-i
United Stnw
Environmental Protection
Office ot
P«fitcidei and Toxic SubttcnoM
Wasnington OC 20460
Sent ember 1986
fssticidsn
Guidance for the
Rereglstration of
Pesticide Products
Containing Terbutryn
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
TERBUTRYN
AS THE ACTIVE INGREDIENT
CASE NUMBER: 085
CAS (DOCKET) NUMBER: 886-50-0
September 1986
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Glossary of Terms and Acronyms
I. Introduction
II. Chemical Covered by this Standard
A. Description of Chemical
B. Use Profile
C. History
III. Agency Assessment 5
A. Summary of Assessment
B. Toxicoloqical Assessments
C. Worker Exposure Hazard and Risk Assessment
D. Tolerance Reassessment
E. Environmental Fate
F. Hazard Assessment for Terrestrial
and Aquatic Organisms
G. Endangered Species
H. Product Chemistry Evaluation
IV. Regulatory Position 23
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subiect to this Standard 32
VI. Requirement for Submission of Generic Data 34
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Reguirement for Submission of Product-Specific Data . . 39
VIII. Requirement for Submission of Revised Labeling 39
IX. Instructions for Submission 40
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA TABLES 43
Guide to Tables
Table A
Table B
II. LABELING 70
Summary of label requirements and table
40 CFR 162.10 Labelinq Requirements
Physical/Chemical Hazards Labelinq Statements
Storaqe Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. EPA INDEX TO PESTICIDE CHEMICALS - TERBUTRYN 89
IV. BIBLIOGRAPHY 105
Guide to Biblioqraphy
Bibli oqraphy
V. FORMS . 113
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into
an Aqreement with Other Registrants for
Development of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Formulator's Exemption Statement
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GLOSSARY OF TERMS AND ABBREVIATIONS
The following terms are used throughout this Registration
Standard and are defined here for the convenience of the reader.
ADI: Acceptable Daily Intake
a.i.: Active ingredient
CAS: Chemical Abstract Society (number)
Core Classifications: A general guide to the acceptability of data
for the purpose of supporting registration
(invalid, supplementary, minimum, or guideline)
CSF: Confidential Statement of Formula
EP: End-use Product
EPA: The Environmental Protection Agency, also "the Agency"
FQ, F]_, F2 Refers to the generations in a multi-generation study
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
LCsQ: (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., ing/kg)-.
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number)--EPA's system of
tracking studies used in support of registrations
MUP: Manufacturing-use product
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level-The maximum dose used in a
test which produces no observed adverse effects.
OPP: The Office of Pesticide Programs (EPA)
OES: Office of endangered Species, rJ.S. Fish and Wildlife Service
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Glossary (cont.)
OM: Orqanic matter (used to describe soils)
ppm: Parts per million
PADI: Provisional Acceptable Daily Intake
PAI: Pure active ingredient
Q]_*: The mathmatical factor for the potency of a hazard, such
as oncogenicity--the Q]_* is a parameter of the linearized
multistage extrapolation model. It is used as a multiplier
of the estimated exposure (in units of mg/kg/day) to
obtain the estimated 95% upper bound on risk. A change
in the Q]_* will result in a proportional change in risk.
RPAR: Rebuttable Presumption Against Registration, the term
formerly used by the Agency to refer to the interim
administrative review which is now called "Special
Review". See 40 CFR Part 154.
SAR: Structure/activity relationship
Technical: Active ingredient as manufactured
TMRC: Theoretical Maximuirt Residue Contribution
ug: microgram
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I. INTRODUCTION
The Registration Standards Program
The Environmental Protection Agency (EPA) has established the
Registration Standards program in order to provide an orderly
mechanism by which 'pesticide products containing the same active
ingredient can be reviewed and standards set for compliance
with the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). The standards are applicable to reregistration
and future applications for registration of products containing
the same active ingredient. 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 the product and its labeling into compliance with FIFRA,
as instructed by this Standard. Pesticides have been grouped
into use clusters and are reviewed on the basis of a ranking
scheme giving higher priority to (1) pesticides in clusters
used on food and feed crops; and (2) pesticides produced in
large volumes.
The Registration Standards program involves a thorough review
of the scientific data base underlying a pesticide's registration.
The purpose of EPA'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 the following:
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
reguired when the product was initially registered or
may be needed to replace studies that are now considered
inadeguate.
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 presents primarily
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 also looks
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 people and the environment.
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s_reassessment results in the development of a regulatory
position, contained in this Registration Standard, on the pesti-
cide and each of its registered uses. See Part 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 any or all of the following:
1. Submission of data in support of product registration
2. Modification of product labels
3. Modifications to the manufacturing process of the pesti-
cide 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
6. Specification of packaging limitations
Failure to comply with these reguirements 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 people 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 thafthe 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 section 3(c)(2)(B) to require that registrants submit data
to answer guestions regarding the toxicological, chemical, and
environmental characteristics, and fate of a pesticide. This
Registration Standard lists the data EPA believes are necessary
to resolve concerns about terbutryn. These data are listed in
Tables A and B 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 section 6(a)(2) reguires them
to submit factual information concerning possible unreasonable
adverse effects of a pesticide at any time they become aware
of such information. Registrants should notify the Agency of
any information, including interim or preliminary results of
studies, if those results suggest possible adverse effects on
people or the environment. This requirement continues as long as
a product is registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
DESCRIPTION OF CHEMICAL
Common Name
Chemical Name
Empirical Formula
Trade Name
OPP/Shaugnessy No.
CAS Registry No.
B. USE PROFILE
Type of Pesticide
Pest Controlled
Registered Us.es
Predominant Uses
Acres treated
(approximate)
Method of
Application
Mode of Activity
Formulation
Manufacturing -
Use Product
Sad-Use Products
Terbutryn
2-(tert-butylamino-4-(ethylamino)-
6-(methylthio)-s-triazine
C10H19N5S
Igran, Prebane, Terbutrex, Terbutryne,
GS-14260, Clarosan and Short-stop
(discontinued)
080813
886-50-0
Herbicide
Annual broadleaf and grass weeds
Winter wheat, winter barley, grain
sorghum, fallow land, and non-crop
(including industrial and right-of-
way weed control)
Grain Sorghum (approximately 50%)
Winter wheat (approximately 50%)
Winter wheat--350,000 acres--less
than 1.0% of U.S acres planted
(420,000 to 770,000 Ibs. a.i./yr).
Sorghum—350,000 acres—less than
2% of U.S. acres planted
(520,000 to 780,000 Ibs. a.i./yr)
Broadcast or band by ground or
aerial equipment, pre-emergence,
preplant, or early postemergence
Inhibition of water photolysis
in the photosynthetic process.
95-96% active ingredient (technical
30% wettable powder and
30% dry flowabls formulation
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C. HISTORY
Terbutryn was first tested in 1952 in Switzerland by
J. R. Geigy (now Ciba-Geigy) under the designation
GS-14260. Terbutryn's herbicidal properties were
first reported in 1965 by A. Cast, et'al. in Paris and
J. R. Geigy introduced it to the United States in 1968
(U.S. patent #3,145,208; Swiss patent #393,344; British
patents #814,948 and #978,249). It was registered in the
United States cnr July 31, 1969. At the present time,
Ciba-Geigy and Gowan Company are the registrants of
products containing terbutryn.
Terbutryn was referred as a candidate for the Rebuttable
Presumption Against Registration (RPAR, now referred to
as Special Review) process in 1980 based on preliminary
results of a two-year study indicating that terbutryn
is carcinogenic in laboratory rats. A review of the
data base was initiated.
In addition to the rat oncogenicity study, the Agency
reviewed a mouse oncogenicity study, a three generation
study of reproductive effects in rats, and the report of
a 1973 lecture by Kalman Szende which suggested that
terbutryn may be weakly mutagenic.
The Agency concluded that terbutryn was not shown to be
oncogenic in mice, found no evidence that it is mutagenic
in mammalian systems, and reported the no observed effect
level (NOEL) to be 15 mg/kg/day for reproductive effects
in rats.
The Agency also concluded that the two year rat oncogenicity
study did demonstrate an increased incidence of tumors in
rats, but that the oncogenic risk to humans could be suffi-
ciently reduced by reducing worker exposure. Thus the
Agency required that certain changes be made in product
labeling in order to reduce worker exposure. These changes
reguire mixers and/or loaders handling terbutryn to wear
impermeable gloves, long-sleeved coveralls, and a dust
mask capable of trapping particulates 0.6 microns in size.
In its Decision Document of October 8, 1981, the Agency
concluded that available data did not support an RPAR
under the risk criteria specified in 40 CFR 162.11.
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The followinq data have been required under section
3(c)(2)(B) of FIFRA since the 1981 Decision Document:
Teratoqenicitv (one species) Submitted 10/85
Environmental fate studies
Hydrolysis " 5/85
Photodegradation in water " 6/85
Photodearadation in soil " 3/85
Aerobic soil " 3/85
Anaerobic soil " 3/85
Mobility " 3/85
Field Dissipation in soil " 3/85
Product Chemistry
Water solubility " 4/85
Vapor Pressure " 4/85
Octanol water partition coefficient " 4/85
The regulatory conclusions regarding these data and
the relationship to the concerns of the 1981 Decision
Document are discussed in Part III (Agency Assessments).
III. AGENCY ASSESSMENT
The Agency has conducted a thorough review of the scientific
data base on terbutryn. This part of the Standard sets forth
the results of that review.
A. SUMMARY OF ASSESSMENT
Based on the review of the data filed in support of the
registration of terbutryn, the Agency has reached the
followinq major conclusions. A more detailed discussion
of the full assessment appears in Section B.
1. Terbutryn may pose an oncogenic risk from worker exposure,
It has been classified as a Group C Oncogen (possible
human carcinogen) based on the followinq:
In a two-year rat feeding study terbutryn produced
1) a marginal response in a tissue (mammary gland)
known to have a high and variable background rate
of tumors, and 2) an increase in combined benign
and malignant tumors (testicular, thyroid, and
liver) with the chemical producing no response in a
variety of short-term tests for mutagenicity (limited,
but negative mutagenicity data were available).
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2. Worker exposure can be reduced to acceptable limits
through the classification of products containing
terbutryn as restricted use pesticides and through
the use of protective equipment, clothing, and gloves.
Additional data are reguired to fully assess the
quantitative exposure to workers (mixers, loaders, and
applicators) and margins of safety. Additional studies
have been required. However, estimates have been made
using data on other chemicals with similar use patterns,
and a risk assessment has been conducted. This is dis-
cussed more fully in Section C of this Part.
3. Terbutryn poses a limited oncogenic risk from dietary
exposure. The Theoretical Maximum Residue Contribution
(TMRC) for terbutryn in the daily diet based on the total
tolerances and daily food intake of 1.5 kg is 0.000260
mg/kg/day. Under these conditions 2.6% of the PADI
(Provisional Acceptable Daily Intake) has been used.
4. Although no data are available, since it is a relatively
non-selective herbicide, terbutryn is expected to be
highly toxic to plants. Therefore, interim protective
labeling will be required for endangered plant species.
In the course of its review, the Agency has identified data
which are necessary to evaluate risjcs associated with the
use of terbutryn. These data must be developed and submitted
in order to maintain registrations of products or register
new products' containing terbutryn. Figure 1 summarizes
the data gaps. Please note that this is only a summary,
and more details can be obtained by referring to Data
Tables A and B in Appendix I.
The Agency has also determined that certain additional or
revised label restrictions are necessary. They include:
0 Restricted Use Classification
0 Protective equipment and clothing
0 Grazing and feeding restrictions
0 Environmental hazard precautions
0 Endangered species warnings
A more detailed discussion of the Agency's assessments
follows. In Part IV, the Regulatory Position and Rationale
section details the Agency's position regarding the regula-
tion of terbutryn, and Section D of Part IV, Required
Labeling, contains the required wording for label revisions.
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SUMMARY OF DATA GAPS
PRODUCT CHEMISTRY
Manufacturing process
Identification of suppliers of material
Discussion of impurities
Certification of ingredients
Quantitative methods for impurities
ENVIRONMENTAL FATE
Photodeqradation (water, soil)
Anaerobic soil metabolism
Field dissipation study (soil)
Rotational crop study (confined)
Fish accumulation study
FISH AND WILDLIFE
Avian dietary (upland gamebird)
Freshwater fish (warm water, cold water) LC5Q
Acute estuarine and marine organism LC5Q studies
Fish early life-stage and aquatic invertebrate life cycle
studies
Non-tarqet phytotoxicity (aquatic plant qrowth,
seed germination/seedling emergence and vegetative vigor)
TOXICOLOGY '
Acute inhalation (rat)
21-Day dermal
Chronic toxicity (rodent) (special 24-month rat study)
Mutaqenicity battery
General metabolism
RESIDUE CHEMISTRY
Metabolism studies (ruminants, poultry)
Uptake, distribution, and metabolism in plants
(postemerqent application)
Storage stability data
Processed commodity data
Residues of concern on grain and milled products
Residues of concern on qreen wheat, qreen barley, wheat straw
and barley straw
Fiqure 1
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B. TOXICOLOGICAL ASSESSMENTS
1. Acute Oral, Dermal and Inhalation Toxicity
Acute toxicity studies show that via the oral, dermal
and inhalation routes, terbutryn is relatively non-toxic
An acute oral study with CD rats showed an oral LD5Q of
1.9 g/kg for males and 2.1 g/kg for females (Toxicity
Cateqory III*). An acute dermal study using New Zealand
albino rabbits showed a dermal LD5Q of >20.0 g/kg
(Toxicity Category IV*). Acute inhalation studies are
not available for technical terbutryn and are being
reguired; however an acute inhalation study using the
80% formulated product with Sprague-Dawley rats resulted
in the classification of terbutryn in Toxicity Category
III for acute inhalation.
2. Irritation and Sensitization (Eye and Dermal)
Terbutryn caused very slight irritation to the eyes.
An eye irritation study with the 80% formulated product
with New Zealand White rabbits resulted in placement
of terbutryn in Toxicity Category III*.
A primary skin irritation test with New Zealand White
rabbits produced no irritation at 72 hours (Toxicity
Category IV*).
The dermal sens itization study in male Hartley albino
guinea pigs indicated that terbutryn is not a skin
sens itizer.
3. Subchronic Toxicity
Valid subchronic oral toxicity studies are not available
on technical terbutryn; however, chronic studies in the
rat and the dog are available and are discussed below.
Subchronic oral toxicity studies are therefore not being
reguired.
Technical terbutryn has not been evaluated in a 21-day
subchronic dermal study, and thus the subchronic dermal
hazard of the product cannot be evaluated. A 21-day
dermal study in the rabbit is required.
Toxicity Cateqories are based on the acute toxicity of the
chemical (LD5Q or LC5Q values) and are used to determine the
appropriate signal word and precautionary language for product
labeling. Toxicity Category III requires the signal word
CAUTION and precautions against swallowing, inhaling, or
contact with the skin and eyes, along with appropriate first
aid instructions. Toxicity Category IV also requires the
signal word CAUTION, but no precautionary statements are
rsauired. See 40 CFR 162.10.
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Extended dermal exposure to technical terbutryn is not
expected to occur, and thus testing in a 90-day dermal
study is not required.
The Agency is reserving its decision on the need for
a subchronic inhalation study until the acute LD^Q has
been determined.
Terbutryn is not structurally related to any known group
of cholinesterase inhibitors, and no sign of neurotoxicity
was seen in subchronic or chronic toxicity tests in rats,
mice, and dogs. Thus acute delayed neurotoxicity testing
is not reguired.
4. Chronic Toxicity
The available chronic toxicity studies on terbutryn
include a rat study (MRID 00035923) and an acceptable
beagle study (MRID 00029152).
