&EPA
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Environmental Prottction
Agancy
Officaof
P««icid«t and Toxic Subatancaa
Washington DC 20460
March 1987
PMtickto
Guidance for the
Reregistration of
Pesticide Products
Containing Prometryn
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PROMETRYN
AS THE ACTIVE INGREDIENT .
OPP NUMBER 080805
CAS (DOCKET) NUMBER 7287-19-6
MAR 2 0-1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Glossary of Terms and Acronyms
I. Introduction ,
II. Chemical(s) Covered by this Standard
A. Description of Chemical1
B. Use Profile
III. Agency Assessment ......
A. Summary
B. Toxicology Characteristics
C. Other 'Science Findings .
D. Tolerance Reassessment •
IV. Regulatory Position and Rationale.
A. Regulatory Positions
B. Criteria .for ^Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard'.
VI. Requirement for Submission of Generic Data . . . . .
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data
VIII. Requirement for Submission of Revised Labeling . . .
IX. Instructions for Submission. . . *
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements.
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX '•'
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES '.
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
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GLOSSARY OF TERMS AND ABBREVIATIONS
The following terms are used throughout this Registration
Standard and are defined here for the convenience of the reader.
ADI: (Acceptable Daily Intake) An acceptable daily intake of
pesticide residue based on a complete data base.
A/D Ratio: This ratio determines a level of concern regarding
whether effects observed in embryos and fetuses
from treated females are "primary" (due to direct
compound-related effects) or "secondary" (to
maternal toxicity). Thus, the NOEL for maternal
effects ("A" numerator) divided by the embryo/
fetal NOEL ("D" for "developmental"), including
frank terata (gross congenital defects), defines
this concern. If A/D is less than "1",
developmental toxicity of a substance may be
ascribed to secondary effects of maternal toxicity;
if greater than 2, the substance is considered a.
direct (primary) developmental toxicant.
Scientific interpretation is required in the range,
1 to 2 (LEL's may be used; or effects from other
types of studies, e.g., reproduction).
ai: Active ingredient .-. • '
CAS: Chemical Abstract Society (number)
Core Classification: A general guide to the acceptability of data
for the purpose of supporting registration
(invalid, supplementary, minimum, or guideline)
Core Guideline: Studies which satisfy Agency data requirements.
Core Minimum: Studies which are acceptable to support
registration of pesticide products but were not
necessarily done according to Agency guidelines.
Core Supplementary: Studies in this category are scientifically
sound, thus the information may be useful.
However, the studies were performed under
conditions that deviated substantially from
recommended protocols. Studies do not
meet guideline requirements and thus do not
support registration of a product.
EEC: (Estimated Environmental Concentration) Estimated pesticide
concentration in the environment (terrestrial or aquatic
ecosystem).
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EP: End-use Product
EPA: The Environmental Protection Agency, also "the Agency"
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
HDT: Highest dose tested
Invalid: Studies which are deficient in some vital parameter
or those studies which have been judged not to be
scientifically sound or those studies whose
reliability is seriously questioned.
L.C-5O1 (median lethal concentration): a statistically derived
concentration of a substance that can be expected to cause
death in 50 percent of test animals, expressed as weight
or volume of test substance per volume of air or water
or per weight of feed (e.g., mg/L or ppm).
(median lethal dose): a statistically derived single dose
that can be expected to cause death in 50 percent of animals
when administered by the route indicated, expressed as
weight of substance per unit weight of test animal (e.g.,
mg/kg).
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number)—EPA's system of
tracking studies used .in support of registrations
MP: Manufacturing-use product
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level—the maximum dose used in a
test which produces no observed adverse effects.
OPP: The Office of Pesticide Programs (EPA)
OES: Office of Endangered Species, U.S. Fish and Wildlife
Service
OM: Organic matter (used to describe soils)
ppm: Parts per million
PADI: (Provisional Acceptable Daily Intake) An acceptable daily
intake of pesticide residue based on a limited data base.
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PAI: Pure active ingredient
Technical: Active ingredient as manufactured
TMRC: (Theoretical Maximum Residue Contribution) An estimate of
dietary exposure obtained by multiplying residue tolerance
levels for a given pesticide by the average daily per
capita food consumption figure, then adding the exposure
figures for each crop. TMRC is usually expressed in
terms of mg ai/day, assuming a 60 kg person.
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I. INTRODUCTION
EPA has established the Registration Standards program
xn 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.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes. :
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies;
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
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 request1, 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
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington., D.C. 20460.
1' 1
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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.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in :
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 :
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may ; propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
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EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICALS COVERED BY THIS STANDARD
A. Description of Chemical
Common Name: Prometryn
Chemical Name: 2,4-bis (isopropylamino)-6-(methylthio)-
£-triazine
Other Names: Prometryne, Caparol, G-34161, Gesagard,
Primatol Q, Prometrex
CAS Number: 7287-19-6
OPP (Shaughnessy) Number: 080805
Empirical Formula: C^oH19N5s
Molecular Weight: 241.4
Description of chemical characteristics:
White, odorless, solid powder with a melting point of
118 to 120 CC. The chemical is readily soluble in
organic solvents and soluble in water to 33 ppm at
20 °C.
Density: 1.15 + 0.02 g/cm3 at 20 °C
Stability: Stable in neutral, slightly acidic or basic
media. Half-life at 25 °C of 22.2 days and 1200 days
in 0.1 N HC1 and 0.1 N NaOH, respectively. Stable
for a minimum of 3 years at room temperature.
B. Use Profile
Type of Pesticide: Herbicide
Pests Controlled: Annual broadleaf and grass weeds
Registered Uses: Cotton, celery, pigeon peas, corn,
ornamental plants, and forest trees (nursery seed
beds)
Predominant Uses: Cotton (approximately 97%)
Celery (approximately 3%)
Mode of Activity: Interferes with electron transport
in the plant's photosynthetic process.
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Formulation
Manufacturing-Use Products: 95% and 97% active
ingredient (technical)
F,nd-Use Products: 80% ai wettable powder; 44.4%
(4 Ib ai/gal) emulsifiable concentrate; 45.41%
(4 Ib ai/gal) flowable concentrate.
Methods of Application: Applied broadcast or in a band
as a preplant incorporated, a preemergence, a directed
postemergence, or a layby spray using ground equipment
or aircraft.
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III. AGENCY ASSESSMENT
A. Summary of Assessment
Based on the review of the data filed in support of the
registration of prometryn, the Agency has reached the following
conclusions. A more detailed discussion of the full assessment
appears in Section B.
1. Data from acute oral and acute dermal studies indicate
that prometryn has low acute toxicity (Toxicity Category III).
The chemical falls within Toxicity Category IV for primary
dermal irritation.
2. The teratogenic, oncogenic, reproductive, and mutagenic
potential cannot be determined until the chronic studies listed
in Data Table A are submitted and reviewed.
3. Available data indicate that prometryn has intermediate
mobility in sandy loam soils and high mobility in sandy soils.
However, degradation, soil field dissipation, leaching,
accumulation and metabolism studies are required in order to
fully assess the environmental fate of prometryn. Pending the
results of soil field dissipation and leaching studies, a
ground water monitoring study may be required. .
4. Prometryn is not acutely hazardous to birds. It is
slightly toxic to freshwater invertebrates and moderately
toxic, to fish. Prometryn may pose a risk to some endangered
plant and animal species. Therefore, phytotoxicity, avian and
aquatic organism studies are required. Proposed restrictive
labeling for endangered species will be required once the
Agency receives concurrence on the assumption of jeopardy, based
on the crop cluster, from the U.S. Fish and Wildlife Service.
5. The Theoretical Maximum Residue Contribution (TMRC)
for prometryn in the daily diet based on the total tolerances
and daily food intake of 1.5 kg is 0.000205 mg/kg/day. Under
these conditions 5.13% of the PADI (Provisional Acceptable
Daily Intake) has been used.
In the course of its review, the Agency has identified data
which are necessary to evaluate risks associated with the use
of prometryn. These data must be developed and submitted in order
to maintain registrations of products or register new products
containing prometryn. Table 1 summarizes the data gaps. Please
note that this is only a summary, and more details can be
obtained by referring to Data Table A in Appendix I.
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The Agency has also determined that certain additional or
revised label restrictions are necessary in order for prometryn
registrations to remain in compliance with the provisions of
FIFRA. These restrictions include a feeding/grazing restriction
and an environmental precautions statement.
A more detailed discussion of the Agency's assessments
follows. In Part IV, the Regulatory Position and Rationale
section details the Agency's position regarding the regulation
of prometryn, and Section D of Part IV, Required Labeling,
contains the specific wording for label revisions.
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TABLE 1
Summary of Data Gaps
Product Chemistry
All product chemistry data
Residue Chemistry
Metabolism studies (plants, livestock)
Residue analytical method (plant & animal residues)
Storage stability
Residue studies
Toxicology
Acute inhalation
Eye irritation
Dermal sensitization
21-Day dermal (rabbit)
Chronic toxicity (rodent)
Oncogenicity (2 species)
Teratology (rat)
Reproduction (rat)
Mutagenicity battery
General metabolism
Fish and Wildlife
Avian dietary (upland gamebird)
Avian reproduction (upland gamebird & waterfowl)
Acute toxicity to estuarine and marine organisms
Fish early life stage and aquatic invertebrate life-cycle
Aquatic organisms accumulation
Plant Protection
Seed germination/seedling emergence
Vegetative vigor
Aquatic plant growth
Environmental Fate -
Hydrolysis
Photodegradation (water, soil, air)
Anaerobic soil metabolism
Leaching, adsorption/desorption
Volatility (lab and field)
Soil dissipation
Soil dissipation (long-term)
Rotational crop accumulation (confined and field)
Fish accumulation
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B. Toxicology Characteristics
Extensive data gaps exist for prometryn and few definitive
conclusions can be made pending receipt and evaluation of
additional data. The following assessment is based on the
limited data available.
Several long-term studies were performed using formulated
end use products. While data on formulated products are not
routinely included in Registration Standards, an exception was
made in this case since these represent the only long-term
studies for prometryn. These studies are discussed under the
headings, Chronic Toxicity, Teratogenicity and Reproduction.
Acute Toxicity
. Data from acute oral and acute dermal toxicity studies
place technical prometryn in Toxicity Category III.* Primary
skin irritation data indicate that technical prometryn is not
a primary skin irritant (Toxicity Category IV). There are no
acceptable acute inhalation, eye irritation or dermal
sensitization studies. These studies are required.
Subchronic Toxicity
Data are not available to assess subchronic toxicity.
A 21-day dermal study in rabbits using technical prometryn is
required. '.
Chronic Toxicity
A chronic feeding study in rats was performed using a 50WP
(wettable powder) formulation (50% ai). The doses tested,
2.5, 12.5, and 62.5 mg ai/kg/day, were too low to elicit toxicity
and too few animals were tested. For these reasons, this.
study was classified Core Supplementary.
A chronic feeding study in dogs tested dosages of 0.0,
0.375, 3.75, and 37.5 mg ai/kg/day, using prometryn 80WP
(80% ai). Groups of three male and three female beagle
dogs were dosed with prometryn in their feed for 106 weeks.
Toxicity Categories are based on the acute toxicity of the
chemical (LD5Q or LC5Q values) and are used to determine the
appropriate signal word and precautionary language for product
labeling. Toxicity Category III requires the signal word
CAUTION and precautions against swallowing, inhaling, or
contact with the skin and eyes, along with appropriate first
aid instructions. Toxicity Category IV also requires the
signal word CAUTION, but no precautionary statements are
required. See 40 CFR 162.10.
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Three dogs/sex/group were used instead of the currently
recommended four dogs/sex/group, and a minimum of clinical
pathology tests were used. Despite these deficiencies, this
study was well run and adequately documented and was therefore
classified Core Minimum. The only indications of toxicity were
found histopathologically and included degenerative hepatic
changes, renal tubular degeneration, and bone marrow atrophy.
These effects are considered minor since no corresponding
anomalies were seen in the clinical pathology tests. The
NOEL (no-observable-effect level) for these effects was
3.75 mg ai/kg/day. The LEL (lowest effect level) was
37.5 mg ai/kg/day. This study fulfills the chronic feeding
(non-rodent) data requirement.
A chronic feeding, study in rodents using technical
prometryn is required.
Oncogenicity
There are no oncogenic studies available to assess
oncogenicity. Neither the rat nor the dog chronic feeding
studies (previously discussed) demonstrated any oncogenic
potential. ^Oncogenic studies in 2 species (rat and mouse) are
required.
