4>EPA
United Sutw
Environmental Protection
Agency
Office of
PwticidM and Toxic SuMmcM
WMhington DC 20460
December 1987
PMioMM
Guidance for the
Reregistration of
Pesticide Products
Containing
Chlorpropham
as the Active Ingredient
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OMB Control No. 2070-005
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CHLORPROPHAM
AS THE ACTIVE INGREDIENT
OPP NUMBER 018301
CAS NUMBER 101-21-3
CASE NUMBER 0271
December 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
C. Chemical Structure . .
III. Agency Assessment 7
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings . .
D. Tolerance Reassessment . .
IV. Regulatory Position and Rationale 17
A. Regulatory Positions and Rationales ....
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 24
VI. Requirement for Submission of Generic Data . . 26
A. What are Generic Data?
B. Who Must Submit Generic Data?
C. What Generic Data Must be Submitted? ...
D. How to Comply with DCI Requirements . . .
E. Procedures for Requesting a Change in Protocol
F. Procedures for Requesting Extensions of Time
G. Existing Stocks Provisions Upon Suspension or
Cancellation
VII. Requirement for Submission of Product-Specific
Data 32
VIII. Requirement for Submission of Revised Labeling 33
IX,, Instructions for Submission 33
A. Manufacturing-Use Products (Sole Active)
B. Manufacturing-Use Products (Multiple Active)
C. End-Use Products
D. Intrastate Products ...
E. Addresses
Glossary of Terms and Abbreviations ..... . iii
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of Label Requirements and Table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA S3(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 8587-27 Generic Data Exemption Statement
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: Acceptable' Daily Intake
ai: Active Ingredient
CAS: Chemical Abstract System (Number)
Core Classifications: A general guide to the acceptability of
data for the purpose of supporting
registration (invalid, supplementary,
minimum, or guideline).
CSF: Confidential Statement of Formula
DNA: deoxyribonucleic acid
EP: End-Use Product
.*
EPA: The Environmental Protection Agency, also "the Agency"
Epicotyl - The growing point of the embryo, which gives rise to
the shoot, or aboveground part of the plant.
FQ, FT: Refers to the generations in a multigeneration study.
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
HOT: Highest Dose Tested
Interim Tolerance - As per 40 CFR 180.319, interim tolerances
were formerly established for residues of various pesticides
while petitions for tolerances for negligible residues were pending
Note that negligible residue tolerances are no longer established.
LC5Q: (median lethal concentration) a statistically derived
concentration of a substance that can be expected to cause
death in 50% of test animals, expressed as weight or volume
of test substance per volume of air or water (e.g., rag/L
or ppm).
LD5Q: (median lethal dose) a statistically derived single dose
that can be expected to cause death in 50% of animals when
administered by the route indicated, expressed as weight
of substance per unit weight of test animal (e.g., mg/kg).
LOT: Lowest Dose Tested
LEL: Lowest-Effect Level
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MDT: Mid dose tested
MP: Manufacturing-Use Product
MPI: Maximum Permissible Intake
MRID: Master Record Identification (Number) - EPA's system of
tracking studies used in support of registrations.
NPDES: National Pollution Discharge Elimination System
NOEL: No-Observed-Effect Level --the maximum dose used in a test
which produces no observed effects.
OPP: The Office of Pesticide Programs
OES: Office of Endangered Species, U.S. Fish and Wildlife Service
PADI: Provisional Acceptable Daily Intake --an acceptable daily
intake of pesticide residue based on a limited data base.
PAI: Pure Active Ingredient
ppm: parts per million
RACs: Raw Agricultural Commodities
Technical: Active ingredient as manufactured
TGAI: Technical Grade of the Active Ingredient
TMRC: Theoretical Maximum Residue Contribution --an estimate of
dietary exposure obtained by multiplying residue tolerance levels
for a given pesticide by the average daily per capita food
consumption figure, then adding the exposure figures for each
crop. TMRC is usually expressed in terms of milligrams of active
ingredient per kilogram body weight per day.
IV
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I. INTRODUCTION
EPA has established the Registration Standards program in
order to provide an orderly mechanism by which pesticide products
containing the same active ingredient can be reviewed and standards
set for compliance with FIFRA. The standards are applicable to
reregistration and future applications for registration of products
containing the same active ingredient. Each registrant of a
product containing an active ingredient subject to this Standard
who wishes to continue to sell or distribute that product must
bring his product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough review
of the scientific data base underlying a pesticide's registration.
The purpose of the Agency's review is to reasses the potential
hazards arising from the currently registered uses of the pesticide;
to determine the need for additional data on health an'd environ-
mental effects; and to determine whether the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA. In its
review EPA identifies:
1. Studies that are acceptable to support the data requirements
for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been required
when the product was initially registered or may be needed to
replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product is
not misbranded and that the labeling is adequate to protect man
and the environment.
The detailed scientific review, which is not contained in
this document but is available upon request1, focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from available
data in its files pertaining to the pesticide active ingredient.
However, during the review of these data, the Agency is also
looking for potential hazards that may be associated with the EPs
that contain Che active ingredient. The Agency will apply the
provisions of this Registration Standard to EPs if necessary to
protect man and the environment.
1The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW., Washington, DC 20460.
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EPA1s 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
Postion 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 Part 154 of Title 40
of the Code of Federal Regulations (40 CFR Part 154) to examine
in depth, the risks and benefits of use of the pesticide. If the
Agency determines that the risks of the pesticide's use outweigh
the benefits of use, the Agency may propose additional regulatory
actions, such as cancellation of uses of the pesticide which have
been determined to cause unreasonable adverse effects on the
environment.
EPA has authority under the Data Call-In (DCI) provisions of
FIFRA section 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 and B in Appendix I. Failure to comply with
the DCI requirements enumerated in this Registration Standard may
result in issuance by EPA of a Notice of Intent to Suspend the
affected product registrations.
Registrants are reminded that FIFRA section 6(a)(2) requires
them to submit factual information concerning possible unreasonable
adverse effects of a pesticide at any time that they become aware
of such information. Registrants should notify the Agency of any
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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
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common Name: Chlorpropham
Chemical Name: Isopropyl N-(3-chlorophenyl) carbamate
CAS Number: 101-21-3
Office of Pesticide Program Shaughnessy Number: 018301
Empirical Formula: CIQ^I 2C1NC-2
Trade Names: Beet-Kleen, Furloe, Sprout Nip, Spud-Nic,
Taterpex, Triherbicide-CIPC, Unicrop CIPC,
Chloro IPC, Bud Nip
Year of Initial Registration: 1962
Chemical Family: Carbamate
Description of Physical Characteristics of Chemical:
Off white to light brown fused solid with a
melting point of 37 to 40 °C.
Density - ca. 1.2 gram/milliliter (g/ml)
pH - 6.5 to 7.5 and 0.6 to 0.7 g/ml
B. Use Profile
Type of Pesticide: Herbicide and plant regulator.
Pests Controlled: Suckers on tobacco plants, sprouting in
stored potatoes, broadleaf weeds, and grasses.
Registered Uses: Terrestrial food and nonfood crop and
ornamentals.
Predominant Uses: Alfalfa and ladino clover crops, berry
crops, and ornamentals.
Mode of Activity: Chlorpropham suppresses transpiration and
respiration as well as inhibits root growth and epicotyl
growth.
Formulation Types Registered: 98% TGAI; 5%, 10.3%, and 20%
ai granule (G); 11.9% ai; 15% ai, 22.2% ai, 25% ai, 36%
ai and 47% ai eraulsifiabie concentrate (EC); 46% ai,
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46.5% ai, 49.65% ai, 78.4% ai and 78.5% ai liquid ready to
use (RTU).
Methods of Application: Chlorpropham is a selective preplant
incorporated, preemergence and postemergence herbicide and
plant growth regulator. Chlorpropham may be applied by
ground or by air.
Application Rates: Alfalfa 1-6 Ib ai/A; beans (lima and
snap) 4 Ib ai/A; perennial grasses (seed crop) no rate
given; flowers (annual, biennial, perennial (bulbs)) 4-6
Ib ai/A; garlic 2-4 Ib ai/A; spinach (fall seeded) 1-2 Ib
ai/A; clovers 2-4 Ib ai/A; onions 4-8 Ib ai/A; ornamentals
4-8 Ib ai/A; safflower. 3-6 Ib ai/A; blackberries, raspberries
6 Ib ai/A; blueberries 8-12 Ib ai/A; cranberries 10-20 Ib
ai/A; southern peas 4-6 Ib ai/A; soybeans 2-4 Ib ai/A;
sugar beets (seed crop) 3-4 Ib ai/A; tomatoes 4 Ib ai/A.
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C. Chemical Structure
COMMON NAME OR
STRUCTURE CHEMICAL NAME ABBREVIATION
~ 0 CH,
it ' . -
H-C-O-CH isopropyl 3-chlorocarbanilate Chlorpropham
CH, or CIPC
Cl
N H»C~Q-r CM
i 1-hydroxy-2-propyl 3-chloro- laopropyl-OH-
carbanilate CIPC
Cl
j_/ Chemical structure for the herbicide chlorpropham.
2_/ Chemical structure for the metabolite 1-hydroxy-2-propyl
~~ 3-chlorocarbanilate.
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III. AGENCY ASSESSMENT
A. Summary
No acceptable data are available for acute oral, dermal, or
inhalation toxicity; primary eye or dermal irritation; or dermal
sensitization studies. These studies are required.
No data are available for subchronic oral, dermal or inhalation
toxicity or subchronic neurotoxicity studies. Subchronic dermal
(21-day) and subchronic oral toxicity studies in the rodent and
non-rodent are required.
Chronic toxicity studies in the rodent and non-rodent are
required.
Acceptable data include rat and rabbit teratology'Studies.
The No Observed Effect Level (NOEL) in the rat for maternal
toxicity is 100 mg/kg/day and for developmental toxicity 350
mg/kg/day. The rabbit teratology study showed the NOEL for
developmental toxicity to be 125 mg/kg/day and for maternal
toxicity 250 mg/kg/day. Sufficient data are available on the
reproductive toxicity of chlorpropham. Chlorpropham caused
little toxicity and virtually no effect on reproduction in rats
administered chlorpropham in their diets at doses of 1000, 3,000
and 10,000 parts per million (ppm).
A complete toxicological assessment is not possible until
the additional toxicology data required in Tables A and B of this
document are submitted.
Available data are insufficient to fully assess the
environmental fate of chlorpropham. The data requirement for a
hydrolysis study has been satisfied. Photodegradation in water
and soil, aerobic and anaerobic soil metabolism, leaching and
absorption/desorption, volatility (lab), field dissipation,
irrigated crops and fish accumulation studies must be submitted.
Additional rotational crop studies (confined and field) are also
required.
The Agency is concerned about the potential for ground water
contamination by chlorpropham. The Agency has determined that
additonal data are needed to characterize the potential for
chlorpropham to enter ground water; therefore chlorpropham is the
subject of a ground water DCI notification.
Available data are insufficient to fully assess the ecological
effects of chlorpropham. Avian studies, aquatic studies and
residue monitoring studies must be submitted.
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B. Preliminary Risk Assessment
Toxicology Characteristics
The acute toxicity, primary eye irritation, primary dermal
irritation, and dermal sensitization data available are unacceptable.
These studies are required.
Subchronic Toxicity Studies
No acceptable data are available on the subchronic oral
toxicity of chlorpropham. Studies are required in the rodent and
the nonrodent. If adequate chronic rodent and nonrodent studies
are submitted, these subchronic studies will not be required. No
data are available on the 21-day subchronic dermal, subchronic
inhalation and subchronic neurotoxicity studies. The 21-day
subchronic dermal toxicity study is required.
In a 21-day smoke inhalation study, standard samples of
tobacco were spiked with chlorpropham and the metabolites 2-
hydroxychlorpropham and 4-hydroxychlorpropham. Mice were exposed
to smoke from these samples of tobacco in a head-only method, at
nominal concentrations of chlorpropham at 0, 60, 180, and 600
ppm. Dose-related increases in kidney and spleen weights were
reported to have occurred at all dose levels. Although this
study was considered acceptable, it failed to demonstrate a NOEL.
If chlorpropham residues on tobacco greater than 0.1 ppm
are detected, an additional smoke inhalation study will be required„
Chronic Toxicity and Oncogenicity Studies
There are currently no acceptable oncogenicity studies
available with chlorpropham. Studies are required in two species.
In a supplementary rat study, 25 rats/sex/group were dosed
at 0, 10, 100, and 1000 mg/kg/day for two years. A decreased body
weight over control values was accompanied by an increase in food
consumption in the highest dose group. A depressed hematocrit
and hemoglobin concentration first appeared in data analyses
conducted on the 3 month bleedings and continued to the end of
the study in the highest dose group. The hemoglobin concentration
was approximately 93% (not reported to be statistically significant)
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of controls in the 2,000 ppm dose group. Organ/body weight
ratios were increased for the liver (146% and 126%), and spleen
(785% and 382%) in the males and females, respectively, dosed at
the 20,000 ppm highest dose tested (HDT); but with only 1 and 3
animals surviving to terminal sacrifice in males and females,
respectively. Since most animals died before terminal sacrifice,
and autolysis was frequent, the failure to find histopathology at
the highest dose level is meaningless. Survival at the 2,000 ppm
raid dose tested (MDT) dose level was only five males and 16
females.
This study is unacceptable because of inadequate numbers of
study animals, histology, and other reasons including test
compound identification.
In a supplementary dog study, 2 dogs/sex/group were dosed at
the same dietary levels as rats and demonstrated simil'ar toxicity,
and at the same dietary level. Reduced body weight, increased
spleen/body weight ratio, and reduced hematocrit and hemoglobin
concentration occurred in males and females in the high dose
group. The NOEL was 2,000 ppm or 40.8-54.8 mg/kg/day. This
study is unacceptable because only 2 animals/sex/group were used,
histology was inadequately reported, and other deficiencies,
including test material identification were noted.
There are currently no acceptable chronic studies available.
Chronic studies in the rodent and non-rodent are required.
Teratology
The data requirement for a teratology study in the rat and
rabbit have been satisfied.
A teratology study was conducted on 20 rats/group using
chlorpropham technical at 0, 100, 350, and 1000 mg/kg/day.
Maternal toxicity was noted at 350 and 1000 mg/kg/day in the form
of body weight decrements and increased spleen weights. No terata
occurred, but developmental toxicity occurred at 1000 mg/kg/day
in the form of increased incidence of rudimentary 14th rib. The
NOEL for maternal toxicity is 100 mg/kg/day (dose level that
produces no observable effects in pregnant rats) , and for
developmental toxicity, 350 mg/kg/day.
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A teratology study was conducted on 16 rabbits/group using
chlorpropham technical at 0, 125, 250, and 500 mg/kg/day.
Maternal toxicity was noted at 500 mg/kg/day in the form of
reduced weight gain, anorexia, reduced fecal output, and blood-
stained urine. No statistically significant increase in terata
occurred, but developmental toxicity occurred at 250 and 500
mg/kg/day in the form of postimplantation loss. The NOEL for
developmental toxicity is 125 mg/kg/day (dose level that produces
no observable effects in the embryo or fetuses of rabbits), and
for maternal toxicity 250 mg/kg/day.
Reproduction
Sufficient data are available on the reproductive toxicity
of chlorpropham. Chlorpropham administered in the diet to rats
(15 males and 30 females per group) at doses of 1000, 3000, and
10,000 ppra caused little toxicity and virtually no effect on
reproduction. Mating and fertility indexes in the FQ and Fj rats
were not significantly reduced. Similarly, gestation length,
litter size, and survival of FQ and F^ pups were not affected.
Body weight gain was slowed in FQ and F-| adult rats dosed at 300Q
and 10,000 pptn, but no effect was seen at the 1000 ppm dose level.
Dose-related effects were seen on histological examination of FQ
and Fj adults, where brown pigment granules were seen in the
reticuliendothelial cells of the liver, and the convoluted tubular
epithelial cells of the kidney in the 3000 and 10,000 ppm dose
level groups. Hypercellularity of the bone marrow was also seen
in these two dose groups. Body weight and organ weight changes
in the Fj pups (lactation day 21) were not significant; ?2
male pups had significant reductions in absolute and relative
splenic weights. In F-j adults, a severe increase in absolute
and relative spleen weights was seen in males (10,000 ppm) and
females (3000 and 10,000 ppm).
Measurements of cholinesterase levels in the brain, plasma,
and erythrocytes of Fj rats failed to demonstrate any significant
changes.
Mutagenicity
The available data are acceptable for demonstrating no
mutagenic effects in this test system. The test system was
the Mouse Lytnphoma (L5178y+/-) and chlorpropham technical. The
concentrations of the test material used ranged from 13 to 75
ug/ml (resulting in 100 to 41% growth) in the nonactivated system,
and 13 to 100 ug/ml (resulting in 52 to 80% growth) in the activated
system; thus both systems demonstrated toxicity and were negative
for mutagenicity.
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Studies are required on tests for other genotoxic effects
and structural chromosome aberrations.
Metabolism
There is currently no acceptable animal metabolism study
with chlorpropham. Limited data is available from the literature.
Special studies may be necessary on a metabolite of chlorpropham
(p-methoxy-chlorpropham) found in potatoes and possibly in
animals. This metabolite has been found at levels as high as
0.17 ppm in treated raw potatoes and 0.063 ppm in french fried
potatoes. If p-methoxy-chlorpropham is not a metabolic product
produced by chlorpropham dosed rats, then mammalian tesfing may
be required for this metabolite. However, if p-methoxy-chlorpropham
is a metabolic product produced by chlorpropham dosed rats (i.e,
the required metabolism studies) then the required toxicology
studies will adequately assess the potential hazards of p-methoxy-
chlorpropham. The acute oral (rat), teratology (rat) , and
mutagenicity studies may be required to depict the toxicity of
this metabolite.
In addition, if the plant and livestock metabolism and residue
studies reveal metabolites which are present at significant
levels, additional studies depicting their toxicity may also
be required.
C. Other Science Findings
Environmental Characteristics
Available data are insufficient to fully assess the
environmental fate of chlorpropham. The data requirement for a
hydrolyis study has been satisfied.
A hydrolysis study showed that chlorpropham is relatively
stable in sterile water in the dark. After 32 days in aqueous
buffered solutions at pH 4-, 7, and 9 held in the dark at 40°C,
about 90% of the applied chlorpropham remained undegraded.
The remaining environmental fate studies are inadequate, but
supplementary data indicated that chlorpropham dissipates with a
half-life of <14 days in the upper 3 inches (parent compound) of
silty clay loam and silt loam soils regardless of site or
application procedure (incorpoated or suface-applied).
Fish accumulation data indicated that chlorpropham bioaccumulated
in the skinless fillet of a bluegill sunfish to <100 times the
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levels in water.
Supplementary data indicate that chlorpropham accumulated in
rotational crops planted 12 months after treatment.
Reentry data are not required because available toxicological
data do not indicate a need for reentry data.
The Agency is concerned about pesticide residues reaching
ground water. The potential for chlorpropham to reach ground
water cannot be assessed since no leaching data are available.
Taking into consideration chlorpropham's high solubility and its
relative stability in water and the mobility of a related chemical,
propham, chlorpropham can be expected to leach and thus might
enter ground water.
Chlorpropham is the subject of a ground water DC? notification
and additional data are needed to fully characterize the potential
for it to enter ground water.
Ecological Characteristics
Available data are insufficient to fully assess the ecological
effects of chlorpropham.
Toxicity to Birds
A supplementary study indicates that chlorpropham is
practically nontoxic to waterfowl (mallard LDsn is greater than
2000 mg/kg).
Avian acute toxicity studies must be submitted.
Toxicity to Fish and Aquatic Invertebrates
A core study indicates that chlorpropham is moderately
toxic to coldwater and warmwater freshwater fishes (bluegill
sunfish LCso • 6.3-6.8 ppm; rainbow trout LCso » 3.02-5.7 ppm).
Aquatic toxicity studies are required.
Special Testing
Residue monitoring studies will be required to support reliable
ecological risk assessments.
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Product Chemistry
The Agency has evaluated the available data which identify
the composition, beginning materials and manufacturing process
and discuss the physical and chemical properties of chlorpropham.
The Agency has determined that these data must be resubmitted for
each pesticide. New requirements have been introduced, and
previously submitted data must be updated.
Residue Chemistry
Metabolism
The metabolism of chlorpropham (CIPC) in growing
plants has been adequately described. Additional data are required
regarding the metabolism of chlorpropham in stored potato tubers
treated postharvest and in livestock (ruminants and poultry).
Although the available data for dairy animals are inadequate, the
following metabolites have been identified in milk: isbpropyl
3-chloro-4-hydroxycarbanilate and 3-chloro-4-hydroxyacetanilide.
Although tolerances for chlorpropham and. its metabolite isopropyl-
OH-CIPC and interim tolerances for chlorpropham per sje have been
established, the tolerance definition will be reassessed on
receipt of the required metabolism data.
D. Tolerance Reassessment
Tolerances have been established for residues of chlorpropham
in a variety of RACs, in meat, fat, and meat byproducts (40 CFR
180.181; 40 CFR 180.319 interim tolerances). EPA has evaluated the
residue and toxicology data supporting tolerances, and has addressed
the following regulatory issues:
o Whether the current tolerances and food additive regulations
are sufficient to cover the actual residues resulting
from use (including uses registered under FIFRA section
24(c) and intrastate uses).
o Whether group tolerances can be established in accordance
with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are
necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
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The regulatory determinations resulting from EPA's review
are set out in Section IV.A., Regulatory Positions and Rationales.
Tolerances have been established for residues of chlorpropham
and isopropyl-OH-CIPC at 50 ppm in or on potatoes and at 0.2 ppm
in or on soybeans.
