UnftcdStatM
Environment*! Protection
Agency
Off in of
Pmticidw end Toxic
Washington DC 20460
PMtieidM
December 1937
Guidance for the
Reregistration of
Pesticide Products
Containing
Propanil
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PROPANIL
(OPP NUMBER 028201)
AS THE ACTIVE INGREDIENT
CASE NUMBER 0226
CAS (DOCKET) NUMBER 709-98-8
DEC 2 31987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Glossary of Terms and Acronyms iii
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment .... 6
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale. . 18
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable .Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 25
VI. Requirement for Submission of Generic Data 27
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 . . 33
VIII. Requirement for Submission of Revised Labeling 34
IX. Instructions for Submission .34
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA $3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
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GLOSSARY OF TERMS AND ABBREVIATIONS
The following are terms used throughout Registration Standards
and are defined here for the convenience of the reader.
ADI (Acceptable Daily Intake): An acceptable daily intake of
pesticide residue based on a complete data base.
A/D Ratio: This ratio determines a level of concern regarding
whether effects observed in embryos and fetuses from treated
females are "primary" (due to direct compound-related effects)
or "secondary" to maternal toxicity). Thus, the NOEL for
maternal effects ("A" numerator) divided by the embryo/fetal
NOEL ("D" for "developmental"), including frank terata (gross
congenital defects), defines this concern. If A/D is less
than "1", developmental toxicity of a substance may be
ascribed to secondary effects of maternal toxicity; if
greater than 2, the substance is considered a direct (primary)
developmental toxicant. Scientific interpretation is required
in the range, 1 to 2 (LELs may be used; or effects from
other types of studies, e.g., reproduction).
ai: Active ingredient.
CAS: Chemical Abstract Service (number).
Core Classification: A general guide to the acceptability of
data for the purpose of supporting registration (invalid,
supplementary, minimum, or guideline).
Core Guideline: Studies which satisfy Agency data requirements.
Core Minimum: Studies which are acceptable to support registration
of pesticide products but were not necessarily done according
to Agency Guidelines.
Core Supplementary: Studies in this category are scientifically
sound, thus the information may be useful. However, the
studies were performed under conditions that deviated sub-
stantially from recommended protocols. Studies do not meet
Guideline requirements and thus do not support registration
of a product.
EEC (Estimated Environmental Concentration): Estimated pesticide
concentration in the environment (terrestrial or aquatic
ecosystem).
EP: End-Use Product.
EPA: The Environmental Protection Agency, also "the Agency."
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FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act.
HDT: Highest dose tested.
Invalid: Studies which are deficient in some vital parameter or
those studies which have been judged not to be scientifically
sound or those studies whose reliability is seriously
questioned.
LC5Q: (Median lethal concentration): a statistically derived
concentration of a substance that can be expected to cause
death in 50 percent of test animals, expressed as weight or
volume of test substance per volume of air or water or per
weight of feed (e.g., mg/L or ppm).
LD5Q: (Median lethal dose): a statistically derived single dose
that can be expected to cause death in 50 percent of animals
when administered by the route indicated, expressed as weight
of substance per unit weight of test animal (e.g., mg/kg).
MOS (Margin of Safety): The calculation of a'margin of safety
involves division of an appropriate NOEL by a worker's estimated
exposure. The result is a unitless figure which gives an
indication of how close a worker's internal dose is in relation
to the NOEL for laboratory animals.
MPI: Maximum Permissible Intake.
MRID (Master Record Identification (number)): EPA's system of
tracking studies used in support of registrations.
MP: Manufacturing-use product.
NPDES: National Pollution Discharge Elimination System.
NOEL (No Observed Effect Level): The maximum dose used in a test
which produces no observed adverse effects.
OPP: The Office of Pesticide Programs (EPA).
OES: Office of Endangered Species, U.S. Fish and Wildlife Service.
OM: Organic matter (used to describe soils).
ppm: Parts per million.
PADI (Provisional Acceptable Daily Intake): An acceptable daily
intake of pesticide residue based on a limited data base.
IV
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PAI: Pure active ingredient.
TEP: Typical end-use product
Technical: Active ingredient as manufactured.
TMRC (Theoretical Maximum Residue Contribution): An estimate of
dietary exposure obtained by multiplying residue tolerance
levels for a given pesticide by the average daily per
capita food consumption figure, then adding the exposure
figures for each crop. TMRC is usually expressed in terms
of mg/kg body weight per day.
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data*on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon 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 end use products that contain th* active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
1-The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), SPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
aware of such information. Registrants should notify
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the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
Common Name: Propanil
Chemical Name: 31,4'-dichloropropionanilide
Other Names: Surcopur, Supur, Propanex, Propanilo, Supernox,
FW-734, Stam, Stampede, DPA, Herbax, Riselect,
Erban, Chem Rice, Rogue, S-10165, Strel, Bay
30130
Chemical Abstracts Service (CAS) Number: 709-98-8
OPP (Shaughnessy) Number: 028201
Empirical Formula: CgHgC^NO
Molecular Weight: 218.1
Description of Chemical Characteristics: Medium to dark grey
solid with a mildly acrid odor. The chemical
is readily soluble in ketones, alcohols and
chlorinated solvents and has a melting point
of 89 to to 92 °C. The density of propanil
at 25°C is 1.25 g/ml. In strong acid or alkali,
the chemical will hydrolyze to 3,4-dichloro-
aniline and propionic acid.
B. Use Profile
Type of Pesticide: Herbicide
Pests Controlled: Grass, broadleaf, and aquatic weeds
Registered Uses: Rice, spring barley, oats, and durum wheat
Predominant Uses: Rice (approximately 95% of manufactured
pesticide)
Mode of Activity: Inhibition of a number of biochemical
reactions, especially photosynthesis.
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Formulation: Manufacturing-Use Products - 85%, 90%, and
96% ai (technical).
End-Use Products - 33%, 33.8%, 35%, and
35.9% ai (3 Ib ai/gal) emulsifiable
concentrate; 43.48%, 43.5%, 44.5%, 45%,
and 45.4% ai (4 Ib.ai/gal) emulsifiable
concentrate; 35% ai (3 Ib ai/gal) soluble
concentrate/liquid.
Methods of Application: Applied by conventional aerial or
ground equipment as a postemergence
application.
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III. AGENCY ASSESSMENT
A. Summary
Based on the review of available data, the Agency has reached
the conclusions set forth in this Standard. A summary of those
conclusions follows. A more detailed discussion is contained in
the remainder of this Chapter.
1. Acute toxicity cannot be assessed due to a lack of
acceptable data. Two invalid acute oral studies indicate
Toxicity Category III for propanil. The chronic toxicity data
were developed from testing three technicals ranging in purity
from 85 to 98% ai. Pending review of the impurity profiles
of these technicals, certain studies may need to be repeated. A
mouse pncogenicity study performed with 85.4 and 98% ai
technicals reported findings of bilateral retinal degeneration
and thyroiditis. Additional information is required on this
study.
2. There are numerous data gaps under the environmental
fate data requirements. Available data indicate that propanil is
stable to hydrolysis at pH 7 and 9. Leaching studies indicate
that the chemical is mobile to very mobile on sandy loam, silt
loam, clay loam, clay, and sand soils. Pending the results of a
mobility study with aged propanil and a field dissipation study,
a ground water monitoring study may be required.
3. Effects to fish and wildlife cannot be fully assessed
until all required studies are submitted and reviewed. There is
a potential for risk to endangered aquatic species based on the
use on rice. After formal consultation between the Agency and
the U.S. Fish and Wildlife Service, labeling to protect
endangered species may be required.
As a result of this review, the Agency has identified missing
data necessary to evaluate the environmental and human risks
associated with the use of propanil. Registrants must agree to
develop these data in order to maintain registrations of products
or register new products containing propanil. A summary of these
data gaps appears in Table 1. Please note that this is only a
summary and complete details can be obtained by referring to the
tables in Appendix I.
The Agency is requiring a label restriction on drainage water
from treated rice fields. Refer to Section D of this Chapter for
specific language.
The Regulatory Position and Rationale section discusses the
Agency's position regarding the regulation of propanil.
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Table I. Summary of Data Gaps
Product Chemistry
All product chemistry data
Residue Chemistry
Metabolism studies (plants, livestock)
Residue analytical method "(plant"and animal residues)
Storage stability
Residue studies
Toxicology
Acute oral
Acute dermal
Acute inhalation
Eye irritation
Dermal irritation
Dermal sensitization
21-day dermal
Chronic toxicity (rodent and nonrodent)
Oncogenicity (rat and mouse)
General metabolism
Environmental Fate
Hyrolysis
Photodegradation (water and soil)
Aerobic soil metabolism
Anaerobic soil metabolism
Anaerobic aquatic metabolism
Aerobic aquatic metabolism
Leaching, adsorption/desorption
Soil dissipation
Aquatic (sediment) dissipation
Rotational crop (confined) accumulation
Irrigated crops accumulation
Fish accumulation
Fish and Wildlife
Avian acute oral
Avian subacute dietary (upland game bird and waterfowl)
Freshwater fish toxicity [TEP] (coldwater fish and
warmwater fish)
Freshwater invertebrates acute toxicity [TEP]
Estuarine and marine organisms acute toxicity
Fish early life stage and aquatic invertebrate life cycle
Fish life cycle
Plant Protection
Seed germination/seedling emergence
Vegetative vigor
Aquatic plant growth
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B. Toxicological Characteristics
The current toxicology data base for propanil is comprised
of studies testing three different technicals. Rohm and Haas has
two registered propanil technicals. One technical is labeled at
85% ai with a range of 85-88% (by weight) and was registered in
1972. The studies, discussed below, using this technical list the
purity as 85.4%. The other technical propanil is of 97% purity*
(although labeled at 96% ai) with an-actual range of 95-99% ai
(by weight). This technical was registered in April 1985.
Studies using this technical list the purity as 98%. Additionally,
a 97% purity technical was tested by Rohm and Haas, in the 1960's.
This unregistered 97% technical may be chemically different from
both registered technicals in use since that time. Depending
upon the impurity profile of these technicals, it may be necessary
to repeat certain studies such as reproduction (using 85% and/or
96% registered technicals), the teratology studies (with 96%
registered technical), the mouse oncogenicity study (with 85%
technical product) and possibly other studies. The registrant is
required to addres.s this issue in satisfactory detail.
1. Acute Toxicity
There are no acceptable data to assess acute toxicity.
However, data from two invalid acute oral studies place propanil
in Toxicity Category III.** An invalid primary skin irritation
study indicates that propanil is a moderate skin irritant.
Thus, due to a lack of valid data, the following studies are
required: acute oral, acute dermal, acute inhalation, eye
irritation, dermal irritation, and dermal sensitization.
2. Subchronic Toxicity
In a subchronic oral toxicity study, mice were dosed
with 0, 25, 200, 1600 and 12,800 ppm technical propanil (98% ai).
Ten male and ten female CD-1 mice were used per dose level.
A No Observable Effect Level (NOEL) was established at 25 ppm
and a Lowest Effect Level (LEL) was determined to be 200 ppm
based on an increase in hepatocytic pleomorphism and
hepatocellular multifocal necrosis. This study was classified
Core Minimum and fulfills the requirements for a 90-day feeding
study in a rodent species.
*Based on available data.
** Toxicity Categories are based on the acute toxicity of the
chemical (LD5Q or LC5Q values) and are used to determine the
appropriate signal word and precautionary language for
product labeling. Toxicity Category III requires the signal
word CAUTION and precautions against swallowing, inhaling, or
contact with the skin and eyes, along with appropriate first
aid instructions.
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There are no data available to assess subchronic dermal
toxicity. A 21-day dermal study is required.
3. Chronic Toxicity
In a chronic feeding study, Wistar rats were dosed
with 0, 100, 400 and 1600 ppm technical propanil (97% at).
Twenty-five male and twenty-five female rats were used per
dose level. A NOEL was established at 100 ppm Lowest Dose
Tested (LOT). A LEL was determined to be 400 ppm, based on
increased relative spleen weight in females. The study was
classified as Core-Supplementary because of inadequate
histological examination of tissues in both sexes of rats,
clinical chemistries were not performed and the limited
number of rats used.
In a chronic feeding study, beagle dogs were dosed
at 0, 100, 600 and 4000 ppm with technical propanil (97% ai).
Two dogs per sex per dose were used. A NOEL was established
at 600 ppm. A LEL was determined to be 4000 ppm based on
decreased body weight, decreased food consumption and increased
SCOT* and SAP** values. The study was classified as Core-
Supplementary because of the inadequate number of dogs used
and limited clinical chemistry and limited histopathology were
performed.
Chronic feeding studies in rodents and in nonrodents
are required.
