vvEPA
United StatM
Environmental Protection
Agency
Offlo* of
PwticidM and Toxic SubctanoM
Wnhlngton DC 20460
June 1988
540/RS-88-106
Guidance for the
Reregistration of
Pesticide Products
Containing ETHOPROP
as the Active Ingredient
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Expires ri/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
ETHOPROP
AS THE ACTIVE INGREDIENT
Case Number 106
OPP (Shaughnessy) Number 041101
CAS Registry Number 13194-48-4
June 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Covered by this Standard
A. Description of Chemical 3
B. Use Profile 3
C. Usage Information 5
III. Agency Assessment
A. Summary 5
B. Health Risk Assessment 6
C. Other Science Findings 11
D. Tolerance Reassessment 13
IV. Regulatory Position and Rationale
A. Regulatory Positions 16
B. Criteria for Registration 20
C. Acceptable Ranges and Limits 20
D. Required Labeling 21
V. Products Subject to this Standard 23
VI. Requirement for Submission of Generic Data
A. What are generic data? 25
B. Who must submit generic data? 25
C. What generic data must be submitted? 26
D. How to comply with DCI requirements 26
E. Testing Protocols, Standards For Conducting
Accepting Tests, Guidance On Evaluating And
Reporting Data 29
F. Procedures for requesting a change in protocol.... 29
G. Procedures for requesting extensions of time 29
H. PR Notice 86-5 And Any Other Requirements
Referenced Or Included Within This Notice 30
I. Existing stocks provisions upon suspension or
cancellation 30
VII. Requirement for Submission of Product-Specific Data 31
VIII. Requirement for Submission of Revised Labeling 32
IX. Instructions for Submission
A. Manufacturing use products (sole active) 32
B. Manufacturing use products (multiple active) 33
C. End use products (sole active ingredient) 34
D. End use products (multiple ingredients) 34
E. Intrastate products 35
F. Addresses 35
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APPENDICES
I. DATA APPENDICES
Guide to Tables 37
Table A 39
Table B 66
II. LABELING APPENDICES
Label Contents 71
Classification Labeling Requirements 74
Collateral Labeling 75
Labeling Requirements 76
Physical/Chemical Hazards Labeling Statements 90
Storage Instructions 91
Pesticide Disposal Instructions 92
Container Disposal Instructions 93
III. BIBLIOGRAPHY APPENDICES
Guide to Bibliography 95
Bibliography 97
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA S3(c)(2)(B)
Summary Sheet 105
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other Registrants for
Development of Data 106
EPA Form 8580-4 Product Specific Data Report 107
EPA Form 8570-27 Generic Data Exemption Statement... 109
EPA Form Certification With Respect To
Citation Of Data 110
EPA Form 8580-4 Product Specific Data Report Ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI; Acceptable Daily Intake.
a.i.: Active ingredient.
ARC; Anticipated Residue Contribution.
CAS; Chemical Abstracts Service.
CSF; Confidential Statement of Formula.
PCI; Data Call-in.
EEC; Estimated Environmental Concentration.
EC; Emulsifible Concentrate
EP: End Use Product.
EUP; Experimental Use Permit
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
that 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.,
mg/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.
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MP: Manufacturing Use product.
NPDES; National Pollutant Discharge Elimination system.
NOEL; No Observed Effect Level.
OPP: Office of Pesticide Programs.
FWS; U.S. Department of Interior, 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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1. 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 ident-
ifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesti-
cide.
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.
A glossary of uses included in the "EPA Compendium of
Acceptable Uses" and the detailed scientific review (neither
of which are contained in this document), are available upon
request*. The scientific review primarily presents 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.
^Scientific reviews and the EPA Compendium of Acceptable Uses
may be obtained from the National Technical Information
Service, 5285 Port Royal Rd., Springfield, VA. 22161. Phone:
(703) 487-4650.
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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 registra-
tions 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 con-
taminants;
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, toxicolo-
gical, and environmental characteristics and fate of a pest-
icide. This Registration Standard lists the data EPA be-
lieves 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 iss-
uance by EPA of a Notice of Intent to Suspend the affected
product registrations.
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Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unrea-
sonable adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
II. CHEMICAL COVERED BY THIS STANDARD
A. Description Of Chemical
The following chemical is covered by this Registration
Standard:
Common Name; Ethoprop
Chemical Name: O-ethyl S,S - dipropyl phosphorodithioate
CAS Number; 13194-48-4
OPP (Shaughnessy) Number; 041101
Chemical Class; Organophosphate
Empirical Formula;
Molecular Weight; 242.307
Trade Names; Mocap®, VC 9-104
Description Of Physical Characteristics Of Chemical;
"Clear yellow tinted liquid with a strong mercaptan
odor.
°Boilrng point 86-9l°C at 0.2 mm Hg.
"Solubility in water to 843 ppm at 21°C and soluble
in most organic solvents.
°No corrosion observed on SAE type 1020 steel or
aluminum foil of the type used to line a bag of
granular formulation 332 hours at 21°C.
B. Use Profile
Type Of Pesticide; Insecticide, nematocide, and
fungicide (suppression of white mold on peanuts).
Pests Controlled (In General); banana rootborer,
nematodes, cutworms, rootworm, white mold, white
grubs, flea beetle, aphid, mole crickets, wire-
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Reqistered Uses (By General Groups): The registra-
tion is for use as an insecticide, nematocide, and
fungicide.
Food crop application of ethoprop: bananas,
broccoli (EUP), cabbage, cauliflower (EOF),
corn grain, corn fodder and forage, cucumbers,
mushrooms, okra, fresh corn including sweet
corn (kernals plus cob with husk removed),
lima beans, lima bean forage, snap beans, snap
bean forage, peanuts, peanut hay, pineapples,
pineapple fodder and forage, potatoes, soybeans,
soybean forage and hay, sugarcane, sugarcane
fodder and forage, and sweet potatoes (40 CFR
S180.31 and S180.262). There are no internat-
ional tolerances or Codex Maximum Residue Limits
for residues of ethoprop. The ethoprop toler-
ances (40 CFR 5180.262) should be revised to
read, "pineapples, pineapple fodder and forage,"
instead of "pineapple fodder and forage."
Terrestrial non-food crop uses include tobacco,
ornamental plants, and root dip treatments for
citrus seedlings.
Domestic non-food crop uses on; Lawns [(24-c)
registration for commercial applicator use
only, FL800028].
Mode Of Activity; Contact.
Formulation Types Registered; Emulsifiable concen-
trate formulations containing 40% or more active
ingredient are "Restricted use" pesticide, and
applicators must be certified or under the direct
supervision of applicators certified to apply these
products (44 CFR 45131, August 1, 1979). In addit-
ion, granular formulations 10% and greater have
been proposed for "Restricted Use" classification
on the basis of acute dermal toxicity and avian
hazard (44 CFR 45218, August 1, 1979). These will
be classified in accordance with the criteria for the
"Restricted use classification groups" explained under
40 CFR 162.30, "Optional procedures for classification
of pesticide uses by regulation", and hereafter known
as "optional procedures of 40 CFR 162.30". There are
no products for use or storage in or around the home.
Method of Application; Ethoprop formulations are com-
monly applied by using ground equipment and are in-
corporated into the soil immediately after applic-
ation with the use of cultivating equipment and/or
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by irrigation. For the emulsifiable concentrate
formulation, spray equipment (i.e., backpack spray-
ers) and watering cans may be used for application.
The specific type of equipment is determined by
site and equipment availability.
C. Usage Information
It is estimated that domestic annual usage of etho-
prop ranges from 1.6-2.6 million pounds of active ingred-
ient. Usage appears to be declining although data
supporting this are limited. Ethoprop is registered for
use as an insecticide, nematicide, and fungicide.
Domestic usage of ethoprop during 1985-86 was dis-
tributed among field corn (26-30%), tobacco (19-33%),
potato (11-13%), soybean (11-13%), turfgrass (11-13%),
peanut (5-6%), cabbage (3-4%), sweet potato (3-4%),
sweet corn (1%), and lima and snap beans (<1%). Esti-
mates are unavailable for ethoprop use on cirtus seed-
lings, cucumber, pineapple, and sugarcane. Estimates
of the proportions of total crop acreage treated with
ethoprop are presented for lima and snap beans (<3%),
cabbage (15-20%), field corn (<1%), sweet corn «5%),
peanut «5%), potato «3%), soybean «1%), sweet potato
(18-22%), and tobacco «15%).
III. AGENCY ASSESSMENT
A. summary
As part of the registration process, the data base for
ethoprop was first reviewed in 1983, and a Ethoprop Regist-
ration Standard was published. In that Standard, data gaps
were identified according to policies then in place. Regist-
rants were notified of the required studies and the time
frames for submittal of data to the Agency. Data were sub-
mitted. The Agency has now evaluated all new data supporting
the registration of Ethoprop, and reevaluated earlier studies
especially in cases where the policy on criteria for accept-
ability has changed. This Standard summarizes, identifies,
and discusses the Agency's concerns.
1. The Agency has identified a potential avian
adverse effect concern. Precautionary statements are needed
on manufacturing-use and end-use product labels to protect
avian species.
2. The "Restricted use" classifications for all
ethoprop emulsible concentrate formulations containing 40%
and greater will continue. Granular formulations 10% and
greater have been proposed for "Restricted Use" classification
on the basis of acute dermal toxicity and avian hazard (44
FR 45218, August 1, 1979). These will be classified in
accordance with optional procedures of 40 CFR 162.30.
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3. Tolerances are presently established (40 CFR
S180.262, S180.31) at 0.02 ppm for residues of ethoprop
per se. A major change in the tolerances for this chemical
il~~not anticipated. A final reevaluation of the acceptable
daily intake will be made when the requested new data are
received and evaluated, in the interim, no new tolerances
for ethoprop will be granted. There are no international
tolerances or Codex Maximum Residue Limits for residues of
ethoprop.
4. Due to the incomplete environmenal fate data
base, no determination regarding the potential for ground
water contamination can be made. Submission of ground water
data is required. In the column study, ethoprop was very
mobile. K
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active ingredient (ethoprop) by weight)], and no further
testing is required. The acute oral LD50 of Mocap EC in
chickens is 9.9 (8.1-12.1) mg/kg.
2. Subchronic Toxicity
Subchronic oral (non-rodent); An acceptable 13-week
study was conducted using the beagle dog. Ethoprop (tech-
nical) was tested using dietary dose levels of 1.0, 3.0, and
100 ppm. Cholinesterase inhibition was the only treatment-
related effect noted. No lexicologically significant inhib-
ition of plasma or erythrocyte Cholinesterase was judged to
have occurrred at the lowest dose tested (1.0 ppm; 0.075
mg/kg). The lowest effect level for Cholinesterase depression
was 3.0 ppm (0.225 mg/kg/day).
Subchronic oral (rodent): Three groups of 25 albino
(Charles River Strain) rats per sex were fed ethoprop technical
in the daily diet at doses of 0. 0.3, 1.0, or 100 ppm for 90
days. The pattern of Cholinesterase inhibition suggests
that the NOEL is approximately 0.3 ppm (0.015 mg/kg/day).
The subchronic feeding study (rats) is considered supplemental,
and has been used to establish a provisional acceptable
daily intake (PADI). A new subchronic rat study is not
required provided an acceptable rat chronic feeding study
is conducted. The data obtained from the chronic study will
suffice in this case for the information needed for a sub-
chronic oral toxicity study.
Subchronic dermalt The 21-day dermal study showed no
treatment related clinical signs of toxicity or mortality.
However, brain Cholinesterase inhibition was observed at all
doses tested. This study is considered flawed, and an
acceptable study is required. Large variations existed
in plasma and erythrocyte Cholinesterase levels observed
among the animals on test. No additonal subchronic studies
(90-day dermal, inhalation) are required, because the exist-
ing acceptable use pattern should not result in repeated
or extended exposure. A study for subchronic neurotoxicity
is not required, because the acute neurotoxicity data do
not indicate a delayed neurotoxicity problem.
3. Chronic Toxicity
Beagle dogs were fed ethoprop in their diets at 0, 0.025,
1.0 and 10 mg/kg/day for 52 weeks. Plasma Cholinesterase
(ChE) was inhibited in females at all dose levels. Whereas,
the mid- and high dose levels are effect levels for erythro-
cyte ChE inhibition, and the high-dose is an effect level
for brain ChE inhibition. Also, all male dogs at all dose
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levels exhibited less weight gain than the control group.
No NOEL could be determined from the study, in order to
determine a NOEL for plasma erythrocyte and and the issue of
decreased male body weight gain in all test groups, the
Agency is requiring an abbreviated study of 17 weeks.
In the chronic feeding study, Fisher 344 rats were fed
0, 4.5, 9.0 and 18 ppm of ethroprop for 12 weeks, and then
placed on diets of 0, 49, 98 or 196 ppms for the remaining
52 weeks. Cholinesterase inhibition was observed at all
the dose levels and a NOEl could not be determined. The
MTD was considered to be the highest dose tested. The study
is considered supplemental, and additional information is
required.
The one year dog chronic feeding study is evaluated to
be inadequate, but does not need to be repeated. The Agency
is requiring specified special studies to resolve the defic-
iencies noted in the one-year dog chronic feeding study. The
Agency review for chronic and oncogenic potential in rats
(MRID 00138636) indicated that for the chronic feeding portion
of this study the classification was core-supplemental. It
cannot be upgraded since no NOEL for Cholinesterase inhibition
was observed. At all doses of ethoprop tested, Cholinesterase
inhibition of >20% was observed. Additional information must
be submitted. In addition, the Agency is requiring summary
incidence tables for clinical observations.
4. Oncoqenicitv
B6C3F1 mice were fed 0, 15, 30, and 60 ppm of ethoprop in
their diet for 78 weeks. The study did not demonstrate
oncogenic effects under the conditions of this study. However,
the highest dose tested (60 ppm) is considered to be at
least two times under the maximum tolerated dose. This
study is considered supplemental and must be repeated.
Fisher 344 rats were fed 0. 4.5, 9.0, and 18 ppm of
ethoprop for 12 weeks, and then placed on diets containing 0,
49, 98, or 196 ppm of ethoprop for the remaining 52 weeks.
Under the conditions of this study, there was an increase in
the number of c-cell adenomas of the thyroid in males re-
ceiving the high-dose when compared to controls, and there
was a dose-related increase in the number of endometrial
polyps in females. However, the total number of individual
tissues examined histologically per group was not presented.
Consequently, the incidence of these lesions cannot be deter-
mined or analyzed statistically, and an evaluation of the
oncogenic potential of ethoprop cannot be performed from
the reported study. This study is considered by the Agency
to be supplementary. Additional data are required.
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5. Mutaqenicity
An acceptable battery of mutagenicty tests (gene muta-
tion, chromosomal aberration, and DNA damage) are available.
However, an acceptable bone marrow cytogenetic analysis in
rats is needed to provide in vivo confirmation of in vitro
findings in the chromosomal aberration studies submitted.
The results of the available mutagenicity studies are
as follow:
1. Gene mutation; a) Reverse Mutation in Salmonella typh-
imurium (negative), b) In vitro CHO Sister Chromaid Exhange
Assay (positive).
2. Chromosomal Aberration; a) In vitro CHO Cell Cytogenic
Assay (positive), b) In vitro CHO Sister Chromaid Exchange
Assay (positive).
