United State*
Environmental Protection
Agency
Off ice of
Pecticides end Toxic Subetancw
Weehington DC 20460
PMicidM
July 1987
Guidance for the
Reregistration of
Pesticide Products
Containing Tebuthiuron
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
Tebuthiuron
AS THE ACTIVE INGREDIENT
OPP NUMBER 105501
CAS NUMBER 34014-18-1
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
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. fJSE INDEX APPENDIX '
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES.
EPA Form 3580-1 PIFRA S3(c)(2)(B) Summary Sheet
EPA Form 3530-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Oat*
EPA Form 8540-4 Product Specific Data Report
EPA Form 8570-27 Formulator's Exemption Statement
ii
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TABLE OF CONTENTS
Glossary of Terms and Abbreviation . „ iii
Introduction 1
II. Chemical Covered; by this Standard 4
A. Description of Chemical
B. Use Profile
C. Chemical Structures
III. Agency Assessment .... 3
A. Summary
3. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 17
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 26
VI. Requirement for Submission of Generic Data 28
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. Testing Protocols, Standards for Conducting
Acceptable Tests, Guidance on Evaluating and
Reporting Data
F. Procedures for requesting a change in testing
protocol
G. Procedures for requesting extensions of time
H. PR Notice 86-5 and Any Other Requirements
Referenced or Included Within this Notice
I. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Revised Labeling 35
VIII. Instructions for Submission 35
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Addresses
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: Acceptable Daily Intake
a.i.: Active ingredient
CAS : Chemical Abstract Services (number)
CSF: Confidential Statement of Formula
EPA: The Environmental Protection Agency, also "the Agency"
F-] , F2 : Refers to the generations in a multi-generation study
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
LC5Q: (median lethal concentration) a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals, expressed as weight
or volume of test substance per volume of air or
water or per weight of feed (e.g., mg/1 or ppm).
LD5Q: (median lethal dose) a statistically derived single
dose that can be expected to cause death in 50% of animals
when administered by the route indicated, expressed as
weight of substance per unit weight of test animal
(e.g., mg/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Indent ification (number) - EPA's system
of tracking studies used in support of registrations.
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs
OES : Office of Endangered Species, U.S. Fish and-- Wildl if e Service
111
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Technical: Active ingredient as manufactured
MATC: Maximum Allowable Toxic Concentration
rag/kg bwt/day: milogram per kilogram of body weight per
day
mbyp : meat by ::roduct
Kd : Soil-water adsorption partition cofficients
Screen: A process through which EAB asseses the Leaching
potential of a pesticide
EL-103: Tebuthi .iron Technical
EPs: End-Use-Prjducts
2AA:- 2-Amino anr.hracin
AmAc: 9- Amino oindine
MMNG: N-Methyl N'Nitroguanidine
2NF: 2-Nitroflourene
> : greater than
< : l-ess than
LV
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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 Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request-'-, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data ,in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
•'-The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Divi.c3ion
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with. FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to 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
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
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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 the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard.
Common Name: Tebuthiuron
^Chemical Name: N-[5-(t,1-dimethylethyl)-1,3,4-thia
diazol-2-yl]- N.N'dimethylurea
CASE No.: GS 0054
OPP Shaughnessy No.: 105501
Empirical Formula:
Year of Initial Registration: 1974
B. Use Profile
Type of Pesticide: A relatively nonselective, soil
actived herbicide for the control of broadleaf weeds,
grasses and brush in noncrop areas, and for spot treat-
ment of woody brush on rangelands. It is readily absorbed
through roots of broadleaf weeds, grasses and brush.
Registered uses: Terrestrial food crop
(rangelands and pastures), noncrop areas (airport
runways, fencerows, firebreaks, industrials sites,
paved surface), and aquatic non-crop (ditchbanks).
Predominant Uses: Terrestrial noncrop areas
Method of Application: Applied as broadcast or band by
ground or aerial equipment, spot treatment, drop zone
or drip zone treatment or grid pattern treatment.
Formulation: 95% (a.i.) technical; 1%, 2%,"3%, & 5% gran-
ular; 10%, 13.8%, 15.2%, 20%, 30.5% , 40% pelleted/table-
ted; 80% wettable powder; 85% flowable concentrate;
and 0.36% soluble concentrate/liquid.
Mode of activity: Photosynthesis inhibitor
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III. AGENCY ASSESSMENT
A. Summary
The Agency has reviewed all of the data submitted to support
the registration of tebuthiuron. Based on the review of
these data, the Agency has reached the following conclusions:
1. Tebuthiuron is only slightly acutely toxic by inhalation
in rats and is in toxicity category III..
2. A rat raultigeneration study showed no adverse reproductive
effects.
3. Tebuthiuron did not cause DNA damage in bacteria and was
only slightly mutagenic in a mouse lymphoma assay.
4. The Agency is concerned about the potential for ground
water contamination by tebuthiuron. The Agency has
determined that additional data are needed to fully
characterize the potential for tebuthiuron to enter
ground water.
5. The use of tebuthiuron on rangeland and pastureland
will pose a hazard to endangered species.
6. As a result of this review, the agency has identified
missing data necessary to evaluate the environmental and
human risks associated with the use of tebuthiuron.
These data must be developed in order to maintain registra-
tion of products or to register new products containing tebu-
thiuron. A summary of these data gaps appear in figure 1.
Please note that this is only a summary and complete details
can. be obtained by referring to the tables in Appendix I.
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Figure 1
Summary Of Data Gaps
Tebuthiuron
§158.120-Product Chemistry
§158.125 Residue Chemistry:
171-4 Nature of the Residue (Plant & Animal Metabolism)
i 171-4 Residue Analytical Methods
171-4 Storage Stability
1 171-4 Residue Studies on crops, Processed Food/Feed
Commodities
§158.135 Toxicology:
81-1 Acute Oral-Rat
81-2 Acute Dermal
81—4 Eye Irritation-Rabbit
81-5 Dermal Irrition-Rabbit
81-6 Dermal Sensitization
Guinea Pig
83-1 Chronic Toxicity (Rodent)
83-2 Oncogenicity Study (Two Species)
83-3 Teratogenicity (Two Species)
84-2 Mutagenicity
85-1 Metabolism
§158.130 Environmental Fate
161-2 Photodegradation in water/soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic
163-1 Leaching and Adsorption/Desorption
164-1 Soil Dissipation
164-2 Aquatic (Sediment)
164-5 Soil, Long Term
165-3 Irrigated crops
165-5 Accumulation Studies in Fish
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§158.145 Wildlife and Aquatic Organisms
71-2 Avian Dietary LC$Q
72-6 Aquatic Organism Accumulation (Fish)
70-1 Special Studies Field Monitoring
§158.150 Plant Protection
122-1 Seed Germination/Seedling Emergence
122-1 Vegetative vigor
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B. Preliminary Risk Assessment
1. Acute Toxicology
There are no valid studies available to assess the potential
acute oral and acute dermal toxicity of tebuthiuron. Studies
are required. Sufficient data are available to assess the
acute inhalation toxicity of technical tebuthiuron. The
4-hour LCjQ in rats is greater than 3.696 mg/L. (Toxicity
Category III).
There are no valid studies available to assess the primary dermal,
and dermal sensitization potential of technical tebuthiuron;
studies are required.
2. Chronic Toxicity
In a1 study of beagle dogs, 4 animals per sex per dose level
were given technical tebuthiuron by capsule for one year at
levels of 0 (Control), 12.5, 25.0, or 50.0 milligram per
kilogram of body weight. The effects produced included
increased liver to body weight ratios in high dose males and
females; increased kidney to body weight ratios in high dose
females, and increased thyroid ratios in high dose males.
There were no adverse histopathological findings for these
organs, however, alanine transaminase and alkaline phosphatase
values were significantly increased in the high dose males,
as was alanine transaminase in the high dose females. This
indicates a significant hepatotoxic effect at this level in
both sexes. Increased thrombocyte counts in the high dose
males throughout the study appear to be an isolated finding.
The NOEL based on these effects is 25 mg/kg bwt/day.
3. Oncogenicity
No acceptable oncogenicity studies are available. Studies
in two species are required.
Tebuthiuron is one of a class of substituted dimethylurea
compounds. Other such compounds include monuron and diuron.
Monuron has produced increased incidences of renal tubular
adenomas and carcinomas in male rats; diuron has produced
increased incidences of bladder carcinomas in male and female
mice. Linuron, a substituted monomethylurea compound,
has induced testicular adenomas and interstitial-;cell tumors
in male mice. These findings strongly suggest that urogenital
tissues are sensitive to subtituted raethylurea materials.
However, further evaluation of tebuthiuron is not possible
until the required oncogenicity studies are available.
8
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4. Mutagenicity
An Ames assay was performed using bacterial strains of Si.
Typhimurium LT-2 with and without activation.
Doses of technical tebuthiuron used were 5 to 5000 ug/plate.
No tests showed evidence of induction of point mutation in 8
testor strains of j>. Typhimurium. Technical tebuthiuron was
not mutagenic either with or without metabolic activation.
Mouse lymphoma assay for the induction of forward mutations
using the Tk+/- cell line was sensitive to direct acting and
activation-dependant mutagens. Technical tebuthiuron was
slightly mutagenic without metabolic activation. Mutation
indices of 2.0, 2.0 and 2.7 were detected in technical
tebuthiuron treated cultures at concentrations of 200, 400,
and 500 ug/ml respectively. Technical tebuthiuron was not
mutagenic in activated assays.
5. Teratology
A teratology study was submitted but was found to be inade-
quate to support registration of tebuthiuron. Gravid Harlan
rats, 25 per group, were offered diets containing 0 (Control),
600, 1200, or 1800 ppra technical tebuthiuron on days 6
to 15 of gestation. No detailed analytical data, such as
individual dam body weights or individual litter data were
supplied. In adddition, the test material was offered in the
diet rather than being given by gavage as recommended.
Teratology studies in two mammalian species are required.
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6. Reproduction
Sufficient data are available to satisfy the requirement for
a multigeneration reproduction study. Harlan rats, 25/sex/
dose, were offered diets containing 0 (Control), 100, 200,
or 400 ppm 0(Control)-, 5, 10, or 20 mg/kg bwt/day) technical
tebuthiuron through 2 generations of offspring. No adverse
effects were reported except that F1 females, in the pre-raating
phase, showed a lower rate of body weight gain in the 200 and
400 ppm groups. No adverse effects were reported on reproductive
performance at any level. The NOEL for reproductive effects
is > 400ppm (20 mg/kg bwt/day). The NOEL for systemic effects
is 100 ppm (5.0 mg/kg bwt/day).
7. Subchronic Toxicity
Sufficent data are available to satisfy the requirment
for subchronic dermal toxicity testing. New Zealand White
rabbits, 10/sex/dose, were exposed dermally to 0 (control)
or 1000 mg/kg of dry-form technical tebuthiuron applied to
10 percent of the total body surface area for 21 days, 6
hours per day. No signs of dermal toxicity or deaths were
reported. Two of the ten treated animals showed slight
erythema, which cleared by day 7. No systemic effects that
could be attributed to dermal exposure were reported.
8. Metabolism
Radiolabeled technical tebuthiuron was administered in the
diet at 100 and 200 ppm (5 and 10 mg/kg bwt/day, respectively),
to lactating rats immediately postpartum. The period of
diet administration was 48 hours. The dams were milked and
the amount of activity in the milk was determined. The mean
14c levels in rats' milk were 2.7 ppm and 6.2 ppm for the
100 and 200 ppm rats, respectively. Technical tebuthiuron
and/or its metabolites appear in milk of lactating rats.
General metabolism studies are not available for technical
tebuthiuron. These studies are required.
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C. Other Science Findings
1. Enviornmental Characteristics
Degradation
Tebuthiuron did not undergo significant degradation at pH 5,
7 and 9 at 25°C in 64 days and is considered stable in sterile
water.
Preliminary data indicate that tebuthiuron is also quite stable
under aerobic and anaerobic soil conditions. Tebuthiuron only
degraded from 8 ppm to 5.7 ppm after 273 days (half life > 1
year); when incubated in loam soil at 25°C and was reported to
degrade in an identical soil under anaerobic conditions with a
halflife of >48 weeks. Similarly, irradiation with an artifical
light that did not quite simulate sunlight resulted in only
42% decomposition after 15 days.
Tebuthiuron appears stable to biological and chemical degrada-
tion under environmental conditions and can be considered
persistent.
; : • Leaching
Preliminary data indicate that tebuthiuron is mobile to very
mobile in loam, loamy sand, and lakeland sand soils and slightly
mobile in silty loam soil. Values of lower than 2 were re-
ported for clay, sandy loam and sand soils. About 40% of residues
of a 30 days sandy loam aged tebuthiuron were found in the
leachate.
Based on the above information, tebuthiuron has the
potential to leach through a variety of soils and contaminate
groundwater. Tebuthiuron was flagged as a groundwater
contaminant through the GWDCI (Ground Water Data Call In)
screen and has been found in shallow groundwater in Texas.
Tebuthiuron will be furthur analyzed in the Agency's
National Pesticides in Well Water Survey.
Existing data which were submitted in response to a Ground
Water Data Call-in have been found to be inadequate to full-
fill Agency guideline requirements. Therefore, additional
data are necessary to fully characterize tebuthiuron1s ability
to contaminate ground water.
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2. Ecological Characteristics
Through dietary administration, tebuthiuron is no more than
slightly toxic to birds; however, avian dietary data are in-
complete. Avian reproductive studies show that tebuthiuron
has no effect on avian reproduction at dietary levels up to
100 ppm.
Tebuthiuron is practically non-toxic (acutely) to fish and
aquatic invertebrates. A fish early life-stage study gives a
MATC (Maximum Allowable Toxic Concentration) between 9.3
and 18 mg/1 based on impaired growth. Aquatic invertebrates show
significant reduction of growth and fecundity at 44 mg/1. The
MATC'for aquatic invertebrates is between 21.8 and 44.2 ppm.
\
Tebuthiuron was practially non-toxic to oyster embryos and
slightly toxic to pink shrimp. No data are included on non-
target insects. As some of the uses of tebuthiuron involve
foliar application to non-crop areas, honey bee exposure is
possible and toxicity to honey bees must be assessed. Therefore,
a honeybee acute contact LD5Q is required.
3. Residue Monitoring
In 1972 tebuthiuron was conditionally registered for control
of brush in rangeland in Texas and Oklahoma. As a requirement
of the registration the registrant was requested to perform
a field monitoring study which would better define this
chemical's actions in aquatic and terrestrial environments.
Instead of a single monitoring study, several studies (EPA
Accession No. 246373) were submitted by the registrant to
fulfill the conditional requirement. While each study had
several deficiencies and none of them would satisfy individ-
ually the data requirement, the series of studies were consider-
ed sufficient to satisfy the monitoring condition of the 1979
registration. In 1982, in response to a request for the addi-
tion of 17 states to the tebuthiuron registration, the Agency
requested that the registrant continue (into a second year) the
monitoring of water and hydrosoil at four study sites. The
Agency is now requiring that these data be submitted to
support the registration of tebuthiuron.
12
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Because of tebuthiuron1s extreme persistence, these monitoring
data are still necessary to determine the long-term availability
of the chemical for runoff into aquatic systems and the likeli-
hood of long-term buildup of tebuthiuron in the soil. Monitor-
ing data are being required through this Registration Standard.