In the two year rat feeding study, Charles River CD rats
received technical terbutryn in their diet at levels of
0, 2, 300, and 3000 ppm. Decreased body weight gain
for both males and females and an increased incidence
of focal cytomegaly in livers of female rats was seen
at 3000 ppm. Complete hematology and clinical .chemistry
according to guideline standards were not done in this
study and thus a NOEL for these parameters could not
be determined.
Because of the deficiencies noted above, a special 24-
month study in the same strain of rats is reguired for
reregistration, with emphasis on hematology and clinical
chemistry parameters in order to determine a NOEL for
these effects. Histopathology and urinalysis are not
required for this study.
In the six-month beagle study, dogs received technical
terbutryn at levels of 0, 10, 25, and 50 mg/kg/day in
the diet. At 25 and 50 mg/kg/day mucosal thickening of
various segments of the small intestine and submucosal
lymphoid hyperplasia in the pyloric region of the
stomach was observed. The NOEL was 10 mg/kg/day. The
requirement for chronic toxicity testing in a non-rodent
has been satisfied,and the NOEL from this study is used
as the basis of the ADI.
5. Teratology and Reproductive Effects
Teratology studies have been conducted on terbutryn in
rats (MRID 00152764) and New Zealand White rabbits
(MRID 00152763). Terbutryn was not teratogenic to
either species. The NOEL for maternal toxicitv in the
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rabbit was 10 mq/kq and 50 mq/kq for the rat, based
upon decreased food consumption, increased food efficiency
index (qrams of food consumed per kiloqram of body weiqht
qained), decreased body weiqht qain, and stool chanqes
in rabbits at 50 mq/kq and increased mortality, saliva-
tion, urine staininq, bloody discharqe, and weiqht loss
at 500 mq/kq in the rat. The NOEL for fetotoxicity in
the rat and rabbit was 50 mq/kq based upon reduced ossifi-
cation and misaliqnment of the sternebrae and centrum
vertebrae; reduced ossification of the metacarpals,
proximal phalanqes, phalanqes, and distal phalanqes of
the forepaw; and reduced ossification of the metacarpals
and distal phalanqes of the hindpaw in rats at 500 mq/kq
and reduced ossification of sternebrae in rabbits at
75 mq/kq. Teratoqenicity testinq requirements have
been satisfied.
A three qeneration reproduction study in Charles River
CD rats (MRID 00035659) is also available. Terbutryn
was administered in the diet at levels of 2, 300, and
3000 ppm. At 3000 ppm, decreased mean body weiqhts and
food consumption values were found for the Fo, F]_, and
?2 parents as well as decreased pup weiqhts in all qener-
letions at lactation day 21. This study satisfies the
requirements for a reproduction study in rodents. The
data from the teratoloqy and reproduction studies do
not demonstrate a siqnificant risk to humans.
i
6. Mutaqenicity Data
The requirements for mutaqencity testinq have not been
satisfied. One chromosomal study (in-vivo cytoqenetics
in Chinese hamsters; MRID 00100654) was acceptable and
indicated no mutaqenic activity. Terbutryn has also
been tested in the nucleus anomaly test (Chinese hamster;
MRID 00157846). The nucleus anomaly test was neqative
but was found to be an unacceptable assay because the
methods used to detrmine micronuclei induction were
inadequate to detect compound-related effects. Two other
tests (host-mediated rat and a mutaqenicity chromosome
study in qerminal epithelium of male mice) were neqative
for mutaqenicity, but were classified as supplementary
because of protocol limitations, inadequate reportinq
of data and lack of positive controls.
The followinq mutaqenicity studies will be required for
the reqistration of terbutryn in order to better define
the mechanism of tumor induction of terbutryn in rats:
a. in-vitro mammalian qene mutation assay;
b. unscheduled DNA synthesis assay in rat'hepatocytes;
c. a chromosome aberration study in rats; and
d. sister chromatid assay in rats.
10
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These assays are required to provide more information
on the mutagenic potential of terbutryn and the mechanism
of tumor production in the rat. The additional data may
also aid in determining the classification of terbutryn
as an oncogen.
7. Metabolism Data
Metabolism studies (MRID 00100640) have been conducted
in the rat using both ring and methylthio-l^C-labeled
terbutryn. Eighty-five percent of the ring-labeled
dose was excreted within 72 hours in urine and feces.
Sixty-two percent of 14C methylthio-labeled terbutryn
was recovered within 72 hours in expired CC>2. The major
pathways for metabolism are desulfuration, N-deethylation
and S-demethylation.
These studies only partially meet requirements for a
metabolism study on terbutryn. A metabolism study that
meets present guideline standards (i.e. multiple dosing)
is reguired for the registration of terbutryn.
8. Oncoqenicity Data
In a two year carcinoqenicity study on Charles River
CD-I mice (MRID 00029153), technical terbutryn was
administered in the diet at levels of 0, 3, 1000, and
3000 ppm. No evidence of oncogenicity was observed
for terbutryn in this study.
In a two year chronic toxicity study in CD rats (MRID
00035923), the oncogenic potential of technical terbutryn
was studied. Levels tested were 0, 2, 300, and 3000 ppm.
When administered in the diet to Charles River CD rats
at 3000 ppm., terbutryn induced a statistically signifi-
cant increase in combined mammary tumor-bearing females
(adenomas, fibroadenomas and adenocarcinomas) and in
combined hepatocellular adenomas and carcinomas in
females. In male rats, it induced a statistically
significant increase in combined thyroid follicular
adenomas and carcinomas and in testicular interstitial
cell adenomas.
The incidence of tumors in the animals tested is
represented in the chart on the next page.
11
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INCIDENCE OP TUMORS IN RATS
FED TERBUTRYN IN THE DIET FOR TWO YEARS
Organ/Tissue
0
DOSE (ppm)
2 300
3000
Thyroid
follicular cell
adenoma
carcinoma
adenoma + carcinoma
Testes
interstitial cell
adenoma
Males
1/59
0/59
1/59
13/59
Females
1/59
0/59
1/59
1/60
1/60
1/60
11/60 14/60
6/57
3/57
9/57
9/57
Liver
hepatocellular
adenoma
carcinoma
adenoma + carcinoma
Mammary Gland
adenomal
adenocarclnomal
fibroadenomal
Total anomals with
one or more mammary
gland tumors 2
3/57
2/57
5/57
6/57
15/57
12/57
2/60
0/60
2/60
9/58
8/58
15/58
3/59
0/59
3/59
8/58
7/58
20/58
24/57 29/58 29/58
12/56
4/56
16/56
13/55
20/55
18/58
34/55
iThese animals could have other types of mammary tumors as well
2There Is no duplication of animals in these numbers.
12
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In accordance with EPA's 1984 Proposed Guidelines for
Carcinogen Risk Assessment (49 FR 42694, Novembr 23,
1984), the Agency has classified terbutryn as a Group C
carcinogen—that is, a possible human carcinogen.
The guidelines categorize the evidence on carcinogenicity
of a chemical in terms of how likely it is that the
chemical is a human carcinogen. Under this scheme,
Group A, ("Human Carcinogen") is reserved for those
chemicals for which there is sufficient evidence of
carcinogenicity from human epidemiological studies.
Group B, ("Probable Human Carcinogen") is divided into
subgroups 1 and 2. Group Bl requires some human epidem-
iological evidence. Since there are no data from human
epidemiological studies on terbutryn, there is no reason
to classify it under Group A or Bl. Group B2 is appro-
priate if there is "sufficient evidence" of the chemical's
carcinogenicity from animal studies. "Sufficient
evidence" is defined as an increased incidence of
malignant (or combined malignant and benign) tumors
(1) in multiple species or strains, (2) in multiple
experiments, or (3) to an unusual degree with regard to
incidence, site or type of tumor, or age at onset.
Group C ("Possible Human Carcinogen") is appropriate if
there is "limited evidence" of carcinogenicity in animals
in the absense of human _data. "Limited evidence" means
that the data suggest a carcinogenic ef.iect but are
limited because (1) the studies involve a single species,
strain, or experiment; or (2) the experiments are
restricted by inadeguate design or reporting; or (3) an
increase [is seen] in the incidence of benign tumors
only. Among the types of evidence which may be seen
are definite malignant tumor response in a single well-
conducted experiment or marginal responses in a tissue
known to have a high and variable background rate.
There is also a Group D ("Not Classified") and a Group E,
which is reserved for chemicals determined to be non-
carcinogenic in animal and/or human studies.
The Agency concluded that terbutryn should be classified
as a Group C carcinogen. Based on one study in one
strain of one species, the chemical produced 1) a
marginal response in a tissue (mammary gland) known to
have a high and variable background rate of tumors, and
2) an increase in combined benign and malignant tumors
(testicular, thyroid and liver) with terbutryn producing
no response in a variety of short-term tests for muta-
genicity (limited, but negative mutagenicity data
were available).
13
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The Agency also considered a Group B-2 classification
for terbutryn since tumors were produced at multiple
sites and since positive, but not conclusive, structure
activity relationship (SAR) data were available. The
Agency reviewed data on two structurally similar compounds,
propazine and atrazine. The SAR data was not considered
conclusive since, for propazine, historical control data
on the mammary tumors seen in the study is still out-
standing and, for atrazine, only a preliminary report
on the incidence of mammary tumors was available and
the final report has not been evaluated. In addition,
four thyroid inhibitors which are structurally similar
to terbutryn, are known to induce thyroid neoplasia.
On the basis of the foregoing, the Agency finds the Group C
classification the most appropriate, but positive informa-
tion in the area of mutagenicity for terbutryn and/or
mutagenicity and oncogenicity for other structurally
related triazines could raise terbutryn to the Group B-2
classification. In light of this possibility, it was
decided that a quantitative estimation of the oncogenic
potential for humans should be developed.
A quantitative estimation of the oncogenic potential
in rats has been completed by the Agency as summarized
below.
[Q1*(ppm)~1]
Females
Mammary: adenomas + carcinomas 1.89 x 10~4
adenomas + carcinomas +
fibroadenomas 2.27 x 10~4
Liver: adenomas 1.09 x 10~4
adenomas + carcinomas 1,33 x 10~4
Males
Thyroid: adenomas 5.12 x 10~5
adenomas + carcinomas 8.70 x 10~5
Testes: adenomas 1.68 x 10~4
The Q-,* estimate for terbutryn is approximately 10~4 (ppm)~
in rats which converts (via Lehman's Tables and the surface
area correction) to approximately 10~2 (mg/kg/day)~1 for
humans.
The upper 95% confidence limits on the dietary oncogenic
risks for terbutryn (possible human oncogen) is 2.6 x 10~6-
This is based on ingestion of barley, sorghum and wheat
which had residues at the tolerance levels of 0.1 opm.
14
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9• Dermal Absorption
In a dermal absorption study with male Harlan Sprague-
Dawley rats, (MRID 157844), significant quantities of
terbutryn were absorbed dermally at all doses and time
intervals. Representative percent absorptions for 10
hours exposure were 22.02%, 4.44%, and 2.25% for doses
of 0.05, 0.5, and 5.0 mg/10cm2. Animals which were
washed at ten hours and maintained for an additional
48 hours showed total absorptions of 34.48%, 12.26%, and
8.25% of the respective doses. Further studies on dermal
absorption are not required.
C. Worker Exposure Hazard
An assessment of worker exposure to terbutryn which
estimated worker exposure during different application
techniques was conducted in 1981 for the RPAR Decision
Document. The exposure estimates were derived from
surrogate data corrected for terbutryn's use rates.
More recently, a worker exposure re-evaluation and dermal
exposure risk assessment have been conducted by the Agency.
The estimates of risk were determined by using an estimate
of the number of man hours associated with various applica-
tion techniques, estimates of the hourly exposure for
workers, and the calculated carcinogenic potency (0^*) of
terbutryn. The estimated risks associated with various
workers are shown on the next page.
Based on the 1982 dermal absorption study (MRID 00157844),
calculations were made using the absorption rate of 22%
as opposed to a rate of 10% which was used in 1981. It
should be noted that, the study indicated that absorption
continued after washing up to 34%. However, the Agency
chose the 22% absorption figure for its calculations because
the 22% figure is more representative of the exposure time
estimated for workers in the field. (Use of the 34%
absorption rate would have increased risk less than one
order of magnitude.)
Since 1981, the Agency has added to its data base of surrogate
studies and the methods for estimating worker exposure have
been refined. The Agency's current practice is to use all
available data which may be applicable for calculations of
exposure and risk, including both surrogate data and studies
specific to the chemical in question. In this case, an
applicator exposure monitoring study submitted by the regis-
trant for terbutryn corroborates the projected exposures in
the Agency's current analysis.
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YEARLY RISK FROM DERMAL EXPOSURE
Typical Range
MIXER/LOADERS (WITH PROTECTIVE CLOTHING—GLOVES ONLY)
ground wheat/barley
private 3.6 x 10~6 6 x 10~8 - 1 x 10~5
commercial 2.9 x 10~5 1 x 10~7 - 1 x 10~4
aerial wheat/barley
commercial 1.1 x 10~5 3 x 10~7 - 2 x 10~4
ground sorghum
private 2.9 x 10~6 8 x 10~8 - 1 x 10~5
commercial 8.6 x 10~6 1 x 10"7 - 1 x 10~4
aerial sorghum
commercial 1.1 x 1CT5 1 x 10~7 - 1 x 10~4
MIXER/LOADERS (WITHOUT PROTECTIVE CLOTHING)
ground wheat/barley
private 1.8 x 10~5 3 x 10~7 - 7 x 10~5
commercial 1.4 x 10~4 7 x 10~7 - 6 x 10~4
aerial wheat/barley
commercial 5.4 x 10~5 2 x 10~6 - 1 x 10~3
ground sorghum
private 1.4 x 10~5 4 x 10~7 - 9 x 10~5
commercial 4.3 x 10~5 7 x-10~7 - 9 x 10~4
aerial sorghum
commercial 5.6 x 10~5 5 x 10~7 - 1 x 10~3
GROUND BOOM APPLICATOR (WITHOUT PROTECTIVE CLOTHING)
wheat /barley
private 7.2 x 1CT6 5 x 1CT7 - 2 x 10~5
commercial 6.5 x 10~5 2 x 10~6 - 1 x 10~4
sorghum
private 5.0 x 1CT6 5 x 10~7 - 2 x 10~5
commercial 1.6 x 10~4 5 x 10~7 - 2 x 10~4
FLAGGERS
sorghum 3.1 x 10~6 7 x io~8 - 3 x io~4
PRIVATE APPLICATORS WHO DO THEIR OWN MIXING AND LOADING
wheat/barley
without gloves 2.5 x 10~^ 8 x 10~7 - 9 x lf)~5
with aloves 1.1 x 10~5 5 x io~7 - 3 x ]_Q-5
sorghum
without aloves 2.0 x 10~b 9 x irr~ -
with gloves 7.9 x 10-5 ^xlO-'-
16
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D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of terbutryn
in or on barley grain, barley fodder, green barley, barley
straw, sorghum grain, wheat grain, wheat fodder, wheat straw,
and green wheat at 0.1 ppm (40 CFR 180.265).
1. Residue data
The residue data reviewed in support of these tolerances
include:
a. Data on the nature of the residues in both plants and
animals, including identification of major metabolites
and degradates of terbutryn. Tolerances are set on
the parent compound only.
b. Radiological studies on the uptake, translocation, and
metabolism of terbutryn in plants show that terbutryn
is metabolized in plants.
c. Radiolabeled studies on the metabolism and translocation
of terbutryn in ruminants and poultry.
d. Analytical methodology for determining the levels of
residues of terbutryn in plants and animals. Such
methods have been determined to be suitable for residue
determinations and for enforcement of tolerances for
the parent compound only.
e. Data on the magnitude and levels of residues in
individual raw agricultural commodities.