4. Oncogenicity
An oncogenicity study was conducted in mice with technical
propanil of two purities, 98% and 85.4% ai. Dose levels for the
study were 0, 5, 30, and 180 ppm for the 98% ai technical and a
second dose level of 180 ppm using the 85.4% ai technical. The
oncogenic potential was negative at 180 ppm (HOT) for both techni-
cals. There were no compound-related effects on survival,
clinical observations, tissue masses, body weight, food consump-
tion, hematology, or organ weights. Dose-related histologic
findings were observed in the male liver as centrilobular hepato-
cytic enlargement beginning by week 15 and continuing for the
104-week study. The NOEL for this lesion was 30 ppm for the
98% ai technical. The LEL for this effect was 180 ppm (HOT) for
both technicals. Bilateral retinal degeneration in male and
female mice and thyroiditis in female mice were observed at
180 ppm (85.4% ai technical only), the only dose level tested for
this technical. NOELs for these effects were not established.
This study was classified as Core-Supplementary because the
maximum tolerated dose (MTD) was not employed and NOELs for
*Serum glutamate oxalacetate transaminase
** Serum alkaline phosphatase
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bilateral retinal degeneration and thyroiditis with the 85.4% ai
technical were not established. Pending the results of any
additionally submitted data on this study, the 2-year mouse study
may need to be repeated with the 85.4% ai technical.
5. Teratogenicity
A teratology study in rats with 85.4% ai technical
propanil tested the following doses: 0, 0.8, 4.0, 20, and
100 rag/kg. Results indicated a maternal toxicity NOEL of
20 mg/kg/day, a developmental toxicity NOEL of 20 mg/kg/day, and
the teratogenic potential was negative. The study was
classified as Core-Minimum and fulfills the teratology (rat)
data requirement.
A teratology study in rabbits was performed with the
85.4% ai propanil technical. The following dosages were tested:
0, 4, 20, and 100 mg/kg/day. Results indicated a maternal toxi-
city NOEL of 20 mg/kg/day, a developmental toxicity NOEL of
20 mg/kg/day and teratogenic potential was negative. The study
was classified as Core-Minimum and fulfills the teratology (rabbit)
data requirement.
6. Reproduction
A 3-generation rat reproduction study using the 97%
purity propanil technical tested dosages of 0, 100, 300, and
1000 ppm. There were no compound-related effects on fertility,
gestation, viability, and lactation indicies, or sex ratios for
each generation. Histopathologic examination of F3b pups did
not reveal any compound-related lesions. The reproductive and
systemic NOEL is 300 ppm. The study is acceptable and fulfills
the 3-generation reproduction (rat) data requirement.
7. Mutagenlcity
Acceptable studies have been submitted to satisfy the
Agency's data requirements for gene mutations, chromosomal aber-
rations, and direct DNA damage. Propanil was not mutagenic in
gene mutation assays, chromosomal aberration assays, and in all
but one direct DNA damage assay.
8. Metabolism
In a rat metabolism study using only males, approximately
90 to 92 percent of the radioactivity was recovered in urine,
feces, and cage washings within 2 days. Less than 1 percent was
found in rat tissues. The predominant metabolite was 3',4'-
dichloroaniline. The study was classified as Core-Supplementary
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because (1) individual data were not provided; (2) female rats
were not studied; and (3) T 1/2 (half-life) was not determined.
Another rat metabolism study is required to fulfill this data
requirement.
C. Other Science Findings
1. Environmental Fate-
Available data are insufficient to fully assess the
environmental fate of propanil. Data Table A lists the required
environmental fate studies. Available data indicate that
propanil is stable to hydrolysis at pH 7 and 9. Leaching studies
(adsorption/desorption) indicate that the chemical is mobile to
very mobile on sandy loam, silt loam, clay loam, clay, and sand
soils. Mobility appears to be related to organic content of the
soil; the lower the organic content, the more mobile propanil is
in the soil. Pending the results of anaerobic/aerobic soil
metabolism, aquatic metabolism, mobility and field dissipation
studies, a groundwater monitoring study may be required.
2. Exposure
Since the currently available data do not indicate a
basis for concern and based on current use patterns, the Agency
is deferring any requirements for exposure data. Should the
toxicity studies required in this Standard indicate a concern
for human exposure, appropriate exposure data will be required.
3. Ecological Effects
a. Terrestrial Organisms
Available data indicate that propanil, on a
subacute dietary basis, is slightly to practically nontoxic to
birds. Eight-day dietary studies on bobwhite quail and mallard
duck reported LCjo values of 1924 ppm and greater than 5000 ppm,
respectively. Although these studies provide enough information
to characterize propanil, deficiencies in testing procedures
prevent fulfillment of the avian subacute dietary data requirement,
Thus, avian dietary studies on an upland game bird and waterfowl
are required. No data are available to assess the acute oral
toxicity of propanil to birds. An avian oral study is required.
An avian reproduction study is not required at this
time since insufficient data are presently available to determine
if this study will be required.
There is sufficient information to characterize
propanil as relatively nontoxic to honey bees, when bees are
exposed to direct treatment.
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b. Aquatic Organisms
There are sufficient data available to characterize
technical propanil as moderately to very highly toxic to fresh-
water fish. Reported 96-hour LC$Q values for bluegill range from
less than 3.7 to 5.36 ppm and for rainbow trout it is 2.3 ppm.
The data requirements for freshwater fish LCso studies (warmwater
and coldwater fish species), using technical propanil, are
satisfied.
Available data from acute fish toxicity studies
using a typical end-use product (TEP) indicate the TEP as slightly
to moderately toxic to fish. A bluegill study, testing a 45% ai
TEP, reported a LCso value of 16.49 ppm. An LCso value of 6.9 ppm
was reported when rainbow trout were tested with a 36.5% ai TEP.
The information provided from these studies is sufficient
to characterize the TEP. However, in both studies, only a
48-hour LC5Q was determined; not the required 96-hour LCsQ. Thus,
the data requirement for the TEP has not been satisfied. Testing
of the TEP is required since the application of propanil on rice,
as allowed by the label, of 6 Ib ai/A would result »in an aquatic
estimated environmental concentration (EEC) of 4.4 ppm (as
calculated by the Agency) , which exceeds the technical propanil
values for finfish.
A fish early life stage study and aquatic invertebrate
life cycle study are required since the use of propanil to control
weeds in rice is expected to result in water, containing the
chemical, being transported from the site of application.
Results of a 48-hour study using Daphnia magna and
testing technical propanil indicate a LCso value of 6.7 ppm. This
study characterizes technical propanil as slightly to moderately
toxic to aquatic invertebrates. The freshwater invertebrate
acute LC5Q data requirement has been satisfied.
An acute LCso freshwater invertebrate study using a
TEP is required since the end use product is introduced directly
into an aquatic environment when used as directed and the EEC of
4.4 ppm in 6 inches of water is very near the LCso for Daphnia
magna.
There is sufficient information to characterize
propanil as slightly Co moderately toxic to estuarine and
marine organisms. However, the available studies do not satisfy
the acute LCso data requirement, since insufficient data were
submitted and an unacceptable test species (mud crab) was used
in one of the studies. The acute LCjo estuarine and marine
organism data requirement must be fulfilled.
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c. Plant Protection
Plant protection testing is required for propanil in
order to assess the potential hazard to both terrestrial and
aquatic nontarget plants.
d. Endangered Species
There are no endangered plant species associated with
the registered xises of propanil. There is potential for endangered
avian and aquatic species to be adversely affected by applications
of propanil. However, no avian or aquatic endangered species
have been identified in the small grain cluster.* The rice
cluster is currently being developed by the Agency, and the Agency
believes that the fat pocketbook pearly mussel (Potamilus capax)
could be at jeopardy. Endangered species labeling may be required
for propanil upon completion of a formal consultation with the
U.S. Fish and Wildlife Service if their review concludes that the
use of propanil on rice causes jeopardy to endangered species.
4. Product Chemistry
% -^
a. Potential Contamination with Halogenated Dibenzo-p-
dioxins or Dibenzofurans'
The Agency finds that chemicals such as propanil that
have had a halogenated cyclic moiety within their structures
have the potential of becoming contaminated with halogenated
dibenzo-p-dioxins or dibenzofurans under certain conditions of
manufacture. Information on the manufacture of propanil is
needed in order to determine whether conditions favoring the
formation of halogenated dibenzo-p-dioxins or dibenzofurans
occur during propanil manufacture. Submission of product
identity and composition and manufacturing process data on all
propanil products was required in a data call-in notice dated
June 9, 1987. The data were required by January, 1988. If
the manufacturing process data show that halogenated dibenzo-p-
dioxins are likely to be present in propanil products, the
Agency may require analytic data to characterize or quantify
any such contaminants.
Under the cluster program, the Agency assesses the individual
risk to endangered species from all chemicals within the same
use pattern (or "cluster") together.
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b. Composition of Technical Grade Products
The amount of propanil in each of four technical grade
propanil products ranges from 85% in one Rohm and Haas product
to 97% in another technical grade product made by the same
company. A Cedar Chemical Corp. technical contains 90% propanil.
An unregistered technical-made by Agrotan S.A. contains 95%
propanil. Because the proportion of propanil varies so widely
among the four technical grade products, the Agency is concerned
that these products may be quite dissimilar in composition with
respect to impurities and contaminants. Accordingly, the
Agency is requiring submission of product chemistry data on
each technical grade propanil product. If the product chemistry
data show that the compositions of the technical grade propanil
products are not comparable, it may be necessary to require
complete toxicological testing of each technical grade propanil
product.
D. Tolerance Reassessment
Tolerances have been established for residues of propanil in^
or on a variety of raw agricultural commodities (RACs) (40 CFR
180.222). EPA has evaluated the residue and toxicology data
supporting tolerances, and has addressed the following regulatory
issues:
0 Whether the current tolerances are sufficient to cover
the actual residues resulting from use (including uses registered
under FIFRA section 24(c) and intrastate uses and methods of
applications).
0 Whether group tolerances could be established in accordance
with 40 CFR 180.34(f).
0 Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are necessary.
0 Whether the tolerances are expressed accurately and in
current terminology.
The regulatory results of the Agency's reviews are set out in
Section IV.A., Regulatory Positions and Rationales.
1. Residue Data
The residue data reviewed in support of these tolerances
include the following:
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a. Data on the nature of the residues in both plants and
animals, including identification of major metabolites and
degradates of propanil. The metabolite 3,4-dichloroaniline
is common to plant and animal systems. Since its analog
4-chloroaniline is an oncogen, particular attention will be
given to 3,4-dichloroaniline when quantifying residues in food
crops and livestock.
b. Radiolabeled studies on the uptake, translocation, and
metabolism of propanil in plants. Available data, although
inadequate, indicate that residues of propanil are taken up
systemically from soil into rice straw and grain.
c. Radiolabeled studies on the metabolism of propanil in
poultry and ruminants. The limited data available indicate that
'^C-residues of propanil will occur in tissues of ruminants and
poultry following ingestion of feeds containing [^C] propanil.
d. Analytical methodology for determining the levels of
residues of propanil in plants and animals. Since the nature of
the residue in plants and animals has not been adequately
described, the adequacy of available analytical methods cannot be
ascertained. The current preferred enforcement method is a gas
chromatographic procedure (Method I in the Pesticide Analytical
Manual. Vol. II, Pesticide Reg. Section 180.274).This method
has undergone a successful method tryout on milk. A colorimetric
method has also been developed (Method II in the PAM, Vol. II).
This method has, in the past, been considered acceptable for data
collection but not for enforcement due to its inability to
differentiate between substituted anilines.
e. Storage stability data. Available data indicate that
residues of propanil in frozen rice grain will be stable for up
to 525 days and in rice straw kept at room temperature for up to
235 days.
f. Data on the magnitude and levels of residues of propanil
in individual RACs, animal products, and processed food and feed
items. Data are insufficient to assess the established tolerances
for residues in meat, milk, eggs, and rice grain. Furthermore,
if the required plant metabolism and analytical method validation
data indicate that all residues of concern were not determined
in the currently available studies for the processed products of
rice, rice straw, or the grain and straw of barley, oats and
wheat, additional data may be required for these commodities as
well. A wheat processing study is needed to determine whether
food/feed additive tolerances are needed for the processed
products of barley, oats and wheat.
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2. Toxicology Data
The 2-year rat feeding study was used in determining the
provisional acceptable daily intake (PADI). The NOEL for the rat
study was 5 mg/kg/day (100 ppm). An uncertainty factor of 1000
was used to account for the inter- and intraspecies differences
and the toxicology data gaps. The PAD! was obtained by dividing
the NOEL by the uncertainty factor of 1000. The resultant PADI
was 0.005 mg/kg/day. The theoretical maximum residue contribution
(TMRC) of propanil in the daily diet of the U.S. population
average is 0.0015 mg/kg/day, based on the existing tolerances,
with 29% of the PADI being utilized.
