hali;'|h*
stated In terms of the largest suitable
unit*. I.e., "1 pound 10 ounce*" rattier
than "ad ounces.- .-4
(B) In addition to the required unit*
specified, net content may be. ex-
pressed In metric unit*. U
(6) Variation above minimum con-
tent or around an average Is permlsiil-
ble only to the extent that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content. ,1
(e> Product reotttrattnn number.
The registration number assigned <;'to
the pesticide product at the time'of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tratlon No.." or the phrase "EPA Rf«.
No." The registration number shall A*
set In type of a.ttce and style similar.to
other print on that part of the UJjrl
«-•-«. i. •• .ft,
CD
CD
-------
13:
| U2.10
allel to It The registration number
and the required Identifying phrase
•hall not appear In such a manner as
to suggest or Imply recommendation
or endorsement' of the product by the
Agency.
Ingredient statement—<1) Oener-
at 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 element*! 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 she. 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 as a
heading for the Ingredient statement.
(3) Potitlon o/ ingredient statement.
.(I) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement.cannot be clearly
read, the Ingredient statement must
also appear on such outside container.
or wrapper. If the stse or form of the
package makes It {Impracticable to
place the Ingredient statement on the
front panel of the! label, permission
may be granted for the Ingredient
statement to appear elsewhere.
Till* 40—rrotocHon of IirvV
(II) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which It appears.
and must be clearly distinguishable
from and must not be placed In the
body of other text.
(1) Name* to be m*ed 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 propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section M Deterioration. Pesticides -which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
Idatel."
(II) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(1) Inert tngredtenU The Adminis-
trator may require the name of any
Qiwpter I—Envltonmenlal frefection Agency
(continued)
9 141.10
Inert IngredlenUs) to be tinted In the
Ingredient statement If be determines
that such Ingredlentls) may pose a
hazard to man or the environment.
(It) Warning* and precautionary
itatementt. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard Including hazard to children.
environmental hazard, and physical or
chemical hawd fall Into two groups;
thoae required on the front panel of
the labeling and those which may
appear elsewhere, Specific require-
ments concerning content, placement.
type sbie. and prominence are given
below.
(I) Regal ml front panel statement*.
With the exception of I he child
hazard warning Mulrmrnt. Hie le«t re-
quired on the front panel of the label
Is determined by the Ton kit y Otfto
ry of the pesticide. The category I* un-
signed on the ban)* of the hlghcnl.
hazard shown by any of the Indicator*
In the table below:
lO.
(I) Human hatard itgnal word— Utr of ilonal inonf». Use of any
•lunal worri(n) aaxoclfttcd with a higher
Toxlclty Category I" not permitted
except when the Agency determine*
that such labeling Is necetvwry to pre-
vent unreasonable adverse effect* on
man or the environment. In no cane
shall more than one human h'arjird
signal word appear on the front panel
of a label.
(II) Child Aosanf vamlng. Rvery pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only In own
where the likelihood of contact,with
children during distribution. market-
Ing, storage or use Is demonstrated by
the applicant to be extremely remote.
or If the nature of the pesticide Is such
that It Is approved for me on Infants
or small children, may the Administra-
tor waive this requirement.
(Ill) Statement o/ practical treat-
ment—
-------
134
I U1.10
cal treatment to tome reference such
M "See iUUment of practical treat-
ment on back panel" appear* on the
front panel near the word "Poison"
and the skull and croabone*.
(B) Other forfeit* categories. The
statement of practical treatment to not
required on the front panel except M
described In paragraph (hMlMlllMA) of
thto section. The applicant may. how-
ever. Include such a front panel state-
ment at hto option'/ Statements of
practical treatment are. however, re-
quired elsewhere on the label In
accord with paragraph (hX» of thto
section If they do not appear on the
front panel.
(Iv) Placement and prominence All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type slse require-
ments for the front panel warning
statements on various' stoes of labels:
TIM* 40—frotecHon of Invfre-mnanf
ttot*—
WtotS.
Itto]
•0
If
(» Otter required warning* and pre-
cautionary statement*. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(I) Jfosard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animal*, precau-
tionary statements are required Indi-
cating the particular hazard, the
routeU) 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 (able deplete typi-
cal precautionary statements. These
statements must be modified o» ex-
panded to reflect specific hazards.
•**! P* Ml •* to •)•*, •• tfto. •
«• Mil. O* MI UM»» MI
•Ml. O* Ml Ml to M*. •»
IN*
•M to* Ml «••»«• I* Ml
0* Ml Ml to OM. •» M\ •> «•
I |M»t»> • toM MM •* <
«U) s7nvlronm«nlal[nasard<. Where a
(hazard exists to nonj target organisms
including humans and domestic an9-
r-MOs. precautionary statements are re-
quired stetlng IhS nature of the
Injury or damage. Examples of the
hazard statements and the <^lreum-
stancea under which they are required
follow:
(A) If a pesticide Intended for oui-
Chapter I—Environmental PreJectlan Agency
100 or less, the statement "Thto Pesti-
cide to Toxic to Wildlife" to required.
(B) If a pesticide Intended for out-
door use contains an active Ingredient
with a fUh acute LC» of I ppm or lens.
the statement "Thto Pesticide to Toxic
to FUh" to required.
(C) If a pesticide Intended for) out-
door use contains an active Ingredient
with an avi*n acute oral LD- of 100
mg/kg or less, or a subactile dietary
LCM of 600 ppm or lew. the statement
"Thto Pesticide to Toxic to WlMllfe" to
required.
(D) If either accident htotory or field
studies demonstrate that use of the
pesticide may result In fatality to
bird*, flnh or mammals, the statement
(contlnued)
9 147.10
"Thto pesticide Is extremely toxic to
wildlife (fish)" to required.
(R) For uses Involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito" abate-
ment treatments, pesticides toxic to
pollinating Inserts mast bear appropri-
ate label cautions. '
i*M I _ ni>«n Adequacy am! cfar-
tfir of directions. Directions for use
must' be stated In terms which >:an be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud and
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
HI) Placement oj directions for «*e.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
b> the vtser of the pestlcflie product.
Directions for use may appear on
printed or gr»nhte m«ll»r *>M-K •-
(A) If required by the Agency, such
printed or graphic matter to 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 "Ser.Di-
rections In the enclosed circular:" and
(C) The Administrator determlnr*
that It to not necessary for such direr
tlons to appear on the label. ;•
(III) exception* to reoutwnrn/ for
direction for tue-
-------
1IWL10
(J) The label clearly show* that the
product to Intended for use only In
manufacturing pioctssts and specifies
the typed) of products Involved.