If information from past monitoring is not available or is
determined to be unsatisfactory, a new monitoring study will
be required.
4. Endangered Species
The use of tebuthiuron on rangeland, pastureland, and general
nondrop areas should not pose a hazard to endangered or
threatened terrestrial or aquatic animal species. However,
the use of tebuthiuron on rangeland and pastureland will pose a
hazard to endangered and threatened plant species. Products
containing tebuthiuron with range and pasture uses which are
released for shipment after February 1, 1988 must bear Endangered
Species Labeling.
Endangered Species Labeling for non-crop, wide area, and general
indoor/outdoor treatments is deferred until completion of the
analysis by OES and the Agency of the Non-crop use Cluster.
13
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5. Product Chemistry
The Agency has evaluated the available data, which
identify the ingredients, materials, and manufacturing process
and discuss the physical and chemical properties of tebuthiuron,
In particular, the Agency has noted the possibility of the
formation of nitrosamines. Analysis to identify and quantify
nitrosamines is being required along with additional product
chemistry data requirements identified in the data tables.
D. Tolerance Reassessment
Tolerances have been established for residues of
tebuthiuron in a variety of raw agricultural commodities, in
meat;, fat, and meat byproducts (40 CFR 180.390). EPA has
evaluated the residue and toxicology data supporting tolerances
and has determined:
0 Whether the current tolerances and food additive
regulations are sufficient to cover the actual
residues resulting from use (including uses re-
gistered under FIFRA section 24(c) and intrastate
uses-).
0 Whether group tolerances can be established in
accordance with 40 CFR 180.34(f).
0 Whether in the absence of tolerances, restrictions
on use, grazing, or feeding of treated commodities
are necessary.
0 Whether the tolerances are expressed accurately and
in current terminology.
The regulatory results of the Agency's review are set out in
Section IV.A, Regulatory Positions and Rationales.
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1. Residue Data
The residue data reviewed in support of tebuthiuron
tolerances include the following:
a.. Data on the nature of the residues in both
plants and animals, including identification of major metabo-
lites and degradates of tebuthiuron. The metabolism is not
completely understood. The available plant metabolism data
from the sugarcane study are not adequate because 76 percent of
the total 1^c-activity was nonextractable and was not character-
ized. The metabolites 104(OH), 106, 107, and 108 are not re-
ported to be quantified by the residue analytical method for
grasses.
b. kadiolabeled studies on the uptake, translocation,
and metabolism of tebuthiuron in grass. These studies do not
provide sufficient information regarding residues in plants.
c. Radiolabeled studies on the metabolism of tebuthiuron in
ruminants, including milk. The ruminant studies are not
adequate to permit conclusions regarding the adequacy of exist-
ing or pending tolerances. Animals must be dosed for at least 3
days with ringlabeled [14C] tebuthiuron at a concentration that
will result in sufficient residues for characterization in the
tissues and milk. This study must also elucidate the identities
and quantities of all metabolities in milk, liver, kidney, muscle,
and fat.
d. Storage stability data are needed which demonstrating
residues of tebuthiuron are stable in or on plant and animal
commodities. Sample history information is also needed.
e. Data on the magnitude and levels of residues of
tebuthiuron in individual raw agricultural commodities, animal
products, and processed food and feed items are needed.
2. Toxicology Data
The toxicology data considered in support of the
tolerances include a 1-year dog feeding study,90-day rat feed-
ing study and a raultigeneration rat reproduction study. The
one year dog study showed a NOEL of 25.0 mg/kg bwt/day based on
increased liver, kidney, and thyroid gland ratios-.'and increased
alkaline phosphatase, alanine transaminase, and thrombocyte
count values in high-dose males and females. The 90-day rat
feeding study, had a NOEL of 50 mg/kg bwt/day based on increased
liver and kidney in body weight ratio in males and females in
the high-dose group.
* 15
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3. Tolerances Issued
Tolerance are established for residues of the herbicide
tebuthiuron and its metabolites containing the dimethyl ethyl
thiadiazole moiety in or on the following raw
agricultural commodities (40 CFR 180.390):
Commodities Tolerance(ppm)
Cattle, fat 2
Cattle,*mbyp 2
Cattle, meat 2
Goat, fat 2
Goat, mbyp 2
i Goat, meat 2
;Grass, hay 20
'Grass,rangeland,forage 20
Horse,fat 2
Horse,mbyp 2
Horse,meat 2
Milk 0.3
Sheep, fat 2
Sheep, mbyp 2
Sheep,, meat 2
* mbyp meat product
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationales
Based on a review and evaluation of all available
data and other relevant information on the herbicide tebuthiu-
ron, the Agency has reached the determinations listed below.
1. The Agency will not place tebuthiuron into
special review at this time.
Rationale: Based on available data tebuthiuron does not
exceed the risk criteria for adverse effects in 40 CFR
154.7. Tebuthiuron is not acutely toxic by inhalation in rats
and is Category III. Subchronic feeding studies in rats and
chron'ic feeding studies in dogs indicate only mild effects on
the liver, kidneys, gonads, spleen, and prostate and thyroid
glands.
2. The Agency will not require reentry protection data to be
submitted or impose an interim reentry interval for tebuthiuron
products- at this time.
Rationale; Tebuthiuron does not meet the criteria in Section
158.140 reentry data submitted: acute toxicity appears to be
low (toxicity Category III by the inhalation route), and the
Agency has insufficient evidence of chronic effects and no
evidence of poisoning incidents associated with its use.
Little reentry exposure would be expected from pre-emergent
and early postemergent use of tebuthiuron on non-crop and
rangeland sites.
3. The Agency's data on tebuthiuron in meat and milk
residues are not being assessed at the present time. New data
defining the nature of the residue in animals are required.
Rationale; The Agency has determined a secondary
residue of tebuthiuron in meat and milk occurs through the
ingestion by livestock of treated grass hay, forage, and range
land. However, data defining the nature of the residue in
animals are unavailable. Therefore, the adequacies of avail-
able data on these residues in meat and milk cannot be assessed,
4. The Agency is requiring endangered species lab.eling on
tebuthiuron End-Use-Products registered for use oti range
and/or pastureland in accordance with PR Notice 87-5 (issued
May 1, 1987).
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Rationale; Tebuthiuron was reviewed for endangered species
implications in consultation with the Office of Endangered
Species, U.S. Fish and Wildlife Service. This review resulted
in a determination that use of tebuthiuron on range and/or
pastureland may pose jeopardy to endangered and threatened
plant species. In order to protect these species from harm
endangered species labeling is required. The Labeling is
indentified in Section 4.D of this document.
5. The Agency will not require groundwater advisory state-
ments on tebuthiuron products at this time, but will further
evaluate the potential of tebuthiuron to contaminate ground
water after it has received and evaluated additional required
environmental fate data.
Rationale: Base on column leaching studies, tebuthiuron
is mobile to very mobile in loam, sandy loam, and sand soils,
which indicates that a potential for leaching into ground
water exists. This potential, however, can not be fully
characterized until the Leaching and Adsorption/Desorption
studies are submitted.
6. Additional residue monitoring data for water and hydrosoil
are required.
Rationale: Because of the extreme persistence of tebuthiuron,
monitoring is essential in order to better determine the
long-term availability of tebuthiuron for runoff into aquatic
systems and the likelihood of long-term buildup of tebuthiuron
in the hydrosoil.
7. The present precautionary statements for persons who handle
tebuthiuron products are sufficient for the labels of manufactur-
ing-use and end-use products.
Rationale; Available data indicate that tebuthiuron appears
to have low acute toxicity (Category III). Therefore, the
labeling of these products which contains statements that
caution persons applying or handling this compound, give
first aid instructions, and require the use of precautionary
measures to ensure safe handling of pesticide product, are
adequate.
18
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8. The Agency is requiring residue data for rangeland,
forage grasses, and grass hay.
Rationale; The data available are inadequate to support the
group tolerance in animal feedstuffs because the studies sub-
mitted were for unidentified grass and forage.
9. The Agency has determined that, based on the available
data, it will not establish further food tolerances pending
receipt of the required chronic and oncogenicity studies.
Rationale; These studies must specifically address the
question of potential oncogenic response in the urogenital
system and the liver, with careful attention given to the
histopathology of the kidney and other surrounding organs
due'to tebuthiuron's similarity to Linuron, Diuron and Monuron,
\
10. The Agency has identified certain data that will
receive priority review when submitted to the Agency.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger
the need for further studies which should be initiated as
soon as possible. The following studies have been identified
to receive priority review as soon as they are received by
the Agency.
§158.130 Environmental Fate
161-2 Photodegradation in Water
161-3 Photodegradation on Soil
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching and Adsorption/Desorption
164-1 Soil Dissipation
164-2 Aquatic (sediment) Dissipation
164-5 Soil, Long Term Dissipation
19
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§15,8.145 Wildlife and Aquatic Organisms
70-1 Special Studies - Field Monitoring
§158.150 Plant Protection
122-1 Tier I - Seed Germination/Seedling Emergence
122-1 Tier I - Vegetative Vigor
11. While data gaps are being filled, currently
registered manufacturing-use products and end-use products
containing tebuthiuron must be 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 in order to maintain
existing registrations.
Rationale: Under FIFRA, the Agency may choose not to
cancel or withhold registration if data are missing or are
inadequate. See FIFRA section 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and
evaluated, after which the Agency will determine if additional
regulatory changes are necessary.
20
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain Tebuthiuron as the sole active
ingredient, bear required labeling, and conform to the product
composition, acute toxicity limits, and use pattern requirements
listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain Tebuthiuron
as,the sole active ingredient. Each MP formulation proposed
f6r registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert ingredients which are
present in products/ as well as impurities found at greater
than O.lt.
2.. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing Tebuthiuron
provided that the product labeling bears appropriate precaution-
ary statements for the acute toxicity category in which each
product is placed.
e
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
registered for the uses listed in Appendix B, EPA Index to
Pesticide Chemicals — Tebuthiuron. The EPA Index to
Pesticide Chemicals lists all registered uses, as well as
approved maxinun application rates and frequencies.
21
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D. REQUIRED LABELING
Products subject to the requirements of this Registration
Standard may not be released for shipment after August 1, 1988
unless the product bears amended labeling which complies
with the requirements of this Standard. [EXCEPTION: Endanger-
ed Species labeling must be on products released for shipment
after February 1, 1988 and on all products after February 1,
1989 as specified in. Pesticide Registration (PR) Notice 87-5
(issued May 1, 1987).] After reviewing data to be submitted
under this Standard, the Agency may impose additional labeling
requirements.
Products subject to the requirements of this Registration
Standard may not be distributed, sold, offered for sale, held
for sale, shipped, delivered for shipment, or received and
(having been so received) delivered or offered to be delivered
by any person after August 1, 1989 unless the product bears
amended labeling which complies with the requirements of
this standard.
All products must bear appropriate labeling as specified in
40 CFR 162.10 and in Pesticide Registration Notices applicable
to these products. Specific information regarding 40 CFR
162.10 label requirements is included in Appendix II.
Ingredients Statement
The ingredient statement for MPs must list the active
ingredient as:
N-[5-1,1-dimethylethyl 1-1,3,4-thiadiazol-2yl]
N.N'dimethylurea
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 Appendix B, EPA Index to Pesticide Chemicals -- Tebuthiuron.
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.
22
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Required Precautionary Labeling Statement
Manufacturing-Use Products
"Do not discharge effluent containing this product into lakes,
stream, ponds, estuaries, oceans, or public water unless
this product is specifically identified and addressed in the
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."
End-Use Products with Granular/Pelleted Use
"Collect, cover, or incorporate granules/pellets spilled on the
soil surface. Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes). Do not contaminate
water by cleaning of equipment or disposal of wastes."
End-Use Products with Nongranular/Nonpelleted Use
"Do not apply directly to water or wetlands (swamps, bogs,
marshes.and potholes). Do not contaminate water by cleaning
of equipment or disposal of wastes."
End-Use Products with Ditchbank Use
"Do not apply to any portion of the ditchbank that will
come into contact with water. Do not apply on ditches used to
transport irrigation or potable water."
End-Use Products with Range and/or Pastureland Use
The following information on endangered species must appear on
the labeling of all EPs registered for use on range and/or
pastureland. Statement "A" is to be used on product
labels only if Statement "B" is not on the product label, but
instead, in the product labeling.
[NOTE - EXCEPTIONS: Products used directly on humans or
pets; in, on or around any structure, or vehicle, article,
surface, or area associated with the household, including
but not limited to areas such as out-buildings, non-commercial
greenhouses, pleasure boats, and recreational vehicles, or in
any pre-school or day care facility, and which are labeled
only for such uses are exempt from the labeling^ requirements
to protect endangered species.]
23
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A. "Refer to product labeling for use restrictions to
protect ENDANGERED SPECIES."
B. "ENDANGERED SPECIES RESTRICTIONS
The following restrictions apply to use of this product
after February 1, 1988.
Before using this pesticide on range and/or pastureland
in the counties listed below, you must obtain the PESTICIDE
USE BULLETIN. FOR PROTECTION OF ENDANGERED SPECIES for the
county in which the product is to be used. The bulletin
is available from your County Agricultural Extension
Agenct, State Fish or Game Office, or your pesticide
dealer. Use of this product in a manner inconsistent
with the PESTICIDE USE BULLETIN FOR PROTECTION OF
i ENDANGERED SPECIES is a violation of Federal laws.
' ALABAMA
Cherokee, DeKalb, Etowah, Jackson and Marshall
ARIZONA
Cochise, Coconino, Gila, Graham, Maricopa, Mohave,
Navajo, Pima, Pinal, and Yavapai
CALIFORNIA
Alameda, Butte, Colusa, Contra Costa, Fresno, Glann,
Inyo, Lake, Los Angeles, Mendocino, Merced, Nevada,
Orange, Sacramento, San Benito, San Bernardino, San
Clemente Island, San Diego, San Francisco, San Joaquin,
San Luis Obispo, San Mateo, Santa Barbara, Santa Barbara
Island, Solano, Sutter, Tehema, Ventura and Yolo
COLORADO
Delta, Jackson, La Plata, Mesa, Montezuma and Montrose
FLORIDA
Charlotte, Franklin, Jefferson, Lee, Liberty and
Orange
GEORGIA
Brantley, Towns and Wayne
HAWAII
Islands of Hawaii and Maui and the District of Lahaina
IDAHO
Idaho
ILLINOIS
DuPage, Lee, McHenry, Ogle and Winnebago
IOWA
Butler, Clarke, Dickinson, Emmet, Howard, Kossuth,
Lucas, Oscocola, Story and Winneshiek
24
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KENTUCKY
Fleming, Nicholas and Robertson
MINNESOTA
Cottonwood, Goodhue, Jackson and Renville
MISSOURI
Christian, Dade and Greene
NEBRASKA
Cherry, Garden and. Hooker
NEVADA
Nye
NEW MEXICO
Catron, Chaves, Dona Ana, Eddy, Lincoln, McKinley,
' Otero, San Juan and Sierra
NORTH CAROLINA
Henderson
OREGON
Harney and WaiIowa
SOUTH CAROLINA
Greenville and McCormick
TENNESSEE
Davidson, Rutherford and Wilson
TEXAS
Bandera, Brazos, Brewster, Burleson, Culberson,
Edwards, El Paso, Grimes, Harris, Hays, Hudspeth, Jim
Wells, Kerr, Kimble, Kleburg, Nueces, Pecos, Presidio,
Real, Refugio, Robertson, Runnels, San Augustine, Starr,
Terrell, Uvalde, Val Verde and Zapata
UTAH
Beaver, Cache, Carbon, Duchesne, Emery, Garfield,
Grand, iron, Kane, Piute, San Juan, Sanpete, Sevier,
Uintah, Utah, Washington and Wayne
WISCONSIN
Dane, Pierce, Rock and Sauk "
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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:
i
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 8 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.