2. Tolerances
In its evaluation of the data supporting tolerances, EPA
reached the following conclusions:
0 The available data are inadequate to support the
existing tolerances on sorghum forage, fodder,
silage, hay, and flour and milled products bearing
measurable weathered residues; wheat grain, forage
(green wheat), hay straw, and wheat milled products
bearing measurable weathered residues; and barley
forage, hay, straw, flour, and milled products.
Data are required for all the above except the barley
products since the data required for wheat can be
extrapolated for barley.
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0 No tolerances exist for terbutryn residues in animal
commodities; no analytical methods or supporting data
have been submitted for the determination of terbutryn
residues in animal commodities. Unless data show that
residues do not remain in meat, milk, poultry, and
eggs, either tolerances must be obtained or feeding
and grazing restrictions must be required.
0 If residues in the raw agricultural commodities
concentrate as a result of processing, appropriate
food additive tolerances must be extablished.
0 The following tolerances expressions should be revised
to conform with current practices and terminology?
The designation "N" (negligible) must be deleted
from all tolerance entries.
The term "green barley" should be amended to read "
barley forage" and the category "green wheat" should
be amended to read "wheat forage."
The categories "barley fodder" and "wheat fodder"
must be deleted.
3. Plant and Animal Residues
Currently tolerances for residues are expressed as
terbutryn per se_ and are given as negligible residues
(based on the limits of detection). It has been deter-
mined that any metabolite of terbutryn which contains
an intact triazine ring is of toxicological concern
and should be included in the tolerance expression.
Currently the nature, or identity, of metabolites is not
adequately understood. Residue data for the terbutryn
parent material are adequate for barley and sorghum
grain, but residue data on the metabolites are inade-
quate. Only the tolerance for terbutryn parent material
in wheat is not supported. The tolerances for wheat
and barley forage, hay and straw are not supported.
Additional data are being required.
The Agency has determined that a group tolerance for
cereal grains would not be appropriate at this time.
A review of Agency files indicates that no data are
available and no proposal has been made to establish
tolerances for residues of terbutryn in or on corn or
rice. Such proposals, with acceptable supporting data,
would be necessary to establish a group tolerance for
cereal grains. Additional data also would be required
for wheat and barley products.
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3 . Dietary Assessment
The toxicity data considered to establish a Provisional
Acceptable Daily Intake (PADI) include the following:
a. A chronic feeding study in rats with an undetermined
NOEL is available, but this study was not conducted
according to guideline requirements and has been
rejected as the basis for the ADI calculation.
b. A six-month feeding study in beagles (MRID 00029152)
with a NOEL of 10 mg/kg/day, was selected as the
basis for the PADI. A more detailed discussion of
this study may be found in Section B, 5 of this Part.
Based on this study and a safety factor of 1000, a
PADI of 0.100 mg/kg/day was calculated.
The TMRC (Theoretical Maximum Residue Contribution) for
terbutryn is 0.000260 mg/kg/day. The TMRC is based on
the assumption that the full amount of residues permitted
by the published tolerances is present in treated crops.
The TMRC for terbutryn constitutes 2.6% of the PADI.
Daily dietary exposure to terbutryn is thus substantially
less than the calculated provisional acceptable daily
intake for humans.
In addition, the TMRC assumes that 100% of the crop is
treated. The percentage of food crops actually treated
is very limited—less than 1% of the winter whaat and
less than 2% of the grain sorghum grown in the U.S. and
a negligible amount of barley and fallow land. Because
of the limited percentage of crop treated, the resulting
dietary risk is actually reduced one hundredfold (from
10~6 to 10~8).
ENVIRONMENTAL FATE
Available data are insufficient to fully assess the
environmental fate of terbutryn.
Terbutryn (unaged) is expected to be relatively immobile in
soils ranging in texture from sand to clay loam to peat, based
on soil column and batch equilibrium tests. Therefore, the
potential for contamination of groundwater appears to be low.
However, a metabolite, hydroxy-terbutryn, does appear to have
potential to contaminate groundwater, and additional data are
being required to evaluate this potential.
Radiolabeled terbutryn (50% WP) residues were relatively
immobile in sand, silt loam, and sandy clay loam soil in
30 cm columns leached with 20 cm of water: approximately
80-90% of the applied radiolabeled terbutryn was detected
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in the top 8 cm of each soil
leachate from all four soils
radiolabeled terbutryn.
column (Guth, 0142913). The
contained less than 0.4% of
Radiolabeled terbutryn (50% WP) residues were detected at
maximum depths of 10, 6, and 2 cm in 30 cm columns of 'sand,
silt loam, and sandy clay loam soils, respectively, after
eluting with 20 cm of water (Guth, 00038374). Freundlich K
values were determined for sand of 1% organic matter (OM)--
2.34; for sand of 2.2% OM—4.35; for silt loam (3.6% OM)—
9.95; for clay loam (5.6% OM)--20.7; and for peat soils
(22.6% OM)—156.6, indicating a positive correlation between
adsorption of radiolabeled terbutryn residues and soil
organic matter content.
F. HAZARD ASSESSMENT FOR TERRESTRIAL AND AQUATIC ORGANISMS
Aguatic Organisms:
Available acute toxicity data indicate that terbutryn is
moderately toxic to warmwater fish and highly toxic to cold-
water fish. Minimum data reguirements to establish acute
toxicity are the results of two 96-hour studies using the
technical grade material. In studies using technical
material, LC5Q values of 2.4 ppm in rainbow trout and
4.7 ppm in crucian carp, were reported, but those studies
did not'satisfy guideline reguirements—the trout used
were too large and aeration was used and crucian carp is
not an acceptable species. Four fish studies using the
80% wettable powder gave the following results:
Rainbow trout (coldwater)
Rainbow trout "
Bluegill (warmwater)
Bluegill
48-hour LC5o—3.5 ppm
96-hour LCso—0.82 ppm
96-hour LC50—4.8 ppm
96-hour LC50—2.7 ppm
One simulated field study with bluegill was conducted for
35 days in miniature ponds. At 5 ppm, 100 percent mortality
occurred in 11 days; at 1 ppm and below, no mortality
occurred throughout the 35-day study.
Terbutryn is moderately toxic to aguatic invertebrates. A
48-hour study on toxicity to Daphnia magna was evaluated,
and the LC5Q is 2.66 ppm.
No assessment can be made regarding the toxicity to estuarine
and marine organisms because no studies have been evaluated.
These studies are reguired for rights-of-way and other non-'
crop uses.
20
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No assessment can he made reqardinq the fish early life
staqe toxicity or the aquatic invertebrates life cycle
toxicity because no studies have been evaluated. These
studies are required for riqhts-of way and other non-crop
uses and reserved for the sorghum use.
The Agency calculated the levels of residue which could be
expected to remain in the top 6 inches and the top 6 feet of
water as a result of run-off, drift, and direct application
to the water. Except for the direct application to 6 inches
of water, the expected residues are all less than one-half
of the LC5Q of the most sensitive aquatic animal species
(rainbow trout, LC5Q=0.82 ppm). Neither the run-off or
drift worstcase estimates would exceed the criteria for
endangered species concerns. Therefore, the current uses
of terbutryn, which do not include direct application to
water, are unlikely to result in significant adverse acute
ecological effects to aquatic animal species.
Terrestrial Organisms:
There is no evidence to suggest that the use of terbutryn
has resulted in kills or has affected mammalian or avian
populat ions.
The data indicate that technical terbutryn is practically
nontoxic to waterfowl and upland gamebirds on acute oral
and subacute dietary bases. Oral acute toxicity studies
indicate LD5Q values greater than 4,640 mg/kg for very
young mallards; greater than 2,000 mg/kg for older mallards;
and greater than 2,000 mg/kg for pheasants. These three
studies in combination satisfy the data requirement. The
avian dietary LC5Q values are greater than 4,640 ppm for
the mallard duck, greater than 20,000 ppm in 7-day exposures
and greater than 2,000 ppm in 4-week exposures for Bobwhite
quail adults. The avian dietary LC5Q requirement for water-
fowl is satisfied but the requirement for upland gamebirds
is not. Therefore, a study is required for upland qamebirds.
No avian reproduction study was available for evaluation;
the requirement for a study is being reserved pending review
of environmental fate data.
There is sufficient information to characterize terbutryn
as relatively nontoxic to honeybees.
Plant Protection
No plant protection studies were reviewed. Tier 1 testing
is required on a case-by-case basis to support the regis-
trations of (1) products for which phytotoxicity problems
arise, and open literature data are not available and (2)
21
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products that may pose hazards to endangered or threatened
species. Since terbutryn has use patterns similar to those
chemicals that have jeopardy opinions prepared by OES, the
Agency is assuming that use of terbutryn may also pose
hazards to endanqered plants. The Aqency is requiring that
Tier 1 testing be performed with terbutryn. Refer to
Appendix I for testing requirements.
G. ENDANGERED SPECIES
There are sufficient toxicity and exposure data to indicate
that the currently registered uses of terbutryn are unlikely
to pose a hazard to endangered aquatic or avian species.
Concerning endangered plants, on October 12, 1983, the
Office of Endangered Species (OES) issued a jeopardy opinion
for pesticides used on the crop cluster that includes wheat,
barley, and sorghum. Solano grass (Orcuttia mucronata) is
the only endangered plant that was considered likely to be
associated with these uses. In addition, the valley elder-
berry longhorn beetle (Desmocerus californicus dimorphus)
is restricted to elderberry thickets in Central Valley of
California. Sorghum and small grains are grown in this
vicinity, and OES indicated that herbicides should be
prohibited in this area to protect the host elderberry
plants and conseguently the beetle. See Section D of
Part IV for required labeling.
Since terbutryn is a relatively nonselective herbicide
registered for the crop uses mentioned in the OES opinions,
the Aqency concludes that endangered plants in those areas
may be adversely affected. The potential for adverse
effects is dependent upon the exposure. Additional data
are required to evaluate exposure in crop and noncrop
areas.
To protect endangered species in -noncrop lands, restrictive
labeling may be required when the Agency completes its con-
sultation with the OES for the generic cluster of noncrop
pesticides. To protect endangered plant species associated
with use on sorghum, barley, and wheat, interim labeling is
required pending a review of environmental fate data and
possibly an OES jeopardy opinion.
H. PRODUCT CHEMISTRY EVALUATION
The Aqency has evaluated the available data which identify
the ingredients, materials, and manufacturing process and
discuss the physical and chemical properties of the technical
grade of the active ingredient and of the manufacturing use
product. Additional data requirements have been identified
and are listed in the data tables.
22
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IV. REGULATORY POSITION
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on terbutryn, the Agency has
made the following determinations:
1. Terbutryn does not meet any of the criteria specified
in 40 CFR 154.7; therefore a Special Review is not
being initiated at this time.
Rationale;
If a pesticide meets or exceeds any of the criteria
specified in 40 CFR 154.7, a Special Review of the
chemical may be conducted. Although terbutryn has
been found to be oncogenic in rats (a Group C oncogen),
the Agency does not believe it meets the criterion in
40 CFR 154.7(b)(2) for oncogenic effects requiring
Special Review. The regulations provide that the
Administrator may conduct a Special Review if a pesticide
use "may pose a risk of inducing in humans an oncogenic
...effect, which risk is of concern in terms of either
the degree of risk to individual humans or the number
of humans at some risk..." (50 FR 49016, November 27,
1985).
The greatest potential hazard is to workers who mix, load,
and apply the pesticide. Having reevaluated exposure to
the pesticide and available means of reducing exposure,
the Agency has concluded that the risks posed to workers
workers by exposure to terbutryn can be reduced signifi-
cantly by implementation of protective measures through
this standard.
Dietary risk is not considered significant in light of
the following facts:
Actual residues are expected to be lower than the
established tolerances of 0.1 ppm.
Less than 2% of the sorghum and less than 1 % of the
wheat planted in the United States are treated with
terbutryn; other uses of terbutryn are minimal.
2. The Agency is classifying all end-use pesticide products
containing terbutryn for "Restricted Use" and requiring
appropriate labeling language. The specific language
may be found in Section D of this Part.
23
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Rationale;
The oncogenic risk to applicators can only be reduced
to an acceptable level if the special precautions which
are being required are closely followed. The Agency
believes classification of terbutryn as a restricted use
pesticide is necessary to avoid unreasonable adverse
effects to users due to dermal exposure. Only certified
applicators who have received instruction on the safe
handling of pesticides, or those under the direct super-
vision of certified applicators, will be permitted to
handle terbutryn products. The Agency believes that,
because of their training, certified applicators are
more likely to conscienciously follow complex label
instructions than are lay pesticide users.
In order to remain in compliance with FIFRA, Registrants
must place statements on the labels of manufacturing-use
and end-use products containing terbutryn requiring
protective clothing for mixers and loaders and closed
vehicles for flaggers. The specific language required
appears in Section D of this Part.
Rationale;
The potential oncogenic risks to workers can be reduced
substantially if persons who may come in contact with
the chemical wear protective clothing and/or are shielded
from the chemical by an enclosed vehicle.
4. In order to remain in compliance with FIFRA, registrants
must package all end use products in water soluble bags
with appropriate use directions.
Rationale;
The use of water soluble bags will reduce worker exposure
to terbutryn by preventing dermal contact with the
chemical during mixing.
5. Reentry intervals are not necessary for currently
registered uses of terbutryn.
Rationale;
The acute toxicity for terbutryn is low (category III).
Terbutryn is a pre-emergence and early postemergence
herbicide. Because of cultural practices, it is not
anticipated that field workers are likely to come in
contact with the wet herbicide after application.
Therefore, no reentry interval is required at this
time. Following review of additional data, the Agencv
will give furnner consideration -3 chis decision.
24
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The Agency is not placing a restriction against the
planting of crops for which terbutryn is not registered
in terbutryn treated fields.
Rationale;
Data currently available indicate that terbutryn does
not persist in the soil. "Rotational crop" data have
been reguired, and once those data have been reviewed,
the Agency will reassess the need for a restriction.
7. In
In order to remain in compliance with FIFRA, registrants
must do one of the following:
a) amend product labels to incorporate grazing and feeding
restrictions for all raw agricultural commodities
(i.e., wheat hay, straw, and forage; barley hay, straw,
and forage; and sorghum forage, fodder, silage, and
hay) if treated with terbutryn;
b) submit data which demonstrate that no residues remain
in meat milk, eggs, and poultry as a result of feeding
treated commodities; or
c) propose tolerances and provide appropriate supporting
data for all food and feed.
Rationale;
Terbutryn residues may be found in the above commodities.
If residue-bearing commodities are fed to cattle or poultry,
residues may be present in meat, milk, poultry, or eggs
(which may be used for human foo). However, no tolerances
exist for those foods. In order to avoid unsafe levels of
terbutryn residues in human food, grazing and feeding
restrictions are necessary unless either (1) it is demon-
strated that residues will not be found in human food, or
(2) tolerances are established.
Additional residue data must be submitted for the following
raw agricultural commodities: sorghum forage, fodder,
silage, hay, and flour and milled products bearing
measurable weathered residues; wheat grain, forage (green
wheat), hay, straw, and wheat milled products bearing
measurable weathered residues. If residues concentrate
in any of the processed products, the appropriate food
additive tolerance(s) must be established. Specific
data requirements may be found in the Data Tables.
Rationale;
The available data are inadequate to support existing
tolerances for these commodities. Previously submitted
25
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barley are not required, since the data to be submitted
for wheat can be translated for barley.
9. The Aqency is requiring data on plant and animal
metabolism as well as storage stability studies.
Appropriate validated methodology as well as storage
stability and residue data (crops, meat, milk, poultry,
and eqgs) are required for all plant and animal meta-
bolites of terbutryn which contain an intact trfazine
rinq as identified in the metabolism studies.
Rationale;
Current tolerances are expressed in terms of the parent
compound only; however, the Agency has determined that
the metabolism in plants and animals is not adequately
defined. Metabolites of terbutryn which contain an intact
triazine rinq are of toxicoloqical concern and should be
included in the tolerance expression. In addition, some
of the data required are dependent on the results of meta-
bolism studies, and currently available data are inadequate
to quantify the metabolites. Storaqe and stability data
are not available and are necessary to ascertain whether
residues are stable in plant commodities when stored.