(J) Adequate Information such aa
technical data sheets or bulletins, to
available to the trade specifying the
type of product Involved and IU
proper use In manufacturing process-
es;
(J» The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment.
Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale to limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product to for use only by physicians
or veterinarians?
(*> The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product to also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed direction* tor uae may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formutators In preparing
pesticides for sale to the public, pro-
vided that:
<1> Thar* to Information readily
available to the tormulators on the
composition, toxldty. methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes!
(1) The label clearly states that the
product to Intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the typets) of pesticide prod-
ucts Involved;
< OMiteftb o/ INrecMoiU for I/ce.
The directions for use shall Include
the following, under the headings "Di-
rections for Use**:
(I) The statement of use classifica-
tion as prescribed In IM.IMJ) Immedi-
ately under the heading "Directions
for Use."
Oil Immediately below the state-
ment of use classification, the state-
ment -It to a violation of Federal law
to use thto product bi a manner Incon-
sistent with IU labeling."
4III> The stleu) of application, as for
example the crops, animate, areas, or
objects to be treated.
(Iv) The target pesUs) associated
with each site.
of this nee-
lion. Any pesticide product for Which
•omi! uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In thto sub-
section, and shall be marketed aa sepa-
rate product* with different registra-
tion numbers, one bearing directions
only for general useXs) and thr other
bearing directions for restricted usets)
except that. If a product has both re-
stricted u*e<*> and general tiseU). both
of these tun may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
or i laa.KxjMai.
(I) General Vte CliutVtcmUom. Pesti-
cide products bearing directions for
ui«s) classified general shall be la-
beled with the exact words "General
• Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Reitrtcted Ute CIoMl/lcafloit.
Pesticide producU bearing direction
for iMrts) classified restricted shall
bear statemenU of restricted use clas-
sification on the front panel as de-
scribed below:
Directly below thto statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use to restricted In 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 cert If leal Ion." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k> Advertising. IReservedl
HO FR ISMS. July ». int: «s m sni*.
AIM. I. in>: «e FR Mmi. Aw. 71. ins. »
amended at «> FR 57M. Feb. S. irtSI
ll«S.tt Criteria to JHmnUalUfM •* i
reaMNtaMe adverse efferU
of the Act. /notice of
Intent to cVutcel registration pursuant
to section wbXI) of the Art. or a
notice of Intuit to hold'a hearing to
determine wnether Ufe remlstrallon
should be cancelled or denied, as ap-
propriate, shall \>e tabued, upon a de-
termination by tHtXdmlnlslrator that
the pesticide meeOtor exceeds any-of
the criteria for rJkkyel forth In para-
graph (aX3> of Into station. Upon such
determination/ the\ Administrator
shall Issue notice by cKrtlfled mall to
the appllcan/or regtstraWt, as the case
may be. staling that IheYPPIIcant or
registrant/ has the opportunity to
submit ovMenee In rebultaJ of such
presuminlon In accordance win para-
graph lmX4) of thto section. Tste appli-
cant w registrant shall have forty-five
(45>>Aays frotn the dale such notice b
to submit evidence In rebulVal of
presumption: provided, however.
rfiat for good cause shown the Adnlfn-
strator may grant an additional sis
OO
-------
I'll
»ni }iti|u|Hil
C Alt 1 ION .
lilt
n|
Mini
1
STOnAGH AMD
DISPOSAL
^ €"<)••
PRODUCT
NAME
ACIIWI
IOIM
100110%
nn] rnuuuci CONIAMS ins o* rmn*iioii
KEEP OUT OF REACH OF CHILDREN
CAUTION
suiiMiin or
mi ini
» os s«ti ^
sri s*>f "NM inn Minunxu rni c*uio»i«n«
in oir,>*in>io>i MO ~~
vs« co*«fl*«j:
-40
<©
<©
COOP
00
-fc*
cno««
w»nn»fii-» jl»ili'l'«l
-------
rniCAUIOWAWV 8f AICMINIS
HAJAflOJ IO HUMANS
II OOMfSIC
DANCUM
(NWIONUINIAL
on
HAJArtOS
tww cnoNS row i»c
I • • »»i.i « r**rtf to* to
•»• »»»tm« M •
"I CMIftV StATtMtNT
STORAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
for rtl|H til* I* n>4 «M »«lr kr CtMlfltd Oppllcileri
•r |>«rii«i nnd«r t»>tlr 4lr«tl'luptr*liU« *«d oolf f*r
^ei« ftti c«f»rt< by Iht CtrllfUd Appllcilort ttrllfl-
citUn. .
PRODUCT
NAME
ACTWf i
NCIH WONflXNIS »
TJOTAI IOOOO*
1MB rMOOUCT CONTAMS LM Of MM OAUON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
SIAtCUINI Of PMACICAi. 1RCATUINT
r
r
r OH MM:
r i
Sit SDf PAMCl
ApOmOHAt MttCMITDNAIIv •TAIEMtNIS
5)f StAMl)MUENt NO =
•A nr<)l9tflAtON NQ
CNO**
oo
ui
-------
86
PHYS/CHEM-l
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20'F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20'F
and not over 80'F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20'F.
B. Flashpoint above 20'F
and not over 80'F.
C. Flashpoint over 80'F
and not over 150'F.
D. Flashpoint above
150'F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130'F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130'F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130'F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
87
STOR-l
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering/ when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal.
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper.and discard in trash."
-------
° 'PEST/DIS-2
'PESTICIDE ACTIVE INGREDIENTS THAT ARE- ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST
[40 CFR 261.33(e)]
(with RCRA # and CAS #
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
•Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
0,0-Diethyl 0-pyrazinyl
phosphorothioate (Zinophos\)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide
(OMPA,. schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
POOS
P070
P004
POOS
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
-------
90
PEST/DIS-3
Strychnine, and salts.. ..............^ ,. P108
0,0,0,0-Tetraethyl P109
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill
Thallium sulfate P115
Thiofanox P045
Toxaphene P123
Warfarin (>0.3%) P001
Zinc phosphide (>10%) P122
57-24-9.
