P/ERA
United States
Environmental Protection
Agency
Pesticides and
Toxic Substances
(H-7501C)
540/RS-89-064
Registration Standard For
Pesticide Products
Containing TERBACIL
As The Active Ingredient
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OMB Control No. 2070-0057
Expires November 1989
REGISTRATION STANDARD
(SECOND ROUND REVIEW)
FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
TERBACIL
AS THE ACTIVE INGREDIENT
CASE NUMBER
0039
OPP CHEMICAL CODE
012707
August 1989
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS Page
I.INTRODUCTION 1
II. CHEMICAL COVERED BY THIS STANDARD 3
A. DESCRIPTION OF CHEMICAL 3
B. USE PROFILE 4
D. REGISTRATION HISTORY 4
III. AGENCY ASSESSMENT 5
A. Current Status and Summary of the Terbacil Data
Base 5
B. HEALTH EFFECTS 9
C. ECOLOGICAL EFFECTS 14
D. ECOLOGICAL RISK ASSESSMENT 16
E. ENVIRONMENTAL FATE 17
F. GROUND WATER ASSESSMENT 18
G. WORKER EXPOSURE/REENTRY ASSESSMENT 19
H. TOLERANCE REASSESSMENT 19
IV. REGULATORY POSITION RATIONALE 25
A. REGULATORY POSITIONS 25
B. CRITERIA FOR REGISTRATION 30
C. ACCEPTABLE RANGES AND LIMITS 30
D. REQUIRED LABELING 30
V. PRODUCTS SUBJECT TO THIS STANDARD 33
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA 36
A. What are generic data? 36
B. Who must submit generic data? 36
C. What generic data must be submitted? 37
D. How to comply with DCI requirements 37
E. Registrant Requests Regarding Data Requirements and
Agency Responses
40
F. Test Protocols and Standards 40
G. Procedures for requesting a change in
test protocol 41
H. Procedures for requesting extensions of time 41
I. Data Format and Reporting Requirements 41
J. Existing stocks provision upon suspension or
cancellation 42
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA . . 42
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING 43
IX. INSTRUCTIONS FOR SUBMITTAL 43
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APPENDICES
I. DATA APPENDICES 48
Guide to Tables 49
Table A 52
Table B 78
Table C 82
II. LABELING APPENDICES 86
Summary of label requirements and table 87
40 CFR 156.10 Labeling Requirements 96
Physical/Chemical Hazards Labeling Statements 108
Storage Instructions 109
Pesticide Disposal Instructions 110
Container Disposal Instructions Ill
III. BIBLIOGRAPHY APPENDICES 112
Guide to Bibliography 113
Bibliography 115
IV. FORMS APPENDICES 125
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants for
Development of Data
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a.i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HOT
LC50
LD50
LOT
LEL
MPI
MRID
Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
Active ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
End Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
Median lethal dose - a statistically derived single
dose than can be expected to cause death in 50% of the
test animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
Lowest Dose Tested
Lowest Effect Level
Maximum Permissible Intake
Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
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MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts per million
RfD Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
IV
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I.INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued on May 1982,
the Agency summarized the available data supporting the regis-
tration of the pesticide and its assessment of those data to
determine whether the pesticide met the "no unreasonable adverse
effects" standard of FIFRA. The Agency concluded that additional
data were necessary to fully evaluate the pesticide, and, as part
of the issuance of the Standard, required that registrants supply
those data. The Standard also set out labeling requirements that
the Agency believed were necessary to ensure that products
containing the pesticide were adequate to protect public health
and the environment while the data were under development.
The Agency has since reviewed the additional data and has
updated and revised its scientific and regulatory conclusions
concerning the pesticide in light of expanded data requirements
promulgated in 1984 as 40 CFR Part 158. The Registration
Standard contains the Agency's updated scientific assessment of
this pesticide and its currently registered uses. As part of its
review, the Agency has reassessed the tolerances for the
pesticide and determined whether they are adequate. The
tolerance reassessment is included in this Registration Standard.
Based on the new data, the Agency has also reviewed the
labeling requirements for the pesticide and is requiring label
revisions.
This revised Registration Standard supersedes the original
Registration Standard in its entirety.
This document contains the following sections:
0 Section II describes the particular pesticide(s)
covered by this Registration Standard, and gives a brief
profile of its usage and composition. Regulatory
history may be provided as well.
0 Section III sets out the Agency's scientific
assessment of the health risks and environmental
characteristics and effects of the chemical, updated
based on data submitted to the Agency under the original
Registration Standard.
xThe scientific reviews and Compendium of Acceptable Uses may
be obtained from the OPP Public Docket. Write to OPP Public
Docket, Field Operations Division (H7506C), Office of Pesticide
Programs, EPA, Washington, D,C. 20460.
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0 Section IV explains the regulatory decisions and
conclusions arising from the Agency's assessment, and
the rationales for its decisions. Section IV also
describes the labeling statements required for products
containing the chemical. These are divided into
statements for manufacturing use products and statements
for end use products.
0 Sections V, VI, VII, VIII and IX describe what
products are subject to the data and labeling
requirements set out in this Registration Standard, and
what is required of registrants to comply with the
requirements.
0 Appendix I contains a series of tables setting out
data requirements for the chemical. The tables identify
which requirements have been satisfied, as well as those
for which gaps remain. A Guide to Tables introduces the
tables.
0 Appendix II is a series of labeling information
sheets, setting out general labeling information that
must be placed on labeling.
0 Appendix III is a bibliography of the data evaluated
by the Agency in its assessment. A Guide to Biblio-
graphy explains how to read and use the Bibliography.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submittal of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common name: Terbacil
Chemical name: 3-tert-butyl-5-chloro-6-methyluracil
Other Chemical Nomenclature: 5-chloro-3-(l,1-
dimethylethyl)-6-methyl-2,4(IH,3H)-pyrimidinedione
CAS Number: 5902-51-2
OPP (Shaughnessy) Number: 012701
Empirical Formula: C9H13C1N202
Molecular Weight: 216.7
Trade names: Sinbar11, DuPont Herbicide 732, and
Geonter.
Physical Chemical Properties
Color: White
Physical State: Crystalline solid
Odor: None
Melting Point: 175°-177°C
Boiling Point: N/A substance is a solid at room
temperature.
Specific Gravity: 1.34
Solubility: at 25°C q/100 a solvent
DimethyIformamide 33.7 ppm
Xylene 6.5 ppm
Water 710 ppm
Vapor Pressure: 4.7 x 10 mm Hg at 29.5 C
Octanol/water
partitioning: Kow: 81.9
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B. USE PROFILE
Type of Pesticide: Herbicide
Pests Controlled:
C. REGISTERED USES
Major Uses:
Minor Uses:
Annual Usage:
A broad spectrum of broadleaf weeds
and grasses.
Sugarcane (37 - 53%)
Mint (16- 31%)
Apples (ca. 20%)
Peaches (ca. 10%)
Alfalfa (ca. 6%)
Blueberries, caneberries, citrus
fruits, mints, pecans, strawberries,
and grass seed crops.
290,000 - 610,000 pounds active
ingredient
Mode of Activity: Photosynthetic inhibitor
Formulation Types
Registered:
Method(s) of
Application:
Wettable Powder 80%, and
Wettable Powder 40%.
-Tractor-mounted spray boom
application to soil surface
and small emerged weeds.
-Aerial application
D. REGISTRATION HISTORY
Year of Initial
Registration:
Basic (USA)
Producers:
1966
E.I. duPont de Nemours Company, Inc.
End-use Registrants: 1
Number of Registrations:
Sec 3
Sec 24c
Single Active
1
21
Multiple Active Total
1
0
2
21
Total
22
23
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III. AGENCY ASSESSMENT
A. Current Status and Summary of the Terbacil Data Base
The Agency has reviewed all data currently supporting the
registration of terbacil as of July 1989. Based on the available
data, EPA has reached the following conclusions. The points
summarized below are presented in further detail, in the context
of EPA's science findings and additional data requirements, in
sections B through D.
1. TOXICOLOGICAL EFFECTS
The acute toxicity data requirements for technical terbacil
have been satisfied.
In the 1982 Registration Standard (RS), the Agency required
submission of all acute toxicity data for the unregistered
technical. In response to the 1982 RS the Agency accepted data
submitted on the 80% wettable powder (WP) in lieu of data on the
unregistered technical. Based on data submitted on the
unregistered technical and the 80% WP, the Agency concludes that
terbacil has a low order of acute toxicity by the oral, dermal,
and inhalation routes (Toxicity Category III). The technical
material produces slight eye irritation, no skin irritation, and
no allergic reactions when tested.
In the 1982 RS, the Agency required additional data
to complete its evaluation of the subchronic effects of terbacil.
In that review, the Agency required additional data on a 21-day
dermal study and waived the requirements for a 90-day non-rodent
feeding study. Data submitted previously for a 90-day rat
feeding study was reviewed in the 1982 RS and found to be
acceptable.
The subchronic toxicity data requirements for technical
terbacil have been satisfied. Refer to section B.2 for study
reviews.
In the 1982 RS, the subchronic data base for terbacil was
essentially complete except for a 21-day dermal study. The Agency
had classified this study as supplemental and required additional
data to address deficiencies.
The 1989 Reregistration Document accepted the data
submitted to address deficiencies in the 21-day dermal study and
upgraded this study to core minimum. The Agency did not require
a 90-day inhalation, or dermal irritation study for terbacil due
to its use patterns. Neurotoxicity testing was not required
because this compound is not an organophosphate nor was there any
evidence of neurotoxicity in a mammalian species.
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The chronic toxicity data requirements for technical
terbacil have not been satisfied. Additional data are required
for the following studies: Oncogenicity rat and mouse, and
chronic oral rat study.
In the 1982 RS, the following chronic studies were reviewed
and found to be acceptable: 2-year rat feeding study, and a 2-
year dog feeding study. A rat teratology and a rat 3-generation
reproduction study were initially reviewed in the 1982 RS and
found to be supplemental but repairable. No data were available
to assess the oncogenicity, mutagenicity, or the metabolism of
terbacil.
The 1989 Reregistration Document reevaluated all chronic
data available for terbacil. In this review, the following
studies were found to be acceptable: 2-year dog feeding study,
teratology (rat and rabbit), reproduction (rat), and two of the
three required mutagenicity studies ( a gene mutation study was
reviewed and classified as supplemental). Refer to section B.3
for study reviews.
The mouse oncogenicity study submitted in response to the
1982 RS was initially reviewed in 1983 and was classified as core
minimum. This study was re-reviewed for the 1989 Reregistration
Document and was reclassified as core supplemental but repairable
(refer to Section B.3 for study deficiencies and review).
The rat chronic/oncogenicity study had been deemed
acceptable in the 1982 RS, but was reclassified as invalid and
unrepairable in the 1989 Reregistration Document. This study was
considered inadequate to satisfy the Agency 1984 Health
Assessment Guidelines for a rat chronic/oncogenicity study (refer
to Section B.2 for study deficiencies and review).
The rat metabolism study required in the 1982 RS is
currently under review.
Based on acceptable data, the following scientific
conclusions can be made on the chronic effects of terbacil:
. A chronic (2-year) feeding study in dogs, resulted in a
systemic NOEL of 1.25 mg/kg/day (lowest dose tested). This NOEL
was based on an increase in thyroid weights in dogs fed greater
than 6.25 mg/kg/day. A Provisional Acceptable Daily Intake
(PADI) of 0.013 mg/kg/day, with a 100 uncertainty factor, was
established based on the NOEL for dogs.
. Terbacil did not produce any teratogenic effects in rats
or in rabbits tested.
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. Results of a 3-generation reproduction study in rats,
indicated terbacil did not produce any reproductive effects at
the highest dose tested 250 ppm (approximately to 62.5
mg/kg/day).
. Terbacil did not induce mutagenic effects in assays tested
(Unscheduled DNA Synthesis and in vivo bone marrow chromosome
study).
. The oncogenicity potential of terbacil has not been
defined.
2.TOLERANCE REASSESSMENT
Tolerances have been established for residues of Terbacil in
or on the following raw agricultural commodities: alfalfa,
apples, asparagus, blueberries, caneberries (blackberries,
boysenberries, dewberries, loganberries, raspberries, and
youngberries), citrus fruits (including grapefruit, lemons, and
oranges), grasses grown for seed, mint (peppermint and
spearmint), pecans, peaches, strawberries, and sugarcane.
Tolerances for residues of Terbacil are currently expressed as
residues of terbacil per se (40 CFR 180.209 (a)) and terbacil
and its metabolites A, B, and C (40 CFR 180.209 (b)).
The available data indicate that the established tolerances
for residues of terbacil and its metabolites A, B, and C
(calculated as terbacil) in or on alfalfa forage, blueberries,
and strawberries are adequate. However, this conclusion cannot
be finalized until all required plant metabolism and storage
stability data have been reviewed and accepted.
Additional data are required regarding residues of terbacil
in or on citrus fruits, apples, caneberries, pecans, alfalfa hay,
asparagus, mint, sugarcane and grass forage, hay, seed, and seed
screenings and straw.
Processing studies are required to determine the need for
food/feed additive tolerances for terbacil residues in or on
citrus fruits, apples, mint, and sugarcane. In lieu of
processing data for spent hay, a feeding restriction may be
proposed.
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3. AVERAGE DAILY INTAKE REASSESSMENT
The Provisional Average Daily Intake (PADI) was derived from
a verified reference dose (RfD) of 0.013 mg/kg/day based on a
NOEL of 1.25 mg/kg/day from a two year dog feeding study with an
uncertainty factor of 100.
Dietary exposure to terbacil was calculated using the
published tolerances in 40 CFR 180.209(a) and 40 CFR 180.209 (b).
The Theoretical Maximum Residue Contribution (TMRC) for the
overall U.S. population is estimated to be 0.001594 mg/kg/day,
which occupies approximately 12% of the ADI. The two most highly
exposed subgroups are non-nursing infants, less than l year old
(TMRC= 0.008122 mg/kg/day or 62% of the ADI), and children , 1- 6
years of age (TMRC= 0.004361 mg/kg/day or 34% of the ADI).
4. ECOLOGICAL EFFECTS
In the 1982 Terbacil Registration Standard (RS), data were
available to characterize the effects of terbacil on avian
species (practically non-toxic), freshwater invertebrates
(slightly toxic), coldwater fish (slightly toxic), warmwater fish
(practically non-toxic), and honey bees (practically non-toxic).
Information reviewed in response to the 1982 RS indicated
that terbacil was moderately toxic to oysters and practically
non-toxic to birds on an acute oral basis and that additional
studies were needed to fully evaluate the risk to marine fish.
In addition, due to aerial application and the use of
terbacil near aquatic habitats Nontarget Area Phytotoxicity
studies are now required.
5. ENVIRONMENTAL FATE
In the 1982 RS, data were insufficient to fully characterize
the environmental fate of terbacil. Data from the 1982 RS
indicated that: terbacil is stable to hydrolysis and photo-
degrades slowly in water (half-life: 12 weeks). It has a
potential to contaminate ground water particularly in areas with
sandy soil surfaces. It leaches slower in fine textured soils and
also in soils having higher organic contents. It does not
accumulate to significant levels in bluegill sunfish, and
phytotoxic residues resulting from multiple applications of
terbacil persisted for 2 years following the final application.
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In response to the 1982 RS, six studies were required:
aerobic and anaerobic soil metabolism, long-term terrestrial
field dissipation, photodegradation on soil, leaching-adsorption/
desorption, and hydrolysis. These studies were reviewed and only
three of the six studies were found to be acceptable; hydrolysis,
photodegradation, and the unaged portion of the leaching
adsorption-desorption study (refer to section E for study
reviews).
Based on preliminary data, terbacil appears to be a
potential leacher. Preliminary data indicate that terbacil is
persistent in soils with a half-life of 520 days under aerobic
conditions and 178 days under anaerobic conditions. Rotational
crops studies demonstrate that terbacil can persist in soil and
is available for uptake by crops 2-years following application.
B. HEALTH EFFECTS
The following is an assessment of the human health risks
associated with the herbicide terbacil based on data submitted in
response to the 1982 Registration Standard (RS) and data
previously reviewed and determined to be acceptable to support
the reregistration of products containing terbacil.
1. Acute Toxicities and Irritation Studies;
Manufacturing Use Products
Acute Oral and Dermal Toxicity
No data were submitted to evaluate the acute oral or dermal
toxicities of the unregistered technical; however, data submitted
for the 80% wettable powder satisfies these data requirements.
Refer to "End-Use Formulation" toxicity discussion.
Acute Inhalation
Sufficient data are available to indicate that terbacil has
a low degree of acute inhalation toxicity (Toxicity Category III)
with a LC50 >4.4 mg/L.
Primary Eye Irritation
Sufficient data are available to indicate that terbacil has
a low degree of ocular irritation (Toxicity Category III),
causing slight eye irritation (conjunctiva) that cleared 3 days
after exposure.
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Primary Dermal Irritation
No primary dermal irritation study is available on terbacil;
however, an acceptable 21-day dermal study indicated that no
dermal irritation effects were observed. No additional data are
required.
Dermal Sensitization
Sufficient data are available to indicate that terbacil is
not an dermal sensitizer.
End-Use Formulations
Acute Oral Toxicity
Sufficient data are available to indicate that the 80%
wettable powder formulation of terbacil demonstrates a low order
of oral toxicity with a LD50 value > 5000 mg/kg (Toxicity
Category IV).
Acute Dermal Toxicity
Sufficient data are available to indicate that the 80%
wettable powder formulation of terbacil demonstrates a low order
of acute dermal toxicity with a LD50 value of >5000 mg/kg
(Toxicity Category III).
2. Subchronic Testing
Acceptable data are available on the oral and dermal
subchronic toxicities of terbacil.
90-Day Feeding-Rodent
A 90-day oral rat feeding study was reviewed in the 1982 RS.
In this study male and female rats were fed diets containing 100,
500, and 5000 ppm of terbacil (80% active ingredient). The NOEL
was 100 ppm (approximately 5 mg/kg/day) based on increase in
liver weights and enlargement of liver parenchymal cells in males
in and females rats administered 500 ppm.
