EPA
UnittdSUtM
EiwJronimnttl Protection
Agency
Off iot of
Pwttekte* and Toxic Subrtancw
Waihinaton DC 20460
PMicidM
Guidance for the
Reregistration of
Pesticide Products
Containing PROPAZ INE
as the Active Ingredient
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OMB Control No. 2070-0057
Expires November 1989
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PROPAZINE
OPP Chemical Code 080808
AS THE ACTIVE INGREDIENT
CASE NUMBER 0230
CHEMICAL ABSTRACTS SERVICE NUMBER: 139-40-2
DECEMBER 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
C. Background
III. Agency Assessment 6
A. Summary
B. Toxicological Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 13
A. Regulatory Position and Rationale
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Labeling
V. Products Subject to this Standard 15
VI. Requirement for Submittal of Generic Data 17
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Registrant requests regarding data
requirements and Agency responses
F. Test protocols and standards
G. Procedures for requesting a change in protocol
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements
J. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submittal of
Product-Specific Data 24
VIII. Requirement for Submittal of Revised Labeling ... 25
IX. Instructions for Submittal 26
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate Products
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APPENDICES
I. DATA APPENDICES 29
Guide to Tables
Table A
Table B
II. LABELING APPENDICES 54
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES 79
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES 89
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
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a. i.
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
LC50
LD50
LEL
MPI
MRID
MP
Acceptable Daily Intake. Also known as the
Reference Dose or RfD.
Active ingredient
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
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 Effect Level
Maximum Permissible Intake
Master Record Identification (number). EPA's
system of recording and tracking studies submitted
to the Agency.
Manufacturing Use Product
111
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NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts per million
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing an
active ingredient subject to this standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request,1 focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
conclusions from available data in its files pertaining to
the pesticide active ingredient. However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end use products that
contain the active ingredient. The Agency will apply the
provisions of this Registration Standard to end use products
if necessary to protect man and the environment.
The scientific reviews 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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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submittal of data in support of product
registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI)
provisions of FIFRA sec. 3(c)(2)(B) to require that
registrants submit data to answer our questions regarding the
chemical, toxicological, and environmental characteristics
and fate of a pesticide. This Registration Standard lists the
data EPA believes are necessary to resolve our concerns about
this pesticide. These data are listed in the Tables A, B, and
C in Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in
issuance by EPA of a Notice of Intent to Suspend the affected
product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
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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
Common Name: Propazine
Chemical Name: 2-chloro-4 ,6-bis( isopropylamino) -s-triazine
Chemical Abstracts Service (CAS) Number: 139-40-2
OPP Chemical Number: 080808
Molecular Weight: 229.7
Empirical Formula:
Trade Name(s): Milogard®, Gesamil®, Milo-Pro, Pramitol,
Prozinex
Physical State: Crystalline solid
Color: Colorless
Odor: Odorless
Melting Point: 212 to 214°C
B. USE PROFILE
Type of Pesticide: Herbicide
Pests Controlled: Grassy and broadleaf weeds
Registered Uses: Terrestrial food crops and nonfood crop
areas
Predominant Use: >99 percent is used on sorghum
Mode of Activity: Inhibition of cell division and
photosynthesis
Formulation Types: Wettable powders (90 to 26.6 percent active
ingredient); flowable concentrates (44.5 to 18.7 percent
active ingredient); soluble concentrate liquid (43 percent
active ingredient)
Method of Application: Preplant or preemergent, as a spray
by ground or aerial equipment
Application Rates: 1 to 2 pounds active ingredient per
acre; however, as much as 3.2 pounds active ingredient
per acre may be used on certain fine textured or highly
organic soils for sorghum and from 1.6 to 13.3 pounds
per acre for nonfood crop areas
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C. BACKGROUND
Three Data Call-in (DCI) Notices have been issued for propazine.
The first, in August 1983, required chronic toxicity data.
Studies submitted in response to this DCI have been reviewed
and are discussed in this document. Many of the submitted
studies were unacceptable and additional chronic data continue
to be required.
In July 1984, the Agency issued a DCI Notice for groundwater
data for propazine. This Notice was issued for chemicals
which may have the potential to contaminate groundwater based
on such factors as the chemical's structure, solubility and
use patterns.
Based on the Agency's review of the data submitted in response
to the July 1984 DCI, it was determined that propazine and/or
its degradate(s) do have the potential to leach into groundwater
However, the Agency decided that additional data were needed to
define further the extent of the groundwater problem, and, in
April 1988, issued the third DCI Notice. This Notice required
a small-scale retrospective groundwater monitoring study on
propazine.
Based on its potential to contaminate groundwater, propazine
has been included in EPA's National Pesticide Survey.
In response to the 1988 DCI Notice, the manufacturer of
propazine, Ciba-Geigy, elected to cancel its registrations of
propazine. To date, no other registrant has committed to
generate data required by that Notice. All products have
either been cancelled or suspended.
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Til. AGENCY ASSESSMENT
A. SUMMARY
Based on a review of the available data on propazine, the
Agency has reached the following conclusions regarding this
chemical. These data are discussed in more detail in the
following sections.
1. Propazine has low acute toxicity. It is not teratogenic
in the rat. It is, however, oncogenic and the Agency has
classified propazine as a Group C oncogen (potential
human carcinogen) based on positive findings in the rat.
2. Propazine has been designated as a chemical with a high
potential for leaching into groundwater and is included in
the EPA National Pesticide Survey.
3. The Agency will not, at this time, formulate specific
regulatory positions regarding propazine unless a registrant
commits to generate data in support of this chemical.
B. TOXICOLOGICAL ASSESSMENT
The Agency has reviewed the available acceptable toxicological
data for propazine. The results of that review are set forth
below:
ACUTE TOXICITY. Propazine has low acute oral toxicity, with
an LD5Q for rats of >5 g/kg (Toxicity Category IV). It has
moderate acute dermal and inhalation toxicity, with an acute
dermal LD5Q of of >2 g/kg for rabbits (Toxicity Category III)
and an acute inhalation LC5Q of >2.1 mg/L/4 hour for rats
(Toxicity Category III).
Propazine is moderately irritating to rabbit eyes. No corneal
opacity was observed but some conjunctival irritation was
observed at 24 hours with clearing by day 4 (Toxicity Category
IV). It is moderately irritating to rabbit skin demonstrating
a Primary Irritation Score of 3.9/8.0 with erythema, eschar,
and edema. Improvement was noted by 72 hours. (Toxicity
Category III)
SUBCHRONIC TOXICITY. No acceptable subchronic studies are
available. However, because an acceptable chronic rat study
is available and a nonrodent chronic study is required, oral
subchronic studies are not required.
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Since the use-of propazine would result in repeated human
skin contact, but of a limited frequency and duration, a
21-day dermal toxicity study is required. Other subchronic
studies are not required.
CHRONIC TOXICITY. Sufficient data are available to satisfy
the data requirements for a chronic feeding study in a rodent
species (rat). A chronic feeding study in nonrodents is
required.
In the rat study, 60 male and 60 female CD rats/dosage level
were given 0, 3 ppm (0.15 mg/kg/day), 100 ppm (5.0 mg/kg/day),
and 1000 ppm (50 mg/kg/day) of propazine in their diets for 2
years. Generally, there were no treatment-related toxicity
signs, or changes in hematology, clinical chemistry, or
urinalysis. Body weights of both males and females of the
high-dose groups were significantly decreased in comparison
to controls, as well as mean food consumption. There was an
increase in subcutaneous masses and nodules in females of the
1000 ppm dose group which correlated with the increased
microscopic findings of mammary gland tumors (see below).
The systemic NOEL was designated as 100 ppm based on the
depression in body weights in the high-dose male and female
groups.
ONCOGENICITY. There are sufficient data available to satisfy
the data requirements for oncogenicity studies.
In the rat study (discussed above), gross necropsy showed an
increase in subcutaneous masses and nodules in females of the
1000 ppm dose group, which correlated with an increase in
mammary neoplasms. These neoplasms included benign tumors
(adenomas, fibroadenomas) and malignant tumors (adenocarcinomas,
papillary carcinomas).
In a mouse study, 60 male and 60 female CD-I mice/dosage
levels were given 0, 3 ppm (0.45 mg/kg/day), 1000 ppm (150
mg/kg/day, and 3000 ppm (450 mg/kg/day) of propazine in their
diets for 2 years. Propazine was not found to be oncogenic
in this study. There were increased incidences of non-
neoplastic lesions in high-dose males of hemosiderin-laden
macrophages and in high dose females of myocardial degeneration.
The systemic NOEL was 1,000 ppm.
In accordance with the Agency's Guidelines for Assessing
Carcinogenic Risk, EPA has classified propazine as a Group C
compound (potential human carcinogen). This classification
is based on the following:
In the rat study, female rats developed benign and malignant
mammary tumors. A statistically significant dose-related trend
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was found for malignant and benign tumors, combined, and a
statistically significant pairwise comparison was found
for high dose vs. control for malignant and benign, combined.