3. Tolerances Issued
The following tolerances have been established for residues
of propanil:
Commodity Tolerance (ppm)
Barley, grain 0.2
Barley, straw 0.75
Cattle, fat 0.1 (N)*
Cattle, rabyp** 0.1 (N)
Cattle, meat 0.1 (N)
Eggs 0.05 (N)
Goats, fat 0.1 (N)
Goats, mbyp 0.1 (N)
Goats, meat 0.1 (N)
Hogs, fat 0.1 (N)
Hogs, mbyp 0.1 (N)
Hogs, meat 0.1 (N)
Horses, fat 0.1 (N)
Horses, mbyp 0.1 (N)
Horses, meat 0.1 (N)
Milk 0.05 (N)
Oats, grain 0.2
Oats, straw 0.75
Poultry, fat 0.1 (N)
Poultry, mbyp 0.1 (N)
Poultry, meat 0.1 (N)
Rice 2
Rice, straw 75 (N)
*Negligible residues
** Meat byproducts
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Commodity
Sheep, fat
Sheep, mbyp
Sheep, meat
Wheat, grain
Wheat, straw
Tolerance (ppm)
0.1
0.1
0,
0,
(N)
(N)
1 (N)
2
0.75
A feed additive tolerance of 10 ppm is established for
propanil in or on rice bran, rice hulls, rich polishings and
other milling fractions resulting from application of the
herbicide to the growing RAG rice.
Canadian Tolerances
Commodity
Barley
Oats
Wheat
Tolerance (ppm)
0.1 ppm (N)
0.1 ppm (N)
0.1 ppm (N)
Mexican Tolerances
Commodity
Rice
Rice, straw
Tolerance (ppm)
2 ppm
75 ppm
There are no Codex Alimentarius maximum residue limits.
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Position and Rationale
Based on review and evaluation of all available data and
other relevant information on propanil, the Agency has made the
following determinations:- - .
1. . The Agency is not initiating a Special Review of propanil
at this time.
Rationale; Since available data are limited, the Agency
is not yet able to make a determination as to whether any of the
criteria specified in 40 CFR 154.7 have been met or exceeded.
2. The Agency will not establish significant* new food uses
at this time.
Rationale: Because of extensive data gaps in the areas
of residues and chronic toxicity, the Agency cannot assess
existing uses. When additional data are evaluated, the Agency
will determine whether significant new food uses may be established.
3. The Agency is not imposing any reentry statements nor
is it requesting that reentry data be submitted.
Rationale; No toxicological concerns which would
indicate the need for reentry statements or reentry data have been
identified at this time. This conclusion is subject to change
based on evaluation of required toxicological data.
4. Tolerances for residues in catfish and crayfish must be
proposed and supporting data submitted. In lieu of proposing
tolerances for catfish and crayfish, the following label
restrictions may be implemented:
"Do not drain water from treated fields into areas where
catfish farming is practiced." and
"Do not apply to fields where commercial crayfish farming
is practiced and do not drain water from treated fields
into areas where crayfish farming is practiced."
Significant new use is defined in 44 FR 27934, May 11, 1979.
In the case of a new food or feed use, the Agency will consider
as significant an increase in Theoretical Maximum Residue
Contribution of greater than 1 percent.
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Rationale; Available data on residues in catfish and
crayfish indicate some likelihood of measurable residues occurring
in edible portions of these fish/crustaceans. The registrant(s)
must inform the Agency within 90 days which option is selected.
5. The Agency has determined that label restrictions on
drainage water must be implemented. Refer to Section D of this
Chapter for the specific language.
Rationale; Available data indicate that residues may
occur up to 15 ppb in rice flood water drained 3 weeks prior to
harvest from fields treated 56 days prior to harvest. Thus,
application to rice may result in residues in catfish, crayfish,
irrigation, and potable water due to drainage of rice flood
water into catfish/crayfish farming waters, irrigation systems
and potable water intakes.
6. The registrant must propose a resolution to the
apparent conflict between feed additive tolerances for residues
in rice bran and expected residues, if available rice processing
studies are determined to be adequate.
^ Rationale; Available data indicate that the current
5X concentration factor may be inappropriate and that
concentration may be as high as 13X in bran processed from rice
grain. However, the Agency cannot determine if these data are
adequate until plant metabolism and analytical method validation
data are submitted and reviewed. If these data are determined
to be adequate, the registrant must propose a means to resolve
the difference between the existing feed additive tolerance and
the expected residues. This may include, but is not limited to,
proposed modifications to application rates or methodologies,
or proposed tolerance revisions.
7. The registrant must propose a resolution to the apparent
conflict between tolerances for residues in or on barley, oats
and wheat straw, and expected residues, if available straw data
for these commodities are determined to be adequate.
Rationale; Available data indicate that residues on
these commodities may be as high as 1.5 ppm (existing tolerance
is 0.75 ppm). However, the Agency cannot determine if the
available data are adequate until plant metabolism and analytical
method validation data are submitted and reviewed. If these data
are determined to be adequate, the registrant must propose a means
to resolve the difference between the existing tolerance and the
expected residues. This may include, but is not limited to,
proposed modifications to application rates or methodologies,
or proposed tolerance revisions.
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8. The Agency has determined that the following revision
in the tolerances listed in 40 CFR 180.274 is necessary and will
initiate actions to effect these changes.
0 The designation "(N)" for negligible residues will be deleted
from the entries for milk, eggs, meat, fat, and meat byproducts
of cattle, goats, hogs, horses, sheep, and poultry, and rice
straw.
Rationale; The Agency does not accept the concept of
negligible residues therefore, the designation "(N)" will no
longer be used.
9. The Apency is requiring complete product chemistry
data on each technical grade propanil.product.
Rationale; Available data on product identity and
composition of each of the four technical grade products show
that the percentage of active ingredient in the technical
product varies widely among the four products. Accordingly,
the Agency is concerned that differences in composition among
the four products may be so great that toxicological data
developed on one* technical may not support products derived
from the other technical grade propanil products. Review
of product chemistry data on each technical will enable the
Agency to determine whether this concern is founded, and if
so, what additional data will be required.
10. 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:
§158.120 Product Chemistry
61-1, 61-2 and 61-3; Product Identity,
Manufacturing Process and Formation of
Impurities
§158.125 Residue Chemistry
171-4 Metabolism Studies
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§158.130 Environmental Fate
163-1, 164-1, 164-2; Leaching and
Adsorption/Desorption, Soil Field
Dissipation and Aquatic Sediment Field
Dissipation
11. While data gaps are being filled, currently registered
MPs and EPs containing propanil as the sole active ingredient may
be sold, distributed, formulated, and used, subject to the terms
and conditions specified in this Standard. Registrants must
provide or agree to develop additional data, as specified in the
Data Appendices, in order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data are missing
or are inadequate [see FIFRA section 3(c)(2)(B) and 3(c)(7)].
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory changes
are necessary.
B. Criteria for Registration
To be registered or reregistered under this Standard, products
must contain propanil 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 propanil 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 propanil provided that the product labeling
bears appropriate precautionary statements for the acute toxicity
category in which each product is placed.
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3. Use Patterns
To be registered under this Standard, manufacturing-use
products must be labeled for formulation into end-use products
for registered uses, as listed in the EPA Compendium of Acceptable
Uses, Appendix III.
D. Labeling
All propanil products must bear appropriate labeling as
specified in 40 CFR 162.10. Appendix II contains information on
label requirements.
No pesticide product containing propanil may be released for
shipment by the registrant after February 1, 1989, unless the
product bears an amended label which complies with the require-
ments of this Standard.
No pesticide product containing propanil 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 February 1, 1990,
unless the product bears an amended label which complies with the
requirements of this Standard.
In addition to the above, in order to remain in compliance
with FIFRA, the following information must appear on the
labeling:
1. Ingredient Statement
The ingredient statement for MPs must list the active
ingredient as:
"31 ,4'-dichloropropionanilide"
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable use
patterns. Labeling must specify sites, which are listed in 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.
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3. Precautionary Statements
The following statement must appear on manufacturing-use
products under the heading "Environmental Hazards":
"This pesticide is toxic to fish.
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."
The following statement must appear on end-use products
labeled for aquatic uses under the heading "Environmental Hazards"
"This pesticide is toxic to fish.
Drift and runoff from treated areas
may be hazardous to aquatic organisms
in neighboring areas. Do not apply
directly to water except as specified
on this label. Do not contaminate
water by cleaning of equipment or
disposal of wastes."
All end-use products labeled for rice must contain the
following label statement:
"Water drained from treated rice fields must
not be used to irrigate other crops or
released within 1/2 mile upstream of a
potable water intake in flowing water (i.e. ,
river, stream, etc.) or within 1/2 mile of
a potable water intake in a standing body
of water such as a lake, pond or reservoir."
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The following statement must appear on end-use products
labeled for nonaquatic uses under the heading "Environmental
Hazards":
"This pesticide is toxic to fish.
Drift and runoff from treated areas
may be hazardous to aquatic organisms
in neighboring areas. Do not apply ---
directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do
not contaminate water by cleaning
of equipment or disposal of wastes."
The following statements must appear on end-use products
labeled for aquatic uses, if the .registrant of the product chooses
not to conduct tests and propose tolerances for catfish and
crayfish:
"Do not drain water from treated fields into
areas where catfish farming is practiced."
"Do not apply to fields where commercial
crayfish farming is practiced and do not
drain water from treated fields into areas
where crayfish farming is practiced."
4. Disposal Statements
The labels of all products must bear the appropriate
pesticide and container disposal statements (See Appendix II).
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and Ij2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
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 exemption3, 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.
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2. If eligible for the formulator'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.
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
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
28
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EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3.) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve .the terras.
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
your offer. You request that EPA not suspend your regisTration
for non-compliance with the PCI.EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
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registrant and proof»of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data 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 needeTH
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, 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 using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
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
31
-------
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
a 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 NottceT
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
32
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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.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
33
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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 ingredient!
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(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.)
34
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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.
35
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3. Within the time frames set forth in Table A. you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing 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
36
-------
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).
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.
37
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TGUIDE-1
GUIDE TO TABLES
Tables A, and B 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.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI » Technical grade of the active ingredient
PAI - Pure active ingredient
PAIRA - Pure active ingredient, radio labeled
TEP - Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A - Terrestrial, food
B » Terrestrial, non-food
C - Aquatic, food
D - Aquatic, non-food
E - Greenhouse, food
F *• Greenhouse, non-food
G » Forestry
H » Domestic outdoor
I » Indoor
Any other designations will be defined in a footnote to the table,
38
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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 files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the 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.
39
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SPECIAL NOTE REGARDING THE DATA TABLES
Testing of each technical grade propanil product is required under
the Data Tables wherever "TGAI" is listed as the test substance,
unless the registrant can demonstrate to the Agency that the
compositions of the various technical propanil products are comparable.
40
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TABLE A
GENERIC DATA REQUIREMENTS FDR PROPANIL
Data Requirement
SI 58. 120
Product
61-2 -
61-3 -
Analysis
Product
— ' 62-1 -
Physical
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
63-7 -
63-8 -
Product Chemistry
Identity
Description of Beginning
Materials and Manufac-
turing Process
Discussion of Formation
of Impurities
and Certification of
Ingredients
Preliminary Analysis
and Chemical Characteristics
Color
Physical State
Odor
Melting Point
Boiling Point
Density, Bulk Density, or
Specific Gravity
Solubility
Test Use
Substance Patterns
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
All
All
All
All
All
All
All
All
All
All
Does EPA Bibliographic
Have Data?1/ Citation1/
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
Must Additional
Data Be
Submitted?
Yes2/3/
Yes2/V
YesV
Yesfy
Yes6/
Yes6/
Yes6/?/
Yes£/£/
Yes6/
Yesfy
Timeframe
for
Submission
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
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TABLE A
GENERIC DATA REQUIREMENTS TOR PROPANIL (cont'd)
Data Requirement
SI 58. 120 Product Chemistry
Test Use
Substance Patterns
Does EPA Bibliographic
Have Data?1/ Citation'/
Must Additional
Data Be
Submitted?
Timeframe
for
Submission
*
Physical and Chemical Characteristics
(cont'd)
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-1 1 - Octanol/Water Partition
Coefficient
4* 63-12 - pH
63-13 - Storage Stability
Other Requirements
64-1 - Submittal of Samples
TGAI or PAI All
TGAI or PAI All
PAI All
TGAI All
TGAI All
TGAI, PAI All
No N/A
No N/A
No N/A
No N/A
No N/A
N/A N/A
I/Not applicable. Although product chemistry data may have been submitted in the past
~~ that these data must be resubmitted for each pesticide. New requirements have been
submitted data must be updated. Therefore, bibliographic citations for the old data
2J Required for all technical grade
Yes6_/
Yesfy
Yesfy£/
Yes*/™/
Yes6_/
No
6 Months
6 Months
6 Months
6 Months
15 Months
, the Agency has determined
introducted and previously
are not applicable.
propanil products (registered and unregistered).