60-41-3
3689-24-5
107-49-3
7446-18-6
39196-18-4
8001-35-2
81-81-2
1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro- F027
phenoxy) ethyl ether
Dehydroabietylammonium F027
pentachlorophenoxide
Erbon F027
0-ethyl 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate F027
2,2'-Methylenebis F027
(3,4,6-trichlorophenol)
(Hexachlorophene)
—Potassium salt of F027
—Sodium salt of F027
—Disodium salt of F027
Pentachlorophenol F027
—Potassium salt of F027
—Sodium salt of F027
—Zinc salt of F027
—Zinc salt of N-alkyl F027
(Clg-C., g)-1,3-propanediamine
—Pentacnlorophenyl laurate F027
Potassium trichlorophenate (2,4,6) F027
Potassium trichlorophenate (2,4,5) F027
Silvex F027
—2-Butoxyethyl ester F027
—Butoxypolypropoxypropyl ester F027
—Butoxypropyl ester F027
—Diethanolamine salt F027
—Diisopropanolamine salt F027
—Dimethylamine salt F027
—Dipropylene glycol isobutyl F027
ether ester
—Ethanolamine salt F027
—2-Ethylhexyl ester F027
—Isooctyl ester F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
-------
91
PEST/DIS-4
—Isopropanplamine_salt
—Monohydroxylaluminum salt
—Polypropoxypropyl ester
—Potassium salt
—Propylene glycol isobutyl
ether ester
•—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Triisopropanolamine salt
—Tripropylene glycol isobutyl
ether ester
Sodium 2-(2,4,5-trichlorophenoxy)
ethyl sulfate
Tetrachlorophenols
—Alkylamine*amine salt (as in
fatty acids of coconut oil)
—Potassium salt
—Sodium salt
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenol salt of
2,6-bis[(dimethylamino)methyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt
2,4,6-Trichlorophenol, sodium salt
2,4,5-Trichlorophenoxyacetic acid
—Alkyl C-12 amine salt
—Alkyl C-13 amine salt
—Alkyl C-14 amine salt
—N,N-diethylethanolamine salt
—Dimethylamine salt
—N,N-dimethyllinoleylamine salt
—N,N-dimethyloleylamine salt
—N-oleyl-1,3-propylene
diamine salt
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Alkyl (C3H7 - C7H9) ester
—Amyl ester
—Butoxyethoxypropyl ester
—2-Butoxyethyl ester
—Butoxypropyl ester
—Butyl ester
—Dipropylene glycol isobutyl
ether ester
—2-Ethylhexyl ester
—Isobutyl ester
.F0.27....... 53404-13^0,
F027 69622-82-8
F027 83562-66-7
F027 2818-16-8
F027 53466-84-5
F027 37913-89-6
F027 17369-89-0
F027 53404-74-3
F027 53404-75-4
F027 53535-30-1
F027 3570-61-4
F027 25167-83-3
F027
F027 53535-27-6
F027 25567-55-9
F027 95-95-4
F027 88-06-2
F027 53404-83-4
F027 136-32-3
F027 3784-03-0
F027 93-79-8
F027 53404-84-5
F027 53404-85-6
F027 53535-37-8
F027 53404-86-7
F027 6369-97-7
F027 53404-88-9
F027 53404-89-0
F027 53404-87-8
F027 13560-99-1
F027 3813-14-7
F027 2008-46-0
F027
F027 120-39-8
F027 1928-58-1
F027 2545-59-7
F027 1928-48-9
F027 93-79-8
F027 53535-31-2
F027 1928-47-8
F027 4938-72-1
-------
92
PEST/DIS-5
—Isopropyl ester F027 93-78-7
—Propylene glycol isobutyl F027 53466-86-7
ether ester
—Tripropylene glycol isobutyl F027 53535-32-3
ether ester
4-(2,4,5-Trichlorophenoxy)butyric F027 93-80-1
acid [2,4,5-TB]
2-(2,4,5-Trichlorophenoxy)ethyl F027 69633-04-1
hydrogen sulfate [2,4,5-TES]
1,4'/5'-Trichloro-2'-(2/4/5- F027 69462-14-2
trichlorophenoxy)
methanesulfonanilide [Edolan U]
-------
93
PEST/DIS-6
PESTICXDES... THAT- ARE-T.QXI.C •..•
PESTICIDES ON THE "F" LIST fwith
[40 CFR 261.33(f) ]
Acetone
Acrylonitrile*
Amitrole
Benzene*
Bis ( 2 -ethy Ihexyl ) phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chl oroacetaldehyde )
Chlordane, technical*
Chlorobenzene*
4 -Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1, 3 , 4-metheno-
2H-cyclobuta[c,d]-pentalen-2-one
(Kepone, chlordecone)
1, 2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-2 , 3- (Dichloroallyl diisopropyl-
thiocarbamate) (diallate,Avadex)
o-Dichlorobenzene*
p-Dichlorobenzene*
Dichlorodifluoromethane
(Freon 12\)
3 , 5-Dichloro-N- (1 , l-dimethyl-2-
propynyl) benzamide
(pronamide, Kerb\)
Dichloro diphenyl dichloroethane
(ODD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2 , 4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1,3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2 , 3-epoxypropane)
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
( chlorobenz ilate )
RCRA #.
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
U066
U069
U062
U070
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
and CAS #
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
.
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
23950-58-5
72-54-8
50-29-3
1191-17-9-
94-75-7
' 8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*Proposed for deletion by TCLP proposal
-------
94
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol*
Pyridine*
Resorcinol
Safrole
Selenium disulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(•methyl chloroform)
Trichloroethylene*
Trichloromonofluoromethane
(Freon ll\)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
-------
95
CONT/DIS-l
.....;..,._./.' .CONTAINER.. DISPOSAL. INSTRU-CTJQNS,...^^^
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
(Non-aerosol products
I(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash,
Non-aerosol products | Do not reuse bag.
(baas) I
Discard bag in trash.
I.
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)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
•
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer |
for recycling or reconditioning, or puncture]
and dispose of in a sanitary landfill, or byj
other procedures approved by state and local
authorities .