Although these tumors were significant only at the high dose,
at which the maximum tolerated dose was apparently achieved
or slightly exceeded, the Agency believes that they were,
nevertheless, convincing since the increase in these tumors
in females at the high dose exceeded that of historical
controls.
Structure activity on related triazines provides support
for the association of mammary tumors with this class of
chemicals. Propazine is structurally related to simazine,
cyanazine, atrazine and terbutryn. Atrazine and terbutryn
have both been classified as Group C oncogens (mammary tumors
in rats).
Propazine induced a dose-related, positive response (without
metabolic activation) in Chinese hamster cells (and a weak
non-dose-related one with activation). Propazine was negative
in a nucleus anomaly assay and in a DNA damage/repair assaay
in rat hepatocytes.
Propazine was negative for oncogenicity in mice. For
malignant lymphomas in females, multiplicity of tumors per
animal (tumor load) was enhanced relative to dose. This
suggests that increased or enhanced metastatis factors may be
operating in the mouse.
Although the Agency determined that a Group C classification
is appropriate for propazine, EPA has concluded that quanti-
tative risk assessment is not warranted. This conclusion is
based on the fact that the tumors observed in the rat study
occurred in only one sex, were mostly benign, and were
significantly increased only at the highest dose.
TERATOGENICITY. There is an acceptable teratogenicity study
in the rat. A developmental toxicity study in a second
species (rabbit) is required.
In the rat study, propazine was administered to groups of 25
female Sprague-Dawley rats at dosage levels of 0, 10, 100
and 500 mg/kg/day. It was not teratogenic at dosages up to
500 mg/kg/day, the highest dose tested (HOT). Maternal
toxicity was observed in the mid- and high-dose females as
decreased food consumption and decreased body weight gain.
Additionally, high-dose females exhibited periods of sali-
vation (clear) during gavage. The NOEL for maternal toxicity
was 10 mg/kg/day.
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Developmental toxicity was observed at the high dose as
increased 14th ribs, incomplete ossification of skeletal
structures and decreased fetal body weight. At the mid-dose,
delayed ossification of the interparietals was observed. The
NOEL for developmental toxicity was 10 mg/kg/day.
REPRODUCTION. There are sufficient data available to satisfy
the requirements for a reproductive toxicity study for propazine.
In a three-generation, 2-litter per generation, study, male
and female CD rats were continuously given propazine in
their diets at dosage levels of 0, 3 ppm (0.15 mg/kg/day),
100 ppm (5 mg/kg/day), and 1000 ppm (50 mg/kg/day). No
compound-related effects for clinical signs or mortality were
observed during the study.
At the 1000 ppm dosage level, a depression in body weight was
observed in both male and female parental animals. Food
consumption was reduced at the high dose in the Fg and F2
females and at all dosage levels of the F]_ and F2 male groups.
No compound-related effects in male or female fertility, gestation
length, pup viability, and pup survival were observed. Mean
body weights of male and female pups at day 21 of lactation
were significantly reduced at 1000 ppm in the F^, F2a, F2b'
F3a, and F3b litters. Altered absolute or relative organ
weights were observed in all parental groups at the high dose
level. Fg males showed an increased relative testicular and
relative heart weight, F]_ males displayed an increased relative
liver and heart weight, and F2 males and females had decreased
absolute liver weights while the F2 males had decreased
relative liver weight, relative testicular weight, and kidney
weight. No histological findings attributable to propazine
were observed in parental or weanling animals. The reproductive
NOEL is 100 ppm, based on the depression in pup weights at 21
days postpartum in the FIJ-,, ?2a' F2b' F3a' and F3b litters.
MUTAGENICITY. There are sufficient data available to satisfy
the mutagenicity data requirements.
In a gene mutation assay, propazine was tested in V79 Chinese
hamster cells with and without microsomal activation. It
produced a dose-related positive mutagenic response without
metabolic activation and a weak (non-dose-related) positive
response with metabolic activation.
In a structural chromosomal aberration assay, propazine was
administered in the diet to groups of six male and six female
Chinese hamsters. The cells displaying anomalies on nuclei
in treated cells did not differ significantly from the negative
controls. Propazine was not considered mutagenic in this
assay.
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DNA damage/repair assays were performed on rat hepatocytes
with propazine. The mean number of silver grains per nucleus
in the vehicle control and treated cells was not markedly
different. Propazine was not mutagenic under the conditions
of this assay.
METABOLISM. There are no acceptable metabolism studies;
a general metabolism study is required.
C. OTHER SCIENCE FINDINGS
ECOLOGICAL EFFECTS. The Agency has limited ecological effects
data.
Based on an acceptable fish acute toxicity study on
technical propazine, with an LC5Q of 16.5 ppm for Rainbow
trout, propazine can be characterized as slightly toxic to
coldwater fish.
In the partially acceptable avian dietary study with a
formulated product, an LC5Q of 32000 ppm was reported for
Mallards, which indicates that the compound is practically
nontoxic for waterfowl. There are, however, currently no
requirements for studies on formulated products.
There are sufficient data to characterize propazine as
relatively nontoxic to honey bees when bees are exposed to a
direct treatment.
Based on use patterns, estimated concentrations and the
available toxicity data, EPA has determined that the use of
propazine will not pose a hazard to endangered wildlife (fish
and avian) or plants.
ENVIRONMENTAL FATE. Available data are insufficient to fully
assess the environmental fate of propazine.
In an acceptable aerobic soil study, propazine degraded with
a half-life of 12-24 weeks in nonsterile loamy sand soil
incubated in the dark at 25°C. In sterile loamy sand soil,
propazine degraded with a half-life of 8-12 weeks in the
dark at 25°C.
In an acceptable anaerobic soil study, propazine degraded
with a half-life of 8 weeks in nonsterile loamy sand soil
incubated anaerobically in the dark at 25°C following 4 weeks
of aerobic incubation.
In an acceptable leaching and absorption/desorption study,
propazine was mobile in sandy loam, loam, and clay loam soils,
and was very mobile in loamy sand soil.
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The following information is based on studies which, while
not acceptable for fulfilling data requirements, do provide
supplemental information on propazine:
Propazine was stable to hydrolysis during 28 days of incubation
at 30°C in aqueous solutions buffered at pH 7 and 9. In the
pH 5 buffered solution, the half-life was >28 days. It was
relatively stable to photolysis in aqueous solutions irradiated
with natural sunlight.
Propazine was very mobile in loamy sand and loam soils;
mobile in sandy loam, silt soils, and sand soil; and slightly
mobile in loam soil.
Propazine dissipated with a half-life of OO-149 days and <31
days in sandy loam soil in tests conducted in two different
locations. It dissipated with a half-life of 60->357 days in
silt loam soil.
Groundwater. Based on the available data, propazine is
persistent, moderately mobile and stable to hydrolysis,
photolysis and microbial degradation, demonstrating a potential
to contaminate groundwater. Propazine has been detected in
groundwater samples in a total of 8 states. The maximum
concentrations found were 20 ppb in surface water and 300 ppb
in groundwater.
Reentry. Based on the low acute toxicity of propazine and
its use patterns, the Agency finds that reentry data are not
required.
Spray Drift. No data are available to evaluate the spray
drift potential of propazine and data are required.
PRODUCT CHEMISTRY. EPA has evaluated the available data
which identify the ingredients, materials and manufacturing
process and provide information on the physical and chemical
properties of propazine. Since propazine is a secondary
amine, there is a concern regarding potential for nitrosoamine
contamination. However, currently available data
are insufficient to thoroughly evaluate this potential
contamination.
D. TOLERANCE REASSESSMENT
Tolerances have been established for negligible residues of
propazine in or on sweet sorghum and its fodder, forage and
grain at 0.25 ppm (40 CFR 180.243).
EPA has evaluated the residue data supporting these tolerances.
The results of this evaluation follow.
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Residue Data. The nature of the residues in both plants and
animals are not adequately understood. Additional data are
required. Data on storage stability are unavailable. Adequate
analytical methods are available for data collection pertaining
to residues of propazine. Additional methods may be required
if metabolism studies indicate that additional metabolites
constitute residues of toxicological concern in plants or
animals.
Sufficient data are available to ascertain the adequacy of
the established tolerances for residues of propazine in or on
sorghum fodder, sorghum forage, sorghum grain, and sweet
sorghum. However, processing studies are required for grain
sorghum and sweet sorghum.
There are no Canadian, Mexican or Codex MRL tolerances for
sorghum; therefore, no compatibility questions exist.
Toxicology Data. The Provisional Acceptable Daily Intake
(PADI) for this chemical is 0.02 mg/kg/day, based on the
2-year rat feeding/oncogenicity study. The systemic NOEL
was set at 100 ppm (5 mg/kg). The safety factor used was
300 based on an uncertainty factor of 100 to account for
inter- and intra-species differences with an additional factor
of 3 to account for the incompleteness of the chronic data base
since the one-year dog feeding study may yield a more sensitive
toxicological endpoint.