Interim tolerances have been established for residues of
chlorpropham per se in the following RACs:
Parts Per Million
Commodities (ppm)
Hay of alfalfa, clover, 50
and grass
Alfalfa, clover, and 20
grass
Beans (dry and succulent), 0.3
blackberries, blueberries,
cranberries, peas (dry and
succulent), raspberries,
spinach, and sugar beet tops
Carrots, garlic, onions, rice 0.1
grain, safflower seed,
sugar beet roots, and
tomatoes
Eggs; milk; and the meat, fat, 0.05
and meat byproducts of
cattle, goats, hogs, horses,
poultry, and sheep
1. Residue Data
The residue data reviewed in support of these tolerances
include che following:
a. Data on the nature of the residue in both plants and
animals, including identification of major metabolites and
degradates of chlorpropham. The established tolerances are based
on occurrence of chlorpropham (CIPC) and its metabolite isopropyl-
OH-CIPC. The interim tolerances are based on occurrence of
chlorpropham per se.
b. Radiolabeled studies on the uptake, translocation,
and metabolism of chlorpropham in plants which show that residues
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appear in Che shoots of soybeans, alfalfa, and cucumber.
c. Radiolabeled studies on Che metabolism and Cranslocacion
of chlorpropham in cows and chickens, which show that ruminants
and poultry fed preconditioning diets of unlabeled chlorpropham,
followed by [J^C]chlorpropham will accumulate 1^C-residues in
milk and eggs, in fat, muscle, kidney and liver tissues and will
eliminate '^C-activity primarily in urine and in the "excreta" of
chickens.
d» Analytical methodology for determining the levels of
residues of chlorpropham in plants and animals. Adequate
spectrophotometric and gas-liquid chromatographic methods exist
for collection of data on combined residues of chlorpropham and
its metabolite isopropyl-OH-CIPC from plant and animal commodities.
e. Storage stability data demonstrating that ^residues
of chlorpropham plus isopropyl-OH-CIPC are stable in or on frozen
plant commodities for up to 21 months. No data are available for
animal tissues or milk.
f. Data on the magnitude and levels of residues of
chlorpropham in individual RACs, animal products, and processed
food and feed items. The metabolism of chlorpropham in growing
plants has been adequately described. The conclusions regarding
the adequacy of data for all commodities are subject Co change
uncil Che plane mecabolism issues are successfully resolved.
2. Toxicology Data
The Coxicology data considered in support of the tolerances
include a rat teratology study with the NOEL for maternal toxicity
of 100 mg/kg/day and for developmental toxicity 350 mg/kg/day, a
rabbic ceraCology study wich Che NOEL for macemal toxicity
250 mg/kg/day and 125 mg/kg/day for developmental coxicicy; and a
rac reproduccion study with a reproductive NOEL > 500 mg/kg/day
(HOT) and a systemic NOEL - 50 mg/kg/day (LOT). "Refer to the
toxicology section (Section III B, Preliminary Risk Assessment )
for detailed information on available data and additional require-
ments. Also refer to data tables for specific requirements.
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3. Tolerances Issued
Tolerances are established for chlorpropham (CIPC) and
its metabolite 1-hydroxy-2-propyl-3'-chlorocarbanilate (calculated
as CIPC) in or on potatoes and soybeans. Interim tolerances are
established for CIPC in or on the following RACs: Hay of alfalfa,
clover, and grass; alfalfa, clover, and grass; beans (dry and
succulent), blackberries, blueberries, cranberries, peas (dry and
succulent), raspberries, spinach, sugar beet tops, carrots,
garlic, onions, rice grain, safflower seed, sugar beet roots,
tomatoes, eggs, milk, and the meat, fat, and meat byproducts of
cattle, goats, hogs, horses, poultry, and sheep.
Canadian tolerances have been established for residues
of chlorpropham in or on potatoes, snap beans, soybeans, and
cranberries.
*
No Mexican tolerances or Codex Maximum Residue Limits
(MRLs) have been established for chlorpropham.
16
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Positions and Rationales
1. The Agency is not initiating a Special Review of
chlorpropham at this time.
Rationale; Since available data are limited, the Agencv
is not yet able to make a determination as to whether any of the
criteria specified in 40 CFR 154.7 have been met or exceeded.
2. The Agency is requiring submission of environmental
fate data. .
*
Rationale; Such data -is required by 40 CFR 158.130. In
addition the Agency is concerned about the potential contamination
of ground water. The Agency believes that chlorpropham has this
potential based on such factors as chemical structure, solubility,
and use patterns. These concerns cannot be adequately addressed
until sufficient data are submitted and evaluated.
3. The Agency will not approve any significant new food
uses* of chlorpropham until additional residue chemistry data are
available to assess existing uses.
Rationale; It is Agency policy not to establish
significant new uses where major data gaps exist. When additional
data are evaluated, the Agency will determine whether significant
new food uses may be established.
4. The Agency is requiring registrants to submit residue
monitoring studies.
Rationale; These studies will be required to quantitate
the residue levels resulting from terrestrial non-food, and aquatic
food crop uses of chlorpropham. These field studies will be valuable
in supporting theoretical hazard assessments made from laboratory
acute and chronic studies'.
5. The Agency is requiring supporting data for the established
tolerance for residues of chlorpropham and isopropyl-OH-CIPC in
or on potatoes.
* Significant new use is defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will consider
as significant an increase in Theoretical Maximum Residue Contribution
of greater than 1 percent.
17
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Rationale! The available data are insufficient to
assess the established tolerance.
6. The Agency is requiring that registrants propose an
appropriate permanent tolerance for chlorpropham residues of
concern in or on carrots, sugar beet roots, sugar beet tops, garlic,
onions, spinach, beans, tomatoes, blackberries, blueberries,
cranberries, raspberries, alfalfa forage, alfalfa hay, grass
forage, grass hay, clover forage, clover hay and safflower.
Rationale; On submission and acceptance of all required
data and/or tolerance proposals, the interim tolerances will be
revoked concomitant with the establishment of permanent tolerances
for chlorpropham residues in or on these commodities by amendment
to 40 CFR 180.181.
7. Additional supporting data for a group tolerance
must be submitted if the registrant seeks a crop group tolerance.
Rationale! The available data are insufficient to
determine if a group tolerance is appropriate for bulb vegetables ,
root and tuber vegetables, leafy vegetables (except Brassica),
legume vegetables, fruiting vegetables (except cucurbits), small
fruits and berries, nongrass animal feeds (forage, fodder, straw
and hay).
8. The Agency is requiring additional data depicting the
potential for concentration of chlorpropham residues of concern
(a) in meal, hulls, soapstock, crude oil, refined oil, and the
resulting "grain" dust processed from soybean seeds bearing
measurable, weathered residues; (b) in potato granules, potato
chips, and potato peels (wet and dried) processed from raw tubers
bearing measurable weathered residues; (c) in safflower meal
and oil processed from safflower seed bearing measurable weathered
residues; (d) in dried pulp, molasses, and refined sugar processed
from sugar beet roots bearing measurable weathered residues; and
(e) in dry pomace, puree, catsup, and juice processed from tomatoes
bearing measurable weathered residues.
Rationale; Support for these positions are respectively
as follows: (a) The data submitted from processing studies do
not depict processed commodity samples derived from soybean seed
bearing measurable weathered residues and no data were submitted
depicting residues in "grain" dust from soybeans, (b) The
analysis of potato peels was not matched with corresponding
analysis of whole tubers to determine the degree of concentration
of residues, (c) No processing study was submitted, (d) The
studies failed to analyze molasses and refined sugar, and did
18
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not: use roots bearing measurable weathered residues, (e) No
data pertaining to the potential for residue concentration in
processed products of tomatoes were submitted.
9. A tolerance must be proposed and supporting data
submitted for birdsfoot trefoil forage and birdsfoot trefoil hay.
Rationale; The registrant must either propose appropriate
tolerances or remove this commodity from the pertinent product
labels.
10. The Agency will revoke interim tolerances for residues
of chlorpropham per jse_ in or on rice grain and peas (dry and
succulent).
Rationale; Currently no registered uses exist for
these commodities. -
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:
§158.125 Residue Chemistry
171-4 Nature of the Residue of Plants
171-4 Nature of the Residue of Animals
§158.130 Environmental Fate
161-2 Photodegradation (in water)
161-3 Photodegradation (on soil)
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
163-1 Leaching and Adsorption/Desorption
163-2 Volatility (lab)
164-1 Dissipation (soil)
165-1 Rotational Crops (confined)
165-3 Irrigated Crops
165-4 Accumulation (in fish)
19-
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§158.135 Toxicology
81-1 Acute oral toxicicy (rat)
81-2 Acute dermal toxicity (rabbit)
81-3 Acute inhalation (rat)
81-4 Primary eye irritation
81-5 Primary dermal irritation
81-6 Dermal sensitization
82-2 21 day dermal (rabbit)
83-1 Chronic toxicity (rodent and non-rodent)
83-2 Oncogenicity (rat and mouse)
84-2 Chromosomal aberration
Other mechanisms of mutagenicity
85-1 General metabolism
§158.145 Wildlife and Aquatic Organisms
70-1 Residue monitoring protocol and studies
71-1 Avian acute oral
71-2 Avian subacute dietary
72-1 Acute freshwater fish
72-2 Acute invertebrate acute
72-3 Acute estuarine and marine organism
72-4 Fish early life stage/aquatic invertebrate
life cycle
72-5 Fish life cycle
§158.150 Plant Protection
122-1 Seedling germination/seedling emergence
122-1 Vegetative Vigor
122-2 Aquatic plant growth
12. While data gaps are being filled, currently registered
MPs and EPs containing chlorpropham 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 sections 3(c)(2)(B) and 3(c)(7)).
Issuance of this Standard provides a mechanism for
identifying data needs. These data will be reviewed and evaluated,
after which the Agency will determine if additional regulatory
changes are necessary.
20
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B. Criteria for Registration
To be registered or reregistered under this Standard, products
must contain chlorpropham as the sole active ingredient, bear
required labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in this
section.
C. Acceptable Ranges and Limits
1 . Product Composition Standard
To be registered or reregistered under this Standard, MPs
must contain chlorpropham as the sole active ingredient. Each MP
formulation proposed for registration must be fully described
with an appropriate certification of limits, stating maximum and
•minimum amounts of the active ingredient and inert ingredients
which are present in products, as well as impurities found at
greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and MPs containing chlorpropham 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, MPs may be labeled
for formulation into EPs only for the commodities listed in
Appendix III, EPA Compendium of Acceptable Uses--Chlorpropham.
The EPA Compendium of Acceptable Uses lists all acceptable uses,
as well as approved maximum application rates and frequencies.
D. Labeling
All MPs (and EPs, if covered by this Standard) must bear
appropriate labeling as specified in 40 CFR 162.10. Appendix
II contains information on label requirements.
No pesticide product containing chlorpropham may be released
for shipment by the registrant after January 1989, unless the
product bears an amended label which complies with the requirements
of this Standard.
21
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No pesticide product containing chlorpropham may be distributed,
sold, offered for sale, held for sale, shipped, delivered for
shipment, or received and (having been so received) delivered or
offered to be delivered by any person after January 1990 unless
the product bears an amended label which complies with the
requirements of this Standard.
In addition to the above, the following information must
appear on the labeling:
1. Ingredients Statement
The ingredient statement for MPs must list the active
ingredient as:
Isopropyl N-(3-chlorophenyl)carbamate .... %
«
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. Precautionary Statements
Statements for Manufacturing Use Products
Do not discharge effluent containing this
product into lakes, streams, ponds,
estuaries, oceans, or public waters unless
this product is specifically identified
and addressed in 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
the EPA.
Statement for End-Use Products
Terrestrial Food and Nonfood Crop
Do not apply directly to water or wetlands
(swamps, bogs, marshes, potholes). Do
22
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not apply where runoff is likely to occur,
Do not contaminate water by cleaning of
equipment or disposal of wastes.
23
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V. PRODUCTS SUBJECT TO THIS STANDARD
All produces containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether.the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed-in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B?
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
fonnulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
*
3. If not eligible for the formulator's exemption, the
_data requirements listed in Table A and the data require^
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and 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.
25
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2. If eligible for the forraulator's exemption, the ,
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
•
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.^
A. What are generic data?
Generic data pertain to the properties or effects'of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
26
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chat both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
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
the application is submitted, the_data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)>.
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of~
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
27
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EPA with documentary evidence chat 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:
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
rour offer. You request that EPA not suspend your registration
or 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 Co enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
28
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2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA\sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(lii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data 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.
1 29
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E. Testing Protocols. Standards for Conducting Acceptable
Testa. Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies uaing 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.
G. 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
30
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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 by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission 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.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
£i time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
31
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
•
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note,.however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.1. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredientl
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)(1)(D). Refer to 40 CFR
152.80-152.99.
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.)
33
-------
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).
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 the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
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.
34
-------
3. Within the time frames set forth in Table A. you must
submit to che Registration Division all generic data, unless
you are eligible for the forraulator1s 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 the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments* (EPA Form 8580-1).
b. Confidential Statement .of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients'
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
35
-------
of Che 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).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
F. 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 Assurance Division
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
36
-------
APPENDIX I
DATA TABLES
- 36-A -
-------
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 Co which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A - Terrestrial, food
B - Terrestrial, non-food
C » Aquatic, food
D " Aquatic, non-food
E - Greenhouse, food
F • Greenhouse, non-food
G - Forestry
H - Domestic outdoor
-I » Indoor
Any other designations will be defined in a footnote to the table,
37
-------
TGUIDE-2
4. 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 tiles, 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
MR{D number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the 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.
38
-------
TABLF. A
GENERIC DATA REQUIREMENTS FDR CHLORPROFriAM
\G
Test
Data Requirement Substance
SI 58. 120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning
Materials and Manufac-
turing Process TGAI
61-3 - Discussion of Formation
of Impurities TGAI
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
of Product Samples TGAI
Physical and Chemical Characteristics
Does EPA Have Data
To Satisfy Require- Tiroeframe
ment? (Yes, No or Bibliographic Must Additional for
Partially) Citation fj Data Be Submitted? Submission^
No N/A Yes2/ 6 Months
No N/A YesV 6 Months
No N/A YesV 12 Months
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
Yesfy
Yesfy
^/ , 8/
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Test
Data Requirement Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or Bibliographic
Partially) Citation */
Must Additional
Data Be Submitted?
Timeframe
for
Submission^/
$1 58. 120 Product Chemistry (continued)
63-7
63-8
63-9
-63-10
63-11
363-12
63-13
- Density, Bulk Density,
or Specific Gravity TGAI
- Solubility TGAI or PAI
- Vapor Pressure TGAI or PAI
- Dissociation Constant TGAI or PAI
- Octanol/Water Partition
Coefficient PAI
- pH TGAI
- Stability TGAI
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yesfy
Yesfy
Yesfy
Yesfy
Yesfy ,9
Yesfy , JO/
Yesfy
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Other Requirements;
64-1 - Submittal of Samples
N/A
N/A
N/A
N/A
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CKLDRPROFHAM
SI58.120 Product Chemistry Footnotes
\j Data must be submitted within the Indicated timeframes, which begin on the date of the Guidance Document (see front
cover for this date).
21 Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
3/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of the beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding the properties of each beginning material used to manufacture each product.
4/ A detailed discussion of all impurities that are or may be present at J> 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contanination during and
after production must be submitted.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
6/ Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, KW pH» an^ stability) as required in 40 CFR 158.120 and more
fully described in*the Pesticide Assessment Guidelines, Subdivision D must be submitted.
l_l Data needed if the technical chemical is a solid at roan temperature.
8/ Data needed if the technical chemical is a liquid at room temperature.
9/ Required if the technical chemical is organic and nonpolar.
10/ Required if the test substance is dispersible with water.
-------
TABLE A
CENTO 1C DATA REQUIREMENTS FOR CHLORPROPHAM
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or
Partially)
Timefraroe
Bibliographic Must Additional for
Citation Data Be Submitted? Submission1/
SI58.125 Residue Chemistry
171-2 - Chemical Identity^/
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
PAIRA
(See product labels)
Partially
- Livestock
PAIRA
Partially
00035475
00035485
00035489
00035496
00035498
00036377
00036395
00036629
00036632
00036638
00036640
00037860
00037866
00114715
00139860
40378102
,00035480
,00035488
,00035490
,00035497
,00035505
,00036394
,00036628
,00036630
,00036635
,00036639
.00036644
,00037861
,00037881
,00114794
,40378101
00114700, 00114701,
00114739.
Yes/
6 Months
6 Months
YesV
18 Months
YesV
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLDRPROPHAri
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or
Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe
for
Submission^ /
SI58.125 Residue Chemistry (continued)
171-4 - Residue Analytical
Method
- Plant Residues
- Animal Residues
TOM and
Metabolites
171-4 - Storage Stability
Data
PAI or TEP
Metabolites
Partially 00035896,00036385.
00036626.00036636,
00036637.00036641,
00037032,00037033.
00037034.00037037,
00037046,00037863,
00039946,00045294,
00045295,00051807,
00051812,00051814.
00051822.00051824,
00051834,00051838,
00051845.00051856,
00051861,00083334,
00106293,00114710,
00114715,00114717,
00114718,00114739.
00114740,00114741,
00114743,00114751,
00114785,00114794,
00115388,05016141,
Partially 00037031.00054672
Reserved7/
15 Months
Yes£/9/
Reserved"'0/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Data Requirement
Test
Substance
Itoes EPA Have Data
To Satisfy Require-
ment? (Yes, No or
Partially)
Timeframe
Bibliographic Hist Additional for
Citation Data Re Submitted? Submission1/
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the
Residue - Crop
Field Trials
- Root and Tuber
Vegetable Group
o Carrots
o Potatoes
o Sugar Beet Roots
Leaves of Root and
Tuber Vegetables
Group
o Sugar Beet Tops
Bulb Vegetables
Group
o Garlic
TEP
TEP
TEP
TEP
TEP
Partially
Partially
Partially
Partially
00114725,00115388
00083155,00114695
00114718,00114741,
00114747,00114750,
00114777,00114785,
00114795,
00051824,00114725,
00114794,00115388.
00051824,00114794,
00115388.
Partially 00051834,00114725.
YesJJy
Yes12/,39/
Yes1*/
Yes16/
18 Months
18 Months
24 Months
18 Months
24 Months
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLGRPROFriAM
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or
Partially)
Timeframe
Bibliographic Must Additional for
Citation Data Be Submitted? Submission1/
SI58.125 Residue Chemistry (continued)
171-4 - Magnitude of the
Residue - Crop Field
Trials (cont'd)
o Ghions TEP
Leafy Vegetables
Group
o Spinach TEP
LH
Legume Vegetables
Group
o Beans (Succulent
and Dried) TEP
o Soybeans TEP
Partially
Partially
Partially
Partially
00083158.00114725.
00115388.
00114710,00114715,
00114794.
00051812,00051822,
00114715.00115388.
00030995
00036642
00037037
00037042
00037045
00051817
00114715
00114778
.00036382.
,00037035,
,0*0037038.
.00037043,
.00051815.
.00106293.
.00114717,
Yes18/,39/
Yes'*/
Months
18 Months
Yes20/ 18 Months
18 Months
Yes22/,39/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROPHAM
Test
Data Requirement Substance
SI 58. 125 Residue Chemistry (continued)
171-4 - Magnitude of the
Residue - Crop Field
Trials (cont'd)
- Fruiting Vegetables .
Group
o Tomatoes TEP
- Shall Fruits and
Berries Group
o Blackberries TEP
^
* o Blueberries TEP
o Cranberries TEP
Does EPA Have Data
To Satisfy Require- Tiroeframe
ment? (Yes, No or Bibliographic Must Additional for
Partially) Citation Data Be Submitted? Submission^
Partially 00114710,00114725, Yes23/
00051838. Yes^V
Partially 00051807 Yes££/
Partially 00114710 Yes£fy
Partially 00051 86 1 , 001 1 471 5 , Yes£7/
18 Months
24 Months
18 Months
18 Months
18 Months
00114725,00114737,
00114748.
o Raspberries
TEP
Partially 00114710
Yes28/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or
Partially)
Timefrane
Bibliographic Must Additional for
Citation Data Be Submitted? Submission1/
SI58.125 Residue Chemistry (continued)
171-4 - Magnitude of the
Residue - Crop Field
Trials (cont'd)
- Grass Forage, Fodder;
and Hay Group
o Grass Forage
and Hay
Nopgrass Animal
Feeds Group
o Alfalfa Forage
and Hay
o Birdsfoot Trefoil
Forage and Hay
o Clover Forage
and Hay
TEP
TEP
TEP
TEP
Partially
Partially
No
Partially
00114715,00114794,
00114737.
00051851,00051852,
00051853,00051854,
00051855,00114710,
00114725,00114737,
00114794.
00036390,00036392,
00037285,00058143,
00058147,00114725,
00114737.
Yes29/
18 Months
18 Months
Yes3!/._3?_/ 18 Months
Yes32/
Yes33/
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROPHAM
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or
Partially)
Timeframe
Bibliographic Must Additional for
Citation Data Be Submitted? Submission1/
00
SI58.125 Residue Chemistry (continued)
171-4 - Magnitude of the
Residue - Crop Field
Trials (cont'd)
- Miscellaneous
Commodities
o Safflower Seed TEP
- Tobacco
171-4 - Magnitude of the Residue
in Meat/Milk/Poultry/Eggs
- Fat, Meat, and Meat
Byproducts of Poultry,
Cattle, Goats, Hogs,
Horses, and Sheep,
Eggs, and Milk
171-4 - Magnitude of the Residue
in Drinking and Irrigation
Water
171-4 - Nature and Magnitude
of the Residue in
Fish and Shellfish
Partially
Yes
No
00114710,00114715
00114725.
00094865.00094866
00094867
Yes34/,39/
18 Months
24 Months
No
Partially 00037029,00054669 Reserved^/
Yes37/
15 Months
Partially 00035995,00035998 Reserved3^/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHIDRPROPHAM
5158.125 Residue Chanistry Footnotes
\J Data must be submitted within the indicated tlraeframes, which begin on the date of the Guidance Document (see
front cover for this date).
2J Refer to Product Chemistry Data Requirement tables.
y Refer to footnotes 14, 21, and 23 for details of required product label amendments.
4/ Data must be submitted depicting the uptake, distribution, and metabolism of ring-labeled [^Cjchlorpropham £n
stored potatoes following postharvest application at a rate sufficiently high to permit complete ^-residue
characterization. Representative samples from the required metabolism studies must also be analyzed using accepted
enforcement methods to ascertain that these methods will determine all possible metabolites of concern including
any bound/ conjugated residues of concern.