Teratogenicity
A rabbit teratology .study using formulated prometryn
(purity not given) tested doses of 0, 2, 12, and 72 mg ai/kg/day,
Although the purity is unknown, the Agency believes that the
test material did approach the purity of the technical. The
results were:
Embryotoxicity NOEL and developmental toxicity
NOEL > 72 mg ai/kg/day (HOT) :
Maternal toxicity NOEL and fetotoxicity
NOEL =12 mg ai/kg/day
Maternal toxicity LEL and fetotoxicity
LEL = 72 mg ai/kg/day
Developmental toxicity index (A/D) = 72/72 = 1
This study was well run and adequately assessed the potential
for teratogenicity in rabbits. The study is classified Core
Minimum and fulfills the teratology (rabbit) data requirement.
A teratology study in rats using technical prometryn
is required.
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Reproduction
Data are not available to assess reproductive effects
of technical prometryn. One study is available but was
performed using prometryn 50WP (50% ai). The doses tested,
0«0, 2.5, and 5.0 mg ai/kg/day, were too low to elicit a toxic
effect. The study is classified as Core Supplementary and
does not fulfill the data requirement for a 3-generation
reproduction study.
A reproduction study in rats using technical prometryn
is required.
Mutagenicity .J
There are no acceptable data to assess mutagenicity.
Thus, gene mutation, chromosomal aberration, and direct
DNA damage assays.are required.
C. Other Science Findings
Environmental Fate
Available data are insufficient to fully assess the
environmental fate of prometryn. Data Table A lists the
required environmental fate studies. Available data indicate
that prometryn has a propensity to leach, has hydrolytic
stability, and is persistent in the soil. The leaching studies
reviewed (soil columns, soil thin layer chromatography and
adsorption/desorption) indicate that prometryn has intermediate
mobility in sandy loam soils and high mobility in sandy
soils. Mobility appears to be related to organic content of
the soil; the lower the organic content, the more mobile
prometryn is in the soil. Pending the results of additional
required leaching and soil field dissipation studies, a ground
water monitoring study may be required.
Exposure
Since the currently available data do not indicate a
basis for concern,.the Agency is deferring any requirements
for exposure data. Should the toxicity studies required in
this Standard indicate a concern for human exposure, appropriate
exposure data will be required.
Ecological Effects
a. Terrestrial Organisms
Based on available data, technical prometryn is not acutely
toxic to birds. An acute oral LD5Q value was determined to be
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greater than 4640 mg/kg for mallard ducks. When administered
through the diet, prometryn (80% ai) was found to have an LC5Q
value (converted to 100% ai) of 34,512 ppm (5-day exposure) for
mallards. The avian dietary LC5Q Guidelines requirement for
upland game birds is unfulfilled, therefore this study is
required.
No avian reproduction study was available for evaluation.
This study is required because (1) prometryn is expected to be
stable in the environment, (2) the pesticide may be stored or
accumulated in plant or animal tissues, and (3) prometryn may be
applied up to five times (on cotton) thus, permitting repeated
or continuous exposure.
There is sufficient information to characterize prometryn
as relatively nontoxic to honeybees.
b. Aquatic Organisms
A Daphnia magna 48-hour LC5Q value of 18.59 ppm indicates
that technical prometryn is slightly toxic to freshwater
invertebrates. Fish acute tbxicity data indicate that technical
prometryn is moderately toxic to warmwater (bluegill sunfish)
and coldwater fish (rainbow trout). Acute LCsg values of 10.0
ppm and 2.9 ppm were reported in bluegill sunfish and rainbow
trout, respectively;.
The aquatic estimated environmental concentration (EEC)
calculated by the Agency is 0.25 ppm. Since the EEC is
greater than 1% of both freshwater fish and aquatic invertebrate
LC5Q in acute toxicity testing of the technical, a fish early
life stage and aquatic invertebrate life-cycle study on the
technical are required. The use pattern on corn and cotton
triggers concern for exposure to estuarine and marine organisms.
Therefore, acute estuarine and marine studies are required to
assess the potential hazard to these organisms.
c. Endangered Species
The use of prometryn on corn and cotton may pose a hazard
to endangered species. The registered use of this chemical on
corn permits a single application, as well as multiple
applications. A single application of prometryn per year is
not expected to harm most animal species, due to its low
toxicity, except by destruction or adverse modification of
habitat. However, there is concern for the endangered species,
Solano grass and Valley Elderberry longhorn beetle, both of
which occur in California, following a single application on
corn. Proposed Labeling has been designed to protect these
species.
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For multiple applications per year, and based on an
assumption of jeopardy for the endangered species cluster*
information available to the Agency, prometryn was found to
pose potential hazards (due to sufficiently high application
rates and the half-life of prometryn) to the following endangered
species:
For corn: Everglade kite (potential harm to the apple
snail), Mollusks, Scioto madtom, Slackwater darter,
Solano grass, Valley Elderberry longhorn bettle
(destruction of elderberry wood), Woundfin, Delta Green
ground beetle, Kern Primrose sphinx moth.
For cotton: Alabama cavefish, Bayou darter, Comanche
Springs pupfish, Fountain darter, Gila topminnow,
Mollusks, Leopard darter, San Marcos gambusia,
Slackwater darter, Houston toad, Pecos gambusia.
Proposed endangered species labeling has been designed to
protect these species when there are multiple applications of
prometryn.
The following proposed endangered species labeling is
based on an assumption of jeopardy from the crop cluster and
will be required once the Agency receives concurrence from the
U.S. Fish and Wildlife Service.
a. THE FOLLOWING ENDANGERED SPECIES LABELING FOR CORN
USE WITH ONE APPLICATION PER SEASON IS PENDING U.S.
FISH AND WILDLIFE SERVICE CONCURRENCE.
"ENDANGERED SPECIES RESTRICTIONS
Use of this product is controlled to prevent death
or harm to endangered or threatened species that
occur in the counties listed below. The use of
this product may pose a hazard to certain Federally-
designated endangered species (namely Solano grass
and Valley F.lderberry longhorn beetle) known to
occur in specific areas within the CALIFORNIA
counties of Butte, Colusa, Glenn, Merced, Sacramento,
San Joaquin, Solano, Tehama, and Yolo. Before
using this pesticide in these counties, you must
obtain the ENDANGERED SPECIES BULLETIN for the county
in which the product is to be used. These bulletins
* Under the cluster program, the Agency assesses the
individual risk to endangered species, from all chemicals
within the same use pattern (or "cluster") together.
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are available from your local pesticide distributor,
your County Agricultural Extension Agent, the
Endangered Species Specialist in your State
Wildlife Agency Headquarters, and the appropriate
Regional Office of either the U.S. Fish and
Wildlife Service in Sacramento, California or the
U.S. Environmental Protection Agency. THESE
BULLETINS MUST BE REVIEWED PRIOR TO PESTICIDE USE.
USE OF THIS PRODUCT IN A MANNER INCONSISTENT WITH
THE ENDANGERED SPECIES BULLETIN IS A VIOLATION OF
FEDERAL LAWS."
THE FOLLOWING ENDANGERED SPECIES LABELING INFORMATION
FOR CORN AND COTTON USES WITH MULTIPLE APPLICATIONS IS
PENDING CONCURRENCE FROM THE U.S. FISH AND WILDLIFE
SERVICE.
"ENDANGERED SPECIES RESTRICTIONS
Use of this product is controlled to prevent death
or harm to endangered or threatened species that
occur in the counties listed below. Before using
this pesticide in these counties, you must obtain
the ENDANGERED SPECIES BULLETIN for the county in
which the product is to be used. These bulletins
are available from your local pesticide distributor,
your County Agricultural Extension Agent, the
Endangered Species Specialist in your State Wildlife
Agency Headquarters and the appropriate Regional
Office of either the U.S. Fish and Wildlife Service
or the U.S. Environmental Protection Agency. THESE
BULLETINS MUST BE REVIEWED PRIOR TO PESTICIDE USE.
USE OF THIS PRODUCT IN A MANNER INCONSISTENT WITH
THE ENDANGERED SPECIES BULLETIN IS A VIOLATION OF
FEDERAL LAWS.
ALABAMA
Counties
Colbert, Jackson, Lauderdale, Limestone, Madison,
Marshall, Morgan
ARIZONA
Counties
Graham, Maricopa, Mohave, Pima, Final, Santa Cruz
ARKANSAS
Counties
Clark,Clay, Cross, Hot Spring, Jackson, Lawrence,
Monroe, Poinsette, Polk, Randolph, Sharp, St. Francis,
Swier, White, Woodruff
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CALIFORNIA
Counties
Butte, Colusa, Glenn, Kern, Merced, Sacramento,
San Joaquin, Solano, Tehama, Yolo
FLORIDA
Counties
Broward, Dade, Glades, Indian River, Osceola,
Palm Beach, Polk, St. Lucie
KENTUCKY
Counties
Ballard, Edmundson, Green, Jackson, Laurel,
Livingston, Marshall, McCracken, Monroe,
Pulaski, Rockcastle, Russell, Taylor, Trigg,
Warren, Wayne, Whitley
MISSISSIPPI :::
Counties
Claiborne, Copiah \ '
NEVADA
Counties
Clark
NEW MEXICO
Counties
Chaves, Eddy
OHIO
Counties
Champagne, Franklin, Logan, Madison, Pickaway,
Union
OKLAHOMA
Counties
McCurtain, Pushmataha
TENNESSEE
Counties
Benford, Blount, Claiborne, Coffee, Decatur,
Franklin, Hancock, Hawkins, Lawrence, Lincoln,
Loudon, Marion, Marshall, Maury, Perry, Rhea,
Roane, Scott, Sequatchie, Smith, Sullivan,
Trousdale, Wayne, Wilson
TEXAS
Counties
Bastrop, Burleson, Comal, Hays, Jeff Davis,
Pecos, Reeves
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UTAH
Counties
Washington
VIRGINIA
Counties
Lee, Russell, Scott, Smyth, Tazewell, Washington,
Wise"
Prometryn is registered for use on celery and pigeon peas
which have not yet been reviewed in the cluster program. It is
anticipated that little exposure to threatened and endangered
species will occur with these uses. • ;
d. Plant Protection
No plant protection studies were available for review. :
Phytotoxicity testing is required on a case-by-case basis
to support products that may pose hazards to endangered or
threatened species. As previously discussed, prometryn when
applied as a preemergent herbicide on corn may pose a hazard
to several endangered species including Solano grass and the
Elderberry longhorn beetle (an insect which feeds on elderberry
wood). Therefore, the following phytotoxicity studies are
required: seed germination/seedling emergence, vegetative
vigor, and aquatic plant growth.
D. Tolerance Reassessment
Tolerances have been established for residues of prometryn
in or on a variety of raw agricultural commodities (40 CFR
180.222). EPA has evaluated the residue and toxicology data
supporting tolerances, and has addressed the following
regulatory issues:
a. Whether the current tolerances are sufficient to cover
the actual residues resulting from use (including uses
registered under FIFRA section 24(c) and intrastate
uses and methods of applications).
b. Whether group tolerances could be established in
accordance with 40 CFR 180.34(f).
c. Whether, in the absence of tolerances, restrictions
on use, grazing, or feeding of treated commodities are
necessary.
d. Whether the tolerances are expressed accurately and in
current terminology.
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The regulatory results of the Agency's review are set out
in Section IV.A., Regulatory Positions and Rationales.
Residue Data
The residue data reviewed in support of these tolerances
include the following:
a. Data on the nature of the residues in both plants and
animals, including identification of major metabolites
and degradates of prometryn.
b. Radiolabeled studies on the uptake, translocation and
metabolism of prometryn in plants which show that
prometryn is absorbed by the roots and is translocated
to the foliage.
c. Radiolabeled studies on the metabolism and
translocation of prometryn in rats which show that
most of the administered r^C] prometryn was excreted
in urine and feces. Tissues contained 2.94 to 3.71
percent of the total dosed ^4C-activity. 14C-activity
was detected in blood, kidney, liver, heart, muscle,
fat, and reproductive organs.
d. Analytical methodology for determining the levels of
residues of prometryn in plants and animals. Adequate
gas chromatographic (GC) and ultraviolet (UV) spectro-
photometric methods are available for the collection
of data pertaining to residues of prometryn per s_e_
in or on plant commodities. Neither method has been
subjected to a method tryout. The Agency recommends
that the gas chromatographic method undergo a method
trial (performed by the Agency) to confirm that this
method is adequate for enforcement purposes.
e. Storage stability data demonstrating that residues of
prometryn are stable in or on pigeon peas for up to 42
days when stored in plastic containers at 10 °F (-12 °C)
and in milk stored at -10 °C for up to 28 days.
f. Data on magnitude and levels of residues of prometryn
in individual raw agricultural commodities.
Toxicology Data
The toxicology data considered in support of the tolerances
include: a chronic feeding study in dogs with a NOEL of 3.75
mg ai/kg/day and a rabbit teratology study with a fetotoxic and
maternal NOEL of 12 mg ai/kg/day, and an embryotoxicity and
developmental toxicity NOEL of 72 mg ai/kg/day.