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
§158.120 Product Chemistry
Footnotes (cont'd)
3/Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions including
specification of the acceptable conditions of temperature, pressure and pH, the duration of each step of the
process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, producer, or supplier of each beginning material must be provided, along with information regarding
the properties of each beginning material used to manufacture each product.
4/A detailed discussion of all impurities that are or may be present at ^> 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. The discussion must include all details regarding possible formation of
dibenzo-p-dioxins and dibenzofurans.
5/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which 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, K^, pH, and stability) as required in 40 CFR 158.120 and
more fully described in the Pesticide Assessment Guidelines, Subdivision D must be submitted.
7/Data needed if the technical chemical is a solid at roan temperature.
ft/Data needed if the technical chemical is a liquid at room temperature.
^/Required if the technical chemical is organic and nonpolar.
H)/Required if the test substance is dispersible with water.
-------
Data Requirement
SI 58. 125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue
(Metabolism)
- Plants
"** - Livestock
171.4 . Residue Analytical
Method
- Plant Residues
- Animal Residues
171-4 - Storage Stability
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL
Must Additional
Test Does EPA Bibliographic Data Be
Substance Have Data? Citation Submitted?
TCAI No Yes
Yes Product Label No
PAIRA Partially 00035588,00035589, Yes2/
00035684,00036100.
00052347,00052348.
00052349,00052350
PAIRA Partially 00035697,00035698, Yes3/
00035699,00035905,
00067394
TCAI & Partially 00035587,00055547, Yes2/
Metabolites 00067394 ,000761 1 3 ,
00111367,00111388
TCAI & Partially 00055547 , 00067394 , Yes3/ 1 1 /
Metabolites 00111367
PAI or TEP Partially 00035683 YesV5/
&
Metabolites
Timeframe
for
Submission
I/
18 Months
18 Months
18 Months
18 Months
18 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
Data Requirement ,
§158.125 Residue Chemistry
171-4 - Magnitude of the Residue -
Residue Studies for Each
Food Use
- Crop Group #1
(Cereal Grains)
- Forage, Fodder, and Straw
of Cereal Grain Group
- Barley, Oats, and Wheat
cn
- Processed Products of
Barley, Oats, and Wheat
- Rice
- Processed Products of Rice
- Potable & Irrigation Water
- Crayfish
- Catfish
- Meat, Milk, Poultry,
& Eggs
Must Additional Timefrane
Test Does EPA Bibliographic Data Be for
Substance Have Data? Citation Submitted? Submission
N/A
N/A
TEP Partially 00055546,00078930,
00111370,00111373
EP No
TEP Partially 00035687,00035688
EP Partially 00035576,00035687,
00035688,00052347
EP Partially 00035688
PAIRA & EP Partially 00035692 ,001 1 1 394
EP Partially 00111394
TGAI or Partially 00035694,00035695
Plant
Metabolites
Nofy
Nqfy
YesT/Jjy 18 Months
Yes8_/_|5_/ 24 Months
Yes9/V5/ is Months
YesJfy^V 24 Months
Yes 15 Months
YesJJ/2£/ 18 Months
YesjjV 18 Months
YesJV 18 Months
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ON
TABLE A
GENERIC [fcTA REQUIREMENTS FDR PROPANIL (cont'd)
SI 58. 125 Residue Chemistry
Footnotes
jyRefer to Product Chemistry Data Requirement tables.
^/Metabolism studies must be submitted in which rice and wheat are treated foliarly and via the soil (in separate
tests) with I '^C-ring] propanil at a rate sufficiently high to permit complete characterization of I^C-residues
in straw and mature grain. Plants should be grown under environmental conditions that approximate actual field
conditions (i.e., rice should be flooded within 24 hours after treatment). Wheat should be treated at the four-
or five-leaf stage and rice at die mid-tillering stage. Plants should be harvested at several intervals thereafter
(every 2 weeks) and at maturity. At maturity, straw and grain must be analyzed separately. 1^C-Balance data must
be presented for each sample analyzed. Conjugated or bound ^-residues must be characterized. Particular
attention should be given to quantification of 3,4-dichloroaniline. Representative samples from these studies must
be analyzed using all current and proposed enforcement procedures (including FQ& multi residue methods) to ascertain
that the methods are capable of accurately quantifying all residues of toxicological concern.
^/Metabolism studies must be submitted in which ruminants and poultry are fed [C-r ing] propanil for at least 3
consecutive days at a rate sufficient to permit complete characterization of 1 \:- residues in muscle, fat, kidney,
liver, milk, and eggs. Animals must be sacrificed within 24 hours of the final dose. Milk and eggs must be
collected twice daily. I^C- Balance data must be presented for each sample analyzed. Conjugated or bound ^C-
. residues must be characterized. Particular attention should be given to quantification of 3,4-dichloroaniline
Representative samples from these studies must be analyzed using all current and proposed enforcement procedures
(including FQ& multiresidue methods) to ascertain that the methods are capable of accurately quantifying all
residues of toxicological concern. If metabolism of propanil in ruminants or poultry differs significantly from
that in rats, a swine metabolism study may be required also.
4/A11 residue data required in this Standard must be accompanied by (i) sample storage information (storage
~~ conditions and length of time in storage) and (ii) data depicting the stability of propanil residues of concern in
similar samples stored for the time intervals and under the conditions specified. If Method II in Pesticide
Analytical Manual (PAM) Volume II is found to be adequate for data collection, based on the required plant
metabolism and residue analytical method validation data, no additional storage stability data will be required for
plant samples kept frozen for <^ 525 days.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
§158.125 Residue Chemistry
*
Footnotes (cont'd)
• ~ —^^ ^
5/If the required animal metabolism and analytical method validation data indicate that Method II in PAM Volume II is
adequate for collection of data regarding residues of propanil in meat and milk, then the cattle feeding study data
contained in MRIDs 00035694 and 00035695 must be validated by submission of sample storage information (length of
time in storage and conditions of storage) and by data depicting the stability of propanil residues of concern in
similar samples under the conditions and for the time intervals specified.
6/Crop group tolerances are not appropriate at the present time because: (1) additional data are required for rice
grain; (2) tolerances for residues in the grain and straw of barley, oats, and wheat and in the grain and straw of
rice differ by more than a factor of 5; and (3) a lack of data for corn (fresh sweet and dried field) and sorghum,
representative commodities of the cereal grains group.
7/The established tolerances for residues in straw are too low. The registrant should propose that they be revised
from 0.75 to 1.5 ppm, provided the required plant metabolism and analytical method validation data indicate that
the available data for straw are adequate (refer to footnote 2).
8/Data must be submitted depicting residues in bran, flour, middlings, shorts, and grain dust processed or obtained
from wheat grain bearing measurable weathered residues. It may be necessary to treat with exaggerated rates to
• obtain measurable residues in the raw agricultural commodity. If residues concentrate in any of these processed
commodities, appropriate food/feed additive tolerances must be proposed.
9/Data must be submitted depicting residues in or on rough rice grain (short season varieties) treated 60 days after
~~ planting at 6 Ib ai/A and harvested 56 days after treatment. Both ground and aerial applications must be made, in
separate tests, according to the label directions. Tests must include the use of both EC and SC/L formulations.
Fields must be drained of flood water prior to treatment and reflooded within 24 hours of treatment. Tests must be
conducted in Arkansas (38.6%), California (22.1%), Louisiana (16.0%), and Texas (14.7%), which represent > 90% of
the U.S. rice production States.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
CD
SI58.125 Residue Chemistry
Footnotes (cont'd)
JO/Residues must be determined in the rice grain dust obtained from rough grain bearing measurable weathered residues.
If residues are higher in dust than in the rough grain, a feed additive tolerance must be proposed. Also, feed
additive tolerance revisions representing a 13X concentration in rice bran and, if necessary (if the tolerance for
residues in grain must be revised), a 5X concentration in hulls must be proposed. If the required plant
metabolism and analytical method validation data (refer to footnete 2) indicate that the available rice processing
studies are adequate, the registrant should propose that the feed additive tolerance for residues in rice bran
be revised from 10 ppm to 26 ppm.
11/A metabolism study must be submitted in which crayfish are exposed to [I^C-ringJpropanil for at least 3 days at
a concentration in water sufficiently high to permit complete quantification and characterization of IV-residues
in edible meat. ^-Balance data must be presented for each sample analyzed. Conjugated or bound ^^C-residues
must be characterized. Representative samples from this study must be analyzed using current and proposed residue
procedures (including FDA mult ires idue methods) to ascertain that the methods are capable of accurately quantifying
all residues of toxicological concern. This study should be completed and submitted prior to initiation of the
crayfish field residue trial required below (footnote 12).
J^/Data must be submitted depicting residues in crayfish harvested in early December following treatment of short-
season rice fields in Louisiana in mid-July at 6 Ib ai/A. The studies may be conducted in conjunction with those
' required for rice grain. A tolerance for residues in crayfish must be proposed. As an alternative to submitting
the crayfish metabolism and residue studies, the following label restrictions may be implemented: "Do not apply to
fields where commercial crayfish farming is practiced and do not drain water from treated,fields into areas where
crayfish fanning is practiced." : •
r3/Data must be submitted depicting residues in catfish collected 0, 3, 7, 14, 21, and 28 days after the fish are
transferred to a catfish-farming reservoir initially containing 15 ppb propanil residues. A tolerance for residues
in catfish must be proposed. Alternatively, the following label restriction may be implemented: "Do not drain
water from treated fields into areas where catfish farming is practiced." [The catfish residue trial should not be
initiated until the fish bioaccuraulation study required under Guideline No. 165-4 has been submitted for evaluation
by the Agency.]
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
§158.125 Residue Chemistry
Footnotes (cont'd)
J^f/On receipt of all data pertaining to metabolism, analytical methods and feed items, the adequacy of the available
cattle feeding study will be determined and specific requirements for a poultry feeding study will be outlined.
Jj>/0n receipt of the required data for plant metabolism and analytical method validation, additional data may also be
required for the straw and grain of barley, oats, and wheat; the processed products of rice; and rice straw. ALL
REQUIRED PLANT METABOLISM AND ANALYTICAL METHOD VALIDATION DATA MUST BE SUBMITTED FOR EVALUATION BY THE AGENCY PRIOR
TO INITIATION OF RESIDUE FIELD TRIALS AND PROCESSING STUDIES.
MD
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PROPANIL
Data
§158.
Requirement
i
135 Toxicology
Test
Substance
Use
Patterns
Does EPA
Have Data?
Must Additional
Bibliographic Data Be
Citation Submitted?
Timeframe
for
Submission
Acute Testing
81-1
81-2
81-3
81-4
cn
0 81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal - Rabbit
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
NoV
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Subchronic Testing
82-1
82-2
82-3
82-4
- 90-Day Feeding
- Rodent
- Nonrodent
- 21 -Day Dermal - Rabbit
- 90-Day Dermal - Rabbit
- 90-Day Inhalation - Rat
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
Yes
No
No
No
No
40402901 No
Nq2/
Yes
No3/
No3/
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
Must Additional
Test Use Does EPA Bibliographic Data Be
Data Requirement Substance Patterns Have Data? Citation Submitted?
Timeframe
for
Submission
§158.135 Toxicology
Subchronic Testing
82-5 -
Chronic
83-1 -
83-2 -
83-3 -
83-4 -
90-Day Neurotoxicity
- Hen
— Mammal
Testing
Chronic Toxicity - Two Species
- Rodent
- Nonrodent (Dog)
Oncogenicity - Two Species
- Rat (Preferred)
- Mouse (Preferred)
Teratogenicity - Two Species
- Rat
- Rabbit
Reproduction - Rat
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A No NqV
A No NqV
A No Yes
A No Yes
A No Yes
A Partially 00155215 Yes£/
A Yes 00058588 No
A Yes 00058589 No
A Yes 00036091,00015419 Nq6/
V
50 Months
50 Months
50 Months
50 Months
2-Generation
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Hist Additional Timeframe
Bibliographic Data Be for
Citation Submitted? Submission
ro
§158.135 Toxicology
Mutagenicity Testing
84-2 - Gene Mutation (Anes Test)
84-2 - Structural Chromosomal
Aberration
84-4 - Other Genotoxic Effects
Special Testing
85-1 - General Metabolism
TGAI
TGAI
TGAI
PAI or
PAIRA
A
A
Yes 00155084,00155085, No
00152096
Yes 00155083 No
Yes 00155085,00152096 No
No Yes
24 Months
VNot required since propanil is not expected to elicit a neurotoxic reaction.
2/Not required since a chronic nonrodent study is required.
j}/Based on the registered use patterns, this study is not required.
4/This study is not required since the acute neurotoxicity study is not required.
5/lt must be demonstrated that the highest dose tested (180 ppm) was the maximum tolerated dose (MTD). NOELs must
be established for bilateral retinal degeneration in males and females and thyroiditis in females (for the 85.4%
technical). Depending on the outcome of the above issues an additional mouse oncogenicity study may be required.