3. DNA Damage Unscheduled DNA Synthesis In Primary Rat
Hepatocytes (inactive in this assay).
6. Teratology
Ethoprop technical was adminstered by oral intubation
to groups of Sprague-Dawley rats at doses of 0. 0.16, 1.6,
and 16.0 mg/kg/day (MRID 00104532). However, based on the
data presented and the current guidelines for examining
teratology studies, the potential of the test material to
cause developmental toxicity cannot be fully evaluated.
More specifically, certain deficienceis were noted in the
rat study at the time the initial registration standard
was prepared (although occurrances of compound-related terata
were not). At that time, a request was made for historical
control data with regard to parameters such as delayed
ossification. Apparently, these data were not submitted.
Since then, new Agency guidelines have stressed that obser-
vations be made for all aspects of developmental toxicity,
and not just occurrances of terata. For these reasons,
complete historical control data for all measured fetal
and maternal parameters (details in MRID 00104532) and
individual litter data for all measured fetal parameters
are now required. The issue of potential developmental
toxicity in the rat needs to be addressed before the status
of the study (now supplemental) can be upgraded.
A teratology study in New Zealand White rabbits was
submitted in which ethoprop technical was administered by
gavage to groups of animals at doses of 0, 0.125, 0.500,
and 2.00 mg/kg. Since the data submitted in the study
were not sufficient to fully evaluate such things as
whether test material adminstration resulted in maternal
toxicity or resulted in an increase in skeletal variations,
a NOEL and LEL for maternal and developmental toxicity
could not be determined. Additional data, including his-
torical control data for fetal and maternal parameters, are
needed for the resolution of these issues (MRID 00161619).
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7- Reproduction
A three-generation study in Fisher 344 rats in which
ethoprop technical was administered at dose levels of 0,
60.5, 131, and 262 ppm was not sufficient to satisfy the data
requirements for reproductive toxicity (MRID 00162164). The
data presented were considered insufficient to determine a NOEL
and LEL for maternal and developmenal toxicity. Questions
were raised with regard to culling procedures and the appro-
priateness of other parts of the protocol, animal illness,
lack of food consumption and diet analysis data, inadequate
data presentation, and descrepancies in data reporting.
8. Metabolism (S85-1; special study)
Available studies are not adequate to fulfill the require-
ment for metabolism data. An adequate study is required in the
rat. Total [14C] recovery in the three test groups accounted for
74 to 82 percent of the [l^c] dose. The low recoveries may have
been associated with the volatility of the test material and its
metabolites. However, an adequate intercomparison of [*4CJ
elimination data and levels of metabolites between sexes and
test groups cannot be made because of the low recoveries.
0-ethyl-S-propylphosphorothioic acid and 0-ethyl-phosphoric acid
were detected in urine as well as unchanged ethoprop (<0.7% of
the dose) in animals receiving the low dose. Analysis for
fecal metabolites was not performed. The study presented is
classified as supplementary.
9. Other Special Studies (See pages 42 and 43 for
additional information).
The following special studies are required in support
of the registration standard to address questions generated
from the evaluation of the submitted data:
a) A special study is required in rats for the purpose of
determining a definitive NOEL for plasma, erythrocyte, and
brain cholinesterase inhibition. A protocol should be sub-
mitted to the Agency for approval prior to commencement of
this study.
b) A subchronic feeding study in dogs is required to
address issues of decrease in animal body weight gain and
the lack of a NOEL for cholinesterase inhibition in the
present 1-year study. This study is required for purposes
of determining a sensitive species for cholinesterase
inhibition. A protocol should be submitted to the Agency
prior to initiation of this study.
c) An acceptable rat bone marrow cytogenetic analysis study
is required for in vivo confirmation of in vitro cytogenetic
findings observed in the chromosomal aberration studies.
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d) Two 60-day mouse studies are required in order to resolve
the question of whether eye lesions observed in the 78-week
mouse oncogenicity study were systemic effects of the test
material administration. One test must be conducted by
oral gavage in the B6C3F1 mouse, and the other one must be a
dietary study in another mouse strain.
C. Other Science Findings
1. Ecological Effects
a. Avian studies
Ethoprop technical is highly toxic (acute oral, dietary,
and dermal) to bird species. There are sufficient data to
characterize ethoprop as highly toxic to very highly toxic
orally to upland game birds [ring-neck pheasants; 95% a.i.;
LD50= 118 (103-134) mg/kg] & [bobwhite quail; 95% a.i.; LD50
= 33 (27-40 mg/kg]. Ethoprop is highly toxic to waterfowls
[mallards; LC50 = 287 (215-382) mg/kg].
Acceptable acute and subchronic dietary toxicity studies
are available. Pending the results of the field dissipation
study, an avian reproduction study is required. Acute and
simulated field studies show sufficient hazard to wildlife
to require the following field studies: 1) One study with
the emulsifiable concentrate (EC) on pineapple. 2) One
study with the granular product on corn or potatoes.
b. Aquatic Studies
Technical ethoprop is very highly toxic to aquatic
invertebrates. [Daphnia maqna; 99.7% a.i.; EC50 = 0.093
(0.056-0.18) ppm].
Ethoprop is moderately to highly toxic to rainbow trout
[92% a.i.; LC50 * 1.02 (0.56-2.10) mg/1], and highly toxic
to bluegills [92% a.i.; LC50 = 0.30 (0.23-0.40 mg/1].
Ethoprop is highly toxic to crustaceans, and the data
are as follow: a) Mysidopsis bahia (shrimp); LC50 * 23 ppb.
b) Penaeus tvlirostris (shrimp); LC50 = 7.2 ppb. c) Calli-
nectes sapidus (blue crabs); 100% mortality at 24 hrs when
exposed to 1 ppm.
For marine fish species, ethoprop is highly toxic. The
96 hour LC50s found during static testing with technical etho-
18op wre 748.3 ppb for sheepshead minnows (Cyprinidon varieqatus)
and 32 ppb for spot (Leiostomus xanthurus). Flow-through pro-
cedures established 96-hour LC50s of 232.67 ppb for sheepshead
minnows and 7.2 ppb for pinfish (Lagodon rhomboides).
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Ethoprop is slightly toxic to embryo larvae of oyster
species [95% a.i.; EC50 = 11.0 (5.6-32) ppm].
Further assessment of the potential hazards to aquatic
organisms cannot be made until certain environmenal fate
data are submitted and reviewed. At that time, an estimated
environmental concentration (EEC) will be developed. Further
aquatic data requirements will be developed. Further aquatic
data requirements will be reserved until the EEC and environ-
mental fate data are available.
2. Summary Of Data Gaps
The Agency has identified missing data required to
fully evaluate the human and environmental risks associated
with the use of ethoprop. Complete data gaps details may be
obtained by referring to the tables in Data Appendices I.
A summary of these data gaps has been made (Table 1).
Table 1; Summary Of Data Gaps.
Please refer to the tables in Data Appendices I
for detailed information regarding these requirements.
Toxicology
°21 day dermal toxicity (rabbit).
°90 day feeding (rodent; not required if a chronic rat
feeding study is performed).
"Chronic toxicity (rodent and nonrodent).
•Oncogenicity (mouse, rat).
•Teratogenicity (rat, rabbit).
"Reproduction (2-generation rat).
°Mutagenicity testing (structural chromosomal).
•Metabolism (§85-1).
"Special testing.
Environmental Fate/Exposure
•Hydrolysis.
"Leaching and adsorption/desorption.
°Soil dissipation.
•Soil dissipation, long term.
•Spray drift
"Photodegradation in air, soil, and water.
•Volatility (lab).
•Volatility (field).
•Rotational crops (confined; accumulation).
•Rotational crops (field; accumulation).
•Accumulation (fish).
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Table 1; Summary Of Data Gaps Con't.
Fish & Wildlife
•Actual field testing with birds.
Residue Chemistry
"Nature of residue (metabolism, plants, and livestock).
•Residue analytical methods.
•Storage stability data.
•Magnitude of residue in meat, milk, poultry, and eggs.
•Residue Data
Product Chemistry
•All purity and composition.
•Analysis and certification of product.
•physical and chemical characteristics; i.e. color,
physical state, odor, boiling point, dissociation
constant, stability.
•All analysis and certification of product ingredients.
D. TOLERANCE REASSESSMENT
Tolerances have been established (40 CFR S180.262,
5180.31) at 0.02 ppm for residues of ethoprop per se in or
on the raw agricultural commodities. A conclusive tolerance
reassessment was not made at this time due to the lack of
information on : a) The metabolism of ethoprop in plants
and animals, b) Storage stability, c) Residue and toxicity
studies. A final reevaluation of the tolerances and ADI
will be made as soon as the requested data concerning storage
stability, metabolism, residue, and toxicity are evaluated.
No new tolerances for ethoprop will be granted in the
interim. There are no international tolerances or Codex
Maximum Residue Limits for residues of ethoprop. The ethoprop
tolerances (40 CFR S180.262) should be revised to read,
"pineapples, pineapple fodder and forage," instead of "pineapple
fodder and forage." Temporary tolerances have expired for the
following: grapes (12-31-84), Broccoli and cauliflower (4-28-88),
1. Evaluation Of Residue Data
a. Metabolism
Data on the metabolism of ethoprop in plants are not
considered adequate. These data identified several plant
metabolites of ethoprop, but did not quantitate them. Given
the nature of this chemical, unusual or exceptionally toxic
metabolites are not expected. Quantitation of known and/ or
supposed metabolites will allow a more complete toxicological
evaluation. Additional 14C-radiolabeled experiments on corn,
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potatoes, and cabbage are needed. Although not required
previously, metabolism studies on ruminants and poultry are now
needed to elucidate the pathway for metabolism of ethoprop in
animals. Tolerances for ethoprop are currently expressed in
terms of parent compound per se, and will be reassessed when
the additional required studies are submitted and reviewed.
b. Analytical Enforcement Methods
Adequate analytical methodology is available for enforce-
ment of the present tolerances in terms of ethoprop per se.
Ethoprop is completely recovered by the multiresidue pro-
cedures in the Pesticide Analytical Manual, vol. 1 (protocols
II and III), and partially recovered by protocol I. No data
are available for protocol IV. These data are required. If
any metabolites of toxicological concern are identified in
the metabolism studies required, additional validated method-
ology may be needed.
c. Storage Stability
Current quidelines require storage stability studies
for appropriate raw agricultural commodities using weathered
and fortified samples (40 CFR §158.120). This information
and sample histories for previously submitted residue trials
are required (see Appendix I).
d. Residues
The available data support the tolerances for ethoprop
per se in potatoes, sweet potatoes, bananas, peanut nutmeats,
and sugarcane. Based on available data, the established
tolerance levels appear to be adequate. However, the avail-
able data are insufficient to fully assess the tolerances
for residues in or on cabbage, lima beans, lima bean forage,
snap beans, snap bean forage, soybeans, soybean forage,
soybean hay, cucumbers, corn grain, sweet corn (kernel plus
cob with husk removed), corn forage, and pineapples. Addit-
ional field residue data are required for these crops. There
are no registered uses for mushrooms or okra, and the toler-
ances of .02 ppm are to be rescinded.
Food or feed additive tolerances may be required to
cover possible residues of ethoprop and any metabolites of
toxicological concern in the processed commodities of potatoes,
soybeans, corn, peanuts, pineapples, and sugarcane. Process-
ing studies on these commodities are therefore required in
order to determine the need for these tolerances.
Tolerance proposals as well as appropriate supporting
residue data are needed for the following raw agricultural
commodities of crops having registered uses: bean hay (includ-
ing snap bean, and lima hay), soybean straw, peanut hulls, and
peanut vines. Consistent with current guidelines, these raw
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agricultural commodities are now considered to be major feed
items.
2. Evaluation of The ADI
The acceptable daily intake (ADI) for cholinesterase
inhibition in man is usually determined on the basis of a no-
observed effect level (NOEL) from a chronic feeding study.
Because the chronic feeding studies evaluated for this standard
were unacceptable, the Agency will continue to use the sub-
chronic rat study to establish the Provisional Acceptable
Daily Intake (PADI) as in 1983. The PADI of 0.000015 mg/kg/day
is used for Tolerance evaluations and is based on a 90-day
rat feeding study (MRID 00075239), a NOEL for cholinesterase
inhibition estimated to be 0.015 mg/kg/day, and a safety
factor of 1000.
A 200-fold safety factor is normally used when a 90-day
study is substituted for a long-term study. In this case a
safety factor of 1000 was used because the 90-day rat study
only suggested a NOEL. It did not definitively support it.
To assure safety, the larger safety factor was used.
A comparison of published tolerances to the PADI was
conducted using the TAS Routine Chronic Analysis. The TAS
analysis estimates the average dietary exposure for the U.S.
population. The TMRC is 0.000073 mg/kg/day which occupies
489% of the PADI. The actual residues to which the public is
exposed are likely to be considerably less than the Theoretical
Maximum because:
a) as published in 40 CFR 180.262, the established
tolerances on all but two minor crops are based on limits of
detection for the analytical method used for ethoprop.
Additionally, every crop having a tolerance is not treated;
b) processing and time-to-market often results in residue
reduction;
c) not all crops contributing to the TMRC are likely to
be consumed by an individual, and;
d) market basket surveys conducted by FDA indicate that
little if any real pesticide residues of organophosphates
actually remain in/on finished foods.
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IV. REGULATORY POSITION AND RATIONALE
A. Regulatory Position And Rationale
1. Special Review
The Agency is not initiating a special review of etho-
prop at this time. The Agency has identified a potential
avian adverse effect concern. As an interim measure, pre-
cautionary statements are required on manufacturing-use and
end-use product labels to protect birds. The Agency is
calling in all of the data identified as gaps in the Agency's
ethoprop data base. When the new data are evaluated, the
Agency will determine whether or not ethoprop meets or exceeds
any of the special review criteria.
Rationale: Based on the review and evalu-
ation of all available data for ethoprop, the Agency has
determined that a special review of ethoprop is not warranted
at this time.
2. Restricted Use
The "Restricted Use" classification of all ethoprop
emulsifiable concentrate formulations containing 40% or
greater under FIFRA §162.31 will remain in effect, and appli-
cators must be certified or under the direct supervision of
applicators certified to apply these products (44 FR, 45131,
August 1, 1979). It is the Agency's position that these
products must bear appropriate restricted use labeling in
order to remain in compliance with FIFRA. In addition,
granular formulations 10% and greater have been proposed
for restricted use.
Rationale; All ethoprop emulsifiable
concentrate formulations (40% or greater) have been classified
for retricted use based on toxicity data. Technical ethoprop
is in Toxicity Category I on the basis of acute oral and
inhalation effects. Ethoprop can be acutely lethal from ex-
posure to skin and/or eye(s). Due to the early deaths of the
test animals from ethoprop by the ocular and dermal routes,
the eye and dermal irritation tests could not be completed.
Although there are numerous toxicology and ecological effects
data gaps, available data are sufficient to show continuing
concern. To enable the public and/or user to be aware of the
reasons for the restricted use classification, a statement iden-
tifying the reasons for the restriction are to appear on the
label. Granular formulations 10% and greater have been pro-
posed for "Restricted Use" classification on the basis of
acute dermal and avian hazard (44 FR 45218, August 1, 1979).
