v>EPA
Unitod Stttw
Environmental Protection
Agency
Off in of
PwticidM «nd Toxic Subrtanew
Wnhington DC 20460
540/RS-88-062
March 31, 1988
Guidance for the
Reregistration of
Pesticide Products
Containing MEVINPHOS
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
MEVINPHOS
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 7786-34-7
OPP SHAUGHNESSY NO. 015801
EPA CASE NUMBER GS-0250
MARCH 31, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
I. Introduction 1
II. Chemical Covered by This Standard 4
A. Description of Chemical 4
B. Use Profile 5
III. Agency Assessment 7
A. Summary Science Findings 7
B. Summary of Data Gaps 8
C. Preliminary Health Risk Assessment 10
D. Environmental Profile 16
E. Tolerance Reassessment 20
IV. Regulatory Position and Rationale 25
A. Regulatory Position 25
B. Criteria for Registration 34
C. Acceptable Ranges and Limits 34
D. Required Labeling 35
V. Products Subject to This Standard 43
VI. Requirement for Submission of Generic Data .... 46
A. What are generic data? 46
B. Who must submit generic data? 46
C. What generic data must be submitted? 47
D. How to comply with DCI requirements 47
E. Testing Protocols, Standards for Conducting
Acceptable Tests, Guidance on Evaluating
and Reporting Data 49
F- Procedures for requesting a change in
testing protocol 50
G. Procedures for requesting extensions
of time 50
H. PR Notice 86-5 and Any Other requirements
Referenced or Included Within this Notice . 51
I. Existing stocks provisions upon
suspension or cancellation 51
VII. Requirement for Submission of Product-Specific
Data 53
VIII. Requirement for Submission of Revised Labeling . . 54
IX. Instructions for Submission 55
A. Manufacturing-Use Products (Sole Active) ... 55
B. Manufacturing-Use Products (Multiple Active) . 56
C. End-Use Products (Sole Active) 57
D. End-Use Products (Multiple Active) 57
E. Intrastate Products 58
F. Addresses 58
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APPENDICES
Page
I. DATA APPENDICES 59
Guide to Tables 60
Table A 63
Table B 102
Table C N/A
II. LABELING APPENDICES 107
Summary of Label Requirements and Table 108
40 CFR 162.10 Labeling Requirements 118
Physica I /Chemica I Hazards Labeling Statements ... 127
Storage Instructions 128
Pesticide Disposal Instructions 129
Container Disposal Instructions 130
III. USE INDEX APPENDIX 131
IV. BIBLIOGRAPHY APPENDICES 166
Guide to Bibliography 167
Bibliography 170
V. FORMS APPENDICES ...... 174
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet .... 175
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement With Other Registrants for
Development of Data 176
EPA Form 8580-4 Product-Specific Data Report 177
EPA Form 8570-27 Generic Data Exemption Statement . . . 179
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: Acceptable Daily Intake
a.1.: active ingredient
CAS: Chemical Abstract Services (number)
CSF: Confidential Statement of Formula
Median Effective Concentration - the concentration of
substance producing a specific effect or response 1n
50 percent of the test organisms.
EEC: Estimated Environmental Concentration - an estimate of
the concentration of a pesticide occurring in or on
various media (i.e., soil, water, vegetation) after
pesticide application.
EPA: The U.S. Environmental Protection Agency (Agency)
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
LC5Q: Median Lethal Concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals, expressed as weight
or volume of test substance per volume of air or water
or per weight of feed (e.g., mg/1 or ppm).
LDso: Median Lethal Dose - a statistically derived single
dose that can be expected to cause death 1n 50% of test
animals when administered by the route indicated,
expressed as weight of substance per unit weight of
test animal (e.g., mg/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number) - EPA's system of
tracking studies used in support of registration.
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs of the U.S. EPA
OES: The Office of Endangered Species, U.S. Fish and
Wildlife Service
RfD: Reference Dose
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I. INTRODUCTION
EPA has established the Registration Standards program 1n
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 rereglstrati on 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 1s to reassess
the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criteria of
FIFRA. In Its review EPA Identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been required
when the product was Initially registered or may be needed to
replace studies that are now considered Inadequate.
3. Labeling revisions needed to ensure that the product is
not misbranded and that the labeling 1s adequate to protect man
and the environment.
The detailed scientific review, which is not contained in
this document, but 1s available upon request1, focuses on the
pesticide active Ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data In Its files pertaining to the pesticide active
Ingredient. However, during the review of these data the Agency
is also looking for potential hazards that may be associated with
the end use products that contain the active Ingredient. The
Agency will apply the provisions of this Registration Standard to
end use products 1f necessary to protect man and the environment.
1The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard, on
the pesticide and each of its registered uses. See Section IV-
Regulatory Position and Rationale. Based on its regulatory
position, the Agency may prescribe a variety of steps to be taken
by registrants to maintain their registrations in compliance with
FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in the
issuance of a Notice of Intent to Cancel or a Notice of Intent to
Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the pesticide.
If the Agency determines that the risks of the pesticide's use
outweigh the benefits of use, the Agency may propose additional
regulatory actions, such as cancellation of uses of the pesticide
which have been determined to cause unreasonable adverse effects
on the environment.
EPA has authority under the Data Call-in (DCI) provisions of
FIFRA sec. 3(c)(2)B) to require that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide. This
Registration Standard lists the data EPA believes are necessary
to resolve our concerns about this pesticide. These data are
listed In the Tables A, B", and C. 1n Appendix I. Failure to
comply with the DCI requirements enumerated In this Registration
Standard may result 1n Issuance 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
unreasonable adverse effects of a pesticide at any time that they
become aware of such Information. Registrants must notify the
Agency of any Information, Including Interim or preliminary
results of studies, 1f that Information suggests possible adverse
effects on man or the environment. this requirement 1s
Independent of the specific time requirements Imposed by EPA for
submission of completed studies called 1n by the Agency and
continues as long as the products are registered under FIFRA.
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4
II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following chemical is covered by this Registration
Standard:
Common Name: Mevinphos
Chemical Name: 3-[(Dimethoxyphosphinyl)oxy]-2-butenoic
acid methyl ester; 3-hydroxycrotonic
acid methyl ester dimethyl phosphate.
Trade Names: Apavinphos, Duraphos, Menite, Mevinox,
OS-2046, Phosdrin, and Phosfene
Chemical Class: Organophosphate
Empirical Formula: CyHisOsP
Molecular Weight: 224.1
CAS Registry No.: 7786-34-7
ENT Registry No.: 22374
OPP Shaughnessy No.: 015801
Year of Initial Registration: early 1950s
U.S. and Foreign Producers: E.I. DuPont (U.S.);
Amvac Chemical Corp.
(U.S.); APA Spa (Italy);
Comlets Chemical
Industrial Co., Ltd.
(Taiwan); GENP Inter-
national Corp. (Taiwan);
KenoGard VT AB (Sweden);
and Shell International
Chemical Co., Ltd.
(England)
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5
Physical/chemical properties of mevinphos.
Color: light yellow to orange
Physical State: Liquid
Odor: Mild to none
Boiling Point: 99 - 103°C at 0.03 mm Hg
Density: 1.24 at 16°C
Solubility: Miscible with water, acetone,
benzene, carbon tetrachloride,
chloroform, ethanol, isopropanol,
methanol, toluene, and xylene;
slightly soluble in carbon disulfide
and kerosene; insoluble in hexane.
Vapor Pressure: 0.003 mm Hg at 21°C
pH: 3.2 - 3.5 (0.25%)
B. Use Profile
Mevinphos is a broad spectrum organophosphate
insecticide/acaricide registered for use to control a wide
variety of pests on field, forage, vegetable, fruit crops;
one greenhouse food crop (lettuce); one aquatic food crop
(watercress); and one aquatic nonfood use (sewage disposal
plants).
Usage information indicates that about 25% of the
mevinphos used in the United States is applied to alfalfa. The
second major use, approximately 20%, is on lettuce. Use on cole
crops (15%) is third, and in decreasing volume, artichoke (7%),
beans (5%), grapes and potatoes (each 4%), apples, sweet corn,
and sugar beets (each 3%), corn and strawberries (each 2%), and
carrots, celery, melons, onions and turf (each 1%). Other uses
(peppers and tomatoes) account for less than one percent
individually.
Mevinphos is marketed as 2% dust (D) formulations;
1, 2, and 4 pound (Ib) active ingredient (ai) per gallon (gal)
emulsifiable concentrate formulations (EC); 25.4% EC formulation;
2, 4, and 10.3 Ib/gal soluble concentrate/liquid (SC/L)
formulations; and 3.64 and 5% ready to use (RTU) formulations.
Foliar applications of mevinphos may be applied to crops using
conventional ground or aerial equipment. Foliar applications are
also permitted in greenhouses. Water treatment is permitted 1n
sewage disposal plants.
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There .ire 49 federally registered [FIFRA Section 3]
products (?. technical and 47 end-use), 16 Special Local Need
I FIFRA Section ? 4 c ) ] registrations, and 36 1ntr
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III. AGENCY ASSESSMENT
A. Summary Science F1n 1.00 mg/kg/day and concluded that
mevlnphos does not Induce developmental effects 1n rats.
2. Worker Exposure
The use of mevlnphos poses risks to mixer/loaders,
applicators, and persons reenterlng fields treated with
mevlnphos. Exposure may be by dermal, Inhalation, and ocular
routes of entry. A review of poisoning Incident data provided by
California (the only State that enforces mandatory reporting of
of 89 Illnesses were reported as being due to exposure to
mevlnphos. Physicians reported treating an average of 16.6
mevlnphos poisonings each year during that time period. In
addition, an average of 1.2 mevlnphos related skin or eye Injury
cases per year were reported.