V Metabolism studies must be submitted utilizing ruminants and poultry. Animals must be dosed for a minimum of 3
days with ring-labeled [I^Cjchlorpropham at a level sufficient to make identification and quantification of
residues possible. Milk and eggs must be collected for analysis twice daily during the dosing period, and
animals must be sacrificed within 24 hours after administration of the final dose. The distribution and identity
of residues must be determined in milk, liver, kidney, muscle, and fat of ruminants, and in eggs, liver, kidney,
muscle, and fat of poultry. Samples from the requested animal metabolism studies must also be analyzed using
current enforcement methods to determine the usefulness of these methods for analysis of animal commodities.
The enforcement method must be capable of determining all free and bound/conjugated residues of concern.
6/ Chlorpropham per se must be subjected to Multiresidue Protocols II, III, and IV and isopropyl-OH-CIPC must be
subjected to analysis by Multiresidue Protocols I-IV available from National Technical Information Service
under order No. PB 203734/AS. The registrant must select the specific method(s) recommended for tolerance
enforcement. The method must include a hydrolysis step at the tissue stage to release bound/conjugated residues.
Spiking may not produce conjugates. Therefore, enforcement methods must be tested in conjunction
with plant and animal metabolism studies. The efficiency of extraction of bound/conjugated residues of concern
must be determined for any or all residue data collection methods the registrant has used or will use to support
tolerances. Residues must be "weathered" and not simply spiked into samples prior to analysis. This may best
be conducted in conjunction with plant and animal metabolism studies involving radiolabeled material. This is
required because conjugates are expected to occur with both soluble and insoluble plant constituents. Such a
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLDRPHOPHAM
SI58.125 Residue Chemistry Footnotes (cont'd)
hydrolysis step must be incorporated into all methods to be used for data collection in support of tolerances.
The method(s) selected for 3-chloroaniline analysis must be validated by submission of data relating to specificity,
sensitivity, precision, and accuracy; one approach may be to spike radiolabeled 3-chloroaniline prior to extraction
and hydrolysis if one of the existing methods for chlorpropham analysis is used.
]_/ If the requested data regarding the nature of the residues in plants and animals reveal the occurrence of additional
metabolites of concern, additional analytical methods for data collection and enforcement is reserved pending
results.
8/ Hie storage intervals and conditions of samples used to support all established tolerances for residues of
chlorpropham must be submitted. These data must be accompanied by data depicting the percent decline in residues
of chlorpropham for all plant samples stored frozen for periods longer than 21 months. Data for animal tissues
and milk are also needed. On receipt of these data, the adequacy of the aforementioned tolerances will be
reevaluated. In laboratory tests using fortified samples, the pure active ingredient and pure metabolite must
be used. However, if field-weathered samples are used, the test substance must be a typical end-use product.
9/ All residue data requested in this Standard must be accompanied by data regarding storage length and conditions
of sample storage. The data must also be submitted depicting the stability of residues of chlorpropham (including
3-chloroaniline) under the conditions and for the time intervals specified, if different than those discussed in
footnote 8. In laboratory tests using fortified samples, the pure active ingredient and pure metabolites must be
used. However, if field-weathered samples are used, the test substance must be a typical end-use product.
107 If the requested metabolism data indicate the presence of additional residues of toxicological concern in plant
and animal commodities, data depicting stability of such residues in storage will be required.
11/ Data depicting chlorpropham residues of concern in or on mature carrots harvested ca. 65 days following a single
preanergence application of the 20% G or 4 Ib/gal EC formulation at 6 Ib ai/A. Tests must be conducted in TX
(19%), WA (17%), and either MI (19%) or WI (17%); numbers in parentheses are percentages of carrot production
outside of CA. Such data is necessary for establishment of a permanent tolerance for chlorpropham residues of
concern in or on carrots.
-------
TABLE A
GENERIC DATA REQUIR01EOTS FOR CHLDRPROPHAM
SI58.125 Residue Chemistry Footnotes (cont'd)
12/ Data depicting chlorpropham residues of concern (including 3-chloroaniline) in potatoes analyzed immediately after
treatment in commercial storage with, in separate tests, an RTU formulation at 0.033 Ib ai/1000 Ib of potatoes
applied as an aerosol through forced air circulation systems, and an EC formulation at 0.027 Ib ai/1000 Ib of
potatoes applied as a dilute aqueous spray to potatoes moved along a conveyer belt. Samples from each test must
be taken from several positions in the storage pile.
1_3/ A processing study depicting chlorpropharo residues of concern (including 3-chloroaniline)
in potato granules, potato chips, and potato peels (wet and dried) processed from raw tubers bearing measurable,
weathered residues. If residues concentrate in any of these processed commodities, the registrants must propose
appropriate food/feed additive tolerances.
14/ Data depicting chlorpropharo residues of concern in or on sugar beet roots harvested following post emergence
application of the 4 Ib/gal EC formulation at 4 Ib ai/A by ground equipment and metered into irrigation water in
separate tests. Tests must be conducted in the State of CA, the only State in which these uses are registered.
The registrants must propose a PHI that is consistent with accepted cultural practices and the current use direc-
tions and limitations and is reflected by the requested data. The registrants must also propose an appropriate
permanent tolerance for chlorpropharo residues of concern in or on sugar beet roots.
15/ A processing study depicting chlorpropham residues of concern in dried pulp, molasses, and refined sugar processed
from sugar beet roots bearing measurable, weathered residues of chlorpropham. If residues are shown to concentrate
in any of these commodities, the registrants must propose appropriate food or feed additive tolerances.
16/ Data depicting chlorpropham residues of concern in or on sugar beet tops harvested following postemergence
application of the 4 Ib/gal EC formulation at 4 Ib ai/A by ground equipment and metered into irrigation water.
in separate tests. Tests must be conducted in the State of CA, the only State in which these uses are registered.
The registrants must propose a PHI that is consistent with accepted cultural practices and the current use direc-
tions and limitations. The registrants must also propose an appropriate permanent tolerance for chlorpropham
residues of concern in or on sugar beet tops. *
17/ The registrants must propose an appropriate permanent tolerance for chlorpropham residues of concern in or on
garlic.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROPHAM
5158.125 Residue Chemistry Footnotes (cont'd)
18/ Data depicting residues of chlorpropham (including 3-chloraniline) in or on onions (including green onions)
harvested 30 days after the postemergence application of 8 Ib ai/A. The 4 Ih/gal EC and 20% C formulations
must both be represented in the data submitted. Tests must be conducted in the States of CA (27%), CO (13%).
Ml (4%)/TX (4%). OR (18%) and MI (8%) or NY (9%) representing ca. 90% of U.S. bulb onion production. Tests
must be conducted in the states of CA (40%) and TX (49%) in the case.of green onions. Such data is necessary
for establishment of a permanent tolerance for chlorpropham residues of concern in or on onions.
19/ Data must be submitted depicting chlorprophan residues of concern in or on spinach harvested 30 days after
postemergence application of the 4 Ib/gal EC formulation at 2 Ib ai/A at the six- to eight-leaf growth stage.
Tests must be conducted in the States of AR, MD, OK, and VA where special local needs registrations are in
effect. Such data is necessary for establishment of a permanent tolerance for chlorpropham residues of concern
in or on spinach.
20/ Data must be submitted depicting chlorpropham residues of concern in or on succulent and dried beans harvested
at maturity following a preemergence application with the 4 Ib/gal EC formulation at 4 and 6 Ib ai/A, respectively.
Tests with succulent beans must be conducted in NY (13%), OR (18%), and WI (35%), and tests with dried beans
must be conducted in CA (16%), CO (13%) or NE (12%), and MI (24%) or ND (14%). Such data is necessary for
establishment of a permanent tolerance for chlorpropham residues in or on beans (dry and succulent).
<~n 21/ Since bean vines and bean hay are raw agricultural commodities, the registrant must propose tolerances for
^ chlorpropham residues in or on bean vines and hay and submit appropriate supporting residue data.
Alternatively, the registrants may propose amendments to the pertinent product labels that restrict feeding
or grazing of treated bean vines and bean vine hay by livestock.
22/ Data must be submitted depicting the potential for concentration of chlorpropham residues of concern (including
3-chloroaniline) in meal, hulls, soapstock, crude oil, refined oil, and the resulting grain "dust" processed
from soybean seeds bearing measurable, weathered residues. If the data indicate a potential for concentration
of residues in any of these processed products, appropriate food/feed additive tolerances must be proposed.
t
23/ Data must be submitted depicting chlorpropham residues of concern in or on tomatoes harvested at regular
intervals after application according to the following treatment regimes with the 4 Ib/gal EC formulation:
(i) a single preplant broadcast application in FL at 4 Ib ai/A; and (ii) a single preplant treatment followed
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHtORPROPHAM
SI58.125 Residue Chemistry Footnotes (cont'd)
by a single postemergence directed spray each at 4 Ib ai/A in CA. Such data is necessary for establishment of
a permanent tolerance for chlorpropham residues in or on tomatoes and propose an appropriate PHI.
24/ Data must be submitted depicting chlorpropham residues of concern in dry pomace, puree, catsup, and juice
processed from tomatoes bearing measurable weathered residues. It may be necessary to use exaggerated rates
to obtain measurable residues in or on the raw agricultural commodity. If residues concentrate in any of
these processed products, appropriate food/feed additive tolerances must be proposed.
25/ The registrant must propose an appropriate permanent tolerance for chlorpropham residues in or on blackberries.
26/ Data must be submitted depicting chlorpropham residues of concern in or on blueberries following fall and spring
application of the 20% G or 4 Ib/gal EC formulations at 12 Ib ai/A/application. Tests must be conducted in NJ
(34%), MI (41%), and OR (3%)/WA (6%) representing ca. 80 percent of U.S. blueberry acreage. Such data is
necessary for establishment of a permanent tolerance for chlorpropham residues in or on blueberries.
27/ The registrants must propose a permanent tolerance of 0.3 ppm for chlorpropham residues in or on cranberries.
28/ Data must be submitted depicting chlorpropham residues of concern in or on raspberries following early spring
application of the 20% G or 4 Ib/gal EC formulations at 6 Ib ai/A. Tests must be conducted in OR (38%)/WA (44%),
and MI (3%) representing ca. 90 percent of U.S. raspberry acreage. Such data is necessary for establishment of
a permanent tolerance for chlorpropham residues in or on raspberries.
29/ The registrants must amend the federally-registered 4 Ib/gal EC label and specify a dosage rate for this use.
Appropriate supporting residue data must be submitted. Such data is necessary for establishment of a permanent
tolerances for chlorpropham residues of concern in or on grass forage and grass hay.
30/ Data must be submitted depicting chlorpropham residues in or on Bermuda grass, bluegrass, and bromegrass or
fescue (as hay mixed with alfalfa) harvested 40 days following a single pqstemergence broadcast soil application
of the 4 Ib/gal EC formulation at 3 Ib ai/A. Tests must be conducted in KY. Alternatively, the registrant may
elect to cancel this use permitted under EPA SLN No. KY-780006.
31/ Data must be submitted depicting chlorpropham residues (including 3-chloroaniline) in or on alfalfa and alfalfa
hay harvested 20 days following postemergence application of (in separate tests) the 20% G and 4 Ib/gal EC
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
SI58.125 Residue Chantstry Footnotes (cont'd)
fotraulations at 6 Ib ai/A. Ground application of the EC formulation must be made in 20 gal water/A and aerial
applications must be made in 5 gal/A. Tests must be conducted in CA (8%) or OR (2%), IA (7%) or IL (4%),
KS (5%) or NE (6%) or SD (2%), and MI (6%) or MN (7%) or WI (12%) which collectively produced ca. 60 percent of
the total U.S. alfalfa crop in 1985 and represent the major U.S. alfalfa production regions. Such data is
necessary for establishment of a permanent tolerances for chlorpropham residues of concern in or on alfalfa
forage and alfalfa hay.
32/ The registrants must propose permanent tolerances for chlorpropham residues in or on birdsfoot trefoil
forage and birdsfoot trefoil hay, and submit appropriate supporting residue data. The 4 Ib/gal EC is to be
applied postemergence at 4 Ib ai/A in MI (46%) or WI (40%). Numbers in parentheses represent percentages of birds-
foot trefoil acreage. Residues must be determined in or on forage and field-dried hay.
337 Data must be submitted depicting chlorpropham residues in or on clover hay harvested 40 days following
a single postemergence application of the 20% G and 4 Ib/gal EC formulations (in separate tests) at 4 Ib ai/A.
Tests must be conducted in CA which produced virtually all of the 1982 ladino clover crop, MN which produced 36
percent of the 1982 U.S. sweet clover crop and 10 percent of the U.S. red clover crop, and OR which produced 24
percent of 1982 red clover, 95 percent of U.S. crimson clover, and 84 percent of 1982 U.S. white clover.
Ln The registrants must propose appropriate tolerances for chlorpropham residues of concern in or on clover forage
•t* and clover hay.
34/ Data must be submitted depicting chlorpropham residues of concern (including 3-chloroaniline) in or on samples of
safflower seed harvested at normal crop maturity following preplant incorporated application of the 4 Ib/gal EC
formulation at 6 Ib ai/A. Tests must be conducted in the States of CA (57%) and NV (30%) representing ca. 90
percent of the 1982 U.S. safflower acreage. Such data is necessary for establishment of a permanent
tolerance for chlorpropham residues in or on safflower seed.
35/ A processing study must be submitted depicting chlorpropham residues (including 3-chloroaniline) in safflower
meal and oil processed from safflower seed bearing measurable, weathered residues. If concentration of residues
occurs in either of these commodities during processing, the registrants must propose appropriate food/feed
additive tolerances.
36/ Presently, the nature of the residue in animals is not adequatly understood. Upon receipt of the data requested
-------
TABLE A
GENERIC DATA. REQUIREMENTS FOR CKLORFROFriAM
SI58.125 Residue Chemistry Footnotes (cont'd)
in the section "Nature of the Residue in Animals," the need for, and the nature of tolerances for chlorprophan)
residues in livestock will be assessed.
37/ Data must be submitted depicting the nature and magnitude of chlorprophan residues in potable water
following the registered treatment of cranberries. Degradation products in water must be identified
and quantified. Should detectable residues of concern occur in water then the registrants must propose an
Acceptable Residue Level in Drinking Water (ARLDW) and a tolerance for residues from irrigation water in all
crops, or propose label amendments restricting the exposure to drinking or irrigation water.
38/ The nature and magnitude of residues of chlorprophan in water resulting from aquatic use have not been identified,
If detectable residues of concern are found in water (refer to footnote 37), then additional residue data for
fish may be required.
39/ A metabolite/degradate of chlorpropham, 3-chloroaniline, is a probable mutagen. This compound was found to be a
plant residue in a published metabolism study (James and Prendeville. 1969. J. Agric. Food Chan. 17(6):1257).
To ascertain the magnitude of its presence in plant commodities and their processed products, residue data are
required for the following representative commodities and any processed products: alfalfa, potatoes, onions,
safflower seed, and soybeans. If 3-chloroaniline is detected in any of these RACs or their processed products,
residue data on 3-chloroaniline will be required for all registered crops and their processed products. Note
that the method must specifically determine 3-chloroaniline present in the sample prior to any hydrolysis step
associated with the analytical method used. Refer to footnotes 9, 12, 13, 18, 22, 31, 34 and 35 (above) for
specific deficiencies regarding 3-chloroaniline.
Ui
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROPHAM
Test
Data Requirement Substance
$158
.135 Toxicology
Use
Patterns
Does EPA Have Data
To Satisfy This Timeframe
Requirement? (Yes. Bibliographic Must Additional for Sub-
No or Partially) Citation Data Be Submitted? mission1/
ACUTE TESTING:
81-1
81-2
81-3
81-4
Ln
ON 81-5
81-6
81-7
- Acute Oral Toxicity
- Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation
Toxicity - Rat
- Primary Eye
Irritation
- Primary Dermal
Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A.B
A.B
A.B
A.B
A.B
A.B
A.B
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
0009391 5 No2/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
82-2
- 90-Day Feeding
- Rodent, and
- Nonrodent (Dog)
- 21 -Day Dermal - Rabbit
TGAI
TGAI
TGAI
A.B
A.B
A.B
No
to
No
Yes3/
Yes
15 Months
18 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLQRFRDFHAM
S158.
82-3
82-4
82-5
82-X
Data Requirement
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes, Bibliographic
Substance Patterns No or Partially) Citation
Must Additional
Data Be Submitted Timeframe
Must Additional for Sub-
Data Be Submitted? mission)/
.135 Toxicology (continued)
- 90-Day Dermal
- Rabbit
- 90-Day Inhalation
- Rat
- 90-Day Neurotoxicity
- Hen/ Mammal
- Smoke Inhalation
TGAI A.B No
TGAI A.B No
TGAI A.B No
TGAI B Partially 00126737
NbV
NoV
•*/
Yes?/
15 Months
CHRONIC TESTING:
83-1
83-2
83-3
- Chronic Toxicity -
2 Species:
- Rodent, and
- Nonrodent (Dog)
- Oncogenicity
2 Species:
- Rat (Preferred).
and
- Mouse (Preferred)
- Teratogenicity
2 Species:
- Rat
- Rabbit
TGAI A.B No
TGAI A.B No
TGAI A.B No
TGAI A.B No ' *
TGAI A.B Yes 00093921
TGAI A.B Yes 00129940
Yes
Yes
Yes
Yes
No
No
50 Months
50 Months
50 Months
50 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORFROPHAM
Does EPA Have Data
To Satisfy This Timefrane
Test Use Requirement? (Yes, Bibliographic Must Additional for Sub-
Data Requirement Substance Patterns No or Partially) Citation Data Be Submitted? missionV
SI58.135 Toxicology (continued)
83-4 - Reproduction - Rat
2-Generation
MUTAGEKICITY TESTING
84-2 - Gene Mutation
TCAI
A.B
Yes
84-2
84-2
(Ames Test)
- Structural Chromosomal
Aberration
- Other Mechanisms of
Mutagenicity
TGAI
TGAI
TGAI
A.B
A.B
A.B
Ye<
No
No
<-n SPECIAL TESTING
GO
85-1
85-2
86-1
- General
Metabolism PAI or PAIRA
- Dermal Absorption
- Domestic Animal
Safety
- Additional Test
Data
Choice
Choice
Choice
A.B
A.B
A.B
A.B
No
No
No
No
00129545
00129938
No
No
Yes
Yes
Yes
Nofy
12 Months
12 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHUORPRQPHAM
S158.135 Toxicology Footnotes
\J Data must be submitted within the indicated t iroeframes, which begin on the date of the Guidance Document
(See front cover for this date).
2/ The test is required only for organophosphates, metabolites, or other potential inhibitors of cholinesterase.
Chlorpropham does not fit these criteria; therefore, a study is not required.
y This requirement is waived based on submission of an acceptable chronic feeding study in the rat/dog.
4/ This study is not required because existing acceptable end uses should not result in repeated human skin
contact.
5/ This study is not required because existing acceptable end uses should not result in repeated human inhalation
exposure.
6/ Since an acute neurotoxicity study is not required for this compound, and there is not evidence of
neurotoxicity in mammalian species, this study is not required.
l_l The requirements for smoke inhalation studies are included under "Special Testing" in these tables.
Ln
M)8/ No data are required under current use patterns.
9/ If residues on tobacco greater than 0.1 ppm are detected, then an additional smoke inhalation study will be
required. However, since formal guidelines for such a study have not been developed, the registrant should
consult with the Agency before performing the study.
10/ If the required metabolism studies indicate that p-methoxy-chlorpropham (a metabolite of chlorpropham in
potatoes) is not a metabolite in chlorprophara-dosed rats, then Guideline studies 81-1 (rat), 82-1 (rat only),
83-3 (rat only), and 84-2 may be required on p-methoxy-chlorpropham. However, toxlcity studies on
p-methoxy-chlorpropham are not required at this tine.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Data Requirement
SI 58. 130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Pho todegradat ion
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
ON
0 162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
163-4 - Aerobic Aquatic
MOBILITY STUDIES:
Test
Substance
PAIRA
•
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
PAIRA
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Patterns No or Partially)
A,B Yes
A.B No
A,B No
A,B No
A.B No
Bibliographic Must Additional
Citation Data Be Submitted?
00114729 No
Yes 9
Yes 9
No2/
Yes 27
Yes 27
No3/
Reserved^/
Timefraroe
for Sub-
mission^/
Months
Months
Months
Months
163-1 - Leaching and
Adsorption/
Desorption
PAIRA
A,B
No
Yes
7 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROFHAM
Data Requirement
SI 58. 130 Environmental Fate
163-2 - Volatility (Lab)
163-3 - Vblatility (Field)
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-Tern
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
Test
Substance
(continued)
TEP
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
PAIRA
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Patterns No or Partially)
A.B No
A,B N>
A.B No
A,B No
A No
A No
A No
A,B Partially
Bibliographic Must Additional
Citation Data Re Submitted?
Yes
Reserved^/
Yes
Nq3/
Nq3/
Reserved^/
Yes
Reserved 7 /
Yes§/
00035997 Yes
00035998
Timefraroe
for Sub-
mission^/
12 Months
27 Months
50 Months
39 Months
50 Months
39 Months
12 Months
165-5 - In Aquatic Nontarget
Organisms
TEP
A,B
No
Reserved^/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORFROPHAM
SI58.130 Environmental Fate Footnotes
]_/ Data must be submitted within indicated tiroeframes, which begin on the date of the Guidance Document
(see front cover for this date).
2J Data are not normally requested unless this chemical has a high vapor pressure (>10~6 mmHg) and there are
toxicological and rentry concerns.
y Data are not required for use pattern.
4/ Reserved pending evaluation of acceptable aerobic metabolism data (cranberry use).
V Reserved pending results of laboratory volatility data and review of toxicological and reentry issues.
6/ Reserved pending results of field dissipation study.
TJ Reserved pending results of confined rotational crop study.
8/ Data are required for the registered cranberry use.
9/ Reserved pending ecological issues and fish accumulation data.