These will be classified in accordance with the optional
restricted use classification procedures of 40 CFR 162.30.
There are no products for use in or around the home.
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3. Tolerance And New Uses
The Agency will not grant any new tolerances or new
uses for ethoprop until data required under this Standard
have been received and all tolerances reassessed. The
ethoprop tolerance of 0.02 for certain foods appears to be
adequate. A final reevaluation of the tolerances and accept-
able daily intake (ADI) will be made when the new data re-
quested are received and evaluated.
Rationale; A conclusive tolerance assess-
ment was not possible at this time due to the following:
a) Metabolism of ethoprop in plants and animals is not fully
understood, b) Storage stability, c) Residue and toxicity
studies. A final reevaluation of the tolerances will be
made when these concerns are resolved.
4. Groundwater
The Agency is unable to provide a quantitative esti-
mate of the ethoprop potential for groundwater contam-
ination.
Rationale; Ethoprop was found to be very
mobile in columns of loamy sand and loam soil types. Addition-
al studies required to assess the potential for groundwater
contamination include hydrolysis, photolysis in water and
soils, leaching of soil degradates, and field dissipation.
5. Nontarqet Organism Labeling
In order to remain in compliance, updated label pre-
cautions are required by this Standard to address the hazard
to fish and wildlife.
Rationale-; Based on studies available to
assess hazards to wildlife and aquatic organism, ethoprop is
characterized as highly toxic to birds, marine/estuarine
crustaceans, and marine/estuarine fish species. Ethoprop is
slighly toxic to embryo larvae of oyster species. It is
moderately toxic to honey bees.
6. Reentry Requirements
The Agency will reevaluate reentry protection when the
requested data are received (40 CFR S158.140, Appendix I).
In the interim, PR Notice 83-2 (March 29, 1983), and 40 CFR
S170 pertaining to worker protection standards for agricul-
tural pesticides must be followed.
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Rationale: PR Notice 83-2 and 40 CFR
S170 address worker protection standards for pesticides.
The Agency has established for the present time a 24 hours
reentry interval for all uses. The Agency is requiring soil
dissipation data for those crops where agricultural practices
involve human tasks, and where there would be direct exposure
to pesticide treated soil (e.g., the harvest of potatoes).
The reasons for the requirement of foliar and soil dissipa-
tion studes are as follow: 1) Ethoprop is in toxicity cate-
gory I. 2) Ethoprop has a high vapor pressure (3.7 x iO"2
mmHg at 26°C). 3) Ethoprop is registered for food and non-
food uses. 4) From 10-20% of applied ethoprop has been found
on the surface of the soil. 5) Ethoprop exceeds both the
criteria for toxicity and exposures as delineated in sub-
division K of the Pesticide Assessment Guidelines.
7. Endangered Species
The U.S. Department Of interior's Fish and wildlife Ser-
vice (FWS) has determined that certain uses of ethoprop may
jeopardize the contined existence of endangered species or
certain endangered species. EPA is develoing a program to
reduce or eliminate exposure to these species to a point where
use does not result in jeopardy, and will issue notice of any
necessary labeling revisions when the program is developed.
No new labeling is being required at this time. As
explained below, labeling requirements issued in PR Notices
87-4 and 87-5 have been withdrawn pending reissuance.
Rationale; In May 1987, EPA issued PR
Notices 87-4 and 87-5 in response to the FWS findings that
certain pesticides, including ethoprop, jeopardized the
continued existence of endangered species. Subsequent to
issuance of these PR Notices, EPA identified a number of
significant technical errors and inconsistencies in the
information to which users would have been referred. There-
fore, on January 26, 1988, the Agency issued PR Notice 88-1
which withdrew PR Notices 87-4 and 87-5 pending development
of a more focused program to protect endangered species.
EPA is working to correct these errors prior to re-
quiring labeling to protect endangered species. When that
program is fully developed, notice of any labeling necessary
to protect endangered species will be issued.
8. Continuation Of Registration
While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing ethoprop may be sold, distributed, formulated and
used, subject to the terms and conditions specified in this
Standard. Registrants must provide or agree to develop
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additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does
not normally cancel or withhold registration simply because
data are missing or are inadequate (see FIFRA sec. 3(c)(2)(B)
and 3(c)(7). Issuance of this Standard provides a mechanism
for identifying data needs. These data will be reviewed and
evaluated, and then the Agency will determine if additional
regulatory changes are necessary.
9. Review Of Data Submitted
The Agency has identified certain data that will receive
priority review when submitted.
Rationale; Certain data are essential
to the Agency's assessment of this pesticide and its uses
and/or may trigger the need for further studies which should
be initiated as soon as possible. The following studies have
been identified to receive priority review as soon as they
are received by the Agency.
5158.125 - Residue Chemistry
171-4 - Residue Analytical Method
171-4 - Nature of Residues (Metabolism)
171-4 - Magnitude of the Residues in
Plants
$158.130 - Environmental Fate
161-1 - Hydrolysis
161-2 - Photodegradation - in water
161-3 - Photodegradation - in soil
161-4 - Photodegradation - in air
163-1 - Leaching and Adsorption/Desorption
163-2 - Volatility (Lab)
164-1 - Field Dissipation - Soil
165-1 - Confined Rotational Crop
165-2 - Field Rotational Crop
5158.135 - Toxicology
00-0 - Special Studies required on
pages 10 and 11 of this Standard
83-1 - Chronic Toxicity (rodent)
83-2 - Oncogenicity - mouse, rat
83-3 - Teratology (rat, rabbit)
83-4 - Reproduction (rat)
85-1 - Metabolism
5158.145 - Wildlife and Aquatic Organisms
71-5 - Simulated and Actual Field Testing
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§158.142 - Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
$158.142 - Spray Drift
202-1 - Drift Field Evaluation
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
manufacturing-use and end-use products must contain etho-
prop as the sole active ingedient, bear required labeling,
and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in Section C
below.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain ethoprop.
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 ethoprop provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category into which each
product falls.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below.
°Terrestrial, food uses on: bananas, broccoli (EUP),
cabbage, cauliflower (EUP), corn grain, corn
fodder and forage, cucumbers, fresh corn including
sweet corn (kernals plus cob with husk removed), lima
beans, lima bean forage, snap beans, snap bean forage,
peanuts, peanut hay, pineapples, pineapple fodder and
forage, potatoes, soybeans, soybean forage and hay,
sugarcane, sugarcane fodder and forage, and sweet
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potatoes (40 CFR §180.262). The ethoprop tolerances
section (40 CFR §180.262) is being revised to read,
"pineapples, pineapple fodder and forage," instead of
"pineapple fodder and forage."
"Terrestrial, non-food uses on: citrus seedlings, orna-
mentals (including aglaonema, azalea, boxwood, bromel-
iads, cacti, caladium, camellia, Cape Jasmine, fern,
gardenia, holly, philodendron, pothos, sanservieria,
and yew), and tobacco.
"Domestic outdoor use on: lawns [Special Local Needs
(24) (c)J registration for commerical applicator use
only, Florida (FD-800028.
"Greenhouse non-food use on: ornamentals (as specified
above).
The EPA Index to Pesticide Chemicals lists all registered
uses, as well as approved maximum application rates and fre-
quencies.
D. Required Labeling
All products must bear appropriate labeling as speci-
fied in 40 CFR §162.10, PR Notices 83-2, 83-3, and below.
Appendix II contains further information on label require-
ments.
Pesticide products containing ethoprop as an active
ingredient may not be released for shipment by the regist-
rant after July 1, 1989 unless the product bears amended
labeling that complies with the requirements of this Stan-
dard. Five (5) copies of the labeling, revised in accord-
ance with this Standard, must be submitted prior to release
for shipment.
Pesticide products containing ethoprop as an active
ingredient may not be distributed, sold, offered for sale,
(having been so received) delivered or offered to be de-
livered by any person after July 1, 1990 unless the product
bears amended labeling, five copies of which have been sub-
mitted to the Agency, that complies with the requirements of
this Standard.
1. Use Pattern Statements
The ingredients statement for MPs must list the active
ingredient as: Ethoprop, (0-ethyl S,S-dipropyl phosphate)...
%. In addition, the total percentage by weight of all
Unert ingredients must be listed. All MPs must state that
they are intended only for formulation into end-use products
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for any of the use patterns listed agove. See the specify
sites listed in Use patterns listed on the pages 19 and 20.
A limiting factor will be included on the label where the
registrant fails to agree to comply with the data require-
ments in either Table A or B for that use pattern.
2. Precautionary Statements
Labeling for all MP products containing ethoprop must
bear statements reflecting the acute human toxicity of the
compound. Ethoprop is in Toxicity Category I when administer-
ed orally, dermally, or via inhalation. Ethoprop can be acute-
ly lethal if absorbed through the eye. The required precau-
tionary statements associated with Toxiciy category I are
specified in 40 CFR 162.10.
3. Human Hazard statement
In addition to the Toxicity Category I labeling re-
quirements identifided above, the following human hazard
statement, based on data reveiwed by the Agency, must appear
on all manufacturing-use product labels: "Poisonous if
absorbed through the eye(s). Do not get in eyes."
4. Manufacturing-use Products
The following revised environmental hazard statement
must appear on all manufacturing-use product labels:
"This pesticide is toxic to fish and wildlife. Do not
discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or public water unless
this product is specifically identified and addressed in an
NPDS permit. Do not discharge effluent containing this
product to sewer systems without previously notifying the
sewage treatment plant authority. For guidance, contact
your local State Water Board or Regional Office of the EPA.
5. For Granular End-use Products
The following label is required: "This pesticide is
toxic to aquatic organisms (fish and invertebrates), and
wildlife. Birds feeding in treated areas may be killed. Do
not apply directly to water or wetlands (swamps, bogs, marshes,
and potholes). Runoff from treated areas may be hazardous
to aquatic organisms in neighboring areas. Cover or incorp-
orate granules that are spilled during loading or are visible
on soil surface in turn areas. Do not contaminate water
when disposing of equipment wash water."
6. For Non-granular End-Use Products
"This pesticide is toxic to aquatic organisms (fish and
invertebrates) and extremely toxic to birds. Cover or disc
spill areas. Birds in treated areas may be killed. Do not
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apply directly to water or wetlands (swamps, bogs, marshes, and
potholes). Drift and runoff may be dangerous to aquatic organ-
isms in neighboring areas. Do not contaminate water by cleaning
of equipment or disposal of wastes.
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
products are subject to this Registration Standard as
follow:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions upon use, composition, or packaging
listed in Section IV.
2. The data requirements listed in Tables A and B2.
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, and data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption3, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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2. If eligible for the formulator's exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.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 submission or citation of the data listed
in this Registration Standard.
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
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EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy,it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
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registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. Good Laboratory
Practices standards must be followed (40 CFR, Part 160).
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). All studies must be submitted in the form of
a final report; a preliminary report will not be considered
to fulfill the submission requirement.
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIPRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
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such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MPs) containing the subject
pesticide as sole active ingredient"!
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met/ immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft label must indicate the
intended colors of the final label, clear indication of
the front panel of the label, and the intended type
sizes of the text.
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3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory position and Rationale).
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
Within 9 months from the receipt of this document, you
must submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. The draft labeling must indicate
the intended colors of the final label, clear indication
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of the front panel of the label, and the intended type
sizes of the text. End use product labeling must comply
specifically with the instructions in Section IV (Regulatory
Position and Rationale).
E. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
Applications for full Federal registration of intrastate
products are required to be submitted no later than July 31,
1988.
F. Addresses
The required information must be submitted to the following
address:
William H. Miller (PM-16)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Assurance Division Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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I. DATA APPENDICES
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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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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.
-------
TABLE A
Generic Data Requirements for Ethoprop
Test \J Use 2/
Data Requirement Substance" Patterns"
Does EPA
Have Data?
Time Frame
Bibliographic Must Additional for 3_/
Citation Data be Submitted? Submission
$158.135 Toxicology
Acute
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Testing
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Eye Irritation
- Dermal Irritation
- Dermal Sensitlzation
- Delayed Neurotoxicity
- Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI . •
TGAI
A
A
A
A
A
A
A
Yes
Yes
Yes
Yes
Yes
No
Yes
00078053
00078035
00128218
0078036
0048774
0078037 ,
0078038
No
No
No
No
No ~ ^
No*/ " *
No
Subchronlc Testing
82-1 - 90-Day Feeding
- Rodent, and
- Nonrodent (Dog)
82-2 - 21-Day Dermal - Rabbit
TGAI
TGAI
TGAI
A
A
No
Yes
No
00075240
Yes5/
No'"
Yes*/
15 Months
12 Months
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Table A (Cont'd)
Generic Data Requirements for Ethoprop
Test JV
Data Requirement Substance
Time Frame
Use 21 Does EPA Bibliographic Must Additional for 3/
Patterns Have Data? Citation Data be Submitted? Submission
1158.135 Toxicology (cont'd)
Subchronic Testing (cont'd)
82-3 -
82-4 -
82-5 -
Chronic
83-1 -
83-2 -
83-3 -
90-Day Dermal - Rabbit
90-Day Inhalation - Rat
90-Day Neurotoxiclty
Testing
Chronic Toxiclty - 2 Species
- Rodent, and
- Non rodent (Dog)
Oncogenlcity - 2 Species
- Rat (preferred), and
- Mouse (preferred)
Teratogenlcity - 2 Species
- Rat
- Rabbit
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
mx* AT
A No
A No
A No
A No
A Yes 00160179
A Partial 00138636
A Partial 00137496
A Partial 00104532
A Partial 00161619
A Pnrflfll ~
No7/
No8/
No9/
Yes
Yesii/
Yegl2/
Yesl^/
Yes]*/
Yesl5/
—
—
—
50 Months
50 Months
50 Months
50 Months
15 Months
15 Months
39 Months
o
_4 . Reproduction - Rat
2-Generation
-------
Table A (Cont'd)
Generic Data Requirements for Ethoprop
Data Requirement
Test I/ Use 2/
Substance Patterns
Time Frame
Does EPA Bibliographic Must Additional for 3/
Have Data? Citation Data be Submitted? Submission
5158.135 Toxicology (cont'd)
Mutagenicity Testing (cont'd)
84-2
84-2
84-4
- Gene Nutation (Ames Test)
- Structural chromosomal
Aberration
- Other Genotoxic Effects
TGAI
TGAI
TGAI
A
A
A
Yes 00160180,
00160181
Yes 00160183,
00160184
Yes 00160182
No
^
No
—
12 Months
—
Special Testing
85-1
85-2
86-1
Other
- General Metabolism
- Dermal Penetration
- Domestic Animal Safety
Special Testing
Rat Study18
Subchronic Study19
Rat Bone Narrow
Cytogenetic analysis20
Subchronic Studies (2)21
PAI or PAIRA
Choice
Choice
TGAl
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
No —
No —
No —
No —
No —
No —
No
Yes
No
No£/
Yes19
Yes20
Yes21
24 Months
—
—
14 Months
18 Months
14 Months
24 Months
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Table A (Cont'd)
Generic Data Requirenents for Ethoprop
Footnotes
\J Composition: TGAI - Technical Grade Active Ingredient; PAI - Pure Active Ingredient; PAIRA - Pure Active Ingredient.
Radiolabeled; Choice - Choice of several test substances determined on a case-by-case basis.