6/Pending review of the impurity profile of the two registered technicals, this study may need to be repeated.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL
Data Requirement
§ 1 58 . 1 30 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Pho t odegradat ion
161-2 - In Water
Ul
0-4
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Test
Substance
TGAI or
PAIRA
TGAI or
PAIRA
TGAI or
PAIRA
TGAI or
PAIRA
TGAI or
PAIRA
TGAI or
PAIRA
TGAI or
PAIRA
TGAI or
PAIRA
Use Does EPA
Patterns Have Data?
A,C Partially
. •
A,C No
A No
A No
A No
A No
C No
C No
Must Additional
Bibliographic Data Be
Citation Submitted?
00111395 YesV
Yes
Yes
No£/
Yes
Yes
Yes
Yes
Timeframe
for
Submission
9 Months
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
Data Requirement
§158.130 Environmental Fate
Mobility Studies
163-1 - Leaching and
Adsorpt ion/ Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
Dissipation Studies - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-Term
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
Test
Substance
TGAI or
PAIRA
TEP
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or
PAIRA
Use
Patterns
A,C
A,C
A,C
A
C
—
A,C
A,C
A,C
C
A,C
Does EPA
Have Data?
Partially
No
No
No
No
No
No
No
No
No
No
Must Additional
Bibliographic Data Be
Citation Submitted?
00080125,00143619, Yes3/
00143620
No2/
Nq2/
Yes
Yes
NoV
Reserved^/
Yes
Reserved^/
Yes
Yes
Timeframe
for
Submission
12 Months
27 Months
27 Months
39 Months
39 Months
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Mist Additional Timeframe
Bibliographic Data Be for
Citation Submitted? Submission
§158.130 Environmental Fate
Accumulation Studies (cont'd)
165-5 - In Aquatic Nontarget
Organisms
Special Studies
Ground Water Monitoring
TEP
TEP
No
No
Reserved?/
Reserved**/
J/Data on the hydrolysis of propanil at pH 5 are required.
2/Not required, based on currently registered use patterns.
3/Data on the mobility of aged propanil are required.
4/Not required because there are no forestry uses for propanil.
VReserved pending results of the snort-terra soil dissipation study. The study will be required if more than half
of the applied material remains at the time of the next recommended application.
6/Required if detectable residues are found in the confined rotational crop study.
2/Reserved pending the results of the fish bioaccumulatiort study.
8/Pending the results of acceptable leaching and soil field dissipation studies, a ground water monitoring study
may be required. A ground water monitoring study protocol must be submitted, reviewed, and approved prior to
conducting study.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FROPANIL
Data Requirement
Test
Substance
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data Be
Submitted?
Time frame
for
Submission
§158.145 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
in - Upland Game Bird
- Waterfowl
71-5 - Simulated Field Testing
- Mammals
- Birds
- Actual Field Testing
- Mammals
- Birds
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
TEP
TEP
A,C
A.CI/
A,C
A,C
A,C
A,C
A,C
A,C
A,C
A,C
No
PartiallyV 00088872
No
N/A3/
No
No
No
No
No
No
Yes
Yes
Yes
No
Reserved2/
Reserved^/
i
Reserved^/
Reserved^/
•
Reserved2/
Reserved2/
9 Months
9 months
9 Months
-------
TABLE A
UEINCJVJ.U LiAirt luu^uiiuu-iEiNiD r\jR rnurfliMiJ.! v,cont a^
Test
Data Requirement Substance
§158.
Use
Patterns
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data Be
Submitted?
Timeframe
for
Submission
145 Wildlife and Aquatic Organisms
Aquatic Organism Testing
72-1 - Freshwater Fish Toxicity
^"72-2
72-3
, .- •
72-4
72-5
72-6
72-7
- Coldwater Fish Species
- Warmwater Fish Species
- Coldwater Fish Species
- Warmwater Fish Species
- Acute Toxicity to Freshwater
Invertebrates
- Acute Toxicity to Estuarine
and Marine Organisms
- Fish Early Life Stage and
Aquatic Invertebrate
Life Cycle
- Fish Life Cycle
- Aquatic Organism
Accumulation
- Simulated or Actual Field
Testing - Aquatic Organisms
TGAI
TGAI
TEP
TEP
TGAI
TEP
TGAI
TGAI
TCAI
TGAI
TEP
A,Cl/
A,C
C
C
A,c]y
c
c
c
c
c
c
Yes 00084821
Yes 00124276
No
No
Yes 00124277
No
Partially*/ 00111392
00111391
Partially^/ 00117967
No
No
No
No
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Reserved2/
Reserved2/
9 Months
9 Months
9 Months
12 Months
15 Months
27 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL (cont'd)
§158.145 Wildlife and Aquatic Organisms
Footnotes
V Required to support the manufacturing- use product.
^/Reserved pending receipt and review of environmental fate data.
currently a requirement.
4/ Insufficient data submitted with study. Submission of required data may result in fulfillment of this data
requirement.
en
CD
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL
Data Requirement
§158.150 Plant Protection
121-1 - Target Area Phytotoxicity
Nontarget Area Phytotoxicity
Tier I
122-1 - Seed Germination/ Seed ling
Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
Tier II
123-1 - Seed Germination/Seedling
Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
Tier III
124-1 - Terrestrial Field
124-2 - Aquatic Field
Test
Substance
EP
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
Use
Patterns
A,C
A
A
C
A
A
C
C
C
Does EPA
Have Data?
N/AV
No
No
No
No
No
No
No
No
Must Additional
Bibliographic Data Be
Citation Submitted?
No
Yes
Yes
Yes
Reserved^/
Reserved^/
Reserved2/
Reserved^/
Reserved3/
Time frame
for
Submission
9 Months
9 Months
9 Months
currently a requirement.
2/Reserved pending results of Tier I.
jj/Reserved pending results of Tier II.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRQPANIL
Data Requirement
Test Use Does EPA
Substance Patterns Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Tuneframe
for
Submission
§158.155 Nontarget Insect
Nontarget Insect Testing - Pollinators
141-1 - Honey Bee Acute Contact TGAI
Toxicity
141-2 - Honey Bee - Toxicity of
Residues on Foliage
141-4 - Honey Bee Subacute Feeding
Study
141-5 - Field Testing for
Pollinators
Nontarget Insect Testing - Aquatic
Insects
142-1 - Acute Toxicity to Aquatic
Insects
142-1 - Aquatic Insect Life
Cycle Study
142-3 - Simulated or Actual Field
Testing for Aquatic
Insects
143-1 - Nontarget Insect
thru Testing - Predators
143-3 and Parasites
TEP
(Reserved)2/
TEP
(Reserved)^/
(Reserved)^/
(Reserved)^/
(Reserved)3/
Yes
00018842
No
NoV
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PROPANIL (cont'd)
§158.155 Nontarget Insect
Footnotes
jy Since data from the acute contact test indicate low toxicity, no further testing is required.
2/Reserved pending development of test methodology.
3/Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PROPANIL
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
Test
Substance
TEP
TEP
TEP
TEP
Use
Pattern
A
A
A
A
Does EPA
Have Data?
No
No
No
No
Bibliographic
Citation
Most Additional
Data Be
Submitted?
NoV
NoV
NoV
NoV
Timeframe
for
Submission
J_/Based on acute toxicity and use patterns, no data are required at this time.
ON
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPANIL
Test
Data Requirement Substance
§158.
61-1
61-2
61-3
120 Product Chemistry
- Product Identity and
Disclosure of
Ingredients
- Description of Beginning
Materials and
Manufacturing Process
- Discussion of Formation
of Impurities
MP
MP
MP
Use
Patterns
All
All
•
All
Does EPA Bibliographic
Have Data?1 / Citation1 /
No
No
No
N/A
N/A
N/A
Must Additional Timeframe
Data Be for
Submitted? Submission
Yes2_/
Yes3_/
YesV
January, 1988
January, 1988
January, 1988
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2
62-3
- Certification of Limits
- Analytical Methods to Verify
Certified Limit
MP
MP
MP
All
All
All
No
No '
No
N/A
N/A
N/A
Yes£/
Yesfy
Yes?/
12 Months
12 Months
12 Months
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
- Color
- Physical State
- Odor
- Density, Bulk Density, or
MP
MP
MP
MP
All
All
All
All
No
No
No
No
N/A
N/A
N/A
N/A
Yes**/
YesjV
Yes|V
Yes8/
6 Months
6 Months
6 Months
6 Months
Specific Gravity
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPANIL (cont'd)
Data Requirement
Test
Substance
Use
Patterns
Mast Additional
Does EPA Bibliographic Data Be
Have Data?1/ Citation1/ Submitted?
Timeframe
for
Submission
§158.120 Product Chemistry
Physical and Chemical Characteristics
(cont'd)
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64-1
- pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements
- Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All ,
All
All
All
All
All
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
Yes8/9/
YeS8/U)/
Yes*/1!/
Yes8/12/
Yes^/
Yes8/B/
Yes8_/M/
Yes£/
No
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPANIL (cont'd)
§158.120 Product Chemistry
Footnotes
j_/Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each manufacturing-use product. New requirements have been introduced
and previously submitted data must be updated. Therefore, bibliographic citations for the old data are not
applicable.
2/The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts Service (CAS) Registry
Number, and purpose of the active ingredient and each intentionally added inert must be provided. For the active
ON ingredient, the following must also be provided: the product name, trade name, and common name; the molecular,
U1 structural, and empirical formulas; the molecular weight or weight range; and any experimental or internally
assigned company code numbers.
^/Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
' reaction, equipment used to produce each intermediate and the final product, reaction conditions including
specification of the available conditions of temperature, pressure and pH, the duration of each step of the
process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, producer, or supplier of each beginning material must be provided, along with information regarding
the properties of each beginning material used to manufacture each product.
4/A detailed discussion of all impurities that are or may be present at >_ 0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. The discussion must include all details regarding possible formation of
dibenzo-p-dioxins and dibenzofurans.
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.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING PROPANIL (cont'd)
§158.120 Product Chemistry
Footnotes (cont'd)
(>/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 to 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.
^/Analytical methods must be provided to determine the active ingredient and each toxicologically significant impurity
and intentionally added inert for which certified limits are required. Each method must be accompanied by validation
studies indicating its accuracy and precision. These methods must be suitable for enforcement of certified limits.
8/Physicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing action,
flammability, explodability, storage stability, viscosity, miscibility, and corrosion characteristics) as required
in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D must be submitted.
9/Required if the test substance is dispersible with water.
^0/Required if the product contains an oxidizing or reducing agent.
\\jRequired if the product contains combustible liquids.
_^2/Required if the product is potentially explosive.
JJV Required if the product is a liquid.
^4/Required if the product is a liquid and is to be diluted with petroleum solvents.
-------
Ox
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PROPANIL
Test
Data Requirement Substance
§158.
Acute
81-1
81-2
81-3
81-4
81-5
8f-6
135 Toxicology
Testing
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity -
Rabbit
- Acute Inhalation Toxicity -
Rat
- Primary Eye Irritation -
Rabbit
- Primary Dermal Irritation -
Rabbit
- Dermal Sensitization -
MP
MP
MP
MP
MP
MP
Use
Pattern
A
A
A
A
A
A
Must Additional Timeframe
Does EPA Bibliographic Data Be for
Have Data? Citation Submitted? Submission
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Guinea Pig
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
68
-------
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)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the .skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(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)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
69
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 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 product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
70
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table- in 40
CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
71
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instrtictions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
72
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
~3 —
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
a i /unit area
All products
i
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
04
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SIH1ARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I. II. and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
5
All products
in Categories
I, II, and III
i
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
PKKtaKKKU
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above .
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
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SUMMARY-8
ITEM
8C
9A
9B
IDA
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150'F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Chapter 1~ Environmental Protection Agency
$162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following}
(i) The name/ brand/ or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer/ registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section; <
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility, (i) All words/ statements/
graphic representations/ designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision/ and must be placed
with such conspicuousness (as compared with other words/ state-
ments/ designs/ or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and" •
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However/ the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary/ all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
76
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act/ "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk-containers--(A) "Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to $ 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
77
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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 ana* accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or v
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to S 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall he considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°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."
78
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on^the label, preceded by the phrase "CPA Registration
No.," or the ptirase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.*, of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form/ a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients* and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement, (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
79
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in" tecms of weight-to-weight. The sum'of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
80
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Hazard indicators
Oral LD5fl
Inhalation LC
Dermal U>-rt
5O
Eye affects
Skin effects
1
Up to and
Including
50 «g/kg
Up to and
. 1 nc 1 ud 1 ng
.2 ng/l Iter
Up to and
Including
200 mg/kg
Corrosive;
corneal opacity
not reversible
• ltf» In 7 days
Corroslva.
