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Guidance for the
Reregistration of
Pesticide Products
Containing ROTENONE
as the Active Ingredient
protection
230 South Dearborn Street
Chicago, Illinois 60604
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OMB Control No.2070-0057
Expires November 1989
GUIDANCE FOR THE REREGISTRATION OF PESTICIDE
PRODUCTS CONTAINING ROTENONE
AND ASSOCIATED RESINS
AS THE ACTIVE INGREDIENT
OPP Chemical No. 071003, 071004 and 071001
CASE NO. 0255
CAS (DOCKET) NUMBER: 83-79-4
October 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
Profection
230 South Dearborn Street
Chicago, Illinois 60604
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical 4
B. Regulatory History 5
C. Use Profile 7
III. Agency Assessment 9
A. Summary 9
B. Other Science Findings 10
C. Tolerance Reassessment 18
IV. Regulatory Position and Rationale 20
A. Regulatory Positions 20
B. Criteria for Registration 23
C. Acceptable Ranges and Limits 23
D. Labeling 23
V. Products Subject to this Standard 26
VI. Requirement for Submittal of Generic Data 28
A. What are generic data? 28
B. Who must submit generic data? 28
C. What generic data must be submitted? 29
D. How to comply with DCI requirements 29
E. Registrant Requests Regarding Data
Requirements and Agency Responses 32
F. Test Protocols and Standards 32
G. Procedures for requesting a change in protocol 33
H. Procedures for requesting extensions of time. 33
I. Data Format and Reporting Requirements. ... 33
J. Existing stocks provisions upon suspension or
cancellation 34
VII. Requirement for Submittal of Product-Specific
Data 34
VIII. Requirement for Submittal of Revised Labeling ... 35
IX. Instructions for Submittal 35
A. Manufacturing use products (sole active) . . 35
B. Manufacturing use products (multiple active) 36
C. End use products (sole active) 37
D. End use products (multiple active) 37
E. Intrastate products 38
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APPENDICES
I. DATA APPENDICES
Guide to Tables 39
Table A 41
Table B 73
II. LABELING APPENDICES
Summary of label requirements and table 77-86
40 CFR 156.10 Labeling Requirements 87
Physical/Chemical Hazards Labeling Statements . . 100
Storage Instructions 101
Pesticide Disposal Instructions 102
Container Disposal Instructions 103
III. BIBLIOGRAPHY APPENDICES
Guide to Bibliography 104
Bibliography 106
IV. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet 112
EPA Form 8580-4 - Product Specific Data Report . . 113
EPA Form 8580-6 - Certification of Attempt to Enter
Into an Agreement with Other Registrants for
Development of Data 115
EPA Form 8580-27 - Generic Data Exemption Statement 116
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single
dose than can be expected to cause death in 50% of the
test animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
ing/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
111
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OES Office of Endangered Species, U.S. Fish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
The scientific reviews and Compendium of Acceptable„
Uses may be obtained from the OPP Public Docket. Write to
OPP Public Docket, Field Operations Division (H7506C),
Office of Pesticide Programs, EPA, Washington, D.C. 20460
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. 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
become aware of such information. Registrants must notify
the Agency of any information, including interim or prelim-
inary results of studies, if that information suggests possible
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adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as the products are registered
under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common name: Rotenone (and "other cube1 resins" or "other
cube1 extractives" or "other derris resins"
or "other derris extractives")
Chemical name: (2R, 6aS, 12aS)-l , 2, 6, 6a, 12, 12a-hexahydro-2-
isopropenyl-8 , 9-dimethoxychromeno[ 3 , 4-b] f uro
[2, 3-h]chromen-6-one.
Other chemical
nomenclature : ( R) -1 , 2-dihydro-8 , 9-dimethoxy-2- ( 1-methy 1-
ethenyl)[l]benzopyrano[3,4-b]furo[2,3-h][l]
benzopyran-6,12-dione (9th Collective Index);
1, 2, 12, 12a alpha-tetrahydro-2a-isopropenyl-
8,9-dimethoxy[l] benzopyranol[3,4-b]furo[2 , 3-
h][l]benzopyran-6(6aH)-one (8th Collective
Index) ; 1,2,12, 12a-tetrahydro-8 , 9-dimethoxy-
2- ( 1-methy lethenyl )-l[2R- (2a, 6a, alpha, 12a
alpha) ]-(l)benzopyrano (3,4-b)furo(2, 3-h)-
( 1 ) benzopyran-6 ( 6aH ) -one .
Other names: aker-root; Chem Fish; Derris; derris root;
Nicouline; Rotacide; Protex; Tubatoxin; tuba-
root; ENT-133; Barbasco; Cube; Haiari; Nekos;
and Timbo
CAS Registry Number: 83-79-4
EPA Pesticide Chemical Code
(Shaughnessy Number): 71003 - rotenone; 71004 - cube1
resins other than rotenone;
71001 - derris resins
Empirical Formula:
Molecular Weight: 394.4
Chemical/Physical Characteristics of Rotenone (purity 99.5%
or unspecified) and its associated resins:
Color: colorless (rotenone, purity 99.5%)
Physical State: Crystalline solid
Specific Gravity: 1.27 at 20 °C
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Melting Point: 165-166 °C
Solubility: Water 0.00002 g/100 ml at 20 °C; Ethyl alcohol
0.2 g/100 ml at 20 °C; Carbon tetrachloride 0.6 g/100 ml
at 20°C? Amyl acetate 1.6 g/100 ml at 20°C; Xylene 3.4
g/100 ml at 20 "C; Ethylene dichloride 33.0 g/100 ml at 20
°C; Chloroform 47.2 g/100 ml at 20 °C; Acetone 6.6 g/100
ml at 20 °C; Benzene 8.0 g/100 ml at 20 °C; Chlorobenzene
13.5 g/100 ml at 20°C.
Stability: Decomposes rapidly in organic solvents exposed to
light and air.
Rotenone is a botanical insecticide/acaricide/piscicide
derived from roots of Derris spp., Lonchocarpus spp., and
Tephrosia spp. primarily from Malaya, South America and East
Africa, respectively. It also occurrs in many other related
species of legumes growing mostly in the tropics of South
America, Pacific islands, Australia, Asia and Africa. Tephrosia
virginiana grows as far north as Wisconsin and was used by the
Indians as a fish poison in what is now southern and southwestern
United States.
In some species, rotenone is concentrated in the leaves,
seeds and bark rather than the roots. The concentration of
rotenone and associated resins varies considerably depending
upon species, plant parts examined, geographic location and
climate. Selected varieties of Lonchocarpus utilus roots may
contain as much as 12% rotenone and 25% total extractives.
Crushed roots or other plant parts containing rotenone
were used in the tropics primarily as piscicides to obtain fish
for food. Extracts from Derris spp. have been used as an
ingredient in arrow poisons in Sumatra. The earliest record
of crop use was in Malaya in 1848.
In 1985 54% of the rotenone used domestically was put to
general use including home gardens, livestock, pet, and house-
hold use, 32% was used to kill fish and 14% was applied to
commercial crops, primarily on potatoes, tomatoes, pears, and
apples.
B. Regulatory History
Rotenone or derris or cube root, when applied on growing
crops, is currently exempt from the requirement of tolerances
(40 CFR 180.1001(b)(8)).
In May, 1980 rotenone was originally included with 44
other chemicals on a list of chemicals considered for special
review because of questions regarding acute toxicity to
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aquatic organisms, non-target wildlife population reductions,
hazard to endangered species, and possible oncogenicity,
mutagenicity, teratogenicity reproductive, and other chronic
effects. The following conclusions were reached.
Rotenone products registered for use as piscicides have
a high enough toxicity to fish to exceed special review
criterion, which was designed to protect against unintended
adverse effects to wildlife. However the Agency decided that
" A pesticide should not be presumed against because it performs
its intended effect by preventing, destoying, controlling,
or mitigating target organisms". Since toxicity of rotenone
to fish is considered an intended effect, the provision of 40
CFR 162.11 (a)(3)(i)(B)(3) should not be invoked against
rotenone by reason of this acute toxicity to fish.
Rotenone treatments appear to cause temporary reductions
in overall invertebrate populations replenished with time by
migration into the treated areas and by the gradual re-population
by survivors. The treatments can cause a permanent local loss of
certain species or genera of invertebrates, particularly aquatic
invertebrates. Whether or not this shift in a local or regional
pattern of species would significantly affect other ecological
balances could not be determined from available data. Hazards
to endangered species can be effectively prevented by requiring
each proposed treatment site to be evaluated by state or federal
fish and wildlife biologists as already required by label
statements.
The Agency concluded that the available data did not show
that the criterion for oncogenicity (40 CFR 162.11 (a)(3)(ii)(A)
was met or exceeded for rotenone and its related compounds.
The data available were not sufficient to show that the
criterion of 40 CFR 162.11 (a)(3)(ii)(A) with respect to repro-
ductive effects was met or exceeded for rotenone and its
related compounds. However there was sufficient cause for
concern to support a requirement for additional testing.
The chronic feeding data available were not sufficient to
show that the RPAR criterion 40 CFR 162.11 (a)(3)(ii)(A) with
respect to chronic effects was met or exceeded for rotenone in
its various forms.
Three conclusions were reached regarding the establishment
of tolerances for rotenone. First, tolerances should be estab-
lished for food and feed crops. Second, even though tolerances
cannot be enforced in produce from home gardens, the Agency
should re-examine the recommended pre-harvest interval based
on plant metabolism and residue data which the Agency should
require. Third, because there are several means by which the
aquatic uses of rotenone can result in residues in edible
fish, the aquatic use will be considered a "food use",and
rotenone's aquatic use will require a tolerance or tolerance
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exemption.
In a Federal Register Notice published July 15, 1981 it
was concluded that available data did not indicate that
rotenone presented a risk of unreasonable adverse effects to
man or the environment. The Agency therefore removed rotenone
from its list of suspect chemicals.
A Data Call-in Notice for rotenone issued May 28, 1986
required data for product chemistry of rotenone manufacturing-use
products. The Agency required submission of product identity
and composition data for brittle extract of cube', technical
rotenone, crystalline rotenone, and powdered cube' root. Although
product chemistry data may have been submitted in the past, the
Agency has determined that these data must be resubmitted.
C. Use Profile
Type of Pesticide: Insecticide, acaricide and piscicide
Year of Initial Registration: 1947
Pests Controlled: Undesirable fish. Number of diverse
insect pests attacking field crops,
vegetables, fruits, ornamentals,
livestock, and pets
Registered Uses:
Terrestrial Food Crops: Rotenone , cube1 resins other
than rotenone , and derris resins are registered for
foliar preharvest applications to vegetables, field
crops, tree fruit, and nuts.
In addition to foliar applications, delayed dormant
applications may be made to tree fruit.
Soil applications may be made to vegetables,berries
and nuts.
Terrestrial Nonfood Crop: Ornamentals, turf, shade trees,
and tobacco.
Greenhouse Food Crop: Vegetables.
Greenhouse Nonfood: Ornamentals.
Aquatic Non-Crop: Fish.
Domesticated Pets and Their Man-made Premises: Cats and Dogs.
Livestock: Cattle (Beef and Dairy), Goats, Horses, Sheep,
and Swine.
Household: Flying and crawling insects.
Commercial and Industrial Uses: Flying and crawling insects.
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Methods of Application: Foliar application by ground and
aerial equipment, soil application by ground equipment,
hand and mechanical spraying and dusting, dip treatment,
shampoos, ear drops, boat bailers, and mothproofing.
Annual Usage: 50,000 to 120,000 Ib
Predominant Usage: Aquatic (piscicide); agriculture
(potatoes, tomatoes, pears, apples); livestock, pets, and
household.
Mode of Activity: Interference in cellular energy reproduction
through an inhibition of oxidative phosphorylation - the
phosphorylation of adenosine diphosphate (ADP) to adenosine
triphosphate (ATP).
Manufacturing Use products: There are 43 manufacturing use
products which contain from 0.045% to 50% rotenone.
Formulations: Technicals, formulation intermediates, dusts,
pelleted/tableted, wettable powders, wettable powder/dusts,
impregnated material, emulsifible concentrates, soluble
concentrate/liquids, ready-to-use, pressurized liquids.
Basic Producers: Penick-Bio UCLAF Corporation, Prentiss
Drug and Chemical Company, TIFA, Ltd., Fairfield
American Corporation
Number of Registrants: 176
Number of Registration: 465; 43 of these products are
Manufacturing-Use Products
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all data in Agency files as of
December 1987 supporting the registration of rotenone.
Based on the available data, EPA has reached the following
conclusions. The points summarized below are presented in
further detail, in the context of EPA's science findings and
additional data requirements, sections B through D.
1. The Agency has categorized rotenone as a Category E
carcinogen (no evidence of carcinogenicity).
2. Rotenone is highly toxic to fish and moderately to highly
toxic to freshwater invertebrates. Based on available data,
it is slightly toxic to birds.
3. Based on acute oral toxicity to rats, rotenone technical
and manufacturing concentrates are classified in Toxicity
Category I.
4. The Agency believes that the existing exemption from
tolerance for rotenone is not warranted and will require the
establishment of finite tolerances. Residue data on commercial
crops, fish killed by water treatment, and fish used to
restock treated bodies of water must be submitted before
appropriate tolerances or exemptions from tolerances can be
established.
5. Rotenone is unlikely to leach to ground water because of
its short half-life in soil and water and low mobility in
soils containing more than 1% organic matter. Also, because
of its short half-life the potential for runoff into surface
waters is low.
6. During the past 10 years, California reported 5 illnesses
related to rotenone exposure. All 5 were applicator exposures:
2 were poisonings, 2 were skin injuries, and 1 was an eye
injury.
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B. OTHER SCIENCE FINDINGS
1. Environmental Fate Profile.
The environmental fate data'-base for rotenone is incomplete,
The available information indicates that it rapidly degrades
in water and soil. Except for the piscicide use, there is a
low potential for environmental exposure. Rotenone degrades
very rapidly under both aerobic aquatic and anaerobic aquatic
soil conditions, with a half-life of 1 to 3 days. The major
degradate is rotenolone with a half-life of <3 days under
aerobic aquatic conditions and 10 weeks under anaerobic
aquatic conditions.
The short soil half-life reduces the potential for runoff
into surface waters from crop uses. Available studies indicate
that rotenone is mobile only in sand sediment containing £1%
organic matter. It is not very mobile in loam sediment, silt
loam sediment, and loamy sand sediment.