The Theoretical Maximum Residue Contribution (TMRC) for the
U.S. population average is 0.0003 mg/kg/day, equivalent to
1.7 percent of the PADI. The TMRC is based on published as
well as pending tolerances.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITION AND RATIONALE
Position. The Agency has determined that it is not necessary,
at this time, to formulate specific regulatory positions
regarding propazine. Should it become necessary to establish
individual positions, based on review and evaluation of the
available data and other relevant information, the Agency
would consider regulatory positions regarding such areas as
special review, tolerances and groundwater.
EPA will, however, remove the reference to the designation
"negligible residue," a term which is now considered obsolete,
from the tolerance expression in 40 CFR 180.243 at such time
as the regulation may be amended in the future or as soon as
practicable. In the event that all registrations for food
uses of this pesticide are cancelled prior to the amendment
of the tolerance regulation, the tolerances will be scheduled
for revocation and the need to amend the regulation will have
become moot.
Rationale: In April 1988, the Agency issued a DCI Notice to
the registrants of propazine products requiring a small-scale
retrospective groundwater monitoring study. In response to
that Notice, the manufacturer of propazine elected to cancel
its registrations of propazine. No other registrant has
committed to generate the required data, and, therefore, all
products have been cancelled or suspended. Since suspended
products cannot be marketed, there is no reason to impose
new label requirements which apply only to products introduced
into the marketplace after issuance of a Standard.
If a registrant commits to generate these data and complies
with the requirements of FIFRA, as set forth in this document,
the Agency will formulate specific regulatory positions
regarding this chemical. However, EPA believes revision to
the tolerance expression, if the suspended registrations are
not cancelled, is appropriate to eliminate obsolete terminology.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain this pesticide, bear required labeling, and
conform to the product composition, acute toxicity limits,
and use pattern requirements listed in this document.
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C. ACCEPTABLE RANGES AND LIMITS
Product Composition Standard. To be registered or reregistered
under this Standard, manufacturing-use products (HP's) 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.
Acute Toxicity Limits. The Agency will consider registration
of technical grade and MP's containing this pesticide provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
Use Patterns. To be registered under this Standard, MP's may
be labeled for formulation into end-use products for acceptable
use patterns. 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.
D. LABELING
Should a registrant commit to generate data and maintain
product registrations for propazine, labeling must be updated.
Once a registrant has committed, the Agency will provide
specific labeling statements unique to propazine. In addition,
the following standard labeling requirements will apply.
All products must bear appropriate labeling as specified in
40 CFR 156.10, PR Notices 83-2, 83-3 and below. Appendix II
contains information on label requirements.
The ingredient statement must list the active ingredient as:
Propazine (2-chloro-4,6-bis(isopropylamino)-
s-triazine) %
Time Frames for Compliance. Pesticide products containing
propazine as an active ingredient may not be released for
shipment by the registrant after December 1989, unless the
product bears an amended label which complies with the require-
ments of FIFRA as set out in this Standard.
Pesticide products containing propazine as an active ingredient
may not be distributed or sold by any person after December
1990, unless the product bears an amended label which complies
with the requirements of this Standard.
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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 B.2
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.
B. Manufacturing use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2Data 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. The Agency has decided that, in most cases, it
will noh require the submittal of product-specific data for
end-use products at this time. Therefore, most Registration
Standards do not contain a Table C.
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2. The labeling requirements specified for
manufacturing use products in Section IV.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption,3 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.
3If 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-vise producers lose the exemption, and become subject
to the data requirements in TabJe 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
registration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often
required for ecological effects studies and applies to all
products having that formulation type. These are classed as
generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is
complying with the data request.
If you are 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__aaw.._=eligAb.le,.J[or_a. generic data
exemption, you may qualify for one if you change youF 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
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who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, 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 DCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
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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 timeframes 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 registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the regis-
tration of your product(s) 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
- 20 -
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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, B.C.
20006.
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
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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.
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
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stocks and your estimate of the time required for their sale
or distribution; and
2. Demonstration that such a provision would be
consistent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that
certain product-specific data are required to maintain your
registrations in effect. Product-specific data are derived
from testing using a specific formulated product, and, unlike
generic data, generally support only the registration of that
product. All such data must be submitted by the dates
specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for
generic data. See Section 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
requirements 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.
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IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration
Standard must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, B.C. 20460
Attn: Propazine Registration Standard
All submittals in response to this Registration
Standard are non-fee items, including 90-day responses,
protocols and waiver requests, data, and revised labeling.
Submittals must be clearly identified as being in response to
the Registration Standard. Under no circumstances may
Registration Standard responses be combined with other types
of filings for which fees are required.
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, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1) .
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
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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.
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, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
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.
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, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if
required by Table C.
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b. Product Specific Data Report (EPA Form 8580-4) , if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
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.
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, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three 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.
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
- 29 -
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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 153.
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 laoeled
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 153. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
3 = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I- = Indoor
Any other designations will be defined in a footnote to the table.
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TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of threeanswers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species
or may possess data on one test substance but not all.
The terra may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data inits files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
columnindicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted,this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timefraraes 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.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data To
Satisfy This
Requirement?
Must Additional Timeframe
Bibliographic Data be for
Citation Submitted? Submission
§158 - Subpart C - 120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
i Analysis and Certification of
to Product Ingredients
NJ
i 62-1 - Preliminary Analysis of TGAI
Product Samples
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
All
All
All
All
All
All
All
All
No
NO
No
No
NO
NO
NO
NO
Yes1
Yes2
Yes3
Yes4
Yes4
Yes4
Yes4/5
Yes4/6
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
- DATA KWJUlKEMtNTS tXJR PROPAZINE
Data Requirement
Does EPA
Have Data To
Test Use Satisfy This
Substance Patterns Requirement?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission
CO
OJ
§158 - Subpart C - Product Chemistry
Physical and Chemical Characteristics (cont'd)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
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
TGAI
TGAI
N/A
All
TGAI or PAI All
TGAI or PAI All
TGAI or PAI All
PAI All
All
All
All
No
No
NO
NO
No
No
NO
N/A
Yes4
6 Months
Yes4
Yes4
Yes4
Yes4/7
Yes4 »8
Yes4
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
No
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
§158 - Subpart C - Product Chemistry
I/ Complete information must be provided regarding the nature of the process (batch or continuous)/ 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.
2/ A detailed discussion of all impurities that are or may be present at _> 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. This discussion must also address the possible formation of nitrosamines.
_3_/ 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 submitted for each
analytical method used. All nitrosoamines must be identified and quantified in six samples of each product;
two samples of each must be analyzed shortly after production, 3 months after production, and 6 months after
production. A method sensitive to 1 ppm of N-nitroso contaminants must be used. An upper limit must be
provided (and certified) for all nitrosoamines found. Certifications should be submitted on EPA Form 8570-4
(Rev. 2-85).
4/ Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, K^, pH, and stability) as required in 40 CFR 158.120 and
more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
V Data needed if the technical chemical is a solid at room temperature.
6/ Data needed if the technical chemical is a liquid at room temperature.
"]_/ Required if the technical chemical is organic and nonpolar.
8/ Required if the test substance is dispersible with water.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data
Be Submitted?
Timeframe
for
Submission
§158.240 Residue Chemistry
171-4 - Nature of the Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Methods
<_n
I
PAIRA
Partially
00024330, 00024436
00024728, 00087881
00111694
YesV2/
PAIRA Partially
TGAI and Yes
Metabolites
00087890
00016404, 00023280
00038224, 00041371
00068044, 00080630
00087887, 00087889
00112982, 00118949
00119532, 00140830
40933501
Yes!/!/
Reserved^/
18 Months
18 Months
171-4 - Storage Stability Data
PAI
No
Yes5/6/
18 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
I
U)
Data
§158.
171-4
171-4
Test
Requirement Substance
125 Residue Chemistry
- Magnitude of the Residue
- Cereal Grains Group]/
o Sorghum TEP
- Forage, Fodder, and Straw of
Cereal Grains Group^/
o Sorghum forage, TEP
fodder, hay, and
silage
- Meat/Milk/Poultry/Eggs TEP
Must Additional
Does EPA Bibliographic Data
Have Data? Citation Be Submitted?
Partially 00016607,
00016991,
00026271,
00047878,
00065582,
00087880,
00105170,
00111693,
Yes 00016607,
00016992,
00044427,
00063246,
00068044,
00087884,
00111672
Partially 00087885,
00140830
00016990, Yes8/
00016992,
00044427,
00063246,
00068044,
00087884,
00111672,
00118949
00016990, No
00026271,
00047878,
00065582,
00087880,
00105170,
00093525, Reserved |W
Time Frame
for
Submission
24 Months
I/ Data depicting the uptake, distribution, and metabolism of ring-labeled [l^cjpropazine in sorghum following
preplant application at a rate sufficiently high to permit complete l^C-residue identification must be submitted.
