r/EPA
Unrtad StotN
Environmental Protection
Agancy
1987
Pacticidaa ind Toxic SubcttncM
Washington DC 20460
Guidance for the
•
Reregistration of
Pesticide Products
Containing Propham
as the Active Ingredient
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3 0 MAR 1987
GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
THE ACTIVE INGREDIENT
PROPHAM
(047601)
CAS Number 122-42-9
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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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.
ADT: (Acceptable Daily Intake) An acceptable daily intake of
pesticide residue based on a complete data base.
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 in the environment
(terrestrial or aquatic ecosystem).
EP: End-use Product
EPA: The Environmental Protection Agency, also "the Agency"
PIPRA: The Federal Insecticide, Fungicide, and Rodenticide Act
HOT: 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.
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LCCQ: (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).
LD5Q' (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, ex-pressed 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. Pish and Wildlife
Service
OM: Organic matter (used to describe soils)
ppm: Parts per million
PADI: (Provisional Acceptable Dally Intake) An acceptable daily
Intake of pesticide re.sidue based on a limited data base.
PAI: Pure active ingredient
PGI: Pre Grazing Interval, a time period after pesticide
application, specified on the products labeling, that
livestock are not permitted in the treated field for
grazing.
PHI: Pre Harvest Interval, a time period after pesticide
application, specified on the products labeling, when
harvest of the crop is not permitted.
PLD: Provisional Limiting Dose, a limiting dose level used
when the available data are insufficient to establish
an ADI or PADI. ( the lowest NOEL X a safety factor,
where the safety factor is higher than normally used
due to lack of confidence in the data base for the
ADI or PADI calculations)
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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 dally per
capita food consumption figure, then adding the exposure
figures for each crop. TMRC is usually expressed in
terms of mg al/day, assuming a 60 kg person.
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TABLE OF CONTENTS
Glossary of Terras and Acronyms
I. Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Toxicology Characteristics
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 11
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 17
VI. Requirement for Submission of Generic Data 19
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
P. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 24
VIII. Requirement for Submission of Revised Labeling 25
IX. Instructions for Submission 26
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 CPR 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 PIFRA §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
ii
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with PIFRA. 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 FIPRA, 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 FIPRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered Inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request*, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
iThe 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.
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active ingredient. However, during th.e 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 UO CFR Part 151*
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 PIFRA 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. CHEMICAL COVERED BY THIS STANDARD
Description of Chemical
Common Name
Chemical Name
- Propham
- Isopropyl carbanilate
Chemical Abstracts Service - 122-42-9
(CAS) Number
EPA Shaughnessy Number
Empirical Formula
Trade Name
Physical State
Color
Odor
Melting Point
Octanol/Water Partition
Coefficient
B. Use Profile
Type of Pesticide
Pests Controlled
Registered Uses
Predominant Uses
Mode of Activity
Formulation Types
Registered
Method of Application
- 047601
- Chem-Hoe, Birgin, Triherbide
- Solid
- Tan to light grey
- Faint amine-like odor
- 87 to 88 °C
- 445 i 17 over a propham
concentration range of
0.5 to 100 ppm (pure
active ingredient)
- Herbicide
- Grassy weeds and some
annual broadleaf weeds
- Terrestrial food and
nonfood crops
- Alfalfa, clover, sugar
beets, and lettuce
- Inhibition of cell
division
- Flowable concentrate (43 and
31 percent active Ingredient)
and granular (15 percent
active ingredient) formulations
- Ground or aerial equipment
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III. AGENCY ASSESSMENT
A. Summary. The following summarizes the results of the
Agency's assessment of the existing scientific data base
for propham. A more thorough discussion of the Agency's
assessment follows this section.
1. Propham has low acute oral and dermal toxlclty and
Is classified In toxlclty Category III. Available
data Include a rat subchronlc toxlclty study deemed
supplementary because of numerous deficiencies (no
ophthalmologlc examinations were performed; analytical
data for analysis of blended diet for stability,
homogeneity and concentration were not presented;
certain recommended tissues were not examined hlsto-
logically; and several recommended blood electrolyte
assays were not performed), and an acceptable rat
teratology study in which the no observed effect
level (NOEL) for developmental effects (37.6 mg/kg)
is lower than the NOEL for maternal toxicity (375.8
mg/kg). A complete toxicological assessment Is not
possible until the additional toxicology data required
in table A of this document are submitted.
2. Data are Insufficient to thoroughly assess the environ-
mental fate, Including the potential to contaminate
ground water. Additional data are being required.
As a result of this review, the Agency has identified
missing data which are essential in completing assessment
of the environmental and human risks associated with the
use of propham. These data must be submitted In order to
maintain registrations of products or register new products
containing propham. Specific data requirements are listed In
Appendix A, Tables A and B.
B. Toxicological Assessment
1. Acute toxicity. Propham has low acute oral and dermal
toxicity and Is classified In toxicity Category III (see
Appendix II for discussion of toxicity categories).
In an acute oral toxlclty study, female Sprague-Dawley
rats were slightly more sensitive than male rats with
respective oral LDc0 values of 2360 _+ 118 mg/kg and
3000 + 232 mg/kg.
In an acute dermal toxicity study with rabbits, the
acute dermal LDejg is greater than 3000 mg/kg.
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Studies are required to establish the irritation
potential of the technical material to the eye and
skin. There are no reliable data available with
respect to acute inhalation toxicity; a study in rats
is required. A subacute dermal toxiclty study is also
required.
2. Subchronic Toxiclty. Only one subchronlc toxicity
study in rats is available. In a 90-day feeding study,
using dietary levels of propham technical of 0, 250,
1000 and 2000 ppm, 30 rats/sex/group were assigned to
each of the treatment groups; 10/sex/group were sacri-
ficed at the midpoint of the study (6 weeks) for interim
evaluation. The NOEL was found to be 250 ppm (approxi-
mately 12.5 mg/kg/day), based upon transient but signi-
ficant dose-related plasma chollnesterase inhibition in
females in the 1000 ppm and 2000 ppm groups. Because
of numerous deficiencies, the subchronic toxicity
study must be repeated in rodents. An additional sub-
chronic oral toxicity study, in a nonrodent species,
and a 21-day dermal toxicity study are also required.
3." Chronic and Long Term Studies
a. Chronic Toxiclty. Potential effects of chronic
exposure to propham have not been established.
No studies are available which meet EPA standards.
Chronic oral toxiclty studies are required in
rodent and nonrodent species.
b. Oncogeniclty. Sufficient data are not available
to definitively assess the oncogenic potential of
propham. The following information is available
from studies which do not meet requirements but are
considered to provide supplementary information:
In a screen of 130 chemicals, propham was adminis-
tered (1) to newborn mice (B6C3F]. and B6AKFi strains)
via gastric Intubation at a dose level of 215 mg/kg
daily from 7 days to 4 weeks (weaning), and a
dietary concentration of 560 ppra until termination
at 18 months; and (2) by a single subcutaneous
injection to 4 week old weanling mice of both
strains, with no further treatment through termination
at 18 months. Propham was "listed among those
compounds which did not cause a significantly (p
• £ 0.01) increased incidence of tumors in comparison
with negative controls in any of the major tumor
groups studied (i.e., hepatomas, pulmonary tumors,
lymphomas). However, there was reported to be a
significant (p £ 0.02) increase in total tumors
among orally treated animals. In the absence of
a tissue specific Increase in tumors, these data
do not provide compelling evidence of oncogenic
potential.
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No slgnlflcient compound-rrelated toxic effects were
found in a 2-year oncogenicity study with B6C3Fi
mice. The test consisted of in utero exposure by
treatment of the parents with a diet containing
0, 100, 330, or 560 ppm for 16 weeks prior to
mating and through gestation and lactation. The
weanlings were fed 0, 300, 1000, and 3000 ppm
with the high dose doubled at 62 weeks through
termination (6000 ppm).
In a study with golden hamsters fed a diet containing
2000 ppm propham for 33 months, no evidence of an
increase over control incidence of tumors was found.
Oncogenicity testing in two mammalian species (rats
and mice) is required (guideline §158.135, 83-2).
Teratogenlclty. In a teratology study, pregnant
rats (16 to 20 per dose group) were administered
propham by gavage on days 5 through 15 of gestation
at doses of 0, 37.6, 375.8 and 1878.8 mg/kg. The
high level tested exceeded the maximum tolerated
dose, resulting in excessive mortality. Body weight
gain of surviving high dose dams was significantly
reduced. Increased resorptions and dead fetuses,
as well as reduced fetal body weights, were
associated with treatment at the high dose level.
Developmental effects Including hydrocephalus,
myelomeningocele, and incomplete ossification of
the parietal and frontal bones of the skull, were
attributable to treatment with propham at the
high dose level. Fetuses in the mid-dose group
also showed increased incidences of incomplete
ossification of the skull. The NOEL'S for maternal
toxiclty and developmental effects were found to
be 375.8 and 37.6 mg/kg,- respectively. A NOEL
for fetotoxiclty was not established due to
excessive mortality of the dams at the high dose.
Results of a teratology study in mice were incon-
clusive. In that study, only one dose level of
propham (850 rag/kg) was tested and no maternal
toxiclty was reported; controls were Inadequate;
and individual data were not reported. These
data do not meet minimum Agency standards, and
are considered supplementary.
An additional teratology study with propham, using
a second mammalian species (other than the rat),
is required (§158.135, 83-3).
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d. ' Reproduction. No studies on reproductive effects
of propham technical material are available. A
study Is required (§158.135, 83-4).
e. Mutageniclty. No mutagenlclty tests with propham
technical are available. These tests are required
(§158.135, 8l*-2, three studies).
f. Metabolism. No metabolism studies are available.
These studies are required (§158.135, 85-1).
C. Other Science Findings
1. Ecological Effects. Propham has a very low acute
oral toxlcity to birds based on poorly designed tests,
is slightly toxic to coldwater and warmwater fishes
and is moderately toxic to freshwater invertebrates.
Additional data are required on avian oral and dietary
toxicity. The application of propham on registered
use sites is unlikely to result in an environmental
hazard to nontarget organisms.
No data are available on plant protection. However,
based on propham's use patterns (crops and fallow
land where there Is no exposure to endangered plants)
the phytotoxicity data are not required. According
to available information, application of propham on
registered use sites is unlikely to result in an
environmental hazard to nontarget plants and animals.
2. Environmental Fate. With the exception of an aerobic
soil metabolism study, available data are insufficient
to fully assess the environmental fate of, and the
exposure of humans and nontarget organisms to, propham.
Data are required as set forth in Table A of this
document.
Based on the acceptable aerobic soil metabolism study,
ring-labeled [l^C]propham (test substance uncharacterized),
at 2 ppm, degraded with a half-life of 7 to 1*1 days under
aerobic conditions In a sandy loam soil Incubated in the
dark at 25 °C and 60% of water holding capacity. By
the day 91 interval, 1% of the applied propham remained
unaltered, 68.5% had been evolved as 14C02, and
36% was soil-bound. Two degradates, each < 0.02
ppm, were Isolated from the soil but not identified.
8
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D. Tolerance Reassessment. Interim tolerances have been
established for residues of propham in the following raw
agricultural commodities (40 CPR 180.319):
Parts Per Million
Commodities (ppm)
Hay of alfalfa, clover, 5.0
and grass
Alfalfa, clover, and grass 2.0
Flaxseed, lentils, lettuce, peas, 0.1
safflower seed, spinach, and
sugar beets (roots and tops)
Eggs; milk; and the meat, fat, and 0.05
meat byproducts of cattle, goats,
hogs, horses, poultry, and sheep
EPA has evaluated the residue and toxicology data supporting
these interim tolerances. The results of this evaluation
follow:
Data gaps exist for plant and animal metabolism and for
storage stability. When the required data are received,
the conclusions summarized below with respect to adequacy
of tolerances and sufficiency of residue data are subject
to change. Tolerances for residues in animal commodities
will not be assessed until the requested animal metabolism
studies are completed and reviewed.