21 The use patterns are coded as follows: A - Terrestrial, Pood Crop; B - Terrestrial, Nonfood; C - Aquatic, Food Crop;
D - Aquatic, Nonfood; E - Greenhouse, Food Crop; F - Greenhouse, Nonfood; G - Forestry; H - Domestic Outdoor;
I - Indoor; IP - Industrial Preservative.
3f Due dates refer to the number of months following the registrants receipt of this Registration Standard unless
indicated.
4/ A study Is not required because of the high acute dermal toxicity of technical grade Ethoprop.
S/ This study is not required if a chronic rat feeding study is performed.
?/ This requirement may be satisfied if questions raised about the study, such as too many hemolyzed blood samples and
large variations In plasma and erythrocyte cholinesterase levels, are satisfactorily addressed.
Tj This study Is not required because existing acceptable use patterns should not result in repeated or extended human
skin contact.
S/ This study is not required because existing acceptable use patterns should not result in repeated or extended human
~~ contact by the Inhalation route.
9/ This study is not required because the available acute delayed neurotoxlcity data do not indicate a delayed
~~ neurotoxlcity problem.
Id/ This requirement may be satisfied if a special study resolves certain issues raised about the study (such as
decreases in body weight gain and cholinesterase inhibition at the lowest dose tested).
it/ This requirement may be satisfied if additional data, needed to fully evaluate oncogenlc potential, are supplied
(such as the numbers of individual animal tissues and organs subjected to hlstopathological exam). i.
12/ This study does not fulfill requirements because a maximum tolerated dose was not attained or approximated. V
Additional supporting data are required prior to the final decision regarding the acceptability of this study. Two
addtlonal special subchronic studies in the mouse are required to resolve the issue of eye lesions in the mouse
oncogencity study.
13/ This requirement may be satisfied if issues regarding potential developmental toxicity (such as delayed ossification)
are satisfactorily addressed.
U/ This requirement may be satisfied if additional data, Including historical control data for fetal and maternal
— parametes, is submitted in order to satisfactorily resolve questions regarding such things as potential maternal
toxlcly and possible increases in skeletal variations.
15/ This requirement may be satisfied if additional data Is submitted in order to satisfactorily resolve questions
— regarding such things as animal illness, lack of food consumption and diet analysis, Inadequate data presentation,
discrepancies in data reporting, and the appropriateness of certain parts of the protocol.
16/ Generic data requirements for this type of testing are filled. However, an In vivo rat bone marrow cytogenetic assay
— Is needed to confirm In vitro cytogenetic findings of genotoxicity.
ill This study is not required at this time.
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Table A (Con't)
Generic Data Requirements for Ethoprop
Footnotes
18. A special study in rats is requested in order to determine a definitive NOEL for plasm, eyrthrocyte,
and brain cholinesterase (ChE) inhibition. A protocol must be designed by the registrant and submitted
to the Agency for approval prior to commencement of the study. This study is requested for the follow-
ing reasons: a) ChE activity inhibition by very low doses of ethoprop. b) Uncertainty of a NOEL in
estimated for ChE inhibition in a 90-day rat study (MRID 0075239). c) Lack of a NOEL in an available
rat chronic/oncogenicty study (MRID 00138636).
19. In order to determine the NOEL for female plasma cholinesterase and resolve the issue of decreases in
male body weight gain in all test groups (MRID 00160179), an additional study is required. It will
not be necessary to repeat the comprehensive 1-year dog study in its entirety, but an abbreviated
study of lesser complexity is required to resolve two issues. The new study should have a duration of
approximately 17 weeks, because differences in body weight gain between males in the low-dose and control
groups could not be discerned until approximately the 17 week of the study (MRID 00160179). Cholin-
esterase levels must be monitored until a plateau of at least 3 weeks duration is reached in which chol-
inester levels remain fairly constant. Plasma and erythrocyte cholinesterase levels in males and
females must be monitored, and least two dose levels be employed. A protocol must be submitted to the
Agency for approval prior to initating the study. The laboratory data (MRID 00160179) must be reexam-
ined in order to determine whether a rationale exists that would mitigate the Agency's concern regarding
the "across the board" decrease in mean body weight gain in all male test groups. If there is a rationale
explaining the decrease in mean body weight gain in all male test groups, the duration of the requested
study could possibly be shortened substantially.
20. Ethoprop, in the presence of a metabolic activation system, was found to be clastogenic in one and
genotoxic in the other of two acceptable chromosomal abberrations studies (MRID 00160183 and 00160184).
An acceptable rat bone marrow cytogenic analsysis is required for in vivo confirmation of the in vitro
cytogenetic findings.
21. Eye lesions were noted in the 78 week mouse oncogenicity study (MRID 000137496). Since it could not
be concluded whether or not the lesions noted were systemic effects of test administration, two
special subchronic studies in the mouse, one an oral gavage study in B6C3F1 mouse and the other a
dietary study in a stain of mouse other than B6C3F1 mouse, are required to resolve this issue (details
are in MRID 00137496). The protocol should be submitted to the Agency for approval prior to commence-
ment of the studies.
An oral gavage study must be conducted with 30 male and 30 female mice in the control group, and 30
male and 30 female mice in the treated group. B6C3P1 mice must be used, but chained from a supplier
-------
Table A con't
Footnotes
other than than Harley Industries of Indianapolis (used on previous test). A single daily dose
of ethoprop (technical MCTR-60-78; lot no. 2225-62) must be administered for a period of 60 days
and be sufficient to give biologically meaningful RBC and plasma chollnesterase depression. All
animals must be observed daily, and five animals/sex/group be sacrificed on days 5, 11, 15, 20,
30, and 60. The sacrificed animals are to be only examined for gross and microscopic findings
of the eye, and the investigator is to address those adverse findings previously noted (lesions).
The results of the study must be reported in full to the Agency with a discussion to the findings
and a conclusion.
A seperate study must be conducted with 30 male and 30 female mice in each of the test and control
groups. The possibility of cross contamination must be eliminated between treated and control
groups In this study and the above mentioned gavage study. The strain of mice used must be one
other than the B6C3F1, and be obtained from a supplier other than Harlan Industries. The dose
Is to be adminstered in the feed for a period of 60 days, and be sufficient to give biologically
meaningful RBC and plasma chollnesterase inhibition. The test material to be administered is
Ethoprop (MCTR-60-78; lot no. 2225-62). All animals are to be observed daily. Five animals/
sex/group are to be sacrificed on days 5, 10, 15, 20, 30, and 60, and only examined for gross
and microscopic findings of the eye. The adverse effects previously noted (lesions, MRID
00137496) must be addressed. At 60 days, the experiment is to be terminated. The results
of the study be reported to the'Agency with a discussion of the findings and a conclusion drawn.
If the results of the gavage study are negative and the dietary study are positive, a scient-
ifically sound argument must be presented as to the causation of the adverse eye effects prev-
iously noted and the probability of those effects occurlng from topical exposure to ethoprop
via' the eye with time.
-------
Table A (Cont'd)
Generic Data Requirements for Ethoprop
Data Requirement
$158.130 Environmental Pate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
Mobility Studies
163-1 - Leaching and Adsorption/
Desorption
163-2 - Volatility (Lab)
ifil-1 - volatility (Field)
Test I/ Use 2/
Substance Patterns
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TEP
TEP
A,B
A,B
A
A
A,B
A
N/A
N/A
A,B
A
A
Time frame
Does EPA Bibliographic Must Additional for 3/
Have Data? Citation Data be Submitted? Submission
No —
No —
No —
NO
Yes 00160171
Yes 00160171
No —
No —
Partially 00160172/73
No —
No —
Yes- /
Yes
Yes
Yes
NO
No
No
No
Yes 5/
Yes
Yes J/
9 Months
9 Months
9 Months
9 Months
—
—
—
—
12 Months
12 Months
15 Months
-------
Table A (Cont'd)
Generic Data Requirements for Ethoprop
Data Requirement
1158.130 Environmental Fate (cont
Dissipation Studies - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and Tank
Mixes
164-5 - Soil, Long-term
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
i£c_c _ T« AsiuflMr Nnntareet
Test \J
Substance
'd)
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
Use 2/
Patterns
A,B
A,B
N/A
N/A
A
A
A
N/A
A,B
N/A
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
Time Frame
Bibliographic Must Additional for 3/
Citation Data be Submitted? Submission
Yes 27 Months
No
No
NoV
Yes£/
i
Yesjl/ 39 Months
YeslO/
No
Yes 12 Months
No
Organisms
-------
Table A (Cont'd)
Generic Data Requirements for Ethoprop
Data Requirement
$158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
$158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
158.75 Human Exposure Data
Test I/
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use 2/ Does EPA Bibliographic
Patterns Have Data? Citation
A,B No
A,B No
A,B No
A,B No
A,B No
A,B No
Must Additional
Data be Submitted?
Yes
Yes"/
Optional^2/
Optional
Yes
Yes
MX
Time Frame
for 3
Submission
27 Months
27 Months
27 Months
27 Months
27 Months
27 Months
O*7 U^nl-kn
/
£
1
Other Exposure Data
TEP
A,B
No
-------
Table A (Cont'd)
Generic Data Requirements for Bthoprop
Footnotes
I/ Composition: TGAI - Technical Grade of the Active Ingredient; PAIRA » Pure Active Ingredient, radiolabeled;
TEP « Typical End-Use Product.
The use patterns are coded as follows: A - Terrestrial, Food Crop; B - Terrestrial, Nonfood; c - Aquatic, Food crop;
D = Aquatic, Nonfood; E » Greenhouse, Food Crop; F = Greenhouse, Nonfood; G « Forestry; H = Domestic Outdoor;
I = Indoor.
Due dates refer to the number of months following the registrant's receipt of this Registration Standard unless
otherwise indicated.
4/ Registrant must repeat the hydrolysis study at pH 9 to confirm chemical degradation.
5/ Data on leaching of imaged ethoprop are acceptable. Additional data on leaching of soil degradates of ethoprop are
required.
6/ Reserved pending results of the laboratory volatility study (163-2).
7/ Currently not being imposed for this product.
&/ All data are required if the results from the aerobic soil metabolism/field dissipation studies show that > 50% i
ethoprop remains in the soil prior to the recommended subsequent application. £
V Supplementary data indicated [14C] ethoprop residues accumulated in rotational crops. Therefore, a label '
restriction such as "Do not plant unregistered rotational crops for 8 months after last application" is needed, if
ethoprop residue uptake in rotational crops occur after 12 months a tolerance petition must be submitted.
107 Pending results of confined rotational crops study (165-1).
U/ soil dissipation data are only required for those crops where agricultural practice involves human tasks where there
wold be direct exposure to pesticide-treated soil, as in the harvest of potatoes.
12/ The Agency does not require the submission of reentry human exposure data, but will accept those data for review for
establishment of field worker protection if submitted.
13/ Dependent on evaluation of poisoning incidence data and adequacy of worker stafety statement on product labeling.
-------
Table A
Generic Data Requirements for Ethcprop
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes, Bibliographic
Composition Patterns No, or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(C)(2)(b)7
§158.145 Wildlife and Aquatic
71-1
71-2
71-3
71-4
71-5
- Avian Oral LDso
- Avian Dietary LCso
- Wild Manual Toxicity
- Avian Reproduction
- Simulated and Actual
Field Testing
- Manuals and Birds
(Level I)
(Level II)
Organisms
TGAI
TGAI
TGAI
TGAI
TEP
TEP
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
Yes
Yes
No
No
Partial
No
00091247*,
05008363,
40378401
00022923
00092113*,
00161449
No
No
NO!/
Reserved!/
Reserved!/
Aquatic Organism Testing
72-1
72-2
- Freshwater Fish LCso
- Acute LCso Freshwater
Invertebrates
TGAI
TEP
TGAI
M'KP
A,B,H
A,B,H
A,B,H
A,B,H
Partial
Partial
Yes
Partial
40378201
40663401
00048777*
001610188
40378202
No
No7,9/
No ,
NO!/
VO
I
*Data submitted by Mobil Chemical Company, and subsequently transferred to Rhone-Poulenc Chemical Company,
the current data owner. These data may be compensable.
-------
TABLE A
DATA REQUIREMENTS FDR EMDPKDP
Data Requirement
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Composition1/ Pattern2/ No, or Partially)
Must Additional
Data Submitted
Biblio- Under FIFRA
graphic Section
Citation 3(C)(2)(B)
§158.145 Wildlife and
Aquatic Organisms (cont'd)
72-3 - Acute LC^g Estuarine and TGAI A,B,H
Marine Organisms
72-4 - Fish Early Life Stage TGAI A,B,H
and Aquatic Invertebrate
Life Cycle
72-5 - Fish Life Cycle TSAI A,B,H
72-6 - Aquatic Organism
Accumulation
TGAI, PAI, or A,B,H
Degradation
Product
72-7 - Simulated or Actual
Field Testing
- Aquatic Organisms TEP A,B,H
Partial 00092111*,
00066341
Partial 00066341
No
Reserved8/
Reserved8/^/
Reserved8/
Ui
o
o
3
Reserved8/
*Data submitted by Mobil Chemical Company, and subsequently transferred to Rhone-Pculenc Chemical Company, the
current data owner. These data may be oompensable.
-------
Table A (Cont'd)
Generic Data Requirements for Ethoprop
SlSR.JAS Wildlife and Aquatic Organisms Footnotes
\l Composition: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, radiolabeied;
TEP - Typical End-Use Product.
2f The use patterns are coded as follows: A - Terrestrial, Food Crop; B - Terrestrial, Nonfood; C - Aquatic,
Food Crop; D - Aquatic, Nonfood; E - Greenhouse, Food Crop; F - Greenhouse, Nonfood; G - Forestry; H » Domestic
Outdoor; I - Indoor.
3/ No requirement currently exists.
7/ Reserved pending submission of appropriate environmental fate data needed, such as field dissipation studies to
better define expected residues on vegetable and soil for both crop and turf use.
5f Actual field testing with birds (Level I) is required, as per 40 CFR 158.145, to support the use of end-use
products containing ethoprop on corn or potatoes, and pineapples. For the pineapple use the EC formulation
must be used and for the corn or potatoes study the granular must be tested. The design of the field studies
must include appropriate methods, such as thorough carcass searching to determine whether there is pesticide-
induced mortality and, if so, the extent of mortality. Acceptable protocols for conducting these field studies
should be submitted to the Agency within 6 months from receipt of this document, for review and comment prior
to the initiation of the study. A Guidance Document is available from the Agency, which outlines an acceptable
approach to these studies. The Agency encourages registrants to consult with EEB staff for assistance as needed.
If the terrestrial field studies on field crops indicate a hazard to wildlife then the Agency is reserving the
option to require other terrestrial field studies where the use patterns require application rates of 2 Ib ai/A
or greater. If any of these use patterns are cancelled, then field studies (Level I) are still required for
use patterns where the estimated environmental concentration (EEC) exceed the levels of the most sensitive
species of avian wildlife.
67 A level II field test with birds and mammals is reserved pending the results of the level I study. The level
~~ II study will be required where the Level I studies have identified a potential field effects on populations of
birds and mammals. A Guidance Document is available from the Agency, which outlines an
acceptable to these studies. The Agency encourages registrants to consult with EEB staff for assistance,
as needed.