21-Day Dermal
A 21-day dermal study on rabbits was reviewed in the 1982 RS
and considered supplemental, additional data were submitted in
response to the 1982 RS and the classification of this study was
upgraded to core-minimum. In this study, 5000 mg/kg of terbacil
(80% wettable powder) was applied to abraded skin sites daily for
three weeks (5 hours per day, and 5 days per week). No sub-
chronic toxicities were observed. Mild scaliness and staining
were detected at the test sites.
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No data are available on the 90-day subchronic oral toxicity
of terbacil in non-rodents. Additional studies are not required
since an acceptable 2-year chronic study in the dog satisfies
this data requirement.
No data are available on the subchronic neurotoxicity of
terbacil. Since an acute neurotoxicity study is not required and
there is no evidence of terbacil neurotoxicity in mammalian
species, no testing is required.
3. Chronic Toxicity Testing
Chronic Non-Rodent (Dog):
An acceptable non-rodent study was reviewed in the 1982 RS.
In this study, terbacil (80% active ingredient) was administered
in the diet to beagle dogs (4/sex/group) at levels of 50, 250,
2500, and 10000 ppm (approximately 1.25, 6.25, 62.5, and 250
mg/kg/day respectively) for 2 years. No adverse effects were
observed with respect to food consumption, weight gain, gross or
microscopic changes, or biochemical changes. The NOEL was 50 ppm
(approximately 1.25 mg/kg/day), lowest dose tested (LDT), based
on an increase in thyroid weight in dogs administered >250 ppm
(approximately 6.25 mg/kg day) of terbacil in the diet.
Chronic Rodent (Rat):
In an older (1967) study previously reviewed (for the 1982
RS), Charles River CD rats were fed terbacil (80% active
ingredient) at levels of 0, 50, 250, 2500, and 10000 ppm
(approximately 2.5, 12.5, 125, and 500 mg/kg/day, respectively)
for two years, with a NOEL of 250 ppm (approximately 125 mg/kg/
day) .
Although initially judged acceptable in the 1982 RS, this
study is considered inadequate to satisfy current guideline
requirements for a chronic and/ or oncogenicity testing in a
rodent species for the following reasons: a) an insufficient
number of animals was used at the start of the study
(36/sex/group), b) an intercurrent infection was present in the
animal colony, c) an insufficient number of animals survived the
study (the highest survival rate was 16 in the high dose
females), d) only terminally sacrificed control and high dose
animals were examined microscopically, and e) biochemical
determinations were incomplete and were done on only six
animals/sex/group. A new study is required.
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Oncogenicity
No acceptable data are available on the oncogenicity of
terbacil. The rat chronic/oncogenicity study has been classified
as invalid and unrepairable due to deficiencies outlined in the
discussion above.
A rat oncogenicity study is required.
A mouse chronic/oncogenicity study was submitted in response
to the 1982 RS and accepted in 1983. This study was re-evaluated
as part of the SRR using the current 1984 Health Assessment
Guidelines and determined to be inadequate to satisfy the
requirement for oncogenicity testing in mice. The interpretation
of findings presented by the study researchers, increased
incidence of hyperplastic nodules in the liver of high dose males
when compared to the controls, are considered by the Agency to be
questionable. The Agency's interpretation of neoplastic nodules
(including hyperplastic nodules and nodular hyperplasia) is that
these lesions are benign neoplasias.
Pending evaluation and acceptance of additional data;
reexamination of liver slides to determine the type of lesion,
and information pertaining to the concentration, homogeneity, and
stability of the test diet, this study is reclassified as
supplemental.
Additional data to address the above mentioned deficiencies
are required or submission of a new study.
Developmental Toxicity (Teratogenicity)
Sufficient data are available to satisfy the data
requirements for teratogenicity studies in two species.
In the 1982 RS, a rat teratology study had been reviewed and
classified as supplemental due to concerns in dosing procedures,
and adverse effects seen (i.e. increased post implantation loss
in the treated dams, and statistically significant increases in
hydronephrosis (collection of urine in pelvis of kidney) in
fetuses from the treated dams). These concerns were addressed in
responses to the 1982 RS and the study was re-classified to core
minimum. The NOEL for developmental effects was > 5000 ppm
(approximately 250 mg/kg/day). The maternal NOEL was 250 ppm
(approximately 12.5 mg/kg/day) based on decreased body weight at
1250 ppm (approximately 62.5 mg/kg/day) and above. The
requirement for a rat teratology study has been satisfied.
A rabbit teratology study was submitted in response to the
1982 RS. In this study, terbacil was administered to pregnant
New Zealand rabbits at daily oral doses of 0, 30, 200, and 600
mg/kg. Mean live fetal weights were significantly reduced in the
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HOT. There was no significant increase in malformed fetuses in
the treated animals when compared to the control groups. The
NOEL for developmental effects was 600 mg/kg/day (HOT). The NOEL
for maternal toxicity and embryotoxicity was 200 mg/kg/day.
Reproduction
In the 1982 RS, a three-generation rat reproduction study
had been reviewed and classified as supplemental due to concerns
in study design (only two dose levels; 50 and 250 ppm), and the
use of antibiotics to control a respiratory illness in the
laboratory. These concerns were addressed in responses to the
1982 RS and the study was re-classified to core minimum. In this
study terbacil (80% wettable powder) was administered to 10 male
and 20 female Charles River rats at dietary levels of 50 and 250
ppm (approximately 2.5 and 62.5 mg/kg/day, respectively). Body
weight gains were significantly reduced in male but not in female
rats at the HOT. No reproductive effects were seen at the HOT.
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The NOEL for reproductive effects was >250 ppm (62.5 mg/kg/day).
The systemic NOEL was < 50 ppm (2.5 mg/kg/day) based on reduction
of body weight gain in the male seen at the HDT.
Mutagenicity
Adequate mutagenicity studies in all generic categories were
lacking when the 1982 RS was issued. Two of the three required
studies have been accepted. These studies indicate that terbacil
was not mutagenic when tested in the following assays:
Unscheduled DNA Synthesis and in vivo bone marrow chromosome
study.
A gene mutation study was reviewed and found to be
supplemental due to submission flaws (e.g., missing pages and
tables). This study is repairable.
C. ECOLOGICAL EFFECTS
In the 1982 Terbacil Registration Standard (RS), data were
available to characterize the effects of terbacil on avian
species (practically non-toxic), freshwater invertebrates
(slightly toxic), coldwater fish (slightly toxic), warmwater fish
(practically non-toxic), and honey bees (practically non-toxic).
Information reviewed in response to the 1982 RS indicated that
terbacil was moderately toxic to oysters and practically non-
toxic to birds on an acute oral basis and that additional studies
were needed to fully evaluate the risk to marine fish. In
addition, due to aerial application and the use of terbacil near
aquatic habitats Nontarget Area Phytotoxicity studies are now
required.
1. Avian Species
Based on acceptable laboratory data, terbacil is
characterized as practically non-toxic to avian species on both
an acute oral and dietary basis. Data are summarized below;
Species %ai Study Type Toxicity Value
Bobwhite Quail 96 Acute Oral LD50 >2250 mg/kg
Mallard Duck 96 Dietary LC50 >5000 ppm
Mallard Duck 80 Dietary LC50 >5000 ppm
Pheasant 80 Dietary LC50 >5000 ppm
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2. Aquatic Organisms
Based on acceptable laboratory data, terbacil was
characterized for acute toxicity in the following freshwater
aquatic organisms:
Freshwater Invertebrates;
Species
Daphnia
maana
95
Freshwater Fish;
Species
Rainbow
trout
Rainbow
trout
Bluegill
sunfish
Bluegill
sunfish
96.6
80.0
96.6
80.0
LC50
fppm)
65
LC50
(ppm)
46.2
79.0
102.9
123.0
Toxicity
Characterized
Slightly Toxic
Toxicity
Characterized
Slightly Toxic
Slightly Toxic
Practically Non-
Toxic
Practically Non-
Toxic
Estuarine and Marine Oraanisms
Species
Oyster
Shrimp
84.7
84.7
LC50 Toxicity
fppm) Characterized
>4.9 Moderately Toxic
49 Slightly Toxic
3. Non-Target Insects
Terbacil was determined to be practically non-toxic to honey
bees in a laboratory acute contact toxicity test with a LD50
value > 193 micrograms/bee. No additional testing is required.
15
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D. ECOLOGICAL RISK ASSESSMENT
Birds
The available data indicate that terbacil is practically
non-toxic to birds on an acute oral (LD50 > 2250 rag/kg) and on a
dietary basis (LC50 >5000 ppm). Using a maximum application rate
of 8 Ibs a.i./Acre for citrus use, the maximum expected residues
that could be expected to occur on a variety of terrestrial
wildlife dietary food items immediately after one application
were:
Dietary Food Items Maximum Expected Residues
(ppm)
Short grass 1900
Long grass 900
Leafy crops 1000
Forage, small insects 450
Pods, large insects 950
Fruits 60
These residue levels when compared to the acute oral and
dietary values for avian species tested are not expected to cause
adverse effects.
Avian reproduction studies were not required in the 1982 RS
nor are they required under this Registration Standard. An
assessment of the acute oral, dietary, and residue data indicated
that chronic and reproductive adverse effects are unlikely to
occur.
Aquatic Organisms
Terbacil has no currently registered uses that would involve
direct application to water. Terbacil can enter aquatic systems
through spray drift and runoff from treated sites adjacent to
streams, ponds, or other bodies of water.
The terbacil's maximum application rate is 8 Ibs a.i./Acre.
Based on the theoretical calculations, available ecological data,
and its low toxicity to aquatic organisms, terbacil is not
expected to cause unreasonable adverse effects to aquatic
species. However, an additional study is needed to fully
evaluate the risk to marine fish.
Endangered Species
The registered uses of terbacil do not represent a potential
hazard to endangered terrestrial or aquatic organisms on an acute
or chronic basis.
16
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E. ENVIRONMENTAL FATE
In the 1982 RS, data were insufficient to fully characterize
the environmental fate of terbacil. Data from the 1982 RS
indicated that: terbacil is stable to hydrolysis and photo-
degrades slowly in water (half-life: 12 weeks). It has a
potential to contaminate ground water particularly in areas with
sandy soil surfaces. It leaches slower in fine textured soils and
also in soils having higher organic contents. It does not
accumulate to significant levels in bluegill sunfish, and
phytotoxic residues resulting from multiple applications of
terbacil persisted for 2 years following the final application.
In response to the 1982 RS, six studies were required:
aerobic and anaerobic soil metabolism, long-term terrestrial
field dissipation, photodegradation on soil, leaching-adsorption/
desorption, and hydrolysis.
1. Hydrolysis
Terbacil was stable in aqueous hydrochloric acid and sodium
hydroxide solutions at pH's 4 to 10 at 25°C. No additional
testing is required.
2. Photodegradation on Soil
Carbonyl-labeled [2-14C] terbacil (purity >99%), at 1.2
Ib/A, degraded with a half-life of >15 days on silty clay loam
soil when continuously irradiated with a lamp at 25-26°C. The
calculated half-life was 61 days, based on continuous
irradiation. No additional studies are required.
3. Leaching and Adsorption/Desorption
Based on acceptable batch equilibrium studies, [ C]terbacil
was very mobile in two sandy loam and two silt loam soils when
equilibrated at 25°C in 1:1 soil:calcium sulfate solution
slurries that contained 0.2-6.0 ppm of carbonyl-labeled [2-14C]
terbacil (purity >99%). Freundlich K^ values were 0.39-0.71 for
sandy loam soils and 1.2-1.3 for silt loam soils. Adsorption of
terbacil was highly correlated with the percentage of soil
organic matter.
Based on acceptable soil TLC studies, [2-14C] terbacil, was
mobile (Rf0.27-0.28) in silt loam soil, and silt soil and mobile
to very mobile (Rf0.36-0.54) in sandy loam soils.
An aged leaching-adsorption/desorption study is required.
17
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4. Soil Metabolism Studies
Studies submitted in response to the 1982 RS were reviewed
and found to be unacceptable. Preliminary data indicates that
terbacil is extremely persistent (half-life: 520 days aerobically
and 178 days anaerobically). These studies were deemed
unacceptable due to design flaws and reporting deficiencies and
are unrepairable. Aerobic and anaerobic soil metabolism studies
and a long-term soil field terrestrial dissipation study are
required.
5. Confined Rotational Crop Study
Two studies reviewed in the 1982 RS indicated that beets
(roots and tops), sunflower seeds, and cabbage grown in a
greenhouse in silt loam soil contained no detectable residues of
terbacil (<0.04 ppm). Terbacil was detected in cabbage grown in
muck soil sampled 2 years after the last application (1-2 Ib
ai/Acre), but was not detected in beets or sunflower seeds.
Due to the degree of persistence, a rotational crop interval
of one year or less could not be set and the confined rotational
crop requirement was waived in the 1982 RS. Rotational crop tol-
erances are required for all crops rotated in fields treated with
terbacil.
F. GROUND WATER ASSESSMENT
Limited monitoring has been conducted for terbacil in ground
water. No detections have been found in 12 wells sampled in a
statewide survey in Louisiana by the Louisiana Department of
Agriculture and Forestry. Although pesticide use was a criteria
in designing the study, the extent to which terbacil had been
used in the vicinity of all sampled wells is unknown.
Very little is known about the degradation products of
terbacil due to terbacil's persistence. The physicochemical
properties (e.g., persistence and mobility) of the degradates,
and their relative proportions to the parent compound have not
been adequately identified. Insufficient data exists to predict
concentrations of the parent and/or its degradation products in
ground water under typical application rates and use areas. A
small scale retrospective ground water monitoring study is
reserved pending evaluation of the long-term soil field
dissipation study.
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G. WORKER EXPOSURE/REENTRY ASSESSMENT
The current application practices for terbacil (pre-emergent
and dormant application) would present minimum exposure to
fieldworkers entering sites treated. Available acute and chronic
toxicological data do not demonstrate a risk to workers exposed
to terbacil during handling, mixing, and application. The Agency
believes that the updated protective clothing statements required
under this Standard will adequately protect individuals against
any potential hazard.
H. TOLERANCE REASSESSMENT
Tolerances have been established for residues of Terbacil in
or on the following raw agricultural commodities: alfalfa,
apples, asparagus, blueberries, caneberries (blackberries,
boysenberries, dewberries, loganberries, raspberries, and
youngberries), citrus fruits (including grapefruit, lemons, and
oranges), grasses grown for seed, mint (peppermint and
spearmint), pecans, peaches, strawberries, and sugarcane.
Tolerances for residues of Terbacil are currently expressed as
residues of terbacil per se (40 CFR 180.209 (a)) and terbacil
and its metabolites A, B, and C (40 CFR 180.209 (b)). EPA has
evaluated the residue and toxicology data supporting these
tolerances. The following were considered during this evaluation:
o Whether the tolerances are adequate to protect the public
health, including that of sensitive subpopulations.
o Whether the current tolerances and food/feed additive
regulations are sufficient to cover the actual residues resulting
from use (including uses registered under FIFRA sec. 24(c).
o Whether group tolerances can be established in accordance
with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
The regulatory determinations resulting from EPA's review
are set out in Section IV.A., Regulatory Positions and
Rationales.
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1. Residue Data
a. Nature of the Residue in Plants
In the 1982 Registration Standard, the nature of the residue
in plants was considered to be adequately understood based solely
on data pertaining to the metabolism of [UC]terbacil in field-
treated alfalfa. The metabolites of terbacil in alfalfa forage
are illustrated in Table 1. Other metabolism studies on orange
seedlings, peppermint, and sugarcane failed to characterize
radioactivity residues following [14C] terbacil "treatment. These
studies are no longer considered to be adequate to characterize
the qualitative nature of terbacil in plants. Additional studies
on apples and sugarcane which characterize terbacil residues in
plants are needed.
Presently, terbacil and its metabolites, A, B, and C are the
residues of concern; however, it should be noted that if the
additional required metabolism studies indicate additional
residues of concern, the established tolerance definition, as
stated in 40 CFR 180.209(b), may need to be revised.
Table 1. Terbacil and its metabolites in plants and animals
Code
Chemical name
Structure
Substrate
I. 3-tert-butyl-5-chloro-6-methyluracil
(Terbacil)
Alfalfa Forage
Orange seedlings
Peppermint
Sugarcane
Goat, kidney, liver,
and muscle.
II. 3-tert-butyl-5-chloro-6-hydroxymethyluracil
(Metabolite A) Alfalfa forage
20
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Table 1 (continued).
Code
Chemical name
Structure
Substrate
III. 6-chloro-2,3-dihydro-7-(hydroxymethyl)-3,3
-dimethyl-5H-oxazolo [3,2-a]pyrimidin-5-one
(Metabolite B) Alfalfa forage
CH
IV. 6-chloro-2,3-dihydro-7-methy1-3,3-
dimethyl-5H-oxazolo [3,2-a]pyrimidin-5-one
(Metabolite C) Alfalfa forage
V. 3-tert-butyl-6-hydroxymethyluracil
(Metabolite D)
Alfalfa forage
H
HOH2CY' ^°
n-Y4'0
21
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b. Nature of the Residues in Animals
The 1982 RS for terbacil concluded that the nature of the
residue in animals was adequately understood. Although residues
were characterized in milk, the studies reviewed in the 1982 RS
failed to adequately characterize residues in tissue even though
feeding studies indicate that total terbacil equivalent 14C-
residues were 0.06-0.07 ppm in liver, 0.12-0.14 ppm in kidney,
and 0.01 ppm in muscle of a single lactating goat following
ingestion of [14C] terbacil. Metabolism data are required in
livestock and in poultry.
c. Residue Analytical Methods
The 1982 RS concluded that adequate analytical methods were
available for data collection and tolerance enforcement
pertaining to residues of terbacil per se in or on plant
commodities and to the combined residues of terbacil and its
metabolites A,B, C, (calculated as terbacil) in or on plant and
animal commodities. However, the nature of the residue in plants
and animals has not been adequately described. Therefore, the
adequacy of the available analytical methods cannot be
determined.
Enforcement method I in the PAM, Vol. II is a gas-
1iquid/microcoulometric (GLC/MC) method for determination of
residues of terbacil per se in or on apples, citrus fruits,
peaches, pears, and sugarcane. This method has undergone a
successful Agency validation study on oranges and peaches.