ON
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROPHAM
Data Requirement
Test Use
Substance Patterns
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timeframe
for J/
Submission
SI 58. 140 Reentry Protection
132-1 - Foliar Dissipation TEP No
132-1 - Soil Dissipation TEP No
132-3 - Dermal Exposure ' TEP No
132-4 - Inhalation Exposure TEP No
$158.142 Spray Drift
201-1 - Droplet Size Spec t run A,B. No
201-1 - Drift Field Evaluation A,B. No
2/
No
2/
No
2/
No
No~
No~
No~
J_/ Data must be submitted within indicated timeframes, which begin on the date of the Guidance Document
(see front cover for this date).
2J lexicological data do not indicate a need for reentry data.
3/ No apparent issues have been raised with present registered uses to require spray drift data.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Test
Data Requiranent Substance
$158
Does EPA Have Data
To Satisfy Require- Timeframe
Use ment? (Yes. No or Bibliographic Must Additional for Sub-
Patterns Partially) Citation Data Be Submitted? mission1/
.145 Wildlife and Aquatic Organisms
SPECIAL TESTING
70-1
- Residue Monitoring
TEP
A.B.C
No
2/
Yes"
9 Months
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Acute Avian Oral
Toxicity
- Avian Subacute Dietary
- upland Game Bird
- Waterfowl
- Wild Mammal Toxicity
- Avian reproduction
- upland Game Bird
- Waterfowl
- Simulated and Actual
Field Testing
- Mammals
- Birds
- Actual Field Testing
- Mammals
- Birds
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
A.B.C
A.B.C
A.B.C
A.B.C
A.B.C
A.B.C
A.B.C
A.B.C
A.B.C
A.B.C
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
Reserved^/
Reserved^/
Reserved4/
Reserved**/
Reserved^/
Reserved2*/
9 Months
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORFROFHAM
Data Requirement
Does ERA Have Data
To Satisfy Require-
Test Use merit? (Yes, No or
Substance Patterns Partially)
Bibliographic
Citation
Mist Additional
Data Be Submitted?
Timeframe
for Sub-
mission^ /
S158.145 Wildlife and Aquatic Organisms (continued)
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity
- Coldwater Fish Species, TGAI A,B,C
TEP A,B,C
Degradation
Product A.B.C
O\
- Warmwater Fish
Species
72-2 - Acute Toxicity
to Freshwater
Invertebrates
72-3 - Acute Toxicity to
Estuarine and
Marine Organisms
- Fish
TGAI A.B.C
TEP A.B.C
Degradation
Product A.B.C
TGAI A.B.C
TEP A.B.C
Degradation
Product A.B.C
TGAI A.B.C
TEP A.B.C
Degradat ion
Product A.B.C
Yes
No
No
Yes
No
No
No
No
No
No
No
No
40208604
No
Yes
Reserved^/
40208603
No
Yes
Reserved^/
Yes
Yes
Reserved^/
Yes
Yes
Reserved^/
9 Months
9 Months
9 Months
9 Months
12 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROPHAM
Data Requirement
Does EPA Have Data
To Satisfy Require-
Test Use ment? (Yes, No or
Substance Patterns Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted?
Timefrane
for Sub-
S158.145 Wildlife and Aquatic Organisms (continued)
72-3 - Acute Tbxicity to
Estuarine and
Marine Organisms
(cont'd)
- Mollusk TGAI A.B.C
TEP A.B.C
Degradation
Product A.B.C
- Shrimp
TGAI A.B.C
TEP A.B.C
Degradation
Product A.B.C
72-4 - Fish and Early Life Stage
and Aquatic Invertebrate
gs Life Cycle
- Freshwater Species
- Estuarine/Marine
Species
72-5 - Fish Life Cycle
TGAI A.B.C
Degradation
Product A.B.C
TGAI A.B.C
Degradation
Product A.B.C
No
No
No
ND
No
No
TGAI
A.B.C
No
No
ND
No
No
Yes
Yes
Reserved^/
Yes
Yes
Reserved^/
Yes
Reserved^/
Yes
Reserved^/
Yes
12 Months
12 Months
12 Months
12 Months
15 Months
15 Months
27 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHI/)RPROPHAM
ON
Does EPA Have Data
Tb Satisfy Require- Timeframe
Test Use ment? (Yes, No or Bibliographic Must Additional for Sub-
Data Requirement Substance Patterns Partially) Citation Data Be Submitted? mission1/
S158.
72-6
145 Wildlife and Aquatic Organisms (continued)
- Aquatic Organism
Accumulation TEP A.B.C
Degradation
Product A.B.C
- Crustacean No
- Fish No
- Insect Nymph No
- Mollusk No
- Shrimp No
Reserved**/
Reserved*^/
Reserved**/
Reserved**/
Reserved**/
Testing
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
TEP
TEP
A.B.C
A.B.C
No
No
Reserved^/
Reserved^/
-------
TABLE A
GENERIC DATA REQUIR01ENTS FOR CHLORFROPHAM
S158.145 Wildlife and Aquatic Organisms Footnotes
jy Data must be submitted within the indicated timeframes, which begin on the date of the Guidance Document
(see front cover for this date).
2J Residue monitoring must be conducted on terrestrial food crop, and aquatic crop use
sites using the highest registered rates for each. The studies must be conducted on alfalfa, onion,
blueberry, and cranberry crop sites. Terrestrial and aquatic monitoring must be conducted on each crop in
locations where climatic conditions are favorable to the type of monitoring. A minimum of three terrestrial
monitoring studies (five sites per crop) must be conducted on alfalfa, onions, and blueberries. A minimum of six
aquatic residue monitoring studies (five sites per crop) must be conducted on alfalfa, cranberries and blueberries.
Terrestrial site selection rationale must include agricultural areas where limited rainfall conditions favor the
persistence of residues in terrestrial environments. Aquatic site selection rationale include be in those areas
where rainfall conditions favor the movement of residues into aquatic environments in or near the test agricultural
site. Alfalfa and cranberry sites must include residue monitoring from aerial applications where drift to adjacent
terrestrial and aquatic environments can be monitored. Residue sampling parameters must include water, sediment,
foliage, fish, insects, invertebrates, small mammals, birds, and pertinent feed and habitat items. Residue
monitoring study protocols must be submitted within 90 days. Progress reports must be submitted at 6-month
intervals.
_3/ Avian reproduction studies are reserved pending the results of the avian acute toxicity, residue monitoring,
and environmental fate studies.
CO
4/ Field study requirements are reserved pending the results of acute avian oral, avian subacute dietary, freshwater
fish toxicity, acute toxicity to freshwater invertebrates, acute toxicity to estuarine and marine organisms,
avian reproduction, fish and early life stage and aquatic invertebrates, fish life cycle, residue monitoring, and
environmental fate studies.
5/ Degradation studies are reserved pending the results of environmental fate studies.
t
61 Aquatic organism accumulation studies are reserved pending the results of the environmental fate and residue
monitoring studies.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLDRPPOPHAM
SI 58.
Test
Data Requirement Substance
150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY EP
NONTARGET AREA PHYTOTQXICITY
121-1
122-1
Ox 122-2
123-1
123-1
123-2
TIER I
- Seed Germination/
Seedling Emergence TGAI
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER II
- Seed Germination/
Seedling Emergency TGAI
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
Does EPA Have Data
To Satisfy Requ ire-
Use ment? (Yes, No or Bibliographic Must Additional
Patterns Partially) Citation Data be Submitted?
A.B.C No NojV
A,B,C No Yes
A.B.C No Yes
A,B,C No Yes
A.B.C No Nq2/
A.B.C No Nb£/
A.B.C No » Nb2/
Timeframe
for Sub-
mission^/
9 Months
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Data Requirement
Does EPA Have Data
To Satisfy Require-
Test Use went? (Yes, No or
Substance Patterns Partially)
Bibliographic Must Additional
Citation Data Be Submitted?
Timeframe
for Sub-
miss ionl /
SI58.150 Plant Protection (continued)
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
A.B.C
A.B.C
No
No
Nq£/
No2/
\J Data must be submitted within the indicated timeframes, which begin on the date of the Guidance Document
(see front cover for this date).
2_/ These requirements are generally waived unless it is believed there is a phototoxicity problem,
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORPROFHAM
Data Requirement
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes,
Substance Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted?
Tiroeframe
for Sub-
mission^ /
8158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey Bee Acute
Contact Toxicity TGAI
141-2 - Honey Bee - Toxicity
of Residues on
Foliage TEP
141-4 - Honey Bee Subacute
Feeding Study
1^141-5 - Field Testing for
Pollinators TEP
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
A.B.C.G
A.B.C.G
Yes
No
A.B.C.G
No
00018842
No
No?/
Reserved^/
NojV
Reserved^/
Reserved^/
Reserved^/
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORPROPHAM
Does EPA Have Data
To Satisfy This Tiraeframe
Test Use Requirement? (Yes, Bibliographic Must Additional for Sub-
Data Requirement Substance Patterns No or Partially) Citation Data Be Submitted? mission]/
SI58.155 Nontarget Insect (continued)
143-1 - NONTARGET INSECT Reserved*/
thru TESTING - PREDATORS
143-3 - AND PARASITES
\J Data roust be submitted within the indicated timeframes, which begin on the date of the Guidance Document
(see front cover for this date).
21 As data from the acute contact test indicate low toxicity, no further testing is required.
_3/ Reserved pending development of test methodology.
4/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHLORPROPHAM
CA!
Test
Data Requirement Substance
SI 58. 120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity
and Disclosure of •
Ingredients MP
61-2 - Description of Beginning
Materials and Manufac-
turing Process MP
61-3 - Discussion of Formation
of Impurities MP
Analysis and Certification of
Product Ingredients
Does EPA Have Data
To Satisfy Require- Timeframe
ment? (Yes, No or Bibliographic Must Additional for
Partially) Citation £/ Data Be Submitted? Submission^/
No N/A YesJV 6 Months
No N/A YesV 6 Months
No N/A YesV 6 Months
62-1 - Preliminary Analysis MP
62-2 - Certification of
Limits MP
62-3 - Analytical Methods
to Verify Certified
Limits MP
No
No
No
N/A
N/A
N/A
Yesfy
Yes?/
Yes8/
12 Months
12 Months
12 Months
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHLORPROPHAM
Test
Data Requirement Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes, No or Bibliographic
Partially) Citation 2/
Timeframe
Must Additional for
Data Be Submitted? SubmissionV
$158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
63-14
63-15
63-16
63-17
63-18
63-19
- Color
- Physical State
- Odor
- Density, Bulk Density,
or Specific Gravity
-pH
- Oxidizing or Reducing
Action
- Flanmability
- Explodability
- Storage Stability
- Viscosity
- MIscibility
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes9/
Yes9/
YesjV
Yes9/
Yes?/, JO/
Yes9/.jMy
Yes£/,_[2/
YesjV J3/
YesjV
YesjV.JV
YesjV.Jjy
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
63-20 - Corrosion
Characteristics
MP
No
N/A
Yes9/
15 Months
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORPROPHAM
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy Require-
ment? (Yes. No or
Partially)
Bibliographic
Citation 2/
Timefrane
Must Additional for
Data Be Submitted? Submission1/
SI58.120 Product Chemistry (continued)
Other Requirements;
64-1 - Submittal of Samples N/A
N/A
N/A
N/A
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHLORPROPHAM
SI58.120 Product Chemistry Footnotes
\J Data must be submitted within the indicated timeframes, which begin on the date of the Guidance Document
(see front cover for this date).
21 Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
3/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and
purpose of the active ingredient and each intentionally added inert must be provided. For the active ingredient,
the following must also be provided: the product name, trade name, and cannon name; the molecular, structural,
and empirical formulas; die molecular weight or weight range; and any experimental or internally assigned company
code numbers.
4/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, die chemical equations for each intended
reaction, equipment used to produce each intermediate and final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and
address of die manufacturer, producer, or supplier of each beginning material must be provided, along with
information regarding die properties of each beginning material used to manufacture each product.
5/ A detailed discussion of all impurities diat are or may be present at *>_ 0.1%, based on knowledge of die beginning
materials, chemical reactions (intended and side) in die manufacturing process, and any contamination during and
after production must be submitted.
I
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity
for which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for
each analytical method used. *
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TABLE B
PRODUCT SPECIFIC DATA RBQUIREnENTS FOR HftNUFACTLRING-USE PRODUCTS CONTAINING CHLORPROPHAM
SI58.120 Product Chemistry Footnotes (cont'd)
TJ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at ^ 0.1% (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and precision
data have been provided. Limits for impurities not associated with the active ingredient need be provided only
if they are considered to be of toxicological significance, regardless of the concentration at which they are
present. Certifications must be submitted on EPA Form 8570 (Rev. 2-85).
J}/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
~ impurity and intentionally added inert for which certified limits are required and each toxicologically significant
impurity (unintentionally) added at > 0.1%. Each method must be accompanied by validation studies indicating its
accuracy and precision. These method's must be suitable for enforcement of certified limits.
9/ Physicochanical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing action,
flammability, explodability, storage stability, viscosity, miscibility, and corrosion characteristics) as required
in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D must be submitted.
_10/ Required if the test substance is dispersible with water.
11/ Required if the product contains an oxidizing or reducing agent.
J2/ Required if the product contains combustible liquids.
13/ Required if the product is potentially explosive.
14/ Required if the product is a liquid.
15/ Required if the product is a liquid and is to be diluted with petroleum solvents.
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORPROPHAM
Does EPA Have Data
To Satisfy Require- Timeframe
Test ment? (Yes, No or Bibliographic Must Additional for
Data Requirement Substance Partially) Citation Data Be Submitted? Submission^
SI 58. 135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral - Rat MP No
81-2 - Acute Dermal MP No
81-3 - Acute Inhalation MP No
81 -A - Eye Irritation - Rabbit MP No
81-5 - Dermal Irritation -
Rabbit MP No
0° 81-6 - Dermal Sens itizat ion -
Guinea Pig MP No
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
\j Data must be submitted within the indicated timefraraes, uhich begin on the date of the Guidance Document
(see front cover for this date).
-------
APPENDIX II
LABELING
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than~
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)J
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)J
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by Che phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)J
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of ail inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement muse run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
79
-------
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)(li)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicicy Category I on the basis of oral, dermal,
or inhalation toxicicy, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Itea 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)J
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists Co humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under 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 produce 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 uae. If they are restricted the draft label(s)
submitted to Che Agency as part of your application must
reflect this determination (see below).
If you do noc believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the. provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
81
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SUMMARY-5
Icetn 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products. '
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed,- directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations chat 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.
82
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SIM1ARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
>
VA
>B
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 word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
FKEKEKKKU
Center front
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
V
Above signal
word
i
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, roust
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.
-------
SIM1ARY-7
ITEM
1C
7D
7E
8
flA
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of1
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I. II. and III
All products
where pre-
cautionary
label ing
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 t
Same as above
Same as above
cortiEwrs
1
Must be grouped under the headings in
8A. 8B, and 8C; preferably blocked.
Mist be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
00
-------
SUtlAKY-8
ITEM
sc
9A
9B
16A
10B
loc
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
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 sane 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,
COOT/ D IS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
00
tn
-------
Chapter 1—Bavirouwntal Protection Agency
5162.10 Lab*ling 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
arid use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used,. All required label or labeling text
shall appear in the English language. However/ the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public, when
additional text in another language is necessary* all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(r) General. The label shall appear
on or be securely attached to the immediate container of the
86
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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 CPR 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 S 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 includet
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) . A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal GovernxMnt;
(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 falsa
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
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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 thj»
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 whoa 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 miniauai quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68*P (20*C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons. \
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e... "1 pound 10 ounces* rather than
"26 ounces."
88
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(5) In addition to the required units specified, net content
nay 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
y may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement-*(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages.of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients* and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required Cor pesticides which contain 100 percent
active ingredient*. Unless the ingredient statement is a complete
analysis of the pesticide, the terra "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 i« an outside conVainer 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 font 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 «ust 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.
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(3) Name* to be used in ingredient statement. The name used
foe 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 oC weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%.* If the uses of the pesticide product are expressed as
weight of active ingredient per unit area/ a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages' given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches/ the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re--
quirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly/ the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after (date].*
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the'name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children/ environmental
hazard/ and physical or chemical hazard fall into two groups; those
required on the front'panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content/
placement/ type size/ and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
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Hazard Indicators
Oral lOjg
inhalation 1C
OanMl LO
Eya af facts
%
Skin affacts
I
Up to and
Including
90 «ag/kg
Up to and
Including
.2 «g/l Itar
Up to and
Including
200«g/kg
Corroslva;
cornoal opacity
not ravarslbla
•Ithln 7 days
Corrof lv«
Toatcltv c
II
Froa 30 thru
900 «g/kg
from .2 thru
2 ag/l Itar
Fro. 200
thru 2000
Cornaal opacity
ravarslbla
within 7 days;
Irritation
persisting for
7 days
Savara Irritation
at 72 tours
tatagorlas
III
from 900 thru
9000 «g/kg
-
Fro* 2 thru
20 ag/Mtar
from 2.000 thru
20.000
No cornaal opacity;
Irritation
ravarslbla
•Ithln 7 days
Mod«!°ata Irritation
at 72 heirs
•
IV
Graatar than
9000 «g/kg
Graatar than
20 •g/Mt«r
Graatar than
20.000
No Irritation
Mild or slight
Irritation at
*72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products m««ting th« crittria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxieity Category I on
the basis of its ora^, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison* shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison.* \
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel*
the signal word "Warning."
(C) Toxicity Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel-
the signal word "Caution.*
(0) Toxicity Category IV." All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
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(E) Use) of signal words* Use of any signal word(s) associated
with a higner 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 hit 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 partel
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:
V
Size of label front panel
in square inches
Above 10 to 15
Above IS to 30
Over 30 .... %
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8"
10
12
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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.
Tdxlclty
category
Precautionary statements by toxic I ty category
Oral. Inhalation, or dermal to*lell>
Skin and eye local effects
I
it
III
IV
Fatal (poisonous) If svalloved (Inhaled or
absorbed through skin). Do not breathe
vapor Idust| or spray mistI. Do not gat
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
reau'red.I.
May be fata' If s»ofloved I Innate* or
abso-bed through the sklnl. Oo not breathe
vapors (dust or spray mlstl. Oo not get In
eyes, on skin, or o* clothing. (Appropriate
first aid statements required.I.
Harmful I f tval fOMd I fnmtlad or abaorbed
through the skin). Avoid breothlng vapors
.(dust or spr«y elstt. Avoid contact with
sk'n leyee or cletftlmfI. IAppropriate
first aid stitsmantVequlred.l.
(NO
statements required.!,
Corrosive, causes eye and sktn da*ago lor
skin IrrltatlonI* Oo not get In efes, on
skin, or on cloth'ng. Wear goggles or face
shield and rubber gloves when handling.
Hansfut or fatal If svalloved.
(Appropriate first aid statement required.)
•
Causes eye land sktnl Irritation. Oo not
got la eyes, on skin, or on clothing.
Harmful If Ma Moved. (Appropriate first
aid statement required.!.
Avoid contact vltti skin, eyes or clothing.
In caso of contact Immediately flush
eyes or skin v'th plenty of water. Gat
medical attention If Irritation persists.
(No precautionary statements required.!. |
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
93
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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 LOso 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 LCso 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 LOso °* 10° mg/kg or less, or
a subacute dietary LCso 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
flamenability or explosive characteristics of the pesticide are
required as follows:
Masn point
(A) MCSSUNI2EO
'las* point at or bale* 20*P} If tuere !• •
flaSftbOCk at any «Olve OpMlng.
1
II
Hash point above 20*T «* flfe ever IO*F or If
rn« f l OM e*teM Ion Is MTO tHM.lt In. long
at • tfisteeae e» ft In. *rm t*e HMO.
.
CD NONM.CSSUII;
ftMulred tvvt
CONTAINCRS
CxtroMly flMMOle. Content* un««r pressure.
Keep e*ov fro» flro, sporiu, «nd n««t«4
turf KM. Oo not punetur* or Inelnorat*
eonttlnor* hooMiro to toaporaturM tbo»«
I30*F MY CMM bursting.
FlMMblo. Contoats wnoar prossura. Kaop a«ay
from noat, sparks, a** opon Mama. Oo not
punctvro or Inclnorata cental nor. bpotura to
taav«r«tvrM abovo 130*F MT eawsa bursting.
Contacts unoor prat sura. Oo not uso or ttora
naar no«t or opon flaao. Oo not pvnetur* or
Inelnorato cental nor* Cxposura to ta«para-
turas aoovo 130*f My causa bursting.
ECO CONTAINCMS
Cxtraaaly flaaMbla. Kaoe «••¥ fro* f Ira,
-------
(i) Direction* for Use—(1) General requirementa—(i) Adequacy
and clarity ot directions. Directions Cor use muse be stated in
terns whicn can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions oust 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:
U) 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
(j4) 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 Cor which sale is limited to physicians,
veterinarians* or druggists, provided that:
U) The) label clearly states that the product is for use only
by physicians or veterinarians;
(2) The) Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(2> 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 fqrmulators
in preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
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(£) Tte 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(a) of pesticide products
involved;
(2) 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 tht
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CPR Part 170.
(ix) Specific direction* concerning the storage and disposal
ol! the pesticide and its container, meeting the requirements of
40 CPR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the S«JM 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 internals 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) Por 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 ctrtifisd
applicator who is physically present.
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(P) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of $ 162.10(j)(2).
(1) General Use Classification. Pesticide products'bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in S 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear*
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall*appear. If use is restricted to certified
applicators* the following statement is required! "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." if, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording Cor the terras of restriction by regulation
(k) Advertising. [Reserved]
*
(40 PR 28268, July 3, 1975; 44 PR 32329, Aug. I, 1975; 40 PR
38S71, Aug. 21, 1975, as amended at 43 PR 5786, Feb. 9, 1978]
97
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
.opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers~~
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and noc over 80°F.
C. Flashpoint over 80°F
and noc over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep* away from
heat, sparks, and flames Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required co bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors: '
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container Is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
99
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all produces, except chose intended solely for domestic
use, muse 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 Ehvironmental 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:
"Waste* 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."
100
-------
CONT/DIS-1
'CONTAINER DISPOSAL INSTRUCTIONS
The label of each produce muse 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, iars)
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)
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.