Toxic Ity <
II
Prow 50 thru
500 mg/kg
From .2 thru
2 mg/l Itar
From 200
thru 2000
Cornea 1 opacity
reversible
vlthln 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
rategorles
III
F-am 500 thru
5000 mg/kg
F-o» 2 thru
20 mg/llter
Fran 2,000 thru
20,000
No corneal opacity;
Irritation
reversible
vlthfn 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/Mter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned
the basis of its oral, inhalation or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
(B) Toxicity Category II.
to Toxicity Category I on
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV,
criteria of Toxicity Category
the signal word "Caution."
All pesticide products meeting the
II shall bear on the front panel'
All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing/ storage or use is
demonstrated by^the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1) ( iii) (A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of .purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 5 to 10..
Above IS to 30
Over 30
Poir
Required
signal word,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
82
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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;
category
Precautionary statements by toxic I ty category
Oral. Inhalat'on. or dermal toxlclty
Shin and eye local effects
I .
II
III . .
IV .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through sklnl. Do not breathe
vapor (dust! or sprajr mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
May be fatal If swallowed {Inhaled or
at so -bed through the sklnl. Oo not breathe
vapors (dust or spray ulstl. Do not get ln|
eyes, on skin, or on clothing. (Appropriate)
aid statements required.!.
Harmful If Swallowed (Inhaled or absorbed
through the sklnl. Avoid breathing vapors
(dust or spray Mist). Avoid contact with
sk'n (eyes or clothlngl. (Appropriate
first aid statement required.!.
(No precautionary statements required.!.
Corrosive, causes eye and skin damage lor
sktn Irritation!. Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.I
Causes eye (and skin! Irritation. Oo not
get In eyes, on skin, or on clothing.
Hanaful If swallowed. (Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
ilcal attention If Irritation pers'sts.
(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
83
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD$Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC$Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, or-
a subacute dietary LCso of 500 ppm or less, the statement "This
Pesticide is Toxrc" to"'Wildlife" is required.
(D) If "either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash oolnr
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or belc« 20'F; If tnere Is a
flashback at any .valve opening.
Flash point above 20*F and not over 80*F or If
the flan* extension Is more than 18 In* long
at a distance of 6 In. fro* the flame.
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
ISO'F may cause bursting.
Flammable. Contents under pressure. Keep away
fro« heat, sparks, and open flame. Oo not
puncture or Incinerate container. Exposure to
temperatures above t30*F may cause bursting.
Contents under pressure. Oo not use or store
near heat or open flame. Oo not puncture or
Incinerate container. Exposure to tempera-
tures above t30*F may cause bursting.
(B) NONPRESSURI ZED CONTAINERS
Extremely flammable. Keep e«ay from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Oo not use or store near heat or open flame. j
84
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(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the""pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompany..ng 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:
(I) The label clearly shows that the product is intended for
use~only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(2) The product will not come into the hands of the general
public except after incorporation into finished products; and
(_4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(I) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) Th« Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(.3) The product is also a drug and regulated under the provisions
of "the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(I) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
85
-------
(2) The label clearly states that the product is intended for
use~only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(30 The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use":
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CPR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in S 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who. is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
86
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product, for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of S 162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in $ 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators* the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation
(k) Advertising. [Reserved]
140 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978]
87
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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 not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 1308F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
88
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
89
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products Intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
90
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must
based on container type, listed
Container Type
bear container
below:
disposal instructions
Statement
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning* If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused lf dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
^J Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
91
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EPA Compendium of Acceptable Uses
3',4'-DICHLCROPROPIONANILIDE
TABLE OF CONTENTS
Site Name Pase
TERRESTRIAL FOOD CROP 4
(Agricultural Crops) 4
AQUATIC FOOD CROP :S
(Agricultural Crops) 5
Barley, Spring 4
Oats 4
Rice 5
Wheat, Durum 4
Wheat, Spring (hard red) 4
Issued s £-21-86 1-02S£01-i
Provisional Update: 11-06-87
92
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EPA Compendium of Acceptable Uses
' 3', 4'-DICHLOROPROPIONP,NILIDE*
TVPE PESTICIDE! Herbicide
FORMULATIONS!
Tech (85%, 90%, 96%)
EC (3 Ib/gal or 33% a. i. or 33. 1% a. i. or 33.7% a. i. or 33.8%
a. i. or 33% a. i. or 35.9% a. i., 4 Ib/gal or 43.48% a. i. or
43.5% a. i. or 44.5% a. i. or 45% a. i. or 45. 4% a. i. )
SC/L (3 Ib/gal or 35% a.i.)
GENERAL WARNINGS AND LIMITATIONSi A contact postemergent herbicide
for selective control of grasses and broadleaf weeds in durum
wheat, oats, rice fields, spring barley, and spring wheat. Do not
tank mix with, or use carbaryl or any organic phosphate insecticide
within 14 days before or after treatment. Do not use systemic phos-
phate insecticides on fields to be treated. Most chlorinated hydro-
carbons may be used in separate sprays or as seed treatments. Tank
mix sprays may cause some temporary tip burn to crops. Do not add
oils, adjuvants, or liquid fertilizers. Wastes resulting from the
use of this product may be disposed of on site or at an approved
waste disposal facility.
Environmental Hazardsi This pesticide is toxic to fish. Do not ap-
ply when weather conditions favor drift from treated areas. Do not
apply directly to water except as specified on labeling or, for non-
aquatic use, in wetlands (swamps, bogs, marshes and potholes). Do
not contaminate water by cleaning of equipment or disposal of
wastes.
Livestock Tolerances*
Cattle, fat
Cattle, meat
Cattle, mbyp
Eggs
Goats, fat
Goat s, meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses, meat
Horses, mbyp
Milk
Poultry, fat
Poultry, meat
Poultry, mbyp
Sheep, fat
Sheep, meat
Sheep, mbyp
0.1
0.1
0. 1
0.09
0. 1
0. 1
0. 1
0. 1
0. 1
0.1
0.1
O. 1
0.1
0.05
0.1
O. 1
0.1
0. 1
O.I
0.1
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
(N)
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
TIME REQUIRED FOR CONTROLi Three to 5 days.
PHYTQTOXICITY TO TftRGET HEEDSr Causes chlorosis followed by necro-
sis of leaves of susceptible plants.
*Propanil
2-21-86 1-028201-1
.1 ll«x^MA.A* 4 4 S\£ O^
93
Issuedi 2-21-66 I-088201-
Provisional Updatei 11-O6-87
-------
EPA Compendium of Acceptable Uses
'. 3' , V-DICHLORQPROPIONANILIDE
PHYTOTOXICITY TO CROPS; Under some conditions, yellowing or tip
burning is visible.
MODS OF ACTION; Inhibits a number of biochemical reactions, espe-
cially photosynthesis.
BRQADLEAF WEEDS CONTROLLED;
PAAAAAC Broad leaf weeds
PCQATBA Coffeeweed
PCBABBA Common St. Johnswort
PBVAEAA Croton
PEAAHBE Curly dock
PCOBSBB Hemp sesbania
PCQCBAA Indigo
PBDAIBA Kochia
PBDAEAB Larnbsquarter
PBVACBA Mexicanweed
PCQADBB Northern jointvetch
PAFACBC Prostrate pigweed
PAFACBI Redroot pigweed
PEYABBA Redweed
PEAAHAB Sour dock
PBFBVBB Spikeweed
PCAOSBA Texasweed
PBVAEBA Woolly croton
PEAAGBH Wild buckwheat
PBKBKBB Wild mustard
GRASSES AND QTh£R MONCCOT5 CONTROLLED;
PZAAAAO Baronetgrass
PCABHBB Barnyardgrass
PZAAAAP Bashfulweed
PCAAHAA Bluestem
PCABFAP Crabgrass
PCABIBA Goosegrass
PCAAAAA Grasses
PCACUBF Green foxtail
PCABHBD Gulf cockspur
PBMAHBA Horned beakrush
PCACFBJ Hurrahgrass
PCACWBC Johnsongrass
PBMADBC Jointed flatsedge
PCABHBA Junglerice
PCACFBD Knotgrass
PCACFBK Longtom
PCftfiAAI Millet
PBWADAA Nutsedge
PCAARBB Paragrass
PCAAHAA Plains bluestem
PBMADBM Purple nutsedge
(a)
(a)
(a)
Issued: 2-21-86
1-028201-2
94
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PBMABAA
PCAARAA
PBMAEAA
PCACEBL
PCACEBL
PAAAABC
PCACUBF
EPA Compendium of Acceptable Uses
3',4»-DICHLOROPROPIONANILIDE
GROSSES AND OTHER MONOCOTS CONTROLLED (continued)
Sedge
Signal grass
Spikerush
Texas millet
Texas panicum
Wiregrass
Yellow foxtail
(a) Partial control. Weeds temporarily injured but usually
recover.
QQUflTIC WEEDS CONTROLLEDa
PP.FABBA Aligatorweed
PPPAAAN Aquatic Meeds
PAEPDAA Arrowhead
PBMAGAA Bulrush
PFDABAA Cattail
PECACBB Ducksalad
PCYABBA Redstem
PftEftBAA Waterplantain
(a) Partial control.
recover.
(a)
(a)
(a)
(a)
(a)
(a)
(a)
Weeds temporarily injured but usually
Issued: £-21-86
I-028£01-3
95
-------
Site. Dosaoe and
Formulat ion
(lb a. i. /A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
/£4001AA Barlev. Spring
/£4003AA Oats
/£4O07AA Ulheat. Durum
CMAI3
*»
(3 Ib/gal EC)
/£4007AA Wheat. Spring (hara
red)
EPA Compendium of Acceptable Uses
3' , 4» -DICHLOROPROPICNAIMILIDE
Tolerance. Use. Lirnitat ions
1.13-1.50
(3 Ib/gal EC)
CMAI3
**
(3 Ib/gal EC)
0.2 ppm (barley, grain)
(oats, grain)
(wheat, MCPA, isooctyl ester.
Label data incomplete.
Formulated with MCPA, isooctyl ester.
O. £ ppm (wheat, grain)
0.75 ppm (wheat, straw)
General Information: Do not
spring wheat beyond the 5-le
not spray within 600 feet of
body of watar. Do not spray
conditions or allow spray to
cent susceptible crops. Do
frost is expected within £4
temperatures are above 85 F
apply to
af stage. Do
any permanent
under windy
drift to adja-
not apply if
hours or when
(£9.4 C) .
Post emergence. Broadcast. Apply in 15 to
£0 gallons of water per acre by ground or
5 to 10 gallons of water per acre by air
when weeds are in the £- to 4- leaf stage.
Use the higher dosage when weeds are in
the 4- to 6-leaf stage. Make 1 applica-
tion per growing season. May be tank
mixed with MCPA, isooctyl ester.
Label data incomplete.
Formulated with MCPA, isooctyl ester.
Issued: £-£1-86
I-0£8£01-4
96
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EPA Compendium of Acceptable Uses
3',4»-DICHLORQPROPIONANILIDE
Tolerance. Use. Limitations
Site. Dosage and
Formalat ion
(Ib a. i. /A)
Wheat. Soring (hard red) (continued)
CSLN3
1. 1£-1.50
(3 Ib/gal EC)
SLN - Use limited to ND.
Postemergence. Broadcast. For control of
Qreen foxtail, yellow foxtail, and broad-
leaf weeds. Apply in 10 gallons of water
per acre by air. Use the lower dosage
when foxtaiIs are in the £- to 3-leaf
stage and broad leaf weeds are in the £- to
4-leaf stage and actively growing. Use
the higher dosage when foxtaiIs are in the
3 to 4-leaf stage.
AQUATIC FOOD CROP
(Agricultural Crops)
/£4004AA Rice
Issued: £-£1-86
£ ppm (rice)
1O ppm (rice bran, hulls, polishings,
milled fract i ons)
75 ppm (rice, straw)
56 day preharvest interval.
To avoid residues at harvest, do not apply
after mid-tillering stage or later than 60
days after planting rice. Do not exceed a
total of 9 pounds active ingredient per
acre per season. Do not apply to second
rice crop when double cropping .is prac-
ticed.
Water drained from treated rice fields
must not be used to irrigate other crops
or released within one-half mile upstream
of a potable water intake in flowing water
(i.e., river, stream, etc.) or within one-
half mile of a potable water intake in a
standing body of water such as a lake,
pond or reservoir.