Federally registered end-use mevlnphos
products currently have a reentry statement on the label that
reads "Do not enter treated areas without protective clothing
until sprays have dried." As a result of the Agency's review of
foliar dlslodgeable residue data submitted 1n response to the
July 1985 reentry data call-in for mevlnphos, and In response to
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8
reports of fleldworker poisoning Incidents attributed to
mevlnphos, the Agency 1s requiring reentry Intervals for
mevlnphos as follows:
96 hours (4 days) for citrus, grapes, nectarines and
peaches.
48 hours (2 days) for all other treated crops (leafy
vegetables, strawberries, corn, melons, etc.).
3. Ecological Effects
The ecological effects data available to the
Agency show that technical mevlnphos 1s very highly toxic to
birds on an acute oral basis; highly toxic to upland game birds
and slightly toxic to waterfowl on a dietary basis; very highly
toxic to both warmwater and coldwater fish species; very highly
toxic to aquatic invertebrates; highly toxic to the brown shrimp
and sheepshead minnow and moderately toxic to the Eastern
oyster; and highly toxic to honey bees. Because of Its
demonstrated toxicity to nontarget species and its Intended use
pattern, mevlnphos has been identified by the (TFfice of
Endangered Species (OES), U.S. Fish and Wildlife Service (FWS),
as being likely to jeopardize endangered species when used on
corn and sorghum.
4. Environmental Fate
The available data are insufficient to fully
assess the environmental fate of mevlnphos, including the
potential for groundwater contamination, mevinphos1 persistence
1n the environment, and the need for crop rotational label
restrictions. Data gaps exist for nearly all applicable studies.
5. Tolerance Reassessment
Insufficient data are available for the Agency to
ascertain the adequacy of the established tolerances for residues
of mevlnphos alpha and beta isomers.
B. SUMMARY OF DATA GAPS
The Agency has identified missing data necessary
to fully evaluate the human and environmental risks associated
with the use of mevlnphos. A summary of those data gaps is given
below. Please note, this is only a summary and complete details
can be obtained by referring to the data tables in Appendix I.
These data must be developed in order to maintain registrations
of existing products or to register any new products containing
mevi nphos.
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Toxlcology
Acute Oral Toxldty
Acute Dermal Toxlclty
Acute Inhalation Tox1c1ty
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensltlzatlon
Acute Delayed Meurotoxldty
Acute Dermal (to define lethality, toxlclty. and ChE
NOELS)
Subchronlc 90-Day Feeding, two species (rodent and
nonrodent)2
Subchronlc 90-Day Inhalation (to define toxlclty
from greenhouse exposure)
Subchronlc 21 Day Dermal
Subchronlc Neurotox1c1ty (conditionally In hen
and/or mammal)
Chronic Toxlclty, two species (rodent and nonrodent)
Oncogem'clty, two species
Teratogenlclty (rabbit)
Reproduction
Mutagen1c1ty (full battery - Gene Mutation,
Chromosomal Aberration and Other Mechanism of
Mutagenlclty Studies)
Metabolism
Environmental Fate/Exposure
Hydrolysis
Photodegradation, water
Photodegradatlon, soil
Photodegradatlon, air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Volatility, laboratory
Volatility, field (pending results of the
laboratory volatility study)
Terrestrial Field Dissipation
Aquatic Field Dissipation
Soil Dissipation, long term (reserved pending the
results of the laboratory fish accumulation
study)
Confined Accumulation, rotational crops
2Th1s requirement Is waived since chronic studies are
requlred.
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10
Field Accumulation, rotational crops (deferred
pending receipt of acceptable confined
rotational crop accumulation data)
Accumulation, Irrigated crops
F1sh Accumulation, laboratory
Field Accumulation, aquatic nontarget organisms
(deferred pending the receipt of acceptable
accumulation 1n laboratory fish data)
Leaching and Adsorptlon/Desorpt1on
Droplet Size Spectrum
Drift Field Evaluation
Ecological effects
Wild Mammal Toxicity
Avian Reproduction (upland game bird and waterfowl)
Freshwater F1sh 1050 (warmwater and coldwater
species) (test material: typical end-use
product)
Freshwater Invertebrate LCso (test material: typical
end-use product)
Estuarine and Marine Organisms LCso (fish and
shrimp)
Fish Early Life Stage and Invertebrate Life Cycle
Aquatic Organism Accumulation
Honeybee - Toxicity of Residues on Foliage
Special Test - (Terrestrial Residue Monitoring of
Avian and Mammalian Food Items)
Residue Chemistry
Nature of Residues (Plants, Livestock)
Storage Stability
Magnitude of Residues
Product Chemistry
All product chemistry studies
C. PRELIMINARY HEALTH RISK ASSESSMENT
Numerous data gaps exist for mevinphos and few
definitive conclusions can.be made pending receipt of additional
data. However, the Agency is concerned with the number of
mevinphos poisoning Incidents that have been reported in
California, and believes that they may reflect a nationwide
problem. The Agency 1s also concerned about acute toxicity of
mevinphos to birds and aquatic organisms.The following
preliminary health risk assessment is based on the available
data.
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1. Acute Toxlcity
There are no acceptable acute toxicology
studies available for technical mevinphos. Mevinphos is an
organophosphate insecticide whose primary mechanism of action is
inhibition of chol i nesterase activity. Because mevinphos is a
potent cholinesterase inhibitor, as indicated by two chronic
feeding studies reviewed by the Agency, there is a potential for
accidental poisoning, with neurologic involvement, of applicators
and farmers who are not protected. Technical mevinphos is
currently labeled as a Toxlcity Category I pesticide. Results of
a preliminary review of recently received studies are consistent
with a Toxicity Category I classification for acute oral and
dermal toxicity for mevinphos. Therefore, the currently assigned
Toxicity Category I will be retained until additional acute data
for mevinphos are received and/or evaluated.
2. Subchronlc Toxicity
There are no subchronic feeding data
available. However, these data requirements are waived since
chronic feeding studies are required. A subchronic 90-day dermal
study is not required because of the nature of the exposure
pattern. The requirement for a subchronic 90-day neurotoxicity
study is reserved pending the results of the required acute
neurotoxicity study in hens and whether neurotoxic lesions are
found in mammalian studies. A subchronic 21-day dermal study is
required. A subchronic 90-day inhalation study is required to
support the use of mevinphos in greenhouses.
3. Chronic Toxicity
Only supplementary chronic feeding studies
for the dog and the rat were reviewed. In the dog chronic
feeding study groups of 4 male and 4 female beagles were dosed
daily by gelatin capsule with technical mevinphos at doses of 0
(vehicle control), 0.025, 0.075, 0.25, and 0.75 milligrams per
kilogram of body weight per day (mg/kg/day). The doses were
selected to approximate diet doses of 0, 0.5, 1.5, 5.0, and 15.0
parts per million (ppm). A cholinesterase inhibition no observed
effect level (NOEL) of 0.025 mg/kg/day was reported in this
study. In a similar study in rats groups of 39 male and 39
female Carworth Farm E rats were dosed with diets containing
technical mevinphos at nominal doses of 0.5, 1.5, 5.0, and 15.0
ppm (0.019, 0.056, 0.186, and 0.557 mg/kg/day). The rat chronic
feeding study reported a cholinesterase inhibition NOEL of 0.019
mg/kg/day. These data indicate that mevinphos is a potent
cholinesterase inhibitor. Because these studies were
unacceptable for filling this data requirement, the submission of
acceptable rodent and nonrodent studies is required.
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4. Oncogem'ci ty
No acceptable data are available on the
oncogenic potential of mevinphos. Oncogenicity studies are
required in two species.
5. Developmental Effects (Teratogenicity)
The Agency reviewed teratology studies for
the rat and rabbit, but only the rat study was found to be
acceptable. Because the rabbit study had serious deficiencies,
the Agency is requiring the submission of an acceptable rabbit
teratology study.
In the rat teratology study, groups of 24
male and 24 female Sprague-Dawley rats were mated by
cohabitation. The females were dosed by gastric intubation with
0, 0.20, 0.75, 1.00, and 1.25 mg/kg/day of technical mevinphos in
water on gestation days 6 through 15. The 1.25 mg/kg/day dose
group was terminated early because of high mortality. In this
study the maternal NOEL was 0.20 mg/kg/day; the maternal Lowest
Effect Level (LED was 0.75 mg/kg/day; the fetotoxic NOEL,
embryotoxic NOEL, and teratogenic NOEL were >1.00 mg/kg/day. The
Agency concluded that mevinphos does not induce developmental
effects in rats.
available to
reproductive
evaluate
study is
6. Reproductive effects
No acceptable data are
the reproductive toxicity of mevinphos. A
required.
7. Mutagenicity
No acceptable data are available to evaluate
the mutagenic potential of mevinphos. Gene mutation, chromosomal
aberration, and other mechanism of mutagenicity studies are
required.
8. Metaboli sm
No data are available on the metabolic
pathway of mevinphos. A metabolism study is required.