The available data are not sufficient to assess the
adequacy of interim tolerances for residues of propham in
or on sugar beet roots, sugar beet tops, lettuce, spinach,
peas (succulent and dry), lentils, grass forage, grass
hay, alfalfa forage, alfalfa hay, flaxseed, and safflower
seed. Additional data are required.
Processing studies are required for the following commodi-
ties: (1) dried pulp, molasses, and refined sugar from
sugar beets; (ii) meal and hulls from flaxseed; and (111)
meal and oil from safflower seed. If residues concentrate
1n any of these processed commodities, appropriate food/feed
additive tolerances must be proposed.
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Based on the current registered uses and available data, the
registrant must: (1) propose appropriate Pregrazlng Intervals/
Preharvest Intervals (PGIs/PHIs) for clover, lettuce, spinach,
and sugar beets; (ii) designate propham registration for
grasses as either pasture or rangeland use, and propose an
appropriate PGI and PHI if pasture use is designated; (iii)
propose tolerances and provide supporting residue data for
pea vines, pea vine hay, lentil forage, lentil hay, and flax
straw; and (iv) propose that the Interim tolerances under 40
CFR 180.319 be converted to "permanent" tolerances at the
same or, if necessary, different concentrations and that
these be supported by the requested residue data. As an
alternative to item (iii) above, the registrant may propose
feeding restrictions for pea vines, pea vine hay, and flax
straw. If the registrant(s) does not make the required
selections, EPA will presume that residue levels remain at
day 0 levels.
The following changes must be made to commodity definitions
in the tolerance statement when permanent tolerances are
requested, and the data gaps listed in this standard are
satisfied: (i) "alfalfa" to "alfalfa forage"; (ii) "clover"
to "clover forage"; (iii) "grass" to "grass forage"; and (iv)
"peas" to "peas (succulent and dry)", in keeping with current
terminology.
The Provisional Limiting Dose (PLD) for propham is 0.0125
mg/kg. This PLD is based on a 3-month rat feeding study,
with a NOEL of 12.5 mg/kg/day (approximate conversion
from 250 ppm), and applying a safety factor of 1000.
This is equivalent to a PLD of 0.75 mg/day for a 60 kg
individual. The Theoretical Maximum Residue Concentration
(TMRC), based on the total tolerances listed and a daily
food intake of 1.5 kg, is 0.0^3 mg/day, utilizing 5.7
percent of the PLD.
10
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IV. REGULATORY POSITION AND RATIONALE
Regulatory Positions and Rationales. Based on review and
evaluation of all available data and other relevant
information on propham, the Agency has made the following
determinations. Where labeling requirements are imposed,
specific language is set out in Section D of this Chapter.
1. The Agency is not initiating a Special Review of
propham 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
7 have been met or exceeded.
<>. No significant new uses* will be considered until the
Agency has received data sufficient to thoroughly
evaluate propham.
Rationale; The toxicology data base on propham is not
sufficient to consider establishment of new significant
tolerances. In addition, the metabolism of propham
in plants and animals is not adequately defined.
3. The Agency is requiring the following residue chemistry
data: plant and animal metabolism and storage stability
studies; residue studies for sugar beet roots, sugar
beet tops, lettuce, spinach, peas (succulent and dry),
lentils, grass forage, grass hay, alfalfa forage, alfalfa
hay, flaxseed, and safflower seed: and processing studies
to determine residues in dried pulp, molasses, and
refined sugar from sugar beets; meal and hulls from
flaxseed; and meal and oil from safflower seed.
Petitions for food/feed additive tolerances will be
required if residues concentrate.
Rationale ; Adequate data are not available to assess
the adequacy of existing tolerances or to ascertain
the need for food/feed additive tolerances in processed
commodities.
* Significant new use is defined in M PR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will
consider as significant an Increase in the Theoretical
Maximum Residue Contribution of greater than 1 percent.
11
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The Agency Is requiring the registrant to: (1) propose
appropriate Pre Grazing Intervals/Pre Harvest Intervals
(PGIs/PHIs) for clover, lettuce, spinach, and sugar
beets; (il) designate the propham registration for grasses
as either pasture or rangeland use, and propose an
appropriate PGI and PHI if pasture use is designated;
and (ill) propose tolerances and provide supporting
residue data or propose feeding restrictions for pea
vines, pea vine hay, lentil forage, lentil hay, and
flax straw. These proposals must be submitted with the
revised labeling and in accordance with the timeframe
required by this document for submittal of revised
labeling or the Agency will impose appropriate feeding
restrictions, (refer to chapter IV, D of this document,
Required Labeling)
Rationale; Data are unavailable to demonstrate what
PGI/PHI is needed for the cited crops in order to
assure that tolerance levels are not exceeded.
Adequate information is not available regarding the
use for grasses and this use must be clarified and
fully supported. There is currently no protective
mechanism (either tolerances or feeding restrictions)
to prevent excessive residues of propham in pea vines,
pea vine hay, lentil forage, lentil hay, and flax
straw. If the requested information is not submitted,
EPA will have no alternative but to assume that day
zero residues remain on cropsand appropriate action will
be initiated using that assumption.
The Agency is requiring the registrant to propose that
the interim tolerances under 40 CPR 180.319 be converted
to "permanent" tolerances under a separate paragraph
of the published tolerance expressions at the same
or, if necessary, different concentrations and provide
the requested residue data to support these tolerances.
In addition, the registrant must propose the following
changes to commodity definitions in the tolerance state-
ment: (1) "alfalfa" to "alfalfa forage"; (11) "clover"
to "clover forage"; (ill) "grass" to "grass forage"; and
(iv) "peas" to "peas (succulent and dry)".
Rationale; Interim tolerances were established when
petitions for tolerances for negligible residues were
pending. Since available data do not support the interim
tolerances, as established, permanent tolerances can not
be set based on currently available data. Therefore, when
data are submitted in accordance with this document, the
registrant must request conversion to permanent tolerances,
and revise the commodity definitions to conform to current
terminology or the Agency will propose revocation of the
tolerances.
12
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6. The Agency Is requiring additional toxlcological data,
as set forth in Table A of this document to assess the
toxicity of propham. Certain acute, subchronic, and
chronic testing is required.
Rationale; These data are normally required under 40 CFR
158 for products with propham's use patterns. Existing
data are insufficient to permit the Agency to thoroughly
assess the toxicity of propham.
7. The Agency is requiring additional ecological effects
data (see Table A) .
Rationale; Available data are Insufficient or lacking
to fully assess the hazard from propham use to the avlan
population.
8. The Agency is requiring environmental fate data as set
forth in Table A.
Rationale: Because the requirements have not been
fully satisfied available data are insufficient to
fully assess the environmental fate of propham.
The leaching data that are available indicate a potential
for ground water contamination. Hydrolysis, photo-
degradation, metabolism, leaching, dissipation, and
accumulation studies are required.
9. The Agency is not establishing a reentry interval at
this time.
Rationale; Data adequate to assess the need for a
reentry interval for field workers are not available.
Once data are received and evaluated, the Agency will
determine the need for such an interval. An interim
interval is not required because of the low acute
toxicity demonstrated by the available data.
10. The Agency Is requiring environmental precautionary
labeling.
Rationale: The Agency's regulations (40 CFR 162.10)
require environmental hazards labeling. Updated
labeling consistent with 162.10 Is required. Additional
required labeling statements to protect wetlands are
specified in the registration standard Section D.3.
13
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11. 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:
§158.130 Environmental Fate
161-1 Hydrolysis
161-2,3 Photodegradation
163-1 Leaching and Adsorption/Desorption
164-1 Soil Dissipation (Field)
165-1 Rotational Crops (confined)
12. While data gaps are being filled, registered manufact-
uring-use products (MPs) and end-use products (EPs)
containing propham 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)). The limited, available data do not
indicate any immediate, serious concern.
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.
B. liriteria for Registration. To be registered or reregistered
under this Standard, products must contain propham 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 as well
as comply with the data requirements in the attached
3(c)(2)(b) notice.
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C. Acceptable Ranges and Limits
1. Product Composition Standard. • To be registered or
reregistered under this Standard, MPs must contain
propham 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 each impurity found at greater
than 0.1 percent.
?. Acute Toxicity Limits. The Agency will consider
registration of technical grade and MPs containing
propham 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,
EPs may be labeled only for the commodities listed
below. The Use Index lists all registered uses, as
well as approved maximum application rates and
frequencies.
a. Terrestrial, nondomestic, food uses on: sugar
beets, lettuce, alfalfa, clovers (lidino,white,
red, and crimson), peas (dry or green), lentils,
safflower, and spinach.
b. Terrestrial, nondomestic, nonfood uses on: estab-
lished grasses grown for seed, flax and established
perennial grass and fallow land, drainage ditchbanks,
fencerows, roadsides, and lanes.
D. Required Labeling All products must bear appropriate
labeling as specified in 40 CFR 162.10. Appendix II
contains additional label requirements.
No pesticide product containing propham may be released
for shipment by the registrant 4 months after Issuance
of this Standard unless the product bears an amended label
which complies with the requirements of this Standard.
No pesticide product containing propham may be distributed,
sold, offered for sale, held for sale, shipped, delivered
for shipment, or received and (having so received) delivered
or offered to be delivered by any person 18 months
after issuance of this Standard unless the product bears
an amended label which complies with the requirements of
this Standard.
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In addition to the above, the following information must
appear on the labeling:
1. Ingredients Statement. The ingredient statement for
MPs must list the active ingredient as: isopropyl
carbanilate.
2. Use Pattern Statements. All MPs must state that
they are intended for formulation into EPs for
acceptable use patterns. Labeling must specify
sites, which are listed in Use Patterns, Section C.3.
However, no use may be included on the label where the
registrant fails to agree to comply with the data
requirements in Table A for that use pattern.
3. Required Precautionary Statements All Products
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is specifically
identified and addressed in 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 regional office of EPA."
"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."
4. Pregrazing and Preharvest Interval Requirements
The -registrant must: propose appropriate PGI's/PHI's
for clover, lettuce, spinach, and sugar beets;
designate the propham registration for grasses as
either pasture or rangeland use; propose an
appropriate PGI and PHI if pasture use is designated;
propose feeding restrictions for pea vines, pea
vine hay, lentil forage, lentil hay, and flax
straw. These changes must appear on the label
as specified above or EPA will take actions
.referred to in regulatory position number 4
chapter IV, A of this document.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as or.e 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 exemptionB, 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.
1. 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.1*
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 FIPRA sec.
3(cU2)(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
^ 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 FIPRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to Jointly develop (or share in the cost of
developing) the datajbut 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. Pile 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 PIPRA 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 PIPRA
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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^. You request a waiver of the data requirement. If
you oelieve 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 Fxpert Groups to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the timeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
F. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an Initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
22
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in writing to the Office of Compliance Monitoring at the
address given in Section IX.E.
EPA will view failure to request an extension before
the 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
PIFRA 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 PIFRA.
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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, P, 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.
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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 CPR 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 UO CPR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under PIFRA sec. 6.
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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.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
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.)
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3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing 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
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-11)
. 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^ (SPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-M).
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-U),
if Table C lists required product-specific data.