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The provisional acceptable daily intake (PADI) for prometryn
is 0.004 ing/kg/day. The PADI is based on the 2-year dog feeding
study. The NOEL was 3.75 mg/kg/day and an uncertainty factor
of 1000 was used. An uncertainty factor of 1000 was chosen
because (1) it is not clear whether another species will prove
to be more sensitive to prometryn than the dog and (2) calculations
were based on the inadequate chronic rat data available to the
Agency. The PADI of 0.004 mg/kg/day is equivalent to a maximum
permissible intake (MPI) of 0.24 mg/day for a 60 kg individual.
The theoretical maximum residue contribution (TMRC) of prometryn
in the daily diet is 0.000205 mg/kg/day based on the existing
tolerances and a daily food intake of 1.5 kg, with 5.13 percent
of the PADI being utilized.
Tolerances Issued
The following tolerances have been established for residues
of prometryn:
Commodity Tolerance (ppm)
Celery 0.5
Corn, fodder, field 0.25
Corn, fodder, pop 0.25
Corn, fodder, sweet • 0.25
Corn, forage, field 0.25
Corn, forage, pop 0.25
Corn, forage, sweet 0.25
Corn, fresh (inc. sweet K+CWHR) 0-25
Corn, grain 0.25
Cotton 1.00
Cottonseed 0.25
Pigeon peas 0.25
Canadian tolerances have been established for residues of
prometryn in or on celery, pigeon peas and corn at 0.1 ppm
(negligible residues).
No Mexican or Codex Alimentarius tolerances have been
established for prometryn.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITION AND RATIONALE
Based on review and evaluation of all available data and
other relevant information on prometryn, the Agency has made
the following determinations:
1. The Agency is not initiating a Special Review of
prometryn at this time.
Rationale; Since available data are limited, the
Agency is not yet able to make a determination as
to whether any of the criteria specified in
40 CFR 154.7 have been met or exceeded.
2. The Agency will not establish significant* new food uses
until additional residue chemistry and chronic
toxicology data are available to assess existing uses.
Rationale; It is Agency policy not to establish
significant new uses where major data gaps exist. When
additional data are evaluated, the Agency will determine
whether significant new food uses may be established.
3. The Agency is not imposing any reentry statements nor
is it requesting that reentry data be submitted.
Rationale; No toxicological concerns which would
indicate the need for reentry statements or reentry
data have been identified at this time. This
conclusion is subject to change based on evaluation
of required toxicological data.
4. The Agency is proposing endangered species labeling
for prometryn products labeled for corn and cotton
use. Refer to Section III C, under Endangered Species
for proposed labeling, requirements.
*Significant new use is defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will
consider as significant an increase in Theoretical Maximum
Residue Contribution of greater than 1 percent.
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Rationale; The uses, corn and cotton, pose potential
hazard to endangered species, based on an assumption
of jeopardy for the crop cluster. In order to protect
endangered species in areas where prometryn is used, on
corn and cotton, endangered species labeling will be
required once the Agency receives concurrence from
the U.S. Fish and Wildlife Service. At that time,
a PR (Pesticide Registration) Notice will be issued
in order to notify registrants of the final label
requirements for endangered species.
5. The Agency is requiring toxicology studies. Refer to
the data table in Appendix I for details of toxicology
studies required.
Rationale; Acute, subchronic, chronic, oncogenicity,
reproduction, mutagenicity, teratology, and metabolism •
studies on technical prometryn are required in order
to complete the data base for prometryn.
6. The Agency is requiring environmental fate studies
on prometryn and may require a ground water monitoring
study. Refer to the data table in Appendix I for
details of environmental fate studies required.
Rationale: Available data are inadequate to fully
assess the environmental fate of prometryn.
Degradation, leaching, accumulation, soil field
dissipation and metabolism studies are required.
A decision regarding the need for a ground water
monitoring study will be made following submission
and review of leaching and soil field dissipation
studies.
7. The Agency is requiring additional fish and wildlife
studies which are necessary to support continued
registration of prometryn products. Refer to the data
table in Appendix I for details on the fish and wildlife
studies required.
Rationale; Available data are insufficient to fully
assess the effects of prometryn on fish and wildlife.
8. The Agency is requiring plant protection studies.
Rationale; Based on endangered species concerns,
phytotoxicity data are required. Refer to the data
table in Appendix I for details.
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9. The Agency is requiring residue chemistry data
on prometryn.
Rationale; The metabolism of prometryn in plants and
animals is not adequately understood. Metabolism
studies are required in cotton and celery. Metabolism
studies utilizing ruminants and poultry are also
required. Storage stability and residue data in or on
meat, milk, poultry, and eggs are required.
10. The Agency will not require additional residue data on
corn, corn forage, corn fodder, pigeon peas and cotton.
Rationale; Sufficient data are available to ascertain
the adequacy of the established tolerances.
11. The Agency is requiring crop residue data on celery
and processing studies on corn.
Rationale: Available data are insufficient to ascertain
the adequacy of the established tolerances for residues
on celery. Storage stability.and plant metabolism data .
must .be submitted prior to magnitude of residue data on
celery and corn. Processing studies on corn are
required.
12. The Agency has determined that the following revisions
in the tolerances listed in 40 CFR 180.222 are
necessary and will initiate actions to effect these
changes. ;
0 The entries "corn fodder, sweet" and "cotton" must
be deleted from 40 CFR 180.222.
0 The tolerance expression should include the parent
compound and all triazine-containing analogs _and
metabolites which are of toxicological concern.
Rationale;
0 "Corn fodder, sweet" is not considered
a raw agricultural commodity of sweet corn.
. This term is a misnomer since corn fodder is
harvested at a different time interval than
sweet corn. A feeding/grazing restriction is
currently in effect for cotton forage, thus the
entry "cotton" (presumably intended to cover
cotton forage), must be deleted.
0 Established tolerances are based on the parent
compound only. All triazine-containing analogs and
metabolites of toxicological concern must be
included in the tolerance expression. The
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toxicological relevance of the 11 impurities
representing 3% of the 97% technical, cannot be
determined until mammalian metabolism and
quantitative product chemistry data are submitted.
13. Crop group tolerances are not being established at
this time.
Rationale; Crop group tolerances are not appropriate
at the present time due to a lack of proposed use
directions and appropriate supporting residue data.
14. The Agency has identified certain data that will
receive immediate review when submitted.
Rationale: Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may
trigger the need for further studies which should be
initiated as soon as possible. The following
studies have been identified to receive priority
review as soon as they are received by the Agency:
§153.130 Environmental Fate
163-1 Leaching and Adsorption/Desorption
164-1 Soil Field Dissipation
15. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products
(EPs) containing prometryn as the sole active ingredient
may be sold, distributed, formulated, and used, subject
to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional
data, as specified in the Data Appendices, in order to
maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data
are missing or are inadequate (see FIFRA section
3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed
and evaluated, after which the Agency will determine
if additional regulatory changes are necessary.
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B. CRITERIA FOR REGISTRATION
TO be registered or reregistered under this Standard,
products must contain prometryn as the sole active ingredient,
bear required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in
this section.
:C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain prometryn as
the sole active ingredient. 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.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing prometryn provided .
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each product
is placed.
3. Use Patterns
To be registered under this Standard, technical grade or
manufacturing-use products containing prometryn must be labeled
for formulation into end-use products registered only for the.
uses listed in Appendix III, EPA Index to Pesticide Chemicals—
Prometryn. This Index lists all registered uses, as well as
approved maximum application rates and frequencies.
D. REQUIRED LABELING
All MPs (and EPs if covered by this Standard) must bear
appropriate labeling as specified in 40 CFR 162.10. Appendix
II contains information on tabel requirements.
No pesticide product containing prometryn may be released
for shipment by the registrant after May 1, 1988, unless the
product bears an amended label which complies with the
requirements of this Standard.
No pesticide product containing prometryn may be
distributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having been so received)
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delivered or offered to be delivered by any person after
May.1, 1989, unless the product bears an amended label which
complies with the requirements of this Standard.
In addition, to the above, the following information must
appear on the labeling:
1. Ingredient Statement
The ingredient statement for MPs must list the active
ingredient as:
"Prometryn: 2,4-bis(isopropylamino)-6-(methylthio)-
: £-triazine"
2. Use Pattern Statement
All technical grade and manufacturing-use products shall
state that they are intended only for formulation into end-use
products registered for one or more of the uses listed in the
EPA Index to Pesticide Chemicals for Prometryn, Appendix III.
However, no use may be included on the label if the registrant
fails to agree to comply with data requirements in Table A Jfor
that use pattern.
3. Precautionary Statements
The following statement shall appear on manufacturing-use
products:
"Do not discharge effluent containing technical
grade or manufacturing-use products containing
prometryn into lakes, streams, ponds, estuaries,
oceans, or public waters unless this product
is specifically identified and addressed in an
NPDES permit. Do not discharge effluent
containing this product to sewer systems without
'previously notifying the sewage treatment plant
authority. For guidance, contact your State Water
Board or the Regional Office of EPA."
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All end-use products shall bear the following
statements:
a. Feeding/Grazing Restriction
"Do not allow livestock to feed or graze on
treated cotton crops."
b. Environmental Precautions
"Do not apply directly to water
or wetlands (swamps, bogs, marshes, :
and potholes). Do not contaminate
water by cleaning of equipment
or disposal of wastes."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not. contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption-*, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.^
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement, inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data; you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the •
Agency.
D. How to comply with PCI requirements. :
Within 90 days.of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
85BO-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data,but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also.provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The-request must
include the following information:
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a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the. products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement: to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a .product when the registrant has in good faith sought and '
continues to seek to enter into a data development/cost '
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter .into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your :
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA'
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data.
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4. You request a waiver of the data requirement. If
you believe that a data requirement does not(or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses, of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed"!
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before.beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given, to conduct studies due to submittal of inappropriate
protocols.
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
reque.st for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
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xn writing to the Office of Compliance Monitoring at the
address given in Section IX.E.
EPA will view failure to request an extension before
the response deadline as a waiver of any future claim that
there was insufficient time to submit the data. While EPA
considers your request, you must,strive to meet the deadline
for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency.believes
that with proper planning these can be overcome. Time extensions
may be considered when joint data development is planned,
or when the Agency must approve a' new or modified protocol
before the study can be begun.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may .not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data) ',
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the .
product's registration.
33
-------
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
34
-------
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing Prometryn
as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.^
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.PO-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B) .
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a moekup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
35
-------
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data,.unless
you are eligible for the formulator's exemotion. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing Prometryn
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing Prometryn as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments* (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
36
-------
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mocTcup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing Prometryn either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructxng them how to submit an application for registration.
E. Addresses
The required information must be submitted to the following
address:
Robert J. Taylor, PM-25
Registration Division (TS-767C)
Office of Pesticide Programs ;
Environmental Protection Agency
401 M St., SW
Washington, B.C. 20460
The address for submissions to the Office of Compliance
Monitoring is: •
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW ;
Washington, D.C. 20460.
37
-------
GUIDE TO TABLES
Tables A and B contains listings of data requirements for the
pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the following
format:
1. Data Requirement (Column 1). The data requirements are :
listed in the order in which they appear in 40 CPR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
'follows: ;
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product :
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CPR Part 158. The following
: letter designations are used for the given use patterns:
A = Terrestrial, food _ • .
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
38
-------
1. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by other
registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitted, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional
information. .
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the .
identifying number of each study. This normally is the
Master Record Identification (MRID) number, but may be a
GS number if no MRID number has been assigned. Refer to
the Bibliography Appendices for a complete citation of the
study.
6. Must additional data be submitted? (Column 6). This column
indicates whether the data must be submitted to the Agency.
If column 3 indicates that the Agency already has data, this
column will usually Indicate No. If column 3 indicates that
the Agency has only partial data or no data, this column will
usually indicate YES. In some cases, even though the Agency
does not have the data, EPA will not require its submission
because of the unique characteristics of the chemical;
because data on another chemical can be used to fulfill the
data requirement; or because the data requirement has been
waived or reserved. Any such unusual situations will be
explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires that
data be submitted, this column indicates when the data are to
be submitted, based on the issuance date of the Registration
Standard. The timeframes are those established either as a
result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
39
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Data Requirement Test Use Does EPA Bibliographic
Substance Patterns Have Data?J/ Citation^/
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI All N/A N/A
Materials and Manufacturing
Process
61-2 - Discussion of Formation of TGAI All N/A N/A
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI All N/A N/A
Physical and Chemical
Characteristics
Must Additional
Data be
Submitted?