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused—, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wordina)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
96
PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin (<0.3%) U248 81-81-2
Xylene U239 1330-20-7
Zinc phosphide (<10%) U249 1314-84-7
83 ACTIVES
-------
97
EPA Index to Pesticide Chemicals
HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
" .-TABLE OF CQNTENTS^::--: • ^
Site Name Page
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Almond
Apple
Cherry
Citrus Fruits
Eggplant
Grapes
Papaya
Peach
Pear
Pecan
Plum
Prune
Strawberry
Walnut
TERRESTRIAL NONFOOD CROP
2
2
2
3
3
4
4
5
5
6
6
7
6
6
7
8
8
(Agricultural Crops) 8
Research Crops [including beans (snap, lima and wax), beets
(table), corn (field and sweet), cucumbers, peas, peppers,
spinach,'squash (summer), tomatoes, and weed hosts of
pathogens] 8
(Ornamental Plants and Forest Trees) 8
Ornamental Plants 8
SIEENHOUSE NONFOOD CROP 9
(Agricultural Crops) 9
Epcot Display Crops (not for consumption) 9
Research Crops [including beans (snap, lima and wax), beets
(table), corn (field and sweet), cucumbers, peas, peppers,
spinach, squash (summer), tomatoes, and weed hosts of
pathogens] 10
(Ornamental Plants and Forest Trees) 10
Ornamental Plants 10
Issued: 3-10-86 III-104601-i
-------
98
EPA Index to Pesticide Chemicals
C104601 HEXAKIS(2-METff?L-2-PHENTLPROPYL)DISTANNOXANE*
TYPE PESTICIDErj'-~Acaricide*^-»>.-^....~.--.., , ^^.-.^. --....,, , .^ _„.
FORMULATIONS;
Tech (97%)
WP (50%) (water soluble package)
F1C (4 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; Do not get into eyes, on skin, or on
clothing. Wear suitable eye protection, such as goggles or safety glasses
with side shields or their equivalent, when pouring liquid product from
container or handling wettable powder products. Avoid handling inner
water soluble bag of wettable powder products as moisture will cause
breakage. During commercial application or other prolonged exposure, use
goggles and face mask. Wear clean protective clothing that covers the
body well. Do not graze or feed animals on cover crops grown in treated
areas. Avoid contamination of food, feedstuffs and domestic water sup-
plies.
ENVIRONMENTAL HAZARDS; This product is toxic to fish. Keep out of lakes,
ponds and streams. Do not contaminate water by cleaning of equipment or
disposal of wastes.
USE DIRECTIONS; Apply hexakis only by ground equipment. Hexakis may be
applied when honeybees and other beneficials are present.
REENTRY STATEMENTS; Do not apply hexakis in such a manner as to directly
or through drift expose workers or other persons. The area being treated
must be vacated by unprotected persons. Do not enter treated areas with-
out protective clothing until sprays have dried. California and Texas
nave a j. uay teeuury
Commodity Tolerances
Cattle, fat
Cattle, meat
Cattle , mbyp
Cucumbers
Eggs
Goats, fat
Goats , meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses; meat
Horses, mbyp
Milk, fat
Poultry, fat
Poultry, meat
periou.
(other than those listed in the text):
0.5 ppm
0.5 ppm
0.5 ppm
4.0 ppm
0.1 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.5 ppm
0.1 ppm
0.1 ppm
0.1 ppm
*hexakls (beta,beta-dimethylphenethyl)distannoxane
Vendex
Fenbuta tin-oxide
Issued: 3-10-86 III-104601-1
-------
99
EPA Index to Pesticide Chemicals
HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
-iQip^Lim^
MMMWBMMMH^MM«•^H0^MM^^B • —-•Jii.Cj- ._ . .Jg|, .^"If t',Tii£ ^ |'f T* • J'CSS
Poultry, mbyp
Raspberry
Sheep, fat
Sheep, meat
Sheep, mbyp
0.1 ppm
10 ppm (proposed 6/11/86)
0.5 ppm
0.5 ppm
0.5 ppm
'03001AA
Site and Pest
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Almond
Dosages and Tolerance, Use, Limitations
Formulation(s)
ILAVASA
ILAVBAA
ILAVBQA
ILAVBEA
' European red mite
2Pacific spider mite
2 Pecan leaf scorch
mite (Pecan spider
mite/Hickory
spider mite)
- Twospotted spider
mite
0.125-6.25
lb/100 gal
[up to 500
gal /A]
(50Z WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
or
0.5 ppm (almonds)
80 ppm (hulls)
14 day preharvest interval through
1.25 pounds per acre.
Do not apply more than 2 times per
season.
Dilute foliar application. Apply
when mites first appear and repeat
as necessary to maintain control.
•pplirnfj-m. Ap-
0.5-1.25 Ib/A Concentrate
(50Z WP) ply when mites first appear and re-
(4 Ib/gal peat as necessary to maintain con-
F1C) trol.
Issued: 3-10-86
III-104601-2
-------
EPA Index to Pek4iM.de Chemicals
HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
'*and-Pest •^^^•»^-ft-«aan-De.8a.geLS.aaa,(|aa^TQlfigance> Use, Limitations
Formulat ion (a )
/04001AA
Apple
ILAJAKA
ILAVASA
ILAVAYA
IIAVBEA
HAVAZA
Apple rust mite
European red mite
McOaniel spider
mite
Twospotted spider
mite
Yellow spider mite
(Carpini spider
mite)
/05002AA
Cherry
ILAJBEA
ILAVASA
ILAVAYA
Cherry rust mites
European red mite
McDaniel spider
mite
15 ppm (apples)
75 ppm (dried apple pomace)
14 day preharvest interval through
1.5 pounds per acre.
Do not apply more than 4 times per
season including a prebloom spray;
apply no more than 3 times between
petal fall and harvest.
Dilute foliar application. Apply
when mites first appear and repeat
as necessary to maintain control.
0.125-0.25
lb/100 gal
[up to 600
gal/A]
(50% WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
or
0.5-1.5 Ib/A Concentrate foliar application. Ap-
(50X WP) ply when mites first appear and re-
(4 Ib/gal peat as necessary to maintain con-
P1C) trol.
6 ppm (cherries, sweet and sour)
14 day preharvest interval through
1.5 pounds per acre.
Do not apply more than 2 times per
season.
0.125-0.25 Dilute foliar application. Apply
lb/100 gal when mites first appear and repeat
[up to 600 as necessary to maintain control.
gal/A]
(SOX WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
or
0.75-1.5 Ib/A Concentrate foliar application. Ap-
(501 WP) ply when mites first appear and re-
(4 Ib/gal peat as necessary to maintain con-
F1C) trol.
Issued: 3-10-86
III-104601-3
-------
101
02000AA
Site and Pest
Citrus Fruits
EPA Index to Pesticide Chemicals
HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
Dosages and Tolerance, Use, Limitations
Formulation( s)
20 ppra (citrus fruits)
35 ppm (dried citrus pulp)
7 day preharvest interval through 4
pounds per acre.
Do not apply more than 4 sprays in
any 12 month period.