7/ Not applicable to this Manufacturing-Use Standard.
F/ Reserved pending the submission of the acute toxicity data on a warmwater fish species and a freshwater aquatic
invertbrate along with appropriate environmental fate information (i.e., hydrolysis and photolysis in water).
These data are needed to determine if hazardous concentration of ethoprop will reach the aquatic environment when
prodcts are used as directed.
9/ All data citations are required to support the data requirement.
-------
Table A
Generic Data Requirements for Ethoprop
Does EPA Have Must Additional
Data to Satisfy Data Be Submit-
This Require- ted Under FIFRA Tlmeframe
I/ Use 2/ ment? (Yes, No, Bibliographic Section 3f for
Data'Requirement Composition Patterns or Partially) Citation 3(C)(2)(b)7 Submission
<158:155 Nontarget"insect
Nontarget Insect Testing -
Pollinators
141-1 - Honey Bee Acute TGAI A,B,H Yes 00011934** No!/
Contact LD50 000132710***
141-2 - Honey Bee - Toxicity TEP A,B,H No — No!/
of Residues on
Foliage
141-3 - Wild Bees Important TEP A N/A
in Alfalfa Polli-
nation - Toxicity
of Residues on
Foliage
141-4 - Honey Bee Subacute TEP A,B,H No — No!/
Feeding Study
-5 - Field Testing for TEP A,B,H No — No!/
Pollinators
K)
I
**Data submitted by ICI Americas, Inc. These data may be compensable.
***Data submitted by Penick Corporation. These data may be compensable.
I/ Composition: TGAI - Technical Grade of the Active Ingredient; TEP - Typical End-Use Product.
7/ The use patterns are coded as follows: A - Terrestrial, Food Crop; B - Terrestrial, Nonfood; C - Aquatic, Food
~~ crop; D - Aquatic, Nonfood; E - Greenhouse, Food Crop; F - Greenhouse, Nonfood; G - Forestry; H - Domestic Out-
door; I - Indoor.
S/ None of the registered uses will result in significant honey bee exposure.
-------
Table A
Generic Data Requirements for Ethoprop
Data Requirement
J7 Use j
Composition Patterns
Does EPA Have
Data to Satisfy
This Require-
ment? (Yes, No,
or Partially)
Bibliographic
Citation
Must Additional
Data Be Submit-
ted Under F1FRA
Section 3/
3(C)(2)(b)?
Timeframe
for
Submission
S J58.J55'Nontarget'insect
Nontarget'insect testing -
Aquatic Insects
142-1 - Acute Toxlclty to
Aquatic Insects
142-2 - Aquatic Insect
Life-Cycle Study
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects
143-1 - Nontarget Insect
thru Testing - Predators
143-3 and Parasites
A,B,H
A,B,H
A,B,H
A,B,H
Reserved^/
Reserved^/
Reserved^'
Reserved3/
^/Composition: TGAI - Technical Grade of the Active Ingredient; TEP - Typical End-Use Product.
T/The use patterns are coded as follows: A - Terrestrial, Food Crop; B - Terrestrial, Nonfood; C
Crop; D - Aquatic, Nonfood; E - Greenhouse, Food Crop; F =» Greenhouse, Nonfood; G - Forestry; H
I - Indoor.
3/Reserved pending decision as to whether data requirement should be established.
Aquatic, Food
Domestic Outdoor;
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR ETHOPROP.
Data Re
quifement
Must addi-
Test Does EPA Bibliographic tlonal data
substance1 have data? citation2 be submitted?
Time frame
tor
submission^
158.125 Residue Chemistry
171-2.
171-3.
171-4.
171-4.
171-4.
171-4.
Chemical Identity4
Directions for use
Nature of the residue
(Metabolism)
- Plants
Nature of the residue
(Metabolism)
- Livestock
Residue analytical
methods
Storage Stability Data
PAIRA
PAIRA and
plant metabo-
lites
TGAI and
metabolites
TEP and
metabolites
(See Index)
Partially *00040380, 00075253, Yes5
00075254, 00075255,
00075256, 00092103,
00075252, 40653205,
Partially 00092070. Yes&,7
Partially 00075245, *00075246, Yes8,9
*00092079, 00092080,
*00125395,*00125397,
*00129928,*00145970,
*00153065,*00153326,
*00154203,*00160441,
Partially *00160441. Yes^O
18 months
18 months
15 months
15 months
[Continued, footnotes follow.)
-------
TABLE A. (Continued).
Must addi- Time frame
Test Does EPA Bibliographic tional data for
substance 1 have data? citation2 be submitted? submission^
Data Requirement
171-4. Magnitude of the residue
in plants
Root and Tuber Vegeta-
bles
- Potatoes TEP
- Sweet potatoes TEP
Brasslea Leafy Vegetables
- Cabbage TEP
Legume Vegetables
- Beans (Phaseolus)
- Soybeans
Foliage of Legume Vege-
tables
- Beans (Phaseolus)
- Soybeans
Cucurbit Vegetables
- Cucumbers
TEP
TEP
TEP
TEP
Partially *00153065,*40028502, Yes11
Yes 00075252 No
Partially *00125397, 00092068 Yes12
Yes
13
Partially 40653204
Partially *00076720, 00092072,
00092074 Yes15
Partially 40653204
Partially *00076720, 40653201
TEP Partially 40653204
24 months
18 months
18 months
18 months
24 months
18 months
18 months
18 months
Ui
(Continued, footnotes follow.)
-------
TABLE A. (Continued).
Test
Data Requirement substance*
Cereal Grains
- Corn TEP
Forage, Fodder, and
Straw of Cereal Grains
- Corn TEP
Miscellaneous Commodities
- Bananas TEP
- Peanuts TEP
Pineapples TEP
- Sugarcane TEP
Tobacco TEP
171-4. Magnitude of residue In TGAI or plant
Meat/Mllk/Poultry/Eggs metabolites
Does EPA
have data?
Partially
Partially
Yes
Partially
Partially
Partially
partially
Partially
Must addi-
Bibliographlc tlonal data
citation2 be submitted?
*00075249, 00075250,
*00092108,*00092109,
*00092135, 40653207
*00075249, 00075250,
*00092108,*00092109,
*00092135, 40653207.
40653206
*00092106,*00092116,
*00 1 29928 ,*00 14 1494,
40653202
00092070, *00154203.
40653203
*00145970,*00153065.
00092101
ye821 22
Yes23
Yes2*
No.
Yes", 26
Yes2?
Yes28
Yes2
Yes30
Yes31,32
Yes33
Time frame
for
submission^
18 months
24 months
18 months
18 months
24 months
24 months
30 months
24 months
15 months
15 months
Cn
[Continued, footnotes toilow.)
-------
TABLE A. Footnotes (continued).
1. Test substance: TGAI - technical grade of the active Ingredient; PA1 - purified active ingredient; PAIRA
- purified active ingredient, radlolabeled; TEP - typical end-use product; EP - end-use product.
2. Asterisks Indicate references submitted since completion of the ethoprop Residue Chemistry Chapter dated
2/28/83 or otherwise reviewed In this FRSTR. Other references listed here were reviewed in the interim
Residue Chemistry Chapter.
3. Data must be submitted within the indicated time frame, based on the date of this Guidance Document.
4. 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.
5. Data depicting the total terminal residue of radiolabeled ethoprop in three representative, dissimilar i
crops (we suggest corn, potatoes, and cabbage). Residues must be characterized in the raw agricultural i3
commodities produced following application of formulated ethoprop to the crops under conditions representing '
normal cropping practices. Exaggerated rates may be necessary in order to have sufficlente l^C-residues
present for characterization. Multiple radiolabels (^C, 3?P, 35S) may be necessary for complete character!
6. Metabolism studies using ruminants and poultry must be submitted. Animals must be dosed for at least
three days with methylene-labeled [^Cjethoprop at a level high enough to permit identification and
quantltation of ^C-residues. Milk and eggs must be collected for analysis twice daily during the dosing
period. The distribution and characterization of residues must be determined in milk, eggs, liver, kidney,
muscle, and fat. Samples from these studies must also be analyzed using enforcement methods (including all
FDA multiresidue protocols I-IV) to ascertain that the methods are capable of adequately recovering and
quantifying all residues of toxlcological concern.
7. Data depicting the nature of ethoprop residues in swine are also required if the metabolism studies
required for ruminants and poultry reveal substantial differences in ethoprop metabolism between these
animals and laboratory rats.
8. Residues of ethoprop occurring in or on raw agricultural commodities must be subjected to analysis by
method 242.2 from PAM Vol. I (multiresidue protocol IV, available from the National Technical Information
Service under Order No. PB 203734/AS).
-------
TABLE A* Footnotes (continued).
9. The nature of the residue In plants and In animals Is not adequately understood. If the requested plant
and animal metabolism studies reveal the presence of additional residues of toxlcologlcal concern In plant
and/or animal commodities, additional validated methods for data collection and tolerance enforcement may be
required.
10. The storage conditions and Intervals for all samples used to provide data previously submitted In
support of the established tolerances and requested In this FRSTR must be submitted. This information must
be accompanied by data depicting the percent decline in ethoprop residues under the storage conditions and
for the Intervals specified. Samples bearing field-weathered residues or fortified samples must be analyzed
Immediately after harvest or fortification and again after storage intervals that are equivalent to those
reflected in all previously submitted and currently requested residue data. Storage conditions for the
samples must reflect data submitted previously and in response to requirements of this FRSTR. The chosen
storage intervals must allow for reasonable unforseen delays in sample analysis. Upon receipt of these
data, the adequacy of the established tolerances for ethoprop residues in raw agricultural commodities will
be reevaluated. i
en
00
11. A processing study depicting ethoprop residues in potato chips, granules or flakes, wet peel, and dry '
peel processed from potatoes bearing measurable weathered residues. If residues concentrate in any of these
processed products, the registrant-must propose appropriate food/feed additive tolerances.
12* Data depicting residues of ethoprop in or on cabbage heads with and without wrapper leaves harvested at
normal crop maturity following pretransplant incorporated broadcast application of the 10-15Z G or 6 Ib/gal
EC formulation at 5 lb ai/A. Tests must be conducted in the states of CA(8Z), FL(16Z) or GA(2Z), MI(3Z) or
WI(9Z), NJ(3X) or NY(15Z) or PA(2Z), and TX(16Z) representing ca. 70Z of U.S. cabbage production (1982
Census of Agriculture, V01 1, Part 51, p. 338).
13. Data depicting residues of ethoprop in or on snap beans harvested at normal crop maturity following a
single preplant application of the 6 Ib/gal EC or a G formulation at 8 lb ai/A (broadcast) or 3.2 oz
ai/1 000 ft of row (3 lb ai/field A, 36-inch row spacing) in a 12- to 15-inch band over the row. Tests must
be conducted in MI(7Z), NY(13Z), OR(18X), and WI(35Z) representing ca. 70Z of 1985 U.S. snap bean production
for processing (Agricultural Statistics J986, p. 149). Short season varieties of snap beans must be
Included In the tests.
-------
TABLE A. Footnotes (continued)4
14. Data depicting Ethoprop residues In or on soybeans harvested at normal crop maturity following preplant
Incorporated application of the 6 Ib/gal EC formulation at 4 oz ai/1,000 ft of row (3 Ib ai/A, 42-inch row
spacing; equivalent to 10.5 Ib ai/treated A). Tests must be conducted in IL(18Z) or IN(9Z), IA(15Z) or
MN(8Z), AR(5%) or NO(9Z), and KS(2Z) or NE(4Z) representing ca. 70Z of 1985 U.S. soybean production
(Agricultural Statistics 1986, p. 126).
15. A processing study depicting residues of ethoprop in soybean meal, hulls, soapstock, crude oil, and
refined oil processed from soybean seed bearing measurable weathered residues (obtained by using exaggerated
field rates if necessary). If residues concentrate in any of these processed commodities, the registrants
must propose appropriate food and/or feed additive tolerances.
16. Data depicting residues of ethoprop in or on snap bean vines harvested at normal crop maturity
following a single preplant application of the 6 Ib/gal EC or a G formulation at 8 Ib ai/A (broadcast) or
3.2 oz a I/1,000 ft of row (3 Ib ai/field A, 36-inch row spacing) in a 12- to 15-inch band over the row.
Tests must be conducted in MI(7%), NY(13Z), OR(18Z), and WI(35Z) representing ca. 70Z of 1985 U.S. snap bean
production for processing (Agricultural Statistics 1986, p. 149).
17. The registrant must propose an appropriate tolerance for residues of ethoprop in or on bean hay (to
Include both lima and snap bean hay) and submit appropriate supporting residue data.
18. Data depicting Ethoprop residues in or on soybean hay harvested at normal crop maturity and soybean
forage harvested at several intervals following preplant incorporated application of the 6 Ib/gal EC
formulation at 4 oz ai/1,000 ft of row (3 Ib ai/A, 42-inch row spacing; equivalent to 10.5 Ib ai/treated A).
Tests must be conducted in IL(18Z) or IN(9Z), IA(15Z) or MN(8Z), AR(5Z) or MO(9Z), and KS(2Z) or NE(4Z)
representing ca. 70Z of 1985 U.S. soybean production (Agricultural Statistics 1986, p. 126). The
registrant must propose label restrictions establishing a pregrazing/preharvest interval for soybean forage
that is reflected in the data requested above.
19. The registrant must propose a tolerance for residues of ethoprop in or on soybean straw and submit
appropriate supporting residue data.
20. Data depicting ethoprop residues of concern in or on cucumbers harvested at maturity following a single
preplant incorporated application of a 10-15Z G or the 6 Ib/gal EC formulation at 4.8 oz ai/1,000 ft of row
(1.9 Ib al/field A, 7-ft row spacing) in a 12- to 15-inch band over the row. Tests should be conducted in
VO
I
-------
TABLE A. Footnotes (continued).
CAU1Z), MI(19Z), NC(14Z), OH(9Z), and WI(9Z), states which account for ca. 62Z of the total 1985 U.S.
production of cucumbers (Agricultural Statistics 1986. p. 157).
21. Data depleting residues of ethoprop In or on field corn grain harvested at normal crop maturity
following application of a 10-20Z G formulation In the following treatments (separate tests): 6 Ib al/A
broadcast preplant and Incorporated; and 1.25 oz ai/1,000 ft of row (2 Ib ai/field A, 20-Inch row spacing)
applied postemergence at layby In 3- to 4-inch bands on both sides of the row near the base of the plants.
Short season varieties must be represented. Tests must be conducted In the states of IL(17Z) or IA(19Z),
IN(9Z or MI(3Z) or OH(6Z), KS(2Z) or NE(llZ), and MN(8Z) or WI(4Z) representing ca. 80Z of 1985 U.S. field
corn production (Agricultural Statistics J986, p. 32).
22. Data depicting residues of ethoprop in or on sweet corn K+CWHR harvested at normal harvest Intervals
following application of a 10-20Z G formulation in the following treatments (separate tests): 6 Ib ai/A
broadcast preplant and Incorporated; and 1.25 oz ai/1,000 ft of row (2 Ib ai/field A, 20-inch row spacing)
applied postemergence at layby in 3- to 4-inch bands on both sides of the row near the base of the plants.