Yes2/3/
YesV
Yes£/
Time frame
for
Submission
6 Months
6 Months
12 Months
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
TGAI
TGAI
TGAI
TGAI
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Data Requirement
§15&r1
Test
Substance
Use Does EPA Bibliographic Must Additional Timeframe
Patterns Have Data?1/ Citation1/ Data be for
Submitted? Submission
20 Product Chemistry (continued)
Physical and Chemical Characteristics
(Continued)
63-6 - Boiling Point
63-7 -
63-8
63-9
63-10
63-11
63-12
63-13
Other
64-1
Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- pH
- Stability
Requirements :
- Submittal of Samples
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
TGAI, PAI
All
All
All
All
All
All
All
All
All
N/A&_/
N/A
N/A
N/A
N/A
N/A
N/AJ£/
N/A
N/A
N/A No
N/A Yes?/
N/A Yes#/
N/A Yes£/
N/A Yes
N/A Yes
N/A No
N/A Yes
N/A No
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
J_/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
{^ data must be updated. Therefore bibliographic citations for the old data are not applicable.
(Footnotes continued on next page)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
FOOTNOTES (cont'd)
§158.120 Product Chemistry
2J Details of the manufacturing process, including the relative amounts of beginning materials, a description of
equipment used to produce the product, reaction conditions, the duration of each step of the process, and
purification procedures and quality control measures for EPA Registration Nos. 100-542, 2749-278, 46386-2, and
the unregistered 97% technical are required.
_3/ The name and address of manufacturer, producer, or supplier of each beginning material used to manufacture
EPA Registration Nos. 100-542, 2749-278, 46386-2, and the unregistered 97% technical are required. Also, a copy
of all available technical specifications, data sheets, and other documents in which the manufacturer, producer,
or supplier of the beginning material describes the composition and properties must be submitted.
kj A discussion of each impurity believed to be present at 0.1% or more based on knowledge of the beginning materials,
all possible chemical reactions and any contamination is required.
_5/ Five or more representative sanples of the registered technicals must be analyzed for prometryn. In addition,
five or more representative samples must be analyzed for each impurity present at 0.1% or more (w/w) and each
additional "toxicologically significant" impurity by analytical methods supported by validation studies of their
precision and accuracy. The Agency determines what is "toxicologically significant" based on the results
from the data required in 61-3 and 62-1.
61 Not applicable since the technical is a solid at room temperature.
TJ Density, bulk density, or specific gravity must be determined at 20 °C or 25 °C.
8i/ Solubility in representative polar and nonpolar organic solvents must be reported in g/100 ml, ppm, or similar
terms and must be determined at 20 °C or 25 °C.
9/ Vapor pressure must be determined at 25 °C.
1Q/ Not applicable since the technical cannot be dispersed with water.
ro
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission
§158.125 Residue Chemistry
171-2 - Chemical IdentityV TGAI
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant Residues
- Animal Residues
PAIRA
PAIRA
TGAI
TGAI &
Metabolites
Yes
Partially
Partially
Partially
Partially
Product Label
00022855,00023213,
00024378,00055672,
00093542,00125011,
00125013
00093337,00093338,
00093339
00024779,00027330,
00056556,00105780,
00106829,00121720,
00123218,00125011,
00125015,05016141
00023280,00093535,
00093536,00121720
No
Yes2/3/4/
Yes3/5/
Yes6/7/
No8/
18 Months
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
Data Requironent
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.125 Residue Chemistry (continued)
4 - Storage Stability PAI
- Magnitude of the Residue -
Residue Studies
Crop Field Trials^/
Leafy Vegetables '
Group1*/
- Celery
Legume Vegetables
Group13/
- Pigeon Peas
Cereal Grains
EP
EP
Corn (Field,
Sweet and
Popcorn)
Forage, Fodder,
and Straw of
Cereal Grains
Group1?/
TEP
Partially
Partially
Yes
Partially
00093535,00121720
Yes4/?/
18 Months
00034043,00093529,
00093548
00125015
00024696,00093530
Yes12/
36 Months
Yes16/
36 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.125 Residue Chemistry (continued)
Corn Forage
and Fodder1"/
TEP
Yes
00024696,00093530,
00125012
No
171-1 - Magnitude of the Residue -
Residue Studies
Crop Field Trials
Miscellaneous
Commodities
- Cottonseed^/
Yes
Ln
Meat/Milk/Poultry/
Eggs
Partially
00027329,00027330,
00056556,00065048,
00093531,00105780,
00106358,00106481,
00106829,00125011
00093535,00093536
No
Reserved*^/
I/ Refer to Product Chemistry Data Requirement table.
2/ Cotton and celery are to receive postemergence soil applications of [-^ C] prone tryn at or above the maximum
registered rate under conditions comparable to those specified in the label directions. Uptake, distribution,
and metabolism of prometryn must be characterized. Terminal residues in or on mature plant parts must be
identified and quantified. Residue identification must be confirmed by a method such as GC, HPLC, and/or
mass spectrometry. Submitted data must also depict efficiency of extraction procedures.
3/ Metabolism data should be submitted prior to completion and submission of residue data, since the data
required for individual commodities are dependent on metabolism data.
V Storage stability and plant metabolism data are required prior to submitting magnitude of residue data
on celery and corn.
(Footnotes continued on the next page)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
§158.125 Residue Chemistry (continued)
5/ Ruminants and poultry are to be dosed for at least 3 days with ring-labeled [l^C]prometryn at a concentration
In the total diet that will result In sufficient residues In tissues, milk, and eggs for characterization.
Animals are to be sacrificed within 24 hours of the final dosing. Milk and eggs must be collected twice daily.
^C-Residues In muscle, fat, kidney, liver, milk, and eggs must be characterized. Samples from requested
metabolism studies must also be analyzed using accepted enforcement methods.
6_/ Submit an acceptable analytical procedure for enforcement of prometryn tolerances in the various commodities of
concern.
77 If the requested data regarding the nature of the residue in plants reveal additional metabolites of toxicological
concern, additional analytical methods for data collection and enforcement may be required.
8/ Data are not required at the present time since there are no tolerances for residues of prometryn in animal
commodities. . •
9/ Details of storage intervals and conditions of samples used to support all established tolerances for
residues of prometryn must be submitted. These data must be accompanied by data depicting the percent
decline in residues at the time and under the conditions specified. It should also be noted that all
residue data requested in this standard must be accompanied by data regarding storage Intervals and conditions
of sample storage. These data must be accompanied by fortification recovery data depicting the stability of
prometryn residues of concern in appropriate sample substrates under the conditions and for the time intervals
specified.
10/ If requested plant metabolism studies reveal the presence of additional metabolites of concern, then data will be
required depicting residues of these metabolites in or on treated foods or feeds. The crop group conclusions
stated below address only the minimum residue chemistry data base acceptable for purposes of establishing a group
tolerance. The registrant should consider the complete data requirements stated In the 40 CFR 180.34 If they
elect to propose crop group tolerances.
ll/ Should the registrant seek a crop group tolerance, proposed use directions and supporting residue data must be
submitted for residues of prometryn in or on lettuce (head and leaf) and spinach. Also, additional data are
required to support the existing tolerance for prometryn In or on celery.
12/ Data must be submitted depicting prometryn residues in or on celery harvested at maturity following a single
posttransplant application of, in separate tests, the 4 Ib/gal EC at: (i) 3.2 Ib ai/A in HI; (ii) 2 Ib al/A in
CA and either MI, OH, or WI; and (ill) 1.6 Ib ai/A in FL.
13/ Should the registrant seek a crop group tolerance, proposed use directions and appropriate supporting residue
data must be submitted for beans (Phaseolus spp. , one succulent variety and one dried variety), and soybeans.
14/ No additional data are required for pigeon peas since no detectable residues were observed in peas or pods treated
at a 1.1X rate.
Os
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TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
§158.125 Residue Chemistry (continued) " .
15/ Should the registrant seek a crop group tolerance, proposed use directions and supporting residue data must be
submitted for rice, sorghum, and wheat.
l6/ Data must be submitted which depict the potential for concentration of prometryn residues of concern during
. processing of crude oil, re'fined oil, starch, grits, meal, and flour derived from treated field corn grain bearing
measurable weathered residues. . If the data Indicate a potential for concentration of residues in any of these
processed commodities, appropriate food/feed additive tolerances must be proposed.
177 If the registrant seeks a crop group tolerance, use directions must be proposed and appropriate supporting residue
data submitted for forage of wheat and one other cereal grain crop.
l8/ The Agency will initiate action to delete the entry "corn fodder, sweet" since this item is not considered
a raw agricultural commodity of sweet corn.
19/ The Agency will initiate action to delete the entry "cotton" since a feeding restriction is currently In effect
for cotton forage.
20/ No conclusions can be reached at this time as to the magnitude of residues of pronetryn in animal products because
the magnitude of the residue in feed items, metabolism in plants, and metabolism in animals are not adequately
defined. Upon receipt of these data the Agency will determine the necessity of tolerances in animal products,
and may require submission of these data.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PROMETRYN
Date
§158.
Requirement
135 Toxicology
Test
Subs tance
Use
Patterns
Does EPA
Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timeframe
for
Submission
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
Yes
Yes
No
No
Yes
No
N/A
00060646,00060314 No
00060647,00060315 No
Yes
Yes
00060649,00060316 No
Yes
No]/
9 ^nths
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90- Day Feeding:
- Rodent, and
- Nonrodent
- 21 -Day Dermal - Rabbit
- 90- Day Dermal - Rabbit
- 90-Day Inhalation - Rat
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
No
No
No
No
No
Nq2/
Nq3/
Yes
NqV
NoV
12 Months
oo
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Date
§158.
82-5
Requirement
135 Toxicology (continued)
- 90-Day Neurotoxicity:
- Hen
- Mammal
Test
Substance
TGAI
TGAI
Use
Patterns
A
A
Does EPA
Have Data?
N/A
N/A
Bibliographic Must Additional
Citation Data be
Submitted?
NoV
NoV
Time frame
for
Submission
CHRONIC TESTING:
83-1
•^
83-2
83-3
83-4
- Chronic Toxicity -
2 species:
- Rodent, and
- Nonrodent (Dog)
- Oncogenicity -
2 species:
- Rat (preferred), and
- Mouse (preferred)
- Teratogenicity -
2 species:
- Rat
- Rabbit
- Reproduction - Rat
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
No
Yes
No
No
No
Yes
No
Yes
00042794 5/ No
Yes
Yes
Yes
00157995 5/ No
Yes
50 Months
50 Months
50 Months
15 Months
39 Months
2-generation
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Date Requirement
Test
Substance
Use Does EPA Bibliographic
Patterns Have Data? Citation
Must Additional
Data be
Submitted?
§138.135 Toxicology (continued)
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
TGAI
84-2 - Structural Chromosomal
Aberration
84-4 - Other Genotoxic Effects
SPECIAL TESTING
85-1 - General Metabolism
A
A
TGAI
PAI or PAIRA
No
No
No
No
Yes
Yes
Yes
Yes
I/
27
3/
*/
5/
Timeframe
for
Submission
9 Months
12 Months
12 Months
24 Months
This study Is not required since .the tost article is not an organophosphate.
Subchronic feeding data need not be submitted since chronic studies in the rat are required. However, the
Registrant should be aware tliat subchronic studies are useful and often necessary In determining the
maximum tolerated dose (MTD) used for oncogenicity studies in rodents (mice and rats).
A subchronic nonrodent feeding study is not required since an acceptable chronic dog feeding study was submitted,
Additional data are not required because of the nature of the exposure pattern.
This study was performed using formulated prometryn. The study is acceptable and fulfills this data
requirement.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
Data Requirement
§158.130 Environmental Pate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradatlon
161-2 - In Water
161-3 - On Son
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
t-H Adsorption/
— * Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Test
Substance
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TEP
TEP
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B No
A,B No
A No
A No
A,B Yes 00148338
A No
No
No
A,B No . .
A No
A No
Must Additional
Data be
Submitted?
Yes
Yes
Yes
YesV
No
Yes
No£/
No£/
Yes
YesV
Yes1/
Time frame
for
Submission
9 Months
9 Months
9 Months
9 Months
27 Months
12 Months
12 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
Data Requirement
§158.130 Environmental Fate
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish -
165-5 - In Aquatic Nontarget
Test
Substance
(continued)
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
; TEP
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B No
No
— No
A No
A,B No
A,B No
No
A,B No
— No
Must Additional
Data be
Submitted?
Yes
No2/
Nq2/
YesV
Yes
Yes
No2/
Yes
No2/
Time frame
for
Submission
27 Months
50 Months
39 Months
50 Months
12 Months
Organisms
SPECIAL STUDIES:
Ground water monitoring TEP
A,B
No
Reserved'*/
CJl
-------
TABLE A . .
GENERIC DATA REQUIREMENTS FOR FROMETRYN
§158.130 Environmental Fate - Continued
I/ Required based on product use pattern and other pertinent factors such as the results of toxicologlcal data
(i.e., acute inhalation studies)..
2/ Not required based on currently registered use patterns.
3/ Required because pesticide residues do not readily dissipate in soil.
¥/ Pending the results of acceptable leaching and soil field dissipation studies, a ground water
monitoring study may be required.
(Jl
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
Data
§158.