10. The Agency has determined that the following revisions in
the tolerances listed in 40 CFR 180.265 are necessary
and will initiate actions to effect these changes.
0 The designation "N" (neqliqible) must be deleted from
all tolerance entries.
0 The term "green barley" should be amended to read
"barley forage" and the category "green wheat" should
be amended to read "wheat forage."
0 The categories "barley fodder" and "wheat fodder" must
be deleted.
Rationale;
0 The designation "N" for negligible residues is no
longer used by the Agency.
0 Forage (rather than "green") is the preferred term for
the succulent plant material.
0 Wheat fodder and barley fodder are not considered
raw agricultural commodities of wheat and barley.
11. The Agency is requiring additional field studies to
evaluate the potential the metabolites of terbutryn
to enter qroundwater.
26
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Rationale;
Based on a review of data recently submitted by the
registrant, terbutryn demonstrated a low potential
to reach groundwater. However, the data showed that
hydroxy-terbutryn, the major environmental metabolite,
is persistent and mobile in the soil profile. Additional
field studies are necessary to further evaluate the per-
sistence and mobility of this and other metabolites.
12. In order to remain in compliance with FIFRA, registrants
must amend their labels to incorporate restrictions to
protect endangered plant species for all end-use products
registered for crop use. Refer to section D of this Part
for specific wording of label statements.
Rationale;
Although additional data on phytotoxity and exposure are
necessary to evaluate potential adverse effects on
endangered plant species, the OES jeopardy opinion of
October 1983 indicates that at least one endangered plant
species is likely to be associated with the crop uses of
terbutryn. In addition to endangered plant species,
certain non-target plants may constitute necessary habitat
for endangered or threatened insects. Therefore, interim
labeling regarding the protection of endangered species is
necessary pending review and evaluation of required data.
13. The Agency will not require labeling to protect endangered
species for noncrop uses at this time.
Rationale;
The Agency has not yet completed generic consultation
for noncrop uses with the OES. Endangered Species
labeling for noncrop uses may be required when generic
labeling has been completed for noncrop pesticides.
14. While the data gaps are being filled, currently registered
manufacturing-use products and end-use products containing
terbutryn as the sole active ingredient may be sold,
distributed, formulated, and used in the United States,
subject to the terms and conditions specified in this
Standard. Registrants must provide or agree to develop
additional data, as specified in Appendix I to'maintain
existing registrations.
The Agency will issue registrations for substantially
similar products. However, new uses will be issued only
on a case-by-case basis after considering the effects
on the theoretical maximum residue contribution (TMRC),
the maximum permissable intake (MPI), and the oncogenic
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Rationale;
Section 6 of FIFRA authorizes the Administrator to
cancel a pesticide registration if he determines that
the pesticide will cause unreasonable adverse effects
on the environment. Based on available data, the
Administrator has not made such a determination as to
terbutryn. The Administrator has authority under FIFRA
sections 3(c)(2)(B) and 3(c)(7) to require registrants
and applicants for registration to provide data needed
to support new or continuing registrations.
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed
and evaluated and the Agency will determine if the data
will affect the registration of terbutryn.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain terbutryn 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 (MUP's) must contain terbutryn
as the sole active ingredient. Each MUP formulation
proposed for registration or reregistration must be
fully described with an appropriate certification of
limits, stating maximum and minimum amounts of the
active ingredient and inert ingredients which are
present in products, as well as impurities found at :
greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing terbutryn
provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category
in which each product is placed.
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3. Use Patterns
To be registered under this Standard, technical grade or
manufacturing-use products containing terbutryn may be
labeled for formulation into end-use products registered
only for the uses listed in Appendix III, EPA Index to
Pesticide Chemicals—Terbutryn. This Index lists all
registered uses, as well as approved maximum application
rates and frequencies.
D. REQUIRED LABELING
In order to remain in compliance with FIFRA, all products
must bear appropriate labeling as specified in 40 CFR 162.10
in addition to the specific labeling requirements which
follow. Appendix II contains information on labeling
requirements.
No pesticide product containing terbutryn may be released
for shipment by the registrant or producer after June 30,
1987, unless the product bears an amended label which
complies with the requirements of this Standard.
No pesticide product containing terbutryn may be distributed,
sold, offered for sale, held for sale, shipped, delivered
for shipment, or received and (having so received) delivered
or offered to be delivered by any person after June 30, 1988,
unless the product bears an amended label which complies with
the requirements of this Standard.
After review of data to be submitted under this Standard,
the Agency may impose additional labeling requirements.
The following information must appear on the labeling:
1. Ingredients Statement
The ingredient statement shall list the active ingredient
as "terbutryn:' 2-(tert-butylamino-4-(ethylamino)-6-
(methylthio)-s-triazine".
2. Use Pattern Statement
All technical grade and manufacturing-use products
shall state that they are intended for formulation
into end-use products registered for one or more of
the uses listed in the EPA Index to Pesticide Chemicals
for Terbutryn, Appendix III. However, no use may be
included on the label if the registrant fails to agree
to comply with data requirements in Table A for that
use pattern, as provided in this Registration Standard.
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3. Disposal Statement
The following statement shall appear on manufacturing-
use products, "Do not discharge effluent containing
technical grade or manufacturing-use products containing
terbutryn into lakes, streams, ponds, estuaries, oceans,
or public waters unless this product is specifically
identified and addressed in an NPDES permit. Do not
discharge effluent containing this product to sewer
systems without previously notifying the sewage treat-
ment plant authority. For guidance, contact your
state Water Board or the Regional Office of EPA."
4. Precautionary Statements
All end-use products shall bear the following restrictions:
a. Restricted Use Classification
"RESTRICTED USE PESTICIDE"
"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."
"The use of this product may be hazadous to your health
This product contains terbutryn, which has been
determined to cause tumors in laboratory animals."
b. Worker Safety Rules
"Persons mixing and/or loading or otherwise handling
this chemical are required to wear impervious gloves,
coveralls (or long-sleeved shirt and trousers), face
shield, socks, and shoes or boots."
"Flaggers are required to be in enclosed vehicles."
c. Feeding Restriction
"Do not graze or feed livestock treated grain,
forage, fodder, hay, silage, or straw to livestock."
d. Environmental Precautions
Terbutryn BOW
"This product is toxic to fish. Do not apply directly
to water or wetlands (swamps, bogs, marshes, and
potholes). Drift and run-off from treated areas may
be hazardous to aquatic organisms in neighboring
areas. Do not contaminate water by cleaning of
equipment or disposal of wastes."
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Terbutryn DF
"Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Drift and run-off
from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate
water by cleaning of equipment or disposal of wastes.
Endangered Species Restrictions (cropland)
"The use of any pesticide in a manner that may kill
or otherwise harm an endangered or threatened
species or adversely modify its habitat is a viola-
tion of Federal law. The use of this product is
controlled to prevent death or harm to endangered
or threatened species that occur in the following
counties or elsewhere in their range.
Before using this pesticide in the following counties
you must obtain the EPA Cropland Endangered Species
Bulletin. The use of this pesticide is prohibited
in these counties unless specified otherwise in the
Bulletin. The Cropland Bulletin is available from
either your county Agricultural Extension Agent, the
Endangered Species Specialist in your State Wildlife
Agency Headquarters, or the appropriate Regional
Office of either the U.S. Fish and Wildlife Service
(FWS) or the U.S. Environmental Protection Agency
(EPA) indicated below.
t
THIS BULLETIN MUST BE REVIEWED PRIOR TO
PESTICIDE USE.
Contact FWS in Portland, Oregon
or EPA in San Francisco, California
CALIFORNIA: Solano County (Solano grass), Merced,
and Sacramento Counties (critical habitat of Valley
Elderberry Longhorn Beetle)"
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides identified
in Section II. A. are subject to certain requirements for data
submission or changes in composition, labeling, or packaging of
the product. The applicable requirements depend on whether the
product is a manufacturing or end use product and whether the
pesticide is the sole active ingredient or one of multiple
active ingredients.
Products are subject to this Registration Standard as follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in Appendix I
of this Registration Standard. The Guide to Tables in that
Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide as
one of multiple activeingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the data
requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption, the
date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the data
requirements listed in Table C.
3 If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you
are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an unregistered
product, formulate your own active ingredient, or acquire
your active ingredient from a firm with ownership in
common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). it refers to
the data listed in Table A, which are required to be submitted
by registrants to maintain in effect the registration of
products containing this active ingredient.5
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to_an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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the application is submitted, the data have been submitted to
the Agency by current registrants. If the required data have
not yet been submitted, any new registration will be conditioned
upon the new registrant's submission or citation of the required
data not later than the date upon which current registrants of
similar products are required to provide such data. See FIFRA
section 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 willnot be submittingthe 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 state-
ment by the person who will be submitting the data that
you may rely upon its submission. The Agency will also
require adequate assurance that the person whom you
state will provide the data is taking appropriate steps
to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement
between the parties or a mechanism to resolve the terms.
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3. You have attempted to enter into an agreement to jointly
develop data/ but no other registrant has accepted your
offer. You request that EPA not suspend your registration
for non-compliance with the PCI.EPA has determined that,
as a general policy,it will not suspend the registration
of a product when the registrant has in good faith sought
and continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt
of your offer (such as a certified mail receipt).
Your offer must, at a minimum, contain the following
language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or .failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c) (2)(B)(iii).
The remainder of your offer may not in any way attempt
to limit this commitment. If the other registrant to
whom your offer is made does not accept your offer, and
if the other registrant informs us on a DCI Summary
Sheet that he will develop and submit the data required
under the DCI, then you may qualify for this option.
In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share
in the burden of developing the data. In addition,
the other registrant must fulfill its commitment to
develop and submit the data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not(or should not)
apply to your product or its uses, you must provide EPA
with a statement of the reasons why you believe this is
so. Your statement must address the specific composition
or use factors that lead you to believe that a requirement
does not apply. Since the Agency has carefully considered
the composition and uses of pesticide products in
determining that a data requirement applies, EPA does
not anticipate that many waivers will be granted. A
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request for waiver does not extend the timeframes for
developing required data, and if your waiver request
is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed.You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol
If you will generate the required data and plan to use test
procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
F. Procedures for requesting extensions of time
If you think that you will need more time to generate the
data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring.
EPA will view failure to request an extension before the
response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline
for submitting the data.
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The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. Time
extensions may be considered when joint data development
is planned, or when the Agency must approve a new or modified
protocol before the study can be begun.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation
The Agency has determined that if a registration is suspended
for failure to respond to a DCI request under FIFRA section
3(c)(2)(B), an existing stocks provision is not consistent
with the Act. Accordingly, the Agency does not anticipate
granting permission to sell or distribute existing stocks
of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted,
you have the burden of clearly demonstrating to EPA that
granting such permission would be consistent with the Act.
The following information must be included in any request
for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic data,
generally support only the registration of that product. All
such data must be submitted by the dates specified in this
Registration Standard.
If you have a manufacturing use product, these data are listed
in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided
that it will not routinely require product-specific data for
end use products at this time. Therefore, Table C may not be
contained in this Registration Standard; if there is no Table C,
you are not required to submit the data at this time.
In order to comply with the product specific data requirements,
you must follow the same procedures as for generic data. See
Section IV. D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data) or
IV. D.6.(cancellation of registration).
Failure to comply with the product-specific data requirements
for your products will result in suspension of the product's
registration.
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate, complete
and sufficient instructions and precautions, reflecting the
Agency's assessment of the data supporting the product and its
uses. General labeling requirements are set out in 40 CFR 162.10
(see Appendix II - LABELING and SUMMARY). In addition, labeling
requirements specific to products containing this pesticide are
specified in Section IV.D of this Registration Standard.
Applications submitted in response to this notice must include
draft labeling for Agency review.
If you fail to submit revised labeling as required, which
complies with 40 CFR 162.10 and the specific instructions in
Section IV.D., EPA may seek to cancel or suspend the registration
of your product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) Containing (name of
pesticide) as Sole Active Ingredient"
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to
40 CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA Form
8570-1 ).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling. Labeling should be either typewritten
text on 8-1/2 x 11 inch paper or a mockup of the
labeling suitable for storage in 8-1/2 x 11 files.
The draft label must indicate the intended colors
of the final label, clear indication of the front
panel of the label, and the intended type sizes of
the text.
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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d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you
are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing (name of 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 ),
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 is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing (name of pesticide) alone
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 attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
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c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch paper
or a mockup of the labeling suitable for storage in
8-1/2 x 11 files. The draft labeling must indicate the
intended colors of the final label, clear indication of
the front panel of the label, and the intended type sizes
of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
D. Intrastate Products containing (name of pesticide) either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a
letter instructing them how to submit an application for
registration.
E. Addresses
The required information must be submitted to the following
address:
[Insert PM name and number]
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.
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TGUIDE-1
GUIDE TO TABLES
Tables A, and B contain listings of data requirements for the
pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, Including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the following
format:
1. Data Requirement (Column 1). The data requirements are
listed In the order in which they appear In 40 CPR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active Ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
P = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
N0_ - 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. iiust 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).
3. Footnotes Cat the end of each table). Self-explanatory.
44
-------
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
.analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
( check
below)
I am comply ing with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
Accession Numbers
Assigned
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
Name of Test
Stability
Oxidiz i ng/reduc inq
reaction
Flammability
Explodability
Storage stability
Viscosity
63-19 | Miscibility
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corros ion
character ist ics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
reguired
for my
product
listed
above
(check
below)
I am complying with
data reguirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
•
-------
TABLE A
DATA REQUIREMENTS FOR TERBUTRYN 96% TECHNICAL1 (EPA REGISTRATION NO. 100-540; CIBA-GEIGY CORP.)
Data Requirement
Composition^
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submit.t-^ol
Under FIFRA Se--f ion
§158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and TGAI
Disclosure of Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation TGAI
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis of TGAI
Product Samples
62-2 - Certification of TGAI
Ingredient Limits
62-3 - Analytical Methods TGAI
to Verify Certified
Limits
Partially
Partially
No
Partially
Partially
No
4
00047595,00065588
00024668
Registration Jacket
Yes
Yes
Yes
Yes
Yes
Yes
-------
TABLE A
DATA REQUIREMENTS FOR TERBUTRYN 96% TECHNICAL1 (EPA REGISTRATION NO. 100-540; CIBA-GEIGY CORP.)
Data Requirement
Composition^
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Color
- Physical State
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- PH
- Stability
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
Yes
Yes
Yes
Yes
N/A5
Yes
Yes
Yes
Yes
No
No
Yes
00047595
00047595,00065588
00065588,00085203
00047595
00047595,00065588
00022855,00047595
00022855,00047595
00065588
00047595,00065588
No
No
No
No
No
No
No
No
No
Yes
Yes
No
00
-------
TABLE A
DATA REQUIREMENTS FDR TERBUTRYN 96% TECHNICAL1 (EPA REGISTRATION NO, 100-540; CIBA-GEIGY CORP.)
Does EPA Have Data Must Additional
To Satisfy This Bibliographic Data Be Submitted
Requirement? (Yes, Citation (MRID Under FIFRA Section
Data Requirement Composition^ No or Partially) or as noted) 3(c)(2)(B)?3
§158.120 Product Chemistry (continued)
1. The 96% technical serves as a manufacturinq-use product.
2. Composition: TGAI = technical qrade of the active inqredient; PAI = pure active ingredient.
3. Data must be submitted no later than 8 months from issuance of this Standard.
4. Information obtained from desk references, (THE MERCK INDEX, Ninth edition, 1976; CRC HANDBOOK OF
CHEMISTRY AND PHYSICS, 59th edition, 1978-1979; and THE HERBICIDE HANDBOOK, 1986).