Plastic containers
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.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
capping 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
reused1. dispose of in the same manner.
Paper and
plastic bags
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.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording) -
]J Manufacturer may replace this phrase with one indicating
" whether and how fiber drum may be reused.
101
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APPENDIX III
USE INDEX
- 101-A -
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
TABLE OF CONTENTS
S,ite Name Pane
TERRESTRIAL FOOD CROP 3
(Agricultural Crops) 3
TERRESTRIAL NONFOOD CROP 16
(Agricultural Crops) 16
(Ornamental Plants and Forest Trees) 1-7
Ageratum 17
Alfalfa 3
Alfalfa (seed crop) 5
Alfalfa-Grass Mixture 6
Alyssum 17
Arborvitae 17
Aster Id
Astilbe . 18
Azalea 17
Balsam Fir 17
Barberry 17
Beans (lima, snap) 6
Begonia 17
Birch 17
Blackberry 6
Bluebell 18
Blueberry 6
Boxwood 17
Camellia 17
Carnation 18
Carrots 7
Cedar 17
Cherry (ornamental) 17
Chrysanthemum 17
Clover 7
Coleus 17
Columbine 18
Coral Bel1m 18
Cotoneaster 17
Crabapple (ornamental) 17
Cranberry 7
Creeping Juniper ' 18
Daffodil* (bulbs) 18
Dahlias (bulbs) 18
Dianthus 17
Dogwood 17
Dutch Iris (bulbs) 18
Easter Lilies 19
English Ivy 1Q
Enkianthus 17
Euonymus 17
Fir 17
Forget-Me-Not IS
Forsythia 17
Issuedi 10-15-86 I-O183O1-1
Provisional Updates 11-1O-87
102
-------
EPA Compendium of Acceptable Use*
ISOPROPYL N-(3-CHLOROPHENYL)CARSAMATE
TABLE OF CONTENTS
Site Name Page
Fuchsia 17
Garden Balsam 17
Garlic S
Geranium 17
Ginkgo 19
Gladiolus (bulbs) IB
Grasses, Perennial (seed crop) 9
Heather 17
Hemlock 17
Holly 17
Honeysuckle 17
Hydrangea 17
Iris 19
Juniper 17
Ladino Clover 9
Larkspur IB
Laurel 17
Leucothoe 17
Ligustrum 17
Lilac 17
Lilies (bulbs) 19
Locust 17
Magnolia 17
Mahonia IB
Maple IB
Marigold 17
Mock-Orange IB
Myrtle IS
Narcissus (bulbs) 19
Onion 9
Ornamental Woody Plants 20
Pachysandra IS
Pansies 17
Peonies 18
Petunias 17
Pieris IB
Pine IB
Plum (ornamental) IB
Poplar IS
Potato 10
Raspberry 6
Red Clover 3
Rhododendron IS
Rose IS
Safflower 12
Salvia 17
Snapdragon 17
Southern Peas 12
Soybeans 1£
Spinach (fall seeded) 14
Issued I 10-15-86 I-O18301-ii
103
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EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
TABLE OF CONTENTS
Site Name Page
Spirea IB
Spruce 18
Sugar Beets 14
Sugar Beets (seed crop) 15
Sycamore 18
Tobacco, Flue-Cured 16
Tomato IS
Trefoil 9
Tulips (bulbs) 19
Viburnum 18
White Clover 9
Wintercreeper 18
Yew 18
Zinnia 17
Issued! 10-15-86 X-018301-1n
• 104
-------
EPA Compendium of Acceptable Uses
hO18301 ISOPROPYL N-(3-CHLOROPHENYL)CARBAM«TE»
TYPE PESTICIDES Herbicide, PlantxRegulator
FORMULATIONS;
Tech OB*)
G (5*, 10.3%, 20*)
EC (1 Ib/gal "or 11.9* a. i. , 1.33 Ib/gal or 15* a. i. , 2 Ib/gal or
££. £* a. i., £5%, 3 Ib/gal or 36% a. i., 4 Ib/gal or 47% a. i. )
RTU (4 Ib/gal or 46% a. i. or 46.5* a. i. , 4.3 Ib/gal or 49.65*
a. i., 7 Ib/gal or 78.4* a. i. or 78.5* a. i.)
GENERAL WARNINGS AND LIMITATIONS; A selective herbicide and plant
regulator for use in agricultural and ornamental crops. This chemi-
cal is toxic to fish. Do not apply directly to water or wetlands
(swamps, bogs, marshes or potholes). Do not apply where runoff is
likely to occur. Do not contaminate water by cleaning of equipment
or disposal of wastes. Adequate soil moisture (rainfall or irriga-
tion) is necessary for effective weed control. Do not cultivate or
disturb soil after treatment. For band and strip treatments, re-
duce dosages and water dilution rates proportionately.
Interim Tolerances: While petitions for tolerances for negligible
1 action is completed, interim toler-
(other than those listed in the text)s
residues are pending and until «
ances are established.
Agricultural Crop Tolerances (o1
Rice, grain 0. 1
Livestock Tolerances:
Cattle, fat
Cattle, meat
Cattle, mbyp
Eggs
Goats, fat
Goats, meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses, meat
Horses, mbyp
Milk
Poultry, fat
Poultry, meat
Sheep, fat
Sheep, m««t
Sheep, mbyp
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0. OS
0.05
0.05
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
(I)
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Not located.
PHYTDTOXICITY TO CROPS: Not located.
*chlorpropham
Issued! 10-15-86 1-018301-1
Provisional Updatei 11-10-87
105
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EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
MODE OF ACTIONi Suppresses transpiration and respiration, inhibits
root and epicotyl growth.
BROADLEAF WEEDS CONTROLLED;
PBKAIAA Bittercress
PEWAIBE Black nightshade
PADABBA Carpetweed
PAZAAAC Chickweed
PBGADAA Dodder
PBKAGAA Falseflax
PCOAFBA Henbit
PBTABAA Horsetail
PEAAGAC Knotweed
PEAA6BP Ladysthumb
PBKBDBB London rocket (a)
PCYAEAA Loosestrife
PDAAHAA . Mallow
PEAAGBO Pennsylvania smartweed
PAAP.P.BP Purslane
PEAAHBB Red sorrel
PAFACBI Redroot pigweed
PBKfiHBft Sheperdspurse (a)
PBKBCBft Si bara
PQPAAAV Summer annual weeds
PEAAGAE Tearthumb
PEAAGBH Wild buckwheat
PBKBKBB Wild mustard (a)
PAAAAAW Winter annual weeds
(a) Controls weeds when treatment is made in conjunction with
irrigation.
GRASSES AND OTHER MONOCOTS CONTROLLED;
PCACKBA Annual bluegrass
PZAAAAD Annual brome
PCAAAAB Annual grasses
PCABHBB Barnyardgrass
PCAADAA Bentgrass
PCAAVBA Bluejoint reedgrass
PCACHBB Canarygrass
PCABRBA Common velvet grass
PCABFAA Crabgrass
PCAATBM Downy brome
PCACUAA Foxtail
PCAAAAF Grain (volunteer)
PCABZBA Italian ryegrass
PCABSBF Little barley
PCACLBB Rabbit foot polypogon
PCAEABE Rattail fescue
Issued: 10-15-86
I-O18301-£
106
-------
PCLABAA
PCABKBC
PZAAAFX
PCAAOBB
PCAAAAM
PCACEBC
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
GRASSES AND OTHER MQNOCOTS CONTROLLED (continued)
Rush
St inkgrass
Turkeyfoot grass
Wild oats
Winter annual grasses
Witchgrass
PLANT REGULATOR CLAIMS;
PZZZZZA Plant regulator (fruit inhibitor)
PZZZZZA Plant regulator (prevent sucker development)
PZZZZZA Plant regulator (flower bud abscission)
PZZZZZA Plant regulator (sprout inhibitor).
Site. Dosaoe and
Formulat ion
(Ib a. i. /A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
/23001AA Alfalfa
Tolerance. Use. Limitations
(20% 3)
SO (I) ppm (alfalfa)
50 (I) ppm (alfalfa, hay)
2O day preharvest interval.
Do not graze or feed treated crop within
4O days of application.
Genera1 Informat i on 8 These uses will not
control attached dodder. Use on alfalfa
planted no later than the spring or fall
of the previous year. Do not apply to
alfalfa foliage that is wet or damp.
Seedling crops should have at least 4-true
leaves. Do not use on grass-legume mixed
stands as grass may be injured. Apply
when soil is moist.
Postemergence. Broadcast. Apply to late
summer seeded or established alfalfa
plantings.
Issuedi 10-15-66
1-018301-3
107
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EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Site. Dosage and
Formulation
(Ib a. i. /A)
Alfalfa (continued)
4-6
(4 Ib/gal EC)
1-3
(4 Ib/gal EC)
2-4
(4 Ib/gal EC)
4-6
<20X G)
CSLN3
4-6
<2O* 6)
CSLND
2-3
(4 Ib/gal EC)
Tolerance. Use. Limitations
Issuedi 1O-13-86
Postemergence. Broadcast or band. For
control of dodder. Apply in 20 or more
gallons of water per acre by ground or 3
or more gallons of water per acre by air
prior to dodder germination. Apply to the
first crop in the early spring prior to
alfalfa breaking dormancy or at lay-by.
Apply to the second crop in early spring
prior to alfalfa breaking dormancy and/or
after removal of first forage crop.
Tank mix with carbaryl.
Use limited to areas east of the Rocky
Mountains. Postemergence. Broadcast or
band. For control of chickweed and downy
brome. Apply in 20 to 40 gallons of water
per acre to late summer seeded or
established alfalfa plantings. Use the
lower dosage from October through January
and the higher dosage after February 1.
May be applied to actively growing
semi—dormant or dormant alfalfa.
Use limited to areas west of the Rocky
Mountains. Postemergence. Broadcast or
band. Apply in 20 to 40 gallons of water
per acre to summer seeded or established
alfalfa plantings.
Use limited to CA, ID, NV, OR, UT and WA.
Postemergence. Broadcast or band. For
control of dodder. Apply in the spring
prior to dodder germination. Use the
lower dosage for repeat applications and
the higher dosage for single applications.
SLN - Use limited to CA and UT.
Postemergence. Broadcast or band. For
control of dodder. Apply by ground or by
air prior to dodder germination. Repeat
application in 4 to 6 weeks.
SLN - Use limited to Yuma County, AZ.
Postemergence. Broadcast. Apply into the
irrigation water system in the late fall
or winter when alfalfa plants have at
least 6-true leaves and are 4 to 6 inches
tall.
1-018301-4
108
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EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
/23001BA
Site. Dosaoe and
Formulation
(Ib a. i. /A)
A1 fa1 fa (seed crop)
4-6
(4 Ib/gal EC)
4-6
(20X G)
CSLN3
4-6
(20% G)
Tolerance. Use. Limitations
20 (I) ppm (alfalfa)
50 (I) ppm (alfalfa, hay)
£0 day preharvest interval.
Do not graze or feed treated crop within
40 days of application.
General Information; These uses will not
control attached dodder. Use on alfalfa
planted no later than the spring or fall
of the previous year. Do not apply to
alfalfa foliage that is wet or damp. Seed-
ling crops should have at least 4-true
leaves. Do. not use on grass-legume mixed
stands as grass may be injured.
•»
Postemergence. Broadcast or band. For
control of dodder. Apply in 20 or more
gallons of water per acre by ground or 5
or more gallons of water per acre by air
prior to dodder germination. Apply to the
first crop in the early spring prior to
alfalfa breaking dormancy or at lay-by.
Apply to the second crop in early spring
prior to alfalfa breaking dormancy and/or
after removal of first forage crop.
Tank mix with carbaryl.
Use limited to CAt ID, NV, OR, UT, and WA.
Postemergence. Broadcast or band. For
control of dodder. Apply in the spring
prior to dodder germination. Use the low-
•r dosage for repeat applications and the
higher dosage for single applications.
SLN - Use limited to CA and UT.
Postemergence. Broadcast or band. For
control of dodder. Apply by ground or by
air prior to dgdder germination. Repeat
application in 4 to 6 weeks.
Issuedi 10-15-86
1-018301-5
109
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLORQPHENYL)CARBAMATE
/28069AA
Site. Dosage and
Formulation
(Ib a. i. /A)
Alfalfa-Grass Mixture
CSLND
2-3
(4 Ib/gal EC)
/15027AA
/O1002AA
/010060ft
/O1009AA
Beans (lima, snap)
A
(20* 6)
(4 Ib/gal EC)
Blackberry
Raspberry
6
(20* G)
(4 Ib/gal EC)
Blueberry
8-12
(20* Q)
(4 Ib/gal EC)
Tolerance. Use. Limitations
20 (I) ppm (alfalfa, grasses)
50 (I) ppm (alfalfa, grasses, hay)
Do not graze or harvest treated crop -For
forage within 40 days of treatment.
Genera1 Informat i on; Includes mixed
stands of alfalfa and orchardgrass, tall
fescue, or smooth bromegrass.
SUM - Use limited to KY.
Postemergence. Broadcast. For control of
chickweed. Apply in 20 to 40 gallons of
water per acre to established stands. Use
the lower dosage before chickweed emerges
until chickweed is 3 inches,tall and the
higher dosage when chickweed is over 3
inches tall and/or after February 1.
0.3 (I) ppm (beans, dried, succulent)
General Information! Seeds should be
planted at least 1 inch deep.
Preemergence. Broadcast or band. May be
applied in 20 to 4O gallons of water per
acre after planting but before bean plants
emerge.
0.3 (I) ppm
Dormant application. Directed spray to
soil. Apply in 40 gallons of water per
acre in late winter or early spring.
Avoid wetting canes.
0.3 (I) ppm
Dormant application. Directed spray to
base of blueberry plants. Apply in 40
gallons of water per acre in the fall.
Retreat in the spring before weed growth
begins.
Issueds 10-15-86
I-O18301-6
no
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
/14003AA
Site. Dosage and
Formulat ion
(Ib a. i. /A)
Carrots
/23003AA
4-6
(2OX G)
(4 Ib/gal EC)
Clover
4
(20* G)
2-4
(4 Ib/gal EC)
/OlOlOftA Cranberry
1O-2O
(SOX G)
Tolerance. Uao. Limitat tons
0. 1 (I) ppm
General Information; Do not use in CA.
Use the lower dosage on clay loam soils
and the higher dosage on heavy, dark miner-
al or muck-soils.
Preemergence. Broadcast or band. Apply
in 20 to 40 gallons of water per acre.
20 (I) ppm (clover)
SO (I) ppm (clover, hay)
40 day preharvest interval.
Do not graze or feed treated crop within
40 days of application.
General Information! Seedling crops
•hould have at least 4-true leaves. Do
not use on grass-clover stands as grass
may be injured. Apply when soil is moist.
Postemergence. Broadcast or band. Apply
to the late summer seeded or established
clover plantings.
Postemergence. Broadcast or band. Apply
in 20 to 40 gallons of Mater per acre to
late summer seeded or established dormant
plantings.
0.3 (I) ppm
Genera1 Informati oni Apply when plants
are dry to avoid contact and possible in-
jury to fruit buds and loss of yield. Do
not allow chemical to contact sensitive
crops such as beets, spinach, and toma-
toes.
Dormant application to established plant-
ings. Broadcast. Apply in the early win-
ter after harvest or in early spring be-
fore cranberry growth begins.
Issued! 10-13-66
1-018301-7
111
-------
Sit<
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Dosaoe and To1erance. Use. L i m i t at i ons
Formulation
(Ib a. i. /A)
Cranberry (continued)
CMAI3
S
(5* G)
/14007AA Garlic
(4 Ib/gal EC)
(4 Ib/gal EC)
CSLN:
2-4
(4 Ib/gal EC)
CSLN]
4
(4 Ib/gal EC)
Use limited to MA. Dormant application to
established cranberry plantings. Broad-
cast. Apply prior to bud break, from
April 1 to May 10, by ground or by air.
When using ground equipment, it is sug-
gested that a piece of canvas or burlap be
dragged behind the application (over the
plants) to brush any granules adhering to
the foliage onto the soil suface.
Formulated with sodium N-1-naphthylphthala-
mate.
0.1 (I) ppm
3O day preharvest interval.
General Information Do not us* on light,
sandy soils or soils containing less than
1 percent organic matter. Irrigate within
5 days of application.
Use limited to CA. Preemergence. Broad-
cast or band. Apply in 20 to 70 gallons
of water per acre to fall seeded sets im-
mediately after planting.
Use limited to CA. Postemergence. Direct-
ed spray to the lower 1 to 2 inches of gar-
lic plant. Avoid wetting plant tops. Ap-
ply in 20 to 70 gallons of water per acre.
SLN - Use limited to CA.
Preemergence. Broadcast or band. Apply
in 20 to 70 gallons of water per acre to
fall .seeded set immediately after plant-
ing. Use the lower dosage on coarse-
textured soils or when soil temperatures
are below SO F (15.5 C) and the'higher
dosage on medium/fine-textured soils or
when soil temperatures are above 60 F
(15.5 C).
SLN - Use limited to CA.
Postemergence. Directed spray to the low-
er 1 to 2 inches of the garlic plant. Ap-
ply in 20 to 70 gallons of water per acre
when garlic plants are 6 inches tall and
have 3 or more true leaves. Avoid wetting
plant tops.
Issuedt 10-15-86
I-O18301-8
112
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EPA Compendium of Acceptable Uses
ISOPROPYL N-<3-CHLOROPHENYL)CARBAMATE
Site. Dosage and
Formulation
(Ib a. i. /A)
/28066BA Grasses. Perennial
(seed crop)
(4 Ib/gal EC)
/23016AA
/23014AA
/23019AA
/23017Afli
Ladino Clover
Red Clover
Trefoi1
White Clover
2-4
<4 Ib/gal EC)
/14011AA
Onion
4-8
(£0% 6)
(4 Ib/gal EC)
Issuedi 10-15-86
Tolerance. Use. Limitations
SO (I) ppm (grass)
50 (I) ppm (grasses, hay)
30 day preharvest interval.
General Information; Do not use on new
varieties or selections without small plot
testing to determine crop tolerance. Only
true perennial .varieties are tolerant.
Crosses with annual varieties may be sus-
ceptible to crop injury. Apply prior to
October 20 for fine fescue varieties.
Use limited to OR, west of the Cascade
Mountains. Postemergence. Broadcast or
band to established grass stands which
have been harvested for seed at least
once. Apply in the fall after the rains
have started but before November 1. The
dosage for this site was not listed on the
label.
2O (I) ppm (clover)
50 (I) ppm (clover, hay)
40 day preharvest interval.
Genera1 In format i on: Seedling crops
should have at least 4-true leaves. Do
not use on grass-clover mixed stands as
grass may be injured. Apply when soil is
moist.
Postemergence. Broadcast or band. Apply
in 20 to 40 gallons of water per acre to
late summer seeded or established dormant
plantings.
O. 1 (I) ppm
3O day preharvest interval.
General Information: Do not use on sandy
soils, coarse-textured soils or soils con-
taining less than 4 percent organic mat-
ter. Do not apply during flag stage as in-
jury to onions may occur. Use the lower
dosage on heavy, dark mineral soils and
the higher dosage on muck soils or when
soil temperatures are above 6O F (15.5 C).
Preemergence. Broadcast to sets or seeded
onions. Apply up to the early loop stage
of seeded onions. The 4 pound per gallon
emulsifiable concentrate formulation is
not recommended for use in CA.
1-018301-9
113
-------
/14013EA
Site. Dosage and
Formulation
(Ib a. i./A)
Onion (continued)
4-8
(20* G)
(4 Ib/gal EC)
Potato
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Tolerance. Use. Limitations
0.09-0.13 gal
diluted spray/
1,000 Ib potatoes
(25% EC)
(3 Ib/gal EC)
1.7-2.2 Ib a. i. /
1,OOO Ib potatoes
(4, 4.3, 7 Ib/gal
RTU)
CSLN3
1.7 Ib a. i. /1,000
Ib potatoes
(7 Ib/gal RTU)
Issued: 10-15-86
Postemergence. Broadcast to sets, seeded
or transplanted onions. Apply when onions
are 6 inches tall and have 3 or more true «
leaves.
50 ppm
General Information; Apply when potatoes
enter storage bins or at the time of grad-
ing or sorting.
Do not apply in fields or on seed pota-
toes. Apply after bruises and cuts on
potatoes have healed (minimOm 2 weeks).
Do not allow vapors to come in contact
with, or get near storage areas used for
seed potatoes. If entry into the storage
area is necessary during or immediately
following application (before the fog has
settled), protective clothing and respira-
tors must be worn. Treated storage areas
should be monitored to prevent overheat-
ing, assure proper air flow, and prevent
excessive moisture build-up.
Postharvest. Plant regulator (sprout inhi-
bitor). Apply 1 gallon of product in 24
to 35 gallons of water. Apply diluted
spray using nozzles placed evenly across
the rollers on which the potatoes are mov-
ing. Potatoes must be cured, washed and
damp dried before treatment.
Postharvest. Plant regulator (sprout inhi-
bitor). Apply after curing but before
sprouting. Forced air distribution: In-
sert aerosol generator intake hose into
product container. Set air ducts for re-
circulation. Place exhaust end of aerosol*
generator at center of air mixing chamber
(plenum) pointing it in direction of air
flow. Keep storage closed during applica-*
tion and for 48 hours after treatment.
Continue to recirculate air in storage
areas until fog has settled then resume
norma1 vent i1at i on.
OR
Areas without recirculating air systems:
Prior to placing potatoes in treatment
areas the following preparations should be
I-O183O1-10
114
-------
Site. Dosage and
Formulation
(Ib a. i./A)
Potato (continued)
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
To1eranee. Urn*. L imi t at ions
CSLN3
1.7-3.3 Ib a. i./
1,000 Ib potatoes
(4 Ib/gal RTU)
Raspberry
Red Clover
made. On the floor, install an air duct
(12 inches by IS inches) running the
length or width of the potato pile. Leave
a false Mall space at both ends for air
circulation. At the end of each duct (in
the false wall space) where the fog is to
be introduced, place a squirrel cage fan
positioned to force air through the duct.
Block the exhaust end of the duct to force
air up through the piles of potatoes.