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c. Three copies of draft labeling1, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing 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
instructing 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, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active Ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 10 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
P = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table
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TGUIDE-2
U. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO^ - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data 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
MRIL 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 da'ta or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
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TABLE A
GENERIC DATA REQUIREMENTS FOR THE UNREGISTERED PROPHAM TECHNICAL
Data Requirement
Does EPA
Have Data to
Satisfy This Bibliographic
Composition Requirement? Citation
Must Additional
Data Be Submitted Tlmeframe
Under PIFRA Section for
3(c)(2)(B)? I/ Submlsslon2/
§158.120 Product Chemistry
Product Identity and Composition:
61-1 - Product Identity and Disclosure TGAI
of Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis of Product Ingredients
62-1 - Preliminary Analysis of TGAI
Product Samples
Physical and Chemical Characteristics
Yes
Partially 00145691
Partially 00145691
Partially 00145691
63-2 - Color
63-3 - Physical State
63-4 - Odor
TGAI
TGAI
TGAI
Yes
Yes
Yes
00145691
00145691
00145691
Yes I/
Yes3/
YesV
Yes5/
No
No
No
6 months
6 months
6 months
12 months
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TABLE A
GENERIC DATA REQUIREMENTS FOR THE UNREGISTERED PROPHAM TECHNICAL
Data Requirement
Composition
§158.120 Product Chemistry (Cont'd)
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted Tlmeframe
Under PIPRA Section for
3(c)(2)(B)7 I/ Submlsslon2/
Physical and Chemical Characteristics
(Cont'd)
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Other
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
- pH
- Stability
Requirements :
TGAI
TGAI
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
Yes
N/A6/
Partially
Partially
Partially
No
Yes
No
Partially
00145691
—
00145691
00145691
00145691
—
00145691
—
00145691
No
No
Yes?/
Yes^/
Yes9/
Yes
No
Yes
Yeslp/
—
—
6 months
6 months
6 months
6 months
—
6 months
6 months
64-1 - Submlttal of samples
N/A
N/A
No
ro
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TABLE A
GENERIC DATA REQUIREMENTS FOR THE UNREGISTERED PROPHAM TECHNICAL
Footnotes
I/ For all unregistered technical or manufacturing-use products product chemistry data must be submitted in accordance
with §158.120.
2/ Timeframes listed start on the issuance date of this document.
3/ Details of the manufacturing process, Including the relative amounts of beginning materials, a description of the
~ equipment used to produce the product, reaction conditions, the duration of each step of the process, and purifi-
cation procedures and quality control measures must be submitted for each unregistered technical. Also, the name
and address of the manufacturer, producer or supplier of each beginning material used to produce the above products,
as well as submission of a copy of all available technical specificatlons, data sheets and other documents in which
the manufacturer, producer or supplier of each beginning material describes its composition and properties must be
submitted.
V A discussion of each Impurity believed to be present at > 0.1 percent, based on knowledge of the beginning materials,
~~ all possible chemical reactions, and any contamination, Ts required for each unregistered technical.
5/ Five or more representative samples of each technical must be analyzed for propham, each Impurity present at >^ 0.1
~ percent (w/w), and each additional "toxlcologlcally significant" impurity by analytical methods supported by
validation studies of their precision and accuracy.
6/ Not required, since the PAI is solid at room temperature.
II Available information is inadequate because determination was performed at 30 °C, Instead of 20 or 25 °C.
8/ Most results were not stated quantitatively, and the temperature at which the determinations were made was not stated.
9/ The identity of the tested compound was not stated (must be pure active Ingredient).
10/ Information was not supplied concerning the effects of metals, metal ions, normal temperatures, or sunlight.
UJ
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Tlmeframe
for
Submission 1,
§158.125 Residue Chemistry
171-4 - Nature of Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal residues
Storage Stability
Data
PAIRA
PAIRA 4 Plant
Metabolites
TGAI 4
Metabolites
TGAI 4
Metabolites
PAI
Partially
Partially
Partlally5/
No
Partially
00038956, 00082681
00115^37, 00115443,
00115446, 00115447
00134707
00082676, 00091226
00091227, 00115396
00115398, 00115439
00115440, 00115441
00115442
00115448, 00119929
Yes2/
YesV
00119929
Yes6/
Yes6/7/
Yes8/
18 months3/
18 Months
36 months
36 months
15 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission I/
§158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residue -
Residue Studies for Each
Food Use9/
- Crop Group #1 - Root and
Tuber Vegetables^"/
o Crop 1 - Sugar beet roots
- Crop Field Trials TEP
-- Processed Food/Feed EP
- Crop Group #2 - Leaves of
Root and Tuber Vegetables1*1/
o Crop 1 - Sugar beet tops
— Crop field trials TEP
- Crop Group #3 - Leafy
Vegetables (except Brasslca
Vegetables) 16/
o Crop 1 - Lettuce
— Crop field trials TEP
Partially
No
Partially
Partially
00119929
00119929
00119929
Yesll/13/
Yes12/13/
Yesl5/
18 Months
24 Months
18 Months
18 Months
LH
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Test Does EPA Bibliographic
Substance Have Data? Citation
Must Additional
Data be
Submitted?
Tlmeframe
for
Submission I/
§158.125 Residue Chemistry (cont'd)
171-lJ - Magnitude of the Residue -
Residue Studies for Each
Food Use
o Crop 2 - Spinach
— Crop field trials TEP
- Crop Group #4 - Legume
• Vegetables (Succulent
or Dried) 19/
o Crop 1 - Lentils
— Crop field trials TEP
o Crop 2 - Peas (succulent
and dried!
— Crop field trials ' TEP
- Crop Group #5 - Grass Forage,
Fodder, and Hay
— Crop field trials TEP
- Crop Group #6 - Nongrass
Animal Feeds (Forage,
Fodder, Straw, and Hay)237
Partially
00119929
Yes18/
18 Months
No
Partially
Partially
00119929
00119929
Yes21/
Yes22/
18 Months
18 Months
18 Months
ON
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data
§158.
171-4
Test Does EPA Bibliographic
Requirement Substance Have Data? Citation
125 Residue Chemistry (cont'd)
- Magnitude of the Residue -
Residue Studies for Each
Food Use
o Crop 1 - Alfalfa forage
and hay
— Crop field trials TEP Partially 00119929
o'Crop 2 - Clover forage
and hay
— Crop field trials TEP Partially 00119929
- Miscellaneous Commodities
o Crop 1 - Flax
— Crop field trials TEP Partially 00119929
— Processed Food/Feed EP No
o Crop 2- Safflower
— Crop field trials TEP No
— Processed Food/Feed EP No
Meat/Milk/Poultry/Eggs TGAI or
Must Additional Tlmeframe
Data be for
Submitted? Submission I/
Yes24_/ 18 Months
No25/
Yes 267 18 Months
Yes£7/ 24 Months
Yes£8_/ 18 Months
Yes29/ 24 Months
Plant Meta-
bolites No
ReservedBO/
Osl
-------
TABI£ A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes
I/ Timeframes listed start on the issuance date of this document.
2/ Tne uptake, distribution, and metabolism of [^C] propham in legume forage, a root crop, and a leafy vegetable
~ following soil and foliar application (tested separately) must be Included. The identities and quantities of
residue in or on mature plant parts must be determined in order to elucidate the terminal residues. Residue
identities must be confirmed by a method such as GC, HPLC, and/or mass spectrometry. Data reflecting solvent
extraction efficiency of propham residues must also be represented. Representative samples from these tests must
also be analyzed by enforcement methods to ascertain that these methods are capable of determining all metabolites
of concern. Depending on the results of the requested plant metabolism studies, additional metabolites may also be
considered of concern in the future.
3/ Registrants are provided 18 months to submit data commencing with the first planting season after Issuance of the
~ Standard, consistent with PR Notice 85-5.
V Metabolism studies are required utilizing ruminants, poultry, and swine in which animals must be dosed for a
~ minimum of 3 days with [^C] propham at a level sufficient to make residue identification and quantification
possible. Milk and eggs must be collected twice a day during the dosing period. Animals must be sacrificed within 2
hours of the final dose. The distribution and characterization of residues must be determined in milk, eggs, liver,
kidney, and muscle and also skin of hen and swine and gizzard of hen. Data reflecting solvent extraction efficiency
of propham residues are also required. Representative samples from the above-described tests must also be analyzed
by current enforcement methods to ascertain the validity of these methods.
5/ The submitted analytical methods have not been subjected to a method trial.
6/ Residues of propham per se in or on crop samples must be subjected to analysis under the multiresldue protocols.
~ Protocols for methods""!,""!!, III, and IV are available from National Technical Information Service under Order No.
PB 86 2C373VAS. If the requested data regarding the nature of the residue in plants and animals reveal additional
metabolites of toxicological concern, additional analytical methods for data collection and enforcement may be
required.
7/ Analytical methodology must be developed and submitted that Is suitable for the enforcement of tolerances for
propham in eggs, milk, and animal tissues. Also, residues of propham per s£ in or on crop samples must be subjected
to analysis by the multiresldue protocols. Protocols for methods I,II,III, and IV are avialable from NTIS under
order no. PB 86 20373 VAS.
8/ The storage Intervals and conditions must be reported for all samples used to support tolerances for residues of
propham in or on raw agricultural commodities and in processed commodities. These data must be accompanied by data
depicting the decline of residues during the Intervals and under the conditions specified. On receipt of these data,
the adequacy of the tolerances can be reevaluated. Residue data requested in this Standard must be accompanied by
CM
CD
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)
Information describing the storage conditions and Intervals for all samples analyzed. These data must be accompanied
by fortification recovery data depicting the stability of residues of concern in appropriate sample substrates under
the storage conditions and for the time Intervals specified. Any samples collected in the future must be stored at
a temperature shown to reduce the loss of propham upon storage of treated samples; a temperature < 0 °C appears to
be necessary. An acceptable analytical method must be used for analysis (see Residue Analytical Methods section).
The method must Include maceration of the sample, i.e., not merely surface washing. If the requested metabolism data
indicate the presence of additional residues of toxicologlcal concern, data depleting the storage stability of such
residues will be required.
£/ It should be noted that the conclusions stated below are subject to change on receipt of the requested plant
metabolism and storage stability data. Also, 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 con-
sider the data requirements stated in 40 CFR 180.3^ to propose group tolerances.
1Q/ The available data are Insufficient to determine whether a group tolerance is appropriate. If the registrant seeks
a crop group tolerance, additional data are required to support the established tolerance for residues of propham
In or on the representative group member sugar beet roots (refer to the "Sugar beet roots" section for details of
data requirements). Use directions must be proposed, and appropriate supporting residue data submitted for the
additional representative group members carrots, potatoes, and radishes.
ll/ The following data are required, in conjunction with data required for sugar beet tops:
o Data depicting propham residues of concern in or on sugar beet roots harvested at the established PHI after
postemergence application of, in separate tests, the 4 Ib/a.i./gal F1C formulation at 6 Ib ai/A as a directed
shielded spray and the 15% active ingredient G formulation at 5.25 Ib al/A by ground or air equipment. Tests
must be conducted In CA(23%), ID(15%), and MN(20%) or ND(10%) which represent 68% of U.S. sugar beet production
(Agricultural Statistics, 1985, p. 76).
o Data depicting propham residues of concern In or on sugar beet roots harvested at the established PHI after
postemergence application of the M Ib/a.i./gal F1C formulation at H Ib ai/A by air and through center pivot
sprinkler Irrigation (in separate tests). Tests must be conducted In ID, OR, or WA since this use Is limited
to these States.
Osl
-------
TABLE A
GENERIC'DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)
o Data depicting propham residues of concern In or on sugar beet roots harvested at the established PHI following
postemergence application, In the irrigation water, of the U Ib/a.i./gal F1C formulation at 6 Ib al/A. Tests must
be conducted In CA. Alternatively, the registrant may elect to cancel the Irrigation water use permitted In
CA under SLN CA-780196.