5. Not applicable since the technical product is a solid at room temperature.
a\
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Data Requirement
Use
Composition1 Pattern
Does EPA Have
Data To Satisfy
Requ i rement ? (Yes,
No or Partially)
Bibliographic
Citation
(MRID or
as noted)
Must Additional
Data Be Submit- Timeframe
ted Under FIFRA for
Section 3(c)(2)(B)? Submission
§158.125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue
(metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal residues
- Storage stability
data
TGAI
TGAI
PAIRA
PAIRA & Plant
Metabolites
TGAI &
Metabolites
TGAI
A,B
A,B
A,B
A,B
A,B
TGAI & A,B
Metabolites
A,B
Yes
Yes
Partially
Partially
Partially
No
No
Registration File
Registration File
00103154,00103155
00103156,00103157
00103173,00109755
00109759,00109784
00085223,00100640
00100647
00065582,00070872
00109793,00111690
00109784,00109786
No
No
Yes"
Yes-
Yes'
Yes4'5
Yes*
18 Months
o
(J~\
18 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Does EPA Have Bibliographic Must Additional
Data To Satisfy Citation Data Be Submit- Ti
Use Requirement? (Yes, (MRID or ted Under FIFRA
Data Requirement Composition1 Pattern No or Partially) as noted) Section 3(c)(2)(B)? Su
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue — residue studies for each food use.
- Crop Group #1, TGAI A,B No —
cereal grains
- Forage, fodder and N/A
straw of cereal
grain group
- Barley grain TGAI A,B Yes 00109752
- Barley, forage TGAI A,B Partially 00109752
No7
N/A7
No
No8
for
hay, and straw
- Barley flour and TGAI
milled products
- Sorghum (grain) TGAI
- Sorghum forage, TGAI
fodder, silage and hay
- Sorghum flour and TGAI
milled products
- Wheat grain TGAI
A,B
A,B
A,B
A,B
A,B
No
Yes
No
No
Partially
00047878,00065582
00070872,00093150
00109784
NO
00029579,00056911
00109759
Yes11
Yes 12
H
ir\
15 Months
24 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Data Requirement
Use
Composition^ Pattern
Does EPA Have
Data To Satisfy
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
(MRID or
as noted)
Must Additional
Data Be Submit- Timeframe
ted Under FIFRA for
Section 3(c)(2)(B)7 Submission
§158.125 Residue Chemistry (continued)
- Wheat, forage, hay, TGAI
and straw
- Wheat flour and TGAI
milled products
- Sugarcane TGAI
A,B
A,B
A,B
- Meat/milk/poultry/ TGAI or Plant A,B
eggs Metaboli tes
Yes
No
No
No
00029579
00109759
Yes13
Yes
No14
No15
15 Months
24 Months
C\J
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
§158.125 Residue Chemistry (continued)
_!/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TEP =
Typical end-use product.
_2_/ The information concerning uptake, distribution, and metabolism of terbutryn in either barley, sorghum, or wheat
following postemergence application is required.
_3/ Metabolism studies utilizing ruminants and poultry with ring-labeled (l^C) terbutryn are required.
_4/ Methodology is needed for all plant and/or animal metabolites of terbutryn containing an intact triazine ring.
_5/ No tolerances exist for residues of terbutryn in animal commodities at the present time.
6/ The information on storage intervals and conditions of samples used to support all established tolerances for
residues of terbutryn must be submitted, as well as storage length and conditions of storage of samples which are
analized for all required residue data and are submitted in support of terbutryn tolerances.
7/ This crop group tolerance is not appropriate at this time as there is no proposal for this use and residue data to
support uses in corn (fresh sweet and dried field) and rice are required. Also additional data to support existing
8/ Data are insufficient to support tolerances for barley forage, hay and straw. However no data are required because
the required wheat data will translate in support of barley.
9/ Data to support tolerances for barley flour and milled products will be translated from wheat data for flour and
milled products.
tolerance on wheat are required.
10/ Sorghum forage, fodder, silage and hay tolerance must be proposed and supported by data, or a feeding restriction
must be placed on product labeling.
ll/ Data are required in a location where sorghum bears measurable weathered residues in sorghum flour and milled
products.
12/ Data are required depicting residues of concern following, a single postemergence broadcast application of the 80% WP
formulation at 2.2 Ib ai/A. Applications using aerial and ground equipment must be represented. Note no data on
processed products have been submitted.
13/ Data are required depicting terbutryn residues of concern from an application as described in footnote 8, for these
commodities as well. Also no data are available for residues in or on wheat.
14/ There is no established or proposed tolerance for residues of terbutryn in or on sugarcane. However Puerto Rico has
requested a section 18 exemption for which no action level has been proposed.
15/ Pedding the out come of the required animal metabolism studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Data Requirement Composition^
§158.
,135 Toxicology
Use
Pattern2
Does EPA Have Data Must Additional
To Satisfy This Bibliographic Data Be Submitted
Requirement? (Yes, Citation (MRID Under FIFRA Section
No or Partially) or as noted) 3(c)(2)(B)?3
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal - Rabbit
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Yes
Yes
No
Yes
Yes
Yes
No4
00045432 No
00048742 No
Yes
00146728 No
00048741 No _^
ir\
00146730 No
No
SUBCHRONIC TESTING:
81-1
82-2
82-3
- 90-Day Feeding
- Rodent
- Nonrodent
- 21-Day Dermal
- 90-Day Dermal
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
Yes
Yes
No
No5
00035923 No
00029152 No
Yes
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
1
Data Requirement
§158.135 Toxicology (continued)
82-5 - 90-Day Neurotoxicity
CHRONIC TESTING:
82-1 - Chronic Toxicity
- Rodent
- Nonrodent
83-2 - Onccqenicity Study
- Rat
- Mouse
83-3 - Teratoqenicity
- Rat
- Rabbit
83-4 - Reproduction - Rat
MUTAGENIC TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Compos ition*
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Pattern2
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
No4
Partially
Yes
Yes
Yes
Yes
Yes
Yes
No
Partially
No
Bibliographic
Citation (MRID
or as noted)
00035923
00029152
00035923
00029153
00152764
00152763
00035659
00100654
Must Add 11
Data Be S>
Under FIFl
3(c)(2)(B
No
Yes6
No
No
No
No
No
No
Yes7
Yes8
Yes9
Mutagenicity
-------
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
I
Data Requirement
Use
Composition^ Pattern^
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.135 Toxicology (continued)
SPECIAL TESTING
85-1 - General Metabolism
b5-3 - Dermal Absorption
85-4 - Special Study
PAI or PAIRA A,B
TGAI A,B
TGAI A,B
Partially
Yes
No
00100640
00157844
No
Yes6
J7 Composition: TGAI = Technical grade active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient radiolabeled; Choice = Choice of several test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; '
I = Indoor; IP = Industrial Preservative.
3_/ Unless otherwise specified data must be submitted no later than 8 months after publication of this Standard.
4/ Terbutryn is not structurally related to a known group of cholinestarase inhibitors, thus neurotoxicity testing is
not required.
5/ Extended dermal exposure is not expected to occur, thus subchronic dermal testing is not required.
j[/ A special 24-month rat study is required to determine a no-observed-effect level for hematology and clinical
chemistry paraneters. This study must be submitted 3 years after publication of this Standard.
7/ An ir^ vivo mammallian gene mutation assay is needed; it must be submitted one year after publication of this
Standard.
8/ A chromosome aberration assay in rats is needed; it must be submitted one year after publication of this standard.
9/ An unscheduled DNA synthesis assay in rat hepatocytes and a sister chromatid exchange assay in rats are needed.
These studies must be submitted 1 year after publication of this Standard.
10/ Additional metabolism information is necessary to meet 1982 EPA Guidelines, i.e., multiple dosing phase. This study
must be submitted 1 year after publication of this Standard.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TF.RBUTRYN
Data Requirement
Does EPA Have
Data To Satisfy
Use Requirement? (Yes,
Composition1 Pattern2 No or Partially)
Bibliographic
Citation
(MRID or
as noted)
Must Additional
Data Be Submit- Timeframe
ted Under FIFRA for Sub-
Section 3(c)(2)(B)? mission
§158.130 Environmental Fate
DEGREDATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegredation
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
163-1 - Leaching and
Adsorption/
Desorption
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA —
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA —
TGAI or PAIRA —
TGAI or PAIRA A,B
Yes
NO
No
No3
Yes
No
No3
No3
Yes
00147480
00147482
00147483
00147484
00147485
No
Yes
Yes
No
No
Yes
No
No
No
9 Months
9 Months
27 Months
t—
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Data Requirement
§158.130 Environmental Fate
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES - FIELD
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-Term
ACCUMULATION STUDIES:
Composition-'-
(continued)
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA Have Bibliographic
Data To Satisfy Citation
Use Requirement? (Yes, (MRID or
Pattern2 No or Partially) as noted)
A,B Yes4 00257857
— Yes4 00257857
A,B Partially 00147482
No3
No3
A Tier
(section 165-1)
Must Additional Timeframe
Data Be Submit- for Sub-
ted Under FIFRA mission
Section 3(c)(2)(B)?
No
No
Yes5'7 27 Months
No
CO
LTN
No
Tier6
165-1 - Rotational Crops
(confined)
165-2 - Rotational Crops
(field)
165-3 - Irrigated Crops
PAIRA
TEP
TEP
No
Tier
(section 165-1)
No3
Yes
Tier6
No3
39 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Data Requirement
Does EPA Have
Data To Satisfy
Use Requirement? (Yes,
Composition! Pattern^ No or Partially)
Bibliographic
Citation
(MRID or
as noted)
Must Additional
Data Be Submit-
ted Under FIFRA
Section 3(c)(2)(B)?
Timp frame
for Sub-
in ission
§158.130 Environmental Fate (continued)
TGAI or PAIRA A,B
TEP A,B
165-4 - In Fish
1x5-5 - In Aquatic Nontarget
Organisms
No-
No
Yes
No3
months
_!_/ Composition: TGAI - Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TEP =
Typical end-use product.
_2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; r -
Indoor
3_/ Not required by reason of use pattern.
4/ EPA Accession No. 257857: V.P. = 1.3 x 10~6 @ 20 °C.
5/ An additional study on another site to include complete field test data per section 164-1.
6/ May be required, depending upon results of confined accumulation studies (165-1).
7/ In order to resolve the groundwater contamination questions associated with the use of this chemical, the following
data are required in addition to the soil dissipation study required in Subpart N:
In at least one soil of the High Plains area, (West Texas), and one type in the Northwest U.S. where terbutryn is used:
a) At least three soil core sites shall be examined for background terbutryn/hydroxy-terbutryn before pesticide
application; b) A conservative water tracer such as bromide ion shall be added (100-200 pounds per acre), to
the field on the same day the pesticide is used; c) All soil cores shall be taken and analyzed in continuous six-
inch segments until the maximum leaching zone is established; d) Soil cores shall be taken and examined until
terbutryn hydroxide has dissipated; e) Terbutryn residues at the zone of maximum leaching shall be speciated as well
as quantified. You should contact EPA for further guidance prior to study protocol submission.
8/ Octanol/H20 participation coefficient: pK = 4.3 @ 20^.
-------
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
§158.
AVIAN
J
Data Requirement
145 Wildlife and Aquatic
AND MAMMALIAN TESTING
71-1 - Avian Single Dose
Oral LDso
71-2 - Avian Dietary LC50
A. Upland Game Bird
B. Waterfowl
71-4 - Avian Reproduction
A. Upland Game Bird
B. Waterfowl
AQUATIC ORGANISMS TESTING
72-1
- Freshwater Fish LC5Q
A. Warmwater
B. Coldwater
Campos ition*
Organisms
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TGAI
TEP
Does EPA Have Data
To Satisfy This Bibliographic
Use Requirement? (Yes, Citation (MRID
Pattern^ No or Partially) or as noted)
A,B Yes3 GS0144012
00073006
A,B No
A,B Yes 00103995
A,B No
A,B No
A,B No
A,B Yes GS1440012
00140836
A,B No
A,B Yes GS1440012
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
No
Yes 9 Months
No
o
Reserved 4
Reserved^*
Yes 9 Months
No
Yes 9 Months
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Data Requirement
Compositionl
Use
Pattern2
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.145 Wildlife and Aquatic Organisms (continued)
72-2 - Acute LC5Q Aquatic TGAI
Invertebrates
72-3 - Acute LC50 Estuarine and TGAI
Marine Organisms
72-4 - Fish and Early Life-Stage TGAI
and Aquatic Invertebrate
Life Cycle
A,B
A,B
A,B
Yes
No
No
00139440
No
Yes5 9 Months
Yes6 12 Months
I/ Composition: TGAI - Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TEP =
Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
~ D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I =
Indoor
_3_/ None of the three studies in the two documents fulfills the requirement individually, but the combination of all three
studies does fulfill the requirement.
_4/ Reserved pending receipt and evaluation of fate data.
5/ Required to support rights-of-way and other noncrop uses associated with coastal counties.
6/ Required to support rights-of-way and other ndncrop use. Reserved for other uses pending receipt and evaluation of
~~ additional fate data.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Does EPA Have Data Must Additional
To Satisfy This Bibliographic Data Be Submitted
Use Requirement? (Yes, Citation (MRID Under FIFRA Section
Data Requirement Composition1 Pattern2 No or Partially) or as noted) 3(c)(2)(B)?
§158.150
Plant Protection
NONTARGET AREA PHYTOTOXICITY
122-1 -
122-1 -
122-2 -
123-1 -
123-1 -
123-2 -
124-1 -
124-2 -
Tier I
Seed Germination/ TGAI A,B No
Seedling Emergence
Vegetative Vigor TGAI A,B No
Aquatic Plant Growth TGAI A,B No
Tier II
Seed Germination/ TGAI A,B,D, No
Seedling Emergence
Vegetative Vigor TGAI A,B,D No
Aquatic Plant Growth TGAI A,B,D No
Tier III
Terrestrial Field TEP A,B No
Aquatic Field TEP D No
Yes3 9 Months
Yes3 9 Months
Yes3 9 Months
i
Reserved1*
Reserved'*
Reserved'*
Reserved ^
Reserved^
OJ
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
§158.150 Plant Protection (continued)
V Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TF.P =
Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I -
Indoor
V These studies are required because data on the extent of phytotoxicity are not available and because the use ot this
product may pose hazards to endangered or threatened species.
4/ Reserved pending results of Tier I phytotoxicity tests.
5/ Reserved pending results of Tier II phytotoxicity tests.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
Does EPA Have Data Must Addi
To Satisfy This Bibliographic Data Be S
Use Requirement? (Yes, Citation (MRID Under FIF
Data Requirement Composition1 Pattern2 No or Partially) or as noted) 3(c)(2)(B
§158.155 Nontarqet Insect
NONTARGET INSECT TESTING - POLLINATORS
141-1 - Honeybee Acute TGAI A,B Yes
Contact LD5Q
141-2 - Honeybee - Toxicity TEP A,B No
of Residues on Foliage
141-4 - Honeybee Subacute TEP A,B No
141-5 - Field Testing for TEP A,B No
Pollinators
NONTARGET INSECT TESTING - AQUATIC INSECTS
142-1 - Acute Toxicity to TEP A,B No
Aquatic Insects
142-2 - Aquatic Insect TEP A,B No
Life Cycle Study
142-3 - Simulated or Actual TEP A,B No
Field Testing for
Aquatic Insects
143-1 - NONTARGET INSECT TESTING TEP A,B No
thru PREDATORS AND PARASITES
00018842 No
— No3
— Reserved4
— No3
— Reserved-^
— Reserved ~"
— Reserved^
— Reserved^
143-3 -
VD
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TERBUTRYN
§158.155 Nontarget Insect (continued)
V Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TCP =
Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I =
Indoor
3/ As data from the acute contact study show very low toxicity to honeybees, no further testing is required.