Short season varieties must be represented. The registrant must propose a PHI for the postemergence use
that is reflected In the data submitted. Tests must be conducted In the states of MN(20Z) or W1(20Z),
OR(HZ) or WA(IOZ), and IL(13Z) representing ca. 70Z of 1985 U.S. sweet corn production for fresh market and
processing (Agricultural Statistics'1986, p. 156).
23. A processing study depicting residues of ethoprop in the following products processed from field corn
grain bearing measurable weathered residues at or near the tolerance level: starch, crude oil, and refined
oil from wet milling process; and grits, meal, flour, crude oil, and refined oil from dry milling process.
If residues are shown to concentrate in any of these processed commodities, appropriate food or feed
additive tolerances must be proposed.
24. Data depicting residues of ethoprop in or on corn (field or sweet) forage harvested at regular
intervals and corn (field or sweet) fodder harvested at normal crop maturity following application of a
10-20Z G formulation In the following treatments (separate tests): 6 Ib ai/A broadcast preplant and
Incorporated; and 1.25 oz ai/1,000 ft of row (2 Ib ai/field A, 20-inch row spacing) applied postemergence at
layby In 3- to 4-inch bands on both sides of the row near the base of the plants. Short season varieties
must be represented. Tests must be conducted in the states of IL(17Z) or IA(19Z), IN(9Z or MI(3Z) or
OH(6Z) KS(2Z) or NE(llZ), and MN(8Z) or Wl(4Z) representing ca. 80Z of 1985 U.S. field corn production
(Agricultural Statistics 1986, p. 32). The registrant must propose label amendments establishing a pre-
-------
TABLE A. Footnotes (continued).
grazlng/pre-harvest interval for corn forage (In reference to the postemergenee use) that is reflected in
the data requested above*
25. The registrant must propose tolerances for the raw agricultural commodities, peanut hulls and peanut
vines, and submit appropriate supporting residue data.
26. The registrants must propose label amendments establishing a maximum number of applications per season,
a maximum seasonal use rate, and a PGI/PHI relative to at-pegging applications. These conditions must be
reflected In the data submitted to support the tolerances, or additional data may be required.
27. Data depicting residues of ethoprop in meal, crude oil, refined oil, and soapstock processed from
peanuts bearing measurable weathered residues. If residues concentrate in any of these processed
commodities, appropriate food and/or feed additive tolerances must be proposed.
28. Data depicting residues of ethoprop in or on pineapple fruit and forage harvested 120 days after the
last of eight applications (If a plant crop) or five applications (if a ratoon crop) of the 6 Ib/gal EC
formulation at 12 Ib al/A/application. Applications must be made by drip irrigation system. Tests must be
conducted in the state of Hawaii.
29. A processing study depicting residues in bran and Juice processed from pineapple fruit bearing
measurable weathered residues. If residues concentrate In either of these processed products, the
registrant must propose appropriated food and/or feed additive tolerances.
30. A processing study depicting residues of ethoprop in molasses, refined sugar, and bagasse processed
from sugarcane bearing measurable weathered residues. If residues concentrate in any of these commodities,
the registrant must propose appropriate food and/or feed additive tolerances.
31. Data characterizing and quantifying the pyrolysls products of radlolabeled ethoprop that occur in
tobacco smoke. Multiple radiolabels (14C, 32P, 35S) might be necessary for complete characterization.
32. Complete analytical methods must be submitted for detecting and quantifying ethoprop residues of
concern in or on tobacco and in tobacco smoke.
-------
TABLE A* Footnotes (continued).
33. Additional animal metabolism data have been requested in this FRSTR (see "Nature of the Residue In
Animals" section for details). Upon receipt of those data the need for and nature of tolerances for
residues of ethoprop in meat, milk, poultry, and eggs will be reevaluated.
N>
-------
TABLE A, GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT
Data Requirement Composition3
158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning Mater- TGAI
ials and Manufacturing Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of Product
Ingredients
Does EPA
Have Data to
Satisfy This
Requirement?0
No
Partial
Bibliographic
Citation0
N/A
00152115,
Reg. Jacket
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Yesc
Yes^
j —
Time Frame
For
Data
Submission
6 months
6 months
62-1 - Preliminary Analysis of Product
Sampl
TGAI
Partial
00152115.
Physical and Chemical Characteristics
63-2
63-3
63-4
63-5
63-6
63-7
- Color
- Physical State
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
No
NO
No
N/A
No
Yes
N/A
N/A
N/A
N/A
N/A
00142272.
ff
Yes*
Yesf
Yesf
Nog
Yesf
No
6 months
6 months
6 months
6 months
-------
TABU! A. (Continued).
Data Requirement
Compositiona
Does EPA
Have Data to
Satisfy This
Requirement?0
Must Additional Tine Frame
Data Be Submitted For
Bibliographic Under FIFRA Section Data
Citation*1
3(c)(2)(B)?
Submission
158.120 Product Chemistry (continued)
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
64-1 - Suhmittal of samples
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
N/A
Yes
Yes
No
Yes
Yes
No
N/A
00142272.
N/A
N/A
00142272.
00142272.
N/A
N/A
No
No
Yes*
No
No
Yesf
No
6 months
6 months
a Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient. The TGAI may also
be used as a Manufacturing-use Product -(MP). See also Table B, "Product Specific Data Requirements for Manu-
facturing-Use Product", for additional data requirements for registered technical products, including parts
61-1 (Product identity and disclosure of ingredients), 62-2 (Certification of ingredient limits) and 62-3
(Analytical methods to verify certified limits), and the physicochemical characteristics 63-14 (Oxidizing or
reducing action), 63-15 (Flanmability), 63-16 (Explodability), 63-17 (Storage stability), 63-18 (Viscosity),
63-19 (Miscibility), and 63-20 (Corrosion characteristics).
b Not aoDlicable. Although product chemistry data may have been submitted in the past, the Agency has determined
thattfiese data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data most be updated. Therefore, bibliographic citations for the old data are not applicable. Data
submitted subsequent toTine previous Product Chemistry Chapter in response to data requirements is evaluated
and cited by MRID number.
-------
TABLE A. (Continued).
c 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 must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
d A detailed discussion of all impurities that are or may be present at ^0.1% based on knowledge of the begin-
ning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted.
e Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
f Physicochemical characteristics (color, physical state, odor, melting point, boiling point, vapor pressure,
dissociation constant, pH, and stability) as required in 40 CFR 158.120 and more fully described in the
Pesticide Assessment Guidelines, Subdivision D must be submitted.
g Data not required because TGAI is a liquid at room temperature.
-------
Table B
Product Specific Data Requirements for Manufacturing-Use Products Containing Bthoprop
Data
MSB;
Acute
81-1
81-2
81-1
81-4
81-5
81-6
Does EPA Have Dat
To Satisfy This
I/ Requirement? (Ye
Requirement Composition No. or Partially)
135 Toxicology
testing
- Acute Oral - Rat MP Yes
- Acute Dermal MP Yes
- Acute Inhalation - Rat MP Yes
- Primary Eye MP Yes
Irritation - Rabbit
- Primary Dermal MP Yes
Irritation - Rabbit
- Dermal Sensitization MP No
Guinea Pig
:a Must Additional
Data Be Submitted Timetranc
>B, Bibliographic Under FIFRA Section for
> Citation 3(C)(2)(b)?2/ Submission
00078035 No
00078035 No
00128218 No
00078036 No — (
<£
i
00048774 No
No3/
i/Composltlon: MP • Manufacturing-Use Product.
7/A study is not required because of the high acute dermal toxiclty of the MP.
-------
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS
Data Requirement Compositiona
158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mater-
ials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
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
MP
MP
MP
MP
MP
' MP
MP
MP
MP
MP
Does EPA Must Additional Time Frame
Have Data to Data Be Submitted For
Satisfy This Bibliographic Under FIFRA Section Data
Requirement?*) Citation^ 3(c)(2)(B)7 Submission
Partial
No
Partial
Partial
Partial
Partial
No
No
No
Yes
00152115,
Reg. jacket
N/A
00152115,
Reg. jacket
00152115
00152115
00152115
N/A
N/A
N/A
00142272
Yesc
Yesd
Yese
Yes*
Yes9
Yes**
Yes1
Yesi
Yesi
No
6 months
6 months
6 months
&•
12 months 7"
12 months
12 months
6 months
6 months
6 months
-------
TABLE B. (Continued),
Data Requirement
Composition^
Does EPA
Have Data to
Satisfy This
Requirement ?*>
Bibliographic
Citation^
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)7
Tine Frame
For
Data
Submission
158.120 Product Chemistry (continued)
63-12 - pH MP
63-14 - Oxidizing or Reducing Action MP
63-15 - Flammability MP
63-16 - Explodability MP
63-17 - Storage Stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP
63-20 - Corrosion Characteristics MP
Other Requirements:
64-1 - Sutndttal of samples N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
N/A
N/A
N/A
N/A
00152115
N/A
N/A
N/A
N/A
N/A
No
No
No
No
Yesi
No
No
No
6 months
6 months
6 months
6 months
15 months
6 months
6 months
15 months
00
a Composition: MP * Manufacturing Use .Product.
b 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.
c The chemical name and nominal concentration of each ijipurity for Which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and
Durpose of the active ingredient and each intentionally added inert must be provided. For the active ingredient,
Sie following must also be provided: the product name, trade name, and cannon name; the molecular, structural,
and empirical formulas; the molecular weight or weight range; and any experimental or internally assigned company
code numbers.
-------
TABLE B. (Continued).
d 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 must be provided, along
with information regarding the properties of each beginning material used to manufacture each product.
e A detailed discussion of all impurities that are or may be present at »0.1%, based on knowledge of the begin-
ning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted.
f Five or more representative samples must be analyzed for the amount of active ingredient and each Impurity for
which a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each
analytical method used.
i
g Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for eachS
impurity present at >0.1% (w/w) and each "toxicologically significant" impurity present at <0.1% (w/w) must be1
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and
precision data have been provided. Limits for impurities not associated with the active ingredient need be
provided only if they are considered to be of toxicological significance, regardless of the concentration at
which they are present. [We defer to the Toxicology Branch regarding the toxicological significance of (i)
impurities associated with the active ingredient present at <0.1% (w/w) and (ii) impurities not associated
with the active ingredient.] Certifications must be submitted on EPA Form 8570 Rev. 2-85.
h Analytical methods must be provided to determine the active ingredient, and each toxioologically significant
impurity and intentionally added inert for which certified limits are required. Each method most be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement
of certified limits. [RCB defers to the TCK Branch regarding the toxicological significance of impurities
and intentionally added inerts for which certified limits are required.]
i Pnysicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing
action, flamrability, explodability, storage stability, viscosity, ndscibility, and corrosion characteristics)
as required in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D
must be submitted.
-------
-70-
II. LABELING APPENDICES
-------
-71-
SUMMARY-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 text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 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 establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 156.10(g)]
-------
-72-
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHiLD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 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 156.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 156.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h) (2 )] .
-------
-73-
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)t(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.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR Part 152, Subpart I. You will be
notified of the Agency's classification decision.
-------
-74-
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 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.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
-75-
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 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.
-------
SUMMARY-6
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
0
«*
i
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
••••v
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-7
ITEM
7C
7D
I 7E
«m»
X,
1
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
30
r^
1
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
Ail products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
PfKCAimOMANY r ATCMCNTt
HA2AAOS TO HUMANS
(I OOMI8TC AMMAU)
KNVWOMUtNTAl, HAZARDS
PMVSCALOMCMIMCAl
HAZARDS
*• tf
k •
» «•
M4NTMV STATBUINT
STORAGEAND
' DISPOSAL
ffOMOt-
RESTRICTED USE
, PESTICIDE ,
ircason for clnsnifylnr)
BUK TO AND on CMJT n cxtmnn AHUCMCM OR
CT tMEi* otncr (UKxvisKM AN> oNtr rw i«8e
IBB oworo IT m cncnnD APMJCAJW* cacnncmot
PRODUCT
NAME
ACTIVf NOMOCNT:,
MCNT NONtMNfl:,
TOTAL:
TNttMOOUeTOONTAM IM Of PfNOAUON
KEEP OUT OF REACH OP CHILDREN
DANGER -POISON
•TATIUCMT Qf riUCTCAL TMtATMINT
PON MM:
•n see rum.ro*
MFOSY:
TOWN, it ATI:
ISTAIUBMMffNT NO. I
WAMMNTV ITATOMOfT
-------
MUCAUTOHMIY VrATXUOff*
NAZAMMIOMUMAMt
•MMtflBANMAtt
CAUTION
It • mtnm
M-CMTKVfTAmtNT
CM*
PRODUCT
NAME
AOIMtMQMBCNT:,
MfKTMQMtOCNTt:.
TOTAl:
IM or MMOMUM
KEEP OUT OP REACH OP CHILDREN
CAUTION
ITAmUNT Of MUCTBAI. TMATUBff
PtWAUOW
rttuuo:
Ml Mt rAMIL KM AHN
oNMrr ITATIMINT»
TOWKITATi;
Nil OONiCNiSa
STORAGE AND
DISPOSAL
o
WAWWfTV tTATMOIT
-------
-81-
40 CFt Ch. I (7-147 Edition)
f 162.10 Labeling requirement*.
(a) General—U> Content* of the
label Every pesticide product* shall
bear a label containing the informa-
tion specified by the Act and the refu-
tations in this Part. The content* of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product Is sold as pre-
scribed in paragraph 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;
-------
-82-
scribed in paragraph (b) of this sec-
tion:
The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
(ill) 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;
(vl) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vil) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph (1) of this section:
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility. (1) All
words, statements, graphic representa-
tions, designs or other information re-
quired 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 custom-
ary conditions of purchase and use.
• (it) All required label text must:
(A) Be set in 6-polnt or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be uted. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as is considered necessary to
protect the public. When additional
text in another language Is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—ID General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it Is a part of the package as
customarily distributed or sold.
(11) Tank can and other bulk con-
tainer*— of the
Act. a pesticide or a device declared
subject to the Act pursuant to
i 162.15. Is mlsbranded if its labeling is
false or misleading In any particular
Including both pesticldal and non-pes-
ticldal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(DA false or misleading statement
concerning the composition of the
product;
(il) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(ill) A false or misleading statement
about the value of the product for
-------
-83-
purposes other than as a pesticide or
dovice;
-------
-84-
registration shall appear on the label,
preceded by the phrase "EPA Regis-
tration 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 par-
allel 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* regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(I) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic In any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 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 nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer 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.
(11) The text of the ingredient state-
ment 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 in-
gredient shall be the accepted
common name, if there is one. fol-
lowed 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 proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of section 25
-------
-85-
the label: "Not for sale or use after
(date]."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredientts) to be listed in the
ingredient statement if he determines
that such ingredienUs) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
MtatemenU. Required warnings and
precautionary statements concerning
the general areas of lexicological
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 require-
ments 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 re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
MuvtJ ndscticn
Oral U>M
inffiMBtoft Lw»— • —
DOTMJ LC.
Er* •fleets
Skd •fleets
1
Up to md incJuckng 50
rng/kg
Up to end ncfcdng 2
mg/kMr
Up to md ncfcOng 200
iKQ/kg
COTMM. aemn»
o^HL/ty not t&tmDit
Mtf«n7diyi
H
From SO Mm 500 mg/kg..