12/ Data from a processing study depicting propham residues of concern in dehydrated pulp, molasses, and refined
sugar processed from sugar beet roots bearing measurable weathered residues. If residues concentrate In any of
these processed commodities, appropriate food and/or feed additive tolerances must be proposed.
13/ The registrant must also propose a label revision establishing an appropriate PHI. The data requested above
(see footnotes 11 and 12) must reflect this revision or the Agency will impose an interval.
IV The available data are Insufficient to determine whether a group tolerance is appropriate. If the registrant
seeks a crop group tolerance, additional data are required to support the established tolerance for residues
of prcJpham in or on the representative group member sugar beet tops (refer to the "Sugar beet tops" section
for details of data requirements). Use directions must be proposed, and appropriate supporting residue data
submitted for the additional representative group member turnip tops.
15/ The following data are required, in conjunction with data required for sugar beet roots:
o Data depicting propham residues of concern In or on sugar beet tops harvested at the established PHI after
postemergence application of, in separate tests, the ^ Ib/a.i./gal FIG formulation at 6 Ib al/A as a directed,
shielded spray and the 15% a.i. G formulation at 5-25 Ib ai/A by ground and air equipment. Tests must be
conducted in CA(23£), ID(15/0, and MN(20%) or ND(10%), which represent 68% of U.S. sugar beet production
(Agricultural Statistics, 1985, p. 76).
o Data depicting propham residues of concern In or on sugar beet tops harvested after postemergence application of
the ^ Ib/a.l./gal F1C formulation at H Ib al/A by air and through center pivot sprinkler Irrigation (in separate
tests). Tests must be conducted In ID, OR, or WA since this use is limited to these States.
o Data depicting propham residues of concern in or on sugar beet tops harvested at the established PHI following
postemergence application in irrigation water of the J| Ib/a.i./gal FIG formulation at 6 Ib ai/A. Tests must be
conducted in CA. Alternatively, the registrant may elect to cancel the Irrigation water use permittee] In CA
under SLN CA-780196. '
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)
o The registrant must also propose a label revision establishing an appropriate PHI. The data requested above
must reflect this revision.
16/ Tne available data are insufficient to determine whether a group tolerance is appropriate. If the registrant
seeks a crop group tolerance, additional data are required to support the established tolerance for residues
of propham in or on the representative group members lettuce and spinach (refer to the "Lettuce" and "Spinach"
sections for details of data requirements). Use directions must be proposer!, and appropriate supporting residue
data submitted for one additional representative group member (celery) or data supporting each crop will be required.
17/ Data must be submitted depicting the residues of propham in or on lettuce (with and without wrapper leaves
attached) harvested at the proposed PHI following postemergence direct shielded application of the 4 Ib/a.l./gal
F1C fomulation at 6 Ib al/A. Tests must be conducted in the States of CA(73%) and AZ(17%) representing 90% of
corrmercial U.S. lettuce production (Agricultural Statistics, 1985, p. 159). The registrant must propose a label
revision establishing an appropriate PHI for the postemergence application or the Agency will set the PHI. The
data requested above mustreflect this revision.
18/ Data must be submitted depicting the residues of propham in or on spinach harvested at the proposer! PHI following
postemergence application of the *J Ib/a.i./gal FIG formulation at 5 Ib ai/A. Tests must be conducted In CA(21%),
and OK (6%) or TX(25%), representing 55% of the commercial U.S. 1982 spinach acreage (1982 Census of Agriculture,
Vol. 1, Part 51, p. 352). The registrant must propose revision of the label to establish an appropriate PHI for the
postemergence application. The data requested above must reflect this proposed PHI. Residue data will not be
required for spinach grown for seed unless all other uses on spinach are cancelled.
19_/ The available data are insufficient to determine whether a group tolerance is appropriate. If the registrant
seeks a crop group tolerance, additional data are required to support the existing tolerance for residues of propham
in or on succulent and dried peas (see "Peas" section for details). The registered use pattern for peas (preplant
and postemergence) is different from that for lentils (preplant). Use directions must be proposed and appropriate
supporting residue data submitted for beans (Phaseolus spp.; one succulent variety and one dried variety) and
soybeans.
20/ Data depicting the residues of propham in or on lentils harvested at normal crop maturity following preplant
incbrporated application of the 4 Ib/a.i./gal F1C formulation by ground equipment at 4 Ib ai/A must be submitted.
Tests must be conducted In ID(31%) or WA(66%), which represent 97% of U.S. lentil production (1982 Census of
Agriculture, Vol. 1, Part 51, p. 320). Since lentil forage and lentil hay are raw agricultural commodities, the
registrant must propose tolerances and submit appropriate supporting residue data.
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)
21 / Data depicting propham residues of concern in or on pea seed (succulent peas plus pods, and dry) harvested at the
proposed PHI following postemergence broadcast application (by ground or aerial equipment) of the 15% a.i. G
formula at U Ib ai/A must be submitted. Succulent and dry varieties must be represented In separate tests. Tests
must be conducted in MN(21%) or WT(26%) and OR(10%) or WA(22%) which represent 79% of U.S. pea production
(Agricultural Statistics, 1985, p. 162). The registrant must propose a PHI which Is reflected by the data
requested above. Since pea vines and pea vine hay are raw agricultural commodities, the registrant must propose
tolerances and submit appropriate supporting residue data. Alternatively, the registrant may elect to propose
feeding restrictions for pea vines and pea vine hay.
22/ Data depicting propham residues of concern In or on grass forage and hay from three species Including:
(1) Kentucky bluegrass; (11) Chewing's fescue, creeping red fescue or tall fescue; and (111) orchardgrass , per-
ennial ryegrass or bentgrass (Astoria/Highland) must be submitted. Grass forage In the various tests must be
harvested 0 days after application (using ground equipment) of the 4 Ib/a.i./gal F1C formulation at 4 Ib ai/A. Hay
should be harvested at the normal harvest tlme(s). Tests must be conducted in OR. Residue data will not be
required for grass grown for seed unless all other grass uses are cancelled. The registrant must also propose a
label revision designating propham use for either pasture (fenced, controlled grazing areas) or range (unfenced,
grazing not controlled) grasses. If pasture use is designate'], the registrant must propose an appropriate PGI and
FHI (or delete the use patterns) after which grazing and harvesting of treated grass is restricted; the data request
above must reflect that FHI. Alternatively, other specific label directions/limitations may preclude the need for
a PGI and/or a PHI or we will assume that residues at any time are equal to residues at 0 day.
23/ A crop group tolerance is not appropriate for the nongrass animal feeds group at this time because additional
data are needed to support the established tolerances for residues of propham in or on alfalfa and clover (see
individual crop sections for details).
2V Data depicting residues of propham in or on alfalfa forage and hay harvested 50 days after postemergence broadcas
application of, in separate tests, the ^ Ib/a.l./gal FIG formulation In 20 gal water/A and the 15% a.l. G
formulation at 5 Ib al/A must be submitted. Ground and aerial applications must be represented in separate tests.
Tests must be conducted In CA(7%), ID(5%) or MT(W, IA(7%) or MN(7%), KS(W or NE(6%), ND(3%) or SD(6%), and
WI(13%), which represent 62% of the U.S. alfalfa production (Agricultural Statistics 1985, p. 2^2). Note that
residup data will not be required for alfalfa grown for seed unless all other uses on alfalfa are cancelled; If
needed in the future, such data will be translated to clover. Data depleting residues In alfalfa forage and hay
harvested 50 days following the postemergence broadcast application of, In separate tests, the 4 Ib/a.i./gal FIG
in 20 gal water/A and the 15% a.l. G at 6 Ib ai/A must be submitted. Ground and aerial applications must be represe
in separated tests. Tests must be conducted In CA, ID, NV, OR, and WA. Alternatively, the registrant may elect
ro
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)
to cancel this postemergence broadcast use permitted In CA under SLNs CA-780057 and CA-780058, In ID under SIM
ID-830006, in NV under SLNs NV-780002 and NV-780003, in OR under OR-830005, and in WA under SLN WA-830002. Data
depicting residues in or on alfalfa forage and hay harvested 8 days following postemergence broadcast application
of the 4 Ib/a.l./gal F1C formulation at 4 Ib al/A by center pivot sprinkler irrigation In 0.5-1.0 Inch water must
be submitted. The tests must be conducted In ID, OR and WA. Alternatively, the registrant may elect to cancel
this postemergence broadcast use permitted in ID under SLN ID-830006, in OR under SLNs OR-770015 and OR-830005, and
in WA under SLNs WA-770003 and WA 830002. Data depicting residues in or on alfalfa forage and hay harvested 50
days following the application of the 1 Ib/ a.l./gal PIC formulation at ^ Ib ai/A in irrigation water. Tests must
be conducted in CA. Alternatively, the registrant may choose to cancel this irrigation water use permitted under
SLN CA-780211.
25/ The submitted data are Insufficient to assess the adequacy of the tolerances for residues' of propham In or on
clover and clover hay because data were not submitted for field dried hay samples and geographic representation of
the acceptable data was inadequate. Residues of 530-1061 ppm were found In or on clover forage samples harvested
at the implied PGI/PHI of 0 days from two OR tests treated at 1.5X the maximum registered use rate. Nevertheless,
no additional data will be specifically required for clover because the data requested for alfalfa can be
translated to support the clover tolerances since the uses are similar. However, the registrant must propose label
revisions establishing a realistic PGI and/or PHI, and data translated from alfalfa must reflect this revision.
Alternatively, other specific label directions/restrictions may obviate the need for a PGI and/or PHI. The
transit*ted data cannot be used to support a crop group tolerance.
26/ Data depicting propham residues of concern In or on flaxseed harvested at normal crop maturity following
postemergence broadcast application of the 15% a.l. G formulation by ground or aerial equipment at 4 Ib ai/A when
the crop is 2-4 Inches high must be submitted. Tests must be conducted In MN(9%), ND(69%), or SD(21%) which
represent 100% of U.S. flaxseed production (Agricultural Statistics, 1985, p. 113). Since flax straw Is a raw
agricultural commodity, the registrant must propose a tolerance and provide appropriate supporting residue data.
Alternatively, the registrant may propose label revisions restricting the feeding of flax straw to livestock.
27/ Data from a processing study depicting propham residues of concern In meal and hulls processed from flaxseed
bearing measurable weathered propham residues must be submitted. If residues, concent rate in either of these com-
modities appropriate feed additive tolerances must be proposed.
28/ Data depicting propham residues of concern in or on safflower seed harvested at normal crop maturity following
preplant Incorporated or preemergence application of the 4 Ib/a.l./gal PIC formulation at 4 Ib al/A must be
submitted. Tests must be conducted In CA(76%) and MT(17%), which represent 93% of U.S. safflower production
(1982 Census of Agriculture, Vol. 1, Part 51, p. 317).
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes (cont'd)
29/ Data from a processing study depicting propham residues of concern in meal and oil processed from safflower seed
bearing measurable weathered residues must be submitted. If residues concentrate in either of the processed com-
modities appropriate food and/or feed additive tolerances must be proposed.