When potatoes are ready for treatment,
close off ventilating systems, start squir-
rel cage fan and introduce fog as near as
possible to the bottom of the false wall
space containing the fans. Keep the fans
operating until the fog has settled. Re-
activate the ventilation system 48 hours
after treatment.
SLN - Use limited to ID, ND, OR and WA.
Postharvest. Plant regulator (sprout inhi-
bitor). For treatment of potatoes in
forced air or refrigerated storage areas.
Use the lower dosage when storing potatoes
for 8 to 3 months at 45 F (7.2 C) to 50 F
(10.0 C) and the higher dosage when stor-
ing potatoes for 4 to & months at 50 F
(10.0 C). Do not retreat storage areas
until potatoes have been analyzed for resi-
dues. When residue levels decrease to 4
parts per million, retreat at a rate of
1.7 pounds active ingredient per 1,000
pounds of potatoes. A maximum of 3.3
pounds active ingredient per 1,OOO pounds
of potatoes may be applied within any &
month period.
See Blackberry cluster.
See Ladino Clover cluster.
Issuedi 10-15-86
1-018301-11
11.5
-------
EPA Compendium of Acceptable Uses
I30PROPYL N-(3-CHLOROPHENYL)CftREAMATE
/28076AA
Sit a. Dosage and
Formulation
(Ib a. i./A)
Saf flower
3-6
(4 Ib/gal EC)
/I5008AA
Southern Peas
/28023AA
4-6
(20* G)
Soybeans
2-3
(20* G)
(4 Ib/gal EC)
2-3
(4 Ib/gal EC)
2-3
(4 Ib/gal EC)
Tolerance. Use. Limitations
0.1 (I) ppm (safflower seed)
General Information; Irrigate following
application.
Preplant incorporate. Broadcast. Apply
in 35 to 50 gallons of water per acre with-
in 1 to 3 days of planting. Shallow incor-
porate 1 to 2 inches. Use 3 pounds active
ingredient per acre on sandy soils, 4
pounds active ingredient per acre on clay
soils, and 6 pounds active ingredient per
acre on peat soils.
0.3
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-<3-CHLOROPHENYL>CARBONATE
Site. Dosaoe and
Formulation
(Ib a. i. /A)
Soybeans (continued)
CMAI3
2-4
<5*, 10.3X G)
(1.33 Ib/gal EC)
CM ft 13
3-4
(a Ib/gal EC)
CMAI3
1. 3-a. S
(2 Ib/gal EC)
To1erance. Use. L i m i t at i ons
of the profluralin and trifluralin tank
mix application and within minutes after
the vernam tank mix application.
Preemergence. Broadcast or band. Apply
Mithin 48 hours of planting soybeans and
before weed emergence. In the black soil
areas of western IN, southern MS, northern
IA and IL the dosage should be reduced by
half. Do not soil incorporate.
Formulated with sodium N-1-naphthylphthala-
mate.
OR
Preemergence. Broadcast or band. Apply
in 30 to 40 gallons of water per acre with-
in 48 hours of planting soybeans and be-
fore weed emergence. Do not use on fine-
textured silt loam soils.
Formulated with sodium N-1-napthylphthala-
mic acid.
Preemergence. Broadcast or band. Apply
in 3O to 40 gallons of water per acre by
ground or S or more gallons of water per
acre by air within 48 hours of planting
soybeans and before weed emergence. Use
the lower dosage on light soils and the
higher dosage on black soils with extreme-
ly high organic matter.
Formulated with sodium N-1-naphthylphthala-
mate.
Preemergence. Broadcast. Apply in 20 to
40 gallons of water per acre.
Tank mix with alachlor.
Formulated with sodium N-1-naphthylphthala-
mate.
Issuedi 10-13-86
1-018301-13
117
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Dosaoj
ind
Formulation
(Ib a. i.
/13024AA
Tolerance. Use. Limitations
Spinach (fall seeded) 0.3 (I) ppm
30 day preharvest interval.
General Informations Not recommended for
use in CA. Do not apply when air tempera-
ture is above 75 F (23.9 C).
1-2
(4 Ib/gal EC)
CSLN:
2
(4 Ib/gal EC)
CSLN3
1-2
(4 Ib/gal EC)
/280200A Sugar Beet*
4
(4 Ib/gal EC)
CSLN3
3-4
(4 Ib/gal EC)
Issued! 10-13-86
Preemergence. Broadcast or band. Apply
in 4O gallons of water per acre after
planting. Use the lower dosage when air
temperature is below 60 F (15.5 C) and the
higher dosage when air temperatuVe is
above 60 F (15.5 C).
SLN - Use limited to AR and'OK.
Postemergence. Broadcast or band. For
control of bittercress, chickweed. henbit.
and sibara. Apply in 20 to 40 gallons of
water per acre, between November 1 and
February 15, when spinach plant has 6 to 8
leaves.
SLN - Use limited to MD and VA.
Postemergence. Broadcast or band. Apply
in 20 to 4O gallons of water per acre, be-
tween November 1 and February 1, when spin-
ach plant has 6 to 8 leaves. Use the low-
er dosage on coarse-textured soils and the
higher dosage on all other soil textures.
0.1 (I) (beets, sugar, roots)
0.3 (I) (beets, sugar, tops)
General Informationi Irrigate within 7
days of application. Use the lower dosage
on coarse-textured soils and the higher
dosage on fine—textured soils.
Use limited to Imperial Valley, CA. Post-
emergence. Broadcast or band. For con-
trol of grain (volunteer) and winter an-
nual grasses. Apply in 10 to 40 gallons
of water per acre when sugar beet plants
have 2 to 6-true leaves.
SLN - Use limited to Imperial Valley, CA.
Postemergence. Apply into the irrigation
water system during the entire irrigation
period when sugar beet plants have at
least 8-true leaves. Do not use runoff
water for domestic purposes or to irrigate
other crops.
I-O18301-14
118
-------
EPA Compendium of Acceptable U»»s
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Site. Dosage and
Formulation
(Ib a. i./A)
Suoar Beeta (continued)
CSLN:
4
(4 Ib/gal EC)
Tolerance. Use. Limitations
/S8O2OBA Sugar Beets (seed
crop)
CSLN:
3-4
(4 Ib/gal EC)
/11005AA Tomato
(4 Ib/gal EC)
CSLN3
4
(4 Ib/gal EC)
SLN - Use limited to CA.
Broadcast to winter fallow beds to be
spring planted with sugar beets. Apply in
20 to 40 gallons of water per acre by
ground or 10 gallons of water per acre by
air in late fall after bed-up. Do not
plant sugar beets within SO days of appli-
cation.
O.I (I) (beets, sugar, roots)
0.3 (I) (beets, sugar, tops)
Genera1 Informationi Use the higher dos-
age when heavier infestation or more ma-
ture weed growth is present. Do not apply
to fields saturated from recent rainfall
or to sugar beet plants under stress from
insect, disease, or other environmental
factors. Irrigate after application.
SLN - Use limited to OR.
Postemergence. Broadcast. For control of
ehickweed and winter annual weeds. Apply
in 10 or more gallons of water per acre
when sugar beet plants have 8 or more true
leaves.
0. 1 (I) ppm
General Information!
days of application.
Irrigate within 5
Postemergence. Directed spray to the base
•of tomato plants. Apply in 20 to 40 gal-
lons of water per acre when crop is well
established. Avoid wetting plant foliage.
SLN - Use limited to CA.
Broadcast to winter fallow beds to be
spring planted with tomatoes. Apply in 20
to 40 gallons of water per acre by ground
or 10 gallons of water per acre by air in
late fall after bed-up. Do not plant toma-
toes within 8O days of application.
Issuedi 10-13-86
I-0183Q1-15
119
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-< 3-CHLOROPHENYL)CARBAMATE
Tolerance. Use. Limitations
Site. Dosage and
Formulation
(Ib a. i. /A)
Tomato (continued)
(piug-pi anted tomatoes)
CSLN] SLN - Use limited to CO.
£-4 Prep1ant. Broadcast or band to tomatoes
(4 Ib/gal EC) seeded in plugs of an artificial growing
mix containing 60 ml to 120 ml of a SO:50
mixture of peat and vermiculite and at
least 5•percent volume activated charcoal.
Apply in 20 to 60 gallons of water per
acre to the bed tops prior to planting.
Trefoi1
White Clover
See Ladino Clover cluster.
See Ladino Clover cluster.
TERRESTRIAL NONFOOD CROP
/26006AA
(Agricultural Crops)
Tobacco. Flue-Cured
1.0-1.5
(1 Ib/gal EC)
N.F.
General Information: Do not apply if rain
is expected within 4 hours of application.
Do not use on tobacco grown for seed. Do
not tank mix with other sucker control
agents. Applications to immature plants
may result in leaf distortion on the upper
portion of the plant. Do not apply to se-
verely wilted, drought stricken, or water
logged tobacco. Apply in the mornings and
on cloudy days when tobacco is actively
growing and soil moisture is ample. Make
application following the use of one or
more contact agents (fatty alcohol) plus a
systemic agent (such as potassium salt of
maleic hydrazide) application. Do not ap-
ply in less than 40 gallons of water per
acre.
Postemergence. Broadcast. Plant regula-
tor (prevent sucker development). Apply
in 40 to 50 gallons of water per acre 5 to
7 days after the systemic agent is ap-
plied. This dosage applies to fields with
a plant population of 5,000 to 7,000.
Issued: 10-15-88
1-018301-16
120
-------
EPA Compendium of Acceptable Ui
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
To1eranee. Use. L im i t at ions
Site. Dosage and
Formulation
(Ib a. i./A)
(Ornamental Plants and Forest Trees)
/31013DA flqeratum
/31017DA Alvssum
/31034DA Benonia
/31065DA Chrysanthemum
/31071DA Coleus
/31087DA Dianthus
/31106DA Garden Balsam
/31108DA Geranium
/31137DA Marigold
/31149DA Pansies
/311S4DA Petunias
/31171DA Salvia
/31184DA Snapdragon
/31213DA Zinnia
4-6
(20* 6)
/3502IDA Arborvitae
/34022DA Azalea
/35O26DA Balsam Fir
/340250A Barberry
/3S028DA Birch
/34031DA Boxwood
/34036DA Camellia
/35O37DA Cedar
/3SO55DA Cherry (ornamental)
/34O45DA Cotoneaster
/3SOS60A Crabaoole (ornamen-
tal)
/35043DA Dogwood
/34255DA Enkianthus
/34053DA Euonvmum
/3505IDA Fir
/34062DA For«vthia
/31104DA Fuchmia
/34068DA Heather
/35068DA Hemlock
/34070DA Hollv
/34O72DA Honeysuckle
/34073DA Hydrangea
/35073DA Junioer
/34215DA Laurel
/34087DA Leucothoe
/34088DA Lioustrum
/34089DA Lilac
/35077DA Locust
/35O82DA Magnolia
Issuedi 10-15-86
Genera1 In format i oni Do not use over 4
pounds active ingredient per acre on alys-
sum, pansies, petunias or salvia. Use the
higher dosage on medium/fine-textured
soils.
Posttransplant
transplants.
Broadcast to established
General Informationi Do not apply to nurs-
ery stock that is to be transplanted with-
in 30 days of treatment. Use the higher
dosage on medium/fine-textured soils.
1-018301-17
121
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
/34090DA
/35083DO
/34094DA
/34111DA
/35096DA
/350600ft
/35101DA
/34555DA
/34120DA
/34130DA
/33116Dfi
/35119DA
/341370ft
/331300ft
/320010ft
/31O26AA
/31O87AA
/31402ftft
/31037AA
/31074«ft
/31072AA
/33l60ftft
/33030flft
/31101flft
/311290ft
/33044AA
/33041AA
/31151AA
/34226ftft
/31063AA
/310S4AA
/31382flfl
/31111ftft
Site. Dosage and
Formulation
(Ib a. i./A)
Tolerance. Use. Limitations
Arborvitae cluster (continued)
Mahonia
Maole
Mock-Orange
P i er i s
Pine
Plum < ornament a1)
Poplar
Rhododendron
Rose
Soirea
Spruce
Sycamore
Viburnum
Yew
4-8
<20X G)
(4 Ib/gal EC)
Aster
Ast i 1 be
Bluebell
Carnation
Coral Bells
Columbine
Creeping Juniper
English Ivv
Foroet-Me-Not
Larkspur
Mvrtle
Pachvsandra
Peonies
W i nt ercreeoer
4-6
(20* G)
Daffodils (bulbs)
Dahlias (bulbs)
Dutch Iris (bulbs)
Gladiolus (bulbs)
4-6
(20% G)
Issuedi 10-15-66
Dormant application to established trees
and shrubs. Broadcast or directed spray«
Apply in late fall through early spring be-
fore new plant growth starts. May be ap-
plied in 4O gallons of water per acre.
Genera1 Informat i on: Use the higher dos-
age on medium/fine—textured soils.
Dormant application to established plant-
ings. Broadcast. Apply in the spring be-
fore plant growth begins.
General Information! Use the higher dos-
age on medium/fine-textured soils.
At planting or prior to crop and weed emer-
gence. Broadcast.
1-016301-16
122
-------
/31093AA
/31126AA
/35O62AA
/31131AA
/31142AA
/31205Aft
Site. Dosage and
Formulation
(Ib a. i. /A)
Easter Lilies
EPA Compendium of Acceptab10 Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Tolerance. Use. Limitations
CSLN3
4
(1, 4 Ib/gal EC)
Iris
CSLN3
1
(4 Ib/gal EC)
Ginkao
CSLND
2 Ib «. 1. /100 gal-
lons of water
(4 Ib/gal EC)
Lilies (bulbs)
Narcissus (bulbs)
Tulios (bulbs)
4-6
(20X 8)
CSLN3
4
(4 Ib/gal EC)
General Information; Some yellowing may
occur and stem elongation will be retard-
ed.
SLN - Use limited to OR.
Postemergence. Broadcast. Plant regula-
tor (flower bud abscission). Apply in 300
gallons of water per acre, directly to
tops of lilies, when lily buds are one-
eighth to one-half inch long.
SLN - Use limited to Santa Cruz County,
CA.
Preemegence. Broadcast. For control of
mallow. Apply in 20 to 100 gallons of
water per acre after planting but no later
than 14 days before emergence of bulbs.
Genera1 Informati oni Do not apply when
temperatures are above 60 F (26.& C).
SLN - Use limited to DC.
Postemergence. Plant regulator (fruit in-
hibitor). Apply within 3 weeks following
pollenation (third week in April). Spray
with a mist blower to the near dripping
point.
General Informationi Use the higher dos-
age on medium/fine-textured soils.
At planting or prior to crop and weed emer-
gence. Broadcast.
SLN - Use limited to WA.
Preemergence. Broadcast. For control of
winter annual weeds. Apply in 30 to 60
gallons of water per acre after planting
and final hilling but no later .than 2
weeks before bulb emergence. Apply in
late September through October when soil
surface is moist but before soil becomes
water-logged.
Issued! 10-15-86
1-018301-19
123
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Sit(
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Dosaoe and Tolerance. Use. Limitations
Formulation
(Ib a. i. /A)
Li 1ies (bulbs) cluster (continued)
CSLN3
2
(4 Ib/gal EC)
Tank mix with dinoseb, triethanolamine
salt or dinoseb, alkanolamine salts or
dinoseb, diethanolamine salt.
SLN - Use limited to WA.
Postemergence. Broadcast. For control of
summer annual weeds. Apply in 30 to 60
gallons of water per acre in the early
spring before weed seed germination. Do
not apply later than April 15.
/32001DA
Ornamental Woody
Plants
Refer to Arborvitae cluster for dose and
use information.
9001500
AAAAAAA
AERIAL AND TANK MIX APPLICATIONS
Aerial Application
— Refer to
9900300
AAAAAAA
Tank Mix
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa, Alfalfa (seed crop), Soybean,
Sugar Beets, Tomato
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa, Alfalfa (seed crop), Soybean
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
Lilies (bulbs). Narcissus (bulbs), Tulip
(bulbs)
Issuedi 10-15-66
1-018301-20
124
-------
EPA Compendium of Acceptable Uses
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Listing of Registered Pesticide Products by Formulation
4O98.OOO1 98* technical chemical
isopropyl N-<3-chlorophenyl)carbamate (018301)
002743-00102 002749-00117
&005.0004 5X granular
isopropyl N- (3-chloropheriy 1) carbamate <018301) plus sodium N-l-
napthylphthalamic acid (030703)
000400-00065
4010.3004 10.3% granular
isopropyl N-(3-chlorophenyl)carbamate (018301) plus sodium N-l-
napthylphthalamic acid (030703)
000400-00087
4020.0004 20* granular
isopropyl N-(3-chlorophenyl)carbamate (018301)
000748-00163
(000748-00163) COS10064 UTS10030 ,
4211.90:12 11.9% (1 Ib/gal) emulsifiable concentrate
isopropyl N-(3-chlorophenyl)carbamate (018301)
OOO748-OO233
(OOO748-OO233) OR850001
4215. 001L2 1SX (1.33 Ib/gal) emulsifiable concentrate
isopropyl N-(3-chlorophenyl)carbamate (018301) plus sodium N-l-
napthylphthalamic acid (030703)
000400-00071
4222.2012 £2.2* (2 Ib/gal) emulsifiable concentrate
isopropyl N—(3-chlorophenyl)carbamate (0183O1)
0004OO-00083
4225.0012 S3* emulaifiable concentrate
isopropyl N-<3-chlorophenyl)carbamate (018301)
OO279a-OOO4O
4236.0012 36X (3 jEk/nal) emulsifiable concentrate
isopropyl N—(3-chlorophenyl)carbamate (0183O1)
OOO748-O0188 002749-00070
4247.0012 47» (4 Ib/oal) emulsifiable concentrate
isopropyl N-(3-chlorophenyl)carbamate (01S3O1)
000748-00161
(000748-00161) RR780025 AZ800O30 C«780103 C078O197
CA790007 CA790054 CA860046 DC800001
KY780006 MD780017 OK780O24 OR840042
OR850001 VA780027 WA79OO12
Issuedi 10-13-86 X-O18301-21
125
-------
EPA Compendium of Acceptable
ISOPROPYL N-(3-CHLOROPHENYL)CARBAMATE
Listing of Registered Pesticide Product* by Formulation (continued)
4246.0016 4S* (4 Ib/oal) liquid-ready to use
isopropyl N—(3-chlorophenyl)carbamate (018301)
OOO748-00178
(000748-00178)
IDS10005 ND810023 OR810020 WAS00086
4246.5016 46.5* (4 Ib/nal) liquid-ready to use
isopropyl N- (3-chlorophenyl) carbarnate (018301)
002749-00264
(002749-00264)
ND820O21 OR850047 WA82O065
4249.6516 49.65% (4.3 Ib/oal) liquid-ready to uaa
isopropyl N-(3-chloroph«nyl)carbamat« (O18301)
002792-00041
«278.4116 78.4* (7 Ib/oal) liquid-ready to use
isopropyl N-(3-chlorophenyl)carbamate (0183O1)
ND850009
4278.5016 7S.5% (7 Ib/oal) liquid-ready to use
isopropyl N-(3-chlorophenyl)carbamate (0183O1)
000748-00234
(000748-00234)
XD830OO3 OR83OOO1
9999999 State Label Registrations
OO0748-1OS6O
CO Reg. No.
OO0748-06OO8
ID Reg. No.
000748-06007
NJ Reg. No.
OOO4OO-O6436
NY Reg. No.
038695-10438
OR Reg. No.
000748-060O9
TX Reg. No.
000478-06005
WO Reg. No.
000748-06006
038655-10447
Issuedi 10-15-66
1-018301-22
126
-------
EPA Compendium of Acceptable Use*
ISOPROPYL N-<3-CHLOROPHENYL>CARBAMATE
Listing of Registered Pesticide Products by Formulation (continued)
WI Reg?* No.
000400-06300
Issuedi 10-15-86 I-018301-23
127
-------
EPA Compendium or Acceptable U*e*
ISOPROPYL N-<3-CHLOROPHENYL>CARBAMATE.
Appendix 0-1
-,«Nr.
Listing^jfcf Active Ingredient (a) Found in Combination with the
Report Chemical
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
030703 sodium N-1-naphthylphthalamate —
— Use Common Name
Z ssuedi 10-15-86 I-018301-24
128
-------
EPA Compendium of Acceptable Ui
I80PROPYL N-<3-CHLOROPHENYL>CftRBAItftTE
Appendix A-2
Listing- of Active Ingredient Which May Be Included in Tank Mixes
Chemical
Code
090501
056801
037511
037514
037506
106601
041404
036101
Common Name
(source)
alachlor
carbaryl
dinoseb, alkanolamine salt
dinoseb, diethanolamine salt
dinoseb, triethanolamine salt
profluralin
vernam
trifiuralin
EPA Acceptable
Common/Chemical Name
dinoseb, alkanol-
amine salts of the
ethanol and iso—
propanol series
8-propyl dipropyl-
t h iocarbamate
— Use Common Name
Issuedi 10-15-66
I-O18301-25
129
-------
BIBGUIDE-1-
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
cicacions of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the. Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also Co be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
130
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BIBGUIDE-2
a. Author. Whenever the Agency could confidencly identify
one, che Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include'
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
131
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00018842 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-
7501. (Unpublished study received May 8, 1971 under 1F1174;
prepared by Univ. of Call form'a--R1verside, Dept. of Entomology,
submitted by Ciba Agrochenical Co., Summit, N.J.; CDL:090973-B)
00030995 Lane, J.R. (1974) Residue Summary. (Unpublished study received Mar
20, 1974 under 400-85; prepared in cooperation with State Univ.
of New York--0swego, Lake Ontario Environmental Laboratory,
submitted by Un1 royal Chemical, Bethany, Conn.; CDL:023356-8)
00035475 Dahmer, L. (1973) Liquid Scintillation Analysis of Bligh-Byer and
Soxhlet Fractions from Extractions of 14C-CIPC-Treated Soybean
Plants and Seeds Grown at Fargo, North Dakota, Spring/Summer,
1972: Research Report No. BR-18625. Method dated Jun 12, 1973.