26
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B. Manufacturing use products containing this pesticide
as one o£ 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 not eligible for the formulator's exemption, the
data requirements listed in Table A.
, 3. 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 data requirements listed in Table A.
^ 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 B1.
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.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(uniless 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 S 152.85) to submit '
generic data in response to a OCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
- Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
28
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If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of;the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
»-
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
•
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost 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.
29
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
i b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
1 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, .b_ut._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 £580-6, 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:
30
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[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 as required by this
Notice in a timely manner. If. the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)*
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, youj: 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.
3!
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelinesr which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the; OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
•
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend, the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the dat-a than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
32
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX. E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
i
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to Despond 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
33
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
34
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. VII. 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.
\
VIII. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days front receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
.'--..•' •
a. The."FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
•
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that, a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of.-the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be^ submitted to the Office of Compliance Monitoring.
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Five 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.
i 3. Within the times set £orth in Table Af you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B»- Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must' submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
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 il 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.
36
-------
C.. End Use Products containing the subject pesticide either as
s*ole active ingredient or In combination with other active
ingredients*
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA. Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
b. Five copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. -Addresses
The required information must be submitted to the following
address:
Robert J. Taylor (PM 25)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is: *
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
37
-------
TGUIDE-1
GUIDE TO TABLES
Tables A 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.
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.
T^he 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, nbn-food
G = Forestry
H = Domestic outdoor
I * Indoor
Any other designations will be defined in a footnote to the table.
38
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
N(3 - 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.
39
-------
TABLE A .
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
Test Does EPA
Data Requirement Substance Have Data?
SI 58. 120 Product Chemistry
Product Identity
61-1 - Product Identity and TGAI Yes
Disclosure of Ingredients
61-2 - Description of Beginning TGAI Partially
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI Partially
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI Partially
62-2 - Certification of Ingredients TGAI No
62-3 - Analytical Methods to Verify TGAI Partially
Certified Limits
Physical and Chemical
Characteristics
63-2 - Color - TGAI No
63-3 - Physical State TGAI No
63-4 - Odor TGAI No
Must Additional
Bibliographic Data be
Citation Submitted?
desk reference
00020664, 00020742,
00020706, 00020743,
00148606
00020706,
00148606
00156561, 00020744,
00156562, 00027811
00020728, 00156562,
00156561, 00020744,
0002781 1
No I/
Yea^/
Yes 3/
Yes 4/
Yes 5/
Yes 6/
Yes TJ
Yes TJ
Yes TJ
Timeframe
for
Submission
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
40
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
Data Requirement
Does EPA Have
Data to satisfy
Test This Requirement? bibliographic
Substance (Yes, No, Or Partially Citation
Must Additional
Data be
Submitted?
Timeframe
For
Submission
SI 58. 120 Product Chemistry (cont'd)
Physical and Chemical
Characteristics (cont'd)
63-5 -
63-
63-7
63-8 '
63-9
63-10
63-11
63-12
63-13
Other
- Melting Point
Boiling Point
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- pH
- Storage Stability
Requirements
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
No
No
No
Yes 00020773
Yes , 00020773
No
Yes 00020781
No
No
Yea_7/
Yes 7/
Yes TJ
No
No
Yes 1J
No
Yes 11
Yes 77
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
64-1 - Submittal of Samples
N/A
N/A
No 8/
41
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
Does EPA Have
Data to satisfy
Test This Requirement? bibliographic
Data Requirement Substance (Yes, No, Or Partially Citation
SI 58. 120 Product Chemistry (cont'd)
Physical and Chemical
Characteristics (cont'd)
63-5 - Melting Point TGAI No
63- Boiling Point TGAI No
63-7 - Density, Bulk Density, or TGAI No
Specific Gravity
63-8 - Solubility TGAI or PAI Yes 00020773
63-9 - Vapor Pressure PAI Yes 00020773
63-10 - Dissociation Constant PAI No
63-11 - Octanol/Water Partition PAI Yes 00020781
Coefficient
63-12 - pH ,;,; TGAI No
63-13 - Storage Stability TGAI No
Other Requirements
Must Additional Timeframe
Data be For
Submitted? Submission
Yes_7/ 6 Months
Yes If 6 Months
Yes TJ 6 Months
No
No
Yes 7/ 6 Months
No
Yes 7/ 6 Months
Yes 77 1 5 Months
64-1 - Submittal of Samples
N/A
N/A
No 8/
42
-------
TABLE A
GENERIC IttTA REQUIREMENTS FOR TEBUTHIURON
SI58.120 Product Chemistry Footnotes
I/ Information obtained from desk reference.
2/ The name and address of the manufacturer, supplier, or producer of each beginning material must be provided, along
with information regarding the properties of each beginning material,
3/ A detailed discussion of all impurities that are or may be present at > 0.1%, based on knowledge of the beginning
materials (including impurities), chemical reactions (intended and side) in the manufacturing process, and any
contamination during and after production.
A/ Complete validation data (accuracy, precision) must be submitted for each method used. In addition, all
nitrosamines must be identified and quantified in six samples; two samples must be analyzed shortly after
production, 3 months after production, and 6 months after production. A method sensitive to 1 ppm of
N-nitroso contaminants must be used.
5/ Upper and lower limits for tebuthiuron must be provided, certified, and validated by sample analysis using
analytical procedures for which accuracy and precision data have been provided. Upper limits for each impurity
present at >^ 0.1% (w/w) and for each toxicologically significant impurity present at < 0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and
precision data have been provided. Upper limits for all nitrosamines must be provided, certified,
and validated by sample analysis using analytical procedures for which accuracy and precision data have been
provided. Certifications must be submitted on EPA Form 8570 (Rev. 2-85).
6/ Analytical methods must be submitted to determine each toxicologically significant impurity for which a certified
limit is required. Each method must be accompanied by validation studies indicating its accuracy and precision.
These methods must be suitable for enforcement of certified limits.
II All physical/chemical characteristics (color, physical state, odor, melting point, specific gravity, Row, pH,
and stability) for the 95% T, as required in 49 FR 42890 (Section 158.120) and more fully described in the
Pesticide Assessment Guidelines, Subdivision D, must be submitted.
8/ Data are not required to support currently registered uses or are otherwise not applicable for this Standard.
43
-------
TABLE A
GENERIC DATA REQUIREMENTS EOR TEBUTHIURON
Data Requirement
Reg
.125
Test
Substance
Does EPA Have
To Satisfy This
Requirement?(Yes
No.or Partially
Bibliographic
Citation
Hist Additional Timeframe
Data be for
Submitted? Submisson
SI 58
Residue Chemistry
171-4 - Nature of the Residue
(Metabolism)
- Plants
- Livestock
PAIRA
PAIRA
171-4 - Residue Analytical Methods
- Plant and Animal
Res idues
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue
- Grass Forage, Fodder,
1 i
and Hay GroUp
- Meat/Milk/Poultry/Eggs
PAI
PAI
TEP
Partially
Partially
Partially
No
Partially
Partially
00020645,00020756,
00020766
00020648,00020650,
00020651,00020652,
00020721,00020767,
00027805,00027810,
00041675,00106080
00020656,00020740,
00041673,00094745,
00106080
00020705,00020757,
00020764,00041671,
00094745
00041673
Yes 1/.2/ 18 Months
Yes 3/,4/ 18 Months
Yes 5/,6/ 15 Months
Yes 7/8/ 15 Months
Yes 9/.10/ 18 Months
Reserved 11/.12/
44
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TABLE A
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
§158.125 Residue Chemistry Footnotes
]_/ Data must be depicting the uptake, distribution, and metabolism of thiadiazole ring-labeled [^C] tebuthiuron in
rangeland and conducted pasture grass following broadcast application at a rate sufficiently high to permit
complete 14c residue identification.
2/ Representative samples from the required metabolism studies must also be analyzed using accepted enforcement methods
to ascertain that these methods will determine all possible metabolites of concern.
3/ A metabolism study utilizing ruminants must be submitted. Animals must be dosed for at least 3 days with ring-
labeled [14C] tebuthiuron at a concentration that will result in sufficient residues for characterization in the
tissues and milk. Studies must also elucidate the identities and quantities of all metabolites in milk, liver,
kidney, muscle, and fat. Milk must be collected twice daily during the dosing period. Animal must be sacrificed
within 24 hours of the final dose. Since grass is not a poultry feed item, no poultry metabolism study is required
at this time.
4/ Representative samples from the above described test must also be analyzed by current enforcement methods to
~ ascertain the validity of these methods.
5/ Residues of tebuthiuron and metabolites 104, 106, 109, and 103(OH) in or on crop samples must be subjected to
analysis by multiresidue protocols. Protocols for Methods I, II, III, and IV are available from the National
Technical Information Service under Order No. PB 203734/AS.
6/ Additional methods, validation data, and residue data (for representative commodities) may be required if the
~ metabolism studies requested in the sections entitled "Nature of the Residue in Plants" and "Nature of the
Residue in Animals" reveal additional metabolites of toxicological concern in or on plants or in animals.
TJ The storage intervals and conditions must be submitted for all samples used to support all tolerances for residues
~ of tebuthiuron in or on plant and animal commodities. These data must be accompanied by data depicting the decline
of residues during the intervals and under the conditions specified.
8/ Residue data requested in this Standard must be accompanied by information describing the storage conditions and
~~ intervals for all samples analyzed. These data must be accompanied by fortification recovery data depicting the
stability of residues of concern in appropriate sample substrates under the storage conditions and for the time
intervals specifiedr
9_/ Data must be submitted depicting tebuthiuron residues of concern in or on fresh grass and field-dried hay of
bermudagrass, bluegrass, and bromegrass or fescue treated with a single application of a Pellet/Tablets
formulation, by ground or air equipment, at 4 Ib/ai/A. Fresh grass samples must be collected every 2 weeks for the
first 3 months following application, and monthly for the following 21 months in order to determine the maximum
residue level that may occur any time following application. Hay samples must be collected up to 2 years following
the application. If other grasses are tested, the grass species must be identified for each test and the species
must be representative for the region in which it was tested. Tests must be conducted in AR (3%), KS (4%), KY (6%),
MO (11%), NY (5%), OK (4%), PA (4%),~TN (4%), TX (13%), and VA (3%), which collectively produced ca. 57% of the
total domestic hay crop in 1982 (production figures follow in parentheses). Tests must also be conducted in CO
(3%). NE (16%), ND (10%), OR (4%), SD (12%), TX (2%), and WY (5%), which together with KS (8%) and OK (5%),
collectively produced ca. 65% of the total wild hay crop (and thus represent rangeland grasses) in 1982. The
45
-------
TABLE A
GENERIC DYEA REQUIREMENTS VCR TEBUTHIURON
SI58-125 Residue Chemistry Footnote (cont^d)
combined tests will adequately represent the major rangeland and pasture regions of the U.S.
10/ Data depicting tebuthiuron residues of concern in or on fresh grass grown around roots of brush and vine clumps
treated with a Pellet/tablet formulation at 5.9 Ib/ai/A. Grass species must be representative of the region in which
the species is grown. Tests must be conducted in major rangeland regions of the United States.
11/ Presently, the nature of the residue in animals is not adequately understood. On receipt of the data requested in
the section entitled "Nature of the Residue in Animals," 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 the residue in fat, meat, and meat byproducts will be
determined.
12/ Presently, the nature of the residue in animals is not adequately understood. On receipt of the data requested in
the section entitled "Nature of the Residue in Animals," the need for and nature of data regarding the magnitude of
residues in milk will be determined.
46
-------
TABLE A
GENERIC DATA REQUIREMENTS.FOR TEBUIHIURON
Does EPA Have
To Satisfy This Mast Additional Timeframe
Test Use Requirement? Yes, Bibliographic Data be for
Data Requirement Substance Patterns No, or Partially Citation Submitted? Submission
S 158. 130 Environmental Fate
Degradation Studies-Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies-Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Mobility Studies
1 63-1 - Leaching and Adsorption/
Desorption
163-2 - Volatility (Lab)
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
TGAI or PAIRA
TGAI or PAIRA
PAIRA
TEP
TEP '--
B,D
B.D
B,D
B.D
B
B
D
D
B.D
M«M
Yes
No
No
No
No
No
No
No
No
No
No
00020779 No
Yes
Yes
No y
Yes
Yes 2/
Yes
Yes
Yes
No jy
No I/
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
12 Months
163-3 - Volatility (Field)
47
-------
TABLE A
GENERIC DATA REQUIREMENTS. FDR TEBUTHIURON
Data Requirement
S 158. 130 Environmental Fate (cont1
Dissipation Studies-Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and Tank
Mixes
164-5 - Soil, Long-Terra
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops,
165-4 - In Fish
165-5 - In Aquatic Nontarget
Test
Substance
d)
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
PAIRA
TEP
Use
Patterns
B
D
—
B
B
B
D
B,D
__
Does EPA Have
To Satisfy This
Requirement? (Yes Bibliographic
No. or Partially Citation
No
No
No
No
No
No
No
to
No
Hist Additional
Data be
Submitted?
Yes
Yes
No!/
Yes _3/
>i_ /• /
l^fj •' /
M /| /
IwJ • /
Yes
Yes
Nq5/
Timeframe
for
Submission
27 Months
27 Months
50 Months
39 Months
12 Months
Organisms
48
-------
TABLE A
GENERIC DATA RBQUIRBCNTS FDR TEBUIHIURON
S158.130 Environmental Fate Footnote
\J Data are not required to support current registered uses or are otherwise not applicable for this Standard
21 Anaerobic soil metabolism data are required since available leaching data indicate that tebuthiuron has the potential
to leach to depths where anaerobic conditions exist.
3/ Required pending results of field dissipation study.
5/ Not required as long as the land to vMch tebuthiuron is applied is not intended for future crop use.
5/ Unless requested by EEB.
49
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
Data
S158,
Test
Requirement Substance
.135 Toxicology
Does EPA Have Data Must Additional
To Satisfy This Data Be Timeframe
Use Requirement? (Yes, Bibliographic Submitted? for
Patterns No, or Partially) Citation Submission
Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
Rabbit
- Dermal Sens itizat ion -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A.B.D
A,B.D
A.B.D
A.B.D
A.B.D
A.B.D
A.B.D
No
No
Yes
No
No
No
No
Yes
Yes
00155730 No
Yes
Yes
Yes
No I/
9 Months
9 Months
9 Months
9 Months
9 Months
Subchronic Testing
82-1
82-2
- 90-Day Feeding.;,;
- Rodent
- Nonrodent
- 21 -Day Dermal
TGAI
TGAI
TGAI
A.B.D
A.B.D
A.B.D
Yes
No
Yes
00020662 No
No 2y
00149733 No
50
-------
TABLE A
GENERIC TATA REQUIREMENTS FDR TEBUIHIURON
Data
S158.