30/ Due to Inadequate understanding of plant metabolism of propham and the lack of established residue tolerances for
several feed commodities which can contribute to the diets of livestock species, the interim tolerances for animal
canmodi»;ies cannot be assessed and dietary intake levels for animal feed studies cannot be determined. When a
theoretical maximum dietary intake level for propham can be accurately estimated, appropriate feeding studies will
be required. Also, the metabolism of propham in animals is not adequately understood (see "Nature of the Residue
In Animals" section for details). Therefore, if the required metabolism studies reveal other residues of concern,
additional residue data will be required from any required feeding studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Test
Substance
Use
Patterns
Must Additional Tljneframe
Does EPA Bibliographic Data be for
Have Data? Citation Submitted? Submission I/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 On Soil
161-1 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
Adsorptlon/Desorptlon
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TEP
TEP
A,B
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
A,B
A
NA3/
NA3/
A
A
No
No
No
No
Yes
No
No
No
No
Yes
00115^70
No
Yes
Yes
ReservedV
Reserved1*/
9 Months
Yes 9 Months
Yes 9 Months
Reserved^/
27 Months
12 Months
en
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
§158.130 Environmental Fate (cont
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and Tank
Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
Test
Substance
'd)
TEP
TEP
TEP
TEP
PAIRA
TEP
Use
Patterns
A
N/A3/
N/A3/
A
A
A
Must Additional
Does EPA Bibliographic Data be
Have Data? Citation Submitted?
No - Yes
No - Reserved/
No - Yes
No - Reserved^/
Tlmeframe
for
Submlssionl/
27 Months
39 Months
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
TEP
N/A3/
TGAI or PAIRA A,B
No
TEP
N/A3/
Yes
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes
I/ Tlmeframes listed start on the issuance date of this document.
2/ Pending results of laboratory volatility data and review of reentry Issues. These studies will be required If the
~ chemical is volitile or use patterns/data warrant a reentry interval.
3/ No aquatic and forestry use pattern. These studies will be required if these use patterns are requested.
V Pending reentry issues. These studies will be required if the use patterns warrant the establishment of a reentry
~~ interval.
5/ Pending results of field dissipation study. These studies will be required If the chemical Is long lived In the soil.
6/ Pending results of confined rotational crop study. This field study will be required If the confined study shows
uptake by rotational crops.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
§158.1110 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
Test
Substance
TEP
TEP
TEP
TEP
Use
Patterns
A
A
A
A
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
Must Additional
Data be
Submitted?
Conditional V
No£/
Optional^/
Optional 3/
_!/ Pending further toxlcological evaluation when used as a post emergent herbicide.
2/ Soil Dissipation data are required only for uses where workers will be exposed directly to substantial quantities of
~ soil during their work, e.g., for use on potatoes or peanuts where hand harvesting will be performed.
3_/ Human-exposure monitoring data may be submitted at the registrant's option. If Dermal Exposure data are submitted,
Inhalation Exposure data must also be submitted.
CO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data
§158.
AVIAN
71-1
71-2
71-3
71-4
Requirement
145 Wildlife and Aquatic
AND MAMMALIAN TESTING
- Avian Oral LDrjQ
- Avian Dietary LCejQ
- Wild Mammal Toxlcity
- Avian Reproduction
Composition
Organisms
TGAI
TGAI
TGAI
TGAI
use
pattern
A,B
A.B
A,B
A,B
Does EPA Have
Data to Satisfy
This Requirement Bibliographic
(Yes, No, Partially) Citation
Partially 160000
No
No
No
Must
Data
Under
tion
Yes
Yes
Nql/
NoV
Additional Tlmeframe
Be Submitted for
FIFRA Sec- Submission
3(c)(2)(B)7 I/
9 Months
9 Months
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater- Pish
72-2 - Acute LC5o Freshwater
Invertebrates
72-3 - Acute 1050 Estuarlne
and Marine Organisms
72-4 - Fish Early Life Stage
and Aquatic Inverte-
brate Life Cycle
TEP
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A
No
Yes
Yes
No
No
40094602, 00115433
GS0144-12
40094602
No
No
NoV
NoV
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Tlmef rame
Does EPA Have Must Additional for
Data to Satisfy Data Be Submitted Submission
Use This Requirement Bibliographic Under FIFRA Sec- I/
Data Requirement Composition Pattern (Yes, No, Partially) Citation tlon 3(c)(2)(B)?
§158.145 Wildlife and Aquatic Organisms (cont'd)
72-5 - Pish Life Cycle TGAI A No
72-6 - Aquatic Organism TGAI, PAI A No
Accumulation or Degra-
dation
Product
72-7 - Simulated or Actual TEP A No
Field Testing -
Aquatic Organism
§158-150 Plant Protection
121-1 - TARGET AREA i
PHYTOTOXICITY TEP A,B No
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Emergence TGAI A,B No
122-1 - Vegetative Vigor TGAI A,B No
122-2 - Aquatic Plant Growth TGAI A,B No
LTI
O
NoV
NoV
NoV
NoV
NoV
NoV
NqV
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Composition
Does EPA Have
Data to Satisfy
Use • This Requirement Bibliographic
Pattern (Yes, No, Partially) Citation
Must Additional Tlmeframe
Data Be Submitted for
Under FIFRA Sec- Submission
tion 3(c)(2)(B)7 I/
§158-150 Plant Protection
TIER II
123-1 - Seed Germination/
Seedling Emergence
-1 - Honey bee acute
contact 11)50
TGAI
TGAI
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth TGAI
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
A,B
A,B
A,B
A,B
D
No
No
No
No
No
Nql/
NoJ/
Nol/
No
TGAI
A,B
Yes
00036935
No
V Available information on the chemical and its use patterns Indicate that these studies are not required.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Composition
Use
Pattern
Does EPA Have
Data to Satisfy
This Requirement Bibliographic
(Yes, No, Partially) Citation
Must Additional Tlmeframe
Data Be Submitted for
Under PIFRA Sec- Submission
tion 3(c)(2)(B)7
§158-155 Nontarget Insect
141-2 - Honey bee - toxlclty
of residues on
foliage
l/jl-i| - Honey bee subacute
feeding study
-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING PREDATORS
143-3 AND PARASITES
TEP A,B
[Reserved]2/
TEP A,B
[Reserved]^/
[Reserved]^/
[Reserved]3/
[Reserved]3/
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Footnotes
V Data from this study is not required at this time. Requirement will depend on results of acute contact study.
- I? the a^ute contact study demonstrates toxiclty to the bees then the field study would be necessary.
2/ Reserved pending development of test methodology.
V Reserved pending Agency decision as to whether the data requirement should be established.
Ui
OJ
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement Composition
§158.135 Toxicology
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under PIPRA Section
No or Partially?) Citation 3(c)(2)(B)?
Tljne frame
for
Submlsslonl/
ACUTE TESTING:
81-1
81-2
81-3
81-1
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensltlzatlon -
Guinea Pig
- Acute Delayed
Neurotoxlclty - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Yes
No
No
No
No
No
00115421 No
00115422 No
Yes
Yes
Yes
Yes
No£/
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
- 90-Day Feeding -
Rodent
. Nonrodent
TGAI
TGAI
No
No
Yes - 15 Months
Yes -' 18 Months
01
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
§158.135 Toxicology (continued)
82-2
82-3
82-4
82-5
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
Rat
- 90-Day Neurotoxicity
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted Timeframes
Requirement? (Yes, Bibliographic Under PIFRA Section for
Composition No or Partially?) Citation 3(c)(2)(B)7 submission I/
TGAI No
TGAI No
TGAI
No
TGAI No
Yes
3/
No~
3/
No
V
No
12 Months
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Toxicity -
Rodent
Nonrodent
- Qncogenicity Study -
Rat
Mouse
- Teratogenlclty -
Rat
Rabbit
- Reproduction
TGAI
No
No
TGAI
No
No
TGAI
Yes
No
TGAI No
Yes
Yes
Yes
Yes
00115^34 No
Yes
Yes
50 Months
50 Months
50 Months
50 Months
15 Months
39 Months
un
en
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPHAM
Data Requirement
Composition
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially?)
Bibliographic
Citation
Must Additional
Data Be Submitted Tlmeframe
Under PIFRA Section for
3(c)(2)(B)7 Submission I/
§158.135 Toxicology (continued)
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenlclty
SPECIAL TESTING
85-1 - General Metabolism
TGAI No
TGAI No
TGAI No
PAI or PAIRA No
Yes
Yes
Yes
Yes
9 Months
12 Months
12 Months
24 Months
I/ Tlmeframes listed start on the Issuance date of this document.
2/ The compound Is not an organophosphate. The test Is not required.
3/ This test Is not currently required, due to the lack of exposure data and may be required after the exposure data
Is submitted and reviewed.
V This test is not required because the acute hen test is not required and the compound has not shown
neurotoxicity in a manrnalian species.
Ul
O\
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPHAM
Data Requirement
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Primary Eye
Composition
MP
MP
MP
MP
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially?)
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Yes - 9 Months
Yes - 9 Months
Yes - 9 Months
Yes - 9 Months
•Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
MP
MP
No
No
Yes - 9 Months
Yes - 9 Months
-------
SUMMARY-1
LABEL CONTENTS
40 CPR 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 CPR I62.10(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 I62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the Immediate
container cannot be clearly read through such wrapper or container.
[40 CPR I62.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CPR l62.10(g)]
58
-------
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 162.10(h)(1)(11)]
Item 78. 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)(!)(!)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(1)]
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 I62.10(h)(1)(ill)]
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;10(h)(l)(lii)]
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 l62.10(h)(2) ].
59
-------
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. [10 CFR 162.10(h)(2)(1)]
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. [10 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product' should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR I62.11(c). You will be notified of
the Agency's classification decision.
-------
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 1*0
CPR
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
reregistratlon, 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.
61
-------
SUMMARY-5
Item IDA. 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.
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.
62
-------
SUMMARY-6
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal wore]
APPLICABILITY
OP REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
al/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
PhEf'EKKEU
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immed lately
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.
CN
-------
SUMMARY-?
ITEM
7C
7D
7E
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 and
domestic
animals
Environmental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxlcity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
CN
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
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
ON-
en
-------
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.
Hi) AH 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
66
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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 is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers/ and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 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
pro^uc*- fo- 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;
67
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(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
onco glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand/ or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°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
pressurizedi 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."
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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 o'f 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. iinii»«« i-he 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.
-------
(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
pract.ice. 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 chcir-ic-l hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement/ type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Oral LD5Q
Inhalation LC
Dermal LD
Eye effects
Skin effects
1
Up to and
Includ Ing
50 rag/ kg
Up to and
Including
.2 mg/llter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive
Toxic Ity <
II
From 50 Thru
500 mg/kg
From .2 thru
2 mg/ liter
From 200
thru 2000
Cornea 1 opacity
reversible
• Ithln 7 days;
Irritation
persisting for
7 days
Seve-a Irritation
at 72 hours
:ategor les
III
F-om 500 thru
5000 mg/kg
F-om 2 thro
20 mg/ liter
From 2,000 thru
20,000
No cornea! opacity;
Irritation
reversible
within 7 days
Mode-ate Irritation
at 72 hou-s
IV
Greater than
5000 mg/kg
Greater than
20 ng/l Iter
Greater than
20,000
No Irritation
Ml Id or si 'ght
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned
the basis of its oral, ir.halat icr. or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
(B) Toxicity Category II.
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
to Toxicity Category I on
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
All pesticide products meeting the
II shall bear 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
71
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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 10 to 15
Above 15 to 30
Poir
Required
signal word,
all capitals
c.
i n
1 7
1 4
18
its
"Keep out
of reach of
Children"
i n
1 U
12
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
I
Toxic I ty |
category | Oral, Inhalation, or dermal toxic I1>
Precautionary statements by toxlclty category
Skin and eye local effects
11 I
IV
Fatal (poisonous) If swallowed (Inhaled or
absorbed through sklnl. Do not breathe
vapor Idustl or spray mlstl. Do not get
In eyes, on skin, or on clothing [Front
panel statement of practical T-eatment
May be fatal If swallowed (Inhaled or
abso-bed through the skin). Oo not breathe
vapo-s Idust or spray nlst). Oo not get ln|
eyes, on skin, or on clothing. I Appropriate)
first aid statements required.!. |
Corrosive, causes eye and skin damage lor
skin Irritation). Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
Causes eye land skin! Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. [Appropriate first
aid statement required.).