The 1982 RS also concluded that the GLC/MC method (Method II
in the PAM, Vol II) which determines residues of terbacil and its
three metabolites A, B, and C as silyl derivatives in or on plant
and animal commodities was adequate for data collection and
enforcement. This method underwent a successful validation study
conducted on alfalfa hay and milk. A confirmatory procedure for
this method is listed in the PAM, Vol. II as Method A.
Residues of terbacil per se are completely recovered (>80%)
by PAM Vol. I method 232.4 (multiresidue protocol II), and poorly
recovered (13-30%) by method 252 (multiresidue protocol I). No
data are available concerning recovery of the terbacil metab-
olites by any of the multiresidue protocols I-IV. These data are
required.
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d. Storage Stability Data
Data on storage stability of terbacil in or on plant
commodities were not required in the 1982 RS. In 1987, a
Position Document (NTIS PB 88112362/AS) was published by the
Agency in which storage stability requirements were expanded.
The Agency now requires that storage intervals and sample storage
conditions must be reported for all residue data submitted in
support of tolerances or otherwise required by the Agency,
and that the residue data be accompanied by data depicting the
stability of all residues of concern in storage.
e. Magnitude of the Residues in Raw Agricultural Commodities
and Food and Feed Items
The available data indicate that the established tolerances
for residues of terbacil and its metabolites A, B, and C
(calculated as terbacil) in or on alfalfa forage, blueberries,
and strawberries are adequate. However, this conclusion cannot
be finalized until all required plant metabolism and storage
stability data have been reviewed and accepted.
Additional data are required regarding residues of terbacil
in or on citrus fruits, apples, caneberries, pecans, alfalfa hay,
asparagus, mint, sugarcane and grass forage, hay, seed, and seed
screenings and straw.
Processing studies are required to determine the need for
food/feed additive tolerances for terbacil residues in or on
citrus fruits, apples, mint, and sugarcane. In lieu of
processing data for spent hay, a feeding restriction may be
proposed.
f. Magnitude of the Residue in Meat, Milk, Poultry, and Eggs
The 1982 RS concluded that data were adequate to support the
established tolerances for residues in fat, meat byproducts, and
meat in cattle, goats, hogs, horses, and sheep. However, the
qualitative nature of the residue in ruminants is not adequately
understood. Also, numerous data gaps exist in determining the
magnitude of the residue in feed items of animals. Accurate
theoretical dietary exposure for beef cattle and swine cannot be
calculated until the required residue data for all feed items
have been submitted and accepted.
23
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There are no established tolerances for residues of terbacil
in eggs and the fat, meat and meat byproducts of poultry. No
data have been submitted pertaining to the metabolism of terbacil
in poultry. The need for tolerances for residues in poultry
products will be determined following review and acceptance of
animal and plant metabolism data, storage stability data, and
data regarding the magnitude of the residue in plants.
2. Tolerances Issued
Codex MRL's or Mexican tolerances have not been established
for any terbacil commodities. Canadian tolerances have been
established for some terbacil commodities but not all.
Compatibility of these tolerances to that of the U.S. tolerances
cannot be determined until all additional metabolism and residue
studies have been evaluated and accepted.
3. ADI Reassessment
The ADI was derived from a verified reference dose (RfD) of
0.013 mg/kg/day based on a NOEL of 1.25 mg/kg/day from a two year
dog feeding study with an uncertainty factor (UF) of 100. This
ADI has been down graded to a Provisional Acceptable Daily Intake
(PADI).
The Agency's verified ADI was based on a two year chronic
feeding study in the dog. Other studies considered in the
established of the ADI were: oncogenicity (two species), chronic
oral (two species), reproduction, and teratogenicity. These
studies were reviewed and the chronic rodent, and the
oncogenicity studies were found to be unacceptable. Therefore,
the ADI was changed to an PADI, however, based on available data
it was not considered necessary to increase the UF.
Dietary exposure to terbacil was calculated using the
published tolerances in 40 CFR 180.209(a) and 40 CFR 180.209 (b).
The Theoretical Maximum Residue Contribution (TMRC) for the
overall U.S. population is estimated to be 0.001594 mg/kg/day,
which occupies approximately 12% of the PADI. The two most
highly exposed subgroups are non-nursing infants, less than 1
year old (TMRC= 0.008122 mg/kg/day or 62% of the PADI), and
children , 1- 6 years of age (TMRC= 0.004361 mg/kg/day or 34%
of the PADI).
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IV. REGULATORY POSITION RATIONALE
A. REGULATORY POSITIONS
Based on review and evaluation of all available data and
other relevant information on terbacil, the Agency has made the
following determinations:
1. Special Review
Terbacil will not be placed in Special Review at this time.
Rationale: Based on available data terbacil does not meet or
exceed the criteria for Special Review as specified in 40 CFR
154.7.
2. Groundwater Concerns
The Agency will impose a ground water contamination advisory
statement to reduce point source contamination. Refer to section
IV.D for specific wording.
Rationale: Based on available data, terbacil is stable to
hydrolysis and photodegrades slowly in water (half life: 12
weeks) and on soil (half life: 17 weeks). Terbacil also shows a
potential to leach into ground water particularly in areas with
sandy soil surfaces, it leaches slower in fine textured soils and
in soils having high organic contents. Preliminary data indicate
that terbacil is extremely persistent in soil with half-lives of
520 days under aerobic conditions and 178 days under anaerobic
conditions.
4. End-Use Data Requirements
The Agency is requiring the following testing on terbacil
end-use products: acute oral, acute dermal, primary eye, primary
skin, dermal sensitization, and acute inhalation if appropriate.
Rationale; These tests are necessary to ensure that end-use
products are properly labeled with respect to human hazard,
signal word, and precautionary statements because available data
does not adequately characterize the toxicity profile of terbacil
end-use products.
5. Reentry Requirements
The Agency will not establish a reentry interval for
terbacil beyond the minimum reentry interval (sprays have dried,
dusts have settled and vapors have dispersed).
25
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Rationale: Based on current use practices, relatively low
acute toxicity (Toxicity Category III for acute oral, dermal, and
inhalation routes of exposure), and no validated toxicological
evidence showing that terbacil causes adverse effects to persons
entering treated fields, the Agency has determined that a reentry
interval beyond the minimum (sprays have dried, dusts have
settled and vapors have dispersed) is not warranted at this time.
6. Protective Clothing Requirements
The Agency will require updated worker safety and protective
equipment statements for end-use products containing terbacil.
Refer to section IV.D for specific wording.
Rationale; Current protective clothing and equipment
requirements for terbacil are not adequate to minimize exposure
to agricultural workers.
7. Rotational Crop Tolerances
The Agency is requiring a rotational crop statement on all
terbacil labels which may involve rotation to crops other than
those currently registered (refer to section IV.D for specific
wording). In addition residue data are required for
representative crops from any crop group which could be rotated
from alfalfa, sainfoin, asparagus, and mint.
Rationale; Terbacil is registered for use on a wide variety
of fruit crops. These crops do not present rotational crop
concerns. The following registered uses of terbacil: grasses
grown for seed, alfalfa, asparagus, and mint, do present
rotational crop concerns because it may not be practical to
rotate from these crops to crops already listed on the product
label.
Environmental fate data demonstrate that for at least 2
years following application of terbacil at >1 Ib ai/Acre, organic
soils may retain phytotoxic residual terbacil that is available
for uptake by rotational crops. Given this degree of
persistence, a rotational crop interval of one year or less could
not be set. Tolerances must be established for all crops to be
rotated in fields treated with terbacil.
8. Tolerance Revocation
The Agency will revoke tolerances associated with the
commodities sainfoin (hay), sainfoin (forage), and pears.
Rationale; Terbacil is no longer registered for use on the
above mentioned crops. Therefore, the Agency intends to revoke
the tolerances for these commodities.
26
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9. Tolerance Definition
Existing Tolerance Terbacil per se should be amended to
include metabolites A,B, and C, as specified in 40 CFR
180.209 (b).
Rationale; Currently tolerances for terbacil are
established in 40 CFR 180.209 (a) for residues of terbacil per se
and in 40 CFR 180.209 (b) for combined residues of terbacil and
its metabolites A,B, and C. (calculated as terbacil). The Agency
has determined that additional residue data are needed for the
crops listed in 40 CFR 180.209 (a). These data should reflect
analysis for terbacil and all metabolites of concern. At such
time as the required metabolism and residue studies are submitted
and reviewed the Agency will combine the crops in 40 CFR 180.209
(a) with the crops in 40 CFR 180.209 (b).
10. Tolerance Revisions
The Agency will revise the tolerance for residues in or on
peaches to 0.2 ppm for combined residues of terbacil and its
metabolites.
Rationale: The current tolerance expression for peaches
(0.1 ppm) is for terbacil per se only. Data submitted in
response to the 1982 RS, indicated that the combined residues of
terbacil and its metabolites A, B, and C (calculated as terbacil)
will not exceed 0.2 ppm in or on peaches following terbacil
application according to the maximum registered use pattern.
Therefore unless the required storage stability data indicate
that these data are invalid or additional residues of concern are
identified the tolerance will be revised.
11. Grazing/Feeding Restriction
The Agency will impose label restrictions against the
feeding and grazing of sugarcane forage and spent hay to
livestock, or require the development and submission of data in
support of tolerances for residues in or on sugarcane forage and
spent hay. The registrant must inform the Agency within 90 days
as to whether he will propose tolerances or adopt the
grazing/feeding restrictions. If the registrant selects the
label restrictions, labeling submitted at the 9 month deadline
must include the grazing/feeding prohibitions. Refer to section
IV.D for specific wording.
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Rationale; Since sugarcane forage and spent hay are raw
agricultural commodities used for livestock, a tolerance and a
pregrazing interval must be proposed. A label restriction
prohibiting grazing/feeding of sugarcane forage and spent hay to
livestock will be accepted in lieu of additional data requested.
12. Food Use Classification
The Agency has determined that grasses grown for seed is a
food use. Therefore, data depicting residues of terbacil in or
on members of the grass forage, fodder and hay group are
required.
Rationale; The Agency believes that cuttings for hay will be
taken and forage will be grazed regardless of label restrictions.
Also the grower will have no control over seed, seed screenings
and straw (from seed processing) diverted for livestock feed.
13. Group Tolerances
The Agency will not propose group tolerances for terbacil.
Rationale; Appropriate residue data must be submitted for
representative crops in each crop group.
14. Food/Feed Tolerances2
The Agency will not grant any significant new food or feed
uses for terbacil until the required residue chemistry and
toxicology studies have been submitted and reviewed.
Rationale; The Agency needs additional residue data, plant
and animal metabolism data, storage stability data, and chronic
toxicity data to reassess the tolerances for terbacil.
2New Uses is defined in 40 CFR 152.3 (p) . In the case of a
new food or feed use, the Agency will generally consider
as significant an increase in the Theoretical Maximum
Residue Contribution (TMRC) of greater than 1%.
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15. Studies that will Receive Immediate Review
The Agency has identified certain data that will receive
priority review when submitted to the Agency.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger the
need for further studies which should be initiated as soon as
possible. The following studies have been identified to receive
priority review as soon as they are received by the Agency:
Section 158.340 Toxicology
83-1 Chronic Oral Feeding (Rat)
83-2 Oncogenicity (Rat and Mouse)
Section 158.290 Environmental Fate
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching Adsorption/Desorption
164-5 Soil, Long Term (field)
Section 158.490 Wildlife and Aquatic Organisms
72-3 Estuarine and Marine Testing (Fish)
122-1 Tier I Nontarget Area Phytotoxicity
Section 158.240 Residue Chemistry
171-4 Metabolism in Plants & Livestock
15. Continuation of Registration
While data are being filled, currently registered
manufacturing use products (MPs) and end-use products (EPs)
containing terbacil may be sold, distributed, formulated and
used, subject to the terms and conditions specified in this
Standard. Registrants must provide or agree to develop
additional data, as specified in the Data Appendices, in order
to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or are
inadequate (see FIFRA section 3(c)(2)(B) and 3(c)(7)).
Issuance of this Standard provides a mechanism for
identifying data needs and labeling changes arising from
available data. Required data will be reviewed and evaluated,
after which the Agency will determine if additional regulatory
actions are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain terbacil, bear required labeling, and
conform to the product composition, acute toxicity limits, and
use pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain this pesticide.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and inert
ingredients which are present in products, as well as impurities
found at greater than 0.1 percent, except for those impurities of
toxicological importance of which upper certified limits of less
than 0.1% may be indicated.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade,
manufacturing-use products, and end-use products containing this
pesticide provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category in which
each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed in the EPA Compendium of
Acceptable Uses (for availability see page 1). The Compendium
lists all registered uses, as well as approved maximum
application rates and frequencies.
D. REQUIRED LABELING
In order to remain in compliance with FIFRA, products must
bear appropriate labeling as specified in 40 CFR 156.10 and this
Standard, or must be revised to conform to those specifications.
Appendix II contains information on label requirements.
No pesticide product containing TERBACIL may be released for
shipment by the registrant after August 31, 1990 unless the
product bears an amended label which complies with the
requirements of this Standard.
No pesticide product containing Terbacil may be distributed
or sold after August 31, 1991, unless the product bears an
amended label which complies with the requirements of this
Standard.
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The following specific information must appear on the label
in order for products to remain in compliance with FIFRA:
1. Ingredient Statement
The ingredient statement for products must list the active
ingredient as:
ACTIVE INGREDIENT
Terbacil %
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable use
patterns. Labeling must specify sites, which are listed in the
EPA Compendium of Acceptable Uses (for availability see page 1).
However, no use may be included on the label where the registrant
fails to agree to comply with the data requirements in TABLE A
for that use pattern.
3. Precautionary Statements
STATEMENTS FOR MANUFACTURING-USE PRODUCTS
"Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
waters unless this product is specifically identified
and addressed in a NPDES permit. Do not discharge
effluent containing this product into sewer systems
without previously notifying the sewage treatment plant
authority. For guidance, contact your State Water
Board or Regional Office of the EPA."
STATEMENTS FOR END-USE PRODUCTS
A. Groundwater Advisory Statements
Terbacil can travel (seep or leach) to ground water that
is used for drinking water. Users are advised to be careful
in mixing and handling terbacil to avoid spills.
Terbacil must not be mixed/loaded, or used within 50 feet of
sink holes or wells, including abandoned wells and drainage
wells.
Terbacil must not be applied more frequently than once per
year.
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B. Environmental Hazards Statement
"Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water when
disposing of equipment wash waters."
C. Personal Protective Clothing and Equipment Statement
"Pesticide handlers are to wear the following personal
protective clothing and equipment: long pants, long
sleeved shirt, shoes, socks. Chemical-resistant gloves
are to be worn during mixing, loading and application."
D. Reentry Statement
"Do not enter or allow entry into treated areas until
[sprays have dried/dusts have settled/vapors have
dispersed as applicable] to perform hand labor tasks. A
person may enter the area only if the person is wearing
the personal protective clothing and equipment listed
on the label for a pesticide handler."
E. Feeding and/or Grazing Restrictions
All End-Use products allowing for use on sugarcane, spent hay,
and orchard crops must bear the following restriction (in the
absence of supporting residue chemistry data on sugarcane forage,
and spent hay):
"Do not graze or feed treated forage to livestock"
F. Rotational Crop Statement
All End-Use products allowing for use on food or feed crops:
"Treated areas may only be replanted with a crop specified
on this label."
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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 submittal 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 B3
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
3Data 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 Registration
Standard. Table B lists product-Specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the generic
data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products.
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B. Manufacturing use products containing this pesticide as one
of multiple active ingredients 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 B4
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
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.
4Data 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 Registration
Standard. Table B lists product-Specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the generic
data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products.
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2. If eligible for the generic data exemption5, the
data requirements listed in Table C.
3. If not eligible for the generic data 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:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the data
requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
5If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data 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 the data
requirements in Table A.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). It refers to the
data listed in Table A, which are required to be submitted by
registrants to maintain in effect the regis-tration of products
containing this active ingredient.6
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of
a product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having
that formulation type. These are classed as generic data, and
are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's exemption
(FIFRA sec. 3(c)(2)(D) and 40 CFR 152.85) to submit generic data
in response to a DCI notice if the registrant who supplies the
active ingredient in his product is complying with the data
request.
If you are granted a generic data exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrants who have committed to generate and
submit the required data fail to take appropriate steps to meet
the requirements or are no longer in compliance with this data
requirements notice, the Agency will consider that both they and
you are not in compliance and will normally initiate proceedings
to suspend the registrations of both your product(s) and their
product(s) unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
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If you are not now eligible for a generic data 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 Generic Data Exemption Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not yet
been submitted, any new registration will be conditioned upon the
new registrant's submittal or citation of the required data not
later than the date upon which current registrants of similar
products are required to provide such data. See FIFRA sec.
3(c)(7)(A). If you thereafter fail to comply with the condition
of that registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form you
must state which of the following six methods you will use to
comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will submit
the data on which you will rely. You must also provide EPA with
documentary evidence that an agreement has been formed which
allows you to rely upon the data to be submitted. Such evidence
may be: (1) your letter offering to join in an agreement and the
other registrant's acceptance of your offer, (2) a written
statement by the parties that an agreement exists, or (3) a
written statement by the person who will be submitting the data
that you may rely upon its submittal. The Agency will also
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require adequate assurance that the person whom you state will
provide the data is taking appropriate steps to secure it. The
agreement to produce the data need not specify all of the terms
of the final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data Submitter
Number, as part of your 90-day response. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative of
the consortium, with whom EPA will correspond concerning
the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of
the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to jointly
develop data, but no other registrant has accepted your offer.
You request that EPA not suspend your registration for non-
compliance with the PCI. EPA has determined that, as a general
policy, it will not suspend the registration of a product when
the registrant has in good faith sought and continues to seek to
enter into a data development/cost sharing program, but the other
registrants developing the data have refused to accept its offer.