Rotenone's potential to leach to ground water is low
because of its short soil half-life (less than 3 days), short
hydrolysis half-life, and extremely low aqueous solubility
(0.00002 g/100 ml). A hydrolysis study indicated that rotenone
has a half-life of 13 days (pH 5), 3 days (pH 7), and 2 days
(pH 9) in water, with the major degradate being identified as
rotenolone. Rotenolone has a half-life of <2 weeks in water.
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2. Toxicology Profile
a. Acute Toxicity
1. Acute Oral Toxicity
A study with purified rotenone indicated that the
pesticide is classified inn Toxicity Category I because of
its high toxicity (LDso = 39.5 ± 2.21 mg/kg for female rats
and 102 + 12.6 mg/kg for male rats).
2. Acute Dermal Toxicity
No date were available for review. An acute dermal
toxicity study with technical grade rotenone is required.
3. Acute Inhalation Toxicity
No data are available on the acute inhalation toxicity
of technical grade rotenone. A study is required if the
technical grade material is in a respirable form.
4. Eye Irritation
No data onn the eye irritation potential of technical
grade rotenone were available. A study is required.
5. Dermal Irritation
No data on the skin irritation potential of technical
grade rotenone wer.e available. A study is required.
6. Dermal Sensitization
No data on the dermal sensitization potential of technical
grade rotenone were available. A study is required.
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b. Subchronic Testing
1. Subchronic Oral Toxicity - Rodents
There were no acceptable subchronic toxicity studies
available. However, long-term studies with rats and mice are
considered below. No additional subchronic toxicity testing
is required.
2. Subchronic Oral Toxicity - Non-Rodents
There were no acceptable subchronic toxicity studies
available. However, a 6-month study with dogs is considered
below. No additional subchronic toxicity testing is required.
3. 21-Day Dermal Toxicity
No data are available, and a study is required.
4. Chronic Toxicity - Dogs
Groups of 6 male and 6 female dogs were given 0, 0.4, 2,
or 10 mg/kg/day by capsule for 6 months. A No-observed-effect-
level (NOEL) of 0.4 mg/kg/day was established in this study.
The lowest effect level (LEL) was 2 mg/kg/day, and dose-
related effects included emesis and decreased body weight.
The highest dose tested was 10 mg/kg/day and was associated
with decreased hematocrit and hemoglobin, serum glucose,
cholesterol, and total lipid levels.
5. Chronic Toxicity - Rats
Fischer 344 rats were fed diets containing 0, 7.5, 37.5,
or 75 ppm rotenone for 2 years.
Those rats given the mid- and high-dose levels had
significantly reduced terminal body weights. Food consumption
for the mid- and high-dose group females was significantly
reduced in comparison to that for the control group females.
Lower total protein and albumin levels in females given
the 75 ppm diet and higher serum urea nitrogen levels in 37.5
and 75 ppm dose group females were observed. These changes
were small and are believed to be associated with reduced
food consumption.
The only treatment-related macroscopic finding was thin
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female rats in the 37.5- and 75-ppm dose groups. The 75 ppm
diet was associated with an increased incidence of angiectasis
and hemorraging in the adrenals of males and females, and
reduced incidences of chronic progressive kidney damage
(females only), liver degeneration, pituitary adenomas, and
mononuclear cell leukemia.
The low effect level (LEL) for decreased body weight and
food consumption was 37.5 ppm, and the NOEL was 7.5 ppm
(0.375 mg/kg/day).
Since no microscopic examinations were performed on low
and mid-dose group rats, a NOEL for the adrenal gland lesions
could not be established. Histopathology for the low and mid-
dose groups must be submitted to fully evaluate the study.
c. Carcinogenicity
1. Rats
Rotenone was given to groups of 50 male and 50
female F344/N (Fisher 344) strain rats at dietary concentrations
of 0, 38, or 75 ppm for 2 years. A statistically insignificant
increase in the incidence of parathyroid adenomas in male
rats given the 75 ppm diety was noted (4/44 in the high-dose
group compared with 1/41 in the control group).
The incidences of pituitary adenomas and mono-
nuclear cell leukemias were significantly decreased in both
sexes in the chronic feeding with Fisher 344 rats given
dietary levels of 0, 7.5, 37.5, or 75 ppm rotenone for 2
years and no parathyroid adenomas were observed in males
given the 75 ppm diet. Increased incidence of other tumors
was not observed in treated rats.
2. Mice
Rotenone was given to groups of 50 male and 50
female B6C3F1 strain mice at dietary concentrations of 0,
600, or 1200 ppm for 2 years. A dose-rated decrease in
mortality for treated males was noted, but no significant
effect on mortality in treated female mice was observed.
There was no evidence that rotenone was carcinogenic in male
or female B6C3F1 mice.
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3. Hamsters
In an 18 month study in the Syrian Golden Hamster,
rotenone was fed in the diet at doses up to 1000 ppm. The
study was judged inadequate because of poor survival and
incomplete reporting of results.''
Based on the negative studies in rats and mice, rotenone
has been categorized as a category E carcinogen (no evidence
of carcinogenicity). No further studies are required.
d. Developmental Toxicity and Teratology Studies
1. Rats
Groups of 25 pregnant rats were given doses of 0,
0.75, 1.5, 3 or 6 mg/kg/day on gestation days 6 through 19.
Decreased body weight and body weight gain were observed in
pregnant rats given daily doses of 6 mg/kg/day. The NOEL for
these effects was 3 mg/kg, and there were no effects observed
at the 1.5 or 0.75 mg/kg dose levels. The 6 mg/kg dose also
caused a reduction in mean fetal weight below that of controls,
and an increased incidence of unossified sternebrae, renal
cavitation, and distended ureters. The adult-to-developmental
toxicity (A:D) ratio (the ratio of the NOEL for adult toxicity
and the NOEL for developmental toxicity) is equal to one.
Thus, rotenone is not teratogenic or fetotoxic to rats at
doses lower than those which also cause maternal toxicity.
2. Mice
Dosages of 3, 9, and 15 mg/kg/day were administered
to groups of 30 female mice on days 5 through 17 of gestation.
Results of the main study suggested a NOEL for maternal and
fetal effects that may be higher than 15 mg/kg/day. No dose-
related effects were observed at any dose level, suggesting
that the NOEL for maternal and fetal toxicity Is greater than
15 mg/kg/day. The results of this study were interpreted
together with those from a preliminary range finding study.
On that basis, the NOEL for maternal effects (weight loss and
mortality) and fetal effects (decreased litter size) in mice
is 15 mg/kg/day. The LEL is 24 mg/kg/day. -The A:D ratio is
equal to one. Rotenone is "not teratogenic or fetotoxic at
doses lower than those which also cause maternal toxicity.
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e. Reproduction Toxicity
Rotenone had no effects on reproduction in groups of 15
male and 25 female rats given dietary levels of 0, 7.5, 37.5,
or 75 ppm. The LEL with respect to decreased body weight
gain in dams and in pups during lactation was 37.5 ppm.
Litter sizes in the FQ and FIA generations were significantly
reduced at 75 ppm, and the reproductive NOEL was 37.5 ppm. The
NOEL for maternal toxicity was 7.5 ppm (approximately 0.375
mg/kg/day). No additional data on reproductive effects are
required.
f. Mutagenicity
1. Gene Mutation
Rotenone did not induce gene mutations in Salmonella
typhimurium with or without metabolic activation or in yeast.
However, concentrations of 0.25 to 4.0 ug/ml rotenone without
metabolic activation increased the frequency of forward
mutations at the Tk locus of L5178Y mouse lymphoma cells in
vitro.
Mice given 0.05, 0.17, 0.5, or 1.0 mg rotenone per kg
body weight on days 8 through 11 of gestation did not show signs
of toxicity or somatic mutations in embryonic melanocytes.
A dose of 1000 mg/kg administered to pregnant mice under the
same conditions caused melanocyte toxicity, but did not cause
somatic mutations.
2. Structural Chromosomal Aberration
Single oral doses of 0.7, 2.5, or 7 mg/kg did not
increase the incidence of chromosomal aberrations or decrease
the mitotic index in bone marrow cells of treated rats. No
increase in the incidence of polychromatic erythrocytes with
micronuclei was observed in bone marrow of mice 6 hours after
the last of 2 consecutive daily doses of 0, 10, or 80 mg/kg.
3. Other Genotoxicity
No mitotic recombination or mitotic gene conversion was
observed in yeast at dose levels up1 to 10,000 ug/mL.
g. Metabolism
The major route of excretion of rotenone (95 to 97% of
the administered dose) is in the feces. Intravenous dosing
results indicated that enterohepatic circulation is possible in
treated rats, and the route of administration, dose level, and
number of doses had no apparent effect on the excretion pattern.
Most of the metabolites in the feces could not be identified.
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3. ECOLOGICAL EFFECTS
a. Toxicity to Birds
Rotenone is slightly toxic to pheasants and practically
non-toxic to mallards. The LDsO of rotenone to mallard ducks
is 2200 mg/kg and the LDsO of rotenone to pheasants is 1680 mg/
kg based on studies using 32.38% rotenone. Additional studies
using technical rotenone and giving procedural detail are needed
No subacute dietary studies or reproduction studies were avail-
able for review. These studies are required.
b. Toxicity to Fish
Acceptable acute toxicity data show that rotenone is
very highly toxic to rainbow trout (LCsO =22.5 ug/1), channel
catfish (LC5Q = 2.6-2.8 ug/1), and bluegill (LCso = 22.5 ug/1).
In fish accumulation studies in which fish were intro-
duced to water 30 days after treatment, the maximum accumula-
tion in largemouth bass occurred six days after stocking. Bio-
accumulation factors were 22x (0.44 ppm) for inedible tissues
and 61x (1.22 ppm) in edible tissues. Rotenone concentrations
in fish in warmwater ponds were much lower. The maximum
rotenone concentration found in bullheads and bluegills were
0.153 ppm in the edible tissues and 0.096 ppm in the inedible
tissues. In a laboratory study, radiolabelled rotenone residues
accumulated in bluegill sunfish with bioaccumulation factors
of up to 3,607x (23.47 ppm)in the viscera but 137x (0.693 ppm)
in the carcass. After 21 days depuration the residue levels
fell to 0.221 ppm in the viscera and 0.083 ppm in the carcass.
c. Toxicity To Freshwater Invertebrates
Technical rotenone is moderately to very highly toxic to
freshwater invertebrates. The 21-day ECso for Daphnia magna
is 2.1 ug/1. The NOEL is 1.25 ug/1. An aquatic mesocosm
study for invertebrates is required for landlocked aquatic
environments typical of rotenone's use as a piscicide.
d. Effects on Estuarine and Marine Organisms
No studies using technical rotenone were available
for review. Piscicide uses of rotenone are of minimum concern
for estuarine organisms because its use is usually restricted
to landlocked target fish populations in ponds, reservoirs,
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and lakes. The agricultural uses are of greater concern
because registered pear, apple, tomato, and potato crop uses
occur in coastal States. There is insufficient information
on usage and acreage on these particular crops to determine
effects on estuarine and marine organisms. The rapid degradation
and mobility characteristics of rotenone limit the potential
for runoff. However, the close proximity of cranberries to
the estuarine environment leads to concerns about estuarine
organisms.
Additional mollusk testing (e. g. oyster embryo-larvae)
is required in order to further evaluate the hazards to fresh-
water mussels. Testing using oyster larvae will allow the
Agency to assess the risks to endangered freshwater mussels
from use of rotenone.
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C. TOLERANCE REASSESSMENT
1. Tolerances Issued
Currently, use of rotenone or derris or cube root on
growing crops or on livestock in the United States is exempt
from the requirement of tolerances (40 CFR 180.1001(b)(8).
Canadian tolerances of 0.1 ppm (negligible residue) have been
established for a variety of vegetable and fruit commodities
and also for poultry and red meat including fat and meat
byproducts. There are no Mexican tolerances or Codex Maximum
Residue Levels established.
Date requirements regarding the magnitude of residues in
raw agricultural commodities, plant and animal products,
including fish, shellfish, and foods present in treated food
handling establishments, will not be determined until all
required data regarding metabolism in animals and magnitude
of residue in feed items have been received. Upon receipt of
the data required under this standard, the tolerance exemption
will be reevaluated.
Under present EPA policy, the Agency does not establish
tolerances for pesticides in potable water (47 FR 56137;
December 15, 1982). No acceptable residue level in drinking
water (ARLDW) has been set.
2. Metabolism Studies - Identity of Metabolites in Plants
and Animals
The nature of the residues of rotenone in plants and in
animals is not adequately understood. Metabolism studies on
plants and animals are needed.
3. Residue Analytical Methods
Methods for determination of rotenone residues in plant
commodities and for enforcement are not available. Currently,
use of rotenone on growing crops is exempt from the requirement
of tolerances.
The HPLC method of Dawson and Allen is useful for deter-
mination of rotenone residues in water, fish, crayfish, and
freshwater clams, but is inadequate for purposes of data
collection because complete validation data (sensitivity,
accuracy, and precision) were not presented for each commodity.
A spectrophotometric method developed by Jacobsen et al.
appears adequate for determination of rotenone residues
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in milk but not in cream because no data were presented for
control samplesi fortification levels were not specified, and
reported recovery values were unacceptably low (17-51%).
4. Storage Stability Data
The available data indicate that rotenone is stable in
crayfish, clams and fish muscle, and offal during storage at
-10 °C for up to 6 months. Data are not available depicting
residue stability in plant or livestock matrices. Such data
are required.
The nature of the residue in plants and animals has not
been adequately described. If the requested plant metabolism
data indicate the presence of additional metabolites of concern,
data depicting the stability of those residues during storage
will be required. Upon receipt of the requested animal metab-
olism data, the need for storage stability data pertaining to
rotenone residues of concern in livestock tissues will be
determined.
*
5. Residues In Plants
Rotenone has been exempted from the requirement of
tolerences and no residue data have been required depicting
rotenone residues in or on plant commodities. These data, are
now being required. Since there are no data, recommendations
for the establishment of crop group tolerances are not possible
at this time.
6. Residues In Animals
The nature of the residue in animals is not adequately
understood. Data requirements regarding the magnitude of the
residues in animal products will not be determined until all
requested data regarding metabolism in animals and magnitude
of residue in feed items have been received.
7. Residues In Fish And Shellfish
The nature of the residue in fish and shellfish is not
adequately understood. The available residue data indicate
that rotenone residues will be present in fish and shellfish
following registered use of rotenone. In a radiolabeled study
46% of the l^c-residues present in bluegill carcasses (presumed
to include flesh and skin) were unidentified; metabolism
data pertaining to shellfish were not submitted. Additional
data are required on the metabolism of rotenone and magnitude
of the residue in fish.