2/ Representative samples from the above-described tests must also be analyzed using accepted enforcement
methods to ascertain that these methods will determine all possible metabolites of concern.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
V Metabolism studies utilizing ruminants and poultry must be submitted. Animals must be dosed for at least 3 days
with ring-labeled [14C]propazine at a concentration that will result in sufficient residues for characterization in
the tissues, milk, and eggs. Studies must elucidate the identities and quantities of all metabolites in milk, eggs,
liver, kidney, muscle, and fat. Milk and eggs must be collected twice daily during the dosing period. Animals must
be sacrificed within 24 hours of the final dose.
4/ Additional methods, validation data, and residue data (for representative commodities) may be required
if the metabolism studies requested in the sections entitled "Nature of the Residue in Plants" and
"Nature of the Residue in Animals" reveal additional metabolites of toxicological concern in plants
or animals.
5/ The storage intervals and conditions for all samples used to support all tolerances for residues of
propazine in or on sorghum must be submitted. These data must be accompanied by data depicting the decline of
residues during the interval and under the conditions specified. In laboratory tests using fortified samples,
the pure active ingredient and pure metabolites (if necessary) must be used. However, if field-weathered
samples are used, the test substance must be a typical end-use product.
6/ Residue data requested in this Standard must be accompanied by information describing the storage conditions
and intervals for all samples analyzed. These data must be accompanied by fortification recovery data
depicting the stability of residues of concern in appropriate sample substrates under the storage conditions
and for the time intervals specified. In laboratory tests using fortified samples, the pure active ingredient
and pure metabolites (if necessary) must be used. However, if field-weathered samples are used, the test
substance must be a typical end-use product.
7/ If registrant seeks a crop group tolerance, use directions must be proposed and appropriate supporting data
must be submitted for three additional representative commodities (corn, rice, and wheat)
8/ Data depicting propazine residues of concern in syrup processed from sweet sorghum and in milled products
(flour and starch) and grain dust processed from grain sorghum bearing measurable, weathered residues must be
submitted. If residues concentrate in any of these processed commodities, appropriate food/feed additive regulations
must be proposed.
9/ If registrant seeks a crop group tolerance, use directions must be proposed and appropriate supporting residue
data submitted for corn and wheat.
10/ Presently, the nature of the residue in animals is not adequately understood. On receipt of the data
requested in the section entitled "Nature of the Residue in Animals," the appropriate nature of tolerances
for residues in animal products will be determined and, with consideration for any newly found metabolites
of toxicological concern, the adequacy of the available data regarding the magnitude of the residue in meat,
milk, poultry, and eggs will be determined.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
oo
CD
Data Requirement
Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional Timeframe
Data for
Be Submitted? Submission
§158.290 Environmental Fate
DEGRADATION STUDIES-LAB
161-1
- Hydrolysis
TGAI or
PAIRA
A,B
Partially 00153708
YesV
9 Months
Photodeq r ada t ion
161-2
161-3
161-4
- In Water
- On Soil
- In Air
TGAI or
TGAI or
TGAI or
PAIRA
PAIRA
PAIRA
A,B
A
A
No
No
No
Yes
Yes
No2/
9 Months
9 Months
METABOLISM STUDIES-LAB
162-1
162-2
162-3
162-4
- Aerobic Soil
- Anaerobic Soil
- Anaerobic Aquatic
- Aerobic Aquatic
TGAI or
TGAI or
TGAI or
TGAI or
PAIRA
PAIRA
PAIRA
PAIRA
A,B
A
N/A
N/A
Yes 00153712
Yes 00153713
No
No
No
No
NqV
NoV
MOBILITY STUDIES
163-1 - Leaching and
Adsorption/
Desorption
TGAI or PAIRA
A,B
Partially
00152997
Yes
12 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Data Requirement
§158.290 Environmental Fate
MOBILITY STUDIES (cont'd)
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD
164-1 - Soil
i 164-2 - Aquatic (Sediment)
^ 164-3 - Forestry
i
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Use Does EPA
Patterns Have Data?
A No
A NO
A,B No
N/A No
N/A NO
A,B No
A No
Must Additional
Bibliographic Data
Citation Be Submitted?
Yes
Reserved^/
Yes
NoV
Npy
NoV
Yes^/
Timeframe
for
Submission
12 Months
15 Months
27 Months
50 Months
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
PAIRA
TEP
No
No
Yes
39 Months
Reserved^/
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Test
Data Requirement Substance
§158.290
Environmental Fate
Use
Patterns
Must Additional Timeframe
Does EPA Bibliographic Data for J
Have Data? Citation Be Submitted? Submission
ACCUMULATION STUDIES (cont'd)
165-3 -
165-4 -
165-5 -
§158.390
132-1 -
i
^ 132-1 -
o
i 133-3 -
133-4 -
§158.440
201-1 -
201-1 -
§158.340
SPECIAL
Irrigated Crops TEP
In Fish TGAI or PAIRA
In Aquatic Nontarget TEP
Organisms
Reentry Protection
Foliar Dissipation TEP
Soil Dissipation TEP
Dermal Exposure TEP
Inhalation Exposure TEP
Spray Drift
Droplet Size Spectrum TEP
Drift Field Evaluation TEP
Human Exposure Data TEP
TESTING
N/A
A,B
N/A
A,B
N/A
A,B
A,B
A,B
A,B
A,B
No
No
No
No
NO
No
NO
No
NO
NO
NO!/
Yes 12 Mont
i
Reserved^/ j
i
i
i
j
NO!/
NO!/
NO!/
NO!/
IS
Yes 12 Months
Yes 24 Months
Reserved^/
Groundwater Monitoring Study
TEP
A,B
No
Yes
36 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
§158.290 Environmental Fate, §158.390 Reentry Protection, §158.440 Spray Drift, and §158.340 Human Exposure Data
I/ The study fulfills data requirements for pH 7 and 9. Data are required for pH 5.
2/ Based on the use patterns, this study is not required.
V Data not required because there are no aquatic or aquatic impact uses.
4/ Pending the result of the laboratory volatility study (163-2).
V Currently not imposed for this product (single ingredient).
6/ Preliminary data suggest that the half-life of propazine > 12 months.
7/ Pending the results of the confined accumulation study.
8/ Pending the results of the laboratory fish accumulation study.
9/ Based on toxicity and use patterns, these data are not required.
10/ Pending the results of the toxicological studies.
ll/ A small-scale retrospective groundwater monitoring study is required as detailed in the Agency's April 11, 1988,
Data Call-in Notice.
12_/ A protocol must be submitted within 120 days. The final study report must be submitted within 3 years of your receipt
of notification of acceptance of the protocol. In the interim, semi-annual progress reports are due.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Test Use
Data Requirement Substance Patterns
§158.340 Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat 90WDG A,B
81-2 - Acute Dermal 90WDG A,B
81-3 - Acute Inhalation - Rat 90WDG A,B
, 81-4 - Eye Irritation - Rabbit 90WDG A,B
£ 81-5 - Dermal Irritation - Rabbit 90WDG A,B
i
81-6 - Dermal Sensitization -
Guinea Pig TGAI A,B
81-7 - Acute Delayed TGAI N/A
Neurotoxicity - Hen
SUBCHRONIC TESTING
82-1 - 90-Day Feeding
o Rodent TGAI A,B
o Nonrodent TGAI A,B
Must Additional Timeframe
Does EPA Bibliographic • Data for
Have Data? Citation Be Submitted? Submission
Yes 00111699 No
Yes 00111700 No
Yes 00111701 No
Yes 00111702 No
Yes 00111703 No
No Yes 9 Months
No No1/
No NojV
No No2/
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Test Use Does EPA
Data Reouirement Substance Patterns Have Data?
§158.340 Toxicology
SUBCHRONIC TESTING (cont'd)
82-2 - 21-Day Dermal TGAI A,B No
82-3 - 90-Day Dermal TGAI A,B No
82-4 - 90-Day Inhalation - Rat TGAI A,B No
82-5 - 90-Day Neurotoxicity TGAI A,B No
' CHRONIC TESTING
u>
( 83-1 - Chronic Toxicity
0 Rodent TGAI A,B Yes
o Nonrodent TGAI A,B No
83-2 - Oncogenicity Study
0 Rat TGAI A,B Yes
0 Mouse TGAI A,B Yes
Must Add i tonal Timeframe
Bibliographic Data for
Citation Be Submitted? Submission
Yes 12 Months
NoV
No4/
No5/
00041408 No
Yes 50 Months
00041408 No
00044335 No
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
*».
I
Test
Data Requirement Substance
§158.340 Toxicoloqy
CHRONIC TESTING (cont'd)
83-3 - Teratogenicity
o Rat TGAI
o Rabbit TGAI
83-4 - Reproduction, TGAI
2-Generation
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA
Use Does EPA
Patterns Have Data?
A,B Yes
A,B NO
A,B Yes
A,B Yes
A,B Yes
A,B Yes
A,B No
Must Additional
Bibliographic Data be
Citation Submitted?
00150242 No
Yes
00041409 No
00163222 No
00150622 No
00150623 No
Yes
Timeframe
for
Submission
15 Months
24 Months
I/ There is no evidence, based on propazine's chemical structure, to suggest that propazine is a neurotoxic compound.