From 2 tni 2 mg/kkv
From 200 On 2000
ComMl opacity
dtys; tfritstion
pmatmg tor 7 dcys
Scvtrt imifcon it 72
Mure
M
From 500 twu 5000 mg/
kg
From 2 twu 20 mg/Wcr...
From 2.000 Blru 20.000....
No eomttl opacity.
mutton ti,nt*»
•*wi7d«yi
Moo>ilH mutonlt 72
tan
IV
QTMI* ttin 5000 mg/
kg
OTMMT ton 20 mg/Kw
GrMtv men 20.000
Nonttkon.
IMd or itgfri nttbon M
72 ham
(i) Human hazard signal word—(.A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition 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 ef-
fects) 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 pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of tignal 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 pre-
vent 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 pes-
ticide 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, market-
ing, 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 Administra-
tor waive this requirement.
(ill) Statement of practical treat-
ment—
-------
-86-
sUtement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing Into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
leity. The Agency may. however.
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment 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 (hxiXliiXA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired 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 require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
So* of total front panel in square
Sand under
Above 510 10
Above 10 to IS —
Rcqund
-Keep out
of reach of
10
12
(2) Other required warning* and pre-
cautionary statement*. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route eyn. on dun. or on
Ctotnmg Wear goggtot or laca cttaM and rubber
glovci whan handing Harmful or tatat * twaaowvd.
(Appropnale %w aid itatamaM raqurad.]
Cam** ay* (and dun] mutton Do not get ft eye*.
on skn. or on ctothng Harmful if twallooad. (Ap-
propnat* fm ma Maiamam raojurad.)
Avod contact wuri akin, ayn or ctotfwg m caaa of
contact mmedataly flush eye* or tlun with ptamy of
vatat. Gat madcal anaotnn t mtabon panels
(No precautionary statements reqund-J
(11) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident,
injury or damage. Examples of the
-------
-87-
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" Is required.
(B) If a pesticide intended for out-
door use contains an active Ingredient
with a fish acute LC» of I ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral IDM of 100
mg/kg or less, or a subacute dietary
LC» 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 applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes.
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(til) Physical or chemical hazards.
Warning statements on the flammabil-
tty or explosive characteristics of the
pesticide are required as follows:.
FlMhpoM
1
Reojjvedttxt
(A) PMC MUMZCO CONTAMMS
Flnh point el or below W F; » Mre e) • flashback el
Fleah pom above V f and not over KT F or « Ota
of 6 1 fcom vie flame
Al other preuunzed oonujnen .,.,_,,,,,,
Extremely tlemmeble Content! under preuure Keep ewey from
Ira. eperks. end hMted lurfecM Oo not puncture or nonenW
oonumer Expoeure to temperWurM eboire 190* F mey ceuM
Flerwntble. Content! under preuure Keep awey ftom hMt
aperki. and open tleme Do not puncture or ronentt oonumer.
Enpoture to tempr^tuvt ebov* 130* F mey C*UM bunfeng
Content* under preuure Do not uee or (tore near heel or open
•erne Do nol puncture or inonerete container. Expoeure to
temperature* above 130* F may oauM bunting
IB) NONMICMUMZtO OONTAMDK
Ai o, tekp. jn- C
*t»~ jo- F ^ — «~ en- e
Ate** BO* F »"fl nol ftir» f (Q> r
Extremely flammable. Keep away from be. aperki
aurlacM
Flammable Keep away from heal and open flame.
Do not UM or atore near hMl or open flame.
and heated
(i) Direction* for Ute—U) General
requirement*—(1) Xde^uocy and clar-
ity of direction*. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(11) Placement of direction* for iue.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter Is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bar.
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular" and
(C) The Administrator determines
that It is not necessary for such direc-
tions to appear on the label.
(Ill) Exception* to requirement for
direction for ute-
-------
-88-
tioni for use may be omitted from la-
belini of pesticides which are Intended
for use only by manufacturers of prod-
ucts other than pesticide product! In
their regular manufacturing processes.
provided that:
U) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type The label clearly states that the
Product is Intended for use only in
manufacturing, formulating, mixing.
Wf repacking for use as a pesticide and
•Peclfies the type(s) of pesticide prod-
ucts involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged Is registered; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Content* of Direction! for Vte.
The directions for use shall Include
the following, under the headings "Di-
rections for Use":
(1) The statement of use classifica-
tion as prescribed in 162.KKJ) immedi-
ately under the heading "Directions
for Use."
(II) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with Its labeling."
(ill) The slte
-------
-89-
(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 phys-
ically 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 ap-
plicator 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 Vie Classification.
By October 22,1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (J) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral 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 di-
rections only for general use(s) and
the other bearing directions for re-
stricted 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 1162.10(j)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment 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 clas-
sification on the front panel as de-
scribed below:
(1) Front panel statement of restrict-
ed 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 1162.10(hXlXiv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "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 per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved!
(40 FR 28268. July 3. 1976: 40 FR 32329.
Aug. 1. 1975; 40 FR 36571, Aug. 21. 1975. as
amended at 43 FR 5786. Feb. 9.1978]
-------
-90-
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
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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:
rontainer Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol
products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or,- if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely- empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
_!/ Manufacturer may replace this phrase with one indicating
~ whether and how fiber drum may be reused.
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III. BIBLIOGRAPHY APPENDICES
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered/ will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
-96-
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z: and the 27th, 123456-AA.
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-77-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of th Data Base Supporting
Registrations Under the Ethoprop Standard
MRID CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00040380 Menzer, R.E.; Iqbal, Z.M.? Boyd, G.R. (1971) Metabolism of O-Eth-
yl-S-,-S-dipropyl phosphorodithioate (Mocap) in bean and
corn plants. Journal of Agricultural and Food Chemistry 19(2):
351-356. (Also in unpublished submission received Sep 2, 1971
under 2F1204; submitted by Mobil Chemical Co., Richmond, Va.;
CDL:094057-D)
00048774 Becker, J. Parke, G.S.E. (1977) Report: A Primary Dermal Irrita-
tion Study of Ethoprop 93% Technical Grade on Abraded and Non-
abraded Skin of New Zealand Albino Rabbits: Laboratory No. 7E-
6084. (Unpublished study received Jul 15, 1977 under 2224-43:
prepared by Cannon Laboratories, Inc., submitted by Mobil Chemi-
cal Co., Industrial Chemicals Div., Richmond, Va.; CDL:230885-C)
00048777 Reinert, H.K.; Parke, G.S.E. (1975) Report: Static 96-Hour Toxicity
Study of Mocap 15% Granular-AC Experimental Formulation in Blue-
gill Sunfish and Rainbow Trout: Laboratory No. 5E-9354. (Unpub-
lished study received JUl 15, 1977 under 2224-43; prepared by
Cannon Laboratories, Inc., submitted by Mobil Chemical Co., In-
dustrial Chemicals Div., Richmond, Va.; CDL:230885-F)
00075240 Weir, R.J.; Kundzins, W. (1967) Final Report: 13-week Dietary
Administration—Dogs: Project No. 230-110. (Unpublished study
received Nov 25, 1968 under 9F0750; prepared by Hazleton
Laboratories, Inc., submitted by Mobil Chemical Co., Industrial
Chemicals Div., Richmond, Va.; CDL:091296-D)
00075245 Mobil Chemical Company (19??) The Determination of Residues of
Mocap on Corn Products. Undated method. (Unpublished study
received Nov 25, 1968 under 9F0750; CDL:091296-J)
00075246 Mobil Chemical Company (19??) Analysis of Fortified Samples. (Un-
published study received Nov 25, 1968 under 9F0750; CDL:
091296-K)
00075249 Mobil Chemical Company (1966) Summary—Results of Corn Sample
Analyses for Mocap Residues. (Compilation; unpublished study
received Nov 25, 1968 under 9F0750; CDL:091296-N)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethoprop Standard
MRID CITATION
00078037 Weir, R.J.; Murphy, J.C. (1967) Final Report: Neurotoxicity Test-
Hens: Project No. 230-109. (Unpublished study received Nov 25,
1968 under 9F0750; prepared by Hazleton Laboratories, Inc.,
submitted by Mobil Chemical Co., Macedon, N.Y.; CDL:091295-E)
00078038 Weir, R.J.; Clark, 0. (1966) Acute Oral LD:50—Bens: Project
No. 230-108. (Unpublished study received Nov 25, 1968 under
9F0750; prepared by Hazleton Laboratories, Inc., submitted by
Mobil Chemical Co., Macedon, N.Y.; CDL:091295-F)
00078053 Cronin, C.H. (1970) Letter sent to United States Dept. of Agricul-
ture, Agricultural Research Service, Pesticides Regulations
Division dated Apr 1, 1970: Pesticide petition OF0897: CHC/
256/70. (Unpublished study received Apr 2, 1970 under OF0897;
submitted by Fisons Corp., Agricultural Chemicals Div., Bedford,
Mass.; CDL:093194-D)
00091247 Fitzgerald, G.P. (1961) Letter sent to Robert Stem dated Dec 7,
1961 [Fish toxicity tests]. (Unpublished study received Mar
6, 1970 under 1F1110; prepared by Univ. of Wisconsin, Hydraulic
and Sanitary Laboratory, submitted by Merck, Sharp & Dohme,
Rahway, N.J.; CDL:090880-G)
00092068 Mobil Chemical Company (1971) Summary—Cole Crop Residue Analysis.
(Unpublished study received Sep 10, 1972 under 2F1250- CDL:
091781-A)
00092070 Mobil Chemical Company (1969) Mocap Residues in Pineapples. (Un-
published study received on unknown date under OF0959; CDL*
091636-B)
00092072 Mobil Chemical Company (1969) [Residue Study of Mocap on Soybeans],
(Compilation; unpublished study received Apr 11, 1970 under
OF0872; CDL:091505-B)
00092074 Downing, C.R. (1969) Effects of Excess Mocap (Prophos) Rates on
Soybeans: Project No. 253. (Unpublished study received Apr 11,
1970 under OF0872; submitted by Mobay Chemical Co., Ashland,
Va.; CDL:091505-D)
00092079 Mobil Chemical Company (19??) The Determination of Residues of
Mocap in Animal Tissues. Undated method, (unpublished study
received Apr 24, 1967 under 9F0750; CDL:093062-E)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethoprop Standard
MRID CITATION
00092080 Mobil Chemical Company (1969) The Determination of Residues of
Prophos in Plant Materials. Method R-89-A dated Cct 7, 1969.
(Unpublished study received on unknown date under OF0872; CDL:
093170-A)
00092101 Holsing, G.C. (1968) Final Report: 21-day Oral Administration-
Dogs: Project No. 230-124. (Unpublished study received Jan 20,
1970 under OF0872; prepared by Hazleton Laboratories, Inc.,
submitted by Mobil Chemical Co., Ashland, Va.; CDL:094845-A)
00092103 Mobil Chemical Company (1968) The Fate of Mocap in Soil and Plants.
(Unpublished study received on unknown date under 9F0750; CDL:
098645-D)
00092106 Mobil Chemical Company (1972) [Residue Study of Mocap on Peanuts].
Includes method R-89-A dated Cct 7, 1969. (Compilation; unpub-
lished study received Apr ]4, 1972 under 2224-37; CDL:119790-A)
00092108 Mobil Chemical Company (1972) Summary of Residue Analyses: [Mocap].
Includes method R-89-A dated Cct 7, 1969. (Compilation; unpub-
lished study received Mar 9, 1972 under 2224-37; CDL:119792-A)
00092109 Mobil Chemical Company (1971) Summary of Residue Analyses. In-
cludes method R-89-A dated Cct 7, 1969. (Compilation; unpub-
lished study received Mar 9, 1972 under 2224-37; CDL:119793-A)
00092113 Swedberg, G.E. (1971) A Study of the Toxicity of the Nematicide
Mocap to Songbirds and Gamebirds under Simulated Field Condi-
tions. (Unpublished study received Aug 26, 1971 under 2224-
EX-1; prepared by Pineapple Research Institute, submitted by
Mobil Chemical Co., Industrial Chemicals Div., Richmond, Va.;
CDL:131553-A)
00092116 Mobil Chemical Company (1974) [Determination of Residues of
Ethoprop in Various Crops]. Includes method R-89-A. (Compila-
tion; unpublished study, including published data, received Dec
17, 1974 under 2224-48; CDL:220399-C)
00092135 Mobil Chemical Company (1976) Summary of Residue Data: Mocap EC—
Corn. (Compilation; unpublished study received Mar 29, 1977
under 2224-44; CDL:229328-A)
00104532 Knickerbocker, M.; Re, T. (1978) MCTR-60-78 Teratologic Evaluation
of Ethoprop in Sprague-Dawley Rats: Laboratory No. 5850. (Un-
published study received Feb 16, 1979 under 2224-38; prepared by
Food and Drug Research Laboratories, Inc., submitted by Mobil
Chemical Co., Industrial Chemicals Div., Richmond, VA; CDL:
237414-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 Ethoprop Standard
MRID CITATION
00111934 Atkins, E.; Kellum, D.: Neuman, K.? et al. (1975) Effect of Pesti-
cides on Apiculture: Project No. 1499. 1975 annual rept. (Un-
published study received Mar 8, 1976 under 201-EX-50; prepared
by Univ. of California—Riverside, Citrus Research Center and
Agricultural Experiment Station, Dept. of Entomology, submitted
by Shell Chemical Co., Washington, DC; CDL:095407-U)
00125395 Interregional Research Project No. 4 (1978) The Results of Tests
on the Amount of Residues Remaining in or on Okra, Including a
Description of the Analytical Method Used: lEthoprop]. (Compi-
lation; unpublished study received Mar 14, 1983 under 359-703;
CDL:071458-A)
00125397 Interregional Research Project No. 4 (1982) The Results of Tests
on the Amount of [Ethoprop] Residues Remaining in or on Broccoli
and Cabbage, Including a Description of the Analytical Method
Used. (Compilation; unpublished study received Mar 14, 1983
under 3E2852; CDL:071459-A)
00128218 Duckworth, S.; Rusch, G.; Rinehart, W. (1980) An Acute Inhalation
Toxicity Study of MCTR 206-79 in the Rat: Project No. 79-7332.
(Unpublished study received May 4, 1981 under 2224-44; prepared
by Bio/dynamics, Inc., submitted by Interregional Research
Project No. 4, New Brunswick, NJ; CDL:070060-B)
00129928 Guyton, C. (1983) Ethoprop Residue Data on Peanuts Treated with a
Narrow Band Application of Mocap 10G: 1982 Field Program C-7:
ASD No. 83/026. (Unpublished study received Jul 26, 1983 under
359-703; prepared by Morese Laboratories, Inc., submitted by
Rhone-Poulenc, Inc., Monmouth Junction, NJ; CDL:250798-A)
00132710 Atkins, E.; Anderson, L.; Kellum, D.; et al. (1977) Protecting Hon-
ey Bees from Pesticides. Riverside, CA: Univ. of California.