Harmful If swallowed (Inhaled or absorbed | Avoid contact with skin, eyes or clothing.
through the skin). Avoid breathing vapors | In case of contact Immediately flush
[dust or spray mist). Avoid contact with | eyes or skin with plenty of water. Get
sk'n [eyes or clothing). [Appropriate
first aid statement required.].
[No precautionary statements required.).
medical attention If Irritation persists.
(No precautionary statements required.).
(ii) Environmental hazards.
target organisms excluding
statements are required stating
appropriate precautions to avoid
Where a hazard exists to non-
humans and domestic animals, precautionary
the nature of the hazard and the
potential accident, injury or
73
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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 LD5Q 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:
Flash point
(A) PRESSURIZED
Flash point at or belo* 20*F; If tnere Is a
flashback at any valve opening.
Flash point above 20"F and not over 80*F or If
trie flame extension Is more than 18 In. long
at a distance of 6 In. from the flame.
(B) NONPRESSURh
Required text
CONTAINERS
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
130*F r'y c«"S» *•• <-«»lng.
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.
ED CONTAINERS
Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
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(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions Cor use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency/ such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for 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:
(_!) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(2) The product will not come into the hands of the general
public except after incorporation into finished products; and
(£) 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 ohysicians,
veterinarians, or druggists, provided that:
(I) The label clearly states that the product is Cor 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
(Y) 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:
(I) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes ;
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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.
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j ) ( 1) 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]
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°P; 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.
". Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
'Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
78
-------
STOR-1
STORAGE INSTRUCTIONS FOR 'PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
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
vrhile 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.
79
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FEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those Intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate Is a 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, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
80
-------
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)
\f Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
81
-------
EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
-V* L
TABLE OF CONTENTS O
Site Name Page
TERRESTRIAL FOOD CROP 2
(Agricultural Crops) 2
Alfalfa 2
Bentgrass (Astoria/Highland) 3
Chewing*s Fescue 3
Clover 4
Creeping Red Fescue 3
Crimson Clover 4
Flax 4
Kentucky Bluegrass 3
Ladlno Clover . 4
Lentils 4
Lettuce 5
Orchardgrass 3
Peas (green or dry) 5
Perennial Ryegrass 3
Red Clover . 4
Saf flower 6
Spinach 6
Sugar Beets 7
Tall Fescue 3
White Clover 4
(Noncrop, Wide Areas, and General Indoor/Outdoor Treatments) 8
Fallowland8
TERRESTRIAL NON-FOOD CROP 8
(Agricultural Crops) 8
Alfalfa (seed crop) 8
Clover (seed crop) 8
Grasses Grown for Seed 8
Spinach (grove for seed) 9
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments) 9
Noncrop Areas 9
Issued: 2-20-86 1-047601-i
82
-------
EPA Index co Pesticide Chemicals
1047601 ISOPROPYL CARBANILATE*
TYPE PESTICIDE: Herbicide
FORMULATIONS:
C (15%)
F1C (3 Ib/gal or 31% a.i., 4 Ib/gal or 43Z a.l.)
GENERAL WARNPfGS AND LIMITATIONS: A selective preplant, preemergence, and
postemergence herbicide for control of certain annual broadleaf weeds and
winter grasses. Keep out of lakes, ponds, or streams. Do not contaminate
bodies of water by cleaning of equipment or disposal of wastes. This
product breaks down rapidly in warm, moist soil, and, therefore is more
effective on cool season crops where soil temperatures are below 55 F
(12.8 C). Do not apply when wind speed favors drift. For strip or band
treatments reduce dosages and water dilution rates proportionately. Main-
tain agitation during application of the flowable concentrate formula-
tions.
Interim Tolerances; While petitions for tolerances for negligible resi-
dues are pending and until action is completed, interim tolerances are
established.
Livestock Tolerances;
Cattle, fat 0.05 (I) ppm
Cattle, meat 0.05 (I) ppm
Cattle, mbyp 0.05 (I) ppm
Eggs 0.05 (I) ppm
Goats, fat 0.05 (I) ppm
Goats, meat 0.05 (I) ppm
Goats, mbyp 0.05 (I) ppm
Hogs, fat 0.05 (I) ppm
Hogs, meat 0.05 (I) ppm
Hogs, mbyp 0.05 (I) ppm
Horses, fat 0.05 (I) ppm
Horses, meat 0.05 (I) ppm
Horses, mbyp 0.05 (I) ppm
Milk 0.05 (I) ppm
Poultry, fat 0.05 (I) ppm
Poultry, meat 0.05 (I) ppm
Poultry, mbyp -0.05 (I) ppm
Sheep, fat 0.05 (I) ppm
Sheep, meat 0.05 (I) ppm
Sheep, mbyp 0.05 (I) ppm
TIME REQUIRED FOR CONTROL! Not located.
PHYTOTOXICITY TO TARGET WEEDS: Not located.
PHYTOTOXICITY TO CROPS; Not located.
MODE OF ACTION; Disrupts normal cell division, inhibits protein and
amylase synthesis, Inhibits photolytic activity of Isolated chloroplasts
and affects the activity of messenger RNA.
*propham
Issued: 2-20-86 1-047601-1
83
-------
FGAEBF
AZAAAC
EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
BROADLEAF WEEDS CONTROLLED;
Burning nettle
Chickweed
GRASSES AND OTHER MONOCOTS CONTROLLED:
PCACKBA Annual bluegrass
3ABSBJ Barley (volunteer)
CACHBB Canarygrass
PCABRBA Common velvetgrass
CAATBM Downy brome
:ACUAA Foxtail
rCABZBA Italian ryegrass
PCACLBB Rabbicfoot polypogon
3AEABE Rattail fescue
lADFBA Wheat (volunteer)
PCAAOBB Wild oats
:ACUBD Yellow foxtail
/'.3001AA
Site, Dosage
and Formulation
(Ib a.i./A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa
Tolerance, Use, Limitations
3-4
(4 Ib/gal F1C)
000748-00207
3-4
(4 Ib/gal F1C)
5.0 (I) ppm (alfalfa, hay)
2.0 (I) ppm (alfalfa)
Do not graze or harvest for feed within 50 days
after application.
General Information; Irrigate within 5 days of
application. U»e the lower dosages on coarse and
medium textured soils and the higher dosages on
fine textured soils.
Preplant. Broadcast. Apply in 20 to 60 gallons
of water per acre by ground, or 5 to 10 gallons
of total spray solution per acre by air within 2
days of planting.
Preemergence. Broadcast. Apply in 20 to 60 gal-
lons of water per acre by ground, or 5 to 10 gal-
lons of total spray solution per acre by air with-
in 2 days after planting.
Issued: 2-20-86
1-047601-2
84
-------
EPA Index Co Pesticide Chemicals
ISOPROPYL CARBANILATE
/33025AA
/33024AA
/33111AA
/22030AA
/22028AA
/22035AA
/22043AA
Site, Dosage
and Formulation
(Ib a.i./A)
Alfalfa (continued)
3-5
(15Z G)
000748-00211
(4 Ib/gal F1C)
[SLN]
4-6
(15Z G)
(4 Ib/gal F1C)
[SLN]
3-4
(4 Ib/gal F1C)
[SLN]
4
(4 Ib/gal F1C)
Bentgrass (Astoria/
Highland)
Chewing 's Fescue
Creeping Red Fescue
KentttcVy
Orchardgrass
Perennial Ryegrass
Tall Fescue
3-4
(4 Ib/gal FIG)
000748-00207
Tolerance, Use, Limitations
Chewing'a Fescue
Postemergence. Broadcast. Apply in the winter
or early spring. Kay be applied to established
alfalfa or to seeding stands with 3 or more true
leaves. Apply in 20 to 60 gallons of water per
acre by ground, or 5 to 10 gallons of total spray
solution per acre by air.
SLN - Use limited to CA, NV, OR, and WA.
Postemergence. Broadcast application to new seed-
ing and established stands. Apply in the late
fall, winter, or early spring when alfalfa has at
least 3 true leaves. Apply before April 15. Ap-
ply the flowable concentrate in 20 to 60 gallons
of water per acre by ground, or 5 to 10 gallons
of total spray solution per acre by air.
SLN - Use limited to OR and WA.
Postemergence. Broadcast. Apply water and prod-
uct mixture by center pivot sprinkler irrigation.
Apply 0.5 to 1 inch of water per acre.
SLN - Use limited to CA.
Postemergence. Mix 1 part product to 4 parts
water and meter into irrigation water. New seed-
ling alfalfa should have at least 3 true leaves
before application.
5.0 (I) ppm (grasses, hay)
2.0 (I) ppm (grasses)
General Information; Straw and plant residues
should be removed before application. Avoid ap-
plying on warm, windy days- Reduce application
rates In low spots where surface water may cause
accumulation of the chemical injuring crops. Use
on established fields which have been harvested
at least once.
Use limited to OR, west of the Cascade Mountains.
Broadcast. Apply in 20 or more gallons of water
per acre. Spray In October after fall rains have
started. Do not spray after October 31. For
chewing*s fescue and creeping red fescue, apply
from October 1 to October 20.
See Bentgrass (Astoria/Highland) cluster.
Issued: 2-20-86
1-047601-3
85
-------
'23003AA
'23018AA
23016AA
23014AA
'23017AA
8009AA
5011AA
Site, Dosage
and Formulation
(Ib a.i./A)
Clover
Crimson Clover
Ladino Clover
Red Clover
White Clover
(4 Ib/gal F1C)
000748-00207
3-4
(4 Ib/gal F1C)
4.00-5.25
(15Z G)
000748-00211
Creeping Red Fescue
Crimson Clover
Flax
4
(15Z G)
000748-00211
Ladino Clover
Lentils
(4 Ib/gal F1C)
000748-00207
EPA Index Co Pesticide Chemicals
ISOPROPYL CARBANILATE
Tolerance, Use, Limitations
5.0 (I) ppm (clover, hay)
2.0 (I) ppm (clover)
General Information: Irrigate within 5 days of
application. Use the lower dosages on coarse and
medium textured soils and the higher dosages on
fine textured soils.
Preplant. Broadcast. Apply in 20 to 60 gallons
of water per acre by ground, or 5 to 10 gallons
of total spray solution per acre by air within 2
days of planting.
Preemergence. Broadcast. Apply in 20 to 60 gal-
lons of water per acre by ground, or 5 to 10 gal-
lons of total spray solution per acre by air with-
in 2 days after planting.
Postemergence. Broadcast. Apply in 20 to 60 gal-
lons of water per acre in the vinter or early
spring. Seedling stands should have 3 or more
true leaves. Apply by ground or by air.
See Bentgrass (Astoria/Highland) cluster.
See Clover cluster.
0.1 (I) ppm (flax seed)
General Information; Irrigate within 3 days of
application.
Postemergence. Broadcast. Apply when flax is 2
to 4 inches high and germinating weeds are less
than 4 Inches high. Apply by ground or by air.
See Clover cluster.
0.1 (I) ppm
Preplant. Broadcast. For control of barley (vol-
unteer), wheat (volunteer), and wild oats. Apply
In 10 to 20 gallons of water per acre by ground,
or 5 to 10 gallons of total spray solution per
acre by air. Spray mixture directly onto soil
surface and Immediately cross disk to a depth of
at least 4 inches. Seed may be planted the same
day but no later than 1 to 2 days after treatment.