_2/ Subchronic oral studies in the rodent are unnecessary since a rat chronic study is available to support permanent
tolerances. A separate subchronic oral study in nonrodents is unnecessary since a chronic study is requirecj.
V This study is not needed because the existing acceptable end uses should not result in repeated human skin qontact
for extended periods. • j
4/ This study is not required because the existing end uses should not result in repeated inhalation exposure.
5/ An acute neurotoxicity study is not required on propazine; therefore, this study is not required.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Test Use Does EPA
Data Requirement Substance Patterns Have Data?
§158.490 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 - Acute Single-Dose TGAI A,B No
Oral LD50
71-2 - Avian Dietary 1X50
- Upland Game Bird TGAI A,B No
( - Waterfowl TGAI A,B No
£ 71-3 - Wild Mammal Toxicity TGAI A No
71-4 - Avian Reproduction TGAI A No
71-5 - Simulated and Actual
Field Testing for
Birds and Mammals TEP A No
Aquatic Organism Testing
72-1 - Freshwater Fish LC50
- Warmwater TGAI A,B No
- Coldwater TGAI A,B Yes
Must Additional Timeframe
Bibliographic Data be for
Citation Submitted? Submission
Yes
Yes
Yes
NoV
NO2/
NoV
Yes
00034123 No
9 Months
9 Months
9 Months
9 Months
72-2 - Freshwater Invertebrate
LG
50
TGAI
A,B
No
Yes
9 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Data
§158.
72-3
72-4
72-5
Requirement
490 Wildlife and Aquatic
- Estuarine and Marine
Organisms LC5Q
- Fish
- Shrimp
- Oyster
- Fish Early Life Stage
and Invertebrate
Life Cycle
- Freshwater
o Fish
o Invertebrate
- Marine/Estuarine
o Fish
o Invertebrate
- Fish Life Cycle
Test
Substance
Organisms
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use Does EPA
Patterns Have Data?
A No
A NO
A NO
A NO
A No
A , No
A No
A NO
Must Additional
Bibliographic Data Be
Citation Submitted?
NoV
YesV 12
Yes4/ 12
Yes!/ 15
YesV 15
Yes^/ 15
Yes^/ 15
No 7/
Timeframe
for
Submission
Months
Months
Months
Months
Months
Months
72-6 - Aquatic Organisms
Accumulation (Fish)
TGAI
No
Yes
12 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Data Requirement Substance Patterns Have Data? Citation Submitted? Submission
§158.490 Wildlife and Aquatic Organisms
Aquatic Organism Testing (con't)
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms TEP A No No//
I/ Based on toxicity data and the use patterns, this study is not required.
2/ Based on use patterns, this study is not required.
3/ This study is not required due to the low estimated environmental concentration (EEC) (0.039 ppm) and the slight
toxicity to freshwater fish (LC50 > 10 ppm).
V Required to support use on sorghum because of potential exposure of estuarine/marine environments through
runoff and drift.
5/ Required to support registration of an end-use product when the product is expected to be transported to water
from the intended use site and it is expected to be highly persistent in this environment.
6/ Required to support the sorghum use. Propazine is primarily used on sorghum in Texas and Kansas.
Over 300,000 acres of sorghum are grown in coastal counties in Texas alone. In addition, propazine is
expected to be highly persistent in the aquatic environment.
7/ Based on the toxicity data and the low EEC, these studies are not required.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPAZINE
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data Be for
3(c)(2)(B)? Submission
CD
I
§158.590 Nontarqet Insect
NONTARGET INSECT TESTING - POLLINATORS
141-1 - Honey Bee Acute
Contact LD5Q
141-2 - Honey Bee - Toxicity
of Residues on Foliage
141-4 - Honey Bee Subacute
Feeding Study
141-5 - Field Testing for
Pollinators
142-1 - NONTARGET INSECT
thru TESTING - AQUATIC
142-3 INSECTS
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES
TGAI
TEP
[Reserved]^/
TEP
[ Reserved ]V
[Reserved]^/
A
A
Yes
No
00036935
No
No1/
No
NO1/
I/ As data from the acute contact test indicate low toxicity, no further testing is required.
2/ Reserved pending development of test methodology.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF PROPAZINE
Test Use Does EPA
Data Requirement Substance Patterns Have Data?
§158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and MP All No
Disclosure of Ingredients
61-2 - Description of Beginning MP All No
Materials and Manufacturing
Process
61-3 - Discussion of Formation MP All No
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of MP All No
Product Samples
62-2 - Certification of Ingredient MP All No
Limits
62-3 - Analytical Methods to Verify MP All No
Bibliographic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data Be
Submitted?
YesV
Yes^/
Yes^/
Timeframe
For
Submission
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
Certified Limits
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF PROPAZINE
Test
Data Requirement Substance
i
en
o
1
§158 - Subpart C - Product Chemistry
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Use
Patterns
All
All
All
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?
No
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Bibliographic
Citation
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data Be
Submitted?
Yes7/
Yes7/
Yes^/
YesV
Yes7/8/
Yes?,9/
yes7,10/
Yes7/11/
Yes7/
Yes7'12/
Yes7/13/
Yes7/
Timeframe
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF PROPAZINE
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Data Requirement Substance Pattern Have Data? Citation Submitted? Submission
§158.120 Product Chemistry
Other Requirements
64- 1 - Submittal of Samples N/A All N/A N/A No
I/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts Service (CAS) Registry Number,
an purpose of the active ingredient and each, intentionally added inert must be provided. For the active ingredient,
the following must also be provided: the product name, trade name, and common name; the molecular, structural,
and empirical formulas; the molecular weight or weight range; and any experimental or internally assigned company
code numbers.
_2/ Complete information must be provided regarding the nature of the process (batch or continuous), 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.
3/ A detailed discussion of all impurities that are or may be present at >^ 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. This discussion must also address the possible formation of nitrosamines.
4/ 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 submitted for each
analytical method used. All nitrosoamines must be identified and quantified in six samples of each product;
two samples of each must be analyzed shortly after production, 3 months after production, and 6 months after
production. A method sensitive to 1 ppm of N-nitroso contaminants must be used. An upper limit must be
provided (and certified) for all nitrosoamines found. Certifications should be submitted on EPA Form 8570-4
(Rev. 2-85).
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF PROPAZINE
§158 - Subpart C - Product Chemistry
5_/ Upper and lower limits for the active ingredient and each intentionally added 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, certified, and validated by sample analysis using analytical procedures for which accuracy and precision
data have been provided. 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 which they are
present. [We defer to the Toxicology Branch regarding the toxicological significance of (i) impurities associated
with the active ingredient present at <0.1% (w/w) and (ii) impurities not associated with the active ingredient.]
Certifications must be submitted on EPA Form 8570-4 (Rev. 2-85).
6/ Analytical 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. [RGB defers to the Toxicology Branch regarding the toxicological significance of impurities
and intentionally added inerts for which certified limits are required.]
7/ Physicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing
action, flammability, explodability, storage stability, viscosity, miscibility, and corrosion characteristics)
as required in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D,
must be submitted.
8/ Required if the test substance is dispersible with water.
9/ Required if the product contains an oxidizing or reducing agent.
10/ Required if the product contains combustible liquids.
ll/ Required if the product is potentially explosive.
12/ Required if the product is a liquid.
1_3/ Required if the product is a liquid and is to be diluted with petroleum solvents.
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF PROPAZINE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Timeframe
for
Submission
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat
MP
A,B,E,F,G,H Yes
00111699
No
81-2 - Acute Dermal
MP
A,B,E,F,G,H Yes
00111700
No
81-3 - Acute Inhalation MP
i -Rat
^ 81-4 - Primary Eye MP
i Irritation - Rabbit
A,B,E,F,G,H Yes
A,B,E,F,G,H Yes
00111701
00111702
No
No
81-5 - Primary Dermal
Irritation
MP
A,B,E,F,G,H Yes
00111703
No
81-6 - Dermal Sensitization MP A,B,E,F,G,H
No
Yes
9 Months
-------
II. LABELING APPENDICES
- 54 -
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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 text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 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 estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 156.10(f)J
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)]
- 55 -
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SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per" gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 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. [40 CFR 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)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.56(h)(l)(iii)J
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)].
- 56 -
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure 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 flaramability 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.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of Part 152, Subpart I. You will be notified
of the Agency's classification decision.
- 57 -
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SUMI1ARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 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.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
- 58 -
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terras which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 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.
- 59 -
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SlMMARY-6
LABELING REQUIREMENT OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gal Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning^
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
Mono
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
ij dined lately
before or
fol lowing
Reg. No.
Immediately
following
product name
Directly below
trie main
ingredients
statement
Above signal
word
Immediately
below child
hazard
u^ i-n i nrt
COMMENTS
.
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statement:
must bo jrouixjd together, preferably
blocked.
Note type size requirements.