9. Worker Exposure
The Agency has evaluated available poisoning
incidence data for mevinphos and has concluded that mevinphos
causes poisonings among all categories of workers who use or come
into direct contact with the pesticide. This risk of poisoning
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extends not
formulators,
bystanders as
13
only to mixer/loaders
transporters/warehouse
well.
and applicators, but to
handlers, fieldworkers and
Poisoning reports from California (the only
state which enforces mandatory reporting of occupational
pesticide Incidents and, at present, the only reliable source of
such information) show that mevinphos was among the top five
pesticides in California in terms of frequency of occupational
pesticide poisoning during the period from 1980 to 1986. The
California data are summarized in Table 1.
Table 1. Summary Data on Major Causes of
Poisoning in California, 1980 -
Occupational Pesticide
1986
Top 5 Pesticides
by Number of
Systemic Poisonings
Top 5 Pesticides
by Number of
Individuals
Hospitalized
Top 5 Pesticides by
by Number of Days
of Hospitalizatlon
1. Diazinon 197
2 Mevinphos 194
3. Malathion 164
4. Chlorpyrlfos 146
5. Parathion 143
1. Mevinphos 27
2. Parathion 18
3. Methomyl 17
4. Methyl Bromide 16
5. Aluminum
Phosphide 10
and Diazinon 10
1. Methyl Bromide 131
2. Parathion 77
3. Mevinphos 53
4. Methomyl 32
5. Diazinon 29
SOURCE: "California Poisoning Reports".
Various Reports Issued by the California Department of
Food and Agriculture, Sacramento, California. Included
are reports number HS-322, HS-544, HS-545, HS-985,
HS-1098, HS-1186, HS-1188, HS-1304, HS-1305, HS-1370.
and HS-1371.
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14
Based on a 12 percent sample of the nation's
hospitals, mevinphos was estimated to have caused an average of
41 hospitalizations each year during the time period 1971 through
1976, accounting for 1.4 percent of the total pesticide
poisonings in the United States. This estimate was based on 29
observed occupationally-rel ated cases, and 2 nonoccupational1y-
related cases.
From 1974 to 1976, mevinphos was associated
with 98.6 occupational hospitalizations per 1 million pounds of
mevinphos reported used in agriculture in 1974. The average
ratio of poisonings for all pesticides was 0.9 cases per million
pounds reported in use. This ratio, 98.fi, is the highest among
the 20 pesticides examined which included parathion, nethomyl ,
methyl bromide, malathion and diazinon, most of which are known
to be highly toxic.
Based on data obtained from California,
physicians treated an average of 16.6 mevinphos poisonings each
year from 1982 through 1986. An additional 1.2 cases per year
were reported as either due to skin or eye injury. Of the 89
mevinphos related illnesses reported in this period 10 were
related to application, 40 were due to exposure to residues or
drift, 24 were due to mixing/loading, 4 were in manufacturing or
formulating plants and 11 in other worker activities. Between
1980 and 1986, there were 27 hospitalized cases of occupational
mevinphos poisoning, more than for any other pesticide. 98
workers were reported to have lost time from work due to
mevinphos poisoning for a total of 495 days. Table 2 lists the
number of reported mevinphos poisoning incidents among different
job categories in California from 1976 through 1986.
The ratio of occupational mevinphos
poisonings in California for the years 1981 through 1985 were
compared with the pounds reported sold for the years 1981 through
1984. The ratio for mevinphos was 43.2 systemic poisonings per 1
million pounds sold. The average ratio for all pesticides was
1.3.
The Agency has requested further information
from the state of California concerning these reported poisoning
incidents, In order to evaluate the causes of the high poisoning
rates for mevinphos and to develop possible risk reduction
measures.
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15
Table 2. Illness Due to Mevinphos Exposure Reported by Type of
Illness and Job Category for 1976 through 1986 in
California.
TYPE OF ILLNESS/
JOB CATEGORY 1976-78
SYSTEMIC ILLNESS
Ground Applicator
Aerial Applicator
M1xer/Loaderl
Field Worker
Coincidental (drift)
Warehouse/
Transportation
Manufacturing/
Formul ation
All Other
SUBTOTAL
SKIN OR EYE INJURIES
Ground Applicator
Mixer/Loader*
Warehouse/
Transportation
Manufacturing/
Formulation
Field Worker
All Other
SUBTOTAL
20
2
73
0
3
4
14
21
13/
0
4
1
2
1
1
9
1979-81 1982-84 1985-86
]
19
0
37
63
1
3
5
15
143
1
0
0
0
0
0
1
4
1
17
3
32
0
1
10
68
0
2
0
0
3
1
6
5
0
5
0
2
0
3
0
15
0
0
0
0
0
0
0
TOTAl
FOR
.1 YRS
48
3
132
66
38
7
23
46
363
1
6
1
2
4
2
16
IIHAL MEVINPHOS
ILLNESS AND
INJURIES 146 144 74 15 379
1 Requirement that mevlnphos be mixed and loaded in a closed
system was Initiated in 1977 and fully implemented in 1978.
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16
D. ENVIRONMENTAL PROFILE
1. Environmental Fate
Available data reviewed by the Agency are not
sufficient to fulfill the data requirements. Therefore, the
environmental fate of mevinphos cannot be fully assessed.
Mevinphos residues are considered to be very
mobile in sandy loam, silt loam, loam, and clay loam soils.
Freundlich Ka
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17
3. Spray Drift
There are no data available to assess the hazard to
nontarget organisms (fish and wildlife, domestic animals, and
humans) caused by drift from aerial applications of mevlnphos.
However, poisoning reports from California show that there were
34 cases of occupational poisoning resulting from drift from
aerial applications of mevinphos in California from 1982 through
1986. Because mevinphos products may be aerially applied and
because of the number of occupational poisonings associated with
drift from aerial applications of mevinphos, the Agency is
requiring droplet size spectrum data and spray drift field
evaluation data for mevinphos. The requirement for human exposure
is reserved and may be needed after the Agency receives the
required toxicology data and establishes a toxicity category for
mevi nphos.
4.
Ecol ogical
a.
Avian
Character!' sties
Species
demonstrated
basis. On
demonstrated
slightly toxic
Technical mevinphos has been
to be very highly toxic to birds on an acute oral
a dietary basis technical mevinphos has been
to be highly toxic to upland game birds but only
to waterfowl.
Acute oral toxicity tests with birds
resulted in acute toxicity values ranging from 1.34 mg/kg in the
sharp-tailed grouse to 4.63 mg/kg 1n the mallard. Subacute
dietary studies demonstrate that there is a range of toxicity
from 236 ppm 1n the Japanese quail to 1991 ppm 1n the mallard.
Additional acute data are not required.
Because of the toxicity of mevinphos to
birds and the patterns of avian exposure, the use of mevinphos at
the higher application rates 1s expected to result 1n adverse
effects to small songbirds. Monitoring of mevinphos residues on
such avian food items as forage, insects, and seeds is required.
Avian reproduction studies for mevinphos
are not available. Data are required to support uses of
mevinphos on crops with multiple applications. Repeat
applications are allowed for all uses of mevinphos. Therefore,
avian reproduction studies with an upland game bird species and a
waterfowl species are required.
mevinphos
warmwater
b. Aquatic Species
The acute toxicity tests
indicate that mevinphos 1s very highly
and coldwater fish species. The 96-hour
with technical
toxic to both
acute toxicity
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18
for rainbow trout is 11.9 parts per billion (ppb) and for the
bluegill sunfish 22.5 ppb. No additional acute data are
required for technical mevinphos. However, since mevinphos is
registered for use on watercress, a use involving direct
application to water, acute toxicity studies 1n both a warmwater
and a coldwater fish species are required using an end-use
mevinphos product (preferably a 4 Ib/gal EC). A fish early Hfe
stage study 1s also required and a fish life cycle study may be
required depending on the results of lower tier studies and the
receipt and evaluation of a complete environmental fate profile
for mevinphos.
Acute toxicity tests with freshwater
invertebrates indicate that technical mevinphos is very highly
toxic to aquatic Invertebrates. The acute toxlcity values ranged
from 0.18 ppb for D a p h n 1 a pul ex to 5.00 ppb for Pteronarcys
californica . Add 1tional acute data are not r equlred F6T
technicalmevinphos. The Agency has no data on the acute
toxicity of formulated end-use mevinphos products to freshwater
Invertebrates. Acute aquatic toxicity studies on freshwater
Invertebrates with the formulated product may be required when
the estimated environmental concentration (EEC) exceeds the ECso
of the technical material to freshwater invertebrates. The
Agency's calculations show the EEC for mevinphos to be 3.05 ppb
for foliar application to corn, sorghum, alfalfa, and vegetables
(3.35 ppb for aerial application); 1.525 ppb for foliar
application to artichokes and Chinese cabbage (1.68 ppb for
aerial application); and 6.1 ppb for foliar application to
vegetable crops and grapes (6.71 ppb for aerial application).
Because the lowest aquatic EEC (for field crops, 3.05 ppb)
exceeds the D a p h n1 a ECso (0.18 ppb) by 17 times, data are
required on tFe toxlci ty of a typical end-use product (the 4
Ib/gal EC formulation) to freshwater invertebrate.
Since aquatic invertebrate life-cycle
data are not available, no conclusions can be drawn regarding the
chronic effects of mevinphos on aquatic invertebrates. Mevinphos
is expected to be transported to water through spray drift during
normal use. EECs derived from spray drift models for orchards
(apples, 9.2 ppb) and for general field crop use (corn, at 0.5
Ibs/A, 3.35 ppb) well exceed the EC5Q of technical mevinphos to
Daphnia. Therefore, an aquatic Invertebrate Hfe cycle study is
requlred.