(Unpublished study received on unknown date under 4F1429; sub-
. mitted by PPG Industries, Inc., Barberton, Ohio; CDL:093808-F).
00035480 Ecke, G.G.; Ferguson, C.E.; Mitten, M.E.; et al. (1973) Agricul-
tural Chemicals: CCLXXXVII: Qualitative Investigation of CIPC
Metabolites in Soybean Shoots: Research Report No. BR-18605.
(Unpublished study received on unknown date under 4F1429; sub-
mitted by PPG Industries, Inc., Barberton, Ohio; CDL:093808-K)
00035485 Gard, L.N.; Oahmer, L.; Wledmann, J.L.; et al. (1973) Analysis of
14C-CIPC Treated Soybean Plants for 2- and 4-Hydroxy CIPC: First
and Second Scheduled Samples Grown at Fargo, North Dakota
(1972): Research Report No. 8TS-18580. Methods dated May 18,
1973. (Unpublished study received on unknown date under 4F1429;
submitted by PPG Industries, Inc., Barberton, Ohio; COL:
093808-P)
00035488 Krochta, W.G. (1973) A Review of the Studies To Account for the
Distribution of Radioactive Carbon in Natural Products from
Soybeans Grown In 14C-CIPC Treated Soils: Research Report
No. BR-18649. (Unpublished study received on unknown date under
4F1429; submitted by PPG Industries, Inc., Barberton, Ohio;
0)1:093808-5)
00035489 Mitten, M.E.; Wledman, J.L. (1973) An Investigation of the Nature
and Distribution of Radioactivity in Soybean 011 Obtained from
Soybeans Grown 1n Soil Treated with 14C Ring Labeled Isopropyl-
N-(3-ch1oropheny1)carbamate at Fargo, North Dakota, 1972: Re-
search Report No. BR-18591. Method dated May 29, 1973. (Unpub-
lished study received on unknown date under 4F1429; submitted by
PPG Industries, Inc., Barberton, Ohio; CDL:093808-T)
132
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00035490 Parker, J.R. (1973) The Presence of 14C in Ami no Acids from Fargo
Soybean Seeds: Anrino Acid Group Separation Using a Dowex 50W-X8
Strong Acid Ion Exchange Column: Research Report No. BR-18600.
(Unpublished study received on unknown date under 4F1429; sub-
mitted by PPG Industries, Inc., Barberton, Ohio; CDL:093808-U)
00035496 Strang, R.H. (1973) Agricultural Chemicals: CCLVII: Procedure for
the Growing, Sampling, and Shipping of Soybean Plants Grown in
14C-CIPC at Boyce Thompson for CIPC Plant Metabolite Analysis:
Research Report No. BAR-18470. (Unpublished study received on
unknown date under 4F1429; submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:093808-AA)
00035497 Strang, R.H.; Kish, D. (1973) Agricultural Chemicals: CCLII: Pro-
cedures Used for the Growing of Turnips, Soybeans and Orchard-
grass in the Presence of 14C-CIPC at Barberton: Research Report
No. BR-18455. (Unpublished study Including letter dated Jan
25, 1973 from R.H. Strang to D.C. Torgeson, received on unknown
date under 4F1429; submitted by PPG Industries, Inc., Barberton,
Ohio; CDL:093808-AB)
00035498 Strang, R.H.; K1sh, D. (1973) Agricultural Chemicals: CCLXXXYIII:
Procedure for the Growing of Soybean Plants Hydroponlcally 1n
the Presence of 14C-CIPC: Research Report No. BAR-18606. (Un-
published study received on unknown date under 4F1429; submit-
ted by PPG Industries, Inc., Barberton, Ohio; CDL:093808-AC)
00035505 Wiedmann, J.L. (1973) The Presence of 14C in Anrino Adds from Fargo
Soybean Seeds: Separation of Glutanrfc and Aspartic adds from
Other Anrino acids: Research Report No. BR-18634. Method dated
Jun 15, 1973. (Unpublished study received on unknown date
under 4F1429; submitted by PPG Industries, Inc., Barberton,
Ohio; CDL:093808-AJ)
00035896 Wiedrann, J.L.; Pensyl, J. (1975) Proposed Regulatory Method for
CIPC Residue (CIPC + Metabolite III): BR 19718. Method dated
May 2, 1975. (Unpublished study received May 8, 1975 under
4F1429; submitted by PPG Industries, Inc., Barberton, Ohio; CDL:
093811-0)
00035995 Smith, K.S. (1976) Report: Catfish Tissue Residue Levels following
Exposure to 14C-CIPC: Laboratory No. 5E-8033. (Unpublished
study received Sep 21, 1976 under 748-161; prepared by Cannon
Laboratories, Inc., submitted by PPG Industries, Inc., Barber-
ton, Ohio; COL:095292-C)
133
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00035997 Ecke, G.G. (1976) Qualitative Investigation of CIPC Metabolites in
81ueg11l Sunflsh: Final Report: BR 20315A. (Unpublished study
received Sep 21, 1976 under 748-161; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; CDL:095292-E)
\
00035998 Smith, K.S. (1976) Report: Bluegill Sunfish Tissue Residue Levels
following Exposure to 14C-CIPC: Laboratory No. 6E-1100A. (Un-
published study received Sep 21, 1976 under 748-161; prepared by
Cannon Laboratories, Inc., submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:095292-F)
00036377 Dahmer, L.; Coffman, D.; Wledmann, J.; et al. (1973) Liquid Scin-
tillation Analysis of 14C-CIPC-Treated Soybean Plants and Seeds
Grown at Fargo, North Dakota, Spring/Summer, 1972: Research Re-
port No. BR-18288. Method dated Dec 29, 1972. (Unpublished
study Including research report no. BAR-18127, received on un-
known date under 2F1276; submitted by PPG Industries, Inc., Bar-
berton, Ohio; CDL:092174-D)
00036382 Ferguson, C.E.; Gard, L. (1971) Analysis of Soybean Plant Samples
for CIPC Residue: Sample Grown in Soil Treated with Tank Mix-
tures of CIPC and Treflan at 7 Locations In Iowa: 1971 Crop: Re-
search Report No. BTS-17390. (Unpublished study received on Oct
12, 1972 under 2F1276; submitted by PPG Industries, Inc., Bar-
berton, Ohio; CDL:092i74-I)
00036385 Ferguson, C.E.; Gard, L. (1972) Re-confirmation of the Analytical
Method for Determining CIPC Residues In Soybean Plants: Minor
Editorial Revision and Up-dating of the Colorlmetrlc Analytical
Procedure: Research Report No. BTS-17989. Includes method dated
Jul 24, 1972. (Unpublished study received Oct 12, 1972 under
2F1276; submitted by PPG Industries, Inc., Barberton, Ohio;
COL:092174-L)
00036390 Gard, L.; Holmes, S.; Ferguson, C.E. (1972) Analysis of Ladlno Clo-
ver (Seed Crop) for CIPC Residues: Research Report No. BTS-
18082. (Unpublished study received Oct 12, 1972 under 2F1276;
submitted by PPG Industries, Inc., Barberton, Ohio; COL:
092174-Q)
00036392 Gard, L.; Holmes, A.S.; Ferguson, C.E. (1972) Analytical Results
from Dissipation of CIPC Applied as Granular Formulations of
Furloe on Ladlno Clover: Research Report No. BTS-18169. (Unpub-
lished study received on unknown date under 2F1216; submitted by
PPG Industries, Inc., Barberton, Ohio; CDL:092174-S)
134
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00036394 Hardies, D.E. (1973) Agricultural Chemicals. CCXXXIII. Procedure
for Growing, Sampling and Shipping of Turnips Grown 1n the Pre-
sence of 14C CIPC. A Protocol submitted to Boyce Thompson for
CIPC Metabolite Study: Research Report No. BAR-18316. (Unpub-
lished study received on unknown date under 2F1276; submitted by
PPG Industries, Inc., Barberton, Ohio; CDL:092174-U)
00036395 Hardies, O.E. (1973) Agricultural Chemicals. CCXXIV. Procedure for
Growing, Sampling and Shipping of Orchardgrass Grown in the
Presence of 14C CIPC. A Protocol Submitted to Boyce Thompson for
CIPC Metabolite Study: Research Report No. BAR-18317. ' (Unpub-
lished study received on unknown date under 2F1276; submitted by
PPG Industries, Inc., Barberton, Ohio; CDL:092174-V)
00036626 Pensyl, J. (1973) A Gas Chromatographic Method for the Determina-
tion of l-Hydroxy-2-propyl-3'-chlorocarbanilate in Soybean
Plants and Seeds: Research Report No. BR-18717. Method dated'
Jul 27, 1973. (Unpublished study received Jan 4, 1974 under
2F1276; submitted by PPG Industries, Inc., Barberton, Ohio; CDL:
092175-V)
00036628 Still, G.G.; Mansager, E.R. (1973) Soybean shoot metabolism of Iso-
propyl-3-chlorocarbanilate: Ortho and para aryl hydroxylation.
Pesticide Biochemistry and Physiology 3(l):87-95. (Also 1n un-
published submission received Jan 4, 1974 under 2F1276; submit-
ted by PPG Industries, Inc., Barberton, Ohio; COL:092175-Y)
00036629 Still, G.G.; Mansager, E.R. (1973) Metabolism of Isopropyl-3-
chlorocarbanllate by cucumber plants. Journal of Agricultural
and Food Chemistry 21(5):787-791. (Also 1n unpublished submis-
sion received Jan 4, 1974 under 2F1276; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; CDL:092175-Z)
00036630 Strang, R.H. (1973) Agricultural Chemicals. CCLXXII. Report on the
Growing, Sampling and Shipping of Turnips and Orchardgrass Grown
In 14C-CIPC Treated Soil at Boyce Thompson for CIPC Metabolite
Study: Research Report No. BAR-18528. (Unpublished study re-
ceived Jan 4, 1974 under 2F1276; submitted by PPG Industries,
Inc, Barberton, Ohio; COL:092175-AA)
00036632 Strang, R.H.; Xish, 0. (1973) Agricultural Chemicals; CCCXXXIX;
Procedure for the Growing of Turnip and Orchardgrass Plants Hy-
droponlcally 1n the Presence of 14C-CIPC: Research Report
BAR-18936. (Unpublished study received Jan 4, 1974 under
2F1276; submitted by PPG Industries, Inc.; Barberton, Ohio; COL:
092175-AC)
135
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OFFICE OF PESTICIDE PROGRAMS
. REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00036635 Wledmann, J.L. (1973) Thin Layer Chromatograph-Autoradlogram Evalu-
ation of the Polar Phase Soluble Metabolites of 14C-CIPC Treated
Soybean Hay and Seeds Grown at Fargo, North Dakota in 1972: Re-
search Report No. BR-18880. Method dated Oct 26, 1973. (Unpub-
lished study received Jan 4, 1974 under 2F1276; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:092175-AF)
00036636 Wiedmann, J.L.; Mitten, M.E.; Pensyl, J.W. (1973) Tentative Regula-
tory Methods for Separating and Determining CIPC and Its Metabo-
lites in Turnip Roots: Research Report No. BR-18920. Methods
dated Nov 12, 1973. (Unpublished study received Jan 4,' 1974 un-
der 2F1276; submitted by PPG Industries, Inc., Barberton, Ohio;
CDL:092175-AH)
00036637 Wledmann, J.L.; Mitten, M.E.; Pensyl, J.W. (1973) Tentative Regula-
tory Methods for Separating and Determining CIPC and Its Metabo-
lites in Turnip Tops: Research Report No. BR-18931. Methods
dated Nov 29, 1973. (Unpublished study received Jan 4, 1974 un-
der 2F1276; submitted by PPG Industries, Inc., Barberton, Ohio;
CDL:092175-AI)
00036638 Wledmann, J.L.; Mitten, M.E.; Pensyl, J.W. (1973) Preliminary De-
termination of CIPC and Metabolites I, II, III, and IV in Turnip
Roots Grown In the Presence of 14C-CIPC at Boyce-Thompson in
1973: Research Report No. BR-18942. (Unpublished study received
Jan 4, 1974 under 2F1276; submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:092175-AJ)
00036639 Wledmann, J.L.; Mitten, M.E.; Pensyl, J.W. (1973) Preliminary De-
termination of CIPC and Metabolites I, II, III, and IV 1n Turnip
Tops Grown In 14C-CIPC Treated Soil at Boyce-Thompson during
1973: Research Report No. BR-18943. (Unpublished study received
Jan 4, 1974 under 2F1276; submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:092175-AX)
00036640 WledMnn, J.L.; Mitten, M.E.; Pensyl, J.W. (1973) Preliminary De-
termination of CIPC and Metabolites I, II, III, and IV 1n Or-
chard Grass Grown in 14C-CIPC Treated Soil at Boyce-Thompson
during 1973: Research Report No. BR-18957. (Unpublished study
received Jan 4, 1974 under 2F1276; submitted by PPG Industries,
Inc., Barberton, Ohio; CDL:092175-AL)
136
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00036641 Wiedmann, J.L.; Mitten, M.E.; Pensyl, J.W. (1973) Tentative Regula-
tory Methods for Separating and Determining CIPC and Its Metabo-
lites In Orchard Grass: Research Report No. BR-18946. Methods
dated Dec 7, 1973. (Unpublished study received Jan 4, 1974 un-
der 2F1276; submitted by PPG Industries, Inc., Barberton, Ohio;
CDL:092175-AM)
00036642 Wiedmann, J.L.; Mitten, M.E.; Pensyl, J.; et al. (1973) Analysis of
1973 Crop Soybean Plant Samples for CIPC, 2-Hydroxy-5-ch1oroiso-
propyl carbanllate, 4-Hydroxy-3-chloro1sopropyl carbanllate, and
l-Hydroxy-2-1sopropy1-3'-chlorocarbanilate: BTS 18967.- (Unpub-
lished study received Jan 4, 1974 under 2F1276; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:092175-AN)
00036644 Wiedmann, J.L.; Krochta, W.G. (1973) Determination of CIPC and Its
Metabolites In Soybeans at Fargo, North Dakota during 1972: Re-
search Report No. BR-18756. (Unpublished study received Jan 4~,
1974 under 2F1276; submitted by PPG Industries, Inc., Barberton,
Ohio; CDL:092175-AG)
00037029 Ware, G.W.; Brake!, W.J. (1963) Excretion of 3-Cl-aniHne and I-
sopropy1-N-(3-Ch1oropheny1) carbamate (CIPC) 1n the milk and u-
rine of dairy cows fed CIPC. Journal of Dairy Science XLYK2):
120-123. (Also 1n unpublished submission received on unknown
date under 4F1429; submitted by Pittsburgh Plate Glass Co.,
Morristown, N.J.; CDl:093807-P)
00037031 Gard, L.; Ferguson, C.E. (1972) A Stability Evaluation of CIPC
Residue in Treated Soybean Plants and Ladino Clover Resulting
from Periods of Frozen Storage: Research Report No. BTS-18024.
(Unpublished study received on unknown date under 4F1429; sub-
mitted by Pittsburgh Plate Glass Co., Morris ton, N.J.; COL:
093807-R)
00037032 Gard, L.; Hledwnn, J.; Mitten, M.E.; et al. (1973) Tentative
Regulatory Analytical Methods for Separating and Determining
CIPC and Major Metabolites in Soybean Plants and Soybean Seeds:
Research Report No. BR-18S99. Methods dated Jun 4, 1973.
(Unpublished study received on unknown date under 4F1429;
submitted by Pittsburgh Plate Glass Co., Morristown, N.J.; COL:
093807-S)
137
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00037033 Pensyl, J.; Mitten, M.E.; Wiedmann, J.; et al. (1973) A Gas Chro-
matographlc Method for the Determination of l-Hydroxy-2-propyl
3'-chlorocarbanilate (III) and Isopropyl 3-chloro-2-hydroxy-
carbanilate (IV) in Soybean Plants and Seeds: Research Report
No. BR-18657. Method dated Jun 29, 1973. (Unpublished study
received on unknown date under 4F1429; submitted by Pittsburgh
Plate Glass Co., Morristown, N.J.; CDL:093807-T)
00037034 Pittsburgh Plate Glass Company (19??) Determination of CIPC Residue
1n Soybean Seeds: Hydroly sis/01stillatlon/Extractlon Colori-
metric Method: Research Report No. BTS 17689. (Unpublished
study received on unknown date under 4F1429; CDL:0938d7-U)
00037035 Wiedmann, J.L. (1973) Analysis of Soybean Shoot Dissipation Study
Samples for CIPC Residue and Metabolites (Isopropyl 5-chloro-2-
hydroxycarbanllate, Isopropyl 3-chloro-4-hydroxycarbanilate,
l-hydroxy-2-propyl,3'-chlorocarban11ate): Research Report
No. BTS-18626. (Unpublished study received on unknown date
under 4F1429; submitted by Pittsburgh Plate Glass Co., Morris-
town, N.J.; CDL:093807-V)
00037037 Pittsburgh Plate Glass Company (19??) Analytical Method: Determi-
nation of CIPC Residue 1n Soybean Plants: (Hydrolysis/01 stilla-
tlon/Extraction Colorimetrlc Procedure): Research Report
No. BTS-16803. Undated method. (Excerpt; unpublished study re-
ceived on unknown date under 4F1429; CDU093807-Y)
00037038 Wiedmann, J.L. (1973) Analysis of Soybean Seed Samples for CIPC
Residue and Metabolites (2-OH-CIPC, 4-OH-CIPC, l-OH-2-propyl
3'chlorocarban1late: Research Report No. BTS-18613. (Unpub-
lished study received on unknown date under 4F1429; submitted by
Pittsburgh Plate Glass Co., Morristown, N.J.; COL:093807-Z)
00037042 Ferguson, C.E.; Holmes, A.S.; Gard, L. (1973) Analysis of Soybean
Seed Samples for CIPC Residue by the Colorimetrlc Method:
Research Report No. BR-18466. (Unpublished study received on
unknown date under 4F1429; submitted by Pittsburgh Plate Glass
Co., Morristown, N.J.; CDL:093807-AD)
00037043 Ferguson, C.E.; Holmes," A.S.; Gard, L. (1973) Analysis of Soybean
Seed Samples for CIPC Residue by the Colorimetrlc Method:
Research Report No. BR-18467. (Unpublished study received on
unknown date under 4F1429; submitted by Pittsburgh Plate Glass
Co., Morristown,.N.J.; CDL:093807-AE)
138
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00037045 Weidmann, J.L.; Mitten, M.E.; Pensyl, J.; et al. (1973) CIPC
Residue and Metabolite Assay of Two Soybean Seed Samples and of
the Seed Fractions Separated from These Samples at the Oilseed
Crops Laboratory, Peorla, 111.: Research Report No. BR-18708.
(Unpublished study received on unknown date under 4F1429; sub-
mitted by Pittsburgh Plate Glass Co., Morristown, N.J.; CDL:
098307-AH)
00037046 Mitten, M.E. (1973) A Gas Chromatographic Method for the Deter-
mination of CIPC 1n Soybean Seeds: Research Report No. BR-18747.
(Unpublished study received on unknown date under 4F1429; sub-
mitted by Pittsburgh Plate Glass Co., Morristown, N.J.; CDL:
093807-AI)
00037285 Wledmann, J.L.; Mattle, O.M.; Chandler, C.M.; et al. (1976) CIPC
and PPG-124 Residues in Yuchi Arrow!eaf Clover, 1976 Crop: BTS
20352. (Unpublished study received Sep 21, 1976 under 748-161;
submitted by PPG Industries, Inc., Barberton, Ohio; CDL:
095292-AG)
00037860 Ecke, G.G. (1973) Agricultural Chemicals. CCXL and CCCL: CIPC
Metabolites in Turnips: Research Report No. BR-18407. (Unpub-
lished study received Jan 4, 1974 under 2F1276; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:092175-M)
00037861 Ecke, G.G. (1973) Synthesis of glucosides of Isopropyl 3-chlorocar-
banllate metabolites. Journal of Agricultural and Food Chemis-
try 21(5):792-794. (Also in unpublished submission received Jan
4, 1974 under 2F1276; submitted by PPG Industries, Inc., Barber-
ton, Ohio; COL:092175-N)
00037863 Ferguson, C.E.; Holmes, A.S.; Gard, L. (1973) Analytical Method and
Analysis of 14C Labeled CIPC Treated Turnip Plants and Roots for
Unaltered CIPC Residue: Research Report No. BTS-18390. Method
dated Feb 12, 1973. (Unpublished study received Jan 4, 1974 un-
der 2F1 2 76; submitted by PPG Industries, Inc., Barberton, Ohio;
CDL:092175-P)
00037866 Gard, L.; Holmes, S. (1973) Analysis of 14C-CIPC (Ring-Labeled)
Treated Turnip Tops and Roots for Unaltered CIPC Residue by the
Colorimetric Method: Research Report No. BTS-18523. (Unpub-
lished study received Jan 4, 1974 under 2F1276; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:092175-S)
139
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloroprophara Standard
MRID CITATION
00037881 Jensen, D.J.; Miller, P.W. (1973) Studies To Determine Possible
Bound Residues of 6-Chloropicolinic acid (6-CPA) in Wheat: GH-C
655. (Unpublished study received Jun 6, 1973 under 2F1265; sub-
mitted by Dow Chemical U.S.A., Midland, Mich.; CDL:092164-P)
00039946 Ercegovich, C.D.; Witkonton, S. (1972) An improved method for the
analysis of residues of Isopropyl N-(3-chlorophenyl)carbamate
(Chlorpropham) in alfalfa. Journal of Agricultural an4 Food
Chemistry 20(2):344-347. (Also in unpublished submission re-
ceived Feb 24, 1977 under 748-161; submitted by PPG Industries,
Inc., Barberton, Ohio; CDL:096029-B)
00045294 PPG Industries, Incorporated (1969) General Analytical Method for
Determining CIPC Residues in Crops Designated in the Summary .