AVIAN
71-1
11-2
71-3
71-4
71-5
cn
Requirement
Test
Substance
Use
Pattern
Does EPA. Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
145 Wildlife and Aquatic Organisms
AND MAMMALIAN TESTING
- Acute Avian Oral Toxicity
— Avian Subacute Dietary
Toxicity
- Upland Game Bird
- Waterfowl
- Wild Mammal Toxicity
- Avian Reproduction
- Upland Game Bird
- Waterfowl
- Simulated Field Testing
- Mammals
- Birds
- Actual Field Testing
- Mammals
- Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B ,
A,B
A,B
Yes 00082966
No
YesV 00070686
No
No
No
No
-•No .
No
No
No
Yes
No
No!/
YesV
YesV
No£/
No£/
No£/
No£/
9 Months
24 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
Data Requirement Test
Substance
Use
Pattern
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
Timeframe
for
Submission
§158.145 Wildlife and Aquatic Organisms (continued)
AQUATIC ORGANISM TESTING
72-1 -
72-2 -
72-3 -
72-4 -
cn
Ln
Freshwater Fish Toxic Ity
- Coldwater Fish Species
- Warmwater Fish Species
Acute Toxicity to
Freshwater Invertebrates
Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Mollusk
- Shrimp
Fish Early Life Stage
and Aquatic Invertebrate
Life-Cycle
- Freshwater
- Estuarine
TGAI
TEP
THAI
TEP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A
A
Yes
Yes
Yes
Yes
Yes
No
. No
No
No
No
00070686 No
00121154,00024738 No
00070686 No
00121155,00040692 No
00070146 No
YesV
YesV
YesV
Yes^/
Reserved^/
12 Months
12 Months
12 Months
15 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
Cata
§158
72-5
72-6
Requirement
.115 Wildlife and Aquatic
- Pish Life-Cycle
- Freshwater
- Estuarine
- Aquatic Organism
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?
Tlmeframe
for
Submission
Organisms (continued)
TOAI
TGAI
TGAI
TGAI
TCAI
TGAI
A
A
A
A
A
A
No
No
No
No
No
No
Reserved7/
Reserved?/
Yes
Yes
Yes
Yes
12 Months
12 Months
12 Months
12 Months
72-7 - Simulated Field Testing
- Aquatic Organisms TEP
- Actual Field Testing
- Aquatic Organisms TEP
No
No
No2/
No2/
0\
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
FOOTNOTES
Wildlife and Aquatic Organisms (continued)
I/ The LC5o value from a study using 80.7? ai was adjusted to 100/6 active Ingredient, to fulfill this
requirement.
2/ Available information on this chemical and its use patterns indicate the study is not required.
3/ Required based on the potential for repeated exposure; ability to be bloaccumulated (Kow of 2880); and the
pesticide Is expected to be stable In the environment.
V Required to support crop uses associated with coastal counties, specifically cotton and corn.
5/ Required because the estimated environmental concentration in water is greater than 0.01 of the l£$Q for rainbow
trout and Daphnia magna, using technical prometryn.
6/ Reserved pending the results of estuarine acute studies.
77 Reserved pending the results of freshwater and marine fish early life stage studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRCMETRYN
Data Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
§158.150 Plant Protection
121-1
- TARGET AREA TEP A No
PHYTOTOXICITY
NoV
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
121-1
124-2
un
00
TIER I "
- Seed Germination/ TGAI A No
Seedling Emergence
- Vegetative Vigor TGAI A No
- Aquatic Plant Growth TGAI A No
TIER II .
- Seed Gemination/ TGAI A No
Seedling Emergence
- Vegetative Vigor TGAI A No
- Aquatic Plant Growth TGAI A No
TIER III
- Terrestrial Field TEP A No
- Aquatic Field TEP A No
Yes 9 Months
Yes 9 Months
Yes 9 IVbnths
Reserved^/
Reserved^/
Reserved^/
Reserved^/
ReservedB/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROMETRYN
FOOTNOTES
§158.150 Plant Protection
I/ Available Information on this chemical and Its use patterns Indicate the study Is not required.
2/ Reserved pending results of Tier I phytotoxicity tests.
3/ Reserved pending results of Tier II phytotoxicity tests.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FRQMETRYN
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time frame
for
Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
-1 - Honey Bee Acute
Contact Toxlcity TGAI
141-2 - Honey Bee - Toxiclty TEP
of Residues on
Foliage
141-4 - Honey Bee Subacute Reserved£/
Feeding Study
141-5 - Field Testing fc>r TEP
Pollinators
NONTARGET INSECT TESTING - .
AQUATIC INSECTS:
142-1 - Acute Toxicity to Reserved^/
Aquatic Insects
142-1 — Aquatic Insect ReservedB/
Life Cycle Study
';
142-3 - Simulated or Actual ReservedjV
ON Field Testing for
O Aquatic Insects
143-1 - NONTARGET INSECT ReservedV
thru TESTING - PREDATORS
143-3 AND PARASITES
A,B
A,B
Yes 00036935
No
No
NoV
A,B
No
NoV
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR ffiOMETRYN
FOOTNOTES
§138.155 Nontarget Insect (continued)
I/ As data frcm the acute study indicate low toxiclty to honey bees, 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.
CTs
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FROMETRYN
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Son Dissipation
133-3 - Dermal Exposure
1 33-4 - Inhalation Exposure
I/ Not required because this
ON
IX)
Test Use
Substance Pattern
TEP
TEP
TEP
TEP
chemical Is
A
A
A
A
classified as
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
Toxicity Category III.
~
Mist Additional
Data be
Submitted?
NoV
NoV
NoV
NoV
Time frame
for
Submission
-------
TABLE B -
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING PROMETRYN
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data?1 Citation1
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-2 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor
ON
LM
MP
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes2/3/
YesV
YesV
Yesfy?/
Yes?/
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
TABLE R
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING PROMETRYN
Data Requirement Test
Substance
§158.1
Use
Pattern
Does EPA Bibliographic Must Additional Timeframe
Have Data?1 Citation1 Data be for
Submitted? Submission
20 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 -
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64- 1
Density, Bulk Density, or
Specific Gravity
- PH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements :
- Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
\
Yes^/ 6 Months
No10/
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 15 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
No
1/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each manufacturing use product. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
FOOTNOTES CONTINUED ON NEXT PAGE
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROMETRYN
§158.120 Product Chemistry (continued) .
2J Details of the manufacturing process, including the relative amounts of beginning materials, a description of
equipment used to produce the product, reaction conditions, the duration of each step of the process, and
purification procedures and quality control measures for EPA Registration Nos. 100-542, 2749-278, 46386-2, and
the unregistered 97% technical are required.
J3/ The name and address of manufacturer, producer, or supplier of each beginning material used to manufacture
EPA Registration Nos. 100-542, 2749-278, 46386-2, and the unregistered 97% technical are required. Also, a copy
of all available technical specifications, data sheets, and other documents in which the manufacturer, producer,
or supplier of the beginning material describes the composition and properties must be submitted.
47 A discussion of each impurity believed to be present at 0.1% or more based on knowledge of the beginning materials,
all possible chemical reactions and any contamination is required.
51 Five or more representative samples of the registered technicals must be analyzed for prometryn. In addition,
five or more representative samples must be analyzed for each impurity present at 0.1% or more (w/w) and each
additional "toxicologically significant" impurity by analytical methods supported by validation studies of their
precision and accuracy. The Agency determines what is "toxicologically significant" based on the results
from the data required in 61-3 and 62-1.
jj/ Upper and lower limits must be validated and certified for prometryn, and upper limits must be validated and
certified for each impurity present at _> 0.1% (w/w) for EPA Registration Nos. 100-542, 2749-278, and 46386-2.
Certifications should be submitted on EPA Form 8570 Rev. 2-85.
77 All N-nitrosamines must be identified and quantified in six samples of each technical (registered and
unregistered); two samples 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 each nitrosamine found.
8/ Quantitative methods to determine all impurities where a certified limit is required. Each method must be
. accompanied by validation studies of the precision and accuracy of the method.
9/ Density, bulk density, or specific gravity must be determined at 20 °G or 25 °C.
10/ Not applicable since the technical cannot be dispersed with water.
ON
Ul
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS KIR MANUFACTURING-USE PRODUCTS CONTAINING PROMETRYN
Data
§158.
Requirement Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
, 1 35 Toxicology
ACUTE TESTING
81-1
81-2.
81-3
81-4
81-5
81-6
- Acute Oral Tpxicity - Rat MP A Yes 00060646,00060314 No
- Acute Dermal Toxicity MP A Yes 00060647,00060315 No
- Rabbit
- Acute Inhalation Toxicity MP A No Yes
- Rat
- Primary Eye MP A No Yes
Irritation - Rabbit
- Primary Dermal MP A Yes 00060649,00060316 No
Irritation - Rabbit
- Dermal Sensitization - MP A No Yes
9 Months
9 Months
9 Months
Guinea Pig
ON
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the . front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred:location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR I62.l0(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 I62.l0(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and.the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from,, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.lO(g)]
67
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18.point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal; word except where contact with children
during distribution or use is unlikely. [40 CFR 162.I0(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
: label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.I0(h)(l)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I62.l0(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three, hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.I0(h)(2)].
68
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(li)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements. .
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (l) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether :
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
69
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
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.
70
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
71
-------
SUMMAPY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
>
LABEL ELEMENT
Product name
Gorrpany name
and address
Net. contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . , "
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
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SUMMARY-7
ITEM
7C
7D
7E
si
•J
8
8A
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 arid
domestic
animals
Envi ronmental
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
l
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.
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SUMMARY-8
ITEM
8C
9A
9.B
10A
10B
IOC
LABEL EILEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry \
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling. "
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
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Chapter 1—Environmental Protection Agency
§162.10 Labeling requirements.
('a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of 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 :
75
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a 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;
76
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisbnous," "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)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
,{c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall he considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is hot 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."
77
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label/ preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", 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.
78
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of. stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
79
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Hazard Indicators
Ora, LD5o
Inhalation LC
Dermal LD
Eye effects
Skin effects
1
Up to and
Including
50 mg/kg
Up to and
Including
.2 rug/liter
Up to and
Including
200 mg/kg
Corrosive;
cornea! opacity
not reversible
within 7 days
Corrosive
'
Toxic Ity <
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/l tter
From 200
. thru 2000
Cornea 1 opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor les
III
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
• .
No cornea! opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hou'-s
;
IV
Greater than
5000 mg/kg
Greater than
20 mg/l Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison." ' •
(B) Toxicity Category II.
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide
II .shall bear
products meeting the
on the front panel*
All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
80
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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
8
10
12
81
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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.
Toxlclty
category
Precautionary statements by toxlclty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
I! I
IV
Fatal (poisonous) If swallowed I Inhaled or
absorbed through skin]. Do not breathe '.
vapor Idust] or spray mist]. Do not get
In eyes,' on skin, or on clothing (Front
panel statement of practical treatment
requ'red.].
May be fatal If swallowed I Inhaled or
absorbed through the skin], ' Do not breathe
vapors Idust or spray mist).; Do not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.].
Harmful If swallowed (Inhaled or absorbed
through the skin], Avoid breathing vapors
Idust or spray mist]. Avoid contact with
sk'n leyes or clothing). (Appropriate
first aid statement required.].
(No precautionary statements required.].
Corrosive, causes eye and skin-damage lor
skin Irritation). Do not get In eyes, on
skin, or on cloth'ng. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
Causes eye land sk'n) 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 w'th plenty of water. ' Get
medical attention If Irritation persists.
(No precautionary statements required.).
(ii) Environmental hazards
target organisms excluding
statements are required stating
appropriate precautions to avoid potential accident,
Where a hazard exists to non-
humans and domestic animals, precautionary
the nature of the hazard and the
injury or
82
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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 LC5Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
. (C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary 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:
1
Flash point | Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; It there Is a
flashback at any valve opening.
Flash point above 20*F end not over 80*F or I f
the flame extension Is more than 18 In. long
at a distance of 6 In. from the flame.
1 .
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
IJO'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 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 tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
Extremely flammable. Keep a»ay from tire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
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:
(JL) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved. ;
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(3) The product will not come into the hands of the general
public except after incorporation into finished products; and
(_£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(\) 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:
(2.) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
84
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(_2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(_3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(_4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use":
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
85
-------
(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment,
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2).
(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 § 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]
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS .
Required Label Statement
I. Pressurxzed Containers
A. Flashpoint at or below
20eF; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above'
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. :Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting. ;
i
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 hear
heat and open flame.
None required. ;
87
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading t
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions, ;
considering, when applicable, the following factors: :
1. Conditions of storage that might alter the composition or.
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
. pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, nust bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that nust appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute .Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at. the nearest
EPA Regional Office for guidance." . . • •
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, nust 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."
89
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, 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 by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent).. . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary .landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum, may be reused.