Test
Requirement Substance
.135 Toxicology
Does EPA Have Data Must Additional
To Satisfy This Data Be Timeframe
Use Requirement? (Yes, Bibliographic Submitted for
Patterns No, or Partially) Citation Submission
Subchronic Testing (cont'd)
82-3
82-4
82-5
- 90-Day Dermal
- 90-Day Inhalation
- 90-Day Neurotoxicity
TGAI
TGAI
TGAI
A.B.D
A.B.D
A.B.D
No
No
ND
No I/
No 3/
No 4/
Chronic Testing:
83-1
83-2
83-3
83-4
- Chronic Toxicity
- Rodent
- Nonrodent
- Oncogenicity Study
- Rat
- Mouse
- Teratogenicity
- Rat
- Rabbit
- Reproduction
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI -
A.B.D
A.B.D
A.B.D
A.B.D
A.B.D
A.B.D
A.B.D
No
Yes
No
No
No
No
Yes
Yes
00146801 No
Yes
Yes
Yes
Yes
00020739, No
00090108
50 Months
50 Months
50 Months
15 Months
15 Months
51
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
Data Requirement
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes,
Substance Patterns No, or Partially)
Bibliographic
Citation
Must Additional
Data Be
Submitted
Timeframe
for
Submission
S158.135 Toxicology (cont'd)
Mutagenicity Testing
84-2 - Gene Mutation
TCAI
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
A,B,D
A.B.D
A.B.D
Special Testing
85-1 - General Metabolism PAI or PAIRA A.B.D
Yes
No
No
Partially
00144041,
00141691
00106081
No
Yes
Yes
Yes
12 Months
12 Months
24 Months
\J This is only for compounds that are organophosphate inhibitors of chlinesterase, or related to such
inhibitors or are metabolites of such inhibitors. Tebuthiuron is not an organophosphate; therefore, a study is
not required.
2/ A subchronic oral toxicity study in a nonrodent species is not required because there is a 1-year dog study
avalable.
3/ This study is not required for the present use pattern.
4/ Since an acute neurotoxicity study is not required, and there is no evidence of neurotoxicity in mammalian species,
this study is not required.
5/ Data defining the absorption, distribution, and metabolites and their excretion patterns must be submitted
and are required.
52
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR TEBUTHIURON
Does EPA Have Data Must Additional
To Satisfy This Data Be Timeframe
Test Use Requirement? (Yes, Bibliographic Submitted for
Data Requirement Substance Patterns No, or Partially) Citation Submission
S158,
.145 Wildlife and Aquatic
Organisms
Avian and Mammalian Testing
71-1
71-2
71-3
71-4
71-5
- Avian Oral UijQ
- Avian Dietary LC5Q
- Wild Mammal Toxiclty
- Avian Reproduction
- Upland Game Bird
- Waterfowl
- Simulated and Actual
Field Testing
- Mammals and Birds
TGAI B Yes 00041692 No
TCAI B No Yes 9 Months
TGAI B No No I/
TGAI B Yes 00104243 No
TGAI B Yes 00093690 No
TEP B No No I/
Aquatic Organism Testing;
72-1
72-2
- Freshwater Fish IC$Q
- Warmwater
- Coldwater
- Acute LCso Freshwater
Invertebrate
TGAI B Yes 00020661 No
TGAI B Yes 00020661 No
TGAI B Yes 00041694 No
53
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEBUTHIURON
Test
Data Requirement Substance
§158.145 Wildlife and Aquatic
Organisms (cont'd)
Aquatic Organism Testing (cont'd)
72-3 - Acute LC5Q Estuarine and
Marine Organisms
- Fish TGAI
- Shrimp TGAI
- Oyster TGAI
72-4 - Fish Early Life Stage
and Invertebrate
life Cycle
Fish
- Fathead Minnow TGAI
- Rainbow Trout TGAI
Invertebrate
i t
- Daphnia magna TGAI
72-5 - Fish Life Cycle
- Estuarine TGAI
- Freshwater TGAI '
Does EPA Have Data Must Additional
To Satisfy This Data Be Timeframe
Use Requirement? (Yes, Bibliographic Submitted for
Patterns No, or Partially) Citation Submission
B No No 21
B Yes 00041684 No
B Yes 00041684 No
B Yes _3/ 00090084 No
B Yes 3/ 00090083 No
B Yes 3/ 00138700 No
B No No \l_
B No No I/
54
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TABLE A
GENERIC DYTA REQUIREMENTS FOR TEBLTTHIURON
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No. or Partially)
Must Additional
Data Be
Submitted
Data Requirement
Test
Substance
Use
Patterns
Bibliographic
Citation
Timeframe
for
Submission
Organisms (cont d)
Aquatic Organism Testing (cont'd)
72-6 - Aquatic Organism
Accumulation (Fish)
72-7 - Simulated or Actual
Field Testing
Aquatic Organisms
TGAI
TGAI
B
B
No
No
Yes 4/
No I/
12 Months
70-1
- Special Studies TEP B
Field Monitoring
Partially
00090105,
00090106,
00090107,
00090109
Yes 5/
36 Months
\J Available information on this chemical and its use pattern indicate the study is not required.
2/ The requirement for testing with a marine or estuarine fish species will be waived because of the demonstrated low
toxicity of tebuthiuron to fresh water fish.
3/ Tebuthiuron is expected to transport to water with terrestrial use, Tebuthiuron is persistent in water (half-life
greater than A days).
4/ Required by the Exposure Assessment Branch, OPP, EPA.
T/ Needed are additional residue monitoring data for water and hydrosoil. In 1982, the registrant was requested to
continue (into the second year) the monitoring of water and hydrosoil at the four study sites, especially in the
catchment pond at the Marietta, Oklahoma site. Tebuthiuron is extremely persistent in soil (half-life 11 to 61
months). Because of this persistence, this additional monitoring is essential in order to better determine the
long term availability of tebuthiuron for runoff into aquatic systems and the likelihood of long -term buildup of
tebuthiuron in the hydrosoil. Monitoring should be conducted at least into the second year. If additional
monitoring was not conducted at that time and if no data addressing the above concerns are available, the
registrant is required to submit a protocol for additional monitoring within 6 months. This residue moniotoring
(for a rangeland use) should be a multiple year study and should be conducted at four separate sites representing
a wide range of climatic, edaphic, and geographical conditions. A pelleted/tableted formulation should be used.
55
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TABLE A
GENERIC D^TA REQUIREMENTS FOR TEBUTHIURON
Data Requirement
SI 58. 150 Plant Protection
121.1 - Target Area
Phytotoxicity
Nontarget Area Phytoxicity
TIER I
122-1 - Seed Germination/
Seedling Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
123-1 - Seed Germination/
Seedling Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER III
124-1 - Terrestrial Field
124-2 - Aquatic Field
Test
Substance
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
Use
Patterns
B
B
B
B
B
B
B
B
B
Does EPA Have Data
To Satisfy This
Requirement? (Yes ,
NOj or Partially)
No
No
No
Yes
No
No
No
No
No
Must Additional
Data Be
Bibliographic Submitted
Citation
No_[/
Yes 2/
Yes 2/
00138697 No
Reserved 3/
Reserved 3J
Reserved 3/
Reserved 4/
Reserved 4/
Time frame
for
Submission
9 Months
9 Months
56
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§158.150 Plant Protection Footnotes~
I/ Data are required only on a case to case basis.
?/ In the opinion provided by the Office of Endangered Species for the Rangeland Cluster, tebuthiuron was list-
ed as causing jeopardy to endangered and threatened plant species.
3/ Reserved pending results of Tier I phytotoxicity tests.
4/ Reserved pending results of Tier II phytotoxicity tests.
57
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TABLE A
GENERIC DYTA REQUIREMENTS FOR TEBUTHIURON
Data Requirement
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes,
Substance Patterns No. or Partially)
Bibliographic
Citation
Must Additional
Data Be
Submitted
Timeframe
for
Submission
§158.155 Nontarget Insect Testing
Nontarget Insect Testing -
Pollinators
141-1 - Honey Bee Acute TGAI
Contact Toxicity
141-2 - Honey Bee - Toxicity TEP
of Residues of Foliage
141-4 - Honey Bee Subacute Reserved
Feeding Study
141-5 - Field Testing for TEP
Pollinators
Nontarget Insect Testing -
Aquatic Insects
142-1 - Acute Toxicity to Reserved
Aquatic Insects
142-1 - Aquatic Insect Reserved
Life Cycle Study
1 i
142-3 - Simulated or Actual Reserved
Field Testing for
Aquatic Insects
143-1 - Nontarget Insect Reserved
thru Testing - Predators
143-3 and Parasites
B
B
No
No
Yes
Reserved JL/
9 Months
B
No
Reserved
58
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TABLE A
GENERIC EfcTA REQUIRETCNTS FOR TEBUIHIURON
S158.155 Nontarget Insect Testing Footnotes
1/ Requirement deferred pending receipt of data from honey bee acute contact LE^O test.
Y/ Reserved pending development of test methodology.
3/ Reserved pending Agency decision as to vrfiether the data requirement should be established.
59
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SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address"
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number' assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)1
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is -immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the Body of other text. [40 CFR 162.10(g)"]
"W--60 -
-------
SUMMARY-2
Item 68. 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
j above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
1 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)(1)(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. J40 CFR 162.10-(h ) ( 2) ] .
- 61
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h) (2) (i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms, excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires" that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
foe 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, yotf must submit any information and
rationale with your application for reregistr^tion. During
the Agency's review of your application, your'proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification-decision.
62
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
1 a summary statement of the terms of restriction must
; appear (including the reasons for restriction if specified
' in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
•. a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products" must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
63
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency/ it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the ,use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasoaable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which *is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
64
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SUMMARY-6
LABELING REQUIREMENTS OF THE! FIFRA, AS AMENDED
ITEM
1
2
3
• • -» *
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Prdduct name
Company name
and address
het contents
fePA Reg. fao.
EPA Est. No.
x*
Ingredients
statement
Pqunds/ga 1 Ion
statement
i-
Front panel
precautionary
• statements
Keep Out of Reach
of Children '..;
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT,
All products
All products
All products
Xll products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
-•- -r -T -> — — •-r->~* — ^r^i-r-i-
PLACEMENT
REQUIRED
Front panel
-•
None
None
Mbhe
None
Front panel
Front panel
Front panel
Front panel
Front panel
— -_T--T«
ON LABEL
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, trust
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
. i
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
65
-------
SUMMARY-7
•
ITEM
7c
+
^7D
7E
8
8A
"~BB r
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or '*'
First Aid
Referral
statement
i i
SideA>ack panel
precautionary
statements
'Hazards to
humans and
domestic
animals
BSAffiBniBntal
APPLICABILITY
OP REQUIREMENT
KQ products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion tpxicit£
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
AH products
PLACEMENT
REQUIRED
Front panel
-» •»_- n-iknii-ii_«»Ti
Category^ I : .
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Vrpht panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above 1
1
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
1 ^^-^
SSMftf§fin»n*f4 flppfctdsbleclude bee ^^
-------
SUMMARY-8
ITEM
8C
9A '
9B
~ft5A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement ^
Reentry
statement
Storage and
disposal block
1 t \
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
„ — - . . •- — . . . j — 4— — -^
PLACEMEN!
REQUIRED
None i
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
P ON LABEL
' PREFERRED
'Same as above
Preferably
blocked
.
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other* directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
67
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Chapter 1—Environmental Protection Agency
5162.10 Labeling requirements.
•(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of bhis section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph ,(h) of this section;
(viiij The. directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this sectign.
(2) Prominence and legibility, (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood .
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear In the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary,-all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
68
-------
pesticide product.. For purposes of this Section, and the mis-
branding provisions of the Act/ "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrappe'r or outside container
through-which the la-be 1 cannot be clearly read* the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii> Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit* the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act. pursuant to S 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
69
-------
(ix) Claims as to the safety of the pesticide^ or its ingredients
including statements such as "safe/" "nonpoisonous/* "noninjurious/1
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as.directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product/ including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except as provided in
paragraph (a)(6)(ii) of this section/ final printed labeling must
be submitted and accepted prior to registration. However/ final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name/ brand/ or trademark. (1) The name/ brand/ or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name/ brand/ or trademark may appear on the label which:
(i) "Is false or misleading/ or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to $-162.6(b)(4).
(c) Name and address of producer/ registrant/ or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer/ or if the name of the person for whom the
pesticide was produced appears on the label/ it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***
/
or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid/ the net content statement
shall be in terms of liquid measure at 68*P (20*C) and shall be
expressed in conventional American units of fluid ounces/ pints/
quarts/ and gallons.
(3) If the pesticide is solid or semisolid/ viscous or
pressurized/ or is a mixture of liquid and solid/ the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases/ net content shall be stated in terms of the
largest suitable units/ i.e., "1 pound 10 ounces" rather than
"26 ounces. " •
70
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by'the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall; not appear in such a manner as to suggest or imply .
recommendation or endorsement of the product by the Agency.
(f)' Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.V of the final establishment at which the product was produced
may appear'in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate.container cannot be clearly read through such wrapper
or container? • - - - •
(g) Ingredient statement—(1) General. The label of each
pesticide, product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental a'rsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot\ be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears/ and must be
clearly distinguishable from and must not be placed in the body
of other text.
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one/ followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone'shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall'be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements;:
(i) In cases where it is determined that a pesticide formulation
changes* chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require -the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas, of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard, warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
72
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Hazard Indicators
Oral L£>
50
Inhalation LCM
so
OenMl LO
; *°
Eye effects
;:.:'.':'"
Skin effects
. •••
1
Up to and
Including
30 eg/kg
Up to and
Including
.2 Bg/t tter
Up to and
Including
200 ag/kg
Corrosive;
cornea! opacity
not reversible
within 7 days
Corrosive
r
Toxicity <
II
FroB 30 thru
300 Bg/kg
\
FroB .2 thru \
2 Bg/l Iter
Froa 200
thru 2000
Cornea! opacity
reversible
vlthtn 7 days;
Irritation
persisting, for
7 days
•
Severe Irritation
at 72 hours
wteoorles
III
FroB 300 thru
3000 ag/kg
Fro» 2 thru
20 Bg/Mter
FroB* 2.000 thru
20.000
No cornea 1 opacity;
Irritation
reversible
vlthtn 7 days
Moderate Irritation
at 72 hours
IV
Greater than
3000 eg/kg
Greater than
20 ng/l Iter
Greater than
. 20.000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger.". In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel'
the signal word "Warning."
(C) Toxicity Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word "Caution."
(D) Toxicity Category IV.
All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
73
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(E) use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazaro" signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where, the likelihood of contact with
children during distributionr marketing, storage or use is
demonstrated by the applicant to be extremely remoter or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—tA) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) ofx this, section. The applicant may,
however, include such a front panel statement at his .option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements.for the
front panel warning statements on various sizes of labels:
Size of label frqnt panel
in square inches
Above 5 to 10
Above 10 to 15
Above 15 to 30 .