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8. Residues in Potable and Irrigation Water
The available residue data indicate that residues of
rotenone in water on the day of treatment with a 5% EC
formulation at 0.25 ppm may be as high as 0.245 ppm.
9. Food Monitoring Data
FDA and USDA do not monitor rotenone as part of the
National Residue Program. Domestic and import samples collected
by FDA from 1978 through 1987 and the Total Diet Samples
collected from April 1982 to April 1986 were not analyzed by
methods known to determine rotenone.
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS
Based on review and evaluation of all available data and
other relevant information on rotenone, the Agency has made
the following determinations.
1. The Agency is not placing rotenone in Special Review.
Rationale; None of the criteria of 40 CFR 154.7 for
initiating Special Review has been met.
2. The Agency is classifying products bearing piscicide and
cranberry uses for restricted use. In addition, a label
statement requiring consultation with a state or federal fish
and wildlife biologist before aquatic application is specified,
to verify that the application will not adversely affect
endangered species.
Rationale; Rotenone is very highly toxic to fish
and other aquatic organisms. The requirement to consult with
a state or federal fish and wildlife biologist will assure
that unreasonable risks to endangered species will be avoided.
The restriction applies to the piscicide uses, and to cranberry
uses because cranberry bogs are periodically flooded.
3. Available residue chemistry data are insufficient to
permit the Agency to conduct a tolerance reassessment. The
Agency is unable to conclude that the current exemption from
tolerance is justified. Accordingly the Agency is requiring
data on plant and animal metabolism, storage stability,
residue analytical methods, and residue levels in raw agricul-
tural commodities and animals treated with rotenone. Data
requirements are established based upon crop groupings, but
registrants may instead propose to limit data development
(and tolerances) to individual crops within the groupings.
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Rationale; Data gaps exist for plant and animal
metabolism and magnitude of residue for raw agricultural
products, for processed food and feed items, and for foods
which may bear residues as a result of treatments in food
handling establishments.
4. Registrants must submit metabolism and residue data and
propose tolerances for crops irrigated with water treated
with rotenone. In addition, a label restriction prohibiting
use of rotenone-treated water for irrigation purposes or its
release for one-half mile above a potable water intake is
specified. This restriction replaces that on current labels,
which must be deleted, (treated water use is now restricted
based upon survival of a sensitive test fish species for 24
hours).
Rationale; Treated water should not be used for
domestic use or irritation until residues are reduced to an
acceptable level. A bioassay using survival of a test fish
for 24 hours is considered semiquantitative and non-specific.
Available data indicate that rotenone degrades rapidly in
water. Dilution with untreated water will further reduce
residue concentrations in the one-half mile before use for
potable water or irrigation purposes is permitted. This
interim distance restriction should provide adequate reduction
of residues until the Agency can establish necessary tolerances
or an appropriate and practical time-based restriction on the
use of rotenone-treated waters.
5. Registrants must amend labels which include directions
for home garden uses so that the rates permitted for these
uses are consistent with rates for commercial agricultural
applications. If the rate for home garden application of any
formulation to any site is greater than the maximum rate
permitted for commercial application to that site, the
registrant must submit appropriate residue data to support
the home garden use.
Rationale; Use of pesticides in home gardens should
not result in produce with residues exceeding those permitted
in commercially treated commodities. Data must be submitted
to show that proposed higher rates and or/increased number of
applications will not result in any proposed tolerances being
exceeded.
6. The Agency is not imposing a reentry interval for
agricultural uses of rotenone. Protective clothing and
equipment are not required.
Rationale; Rotenone does not meet the toxicity
criteria of 40 CFR 158.390 for reentry data. Available
toxicity data do not indicate a need for a reentry interval.
or special protective clothing.
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7. The Agency has identified certain data that will receive
immediate review when submitted. The following studies have
been identified to receive priority review:
171-4 Metabolism in Plants .- Tolerance assessment
Metabolism in Animals' - Tolerance assessment
Residue Analytical Methods - Tolerance assessment
Magnitude of Residue in Irrigated Crops - Tolerance
assessment
161-1 Hydrolysis - Tiered study
161-2 Photodegradation in water - Tiered study
162-4 Aerobic aquatic metabolism - Tiered study
165-3 Accumulation in Irrigated Crops
72-1 Fish toxicity using degradate - tiered
72-2 Invertebrate toxicity using degradate - tiered
72-3 Estuarine/marine toxicity using degradate - tiered
Rationale; Certain of the data being required by
the Agency are essential to resolve risk concerns, or may
trigger the need for further studies which should be initiated
as soon as possible.
6. While the required data are under development all currently
registered products containing rotenone as an active ingredient
may be sold, distributed, formulated, and used, subject to
the terms and conditions specified in the Standard. Registrants
must agree to develop and provide additional data, as specified
in the Data Appendices, in order to maintain existing regis-
trations.
Rationale: Under FIFRA, the Agency may choose
not to cancel or withhold registration if the data are
missing or inadequate (see FIFRA sec. 3{c)(2)(B) and 3(c)(7)).
The issuance of this Standard provides the mechanism for
obtaining necessary data. The data will be reviewed and
evaluated, after which the Agency will determine if additional
regulatory actions are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain rotenone, bear required labeling, and
conform to the product composition, acute toxicity limits,
and use pattern requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing use products (MPs) must contain rotenone. 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%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing use products containing rotenone provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing use
products may be labeled for formulation in to end use products
only for the commodities listed below. The Use Index (EPA
Compendium of Acceptable Uses)(for availability see page 1)
lists all registered uses, as well as approved maximum
application rates and frequencies.
Terrestrial and Greenhouse Food Uses
Terrestrial and Greenhouse Non-Food rises
Aquatic Uses
Pet and Livestock Uses
Domestic/ Commercial and Institutional Uses
D. REQUIRED LABELING
In order to remain in-compliance with FIFRA, manufacturing
use products must bear appropriate labeling as specified in
40 CFR 156.10. Appendix II contains information on label
requirements.
No pesticide product containing rotenone may be released
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for shipment by the registrant after April 30, 1990, unless
the product bears an amended label,which complies with the
requirements of this Standard.
No pesticide product containing rotenone may be distributed
or sold after April 30, 1991, unless the product bears an amended
label which complies with the requirements of this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the
active ingredient as:
ACTIVE INGREDIENTS
Rotenone %
Other Associated Resins %
In accordance with 40 CFR 162.10(g), the label of
each pesticide product must contain the name and percentage
by weight of not only the active ingredient, but also the
percentage by weight of all inert ingredients.
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. Chapter II, Section C.
However, no use may be included on the label where the
registrant fails to agree to comply with the data require-
ments in TABLE A for that use pattern.
3. Precautionary Statements
Statements for Manufacturing-Use Products
This Pesticide is extremely toxic to fish. Do not
discharge into lakes, streams, ponds, estuaries, oceans,
or other 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.
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Statements for End Use Products (Terrestrial, Food
and Non-food and Domestic Outdoor
This pesticide is extremely toxic to fish. Do not apply
directly to water or wetlands (swamps, bogs, marshes, potholes).
Runoff and drift from treated areas may be hazardous to
aquatic organisms in adjacent sites. Do not contaminate
water when disposing of equipment washwaters.
Statement for End Use Products (For Cats and Dogs)
Do not use on puppies or kittens less than 4 weeks old.
Statements for End Use Products (Agricultural Uses).
Do not feed treated foliage to livestock.
Do not apply rotenone in such a manner as to directly or
through drift expose workers or other persons. The area
being treated must be vacated by unprotected persons. Do
not enter treated areas without protective clothing until
sprays have dried or dust has settled.
Statements for End use Products (Cranberry Use)
RESTRICTED USE PESTICIDE
Due to Aquatic Toxicity
This pesticide is extremely toxic to fish. Runoff and
drift from treated areas may be hazardous to aquatic organisms
in adjacent sites. Do not contaminate untreated water when
disposing of equipment washwaters. Do not use water treated
with rotenone to irrigate crops (other than cranberry) or
release within 1/2 mile upstream of a potable water or irrigation
water intake in a standing body of water such as a lake,
pond, or reservoir.
Statements for End Use Products (Piscicide Use)
RESTRICTED USE PESTICIDE
Due to Aquatic Toxicity
This pesticide is extremely toxic to fish. Fish kills
are expected at recommended rates. Consult your State Fish
and Game Agency before applying this product to public waters
to determine if a permit is needed for such an application.
Do not contaminate untreated water when disposing of equipment
washwaters.
Do not use dead fish as food or feed.
Do not use water treated with rotenone to irrigate crops
or release within 1/2 mile upstream of a potable water or
irrigation water intake in a standing body of water such as
a lake, pond or reservoir.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
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
Table's 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 an end use producer who is eligible
for the generic data exemption for that active ingredient.
Table c lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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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 generic data exemption^, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data 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 generic data exemption,
the data 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 generic data exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing "use product
you purchase (Table B).
Two circumstances nullify this- exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to the data
requirements in Table A.
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2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
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.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and S 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 submittal 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 generic data 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 Generic Data Exemption
Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submittal or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with 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
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submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submittal.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
youc 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).
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2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(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. The Agency will respond in writing
to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
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6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identificatioa 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.
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-33-
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for EconomiciCooperation and Development
(OECD) Chemicals Testing programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols. The
Agency will respond in writing to your request for protocol
approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before
the data submittal response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. The Agency
will respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). All studies must be submitted in the form of
a final report; a preliminary report will not be considered
to fulfill the submittal requirement.
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j. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act. The following information must be included in any
request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing 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 through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion Standard. Responses to this Registration Standard must
include draft labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the intended
colors of the final label, clear indication of the front
panel of the label, and the intended type sizes of the text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel the registration of
your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (H-7508C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Rotenone Registration Standard
All submittals in response to this Registration Standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must
be clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration Standard
responses be combined with other types of filings for which
fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
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a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "PIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
»
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
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-37-
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
lj .Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2~)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
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-38-
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption, if for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of acti-on.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 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.
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-40-
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.
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TABLE A. GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT.
Data Requirenent Compositionl
158
Subpart C-Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning Mater-
ials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients x '
62-1 - Preliminary Analysis of Product
Samples
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
63-8 - Solubility TGAI or PAI
63-9 - Vapor Pressure TGAI or PAI
63-10 - Dissociation Constant TGAI or PAI
63-11 - Octanol/Water Partitioning
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
64-1 - Submittal of Samples
j',^,..,. ITJ-T- -t J- , -, —r- . . — •,
vv-ontinuea, tootnotes tollow.)
PAI
TGAI
TGAI
N/A
Does EPA
have data to
satisfy thig
requirement?2
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
N/A
45
Must additional
data be submitted
Bibliographic under FIFRA Sec.
Citation2
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
3(c)(2)(B)7
Yes3
Yes4
Yes5
Yes6
Yes6
Yes6
Yes6,7
Yes6*8
Yes6
Yes6
Yes6
Yes6
Yes6. 9
Yes6,10
Yes6
No
Tims Frame
Foe Data
Submission
6 months
6 months
12 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
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-42-
TABLE A. (Continued).
1 TGAI = technical grade of the active ingredient. PAI = purified active ingredient.
2 Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
3 Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and address
of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must
be provided, along with information regarding the properties of those materials.
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.
5 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation data (accuracy and 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, partition coefficient, 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 room temperature.
8 Data required if the technical product is a liquid at room temperature.
9 Data required if the technical product is organic and nonpolar.
required if the test substance is dispersible in water.
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TABLE A. GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Tine frame
for
submissionl
158.240 Residue Chemistry
171-2. Chemical Identity2
171-3. Directions for use
171-4. Nature of the residue
(Metabolism)
- plants
171-4. Nature of the residue
(Metabolism)
- Livestock
171-4. Residue analytical
methods
PAIRA
No
PAIRA and No
plant metabo-
lites
N/A.
N/A.
Yes2
Yes3
Yes4,5,6
TGAI and Partially 00072106. 00157851,
metabolites 05005830.
3 months
18 months
18 months
18 months
171-4. Storage stability
TEP and Partially
metabolites
171-4. Magnitude of the residue
in plants
(Continued, footnotes follow.)
18 months
Root and Tuber Veg.
-Processed Potatoes
Bulb Vegetables
TEP
TEP
TEP
No
No
No
Yes 10
Yesll
Yes12
18 months
24 months
18 months
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TABLE A. (Continued).
-44-
Test
Data Requirement substance
Leafy Vegetables TEP
Brassica Leafy Vegetab- TEP
les
Legume Vegetables TEP
Fruiting Vegetables TEP
-Processed tomato products
Cucurbit Vegetables TEP
Citrus Fruits TEP
-Processed citrus products
Pome Fruits TEP
-Processed apple products
Stone Fruits TEP
-Prunes
Small Fruits and Berries TEP
-Raisons (processed grapes)
Tree Nuts TEP
Cereal Grains TEP
-Processed grains
Does EPA
have data?
No
No
No
No
No
No
No
No
No
No
No
Must addi-
Bibliographic tional data
citation be submitted?
Yes13
Yes14
Yesl5,16
Yes17
YeslS
Yesl9
Yes20
Yes21
Yes22
Yes23
Yes24
Yes25
Yes26
Yes27
YeS28
YeS29
Yes30
Time frame
for
submission
18 months
18 months
18 months
18 months
24 months
18 months
24 months
18 months
24 months
18 months
24 months
18 months
24 months
6 months
18 months
24 months
(Continued, footnotes follow.)
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-45-
TABLE A. (Continued),
Data Requirement
Non-grass Animal Feeds
Miscellaneous
Commodities
- Artichokes
- Asparagus
Must addi-
Test Does EPA Bibliographic tional data
substance have data? citation be submitted?
TEP
TEP
TEP
- Cottonseed TEP
-Cottonseed byproducts
\ •
- Mint
-Mint oil & hay
- Okra
- Persimmons
- Pomegranates
- Sugarcane
-Sugarcane Byproducts
Tobacco
171-4. Magnitude of residue in
Meat/Milk/Poultry/Eggs
171-4. Food Handling
Establishments
TEP
TEP
TEP
TEP
TEP
TEP
TEP and PAIRA
TGAI or Plant
Metabolites
TEP and PAIRA
No
No
No
No
No
No
No
No
No
No
Partially 00045126. 05005830.
No
Yes31
Yes32
Yes33
Yes34
Yes35
Yes36
Yes37
Yes38
Yes3?