Note type size requirements.
o
I
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8B
LABEL ELEMENT
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 toxicity
All products
in Categories
I. II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II. and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A. 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
StJtlARY-8
ITEM
8C
9A
9B
10A
10 B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
tone
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR.
CONT/DIS. and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
N)
I
-------
Chapter I—Environmental Protection Agency
S156.10 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 para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) warning or precautionary statements as prescribed in
paragraph (h) of this section;
(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, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
- 63 -
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perticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product isin transit,the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary/ which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 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;
- 64 -
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe,^1 "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"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(n) 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 S 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units'of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
- 65 -
-------
(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it .appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container.. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental 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 used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes, it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
- 66 -
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(3) Names to be used in ingredient statement. The name
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 statedin terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. ' With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Ora, LD50
Inhalation LC
50
Dermal LO
Eye effects
Skin effects
1
Up to and
Including
50 «g/kg
Up to and
Including
.2 »g/Mter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
•Ithln 7 days
Corrosive
Toxicity e
II
F-orn 50 thru
500 ng/Kg
From .2 thru
2 mg/l Iter
Fro* 200
thru 2000
Cornea! opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Seve-e Irritation
at 72 hours
:at*gor 'es
HI |
F-om 500 thru
5000 mg/kg
F-om 2 thru
20 mg/ 1 1 ter
From 2,000 thru
20,000
No cornea! opacity;
Irritation
-evers'ble
•Ithtn 7 days
Mod«-at« Irritation
at 72 hou-s
IV
Gr«at*r than
5000 mg/kg
Greater than
20 «g/ 11 ter
Greater than
20,000
No Irritation
Ml Id or si Ight
Irritation at
| 72 hours
_
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned
the basis of its oral, inhalation or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
(B) Toxicity Category II.
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
to Toxicity Category I on
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
All pesticide product-s meeting the
II shall bear on the front panel'
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during 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) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) 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 over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
3
10
12
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals/" "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall 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.
Tox'
category
Precautionary statements by toxic'ty category
Oral. Inhalation, or dermal foxlclty
Shin and eye local effects
I .
II .
Fatal (poisonous) If swallowed I Inhaled or
abso-bed through skin). Do not breathe
vapo- I dust) or spray «lst). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical t-eatwent
requ'red.l.
May be fatal If swallowed (Inhaled or
86so'bed through the skin). Do not breathe
vapo-s Idust or spray •1st). Do not get In
eyes, on skin, or on clothing* (Appropriate
first a'd statements required.!.
Harmful If swallowed (Inhaled or absorbed
through the skfnl. Avoid breathing vapors
Idust or spray •1st). Avoid contact with
sk'n (eyes or clothlngl. (Appropriate
first aid statement required.!.
(No precautionary statements required.!.
Corrosive, causes eye and sk'n damage (or
skin Irritation!. Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement requ'red.l
Causes eye (and skin! Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. [Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
(No precautionary statements required.!.
(ii) Environmental hazards. Where a hazard exists to non-
target, organisms excluding humans and domestic animals, precautionai
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD$Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LCe,Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD^Q of 100 mg/kg or less, or
a subacute dietary LC$Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
(A) PRESSURIZED
Flash point at or below 20*f; If there Is •
flashback at any valve opening*
Flash point above 20' f and not over 80*F or If
the Mame extension Is more than 18 In. long
at a distance of 6 In. fro* the flame.
_
(8) NONPRESSURI2
_
Required text
CONTAINERS
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
130*F may cause bursting.
Flammable. Contents under pressure. Keep away
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to
temperatures above !30*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 tempera-
tures above 130*F may cause bursting.
!ED CONTAINERS
£xt rew*e 1 y f 1 ammab 1 e* Keep away f rom fire
sparks, and heated surfaces.
f | a^Tia ble* Keep away f rom heat and open f| a me •
Do not use or store near heat or open flame*
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(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.
(i i i) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
Q) 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;
O) The product will not come into the hands of the general
public except after incorporation into finished products; and
M) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
env ironment.
(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:
(JL_) 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:
(!_) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restriction;
or limitations, and effectiveness of the product for pesticide
purposes;
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(2) The label clearly states that the product
-------
(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of S 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 misleading
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 S 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 Administrator will define
the appropriate wording for the terms of restriction by regulation
(k)' Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978;
amended at 53 FR 15952, May 4, 1983!
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of .storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all produces, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environnental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
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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 disposalstatements:
Container Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All 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 b)
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)
I/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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III. BIBLIOGRAPHY APPENDICES
- 79 -
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
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.
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.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
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.
- 80 -
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BIBGUIDE-2
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.
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.
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.
Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th. 123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MRID CITATION
00016404 Cheung, M.W. (1975) Determination of 2,4-Diamino-6-chloro-s-
Triazine (G-28273) Residues in Crops and Animal Tissue by Gas
Chromatography. Method no. AG-281 dated Mar 5, 1975. (Unpub-
lished study received Feb 18, 1977 under 100-583; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:228126-Q)
00016607 Cheung, M.W.; Kahrs, R.A. (1979) Residues in Sorghum Resulting from
Applications of Milocep 5L--Preplant Incorporated and Preemer-
gence Applications: Report No. ABR-79015. Summary of studies
237815-B through 237815-F. (Unpublished study received Mar 16,
1979 under 100-604; submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:237815-A)
00016990 Davidson, W.E. (1978) Metolachlor + Propazine; Dual 8E + Milo-
gard 4L: Grain Sorghum: AG-A No. 4883 II A. (Unpublished
study received Nov 24, 1978 under 100-EX-62; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:235981-B)
00016991 Chamberlain, E.; Threewitt, T. (1978) Metolachlor + Propazine;
Dual 8E + Milogard SOW: Grain Sorghum: AG-A No. 4926
II B. (Unpublished study received Nov 24, 1978 under 100-EX-62;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:235981-C)
00016992 Turner, W.E. (1978) Metolachlor + Propazine; Dual 8E + Milo-
gard SOW: Grain Sorghum: AG-A No. 4995 A. (Unpublished
study received Nov 24, 1978 under 100-EX-62; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:235981-D)
00023280 Mattson, A.M.; Solga, J. (1966) The Determination of Atrazine,
Simazine and Prometryne in Cow's Milk by Gas Chromatography.
Method dated Nov 11, 1966. (Unpublished study received Jul 15,
1968 under 7F5034; submitted by Geigy Chemical Co., Ardsley,
N.Y.; CDL:092912-A)
00024330 Foy, C.L. (1964) Volatility and tracer studies with Alkylamino-
s-triazines. Weeds 12(? ):103-108. (Also in unpublished
submission received Jul 19, 1978 under 201-403; submitted by
Shell Chemical Co., Washington, D.C.; CDL:234469-F)
00024436 Lamoureux, G.L.; Stafford, I.E.; Shimabukuro, R.H. (1972) Conjuga-
tion of 2-Chloro-4,6-bis(alkylamino)-s-triazines in higher
plants. Journal of Agricultural and Food Chemistry 20(5):1004-
1010. (Also in unpublished submission received Jul 19, 1978 un-
der 201-403; submitted by Shell Chemical Co., Washington, D.C.;
CDL:234471-C)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MRID CITATION
00024728 Montgomery, M.L.; Freed, V.H. (1964) Metabolism of Triazine herbi-
cides by plants. Journal of Agricultural and Food Chemistry 12
(1):11-14. (Also in unpublished submission received Jul 19,
1978 under 201-403; submitted by Shell Chemical Co., Washington,
D.C.; CDL:234470-AF)
00026271 Gardner, R.C.; Smith, L.L.; Hunter, J.H.; et al. (1979) Supportive
Residue Data for Bladex Herbicide in/on Sorghum. (Unpub-
lished study received Aug 10, 1979 under 201-281; prepared in
cooperation with Dow Chemical Co. and others, submitted by Shell
Chemical Co., Washington, D.C.; CDL:238925-E)
00034123 Woodard Research Corporation (1949) Propazine: Acute Toxicity in
Rainbow Trout. (Unpublished study received Oct 4, 1965 under
100-455; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
000333-C)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00038224 Cannizzaro, R.D.; Rolla, H.; Li, C.K. (1970) Determination of GS-
13529 and Its Monodealkylated Metabolite, GS-26379, in Tissues
and Blood. Method no. AG-142 dated J.un 30, 1970. (Unpublished
study received Jun 19, 1973 under 3F1409; submitted by Ciba-
Geigy Corp., Ardsley, N.Y.; CDL:093763-I)
00041371 Shell Development Company (1974) Residue Determination of Triazine
Herbicides in Crops: GLC-AFID-Method. Method MMS-R-405-1 dated
Jun 1974. (Unpublished study received Aug 28, 1980 under 476-
2156; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:243177-J)
00041408 Jessup, D.C.; Gunderson, G.; Ackerman, L.J. (1980) Two-Year Chronic
Oral Toxicity Study in Rats: IRDC No. 382-007. (Unpublished
study received Sep 26, 1980 under 100-543; prepared by Inter-
national Research and Development Corp., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:243355-A, 243356)
00041409 Jessup, D.C.; Schwartz, C.; Arceo, R.J.; et al. (1979) Three Gener-
ation Reproduction Study in Rats: IRDC No. 382-010. (Unpub-
lished study received Sep 26, 1980 under 100-543; prepared by
International Research and Development Corp., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:243357-A; 243358)
- 83 -
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MRID CITATION
00044335 Jessup, D.C.; Arceo, R.J.; Lowry, J.E. (1980) 2-Year Carginogen-
icity Study in Mice: IRDC No. 382-004. (Unpublished study re-
ceived Sep 26, 1980 under 100-543; prepared by International
Research and Development Corp., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:243350-A; 243351; 243352; 243353; 243354)
00044427 Shell Chemical Company (1974) Sorghum Grown in Soil Treated with
Bladex: TIR-24-154-73. (Unpublished study including TIR-24-
184-73 and TIR-24-177-73, received on unknown date under 5F1532;
CDL:094036-F)
00047878 Hargan, R.P.; DeKraker, J.D.; King, E.; et al. (1968) Residue Re-
port: Sorghum: GS-14260: AG-A No. 1370. (Unpublished study in-
cluding AG-A nos. 1336, 1315 and 1735, received Jan 12, 1969 un-
der OG0953; prepared in cooperation with Lindsey Seed Co., sub-
mitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:091622-F)