4/ Reserved pending development of test methodology.
5/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
DATA REQUIREMENTS FOR TERBUTRYN 95% TECHNICAL1 (EPA REGISTRATION NO. 46386-3; VEROLIT CHEMICAL MANUFACTURING CO., LTD.
Data Requirement
Composition^
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.120 Product Chemistry
Product Identity and Composition!
61-1 - Product Identity and TGAI
Disclosure of Ingredients
61-2 - Description of Begin- TGAI
ning Materials and
Manufacturing Process
61-3 - Discussion of Formation TGAI
of Impurities
Analysis and Certification of Product
Ingredients:
62-1 - Preliminary Analysis TGAI
of Product Samples
62-2 - Certification of TGAI
Ingredient Limits
62-3 - Analytical Methods to TGAI
Verify Certified Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
Partially
Partially
No
No
Partially
Partially
No
No
Yes
Registration File
Yes
V.D
Yes
Registration File
Registration File Yes**
Yes
Yes
-------
TABLE B
DATA REQUIREMENTS FOR TERBUTRYN 95% TECHNICAL1 (EPA REGISTRATION NO. 46386-3; VEROLIT CHEMICAL MANUFACTURING OK, I ,TU.
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
120 Product Chemistry (continued)
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density,
or Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
No
No
No
No
No
No
No
No
Yes
Yes
No5
Yes
Yes
Yes
Yes
Yes
Coefficient
63-12 - pH
63-13 - Stability
TGAI
TGAI
VD
No
No
Yes
Yes
-------
TABLE B
DATA REQUIREMENTS FOR TERBUTRYN 95% TECHNICAL1 (EPA REGISTRATION NO. 46386-3; VEROLIT CHEMICAL MANUFACTURING CO., LTD.
§158.120 Product Chemistry (continued)
1. The 95% technical serves as a manufacturing-use product.
2. Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
3. Data must be submitted no later than 8 months from issuance of this Standard.
4. Information obtained from desk references, (THE MERCK INDEX, Ninth edition, 1976; CRC HANDBOOK OF
CHEMISTRY AND PHYSICS, 59th edition, 1978-1979; and THE HERBICIDE HANDBOOK, 1986).
5. Not applicable since the technical product is a solid at room temperature.
6. Updated information required by this standard or certification fron registrants that EPA has current information
on file.
CO
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING TERBUTRYN
Data Requirement
Compositionl
Does EPA Have Data
To Satisfy This
Requ i remen t ? (Yes,
No or Partially)
Bibliographic
Citation (MRID
or as noted)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)7
§158.135 Toxicology
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Primary Eye Irritation -
MP
MP
MP
MP
Yes
Yes
Yes
Yes
00146725
00146726
00146727
00146729
No
No
No
No
Rabbit
81-5 - Primary Dermal Irritation - MP
Rabbit
81-6 - Dermal Sensitization - MP
Guinea Pig
Yes
Yes '
00146728
00146730
No
No
Ch
MD
I/ Composition: MP = Manufacturing-use product.
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear- on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment.
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
TO
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per qallon 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
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word
Minimum Type Size
All Capitals
6
10
12
14
18
point
point
point
point
point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(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
reguired 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. Sac^i
statements must be headed by the
of the three hazard
appropriate hazard '
wa rn:
'40
10 ( h ) -. 2
71
-------
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
for restricted use may be limited to use by certified applicators
or persons under fieir direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
72
-------
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,
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 reguired: "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.
73
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established bv 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 A*ND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Req. No.
EPA Est. No.
Ingredients
statement
Pounds/qal Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
( Aiild hazard
warninq)
Siqnal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
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
Immed i ately
below child
hazard
warninq
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc!
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Pract ical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
E nv i ronme ntal
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
eqory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
label inq
appears on
other than
front panelM
All products
All products
in Cateqories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
di rect ions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include l>ee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage ard
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
di rect ions
for use
In the
di rect ions
for use
In the
di rect ions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
di rect ions
for use or
at the end of
di rect ions
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 wordM
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 frcm from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and reguired statements.
May be in metric as well as U.S. units
c—
-------
PHYS/CHEM-1
Criteria
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
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.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F,
D. Flashpoint above
150°F.
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.
78
-------
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."
Ttorage Instructions;
All product labels are reguired 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.
Instructions on what to do if the container is damaged
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage
4. Instructions on what to do if the container is damaged in
sen
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.
79
-------
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 (see list in this Appendix) or are assigned to Toxicity Category
I on the basis of oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
L.3A 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
(see list in this Appendix) or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide disposal
statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
80
-------
PEST/DIS-2
P003
P070
P004
POOS
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA ft and CAS ft
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyancqen chloride
Dieldrin
0,0-Daethyl S-[2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
0,0-Daethyl 0-pyrazinyl
phosphorothioate (Zinophos®)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts *
4,6-Danitro-o-cyclchexylphenol
Dinoseb
Endcsulf an
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorchexahydro-exo, exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methomyl
alpha-Naphthylthiourea (SNTU)
Nicotine and salts
Oct ame thy Ipyrcphospnoramide
(OMPA, schradan)
P^rrathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Prcpargyl alcchol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
PI 06
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
81
-------
PEST/DIS-3
Strychnine and salts P108 57-24-9
60-41-3
0,0,0,0-Tetraethyl P109 3689-24-5
githiopyrcohosphate (sulfotepp)
Tetraethyl pyrophosphate Pill 107-49-3
Thallium sulfate PI 15 7446-18-6
Thiofanox P045 39196-18-4
Toxaphene Pi 23 8001-35-2
Warfarin (>0.3%) P001 81-81-2
Zinc phosphide (>10%) Pi22 1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED FRCM TRI-, TETRA-, £ND PENTACHLORCPHENOLS
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro-
phenoxy) ethyl ethec
Dehydroabietylammonium
pentachlorcphenoxide
Erbon
Oethyl 0-(2,4,5-trichlorophenyl)
ethylphosphonothioate
2,2'-Methylenebis
( 3,4,6-trichlorcphenol)
(Hexachlorophene) ,
— Pltassium salt of
—Sodium salt of
— Dasodium salt of
Pentachlorophenol
— Potassium salt of
—Sodium salt of
--Zinc salt of
— Zinc salt of N-alkyl
— Pentachlorcphenyl laurate
Potassium trichlorophenate (2,4,6)
Potassium trichlorcphenate (2,4,5)
Silvex
— 2-Butoxyethyl ester
— Butoxypolypropoxypropyl ester
— Butoxyprcpyl ester
— Diethanolamine salt
— D asopropanolamine salt
— Dimethylamine salt
— Daprcpylene glycol isobutyl
ether ester
— Ethanolamine salt
— 2-Ethylhexyl ester
— Isooctvl ester
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
5324-22-1
35109-57-0
136-25-4
327-98-0
70-30-4
67923-62-0
3247-34-5
5736-15-2
87-86-5
7778-73-6
131-52-2
2917-32-0
3772-94-9
2591-21-1
35471-43-3
93-72-1
19398-13-1
53404-07-2
25537-26-2
51170-59-3
53404-09-4
55617-85-1
53535-26-5
7374-47-2
53404-76-5
53404-14-1
82
-------
PEST/DIS-4
—Isopropanolamine salt
—Monchydroxylaluminum salt
—Polypropoxypropyl ester
—Pit as slum salt
—Propylene glycol isobutyl
ether ester
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Triisopropanolamine salt
—Tripropylene glycol isobutyl
ether estec
Sodium 2-(2,4,5-trichlorcphenoxy)
ethyl sulfate
Tetrachlorophenols
—Alkylamine*amine salt (as in
fatty acids of coconut oil)
—Potassium salt
—Sodium salt
2,4,5-Trichlorophenol
2,4,6-Trichlorcphenol
2,4,5-Trichlorophenol salt of
2,6-bis[(dimethylamino)methy1]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt
2,4,6-Trichlorophenol, sodium salt
2,4,5-Trichlorophenoxyacetic acid
—Alkyl C-12 amine salt
—Alkyl C-13^imine salt
—Alkyl C-14 amine salt
—N,N-diethylethanolamine salt
—Dimethylamine salt
—N,N-dimethyllinoleylamine salt
—N,N-dimethyloleylamine salt
—N-oleyl-1,3-propylene
diamine salt
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Alkyl (C3H7 - C7H9) ester
—Amyl ester
—Butoxyethoxypropyl ester
—2-Butoxyethyl ester
—Butoxypropyl ester
—Butyl ester
—Dipropylene glycol isobutyl
ether ester
—2-5thyihexvi ester
—Isobutyl ester
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
53404-13-0
69622-82-8
83562-66-7
2818-16-8
53466-84-5
37913-89-6
17369-89-0
53404-74-3
53404-75-4
53535-30-1
3570-61-4
25167-83-3
53535-27-6
25567-55-9
95-95-4
88-06-2
53404-83-4
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
?027
136-32-3
3784-03-0
93-79-8
53404-84-5
53404-85-6
53535-37-8
53404-86-7
6369-97-7
53404-88-9
53404-89-0
53404-87-8
13560-99-1
3813-14-7
2008-46-0
120-39-8
1928-58-1
2545-59-7
1928-48-9
93-79-3
53535-31-2
1928-4~-3
4938—2-1
83
-------
PEST/DIS-5
—Isopropyl ester F027 ' 93-78-7
—Poopylene glycol isobutyl F027 53466-86-7
ether ester
—Triprcpylene glycol isobutyl F027 53535-32-3
ether ester
4-(2,4,5-Trichlorophenoxy)butyric F027 93-80-1
acid [2,4,5-TB]
2-(2,4f5-Trichlorophenoxy)ethyl F027 69633-04-1
hydrogen sulfate [2,4,5-TES]
l,4',5'-Trichloro-2'-(2,4,5- F027 69462-14-2
trichlorophenoxy)
methanesulfonanilide [Edolan U]
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with RCRA ft, and CAS ft
[40 CFR 261.33(f)]
Acetone
Acrylonitrile*
Amitrole
Benzene*
Bis(2-ethylhexyl)phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
(chloroacetaldehyde)
Chlordane, technical*
Chlorobenzene*
4-Chloro-m-creso1
Chloroform*
o-Chlorcphenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyclohexanone
Decachlorooctahydro-1,3,4-metheno-
2H-cyclobuta[c,d]-pentalen-2-one
(Kepone, chlordecone)
1,2-D. £>rano-3-chloropropane (DBCP)
Dibutyl-phthalate
S-2,3-(Dichloroallyl diisoprcpyl-
thiocarbamate) (diallate,Avadex)
o-Dachlorobenzene*
p-Dichlorobenzene*
Dachlorodi fluo rone thane
(Freou 12®)
3,5-Dichloro-N-(1,1-dimethy 1-2-
propynyl) benzamide
(pronamide, Ke rb®)
Dichioro diphenyl dichloroethane
(ODD)
Dichioro diphenyl trichloroethane
(DOT)
Dichloroethyl ether
2,4-Dichlorophenoxyacetic,
salts and esters (2,4-D)*
1,2-Di edil orcpr cpane
1,3-Dichloropropene (Telone)
Di«netnyl phthalate
Ep i chlorohydr in
(l-chloro-2,3-epoxyprcoane)
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate
(chlorobenzilate)
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U142
U066
U069
U062
U070
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
67-64-1
107-13-1
61-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
96-12-. 8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*p-ccposed for deletion by TCLP proposal
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfura c
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Landane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorcphenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Methyl-2-pentanone
(methyl isobutyl ketone)
NiqDhthalene
Nitrobenzene*
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCHB)
Pentachlorophenol*
[acute waste per 261.31]
Ptenol*
Pyridine*
Resorcinol
Safrole
Selenium disulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorcphenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Trichloroethylene*
Tr i chloromonofluoromethane
(Freon 11®)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
U080
U159
U161
U165
U169 •
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
86
-------
PEST/DIS-8
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin «0.3%) U243 81-81-2
Xylene U239 1330-20-7
Zinc phosphide «10%) U249 1314-84-7
83 ACTIVES
87
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars
Do not reuse container I
Rinse thoroughly before
bottle, can, jar).
discarding in trash^
trash.
Non-aerosol
(bags)
products
Do not reuse bag. Discard bag in
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
( non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture)
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorit ies.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures!
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in -a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused!, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
L> Manufacturer may replace this phrase with
whether and how fiber drum may be reused.
one indicating
88
-------
EPA Compendium of Acceptable Uses
TERBUTRYN
TABLE OF CONTENTS
Site Name ^ ^ Page
TERRESTRIAL FOOD CROP 3
(Agricultural Crops) 3
Barley (winter)3
Sorghum (grain) 4
Wheat (winter) 7
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments) 7
Fallowland 7
TERRESTRIAL NON-FOOD CROP 8
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments) 8
Uncultivated Non-Agricultural Areas 8
89
Issued: 3-28-85 I-080813-i
Provisional Update: 8-22-86
-------
EPA Compendium of Acceptable Uses
D80813 TERBUTRYN*
TYPE PESTICIDE: Herbicide
FORMULATIONS;
Tech (95%, 96%)
WP (80%)
DF (80%)
GENERAL WARNINGS AND LIMITATIONS: RESTRICTED USE PESTICIDE. For retail
sale to and use only by Certified Applicators or persons under their
supervision and only for those uses covered by the Certified Applicator's
certification. A selective herbicide for control of annual broadleaf
weeds and grasses in winter wheat, winter barley, grain sorghum and non-
crop land areas. When applied preemergence to weeds, the chemical will
enter weeds through the roots after germination. When applied to emerged
weeds, the chemical provides foliar knockdown of existing weeds and resi-
dual control of late germination weeds.
Terbutryn is toxic to fish. Do not apply directly to water or wetlands
(swamps, bogs, marshes and potholes). Drift and run-off from treated
areas may be hazardous to aquatic organisms in neighboring areas. Do not
contaminate water by cleaning of equipment or disposal of wastes.
Persons mixing and/or loading or otherwise handling this chemical are re-
quired to wear impervious gloves, coveralls (or long-sleeved shirt and
trousers), face shield, socks, and shoes or boots. If flaggers are to be
used during application, they are required to be in enclosed vehicles.
Do not graze or feed treated grain, forage, fodder, hay, silage, or straw
to livestock.
Refer to labeling for appropriate ENDANGERED SPECIES LIMITATIONS.
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Not located.
PHYTOTOXICITY TO CROPS; Not located.
MODE OF ACTION; Inhibits the Hill reaction in photosynthesis.
BROADLEAF WEEDS CONTROLLED;
ZAAABP Annual groundcherry
ZAAAAF Annual thistle
EMADAA Bedstraw
BKAKBA Blue mustard
•EUAEAA Bluelips
EHAGBJ Bur buttercup
'ADABBA Carpetweed
EMADBA Catchweed bedstraw
'AZAAAC Chickweed
ARABBB Coast fiddleneck
BFDQAA Cocklebur
(a)
*2-(tert-butylamino)-4-(ethylamino)-6-(methylthio)-s-triazine
1-080813-1..
Issued: 3-28-85
Provisional Update: 8-22-86
90
-------
EPA Compendium of Acceptable Uses
TERBUTRYN
CONTROLLED (continued)
Corn spurry
iPBA Cowcockle
AHA Dock (seedling)
IIBB Dogfennel
1GAA Falseflax
IBM Fiddleneck
IFBA Field pennycress
LJAA Cromwell
IFBA Henbit
(ABK Jacob's ladder
1IBA Kochia
iEAB Lambsquarter
iHBB Mayweed
ICBA Minerslettuce
IAAB Morningglory
4IAA Nightshade
illAA Pepperweed
PI Pigweed
CKBB Pineappleweed
CEBF Prickly lettuce
JUBF Prickly sida
IGBD Prostrate knotweed
SFBB Puncturevine
JABP Purslane
iEAA Ragweed
IBBB Reds tern filaree
iKBA Russian thistle
1HBA Shepherdspurse
IGAD Smart weed
iACA Snow weed
IPAA Speedwell
SEBA Springbeauty
!DBA Tumble mustard (a)
4ACG Tumbleweed
IGBA Umbrella spurry
JBBB Velvetleaf
BJBA White sweetclover
4GBH Wild buckwheat
BKBB Wild mustard
(a) Controls early germinating seedlings only.