Poir
Required
signal word,
all capitals
6
10 -:
12
14 -
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
74
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading 'Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental- Hazard" and "Physical or
Chemical. Hazard«"
*(i) Hazard to humans and domestic animals* (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident* injury
or damage. The precautionary paragraph^shall b« immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards. »
I
Precautionary statements by toxicIty category
Toxic ITy [
category
Oral. Inhalation, or dermal tonic 11>
Skin and eye local effects
I .
II . .
Ill . .
tv . .
I Fatal (poisonous) If svalloved (Inhaled or
)• absorbed through sklnl. Do not breathe
vapor (dust! or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
required.).
May be fatal If svalloved (Inhaled or
absorbed through the sklnl. Do not breathe
vapors (dust or spray mist). Do not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.].
Harmful If svalloved I Inhaled or absorbed
through the skin). Avoid breathing vapors
(dust or spray mist). Avoid contact vlth
skin (eyes or clothing). (Appropriate
first aid statement required.).
ino precautionary statements required.).
Corrosive, causes eye and skin damage lor
skin Irritation). Do not get In eyes, on
skin, or on clothing. Veer goggles or face
shield and rubber gloves vhen handling.
Harmful or fatal If svalloved.
{Appropriate first aid statement required.)
Causes eye land sklnl Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If svalloved. (Appropriate first
aid statement required.).
Avoid contact vlt* skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin vlth plenty of vater. Set
medical attention If Irritation persists.
(No precautionary statements required.).
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
75 -
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damage.* Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoortuse contains an active
ingredient with a mammalian acute oral LD$Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LCso of 1 ppm or less, the statement
•This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LDso of 100 mg/kg or less, or
a subacute dietary LC$Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required. %
; (E) For uses involving foliar application to agricultural
crops, forests* or shade trees, or for mosquito abatement
'treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(i.ii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
(A) PRESSURIZED
Flash point at or belw 20*F; If tnere Is •
flashback it any valve opening.
Flesh point above 20*F and not over 80*F or If
tti* flam extension Is •orethee 18 In. long
at a distance of * In. from the flee*.
\
(B) MONPRESSURI2
Required text
*
CONTAINERS
Extreeely f loanable. Contents under pressure.
Keep aeey fro* fire, sparks, and Mated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
I30*F eey cause bursting.
FlewMble. Contents under pressure* Keep away
from neat, sparks, and open flaaw. Do not
puncture or Incinerate container. Exposure to
temperatures above 130*F eey cause bursting.
Contents under pressure. Oo not use or store
near heat or open flame. Ob not puncturt or
Incinerate container. Exposure to teepere-
tures above t30*F My cause bursting.
!ED CONTAINERS
Extremely flammable. Keep •••y from flr«.
sparks, and heated surfaces.
Flammable. Keep away fro* heet and open flame.
Oo not use or store near heat or open f lame*
76
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( i) Directions for Use— (1) General requirements— ( i ) Adequacy
and clarity of directions* Directions for use nrust be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and-from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided thatr
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag; •
(B) i The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided thatr
H) The label clearly shows that the product is intended for
use~~only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of'
product involved and its proper use in manufacturing processes;
(2) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
U) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to.prevent unreasonable adverse effects on man or the
environment; and \
(3) The product is also a drug and regulated under the provisions
of the Federal Pood, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(I) There is information readily available to.the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
77
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(2) The label clearly states that the product is intended for
use~~only in manufacturing, formulating, mixing/or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use.* The directions for use
shall include the following, under theSheadings "Directions for
Use":
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use.*
(ii) Immediately below the statement of vise classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment* requried.
(viij The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has'been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in S 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops. *
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved] "
(E) For restricted use pesticides, a statement .that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision-of a certified
applicator who is physically present.
78
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be 'subject to the
provisions of $ 162.10(j){2).
(!)• General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement
-------
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20'F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80*F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint abpve 20"F
and not over 80*F.
C. Flashpoint over 80*F
and not over 150*F>
0. Flashpoint above
150'F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130*F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure "to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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STOR-1
\
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
S_ tor age, 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.
8.1
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Pomes tic, .use _p_ro_d_u_c_ts. must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(bags)
Aerosol products
\
Do not reuse container (bottle, can, jar).
Rinse thoroughly^ before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All oth_er products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
\
Glass containers
Fiber drums
with liners
»
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or. equivalent). Then offer
for recycling or reconditioning, pr 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 emp.ty 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
Veusedi., dispose of. in the same manner.
Completely empty bag into application
equipment. Then disposes of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke., ~ .
Return empty cylinder for reuse (or
similar wording) .
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording; that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or Toxicity
Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a viola-
tion of Federal Law. If these wastes cannot be disposed
of by use according to label instructions, contact your
State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 *CFR
261, Subpart C for a hazardous waste must bear the following
pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according
to label instructions, contact your State Pesticide or Environ-
mental Control Agency, or the Hazardous Waste representative
at the nearest EPA Regional Office for guidance."
*
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal state-
ment:
\
"Wastes resulting from the use of this product may be dis-
posed of on site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the follow-
ing disposal statement:
"Securely wrap original container in several layers of
newspaper and discard in trash."
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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,
i 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
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
84
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
; appears as (19??), the Agency was unable to determine
i or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number/of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
' K 85
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthiuron Standard
MRID CITATION
00020645 Ralney, O.P.; Magnussen, J.D. (1975) Metabolism of 14C EL-103 in
Sugarcane. (Unpublished study received Jul 9, 1975 under
5G1562; submitted by Elanco Products Co., Oiv. of Eli Lilly and
Co., Indianapolis, Ind.; CDL:094913-E)
00020648 Rainey, D.P.; Magnussen, J.D.; Herberg, R.J. (1975) 14C EL-103 in
the Ruminant Excretion and Tissue Residues. (Unpublished study
i received Jul 9, 1975 under 5G1562; submitted by Elanco Products
Co., Div. of EH Lilly and Co., Indianapolis, Ind.; COL:
094913-H)
00020650 Herberg, R.J. (1975) 14C EL-103 Milk Residue Experiment: Experiment
VPR 330-766. (Unpublished study received Jul 9, 1975 under
5G1562; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL:094913-J)
0002065L Herberg, R.J. (1975) 14C EL-103 Swine Tissue Residue Study: Experi-
ment SW-457. (Unpublished study received Jul 9, 1975 under
. . 5G1562; submitted by Elanco Products Co., Div. of EH Lilly and
Co., Indianapolis, Ind.; COL:094913-K)
00020652 Herberg, R.J. (1975) 14C EL-103 Chicken Tissue Residue Study: -Ex-
periment VPR 335-766B. (Unpublished study received Jul 9, 1975
under 5G1562; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:094913-L)
00020656 Decker, O.D.; Sullivan, W.L.; Sherman, W.E. (1975) Determination of
Tebuthiuron and Metabolites 1n Cattle Tissues. Undated method
5801644. (Unpublished study received Jul 9, 1975 under 5G1562;
submitted by Elanco Products Co., Div. of EH Lilly and Co.,
Indianapolis, Ind.; COL:094913-Q)
00020661 Todd, G.C.; Kehr, C.C.; West, H.C.; et al. (1972) The Acute Toxi-
city of EL-103 in Mice, Rats, Rabbits, Cats, Dogs, Quail, Ducks,
Chickens, and Fish. (Unpublished study received Mar 13, 1973
under 1471-97; prepared in cooperation with Bionomics, Inc.,
submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
Indianapolis, Ind.; CDL:006422-F)
00020662 Todd, G.C.; Gibson, W.R.; Kiplinger, G.F. (1972) The Toxicological
Evaluation of EL-103 in Rats for 3 Months. (Unpublished study
received Mar 13, 1973 under 1471-97; submitted by-Elanco Prod-
ucts Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:
006422-G)
.86
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthluron Standard
MRID CITATION
00020664 Elanco Products Company (19??) Preparation of Spike SOW (EL 103).
(Unpublished study received Apr 20, 1977 under 1471-97; CDL:
229361-C)
00020705 Loh, A. (1978) Residue Data on Tebuthiuron and Metabolites 1n
Forage Grass and Hay. (Unpublished study received Apr 6, 1978
under 1471-109; submitted by Elanco Products Co., Div. of Eli
; Lilly and Co., Indianapolis, Ind.; CDL:097019-B)
00020706 Tao, E.Y.P. (1977) Appraisal of Thioureas in Tebuthiuron. (Unpub-
lished study received Apr 6, 1978 under 1471-109; submitted by
Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:097019-C)
00020714 Todd, G.C.; Gibson, W.R.; Hoffman, D.G.; et al. (1976) The Toxico-
, logical Evaluation of Tebuthiuron (EL-103) in Rats for Two
...*-:. Years: Toxicology Report # 7. (Unpublished study received Dec
1, 1976 under 1471-EX-43; submitted by Elanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL:230139-A)
00020717 Todd, G.C.; Gibson, W.R.; Hoffman, D.G.; et al. (1976) The Toxico-
logical Evaluation of Tebuthiuron (EL-103) in Mice for Two-
Years: Toxicology Report # 8. (Unpublished study received Dec
1, 1976 under 1471-EX-43; submitted by Elanco Products Co., Div.
of Eli Lilly and Co., Indianapolis, Ind.; CDL:230139-D)
00020721 Ralney, D.P. (1976) Characterization of Milk Residues from a Cow
Fed !4C-Tebuth1uron, (Unpublished study received Dec 23, 1976
under 1471-EX-43; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL.-237161-B)
00020728 Eli Lilly and Company (1973) Raw Material: Corporate Control Labo-
ratory Procedure. Method OA 182R dated Oct 23, 1973. (Unpub-
lished study.
00020739 Adams, E.R.; Todd, G.C.. (1979) Additional Statistical Analyses and
Discussion of Body Weight Data in the Multi-Generation Reproduc-
tion Study with EL-103 1n the Rat. (Unpublished study received
May 22, 1979 under 1471-109; submitted by Elanco Products Co.,
Div. of Eli Lilly and Co., Indianapolis, Ind.; COL:098312-A)
00020740 Macy, T.D.; Loh, A. (1977)-Determination of Tebuthiuron and Metabo-
lites in Milk and Cattle Tissues.. Undated method no. 5801684.
(Unpublished study received Feb 18, 1977 under 1471-109; submit-
ted by Elanco Preducts.Co., Div. of Eli Lilly and Co., Indian-
apolis, Ind.; CDL:095848-C)
' /'.. 87
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthiuron Standard
MRID CITATION
00020742 Tao, E.Y.P. (1977) Preparation of EL103. (Unpublished study re-
ceived Feb 18, 1977 under 1471-109; submitted by Elanco Prod-
ucts Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:
095848-G)
00020743 Tao, E.Y.P. (1976) Source and Purity of Starting Materials for
Spike. (Unpublished study received Feb 18, 1977 under 1471-109;
• submitted by Elanco Products Co., Div. of Eli Lilly and Co.,
! Indianapolis, Ind.; COL:095848-H)
»
00020744 Frank, R. (19??) Determination of Tebuthiuron and Its Related Manu-
facturing By-Products in Technical Grade Material. (Unpublished
study received Feb 18, 1977 under 1471-109; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
CDL:095848-I)
00020750 Elanco Products Company (19??) Storage Stability. (Unpublished
study received Feb 18, 1977 under 1471-109; CDL:095848-P)
00020756 Rainey, D.P.; Magnussen, J.D. (1976) Metabolism of 14C Tebuthiuron
in Range Grasses: Supplemental Report. (Unpublished study re-
ceived Sep 29, 1976 under 1471-EX-43; submitted by Elanco P.rod-
ucts Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:
095298-C)
00020757 Loh, A.; Macy, T.D. (1976) Tebuthiuron and Metabolites in Forage
Grass. (Unpublished study received Sep 29, 1976 under 1471-EX-
43; submitted by Elanco Products Co., Div. of E11 Lilly and Co.,
Indianapolis, Ind.; CDL:095298-0)
00020764 Bovey, R.W. (1975) Summary of Data. Summary of study 210135-E.
(Unpublished study received Sep 3, 1975 under 1471-EX-43; pre-
pared by Texrfs A & M Univ., submitted by Elanco Products Co.,
D1v. of Eli Lilly and Co., Indianapolis, Ind.; CDL:094906-F)
00020766 Rainey, D.; Magnussen, J. (1975) Metabolism of 14C Tebuthiuron
in Range Grasses. 'Unpublished study.
00020767 Herberg, R.J. (1975) 14C EL-103 0.04 PPM Milk Residue Study: Exper-
iment YPR 343-766. (Unpublished study received Sep 3, 1975 un-
der 1471-EX-43; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:094906-J)
00020773 Elanco Products Company (19??) Chemical and Physical Properties:
EL-103. (Unpublished study received "Aug 16, 1977 under un-
known admin, no.: CDL:231275-A)
88-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthiuron Standard
MRID CITATION
00020779 Hosier, J.W.; Saunders, D.G. (1976) A Hydrolysis Study on the Her-
bicide Tebuthiuron. Includes undated method. (Unpublished
study received Feb 18, 1977 under 1471-109; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
COL:095854-F)
00020781 Macy, T.D.; Loh, A. (1976) N-Octanol-to-Water Partition Coefficient
of Tebuthiuron. Includes method dated Nov 1976. (Unpublished
study received Feb 18, 1977 under 1471-109; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.;
., CDL:095854-H)
00020803 Todd, G.C.; Marlcham, O.K.; Adams, E.R.; et al. (1972) Rat Teratol-
ogy Study with EL-103. (Unpublished study received Mar 13, 1973
under 1471-97; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:006422-0)
00027805 Herberg, R.J. (1975) 14C EL-103 Chicken Egg Residue Experiment: Ex-
, perlment VPR 334-766. (Unpublished study received Jul 9, 1975
* under 5G1562; submitted by Elanco Products Co., Div. of EH
Lilly and Co., Indianapolis, Ind.; CDL:094913-M)
000278U Day, E.; Koenig, D. (1976) Determination of N-Nitroso Contaminants
in Tebuthiuron Technical and Spike Pelleted Formulations.
Includes undated method. Unpublished study.
00028710 Channon, E.J.; Cryer, P.C. (1978?) Amltraz: Investigation of
Effects on the Thymus Gland and Oestrous Cycle 1n Mice—Statis-
tical Analysis of Vaginal Smear Data and Thymus Weights:
SS78001; C13. (Unpublished study received Apr 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals Co., Wil-
mington, Del.; CDL:099363-0)
00034756 Davis, E.A.; Sullivan, W.L.; Loh, A. (1980) Tebuthiuron Residues in
Stream Water following the Spot Treatment of a Chaparral Water-
shed 1n Arizona. (Unpublished study received May 8, 1980 under
1471-109; prepared in cooperation with Arizona State Univ.,
Rocky Mountain Forest, and Range Experiment Station, Forestry
Sciences Laboratory, submitted by Elanco Products Co., Div. of
EH Lilly and Co., Indianapolis, Ind.; CDL:242458--A)
00041671 Frank, R.; Loh, A.; Macy, T. (1976) Residue Data on Tebuthiuron and
Metabolites in Forage Grass. Includes undated method no.