[If your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
a. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Development of
Data" (EPA Form 8580-6, enclosed).
b. 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:
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA
sec.3(c)(2)(B) in the [name of active ingredient]
Registration Standard upon terms to be agreed or
failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to limit
this commitment. If the other registrant to whom your offer is
made does not accept your offer, and if the other registrant
informs us on a DCI Summary Sheet that he will develop and submit
the data required under the DCI, then you may qualify for this
option. In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share in the
burden of developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply to
your product or its uses, you must provide EPA with a statement
of the reasons why you believe this is so. Your statement must
address the specific composition or use factors that lead you to
believe that a requirement does not apply. Since the Agency has
carefully considered the composition and uses of pesticide
products in determining that a data requirement applies, EPA does
not anticipate that many waivers will be granted. A request for
waiver does not extend the time-frames for developing required
data, and if your waiver request is denied, your registration may
be suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your reaistration 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.
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6. You request voluntary cancellation of the registration
of your product(si for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such requests
for changes in the requirements do not alter the original
requirements or extend the time allowed for meeting the
requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must be
conducted in accordance with applicable Good Laboratory Practices
regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced in
the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (Part 158.70). Please
note, however, that certain OECD standards (such as test
duration, selection of test species, and degradate identification
which are environmental fate requirements) are less restrictive
than those in the EPA Assessment Guidelines listed above. When
using the OECD protocols, they should be modified as appropriate
so that the data generated by the study will satisfy the
requirements of Part 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies
were not conducted in accord with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue,
N.W., Washington, D.C. 20006.
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G. Procedures for requesting a change in
test protocol.
If you will generate the required data and plan to use test
procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the data,
nor will extensions generally be given to conduct studies due to
submittal of inappropriate protocols. The Agency will respond in
writing to your request for protocol approval or change.
H. 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.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future claim
that there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline for
submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity or
adequacy of funding, since the Agency believes that with proper
planning these can be overcome. The Agency will respond in
writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including, but
not limited to, requirements referenced or included in this
Notice or contained in PR Notice 86-5 (issued July 29, 1986).
All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the
submittal requirement.
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J. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is suspended
for failure to respond to a DCI request under FIFRA sec.
3(c)(2)(B), an existing stocks provision for the registrant is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
information must be included in any request for an existing stocks
provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale or
distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing using a
specific formulated product, and, unlike generic data, generally
support only the registration of that product. All such data must
be submitted by the dates specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided that
it will not routinely require product-specific data for end use
products at this time. Therefore, Table C may not be contained in
this Registration Standard; if there is no Table C, you are not
required to submit the data at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data) or
VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the product's
registration.
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VIII. REQUIREMENT FOR SUBMITTAL 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 156.10
(see Appendix II - LABELING and SUMMARY). In addition, labeling
language specific to products containing this pesticide is
specified in Section IV.D of this Registration Standard.
Responses to this Registration Standard must include draft
labeling for Agency review.
Labeling must 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. 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.
If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in
Section IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard must
be sent to the following address:
Document Processing Desk (RS-0039)
Office of Pesticide Programs - H7504C
U. S. Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit for each product subject to this Registration Standard:
a. Generic Data Exemption Statement (EPA Form
8580-3),if applicable.
b. FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1).
c. Confidential Statement of Formula (EPA Form 8570-4)
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
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2. Within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
c. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A. you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
4. Within the times set forth in Table B, you must submit
all product specific data.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),if
applicable.
b. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments (EPA Form 8580-1).
c. Confidential Statement of Formula (EPA Form 8570-4)
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
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2. Within 9 months of receipt of this document, you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
c. Product Specific Data Report (EPA Form 8580-4).
3. Within the time frames set forth in Table A. you must
submit all generic data, unless you are eligible for the generic
data exemption. If for any reason any test is delayed or aborted
so that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
4. Within the time frames set forth in Table B, you must
submit all product specific data.
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C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable,
b. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1),
if Table C lists required product-specific data.
c. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you must
submit:
a. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A. you must submit all
generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
4. Within the times set forth in Table C, you must submit all
product specific data.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable.
b. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1), if Table C
lists required product-specific data.
c. Confidential Statement of Formula (EPA Form 8570-4).
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2. Within 9 months from the receipt of this document, you
must submit:
a. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
b. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A. you must submit all
generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
4. Within the times set forth in Table C, you must submit all
product specific data.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted by
that date, no product may be released for shipment by the producer
after July 31, 1988.
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I. DATA APPENDICES
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply
to the pesticide in all products, including data
requirements for which a "typical formulation" is the
test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP — Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns are
the same as those given in 40 CFR Part 158. The following letter
designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
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TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such
data do not fully satisfy the data requirement. In
some cases, the Agency may possess data on one of two
required species or may possess data on one test
substance but not all. The term may also indicate that
the data available to EPA are incomplete. In this
case, when the data are clarified, or additional
details of the testing submitted by the original data
submitter, the data may be determined to be acceptable.
If this is the case, a footnote to the table will
usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional
information.
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.
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TGUIDE-3
6. Must additional data be submitted? (Column 6). This column
indicates whether the data must be submitted to the Agency. If
column 3 indicates that the Agency already has data, this column
will usually indicate NO. If column 3 indicates that the Agency
has only partial data or no data, this column will usually
indicate YES. In some cases, even though the Agency does not
have the data, EPA will not require its submission because of the
unique characteristics of the chemical; because data on another
chemical can be used to fulfill the data requirement; or because
the data requirement has been waived or reserved. Any such
unusual situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 6 requires
that data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are those established either as a
result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
51
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Generic Data Requirements for Terbacil
Test
Data Requirement Substance
Does EE&Have
Data to Satisfy Mjst Additional
This Requirement? Data Be Submitted Timef rams
(Yes, Nb, or Bibliographic tinder EEERA, Section for Data
Partially) Citation 3(c)(2HB)? Submission
Part 158. Subpart Cf Product Chemistry
Product-
61-2 -
Composition
Beginning Materials
and Production Process
61-3 - Formation of Impurities
Analysis and GertifJc^tiT1 of Product IiTrrpf:iiSPt'?
62-1 -
Physical
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
63-7 -
Preliminary Analysis
and Chemical Charactf^ri sties
Color
Physical State
Odor
Malting Point
Boiling Point
Density, Bulk Density,
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Partially
Partially
Partially
Yes
Yes
Yes
Yes
N/A4/
Partially
00142302^00012366
00012366
00142302,00012364,
00067336
00011953
00011958
00011958
00011958
00011958
YesV
Yes2/
Yes3/
Nb
Nb
Nb
Nb
Nb
Yes5/
12 Months
12 Worths
12 tenths
12M3TthS
or pacific Gravity
63-8 - Solubility
and EM
Yes
00011958
Nb
-------
liable A
Gsnsric Data Requirements for Terbacil (cont'd)
Test
uct Q^nistrv
Physical and. Chemical Characteristics (cont'd)
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 -pH
63-13 - Stability
Other Requirements
64-1 - Submittal of Samples
KJo: or PAI
or PAI
EAI
TSKL
ISM
Does EEA Have
Data to Satisfy
TliLs Requirement?
(Yes, No, or
Bibliograjhic
ivtist ?dditional
Data Be Sutmitted Tiitef rame
inder E1ERA Section for Data
3(c)(2)(B)?
Partially 00011958
Partially 00125692
Nb
Nb
Yes^/
Yes8/
Yes
Yes
l2Mnths
12M31thS
12Mxttns
12Maiths
u>
-------
Table A
Generic Data, jtequirements for lerbacil (cont'd)
Part 158 . Subcart. - cgnistr Footnotes
I/ Information nust be submitted on the production process for the unregistered technical concerning: (i) a general
characteriaation of the process (e.g. , batch or continuous) used; (ii) the relative amounts of beginning materials, and the
oroer in which they are arJrfcri; (Hi) a description of the equipment used; (iv) a description of the conditions (e.g. ,
temperature, pressure, pH, humidity) that are controlled during each step of the process; and (v) a description of the
procedures used to assure consistent conposition of the substance produced (quality control methods) . In addition, a flow-
chart of the chemical equations of each intended reaction occurring at each step of the process, the necessary reaction
conditions, the ouration of each step of the process and of the entire process, and a description of any purification
procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced) are
required.
2/ A discussion regarding the origin of potential impurities in the unregistered 95% T trust be provided: (i) each impurity
associated with the active ingredient which was found to be present in any analysis of the product conducted by or for the
registrant, and (ii) each impurity which the registrant has reason to believe may be present at a level equal to or greater
than 0.1% (w/to) based on the corposition of each starting material, intended and side reactions which may occur during
production, the possible degradation of ingredients after production, posi^jroduction reactions between the ingredients, the
possible carry over of ccntaminants fron use of production equipment previously used to produce other products or
substances, possible cxaitamination from packaging materials, and process control, purification and quality control measures.
^/Statements of the precision and accuracy of the analytical methods used for sample analysis must be sutmitted.
4/Data on boiling point are not required because the 1GAI is a solid at room temperature.
5/Data are required concerning the measurement temperature and the method of determination of specific gravity.
fi/Ihe method of determination must be supplied.
I/Data concerning dissociation constant are not required since the technical product is neither a strong acid nor a strong
base.
,8/Data are required coicerning the measurement temperature at which the octanol/water partition coefficient was determined.
-------
liable A
Generic Data Requirements for Terbacil
Data Reouirement
158.240 Residue Chemistry
171-2
171-3
171-4
171-4
171-4
171-4
- Chemical Identity!/
- Directions for Use
- Nature of the Residue
(Metabolism)
- Plants
- Nature of the Residue
(Metabolism)
- Livestock
- Residue Analytical
Methods
- Storage Stability
Composition
PAIRA & Plant
Metabolites
PAIRA & Plant
Metabolites
T020: and
Metabolites
TEP and.
Metabolites
Does EE&Have
Data to Satisfy Mjst Additional
This Requirement? Data Be Submitted Timef rame
(Yes, No, or Bibliographic Under ED5RA Section for Data
Partiallv) Citation 3(c)(2)(B)? Submission
(See Index)
Partially 00011965,00012014
05002415,05013194
05013216,05013598
Partially 00011950 , 00011957
Partially 00011949 , 00011953 ,
00011960,00011961,
00012035,00012181,
05012979,05015405,
05013352,05014422
Partially 00011952,00150369
Yes2/ 24 Months
Yes3/ 24 Months
Yes4-*5-/ 24 Months
Yes6-/ 24 Months
171-4 - Magnitude of Residue
in Plants
Citrus Fruits
- Dried pulp, molasses,
oil, and orange juice
TEP
Partially
00012015,00012232,
00013205,00145897,
00149184.
YesS/
24 Months
24 Months
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
Data Requirement
Qmcosition
Does EEAHave
Data to Satisfy
This Requirement?
(Yes, No, or
Bibliographic
Citation
IVUst Additional
Data Be Submitted Timef rame
Under ETERA Section for Data
3(cH2HB)? Submission
158.240 Residue Chemistry
171-4 - Magnitude of Residue
in Plants (cont'd)
Rue Fruits
- Ajples
- Dry ajple porace
and juice
Stone Fruits
- Peaches
Small Fruits
- Blueberries
- canebarries
- strawberries
Tree Nuts
- Pecans
TEP
TEP
TEE*
TEP
TEP
TEP
Partially 00070784,00012015,
00012402,00149184,
00157178
00012402,00128574,
00149184
00012039
05015405
00012097
Yes
Partially
Yes
YeslQ/
Reservedli/
Reserved^2/
Yes13y
Reserved^'
24
24
Partially 00012348
24Mztths
-------
Table A
Generic Data Requirements for Terbacil (cont'd.)
Data Requirement Ccmpositicn
158.240
171-4 -
171-4 -
Residue Chemistrv
Magnitude of Residue
in Plants (cont'd)
Nbngrass Animal Feeds
- Alfalfa forage/hay TEP
Miscellaneous
Caranodities
- Asparagus TEP
- Mint TEP
Spent hay and mint oil
- Sugarcane TEP
Molasses, bagasse,
and refined sugar
Crops Grown Solely for
Seed
- Grass forage/fodder/
hay TEP
- Rotational Crops TEP
Magnitude of the Residue T03U: or Plant
Does EEA Have
Data to Satisfy
This Requiranent?
(Yes, No, or
Partiallv)
Partially
Partially
Partially
Partially
No
No
Partially
Mjst Additional
Data Be Sutmitted Timef rame
Bibliographic Under FIFPA Section for Data
Citation 3(c)(2)(B)? Submission
00011959,00130415, Yes^6-/ 24 Months
00144089,00149202
00028524 Yesi2/ 24 Months
00012103,00012067 Yes^S/ 24 Months
00012179,00012180 Yes20'21/ 24 MDnths
00157178 Yes22/ 24 Months
w* ««*»
Yes 2&/ 24 Mxrths
00011963,00011945 Reserved^/ 24 Mxrths
in
Metabolites
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
158.240 Residue Chemistry Footnotes
Ln
oo
2/Tne same chemical identity data are required as under 158.150-190, with emphasis en impurities that could constitute residue
problems. Refer to Product Chemistry Data Requirements tables.
2/Oata depicting the uptake, distribution, and metabolism of ^-ring-labeled terbacil in or on apples and sugarcane. A
completely characterized test substance representative of technical terbacil used in cormercial formulations (including
impurities) must be used under conditions of normal agricultural practices and at rates sufficiently high to permit
characterization of 14C-residues. The identities of residues in mature plant parts must be determined and confirmed in order
to elucidate terminal residues. Quantitative data must also be provided. Representative samples fron the required
metabolism studies must also be analyzed using Method II in the BW, Vbl. n to ascertain that the method will adequately
recover and quantify all metabolites of concern. Tne registrant is urged to complete and sutntit all required plant
metabolism, studies prior to initiating field trials and processing studies.
3/iyfetabolism. studies characterizing the total terminal residue of terbacil in ruminants and poultry. Animals must be dosed
orally for a minimum of 3 days with uniformly ring-labeled [14C] terbacil fed in the diet at a level sufficient to mate
residue identification and quantification possible. Eggs and milk must be collected twice daily during the dosing period.
Animals must be sacrificed within 24 hours of the final dose. The distribution and identity of residues must be determined
and confirmed in eggs, milk, liver, kidney (except poultry), muscle, and fat. Representative sanples frctn these studies must
be analyzed using tfethcd II in the P?M, "fol. II to ascertain that the method is capable of adequately recovering and
identifying all residues of concern. Data depicting the nature of terbacil residues in swine will be required if the
required metabolism studies with ruminants and poultry reveal that the metabolism of terbacil differs from, that in the rats.
4/Representative plant and aniiTBl tissue samples bearing residues of terbacil and its metabolites A, B, and C must be subjected
to analysis by multiresidue protocols I and ni fran FPM \folume I. MiLtiresidue protocols I through IV are available from
the National Technical Infonration Service (NETS) under Order No. EB 203734/AS.
SyThe nature of the residue in plants and animals is not adequately understood. If the metabolism studies requested in the
sections "Qualitative Nature of the Residues in Plants" and "Qualitative Nature of the Residue in Animals" reveal the
presence of additional metabolites of concern, additional validation methods for data collection and tolerance enforcement
will be required.
jj/The sample storage conditions and intervals must be supplied for all required and previously submitted residue data for plant
and animal comodities. Storage stability data in support of previously submitted residue data are required for only those
samples deemed to be useful for tolerance assessment. Data are also required which depict the decline in levels of terbacil
residues of concern in cotmodities stored under the range of conditions and for the range in intervals specified. Crop
samples bearing measurable weathered residues or fortified with terbacil residues of concern and fortified meat and milk
sanples must be analyzed iirmediately after harvest or fortification and again after storage intervals that represent actual
residue sample storage conditions and allow for reasonable unforseen delays in sample analysis. In laboratory tests using
fortified sanples, the pure active ingredient and pure metabolites must be used. f£&«ver, if field weathered samples are
-------
Table A
Generic Data Requirements for Terbacil (corrt'd)
158.240 Residue Chemistry Footnotes (cont'd)
used, the test substance mast be a typical end-use predict. For additional guidance on conducting storage stability
studies, the Registrant is referred to an August 1987 Keition Document on the Effects of Storage Validity of Basticide
Residue Data available frcm NETS under order No. PB 88112362/AS.
I/Data depicting terbacil residues of concern in or on lemons, oranges, and grapefruits harvested at regular intervals
following a single directed spray soil application of the 80% WP fonrulation at 6.4 Ib ai/A conducted in California and at 8
Ib ai/A conducted in Texas (no lemon data required frcm Texas). Also, data must be submitted for oranges, grapefruit, and
lemons grown in Florida and treated tmce at 4 Ib ai/A. Data must depict the decline in. residues over a suitable range of
posttreatment intervals. In addition, the registrant must propose a Iffl based on the requested residue data and an
appropriate tolerance revision to cover all residues of concern, including metabolites A, B, and C.
3/Data depicting terbacil residues of concern in dried pulp, molasses, oil, and juice fron oranges bearing measurable,
weathered residues- It is recommaTded that an exaggerated rate greater than or equal to the highest theoretical
concentration factor be used. If residues concentrate in any of these processed comodities, an appropriate food/feed
additive tolerance must be proposed.
2/Data depicting terbacil residues of concern in or on apples (early maturing varieties must be included) harvested following a
dormant directed spray soil application at 3.2 Ib ai/A in 20 gal/A. Tests must be conducted in Washington, New York,
Michigan, and California which together represent approximately 70% of the U.S. apple production, if New York represents
Pennsylvania (7%) (Agricultural Statistics. USDA, 1986, p. 186). The registrant must propose an appropriate tolerance
revision to cover all residues of concern, including metabolites A, B, and C.
ID/Data depicting terbacil residues of concern in dry apple pomace and juice processed frcm apples bearing measurable, weathered
residues. It is recotmended that an exaggerated rate greater than or equal to the maximum theoretical concentration factor
be used. If the data indicate a potential for concentration in either commodity, the registrant must propose an appropriate
food/feed additive tolerance.
11/If the required storage stability data invalidate the available data for peaches pr additional residues of ccncern are
discovered in the required plant metabolism studies, additional data will be required.
12/If the required storage stability data invalidate the available data for blueberries or additional residues of concern are
discovered in the required plant metabolism studies, additional data will be required.
13/Residue data depicting terbacil residues of concern in or on blackberries harvested 70 days following a single application of
the 80% WP formulation at 1.6 Ib ai/A. Tests must be conducted in California (13%) and Oregon (76%) since these States
accounted for approximately 90% of the 1982 U.S. blackberry acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 370).