90
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EPA Index to Pesticide Chemicals IS**.
PROMETRYN *V X^
TABLE OF CONTENTS 5 /?_£/ ft) ££
Site Name Page °&O &0£
, •
TERRESTRIAL FOOD CROP f 3
(Agricultural Crops) • 3
Celery 3
Corn A
Cotton 5
Pigeon Peas 9
TERRESTRIAL NONFOOD CROP 9
(Ornamental Plants and Forest Trees) " 9
Loblolly Pine (forest) (nursery seedbeds) 9
Longleaf Pine (forest) (nursery seedbeds) 9
Slash Pine (forest) (nursery seedbeds) 9
Issued: 2-20-86 I-080805-i
91
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DRAFT
EPA Index to Pesticide Chemicals
h080805 PROMETRYN*
TYPE PESTICIDE; Herbicide
FORMULATIONS;
Tech (95%, 97%)
WP (40%, 80%)
EC (4 Ib/gal or 44.4% a.i.)
F1C (4 Ib/gal or 45.41% a.i.)
SC/L (1 Ib/gal or 8.4% a.i.)
GENERAL WARNINGS AND LIMITATIONS; A selective herbicide used to control
annual grasses and broadleaf weeds. When applied before weeds emerge, its
effectiveness depends on rainfall or irrigation to move it into the soil.
Very dry soil conditions require shallow cultivation or rotary hoeing for
effective weed control. Use conventional spray equipment with hydraulic
or mechanical agitation except in AZ and CA where only mechanical agita-
tion is recommended. In cotton, trifluralin may be applied (before Janu-
ary 1) prior to a preplant incorporated application of prometryn. To
avoid spray drift, do not apply under windy conditions. Avoid spray over-
lap, as crop injury may occur. Do not apply directly to lakes, streams,
or ponds. Do not enter treated areas without protective clothing until
sprays have dried. For band treatments reduce dosages proportionally.
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Not located.
PHYTOTOXICITY TO CROPS; Not located.
MODE OF ACTION; Inhibition of photolysis of water in the photosynthetic
process and inhibition of oxidative phosphorylation.
BROADLEAF WEEDS CONTROLLED;
PBFDCBC Annual sowthistie
PEWAIBE Black nightshade
PAZAAAC Chickweed
PBFDQAA Cocklebur
PEDADBA Common purslane
PEDABBA Desert rockpurslane
PEAAHAA Dock (seedling)
PARABAA Fiddleneck
PBZABAA Filaree
PEMAEBB Florida pus ley
PEWAAAB Groundcherry
PADACBA Horse purslane
PBGAFAA Ipomoea
PEWADBD Jimsonweed
(e)
(e)
(a)
(d)
(e)
(b)
(e)
(e)
(f)
(d)
(f)
*Caparol
2,4-bis( iBopropylamino)-6-(ii-thylthio)-s-triazine
Issued: 2-20-86
1-080805-1
92
-------
'BDAEAB
•BKBDBB
•DAAHAA
'BKAAAC
'BGAFAB
'AAAABI
'BFCKBB
>BFBUBF
?DAAJBF
'BVAGBQ
?AAAABP
?BFAEAA
?AFACBI
PBKAHBA
PEAAGAD
PBVAGAA
PDAACBA
PZAAABP
PZAAAHA
RCAAAAB
PCABHBB
PCQATBA
PCABFAA
PCACUAA
PCABIBA
PCOAFBA
PCABHBA
PCABFBF
PCACEAA
PCACKBH
PCAAWAA
PCAARAA
PCAAOBB
EPA Index to Pesticide Chemicals
PROMETRYN
BROADLEAF WEEDS CONTROLLED (continued)
Lambsquarter
London rocket
Mallow
Mustards
Perennial morningglory
Pigweed
Pineappleweed
Prairie sunflower
Prickly sida
Prostrate spurge
Purslane
Ragweed
Redroot pigweed
Shepherdspurse
Smartweed
Spurge
Spurred anoda
Tall morningglory
Wild spiderflower
(e)
(e)
(d)
(e)
(c)
(d)
(e)
(f)
(O
(f)
(a) Controls shallow germinating
(b) Controls winter weeds in TX.
seedlings
(c) Partial control in NM and west TX.
(d) In SLN site.
(e) Controls winter weeds in CA.
(f) In pigeon peas.
GRASSES AND OTHER MONOCOTS CONTROLLED
Annual grasses
Barnyardgrass
Coffeeweed
Crabgrass
Foxtail
Goosegrass
Henbit
Junglerice
Large crabgrass
Pan i cum spp.
Rough blackfoot
Sandbur
Signalgrass
Wild oats
*
•
(d)
(a)
(b)
(d)
(c)
(-1)
(a) Controls shallow germinating stadlings.
(b) Controls winter weeds in TX.
(c) Partial control in NM and west r/l.
(d) In SLN site.
Issued: 2-20-86
I-0808C5-?.
93
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/13002AA
Site, Dosage
and Formulation
(Ib a.i./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Celery
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
1.2-1.6
(80% WP)
000100-00471
(4 Ib/gal EC)
002749-00503
(4 Ib/gal F1C)
001812-00274
0.8-1.0
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
0.6-0.8
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1-2
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
0.5 ppm
General Information:
Use the lower dosage on
coarse textured soils and soils low in organic
matter, and the higher dosage on fine textured
soils and soils high in organic matter. The fol-
lowing rotational crops may be seeded 5 months
after applying no more than 2 pounds active in-
gredient per acre: cabbage, celery, corn, okra,
onions, peas, and red beets.
Use limited to CA. Preemergence. Broadcast. Ap-
ply to direct-seeded celery in 20 to 40 gallons
of water per acre at planting or shortly after
planting before celery emerges. Make 1 applica-
tion per year. Do not use on sand or loamy soil.
Do not apply if crop is under water stress. Do
not apply within 2 weeks after application of an
herbicidal oil.
Use limited to CA. Postemergence. Broadcast.
Apply to direct-seeded celery in 20 to 40 gallons
of water per acre after celery has reached the 2
to S-true leaf stage but before weeds are 2 inches
tall. Apply only after foliar applications of
other pesticides are dry. Do not use on sandy
soils. Do not apply if crop is under water
stress. Do not apply within 2 weeks after appli-
cation of an herbicidal oil.
Use limited to FL. Postemergence. Broadcast.
Apply to seedbeds in 20 to 40 gallons of water per
acre after celery reaches the 2 to 5-true leaf
stage. Make 1 application per year after seedbed
covers have been removed for at least 1 week.
Use limited to CA. Posttrahsplant. .Broadcast or
band. Apply in 20 to 40 gallons of water per acre
2 to 6 weeks after transplanting but before weeds
are 2 inches tall. Do not make more than 1 appli-
cation per crop.
Issued: 2-20-86
1-080805-3
94
-------
Site, Dosage
and Formulation
(Ib a.i./A)
Celery (continued)
0.8-1.6
(80% WP)
, (4 Ib/gal EC)
(4 Ib/gal F1C)
1.6-3.2
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1-2
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1.6-2
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
Use limited to sandy or mucky soils of FL. Post-
transplant. Broadcast or band. Apply in 20 to
40 gallons of water per acre 2 to 6 weeks after
transplanting but before weeds are 2 inches tall.
Do not make more than 1 application per crop.
Use limited to HI. Posttransplant. Broadcast or
band. Apply in 20 to 40 gallons of water per acre
2 to 6 weeks after transplanting but before weeds
are 2 inches tall. Do not make more than 1 appli-
cation per crop.
Use limited to fine textured or mucky soils in MI
and OH. Posttransplant. Broadcast or band. Ap-
ply in 20 to 40 gallons of water per acre 2 to 6
weeks after transplanting but before weeds are 2
inches tall. Do not make more than 1 application
per crop.
Use limited to fine textured soils in WI. Post-
transplant. Broadcast or band. Apply in 2JD to
40 gallons of water per acre 2 to 6 weeks after
transplanting but before weeds are 2 inches tall.
Do not make more than 1 application per crop.
Issued: 2-20-86
1-080805-4
95
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/28005AA
Site, Dosage
and Formulation
(lb a.i./A)
Corn
[MAI]
0.8-1.5
(40% WP)
000100-00492
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
0.25 ppm (corn, field, fodder)
0.25 ppm (corn, field, forage)
0.25 ppm (corn, fresh (incl. sweet) (K+CWHR))
0.25 ppm (corn, grain)
0.25 ppm (corn, pop, fodder)
0.25 ppm (corn, pop, forage)
0.25 ppm (corn, sweet, fodder)
0.25 ppm (corn, sweet, forage)
General Information; Do not use on eroded hill- .
sides as injury to corn may occur. Do not use on
corn grown on alkaline calcareous soils in western
MN and western IA or in the high plains and inter-
mountain areas of the west where rainfall is
sparse. The following rotational crops may be
planted 15 months after treatment: cotton, navy
beans and other large seeded legumes, oats and
other spring-seeded small grains, potatoes, sor-
ghum, and soybeans.
Preemergence. Broadcast, at planting or band.
Apply, at planting or immediately after before corn
emerges. Apply in 20 to 40 gallons of water per
acre. Use the lower dosage on light-textured __.
soils and soils low in organic matter and the
higher dosage on heavier soils and soils high in
clay or organic matter. Do not use on sandy or
loamy soils, peats, muck or highly organic clay
soils.
Formulated with atrazine.
Issued: 2-20-86
1-080805-5
96
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28007AA
Site, Dosage
and Formulation
(Ib a.i./A)
Cotton
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
0.25 pptn (cotton, seed)
1.0 pptn (cotton, forage
Do not feed treated forage to livestock or graze
treated areas.
General Information; Do not use in cut areas of
newly leveled fields, in areas of excess salt, or
. in areas where flooding of beds is likely to oc-
cur. Do not plant cotton in tractor wheel depres-
sions. On mulch planted cotton, water back only
after cotton seedlings are well established. In
NM, apply either preplant incorporated or preemer-
gence. Do not use on glandless cotton varieties.
Do not treat cotton under stress from drought,
cultivation damage, or fertilizer application.
Apply in 20 to 40 gallons of water per acre. For
preplant and preemergent applications, do not use
on sand or loamy sand soil. Use the higher dosage
on finer textured soil. Preemergence application
to cotton planted in furrows more than 2 inches
deep may only be made in bands as wide as the
width of the bottom of the furrow. If necessary,
cotton may be replanted in soil treated with
prometryn, but do not make a second preemergence
application. The following rotational crops may
be fall planted when prometryn has been applied
by preplant incorporation as a preemergent, or as
a single postemergent treatment at the rate of
0.48 to 0.64 pound active ingredient per acre:
cabbage, okra, onions, peas, red beets, sweet corn
and cover crops of oats, sorghum, winter barley,
winter rye, and winter wheat. Cover crops must
be plowed down and not used for food or feed. If
more than 1 postemergent application of 0.48 to
0.64 pound active ingredient per acre is used or
if combinations of preemergent and postemergent
applications are used, fall seeded crops should
not be planted. Spring seeded crops in CA and AZ
and spring vegetables in the Rio Grande Valley of
TX should not be planted until after April 1. Use
aerial application in furrow irrigation cotton
only. Apply where broadcast applications are
specified (except CA) in a minimum of 5 gallons
of total spray per acre.
Issued: 2-20-86
1-080805-6
97
-------
Site, Dosage
and Formulation
(Ib a.i./A)
Cotton (continued)
1.2-2.4
(80% WP)
000100-00471
(4 Ib/gal EC)
002749-00503
(4 Ib/gal F1C)
001812-00274
[SLN]
1.2-2.4
(80% WP)
1.2-2.4
(80% WP)
(4 Ib/gal EC)
1.2-2.4
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
[SLN]
1.2-2.4
(80% WP)
1.2-2.0
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
I SLN]
1.2-2.0
(80% WP)
1.6-2.0
(80% WP)
(4 Ib/gal EC)
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
Use limited to AZ, CA, and NM. Preplant incorpo-
ration. Broadcast or band. Apply in 10 gallons
of water per acre by ground or 5 gallons of water
per acre by air. Do not use on sandy soils, in
cut areas of newly leveled fields, in areas of ex-
cess salt, or in areas where flooding is likely.
In NM, apply either preplant or preemergent.
Use limited to CA. Preplant incorporation.
Broadcast or band. Apply after the initial irri-
gation but before spring planting. Knock off the
top one-third to one-half of the seedbed and in-
corporate into the soil with a power tiller or a
rolling cultivator* Do not cultivate treated soil
back toward the cotton until cotton emergence and
just before the first irrigation.
Use limited to AZ, CA, NM, and the upper and lower
El Paso Valley of TX. Preplant incorporation.
Broadcast or band. Apply to partially finished
or finished beds. Apply in 10 gallons of water
per acre by ground or 5 gallons of water per acre
by air.
Tank mix with pendimethalin.