General Information: Seedbeds should be
well worked and free of large clods to en-
courage uniform and rapid germination of
rice, grass, and weeds, and to ensure uni-
form flood levels. To prevent more weeds
from germinating after treatment, fields
should be flooded within £4 hours of spray-
ing. Apply to fields which have been
drained of flood water. If the rice is
too small to maintain a flood on the
field, treatment should be delayed until
the rice is larger. Avoid treatment if
I-0£8£01-5
97
-------
Site. Dosage and
Formalat ion
(Ib a. i. /A)
Rice (continued)
4-6
(3, 4 Ib/gal EC)
EPA Compendium of Acceptable Uses
3',4'-DICHLOROPROPIONANILIDE
Tolerance. Use. Limitations
CMAI]
2. £-3.0
(3 Ib/gal EC)
CMAn
£. £-3. 0
(3 Ib/gal EC)
Use limited to CA. Postemergence. Broad-
cast. For control of barnyardgrass. Use
where rice fields are not completely
drained. Apply 30 to 45 days after plant-
ing, before rice is fully tillered, when
barnyard grass extends & to 8 inches above
the water surface. If rice has been deep
flooded, water levels may be lowered. Use
4 pounds active ingredient per acre if
grass has 3 to 5 leaves, S pounds active
ingredient per acre if 5 to 6 leaves, and
6 pounds active ingredient per acre if 7
or more leaves are present. Apply in no
less than 10 to IS gallons of water per
acre using a medium-fine spray. If a high
water level is desired after treatment, re-
flooding may start 1£ hours after treat-
ment.
Use limited to southern United States.
Postemergence. Broadcast. Apply in £0 to
50 gallons of water per acre by ground or
in 10 to 15 gallons of water per acre by
air. Use the lower dosage when rice is in
the 1- to £-leaf stage and the higher cos-
age when rice is in the 3- to 4— leaf
stage. Flood rice fields within 5 days
after treatment. Do not apply through ir-
rigation systems.
Formulated with S-ethyl hexahydro—1H-
azepine-1-carbothioate.
Postemergence. Broadcast. Apply in 15 to
£5 gallons of water per acre by grouno or
in 10 to 1£ gallons of water per acre by
air. Use the lower dosage on coarse sandy
loams and when rice is in the 1- to 3-leaf
stage, and the higher dosage on medium or
fine clay loams. Do not apply in liquid
fertilizer. Do not make more than 1 appli-
cation per season. Do not bale or use
rice straw for feeding or bedding.
Formulated with pendimethalin.
Issued: £-£1-86
I-0£8£01-7
99
-------
Site. Dosage and
Formalat ion
(Ib a. i. /A)
Rice (continued)
4-6
(3, 4 Ib/gal EC)
EPA Compendium of Acceptable Uses
3',4'-DICHLOROPROPIONANILIDE
Tolerance. Use. Limitations
CMAI3
Z. £-3. 0
(3 Ib/gal EC)
CMAID
2. £-3.0
(3 Ib/gal EC)
Use limited to CA. Posternergence. Broad-
cast. For control of barnyardcrass. Use
where rice fields are not completely
drained. Apply 30 to 45 days after plant-
ing, before rice is fully tillered, when
barnyardgrass extends 6 to 8 inches above
the water surface. If rice has been deep
flooded, water levels may be lowered. Use
4 pounds active ingredient per acre if
grass has 3 to 5 leaves, 5 pounds active
ingredient per acre if 5 to 6 leaves, and
6 pounds active ingredient per acre if 7
or more leaves are present. Apply in no
less than 10 to 1£ gallons of water per
acre using a medium-fine spray. If a high
water level is desired after treatment, re-
flooding may start 1£ hours after treat-
ment.
Use limited to .southern United States.
Postemergence. Broadcast. Apply in £0 to
5O gallons of water per acre by ground or
in 10 to IS gallons of water per acre by
air. Use the lower dosage when rice is in
the 1- to £-leaf stage and the higher cos-
age when rice is in the 3- to 4— leaf
stage. Flood rice fields within 5 days
after treatment. Do not apply through ir-
rigation systems.
Formulated with S-ethyl hexahydro-lH-
asepine-l-carbothioate.
Postemergence. Broadcast. Apply in 15 to
£5 gallons of water per acre by ground or
in 10 to 1£ gallons of water per acre by
air. Use the lower dosage on coarse sandy
loams and when rice is in the 1- to 3-leaf
stage, and the higher dosage on medium or
fine clay loams. Do not apply in liquid
fertilizer. Do not make more than 1 appli-
cation per season. Do not bale or use
rice straw for feeding or bedding.
Formulated with pendimethalin.
Issued: £-£1-86
I-0£8£01-7
99
-------
EPfl Compendium of Acceptable Uses
3»,4»-DICHLOROPROPIONBIMILIDE
Tolerance. Use. Limitations
9001500
Site. Dosage and
Formalat ion
(Ib a. i. /ft)
QERIflL PND TflNK MIX flPPLICflTIONS
flerial Application
— Refer to
99OO30O
Tank Mix
TERRESTRIQL FOOD CROP
(Agricultural Crops)
Barley, Spring; Oats; Wheat, Durum; Wheat,
Spring
flQUflTIC FOOD CROP
(floricultural Crops)
Rice
Refer to
TERRESTRIflL FOOD CROP
(Poricultural Crops)
Barley, Spring; Oats; Wheat, Durum
Issued: £-21-66
I-028201-8
100
-------
EPA Compendium of Acceptable Uses
3',4'-DICHLOROPROPIONflNILIDE
• Listing of Registered Pesticide Products by Formulation
&OS5.OOOt 85% technical chemical
3»,4'-dichloropropionani1ide <0£8£01)
O00707-O0108
&09O.OOO1 9O* technical chemical
3',4'-dichloropropionanilide <0£fl£01)
056077-00033
&096.O001 96% technical chemical
3',4'-dichloropropionanilide <0£S£01>
000707-00181
&£33.001£ 33'X (3 Ib/oal) ernulsif iable concentrate
3' , 4'-dichloropropionani1ide (0£8£01) plus £-methyl-4-chlorophen-
oxyacetic acid, isooctyl ester (030563)
000707-0018£*
*incomplete label
&£33.101£ 33.1% (3 Ib/pal) emulsifiable concentrate
3',4'-dichloropropionanilide (0£8£01) plus S-ethyl hexahydro-lH-
azepine-1-carbothioate <04140£)
000476-0££36
&£33.701£ 33.7% (3 Ib/gal) emulsifiable concentrate
3' ,4'-dichloropropionani1ide (O£8£01) plus N—(1-ethylpropyl)-3,4-
dimethyl-£,6-dinitrobenzenamine (108501)
038167-00010
&-£33.801£ 33.8% (3 Ib/gal) emulsif iable concentrate
31 ,41-dichloropropionanilide (0£8£01)
O00707-O0075
(000707-00075) NDS00011 . ,
&£35.001£ 35% (3 Ib/gal) emulsifiable concentrate
3',4'-dichloropropionanilide (O£8£O1)
0007O7-OOO94 OOO7O7-00110 001439-OO££9# 048957-00010
056077-00035
^extracted from fiche
&£35.9012 35.9% (3 Ib/oal) emulsifiable concentrate
3' ,4»-dichloropropionani1ide (0£S£01)
019713-00030
&£43.481£ 43.48'X (4 Ib/nal) emulsifiable concentrate
3', 4' -dichloropropionanilide (0£8£01)
005905-0018£ 056077-O0034
&£43.501£ 43.5% (4 Ib/aal) emulsifiable concentrate
3' ,4'-dichloropropionani1ide (0£8£O1)
000707-00109
Issued: £-£1-86 I-O£8£01-9
101
-------
EPfl Compendium of acceptable Uses
3» , 4'-DICHLQROPROPIONflNILIDE
Listing of Registered Pesticide Products by Formulation (continued)
&244.5012 44.5% (4 Ib/gal) emulsifiable concentrate
3»,4'-dichloropropionanilide (028201)
O007O7-00112
&245.OO12 45% (4 Ib/gal) emulsifiable concentrate
3' ,4' -dichloropropionani1ide (028201)
0059O5-O0077 009779-00272 019713-00031 048957-00008
&245.4012 45.4% (4 lb/aal) emulsifiatale concentrate
3» f4*-dichloropropionanilide (028201)
O46193-OOOO8
S235.0015 35* (3 Ib/nal) soluble concentrate/liquid
3' ,4»-dichloropropionanilide (028201)
005905-00068 013166-00014 042545-00046 049857-00009
Issued: 2-21-86 I-O28201-1O
102
-------
EPA Compendium of Acceptable Uses
3',4'-DICHLOROPROPIONANILIDE
Appendix A-l
Listing of Active Ingredient
-------
EPA Compendium of Acceptable Uses
3',4»-DICHLOROPROPIONANILIDE
Appendix A-2
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
030563 MCPA, isooctyl ester 2-methyl-4-chloro-
phenoxyacetic acid,
isooctyl ester
Issued: 2-21-86 1-028201-12
104
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
• and its predecessor 'agencies in "support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
105
-------
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship Is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses .
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
106
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00015419 Ambrose, A.M.; Larson, P.S.; Borzelleca, J.F.; et al. (1972) Toxi-
cologic studies on 3',4'-Dichloropropionanilide. Toxicology and
Applied Pharmacology 23(? ):650-659. (Also in unpublished sub-
mission received Mar 22, 1976 under 5F1606; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:094375-A)
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 California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-B)
00035576 Monsanto Company (1969) Summary of Residue Findings: Rogue. (Un-
published study received Sep 18, 1971 under 1F1036; CDL:
091920-A)
00035587 Beasley, R.K.; Conkin, R.; Lauer, R.; et al. (1970) Final Report on
Rogue Residues: Identification and Analysis: Part I—Determina-
tion of Extractable DCA, DCPA, and TCAB from Soil, Immature
Plants, Straw, and Mature Rice Grain: Agricultural Research and
Development Report No. 175. (Unpublished study received Sep 18,
1971 under 1F1036; submitted by Monsanto Co., Washington, D.C.;
CDL:091920-L)
00035588 Briner, R.C.; Vervynck, D.J.; Lipptnan, A.E.; et al. (1970) Final
Report on Rogue Residues: Identification and Analysis: Part II—
Identification of Insoluble Metabolites: Agricultural Research
and Development Report No. 183. (Unpublished study received Sep
18, 1971 under 1F1036; submitted by Monsanto Co., Washington,
D.C.; CDL:091920-M)
00035589 Khalifa, R.A.; Lippman, A.E.; Huber, S.A.; et al. (1970) Final Re-
port on Rogue Residues: Identification and Analysis: Part III—
Soluble Metabolites: Agricultural Research and Development Re-
port No. 185. (Unpublished study received Sep 18, 1971 under
1F1036; submitted by Monsanto Co., Washington, D.C.; CDL:
091920-N)
00035683 Rohm and Haas Company (1966) Storage Stability of Stam Residues.
(Unpublished study received Jun 11, 1970 under OF0932; CDL:
091588-B)
-1-
107
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00035684 Hudgins, R.H.; Viste, K.L.; Smith, R.J.; Jr.; et al. (1961) Decline
and Residue Study of Stain F-34 on Rice Plants. Includes method
entitled: Residue Determination with the Use of 14C Labelled
Stan F-34. (Unpublished study received Jun 11, 1970 under
OF0932; prepared in cooperation with Texas A & M Univ., Agri-
cultural Experiment Stations and others, submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL:091588-C)
00035687 Mueller, K.E.; Cherry, W.F.; Smith, L.G.; et al. (1966) Stam Resi-
dues on Rough Rice. (Unpublished study including Research Re-
port No. 57-24; received Jun 11, 1970 under OF0932; prepared in
cooperation with Univ. of Arkansas', Agricultural Extension Ser-
vice, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
091588-F)
00035688 Cherry, W.F.; Johnson, W.H.; Owens, F.C.; et al. (1967) Residues
of Stam F-34 on Rice. (Unpublished study received Jun 11, 1970
under OF0932; submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:091589-A)
00035692 Johnson, W.H.; Hendrick, R. (1965) Crayfish from Rice Fields Resi-
due Data. (Unpublished study received Jun 11, 1970 under
OF0932; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
091589-E)
00035694 Gordon, C.F. (1967) A Study To Determine Residue Levels in Milk and
Tissues from Cows Fed Stam Residues as Found in Rice Bran and
Straw: 23-5. (Unpublished study received Jun 11, 1970 under
OF0932; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
091589-G)
00035695 Rao, M.R.; Edmonds, R.S. (1967) Feeding Rice By-Products Containing
Residues from Stam to Dairy Cows To Obtain Samples of Milk and
Tissues for Residue Analyses: Project # 20-201. (Unpublished
study received Jun 11, 1970 under OF0932; prepared by A.M.E. As-
sociates1, submitted by Rohm & Haas Co., Philadelphia1, Pa.; CDL:
091589-H)
00035697 Gordon, C.F.; Haines, L.D. (1967) A Study To Determine Residue
Levels in Eggs and Tissues from Chickens Fed either C14-Labeled
Stam or Stam Residues as Found in Rice Straw. (Unpublished
study received Jun 11, 1970 under OF0932; submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL.-091589-J)
-2-
108
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00035698 Gabriel, K.L.; Eoff, H.J. (1966) Studies of the Administration of
Pelleted Feeds Containing Radioactive Stan to Poultry: Project
# 20-157. (Unpublished.study received Jun.11, 1970 under
OF0933; prepared by A.M.E. Associates and Whitmoyer Laborator-
ies, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
091589-K)
00035699 Lyroan', W.R. (1966) Residues from C14-Stam in Milk, Eggs and Meat:
Part I—Cows; Part II—Hens: Research Report No. 57-25. (Unpub-
lished study received Jun 11, 1970 under OF0932; submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:091589-L)
00035905 Gabriel, K.L. (1965) Feeding of Radioactive Stam to Cattle and
Chickens: Project # 20-122. (Unpublished study received Jun 11,
1970 under OF0932; prepared by A.M.E. Associates1, submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:091589-M)
00036091 Borzelleca, J.F.; Ambrose, AoM.; Larson1, P.S. (1966) Three Genera-
tion Reproduction Study on Rats Receiving Stam F-34 in Their
Diet. (Unpublished study received Jun 11, 1970 under OF0932;
prepared by Medical College of Virginia, Dept. of Pharmacology,
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:091587-R)
00036100 Yih, R.Y.; McRae, D.H. (1965?) Studies on Metabolism of 3f,4'-Di-
chloropropionanillde (Stam) in Rice. (Unpublished study re-
ceived Jun 11, 1970 under OF0932; submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:091587-AB)
00052347 Henshall, A.; Lauer, R.; Beasley, R.; et al. (1970) Final Report on
Rogue Residues: Identification and Analysis—Part VI: Residue
Method Development Studies and the Determination of Recoverable
3,4-Dichloroanilene in Field-Treated Rice, Meat, Milk', and Eggs:
Agricultural Research and Development Report No. 184. (Unpub-
lished study received Sep 19, 1971 under 1F1036; submitted by
Monsanto Co., Washington, D.C.; CDL:091921-B)
00052348 Marvel, J.; Ho, C.; Wolfe, V. (1970) Final Report—Part VII on
Rogue Residues: Identification and Analysis—TCAB Translocation
and Fate: Agricultural Research and Development Report No. 191.