Ln
vo
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
14/Tf the required storage stability data invalidate the available data for strawberries gr additional residues of concern are
discovered in the required plant metabolism studies, additional data vail be required.
15/Data depicting terbacil residues of concern in or on pecans harvested at normal crop maturity following a single broadcast
soil application of the 80% WP formulation at 2.4 Ib ai/A in 30 gal/A made during the early seedling stage of weed growth..
Tests must be conducted in Georgia (41%) and Texas (18%), which accounted for approximately 50% of the 1987 U.S. pecan
production (Agricultural Statistics Board, NftSS, USDA, Crop Database, January 1988). A PHI must be proposed and reflected in
the submitted data.
Ig/Data depicting terbacil residues of concern in or on alfalfa hay harvested at normal crop maturity following a broadcast soil
application of the 80% WP formulation at 0.6 Ib ai/A, followed by an additional broadcast soil application made 50 days later
at 1.2 Ib ai/A. The final application must be made when regrowth or new growth is approxainately 2 inches in height.
Applications must be made using ground equipment in 20 gal/A. Tests must be conducted in New York or Pennsylvania since
these States are representative of the northeastern U.S. where this use is permitted. No additional data are required for
alfalfa forage unless the required storage stability data indicate that the available data are invalid gr. additional residues
of concern are discovered in the required plant metabolism studies.
12/rata depicting terbacil residues of concern in or on asparagus harvested 5 days following a single application of the 80% WP
formulation at 2.4 Ib ai/A. Tests must be conducted in California (49%) or Washington (35%) and Michigan (11%), since these
States accounted for approximately 95% of the 1986 U.S. asparagus production fifegetables,. 1986 Sumary, Agricultural
Statistics Board, NASS, USDA, June 1987, p. 18).
18/Data depicting terbacil residues of concern in or on mint hay harvested 60 days following postemergence broadcast application
of the 80% WP formulation at 1.6 Ib ai/A in 0.5 to 1 pt of surfactant/25 gal of spray. Tests must be conducted in Oregon,
Washington, and Wisconsin which represent the Pacific Northwest and Midwest regions where this use is permitted.
19./A processing study depicting terbacil residues of concern in spent hay and oil processed from mint bearing measurable,
weathered residues. It is recoranended that an exaggerated rate greater than or equal to the highest theoretical
concentration factors for mint hay and mint oil be used. If residues concentrate in any product, an appropriate food/feed
additive tolerance must be proposed. In lieu of data for spent hay, the registrant may propose a feeding restriction.
2Q/Data depicting terbacil residues of ooncem in or on sugarcane harvested at normal crop maturity following: (i) a single
preenergence broadcast application of the 80% WP formulation at 2 Ib ai/A (tests must be conducted in Hawaii and Puerto
Rico); (ii) a single broadcast application of the 80% WP fornulation at 3.2 Ib ai/A in the early spring, followed by a single
directed spray (layby) application applied immediately after the last cultivation at 0.4 Ib ai/A (tests must be conducted in
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
158.240 Residue Chemistry Footnotes (cont'd)
Louisiana) ; and (iii) a preanergence broadcast application of the 80% WP formulation at 1.6 Ib ai/A in the fall followed by a
second application in the spring at 1.6 Ib ai/A (tests imst be conducted in Texas) . A HE must be proposed for the layby
use in Louisiana which irust be supported by the submitted data. Also, the registrant nust propose an appropriate
tolerance revision to cover all residues of concern> including metabolites A, B, and C.
21/Since sugarcane forage is a raw agricultural connodity of sugarcane, a tolerance and a pregrazing interval must be proposed
for this camodity. Alternatively, the registrant may propose a restriction on the feeding of sugarcane forage to livestock.
22/A processing study depicting the potential for concentration of terbacil residues of concern in molasses, bagasse, and
refined sugar processed from sugarcane bearing measurable, weathered residues. It is reccranended that an exaggerated rate
greater than or equal to the highest theoretical concentration factor be used. If residues concentrate in any product,
appropriate food/feed additive tolerances nust be proposed.
23/Oata depicting terbacil residues of concern in or on grass hay and forage (Bermuda grass, bluegrass, and bromegrass or
fescue) harvested following a single broadcast soil application (made after seed harvest) of the 80% WP formulation at 1 Ib
ai/A. Application nust be made by ground equipment in 40 gal/A. A pregrazing interval for forage and a preharvest interval
for hay nust be proposed and reflected in the submitted data. Also, data for seed, seed screenings and straw (as a byproduct
of seed processing) collected at the next seed harvest following treatment must be provided. Tests must be conducted in
Oregon which is representative of this use. The registrant nust propose appropriate tolerances for terbacil residues of
concern in or on the forage, hay, seed, seed screenings, and straw of grass.
are required for representative crops from any crop groups which could be rotated from alfalfa f sainfoin and mint.
These data nust reflect an appropriate plant back interval and analysis for all terbacil residues of concern in mature
plant parts which may be used for food or feed. In addition, the data should involve the maxinum proposed registered uses
of typical end-use products on the subject crops as well as adequate geographical representation. Acceptable processing
studies may also be required. It is recoimended that the registrant(s) submit protocols for these studies for Agency
approval prior to initiation of any of the experiments.
25/Cn receipt of the data requested in the sections entitled "Qualitative Nature of the Residue in Plants and Animals, "
"Tfegnitude of the Residue in Plants," and "Storage Stability Data," the need for additional feeding studies will be
determined.
-------
Table A
Generic Data Requirarents for Terbacil
Data Recjuirenient
158.290 Environmental Fate
Deqr^pt-irn, Shytiefi — T;=ih
161-1 - Hydrolysis
Phctcceqradation
161-2 - In Water
161-3 - Cn Soil
161-4 - m Air
M5tabolisrn stiirHp^ — T^t?
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic aquatic
162-4 - Aerobic aquatic
Does EE&Have
Data to Satisfy
This Requirement?
Use (Yes, No, or
Composition Patterns Partially)
PAIRA A Yes
PAIRA A Yes
EMRA A Yes
RAIRA A NO
PAIRA A NO
IftIRA A NO
PAIRA N/A No
RAIRA N/A NO
Mjst Additional
Data Be Submtted
Bibliographic Under FTFRA Section
Citation 3(c) (2) (B)?
00011946, 41136301 No
00011946 NO
00160235 NO
Nbl/
Yes
Yes
N/A
N/A
Timeframe
for Data
Submission
24 Months
24 Months
Mobility •'frnfliftR
163-1 - Leaching
- Adsorption/Desorption
IMRA
Partially
00155104
Yes2/
12 Manths
-------
lable A
Generic Data Requirenents for lerbacil (cont'd)
Data Requirement
158.290 Ermrcnmsntal Fate
Mobility Stmfl'jpR frmh'ri}
163-2 - -Volatility (Lab)
163-3 - tolatility (Field)
Dissipation StJ'rHeR - Fie>ld
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long Term
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
165-3 - Irrigated Crops
165-4 - In Fish
Use
Ccncosition Patterns
TEP A
TEP A
TEP A
TEP N/A
TEP N/A
TEP A
IMRA A
TEP A
TEP N/A
PATRA A
Does EEA Kkve
Data to Satisfy
This Requirement?
(Yes, No, or
Partiallv)
No
No
No
No
No
No
Partially
No
No
Yes
rust Additional
Data Be Submitted
Bibliographic Under FLFRA Section
Citation 3(c)(2)(B)?
Kb!/
Nbi/
N/A
N/A
Yes4/
Protocol
Progress Rpt.
00011948 , 00011949 No5^
NO
N/A
00011947 No
Timeframe
for Data
Submission
48 Matths
6 Ncnths
l Year
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
Data Reouiranent
Concosition
Does Em Have
Data to Satisfy
This Requirement?
Use (Yes, No, or
Patterns Bartiallv)
Bibliographic
Citation
Mist Additional
Data Be Submitted Timef rame
Under FIFRA Section for Data
3(c) (2)(B)? Submission
158.290 Environmental Fate
Aocurculation Studies (cont'd)
165-5 - In Aquatic Nbntarget
Organisms TEP
158.440 Scarav Drift
201-1 - Droplet Size Spectrum TEP
201-1 - Drift Field Evaluation TEP
158.75 Other Exposure Data
Ground Water Monitoring Data TEP
A
A
No
NO
NO
N/A
121VCnths
24
Reserved?/
l/Terbacil is considered to be nonvolatile.
2/ftn aged leaching study is required for all major degradates of terbacil, including: 5-c±LLoro-6-inethyluracil; 3-tert-butyl-6-
methyluracil; 6-chloro-2 , 3-dihydro-3 , 3 , 7-trimethyl-5H-oxa7Olo (3,2-a)-jyrimidine-5-one; S-tert-butyi'S-chloro-e-
hydrcxymetnyluracil; and 6-chloro-2 ,3-dlhydrc^7-hydroxyniethyl-3 ,3-diinethyl-5H-Qxa7Olo(3 ,2-a)-pyrimidine-5-one.
J/Due to the persistence of terbacil, a short-term study is waived in favor of a long-term soil field dissipation study.
-------
Table A
Generic Data Requirements for Terbacil (cont'd.)
158.290 Environmental Fate Footnotes (cont'd.)
4/A 3-year study conducted in four different representative sites is required. Site locations must include Louisiana
(sugarcane), Texas (sugarcane) and twD apple (orchard) sites. Applications must be made at the maximum application rate as
specified by the product label. Protocols must be submitted and approved before initiating the study. Cte year progress
reports are required.
5/See footnote t 24 under Section 158.240 Residue Chemistry Table A.
f/TXe to the phytotoxic effects of this pesticide, these studies are required to assess the risk of drift to nearby plants.
I/A small-scale retrospective groijndwater mcnitoring study is reserved pending the results of the long-term field dissipation
study. This monitoring study may be required in order to evaluate the impact of long-term use of terbacil on groundwater in
typical and reasonable worst-case use environments. If the groundwater monitoring study is required, the registrant will also
be required to perform Pesticide Root Zone IVbdel (PRZM) model simulations for terbacil to help identify sites for a small-
scale retrospective ground water monitoring study. Prior to conducting the study, the registrant must sutmit a protocol for
conducting this study. Sampling should not be initiated without prior Agency approval.
Ul
-------
liable A
Generic Eata Requirements for Uerbacil
Data Reouirement Corpositicn
158.340 TbKicolcciy
Acute
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Testing
- Acute Oral - Rat TGAI
- Acute Dental TBftI
- Acute Inhalaticn - Rat 1GAI
- Eye Irritaticn - Ratbit TGAI
- Dermal Irritaticn -
Ratbit TGAI
- Dental Sensitizaticn -
Guinea Pig TGAI
- Acute Delayed
Nauroboxicity - Hen TGAI
Does EEAHave
Data to Satisfy Mast Additional
THis Requirarent? Data Be Sutmitted Timeframe
Use (Yes, Kb, or Bibliographic Under FIFRA. Section for Data
Patterns Partially) Citation 3(cH2HB)? Submission
A
A
A
A
A
A
A
Yes 00150946 Nb
Yes 00130945 Nb
Yes 00125700 Nb
Yes 00157179 NO
Nb NbV
Yes 00157180 Nb
NO Nb2/
Subchroiic Testing
82-1
82-2
- 90-Day Feeding
- Rodent TGAI
- NCairoojsnt OEM
- 21-Dav Dental THM
A
A
A
Yes 00068035 Nb
NO NO3-/
Yes 00125785,00148066 No
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
Data Reauirement GorDosition
158.340
Toxicology
Does EEAHave
Data to Satisfy Mist Additional
This Requirement? Data Be Submitted Timeframe
Use (Yes, Nb, or Bibliographic Under FURA Section for Data
I&tterns Bartiallv) citation 3(c)(2)(B)? SutnrLssicn.
Subchrcnic Testing (ccnt'd)
82-3 -
82-4 -
82-5 -
Chronic
83-1 -
-
-
83-2 -
-
-
83-3 -
-
_
90-Day Dermal TGAI
90-Day Inhalation TGAI
90-Day Neurotoxicity TGAI
Testing
Chrcnic Tbxicity
Rodent TGAI
Nbnrodent TGAI
Gncogenicity Study
Rat TGAL
Mouse TGAI
Teratogenicity
Rat TGAI
Rabbit TGM
A
A
A
A
A
A
A
A
A
Nb Nb4/
NO Nb4/
NO Nb4/
Nb Yes5/ 48 Months
Yes 00060851 Nb
Nb Yes5-/ 48 Months
Nb Yes 48 Months
.Yes 00050467 Nb
Yes 00150945 Nb
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
Data Rec
158.340
Chronic
juirement
Toxicology
Testing (cont'd)
Does EE& Have
Data to Satisfy
This Requirement?
Use (Yes, Nb, or
Coroosition Efcttems Partially)
Bibliographic
Citation
Mist Additional
Data Be Submitted
Under FTEKA Section
3(0 (2) (B)?
Timeframe
for Data
Submission
83-4 - Reproduction
Mutagenicity Testing
84-2 - Gene Mitation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
Special Testing
85-1 - General Metabolism
TGAI
TGAI
TGAT
TGAI
EAT or EAIRA
A
A
A
Yes
No
Yes
Yes
No
00060852
Nb
00150944
00150939,00155103
NO
NO
Yes
I/
12 Months
24 Months
I/Satisfied by 21-day dermal toxicity study.
2/Ierbacil is not an organophospnate, and available data at this tine do not reveal a neurotoxicological problem.
3/Satisfied by a chronic toxLcity study in dogs (MRIDtt 00060851).
4/These studies are not required at this tine.
5./A ccntrined chronic/oncogenicity study may be submitted to satisfy this requirement.
£/A gene nutation study (MRH# 00150943) was reviewed and classified as supplemental. This study was deemed supplemental due to
missing study pages and tables identified in the study.
rat netabolism study is currently under review (MRID 40104702).
CO
-------
liable A
Generic Data Requirements for Terbacil
Does EE&Have
Data to Satisfy Mist Additional
This Requirement? Data Be Sutmitted Timeframe
Use (Yes, No, or Bibliographic Under FIFRA Section for Data
Data Requirement Gcmpositicn Patterns Rartiallv) Citation 3(c)(2)(B)? Sutmission
158.490 Wildlife and. Aquatic Organisms
Avian and ftfcuuiHi i 3d Tsstitxr
71-1 -
71-2 -
-
-
71-3 -
71-4 -
71-5 -
-
Aquatic
72-1 -
_
_
Avian Acute Oral
Toxicity TG&I A
Avian Dietary I£$Q
Upland Game Bird IGAI A
Waterfowl 1GAT A
Wild Marrmal IGAI A
Avian Reproduction 1GAT A
Actual Field. Testing
Birds and Journals TEP A
Organisms Testing
Freshwater Fish K^Q
Wantwater T3M A
TEP A
Coldwater T3^I A
1EP A
Yes 00157177 No
Yes 00012346 NO
Yes 00012347, 00134343 No
NO No
NO Noi/
No Nol/
Yes 00138467 No
Yes 00025224 No
Yes 41197801 NO
Yes 00025223 No
-------
Table A
Generic Eata Requirements for Terbacil (cont'd)
Data Rec
158.490
Aouatic
72-2 -
72-3 -
__
-
—
72-4 -
-
-
72-5 -
piranait
Ccmcositicn
Use
Patterns
\Afiirjiife and Aquatic Qraanisms
Organisms Testing (cont'd)
Freshwater Invertebrate
t^SO
Estuarine and Marine
Organisms LCgQ
Mollusk
Fish
Crustacean
Fish Early Life Stage and
Invertebrate Life Cycle
Freshwater
Marine/Estuarine
Fish Life Cycle
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
A
A
A
A
Does EPA Have
Data to Satisfy
This Requirement?
(Yes, No, or Bibliogratgiiic
Bartiallv) Citation
Yes 41197802
No
NO
Yes 00012333
NO
NO
NO
Yes 00012332
No
NO
No
Must Additional
Data Be SutmLtted
Under FTFRA Section
3(c)(2HB)?
NO
NO
NO2/
No
Yes3-/
Reserved4/
NO2/
No
No
Reserved5-/
No
Timefrane
for Data
Sutmission
12 Months
—1
o
-------
Table A
Generic Data Requirements for Terbacil (cont'd)
Data Recmrgrent
Conpositicn
Does EE&Have
Data to Satisfy
This Requirement?
Use (Yes, No, or
Patterns Partially)
Bibliographic
Citation
Mjst Additional
Data Be Submitted Timaframe
Under FIFRA Section for Data
3(cH2HB)? Submission
158.490 WT i r^ i fe and Aquatic Organisms
Ac|uatic Qnxjcinisms Tg^tJ71? (cont'd)
72-6 - Aquatic Organism
AccutoiLation
72-7 - Simulated or Actual
Field Testing
- Aquatic Organisms
No
Nb
I/Due to the nontoxicity of this pesticide to avian species, this study is not required.
2/Requirenent satisfied with formulated product.
-3/A study had been sutmitted in response to 1982 RS and found to be unacceptable. A new study is required.
4/Reserved, pending evaluation of study using technical material.
5/Reserved pending evaluation of IVferine/Estuarine Fish IC50 study.
-------
Table A
Generic Data Requirements for Terbacil
Data Requirement
Composition
Does EEA Have
Data to Satisfy
This Requirement?
Use (Yes, Nb, or
Patterns Partially)
Bibliographic
Citation
Mist Additional
Data Be Submitted Timef rame
Under FIFRA Section for Data
3(cH2HB)? Submission
158.540 Plant Protection
Target Area Phvtotoxicitv-
121-1 - Target Area
PhytotoxLcity
Nbntarget Area Phvtotoxicitv
TIER I
122-1 - Seed Germination/
Seedling Hnergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
122-1 - Seed Germination/
Seedling Bnergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
Nb
NO
NO
NO
Nb
Nb
Nb
No
Yesl/
Yesl/
Reserved2/
Reserved2/
Reserved2/
12 Maoths
12 Maiths
12 IVtnths
N3
-------
Table A
Generic Data. Requirements for Terbacil (cont'd)
Ootosition
Does EEAHave
Data to Satisfy
This Requirement?