Use limited to AZ, CA, NM, and the upper and lower
El Paso Valley of TX. Preplant incorporation.
Broadcast or band. Apply to flat soil before
disking in 20 gallons of water per acre by ground
or 5 gallons of water per acre by air. Use less
than 1.6 pounds active ingredient per acre in AZ
and CA.
Tank mix with treflan.
Use limited to CA. Postbedding. Broadcast or
band. Apply before weeds emerge or to weeds less
than 2 inches tall. For postemergence weed con-
trol add a surfactant or an emulsifiable oil.
Issued: 2-20-86
1-080805-7
98
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Site, Dosage
and Formulation
(Ib a.i./A)
Cotton (continued)
0.6-0.8
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1.2-2.4
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
0.8-1.6
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1.6-2.8
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
2.0-2.8
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1.6-2.4
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
0.48-0.64
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
[MAI]
0.25
(1 Ib/gal SC/L)
000100-00495
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
Use limited to the Gulf Coast and Blacklands of
TX. Postbedding. Broadcast or band. For control
of vinter weeds apply in the fall or winter to
fields to be planted to cotton the following
spring. For control of emerged henbit add a sur-
factant or an emulsifiable oil.
Use limited to the Blacklands of TX and OK, TX
Gulf Coast and the TX Coastal Bend. Preemergence.
Broadcast or band. Apply at or shortly after
planting.
Use limited to the high plains, rolling plains,
and Edward Plateau of TX, southwest TX, and NM.
Preemergence. Broadcast or band. Apply at or
shortly after planting.
Use limited to the mid-south and southeast United
States other than the Mississippi River Delta in
MS. Preemergence. Broadcast or band. Apply at
or shortly after planting. In AZ, apply to shar-
key clay soil only.
Use limited to the Mississippi River Delta in MS.
Preemergence. Broadcast or band. Apply at or
shortly after planting. Do not use on sharkey
clay soils.
Use limited to the Rio Grande Valley of TX. Pre-
emergence. Broadcast or band. Apply at or short-
ly after planting.
Postemergence. Directed spray. Apply to cotton
6 or more inches tall. Apply in 10 to 40 gallons
of water per acre. For emerged weed control add
a compatible surfactant. Leaf fenders or shields
may be necessary to prevent contact to cotton
foliage. Two or 3 applications may be needed.
May be tank mixed with DSMA or MSMA.
May be formulated with MSMA.
Issued: 2-20-86
1-080805-8
99
-------
Site, Dosage
and Formulation
(Ib a.i./A)
Cotton (continued)
0.48-0.5
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
[MAI]
0.25
(1 Ib/gal SC/L)
1.2-1.6
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
0.8-1.6
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1.2-1.6
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
0.8-1.2
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
1.2-1.6
(80% WP)
(4 Ib/gal EC)
(4 Ib/gal F1C)
FPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
fir
Use limited to AK, LA, MS, MI, TN, and TX. Post-
emergence. Directed spray. Apply to cotton 3 to
6 inches tall. Apply in 10 to 40 gallons of water
per acre. For emerged weed control add a compati-
ble surfactant. Leaf fenders or shields may be
necessary to prevent contact to cotton foliage.
Two or 3 applications may be heeded.
May be formulated with MSMA.
Use limited to AZ and CA. Postemergence. Layby
application. Broadcast or band. For control of
germinating or emerged weeds, apply when cotton
is at least 12 inches tall (18 inches tall where
flood-type nozzles are used) and weeds are less
than 2 inches tall. Make 1 application per sea-
son. Do not use in the Coachella Valley.
Use limited to the Blacklands of TX and OK. Post-
emergence. Layby application. Broadcast or band.
For control of germinating and emerged weeds, ap-
ply when cotton is at least 12 inches tall and
weeds are less than 2 inches tall. Make 1 appli-
cation per season. Use the lower dosage on loam
soils and the higher dosage on clay soils.
Use limited to the mid-southern and southeast
United States. Postemergence. Layby application.
Broadcast or band. For control of germinating and
emerged weeds, apply when cotton is at least 12
inches tall and weeds are less than 2 inches tall.
Make 1 application per season.
Use limited to the high plains of TX and NM.
Postemergence. Layby application. Broadcast or
band. For control of germinating and emerged
weeds, apply when cotton is at least 12 inches
tall and weeds are less than 2 inches tall. Make
1 application per season. Use the lower dosage
on loam and clay soils.
Use limited to southwest TX. Do not use in the
Rio Grande Valley. Postemergence. Layby applica-
tion. Broadcast or band. For control of germi-
nating or emerged weeds, apply when cotton is at
least 12 inches tall and weeds are less than 2
inches tall. Make 1 application per season.
Issued: 2-20-86
1-080805-9
-------
15023AA
Site, Dosage
and Formulation
(Ib a.i./A)
Pigeon Peas
2-3
(80% WP)
000100-00471
(4 Ib/gal EC)
000100-00620
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
0.25 ppm
Do not graze or feed forage or hay to livestock.
General Information: The following rotational
crops may be seeded 5 months after applying no
more than 2 pounds active ingredient per acre:
cabbage, celery, corn, onions, peas, and red
beets. •
Use limited to PR. Preemergence. Broadcast or
band. Apply at planting or immediately after
planting before the crop or weeds emerge. Do not
use on sandy or loamy sand soils. Make 1 appli-
cation per year. ' , . ;
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
/30097DA Loblolly Pine
(forest) (nursery
seedbeds)
/30099DA Longleaf Pine
(forest) (nursery
seedbeds)
/30104DA Slash Pine (forest)
(nursery seedbeds)
ISLN]
1
(80% WP)
ISLN]
i
(80% WP)
N.F.
General Information; Total dosages for both pre-
emergent and postemergent applications should not
exceed 2 pounds active ingredient per acre.
Preemergence. Broadcast. Apply in 20 to 40 gal-
lons of water to dry seedbeds within 48 hours af-
ter sowing pine seed and mulching. Incorporate
immediately with 0.5 to 0.75 inches of water by
sprinkler irrigation.
Postemergence. Broadcast.
least 5 to 6 weeks old.
Apply to seedlings at
9001500
AAAAAAA
.:SRIAL AND TANK MIX APPLICATIONS
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Issued: 2-20-86
1-080805-10
10!
-------
9900300
AAAAAAA
Site, Dosage
and Formulation
(lb a.i./A)
Tank Mix
EPA Index to Pesticide Chemicals
PROMETRYN
Tolerance, Use, Limitations
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Cotton
Issued: 2-20-86
1-080805-11
102
-------
EPA Index to Pesticide Chemicals
PROMETRYN
Listing of Registered Pesticide Products by Formulation
&095.0001 951 technical chemical
proraetryn (080805)
002749-00278 046386-00002
&097.0001 972 technical chemical
protnetryn (080805)
000100-005A2
&240.0006
&280.0006
&244.4012
&245.4114
&208.4015
40% wettable powder
prometryn (080805) plus atrazine (080803)
000100-00492 002749-00321*
.^scheduled to be suspended
80Z vettable powder
prometryn (080805)"
000100-00471 002749-00188
010163-00092 038652-00002
(000100-00471)
AL780003 AZ840001 LA810023
44.41 (4 Ib/gal a.i.) emulsifiable concentrate
prometryn (080805)
000100-00620 002749-00503 010163-00094
(000100-00620)
AZ840002
45.412 (4 Ib/gal a.i.) flowable concentrate
prometryn (080805)
001812-00274
8.42 (1 Ib/gal a.i.) soluble concentrate/liquid
prometryn (080805) plus monosodxum methaneareonate (013803)
000100-00495
9999999 State Label Registration
AZ Reg. No.
010163-06398
Issued: 2-20-86
1-080805-12
1
-------
EPA Index to Pesticide Chemicals
PROMETRYN
Appendix A-l
Listing of Active Ingredient(s) Found in Combination With the Report Chemical
Chemical Common Name EPA Acceptable t
Code (source) Common/Chemical Name
080803 — '' ' atrazine
013803 MSMA monosodium acid me thanearsonate
— Use EPA Acceptable Common/Chemical Name
Issued: 2-20-86 1-080805-13
104
-------
EPA Index to Pesticide Chemicals
PROMETRYN
Appendix A-2
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chemical
Code
013802
108501
013803
036101
Common Name
(source)
DSMA
EPA Acce
ptable
Cornmon/Chemical Name
disodium methanearsonate
pendimethalin (ANSI) N-(l-ethylpropyl)-3,4-ilimethyl-2,6
dinitrobenzenamine
MSMA
treflan
monosodium acid methanearsonate
trifluralin
Issued: 2-20-85
1-080805-14
105
-------
EPA Index to Pesticide Chemicals
PROMETRYN
Auxiliary Documentation
SLK Cancellation Date
OH810012 11/85
Registration Number 010155-00014 does not contain prometryn (080805) as
an active ingredient.
Registration Number 000100-00492 could not be located at EPA and therefore
was extracted from the fiche.
Issued: 2-20-86 I-080805-a
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of. review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American.National Standards Institute
(ANSI), expanded to provide for certain special needs.
107
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter, .
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A? the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
108
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Prometryn Standard
MRID CITATION
00022855 Esser, H.O.; DuPuis, G.; Ebert, E.; et al. (1974) s-Triazines.
Pages 129-208, In Without Title. By ? . N.P. (Also in unpub-
lished submission received Oct 7, 1977 under 100-566; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:231969-C)
00023213 Muller, P.M.; Payot, P.M. (1966) Fate of HC-Labelled Triazine
herbicides in plants. Pages 61-70, In Isotopes Weed Research:
Proceedings of IAEA Symposium; 1965-66, Vienna, Austria. N.P.
(Also in unpublished submission received Jul 1, 1971 under un-
known admin, no.; submitted by Shell Chemical Co.,'Washington,
D.C.; CDL:221995-R)
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:0929.12-A)
00024378 Best, J.A.; Weber, J.B.; Monaco, T.J. (.1975) Influence of soil pH
on s-Triazine availability to plants. Weed Science 23(5):
378-382. (Also in unpublished submission received Jul 19, 1978
under 201-403; submitted by Shell Chemical Co., Washington,
D.C.; CDL:234470-AD)
00024696 Richardson, C.; Nalewaja, J.D.; Buchholtz, K.P.; et al. (1964)
Atrazine/Prometryne Residues—Corn: AG-A 540. (Unpublished
study including AG-A 565, AG-A 586, AG-A 644..., received May
26, 1967 under 100-492; prepared in cooperation with North Dako-
ta State Univ., Dept. of Agronomy and others, submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:000510-B) :
00024738 McCann, J.A. (1970) Primaze SOW: Toxicity to Rainbow Trout.
(U.S. Agricultural Research Service, Pesticides Regulation Div.,
Animal Biology Laboratory, unpublished report.)
00024779 Mattson, A.M-.; Kahrs, R.A. (196:7) Extraction and Metabolic Studies
of Triazine Herbicides. (Unpublished study received Jun 23,
1967 under 7F0620; submitted by Geigy Chemical Co., Ardsley,
N.Y.; CDL:092914-B)
00027329 Hoi stun, J.T., Jr.; Frans, R.E.; Hazlewood, B.P.; et al. .(1969)
Summary of Cotton Residue Data. (Unpublished study received Nov
27, 1970 under 100-471; prepared in cooperation with U.S. Agri-
cultural Research Service, Crops Research Div., Delta Branch
Experiment Station and others, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:000464-B)
-1-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Prometryn Standard
MRID CITATION
00027330 Gemma, A. (1970) Determination of Prometryne, G-11354, and GS-
26831 Residues in Cotton and Soybeans by Gas Chromatography.
Method No. AG-150 dated Oct 29, 1970. (Unpublished study re-
ceived Dec 12, 1970 under 100-471; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:000464-C)
00034043 Motko, L.; Alamo, A.; Agamalian, H. (1966) Residue Data Summary.
(Unpublished study received Dec 11, 1972 under 100-471; submit-
: ted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000468-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.)