Table as Being Analyzed by MF (Ext.). (Unpublished study re-
ceived Dec 31, 1970 under 1F1119; CDL:093430-D)
00045295 PPG Industries, Incorporated (1968) General Analytical Method for
- Determining CIPC Residues in Crops Designated in the Summary
Table as Being Analyzed by the MF (TCH-Dist) Method. (Unpub-
lished study received Dec 31, 1970 under 1F1119; CDL.-093430-E)
00051807 Ferguson, C.E. (1967) Analysis of Harvested Blackberries for Resi-
dues of the Herbicide CIPC: Research Report No. BTS-14867. (Un-
published study received on unknown date under 1F1119; submitted
by PPG Industries, Inc., Barberton, Ohio; CDL:090890-B)
00051812 Ferguson, C.E. (1968) Analysis of Dried Southern Peas for Residues
of CIPC: Research Report No. BTS-15245. (Unpublished study re-
ceived on unknown date under 1F1119; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; CDL.-090890-C)
00051814 Ferguson, C.E. (1968) Analysis of Soybeans for Residues of CIPC:
Research Report No. BTS-15132. (Unpublished study received on
unknown date under 1F1119; submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL.-090890-I)
140
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00051815 Mitten, M.E.; Paul 1 In, J. (1970) Analysis of Treated Soybean Sam-
ples from the University of Minnesota for CIPC Residue: Research
Report No. BTS-16278. (Unpublished study received on unknown
date under 1F1119; submitted by PPG Industries, Inc., Barberton,
Ohio; CDL:090890-J)
00051817 Ferguson, C.E.; Mitten, M.E. (1970) Analysis of Treated Soybean
Samples from the University of Arkansas for CIPC Residue: Re-
search Report No. BTS-16280. (Unpublished study received on un-
known date under 1F1119; submitted by PPG Industries, Inc., Bar-
berton, Ohio; CDL:090890-M)
00051822 Ferguson, C.E.; Gard, L. (1970) Analysis of Lima Beans for CIPC
Residue: Samples Grown in California: Research Report No. BTS-
16488. (Unpublished study received on unknown date under
1F1119; submitted by PPG Industries, Inc., Barberton, Ohio; COL:
090890-U)
00051824 Ferguson, C.E.; Holmes, A.S.; Gard, L. (1970) Analysis of Sugar
Beet Tops and Roots for CIPC Residue, and Roots Only for I PC
Residue: Samples Grown 1n California: Research Report No. BTS-
16633. (Unpublished study received on unknown date under
1F1119; submitted by PPG Industries, Inc., Barberton, Ohio; CDL:
090890-W)
00051834 Ferguson, C.E.; Gard, L. (1970) Analysis of Garlic Bulbs for CIPC
Residue: Research Report No. BTS-16432. (Unpublished study in-
cluding letter dated Oct 21, 1970 from H. Agamalian to Warren
H. Zlck, received on unknown date under 1F1119; submitted by
PPG Industries, Inc., Barberton, Ohio; COL:090890-AG)
00051838 Ferguson, C.E.; Holmes, A.S. (1969) Analysis of Tomatoes for CIPC
Residues: Research Report No. BTS-16198. (Unpublished study
received on unknown date under 1F1119; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; CD L: 090890- AK)
00051845 Ferguson, C.E.; Miller, 0.; Gard, L. (1970) Analysis of Red Clover
Samples for CIPC Residue: Research Report No. BTS-16666. (Un-
published study received on unknown date under 1F1119; submit-
ted by PPG Industries, Inc., Barberton, Ohio; COL:090890-AS)
141
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00051851 Ferguson, C.E.; Miller, D.; Card, I.; et al. (1970) Analysis of
Alfalfa Samples for CIPC Residue: Research Report No. BTS-16657.
(Unpublished study received on unknown date under 1F1119; pre-
pared 1n cooperation with Univ. of California--Davis, Botany
Dept. and Baker Brothers, submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:090890-AY)
00051852 Wlnterlin, W.; Archer, T.E. (1969) Determination of CIPC Residue
in Alfalfa (HydroIysis/D1stillat1on/Extraction Colorimetrlc
Method. (Unpublished study including ag. tox. nos. 651 and 376,
received on unknown date under 1F1119; prepared in cooperation
with Univ. of Cal1fornia--Davis, submitted by PPG Industries,
Inc., Barberton, Ohio; CDL:090890-AZ)
00051853 Ferguson, C.E.; Gard, I. (1970) Analysis of Alfalfa Samples for
CIPC Residue: Research Report No. BTS-16804. (Unpublished study
received on unknown date under 1F1119; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; CDL:090890-BA)
00051854 Ferguson, C.E.; Miller, D.; Gard, L. (1970) Analysis of Alfalfa
Samples for CIPC Residue: Research Report No. BTS-16664. (Un-
published study received on unknown date under 1F1119; submit-
ted by PPG Industries, Inc., Barberton, Ohio; CDL:090890-BB)
00051855 Ferguson, C.E.; Miller, D.; Gard, L. (1970) Analysis of Alfalfa
Samples for CIPC Residue: Research Report No. BTS-16665. (Un-
published study received on unknown date under 1F1119; submit-
ted by PPG Industries, Inc., Barberton, Ohio; CDL:090890-BC)
00051856 Ferguson, C.E.; Miller, D.; Gard, L. (1970) Analytical Method and
Results for CIPC Dissipation from Grasses (Tall Fescue and Or-
chard Grass): Barberton Report No. BTS-16776. (Unpublished
study received on. unknown date under 1F1119; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:090890-BD)
00051861 Ferguson, C.E. (1968) Analysis of Treated Cranberries for Residues
of CIPC: Research Report No. BTS-15107. (Unpublished study
received on unknown date under 1F1119; submitted by PPG Indus-
tries, Inc., Barberton, Ohio; COL:090890-BI)
00054669 Ware, G.H.; Brakel, H.J. (1963) Excretion of 3-Cl-an1l1ne and Iso-
propyl-N-(3-chlorophenyl) carbamate (CIPC) In the milk and urine
of dairy cows fed CIPC. Journal of Dairy Science 46:120-123.
(Also in unpublished submission received Aug 26, 1977 under
4581-EX-30; submitted by Pennwal t Corp., Philadelphia, Pa.; GDI:
231831-1)
142
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00054672 Dave, B. (1977) Residue Data of CIPC on Potatoes. (Unpublished
study received Aug 26, 1977 under 4581-EX-30; submitted by Penn-
waltCorp., Philadelphia, Pa.; CDL:231831-T)
00058143 Norrls, J.M.; L1tchf1eld, N.; Dunn, F.L. (1969) Progress Report on
the Toxlcologlcal Studies Being Conducted on Premerge 21
Weed Killer (M-3497). (Unpublished study received Nov 21, 1969
under 264-256; prepared by Dow Chemical Co., submitted by Union
Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL:
002219-B)
*
00058147 Raman, H.P. (1969) Tentative Method for the Determination of Ami ben
1n Anrfben-ONBP Liquid Formulations (Amchem 69-304). (Unpub-
lished study received Nov 21, 1969 under 264-256; submitted by
Union Carbide Agricultural Products Co., Inc., Ambler, Pa.; COL:
002219-H)
00083155 Gard, L.N. (1959) Determination of isopropy! N-(3-chlorophenyl)
carbamate residues 1n potatoes treated for sprout Inhibition.
Journal of Agricultural and Food Chemistry 7(5):339-341. (Also
In unpublished submission received Dec 1, 1959 under PP0234;
submitted by Columbia-Southern Chemical Corp., Pittsburgh, Pa.;
COL:090262-G)
00083158 Gard, L.N.; Pray, B.O.; Rudd, N.G. (1954) Residues 1n crops receiv-
ing pre-emergence treatment with Isopropyl N-(3-ch1oropheny1)
carbamate. Journal of Agricultural and Food Chemistry 2(23):
1174-1176. (Also 1n unpublished submission received Dec 1, 1959
under PP0234; submitted by Columbia-Sou them Chemical Corp.,
Pittsburgh, Pa.; COL:090262-J)
00083334 PPG Industries, Incorporated (1963) Residue of CIPC on Sweetpota-
toes. Includes method no. BTS-11350 dated Jun 12, 1962. (Com-
pilation; unpublished study received Nov 21, 1965 under PP0409;
CDL:090441-B)
00093915 Ross, D.B.; Roberts, N.L.; Phillips, C.N.K.; et al. (1980) The
Acute Oral Toxldty (LD50) and the Neurotoxlc Effects of CIPC
on the Domestic Hen: PPG 4 NT/80188. (Unpublished study re-
ceived Jan 25, 1982 under 748-161; prepared by Huntingdon Re-
search Centre, England, submitted by PPG Industries, Inc.,
Barberton, Ohio; COL:246648-A)
143
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00093921 Rodwell, D.E.; Krabbe, R.; Werchowskl, K.M. (1981) A Teratology
Study in Rats with CIPC: WIL-81107. (Unpublished study received
Jan 25, 1982 under 748-161; prepared by WIL Research Laborato-
ries, Inc., submitted by PPG Industries, Inc., Barberton, Ohio;
CDL:246650-A)
00094865 Pensyl, J. (1982) Characterization of CIPC Residues in Cured To-
bacco Field Treated with 14C-PPG-575: BR 22524. (Unpublished
study received Feb 11, 1982 under. 748-233; submitted by PPG
Industries, Inc., Barberton, Ohio; CDL:246815-B)
00094866 Pensyl, J. (1982) Characterization of CIPC Residues in Smoke from
Cigarettes Spiked with 14C-labelled CIPC: BR 22531. (Unpub-
lished study received Feb 11, 1982 under 748-233; submitted by
PPG Industries, Inc., Barberton, Ohio; CDL:246815-C)
00094867 Pensyl, J. (1982) Characterization of CIPC Residues in Smoke from
Cigarettes Manufactured with Carbon-14 Labeled PPG-575 Field -
Treated Tobacco: BR 22542. (Unpublished study received Feb
11, 1982 under 748-233; submitted by PPG Industries, Inc.,
Barberton, Ohio; CDL:246815-0)
00106293 Uniroyal Chemical (1971) Alanap and Other Insecticide Residues in
Cranberries and Soybeans. (Compilation; unpublished study
received on unknown date under 400-85; COL:023355-A)
00114695 Fredenburg, R. (1960) Letter sent to E. Plant dated Nov 8, 1960:
Emulslflable sprout nip: Chloro-IPC. (Unpublished study re-
ceived Feb 14, 1961 under 748-182; submitted by PPG Industries,
Inc., Barberton, OH; 0)1:024269-8)
00114700 Kennedy, G.; Jenkins, 0. (1970) Report to PPG Industries, Inc.:
Distribution of CIPC 1n Milk and Tissues of a Lactatlng Cow: IBT
No. J8629A. (Unpublished study received on unknown date under
1F1119; prepared by Industrial Bib-Test Laboratories, Inc.,
submitted by PPG Industries, Inc., Barberton, OH; CDL:090892-I)
00114701 Kennedy, G. (1970) Report to PPG Industries, Inc.: Tissue and Egg
Residue Study of CIPC in White Leghorn Chickens: IBT No. J8630A.
(Unpublished study received on unknown date under 1F1119; pre-
pared by Industrial B1o-Test Laboratories, Inc., submitted by
PPG Industries, Inc., Barberton, OH; CDL:090892-J)
00114710.Pittsburgh Plate Glass (1967) Study: CIPC Residue on Selected
Crops. (Compilation; unpublished study received Aug 23, 1967
under 8F0690; COL:091198-A)
144
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00114715 PPG Industries, Inc. (1972) Petition of PPG Industries, Inc. Pur-
suant to Section 408 (d)(l) of the Federal Food, Drug and
Cosmetic Act with Respect to the Pesticide Chemical Chlorpro-
pham. (Compilation; unpublished study received Jun 1, 1972
under 2F1276; CDL:092107-A)
00114717 Anon. (1972) Determination of CIPC Residues in Soybeans. (Compi-
lation; unpublished study received Nov 20, 1972 under 3G1311;
submitted by ?; COL:092241-A)
00114718 Columbia-Southern Chemical Corp. (1960) Analyses for Residues of
CIPC and Other Chemicals in Potatoes. (Compilation; unpub-
lished study received on unknown date under PP0234; COL:
092511-A)
00114725 PPG Industries, Inc. (1977) Results of Tests on the Nature and
Amount of Residue: PPG-124. (Compilation; unpublished study .
received Jun 9, 1977 under 7F1963; CDL:096152-A; 096153)
00114729 Ecke, G.; Pensyl, 0. (1978) Hydrolysis of Isopropyl 3-Chlorocarban-
ilate (CIPC): BR 20955. (Unpublished study received Feb 3, 1978
under 748-161; submitted by PPG Industries, Inc., Barberton, OH;
CDL:096789-B)
00114737 PPG Industries, Inc. (1978) PPG-124 Residues 1n Plants. (Compila-
tion; unpublished study received Nov 15, 1978 under 7F1963; CDL:
097609-B)
00114739 PPG Industries, Inc. (1974) Analyses for Residues of CIPC
Chemicals 1n Various Products. (Compilation; unpublished study
received on unknown date under 4F1429; CDL:098173-A)
00114740 Pittsburgh Plate Glass Co. (1965) Analyses for Residues of CIPC:
in Sweet Potatoes. (Compilation; unpublished study received on
unknown date under PP0409; CDL-.098548-A)
00114741 Columbia Southern Chemical Corp. (1960) Analyses for Residues of
CIPC Chemicals 1n Potatoes. (Compilation; unpublished
study received on unknown date under PP0234; COL-.098745-A)
00114743 PPG Industries, Inc. (1970) Study: CIPC Residue on Soybeans.
(Compilation; unpublished study received Dec 16, 1970 under 748-
161; CDL:101498-A)
00114747 PPG Industries, Inc. (1961) Analyses for Residues of CIPC 1n
Potatoes. (Compilation; unpublished study received Mar 17,
1961 under unknown admin, no.; COL-.120933-A)
145
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00114748 Freed, V. (1962) Analyses for Residues of CIPC 1n Cranberries.
(Compilation; unpublished study received Mar 2, 1962; Mar 19,
1962 under unknown admin, no.; submitted by ?; CDL:120934-A)
00114750 Food Machinery and Chemical Corp. (1956) Sprout Control in Irish
Potatoes. (Unpublished study received on unknown date under
unknown admin, no.; CDL:120940-A)
00114751 Gard, L. (1957?) Determination of ... (CIPC) Residues in Potatoes
Treated for Sprout Inhibition. (Unpublished study received Nov
24, 1958 under unknown admin, no.; submitted by PPG Industries,
Inc., Barberton, OH; CDL:120941-A)
00114777 Agchem (1978) Analyses for Residues of CIPC in Potatoes. (Com-
pilation; unpublished study received Aug 14, 1978 under 4581-EX-
30; CDL:234638-A)
00114778 PPG Industries, Inc. (1978) Analyses for Residues of Furloe
Chloro I PC 4EC and Furloe Chi or o I PC 10G in Soybeans. (Compi-
lation; unpublished study received Sep 13, 1978 under 748-161;
COL:235138-A)
00114785 Agchen (1978) Residue Data of CIPC on Potatoes. (Compilation; un-
published study received Nov 21, 1978 under 4581-338; COL:
235995-G)
00114794 PPG Industries, Inc. (1979) Analyses for Residues of Furloe 124
and Other Herbicides In Various Products. (Compilation; unpub-
lished study received Jun 13, 1979 under 748-220; CDU238627-A)
00114795 PPG Industries, Inc. (1979) Summary of 1978-1979 Tests Using Decco
Brand CIPC-AR under EPA Permit I4581-EUP-30. (Compilation; un-
published study received Jul 18, 1979 under 4581-EX-30; COL:
238857-A)
00115388 PPG Industries, Inc. (1967) CIPC: Residues In M1lk and Other
Subjects. (Compilation; unpublished study received on unknown
date under 1F1120; COL:090894-A)
00126737 Henry, C.; Dansle, 0. (1983) Study of the Toxldty of CIPC Derived
Residues 1n Tobacco Smoke Administered to Mice for 21 Days: Ex-
periment No. 1-1727.005. Final rept. (Unpublished study re-
ceived Apr 11, 1983 under 748-233; prepared by Microbiological
Assoc., submitted by PPG Industries, Inc., Barberton, OH;
CDL:249884-A)
146
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chloropropham Standard
MRID CITATION
00129545 Schroeder, R.; Daly, I.; Hogan, G.; et al. (1983) A Two Generation
Reproduction Study In Rats with CIPC: Project No. 81-2573. Fi-
nal rept. (Unpublished study received Jul 19, 1983 under 748-
161; prepared by Bio/dynamics, Inc., submitted by PPG Indus-
tries, Inc., Bareberton, OH; CDL:250764-A; 250765; 250766)
00129938 Kirby, P.; Pizzarello, R.; Rogers, A.; et al. (1983) L5178Y/TK+/-
Mouse Lynphoma Mutagenesis Assay: ... Test Article CIPC, Isopro-
pyl 3-Chlorocarbanilate: Study no. T1890.701. (Unpublished
study received Jul 26, 1983 under 748-161; prepared by'Micro-
biological Assoc., submitted by PPG Industries, Inc., Barberton,
OH; CDL:250808-A)
00129940 James, P.; Billington, R.; Clark, R.; et al. (1983) A study of the
Effect of CIPC on Pregancy of the Rabbit: HRC Report No. PPG
5&7/832S. (Unpublished study received Jul 26, 1983 under 748- .
161; prepared by Huntingdon Research Centre, Eng., submitted by
PPG Industries, Inc., Barberton, OH; CDL:250809-C)
00139860 Rohm & Haas Company (1966) Determination of Microquantities of Stam
F-34 in Plant Tissues. Rev. Method dated May 12, 1966. (Un-
published studY 2eceived Mar 2, 1977 under 707-EX-88; CDL:
228160-D)
05016141 Ebing, tf. (1972) Routinemethode zur
Duennschichtchromatographischen Identifizierung der
Pestizidrueckstaende aus den Klassen der Triazine-, Carbamate,
Harnstoffe und Uracile Routine method for identification of
pesticide residues of trlazlne, carbamate', urea, and uracil
type compounds by thin-layer chromatography Journal of
Chromatography 65(3):533-545.
40208603 PPG Industries, Inc. (1987) Acute Toxicity of Chlorpropham to
Bluegill Suafish (Lcpomls macrochirus). (ABC Study No. 35418
conducted by ABC Laboratories, Inc.)
40208604 PPG Industries, Inc. (1987) Acute Toxicity of Chlorpropham (CIPC
Technical) to Rainbow Trout (Salmo galrdneri). (ABC Final
Report No. 35419 conducted by ABC Laboratories, Inc.)
40378101 Prendeville, G.; Eshel, Y.; James, C.; et al. (1968) Movement and
metabolism of CIPC In resistant and susceptible species. Weed
Science 16(4):432-435.
40378102 James, C.; Prendeville, G. (1969) Metabolism of Chlorpropham (Iso-
propyl m-Chloroca'rbanllate) in various plant species. Agricul-
tural and Food Chemistry 17(6):1257-1260.
147
-------
APPENDIX V
FORMS
- 147-A -
-------
out
Mo.
FIFHA SECTION 3(C)(2)(BJ SUMMARY SHEET
I
'A MfGISTMATIOM MO.
mooucr NAMI
OATS GUIDANCE DOCUMENT USutO
Whfc rvBMCl to die roqvronwm m Mftmi< "fonoric" tut cnooart by IIM FIFRA Mcttan 1(0(2X81 neiiei canum* * mi itUi/r^t
Cui4Miu Document. I «« r«pondmf in (lit lotiowiM, mmiMr
O I. .1 «*l mjbmft Am in i iim«4» m«nn«r 10 •iaf y in* r not
tp«ct(itd inl AM fl^sintiod C«td*im«i or m* Protocol content* m ffl« Nofant of €SM«I Group* to Clio CAtaicate C/ouo. OECO
ChonieaH T«imf Proartmmo. I onctooi m* groiocoit tn*t I will u»:
Q1 I hm tntorvd into on oBWiMHt witti OM or man otMr royinnnn undtr FIFHA
roouiromontt. Tho wu, tat ony mojiiiroa •raiocoh. mtt bo •ibmrno4 M EPA fey:
3IO(2>(IHa n
NAMC O^ OTHER
Q1 I ofldMi • eomottiM •C*rtrlie«oion ol Antmpt to Enttr Into on Afroommt wtft Olnor Hoiiiuniu (or 0
roptct to HM I oMomiM dta nqwirtmonti:
C 4. I r»n«n Bin you omoM «v rafioMMn oy MofMf
un (m« o»u«* • wt IM^OM» it OMteinti lor ntw oroducti):
Oil!
itffto
•J dH
l« «v •roonca)
'ATlVff
TUHC
OAT«
••A I
148
-------
. art* ^LL lour inmt
. i ATTEMPT TO CNTIlt
INTO AN AOMEMtNTWfTM OTHCM MCOKTIUNT8
fOII OCVtLOPMEMT Of DATA
I. I am duty awWoriMd to rapratant 0M fotiowina firmfe) wAo ara autojaet to «M
mams of a NotJe* under f «f HA Saction 3(e)(2)(8) eontainad in aGuidanea O«
to auomit data oanojminf mt aetiv* inoraditnt:
ACTIV*
Th«t firm or youo o< «.rm« « f«>«rr«d to b»(Ow tt ~mr firm'M
Z My fwm •» willw^ 10 d***too ind memn tn« d«u «t rtquntd by ftwt Notice. M nvenufy. Monnnr. my lirm would erf*** to e«i*>
into «n «o/««ni«nt witn onr or more otlttr rcqitiranti to d«««toO jointly, or to ««•»• in tftt cod ol dr*«4oo>n9. tne to"owinf tenu-tra
Htmtot data:
My Km (MI ofttftd in urnm) to tmt« MM me* M ay»jin«nt CMM •< M* «N«n art titatiMtf. T.tat tHir «w irrtvociM* tM inciuotd tn oH* to at
Bound by an arMratiM 4ttm*t> vndar Flf MA Sottio* ](cJ(2J(ll(nU i>
-------
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Registration Standard for
Registration
Guideline No.
S 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)
HRID Numbers
Assigned
-
150
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S 1.58. 135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corros ion
characteristics
Dielectric break-
down voltage
Acute oral
coxicity, 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 HRID
Nunber or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MR ID Numbers ,
Assigned
*
151
-------
CUB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) Ity firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental 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
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any tine any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with die required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,.
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified tine frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated: '
j 52 (Typed) '
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