LAVARA
LAJBCA
LAVAKA
LAVBEA
LAVAJA
2 Citrus red mite
Citrus rust mite
'-• Texas citrus mite
Tvospotted spider
mite
Yuma spider mite
'11001AA
Eggplant
ILAVCJA
ILAVBEA
Glover's mite
Twospotted spider
mite
0.125-0.25
lb/100 gal
[up to 1,600
gal/A]
(50% WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
or
1.0-2.0 Ib/A
(50% WP)
(4 Ib/gal
F1C)
Dilute foliar application. Apply
when mites first appear and repeat
as necessary to maintain control.
1.0-2.0 Ib/A
(50% WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
Concentrate foliar application. Ap-
ply when mites first appear and re-
peat as necessary to maintain con-
trol.
6 ppm
3 day preharvest interval through 2
pounds per acre.
Do not exceed 6 applications per
season with a total of no more than
6 pounds active ingredient per acre
per year.
Use limited to areas other than CA.
Foliar application. Apply when
mites appear. Repeat as necessary
to maintain control. Thorough
coverage for all leaf surfaces is
required for best control.
In Florida apply when needed or
every 1 to 2 weeks.
Issued: 3-10-86
III-104601-4
-------
Site-and: Pest
EPA Index to Pesticide Chemicals
HEXAKIS(2-METm-2-PHENYLPROPYL)DISTANNOXANE
Dosages and. Tolerance, Use, Limitations
" Formula ti-dtt( &
01014AA
Grapes
XAVARA
IAVBAA
IAVBEA
European red mite 0.25-0.5 lb/
Pacific spider mite 100 gal
Twospotted spider [up to 250
mite gal /A]
(50Z WP)
000201-00369
(4 Ib/gal
F1C)
5 ppm (grapes)
20 ppm (raisins or raisin waste)
100 ppm (dried grape pomace)
28 day preharvest Interval through
1.25 pounds per acre.
Do not apply more than 2 times per
season.
Dilute foliar application. Apply
When mites first-appear and repeat
as necessary to maintain control but
not within 21 days.
(06010AA
Papaya
000201-00412
or
0.5-1.25 Ib/A Concentrate foliar application. Ap-
(502 WP) ply when mites first appear. Repeat
(4 Ib/gal as necessary to maintain control but
F1C) not within 21 days.
2 ppm
7 day preharvest interval through 1
pound per acre.
Do not apply more than once per
month to bearing trees and not more
than 9 times per season.
Not registered for use in Califor-
nia.
ILATABA
IIAVAWA
ILAVARA
ILAVAEA
ILAVAKA
Broad mite
Carmine spider mite
Citrus red mite
Red and black flat
mite
Texas citrus mite
0.125-0.25
lb/100 gal
[up to 400
gal/A]
(50Z WP)
000201-00369
Dilute foliar application. Apply
when mites first appear and repeat
as necessary to maintain control.
Issued: 3-10-86
III-104601-5
-------
103
EPA Index to Pesticide Chemicals
HEXAKIS(2-METHYL-2-PHEMYLPROPYL)DISTANNOXANE
'Site and-.pes.t-
,Dosages. ajad Tolerance, Use, Limitations
Formulation^)""=.——
ar*K*i**wtx.\
'05004AA
'05G05AA
'05006AA
ELBGABA
CLAVARA
[LAVAYA
tIAVBAA
ILAJAIA
I1AJAJA
ILAVBEA
Bigbeaked plum mite
European red mite
McDaniel spider
mite
Pacific spider mite
Peach silver mite
Plum rust mite
(Plum nursery
mite)
Twospotted spider
mite
/04003AA
Pear
ILAVARA
HAVAYA
ILAJAOA
ILAVBEA
European red mite
McDaniel spider
mite
Pear rust mite
Twospotted spider
mite
10 ppm (peaches, plums, prunes)
20 ppm (dried prunes)
14 day preharvest Interval through
1 pound per acre.
Do not apply more than 2 times per
season.
0.125-0.25 Dilute foliar application. Apply
lb/100 gal when mites first appear and repeat
[up to 400 as necessary to maintain control.
gal/A]
(50% WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
or
0.5-1.0 lb/A- Concentrate foliar application. Ap-
(501 WP) ply when mites first appear and re-
(4 Ib/gal peat as necessary to maintain con-
F1C) trol.
15 ppm
14 day preharvest interval through -
1.5 pounds per acre.
Do not apply more than 4 times per
season Including a prebloom spray;
apply no more than 3 times between
petal fall and harvest.
0.125-0.25
lb/100 gal
[up to 600
gal/A]
(50Z WP)
000201-00369
(4 Ib/gal
PIC)
000201-00412
or
0.5-1.5 Ib/A
(50Z WP)
(4 Ib/gal
PIC)
Dilute foliar application. Apply
when mites first appear and repeat
as necessary to maintain control.
Concentrate foliar application. Ap-
ply when nites first appear and re-
peat as necessary to maintain con-
trol.
Issued: 3-10-86
III-104601-6
-------
104
EPA Index to Pesticide Chemicals
HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
and 'Pest'""-
33008AA
Pecan
LATOQA
'01016AA
Strawberry .
ILAVBEA
Twospotted spider
mite
Dosages ^
Formulation(s)
„ .„ ______ ..,_ —
— ^=====*^SA%e!S)S^^
Pecan leaf scorch
mite (Pecan spider
mite/Hickory
mite)
0.5 ppm
14 day preharvest interval through
1.25 pounds per acre.
Do not apply more than 2 times per
season.
Dilute foliar application.
Concentrate foliar application.
Refer to Pecan leaf scorch mite under Almond for
use and limitation information.
- See Peach cluster.
See Peach cluster.
10 ppm
1 day preharvest interval through 1
pound per acre.
Do not apply more than 4 times per
season.
Dilute foliar application. Apply
when mites first appear and repeat
as necessary to maintain control.
Adjust spray volume and nozzle
placement to assure good coverage
of top and underside of leaves.
0.375-0.5
lb/100 gal
[150-200
gal/A]
(50% WP)
000201-00369
(4 Ib/gal
F1C)
000201-00412
or
0.75-1.0 Ib/A Concentrate foliar application. Ap-
(50% WP) ply when mites first appear and re-
(4 Ib/gal peat as necessary to maintain con-
F1C) trol. Adjust spray volume and noz-
zle placement to assure good cover-
age of top and underside of leaves.
Issued: 3-10-86
III-104601-7
-------
03009AA
.Site and-Pest..