The acute toxicity tests with estuarlne
and marine organisms Indicate that mevinphos Is no more than
moderately toxic to the Eastern oyster, with an ECso (96-hour
shell deposition) of greater than 1000 ppb and at least In the
"highly toxic" range for brown shrimp (ECso of 150 ppb) and
sheepshead minnow (LCso of 640 ppb). The tests with brown shrimp
and sheepshead minnow were run for only 48 hours rather than 96
hours as required. Acute studies on the toxlcity of mevinphos to
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19
shrimp and marine fish are required. Testing on a typical end-
use mevlnphos product may also be required depending on the
results of the acute toxldty testing with technical mevinphos on
marine and estuarlne organisms.
c. Wild Mammal Toxlclty
Unvalldated data Indicate that mevlnphos
1s highly toxic to mammals, with LDso values to rats ranging from
3.7 to 12 mg/kg. A five-day dietary toxldty study with a
species of wild mammal Is required, along with residue monitoring
of mammalian food Items.
d. Endangered Species
There are sufficient data to indicate
that the currently registered uses of mevinphos may affect
endangered species.
In aquatic environments, all maximum
application rates for the various uses (0.25 to 3.00 Ib ai/A) are
expected to result in aquatic concentrations above l/20th the
LC50 to rainbow trout (1/20 x 11.9 = 0.595 ppb). There are
substantial concerns for any aquatic species that may be exposed
to mevlnphos.
In terrestrial environments, l/10th the
LCso to ring-necked pheasant (1/10 x 246 = 24.6 ppm) is exceeded
on most avlan food items at most application rates. For example,
residue levels on small insects and forage exceed the avian
endangered species trigger at application rates of 0.5 Ib ai/A
and above; residues on pods containing seeds exceed this level at
2.0 Ib ai/A. Grasses adjacent to treated fields or associated
with orchard trees also show residue levels that are high
relative to this endangered species trigger. Grasses are an
important food item for waterfowl; mevlnphos, however, is only
slightly toxic to waterfowl, with an LC5Q of 1991 ppm. Even so,
residue levels on short grass growing as an orchard understory
exceed l/10th the mallard LCso (1/10 x 1991 = 199 ppm) at the
label rate for apples and pears (3.0 Ib ai/A). There are
substantial concerns for endangered species with habitats
overlapping mevlnphos use sites. Endangered small mammals are
also expected to be at risk, since the acute oral toxiclty of
mevlnphos to mammals Is in the same range as the avlan acute oral
(rat LDso = 3.7 to 12 mg/kg).
Because of its demonstrated toxiclty to
nontarget species and its Intended use pattern, mevlnphos has
been Identified by the Office of Endangered Species (OES), U.S.
Fish and Wildlife Service (FWS), as being likely to jeopardize
endangered species when used on corn and sorghum. Based on this
determination, OES specified reasonable and prudent alternatives
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20
to avoid jeopardizing the continued existence of the identified
species by these uses. EPA is working with the Fish and Wildlife
Service and other Federal and State agencies to implement the
alternatives in a technically sound nanner-
e. Non-target Insects
Data from honey bee acute contact
toxicity studies indicate that mevinphos is highly toxic to honey
bees, when bees are exposed to direct application or oral routes.
The requirement for a honey bee acute contact study is fulfilled.
However, because the acute data indicate high toxicity, a
residual toxicity study is required.
There is sufficient information to
indicate that mevinphos, when used at standard field rates, is
generally highly toxic to predacious mites, parasitic wasps, and
predacious beetles. Study requirements for testing on predacious
and parasitic insects are currently reserved pending development
of test protocol s.
E. TOLERANCE REASSESSMENT
Tolerances for residues of the insecticide
mevinphos (Methyl 3-[(dimethoxyphosphinyl ) oxy ]butenoate , alpha
and beta isomers) have been established in or on various raw
agricultural commodities (40 CFR 180.157) and as a food additive
in food for human consumption (21 CFR 193.290). The present
United States tolerances for residues of mevinphos 1n or on raw
agricultural commodities, Mexican tolerances, and several
International Maximum Residue Limits (MRLs) recommended by the
Codex Alimentarius Commission are listed in Table 3 below. The
current United States food additive tolerance levels for
mevinphos are listed in Table 4 below. The Agency has evaluated
the residue and toxicology data supporting these tolerances and
has determined that it does not have sufficient data to support
the currently established tolerances for residues of mevinphos
alpha and beta isomers in or on raw agricultural commodities
(RACs). Therefore, because of extensive residue chemistry and
toxicology data gaps, a full tolerance reassessment for mevinphos
cannot be made at this time. In addition, processing studies are
required for apples, citrus fruits, grapes, plums, potatoes,
tomatoes, corn, and sorghum.
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21
Table 3. Summary of Present Mevinphos Tolerances
Commodity
Alfalfa
Apples
Artichokes
Beans
Beets, garden
(including tops)
Blrdsfoot trefoil,f
Birdsfoot trefoil,
Broccoli
Brussels sprouts
Cabbage
Carrots
Caul if!ower
Celery
Cherries
Chicory, red (tops)
(also known as
radicchio)
Citrus
Clover
Col 1ards
Corn, field
Corn
Corn
Corn
Corn
Corn
Cucumbers
Eggplant
Grapes
Kale
Lettuce
Melons (including
cantaloupes, honeydew
mellon.and muskmelon,
determined on the
edible portion with
rind removed)
Mustard greens
Okra
Onions (green)
Parsley
Peaches
Pears
Peas
forage
grain, field
pop, forage
pop, grain
sweet (K+CWHR)
sweet, forage
Um ted
1
0
1
0
) 1
rage 1
ay 1
1
1
1
0
1
1
1
0
0
1
1
1
0
1
0
0
1
0
0
0
1
0
To!
erances (ppm)
States Canada
.0
.5
.0
.25
.0
.0
.0
.0
.0
.0
.25
.0
.0
.0
.5
.2
.0
.0
.0
.25
.0
.25
.25
.0
.2
.25
.5
.0
.5
0
0
0
0
0
0
0
0
0
0
0
.25
.25
.25
.25
.1
.25
.25
.2
.25
.25
.25
Me xl co
1
0
1
0
*
1
0
1
0
1
0
1
0
0
1
0
0
0
0
.0
.5
.0
.25
.0
.5
.0
.25
.0
.25
.0
.25
.25
.0
.25
.25
.5
.5
I
0
1
1
1
0
1
1
0
0
0
1
0
(MRL)
nter-
nati ona I
(Codex)
.5
.0
.0
.0
.1
.0
.0
.2
.2
.5
.0
.5
.5
.0
.25
.25
.0
.0
.5
.25
0.25
0.25
0.5
0.25
0.25
0.25
0.25
1.0
0.5
0.25
0.05
0.5
0.2
0.1
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Table 3.
Commodi ty
22
Summary of Present Mevinphos Tolerances (continued)
Tolerances (ppm) (MRL)
united states Canada
ne xic o
Inter-
Nat tonal
icodex)
Pea vines 1.0
Peppers 0.25
Plums 1.0
Potatoes 0.25
Raspberries 1.0
Sorghum, forage 1.0
Sorghum, grain 1.0
Spinach 1.0
Squash, summer 0.25
Strawberries 1.0
Tomatoes 0.2
Turnips 0.25
Turnips, tops 1.0
Walnuts (determined on
the nut meats with
shell removed) 0.25
Watercress 2.0
Watermelon 0.5
0.25
0.1
0.25
0.25
0.25
0.25
0.1
0.25
0.25
1.0
1.0
0.25
1.0
0.25
0.25
0.5
0.1
0.5
1.0
0.2
0.1
K+CWHR = kernels plus cobs with husks removed.
Table 4. Summary of Present Mevinphos Food Additive Tolerances
Tolerances (ppm)
Commodlty
Dehydrated-Parsley
Um tea States
4.0*
1 When present as a result- of application of mevlnphos
growing crop. However, dehydrated parsley Is not
considered a processed
food additive tolerance
to the
presently
product of fresh parsley and therefore a
1s not required for dehydrated parsley.
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23
1. Residue Data
The metabolism of mevinphos 1n plants and
animals is not adequately understood. Available plant
metabolism data do not sufficiently describe the metabolism of
mevinphos in pea plants because the levels of radioactivity in
the initial plant extract, solids, and chloroform and aqueous
extracts were not reported and, therefore, the data do not
adequately quantify the relative amounts of parent material and
metabolites. Residues were not characterized in livestock.
The plant metabolism data indicate that
mevinphos is absorbed by plant roots, translocated readily to
leaves and growing shoots, and is degraded rapidly. The major
residues, identified in pea plants, are the alpha and beta
isomers of mevinphos and dimethyl phosphate. Mevinphos acid is a
minor metabolite in pea plants and it has been demonstrated that
mevinphos acid is converted to desmethyl mevinphos acid. It has
been suggested that the end products of mevinphos metabolism are
methanol, acetone, and carbon dioxide.
The available animal metabolism data indicate
that twelve hours after dosing 57 to 65% of the 32P-residues was
excreted in the urine and feces (45 to 50% in urine; 12 to 15% in
feces). Only mevinphos hydrolysis products were present.
If the metabolism of mevinphos in ruminants
or poultry differs from that in rats, then data on the metabolism
of mevinphos in swine will also be required.
Data gaps exist for plant and animal
metabolism and storage stability. On receipt of the data
requested in these sections of the registration standard, the
conclusions stated above regarding the adequacy of established
tolerances are subject to change. Furthermore, since the data
required for individual commodities are dependent on the
metabolism data, the Agency recommends that metabolism data be
obtained and submitted prior to any required residue data.