Use (Yes, Kb, or
Battems Bartiall)
Bibliographic
citation
Mast Additional
Data Be Sutmitted Timefrarre
Under FIFRA Section for Data
3(c) (2HB)?
158.540 Plant Protection
Ncntaraet Area Hiytotoxicity (cont'd)
TIER HI
124-1 - Terrestrial Field
124-2 - Aquatic Field
TGftl
OEM
A
A
NO
NO
Reserved2/
Reserved2/
I/Tier I testing is required due to aerial application.
2/Reserved, pending results of Tier I testing.
-------
liable A
Generic Data Requiranents for Terbacil (cont'd)
Data Reauiranent
S158.590 Nbntarget Insects
Does EEA Have
Data to Satisfy
Inis Requirement?
Use (Yes, No, or
Oil-position Batterns Bartiallv)
Mist Additional
Data Be Sutmitted
Bibliographic Under FIFRA Section
Citation 3(O(2)(B)?
Timeframe
for Data
Submission
141-1 - Hcney Bee Acute
Contact LD50
141-2 - Ifcney Bee - Ibxicity
Residues on
Foliage
141-4 - Honey Bee Subacut
Feeding Study
141-5 - Field Testing for
pollinators
T3M
TIP
IGNE
TEP
IMSHJI1S
Yes
No
No
No
142-1
142-2
- Acute' Ibxicity to
Aquatic Insects
- Aquatic Insect
Life Cycle Study
142-3 - Sinulated or
?ctual Field
Testing for
Aquatic Insects
NGMffipnRJ1 TK|S^tT 'IVSL'JJVp —
TEP
TEP
TEP
PRFTWTTRS M\D I&KAJ
A N/A
A N/A
A N/A
00009181
No
No
143-1 thur 143-3
TEP
N/A
-vl
-p-
-------
S158.590 Kbntaroet Insects
S158.590 - Nbntarqet Insects Footnotes
J"/ Eata from the acute contact test indicated low toxicity, no further testing is required at this time.
-------
Tables
Product-Specific Data Requirements for ManufacturingHJse Products Containing Terbacil
Does ETA. Have Data Must Additional
Ib Satisfy 'Bus Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
»ition No. or Partially) Citation 3(c)(2)(B)?
Tiiieframe
for Data
Part 158, Subpart C, Product Chemistry
Product Identity and Composition
61-1 - Product Identity MP
61-2 - Descripticn of Beginning MP
Materials and Manufac-
turing Process
Nbl/
Yes2/
61-3 - Discussion of Formation of
Impurities
MP
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of MP
Product Samples
62-2 - Certification of Ingredient MP
Limits
62-3 - Analytical Methods to
Verify Certified Limits
MP
RTysical and Chemical ChgT?cteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
Nbl/
Nbl/
Nbl/
Yes6-/
Yes?/
12 Months
12 Months
12 Months
12Mxtths
12 Months
12 Months
12 Months
12 Months
12 Months
-------
Table B
Product-Specific Data Requirenents for Marofactiiring-Use Products Containing Terbacil (cont'd)
Does EPA Have Data Must Additional
Tb Satisfy This Data Be Sutmitted Timefrane
Requirement? (Yes, Bibliographic Under FIFRA Section for Data
Data Reouirgnent Coiposition No. or Partiallv) Citation 3(c)(2HB)?
Part 158. Subparb Cf Product Chanistry
EfoysT,cgl and Gbgnic^.l, C^PT/^Qristics (cont'd)
MP Nbi/ Yes^/
63-7 - Density, Bulk Density,
or Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Agent
63-15 - Flamnability
63-16 - ExpOodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - MisciMlity
63-20 - Corrosion Characteristics
Other Requirejnents
64-1 - Subnittal of Samples
MP
MP
MP
MP
MP
MP
MP
MP
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
15 Months
-------
Table B
Eroduct-^ecific Data Requirements for I^fcozfacturing-Use Products Ctntaining Terbacil (cont'd)
I/Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Tnerefore, bibliographic citations for the old data are not applicable.
2/Ihe chemical name, nominal concentraticn, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient in each intentionally adrter] inert must be provided. For the active ingredients, the following must
also be provided: the product, cannon and trade names; the molecular, structural, and empirical formulas; the
molecular veight or veight range; and any experimental or internally assigned code numbers.
3/Oomplete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in viiich they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each, beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
4/A detailed discussion of all impurities that are or may be present at > 0.1%, based on tanwledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
5/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
vtoich a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
£/Upper and lower limits for the active ingredients and each intentionally adrtad inert, and upper limits for each
impurity present at > 0.1% (w/w) and each "toxicolcgically significant" impurity present at < 0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g.,
sample analysis using validated analytical procedures, quantitative estimated based on amounts of ingredients
used, etc.). Limits for impurities not associated with the active ingredient need be provided only if they are
considered to be of tcodcological significance, regardless of the concentration at which they are present.
Certification must be sutmitted on EEA Form 8570-4 Rev. 2-85.
00
-------
Table B
Product-Specific Data Requirements for INfemfacturing-Use Products Containing Terbacil (cont'd)
Part 158. Subpart C. Product Chemistry Footnotes (cont'd)
7/7\nalytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which, certified limits are required. Each method must be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
^/Enysicochemical characteristics (color, physical state, odor, melting point, specific gravity, solubility, vapor
pressure, dissociation constant, partition coefficient, pH, and stability) as required in 40 CER 158.190 and more
fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
3/Data required if the test substance is dispersible in water.
10/Data required if the product contains an oxidizing or reducing agent.
11/Data required if the product contains cartoustible liquids.
12/Ihe test must be conducted with the product in its cannercial package. Products must be tested for 1 year under
either of the following conditions: (i) at 20 or 25°C, and, if the package is permeable, at a relative
humidity of 50%; (ii) under warehouse conditions which reflect the expected storage conditions of the catmercial
product.
13/Deta. required if the product is a liquid.
14/Data required if the product is a liquid and is to be diluted with petroleum solvents.
•15/bata required if the product is potentially explosive.
-------
Table B
Product-Specific Data Requirements for ManLifac±uring-Use Products Ccntaining Terbacil
Data !
teouirement Gancositicn
158.340 Ibxicology
Acute
81-1
81-2
81-3
81-4
81-5
81-6
Testing
- acute Oral - Rat MP
- Acute Dermal MP
- Acute Irihalaticn - Rat MP
- Eye Irritaticn - Ratbit MP
- Dermal Irritaticn
- Ratbit MP
- Dermal Sensitizaticn
- Guinea Pig MP
Does EE&Have
Data to Satisfy
This Requirement?
Use (Yes, Kb, or Bibliographic
Patterns Rwtviaiiv) Citation
A Yes 00150946
A Yes 00130945
A Yes 00125700
A Yes 00157179
A NO
A Yes 00157180
Must Additional
Data Be Sutmitted Timef rame
Under ED5SA Section for Data
3(0 (2) (B)? Submission
No
No
No
NO
Nbi/
NO
I/Study satisfied under 158.135 Guideline Series 82-2 (21-Day Dermal).
oo
o
-------
Table C
Product-Specific Data Requirements for Bid-Use Products Containing lerbacil
Data Requirement
Does EPA Have Data Must
To Satisfy Ihis Data Be Submitted
Requirement? (Yes, Bibliographic Under FHE& Section
Cciiiiositicn No. or Partiallv) Citation
Timeframe
for Data
Sutmissicn
Part 158, Subpart Cr Product Chemistry
Product iy*-nfrlty and Caiposition
61-1 - Product Identity and EP
Composition
61-2 - Descripticn of Beginning EP
Materials and Manufac-
turing Process
61-3 - Discussion of Formation EP
of Impurities
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of EP
Product Samples
62-2 - Certification of EP
Ingredient Limits
Physical and Chemical Char^y^yii^tics
63-7 - Density, Bulk Density, EP
or Specific Gravity
63-12 - pH EP
63-15 - Flanmability EP
Yes2/
Yes5y
l2Maiths
12 Mxiths
12 Mxiths
12
12 Months
12 Months
12 Months
12 Months
CO
-------
Table C
Pra3uc±-Specific Data Requirements for Bid-Use Products Containing Terbacil
Part 158. Subcart C. Product- n-ignistrv Footnotes
I/Although product chemistry may have been sutmitted in the past, the Agency has determined that these data nust be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data nust be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/Ihe chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient in each intentionally added inert must be provided. For the active ingredients, the following nust
also be provided: the product, cannon and trade names; the molecular, structural, and empirical formulas; the
molecular weight or weight range; and any experimental or internally assigned code numbers.
^/Complete information must be provided regarding the nature of the process (batch or cxntinuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
4/A detailed discussion of all imparities that are or may be present at > 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any cxrrtamination during and
after production must be sutmitted.
5/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be sutmitted for each
analytical nethcd used. Required for products produced by an integrated system.
£/Upper and lower limits for the active ingredients and each intentionally arlfWl inert, and upper limits for each
impurity present at > 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/W) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g.,
sample analysis using validated analytical procedures, quantitative estimates based on amounts of ingredients
used, etc.). Limits for impurities not associated with the active ingredient need be provided only if they are
considered to be of toxicological significance, regardless of the concentration at vJiich they are present.
Certification must be sutmitted on EE& Form 857 Rev. 2-85.
I/Density or specific gravity, pH, and flammability information must be sutmitted for each product as part of the
Confidential Statement of Formula. Other physiccchemical characteristics (color, physical state, odor, melting
point, solubility, vapor pressure, dissociation constant, partition coefficient, and stability) as required in 40
CER 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, are not required at
this tire.
. 3/Bata required if the test substance is dispersible in water.
3/Data required if the product contains ccmbustible liquids.
oo
S3
-------
Table C
Product-Specific Data Requirements for EndHJse Products Ocntaining Terbacil
Data Reauirement Canposition
158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat wpl/
81-2 - Acute Dental WP
81-3 - Acute Inhalation - Rat WP
81-4 - Eye Irritation - Rabbit WP
Use
Patterns
A
A
A
A
Does EE&Have
Data to Satisfy
This Requirement?
(Yes, No, or Bibliographic
Partially) Citation
Yes 00150946
Yes 00130945
NO
No
Mist Additional
Data Be Submitted
Under FIERA Section
3(c)(2)(B)?
No
No
Yes
Yes
Timeframe
for Data
12 Mxrths
12 Maths
81-5 - Denial Irritation
- Rabbit
81-6 - Dental Sensitization
- Guinea Pig
WP
WP
1/80% wettable powder.
^/Requirement satisfied under 82-2 (21-Day Dermal).
No
No
No2/
Yes
12 M3nths
oo
to
-------
liable C
Product-Specific Data Requirements for End-Use Products Containing Terbacil
Does EEA Have
Data to Satisfy
Tnis Requirement?
Use (Yes, No, or
Bibliografhic
Must Additional
Data Be SutmLtted Timef rame
Under ETERA Section for Data
158.340 Tbxicolooy
Acute Testing
81-1
81-2
81-3
81-4
- Acute Oral - Rat wpl/
- Acute Dermal WP^/
- Acute Inhalation - Rat WP^/
- Eye Irritation - Rabbit WP^/
A
A
A
A
No
No
NO
NO
Yes
Yes
Yes
Yes
12*tnths
12 Maiths
12 Marths
12M3±hs
81-5 - Denial Irritation
- Rabbit
81-6 - Dental Sensitization
- Guinea Pig
Nb
No
Yes
Yes
12M3lthS
12 Maiths
I/Mixture of terbacil (40% active ingredient) and diuron (40% active ingredient).
oo
-------
Table A
Generic Data Requirements forlferbacil
Use
DOGS EEA
Have Data to
Satisfy This
Data.
GaTcositian I&ttems Reauiransit?
Must additional
Data Be Submitted. Tiitef rate
Bibliographic Under KLfcHA. Section for
Citation 3 (c) (2) (B) ? Submission
Sec. 158.390 Reentry Protection
132-1 - Foliar Dissipation IEP A
132-2 - Soil Dissipation TEP A
132-3 =nral Exposure IEP A
132-4 - lalat-ion DqxDsure IEP A
Nb
ND
ND
ND
Terbacil is applied pre-emergent or during crop dormancy.
oo
-------
II. LABELING APPENDICES
86
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 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
test. 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 156.10(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 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment 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 156.10(f)]
87
-------
SUMMARY-2
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
156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.10(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.
[40CFR 156.10(h)(1)(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 156.10(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 156.10(h)(1)(iii)]
88
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel. [40 CFR
156.10(h)(1)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning statements must be headed by the appropriate
hazard title. [40 CFR 156.10(h)(2)]
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 156.10(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 156.10(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 their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
89
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SUMMARY-4
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
classification 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.
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 156.10(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 required: "For retail sale to and use
only by Certified Applicators or persons under
their direct supervision and only for those uses
covered by the Certified Applicator's
Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use. If
you do so, you may include on the label uses
that are unrestricted, but you may not distinguish
them on the label as being unrestricted.
90
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SUMMARY-5
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 simultaneously.
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.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
91
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SUMMARY-6
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and appear
under the heading "Storage and Disposal" in the directions for
use. This heading must be set in the same type sizes as required
for the child hazard warning. Refer to Appendix II, STOR,
PEST/DIS, and CONT/DIS to determine the storage and disposal
instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue 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 156.10]
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.
92
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SUMMARY-7
IAHRT.TNG REQUIREMENTS OF THE FIFRA,. AS AMENDED
ITtM
1
2
3
4
5
6A
6B
7
7A
7B
1VXHRT, Ml J ;
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . , "
"Distributed bv . . .." 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.
U)
-------
SUMMARY-8
IABELING REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
8
8A
8B
TAKFTT. KTFMROT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicitv
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front nanel
All products
All products
in Categories
I, II, and III
All products
PIA<~EMENT ON TARFT,
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
WKKKKkKIl
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-9
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
IABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°OF
All restricted
products
All products
PR Notice 83-2
or as determined
bv the Aaencv
All products
All products
PLACEMENT ON LAKRT.
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
rt<££'EKKtU
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE11 must be same type size as
siqnal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
Ul
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§156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide product
shall bear a label containing the information specified by the Act and the
regulations in this Part. The contents of a label must show clearly and
prominently the following:
(i) The name, brand, or trademark under which the product is sold as
prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or person for
whom produced as prescribed in paragraph (c) of this section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph (e) of
this section;
(v) The producing establishment number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of this
section;
(vii) Warning or precautionary statements as prescribed in paragraph
(h) of this section;
(viii) The directions for use as prescribed in paragraph (i) of this
section; and
(ix) The use classification(s) as prescribed in paragraph (j) of this
section.
(2) Prominence and legibility, (i) All words, statements, graphic
representations, designs or other information required on the labeling by
the Act or the regulations in this part must be clearly legible to a person
with normal vision, and must be placed with such conspicuousness (as
compared with other words, statements, designs, or graphic matter on the
labeling) and expressed in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text shall
appear in the English language. However, the Agency may require or the
applicant may propose additional text in other languages as is considered
necessary to protect the public. When additional text in another language
is necessary, all labeling requirements will be applied equally to both the
English and other-language versions of the labeling.
(4) Placement of Label—fi) General. The label shall appear on or be
securely attached to the immediate container of the pesticide product. For
purposes of this Section, and the misbranding provisions of the Act,
"securely attached" shall mean that a label can reasonably be expected to
remain affixed during the foreseeable conditions and period of use. If the
immediate container is enclosed within a wrapper
96
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or outside container through which the label cannot be clearly read, the
label itust also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or sold.
(ii) Tank cars and other bulk containers—(A) Transportation. While
a pesticide product is in transit, the appropriate provisions of 49 CFR
Parts 170-189, concerning the transportation of hazardous materials, and
specifically those provisions concerning the labeling, marking and
placarding of hazardous materials and the vehicles carrying them, define the
basic Federal requirements. In addition, when any registered pesticide
product is transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to the
shipping papers, and left with the consignee at the time of delivery.
(B) Storage. When pesticide products are stored in bulk containers,
whether mobile or stationary, which remain in the custody of the user, a
copy of the label or labeling, including all appropriate directions for use,
shall be securely attached to the container in the immediate vicinity of the
discharge control valve.
(5) False or misleading statements. Pursuant to section 2(q) (1) (A) of
the Act, a pesticide or a device declared subject to the Act pursuant to
§162.15, is misbranded if its labeling is false or misleading in any
particular including both pesticidal and non-pesticidal claims. Examples of
statements or representations in the labeling which constitute misbranding
include:
(i) A false or misleading statement concerning the composition of the
product;
(ii) A false or misleading statement concerning the effectiveness of
the product as a pesticide or device;
(iii) A false or misleading statement about the value of the product
for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the pesticide
or device is recommended or endorsed by any Agency of the Federal
Government;
(vi) The name of a pesticide which contains two or more principal
active ingredients if the name suggests one or more but not all such
principal active ingredients even though the names of the other ingredients
are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false or
misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
97
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such a
qualifying phrase as "when used as directed;" and
(x) Non-numerical and/or comparative statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"; and
(C) "Pollution approved."
(6) Final printed labeling, (i) Except as provided in paragraph
(a) (6) (ii) of this section, final printed labeling must be submitted and
accepted prior to registration. However, final printed labeling need not be
submitted until draft label texts have been provisionally accepted by the
Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly onto glass
or metal containers or large bag or drum labels. Such reproductions must be
of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or trademark
under which the pesticide product is sold shall appear on the front panel of
the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through registration
or supplemental registration as an additional name pursuant to §162.6(b)(4).
(c) Name and address of producer, registrant, or person for whom
produced. An unqualified name and address given on the label shall be
considered as the name and address of the producer. If the registrant's
name appears on the label and the registrant is not the producer, or if the
name of the person for whom the pesticide was produced appears on the label,
it must be qualified by appropriate wording such as "Packed for ***,"
"Distributed by ***," or "Sold by ***" to show that the name is not that of
the producer.
(d) Net weicfot or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other materials and
shall be the average content unless explicitly stated as a minimum
quantity.
(2) If the pesticide is a liquid, the net content statement shall be
in terms of liquid measure at 68 degrees F (20 degrees C) and shall be
expressed in conventional American units of fluid ounces, pints, quarts, and
gallons.
(3) If the pesticide is solid or semisolid, viscous or pressurized, or
is a mixture of liquid and solid, the net content statement shall be in
terms of weight expressed as avoirdupois pounds and ounces.