Issued: 2-20-86
1-047601-4
86
-------
EPA Index to Pesticide Chemicals
'13020AA
Site, Dosage
and Formulation
(lb a.i./A)
Lettuce
4-6
(4 Ib/gal F1C)
000748-00207
3-4
(4 Ib/gal F1C)
3.75-6.00
(4 Ib/gal F1C)
/15009AA
4.5-6.0
(4 Ib/gal F1C)
Kentucky Bluegraas
Orchardgrass
Peas (green or dry)
(4 Ib/gal F1C)
000748-00207
ISOPROPYL CARBANILATE
Tolerance, Use, Limitations
0.1 (I) ppm
General Information:
Use the lower dosage on
coarse textured soils and the higher dosage on
fine textured soils.
Use limited to AZ and CA. Preplant. Broadcast.
Apply In 20 to 40 gallons of water per acre by
ground, or 5 to 10 gallons of total spray solution
per acre by air within 2 days of planting. Incor-
porate with a rotary tiller into the top 2 inches
of soil. Furrow irrigation a few days after ap-
plication is recommended for preplant treatments.
Use limited to AZ, CA, CO, and NM. Preplant.
Broadcast. Apply in 40 to 60 gallons of water per
acre by ground, or 5 to 10 gallons of total spray
solution per acre by air. Incorporate with a
rotary tiller or a double disk with harrow into
the top 2 Inches of soil. Furrow irrigation a few
days after application is recommended for preplant
treatments.
Tank mix with benfluralin.
Preemergence. Broadcasf. Apply in 20 to 40 gal-
lons of water per acre by ground, or 5 to 10 gal-
lons of total spray solution per acre by air with-
in 2 days after planting. Irrigate by sprinkler
(0.5 inch water) within a few days after applica-
tion if there is no rainfall.
Postemergence. Directed (shielded) spray. Apply
in 40 gallons of water per acre when the lettuce
has at least 4 or more true leaves.
See Bentgrass (Astoria/Highland) cluster.
See Bentgrass (Astoria/Highland) cluster.
0.1 (I) ppm
General Information; Irrigate within 3 days of
application.
Preplant. Broadcast. For control of barley (vol-
unteer), wheat (volunteer), and wild oats. Apply"
in 10 to 20 gallons of water per acre by ground,
or 5 to 10 gallons of total spray solution per
acre by air. Spray mixture directly onto soil
surface and immediately cross disk to a depth of
Issued: 2-20-86
1-047601-5
87
-------
Site, Dosage
and Formulation
(lb a.l./A)
Peas (green or dry) (continued)
EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
Tolerance, Use, Limitations
D8034AA
(15Z G)
000748-00211
Perennial Ryegrass
Red Clover
Safflower
'•".3024AA
3-4
(4 Ib/gal F1C)
000748-00207
3-4
(4 Ib/gal F1C)
Spinach
4-5
(4 Ib/gal FIG)
000748-00207
4-5
(4 Ib/gal F1C)
at least 4 inches. Seed may be planted the same
day but no later than 1 to 2 days after treatment.
Postemergence. Broadcast. Apply when peas have
4 or more true leaves. Apply by ground or by air.
See Bentgrass (Astoria/Highland) cluster.
See Clover cluster.
0.1 (I) ppm (safflower, seed)
General Information! Use the lower dosage on
coarse and medium textured soils and the higher
dosage on fine textured soils.
Preplant. Broadcast. Apply in 35 to 50 gallons
of water per acre within 2 days of planting.
Shallow incorporate 1 to 2 inches and follow with
furrow irrigation within 2 days after application.
Preemergence. Broadcast. Apply in 35 to 50 gal-
lons of water per acre within 2 days after plant-
ing. Sprinkler irrigation is essential after
treatment if no rain occurs.
0.1 (I) ppm
General Information:
Irrigate within a few days
of application. Use Che lower dosage on coarse
textured soils and the higher dosage on fine tex-
tured soils.
Preemergence. Broadcast. Apply in 20 to 40 gal-
lons of water per acre after planting. Follow
with 0.5 inch of water by sprinkler Irrigation if
no rain occurs within a few days.
Postemergence. Broadcast. Apply In 20 to 40 gal-
lons of water per acre when spinach is in the 2
to 4 leaf stage. Follow with 1 inch of water by
sprinkler irrigation if no rain occurs within a
few days.
Issued: 2-20-86
1-047601-6
88
-------
/28020AA
Site, Dosage
and Formulation
(Ib a.I./A)
Sugar Beets
(4 Ib/gal FIG)
000748-00207
4.00-5.25
(15% G)
000748^00211
4.5-6.0
(4 Ib/gal F1C)
(4 Ib/gal F1C)
[SLN]
4-6
(4 Ib/gal F1C)
Tall Fescue
White Clover
EPA Index to Pesticide Chemicals
ISOPROPYL CARBAXILATE
Tolerance, Use, Limitations
0.1 (I) ppm (beets, sugar (roots, tops))
General Information; Irrigate within 3 days after
application. Use the lower dosages on coarse tex-
tured soils and the higher dosages on medium/fine
textured soils.
Preplant. Broadcast. For control of barley (vol-
unteer), wheat (volunteer), and wild oats. Apply
In 10 to 20 gallons of water per acre.Spray mix-
ture directly onto soil surface and immediately
cross disk to a depth of at least 4 inches. Seed
may be planted the same day but no later than 1
to 2 days after treatment.
Fostemergence. Broadcast. Apply when beets are
between the 4 true leaf stage and the rosette
stage but prior to tight crown development. Ap-
ply by ground or by air.
Postemergence. Directed (shielded) spray. Apply
in 40 gallons of water per acre when beets have 4
to 8 true leaves.
Use limited to ID, OR, and VA. Preplant, preemer-
gence, or postemergence. Apply by ground, by air,
or by center pivot sprinkler irrigation. Use the
air or center pivot sprinkler irrigation applica-
tions on preplant or preemergence only.
SLN - Use limited to CA.
Postemergence. Apply in irrigation water when
beets have at least 6 true leaves.
See Bentgrass (Astoria/Highland) cluster.
See Clover cluster.
Issued: 2-20-86
1-047601-7
89
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EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
Site, Dosage
and Formulation
(Ib a.i./A)
Tolerance, Use, Limitations
(Noncrop, Wide Areas, and General Indoor/Outdoor Treatments)
660020A Fallowland
3-4
(3 Ib/gal F1C)
000748-00224
[SLN]
3-4
(3 Ib/gal F1C)
Do not graze or plant crops in treated areas with-
in 8 months of application.
Broadcast. Apply in the fall or winter after soil
temperatures have cooled to 50 F (10.0 C) at a
depth of 1 inch. Apply in 20 or more gallons of
water per acre by ground or 5 to 10 gallons of
water per acre by air. Use the lower dosage for
preemergence weeds and the higher dosage when
weeds have 4 or more leaves.
SLN - Use limited to CO, OR, DT, and WA.
Broadcast to fallowland to be planted to wheat
(wheat-fallow-wheat). Apply in 10 or more gallons
of water per acre by ground or 5 or more gallons .
of water per acre to stubble in fall or early win-
ter but not after March 1.
Tank mix with atrazine, metrlbuzin, paraquat, or
2-chlorsulfuron.
TERRESTRIAL NON-FOOD CROP
(Agricultural Crops)
/73001DA Alfalfa (seed crop)
:3003DA Clover (seed crop)
4-5
(152 G)
000748-00211
8066DA Grasses Grown for
Seed
3-4
(4 Ib/gal F1C)
000748-00207
N.F.
Postemergence. Broadcast. Apply when crops have
3 or more true leaves and the soil temperature has
cooled to 55 F (12.? C) or lower. Apply by ground
or by air.
Straw and plant residues
N.F.
General Information;
should be removed before application.
Use limited to WA. Postemergence. Apply to es-
tablished grasses between September 15 and October
15. Apply when grasses are in the 1 leaf stage.
Issued: 2-20-86
1-047601-8
90
-------
EPA Index to Pesticide Chemicals
/13024DA
Site, Dosage
and Formulation
(lb a.i./A)
Spinach (grown for
seed)
[SLN]
4-5
(4 Ib/gal F1C)
ISOPROPYL CARBANILATE
Tolerance, Use, Limitations
N.F.
Do not use treated crops or crop residue for food
or feed.
General Information; Irrigate 7 to 10 days fol-
lowing application. Crops, except wheat, may be
rotated 3 months after application. Wheat may be
planted 9 months after application.
SLN - Use limited to western WA.
Preemergence. Broadcast. Soil surface treatment.
Apply in 20 to 40 gallons of water per acre.
Tank mix with diethatyl-ethyl.
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
/670000A
Noncrop Areas
3-4
(3 Ib/gal F1C)
000748-00224
Do not graze or plant crops in treated areas with-
in 8 months of application. Do not apply after
March 1.
General Information: This site includes fence-
rows, roadsides, ditches, and lanes.
Broadcast. Apply in the fall or winter after the
soil temperatures haye cooled to 50 F (10.0 C) at
a depth of 1 inch. Apply in 20 or more gallons
of water per acre by ground or 5 to 10 gallons of
water per acre by air. Use the lower dosage for
preemergence weeds and the higher dosage when
weeds have 4 or more leaves.
AERIAL AKD TANK MIX APPLICATIONS
9001500
AAAAAAA
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa, Clover, Crimson Clover, Flax, Ladino
Clover, Peas, Red Clover, Sugar Beets, White
Clover
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments) ~~~
Fallowland
Issued: 2-20-86
1-047601-9
91
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EPA Index Co Pesticide Chemicals
ISOPROPYL CARBANILATE
Site, Dosage Tolerance. Use, Limitations
and Formulation
(Ib a.i./A)
Aerial Application (continued)
TERRESTRIAL NON-FOOD CROP
J900300
tAAAAAA
Tank Mix
(Agricultural Crops)
Alfalfa (seed crop), Clover (seed crop)
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments)
Noncrop Areas
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Lettuce-
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments)
Fallovland
TERRESTRIAL NON-FOOD CROP
(Agricultural Crops)
Spinach (grown for seed)
Issued: 2-20-86
1-047601-10
92
-------
r. 015.0004
il04.0014
EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
Listing of Registered Pesticide Products by Formulation
15% granular
isopropyl carbanilate (047601)
000748-00211
(000748-00211)
CA780057 NV780003
i!03.0014 3 Ib/gal (3U a.i.) flowable concentrate
isopropyl carbanilate (047601)
000748-00224*
Currently unavailable for review
(000748-00224)
C0810025
WA810066
OR810067
WA840072
4 Ib/gal (43Z a.i.) flovable concentrate
Isopropyl carbanilate (047601)
000748-00207
(000748-00207)
CA780058
OR770015
WAS30004
CA780196
OR830005
OR810078 OR840049
CA780211
WA770003
NV780002
WA830002
>999999 State Label Registration
WA Reg. No.
000748-06004
Issued: 2-20-86
1-047601-11
93
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EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
Appendix A-2'
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chemical
Code
080803
084301
118601
116701
101101
061603
Common Name
(source)
benfluralin (ISO)
2-chlorosulfuron
(ANSI)
EPA Acceptable
Common/Chemical Name
atrazine
N-butyl-N-ehtyl-alpha,alpha,alpha-tri-
fluoro-2,6-dini t ro-p-toluidine
2-chloro-N-t((4-methoxy-6-methyl-l,3,5-
triazin-2-yl)amino)carbonyl]benzenesulfon-
amide
diethatyl-«thyl
metribuzin
paraquat
— Use EPA Acceptable Common/Chemical Name
Issued: 2-20-86
1-047601-12
94
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EPA Index to Pesticide Chemicals
ISOPROPYL CARBANILATE
Auxiliary Documentation
Reg. No. Cancellation Date
000748-00206 6/25/85
Registration Number 000748-00224 was extracted from the fiche because it
could not be located at EPA.