Adequate gas-liquid chromatographic (6LC) and
nonspecific chol i nesterase .inhibition (spectrophotometric and pH
change) methods are available for collection of data pertaining
to residues of mevinphos in or on plant commodities. At the
present time, no tolerances exist for residues of mevinphos alpha
and beta isomers in animal commodities, although registered uses
exist on crops which may result in residues in or on feed items.
The submitted cholinesterase inhibition/pH change method is
inadequate for data collection from milk because of unacceptably
low (ca. 37%) recovery efficiency. If tolerances for residues of
mevinphos in animal commodities are proposed, a validated data
collection and enforcement method must be submitted. Also, if
the requested data regarding the nature of the residues of
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24
mevlnphos In plants and animals reveal the occurrence of
additional metabolites of concern, additional analytical methods
for data collection and enforcement may be required.
The Codex Maximum Residue Limits (MRL)
residue definition 1s expressed as the sum of c1s- and trans-
mevlnphos, and the U.S. Tolerance definition 1s expressed as
residues of mevlnphos, alpha and beta Isomers. These definitions
are equivalent. A decision regarding the potential for
compatibility between the permanent Codex MRL and the U.S.
tolerances for carrots, potatoes, turnips, green onions, spinach,
cabbage, cauliflower, peas, tomatoes, cucumbers, melons (except
watermelon), and pears, will not be made until the adequacy of
the U. S. tolerances have been ascertained.
There are no established or proposed direct
animal treatment uses for mevlnphos. Presently, the nature of
the residue In animals Is not adequately understood, and
numerous data gaps exist concerning the magnitude of the residue
1n feed Items of animals. Therefore, the expected dietary
Intakes for beef and dairy cattle, poultry, and swine were not
calculated. Upon receipt of the requested residue data and
animal and plant metabolism data, the need for, and the nature of
tolerances for mevlnphos residues 1n livestock and poultry will
be assessed.
2. Toxicology Data
Mevlnphos 1s a potent chollnesterase
Inhibitor currently registered for use on 45 crops. There are
virtually no acceptable toxldty data to support these registra-
tions. There 1s a potential for accidental poisoning, with
neurologic Involvement, of applicators and farmers who are not
protected.
The Initial Acceptable Dally Intake (ADI) for
mevlnphos was based on a 2-year dog feeding study. On the basis
of plasma and erythrocyte chollnesterase Inhibition, the No
Observed Effect Level (NOEL) In this study was defined as 0.025
mg/kg/day. A safety factor of 10 was used to calculate the ADI
of 0.0025 mg/kg/day. The chollnesterase Inhibition Lowest Effect
Level (LED 1 n this study was defined as 0.075 mg/kg/day. When
the Agency reviewed this study In the rereglstrati on review for
mevlnphos, serious report deficiencies were noted that made the
study unacceptable and the Agency found that 1t was not possible
to define the NOEL and LEL doses. The Agency reviewed seven
chronic toxldty studies during the mevlnphos reregl strati on
review process and all but one of them (a rat teratology study)
were found to be unacceptable. Therefore, the Agency concludes
that there are Insufficient data to establish an ADI or PADI for
mevlnphos at this time.
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25
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
1. Special Review
The Agency 1s not Initiating a special review
for mevlnphos at this time.
Rationale: The Agency 1s concerned about the
significant numbeT67mFvlnphos poisonings reported 1n
California. However, the Agency's existing data base 1s
Insufficient for supporting any further regulatory action at this
time. Major data gaps exist In the areas of acute, subchronlc,
and chronic toxlclty, as well as 1n the areas of oncogenld ty,
teratogen1c1ty, reproductive effects, mutagen1c1ty, and
metabolism. Acute toxlclty studies were called 1n by the Agency
under an earlier notice and will be submitted 1n mid-1988. The
Agency also needs further Information from the state of
California 1n order to adequately characterize the causes of the
reported poisonings 1n that state. That Information has been
requested from California. In addition, major data gaps also
exist 1n the environmental fate and residue chemistry data base.
A number of data gaps also exist 1n the ecological effects data
base. Therefore, the Agency 1s calling In all of the data
Identified as gaps 1n the Agency's mevlnphos data base and 1s
reserving consideration of special review for mevlnphos until
data become available that more clearly Identify the risks posed
by mevlnphos use.
2. Reentry Requirements
The Agency 1s establishing a reentry Interval
of four days (96-hours) for citrus groves, grape vineyards,
nectarine and peach orchards; and two days (48-hours) for all
other crops treated with mevlnphos.
Rationale: Mevlnphos 1s registered for use
on a variety of agriculturalsites which Involve hand labor, and
therefore may pose potential health risks to those workers
because of potential dermal, Inhalation, and ocular exposure
when reenterlng areas treated with this chemical. A relatively
high number of fleldworker poisoning Incidents have been reported
for crops treated with mevlnphos. All mevlnphos products are
currently classified 1n Toxlclty Category I, are rapidly absorbed
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26
through the skin3, and are cholinesterase inhibitors. California
has established a 3 or 4 day reentry interval for all crops
treated with nevinphos, and Texas and New Jersey have imposed a 2
day reentry interval. Current Federal labeling only requires
that fieldworkers not enter treated areas until sprays have dried
unless they are wearing protective clothing.
In order to determine the adequacy of the
reentry statement on current Federally registered mevinphos
products, the Agency, in February 1985, issued a data call-in
requiring the registrants of mevinphos products to provide foliar
dislodgeable residue data to support appropriate reentry
intervals. Those data have been submitted to the Agency, along
with proposed reentry intervals. The Agency has reviewed these
data and the registrant's proposed reentry intervals and has
determined that the data support the proposed reentry intervals
of 96 hours (four days) for citrus groves, grape vineyards,
nectarine and peach orchards, and 48 hours (two days) for all
other crops treated with mevinphos.
3. Restricted Use
The Restricted Use classification for all
uses of mevinphos emulsifiable concentrates and liquid
concentrates, Psycodid filter fly liquid formulations, and 2
percent dust formulations under FIFRA section 162.31 will remain
in effect. In addition, a statement identifying the reasons for
the restriction are to appear on the label as specified in
Section IV.D of this document. It is the Agency's position that
affected products must bear appropriate restricted use labeling
in order to remain in compliance with FIFRA.
Rationale: All mevinphos products, whether
liquid or dust formulations,Fave been classified for restricted
use based on the acute dermal toxicity to humans and expected
toxic residues on wildlife food items and in aquatic habitats.
Although there are numerous toxicology and ecological effects
data gaps, available data are sufficient to show that these
effects are of continuing concern. In order that the public
and/or the user be aware of the reasons for the restricted use
classification, a statement identifying the reasons for the
restriction are to appear on the label as specified in Section
IV.D of this document.
3Labels for current Federally registered mevinphos products
contain the following precautionary statements: "Poisonous if
swallowed, inhaled or absorbed through the skin. Rapidly
absorbed through the skin. Repeated inhalation or skin contact
may without symptoms, progressively increase susceptibility to
mevinphos poisoning."
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27
4. Physical Presence of Certified Applicators
In order for mevinphos products to remain in
compliance with FIFRA, product labels must contain language
requiring certified applicators to be physically present during
application, mixing and loading of the pestlci de,and during
repair and cleaning of application equipment. Certified
applicator labeling statements are specified in Section IV.D of
this document.
Rationale: Untrained workers are likely to
be unaware of the acute hazards associated with mevinphos. On the
other hand, certified applicators are trained in safe methods of
using pesticides and should be aware of the hazards associated
with the use of mevinphos. Requiring the certified applicator
to be physically present during application, mixing and loading
of the pesticide, and during repair and cleaning of application
equipment will not only ensure closer supervision of untrained
workers but will also ensure closer adherence to label
requirements. Certified applicators are being required to ensure
that persons under their direct supervision who are involved in
applying, mixing and loading of the pesticide, and in repairing
and cleaning of application equipment, are informed of
precautionary statements on the label regarding the use of
mevinphos. This requirement will ensure that persons who may
come into contact with the pesticide are aware of and comply with
the required measures to protect their health.
5. Protective Clothing
In order for products to remain in compliance
with FIFRA, product labels must contain language requiring the
use of protective clothing for all end-use products containing
mevinphos. Protective clothing statements are specified in
Section IV.D of this document.
Rati on ale: The acute toxicity of mevinphos
has been documented &"yFFTe number of reported incidents of
applicators and mixer/loaders who have been poisoned by
exposure to mevinphos. Poisoning incidence data show that a
number of incidents have occurred during application from
splashing and spillage during mixing and loading of the
pesticide, and during repair and cleaning of application
equipment. Poisoning reports from California show that mevinphos
was the number one cause of hospitalization and the number two
cause of systemic poisonings in that state from 1981 to 1985.
Those reports also show that the ratio of poisonings to pounds of
pesticide sold in California was higher for mevinphos than for
any of the other agricultural chemicals examined.
In addition mevinphos is registered for use
on a variety of agricultural sites all of which may involve hand
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28
labor, and may pose potential dermal exposure risks to workers.
All mevlnphos products are currently classified In Toxldty
Category I, bear a statement that they are rapidly absorbed
through the skin, and are chol1nesterase Inhibitors.
Although current mevlnphos product labels
contain protective clothing statements, the Agency does not
consider the current language to be adequate. Therefore, 1n an
effort to Increase the level of protection afforded to
mixer/loaders, applicators, and persons reenterlng treated fields
before and after the spray has dried, the Agency 1s requiring
that all end use mevlnphos product labels bear the protective
clothing statements specified In Section IV.D of this document.