00063246 Geigy Chemical Company (1970) Residue Data Summary and Analyses.
(Compilation; unpublished study received Jul 26, 1971 under
1F1048; CDL:091875-I)
00065582 Ciba-Geigy Corporation (1977) Terbutryn—Sorghum; Tank Mixes of
Terbutryn plus Atrazine or Propazine--Sorghum: Preplant Incorpo-
rated Applications: Summary of Residue Data: Report No. ABR-
77044. (Compilation; unpublished study received Aug 26, 1977
under 100-496; CDL:231418-A)
00068044 Wilson, G.R.; Dubelman, S. (1981) Residues of Alachlor in Sorghum
Forage, Stover, and Grain following Preemergent Treatment with
Alachlor in Tank-mix Combinations with Propazine and Bifenox:
Report No. MSL-1577. Final rept. Includes undated methods
entitled: Analytical residue method for alachlor in sorghum
forage, stover, and grain; Analytical residue method for bifenox
(Modown) in sorghum; Analytical residue method for propazine in
sorghum forage, stover, and grain. (Unpublished study received
May 27, 1981 under 524-285; prepared by ABC Laboratories, Inc.,
submitted by Monsanto Co., Washington, D.C.; CDL:245225-A)
00080630 Mattson, A.M.; Solga, J. (1963) Residues in Body Tissues of Sheep
and Cattle Receiving Simazine in Their Diet As Compared with
Residues of Propazine and Atrazine in Animals Similarly Treated.
Includes method nos. AG-9 dated Nov 1, 1962; AG-14 dated Jan 30,
1963; AG-15 dated Jan 31, 1962; AG-26 dated Oct 23, 1963. (Un-
published study received Mar 15, 1965 under 5F0447; submitted by
Geigy Chemical Corp., New York, N.Y.; CDL:090488-E)
- 84 -
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MR ID CITATION
00087880 Kahrs, R.A. (1981) Propazine--Sorghum: Report No. ABR-81044. Sum-
mary of studies 070546-A through 070546-C, 070547-A through
070547-C, 070548-A through 070548-D and 070549-A through 070549-
D. (Unpublished study received Dec 17, 1981 under 2F2618; sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070545-A)
00087881 Keezer, W.S.; Hermes, P.A.A. (1971) Metabolism of Propazine in
Greenhouse Grown Sorghum: Report No. GAAC-71051. (Unpublished
study received Dec 17, 1981 under 2F2618; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:070546-A)
00087884 Ciba-Geigy Corporation (1981) Residue Report: Sorghum. (Compila-
tion; unpublished study, including AG-A nos. 3330, 3373 I-II,
3464..., received Dec 17, 1981 under 2F2618; CDL:070547-A)
00087885 Ciba-Geigy Corporation (1979) Residue Study of Propazine: Hens and
Eggs. (Compilation; unpublished study received Dec 17, 1981
under 2F2618; CDL:070547-C)
00087887 Cheung, M.W. (1975) Determination of Propazine and G-30033 Residues
in Sorghum by Gas Chromatography. Method no. AG-280 dated Feb
25, 1975. (Unpublished study received Dec 17, 1981 under
2F2618; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
070548-B)
00087889 Smith, J.W.; Neal, B. (1978) Gas Chromatographic Method for Assay-
ing Residues of Propazine, Atrazine, Simazine, and Their Chloro
Metabolites in Whole Milk. Method no. AG-331 dated Dec 14,
1978. (Unpublished study received Dec 17, 1981 under 2F2618;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070548-D)
00087890 Robbins, J.D.; Bakke, J.E.; Feil, B.J. (1968) Metabolism of 2-
chloro-4,6-bis(isopropylamino)-s-triazine (propazine-14C)
in the milk goat and sheep: Balance study and urinary metabolite
separation. Journal of Agricultural and Food Chemistry 16(4):
698-700. (Also in unpublished submission received Dec 17, 1981
under 2F2618; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:070549-A)
00093525 Geigy Agricultural Chemicals (1963) Residues in Body Tissues of
Sheep and Cattle Receiving Simazine, Atrazine, and Propazine.
(Compilation; unpublished study received Aug 1, 1966 under
7F0525; CDL:090628-H)
- 85 -
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MRID CITATION
00105170 Adams, S.; Dubelman, S. (1982) Residues of Propachlor, Propazine,
and Atrazine in Field Treated Sorghum Following Preemergent Ap-
pilication with Ramron/Milogard or Postemergent Application with
Ramrod/Atrazine Tank Mixes: MSL 2244. (Unpublished study, re-
ceived Jun 21, 1982 under 524-328; submitted by Monsanto Co.,
Washington, DC; CDL:247704-A)
00111672 Geigy Chemical Corp. (1965) Study: Propazine Residue in Sorghum &
Other Specified Crops. (Compilation; unpublished study re-
ceived Jan 7, 1968 under 8F0687; CDL:091194-A)
00111693 Ciba-Geigy Corp. (1979) Summary of Metolachlor Residues in Sorghum
Milling Fractions: Report No. ABR-79036. (Compilation; unpub-
lished study received Mar 16, 1979 under 8F2098; CDL:098010-A)
00111694 Foy, C. (I960) Distribution and Metabolic Fate of C14 Labeled
... Propazine in Sorghum vulgare. Prelim, rept. (Unpublished
study received Apr 17, 1961 under unknown admin, no.; prepared
by Univ. of California--Davis, Dept. of Botany, submitted by
Ciba-Geigy Corp., Greensboro, NC; CDL:119548-A)
00111699 Sabol, R.; Sabol, E.; Cannelongo, B.; et al. (1979) Rat Acute Oral
Toxicity: Milogard 90WDG: Project No. 1131-79. (Unpublished
study received Jul 6, 1979 under 100-606; prepared by Still-
meadow, Inc., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:238806-B)
00111700 Cannelongo, B.; Sabol, E.; Sabol, R.; et al. (1979) Rabbit Acute
Dermal Toxicity: Project No. 1132-79. (Unpublished study re-
ceived Jul 6, 1979 under 100-606; prepared by Stillmeadow, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:238806-C)
00111701 Ulrich, C.; Rop, D.; Servis, M.; et al. (1979) Acute Inhalation
Toxicity Study on Milogard 90WDG: 382-076. (Unpublished study
received Jul 6, 1979 under 100-606; prepared by International
Research and Development Corp., submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL:238806-D)
00111702 Cannelongo, B.; Sabol, E.; Sabol, R.; et al. (1979) Rabbit Eye
Irritation: Milogard 90WDG: Project No. 1134-79. (Unpublished
study received Jul 6, 1979 under 100-606; prepared by Still-
meadow, Inc., submitted by Ciba-Geigy Corp., Greensboro, NC;
CDL:238806-E)
00111703 Cannelongo, B.; Sabol, E.; Sabol, R.; et al. (1979) Rabbit Pri-
mary Skin Irritation: Milogard 90WDG: Project No. 1133-79.