Yes40
Yes41
Yes42
Yes43,44
Reserved4 5
Yes4*,47
Time frame
for
submission
18 months
18 months
18 months
18 months
24 months
18 months
24 months
18 months
18 months
18 months
18 months
24 months
18 months
24 months
(Continued, footnotes follow.)
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-46-
TABLE A. (Continued).
Must addi- Time frame
Test Does EPA Bibliographic tional data for
Data Requirement substance have data? citation be submitted? submission
171-4. Magnitude of residue in
Potable water, fish, and
irrigated crops
-Fish & shellfish TEP and PAIRA Partially 00157851 Yes48 15 months
-Irrigated crops TEP and PAIRA Partially Yes49 15 months
1. The same chemical identity data are required as under 158.120, with emphasis on impurities that could
constitute residue problems. Refer to Product Chemistry Data Requirements tables.
2. The registrants must amend those labels which include directions for homeowner uses so that the rates permit-
ted for these uses are expressed in a manner consistent with rates listed for commercial applications. If the
rate for homeowner application of any formulation to any site is greater than the maximum rate permitted for
commercial application to that site, the registrant must submit appropriate residue data to support the homeowner
use. Submit doesage recalculations within three months and indicate at that time whether labels will be revised
or a committment made to generate residue data.
3. Data depicting the distribution and metabolism of ring-labeled [^-4C]rotenone in or on three dissimilar food
crops ( e.g., a root crop, oilseed crop, and a leafy vegetable). If metabolism is not similar in the three crops
additional studies using other crops may be required. A completely characterized test substance (including impu-
rities) representative of technical rotenone used in commercial formulations must be applied foliarly several
times up to and including the day of harvest at rates sufficiently high to permit characterization of 14C-resi-
dues. The identities and quantities of residues in or on mature plant parts must be determined in order to elu-
cidate terminal residues. Representative samples must also be analyzed by proposed enforcement methods including
Multiresidue Protocols I-IV to ascertain that all residues of concern are determined.
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-47-
TABLE A. (Continued).
4. Metabolism studies utilizing ruminants and poultry. Animals must be dosed orally for a minimum of 3 days with
ring-labeled [14C]rotenone (the test substance must be completely characterized, including impurities, and
representative of technical rotenone used in commercial formulations) at a level sufficient to make residue
identification and quantification in tissues and milk possible. Milk and eggs must be collected twice daily
during the dosing period. Animals must be sacrificed within 24 hours of administration of the final dose. The
distribution and identity of residues must be determined in eggs, milk, liver, kidney, muscle, and fat. Samples
from these studies must also be analyzed using all proposed enforcement methods (including all FDA Multiresidue
protocols [I-IV]) to ascertain that the methods are capable of adequately recovering all residue of concern.
5. Metabolism studies using cattle and poultry reflecting direct animal treatment. These data are needed because
rotenone is registered for use as a premise treatment in farm animal loafing areas and as a direct treatment to
birds, dairy animals, goats and horses. Animals must be sprayed at a rate sufficiently high to permit complete
characterization of J-4C-residues and sacrificed within one day of the final application. !4C-Residues must be
quantified and characterized in muscle, fat, liver, kidney, milk, and eggs. Eggs and milk must be collected
twice daily throughout the treatment period. Samples from these studies must also be analyzed using all proposed
enforcement methods (including all FDA Multiresidue protocols [I-IV]) to ascertain that the methods are capable
of adequately recovering all residues of concern.
6. Data depicting the nature of rotenone residues in swine are also required unless the metabolism of rotenone in
ruminants or poultry does not differ significantly from that in rats.
7. A complete description of all methods used for collection of residue data submitted in response to this
Standard must be submitted along with method validation data (sensitivity, accuracy, and precision).
8. Additional residue and validation data and appropriate methods may be required if requested metabolism/degrad-
ation studies reveal additional metabolites of concern.
9. All residue data required in this Standard must be accompanied by information specifying the storage interval
and conditions for samples analyzed. Data must also be submitted depicting the storage stability of the residues
of concern under the same conditions and intervals specified. In laboratory tests using fortified samples, the
pure active ingredient and pure metabolites (if necessary) must be used. However, if field weathered samples are
used, the test substance must be a typical end-use product.
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-48-
TABLE A. (Continued).
10. Data depicting rotenone residues of concern in or on the following crops harvested 1 day after the last of
multiple foliar treatments according to the following regimes: (i) beets treated at 0.6 Ib ai/A and carrots and
radishes treated at 0.5 Ib ai/A with a WP/D formulation (applied as a dust and as a spray in separate tests) at
7- to 10-day intervals; (ii) potatoes treated at 0.75 Ib ai/A with a WP/D and an EC at 5- to 10-day intervals;
(iii) potatoes treated aerially (in FL only) with a 0.5% SC/L at 2 pt prod/A in 1-3 gal/A at 5- to 7-day intervals
to support the FL 24(c) label (FL780061); and (iv) turnips treated with the 0.5% EC at 1 pt prod/A in 1 qt veg-
etable oil at 7- to 10-day intervals using aerial ULV equipment. Tests must be conducted in states that represent
the major growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the
1982 Census of Agriculture (U.S. Dept. of Cortrnerce). A tolerance for residues in or on members of the Root and
Tuber Vegetables Group mast be proposed based on the required data. Alternatively, the registrant(s) must submit
a protocol delineating the products, crop sites, and label directions they wish to retain.
11. Data depicting rotenone residues of concern in granules, chips, wet peel, and dry peel processed from potatoes
bearing measurable weathered residues. If residues concentrate, appropriate food/feed additive tolerances must
be proposed.
i •
12. Data depicting rotenone residues of concern in or on green onions and garlic harvested 1 day following the
last of multiple foliar applications made at 7- to 10-day intervals with the 5% D at 0.5 Ib ai/A and the 5% WP at
0.5 Ib ai/100 gal, in separate tests. Tests must be conducted in states that represent the major growing regions
for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture
(U.S. Dept. of Corroerce). A tolerance for residues in or on members of the Bulb Vegetables Group (excluding
bulb onions) must be proposed based on the required data. Alternatively, the registrant(s) must submit a protocol
delineating the products, crop sites, and label directions they wish to retain.
13. Data depicting rotenone residues of concern in or on the following crops harvested 1 day after the last of
multiple foliar applications: (i) lettuce head and leaf varieties) and spinach treated at 5- to 7-day intervals
with a WP/D formulation (applied dry and as a spray in separate tests) at 0.5 Ib ai/A; (ii) lettuce treated with
the 0.5% EC formulation at 0.5 Ib ai/A at 5- to 7-day intervals; (iii) celery treated with a WP at 1 Ib ai/100
gal at 24-hr intervals; (iv) celery treated with the 0.5% SC/L at 2 pt prod/A in 1-3 gal water at 5- to 7-day
intervals support the FL 24(c) label (FL780061); and (v) celery treated with the 0.5% EC at 24-hr intervals at 2
pt prod/25-100 gal (ground) and at 1 pt prod/A in 1 qt vegetable oil using aerial ground equipment.
Tests mast be conducted in states that represent the major growing regions for each crop according to the latest
edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Comnerce). A tolerance
for residues in or on members of the Leafy Vegetables Group must be proposed based on the required data. Alter-
natively, the registrant must submit a protocol delineating the products, crop sites, and label directions
they wish to retain.
-------
-49-
TABLE A. (Continued).
14. Data depicting rotenone residues of concern in or on broccoli, cabbage, and mustard greens harvested 1 day
after the last of multiple foliar applications with a WP/D formulation (applied dry and as a spray in separate
tests) at 0.5 Ib ai/A; (ii) the 0.5 Ib/gal EC formulation applied at 0.5 Ib ai/A; (iii) the 0.5% EC formulation
at 1 pt formulation/A using aerial ULV equipment; and (iv) the 0.5% SC/L formulation at 2 pt formulation in 1-3
gal/A to support the FL 24(c) label (FL780061). Tests must be conducted in states that represent the major
growing regions for each crop according to the latest edition of Agricultural Statistics (USDA) or the 1982
Census of Agriculture (U.S. Dept. of Commerce). A tolerance for residues in or on members of the Brassica Leafy
Vegetables Group must be proposed baser! on the required data. Alternatively, the registrant(s) must submit a
protocol delineating the products, crop sites, and label directions they wish to retain.
i
15. Data depicting rotenone residues of concern in or on beans and peas (one succulent and one dry variety of
each, in separate tests) harvested 1 day following the last of multiple foliar applications made at 5- to 7-day
intervals with (i) a WP/D formulation (as a dust and a spray, in separate tests) at 1 Ib ai/A for beans and 0.75
Ib ai/A for peas; (ii) the 0.5% EC formulation at 2 pt prod/A in 25-100 gal and at 1 pt formulation/A in 1 qt
vegetable oil using aerial ULV equipment; and (iii) the 0.5% SC/L formulation at 2 pt formulation in 1 gal/A to
support the FL 24(c) label (FL780061). Tests must be conducted in states that represent the major growing regions
for beans according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture
(U.S. Dept. of Cotmierce). Tolerances for residues in or on beans (succulent and dry) and peas must be proposed
based on the required data or a crop group tolerance (excluding soybeans) may be proposed. Alternatively, the
registrant must submit a protocol delineating the products, crop sites, and label directions they wish to retain.
16. Since bean and pea vines and hay are raw agricultural commodities, the registrant(s) must propose tolerances
for residues of rotenone in or on bean and peas vines and hay and submit appropriate supporting residue
17. Data depicting rotenone residues of concern in or on eggplant and tomatoes harvested 1 day following multiple
foliar applications (at 5to 7-day intervals for eggplant and 7- to 10-day intervals for tomatoes) with (i) a WP/D
formulation, applied dry and as a spray in separate tests, at 1 Ib ai/A; (ii) an EC formulation applied at 1 Ib
ai/A; (iii) the 0.5% EC formulation at 1 pt formulation/A in 1 qt vegetable oil using aerial ULV equipment.
Also, peppers and tomatoes are to be treated repeatedly at 5- to 7-day intervals with the 0.5% SC/L formulation
at 2 pt formulation in 1-3 gal/A to support the FL 24(c) label (FL780061). Tests must be conducted in states
that represent the major growing regions for each crop according to the latest edition of Agricultural Statistics
(USDA) or the 1982 Census of Agriculture (U.S. Dept. of Conmerce). A tolerance for residues in or on members of
the Fruiting Vegetables Group trust be proposed based on the required data. Alternatively, the registrant(s) must
submit a protocol delineating the products, crop sites, and label directions they wish to retain.
18. Data depicting rotenone residues of concern in products (dry pomace, puree, catsup, and juice) processed from
tomatoes bearing measurable, weathered residues. If residues concentrate in any product, appropriate food/feed
additive tolerances must be proposed.
-------
-50-
TABLE A. (Continued).
19. Data depicting rotenone residues of concern in or on cucumbers, melons (cantaloupe or muskmelon), and suntner
squash (in separate tests) harvested 1 day following multiple foliar applications with (i) a WP/D formulation,
applied dry and as a spray in separate tests, at 0.5 Ib ai/A; (ii) the 0.5% EC formulation at 2 pt prod/A in
25-100 gal water and at 1 pt formulation/A in 1 qt vegetable oil using aerial ULV equipment; (iii) and the SC/L
formulation at 2 pt formulation in 1 gal/A to support the FL 24(c) label (FL780061). Tests must be conducted in
states that represent the major growing regions for each crop according to the latest edition of Agricultural
Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce). A tolerance for residues in or on
members of the Cucurbit Vegetables Group must be proposed based on the required data. Alternatively, the regis-
trant (s) must submit a protocol delineating the products, crop sites, and label directions they wish to retain.
20. Data depicting rotenone residues of concern in or on representative group members sweet orange, lemon, and
grapefruit harvested 1 day following the last of multiple foliar applications of the 0.5% EC at 2 pt prod/100
gal, 0.5% SC/L at 2 pt prod/A in 1-3 gal, and the 5% WP 0.75 Ib ai/A or 2 Ib ai/100 gal, whichever is the greatest
per acre rate. Tests must be conducted in FL to represent the SLN use (FL780061) of the 0.5% SC/L formulation
and in states which represent the major growing regions for each crop according to the latest edition of
Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce) for use of other
formulations. A tolerance for residues in or on members of the Citrus Fruits Group must be proposed based on the
required data. Alternatively, the registrant(s) must submit a protocol delineating the products, crop sites, and
label directions they wish to retain.
21. Data depicting rotenone residues of concern in wet and dried pulp, oil, molasses, and juice processed from
citrus bearing measurable weathered residues. If residues concentrate, appropriate food/feed additive tolerances
must be proposed.
22. Data depicting rotenone residues of concern after multiple foliar applications to the following crops: (i)
apples and pears treated with the 0.5% SC/L at 2 pt prod/A in 1-3 gal spray; (ii) apples and pears treated with
the 0.5% EC at 2 pt prod/A in 100 gal and at 1 pt prod/A in 1 qt vegetable oil using aerial ULV equipment; (iii)
pears treated with a WP at 1 Ib ai/100 gal and a D at 0.5 Ib ai/A; and (iv) apples treated with a WP/D at 0.5 Ib
ai/A and 1 Ib ai/100 gal (applied as a dust and as a spray, in separate tests). Fruit must be harvested 1 day
following the last of multiple foliar applications. Tests must be conducted in FL to represent the SLN use
(FL780061) of the SC/L formulation and in states which represent the major growing regions for each crop according
to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Cotmerce)
for use of other formulations. A tolerance for residues in or on members of the Pome Fruits Group must be
proposed based on the required data. Alternatively, the registrant(s) must submit a protocol delineating the
products, crop sites, and label directions they wish to retain.
-------
-51-
TABLE A. (Continued).
23. Data depicting rotenone residues of concern in juice and wet and dry pomace processed from apples bearing
measurable weathered residues. If residues concentrate in juice and dry pomace, appropriate food/feed
additive tolerances must be proposed.
24. Data depicting rotenone residues of concern in or on the following representative commodities harvested 1 day
after the last of multiple foliar applications! (i) cherries treated with a WP/D formulation at 1 Ib ai/A (as a
dust and spray in separate tests); (ii) peaches treated with the 0.5% EC formulation at 2 pt prod/A in 25-100
gal and at 1 pt prod/A in 1 qt vegetable oil by aerial ULV equipment; (iii) peaches and plums treated with a D at
0.5 Ib ai/A and the 5% WP at 1 Ib ai/100 gal; and (iv) peaches treated with the 0.5% SC/L at 2 pt prod/A in 1-3
gal water at 5- to 7-day intervals. Tests representative of the SUN use (FL780061) must also be conducted in FL
using the SC/L formulation applied to peaches using aerial and ground equipment, in separate tests. Tests must
be conducted in states which represent the major growing regions for each crop according to the latest edition of
Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce) for use of other
formulations. A tolerance for residues in or on members of the Stone Fruits Group must be proposed based on the
required data. Alternatively, the registrant(s) must submit a protocol delineating the products, crop sites, and
label directions they wish to retain.