5801667. (Unpublished study received Feb 18, 1977 under 1471-
109; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL:095852-D)
89
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthluron Standard
MRID CITATION
00041673 Day, E.W.; Decker, O.D. (1976) Residue Data on Tebuthiuron and Me-
tabolites 1n Cattle Tissue. Includes undated methods ATM and
5801661. (Unpublished study received Feb 18, 1977 under
1471-109; submitted by Elanco Products Co., D1v. of Ell Lilly
and Co., Indianapolis, Ind.; CDL:095852-F)
00041675 Ralney, D.P.; Magnussen, J.D.; Herberg, R.J. (1976) Determination
and Chacterization of Radioactive Residues in Milk from a Cow
1 Given 14C Tebuthiuron. (Unpublished study received Feb 18, 1977
\ under 1471-109; submitted by Elanco Products Co., Div. of Eli
Lilly and Co., Indianapolis, Ind.; CDL:095852-H)
00041684 Heitmuller, T.; Parrish, R. (1976) Acute Toxldty of EL-103 to Em-
bryos of Eastern Oysters (Crassostrea vlrginica), to Pink
Shrimp (Penaeus duorarum), and to Fiddler Crabs (Uca pugllator).
(Unpublished study received Feb 18, 1977 under 1471-109;
* submitted by Elanco Products Co., Div. of E11 Lilly and Co.,
Indianapolis, Ind.; CDL:095855-H)
00041692 Kehr, C.C.; Hamelink, J.L.; Todd, G.C.; et al. (1978) The Acute'
Oral Toxiclty of Compound 75503 (EL-103) 1n Mallard Ducks:
Study 7021-77. (Unpublished study received Jun 1, 1978 under
1471-109; submitted by Elanco Products Co., D1v. of EH Lilly
and Co., Indianapolis, Ind.; CDL:097102-A)
00041694 Hamelink, J.L.; Todd, G.C.; Brannon, D.R.; et al. (1978) Acute
Toxlcity of Compound 75503 (EL-103) to Daphnla magna: Study
5058-77. (Unpublished study received Jun 1, 1978 under 1471-
109; submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL:097102-C)
00090083 Sauter, S.; Meyerhoff, R.D.; Todd, G.C.; et al. (1981) The Toxicity
of Tebuthiuron (EL-103, Compound 75503) in Water to Rainbow
Trout (Salmo galrdnerf) 1n a 45-day Embryo-larvae Study:
Study F14580. Includes method AM-AA-CA-J024-AB-755 dated Jan
26, 1981. (Unpublished study received Dec 10, 1981 under 1471-
109; submitted by Elanco Products Co., D1v. of Eli Lilly and
Co., Indianapolis, Ind.; CDL:246375-A)
00090084 Sauter, S.; Meyerhoff, R.D.; Todd, G.C.; et al. U981) The Tox-
icity of Tebuthiuron (EL-103, Compound 75503) in Water to Fat-
head Minnows (Pimephales promelas) in a 33-day Embryo-larvae
Study: Study F08381. Includes method AM-AA-CA-0024-AB-755 dated
Jan 26, 1981. (Unpublished study received Dec 10, 1981 under
1471-109; submitted by Elanco Products Co., Qiv. of Eli Lilly
and Co.,,Indianapolis, Ind.; CDL:246375-B)
90
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthluron Standard
MRID CITATION
00090106 Loh, A.; Davis, E.A.; Helmer, J.D.; et al. (1981) Creation of
Brush Grass Mosaics in Arizona Chaparral Watershed Study with
Tebuthiuron. (Unpublished study, including published data,
received Dec 10, 1981 under 1471-109; prepared in cooperation
with Arizona State Univ., Rocky Mountain Forest and Range
Experiment Station, Forest Sciences Laboratory, submitted by
Elanco Products Co., Oiv. of EH Lilly and Co., Indianapolis,
Ind.; CDL:246373-J)
00090107 Loh, A.; Bjerregaard, R.S.; Eaton, B.J. (1981) Evaluation of
Graslan (Tebuthluron) for Possible Contamination of Catchments
following Application for Rangeland Brush Control: Experiment
RS881-2, Hondo, Texas. (Unpublished study, including published
data, received Dec 10, 1981 under 1471-109; submitted by Elanco
Products Co., Div. of EH Lilly and Co., Indianapolis, Ind.;
COL: 24637 3-K)
«. --..-- - •
00090108 Hoyt, J.A.; Adams, E.R.; Owen, N.Y.; et al. (1981) A Two-generation
Reproduction Study with Tebuthiuron (Compound 75503) in the
. Wistar Rat: Studies R03780 and R08780. (Unpublished study
received Dec 10, 1981 under 1471-109; submitted by Elanco
Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind..;
CDL:246374-A)
00090109 Loh, A.; Bjerregaard, R.S.; Eaton, B.J. (1981) Evaluation of
Graslan (Tebuthluron) for Possible Contamination of Catchments
following Application for Rangeland Brush Control: Experiment
RSB81-1, Marietta, Oklahoma. (Unpublished study, Including
published data, received Dec 10, 1981 under 1471-109; submitted
by Elanco Products Co., D1v. of Eli Lilly and Co., Indianapolis,
Ind.; CDL:246373-L)
00093690 Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report: One-
generation Reproduction Study—Mallard Duck: Compound 75503,
Tebuthluron: Project No. 151-105. (Unpublished study received
Jan 7, 1982 under 147.1-109; prepared by Wildlife International,
Ltd., submitted by Elanco Products Co., Div. of Eli Lilly and
Co., Indianapolis, Ind.; CDL:246557-B)
00094745 Elanco Products Company (1982) Summary Report of Tebuthiuron Res-
idues in Forage Grass and Animal Tissues. Includes procedures
5801667 dated Nov 16, 1978 and 5801643 dated Apr 2, 1975. .(Com-
pilation; unpublished study received Feb 11, 1982 under 1471-
109; CDL:246779-D)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tebuthluron Standard
MRID CITATION
00104243 Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report: One-
generation Reproduction Study—Bobwhlte Quail: Compound 75503,
Tebuthluron: Project No. 151-104. (Unpublished study received
Jan 7, 1982 under 1471-109; prepared by Wildlife International,
Ltd., submitted by Elanco Products Co., Div. of E11 Lilly and
Co., Indianapolis, Ind.; CDL:246557-A)
00106080 Elanco Products Co. (1982) Residues of 14C Tebuthluron in Milk.
(Compilation; unpublished study received Jul 15, 1982 under
i 1471-109; CDL:070985-B)
00106081 Adams, E.; Magnussen, J.; Emmerson, J.; et al. (1982) Radiocarbon
Levels in the Milk of Lactating Rats Given 14C Tebuthluron
(Compound 75503) in the Diet: Study R13781. (Unpublished study
received Jul 15, 1982 under 1471-109; submitted by Elanco
Products Co., D1v. of E11 Lilly and Co., Indianapolis, IN; CDL:
' 070985-C)
00149733 Brown, G. (1985) Subchronlc (21-Day) Dermal Toxlcity Study in New
. Zealand White Rabbits with Technical Tebuthluron: Study BO1484.
Unpublished study prepared by Lilly Research Laboratories.
211 p.
00155730 Markey, T. (1985) The Acute Inhalation Toxicity of Technical Te-
buthluron (EL-103, Compound 75503): Study No. R-H-023-85. Un-
published study prepared by Lilly Research Laboratories. 15 p.
92
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EPA Index to Pesticide Chemical*
TEBOTHITJROH Df? ^ F T
TABLE OF OOHTENTS 5/TT/ "
\
Site Name _ ; _ Page
TERRESTRIAL NONFOOD CROP "_ 9
(Agricultural Crops) • *" 9
Brush *•" 9
Pastureland 9
. Range land 9
(Noncrop, Wide Area, and General Indoor /Outdoor Treatments) 11
Airport Runways 11
Fencerows (nonagricultural) 11
Firebreaks • 11
Highway Rights-of-Way 12
Industrial Sites 12
Paved Surfaces 13
Railroad Rights-of-Way 13
Utility Rights-of-Way ' 14
AQUATIC NONFOOD CROP 14
(Aquatic Sites) 14
Oitchbanks 14
Issued: 2-19-86 -I-105501-i
93
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- Index to Pesticide Chemicals
•
.05501 TEBOTHIURON*
TYPE PESTICIDE: Herbicide
FORMULATIONS;
Tech (95Z)
G (IX, 21, 3Z, 52)
P/T (10Z, 13.8Z, 15.21, 20Z, 30.5Z, 40Z) *"
WP* (80Z)
PIC (85*)
HTU .(0.03 Ib/gal (0.36Z))
GENERAL WARNINGS AND LIMITATIONS; Tebuthiuron is used in noncroplands and
paature/rangelands to control grasses, broadleaf weeds, brush and woody
plants. When applied to the soil, this chemical is* absorbed by the roots
of plants. Effects are slow to appear and will not become apparent until
sufficient moisture has carried the chemical into the root zone. Applica-
tions should be made prior to rainfall. A minimum of 1 to 1.5 inches of
rainfall is required. Time required for plant control is dependent on
soil type, amount of rainfall, and depth of species rooting. Some species
may go through several defoliations and refoliations over a period of 1
to 3 years before dying. Use a mechanical spreader or other device which
will spread the required dosage evenly over the area to be treated. Do
not apply directly to lakes, ponds, or streams or contaminate water
sources by cleaning of equipment or disposal of wastes. Do not apply on
field crops. Do not apply when winds are gusty or to areas where soil
movement by water erosion and/or natural or mechanical means ia likely.
Do not apply when the ground is frozen, snow covered, or saturated with
water. Do not make broadcast applications where forage or maintenance of
grass cover is desired. Desirable plants with feeder roots extending into
treated areas may be seriously injured. Injury to most herbaceous peren-
nials is reduced when treatment is applied when this vegetation is dor-
mant. Do not use on prickly pear, cholla, cactus or sassafras. In areas
treated with 4 pounds active ingredient or less, livestock may be allowed
to graze and grass may be cut for hay 1 year after application. For band
treatments, reduce dosages proportionately. Band treatments in areas of
steep terrain should be applied across existing slopes to prevent soil
erosion. Cut brush should be allowed to resprout to a height of 5 feet
before treatment. Requires actively growing plant to be effective.
Livestock Tolerances: /
Milk
Cattle (fat)
Cattle (meat)
Cattle (mbyp)
Goats (fat)
Goats (meat)
Goats (mbyp)
Horses (fat)
Horses (meat)
Horses (mbyp)
Sheep (fat)
0.3 ppm
2.0 ppm
2.0 ppm
2.0 ppm
2.0 ppm
2.0 ppm
2.0 ppm
2.0 ppm
2 «0 ppm
2.0 ppm
. 2*0 ppm
*Graslan
Spike
N-(5-(l,l-dimethyletnyl)-l,3,4-thiadiazol-2-yl)-N,H'-diinetnylurea
Issued: 2-19-86 1-105501-1 -
••'-.. 94 :
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EPA Index to Pesticide Chemicali
TEBUTHIURON
GENERAL WARNINGS AND LIMITATIONS (continued)
Sheep (aeat)
Sheep (mbyp)
2.0 ppm
2.0 ppm
TIME REQUIRED FOR CONTROL: Not located.
PHYTOTOXICITT TO TARGET WEEDS; Not located.
«
PHKTOTUXICITY TO CROPS; Not located.
MODE OF ACTION; Inhibits photosynthesis.
DRAFT
PDAAJBC
PBFBHBA
PBHADBO
PBPDCBC
PEMADAA
PBFBZBA
PAZAJBA
PBFCRBA
PDXABBC
PBMABBE
PBFBSBE
PBZACBA
PAD ABBA
PBPAVBA
PAZAAAC
PARABBB
PBPDQAA
PBPBRBA
PELAOBD
PEUAOBO
PEDADBA
PBPAEBA
PBFBUBA
PADADBA
PBVAEAA
PBFBPAA
PBPBOBA
PBPBQBA
PBPAMBA
PBPBIBB
PELATBD
PBZABAA
PBr
BROADLEAF WEEDS CONTROLLED;
Alkali sida
Annual fleabane
Annual se-ige
Annual sowthistle
Bedstraw
Bitter, rubberveed
Bouncing bet.
Bristly oxtongue
Buckhorn plantain
Bull sedge
Burroweed
Buttercup
Canada thistle
Camphorweed
Carolina geranium
Carpetweed
Chickory
Chickveed
Coast fiddleneck
Cocklebur
Common broomveed
Common cinquefoil
Common mullein *
Common purslane
Common ragweed
Common sunflower
Common venuslookingglass
Croton
Cudweed
Curly dock
Curlycup gumweed
Desert baileya
Dogfennel
European red raspberry
Pilaree
Pivehook bassia '
Issued: 2-19-86
(g)
(b)
(b)
(b)
(*)
(b)
(b)
(d)
(a)
(g)
(f)
(b)
(b)
(O
(c)
(b)
(b)
(a)
(c)
(d)
(b)
(e)
(f)
(b)
(a)
(b)
(b)
(b)
(g)
1-105501-2
-------
FKAEAA
BFAKBA
BFAYBA
ATACBB
3FARAA
EAAGAC
TOAIBA
BDAEAB
•DAAHAA
•BGAAAB
'BKAAAC
•EAAGBO
•BFBRAG
•BFDCBA
'AAAABI
DXABAA
TPALBA
•AHABBI
'EMACBA
•BPCEBP
•DAAJBF
•BVAGBQ
'BFBNBA
'BFARBI
?BDAK3A
?BDABAA
PBKAHBA
PEWAIBD
PERAGBA
PBPBVBB
PBPCABB
PBVAGBK
PBVAGAA
PELAKAA
PEAAGBG
PBFWBA
PEOABBJ
PAQAHBA
PFKADBA
PBKAHBG
PBPAEBC
PBFAOH
EPA Index to Pesticide Chemicals
TEBuTiu.UK.ON
BROADLEAF WEEDS CONTROLLED (continued)
Giant ragweed (T>) '
Goldenrod (b)(f)
Grape (b)
Heath aster (b)
Horseweed (b)(f)
Japanese honeysuckle- (b)
Knapweed (b)
Knotweed (g)
Kochia (b)
Lambsqnarter (b)
Mallow (g)
Morningglory (b)
Mustard (g)
Pennsylvania smartweed (f)
Pepperweed (f)
Perennial broomweed (a)
Perennial sowthistle (c)
Pigweed (bXfXg)
Plantain (g)
Poison hemlock (b)
Poison.ivy (c)
Poor.loe ' (d)
Prickly lettuce (g)
Prickly sida (b)
Prostrate spurge (c)
Puncturevine (b)(g)
Redstem filaree . (b)
Rlpgut brooe (b)
Rosering gaillardia (b)
Russian knapweed (g)
Russian thistle (b)
Saltbush (d)(g)
Shepherdspurse (b)(g)
Shrubby blue salvia*
Silverleaf nightshade (b)
Smallflower buttercup (b)
Spikeweed % (b)
Spotted catsear (b)
Spotted spurge (b)
Spurge (b)(f)
Strawberry ^ (b)
Swamp snartweed (c)(g)
Telegraphplant (b)(g)
Trembling aspen (c)
Trumpet creeper (b)
Virginia creeper (b)
Virginia pepperveed (b)
Western ragweed (a)(g)
White heath aster (b)
Wild-carrot (b)(f)
Wild parsnip * (f)
DRAFT
Issued: 2-19-8&
1-105501-3
56- .