Issued: 2-20-86 1-047601-a
95
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PROBl
CHEMICAL
Ito»ropy1 ctrb«n|Uto
. ENVIRONMENTAL PROTECTION ACCNCY
OFFICE OF PESTICIDE
RUN DATE! 05/22/Bft
PAGE NO.I 1
INOEK BV BHAUCHNCBST CODEI 047*01 • H
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LETTUCE
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GRASSES, HAY
ALFALFA
ALFALFA, HAY
CLOVER
CLOVER, HAY
BEETS, SUGAR, TOPS
BEETS, SUGAR, ROOT!
FLAX SEED
SAFPLOHEft 3EEO
PEAS
"ILK
CATTLE, NBYP
CATTLE, FAT
CATTLE, HEAT
GOATS, «8YP
COATS, FAT
GOATS, MEAT
HOUSES, MBTP
NORSES, FAT
MOUSES, HEAT
SHEEP, NBYP
8HEE«», FAT
SHEEP, »EAT
HOGS, HBYP
HOGS, FAT
HOGS, MEAT
POULTRY, HBYP
POULTRY, FAT
POULTRY, HEAT
EGGS
\0
-------
ChemName:
Chem. Ho.;
\
'
Date:
Product Total from Printout
Total
Jackets Requested
Total
Received
f
•
Number
Used
Hunter
Not Used
Rec. t
PM
RB
Date
Requested
24
Pfehe
lopy Date
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Used
Comwnts
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98
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BIBGUIDE-1
GUIDE TO USE OP THIS BIB.LIOGRAPHY
1. CONTENT OP 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 OP 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 OP 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 U(d)(U) 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
f.ll MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OP 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.
99
-------
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 i«t 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 123^56-A; the second, 123456-
B; the 26th, 123456-Z; and the 2?th, 123456-AA.
100
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propham Standard
MRID CITATION
00036935 Atkins, E.L.; Greywocd, 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..)
00038956 Chen, Y. (1979) Characterization of IPC Metabolites in Wheat: BR
21572. (Unpublished study received Sep 17, 1979 under 748-224;
submitted by PPG Industries, Inc., Barberton, Ohio; CDL:
240987-N)
00082676 Paulson, G.D.; Jacobsen, A.M.; Zaylskie, R.G.; et al. (1973) Iso-
lation and identification of propham (isopropyl carbanilate)
metabolites from the rat and the goat. Journal of Agricultural
and Food Chemistry 21(5):804-811. (Also in unpublished submis-
sion received Jan 2, 1974 under 2F1277; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; CDL:095l64-G)
00082681 Still, G.G.; Mansager, E.R. (1973) Metabolism of isopropyl car-
banilate by soybean plants. Pesticide Biochemistry and Physi-
ology 3(3):289-299. (Also in unpublished submission received
Jan 2, 1974 under 2F1277; submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:095l64-N)
00091226 Kennedy, G.; Jenkins, D.H. (1970) Report to PPG Industries, Inc.:
Distribution of IPC in Milk and Tissues of a Lactating Cow: IBT
No. J8629B. (Unpublished study received on unknown date under
1F1120; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by PPG Industries, Inc., Pittsburgh, Pa.; CDL:
090895-E)
00091227 Kennedy, G. (1970) Report to PPG Industries, Inc.: Tissue and Egg
Residue Study of IPC in White Leghorn Chickens: IBT No. J8630B.
(Unpublished study received on unknown date under 1F1120; pre-
pared by Industrial Bio-Test Laboratories, Inc., submitted by
PPG Industries, Inc., Pittsburgh, Pa.; CDL:090895-P)
00115396 Paulson, G.; Docktor, M.; Jacobsen, A.; et al. (1972) Isopropyl
carbanilate (propham) metabolism in the chicken: Balance studies
and isolation and identification of excreted metabolites.
J. Agr. Food Chem. 20(4):867-876. (Also in unpublished sub-
mission received Oct 10, 1972 under 2F1277; submitted by PPG
Industries, Inc., Barberton, OH; CDL:09l8l4-I)
-1-
101
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propham Standard
MRID CITATION
00115398 PPG Industries, Inc. (1972) Propham: Residues in Various Sub-
jects. (Compilation; unpublished study received Oct 10, 1972
under 2F1277; CDL:09l8l4-K)
00115^21 Terrell, Y.; Parke, G. (1977) Acute Oral Toxicity in Rats: IPC
Technical: Laboratory No. 7E-6373. (Unpublished study received
Apr 26, 1978 under 748-207; prepared by Cannon Laboratories,
Inc., submitted by PPG Industries, Inc., Barberton, OH; CDL:
097066-3)
00115422 Quinn, R.; Paa, H. (1975) Report to PPG Industries, Inc.: Acute
Dermal Toxicity Study with IPC Technical in Albino Rabbits: IBT
No. 601-07378. (Unpublished study received Apr 26, 1978 under
748-207; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by PPG Industries, Inc., Barberton, OH; CDL:097066-C)
00115433 Reinert, H.; Parke, G. (1975) Static 96-hour Toxicity Study of PPG
Industries, Incorporated Sample: IPC Technical in Bluegill Sun-
fish and Rainbow Trout: Laboratory No. 5E-8036. (Unpublished
study received Apr 26, 1978 under 748-207; prepared by Cannon
Laboratories, Inc., submitted by PPG Industries, Inc., Barber-
ton, OH; CDL:097066-Q)
00115434 Ravert, J.; Parke, G. (1977) Investigation of Teratogenic and Toxic
Potential of IPC 50.1% ... in Rats: Laboratory No. 6E-2504.
(Unpublished study received Apr 26, 1978 under 748-207; prepared
by Cannon Laboratories, Inc., submitted by PPG Industries, Inc.,
Barberton, OH; CDL:097067-A)
00115437 Burt, M.; Corbin, F. (1978) Uptake, translocation, and metabolism
of propham by wheat ..., sugarbeet ... and ... (Medicago sati-
va). Weed Science 26(3):296-303. (Also in unpublished submis-
sion received Jul 2, 1979 under 748-EX-15; submitted by PPG
Industries, Inc., Barberton, OH; CDL:098350-B)
00115439 Chen, Y. (1979) Quantitative Characterization of IPC Metabolites in
Chicken Egg: BR 21501. (Unpublished study received Jul 2, 1979
under 748-EX-15; submitted by PPG Industries, Inc., Barberton,
OH; CDL:098350-D)
00115440 Paulson, G.; Jacobsen, A. (1974) Isolation and identification of
propham ... metabolites from animal tissues and milk. J. Agr.
Food Chem. 22(4):629-631. (Also in unpublished submission re-
ceived Jul 2, 1979 under 748-EX-15; submitted by PPG Industries,
Inc., Barberton, OH; CDL:098350-F)
-2-
102
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propham Standard
MRID CITATION
00115441 Paulson, G.; Jacobsen, A.; Still, G. (1975) Animal metabolism of
propham ...: 'The fate of residues in alfalfa when consumed by
the rat and sheep. Pesticide Biochemistry and Physiology 5:523-
535- (Also in unpublished submission received Jul 2, 1979 under
748-EX-15; submitted by PPG Industries, Inc., Barberton, OH;
CDL:098350-G)
00115412 Smith, K. (1975) Ring-l4C-labelled Propham Egg and Tissue Residue
Study in Laying Hens: Laboratory No. 5E-7077. (Unpublished
study received Jul 2, 1979 under 748-EX-15; prepared by Cannon
Laboratories, Inc., submitted by PPG Industries, Inc., Barber-
ton, OH; CDL:098350-1)
00115443 Still, G.; Mansager, E. (1975) Alfalfa metabolism of propham. Pes-
ticide Biochemistry and Physiology 5:515-522. (Also in unpub-
lished submission received Jul 2, 1979 under 748-EX-15; submit-
ted by PPG Industries, Inc., Barberton, OH; CDL:098350-K)
00115446 Zurqiyah, A.; Jordan, L.; Jolliffe, V. (1976) Metabolism of isopro-
pyl carbanilate ... in alfalfa grown in nutrient solution.
Pesticide Biochemistry and Physiology 6:35-45. (Also in unpub-
lished submission received Jul 2, 1979 under 748-EX-15; submit-
ted by PPG Industries, Inc., Barberton, OH; CDL:098350-N)
00115447 Zurqiyah, A.; Jordan, L.; Jolliffe, V. (1975) Metabolism of Isopro-
pyl Carbanilate ... in Alfalfa. Part II—Soil Application. (Un-
published study received Jul 2, 1979 under 748-EX-15; prepared
by Univ. of California—Riverside, Dept of Plant Sciences, sub-
mitted by PPG Industries, Inc., Barberton, OH; CDL:098350-0)
00115448 Pittsburgh Plate Glass Co. (I960) A Progress Report on IPC and CIPC
Residues in Cranberries. (Compilation; unpublished study re-
ceived Apr 26, 1961 under 748-EX-167; CDL:119968-A)
00115470 Hardies, D.; Studer, D. (1979) Metabolism of Isopropyl Carbanilate
on a Hanford Sandy Loam: BR 21566. (Unpublished study received
Sep 17, 1979 under 748-22*4; submitted by PPG Industries, Inc.,
Barberton, OH; CDL:240988-G)
00119929 PPG Industries, Inc. (1970) Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method: Propham. (Compilation; unpublished study received on
unknown date under 1F1120; CDL:090893-A)
-3-
103
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propham Standard
MRID CITATION
0013^707 PPG Industries, Inc. (1973) Second Substantive Amendment to Pesti-
cide Petition No. 2F1277 concerning Establishment of Tolerances
for Propham on Several Crops: Chemistry Data. (Compilation;
unpublished study received 1973 under 2F1277; CDL:09l8l3-J)
00145691 Trainer, T. (1979) Isopropylcarbanllate Product Chemistry: Techni-
cal IPC and Chen Hoe-135 Fl-3: BR 21592. Unpublished study pre-
pared by PPG Industries, Inc. 14 p.
40094602 Johnson, W.; Flnley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. USDI Publication
137, Washington, D.C.
-4-
104
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OMB Aporwtl No XOO0468
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
Withropect lo lti«rrqu«wi*nl to B/bmil "fcnwic" oete impoicd by lh« fIFRA tection 3(CI(2)(8I nctice :onuin«d ir ii;'«'i'n-v.
Guidtnu Document. I im rcmondino, m the following mtnntr
D 1. .1 will ubmit d«n in I limity mwiwr 10 oiuiy thi lollowuif requimncnts. II Ihf ten procedure* I mil UK dcvutt !< noi
tpecilxd m) rh« fl*g«tf«lion Cuidelinci or ttif Proiocoli conturad in the Reponi o( Eioert Croupi (o (nc C.i«m
-------
QMS Approval No. 30004468
INTO AN AGREEMENT WITH OTHER REGISTRANTS
[fTo qutlHy. c*TifyALL four a*ntl FOR DEVELOPMENT OF DATA
1 1. 1 «m duly «u (honied to r«ore»»nt the following firm(i) who «r« iub|ec( to the require-
ment! of i Notice und«r FlfRA Section 3tth the Notice. I undem»nd EPA win promptly inform
me wtMttw my firm must cubmit cuta to Moid M(Mn»on of its r*otttrMion
-------
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
. Octanol/water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements • by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
107
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Registration
Guideline No.
63-13
63-1*1
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
e>3
81-1
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flenmabillty
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
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
108
-------
CMB 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 terras of the Notice from 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 on 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.
(U) 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 ray 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;
109
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