25. Data depicting rotenone residues of concern in dried prunes processed from plums bearing measurable weathered
residues. If residues concentrate in dried prunes, an appropriate food additive tolerance must be proposed.
26. Data depicting rotenone residues of concern in or on representative group members blackberry/Rubus, blueberry,
grape, and strawberry harvested 1 day following the last of multiple foliar applications according to the follow-
ing treatment regimes: (i) blackberries receiving two treatments at 2- to 3-week intervals of a WP/D (as a dust
and spray in separate tests) at 0.75 Ib ai/A; (ii) blueberries receiving three treatments at 10-day intervals of
the 1% D at 2 Ib ai/A and the 5% WP at 0.75 Ib ai/100 gal; (iii) grapes receiving multiple treatments with a WP/D
(as a dust and spray in separate tests) at 0.5 Ib ai/A at 10- to 14- day intervals; and (iv) strawberries receiv-
ing multiple treatments at 7- to 10-day intervals, of a WP/D (as a dust and spray in separate tests) at 0.5 Ib
ai/A and the 0.5% EC at 2 pt prod/100 gal. A tolerance for residues in or on members of the Small Fruits and
Berries Group (except cranberries) must be proposed based on the required data. Alternatively, the registrant(s)
must submit a protocol delineating the products, crop sites, and label directions they wish to retain.
i
27. Data depicting rotenone residues of concern in raisins, raisin waste, juice, and pomace (wet and dry) proces-
sed from grapes bearing measurable weathered residues. If residues concentrate in any processed product, approp-
riate food/feed additive tolerances must be proposed.
-------
-52-
TABLE A. (Continued).
28. The registrants must amend those labels which include directions for homeowner and/or commercial uses on
almonds and walnuts so that the rates permitted for these uses are expressed in a manner consistent with rates
listed for commercial applications to other orchard trees. Residue data must be submitted that reflect the
amanded labels. Tolerances must the proposed based on the submitted data. Tests must be conducted in geograph-
ically representative areas according to Agricultural Statistics (USDA) or the Census of Agriculture (Dept. of
Commerce). Submit doesage recalculations within three months and indicate at that time whether labels will be
revised or a commitment made to generate residue data.
29. Data depicting rotenone residues of concern in or on field, pop, and sweet corn harvested 1 day following the
last of four foliar applications of the 1% WP/D (including separate tests for dry and spray applications) at 3.5
Ib ai/A at 2- to 10-day intervals. Residue data are required for grain sorghum harvested 1 day following the
last of multiple foliar applications at 5- to 7-day intervals of the 0.5% SC/L formulation using aerial and
ground equipment at 2 pt prod/A in 1-3 gal water conducted in FL to represent the SLN use (FL780061). Tests must
be conducted in states which represent the major growing regions for corn according to the latest edition of
Agricultural Statistics (USDA) or the 1982 Census of Agriculture (U.S. Dept. of Commerce) for the EC formulation
tests. Tolerances for residues in or on corn and grain sorghum must be proposed based on the required data.
Alternatively, the registrant(s) must submit a protocol delineating the products, crop sites, and label
directions they wish to retain.
30. Data depicting rotenone residues of concern in flour, starch, and grain dust of grain sorghum and in crude
and refined oils, wet and dry milling products (including starch, crude and refined oils, grits, meal, and flour),
and grain dust processed from field corn grain bearing measurable weathered residues. If residues concentrate,
appropriate food/feed additive tolerances must be proposed.
31. Data depicting rotenone residues of concern in or on the representative group members alfalfa and clover
harvested at regular intervals following the last of multiple foliar applications of the EC and SC/L formulations
made at 5- to 7-day inntervals , in separate tests, at 2 pt prod/A. Tests must be conducted in FL to represent
the SLN use of the SC/L formulation and, for the EC, in states which represent the major growing regions for
alfalfa and clover according to the latest edition of Agricultural Statistics (USDA) or the 1982 Census of Agri-
culture (U.S. Dept. of Commerce) for the EC formulation. A tolerance for residues in or on members of the Non-
grass Animal Feeds Group must be proposed based on the required data. Alternatively, the registrant(s) must
submit a protocol delineating the products, crop sites, and label directions they wish to retain.
32. Data depicting rotenone residues of concern in or on artichokes harvested 1 day following the last of multiple
foliar applications of the EC formulation at 2 pt prod/A. Ground equipment (25-100 gal spray/A) and aerial ULV
equipment (1 qt vegetable oil/A) must be used. Tests must be conducted in CA which produces virtually all
U.S.-grown artichokes according to the 1982 Census of Agriculture. A tolerance for residues in or on artichokes
must be proposed based on the required data.
-------
-53-
TABLE A. (Continued).
33. Data depicting rotenone residues of concern in or on asparagus harvested 1 day following the last of multiple
foliar applications, at 7- to 10-day intervals, of a WP/D (including separate tests with dry and spray) formula-
tion at 0.5 Ib ai/A and 0.5 Ib ai/100 gal. Tests must be conducted in CA (36%), WA (31%), and MI (20%), which
represent the major asparagus growing regions according to the 1982 Census of Agriculture (U.S. Dept. of Commerce)
parenthetic numbers are percent of U.S. acreage. A tolerance for residues in or on asparagus must be proposed
based on the required data.
34. Data depicting rotenone residues of concern in or on seed and forage of cotton harvested at regular intervals
following the last of nultiple foliar applications of the 0.5% EC formulation at: (i) 2 pt prod/A in 25-100 gal
water per acre using aerial and ground equipment and (ii) 1 pt prod/A in 1 qt vegetable oil per acre using ULV
equipment. Tests must be conducted in CA (25%), TX (31%), and MS (12%) which represent the major cotton growing
regions according to the 1986 Agricultural Statistics (USDA). Tolerances for residues in or on cotton must be
proposed based on the required data.
35. Data depicting rotenone residues of concern in meal, hulls, soapstock, and crude and refined oils processed
from cottonseed bearing measurable weathered residues. If residues concentrate, appropriate food/feed additive
tolerances must be proposed.
36. Data depicting rotenone residues of concern in or on mint hay harvested 1 day following the last of multiple
foliar applications of the D formulation at 0.25 Ib ai/A made at 5- to 7-day intervals. Tests must be conducted
in OR or WA which represent 91% of the mint growing area according to the 1986 Agricultural Statistics (USDA). A
tolerance for residues in or on spent mint must be proposed based on the required data.
37. Data depicting rotenone residues of concern in oil and spent hay processed from mint hay bearing measurable
weathered residues. If residues concentrate, appropriate food/feed additive tolerances must be proposed.
38. Data depicting rotenone residues of concern in or on okra harvested 1 day following the last of multiple
foliar applications, made at 7- to 10-day intervals, of the 1.5% WP/D formulation at 0.75 Ib ai/A (as both a dust
and a spray in separate tests). Tests must be conducted in GA and TX which represent 66% of the okra growing
area according to the 1982 Census of Agriculture (U.S. Dept. of Commerce). A tolerance for residues in or on
okra must be proposed based on the required data.
39. Data depicting rotenone residues of concern in or on persimmon harvested 1 day following the last of multiple
foliar applications of the WP formulation made at 10- to 14-day intervals at 1 Ib ai/100 gal. Tests must be
conducted in CA which produces 96% of the persimmon crop according to the 1982 Census of Agriculture (U.S. Dept.
of Commerce) • A tolerance for residues in or on persimmons must be proposed based on the required data.
-------
-54-
TABLE A. (Continued).
40. Pomegranates grown in CA are to be harvested 1 day after the last of multiple foliar applications of the 5%
WP at 1 Ib ai/100 gal at 14-day intervals. Fruit are to be analyzed for rotenone residues of concern. [CA
produces virtually 100% of the U.S. pomegranate crop according to the 1982 Census of Agriculture (U.S. Dept. of
Commerce).] A tolerance for residues in or on pomegranates must be proposed based on the required data.
41. Data depicting rotenone residues of concern in or on cane and forage of sugarcane harvested at regular
intervals following the last of multiple foliar applications (at 5- to 7-day intervals) of the 0.5% SC/L formula-
tion at 2 pt prod/A using ground and aerial equipment in separate tests. Tests must be conducted in FL to reflect
the registered SLN use. A tolerance for residues in or on cane and forage of sugarcane must be proposed based on
the required data.
42. Data depicting rotenone residues of concern in molasses, refined sugar, and bagasse processed from sugarcane
bearing measurable weathered residues. If residues concentrate, appropriate food/feed additive tolerances must
be proposed.
43. Data depicting rotenone residues of concern in or on green and cured or dry tobacco harvested at regular
intervals following the last of multiple foliar and plant bed applications of the D and WP/D formulations, in the
same tests, at 0.08 oz ai/100 sq yd (plant bed) and 0.5 Ib ai/A (field), respectively. Tests are to be conducted
in KY and NC wh'ich represent >75% of all U.S. tobacco production according to the 1986 Agricultural Statistics
(p. 93).
44. If rotenone residues of concern are M3.1 ppm in or on dry or cured tobacco, pyrolysis products derived from
the active ingredient must be characterized and the level of the residue in smoke must be quantified. (Ring-
labeled [14c]rotenone must be used for identification of pyrolysis products.)
45. Presently, the nature of the residue in animals is not adequately understood. In addition, numerous data
gaps exist concerning the magnitude of the residue in feed items of animals. Upon receipt of data requested in
the section "Nature of the Residue in Animals" and that requested for feed commodities, the need for and nature
of tolerances for residues in animal products will be determined. The specific data requirements regarding the
magnitude of the residues in animal products, possibly including direct animal treatments, will be determined
When all requested data regarding metabolism in animals and magnitude of the residue in feed items have been
received.
46. Data depicting the nature of the residue in representative food products from grain mills, food processing
plants, restaurants, and fruit packing plants resulting from known contamination of ring-labeled [14C]rotenone.
Tests must represent the normal range of heating and processing procedures following fortification with
[l^C]rotenone at typical stages where contamination resulting from treatment of the premise might occur. Char-
acterization of residues must be conducted in samples representing the range of normal shelf life for food.
-------
-55-
TABLE A. (Continued).
products.
47. Data depicting the magnitude of rotenone residues of concern in food products resulting from applications of
rotenone in grain mills, food processing plants, restaurants, and fruit packing plants. Tests are required in
these establishments utilizing EC, RTU, and PrL formulations in indoor space spray treatments. Tests must repre-
sent worst case scenarios for potential residue contamination of food products which might include, but not be
limited to, some of the following: (i) particulate aerosol contact with packaged products or unwrapped fresh
produce present and/or on display at the time of rotenone treatment; (ii) contact of packaged foods with treated
surfaces, such as flour sacks stacked on treated floor surfaces in storage areas; (iii) accidental treatment of
food work surfaces and subsequent contact of food before surfaces are cleaned; (iv) treatment occurring near
stacks of new or cleaned product containers that are then filled without being cleaned; or (v) tracking of residue
by insects or rodents from treated areas to food or food contact surfaces.
48. A metabolism study must be submitted in which fish and shellfish are exposed (for at least 3 days) to water
containing [^-^C]rotenone at 0.25 ppm or a concentration sufficiently high to permit complete quantification and
characterization of -^C-residues in edible tissues (flesh and skin). Representative samples must also be anal-
yzed by proposed enforcement methods including Multiresidue Protocols I-IV to ascertain that all residues of
concern are Determined.
49. The registrant(s) must provide residue data and propose tolerances for residues in or on all crops resulting
from use of treated irrigation water. Pending acceptance of proposed tolerances and appropriate label
restrictions, labels of products containing rotenone must include a statement precluding use of treated water
for irrigation.
-------
-56-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Requirement Test
Substance
§158.290 - Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis PAIRA
Photodegradation
161-2 - In water PAIRA
\«
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Use
Patterns
A,B,D,
E,F,H
A,B,D
A,B
A,B
A,B,E,
F,H
A,B
D
D
A,B,D,
E,F,H
A,B,E,
F
A,B,E,
F
Does EPA Bibliographic
Have Data? Citation
No
No
No
No
No
No
Yes 00141273
No
Partial 00157850
No
No
Must Additional
Data be
Submitted?
Yes
Yes
Yes
Reserved*
Yes
N02
No
Yes
Yes3
Reserved*
Reserved*
Time Frame
for
Submission
9 Months
9 Months
9 Months
27 Months
27 Months
12 Months
-------
-57-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Requirement
§158.290 - Environmental Fate
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targe
Test
Substance^-
- Continued
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
5t TEP
Use Does EPA Bibliographic
Patterns2 Have Data? Citation
A,B,H No
D No
„ VT— . _,_
JNO — — —
No
A,B,H No
A No
AM/-*
MO
D No
A,B Yes 00146183
D No
Must Additional
Data be
Submitted?!
Yes
Yes
No4
No5
Reserved^
Yes
Reserved?
Yes
No
NcB
Time Frame
for
Submission
27 Months
27 Months
39 Months
39 Months
Organisms
-------
-58-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
§158.290 - Environmental Fate - Continued
I/ This study nay be required, depending on rotenone's vapor pressure.
2/ This study is not required because an acceptable anaerobic aquatic study has been submitted.
3/ Additional data are required on the nobility of rotenone and its metabolites in soil and sediment.
4/ There are no forestry uses.
5/ This data requirement is not being imposed at this time.
6/ These data may be required, depending on the results of the field dissipation studies.
7/ These data may be required, depending on the results of the confined rotational crop study.
8/ This data requirement is not being imposed at this time because of rotenone's low
bioaccumulation potential in edible tissues, and rapid degradation in water.