00040692 McCann, J.A. (1970) Primaze 80 W: Bluegill (Lepomis macro-
chirus): Test No. 229. (U.S. Agricultural Research Service,
Pesticides Regulation Div., Animal Biology Laboratory, unpub-
lished study; CDL:129814-A)
00042794 Woodard, M.W.; CockrellI, K.O.; Lobdell, B.J.; et al. (1965) Promet-
ryne Safety Evaluation by Oral Administration to Rats for 104
Weeks and to Dogs for 106 Weeks. (Unpublished study received
Oct 7, 1977 under 100-566; prepared by. Woodard Research Corp.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:231965-C)
00055672 Ciba-Geigy Chemical Corporation (1971) Metabolism of s-Triazine
Herbicides. (Unpublished study including letter dated Dec 29,
1971 from J.R. Forsythe to Harold G. Alford, received Dec 29,
1971 under 100-437; CDL:231915-A)
00056556 Ciba-Geigy Corporation (1975) Residue Data—Tolban in Cotton.
(Compilation; unpublished study received Apr 29, 1976 under 100-
523; CDL:224722-A)
00060314 Kapp, R.W. (1975) Final Report: Acute Oral Toxicity Study in Rats:
Project No. .M915-106. (Unpublished study received Dec 19, 1977
under 33660-5; prepared by Hazleton Laboratories America, Inc.,
submitted by Industrie Prodotti Chimici, S.p.A., Novate Mila-
nese, Italy; CDL:232506-A)
00060315 Kapp, R.W. (1975) Final Report: Acute Dermal Toxicity Study in
Rabbits: Project No. 915-107. (Unpublished study received Dec
19, 1977 under 33660-5; prepared by Hazleton Laboratories Ameri-
ica, Inc., submitted by Industrie Prodotti Chimici, S.p.A.,
Novate Milanese, Italy; CDL:232506-B)
f fl <0)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Prometryn Standard
MRID CITATION
00060316 Kapp, R.W. (1975) Final Report: Primary Skin Irritation Study in
Rabbits: Project No. 915-105. (Unpublished study received Dec
19, 1977 under 33660-5; prepared by Hazleton Laboratories Amer-
ica, Inc., submitted by Industrie Prodotti Chimici, S.p.A.,
Novate Milanese, Italy; CDL:232506-C)
00060646 Sachsse, K.; Bathe, R. (1976) Acute Oral LD50 in the Rat of Tech-
nical G 34161: Project No. Siss 5540. (Unpublished study re-
ceived Dec 29, 1977 under 100-542; prepared by Ciba-Geigy, Ltd.,
Switzerland, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:232550-G)
00060647 Sachsse, K.; Bathe, R. (1976) Acute Dermal LD50 in the Rat of
Technical G 34161: Project No. Siss 5662. (Unpublished study
received Dec 29, 1977 under 100-542; prepared by Ciba-Geigy,
Ltd., Switzerland, submitted.by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:232550-H)
00060649 Sachsse, K.; Ullman, L. (1977) Skin Irritation in the Rabbit after
Single Application of Technical G 34161: Project No. Siss 5662.
(Unpublished study received Dec 29, 1977 under 100-542; prepared
by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:232550-J)
00065048 Ciba-Geigy Corporation (1981) Residue Tests with Cotton. (Com-
pilation; unpublished study received Apr 28, 1981 under 100-597;
CDL:070049-B)
00070146 Vilkas, A.G. (1977) Acute Toxicity of Prometryn~FL-761355 to the
Water Flea (Daphnia magna Straus): UCES Proj. # 11506-04-04.
(Unpublished study received Dec 29, 1977 under 100-542; prepared
by Union Carbide Corp., submitted by Ciba-Geigy Corp., Greens-
boro, N.C.; CDL:232551-D)
00070686 Beliles, R.P.; Scott, W.; Knott, W. (1965) Prometryne: Safety
Evaluation on Fish and Wildlife (Bobwhite Quail, Mallard Ducks,
Rainbow Trout, Sunfish, Goldfish). (Unpublished study received
Dec 29, 1977 under 100-542; prepared by Woodard Research Corp.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:232551-B.)
00082966 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Acute Oral
LD50--Mallard Duck: Project No. 108-131. (Unpublished study
received Dec 29, 1977 under 100-542; prepared by Wildlife Inter-
national Ltd. and Washington College, submitted by Ciba-Geigy :
Corp., Greensboro, N.C.; CDL:232551-C)
-3-
111
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Prometryn Standard
MRID CITATION
00093337 Mattson, A.M.; Solga, J.; Beaudoin, R.L. (1963) Determination of
Prometryne and Its Metabolites in Rat Feces and Urine. (Unpub-
lished study received Nov 26, 1966 under 7F0559; submitted by
Geigy Chemical Co., Ardsley, N.Y.; CDL:090697-F)
00093338 Richman, B.Q. (1964) Report to Geigy Research Laboratories: Meta-
bolic Fate of C™14t-Prometryne--Albino Rats. (Unpublished study
received Nov 26, 1966 under 7F0559; prepared by Industrial Bio-
Test Laboratories, Inc., submitted by Geigy Chemical Co.,
Ardsley, N.Y.; CDL:090697-G)
00093339 Ryskiewich, D.P. (1965) Metabolism of Propazine and Prometryne in
Rats. Ardsley, N.Y.: Geigy Chemical Corp. (Technical bul-
letin, Feb 11; also in unpublished submission received Nov 26,
1966 under 7F0559; submitted by Geigy Chemical Co., Ardsley,
N.Y.; CDL:090697-H)
00093529 Geigy Chemical Company (1966) Determination of Prometryne Residues
in Celery. (Compilation; unpublished study, including AG-A
nos. 352, 424, 629..., received on unknown date under 7F0559;
CDL:090699-A) :
00093530 Geigy Chemical Comp.any (1964) Analyses for Prometryne Residues in
Corn. (Compilation; unpublished study, including AG-A nos.
492, 622, 645..., received Oct 8, 1966 under 7F0559; CDL:
090699-B)
00093531 Geigy Chemical Company (1966) Analyses for Prometryne Residues in
C it tor.. (Compilation; unpublished study, including AG-A nos.
310, 315, 316..., received Oct 8, 1966 under 7F0559; CDL: :
090699-C)
00093535 Geigy Chemical Company (1966) Determination of Prometryne and
Hydroxy-propazine in Milk of Dairy Cows Fed Prometryne in Ra-
tions. Includes method dated Nov 10, 1966. (Compilation;
unpublished study, including AG-A 970, received on unknown date
under 7F0559; CDL:090699-I)
00093536 Mattson, A.M.; Solga, J.; Motko, L. (1966) Determination of Resi-
dues in Body Tissues of Sheep and Cattle Receiving Prometryne in
the Diet. (Unpublished study, including AG-A 969, received on
unknown date under 7F0559; submitted by Geigy Chemical Co.,
Ardsley, N.Y.; CDL:090699-J)
-4-
n;
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Prometryn Standard
MRID CITATION
00093542 Colby, S.R.; Harris, C.I. (1965) Atrazine-prometryne Combinations:
Herbicidal Activity, Fate in Corn, and Soil Persistence. (Un-
published study received Apr 14, 1967 under 7F0525; prepared by
Univ. of Maryland, Agronomy Dept. in cooperation with U.S. Agri-
cultural Research Service, Crops Research Div., submitted by
Geigy Agricultural Chemicals, Yonkers, N.Y.; CDL:090703-B)
00093548 Geigy Chemical Company (1964) Analyses for Prometryne Residues in
Cabbage and Celery. (Compilation; unpublished study, including
AG-A nos. 680 and 598, received Dec 1, 1964 under 7F0559; CDL:
090702-C)
00105780 Elanco Product Co. (1977) Treflan EC Plus Caparol SOW Tank-mix Pre-
.plant Soil Incorporated on Cotton in California, Arizona, New
Mexico and Texas. (Compilation; unpublished study received Aug
2, 1977 under 1471-35; CDL:230951-A)
00106358 United States Borax Research Corp. (1977) Residues of Cobex
(Dinitramine) Caparol (Prometryn) in Cotton. (Compilation; un-
published study received Aug 11, 1977 under 7F1997; CDL:
096307-B)
00106481 Ciba-Geigy Corp. (1975) Sequential and Tank Mix Applications of
Tolban 4E Plus Caparol SOW and Tolban Plus Cotoran 80WP in
Cotton: Residue Data: GAAC-75006. (Compilation; unpublished
study received Apr 29, 1976 under 100-523; CDL:225279-A)
00106829 American Cyanamid Co. (1978) Residues of Prowl Herbicide. (Compi-
lation; unpublished study received Aug 14, 1979 under 241-243;
CDL:238944-B; 241020)
00121154 McCann, 0. (1970) Caparol SOW—Rainbow Trout: Test No. 256.
(Unpublished study received Apr 11, 1970 under 100-471; pre-
pared by U.S. Agricultural Research Service, Pesticides Regula-
tion Div., Animal Biology Laboratory, submitted by U.S. Environ-
mental Protection Agency, Beltsville, MD; CDL:129837-A)
00121155 McCann, J. (1971) Caparol 80W—Bluegill: Test No, 387. (Unpub-
lished study received Aug 7, 1971 under 100-471; prepared by
U.S. Agricultural Research Service, Pesticides Regulation Div.,
Animal Biology Laboratory, submitted by U.S. Environmental Pro-
tection Agency, Beltsville, MD; CDL:129837-B)
00121720 Ciba-Geigy Corp. (1966) Triazine: Residues in Various Subjects.
(Compilation; unpublished study received Jan 20, 1967 under
7F0559; CDL:092847-B)
-5-
113
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Prometryn Standard
MRID CITATION
00123218 Ciba-Geigy Corp. (1969) Prometryne Residues in Soybean Plants,
Whole Beans and Bean Fractions: GAAC-69016. (Unpublished study
received May 13, 1969 under 9G0834; CDL:093537-B)
00125011 Ciba-Geigy Corp. (1963) Study of the Residue of Prometryne on Cot-
tonseed. (Compilation; unpublished study received Feb 19, 1963
under 100-471; CDL:119514-A)
00125012 Ciba-Geigy Corp. (1964) Residue Data: Study of Prometryne on Vege-
tables. (Compilation; unpublished study received Feb 23, 1965
under unknown admin, no.; CDL:119523-A)
00125013 Whitenberg, D. (1962?) Metabolism of Prometryne by Cotton Plants.
(Unpublished study received Dec 3, 1963 under unknown admin.
no.; prepared by U.S. Agricultural Research Service, Crops Re-
search Div., submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:
12418.1-A)
00125015 Interregional Research Project No. 4 (1979) Prometryn Residue Tol-
erance Petition: Pigeon Peas/Shells. (Unpublished study re-
ceived Aug 31, 1979 under 9E2261; CDL:240975-A)
00148338 Ellgehausen, H. (1979) Degradation of Prometryn (Gesagard) in Soil
under Aerobic, Aerobic/Anaerobic and Sterile/Aerobic Conditions:
Project Report 20/79. Unpublished study prepared by Ciba-Geigy
Ltd. 26 p.
00157995 Wallace, P.; Youreneff, M.; Gilknis, M.; et al. (1985) Prometryn
Technical: A Teratology Study in New Zealand White Rabbits:
(MIN 852064): Report 85158. Unpublished study prepared by.Ciba-
Geigy Corp. 381 p.
05016141 Ebing, W. (1972) Routinemethode zur Duennschichtchromatographischen
Identifizierung der Pestizidrueckstaende aus den Klassen
der Triazine, Carbamate, Harnstoffe und Uracile Routine
method for identification of pesticide residues of triazine,
carbamate, urea, and uracil type compounds by thin-layer
chromatography Journal of Chromatography 65(3):533-545.
-6-
114
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OMB Apftro¥»l No.
FIFKA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With rapect to thi requirement to submit "generic"
-------
OMB Appro**! No. 2OOO446S (
(To out/sty, certify ALL *<><" it*ntl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to reproMnt the following firm(t) who are subject to the r*auire^
menu of a Notice under FIFRA Section 3(c)(2H8) oonuined in • Guidance Document
to submit data concerning the active ingredient:
ACTIVE INCMEOIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms ij referred to below at "my firm ".I
2. My firm it willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement w:th one or more other registrants to develop jointly, or to snare in the cost of developing, the following required
items or data :
3. My firm h« offered in writing to enter into such an agreement. Copies of thf offers arc attached. That offer was irrevociblt and included in offer 10 b<
bound by an arbitrition decision under FIFRA Section 3(c)(2HB)(iii) if final agreement on all terms could not be reached otherwise. This otter wis mide
to the following firm(s) on the following datels): . " .
NAME OF FIRM
I
DATE OfOfFER
However, none of those f
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158,120
PRODUCT
CHEMISTRY
61-1
; 61-2
61-3
62-1.
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
• .
Identity of
ingredients ;
Statement of
corposition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical msthods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
117
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20 :
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of: Test
Stability
Oxidizing/reducing
reaction
Flaitmability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute denial
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
3
(For EPA Use Only)
Accession Numbers
Assigned
118
-------
OMB Approval No. 2000-0468
Expiration Date 5/31/86
ATTACHMENT D
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 fran'EPA
dated concerning a requirement for submission of generic data
on the active ingredient named under FIFRA sec. 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 sec. 3,
and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the
above identified product is attached to this statement. That formula
statement indicates, by company name, registration number, and product
name, the source of the subject active ingredient in my firm's product,
OR
The CSF dated oh file with EPA is complete, current and
accurate and contains the information requested on the current CSF Form
No. 8570-4. The registered source(s) of the above named active ingredient
in my product (s) is/are ___
and their registration number(s) is/are
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 sec. 3(c)(2)(B).
Registrant's authorized representative:
Signature
Dated:
(Typed)
.119
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