-------
EPA Index to Pesticide Chemicals
TEBUTHIDRON
BROADLEAP MEEDS CONTROLLED (continued)
Yellow starthistle
Yellow woodsorrel (f)
(a) Use 0.5 to 2.0 pounds active Ingredient per acre.
(b) Use 4 pounds active ingredient per acre.
(c) Use 6 pounds active ingredient per acre.
(d) Use 8 pounds active ingredient per acre.
'(e) Use 16 pounds active ingredient per acre.
(f) Use 1.7 to 2.4 pounds active ingredient per acre In areas east
of the Rocky Mountains.
(g) Use 1.2 to 2.4 pounds active Ingredient per acre in areas west
of the Rocky Mountains.
*See Auxiliary Documentation
?CQBIBE
>CACOA
»CABSBJ
?CABHBB
ttAAZBA
PCQBIBB
>CAAHBH
?CAAUBA
.^A
PCABRBA
PCABFAA
PCA^CBA
?CACFBC
?CAATBM
?CACBBD
PCA3MAA
?CAAW3B
PCAOJAA
PCABSBC
*COAFBA
PCABZBA
PCACOBA
PCAATBP
PCACWBC
PCACOD
PCABSBP
PGABKAA
PCQBHAA
PCABBBA
PCAEABE
PCQ:
JBYBH
GRASSES AND OTHER MONOCOTS CONTROLLED;
Alfalfa (b)
Allthorn*
Annual bluegrass (b)(f)
Barley (g)
Barnyardgrass . (d)
Bermudagrass (e)
Black aedic (b)
Brooasedge (b)
Buffalograss (b)
Bur clover (b)
Cheat . (b)(g)
Common reed (c)
Common velvetgrass . (b)
Crabgrass (d)
Crowfootgrass (b)
Dallisgrass (e)
Downy brome (b>
Pall pan!cum (f)
Fescue (b)
Field sandbur (c)
Foxtail , (b)(g)
Foxtail barley (c)
Renbit (b)
Italian ryegrass (b)(g)
Itchgrass N (d)
Japanese brome (c)
Johnsongrass (seedling) (d)
Kentucky bluegrass (l>)(f)
Little barley (b)
Lovegrass (d)
Lupine (b)
Orchardgrass (d)
Rattail fescue (b)
Red clover (b)
Issued: 2-19-86
1-105501-4
-------
?CAATBE
PCACEBL
PCAAKAA
PCACIBA
PCACFBI
PCQCAAA
PCQBJBA
PCAADBB
PGACEBC
EPA Index to Pesticide Chemicals
TEBUTHTURON
GRASSES AND OTHER MONOCOTS CONTROLLED (continued)
DRAFT
(b)
(b)
(c)
(b)
CO
(b)
Reed canarygrass
Sacahulsta*
Smooth brome
Texas pan!cum
Threeawn
Timothy
Vaseygrass
Vetch
White sveetclover
Wild oats
Witchgrass
(b) Use 4 pounds active ingredient per acre.
! (c) Use 6 pounds active ingredient per acre.
' (d) Use 8 pounds active ingredient per acre.
(e) Use 16 pounds active ingredient per acre.
(f) Use 1.7 to 2.4 pounds active ingredient per acre in areas east
of the Rocky Mountains.
(g) Use 1.2 to 2.4 pounds active ingredient per acre in areas west
of the Rocky Mountains.
*See Auxiliary Documentation
WOODY PLANTS CONTROLLED!
PAPACBC Agarito
PT 1A Allegheny blackberry
P* Jc Alligator junipir
PBWXDBA American beech
PFEAEBB American- elm
PD7ABBA American sycamore
PDMACAA Ash
PFPADBA Ashe juniper
PDUABBA Balsam fir
PEOABBB Balsam poplar
PEWAFBB Berlandier wolfberry
PBPAJBL Big sagebrush
PACABBC Bigleaf maple •
PEOABBP Bigtooth aspen
PELAFBA Birchleaf mountain mahogany
PELAPBF Bitter cherry
PCKABBB Bittenmt hickory \
PELAPBI Black cherry
PCXABBK Black hickory
PCQBQBA Black locust
PBWAFCU Black oak
PELATBH . Black raspberry
PCOAQBE Black sage
PELATAC Blackberry
PCQACBG Blackbrush acacia
P*^€B Blackjack oak ,
-—^ Issued: 2-19-86
(o)
(V)
(»)
(«)
(o)
(k)
(k)
(o)
(m)
(P)
1-105501-5
98
-------
.-.:
PACABBD
PAHACBB
PAYAEBC
PERA3BB
PBMAFCA
PBT-7AFBH
PCQACBP
PCQBKBD
PET7ASBA
PELACBA
PPEAEBD
PBVAJBA
PELAIBA
PENACBC
PELAPBK
PBPABBB
PEOABAA
PEJAFBA
PPKACBA
PBAAEBA
PDUA1BA
PEOABBC
PPPADBK
P! JA
PBi—A?
'"»^C
P!
FBi—
PBRABBB
PBWAPBO
PFEABBC
PBIACBF
PDMACBE
PBUACBI
PBFALBB
PCQACBA
PFMAEBA
PFEABAA
FELAT7BE
PELAIAA
PENACBB
POCABAA
PCQAZBA
FBUAKAB
PCQACBE
PDDAHBB
PFPADAA
PCQBPBA
PFIAFBA
PAHABBF
EPA Index to Pesticide Chemicals
TEBUTHTURON
WOODY PLAMTS CONTROLLED (continued)
Blue oak (k)
Blueberry (k)(q)
Bluewood condalia (k)(p)(q)
Boxelder (k)(p)
Brazilian peppertree (o)
Buckbrush - (k)(p)
- Buckthorn bumella (k)
Bur oak (k)(p)
California scrub oak (k)
Catclaw acacia (k)(p)(q)
Catclaw mimosa (n)(p)
Cenzia (h)(p)
Chamlse (k)
Chinese elm, (c)
Chinese tallovtree (c)
Cockspur hawthorn ' (c)
Collma ' (q)
Common chokeberry (k)
Common persimmon (q)
Cottonwood (k)(p)
Coyotlllo . (k)
Creosotobush . (h)(p)
Desert yaupon . (k)
Douglas-fir (k)
Eastern cottonwood (n)
Eastern redcedar (o)(q)
Elbovbush (k)
Ela - (k)
Evergreen blackberry (o)
Flowering dogwood (k)(p)(q)
Gambel oak (k)(p)(q)
Granjeno (k)
Gray birch (k)
Green ash (o)(q)
Greenleaf manzanlta (c)
Groundsel baccharis (o)
Guajlllo (k)(p)
Guayacan % (k)(p)(q)
Hackberry (k)(p)
Hardback (k)
Hawthorn (k)(p)
Rerculesclub . (p)
Hickory ' (p)(q)
Honeylocust (q)
Huckleberry (k)
Hulsache (k)(p)(q)
Jack pine (o)
Juniper (k)(p)
Kudzu (k)
Largeleaf lantana (o) -
Laurel sumac (c)
DRAFT
Issued: 2-19-86
1-105501-6
-------
EPA Index to Pesticide Chemicals
PW7AFC7
PCQBQAA
PEJAEBB
PELASBC
PBDACAA
PACABAA
PDIAFAA
PCQBNBA
PBWAFDA
PELASBK
PDUAGBF
PTPADBE
FDGACBA
PCQANBC
PBPABAA
PCKABBD
PBWAFCH
PDDAHAA
PDUAHBF
PAAAABM
PBWATCQ
PENA^A
PDMA4AB
PI
PAs
PDGADBC
PBWAFCN
PDOAHBM
PPPADBH
PPPADBI
PELASAA
PBRABBA
PCTAJBD
PZAAAEN
PBQABBB
PBPAJAB
PBDAEBA
PEZABBC
PBFAJBG
PBT7AFBQ
PCKABBI
PAHABBB
PDOAHBE
PACABBH
PAHABBK
PFEAEBG
PEWAPBA
•*AB
JB
TEBUTHTDRON
WOODT PLANTS CONTROLLED (continued)
Leatherstem (k)(p)(q)
Littleleaf sumac (1)
Live oak (It)
Locust (p)
Lotebush condalla (n)(p)(q)
Macartney rose (k)(p)
Manzmnlta (k)
Maple (p)(q)
Helaleuca (o)
Mesquite (p)(q)
Mohr oak (b)
Multiflora rose 00 (p)
New Mexico locust*
Norway maple (o)
Oneseeded juniper (k)(q)
Osage orange (p)(<0
Paloverde (a)(k)(p)
Persimmon (c)
Pignut hickory («)
Pin oak . (k)
Pin* .'••... ...... (k)(p)
Pinyoa pine (1)
Plum (k)(p)
Post oak (k)(p)
Prickly ash (k)
Privet (c)
Red alder . - (k)
Red raaple (q)
Red mulberry (k)(p)
Red oak (k)
Red pine • (o)
Redberry Juniper (k)
Rocky Mountain juniper (k)
Rose (p)
Roughleaf dogwood (1)
Roundleaf greenbrier (c)
Running live oak % (k)(p)
Russian olive (e)(k)(p)
Sagebrush (k)(p)
Salal (o)
Saltcedar . (k)
Sand sagebrush (a)
Sand shlmmery oak (h)(p)
Shagbark hickory (b)
Shinning sumac (1)
Shortleaf pine (o)
Silver maple (o)(q)
Skunkbush sumac (k)(l)
Slippery elm (c)
Small datura (k)
Smooth sumac " (1)
Issued: 2-19-86
1-105501-7
foo
-------
Site, Dosage
and Formulation
(Ib a.i./A)
TERRESTRIAL NONFOOD CROP
EPA Index to Pesticide Chemical*
TEBUTHIURON
Tolerance, Use, Limitations
DRAFT
'28035AA
'28045AA
(Agricultural Crops)
Paatureland
Rangeland
0.5-4.0
(20*, 40Z P/T)
001471-00109
1-4
(20Z P/T)
0.5-1.0
(10Z P/T)
001471-00115
20.0 ppm (grasses, hay)
(rangeland, forage)
Do not allow lactating cows to graze on or consume
hay from treated areas for 2 years after applica-
tion. Do not cat forage grass for hay in treated
areas for 2 years after application.
General Information; Do not use in or near home
sites or landscaped areas. Do not use in soils
containing more than 5 percent organic matter,
more than 30 percent clay, or on Blackland soils.
Do not burn treated areas for at least 2 growing
seasons after application. Not recommended for
sites which contain more than 200 trees per acre.
The use of aerial broadcast sprays are recommended
in areas with high density brush infestation. A
single application is effective for several years.
Treated areas may be overseeded. Consult your
local Range Management Specialist or other agri-
cultural specialist for detail's on suitable spe-
cies, seeding rates, timing, and fertilizer pro-
grams.
•
Broadcast. Woody plant and broadleaf weed con-
trol . Use the lower dosage on coarse textured
soils and the higher dosage on medium or fine tex-
tured soils or when treating deep-rooted plants.
Make 1 application per year. May be applied by
air. ' •- : ••-. • .-••
Broadcast. Soil surface treatment,
woody plant control.
Brush and
Use limited to AZ, AR, CO, ID, KS, MO, MT, NM, NV,
OK, OR, TX, DT, WA and WT. Broadcast. Brush con-
trol. Apply prior to seasonal rains. Use the
lowe* dosage on coarse textured soils and the
higher dosage on medium and fine textured soils
or when treating deep-rooted plants. Apply once
per year.
*
100 sq.ft
(15. 27,, 30.5* P/T)
llmlted to A2* **» CO. ID. KS. MO, MT, NM, NV,
OK, OR, TX, UT, WA and WY. Broadcast. Woody
plant and thicket control. Grid pattern applica-
tion. Do not use more than 2 grams active ingre-
Issued: 2-19-86
1-105501-9 _.
101
-------
Site, Dosage
and Formulation
(Ib a.i./A)
Pastureland cluster (continued)
EPA Index to Pesticide Chemicals
TEBUTHTURON
Tolerance, Use, Limitations
DRAFT
1 gram a.i./inch
of trunk diameter
(15.22, 30.52 P/T)
0.75-3.0
(20% P/T)
1 gram a.1./inch
of trunk diameter
(13,8Z P/T)
0.25-0.50 gram'
a.i./ft of plant
height
(13.8Z P/T)
0.25 gram a,i./ft
of canopy diameter
(13.8Z P/T)
1-4 grams a.i./lOO
sq.ft
(13.82 P/T)
dlent per 100 square feet in areas receiving less
than 20 inches annual rainfall.
Use limited to AZ, AK, CO, ID, KS, MO, MT, NM, N7,
OK, OR, TZ, DT, WA and WY-. Brush and tree con-
trol. Soil surface treatment. Apply no more than
5 grams active ingredient per inch of trunk diam-
eter regardless of tree size. Distribute uniform-
ly over soil surface within drip zone of each
tree. For upright growing Utah juniper, apply
0.25 gram active ingredient per foot of tree
height to the base of the tree trunk.
Use limited to the western United States. Broad-
cast. Soil surface treatment. Brush control.
Distribute pellets uniformly over soil surface.
May be applied by air.
*
Drop zone application based on trunk diameter.
Use this method for single stemmed species only.
Apply uniformly over the soil surface within the
drip zone of each tree.
Drop zone application based on tree height. *Use
this method for single or multi-stemmed trees that
have a height greater than canopy diameter. Apply
uniformly over the soil surface within the drip
zone of each tree. For centre of juniper spe-
cies » use the lower dosage for plants up to 3 feet
tall and the higher dosage for plants 3 to 10 feet
tall. Do not use on junipers over 10 feet tall.
Drip zone application based on canopy diameter.
Use this method for single or multi-stemmed trees
that have a canopy diameter greater than the tree
height. Apply uniformly over the soil surface
within the drip zone of each tree.
\
Grid pattern application. For control of dense
brush in thickets and multi-stemmed brush species.
Use the higher dosage when treating large or deep-
rooted plants growing in fine textured soils. For
dosages of 1 to 4 grams active ingredient per 100
square feet, the grid spacing between pellets is
5 to 2.5 feet respectively.
102
Issued: 2-19-86
1-105501-10
-------
670010A
670150A
670040A
670130A
670090A
670110A
670050A
670060A
EPA Index to Pesticide Chemicals
TEBUTHTDRON
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Pastureland cluster (continued)
0.13 Ib a. 1./1,000 Spot treatment. Brush and vine control. Apply
sq.ft over the root system of brush and vine clumps.
T20?» 40% P/T)
0.1 oz a.i./2-4 Spot treatment based on trunk diameter. Tree
inches of trunk control. Apply to the base of the tree.
diameter
(20%, 40% P/T)
i
(Honcrop, Wide Area, and General Indoor/Outdoor Treatments)
Airport Runways
Fencerows (nonagri-
cultural)
Firebreaks
4-16
(IX, 3%, 5% G)
001471-00104.
(80% TTP)
001471-00097
(85% FIG)
001471-00147
1-6
(1%, 5* G)
(20%, 40% P/T)
001471-00123
(80% WP)
(85% F1C)
1.7-2.5
(80% WP)
(85% F1C)
Broadcast. Annual/perennial grass and broadleaf
weed control. Apply when weeds are actively grow-
ing.