(4) In all cases, net content shall be stated in terms of the largest
suitable unit, i.e., "1 pound 10 ounces" rather than "26 ounces."
(5) In addition to the required units specified, net content may be
expressed in metric units.
98
-------
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation unavoidable in
good manufacturing practice. Variation below a stated minimum is not
permitted. In no case shall the average content of the packages in a
shipment fall below the stated average content.
(e) Product registration number. The registration number assigned to
the pesticide product at the time of registration shall appear on the label,
preceded by the phrase "EPA Registration No.," or the phrase "EPA Reg. No."
The registration number shall be set in type of a size and style similar to
other print on that part of the label on which it appears and shall run
parallel to it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply recommendation or
endorsement of the product by the Agency.
(f) Producing establishment registration number. The producing
establishment registration number preceded by the phrase "EPA Est.," of the
final establishment at which the product was produced may appear in any
suitable location on the label or immediate container. It must appear on
the wrapper or outside container of the package if the EPA establishment
registration number on the immediate container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement— m General. The label of each pesticide
product must bear a statement which contains the name and percentage by
weight of each active ingredient, the total percentage by weight of all
inert ingredients; and if the pesticide contains arsenic in any form, a
statement of the percentages of total and water-soluble arsenic calculated
as elemental arsenic. The active ingredients must be designated by the term
"active ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate. Both
terms shall be in the same type size, be aligned to the same margin and be
equally prominent. The statement "Inert Ingredients, none" is not required
for pesticides which contain 100 percent active ingredients. Unless the
ingredient statement is a complete analysis of the pesticide, the term
"analysis" shall not be vised as a heading for the ingredient statement.
(2) Position of ingredient statement, (i) The ingredient statement
is normally required on the front panel of the label. If there is an
outside container or wrapper through which the ingredient statement cannot
be clearly read, the ingredient statement must also appear on such outside
container or wrapper. If the size or form of the package makes it
impracticable to place the ingredient statement on the front panel of the
label, permission may be granted for the ingredient statement to appear
elsewhere.
99
-------
(ii) The text of the ingredient statement must run parallel with
other text on the panel on which it appears, and roust be clearly
distinguishable from and must not be placed in the body of other text.
(3) Names to be used in ingredient statement. The name vised for each
ingredient shall be the accepted common name, if there is one, followed by
the chemical name. The common name may be used alone only if it is well
known. If no common name has been established, the chemical name alone
shall be used. In no case will the use of a trademark or proprietary name
be permitted unless such name has been accepted as a common name by the
Administrator under the authority of Section 25 (c) (6).
(4) Statements of percentages. The percentages of ingredients shall
be stated in terms of weight-to-weight. The sum of percentages of the
active and the inert ingredients shall be 100. Percentages shall not be
expressed by a range of values such as "22-25%." If the uses of the
pesticide product are expressed as weight of active ingredient per unit
area, a statement of the weight of active ingredient per unit volume of the
pesticide formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given shall be as
precise as possible reflecting good manufacturing practice. If there may be
unavoidable variation between manufacturing batches, the value stated for
each active ingredient shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical composition
significantly must meet the following labeling requirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear the
following statement in a prominent position on the label: "Not for sale or
use after [date]."
(ii) The product must meet all label claims up to the expiration time
indicated on the label.
(7) Inert ingredients. The Administrator may require the name of any
inert ingredient (s) to be listed in the ingredient statement if he
determines that such ingredient (s) may pose a hazard to man or the
environment.
(h) Warnings and precautionary statements. Required warnings and
precautionary statements concerning the general areas of toxicological
hazard including hazard to children, environmental hazard, and physical or
chemical hazard fall into two groups: those required on the front panel of
the labeling and those which may appear elsewhere. Specific requirements
concerning content, placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the child
hazard warning statement, the text required on the front panel of the label
is determined by the Toxicity Category of the pesticide. The category is
assigned on the basis of the highest hazard shown by any of the indicators
in the table below:
100
-------
t^T^l XlJhSA
3)
TnHlrtl LEfen
M
Eye effects
I
tptoand
infill »1i t«j
somjtoj
tb to and
.2ng/litar
Eb to and
200m3/hj
Qarrosive;
CCBDREll CCBCLuV
within? days
OtKLcity<
TT
Ikuu 50 Him
SOOng/hg
2na/litar
Ikon 200
thru 2000
rnmflHi cnscn T^^
within? days;
pyui«d \m fcr
7 days
at 72 hours
Tihmri/es
in
Item 500 thru
5000 yrT^gj
Run 2 thru
20 nryiito:
Ercxn 2000 thru
20,000
Nf CA H 1 KXll ^IHCSLlVf
TW»«ri>>1(k
within 7 days
M-i-Va-^o -in'ital \rn
at 72 hours
3V
5000 nn/far
JM wriynit**'
GtosateBC uidik
20,000
MiM cr fflifjit"
72 hours
(i) Human hazard signal word—(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "Poison."
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel
the signal word "Warning."
(C) Toxicity Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word "Caution."
(D) Toxicity Category IV. All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
101
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(ii) Child hazard warning. Every pesticide product label
shall bear on the front panel the statement "Keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicitv Category
I. A statement of practical treatment (first aid or other) shall
appear on the front panel of the label of all pesticides falling
into Toxicity Category I on the basis of oral, inhalation or
dermal toxicity. The Agency may, however, permit reasonable
variations in the placement of the statement of practical
treatment is some reference such as "See statement of practical
treatment on back panel" appears on the front panel near the word
"Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required
elsewhere on the label in accord with paragraph (h)(2) of this
section if they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be
overlooked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of Label Front Panel
in Square Inches
Above 10 to 15
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
102
-------
(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall
appear together on the label under the general heading "Precau-
tionary Statements" and under appropriate subheadings of "Hazard
to Humans and Domestic Animals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. The precautionary paragraph shall
be immediately preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary
statements. These statements must be modified or expanded to
reflect specific hazards.
TJxkdty
m
Bsceutknazy SLaLauals by ttxicLty Cabegcry
fatal (poisarus) if fwfllfHPrt [iiiaLad cr
tt r*.m\ rid VftfrXATyi Skin] . DO H0t liTMiln*
vapor [dust cr spray mist]. Do not get
in eyes, en skin, cr en dlottring. [Rent
stabBflEnt of practical. txBabnsnt
1
•fahfl if sanllrmyfl [inhaled CC
«flndlral Uihalffi thB Skin] . DO not bEEBthB
\repccs [dust cr sjxay mist]. Do not gat in
eyes, en skin, cr en clnHring. pEpx(riabE
Hannftfl. if sHBUaued [inhaled or Arerijud
tlrcctrft tte skin] . Arctid bDeathinj \opcts
[duster spray nrist]. flraid ccntact wLth
skin [eyescrcOcithing]. pnrrtn'ahe
sAA
pb pcEcautictEDy statanEnt
epa and skin <¥IIHJH [cr
skiniiritaticn]. Do not gat in e^es, on
skin, cr en clothing. Ifear tjrijj\ei* cr
shield and •"•HT»- gioucs tfan handling.
HatmCuL cr fetal if sHaUoNBd.
fir** aid stalnnat.
DO not
Causes eye [and skin]
get in eyes, en skin, cr en clothing.
Hann&a if s«BllcM9d. [T^pxpnate first
aid stabenEnt
Jvcdd. ccnbact wLth skin, eyes, cr cQothing.
In case of u.iJHi.i. inmsduitely fii»!*<
ejes cr skin with plenty of water. Oat
po pEBcauticnaY stabanants
(ii) Environmental hazards. Where a hazard exists to
nontarget 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. Examples of the hazard statements
and the circumstances under which they are required follow:
103
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(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD50 of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute 1>C$Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary LC50 of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
afl
at cc bakw 20 dagnaas F; if thera is
at any \eflvB cpeninj.
Fl
20 dagrees F and net owe 80
f^prfrgy^p f tllS fl?Jff^ QitelfiElCKl IL3 nCT"^ uBfl 2
inches Icng at a distance cf 6 inches firm the
fLane.
Ml othar pnessuriaBcl ccdbainec
i«frtfjH!****ily in**njff^"^fl*T fif^^njh^ i yiiTp^* tt**fHmp&»
:•___ *m**t~lM^u
lJjB> SfSOuKSf
Do not pi
iilt'4»iricu'- B^mallLk
CC
130 dagDaas F nay cause bursting.
ELannabla. Ocribebtsutierpreaguns, %epauay
^^Ty^ f]oat« SQBDC3* and ^p^^ fXaifi* Do KJV
ri^yj^^l^^ cf 3DQXX3C3Db8 CdxtaQJXCa t*3B'ii"i|c^ II ^ uO
tsqpaatuEes afcne 130 <.V»ji^ii» Finey
Do net use or
near beat cc cpen flame. Do net purtuce or
dncdnGEste
-------
(i) Directions for Use—(1) General requirements—(i)
Adequacy and clarity of directions. 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.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular"; and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for directions for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manufac-
turing processes, provided that:
(i) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2.) Adequate information, such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(3.) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4.) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the
labeling of pesticide products for which sale is limited to
physicians, veterinarians, or druggists, provided that:
(1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2.) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3.) The product is also a drug and regulated under the
provisions of the Federal Food, Drug, and Cosmetic Act.
(C) Detailed directions for use may be omitted from the
labeling of pesticide products which are intended for use only by
formulators in preparing pesticides for sale to the public,
provided that:
(1.) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable
105
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restrictions or limitations, and effectiveness of the product for
pesticide purposes;
(2.) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide
products involved;
(3.) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(4.) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the heading "Directions for
Use""
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment required.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in §162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops,
animals, objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
106
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may only be applied under the direct supervision of a certified
applicator who is physically present.
(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(1) and (2) of this
section. Any pesticide product for which some uses are class-
ified for general use and others for restricted use shall be
separately labeled according to the labeling standards set forth
in this subsection, and shall be marketed as separate products
with different registration numbers, one bearing directions only
for general use(s) and the other bearing directions for
restricted use(s) except that, if a product has both restricted
use(s) and general use(s), both of these uses may appear on a
product labeled for restricted use. Such products shall be
subject to the provisions of §162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use," and reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or mis-
leading statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in §162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a
summary statement of the terms of restriction imposed as a
precondition to registration shall appear. If use is restricted
to certified applicators, the following statement is required:
"For retail sale to and use only by Certified Applicators or
persons under their direct supervision and only for those uses
covered by the Certified Applicator's certification." If,
however, other regulatory restrictions are imposed, the Admi-
nistrator will define the appropriate wording for the terms of
restriction by regulation.
(k) Advertising. [Reserved]
[40 CF 28268, July 3, 1975; 40 FR 32329, August 1, 1975; 40 FR
38571, August 21, 1975, as amended at 43 FR 5786, February 9,
1978; amended at 53 FR 15952, May 4, 1988.
107
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PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extensionaway
is more than 18 inches
long at a distance of
6 inches from the valve
opening.
C. ATT. OTPKR
CONIAINERS
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.
Flammable. Contents
under pressure. Keep
from heat, sparks,
and flame. Do not
puncture or incinerate
the 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 °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.
108
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STOR-1
Heading:
All products are required to bear specific label instructions about
storage and disposal. Storage and disposal instructions must be
grouped together in the directions for use portion of the label under
the heading STORAGE AND DISPOSAL. Products intended solely for
domestic use need not include the heading "STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed. Each
registrant must develop his own storage instructions, considering, when
applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely affect
the container of the product and its ability to continue to function
properly. Requirements might include positioning of the container in
storage, storage or damage due to stacking, penetration of moisture,
and ability to withstand shock or friction.
3. Specifications for handling the pesticide container, including
movement of container within the storage area,proper opening and
closing procedures (particularly for opened containers), and measures
to minimize exposure while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled, and
precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
torage 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.
109
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PEST/DIS-1
PESTICIDE DISPOSAL
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients that
are Acute Hazardous Wastes or are assigned to Toxicity Category I
on the basis of oral or dermal toxicity, or Toxicity Category I
or II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is aviolation 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 RegionalOffice for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only roust bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
110
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, nars)
Non-aerosol products
(bacts)
Aerosol products
Do not reuse container (bottle, can, jar) .
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All 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
authorities.
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording) .
and how fiber drum may be reused.
ill
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III. BIBLIOGRAPHY APPENDICES
112
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Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in arriving
at the positions and conclusions stated elsewhere in the
Standard. Primary sources for studies in this bibliography have
been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections
from other sources including the published literature, in those
instances where they have been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study." In the case of published materials, this
corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to
identify documents at a level parallel to the published article
from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for
purposes of review, and can be described with a conventional
bibliographic citation. The Agency has attempted also to unite
basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or MRID,
number. This number is unique to the citation, and should be used
at any time specific reference is required. It is not related to
the six-digit "Accession Number" which has been used to identify
volumes of submitted studies; see paragraph 4(d)(4) below for a
further explanation. 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.
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.
113
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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 following 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.
114
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00009181 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499. (Unpublished study
received Jul 29, 1976 under 352-342; prepared by Univ. of Cali-
fornia—Riverside, Dept. of Entomology, submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C)
00011945 E.I. du Pont de Nemours & Company (19??) Terbacil: Poultry Feed-
ing Study: Residue Data—Tissues and Eggs. (Unpublished study
received on unknown date under 4F1428; CDL:098172-A)
00011946 Rhodes, R.C. (1975) Biodegradation Studies with 2-14C-Terbacil in
Water and Soil. (Unpublished study received Nov 25, 1975 under
4F1428; prepared in cooperation with Univ. of Delaware, College
of Agricultural Sciences, submitted by E.I. du Pont de Nemours &
Co., Inc., Wilmington, Del.; CDL:094842-A)
00011947 Rhodes, R.C. (1969?) Four Week Residue Studies with 2-14C-Terbacil
and Bluegill Sunfish. (Unpublished study received Nov 25, 1975
under 4F1428; prepared in cooperation with Cannon Laboratories,
Inc., submitted by E.I. du Pont de Nemours & Co., Inc., Wilming-
ton, Del.; CDL:094842-B)
00011948 E.I. du Pont de Nemours & Company (1975) Terbacil—Rotational Crop
Studies. (Unpublished study received Nov 25, 1975 under 4F1428;
CDL:094842-C)
00011949 Holt, R.F.; Pease, H.L. (1971?) Residue Procedure for the Determi-
nation of Terbacil and Its Metabolites Using Microcoulometric
Gas Chromatography. Undated method. (Unpublished study re-
ceived Nov 25, 1975 under 4F1428; submitted by E.I. du Pont de
Nemours & Co., Inc., Wilmington, Del.; CDL:094842-D)
00011950 Han, J.C. (1973?) 2-14C-Terbacil Goat Metabolism Study. (Unpub-
lished study received Oct 1, 1974 under 4F1428, submitted by E.
I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:
093805-B)
00011952 E.I. du Pont de Nemours & Company, Incorporated (1974) Freezer
Storage Studies: Terbacil-Metabolites. (Unpublished study re-
ceived Oct 1, 1974 under 4F1428; CDL:093805-E)
115
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00011953 Pease, H.L. (1971?) Confirmatory Procedure for Residues of Terbacil
and Its Metabolites. (Unpublished study received Oct 1, 1974
under 4F1428; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.; CDL$093805-F)
00011957 Rhodes, R.C. (1974?) Five-Dose 2-14C-Terbacil Goat Study—Residue
Analysis of Meat and Milk. (Unpublished study received Apr 25,
1975 under 4F1428; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, Del.; CDL:095530-A)
00011958 E.I. du Pont de Nemours and Company (1973) Name, Chemical Identity,,
and Composition: [Terbacil]. (Unpublished study received Aug
30, 1973 under 4F1428; CDL:093806-A)
00011959 E.I. du Pont de Nemours and Company (1973) Results of Tests on the
Amount of Residue Remaining on Treated Crops: [Terbacil]. Sum-
mary of studies 093806-C through 093806-L. (Unpublished study
received Aug 30, 1973 under 4F1428; CDL:093806-B)
00011960 Holt, R.F.; Pease, H.L. (1971?) Residue Procedure for the Determi-
nation of Terbacil and Its Metabolites in Alfalfa. Undated
method. (Unpublished study received Aug 30, 1973 under 4F1428;
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
Del.; CDL:093806-C)
00011961 E.I. du Pont de Nemours & Company, Incorporated (19??) Determina-
tion of Terbacil and Its Metabolites in Milk and Urine. (Unpub-
lished study received Aug 30, 1973 under 4F1428; CDL:093806-D)
00011963 E.I. du Pont de Nemours and Company (1968?) Terbacil: Livestock
Feeding Study—Milk and Meat. (Unpublished study received Aug
30, 1973 under 4F1428; CDL:093806-G)
00011965 Rhodes, R.C. (1964?) Studies with 14C-Labeled Terbacil in Alfalfa.
(Unpublished study received Aug 30, 1973 under 4F1428; submitted
by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:
093806-J)
11
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID
Citation
00012014 Rhodes, R.C.; Weed, M.B. (19??) Distribution of 2-14C-Labeled
Terbacil in Sugar Cane Following Injection. (Unpublished study
received Dec 13, 1966 under 6F0510; submitted by E.I. du Pont
de Nemours & Co., Inc., Wilmington, Del.; CDL:090603-M)
00012015 E.I. du Pont de Nemours and Company (1966) Results of Tests on the
Amount of Residue in Crops Grown on Treated Soil. (Unpublished
study received Dec 13, 1966 under 6F0510; CDL:090603-N)
00012035 Pease, H.L. (1964?) Determination of Terbacil Residues. Undated
method. (Unpublished study received Jun 30, 1966 under 6F0510;
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
Del.; CDL:092796-K)
00012039 IR-4 Project at Rutgers, the State University (1973) Results of
Tests on the Amount of Residue Remaining on Treated Blueberries:
[Terbacil]. (Unpublished study received Dec 19, 1975 under
6E1719; prepared in cooperation with DuPont Co.; CDL:095364-A)
00012067 E.I. du Pont de Nemours & Company (1975) Results of Tests on the
Amount of Residue Remaining on Treated Crops: [Terbacil]. (Un-
published study received Dec 3, 1975 under 6F1713; CDL:095184-C)
00012097 IR-4 Project at Rutgers, the State University (1972) Analytical
Residues: [Terbacil]. (Unpublished study received Mar 14, 1977
under 7E1936; CDL:097354-A)
00012103 E.I. du Pont de Nemours and Company (1966) Results of Tests on the
Amount of Residue in Crops Grown on Treated Soil: [Terbacil].