6. Tolerances and New Uses
The Agency will not grant any tolerances or
any new uses for mevlnphos until sufficient data are submitted
for the Agency to calculate the Theoretical Maximum Residue
Contribution (TMRC) for mevlnphos and then will not grant any
tolerances or significant new food uses* until all of the
required residue chemistry and toxicology data have been
submitted and reviewed.
Rationale: Available residue chemistry and
toxicology data for mevlnphos are not sufficient for the Agency
to calculate the TMRC for mevlnphos or to reassess the existing
mevinphos tolerances. Plant and animal metabolism data and
residue data on various commodities are required. The pertinent
toxicology data requirements include: chronic feeding,
oncogenlci ty, mutagenicity, reproduction, teratogenicity, and
metabolism (refer to Table A for specific residue chemistry and
additional toxicology data requirements). Until these data are
submitted and reviewed, the Agency cannot calculate the TMtfC for
mevlnphos or perform a tolerance reassessment. f
t
7. Endangered Species Concerns ,'
The Office of Endangered Species (OES) in the
U.S. F1sh and Wildlife Service (FWS) has determined that certain
uses of mevinphos may jeopardize the continued existence of
endangered species or critical habitat of certain endangered
species. EPA 1s developing 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 1s developed.
4 "Significant new use" is defined 1n 44 FR 27934, May 11,
1979. In the case of a new food or feed use, the Agency will
generally consider as significant an Increase In the Theoretical
Maximum Residue Contribution (TMRC) of greater than 1%.
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29
No additional 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 re-Issuance.
Rationale; In May 1987, EPA issued PR Notices
87-4 and 87-5 1n response to OES findings that certain
pesticides, including mevinphos, jeopardized the continued
existence of endangered species. Those PR Notices directed
registrants to add labeling to their products which referred
users to additional Information that, in turn, explained
limitations on use of the pesticide within the range of
jeopardized 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. Therefore, 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 requiring labeling to protect endangered species. When that
program is fully developed, notice of any labeling necessary to
protect endangered species will be issued.
8. Human Flaggers
The Agency is prohibiting the use of human
flaggers during aerial application of mevinphos, unless they are
in totally enclosed vehicles.
Rationale: The Agency is imposing this
requirement to mi nimize hazard to flaggers since human flaggers
face a risk of exposure by direct contact or through drift during
aerial application.
9. Nontarget Organisms Labeling
In order to meet the statutory standard for
continued registration, the Agency has determined that mevinphos
products must bear revised and updated labeling for hazards to
nontarget organisms.
Rationale: Available data show that
mevinphos is very highly toxic to birds, wild mammals, aquatic
organisms, and honey bees. Precautionary label- statements
relative to the potential risks posed by mevinphos to nontarget
organisms will provide useful information to promote practices to
limit such exposure of nontarget species to this pesticide.
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10. Spray Drift Data Requirements
Droplet Spectrum and Spray Drift Field
Evaluation tests are required. The droplet spectrum study must
be performed to reflect the commonly-used nozzle and other
equipment types which are used 1n the application of mevinphos.
The spray drift field evaluation must be performed to reflect the
commonly-used application equipment, use patterns, and typical
locations of use (including different weather factors).
Rationale: The Agency is concerned about
hazards to humans and nontarget fish and wildlife, and domestic
animals caused by drift from aerial and mist-blower applications
of mevinphos. These tests are required because of the toxic
nature of mevinphos and because the methods used to apply
mevinphos (mist-blower and aerial) may lead to exposure of
bystanders and wildlife. These tests will indicate the extent of
possible drift of this chemical from normal applications and the
data from these tests will enable the Agency to evaluate the
potential for drift.
11
Acceleration of Dates When Mevinphos
Must Bear
Amended
Label 1 ng
Required
Products
By
Thl s
Standard
The Agency 1s accelerating the dates for when
mevinphos products must bear the amended labeling required by
this Standard.
Rationale: The Agency usually allows
registrants one yeaT from FFFe issue date of a registration
standard before requiring that their products bear the amended
labeling required by that standard. However, because pesticide
poisoning reports from California show mevinphos to be among*the
top five pesticides in terms of frequency of occupational
pesticide poisoning in California during the period from 1981 to
1985; the extensiveness of the gaps 1n mevinphos1 data base,
particularly with regard to its toxlcity; and the fact that
mevinphos Is considered to be in Toxlcity Category I, the Agency
is accelerating the dates for when mevinphos products must bear
amended labeling required by this Standard. The Agency 1s taking
this action in order to protect applicators and fleldworkers as
soon as possible. The accelerated dates would have the amended
labeling on mevinphos products for the 1989 growing season. The
dates when mevinphos products must bear the amended labeling are
set forth 1n Section IV.D of this Standard.
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12. National Pesticide Telecommunications Network
reiepnone NumpeF
The Agency is requiring the addition of the
telephone number of the National Pesticide Telecommunications
Network to the labels of all end-use mevinphos products.
Rationale: The telephone number is included
in order to provide an additional source of first aid information
in the event of an accident involving exposure to this chemical.
13. Data Identified for Immediate Review
The Agency has identified certain data that
will receive immediate review when submitted.
Ration a 1e: Certain data are essential to
the Agency's assessment or tnis 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:
Section 158.125
Section 158.130
Residue Chemistry
171-4 - Nature of Residues
(Metabolism [Plants
and Livestock])
171-4 - Residue Storage
Stability
171-4 - Magnitude of the
Residues in Plants
Environmental Fate
161-1 - Hydrolysis
161-2 - P h o t ode gr a da 11 o n
(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)
164-2 - Aquatic Dissipation
(sediment)
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165-1
165-2
165-3
165-4
165-5
Section 158.135 - Toxlcology
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Confined Rotational
Crop
Field Rotational
Crop
Irrigated Crops
F 1 sh Accuraulat1on
(Lab)
Aquatic Nontarget
Organl sms
Accumulation
Section 158.142
Section 158.145
Acute Oral
Acute Dermal
Acute Inhalation
- Eye Irritation
Dermal Irritation
Dermal Sensltlzation
Acute Delayed
Neurotoxldty (Hen)
Special- Acute Dermal (to
Testing define lethality,
toxidty, and ChE
NOELs)
82-2 - Subchronlc 21-day
Dermal
82-4 - Subchronlc 90-day
Inhalation
83-2 - Oncogenldty (Rat
and Mouse)
83-3 - Teratogenlcity
(Rabbit)
83-4 - Reproduction
85-1 - General Metabolism
Spray Drift
201-1 - Droplet Size
Spectrum
202-1 _ Drift Field
Evaluation
Wildlife and Aquatic Organisms
71-3 - Wild Mammal Toxlclty
71-4 - Avian Reproduction
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72-1 - Acute Toxldty to
Freshwater F 1 s h
(using a typical
end-use product)
72-2 - Acute Toxlclty to
Freshwater
Invertebrate (using
a typical end-use
product)
72-3 - Acute Toxlclty to
Estuarlne and Marine
Organisms (F1sh and
Shrimp)
72-4 - F1sh Early Life
Stage and
Invertebrate L1fe
Cycle
72-6 - Aquatic Organism
Accumulatlon
70-1 - Special Test
(Terrestrial Residue
Monitoring)
14. Amending Certain Tolerance Commodity Entries
to Reflect Appropriate commodity Definitions
The Agency proposes to: (1) amend the
commodity entry "beets, garden (including tops)" to reflect the
appropriate commodity definition "beet greens"; (11) amend the
commodity entry "melons (including cantaloupes, honeydew melon,
and muskmelon, determined on the edible portion with rind
removed)" to reflect the appropriate commodity definition "melons
(including cantaloupes, honeydew melon, and muskmelon)"; and
(ill) amend the entry "plums" to reflect the appropriate
commodity definition "plums (fresh prunes)".
Rationale: The current tolerance commodity
entries for beets, melons, and plums do not reflect the commodity
definitions currently established by the Agency. The amendments
proposed above would have those commodity entries reflect the
appropriate commodity definition
15. Continuation of Current Registrations
While the required data are being developed,
currently registered manufacturing-use products (MPs) and end-use
products (EPs) containing mevinphos may be sold, distributed,
formulated and used subject to the terms and conditions specified
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1n this Standard. Registrants must provide or agree to develop
and provide 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 because data are missing
or are inadequate [see FIFRA section 3(c)(2)(B) and 3(c)(7)].
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory changes
are necessary.
B. Criteria for Registration
To be registered or reregistered under this
Standard, manufacturing-use and end-use products must contain
mevinphos as the sole active ingredient, 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 conform to this Standard, manufacturing-
use and end-use products must contain mevinphos as the sole
active ingredient. Each formulation proposed for registration
must be fully described with an appropriate certification of
limits, stating maximum and minimum amounts of the active and
Intentionally added inert ingredients present 1n the product, as
well as Impurities found at levels greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of
technical grade, manufacturing-use or end-use products containing
mevinphos, provided the product 1s supported by appropriate acute
toxicity data and the labeling for the product bears appropriate
precautionary statements for the toxicity category in which the
product is placed. Mevinphos manufacturing-use and end-use
products are^ currently in Toxicity Category I and the appropriate
signal word Is DANGER.