(Unpublished study received Jul 6, 1979 under 100-606; prepared
by Stillmeadow, Inc., submitted by Ciba-Geigy Corp., Greens-
boro, NC; CDL:238806-F)
- 86 -
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MRID CITATION
00112982 Geigy Chemical Corp. (19??) The Determination of Chlorotriazine
Residues in Plant Material, Animal Tissues and Water, Using the
Ultraviolet Method. Ardsley, NY: Geigy. (Analytical bulletin
no. 7; also In unpublished submission received Dec 27, 1967
under 8F0687; CDL:092992-B)
00118949 Wilson, G.; Baszis, S.; Dubelman, S. (1982) Residues of Acetochlor
in Sorghum Grain following Preemergent Applications of Aceto-
chlor Alone or in Tank Mix Combinations with Atrazine, Roundup,
Propazine, and Bifenox: MSL-2567. (Unpublished study received
Nov 18, 1982 under 524-EX-56; prepared in cooperation with
Craven Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, DC; CDL:071245-A)
00119532 Adams, S.; Dubelman, S. (1982) Residues of Propachlor, Propazine,
and Atrazine in Field Treated Sorghum following Preemergent
Application with Ramrod/Milogard or Postemergent Application
with Ramrod/Atrazine Tank Mixes: Report No. MSL 2244. (Unpub-
lished study received Nov 3, 1982 under 524-328; prepared in
cooperation with Craven Laboratories, Inc. and Analytical Bio-
chemisty Laboratories, Inc., submitted by Monsanto Co., Wash-
ington, DC; CDL:248721-A)
00140830 Ciba-Geigy Corporation (1978) Residue Study of Propazine on Cat-
tle, Meat and Milk. Includes undated methods entitled: Analy-
sis of propazine and G-30033 in cow tissue; Analysis of G-28273
in cow tissue. (Compilation; unpublished study received Dec 17,
1981 under 2F2618; CDL:070547-B)
00150242 Salamon, C. (1985) Teratology Study in Albino Rats with Propazine
Technical: Study 450-1788. Unpublished study prepared by
American Biogenics Corp. 289 p.
00150622 Strasser, F. (1984) Nucleus Anomaly Test in Somatic Interphase
Nuclei of Chinese Hamster: Test No. 831372. Unpublished study
prepared by Ciba-Geigy Ltd. 11 p.
00150623 Puri, E. (1984) Autoradiographic DNA Repair Test on Rat Hepatocytes
with G 30028 Techn.: Test No. 831371. Unpublished study pre-
pared by Ciba-Geigy Ltd. 12 p.
00152997 Warren, J.(1985) Determination of Adsorption/Desorption Constants
of Propazine and GS-11526: ABC Report # 32641. Unpublished re-
port prepared by Analytical Bio-Chemistry Laboratories, Inc. 59
P-
- 87 -
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________ QF.£1CE_OJE_PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propazine Standard
MRID CITATION
00153712 Keller, A. (1979) Degradation of Propazine (Gesanil) in Aerobic
Soil: Project Rept. No. 15/79. Unpublished study prepared by
Ciba-Geigy Ltd., Basle. 19 p.
00153713 Keller, A. (1979) Degradation of Propazine (Gesamil) in Soil Under
Aerobic, Aerobic/Anaerobic and Sterile/Aerobic Conditions: Pro-
ject Rept. No. 23/79. Unpublished study prepared by Ciba-Geigy
Ltd.,Basle. 28 p.
00163222 Puri, E. (1986) V79 Chinese Hamster Point Mutation Test (with and
without Microsomal Activation): G 30 028 Techn: Test No. 850624.
Unpublished study prepared by Ciba-Geigy Limited. 28 p.
40933501 Mattson, A.; Kahrs, R.; Schneller, J. (1965) Use of Microcoulometric
Gas Chromatograph for Triazine Herbicides. J. Agr. Food Chem.
13(2):120-122.
- 88 -
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IV. FORM APPENDICES
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EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(0(2X6) SUMMARY SHEET
EPA REGISTRATION NO
PRODUCT NAME
APPLICANT S NAME
OATt GUIDANCE DOCUMENT ISSUED
With ruatct to tti» nouftmtnt to Mbmit "itntne" dan rmpottd by tht FIFMA atetion 3(C)(2HI> nonet contained m »ht rclcftnctd
Guidtnct Oocumtnt. I «m mpondinf MI tht lollowina, manntr:
Cj t. I w»ll aubmrt dttt MI t twntiy mtrmtf to •tofy tht foltowma, raqutramtmi. If tht ton proctdurn I wiM vm dmnt from lor art not
totcilwd MI) tht MtfArttMA GurioiMiM or tht Protocol* conttintd MI M fttpom of Eiptrt Grouot to tnt Chtmcjii Group. OECO
Chtmiealt TORMI Protnmmt. I «K!OOI tht protocoU that I will Mt:
Q 2. I htvt tnnrtd Mito w •ortomtm with ona or wort othar rtfanna undor FIFMA MCtion 3(C)(2)(l)(u) to witty tilt Iollowtn9 dau
raquiramtnn. Tht ttra. and any rtqmrtd pratocott. will ba wbmmtd to EPA by:
NAME OF OTHE4 REGISTRANT
D 3. I tndeaa t compiatad "Cartrfcation of Antmpt to Enttr Into in Aa/Hmtnt with Othtr R*tntranu lor Otvtlopmtnt ol Otu" with
ratpact to tht foliowinf daa nquiramantt:
. I raquan mat you amand my raa,«trttton by daiatutf DM (ollowwif uatt Itna option • not avaiiaoit to acplieantt lor ntw produca):
5. I rtquan voluntary carcallation of tha rtfiraition of thii product (Thu option it not avauabit ta ippKanu lor ntw products)
NEOICTMANT-S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
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CMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION! STATEMENT
EPA Product Registration Number:.
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 terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the
product contains the active ingredient solely as the result of the incorporation into
the product of another product which contains that active ingredient, which is
registered under FIFRA Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company
name, registration number, and product name, the source of the subject active
ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are and
their registration number(s) is/are .
My firm will apply for an amendment to the registration 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 time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings
made in this Statement, my firm's product's registration may be suspended under FIFRA
Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have committed to generate and submit
the required data fail to take appropriate steps to meet requirements 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 compliance and will normally initiate proceedings to
suspend the registrations of my firm's product(s) and their product(s), unless my firm
commits to submit and submits the required data in the specified time frame. I
understand that, in such cases, the Agency generally will not grant a time extension
for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
EPA Form 8570-3
- 91 -
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OMB Approval No. 2070-0057
Expires 11/30/89
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No..
Date
Guidance Document for
Registration
Guideline No.
Subpart C
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
1
Name of Test
Identity of
inoredients
Statement of
composition
Discussion of
formation of
incnredi ents
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Meltina point
Boilina point
Density, bulk-
density, or
specific aravity
Solubility
Vapor pressure
Dissociation
constant
Cctanol/water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assioned
EPA Form 8580-4
- 92 -
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GMB Approval No. 2070-0057
Expires 11/30/89
PRODUCT SPECIFIC DMA REPORT (cont'd)
EPA Reg. NO..
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stability
Qxidi zing/reducing
reaction
Flamrwbility
Fxpiory?bilitv
Storage stability
Viscosity
Miscibilitv
Corrosion
characteristics
Dielectric break-
down voltaae
Acute oral
toxicitv. rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicitv. rat
Primary eye
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicity , hen
(Test not
required
for my
product
listed
above
(check
below)
I am complying with
rtet~ a. requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assioned
EPA Form 8580-4 (cont'd)
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EPA Form 8580-6
OMB Approval NO. 2070-0057
Expires 11/30/89
CERTIFICATION OP ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To VMiifY. artify ALL four /ram./ FOR DEVELOPMENT OF DATA
1 . 1 am duly authonitd to rtprtstnt tnt f oilowmg f irm<«> who art mjojtct to (ht rtquirt-
mints of • Notict under FIFRA Section 3(cH2HB) contamtd m aGuidanat Document
to submit dad concerning tnt tcliv* ingr«di«nt:
NAMt OP PIMM
•'
OUIOAMCf OOCUMCNT OATC
ACTivc iNowf OICMT
EPA COMPANY NUMBER
-
(This firm or group of firms it rtftrrtd to bttow M "my firm".)
2. My firm « willing to dtyttoo and submit tnt data at required by thn Not«t. if niottun. Howtvtr. my firm wouW jxtftr to tnt
into an agrttmtnt with ont or mart othtr rttjituanu to dtvttop jotnth/, or to thtrt in tnt oon of dtwtloping. tha following rtquiri
itamt or data:
3. My firm Kai orftrtd in writing to tmar inta a«*J aa aaraniitiiL Caaiai of tht tfftrt art tnaditt. That
to ttit following firm(i) an tht fallowing aataitj:
NA4MO9 PIMM
'
tfftr «w irmocablt ana* indudtd an offw to
M not at nacfttf othtrwaa. Thii afttr wat m.
OAT« OP OPPIN
Howtvtr nont of tnoM firm(t) acotptad my offtr.
4. My firm raqutats that EPA not tuaptnd tha rtg»ftrtoon<») of my firm s product (si. if any of tht firrm namad m paragraph (3) *tx
htvt torttd to submit tha data lined in paragraph (2) toovt m aooordanot with tht NotMa. I undarnand EPA will promptly mfo
mt whtthar my firm mun submit data to avoid autpcrwon of its registrttion(s) undtr FIFRA Saction 3(c)(2)(B). (This nattrrx
do* not apply to applicants for ntw producn.) I giwt EPA ptrmiuion to disdoit this sttttmtnt upon raquctt.
TV^tONAMt
SIGNATURE
DATE
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