(Leaflet 2883; also in unpublished submission received Nov 2,
1983 under 239-2507; submitted by Chevron Chemical Co., Rich-
mond, CA; CDL:251760-B)
00137496 Voss, K.; Davidson, T.; Becci, P.; (1983) Chronic Cncogenic Evalu-
ation of Ethoprop with B6C3F1 Mice: FDRL Study No. 5-5849. (Un-
published study received Feb 8, 1984 under 359-694; prepared by
Food & Drug Research Laboratories, Inc., submitted by Rhone-
Poulenc, Inc., Monmouth Junction, NJ; CDL:252364-A; 252365;
252366; 252367)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethoprop Standard
MR ID CITATION
00138636 Barnett, J.; Jenkins, L.; Parent, R.; et al. (1983) Evaluation of
the Chronic Toxicity and Oncogenic Potential of Ethoprop in
Fischer 344 Rats: GSRI Project No. 413-858-41. Final rept.
(Unpublished study received Feb 8, 1984 under 359-694; prepared
by Gulf South Research Institute, submitted by Rhone-Poulenc,
Inc., Monmouth Junction, NJ; CDL:252358-A; 252359)
00141494 Guyton, C. (1984) Ethoprop Residue Data for Peanut Bay, Bulls and
Nutmeat Following Two Applications of Mocap 106: ASD No. 84/082.
Unpublished study prepared by Rhone-Poulenc Inc. 48 p.
00142272 Orth, D. (1984) Product Chemistry Testing for Ethoprop Technical
and Granular Formulation (MOCAP 10G): Final Report: Project Num-
ber 84-PL-34; 84-PL-28. Unpublished study prepared by Bio-
spherics Inc. 12 p.
00145970 Guyton, C. (1984) Ethoprop Residue Data on Green and Flue Cured
Tobacco: ASD No. 84/085. Unpublished compilation prepared by
Rhone-Poulenc, Inc. and Morse Laboratories, Inc. 43 p.
00152115 Beche, R. (1984) Ethoprop, Technical Grade Analysis and Certifica-
tion of Product Ingredients. Unpublished study prepared by
Rhone-Poulenc Agrochimie. 118 p.
00153065 Rhone-Poulenc Inc. (1985) [Residue Data for Ethoprop]. Unpublished
compilation. 131 p.
00153326 Guyton, C. (1985) Ethoprop Residue Data for California Cole Crops
Treated with Mocap EC at 12 LBAI/A [and Ethoprop Residue Data
for Brussel Sprouts Treated with Mocap 5G at 12 LBAI/A]. Un-
published compilation prepared by Rhone-Poulenc Inc. 102 p.
00154203 Yanagihara, K. (1983) Residue Data in/on Pineapple Resulting from
Mocap Drip Irrigation Treatments. Unpublished study prepared by
University of Bawaii, Dept. of Agricultural Biochemistry. 127 p.
00160171 Jordan, E. (1986) Metabolism of Ethoprop (...) in Soil under Aero-
bic and Anaerobic Conditions: ASD No. 86/199. Unpublished study
prepared by Rhone-Poulenc Inc. in cooperation with Mobil Envi-
ronmental and Science Lab. 147 p.
00160172 Jordan, E. (1985) Adsorption-desorption of Ethoprop-0-ethyl-l-[car-
bon 14] by Four Agricultural Soils: ASD No. 85/128. Unpublished
study prepared by Rhone-Poulenc Inc. 53 p.
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-102r-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Ethoprop Standard
MR ID CITATION
00160173 Perrette, T. (1986) Mobility of O-Ethyl-S,S-di-n-propyl Phosphoro-
dithioate (Ethoprop) in Four Soil Types: ASD No. 86/170. Un-
published revision of ASD No. 84/103, prepared by Rhone-Poulenc
Inc. 35 p.
00160179 Brown, D. (1986) Ethoprophos: 52 Week Oral (Capsule Administration)
Toxicity Study in the Beagle: Rept. No. 4923-198/16. Unpublish-
ed study prepared by Hazleton Laboratories Europe Ltd. 248 p.
00160180 Barfknecht, T. (1985) Ames Salmonella/Microsome Plate Test (EPA/
OECD): Ethoprop: Study No. PH 301-RP-001-85. Unpublished study
prepared by Pharmakon Research International, Inc. 30 p.
00160181 Stankowski, L. (1985) CHO/HGPRT Mammalian Cell Forward Gene Muta-
tion Assay: Ethoprop: Study No. PH 314-RP-001-85. Unpublished
study prepared by Pharmakon Research International, Inc. 52 p.
00160182 Barfknecht, T. (1985) Rat Hepatocyte Primary Culture/DNA Repair
Test: Ethoprop: Study No. PH 311-RP-001-85. Unpublished study
prepared by Pharmakon Research International, Inc. 66 p.
00160183 SanSebastian, J. (1985) In vitro Chromosome Aberration Analysis in
Chinese Hamster Ovary (CHO) Cells: Ethoprop: Study No. PH 320-
RP-001-85. Unpublished study prepared by Pharmakon Research
International, Inc. 50 p.
00160184 SanSebastian, J. (1986) In vitro Sister Chromatid Exchange in
Chinese Hamster Ovary (CHO) Cells: Ethoprop: Study No. PH-319-
RP-001-85. Unpublished study prepared by Pharmakon Research
International, Inc. 92 p.
00160188 Forbis, A.; Frazier, S.; Schoen, L. (1986) Acute Toxicity of
Ethoprop Technical to Daphnia magna: Static Acute Toxicity
Report 134320. Unpublished study prepared by Analytical Bio-
Chemistry Laboratories, Inc. 38 p.
00160441 Perez, G. (1986) Freezer Storage Stability of Ethoprop in Crops:
ASD No. 86/194. Unpublished study prepared by Morse Laborato-
ries, Inc. 81 p.
00161449 Roberts, S.; Parke, G.; Charles, S. (1977) Short-term Simulated
Field Study in Bobwhite Quail: Mocap 10% Granular: Lab. No.
7E-8051. Unpublished study prepared by Cannon Laboratories,
Inc. 16 p.
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-103-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Ethoprop Standard
MR ID CITATION
00161619 Phipps, R. (1981) Rabbit Teratology Study: Ethoprop Technical-
01238101: Final Report: Project No. 230-233. Unpublished study
prepared by Hazleton Laboratories America, Inc. 398 p.
00162164 Pullin, T.; Reddy, A. (1980) Evaluation of Effects of Ethoprop on
Reproductive Performance by a Three Generation Reproduction
Study in Fischer 344 Rats: Second Final Report: GSRI Project No.
413-858-41. Unpublished study prepared by Gulf South Research
Institute. 205 p.
05008363 Hudson, R.H.; Haegele, H.A.; Tucker, R.K. (1979) Acute oral and
percutaneous toxicity of pesticides to mallards: correlations
with mammalian toxicity data. Toxicology and Applied
Pharmacology 47(3):451-460.
40028502 Fronek, P. (1986) Crop Residue Information: UAP 101: Study No. 86-
8A. Unpublished compilation prepared by The Industrial Labo-
ratories Co. 59 p.
40378201 U.S. EPA (1975) Toxicity of Tech. Hocap 92% Concentrate to Rainbow
Trout (S. gairdneri): static Jar Test 1859. Unpublished study
prepared by Animal Biology Laboratory. 6 p.
40378202 U.S. EPA (1975) Toxicity of Hocap 10% Granular to Daphnia magna:
Static Jar Test 4869. Unpublished study prepared by Animal Bio-
logy Laboratory. 7 p.
40378401 Schafer, E.; Brunton, R. (1979) Indicator bird species for toxicity
determinations: Is the technigue usable in test method develop-
ment? Vertebrate Pest Control and Management Materials, ASTM
STP 680. American Society for Testing and Materials. 157-168.
40663401 U.S. EPA (1975) Toxicity of Mocap 10% Granular to Rainbow trout
(S. Gairdneri): Static Jar Test I860. Unpublished study
prepared by Animal Biology Laboratory. 6 p.
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-104-
IV. FORMS APPENDICES
-------
-105- OMB Approval No. 2070-0057
Expires 11/30/89
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
r
A REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to tht requirement to submit "generic" data imposed by the FIFRA action 3(C)(2)(B) notice contained in ths referenced
Guidance Document. I im responding in the following manner.
01. I wBI submit date in • timely manner to satisfy the following requirements. H the tat procedures I wifl use deytte from (or tre nat
specifwd in) the Regbtntion Gaidelinci or the Protocols contained in the Reports of Expert Groups to the Chwniceb Group. OECO
Chemicals Tatting Programme. I enclose the protocols that I wfll we:
D 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C}(2)(B)Ct) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
CD 3. I enclose e completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data*
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
O Su I request voluntary cancellation of the registration of this product (This option is not available to applicants for new product*)
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA Fern 8680-1
SIGNATURE
DATE
-------
-106-
OMB Approval Ho. 207Q-OOS7
Expires 11/30/89
tT» +M
******!
INTO AM AQMCMCNT WITKOTMCM Hf GUTHAMTJ
DATA
1. I «r* duly
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UPKA SMTion Me)(2)ltl oonumM * • Giwdtnai OOC^TH
ACTIVf I
fOuff
O* firm* n r»f»r»d to
• "my firtfi" |
int* an O>»»IT>^U witt on* or
iU ortftr to
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-------
-107-
EFA Reg. No.
PRODUCT SPECIFIC DATA R£PORT
Date
Guidance Document for
Registration
Guideline No.
$158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
*
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
vapor crvuurt
Dissociation
constant
Octanol/vater
partition
coefficient
Dfl
Test not
required
for my
product
listed
above
(check
below)
•
I am complying with
data retirements by
Citing MRID
Number or
EPA Accession
Number
ubmit-
ting
Data
At-
tached)
'!
*'!
3
(For EPA Use Only))
Accession Numbers ;j
Assigned i
',1
\\
'.i
H
1
1
|i
(
-------
-108-
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
5158.135
TOXI OOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidiz ing/reducing
ruction
Flurtbility
Explodability
Storage stability
viscosity
Miscibility
Corrosion
chara cttr is ties
Dielectric break-
down voltage
Acute oral
toxicity* rmt
Acute dernal
toxicity. rabbit
Acute inhalation*
toxicity » rmt
Primary eye
irritation, rabbit
Primry demal
irritation
Oerml seruUtiza-
tion
Test not
required
for my
product
listed
above
(check
below)
•
[ am complying with
data requirements by
Citing MRID
Nunfeer or
EPA Accession
Nuofeer
Submit-
ting
Data
(At-
tached)
,
(for EPA Use Only)
Accession Nunfcers
Assigned
i
-------
-109-
C*B Approval NO. 2070-0057
Expiration oatt 11/30/89
GENERIC DATA EXEMPTION STATEMENT
E*A Product Reoistration Number: —______^^_(
Reaistrant's Name and Address:
As an authorized representative of th« registrant of tht product identified
above, X certify that:
(1) X have read and an familiar with the term of the Notice fron EPA dated
concerning a requirement for submission of "generic* data on the
active ingredient _____________ named under PXPRA Section 3(c)(2)(B).
(2) My firm reouests 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 oroduct contains the active ingredient solely as the result of the
incorporation into the oroduct of another product which contains that active
ingredient, which is registered under PXFKA Section 3, and which is purchased by
us from another producer.
(3) An accurate confidental Statement of Pormula(CST) for the above-identified
product is attached to this statement. That formula statement indicates, by
coroany name, registration number, and product name, the source of-the subject
active ingredient in my firm's product, or .*. '
The CSP dated on file with E*A is complete, current and accurate and
contains the information requested on the current CSP Porm No. 1570-4. The
registered source(s) of the above named active ingredient in my product(s) is/art
_________________ and their registration number (s) is/art _________ •
My firm will apply for an amendment to tht registration prior to changing
the source of the active ingredient in our product.
(4) X understand, and agree on behalf of my firm, that if at any timt any •
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings fmdt in this Statement, my fin's product's registration may be
suspended under PIPJA Section 3(c)(2)(i).
(5) X further understand that If my fin is granted a generic data txtmption
for tht oroduct, my fin relies on tht efforts of other persons to provide tht
Agency with tht required generic data. If tht registrants) who have committed
to generate and sxtmrit tht reouired .data fail to taJtt appropriate steps to meet
reouirtmnts or art no longer in compliance with this Notice's data rtquirtmtnts.
tht reouired data In tht specified time frame. X understand that, in
tht Agency generally will not grant a time extension for satedtting tht data.
Registrant's authorized representative:
(Signature)
Dated: . _^^_^__
-------
-110-
207Q.0060
czjrrxriCATXON WITH RESPECT TO CITATION or DATA
CPA Pile SymbPl/tag. MD. ______________ Date of eoollcatian
Name o& Product ___^^_^_______^__^^^__^^^__^^_^_^^^_^_^^_
Aool leant'• Nm and Address
1. This application is supported by all data sutnitted or cited in the
application. In addition, if cite-all option* an indicated, this application
is sucported by all data in the Agency's files that concern the properties
or effects of this product or of any other product that is identical or
substantially similar, and that is one of the types of data that would be
required to be submitted if this application sought the initial registration
of a product of identical or sinilar composition and intended uses under
the data requirements in effect on the date of approval of this application.
2. X certify that, for each Study cited in support of this application
for registration that Is an exclusive use study, X have obtained the
written permission of the original data sutaitter to cite that study.
3. X certify that, for each study cited In support of this application
for registration that is not an exclusive use study t
X have obtained the written Demission of the original data sutnittsr
to cite that studyi or
X have notified In writing the co— panles «t» have submitted data X have
cited to suocort this application and have offered tot (a) ray compensation
for those data In accordance with section 3(c)(l)(0) and 3(c)(2)(0) of
the federal Insecticide, Fungicide and tooanticide Act: and (bJ Gunmenus-
negotiations to detamine which data are subject to the oo*censation
requirement of PXFUA and the amount and terns of compensation due, 1C
say. The companies X have notified arei (Qiscfc one)
( I All easpsniesj listed on the Pesticide Data Sufcnittsrs list for
all active Ingredient* contained in wy product (Cite-all Method or
cite-all option under Selective Method). (Also sion the General
Offer to FSV Itatsper>t below.)
( 1 The** cospanies who have sutnitted the studies which X h*ve
cited (Selective wchcd)
Qst« ^^ Signs
Tltlo
General Offer to revt I hst^by off«r and agree to oay ooepenMtlon to
other persons, with regard to th* spprovii of this application. t» th«
nunc required by fin* MC. J(c)(U(0) and l(c)(2)(0).
Oats _________ flon-tuFt
Title
•
CM Poos (April IMS)
-------
-13,1-
T
US Environmental Protection Agency Registration Standard tor:
Washington. DC 20460
V>EPA Product Specific
Data Report
Registration
Guideline No.
Sec. 158.120
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
Toxicology
8M
81-2
81-3
81-4
81-5
81-6
Name of Test
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Rammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicity. rat
Acute dermal toxicity. rabbit
Acute inhalation toxicity. rat
Primary eye Irritation, rabbit
Primary dermal irritation
Dermal sensitization
Testing not
required for my
product "*ted
above
(Ch»ck btlow)
EPA Registration Number
1 am complying with
Data Requirements by •
Citing MR ID No.
Submitting Data
fAftae/wd)
(Ch»ckb»k3w)
'
"orm Approved
OMB #2070-0057
Expires 11 -30-89
(For EPA Use
Only)
Accession
numbers
assigned
Certification
I certify that the statements I have made on this form and alt attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
yp*d Nam* and Title
Sgnature
Oat*
EPA form 8MO-4 (Rev. 5-M) Previous edition is obsolete.
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