(Unpublished study received Sep 19, 1971 under 1F1036; submitted
by Monsanto Co., Washington, D.C.; CDL:091921-C)
-3-
109
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00052349 Sutherland, M.L.; Curtis, T.G.; Drosten, B.; et al. (1970) Final
Report on Rogue Residues: Identification and Analysis-^Part
VIII: Transpiration Studies in-Rice:.-Agricultural Research and
Development Report No. 190. (Unpublished study received Sep 19,
1971 under 1F1036; submitted by Monsanto Co., Washington1, D.C.;
CDL:091921-D)
00052350 Sutherland, M.L.; Suba, L.; Marco, G.J.; et al. (1970) Final Report
on Rogue Residues: Identification and Analysis, Part IX: Plant
Fractionatlon: Agricultural Research and Development Report
No. 192. (Unpublished study received Sep 19, 1971 under 1F1036;
submitted by Monsanto Co., Washington, D.C.; CDL:091921-E)
00055546 Rohm and Haas Company (1979) Efficacy of Stampede on Cereal Grains
and Various Crops. (Unpublished study received Oct 21, 1980
under 707-75; CDL:243518-A)
00055547 Rohm and Haas Company (1965?) Gas Chromatographic Determination of
Residues of 3',4',Dichloropropionanilide, the Active Ingredient
of Propanil. Undated method. (Unpublished study received Oct
21, 1980 under 707-75; CDL:243518-B)
00058588 Kara, C.; Stevens, K.R.; Gallo, M.A. (1980) Teratologic Evaluation
of Stam Technical in the Albino Rat: Snell Project # 10065-008.
(Unpublished study received Feb 11, 1981 under 707-75; prepared
by Booz, Allen & Hamilton, Inc., submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:224328-A; 244329; 244330; 244331)
00058589 Florek, M.C.; Christian, M.S.; Christian, G.D.; et al. (1980) Stam
Technical Teratogenicity Study in Rabbits: Argus Project 018-
001; Rohm and Haas Company Study 80P-113. (Unpublished study
received Feb 12, 1981 under 707-75; prepared by Argus Research
Laboratories, Inc., submitted by Rohm & Haas Co., Philadelphia,
Pa.; CDL:244332-A)
00067394 Rohm & Haas Company (1966) Determination of Microquantities of
Stam F-34 in Plant Tissues. Method dated May 12, 1966.
(Unpublished study received Mar 2, 1977 under 707-EX-89;
CDL:228162-D)
00076113 Rohm and Haas Company (1965) Stam Residue Method: Method Reproduc-
ibility: RAR Memorandum No. 357. (Unpublished study received
Dec 23, 1969 under OF0932; CDL:093238-J)
-4-
110
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00078930 Rohm & Haas Company (1980) Summary and Discussion: Stampede.
(Unpublished study received Jul 14, 1981 under 707-75; CDL:
070183-A)
00080125 Fisher, J.D. (1979) Soil TLC Mobility Study with RH-8817: TR 34H-
79-27. (Unpublished study received Aug 6, 1981 under 707-EX-
98; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
070260-C)
00084821 LeBlanc, G.A.; Wilson, B.F. (1980) Acute Toxicity of Stain Technical
(TD No. 80-198) to Rainbow Trout (Salmo gairdneri): Bio-
nomics Report //BW-80-11-778. (Unpublished study received Oct 7,
1981 under 707-75; prepared by EG & G, Bionomics, submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:246087-B)
00088872 Piccirillo, V.J.; Orlanfco, D.A. (1981) Eight-day Dietary LC50
Study in Bobwhite Quail with Stain Technical: Borriston.Project
No. 202-Q. (Unpublished study, including submitter summary, re-
ceived Dec 17, 1981 under 707-75; prepared by Borriston Labora-
tories, Inc., submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:246413-A)
00111367 Monsanto Co. (19??) Residue Study: Rogue in Rice, Dairy Cattle,-
Poultry, and Their Products. (Compilation; unpublished study
received Sep 8, 1970 under 1F1036; CDL:093346-B)
00111370 Rohm & Haas Co. (1978) Stampede Herbicide: (Also Known as Stam
F-34): 3*,4'-dichloropropionanlllde. (Compilation; unpublished
study received Aug 7, 1978 under 707-75; CDL:097298-A; 097299)
00111373 Rohm & Haas Co. (1979) Stampede 3E Herbicide: (Also known as Stam
F-34): 3',4'-dichloropropionanilide. (Compilation; unpublished
study received Feb 16, 1979 under 707-75; CDL:097813-A)
00111388 Rohm & Haas Co. (1961) Residues of Stam F-34 in Rice. (Compi-
lation; unpublished study received Feb 24, 1961 under unknown
admin, no.; CDL:127158-A)
00111391 Sleight, B. (1973) Acute Toxicity of Stam to Atlantic Oyster
(Crassostrea vlrginlca). (Unpublished study received May 16,
1973 under 707-9; prepared by Bionomics, Inc., submitted by
Rohm & Haas Co., Philadelphia, PA; CDL:128509-A)
-5-
111
J
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00111392 Sleight, B. (1973) Acute Toxicity of Stam to Pink Shrimp ... and
Mud Crab (Neopanope texana). (Unpublished study received May
16, 1973 under 707-9; prepared by Bionomics, Inc., submitted by
Rohm & Haas Co., Philadelphia, PA; CDL:128509-B)
00111394 Adler, I. (1973) A Study To Determine Residue Levels in Crayfish
and Catfish Exposed to Known Concentrations of the Herbicide
Stam: Report No. 39-5. (Unpublished study received Oct 9, 1973
under 707-75; submitted by Rohm & Haas Co., Philadelphia, PA;
CDL:129224-A)
00111395 Jones, B.; Adler, I. (1970) Hydrolysis of Propanil in Water as a
Function of pH: Report No. 34-2. (Unpublished study received
Oct 1, 1975 under 707-75; submitted by Rohm & Haas Co., Phila-
delphia, PA; CDL:195113-A)
00117967 Call, D.; Brooke, L.; Kent, R.; et al. (1982) Toxicity, Bioconcen-
tration, and Metabolism of the Herbicide Propanil ... in Fresh-
water Fish. (Unpublished study received Nov 4, 1982 under 707-
109; prepared by Univ. of Wisconsin, Center for Lake Superior
Environmental Studies, submitted by Rohm & Haas Co., Philadel-
phia, PA; CDL:248774-D)
00124276 Graney, R. (1982) The Acute Toxicity of STAM Technical to the
Bluegill Sunflsh (Lepomis macrochirus): Biospherics Project
No. 82-E-401A-BG; Rohm & Haas Protocol No. 82P-305. Final
rept. (Unpublished study received Jan 21, 1983 under 707-75;
prepared by Biospherics, Inc., submitted by Rohm & Haas Co.,
Philadelphia, PA; CDL.-249347-A)
00124277 Graney, R. (1982) The Acute Toxicity of STAM Technical to Daphnia
magna Straus: Biospherics Project No. 82-E-401B-DM; Rohm & Haas
Protocol No. 82P-306. Final rept. (Unpublished study received
Jan 21, 1983 under 707-75; prepared by Biospherics, Inc.',
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:249347-B)
00143619 Garstka, T. (1980) Adsorption and Desorption of Propanil on Soil:
Technical Report No. 34H-80-1. Unpublished study prepared by
Rohm and Haas Co. 105 p.
00143620 Adler, I. (1982) A. Mobility Study with Propanil in Five Soils:
Technical Rept. No. TR36H-82-20. Unpublished study prepared by
Rohm and Haas Co. 9 p.
-6-
112
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Propanil Standard
MRID CITATION
00152096 Simmon, V. (1979) In vitro Microbiological Mutagenicity and Un-
scheduled DNA Synthesis Studies of Eighteen Pesticides. Prepared
by SRI International for the US EPA. Research Triangle Park, NC:
US Enivronmental Protection Agency, Office of Research and De-
velopment, Health Effects Research Lab. EPA-600/1-79-041. 173 p.
00155083 O'Neill, P.; McLeod, P.; McCarthy, K. (1983) Stam(pede) Cytogenetic
Study in Mice: Report No. 82R-255. Unpublished study prepared
by Rohm & Haas. 41 p.
00155084 Kruszewski, F.; McCarthy, K.; Ryers, M. (1984) Stara Technical
CHO/HGPRT Gene Mutation Assay: Report No. 83R-142. Unpublished
study prepared by Rohm & Haas. 59 p.
00155085 Shirasu, Y.; Moriya, M.; Koyashiki, R. (1980) Microbial Mutagenici-
ty Test of DCPA Propanil: Report. Unpublished study prepared by
Rohm & Haas. 7 p.
00155215 Weatherholtz, W. (1983) Twenty-four Month Dietary Oncogenicity
. Study in Mice: Stam Technical: Final Report: Project Noi
417-400. Unpublished study prepared by Hazleton Laboratories
America, Inc. 6120 p.
40402901 McLaughlin, J. (1983) Stam: A Three Month Dietary Study in Mice.
Report Number 82R-0065. Unpublished report prepared by Toxicology
Department, Rohm and Haas Company. 182 p.
-7-
113
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. 30000468
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With tmftet to ctw nquir*m«m to wbmit ~g«uric~ d«U irnpOMd by llM FIFRA action 3(CI(2)(8) nctic* contained in tti* rfl
Guid«nc4 Document. I «ra rtqtondini, in the fottowino, manner
O t. .1 will sibmit dm'm t tiiMy mtnntt to atiriy th« fo^lowmf rtquifimtnta. If KM ten proctdura I mN MM dcvuie dom ior
-------
OMB Appro** No. 3CCOO4CT
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
- .^.
I. I am duty ewdvxued to represent the following fiitn(i) who are subject to the require*
m«nu of • Notiof under FIFHA Section 3(cH2)(B) contained in • Guidance Document
to submit data concerning the active ingredient:
ACTIVC INGMCOICMT
NAME Of PINM
EPA COMPAMV NUMBER
(This firm or group of firms it referred to below »» "my firm".)
2. My firm it willing to develop «nd submit tne d»t» as required by that Notice, if neotttary. However, my firm would orefer to enter
into «n agreement wttft one or more other registrants to develop jointly, or to snare in tne cost of developing, tne following required
items or data:
My firm has offered in writing to tnttr into weft an agreement. Copies of ttM offers art anacftee'. Tfvit offer was irrevocable and included tn offtr te bt
bound by an arbitration decision under FIFRA Section 3(c)(2H8HiiU if final agreement on all terms could not be reached otherwise. Th.i offer was made
to tfie following firm(s) on tfte following datets):
NAMCOF-PIHM
OATE OF OFFER
4. My firm rtojytiu (hat EPA hot
-------
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Registration Standard for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
-
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partiticxi
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)
MRID Numbers
Assigned
116
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flanntability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for ray
product
listed
above
(check
below)
I am camp lying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
117
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OMB 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 PIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer*
*•
(3) An accurate 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 _______ °n fll« 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 time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, ay firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the reglstrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases',
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
EPA Form 8570-27
(Typed)
118
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