-------
-59-
TABLE A
GENERIC DATA REQUIREMENTS FDR ROTENONE
Must Additional Time Frame
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance Patterns Have Data? Citation Submitted Submission
§158.340
Toxicology
ACUTE TESTING:
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
81-7 -
Acute Oral - Rat TGAI ALL YES 00145496 NO
Acute Dermal - TGAI ALL NO YES
Acute Inhalation - Rat TGAI ALL NO YES
Eye Irritaion - Rabbit TGAI ALL NO YES
X •
Dermal Irritation - Rabbit TGAI ATT. NO YES
Dermal Sens itizat ion -
Guinea Pig TGAI ALL NO YES
Acute Delayed TGAI ALL NO NO
Neurotoxicity - Hen
9 MDNTHS
9 MDNTHS
9 MDNTHS
9 MONTHS
9 MDNTHS
SUBCHRONIC TESTING:
82-1 -
90-Day Feeding -
Rodent TGAI ALL YES 00156739, 00141408 NO*
Non-rodent TGAI ALL YES 00141406 NO2
-------
-60-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Must Additional 3/ Time Frame
Test I/ Use 2/ Does EPA Bibliographic Data be for
iata Requirement Substance Patterns Have Data? Citation Submitted Submission
»158.340
82-2 -
82-3 -
82-4 -
82-5 -
Toxicoloqy (Cont.)
21-Day Dermal- TGAI ALL NO
90-Day Dermal- TGAI ALL NO
90-Day Inhalation - TGAI ALL NO
90-Day Neurotoxicity- TGAI ALL NO
YES 12 MONTHS
NO3
NO4
NO5
CHRONIC TESTING:
83-1 - Chronic Toxicity -
Rodent
Non-rodent
83-2 - Oncogenicity Study -
Rat
Mouse
83-3 - Teratogenicity -
Rat
Rabbit
83-4 - Reproduction -
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
NO
NO
NO
NO
PAR-
YES
PAR'
PAR'
YES
YES
YES
PARTIALLY6 00156739
00141406
YES
NO
PARTIALLY 00156739, 40179801 NO
LLY 40179801 NO
00144294 NO
00103047, 00141407 NO
00141408 NO
50 MONTHS
-------
-61-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Requirement
Test I/ Use 2/ Does EPA
Substance Patterns Have Data?
Must Additional 3/ Time Frame
Bibliographic Data be for
Citation Submitted Submission
§158.340 Toxicology
(continued)
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI ALL
84-2 - Chromosomal Aberration TGAI ALL
84-2 - Other Mechanisms of TGAI ALL
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA ALL
85-2 - Domestic Animal Safety Choice ALL
YES
YES
YES
YES
NO
40170502, 40170506
40170505, 00144292
00093702
00093702, 40179801
00144292
00145496
NO
YES7
NO
NO
NO
12 months
-------
-62-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
1. This requirement is waived based on the requirement of a chronic toxicity study in the rat.
2. This study is not required based on the submission of an acceptable 6-month feeding study in the dog.
3. This study is not required because existing end-uses are not expected to result in repeated human skin contact.
4. This study is not required because existing end-uses are not expected to result in repeated inhalation exposure.
5. This study is not required because there is no positive acute neurotoxicity study, and rotenone has shown no evidence
that it causes neurotoxicity in mammalian species.
6. This study can be upgraded and accepted when histopathology for the low and mid dose groups becomes available.
7. Final reports for Sister Chromatid Exchange and Chromosomal Aberration assays summarized by NTP (40179801) are
needed to support a complete assessment of the mutagenicity studies. An in vivo cytogenetics study is required.
-------
-63-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENCNE
Data Requirement
§158.390 - Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.440 - Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Special Tests
Test Use Does EPA Bibliographic
Subetancel Pattern2 Have Data? Citation
TEP A,B No
TEP A,B No
TEP A,B No
TEP A,B No
TEP A,B No
TEP A,B No
Must Additional
Data be
Submitted?
Nol
Nol
NcA
Nol
NOl
Nol
Time Frame
for
Submission
- , -
I/ This data requirement is not being imposed at this time because rotenone dose not meet the toxicity criteria
of 40 CFR 158.390.
-------
-64-
TAELE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Must. Additional Timef rame
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance Pattern Have Data? Citation Submitted? Submission
§158.490 Wildlife and Aquatic Organisms
Special
70-1 -
Testing
Residue Monitor ing-water TEP A,D No
Reservedl
Avian and Mammalian Testing
71-1 -
71-2 -
71-3 -
71-4 -
Acute Avian Oral TGAI A,B,D, No
Toxicity G,H
Avian Subacute Dietary
Toxicity
- Upland Game Bird, and TGAI A,B,D, No
G,H
- Waterfowl TGAI A,B,D,H No
Wild Mammal Toxicity TGAI A,B,D No
Avian Reproduction
- Upland Game Bird, and TGAI A,B,D No
- Waterfowl A,B,D No
Yes 9 Months
Yes 9 Months
Yes 9 Months
No
Yes2 24 Months
Yes2 24 Months
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-65-
GENERIC
TABLE A
DATA REQUIREMENTS FOR ROTENONE (cont'd)
Data Requirement
Test
Substance
Use Does EPA
Pattern Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.490 Wildlife and Aquatic Organisms
Aquatic Organism Testing
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mammals, and
- Birds
72-1 - Acute Toxicity to
Freshwater Fishes
A,B,D
A,B,D
- Coldwater Fish
Species, and
TGAI
TEP(5%WP)
Degradation Product
- Warnwater Fish TGAI
Species TEP(5%WP)
Degradation Product
72-2 - Acute Toxicity to TGAI
Freshwater
Invertebrates TEP(5%WP)
Degradation Product
A,B,D,
G,H
[A,D]9
A,D
A,B,D,G,H
[A,D]9
A,D
A,B,D,
G,H
[A,D]9
A,D
No
NO
No
No
Partially
Yes
No
Partially
Yes
No
Partially
Yes
No
40098001
See Footnote #5
40098001
See Footnote #5
40063303
00097842,40098001
No
No
No
No
Yes7
No
Yes3
Yes7
No
Yes3
Yes7
No
Yes3
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
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-66-
TAELE A
GENERIC DATA REQUIREMENTS FOR ROTENONE (cont'd)
Test Use Does EPA
Data Requirement Substance Pattern Have Data?
§158.490 Wildlife and Aquatic Organisms
Aquatic Organism Testing (cont'd)
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Fish TGAI A,D No
TEP(5%WP) [A,D]9 Partially
Degradation Product A,D No
- Mollusk TGAI A,D No
TEP (5%WP) [A,D] Partially
Degradation Product A,D No
40228402
00108338, 40228402
Yes
Yes6
Yes3
Reserved
Reserved
12 Months
12 Months
12 Months
12 Months
- Shrinp
TGAI A,D No
TEP (5%WP) [A,D]9 Partially
Degradation Product A,D No
40228402
Yes
Reserved6
Yes
12 Months
12 Months
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-67-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENCNE (cont'd)
§158.
Test
Data Requirement Substance
490 Wildlife and Aquatic Organisms
Use
Pattern
Does EPA
Have Data?
Must Additional
Bibliographic Data be
Citation Submitted?
Timeframe
for
Submission
Aquatic Organism Testing (cont'd)
72-4
72-4
72-5
- Fish Early Life Stage,
- Freshwater TGAI
Species
Degradation Product
- Estuarine/Marine TGAI
Species
Degradation Product
- Aquatic Invertebrate
Life Cycle
- Freshwater TGAI
Species
Degradation Product
- Estuarine/Marine TGAI
Species
Degradation Product
- Fish - Life Cycle TGAI
A,D
A,D
A,D
A,D
A,D
A,D
A,D
A,D
A,D
Partially
No
No
No
Partially
No
No
No
No
40063303 Yes?
Reserved3
Reserved
Reserved3
40063303 Yes?
Reserved3
Reserved
Reserved3
Yes
12 Months
12 Months
27 Months
-------
-68-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE (cont'd)
Must Additional Timeframe
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance Pattern Have Data? Citation Submitted? Submission
§158.490 Wildlife and Aquatic Organisms
Aquatic
72-6 -
72-7 -
Organism Testing (cont'd)
Aquatic Organism TEP A,D
Accumulation
Degradation Product A , D
- Crustacean No
- Fish Yes
- Insect Nymph No
- Mollusk No
- Shrimp No
Simulated Field Testing TEP A,D No
Reserved^/
No
No
Reserved3/
Reserved^/
Reserved
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
TEP
A,D
No
Yes8/ 36 months
Protocol: 6 months
-------
-69-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE (cont'd)
Must Additional Timeframe
Test Use Does EPA Bibliographic Data be for
Data Requirement Substance Pattern Have Data? Citation Submitted? Submission
§158.490 Wildlife and Aquatic Organisms
Footnotes
I/ Residue monitoring studies are reserved pending the review results of environmental fate studies
(i.e., degradation product identification and characterization). The Agency will notify the registrants
if and when protocols and studies are due.
2/ Avian reproduction studies are required to support uses in which there are repeat applications.
3/ The 72-1, 72-2, and 72-3 acute degradation studies will require testing on the major degradate
product, rotenolone. Other degradation product testing (72-4) and accumrrulation (72-6) requirements will
be reserved pending the results of the initial acute degradation studies and environmental fate studies.
4/ The data derived from the estuarine mollusk acute studies shall also be extrapolated to freshwater
mussels concerns for risk assessment purposes, particularly since listed endangered mussels are freshwater
species. The TGAI test must be an oyster embryo larvae study.
5/ Due to multiple citations and limited space, the following citations for the TEP requirement ares
121873, 40063301, 89904, 61296, 90420, 90425, 90366, 90365, 90288, 89909, 89908, 89905, 89906,
90421, 90367, 121874, 121875, 121876, 121877, 121880, 121881, 121882, 121883, 121884, 121885,
121885, 121886, and 40094602.
6/ The need for additional data will be determined after completion of the review of data from
EPA's Gulf Breeze Laboratory.
7/ Data submitted by the U.S. Fish and Wildlife Service are under review. The need for additional
data will be determined when the review of these data is completed.
8/ An aquatic mesocosm study must be designed and executed with appropriate techniques to determine
acute mortality and effects on invertebrate populations in landlocked aquatic environments following
controlled fish kills and must identify and quantitate degradation product residues. A guidance
document is available from the Agency, which outlines an acceptable approach to mesocosm studies.
9/ Required to support the piscicide and cranberry use patterns.
-------
-70-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Requirement
Test Use Does EPA
Substance Pattern Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Timeframe
for
Submission
§158.540 Plant Protection
121-1 - Target Area
Phytotoxicity
EP
A,B,D,
G,H
No
NoV
Nontarqet Area Phytotoxicity
TIER I
122-1 - Seed Germination/
Seedling Emergence
TGAI
A,B,D,
G,H
NO
NoV
122-1 - Vegetative Vigor
TGAI
A,B,D,
G,H
No
122-2 - Aquatic Plant Growth
TGAI
A,D
No
9 Months
-------
-71-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission
§158.540 Plant Protection (cont.)
Nontarqet Area Phytotoxicity
TIER II
123-1 -Seed Germination TGAI
Seedling Emergence
A,B,D,
G,H
No
NqV
123-1- Vegitative Vigor
TGAI
A,B,D,
G,H
No
NV
123-2-Aquatic Plant Growth TGAI
A,B,D, No
G,H
I/ These requirements are generally waived unless it is believed there is a phototoxicity problem.
2/ This data requirement is required to address possible impact concerns resulting from the aquatic
food crop (cranberries) and the piscicide use patterns.
-------
-72-
TABLE A
GENERIC DATA REQUIREMENTS FOR ROTENONE
Data Recfuirement
§158.590 Nontarqet Insect
NONTARGET INSECT TESTING -
141-1 - Honeybee acute
contact LD^Q
Test
Substance
POLLINATORS:
TGAI
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B,H YES 00036935
05001991
Must Additional
Data be
Submitted
NO
Time Frame
for
Submission
141-2 - Honeybee - toxicity of
residues on foliage
TEP
A,B,H
NO
NO1
141-5 - Field testing for
pollinators
TEP
A,B,H
NO
1-As data from the acute test indicate low toxicity, further testing is not required.
-------
-73-
TABLE B. PRODUCr SPECIFIC DATA REQUIREMENTS FDR ROTENONE MANUFACTURING-USE PRODUCTS.
Data Requirement Conpositionl
Part 158
Sutpart C-Product Chemistry
Product Identity and Oonposition
6l-l. Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mater-
ials and Manufacturing Process
61-3 - Discussion of Formation of
Irrpurities
\ •
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Sanples -
62-2 - Certification of Ingredient
Limits
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density or
Specific Gravity
63-12 - pH
62-14 - Oxidizing or Reducing Action
62-15 - Flamrability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Does EPA
have data to
satisfy this Bibliographic
requirement?2 Citation^
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must additional
data be submitted
under FIFRA Sec.
3(c)(2)(B)7
YeS3
Yes*
Yes5
Yes*
Yes?
Yes8
Yes9
Yes?
Yes9
Yes?
Yes9,10
Yes9,ll
Yes9,12
Yes9,13
Yes9
Yes9,14
Time Frame
For Data
Submission
6 months
6 months
6 months
12 months
12 months
12 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
15 months
6 months
-------
-74-
TABTJ5 B. (Continued).
Does EPA "Must "additional
have data to data be submitted Time Frame
satisfy this Bibliographic under FtFRA Sec. For Data
Data Requirement Compositionl requirement?2 Citation2 3(c)(2)(B)7 Submission
Part 158
Subpart C-Product Chemistry (cont.)
63-19 -Miscibility MP No N/A Yes9,15 6 months
63-20 -Corrosion Characteristics MP No N/A Yes9 15 months
Other Requirementst
-1 - Submittal "of Samples N/A N/A N/A No
1 Composition: MP » Manufacturing-Use Product.
2 Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, blbUojCcyihlo citations for the old data are not applicable.
3 The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient and each intentionally added inert must be provided. For the active ingredients, the following must
also be provided: the product, common, and trade names; the molecular, structural, and empirical formulas; the
molecular weight or weight range; and any experimental or internally assigned company code numbers.
4 Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and address
of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must
be provided, along with information regarding the properties of those materials.
5 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.
-------
-75-
TABI£ B. (Continued).
6 Five or more representative sanples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation i (accuracy and precision) must be submitted for each
analytical method used.
7 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 and certified. Also, an explanation of how each certified limit was established must be provided (e.g.,
sample analysis using validated analytical procedures, quantitative estimate based on amounts of ingredients used,
etc.). Tjimits for impurities not associated with the active ingredient need be provided only if they are
considered to be of toxicological significance, regardless of the concentration at which they are present.
Certifications must be submitted on EPA Form 8570 Rev. 2-85.
8 Analytical methods mast 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 certi-
fied limits.
9 Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in 40 CFR
158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
10 Data required if the test substance is dispersible in water.
11 Data required if the product contains an oxidizing or reducing agents.
12 Data required if the product contains combustible liquids.
13 Data required if the product is potentially explosive.
14 Data required if the product is a liquid.
15 Data required if the product is a liquid and is to be diluted with petroleum solvents.
-------
-76-
TABLE B
Data
§158
ACUT
81-1
81-2
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAIb
Requirement Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
.340 - Toxicology
E TESTING
- Acute Oral Toxicity - Rat MP ALL YES 00145496
- Acute Dermal Toxicity MP ALL NO
JING ROTENONE
Must Additional
Data be
Submitted?