(b) Partial control.
issued: 3-28-85 1-080813-2
91
-------
EPA Compendium of Acceptable Uses
TERBUTRYN
GRASSES AND OTHER MONOCOTS CONTROLLED;
(b)
(b)
(b)
(b)
CABZBA Annual ryegrass
CABHBB Barnyardgrass
CAATBK Cheat
CABFAA Crabgrass
CAATBM Downy brome
CACUAA Foxtail
CACUBF Green foxtail
CABHBA Junglerice
CAAFBC Pacific meadow foxtail
(b) Partial control.
' 24001AA
Site, Dosage
and Formulation
(Ib a.i./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Barley (winter)
Tolerance, Use, Limitations
1.2-1.8
(80% DF)
000100-00655
1.2-1.8
(80% WP)
0.1 ppm (N) (fodder, grain, green barley, straw)
Do not make more than 1 application per crop
cycle.
Do not plant any crops except wheat or barley un-
til 9 months after application.
General Information: Do not use on sand or loamy
sand soils. Treatments made prior to the develop-
ment of the secondary root system may result in
increased winter injury during severe weather con-
ditions. Do not make postemergence applications
after temperatures exceed 70 F (21.1 C), as crop
injury may occur. Apply in a minimum of 20 gal-
lons of water per acre by ground or 5 gallons by
air.
Use limited to WA, west of the Cascades. Preemer-
gence. Broadcast. Apply after planting and be-
fore crop emergence.
Use limited to ID, OR, and WA. Postemergence.
Apply as soon as the crop has a well developed
root system, as indicated by the development of
secondary roots. If this stage of development is
not reached in the fall, an application may be
made in early spring. For effective weed control,
apply before weed rosettes have a 3 inch diameter
Issued: 3-28-35
1-080813-3
92
-------
Site, Dosage
and Formulation
(lb a.i./A)
EPA Compendium of Acceptable Uses
TERBUTRYN
Tolerance, Use, Limitations
Barley (winter) (continued)
Sorghum (grain)
or exceed 4 inches in height. Do not apply in ,
liquid fertilizer solutions, as injury may occur.
0.1 ppm (N) (grain)
General Information: Use ground equipment for
preplant applications. Preplant applications
should be made within 2 weeks of planting, and
should be incorporated to a depth of 1 to 2 inch-
es. For sorghum planted in beds, apply and incor-
porate after bed formation. In case of planting
failures, sorghum may be replanted into soil pre-
viously treated with this chemical. Do not make
a second broadcast application, as injury may oc-
cur. Rainfall or irrigation is necessary to move
the chemical into the soil. If irrigation is
used, irrigate during the first 36 hours after
planting or wait until the sorghum is at least 2
inches in height. Apply only on sorghum planted
after the minimum soil temperature has reached 60
F (15.6 C) or more for at least 3 consecutive
days. Do not wait more than 2 days after planting
to apply. Rainfall or overhead irrigation at the
time of sorghum emergence until the sorghum is 2
inches in height may cause crop injury. Do not
apply to millets, sudan-sorghum hybrids or sorghum
breeding stocks. Applications may result in crop
injury when made to sorghum growing on alkali
soils, caliche outcroppings or where cuts, fills
or erosion has exposed calcareous subsoils. To
avoid concentration of herbicide in the seed fur-
row, do not make a broadcast application to sor-
ghum planted in furrow deeper than 2 inches.
Width of the band should not exceed the width of
the bottom of the furrow. Do not make a second
application to the same crop. Terbutryn applied
alone in sorghum stubble should be plowed prior
to planting the next crop. Rotational crops may
be planted as follows: 4 months after application
for winter wheat; 7 months or longer for all other
crops, following normal agricultural practices and
planting dates. Use the following guidelines for
crop rotation after an application of terbutryn
and atrazine or terbutryn and paraquat: do not
plant to any crop except corn or sorghum until the
following year if applied after June 10. Injury
Issued: 3-28-85
1-080813-4
93
-------
EPA Compendium of Acceptable Uses
TERBUTRYN
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Sorghum (grain) (continued)
General Information (continued)
1.6-2.4
(80% WP)
000100-00496
(80% DF)
000100-00655
1.6-2.4
(80% WP)
(80% DF)
0.8-1.6
(80% WP)
(80% DF)
0.6-0.8
(80% DF)
1.6
(80% WP)
(80% DF)
may occur to soybeans planted in north central and
northwest LA, south central and southwest MN,
southeast SD, and northeast NE the year following
an application on soils having a calcareous sur-
face layer. Do not plant sugar beets, tobacco,
vegetables (including dry beans, spring-seeded
legumes or grasses) the year following treatment.
Use limited to eastern CO, LA, LL, KS, JIN, MO, NE,
and SD. Preplant or preemergence. Broadcast or
band. Apply preplant with shallow incorporation,
at planting, or immediately after planting. Use
the lower dosage on loamy sand soils and the high-
er dosage on silt loam to clay soils.
Use limited to all sorghum growing regions except
eastern CO, LA, LL, KS, MN, MO, NE, and SD. Pre-
plant or preemergence. Broadcast or band. Apply
preplant with shallow incorporation, at planting
or immediately after planting. Use the lower dos-
age on sandy loams and loam soils and the higher
dosage on silt and clay loam soils. Do not use
on sand or loamy sand soils.
Use limited to the desert regions of AZ and CA,
KS, NM, OK, and TX. Preplant or preemergence.
Broadcast or band. Apply preplant with shallow
incorporation, at planting or immediately after
planting. Use the lower dosage on sandy soils
and loam soils and the higher dosage on all other
soils.
Use limited to the Gulf Coast and Blacklands of
TX. Preplant. Broadcast. For control of winter
weeds. Apply in the fall or winter to fall-bedded
land to be planted to sorghum the following
spring. Add a surfactant, emulsifiable oil, or
oil concentrate.
Use limited to LA, LL, eastern KS, MN, MO, eastern
and central NE, and SD. Preplant or preemergence.
Broadcast or band. Tank mix with propazine. Ap-
ply preplant with shallow incorporation, at plant-
ing or immediately after planting. Use on sandy
loam soils only.
issued: 3-28-85
1-080813-5
94
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EPA Compendium of Acceptable Uses
TERBUTRYN
Site, Dosage^ Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Sorghum (grain) (continued)
<*
1.6-2.0 use limited to IA, IL, eastern KS, KN, MO, eastern
(80% WP) and central NE, and SD. Preplant or preemergence.
(80% DF) Broadcast or band. Tank mix with atrazine. Apply
preplant with shallow incorporation, at planting
or immediately after planting. Use on loam or
finer textured soils. Do not use on sand, loamy
sand, or sandy loam soils.
1-6-2.0 use limited to central KS, western NE, OK, and TX.
(80% WP) Preplant or preemergence. Broadcast or band.
(80% DF) Tank mix with propazine. Apply preplant with
shallow incorporation, at planting or immediately
after planting. Use the lower dosage on sandy
loam soils and the higher dosage on loam or finer
textured soils. Do not use on sand or loamy sand
soils.
1.6 Use limited to eastern CO and western KS. Pre-
(80% WP) plant or preemergence. Broadcast or band. Tank
(80% DF) mix with propazine. Apply preplant with shallow
incorporation, at planting or immediately after
planting. Use on sandy loam and finer textured
soils. Do not use on sand or loamy sand soils.
1.6-2.0 Preplant or preemergence. Broadcast or band.
(80% DF) Tank mix with atrazine and paraquat. Apply pre-
plant with shallow incorporation, at planting, or
immediately after planting. Apply in 20 to 40
gallons of finished spray per acre. Add a non-
ionic surfactant. Use only water or nitrogen
solutions as a carrier. Use the lower dosage on
loam and silt soils and the higher dosage on silty
and sandy clay loam soils, and sandy and silty
clay soils.
Issued: 3-28-85 1-080813-6
95
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!4007AA
660020A
Site, Dosage
and Formulation
(Ib a.i./A)
Wheat (winter)
1.2-2.2
(80% DF)
000100-00655
1.2-2.2
(80% WP)
000100-00496
0.6-0.8
(80% WP)
EPA Compendium of Acceptable Uses
TERBUTRYN
Tolerance, Use, Limitations
0.1 ppm (N) (fodder, grain, green wheat, straw)
Do not make more than 1 application per crop
cycle.
Do not plant any crops except wheat or barley for
9 months after application.
General Information; Do not use on sand or loamy
sand soils. Do not make postemergence applica-
tions after temperatures exceed 70 F (21.1 C), as
crop injury may occur. Treatments made prior to
the development of the secondary root system may
result in increased winter injury during severe
weather conditions. For effective weed control,
apply before weed rosettes are 3 inches in diam-
eter or exceed 4 inches in height. Apply in a
minimum of 5 gallons of water per acre by air, or
in a minimum of 20 gallons of water or nonpres-
surized fertilizer solution per acre by ground.
Use limited to WA, west of the Cascades. Preemer-
gence. Broadcast. Apply after planting and be-
fore crop emergence.
Use limited to ID, OR, UT, and WA. Postemergence.
Broadcast. Apply as soon as the crop has a well
developed root system, as indicated by the devel-
opment of secondary roots. If this stage of de-
velopment is not reached in the fall, an applica-
tion may be made in early spring.
Use limited to ID, OR, and WA. Postemergence.
Broadcast. Tank mix with chlorbromuron.
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
Fa 1 lowland^
1.6-2.0
(80% WP)
000100-00496
(80% DF)
000100-00655
General Information; Apply only once during the
fallow period. Apply in 20 to 60 gallons of water
and a surfactant per acre. Use the higher dosage
if weeds are 4 to 6 inches in height.
Use limited to CO, KS, MT, NE, ND, SD, and WY.
Postharvest application to wheat fallow to be
planted to wheat. Apply July or August following
wheat harvest. Tank mix with atrazine. May be
tank mixed with metribuzin in CO, KS, MT, NE, and
WY. Make 1 application of terbutryn by itself
during the same fallow period. Plant wheat no
Issued: 3-28-85
1-080813-7
96
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EPA Compendium of Acceptable Uses
TERBUTRYN
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Fallowland (continued)
sooner than 4 months after application of terbu-
tryn alone and no sooner than 12 months after the
tank mix application.
1.6-2.0 Use limited to KS and NE. Postharvest application
(80% WP) to wheat fallow to be planted to corn grown under
(80% DF) minimum tillage. Apply July or August following
wheat harvest. Tank mix with atrazine.
1.6-2.0 Use limited to the Great Plains, including KS, OK,
(80% DF) and northern TX. Preemergence or postemergence
to wheat fallow to be planted to wheat, or to sor-
ghum fallow to be planted to wheat. Broadcast or
band. Apply in the spring at the start of the
fallow period. In the Great Plains, do not plant
wheat sooner than 4 months after application, in
KS, OK, and northern TX do not plant wheat sooner
than 2 months after application.
May be tank mixed with paraquat, DMA, and cyana-
zine on wheat fallow to be planted to wheat.
1.6-2.0 Postharvest application to wheat fallow to be
(80% WP) planted to sorghum grown under minimum tillage.
(80% DF) Apply in July or August following wheat harvest.
Tank mix with atrazine.
TERRESTRIAL NON-FOOD CROP
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
Uncultivated Non-
Agricultural Areas General Information: This site includes railroad
rights-of-way, and other noncrop sites.
2.0-2.4 Broadcast. Apply to actively growing weeds not
(80% WP) more than 6 inches in height. Apply in at least
000100-00496 20 gallons of water per acre. May be tank mixed
(80% DF) with atrazine and simazine.
000100-00655
Issued: 3-28-85 1-080813-8 97
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Site, Dosage
and Formulation
(Ib a.i./A)
AERIAL AND TANK MIX APPLICATIONS
EPA Compendium of Acceptable Uses
TERBUTRYN
Tolerance, Use, Limitations
001500
AAAAAA
Aerial Application
900300
AAAAAA
Tank Mix
Refer to
TERRESTRIAL FOOD CROPS
(Agricultural Crops)
Barley (winter), Sorghum (grain), Wheat (winter)
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments)
Fallowland
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Sorghum (grain), Wheat (winter)
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments)
Fallowland
TERRESTRIAL NON-FOOD CROP
(Noncrop, Wide Area and General Indoor/Outdoor
Treatments)
Uncultivated Non-Agricultural Areas
Issued: 3-28-85
1-080813-9
98
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EPA Compendium of Acceptable Uses
TEKBUTRYN
Listing of Registered Pesticide Products by Formulation
,0002 95% formulation intermediate
terbutryn (080813)
046386-00003
,0002 96% formulation intermediate
terbutryn (080813)
000100-00540
[0006 80% wettable powder
terbutryn (080813)
000100-00496
,0011 80% water dispersable granules
terbutryn (080813)
000100-00655
|S99 State Label Registrations
AZ Reg. No.
010163-06402
CA Reg. No.
000100-04282
ID Reg. No.
000100-04305
UT Reg. No.
000100-04262
Issued: 3-28-85 1-080813-10
99
-------
Listing of
Chemical
Code
101101
080803
090701
1001QL
030019
061601
080808
080807
EPA Compendium of Acceptable Uses
TERBUTRYN
Appendix A-2
Active Ingredient(s) Which May Be Included in Tank Mixes
Common Name
(source)
metribuzin
EPA Acceptable
Common/Chemical Name
4-amino-6-(l,ldimethylethyl)-3-(me thyl-
thio)-l,2,4-triazin-5(4H)-one
atrazine
chlorbromuron (ANSI) 3-(4-bromo-3-chlorophenyl)-l-methoxy-l-
methylurea
cyana z ine (IS 0)
DMA
paraquat
2-[[4-chloro-6-(ethylamino)-S-triazin-2-
yl]-amino]-2-methyl propionitrile
2,4-dichlorophenoxyacetic acid, dimethyl-
amine salt
paraquat dichloride
propazine
simazine
— Use EPA Acceptable Common/Chemical Name
Issued: 3-28-85
1-080813-11
100
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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,
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 unigue to the citation, and
should be used at any time specific reference is reguired.
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.
01
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this .
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
102
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbutryn Standard
MRID CITATION
00018842 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-
7501. (Unpublished study received May 8, 1971 under 1F1174;
prepared by Univ. of California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-B)
00022855 Esser, H.O.; DuPuis, G.; Ebert, E.; et al. (1974) s-Triazines.
Pages 129-208, In Without Title. By ? N.P- (Also in unpub-
lished submission received Oct 7, 1977 under 100-566; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:231969-C)
00024668 Ross, J.; Balu, K.; Maher, J. (1976) Laboratory Report: Project
No. 101904. (Unpublished study received Dec 29, 1976 under
6E1725; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
095644-B)
00029152 Liddell, J.A.; Hepler, D.L.; Beck, L.S.; et al. (1980) Six Month
Oral Toxicity Study of Terbutryn Technical in Beagle Dogs:
Project No. 1421. (Unpublished study received Jun 5, 1980
under 100-540; prepared by Elars Bioresearch Laboratories, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:242568-B)
00029153 Jessup,-D.C.; Marshall, P. (1980) Two-Year Carcinogenicity Study
in Mice: IRDC No. 382-005. (Unpublished study received Jun 5,
1980 under 100-540; prepared by International Research and
Development Corp., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:242569-A)
00029579 Anliker, W. (1972) Residue Summary: Maloran 50W + Igran SOW Tank
Mix: Winter Wheat—Washington, Oregon and Idaho. (Unpublished
study received Sep 26, 1973 under 8192-11; submitted by Ciba
Agrochemical Co., Summit, N.J.; CDL:018037-A)
00035659 Jessup, D.C.; Wrenn, J.M.; Rajasekaran, D.; et al. (1980) Three
Generation Reproduction Study in Rats: IRDC No. 382-011. (Un-
published study received Jun 5, 1980 under 100-540; prepared by
International Research and Development Corp., submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:242572-A)
00035923 Jessup. D.C.; Gunderson, G.; Ferrell, J.F.; et al. (1980) 2-Year
Chronic Oral Toxicity Study in Rats: IRDC No. 382-008. Rev.