(Unpublished study received Nov 16, 1966 under 7F0549; CDL:
092838-B)
00012179 E.I. du Pont de Nemours and Company (1966) Sinbar Weed Killer Resi-
due Data—Sugar Cane: Supplemental Information. (Unpublished
study received Apr 13, 1966 under unknown admin, no.; CDL:
124198-A)
00012180 E.I. du Pont de Nemours and Company (1966) Sinbar Weed Killer (3-
tert-Butyl-5-chloro-6-methyluracil) Residue Data—Sugar Cane.
(Unpublished study received Feb 9, 1966 under unknown admin.
no.; CDL:124200-A)
117
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00012181 Pease, H.L. (19??) The Determination of Herbicide 732 Residues in
Citrus. Undated method. (Unpublished study received Feb 9,
1966 under unknown admin, no.; submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:124200-B)
00012232 California Citrus Research Center (1966) Residue Data: Terbacil—
Citrus. (Unpublished study received Feb 16, 1967 under 352-317;
submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
CDL:002958-M)
00012332 Bentley, R.E. (1973) Bioassay Report Submitted to E.I. du Pont de
Nemours & Company, Newark, Delaware: Sinbar Terbacil Weed Kill-
er, 80% Wettable Powder: Acute Toxicity of H-8309 to Grass
Shrimp (Palaemonetes vulgarist) and Fidder Crab (Uca pugilator).
(Unpublished study received Apr 11, 1974 under 352-317;prepared by
Bionomics, Inc., submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:129203-B)
00012333 Bentley, R.E. (1973) Bioassay Report Submitted to E.I. du Pont de
Nemours & Company, Newark, Delaware: Sinbar Terbacil Weed Kill-
er, 80% Wettable Powder: Acute Toxicity of H-8309 to Atlantic
Oyster (Crassostrea virginica). (Unpublished study received
Apr 11, 1974 under 352-317; prepared by Bionomics, Inc., sub-
mitted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:
129203-C)
00012346 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Acute Toxicity in
Wildfowl (Pheasant Chick). (Unpublished study received on
Jan 11, 1978 under 352-317; prepared by International
Research and Development Corp., submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:096709-B)
00012347 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Acute Toxicity in
Wildfowl (Pekin Duckling). (Unpublished study received on
Jan 11, 1978 under 352-317; prepared by International
Research and Development Corp., submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:096709-C)
00012348 E.I. du Pont de Nemours & Company (1977) Results of Tests on the
Amount of Residue Remaining on Treated Crops: [Terbacil]. (Un-
published study received Jan 11, 1978 under 352-317; CDL:
096709-D)
118
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID
Citation
00012364 E.I. du Pont de Nemours and Company (19??) Composition of Technical
Terbacil: Active Ingredient in Sinbar Weed Killer. (Unpublished
study received Nov 7, 1978 under 352-317; CDL:235690-A)
00012366 E.I. du Pont de Nemours and Company (19??) Purity of Starting and
Intermediate Materials Used in the Terbacil Manufacturing Proc-
ess. (Unpublished study received Nov 7, 1978 under 352-317;
CDL:235690-C)
00012402 E.I. du Pont de Nemours & Company (1973) Data Supporting the Use of
Zobar: I Weed Killer in Established Apples and Peaches.
Summary of studies 026721-B through 026721-Y. (Unpublished
study received Oct 17, 1973 under 352-374; CDL:026721-A)
00013205 E.I. du Pont de Nemours and Company (1966) [Results of Tests on the
Amount of Residue in Crops Grown on Treated Soil: Bromacil].
Summary of studies 090253-G through 090253-1. (Unpublished
study received Nov 15, 1966 under 6F0499; CDL:090253-F)
00025223 McCann, J.A.; Pitcher, F. (1972) [Sinbar Terbicil Weed Killer:
Toxicity to Rainbow Trout!: Test No. 520. (U.S. Environmental
Protection Agency, Pesticides Regulation Div., Agricultural Re-
search Center, Animal Biology Laboratory, unpublished report.)
00025224 McCann, J.A.; Pitcher, F. (1972) [Sinbar Terbacil Weed Killer:
Toxicity to Bluegill Fish]: Test No. 515. (U.S Environmental
Protection Agency, Pesticides Regulation Div., Agricultural Re-
search Center, Animal Biology Laboratory, unpublished report.)
00028524 Interregional Research Project No. 4 (1976) Terbacil Residue Data
Summary: Asparagus. (Unpublished study recevied Jun 11, 1980
under OE2371; CDL 099449-A)
00050467 Culik, R.; Wood, C.K.; Kaplan, A.M.; et al. (1980) Teratogenicity
Study in Rats with 3-tert-Butyl-5-chloro-6-methyluracil: Haskell
Laboratory Report No. 481-79. (Unpublished study received Aug
8, 1980 under 352-317; submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL:099540-A)
00060851 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1967) Two-Year Feeding
Study in the Dog: IRDC No. 125-011. (Unpublished study received
Apr 4, 1967 under 6F0510; prepared by International Research and
Development Corp., submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, Del.; CDL:090602-A; 090600)
119
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00060852 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1967) Three-Generation
Reproduction Study in the Rat: IRDC No. 125-012. (Unpublished
study received Apr 4, 1967 under 6F0510; prepared by Interna-
tional Research and Development Corp., submitted by E.I. du Pont
de Nemours & Co., Inc., Wilmington, Del.; CDL:090602-B; 090600)
00067336 Karrh, B.W. (1976) Letter sent to John E. Moss dated Oct 4, 1976
[Results of analyses of du Pont pesticides for dimethylnitrosa-
mines (DMN)]. (Unpublished study received Dec 8, 1976 under
352-378; submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:230783-A)
00068035 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1964) Ninety-day Feeding
Study in the Rat: IRDC No. 125-004. (Unpublished study received
May 20, 1981 under 352-317; prepared by International Research
and Development Corp., submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL:245112-D)
00070784 Stauffer Chemical Company (1980) Devrinol:4-F Selective Herbi-
cide: Summary of Crop Residue Data on Apples, Peaches, and Cit-
rus. (Compilation; unpublished study received Dec 11, 1980 un-
der 476-2199; CDL:243860-A)
00125692 Rhodes, R. (19??) Determination of N-Octanol-water Partition
Coefficients. (Unpublished study received Oct 9, 1982 under
352-317; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, DE; CDL:249455-A)
00125700 Burgess, B.; Ferenz, R.; Koechert, M. (1982) Inhalation Median
Lethal Concentration (LC50): [IND-732-38]: Haskell Laboratory
Report No. 351-82. (Unpublished study received Oct 9, 1982
under 352-317; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, DE; CDL:249455-J)
00125785 Hood, D. (1966) 15-exposure Skin Absorption Studies with 3-tert-
Butyl-5-chloro-6-methyluracil: Report No. 33-66. (Unpublished
study received Feb 15, 1983 under 352-317; submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, DE; CDL:249517-A)
00128574 E.I. du Pont de Nemours & Co., Inc. (1983) Results of Tests on the
Amount of Residue Remaining on Treated Crops: [Terbacil]. (Com-
pilation; unpublished study received May 25, 1983 under 352-317;
CDL:071628-A)
120
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00130415 E.I. du Pont de Nemours & Co., Inc. (1983) Residue Data: [Terbacil
and Others on Alfalfa]. (Compilation; unpublished study re-
ceived 1983 under 352-317; CDL:251051-B)
00130945 Hood, D. (1965) Acute Skin Absorption Toxicity: [3-tert-Butyl-5-
chloro-6-methyluracil: Rabbits]: Haskell Laboratory Report
No. 76-65. (Unpublished study received May 1, 1981 under un-
known admin, no.; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, DE; CDL:251081-C)
00134343 Hinkle, S.; Morre, S. (1979) Avian Dietary Toxicity (LC50) Study
in Mallard Ducks: H-12, 547-02: Project No. 201-520. Final rept.
(Unpublished study received Oct 16, 1979 under 352-317; prepared
by Hazleton Laboratories America, Inc., submitted by E.I. du
Pont de Nemours & Co., Inc., Wilmington, DE; CDL:241146-C)
00138467 E.I. du Pont de Nemours & Co., Inc. (1979) 96-Hour LC50 to Bluegill
Sunfish: [Uracil]: Haskell Laboratory Report No. 701-78. (Un-
published study received Oct 16, 1979 under 352-317; CDL:
241146-A)
00142302 E. I. du Pont de Nemours and Co., Inc. (1984) "Product Chemistry to
Support Terbacil Reregistration". Unpublished study. 27 p.
00144089 E.I. du Pont de Nemours and Co., Inc. (1984) Residue Data to Sup-
port Terbacil and Its Metabolities on Alfalfa at the Increased
Maximum Rate of 2 Lb/a/Yr by Split Application int he Northeast
U.S. Unpublished compilation. 11 p.
00145897 E.I. du Pont de Nemours & Co., Inc. (1985) Terbacil
ta :on Citrus:. Unpublished study. 12 p.
. Residue Da-
00148066 Hood, D. (1966) 15-Exposure Skin Absorption Studies with 3-tert-
Butyl-5-chloro-6-methyluracil: Report No. 33-66. Unpublished
report prepared by Haskell Laboratory for Toxicology. 36 p.
00149184 E. I. du Pont de Nemours & Co., Inc. (1985) Terbacil Residue Data.
Unpublished compilation. 38 p.
00149202 E.I. du Pont de Nemours Co., Inc. (1982) Du Pont Sinbar Weed Killer
Aerial Application—Alfalfa: Residue Data. Unpublished study.
8 p.
121
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00150369 E. I. du Pont de Nemours & Co., Inc. (1985) Terbacil/Metabolites
Freezer Storage Study: :Residue Data:. Unpublished study. 2 p.
00150939 E.I. du Pont de Nemours & Co., Inc. (1984) Unscheduled DNA Syn-
thesis/Rat Hepatocyctes in vitro [with Terbacil (IND-732-53)]:
Haskell Report No. 379-84. Unpublished study. 6 p.
00150944 Cortina, T. (1984) In vivo Bone Marrow Chromosome Study in Rats.
[with H# 14,673]: Final Report: Project Number: 201-723. Unpub-
lished study prepared by Hazleton Labs. America, Inc. 63 p.
00150945 Solomon, H. (1984) Embryo-Fetal Toxicity and Teratogenicity Study
of Terbacil by Gavage in the Rabbit: Medical Research Project
No. 4512-001: Haskell Report No. 528-83. Unpublished study pre-
pared by E.I. du Pont de Nemours & Co., Inc., Haskell Laboratory
for Toxicology and Industrial Medicine. 73 p.
00150946 Cortina, T. (1984) Acute Oral Toxicity Study in Rats: H #14,673:
Final Report: Project No.: 201-713. Unpublished study prepared
by Hazleton Laboratories America, Inc. 21 p.
00155103 McCooey, K. (1984) Unscheduled DNA Synthesis/Rat Hepatocyctes in
vitro: Haskell Laboratory Report No. 379-84:MR No. 4581-143.
Unpublished study prepared by E.I. du Pont de Nemours & Co.,
Inc.: Haskell Laboratory for Toxicology and Industrial Medi-
cine. 11 p.
00155104 Priester, T. (1985) Batch Equilibrium (Adsorption/Desorption) and
Soil Thin-layer Chromatography Studies with :2-Carbon-14: Ter-
bacil. Unpublished study prepared by E.I. du Pont de Nemours
& Co., Inc. 45 p.
00157177 Beavers, J. (1986) H #14,673: An Acute Oral Toxicity Study with the
Bobwhite: Final Report: Project No. 112-168. Unpublished study
prepared by Wildlife International Ltd. 17 p.
00157178 E. I. du Pont de Nemours & Co., Inc. (1986) Terbacil Registration
Standard Response: Additional Residue Data (Apples, Citrus,
Sugarcane). Unpublished compilation. 26 p.
122
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
MRID Citation
00157179 Gargus, J. (1985) Primary Eye Irritation Study in Rabbits: Haskell
No. 14,673: Final Report: Project No. 201-867. Unpublished
study prepared by Hazleton Laboratories America, Inc. 20 p.
00157180 Henry, J. (1986) Skin Sensitization Test of Terbacil (IND-732-53)
in Guinea Pigs for EPA Pesticide Registration: :Revised:: Rept.
No. 600-85: MR No. 4581-277. Unpublished study prepared by
Dupont Haskell Laboratory. 9 p.
00160235 Barefoot, A. (1986) Photolysis of Terbacil on Soil: Document No.
AMR-521-86. Unpublished study prepared by E. I. du Pont de
Nemours and Co., Inc. 63 p.
05012979 Pease, H.L. (1968) Determination of terbacil residues using
microcoulometric gas chromatography. Journal of Agricultural
and Food Chemistry 16(l):54-56.
05013194 Weierich, A.J.; Nelson, Z.A.; Appleby, A.P. (1977) Influence f
fonofos on the distribution and metabolism of 14C-terbacil in
peppermint. Weed Science 25(l):27-29.
05013216 Rhodes, R.C. (1977) Metabolism of [2-14C] terbacil in alfalfa.
Journal of Agricultural and Food Chemistry 25(5):1066-1068.
05013352 Cessna, A.J. (1977) Determination of terbacil in blueberries.
Journal of Agricultural and Food Chemistry 25(2):432-433.
05013598 Jordan, L.S.; Zurqiyah, A.A.; Clerx, W.A.; Leasch, J.G. (1975)
Metabolism of terbacil in orange seedlings. Archives of
Environmental Contamination and Toxicology 3(3):268-277.
05014422 Pease, H.L.; Leitch, R.E.; Hunt, O.R. (1978) Terbacil. Pages
483-492, In Analytical Methods for Pesticides and Plant Growth
Regulators and Food Additives. Vol. 10. Edited by G. Zweig
and J. Sherma. New York: Academic Press.
05015405 Holt, R.F.; Pease, H.L. (1977) Determination of terbacil and
metabolite residues using microcoulometric gas chromatography.
Journal of Agricultural and Food Chemistry 25(2):373-377.
41136301 Acher, A.; Saltzman, S.; Brates, N.; et al (1981) Photosensitized
decomposition of terbacil in aqueous solutions. J. Agric. Food
Chem. 29:707-711.
123
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Terbacil Standard
41197801 Smith, E.; Muska, C. Hartgrove, R. (1980) 96-hr LC50 to Rainbow
Trout. Haskell Lab. Report No. 058-783. E.I.
duPont de Nemours and Co., Haskell Laboratory, Newark, Delware.
3 p.
41197802 Natell, C. (1981) Data Evaluation of US EPA Terrestrial and Aquatic
Biology Unit Static Jar Test #2747: Toxicity of Terbacil Technical
to Daphina magna. Unpublished review. 5 p.
124
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IV. FORMS APPENDICES
125
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Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
'RODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test 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, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(6)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I enclose a completed "Certification 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 registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-821
126
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Forni AoofOtfed. OMB No. 2070-O057 ExoJras 11-3O-89
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessaiy. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to shara in the cost of developing, the following required
items or data:
3. My 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
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
However, none of those firm(s) accepted my offer.
DATE OF OFFER
4. My firm requests that EPA not suspend the registration (s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. 1 understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) 1 give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE DATE
EPA Form 85804 (10-82)
127
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US Environmental Protection Agency Registration Standard for:
Washington, DC 20460
AFPA Product Specific
wtrj-i Dgta Rer Qrt
Registration
Guideline No.
Sec. 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
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
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
Stability
Oxidizing/reducing reaction
Flammabilrty
Exptodabiirty
Storage stability
Viscosity
MistibilHy
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxterty, rat
Acute dermal toxtetty, rabbit
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensltaatton
Testing not
required for my
product listed
above
(Check below)
EPA Registration Number
1 am complying with
Data Requirements by -
Citing MR ID No.
Submitting Data
(Attached)
(Check betow)
Form Approved
OMB #2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
Certification
1 certify that the statements 1 have made on this form and all attachments thereto are
true, accurate, and complete. 1 acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Name and Title
Signature
Date
EPA Form 8580-4 (R«v. 5-88) Previous edition is obsolete.
128
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CMB Approval No. 2070-0057
ES^xLraticn Date 10/30/89
(2NERIC DMA EXEMPEKN SEKHMENT
ERA. Product Registration Nuntoer:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the teams of the Notice from ERA dated
ocncerning a requirement for submissicn of •'generic" data on the active
ingredient _ named under FEFRA Section 3(c) (2) (B) .
(2) My firm requests that ERA not suspend the registraticn of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the product
ccntains the active ingredient solely as the result of the incorporaticn into the product
of another product which ccntains that active ingredient, which is registered under EEE8&
Section 3, and which is purchased by us from another producer.
(3) An accurate Ctnfidental Statement of Fbnrula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by coipany name,
registraticn number, and product name, the source of the subject active ingredient in my
firm's product, or
CSF dated _ en file with ERA is ocnplete, current and accurate and
ccntains the informaticn requested en the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are _
and their registraticn ruiber(s) is/are _ .
Mf firm will apply for an amendment to the registraticn prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any tine any portion of
this Statement is no longer true, or if my firm fails to cotply with the undertakings made
in this Statement, my firm's product's registraticn may be suspended under EEFRA Section
3(c)(2)(B).
(5) I further understand that if ny firm is granted a generic data exemption for the
product, my firm relies on the efforts of other perscns to provide the Agency with the
required generic data. If the registrant(s) who have cormitted to generate and submit the
required data fail to take appropriate steps to meet raqjiippmaibi* or are no longer in
compliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in catpliance and will normally initiate proceedings to suspend "the
registraticns of ity firm's product(s) and their product(s) , unless ny firm ccranits to
submit and submits the required data in the spydfj«=d tine frame. I understand that, in
such cases, the Agency generally will not grant a time extensicn for submitting the data.
Registrant's authorized repre9entative:__ _
(Signature
Dated:
(typed)
ERA Form 8570-3
129
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