NO
YES
Time Frame
for
Submission
9 Months
- Rabbit
81-3 - Acute Inhalation Toxicity MP
- Rat
81-4 - Primary Eye MP
Irritation - Rabbit
81-5 - Primary Dermal MP
Irritation - Rabbit
81-6 - Dermal Sensitization - MP
Guinea Pig
ALL
ALL
ALL
ALL
NO
NO
NO
YES
YES
YES
YES
9 Months
9 Months
9 Months
9 Months
-------
-76b-
II. LABELING APPENDICES
-------
-77-
SUMM7ARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered in
the upper part of the panel. The name of a product will not be
accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The name
and address should preferably be located at the bottom of the
front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end of
the label test. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA estab- lishment
number, preceded by the phrase "EPA Est." is the final
establishment at which the product was produced,
and may appear in any suitable location on the label or
immediate container. It must also appear on the wrapper or
outside container of the package if the EPA establishment number
on the immediate container cannot be clearly read through such
wrapper or container. [40 CFR 156.10(f)]
-------
-78-
SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 156.10(g)]
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.
"Keep Out of
Size of Label Signal Word Reach of
on Front Panel Minimum Type Size 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 I56.l0(h)(l)(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. [40CFR 156.10(h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On
products assigned a toxicity Category I on the basis of oral,
dermal, or inhalation toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting color
and the skull and crossbones shall appear in immediate proximity
to the word POISON. [40 CFR 156.10(h)(1)(i)
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement Of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR I56.10(h)(1)(iii)]
-------
-79-
SUMMARY-3
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 156.lO(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning statements must be headed by the appropriate
hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on the
results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel precautionary
statements section, preceded by the heading "Physical/Chemical
Hazards." Note that no signal word is used in conjunction with
the 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.
-------
-80-
SUMMARY-4
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
classification 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,
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
l. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size as
required for human hazard signal word (see table in 40 CFR
156.10(h)(l)(iv).
b. Directly below this statement on the front panel, a
summary statement of the terms of restriction must appear
(including the reasons for restriction if specified in Section
I). If use is restricted to certified applicators, the following
statement is required: "For retail sale to and use only by
Certified Applicators or persons under their direct supervision
and only for those uses covered by the Certified Applicator's
Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the label as
being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted uses.
-------
-81-
SUMMARY-5
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 simultaneously. 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.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and appear
under the heading "Storage and Disposal" in the directions for
use. This heading must be set in the same type sizes as required
for the child hazard warning. Refer to Appendix II, STOR,
PEST/DIS, and CONT/DIS to determine the storage and disposal
instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
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-82-
StMftRY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
i
2
3
4
5
6A
6B
7
7A
7B
LABEL FTfMFNT
Product name
Company name
and address
Net contents
ETA Reg. No.
ETA Est. NO.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warnincf)
Signal word
APPLICABILITY
OF REX f. f 1 K01NW
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
_aj/unit area
All products
All products
All products
PLACEMENT
RETJUIPEP
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
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
Rea. Ma.
Immediately
following
productL-pame —
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warni-1*1
CTiWIFiNrS
If registrant is not the producer, must
be qualified by "Packed for ... ,"
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other tvoe.
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.
-------
-83-
SUMMARY-7
REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
8
8A
8B
TARFT. FT.FMTW
Skull & cross-
bones and word
POISCN (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT!
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
RPTTTTTRTm
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
-84-
SUMMARY-8
REQUIREMENTS OF THE FIFRA. AS AMENDETi (cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
TATWT. FT.FTVIFTXrT1
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for USP
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
15Q2F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aaency
All products
All products
PLACEMFTNTT ON TARFT,
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
FHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
sional 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 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
-------
PMOAI/nOMAinrtTATIMfMn
MAZAMMTDNUMAN9
CAVTIOW
PRODUCT
NAME
MVION.OIIONMOM,
HAIAAM •
iM»moouorooNTM« IM or
KEEP OUT OF REACH OF CHILDREN
CAUTION
STORAGEAND
DISPOSAL
•TATnitMT V PMCilOM. TMATUtMT
-------
86
MCCAUnONAftV ITATEUINTf
HAtAflOffTOMUUAMS
(•OOMI9TCANMAUI
OAMOIft
IMVMONUCXTAl KAZAN*
M «
» •
STORAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
(reaton for cluanlfytnr)
MO on.» rat
mo OWOEO IT INS conno AJTUCMWS oonncmoi
PRODUCT
NAME
*
ft
ACTMI tMWOCNTl,
MfKf MOftMKMTf:,
TOTAU
TMtMOOUerCONTAMf IM Of KNOAUON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
9TATOICKT W PIUCTCAL TftCATMCMT
1!
f ON 8X11:
•IIIM fUtn. CON WOmONAL WUCAUnOHAUt tTATItlCNTI
TOWH.HATI:
ISTAtUSNUINTNO,:
-won
WAMMNTYCTATtUCNT
-------
-87-
Chapter I—Environmental Protection Agency
§156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information
specified by the Act and the regulations in this Part. The
contents of a label must show clearly and prominently the
following:
(i) The name, brand, or trademark under which the product
is sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of
this section;
(iii) The net contents as prescribed in paragraph (d) of
this section;
(iv) The product registration number as prescribed in
paragraph (e) of this section;
(v) The producing establishment number as prescribed in
paragraph (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, statements,
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
-------
-88-
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 pesticide product. For purposes of this Section, and
the misbranding 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 concerning the labeling, marking and
placarding of hazardous materials and the vehicles carrying
them, define the basic Federal requirements. 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 or 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;
-------
-89-
(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;
(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"; and
(C) "Pollution approved."
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling
must be submitted and accepted prior to registration.
However, final printed labeling need not be submitted until
draft label texts have been provisionally accepted by the
Agency.
(ii) Clearly legible reproductions or photo reductions
will be accepted for unusual labels such as those silk-
screened directly onto glass or metal containers or large bag
or drum labels. Such reproductions must be of microfilm
reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall
appear on the front panel of the label.
(2) No name, brand, or trademark may appear on the label
which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional
name pursuant to §162.6(b){4).
(c) Name and address of producer, registrant, or person
for whom produced. An unqualified name and address given on
the label shall be considered as the name and address of the
producer. If the registrant's name appears on the label and
the registrant is not the producer, or if the name of the
person for whom the pesticide was produced appears on the
label, it must be qualified by appropriate wording such as
"Packed for ***," "Distributed by ***," or "Sold by ***" to
show that the name is not that of the producer.
-------
-90-
(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 degrees F
(20 degrees 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 unit, i.e., "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units specified, net
content may be expressed in metric units.
(6) Variation above minimum content or around an average
is permissible only to the extent that it represents
deviation unavoidable in good manufacturing practice.
Variation below a stated minimum is not permitted. In no
case shall the average content of the packages in a shipment
fall below the stated average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA
Registration No.," or the phrase "EPA Reg. No." The
registration number shall be set in type of a size and style
similar to other print on that part of the label on which it
appears and shall run parallel to it. The registration
number and the required identifying phrase shall not appear
in such a manner as to suggest or imply recommendation or
endorsement of the product by the Agency.
(f) Producing establishment 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—(l) 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
-------
-91-
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.
(3) Names to be used in ingredient statement. The name
used for each ingredient shall be the accepted common name,
if there is one, followed by the chemical name. The common
name may be used alone only if it is well known. If no
common name has been established, the chemical name alone
shall be used. In no case will the use of a trademark or
proprietary name be permitted unless such name has been
accepted as a common name by the Administrator under the
authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of
ingredients shall be stated in terms of weight-to-weight.
The sum of percentages 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
manufacturing batches, the value stated for each active in-
gredient shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling
requirements:
(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]."
-------
-92-
(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:
Hazard indicators
Inhalation IC^
DanallDjo
l^e effects
Toxicdtv Categories
I
including
Ip to and
including
.2ng/liter
l£>toand
including
Corrosive;
corneal opacity
not reversihle
within? days
n
Eran50 thru
Fran .2 thru
2ng/liter
Fran 200
thru 2000
Cornea! opacity
reversible
within 7 days;
irritaticn
persisting for
Skin effects Cbrrosi\e Severe irritation.
at 72 hours
TTT
FranSOO thru
5000 no/kg
Fran2 thru
20 rig/liter
Fran 2000 thru
20,000
fE> comeal opacity;
irritaticn
reversible
within 7 days
Mbderate irritaticn
at 72 hours
IV
Ouster than
SOOOng/kg
Greater than
2Dmg/liter
Geaber than
20,000
JNb irritaticn
MUdor slight
irritaticn at
72 hours
-------
-93-
(i) Human hazard signal word—(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "Poison."
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel
the signal word "Warning."
(C) Toxicity Category III. All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word "Caution."
(D) Toxicity Category IV. All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word "Caution."
(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
-------
-94-
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be
overlooked 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:
Points
Size of Label Front Panel
in Square Inches
5 and under
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children" 1
5
5
8
10
12
(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 "Precau-
tionary 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.
-------
-95-
Tbxicity
Category
Precautionary Statanents by Tcxicity Category
Oral
or Dental Toxicity
Skin ad E^e Local Effects
in
IV
Fatal (poisonus) if swallowed [irhalsd or
absorbedthrough skin]. Do not breathe
vapor [dBt car spray mist]. Do not get
in eyes, on skin, or on clothing. [Front
panel statement of practical treatment
required.]
JVay be fatal if shallowed [inhaled or
atecalBd through the skin]. Do not breathe
vapors [dBt or spray mist]. Eb not get in
eyes, on skin, or on clothing. [?Hxqxiate|
first aid statanents required. ] |
Harmful if swallowed [inhaled or absorbed
through the skin]. Tsroid breathing vapors
[dust or spray mist]. ?s*rid contact with
skin [eyes or clothing]. [?{prcpriate
first aid statarent required. ]
[Kb precautionary statarats required. ]
I
CbrrosKe, causes eye. and stan oarage [or
skin irritation]. Do not get in eyes, en
skin, or on clothing. Wear goggles or face|
shield and ntber globes when handling. |
Harmful or fatal if swallowed. Pfjro- I
priate first aid statanent regjired. ]
Causes eye [and skin] irritaticn. Do not
get in eyes, on skin, or en clothing.
Harmful if swallowed, pjpropriate first
aid statsiHTt required. ]
crntact with skin, eyes, or clothing.
In case of contact iraradiabely flush
eyes or skin with plenty of water. Get
iradical attention if irritaticn persists.
[ISb precajticnary statanents reqjired. ]
(ii) Environmental hazards. Where a hazard exists to
nontarget 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. Examples of the hazard statements
and the circumstances under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC50 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 LD50 of 100 mg/kg or less, or
a subacute dietary LC5Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
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(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:
Flashcoint
Reouired. Tfext
(A) H*S-iKl/J
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(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular"; and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for directions 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 manufac-
turing 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;
(!) 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:
(1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2.) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(!) 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:
(JJ 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;
(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;
(!) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the heading "Directions for
Use. "
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(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 required.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in §162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops,
animals, objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
(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 class-
ified 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
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restricted use(s) except that, if a product has both restricted
use(s) and general use(s), both of these uses may appear on a
product labeled for restricted use. Such products shall be
subject to the provisions of §162.10(j)(2).
(l) 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 mis-
leading 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 Admi-
nistrator will define the appropriate wording for the terms of
restriction by regulation.
(k) Advertising. [Reserved]
[40 CF 28268, July 3, 1975; 40 FR 32329, August 1, 1975; 40 FR
38571, August 21, 1975, as amended at 43 FR 5786, February 9,
1978; amended at 53 FR 15952, May 4, 1988.
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PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate 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.
0. Flashpoint above
150°F.
None required.
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all 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."
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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. 1ars)
Non-aerosol products
(baas)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroucrhly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stav out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wordina) .
/ Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
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III. BIBLIOGRAPHY APPENDICES
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Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA
in arriving at the positions and conclusions stated
elsewhere in the Standard. Primary sources for studies
in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support
of past regulatory decisions. Selections from other
sources including the published literature, in those
instances where they have been considered, will be
included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published
materials, this corresponds closely to an article. In
the case of unpublished materials submitted to the
Agency, the Agency has sought to identify documents at a
level parallel to the published article from within the
typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title
(or at least a single subject), can stand alone for
purposes of review, and can be described with a
conventional bibliographic citation. The Agency has
attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this
bibliography are sorted numerically by "Master Record
Identifier," or MRID, number. This number is unique to
the citation, and should be used at any time specific
reference is required. It is not related to the six-
digit "Accession Number" which has been used to
identify volumes of submitted studies; see paragraph
4(d)(4) below for a further explanation. In a few
cases, entries added to the bibliography late in the
review may be preceded by a nine-character temporary
identifier. These entries are listed after all MRID
entries. This temporary identifier number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record
Identifier (MRID), each entry consists of a citation
containing standard elements followed, in the case of
material submitted to EPA, by a description of the
earliest known submission. Bibliographic conventions
used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for
certain special needs.