3. Use Patterns
To be registered under this Standard,
manufacturing-use products must be labeled for formulation Into
other manufacturing-use products or into end-use products bearing
federally registered uses. The EPA Index to Pesticide Chemicals
(Appendix III) lists all federally registered uses of mevinphos,
as well as approved maximum application rates and frequencies.
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35
The use
as follows:
..._ patterns currently registered for
mevlnphos are
Terrestrial - Food Crop: alfalfa; anise5;
apple; artichoke; beans; beets 11 ncIudf ng tops); Bermudagrass
(seed crop)5; blrdsfoot trefoil5; broccoli; broccoli raab;
Brussels sprouts; cabbage; carrot; cauliflower; celery; cherry
(sour); Chinese broccoli (gal Ion)5; Chinese cabbage (Including
napa or napa cabbage, bok choy, pak choi, gal choy, and
mlzunal)5; clover; collards; corn; cucumber; eggplant; fennel;
grapefruit; grapes; kale; lemon; lettuce; melons (Including
cantaloupes, honeydew melons, muskmelons, and watermelons); mint;
onions (Including green onions); orange;
plum; potato; raspberry; red chicory (tops)
(seed crop)5; sorghum; spinach; squash
tomato; turnips (Including tops); walnut.
mustard greens; okra;
peach; pear: peppers;
radlcch1o5; se same
(summer); strawberry;
flowering plants (field grown)5.
Terrestrial - Nonfood Crop: ornamental
plants.
Greenhouse - Food Crop: lettuce.
Aquatic - Food Crop: watercress5.
Aquatic - Nonfood Crop; sewage disposal
D. Required Labeling
All products must bear appropriate labeling as
specified 1n 40 CFR 162.10, PR Notices 83-2, 83-3, and below.
Appendix II contains further Information on label requirements.
Pesticide products containing mevlnphos as an
active ingredient may not be released for shipment by the
registrant after September 1, 1988 unless the product bears
amended labeling that complies with the requirements of this
Standard. Five (5) copies of the labeling, revised in accordance
with this "Standard, must be submitted prior to release for
snipmenTT
Pesticide products containing mevlnphos as an
active ingredient may not be distributed, sold, offered for sale,
held for sale, shipped, delivered for shipment, or received and
(having been so received) delivered or offered to be delivered by
any person after September 1, 1989 unless the product bears
amended labeling, five copies of which have been submitted to the
Agency, that complies witn tne requirements of tms standard.
5This use is currently registered as a Special Local Need
registration under 24(c) of FIFRA.
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In addition to the above labeling requirements,
the following information must appear on the labeling of all
manufacturing-use and end-use products.
Ingredient Statement
The ingredient statement for all mevinphos
products must list the active ingredient as:
ACTIVE INGREDIENT:
Mevinphos (2-Carbomethoxy-l-methylvinyl
dimethyl phosphate, alpha isomer). . %*
Related Compounds %*
*Equivalent to 50%/w MEVINPHOS Insecticide
1. Manufacturing-Use Product Labeling
a. Use Pattern
All products must state that they are
intended for formulation into other manufacturing-use or end-use
products for acceptable use patterns. Labeling must specify
sites, which are listed in Use Patterns, Appendix III. However,
no use may be included on th"e label where the registrant fails to
agree to comply with the data requirements in Table A for that
use pattern.
b. Environmental Hazards
The following revised environmental
hazard statement must appear on all labels:
"This pesticide is toxic to fish and
wildlife. Do not discharge effluent
containing this product into lakes,
streams, ponds, estuaries, oceans, or
public waters unless this product is
specifically identified and addressed in
an NPDES permit. Do not discharge
effluent containing this product to
sewer systems without previously
notifying the sewage treatment plant
authority. For guidance, contact your
State Water Board or Regional Office of
the Environmental Protection Agency."
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37
c. Personal Protective Equipment and Work
Safety
The following personal protective
equipment and work safety statements must appear on all labels:
"USE ONLY WHEN WEARING THE FOLLOWING
PERSONAL PROTECTIVE EQUIPMENT DURING
MIXING/LOADING, REPAIR AND CLEANING OF
MIXING/LOADING EQUIPMENT, OR DISPOSAL OF
THE PESTICIDE: Protective suit of one
or two pieces covering^ all parts of the
body except head, hands, and feet;
NIOSH or MSHA approved respiratory
protection device; chemical-resistant
gloves; chemical-resistant shoes (or
chemical-resistant shoe coverings or
chemical-resistant boots). In addition,
mixer/loaders must wear a chemical-
resistant apron. During equipment
repair and cleaning, the protective suit
and the respirator need not be worn.
IMPORTANT: If pesticide comes in
contact with skin, wash off with soap
and water and contact a physician
immediately. Always wash hands, face,
and arms with soap and water before
smoking, eating, drinking, or toileting.
AFTER WORK: Before removing gloves,
wash them with soap and water. Take off
all work clothes and shoes. Shower
using soap and water. Wear only clean
clothes when leaving job -- do not wear
contaminated clothing. Personal and
protective clothing worn during work
must be laundered separately from
household articles. Store protective
clothing separately from personal
clothing. Clean or launder protective
clothing after each use. Protective
clothing and equipment that becomes
heavily contaminated or drenched must be
destroyed according to State and local
regulations. HEAVILY CONTAMINATED OR
DRENCHED CLOTHING CANNOT BE ADEQUATELY
DECONTAMINATED."
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38
2. End-Use Product Labeling
a. Restricted Use Statement
The following statement must appear on
the front panel of all products:
"RESTRICTED USE PESTICIDE
Due to Very High Acute Toxlclty to Humans
and
Residue Effects on Avian, Mammalian and
Aquatic Species
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. Direct
supervision for this product Is defined
as the certified applicator being
physically present during application,
mixing, loading, repair and cleaning of
application equipment. Certified
applicators must also ensure that all
persons Involved In these activities are
Informed of the precautionary
statements."
b. Environmental Hazards
One of the following environmental
hazard statements must appear on the label of all products which
permit outdoor uses:
Terrestrial Food and Nonfood Uses
"This pesticide is toxic to fish and
wildlife. Drift and runoff may be
i hazardous to aquatic organisms in
neighboring areas. Do not apply
directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not
cantaminate water when disposing of
equipment washwaters."
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39
Aquatic Food Uses (watercress)
"This pesticide is toxic to fish and
wildlife. Effluent may be hazardous to
aquatic organisms. Do not contaminate
water when disposing of equipment
washwaters."
c. Personal Protective Equipment and Work
Safety
The following personal protective
equipment and work safety statements must appear on the labeling
of all products:
"USE ONLY WHEN WEARING THE FOLLOWING
PERSONAL PROTECTIVE EQUIPMENT DURING
MIXING/LOADING, APPLICATION, REPAIR AND
CLEANING OF MIXING, LOADING, AND
APPLICATION EQUIPMENT, AND DISPOSAL OF
THE PESTICIDE: protective suit of one or
two pieces that covers all parts of the
body except head, hands, and feet;
chemical-resistant gloves; chemical-
resistant shoes (or chemical -resistant
shoe coverings or chemical-resistant
boots); goggles or face shield; hood or
wide brimmed hat; NIOSH or MSHA approved
respiratory protection device.
IF MIXING/LOADING IS PERFORMED USING A
CLOSED SYSTEM, THE FOLLOWING PROTECTIVE
CLOTHING AND EQUIPMENT MAY BE WORN AS AN
ALTERNATIVE: Long-sleeve shirt; long-
legged pants; chemical-resistant gloves;
chemical-re sistant apron; shoes and
socks. Goggles or face shield must be
worn when the system is under pressure.
All other protective clothing and
equipment required for use with open
systems must be available nearby.
IF APPLICATION IS PERFORMED USING AN
ENCLOSED CAB OR COCKPIT, THE FOLLOWING
PROTECTIVE CLOTHING AND EQUIPMENT MAY BE
WORN AS AN ALTERNATIVE: Long-sleeve
shirt and long-legged pants; shoes and
socks. Chemical-resistant gloves must
be available in the cab or cockpit and
must be worn during entry to and exit
from the application vehicle. All
other protective clothing and equipment
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40
required for use during application must
be available 1n the cab and must be worn
when exiting the cab Into treated area.
When used for this purpose, contaminated
clothing may not be brought back Into
the cab unless in an enclosure such as a
plastic bag. REMEMBER - THIS CLOTHING
IS INADEQUATE TO PROTECT YOU DURING
REPAIR AND CLEANING OF APPLICATION
EQUIPMENT AND EARLY REENTRY TO TREATED
AREAS! REFER TO PROTECTIVE CLOTHING AND
EQUIPMENT REQUIREMENTS ABOVE.
IMPORTANT! If pesticide comes 1n
contact with skin, wash off with soap
and water and contact a physician
immediately. Always wash hands, face,
and arms with soap and water before
smoking, eating, drinking, or toileting.
AFTER WORK: Before removing gloves,
wash them with soap and water. Take off
all work clothes and shoes. Shower
using soap and water. Wear only clean
clothes when leaving job -- do not wear
contaminated clothing. Personal and
protective clothing worn during work
must be stored and laundered separately
from household articles. Clean or
launder protective clothing after each
use. Respirators must be cleaned and
filters replaced according to
instructions included with the
respirators. Protective clothing and
protective equipment that be comes
heavily contaminated or drenched with
mevinphos must be destroyed according to
State and local regulations. HEAVILY
CONTAMINATED OR DRENCHED CLOTHING CANNOT
BE ADEQUATELY DECONTAMINATED.