Walnut
1A7ASA
IAVBAA
1AVBEA
EPA Index to Pesticide Chemicals
HEXAKIS(2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
^an.'JL Tolerance, Use, Limitations
~»T££3r«»-;\ > /%3:S^":V/~^i™^1;'f^''"T*tt^".
European red mite
Pacific spider mite
Twospotted spider
mite
0.5 ppm
14 day preharvest interval through
1.25 pounds per acre.
Do not apply more than 2 times per
season.
Dilute foliar application.
Concentrate foliar application.
Refer to pests under Almond for use and limitation
information.
/28085DA
ILAAABA
/32000AA
ILAVBNA
ILAVAPA
liAVBEA
TERRESTRIAL NONFOOD CROP
(Agricultural Crops)
Research Crops (including beans
(snap, lima and wax), beets
(table), corn (field and sweet),
cucumbers, peas, peppers, spinach,
squash (summer), tomatoes, and
weed hosts of pathogens]
Mites
2.25 g/gal
(50% WP)
24(C) CA790076 (renewed 3/9/84)
For use only at premises of Del
Monte Corp., Alameda County. No
part of treated plants may be used
-for foocUor~feed... All applicable
directions, restrictions and pre-
cautions on EPA registered label
(201-369) are to be followed.
Foliar application to containerized
plants using hand held wand. Spray
to runoff.
(Ornamental Plants and Forest Trees)
Ornamental Plants
Do not add to oil spray solutions.
Do not apply more than once every
28 days. Apply to foliage of chry-
santhemums in the prebloom stage and
to poinsettias in the prebract
stage.
•it Oligonychus mites 0.25-0.5 lb/ Dilute foliar application. Apply
Spruce spider mite
Twospotted spider
mite
100 gal ..when mites first appear and repeat
(501 WP) as needed.
000201-00369
(4 Ib/gal
F1C)
000201-00412
Issued: 3-10-86
III-104601-8
-------
Site and Pest
106
EPA Index to Pesticide Chemicals
HEXAKIS (2-METHYL-2-PHENYLPROPYL )DISTANNOXANE
Dosages and Tolerance, Use, Limitations
Formulation( s)
GREENHOUSE NONFOOD CROP
(Agricultural Crops)
Epcot Display Crops (not for con-
sump t
DlSP
ion)
24(C) FL840002
For use only in "The Land", EPCOT
Center, Lake Buena Visa, Florida.
Crops (including resulting produce)
not listed on the federal label must
be destroyed following harvest and
IN NO CASE SHOULD BE CONSUMED. All
applicable directions, restrictions
and precautions on the EPA-register-
ed label are to be followed.
Apple rust mite 0.125-0.5 lb/ Dilute/concentrate foliar applica-
Bigbeaked plum mite 100 gal tion.
Citrus red mite or
Citrus rust mite 0.5-2.0 Ib/A
Cherry rust mites (4 Ib/gal
European red mite F1C)
Glover's mite -•--•...
McDaniel spider
mite
Oligonychus mites
Pacific spider mite
Peach silver mite
Pear rust mite
Pecan leaf scorch
mite (Pecan spider
mite/Hickory
spider mite)
Plum rust mite
(Plum nursery
mite)
Spruce spider mite
Texas citrus mite
Twospotted spider
mite
Yellow spider mite
(Carpini spider
mite)
Yuma spider mite
Issued: 3-10-86
III-104601-9
-------
istlcid
Site and Pest
EPA Index to Pesticide Chemicals
HEXAKIS ( 2-METHYL-2-PHENTfLPROPYL)DISTANNOXANE
Dosages and Tolerance, Use, Limitations
'28085DA
Research Crops [including beans
(snap, lima and wax), beets
(table), corn (field and sweet),
cucumbers, peas, peppers, spinach,
squash (summer), tomatoes, and
weed hosts of pathogens]
2A(C) CA790076 (renewed 3/9/84)
Refer to TERRESTRIAL NON-FOOD CROP, (Agricultural
Crops), Research Crop, for pests, use and limita-
tion information.
(Ornamental Plants and Forest Trees)
/32000AA
Ornamental Plants
ILAVBNA
ILAVAPA
ILAVBEA
Oligonychus mites
Spruce spider mite
Twospotted spider1~
mite
0.25-0.5 lb/
100 gal
Do not add oil spray to solutions.
Do not apply more than once every
28 days. Apply to foliage of chry-
santhemums in the prebloom stage and
to poinsettias in the prebract
stage.
Dilute foliar application. Apply
when mites first appear and repeat
000201-00369
(4 Ib/gal
F1C)
000201-00412
Issued: 3-10-86
111-104601-10
-------
108
EPA Index to Pesticide Chemicals
HEXAKIS (2-METHYL-2-PHENtLPROP'!L)DISTANNOXANE
r£fe^^
i097.0001 97% technical chemical
hexakis(2-tnethyl-2-phenylpropyl)distannoxatie (104601)
000201-00367
»050.0006 501 wettable powder
hexakis(2-methyl-2-phenylpropyl)distannoxane (10A601)
000201-00369
1204.0015 4 Ib/gal flovable concentrate
hexakis(2-inethyl-2-phenylpropyl)distannoxane (104601)
000201-00412
Intrastate Registrations
None
Special Local Need (24(c)) Registrations
(000201-00369): CA78013400 CA79007600 CA800n600 PL79001800
" " " 'FL83002600 " ' FL84002700-—GA8-30004017,-u.MBlOOOaQO
OR78004100 TX83003400
(000201-00412): AR83001400 FL83002700 FL84000200 FL84002800
GA83000402 PA80003300 TX83003300
Issued: 3-10-86
III-104601-U
-------
109
EPA Index to Pesticide Chemicals
HEXAKIS (2-METHYL-2-PHENYLPROPYL)DISTANNOXANE
Auxiliary Documentation
000201-00369 - Jacket missing.
000201-00412 - The statement, "Do not use Vendex 4L on the following
citrus: tangerines, tangelos" appearing on this label was deleted Oct.
17, 1985 in response to a request dated Aug. 12, 1985. The currently
accepted label 11/27/85 was submitted for approval Sept. 23, 1985, i.e.,
before the agreement to delete the statement was approved.
24(C) 790076 renewed 3/9/84 does not take into account that this product
is now marketed in water soluble bags.
24(C) PL840002 fails to list sites of application, pests controlled, dos-
ages, and any other use directions. The only instructions it gives are
to apply to Epcot Display Crops at the dosage rates listed on 000201-
00412. As such I am indicating the full range of dosages, 0.125-0.5
pounds per 100 gallons water or 0.5-2.0 Ib/A and am listing all the pests
on 000201-00412. I believe that the registrant should be asked to list
all crops grown at the Epcot Center and applicable pests and dosages.