a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
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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 following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the EPA accession number of the
volume in which the original submission of
the study appears. The six-digit accession
number follows the symbol "CDL," standing for
"Company Data Library." This accession
number is in turn followed by an alphabetic
suffix which shows the relative position of
the study within the volume. For example,
within accession number 123456, the first
study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-
AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Rotenone Standard
MRID CITATION
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00045126 Claborn, H.V.; Radeleff, R.D.; Bushland, R.C. (1960) Pesticide
Residues in Meat and Milk: A Research Report. (U.S. Agricultur-
al Research Service, Entomology Research Div. and Animal Disease
and Parasite Research Div., unpublished study; CDL:093429-S)
00061296 McCann, J.A. (1969) Security Brand Fish-Tox: Toxicity to Bluegill:
Test No. 145. (U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory; unpublished study;
CDL:104469-A)
00072106 Hazleton Laboratories, Incorporated (1959?) Results of Tests on
the Amount of Residue Remaining; Description of the Analytical
Method: [Rotenone]. (Compilation; unpublished study including
published data, received May 3, 1968 under 9F0766; CDL:091320-B)
00089904 Pitcher, F. (1972) [Prentox Cube Resins: Rainbow Trout (Salno
gairdneri)]: Test No. 491. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL: 130277-A)
00089905 McCann, J.A. (1972) [Security Powdered Cube: Rainbow Trout (Salmo
gairdneri)]: Test No. 472. (U.S. Agricultural Research Serv-
ice, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130278-A)
00089906 McCann, J.A. (1972) [Martin's Cube Powder: Rainbow Trout (Salmo
gairdneri)]: Test No. 481. (U.S. Agricultural Research
service, Animal Biology Laboratory, Fish Toxicity Laboratory;
unpublished study; CDL:130279-A)
00089908 McCann, J.A. (1972) [Unico Rotenone Spray Powder: Rainbow Trout
(Salno gairdneri)]: Test No. 458. (U.S. Agricultural Re-
search Service, Pesticides Regulation Div., Animal Biology Lab-
oratory, Fish Toxicity Laboratory; unpublished study; CDL:
130281-A)
00089909 McCann, J.A. (1972) [Pronoxfish Fish Toxicant: Bluegill (Lepomis
macrochirus)]: Test No. 449. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130282-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Rotenone Standard
MRID CITATION
00090288 McCann, J.A. (1972) [Noxfish Fish Toxicant: Bluegill (Lepomis
macrochirus)]: Test No. 438. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130283-A)
00090365 McCann, J.A. (1970) [Stephenson's 5% Cube Dust: Bluegill Lepomis
nacrochirus]: Test No. 295. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130290-A)
00090366 McCann, J.A. (1968) [Powdered Cube Rotenone: Bluegill (Lepomis
nacrochirus)]: Test No. 126. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130291-A)
00090367 McCann, J.A. (1970) [Unico Rotenone: Rainbow Trout (Salmo
gairdneri)]: Test No. 248. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130292-A)
00090420 Pitcher, F. (1972) [Cube Powder Rotenone (Powder): Rainbow Trout
(Salmo gairdneri)]: Test No. 506. (U.S. Agricultural Re-
search Service, Pesticides Regulation Div., Aniiral Biology Lab-
oratory; unpublished study; CDL:130295-A)
00090421 McCann, J.A.; Pitcher, F. (1972) [Pearson's 5% Rotenone: Rainbow
Trout (Salmo gairdneri)]: Test No. 519. (U.S. Environmental
Protection Agency, Pesticides Regulation Div., Animal Biology
Laboratory; unpublished study; CDL:130296-A)
00090425 McCann, J.A.; Pitcher, F. (1972) [Pearson's 5% Rotenone: Bluegill
(Lepomis macrochirus)]: Test No. 516. (U.S. Agricultural
Research Service, Pesticides Regulation Div., Animal Biology
Laboratory; unpublished study; CDL:130262-A)
00093702 Biotech Research Laboratories, Incorporated (1981) Analytical
Studies for the Detection of Chromosomal Aberrations in Fruit
Flies, Rats, Mice, and Horse Bean: Contract No. 14-16-0009-80-
054. (For U.S. Fish and Wildlife Service, National Fishery Re-
search Laboratory; unpublished study; CDL:246587-A)
00103047 Biotech Research Laboratories, Inc. (1982) Analytical Studies for
the Detection of Chromosomal Aberrations in Fruit Flies, Rats,
Mice, and Horse Bean: Contract No. 14-16-0009-80-054. Final
rept. (U.S. Fish and Wildlife Service, National Fishery Re-
search Laboratory; Unpublished study; CDL:247604-D)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Rotenone Standard
MRID CITATION
00108338 Sanders, H. (1969) Toxicity of Pesticides to the Crustacean Gam-
marus iacustris. By U.S. Fish and Wildlife Service, Fish-pesti-
cide Research Laboratory. Washington, DC: USFWS. (Technical
Papers of the Bureau of Sport Fisheries and Wildlife, 25; pub-
lished study; CDL:091932-T)
00121873 McCann, J. (1970) [Noxfish Fish Toxicant: Rainbow Trout]: Test
No. 242. (Unpublished study received Mar 14, 1970 under 432-
172; prepared by U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory, submitted by U.S.
Environmental Protection Agency, Beltsville, MD; CDL:104495-A)
00121874 McCann, J. (1969) [Security Fish-Tox-5: Bluegill]: Test No. 213.
(Unpublished study received Nov 15, 1969 under 769-309; prepared
by U.S. Agricultural Research Service, Pesticides Regulation
Div., Animal Biology Laboratory, submitted by U.S. Environmental
Protection Agency, Beltsville, MD; CDL:104496-A)
00121875 McCann, J. (1968) [Miller's Rotefive: Rainbow Trout]: Test No. 91.
(Unpublished study received Jun 15, 1968 under unknown admin.
no.; prepared by U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory, submitted by U.S.
Environmental Protection Agency, Beltsville, MD; CDL:104497-A)
00121876 McCann, J.; Ludeman, J. (1968) [Noxfish Fish Toxicant: Rainbow
Trout]: Test No. 93. (Unpublished study received Jun 19, 1970
under unknown admin, no.; prepared by U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory,
submitted by U.S. Environmental Protection Agency, Beltsville,
MD; CDL:104498-A)
00121877 McCann, J. (1968) [Noxfish: Bluegill]: Test No. 112. (Unpublished
study received Sep 21, 1968 under unknown admin, no.; prepared
by U.S. Agricultural Research Service, Pesticides Regulation
Div., Animal Biology Laboratory, submitted by U.S. Environmental
Protection Agency, Beltsville, MD; CDL:104499-A)
00121880 McCann, J. (1971) [Prentiss Cube Powder: Bluegill]: Test No. 354.
(Unpublished study received Apr 24, 1971 under unknown admin.
no.; prepared by U.S. Agricultural Research Service, Pesticides
Regulation Div., Animal Biology Laboratory, submitted by U.S.
Environmental Protection Agency, Beltsville, MD; CDL:128435-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Rotenone Standard
MRID CITATION
00121881 McCann, J.; Pitcher, F. (1973) [Security Powdered Cube: Bluegill]:
Test No. 586. (Unpublished study received Jun 22, 1973 under
769-414; prepared by Pesticides Regulation Div., Animal Biology
Laboratory, submitted by U.S. Environmental Protection Agency,
Beltsville, MD; CDL:128485-A)
00121882 McCann, J; Pitcher, F. (1973) [Security Powdered Cube: Rainbow
Trout]: Test No. 595. (Unpublished study received Jun 1, 1973
under 769-414; prepared by Pesticides Regulation Div., Animal
Biology Laboratory, submitted by U.S. Environmental Protection
Agency, Beltsville, MD; CDL:128486-A)
00121883 McCann, J.; Pitcher, F. (1972) [Pearson's 5% Rotenone: Bluegill]:
Test No. 516. (Unpublished study received Nov 25, 1972 under
728-100; prepared by Pesticides Regulation Div., Animal Biology
Laboratory, submitted by U.S. Environmental Protection Agency,
Beltsville, MD; CDL:128570-A)
00121884 Pitcher, F. (1974) [Durham's 5% Rotenone: Rainbow Trout]: Test
No. 677. (Unpublished study received Mar 19, 1974 under 430-29;
prepared by Pesticides Regulation Div., Animal Biology Labora-
tory, submitted by U.S. Environmental Protection Agency, Belts-
ville, MD; CDL:129217-A)
00121885 Pitcher, F. (1974) [Unico Rotenone Spray Powder: Bluegill]: Test
No. 668. (Unpublished study received Mar 13, 1974 under 1386-
206; prepared by Pesticides Regulation Div., Animal Biology
Laboratory, submitted by U.S. Environmental Protection Agency,
Beltsville, MD; CDL:129218-A)
00121886 Pitcher, F. (1974) [Unico Rotenone Spray: Rainbow Trout]: Test
No. 690. (Unpublished study received Jun 18, 1974 under 1386-
206; prepared by Pesticides Regulation Div., Animal Biology
Laboratory, submitted by U.S. Environmental Protection Agency,
Beltsville, MD; CDL:132483-A)'
00141273 Spare, W. (1984) Final Report: Anaerobic Aquatic Metabolism of :Ra-
diolabeled: Rotenone: Project No. 82-E-076-AM. Unpublished stu-
dy prepared by Biospherics, Inc. 19 p.
00141406 Ellis, H.; Unwin, S.; Cox, J.; et al. (1980) Subchronic Oral Dosing
Study for Safety Evaluation of Rotenone Using Dogs: Final Re-
port: MRI Project No. 4853-B. Unpublished study prepared by
Midwest Research Institute. 64 p.
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-110-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Rotenone Standard
MRID CITATION
00141407 Dickie, S.; MacKenzie, K.? Rao, G. (1981) Teratology Study with
Rotenone in Mice: Final Report: Raltech Study No. 80050. Unpub-
lished study prepared by Raltech Scientific Services. 456 p.
00141408 Kehoe, D.; MacKenzie, K. (1983) Reproduction Study for Safety Eval-
uation of Rotenone Using Rats: Final Report: Study No. 81077.
Unpublished study prepared by Hazleton Raltech, Inc. 732 p.
00144292 Brusick, D. (1981) Mutagenicity Studies on Rotenone: Final Report:
LSI Project No. 22063. Unpublished study prepared by Litton Bi-
onetics, Inc. 44 p.
00144294 MacKenzie, K. (1982) Teratology Study with Rotenone in Rats: Study
No. 81178. Unpublished study prepared by Hazleton Raltech, Inc.
528 p.
00145496 Eisentan, J.; Thakur, A. (1984) General Metabolism Study for Safety
Evaluation of Rotenone Using Rats: Project No. 419-137. Unpub-
lished study prepared by Hazleton Laboratories, America, Inc.
311 p.
00146183 Gingerich, W. ? Rach, J. (1985) Accumulation and Elimination of :6A-
Carbon-14:-Rotenone by Bluegills: Final Report. Unpublished
study prepared by U.S. Fish and Wildlife Service. 115 p.
00156739 Tisdel, M. (1985) Chronic Toxicity Study of Rotenone in Rats: Final
Report: Study No. 6115-100. Unpublished study by prepared
Hazleton Laboratories America, Inc. 1222 p.
00157850 Dawson, V. (1986) Adsorption-desorption of 6a-Carbon-14-Roten-
one by Bottom Sediments: Final Report: ROT-84-988.02. Unpub-
lished study prepared by National Fishery Research Laboratory,
U.S. Fish and Wildlife Service. 144 p.
00157851 Gilderhus, P.; Dawson, V.; Allen, J. (1986) Persistence of Rotenone
in Aquatic Environments at Different Temperatures: Final Report:
Report No. ROT-83-988.02. Unpublished study prepared by Nation-
al by National Fishery Research Laboratory, U.S. Fish and Wild-
life Service. 99 p.
05001991 Stevenson, J.H. (1978) The acute toxicity of unfemulated
pesticides to worker honey bees (Apis mellifera L). Plant
Pathology 27(1):38-40.
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-111-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Rotenone Standard
MRID CITATION
05005830 Matthysse, J.G.; Lisk, D. (1968) Residues of diazinon, coumaphos,
Ciodrin, methoxychlor, and rotenone in oow's milk from
treatments similar to those used for ectoparasite and fly
control on dairy cattle, with notes on safety of diazinon and
Ciodrin to calves. Journal of Economic Entomology
61(5):1394-1398.
40063301 Bills, T.; Marking, L. (1986) Rotenone—Freshwater Fish LC50—Rain-
bow Trout and Bluegills: Laboratory Project ID; TOX 83-626.01B.
Unpublished study prepared by U.S. Fish and Wildlife Service.
17 p.
40063303 Rach, J.; Bills, T.; Marking, L. (1986) Rotenone—Acute LC50 Fresh-
water Invertebrate—Daphnia: Rotenone Aquatic Invertebrate Life
Cycle-Daphnia: Laboratory Project ID; TOX 83-626/01A. Unpub-
lished study prepared by U.S. Fish and Wildlife Service. 26 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Inter-
pretation and Data Base 410 Chemicals and 66 Species of Fresh-
Water Animals. US Fish & Wildlife Service; Resource Publica-
tion (160):1-36.
40170502 Haworth, S. (1978) Salmonella/MamtrBlian-microsome Plate Incorpora-
tion Mutagenesis Assay (Rotenone): Laboratory Project ID: 1019-
563-165-1. Unpublished study prepared by EG&G Mason Research
Institute. 26 p.
40170505 IRI (1984) Mouse Lymphoma Protocol (Rotenone): Laboratory Project
ID: 28037. Unpublished compilation. 8 p.
40170506 SRI International (1987??) The Salronella/Microscme Mutagenicity
Test System (Rotenone). Unpublished compilation. 7 p.
40179801 Abdo, K. (1983) NTP Technical Report on the Toxicology and Carci-
nogenesis Studies on Rotenone...in F344/N Rats and B6C3F1 Mice
(Feed Studies): Draft. Prepared by Battelle Columbus Laborator-
ies for the National Toxicology Program. NIH Publication No.
86-2576. 186 p.
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-lllb-
V. FORMS APPENDICES
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-112-
EFA For* 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIPMA Sf CTIOfI J<0 <2H8t SUMMAMY SMCET
MOOUCT
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6«««4« M:
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Attach separate page with a list of the data requirements your
company agrees to satisfy.
Q 2, I *•«• fnfifMl Mitt IM MpMrnmt wik t«* tr Mtri ttMr '^flmmi uMtr 9 If RA BRIM XC)U)(l>(ul tt •!«*> Ot l«lit«iA«
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Attach list of data requirements
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-------
-113-
OMB Approval No.
2070-005
Expires 11/30/89
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No..
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
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 oravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying
data requiremt
Citing MRID
Number or
EPA Accession
Number
\ with
arts by
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4
-------
CMB Approval No.
2070-005
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT (oont'd)
Date
Guidance Document for
Registration
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of T**st
Stability
Oxidizing/reducing
reaction
Flammabilitv
ExDlodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity. rat
Acute dermal
toxicity. r^N^it
Acute inhalation,
toxicity. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicitv. hen
Test not
required
for my
product
listed
above
(check
below)
I am complyinc
data r**in'ir|9M
Citing MRID
Number or
EPA Accession
Number
1 with
Hlt"^ bv
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4 (cont'd)
-------
EPA rorn asao-e
-115-
0MB Approval No. 2070-0057
Expires 11/30/89
Cf UTIFICATION Of ATTtMTT TO fNTtH
INTO AN AQMfIMfNT WITH OTHKft Mf OlSTftANT*
OCVfLOfMtNT Of OATA
«u«ionN0 to r«or«Mnt frw loHoomr* firmUl «*o art xejtci to ««t rtaw»
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-------
-116- CMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any 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, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
EPA Form 8580-3
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