(Unpublished study received Jun 5, 1980 under 100-540; prepared
by International Research and Development Corp. in cooperation
with Experimental Pathology Laboratories, Inc., submitted by Ci-
ba-Geigy Corp., Greensboro, N.C.; CDL:242570-A)
103
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbutryn Standard
MRID CITATION
00045432 Mastri, C. (1970) Report to Geigy Agricultural Chemicals: Acute
Oral Toxicity Study on GS-13529 Technical and GS-14260 Technical
in Male and Female Albino Rats: TBT No. A8087. (Unpublished
study including submitter summary, received Apr 21, 1971 under
1F1154; prepared by Industrial Bio-Test Laboratories, Inc., sub-
mitted by Ciba-Geigy Corp., Ardsley, N.Y.; CDL:093472-F)
00047595 Geigy Chemical Corporation (1968) Name, Chemical Identity and Com-
position of GS-14260. (Unpublished study received Mar 18, 1968
under 8F0714; CDL: 093024-D)
00047878 Hargan, R.P.; DeKraker, J.D.; King, E.; et al. (1968) Residue Re-
port: Sorghum: GS-14260: AG-A No. 1370. (Unpublished study in-
cluding AG-A nos. 1336, 1315 and 1735, received Jan 12, 1969 un-
der OG0953; prepared in cooperation with Lindsey Seed Co., sub-
mitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:091622-F)
00048741 Dean, W.P. (1977) Priinary Skin Irritation Study in Rabbits: IRDC
No. 382-021. (Unpublished study received Aug 16, 1977 under
100-496; prepared by International Research and Development
Corp., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
231313-M)
\
00048742 Dean, W.P. (1977) Acute Dermal Toxicity Study in Rabbits: IRDC
No. 382-021. (Unpublished study received Aug 16, 1977 under
100-496; prepared by International Research and Development
Corp., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
231313-N)
00056911 Mattson, A.M.; Kahrs, R.A.; Cullen, T.E. (1968) Residues of GS-
14260 and Metabolites Found in Field Treated Wheat (Grain, Green
Foliage and Straw): Report No. GAAC-68007. (Unpublished study
received Apr 14, 1971 under 1G1142; submitted by Ciba-Geigy
Corp., Ardsley, N.Y.; CDL:090929-S)
00065582 Ciba-Geigy Corporation (1977) Terbutryn—Sorghum; Tank Mixes of
Terbutryn plus Atrazine or Propazine—Sorghum: Preplant Incorpo-
rated Applications: Summary of Residue Data: Report No. ABR-
77044. (Compilation; unpublished study received Aug 26, 1977
under 100-496; CDL:231418-A)
00065588 Ciba-Geigy Corporation (1977) Terbutryn Chemical Data Section.
(Unpublished study received Aug 26, 1977 under 100-496; CDL:
231421-A)
104
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OFFICE OF PESTICICE PROGRAM
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbutryn Standard
mip CITATION
00070872 Chevron Chemical Company (1980?) Residue Chemistry Data: Paraquat,
Atrazine, Terbutryn—Grain Sorghum. (Compilation; unpublished
study received Mar 24, 1981 under 239-2186; CDL: 244724-A)
00073006 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Acute Oral
LD50—Mallard Duck: Project No. 108-132. (Unpublished study
received Aug 16, 1977 under 100-496; prepared by Wildlife Inter-
national, Ltd. and Washington College, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:231315-F)
00085203 Aceto Agricultural Chemicals Corporation (19??) Terbutryn: General
Chemistry Data. (Unpublished study received Mar 12, 1979 under
2749-440; CDL: 237762-A)
00085223 Murphy, R.T. (1972) Response to EPA Comments on Igran Sorghum
Pesticide Petition #1F1048: Report No. GAAC-72079. (Unpublished
study received on unknown date under 1F1048; submitted by Geigy
Chemical Corp., New York, N.Y.; CDL: 093362-B)
00093150 Houseworth, L.D. (1978) Residues of Metolachlor in or on Sorghum
Resulting from Alone and Tank Mix Applications with Atrazine or
Terbutryn—Replant Incorporated and Preemergence Applications:
Report No. ABR-78031. (Unpublished study received Jul 12, 1978
under 1-00-597; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097225-A)
00100640 Larsen, G.; Bakke, J.; Feil, V. (1978) Metabolism of 14C Terbutryn
... by Rats and Goat. Source unknown?:? (Also in unpub-
lished submission received May 4, 1982 under 100-496; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:247365-C)
00100647 Honeycutt, R.; Cassidy, J. (1979) Balance and Metabolism of del-
ta-14C-Terbutryn in a Lactating Goat: Report No. ABR-79062.
(Unpublished study received May 4, 1982 under 100-496; submitted
by Ciba-Geigy Corp., Greensboro, NC; CDL:247366-H)
00100654 Hool, G.; Puri, E. (1981) Chrcmoscme Studies in Somatic Cells,
Bone Marrow, GS 14 260, Chinese Hamster—Dosage: 750, 1500,
3000 mg/kg: No. of experiment: 810173. (Unpublished study re-
ceived May 4, 1982 under 100-540; prepared by Ciba-Geigy Ltd.,
Switzerland, submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:247368-C)
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbutryn Standard
MRID CITATION
00103154 Fischer, W.; Cassidy, J. (1978) Uptake and Balance of delta-14C-
terbutryn and Its Soil Metabolites in Field Rotation Lettuce:
MG-10-8PR, 8SR: Report No. ABR-78084. (Unpublished study re-
ceived Jun 10, 1982 under 100-631; submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:070914-N)
00103155 Fischer, W.; Cassidy, J. (1978) Uptake and Balance of delta-14C-
terbutryn and Its Soil Metabolites in Field Rotation Winter
Wheat: MG-10-5PR, 5SR: Report No. ABR-78083. (Unpublished study
received Jun 10, 1982 under 100-631; submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:070914-0)
00103156 Fischer, W.; Cassidy, J. (1978) Uptake and Balance of delta-14C-
terbutryn and Its Soil Metabolites in Field Rotation Soybeans:
M6-10-6SR, 6PR: Report No. ABR-78089; submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:070914-P)
00103157 Fischer, W.; Cassidy, J. (1978) Uptake and Balance of delta-14C-
terbutryn and Its Soil Metabolites in Field Rotation Sugar
Beets: M6-10-7SR, 7PR: ABR-780900. (Unpublished study received
Jun 10, 1982 under 100-631; submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL:070914-Q)
00103173 Hermes, P.; Knaak, J. (1972) The Uptake of Aged 14C-Terbutryn and
Metabolites in Rotation Wheat and the Degradation of Terbutryn
in Soil (Greenhouse): Report No. GAAC-72039. (Unpublished study
received Jun 10, 1982 under 100-631; submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:070915-J)
00103995 Fink, R. (1974) Final Report: Eight-day Dietary LC50—Mallard .
Ducks: Technical GS-14260: Project No. 108-103; unpublished
study received Mar 29, 1974 under unknown admin, no.; prepared
by Truslow Farms, Inc., submitted by Ciba-Geigy Corp., Greens-
boro, NC; CDL:128686-A)
00109752 Ciba-Geigy Corp. (1970) Terbutryn (Igran QS Formulations): Resi-
dues in Grain and Straw. (Compilation; unpublished study re-
ceived Apr 21, 1971 under 1F1152; CDL:090941-B)
00109755 Giegy Chemical Co. (1968) GS-14260: Residues in Wheat. (Compi-
lation; unpublished study received Mar 13, 1968 under 8F0714;
CDL:091236-B)
00109759 Geigy Chemical Co. (1968) Igran: Residues in Wheat and Soil.
(Compilation; unpublished study received Apr 4, 1968 under
8F0714; CDL:091237-A)
106
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbutryn Standard
MRID CITATION
00109784 Geigy Chemical Corp. (1971) Igran SOW Herbicide Residues in
Various Products. (Compilation; unpublished study received Jul
24, 1971 under 1F1048; CDL:091873-A)
00109786 Mattson, A.; Kahrs, R. (1968) Determination of GS-14260 in Wheat
Foliage, Straw and Grain: Method No. AG-46. (Unpublished study
received Jul 25, 1971 under 1F1048; submitted by Geigy Chemical
Corp., New York, NY; CDL:091874-B)
00109793 Ciba-Geigy Corp. (1971) Crop Rotation Residue Summary following
Sorghum Treated with Igran SOW. (Compilation; unpublished study
received May 21, 1974 under 100-496; CDL:120365-A)
00111690 Ciba-Geigy Corp. (1971) Igran SOW: Rotational Crop Residue Review.
(Compilation; unpublished study received Nov 6, 1974 under 100-
496; CDL:101175-A)
00139440 Vilkas, A.G. (1977) Acute Toxicity of Terbutryn FL 761552 to the
Water Flea Daphnia magna Straus: UCES Project # 11506-04-02.
(Unpublished study received Aug 16, 1977 under 100-496; prepared
by Union Carbide Corp., submitted by Ciba-Geigy Corp., Gr.eens-
' boro, N.C:; CDL:231315-J)
00140836 McCann, J.A. (1970) Igran 80W--B1uegil1, Lepomis macrochirus:
Test No. 231. (U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory; unpublished study;
CDL:105208-A)
00146725 Choie, D.; Katz, R. (1984) Igran 80 WDG--Acute Oral Toxicity Study
in Rats: Toxicology/Pathology Report No. 154-84. Unpublished
study prepared by Ciba-Geigy Corp. 21 p.
00146726 Choie, D.; Katz, R. (1984) Igran 80 WDG--Acute Dermal Toxicity
Study in Rabbits: Toxicology/Pathology Report No. 137-84. Un-
published study prepared by Ciba-Geigy Corp. 18 p.
00146727 Breckenridge, C.; Katz, R. (1984) Igran 80 WDG—Acute Inhalation
Study in Rats: Toxicology/Pathology Report No. 144-84. Un-
published study prepared by Ciba-Geigy Corp. 23 p.
00146728 Choie, D.; Katz, R. (1984) Igran 80 WDG--Primary Dermal Irritation
Study in Rabbits: Toxicology/Pathology Report No. 129-84. Un-
published study prepared by Ciba-Geigy Corp. 15 p.
00146729 Choie, D, ; Katz, R. (1984) Igran 30 WDG--D"imary Eye Irritation
Study in Rabbits: Toxicology/Pathology Report No, 130-34. 'jn-
oublished study prepared by Ciba-Geigy Corp, 16 o.
107
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbutryn Standard
MRID CITATION
00146730 Maedgen, J. (1984) Guinea Piq Sensitization—Igran 80 WDG:
Project No. 3307-84. Unpublished study prepared by Stillmeadow,
Inc. 14 p.
00147480 Burkhard, N. (1980) Hydrolysis of Terbutryn (Igran) undex Labora-
tory Conditions: Project Report No. 34/80. Unpublished study
prepared by Ciba-Geigy Corp. 13 p.
00147482 Keller, A. (1979) Degradation of Terbutryn (Igran) in Aerobic Soil:
Project Report No. 41/79. Unpublished study prepared by Ciba-
Geigy Corp. 21 p.
00147483 Franklin, L.; Cranor, W. (1982) Determination of Adsorption/De-
sorption Constant of Terbutryn: ABC Report No. 27959. Unpub-
lished study prepared by Analytical Bio-Chemistry Laboratories,
Inc. 113 p.
00147484 Keller, A. (1980) Leachina Characteristics of Aged [Carbon 14]-ter-
butryn (Igran) Residues in Two Standard Soils: Project Report
No. 32/80. Unpublished study prepared by Ciba-Geigy Corp.
21 p.
00147485 Ellgehausen, H. (1983) Leaching Characteristics of Aged Residues of
[Carbon 14]-terbutryn (Igran) in Two Soils: Project No. 009450.
Unpublished study prepared by Research and Consulting Co. AG.
' 26 p.
00152763 Infurna, R.; Arthur, A. (1985) Terbutryn Technical: A Teratology
Study in New Zealand White Rabbits: (MIN 842105): Report 85010.
Unpublished study prepared by Ciba-Geigy Corp. 309 p.
00152764 Infurna, R.; Wimbert, K.; Mainiero, J.; et al. (1985) Terbutryn
Technical: A Teratology Study in Rats: (MIN 842292): Report
85111. Unpublished study prepared by Ciba-Geigy Corp. 366 p.
00157844 Murphy, T.; Siitoneaux, B. (19??) Advanced Product Chemistry:
Dermal Absorption of Terbutryn in Rats: Report No. ABR-86017.
Unpublished study prepared by Ciba-Geigy Corp. 75p.
GS0144-012 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. USDI Publication
137, Washington, D.C.
108
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QMS Aoorova/ /Vo. 2000-0*63
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEE'
?A n=GiSTRA7iC.N NO
NAME
NAME
OA7 = GUIOANC2 DOCUMENT ISSUED
sect to the requirement to submit "generic" data imposad by the FIFRA section 3(0(21(3) notice contamea .n the reftr»nc2d
i! Document, I am responding in the following manner:
I will submit data in a timely manner to satisfy the following requirements. If the ten procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, QECO
Chemicals Testing Programme, I enclose the protocols that I will uss:
I have entered into an agreement with one or more other ragistrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
F OTHE.R REGISTRANT
I enclose a completed "Cartification-of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
I request that you amend my rsgisrrstion by deleting tha following uws (this option is not available to applicants for new products):
5- I request voluntary cancellation of the registration of this product. (This option ij not available to applicants for new products,)
109
ANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
-------
i"T\rnrv ~~
.1- . -^»J U x A . — ~
OMB Aooroval No. 230&C~£3
ualify, certify ALL four iremsl
im duly authorized to represent the following firm(s) who are subject to the require-
;nts of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
submit data concerning tne active ingredient:
NAME OF FIRM
firm or
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
group of firms is referrea to below as "my firm".)
CcRTi? 1CATICN OF ATTE.VP7 TO S.\7c3
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
/ firm is willing to develoo and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
o an agreement with one or more otner registrants to develop jointly, or to share m the cost of developing, the following requirec
ms or aata:
i firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer.to be
und by an arbitration decision under FIFRA Section 3lc)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was macU
the following firm(j) on th: following date(s):
NAME OF FIRM
DATE OF OFFER
"-rr
*3£
• ^""*>ft^ "^
firm requests that EPA not suspend the registration (y) of my firm's product**), if any of the firms named in paragraph (3) above
/e agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA wiil promptly inform
• whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c){2)
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Appendix III-l
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
comDOsition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of •
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octa no I/water
partition
coefficient
PH'
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data reauirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
-
(For EPA Use Only)
Accession Numbers
Ass igned
-- ' •
111
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ATTACHMENT A
FORMULATOR'S EXEMPTION STATEMENT
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registation of the
product identified above, I hereby certify that:
(1) Our product is an end use product, and it contains the active
ingredient(s):
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling the appropriate text which paragraph •
applies—(A) or (B): '
(A) An accurate Confidential Statement of Formula 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 active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file
with the EPA is complete, current and accurate and contains the information
required on the current CSF Form No. 8570-4. The registered source(s) of
the active ingredient(s) listed in paragraph (1) is/are listed below:
Active Ingredient Source; Product Name and Reg. No.
Signature:
Typed name:
Dated:
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