Issued: 3-10-86 III-104601-a
-------
110
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in,
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
sta'ndards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
Ill
BIBGUIDE-2
a. . Author. ..Jtfhe.ne.v.e.r._.tLhe Agency.. j^OLuLd ,cpnf ide.ntly identify
"'"" "one/ the'~A*gerfcy- ha^^-hos^err-tor-straw •-a--p'eTSonia-lr-^a-u-thoT
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 ~rmmex3d-ate-]ry-"fo-H.owing-:ther word--"3
"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.
-------
112
'''' OFFICE" OP^ESrrcIBE^PRQQR^^
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Vendex Standard
MRID CITATION
00026038 Nugent, K.D.; Zwick, B.; Matsuyama, H.; et al. (1978) Residue Data
Developed from the Use of Vendex Miticide on Cherries.
(Unpublished study received Dec 11, 1979 under 201-369; pre-
pared in cooperation with Univ. of Oregon, Mid-Columbia Exper-
iment Station and others, submitted by Shell Chemical Co.,
Washington, D.C.; CDL:099140-1)
00030349 Nugent, K.D.; Hewitt, A.J.; Simkover, H.G. (1979) Residue Data
Developed from the Use of Vendex Miticide (4 Lb/Gallon Liq-
uid) on Apples, Pears and Citrus. (Unpublished study received
Jan 10, 1980 under 201-412; prepared in cooperation with Mich-
igan State Univ., Dept. of Entomology and others, submitted by
Shell Chemical Co., Washington, D.C.; CDL:241616-1)
00036935 Atkins, E.L.; Greywcod, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
"" gy.' ?:' UC;"Cc<^rativejefixtieraden^^ •• -.-.
study.)
00037581 Granville, G.C.; Simpson, B.J.; Doak, S.M.; et al. (1973) Toxicity
Studies on the Pesticide SD 14114: An 18 Month Feeding Study
in Mice: TLGR.0036.73. (Unpublished study received on unknown
date under 4F1492; prepared by Shell Research, Ltd., submitted
by Shell Chemical Co., Washington, D.C.; CDL:093941-H)
00037582 Simpson, B.J.; Granville, G.; Doak, S.M.; et al. (1973) Toxicity
Studies on the Pesticide SD 14114: Two Year Oral Experiment in
Rats: TLGR.0034.73. (Unpublished study received on unknown
date under 4F1492; prepared by Shell Research, Ltd., submitted
by Shell Chemical Co., Washington, D.C.; CDL:093941-I)
00037583 Granville, G.C.; Dix, K.M.; Stevenson, D.E. (1973) Toxicity Stud-
ies on the Pesticide SD 14114: Two Year Oral Toxicity Test in
Dogs: TLGR.0035.73. (Unpublished study received on unknown
date under 4F1492; prepared by Shell Research, Ltd., submitted
' by Shell Chemical Co., Washington, D.C.; CDL:093941-J)
00045869 University of Hawaii (1979) The Results .of. Tests on the Amount of
Vendex and It's Metabolite Residues Remaining in or on Papaya
Including a Description of the Analytical Method Used. Summary
of study 099547-B. (Compilation; unpublished study received
Aug 15, 1980 under OE2397; submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:099547-A)
-------
113
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Vendex Standard-•
MRJD CITATION
00045870 University of Hawaii (1976) Analytical Procedure for Vendex (R): in
Papaya. Undated method. (Unpublished study received Aug 15,
1980 under OE2397; prepared by Agricultural Biochemistry Dept.,
Pesticide Laboratory, submitted by Interregional Research Proj-
ect No. 4, New Brunswick, N.J.; CDL:099547-B)
00069881 Shell Chemical Company (1975) Summary of Information Regarding Res-
idues of Vendex on Strawberries. (Compilation; unpublished
study, including TIR-24-140-74, TIR-24-706-73, TIR-24-707-73,
..., received Apr 13, 1976 under 201-369; CDL:097032-B)
00070506 Potter, J.C. (1980) 1979—Residue Data for Vendex Miticide and
Its Organotin Metabolites SD 31723 and SD 33608, in Filberts
following Three Applications of Vendex to Filbert Trees, an
Oregon Study: RIR-24-273-79. (Unpublished study received Feb
17, 1981 under 201-412; submitted by Shell Chemical Co., Wash-
ington, .D..C..;..CDL:244429-AL ...._
00071183 Shell Chemical Company (1979) Residue Data Developed from the Use
of Vendex Miticide on Strawberries. (Compilation; unpub-
lished study received Sep 3, 1980 under 201-369; CDL:099580-A)
00071228 Lee, P.W. (1979) Determination of the Mobility of SD 9129, SD 6120,
SD 14114, SD 12011, SD 15418, SD 45328 and Selected Reference
Pesticides by Soil Thin-layer Chromatography: TIR-22-125-79.
(Unpublished study received Jan 22, 1981 under 201-157; submit-
ted by Shell Chemical Co., Washington, D.C.; CDL:099891-M)
00072693 Dix, K.M.; Cassidy, S.L.; Hend, R.W.; et al. (1981) Teratology
Study in Rats Given SD 14114 by Gavage: Group Research Report
TLGR.80.145. (Unpublished study received Apr 27, 1981 under
201-369; prepared by Shell, Ltd., England, submitted by Shell
Chemical Co., Washington, D.C.; CDL:244935-A)
00077245 Shell Chemical Company (1981) Residue Data Developed from the Use
,. of Vendex Miticide on Grapes and Grape Products. (Com-
pilation; unpublished study received Jun 25, 1981 under 201-369;
CDL:245469-A)
00079319 Dix, K.M.; Cassidy, S.L.; Vilkauls, J.; et al. (1981) Teratology
Study in New Zealand White Rabbits given SD 14114: SBGR.18055
(Unpublished study received July 23, 1981 under 201-369;
prepared by Shell Res. Ltd. England; submitted by Shell Chem-
ical Co., Washington, D.C.; CDL 245605-A).
-------
114
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY""-«.—«•»•---.