May be tank mixed with amitrole; atrazine; dicam-
ba; diuron; 2,4-D; MSMA; surfIan; paraquat; or
simazlne.
Broadcast or band. Soil surface treatment. Woody
plant and brush control. Apply the wettable pow-
der formulation in 15 to 150 gallons of water per
acre. Band treatments should be spaced at inter-
«vals of 4 to 10 feet at a rate of 2 to 6 pounds
active ingredient per acre. May be applied by
air.
Use limited to areas east of the Rocky Mountains
treated the previous season with tebuthluron or
other residual herbicide. Broadcast. Total vege-
tation control. Apply prior to or just after weed
emergence in 15 to 150 gallons of water per acre.
Use the higher dosage in areas with more than 25
inches annual rainfall.
Issued: 2-19-86
1-105501-11
103
-------
DRAF
EPA Index to Pesticide Chemicals
TEBuTtiJ.UK.ON
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Airport Runways cluster (continued)
1*2-2.5 Use limited to areas vest of the Rocky Mountains
(802 WP) treated the previous season with tebuthiuron or
.(852 F1C) other residual herbicide. Broadcast. Total vege-
tation control. Apply prior to or just after weed
emergence in 15 to 150 gallons of water per acre.
Use the higher dosage in areas with more than 24
inches annual rainfall.
| 0.13-0.14 Ib a.i./ Spot treatment. Brush and vine control. Apply
. 1,000 sq.ft over the root systems of brush and vine clumps.
(IX, 52 G)
(202, 402 P/T)
0.1 Ib a.i./2-4 spot treatment. Individual tree control. Apply
inches of trunk to the base of the tree.
diameter
<1*H 5Z G)
or.
O.I oz a.i./2-4
inches of trunk
diameter
(202, 402 P/T)
*
1-10 oz finished spot treatment. Woody plant control. Use the
spray/2-4 Inches lower dosage as a low volume application, mixing
of stem diameter 1 pound of tebuthiuron in enough water to make 1
(802 WP) gallon of finished spray; and the higher dosage
(852 PIC) as a high volume application, mixing 1 pound of
tebuthiuron in enough water to make 10 gallons of
finished spray.
[WAI] Soil surface treatment. Broadcast. Apply anytime
2-4 during the year. Repeat spot treatments may be
(12, 22 G) * necessary for deep rooted grasses.
Formulated with diuron.
[MAI] Soil surface treatment. Broadcast. Apply to
2-4 areasNtreated the previous season with tebuthiuron
(22 G) or other residual herbicide. Apply before weeds
emerge.
Formulated with treflan.
Issued: 2-19-86 1-105501-12
-------
EPA Index to Pesticide Chemicals
TEBUTHIURON
DRAFT
'670040A
/670090A
/670110A
Site, Dosage
and Formulation
(Ib a.i./A)
Highway Righta-of-Way
Tolerance, Use, Limitations
Industrial Sites
Paved Surfaces
Railroad Rightsr-of-
Way.
4-16
(0.03 Ib/gal SC/L)
001471-00111
2.1-6.3
(0.03 Ib/gal SC/L)
1.7-2.4
(0.03 Ib/gal SC/L)
1.2-2.4
(0.03 Ib/gal SC/L)
Issued: 2-19-86
General Infornation; Highway Rights-of-Way in-
clude areas around guardrails, signposts, markers,
and road shoulders..
Refer to Airport Runway cluster for use and limi-
tation information.
General Information; Industrial Sites include
areas around buildings, lumberyards and tank
farms.
Refer to Airport Runway cluster for use and limi-
tation information.
general Information; Paved Surfaces include areas
under asphalt and concrete pavements where no
future landscaping is planned.
Refer to Airport Runway cluster for use and limi-
tation information..
General Information; Railroad Rights-of-Way "in-
clude areas around ballast, railroad yards and
roadbeds.
Broadcast. Apply prior to or just after weed
emergence in 40 to 535 gallons of water per acre.
Broadcast or spot treatment. Woody plant and vine
control. Do not use a broadcast spray where for-
age or maintenance of grass cover is desired.
Use limited to areas east of the Rocky Mountains
treated the previous season with tebuthiuron or
other residual herbicide. Broadcast. Total vege-
tation control. Apply prior to or just after weed
emergence in 40 to 535 gallons of water per acre.
Use the higher dosage in areas with more than 25
inches annual rainfall.
Use limited to areas west of the Rocky Mountains
treated the previous season with tebuthiuron or
other residual herbicide. Broadcast. Total vege-
tation control. Apply prior to or just After weed
1-105501-13
0
-------
/670060A
Site, Dosage
and Formulation
(Ib a.i./A)
Railroad Rights-of-Way (continued)
EPA Index to Pesticide Chemicals
TEBUTHIURON
Tolerance, Use, Limitations
1^^ A r*"f*
0.5 oz a.i./l-2
inches of stem
diameter
(0.03 Ib/gal SC/L)
emergence in 40 to 535 gallons water per acre.
Use the higher dosage in. areas with more than 25
Inches annual rainfall.
Spot treatment. Woody plant and vine control.
Refer to Airport Runway cluster for additional use
and limitation information.
Utility Rights-of-Way
General Information; Utility Rights-of-Way in-
clude areas around substations, transmission tow-
ers and poles. The 40 percent pelleted /tableted
broadcast formulation may be applied by air (heli-
copter). *
Refer to Airport Runway cluster for use and limi-
tation information.
/650130A
AQUATIC NONFOOD CROP
(Aquatic Sites)
Ditehbanks
General Information! Do not apply to any portion
of the ditchbank that will come into direct, con-
tact with water. Do not apply on ditches used to
transport irrigation or potable water.
« Refer to TERRESTRIAL NONFOOD CROP, (Noncrop, Wide
Area, and General Indoor /Outdoor Treatments), Air
port Runway cluster, for use and limitation infor
mation.
Issued: 2-19-86
1-105501-14
106
-------
Site, Dosage
and Formulation
(Ib a.i./A)
AERIAL AND TANK MIX APPLICATIONS
EPA Index to Pesticide Chemicals
TEBUTHTORON
Tolerance, Use, Limitations
DR
9001500
AAAAAAA
Aerial Application
9900300
&AAAAAA
Tank Mix
Refer to
TERRESTRIAL NONFOOD CROP
(Agricultural Crops)
Pastureland, Rangelands
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments)
Airport Runways, Fencerows (nonagricultural),
Firebreaks, Highway Rights-of-Way, Industrial
Sites, Paved Surfaces, Railroad Rights-of-Way,
Utility Rights-of-Way
Refer to
TERRESTRIAL NONFOOD CROP
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments) ———————————
Airport Runways, Fencerows (nonagricultural),
Firebreaks, Highway Rights-of-Way, Industrial
Sites, Paved Surfaces, Railroad Rights-of-Way,
Utility Rights-of-Way
AQUATIC NONFOOD CROP
(Aquatic Sites)
Ditchbanks
Issued: 2-19-86
1-105501-15
. .. 107
-------
if "Nx>l
iOOl.0004
1002.0004
1003.0004
&005.0004
SOI0.0005
&013.8005
&015.2005
EPA Index to Pesticide Chemicals
TEBDTHIDRON
Listing of Registered Pesticide Products by Formulation
95% technical chemical
tebuthiuron (105501)
001471-00101
12 granular
DRAFT
tebuthiuron (105501)
.001471-00104 034913-00011
tebuthiuron (105501) plus 3-(3,4-dichlorophenyl)-l,l-dimethylurea
(035505)
034913-00015
22 granular
tebuthiuron (105501) plus 3-(3,4-dichlorophenyl)-l,l-dimethylurea
<035505)
034913-00016
tebuthiuron (105501) plus trtfluralin (036101)
001471-00139
3% granular
tebuthiuron (105501)
034913-00009
57, granular
tebuthiuron (105501)
001471-00103 034913-00010
10% pelleted/tableted
tebuthiuron (105501)
001471-00115
13.81 pelleted/tableted
tebuthiuron (105501)
001471-00129
15.21 pelleted/tableted
tebuthiuron (105501) «
001471-00130
&020.0005 201 pelleted/tableted
&
hut
&030.5005
tebuthiuron (105501) \
001471-00109 001471-00123 '
30.5* pelleted/tableted
tebuthiuron (105501)
001471-00128
&040.0005 40% pelleted/tableted
tebuthiuron (105501)
001471-00119 ,001471-00124
Issued: 2-19-86
1-105501-16
108
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EPA Index to Pesticide Chenicals % + — .
' ^*
_ r
TEBUTHIURON *
Listing of Registered Pesticide Products by Poraulation (continued)
Sr "^006 80Z wettable powder
••) tebuthiuron (105501)
001471-00097
£285.0014 851 flowable concentrate
tebuthiuron (105501)
001471-00147
*• •
&200.0316 0.36Z (0.03 Ib/gal) soluble concentrate /liquid
tebuthiuron (105501)
001471-00111
Issued: 2-19-86 1-105501-17
wi •
fC9
-------
DRAFT
EPA Index to Pesticide Chemicals
TZBDTHIURON
Appendix A-l
Listing of Active Ingredient(s) Found in Combination With the Report Chemical
Chemical Common Name EPA Acceptable
Code(source) Common/Chemical Name
035505 diuron (ANSI) 3-(3,4-dichlorophenyl)-l,l-dimethylurea
*
036101 treflan trifluralin
Issued: 2-19-86 1-10-5501-18
•" '"""MO
-------
Listing of
Chemical
Code
004401
080803
029801
030001
035505
103601
013803
104201
«
061601
080807 :
Active Ingredient
Common Name
(source)
amitrole (ANSI)
—
—
2,4-D
diuron (ANSI)
glyphosate
MSMA
surflan
paraquat
- —
EPA Index to Pesticide Chemical*
TEBUTHIURON
Appendix A-2
EPA Acceptable
Connon/Chemical Name
DRAFT
.3-amino-s-triazole
atrazine
dicamba
2,4-dichlorophenoxyacetic acid
3-(3,4-dichlorophenyl)-l,1-dimethylurea
glyphosate, isopropylamine, salt of
monosodium acid methanearsonate
oryzalin
paraquat dichlorlde
simazine
— Use EPA Acceptable Common/Chemical Name
Issued: 2-19-86
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DRAFT
EPA Index to Pesticide Chemicals
TEBUTHTORON
Auxiliary Documentation
Reg. Ho. Cancellation Pate
001386-00614 3/27/86
Registration number 001471-00123 contains a supplemental label claiming
use of aerial applications for brush and woody plant control. There are
no specific sites listed on the supplemental label. The assumption was
made that this claim referred to all sites listed on the latest acceptable
label. However, aerial applications in ditchbanks does not seem feasible
considering the irrigation and potable water statements and has been omit-
ted for this site.
*These pests could not be located in the EPA generated pest listing dated
April, 1985. Dennis Szuhay is looking into this problem - as soon as
pest codes are found they will be Inserted.
Issued: 2-19-86 I-105501-a
. . - 112-
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FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
€PA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to tti« requirement to submit "etntcfc" data imposed by tht FIFRA section 3(C)(2MB) notice contiintd in tht referenced
Guidance Oocumtnt, I im responding in the following manner
D 1. I will submit dm in i timoty mtnmr to satisfy tht following requirements. If tht-ttn procedures I wiU use deviate from (or irt not
specified in) tilt Registration QukMinti or tht Protocols contained in tht Htporti of Exptrt Groupt to tht Chtmiult Group. OECO
Chwnicals Twting rVognmmt, I tndo» tht protocoli that I will tut:
Q1 I htvt tnttrtd into «n >aTt»mtn» with ont or man othtr rtgtetrantt undtr FIFRA action 3(C)(2)(B)(ii) to ntiify the following diti
rtquirtnitnn. Tht tins, ind my required protocoit, will bt tubmimd to EPA by:
NAME OF OTHER REGISTRANT
Q 3. I endow • completed "Certification of Attempt to Enter Into en Agreement with Other Reginrentt for Development of Oeti" with
respict to tht following dra requirements:
D 4. I request thet you amend my registration by deleting tht following uses (this option is not available to epplicants for new products):
D 5. I request voluntary cancellation of tht registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1 (1042)
113
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OMB Approval No. 20OO-Q468 (Expires: 12-31-83)
(To qualify. ctrtifvALL, four rfevnsV
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who art subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAMC OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm'
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in trie cost of developing, the following required
items or data: •
1 My firm has offered in writing to smtr into such an agreement Copies of the offers are attached. That offer was irrtvocablt and included sn offer to be
Bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(ii!) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME Of FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests thet EPA not suspend the registration^) of my firm's product(J), if any of the firms named in paragraph (3) above
have agreed to submit the data lined in paragraph (2) above in accordance with the Notice. I understand EPA-will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8880-9 (1
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
6l-i
61-2.
61-3
62-1
62-2
62-3
,63-2
65-3
63-4
63-5
63-6
63-7
63-8
6^-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
-Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boil ins jjpint
Density, bulk-
dens ity» or
specific gravity
Solubility \
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
. PH
Test not
required
for ny
product
listed
above
(check
below)
.
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
.
-
''"-•
-
Submit-
ting
Data
(At-
tached)
••
>•
(For EPA Use Only)
MRID Numbers
Assigned
•
115
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135"
TOXICOLOGY
81-1
81-2
8l-3
81-4
81-5
81-6
Name of Test
Stability
Oxidiz ing/reducing
reaction
Flammability_
Explodability_
Storage stability
Viscosity
Miscibility: _
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
tpxicity, rabbit
Acute inhalation,
toxicity/ rat
Primary eye
_ irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
,
.
V
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
,
k
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
,
•
116
-------
CMB Approval No. 2000-0468
Expiration Date 5/31/86
ATTACHCNT D
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Nunber:
Registrant's Name:
-..and Address:
As an authorized representative of the registrant of the product
identified above, I certify that:
(1) I have read and an familiar with the terms of the Notice from EPA
dated concerning a requirement for submission of generic data
on thte active ingredient named under PIPRA see. 3(c)(2)(B>.
(2) My firm requests that EPA not suspend the registration of our
product, despite our lack of Intent to submit the generic data in question,
on the grounds that the product contains the active Ingredient solely as
the result of the Incorporation Into the product of another product which
contains that active Ingredient, which is registered under PIPRA sec. 3,
and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the
above Identified product is attached to this statement. That formula
statement indicates, by company name, registration number, and product
name, the source of the subject active Ingredient in my firm's product,t
OR
The CSP dated on file with EPA is complete, current and
accurate and contains the information requested on the current CSP Form
No. 8570-4. The registered source(s) of the above named active ingredient
In my product(s) is/are ' '. ' '
and their registration number(s) Is/are
Jfy firm will apply for an amendment to the registration prior to
changing the source of the,active Ingredient In our product.
(i») I understand, and agree on behalf of my firm, that If at any
time any portion of this Statement la no longer true, or if my firm falls
to comply with the undertakings nade In this Statement, my firm's product's
registration may be suspended under PTPRA sec. 3(c)(2)(B).
Registrant's authorized representative:
Signature
Dated: •
(Typed)
117
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