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Vendex Standard
MRID CITATION
00088398 Johansen, C.; Eves, J. (1970) Bee Research Investigations, 1970.
(Unpublished study received Feb 1, 1973 under unknown admin.
no.; prepared by Washington State Univ., submitted by Shell
Chemical Co., Washington, D.C.; CDL:222266-D)
00093721 Shell Oil Company (1980) Summary of Information Regarding Residues
of Vendex Miticide on Apples, Pears, and Citrus. Includes
method MMS-R-494-2 dated Dec 1979. (Compilation; unpublished
study received Jan 19, 1982 under 2F2631; CDL:070602-A)
00105161 Reinsfelder, R.; Simkover, H.; Collins, R.; et al. (1982) The Re-
sults of Tests on the Amount of Residues Remaining, Including a
Description of the Analytical Methods Used: Vendex. (-Unpub-
lished study received Jun 24, 1982 under 201-369; prepared in
cooperation with Louisiana State Univ., Pecan Station and Henry
Agri-Scientific, submitted by Shell Chemical Co., Washington,
DC; CDL:070967-A)
*b"6l05203' Shell Chemical" Co." (1982) * Summary of J4sV6nde-x"-Miticide-i'Residue-Data—
Grapes (4L). (Conpilation; unpublished study received Jun 17,
1982 under 201-412; CDL:247721-A)
00105204 Shell Chemical Co. (1982) Summary of Corridor Residue Data for
Apples, Pears, and Citrus Which Had Received Applications of
Vendex 50WP or 4L Miticide. (Compilation; unpublished study
received Jun 17, 1982 under 201-412; CDL:247722-A)
00109280 Shell Oil Co. (1982) Summary: Evendex 4L Miticide. (Compilation;
unpublished study received Jul 20, 1982 under 201-412; CDL:
247906-A)
00112902 Shell Chemical Co. (1982) Residue Data Developed from the Use of
Vendex 4L Miticide on Cherries, Plums and Prunes. (Compilation;
unpublished study received Aug 25, 1982 under 201-412; CDL: .
071061-A)
00112990 Ebbens, K. (1972) Report to Shell Chemical Company, a Division of
Shell Oil Company: Acute Toxicity Studies with SD 14114 Techni-
cal: IBT No. A1T61. (Unpublished-study-received on--unknown-date
under 3G1354; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Shell Chemical Co., Washington, DC; CDL:
093620-G)
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115
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Vendex Standard
MRID CITATION
00113001 Simpson, B.; Stevenson, D. (1972) Toxicity Studies on the Pesticide
SD 14114: Two Year Oral Experiment in Rats; Interim Report after
One Year: Group Research Report TLGR.0039.72. (Unpublished
study received on unknown date under 3G1354; prepared by Shell
Research, Ltd., Eng., submitted by Shell Chemical Co., Washing-
ton, DC; CDL:093620-R)
00113018 Shell Chemical Co. (1974) SD 14114 Residues in Apples, Pears,
Citrus, Milk and Tissues from Cows. (Compilation; unpublished
study received on unknown date under 4F1492; CDL:093938-B)
00113020 Potter, J. (1974) Characterization of the 1195n Residues in the
Kidney and Liver of Cows Fed SD 14114-1195n: TIR-22-112-74.
(Unpublished study received on-unknown date under 4F1492; sub-
mitted by Shell Chemical Co., Washington, DC; CDL:094515-A)
00113029 Loeffler, J. (19??) The Fate of Ingested 119Sn-SD 14114 in Rats:
. TIR-22-117-J2^-:XUnpublis^
4F1492; submitted by Shell Chemical"Co., Washington, DC; CDL:
094519-H)
00113063 Shell Chemical Co. (1976) The Results of Tests on the Amount of
Vendex Residues Remaining, Including a Description of the
Analytical Methods Used. (Compilation; unpublished study re-
ceived Apr 15, 1977 under 7G1947; CDL:096090-C)
00113073 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Acute Oral LD50—
Bobwhite Quail: SD 14114: Project No. 109-119. Final rept.
(Unpublished study received Apr 2, 1979 under 201-369; prepared
by Wildlife International, Ltd., submitted by Shell Oil Co.,
Washington, DC; CDL:098036-C)
00113074 Fink, R.; Beavers, J.; Grimes, J.; et al. (1978) Eight-day Dietary
LC50—Mallard Duck: SD-14114: Project No. 109-120. Final rept.
(Unpublished study received Apr 2, 1979 under 201-369; prepared
by Wildlife International, Ltd., submitted by Shell Oil Co.,
•.. Washington, DC; CDL:098036-D)
00113075 Johnson, W. (1972) Acute Toxicity of Technical SD 14114 to Rainbow
Trout. (U.S. Fish and Wildlife Service, Fish-pesticide Research
Laboratory; unpublished study; CDL:098036-H)
00113076 Johnson, W.; Jones, T. (1971) Static Acute Toxicity of SD 14114 to
Bluegill. (U.S. Fish and Wildlife Service, Fish-pesticide Re-
search Laboratory; unpublished study; CDL:098036-1)
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116
... . •'• :-.: OFFICE
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Vendex Standard
MRID CITATION
00113078 Shell Oil Co. (1979) The Results of Tests on the Amount of Residues
Remaining, Including a Description of the Analytical Methods
Used: Vendex. (Coupilation; unpublished study received Apr 2,
1979 under 201-369; CDL:098036-K)
00130837 Interregional Research Project No. 4 (1983) The Results of Tests on
the Amount of Fenbutatin-oxide Residues Remaining in or on Egg-
plant, Including a•Description of the Analytical Method Used.
(Compilation; unpublished study received Sep 21, 1983 under 201-
369; CDL:071955-A)
00143694 Interregional Research Project No. 4 (-19??) The Results of Tests on
the Amount of Fenbutatin-Oxide Residues Remaining in or on Avo-
cado Including a Dsecription of the Analytical Method Used. Un-
published compilation. 43 p.
00145444 Interregional Research Project No. 4. (19??) The Results of Tests
on the .Amount MJ"ejib^tatijaTP^ide.JResidues Remaining in or on
Raspberries Including a Description of the Analytical Method"
Used. Unpublished compilation. 49 p.
00146038 Interregional Research Project No. 4 (19??) The Results of Tests on
the Amount of Fenbutatin-oxice Residues Remaining in or on Cu-
cumbers Including a Description of the Analytical Method Used.
Unpublished compilation. 18 P.
00148257 Shell Oil Company (1982) Residue Data Developed from the Use of
Vendex 4L Miticide on Peaches and Strawberries. Unpublished
study. 116 p.
00148733 Shell Oil Co. (1985) Vendex 4L Miticide: Vendex 50WP Water Soluble
Bag Miticide: Amendment to Strawberries: [Residue Data in Straw-
berries]. Unpublished compilation. 40 p.
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