The National Pesticide Telecommunication
Network 1s available for recommendations
regarding poisoning management,
emergency treatment, and other
information regarding the toxidty of
mevinphos. The toll free number for the
National Pesticide Telecommunication
Network is 1-800-858-7378.
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d.
statement must appear on
41
IF HANDLED INDOORS provide mechanical
exhaust ventilation. Keep all
unprotected persons, children,
livestock, and pets away from treated
area or where there 1s danger of drift.
Do not rub eyes or mouth with hands. If
you feel sick 1n any way, STOP work and
get help right away, see the First Aid
(Practical Treatment) section of this
label."
Bee Precautions
The following be*e precautionary
the label of all products:
"This product is highly toxic to bees
exposed to direct treatment on blooming
crops or weeds. Do not apply this
product or allow it to drift to blooming
cro.ps or weeds while bees are actively
visiting the treatment area."
appear on the
use products:
1abel1ng
Reentry
The following
of all products
Reentry
reentry statements must
except aquatic non-food
"Reentry into treated citrus groves,
grape vineyards, and nectarine and peach
orchards Is prohibited for 96 hours (4
days) after the end of application,
unless the protective clothing
specified on this label for early
reentry is worn. Reentry into all other
treated areas 1s prohibited for 48 hours
(2 days) after the end of application,
unless the protective clothing specified
on this label for early reentry is worn.
FOR EARLY REENTRY INTO TREATED AREAS
BEFORE SPRAYS HAVE DRIED, wear all
protective clothing specified on this
label for an applicator-
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42
FOR EARLY REENTRY INTO TREATED AREAS
AFTER SPRAYS HAVE DRIED, wear protective
suit of one or two pieces covering all
parts of the body except head, hands,
and feet; chemical-resistant gloves;
chemical-resistant shoes {or chemical-
resistant shoe coverings or chemical-
resistant boots).
Written or oral warnings must be given
to workers who are expected to be 1n
treated areas or in an area about to be
treated with this product. (Indicate
specific oral warnings which Inform
workers of areas or fields that may not
be entered without specific protective
clothing, period of time field must be
vacated and appropriate actions to take
in case of accidental exposure.) When
oral warnings are given, warnings shall
be given in a language customarily
understood by workers. Oral warnings
must be given 1f there is reason to
believe that written warnings cannot be
understood by workers. Written warnings
must Include the following information:
DANGER: Area treated with MEVINPHOS on
(Date) .
Do n of enter wlthout appropriate
protective clothing until (Insert
date/time reflecting end of reentry
Interval set forth on this label). In
case of accidental exposure see
STATEMENTS OF PRACTICAL TREATMENT found
on the MEVINPHOS product label."
f. Human Flaggers
The following statement must appear on
the labeling of all products, except aquatic non-food use
products, wh-1ch permit aerial application:
"HUMAN FLAGGERS ARE PROHIBITED during
aerial application of this product
unless in totally enclosed vehicles."
g. Storage and Disposal
All products must have the appropriate
storage and disposal statements on the label. Refer to Appendix
II for the appropriate statements.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product is a manufacturing or end use product and
whether the pesticide is the sole active ingredient or one of
multiple active ingredients.
Products are subject to this Registration Standard as
fol1ows:
A. Manufacturing-use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition,
or packaging listed in Section IV, if they pertain to the
manufacturing-use product.
2. The data requirements listed in Tables A and B6
3. The labeling requirements specified for
manufacturing-use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with reregistration.
6Data 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 Registration
Standard. Table B lists product-specific data applicable to
manufacturing use products. The data in Tables A and B need not
be submitted by a producer who is eligible for the formulator's
exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it will
not require the submission of product-specific data for end use
products at this time. Therefore most Registration Standards do
not contain a Table C.
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44
B. Manufacturing-use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The restrictions (1f any) upon use, composition,
or packaging listed In Section IV, If they pertain to the
manufacturing-use product.
2. The labeling requirements specified for
manufacturing-use products 1n Section IV.
3. The data requirements listed in Table A.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with reregistration.
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 exemption7, the
data requirements listed in Table C (if Included).
3. If not eligible for the formulator's exemption,
the data requirements listed in Table A and the data requirements
listed in Table C ( 1f Included).
7If 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:
i
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
requi rements.
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45
4. The labeling requirements specif-fed for end-use
products 1n Section IV.
5. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with rereglstratlon.
D. End-use products containing this pesticide as one of
multiple active ingredients 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 not eligible for the formulator's exemption,
the data requirements listed in Table A and Table C (if
included).
3. If eligible for the formulator's exemption, the
data requirements listed in Table C (1f included).
4. The labeling requirements specified for end-use
products in Section IV.
5. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation provisions)
associated with rereglstration.
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46
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 registration of products
containing this active ingredient.8
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 40 CFR sec. 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 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.
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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47
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 da tin but will fToT 6~esubml tti ng FFfedata
yourself.If you use this method, you must state who will submit
the data on which you will rely. You must also provide EPA with
documentary evidence that an agreement has been formed which
allows you to rely upon the data to be submitted. Such evidence
may be: (1) your letter offering to join 1n 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
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48
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
consortium 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 w i t h t h e D C F7 ETA Fa's determi ned that, as a
generalpolicy, it willnot 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
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the
other registrant and proof of the other registrant's receipt of
your offer (such as a certified mall receipt). Your offer must,
at a minimum, contain the following language or Its equivalent:
[Your company name] offers to share 1n the burden of
producing the data required pursuant to FIFRA sec.
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49
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) (1ii).
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 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 thai 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 requirement
applies, EPA does not anticipate that many waivers will be
granted. A request for waiver does not extend the timeframes for
developing required data, and if your waiver request is denied
your registration may be suspended if you fail to submit the
data.
5.
del eti ng th
requl
label
red to
•
You
e uses
submit
request that
for
data
wmcn
for
the
uses
EPA amend your registration
data
whi c
are needed.
h are
no 1 o
YOU
nger
are
on y
by
not
our
6. You request voluntary cancellation of the
registration of your product(s) for which the data are needed.
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
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50
Pesticide Assessment Guidelines, unless other protocol or
standards are approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are
referenced in the Data Tables, are available from the National
Technical Information Service (NTIS), Attn: Order Desk, 5385 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 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 then is allowed.by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted 1n 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
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51
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 1s 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
tlmeframe 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).
I. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision 1s not consistent
with the Act. Accordingly, the Agency does not anticipate
granting permission to sell or distribute existing stocks of
suspended product except in rare circumstances. If you believe
that your product will be suspended or cancelled and that an
existing stocks provision should be granted, you have the burden
of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. The following Information must
be included In any request for an existing stocks provision:
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52
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
cons istent
2. Demonstration that such
with the provisions of FIFRA.
a provision would be
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning possible
unreasonable adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify the
Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues as
long as the products are registered by the Agency.
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53
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
requirements, 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
requirements for your products will result in suspension of the
product's registration.
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54
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELS
FIFRA requires each product to be labeled with
accurate, complete and sufficient instructions and precautions,
reflecting the Agency's assessment of the data supporting the
product and its uses. General labeling requirements are set out
in 40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registration
Standard. Applications submitted in response to this notice must
include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
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55
IX. INSTRUCTIONS FOR SUBMISSION
A. Man u f acturing-Use Products (MUPs) containing the
subject pesticide as sole active Ingredient.
1. Within 90 days from receipt of this document, you
must submit to theProduct 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.9
b. Confidential Statement of Formula (EPA Form
8570-4)
c. Formulator's Exemption Statement (EPA Form
8570-27), if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer
to 40 CFR 152.80 - 152.99.
2. By September 1, 1988, you must submit to the
Product Manager^five copies of I abeling, as specified in Chapter
IV.D. Required Labeling, including the container label and any
associatedsupplementai 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.
3. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration/Amend-
ment (EPA Form 8570-1).
^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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56
b. Two copies of any required product-specific
data (see Table B).
c. Product Specific Data Report
(EPA Form 8580-4).
4. Within the times set forth In Table A, you must
submit to the Registration Division allgenericdata, unless you
are eligible for the fornulator'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 attachmentsx (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. By September 1, 1988, you must submit to the
Product Manager^five copies of label ing, as specified in Chapter
IV.D. Required labeling, including the container label and any
associafeUsupplemental 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.
3. Within 9 months from receipt of this document you
must submit to the Product Manger:
a. Application for Pesticide Registration/Amend-
ment (EPA Form 8570-1).
4. Within the time frames set forth in Table A, you
must submit to the Registration Division allgeneric 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.
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57
C. End-Use Products containing the subject pesticide as,
sole active ingredleriTT
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 attachmentsx (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. By September 1, 1988, you must submit to the
Product Manager"five copies of label ing, as specified in Chapter
IV.D. Required Labeling, including the container label and any
associatedsupplementaI 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.
3. 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 (if included).
b. Product Specific Data Report (EPA Form 8580-4
if Table C lists required product-specific
data.
D. End-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 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.
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58
2. By September 1, 1988, you must submit to the
Product Manager, five copies of labeling, as specified in Chapter
IV.D. Required Labeling, including the container label and any
associ a ted 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.
3. 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 (if included).
b. Product Specific Data Report (EPA Form
8580-4), if Table C lists required product-
specific data.
E. Intrastate Products containing the subject pesticide
either as~s~o1e 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
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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59
I. DATA APPENDICES
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60
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
fothe pesticide in all products, including data
requirements for which a "typical formulation" is the
test substance.
Table B contains product-speci fi c 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
fol1owi ng 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 Prot Royal Road, Springfield, VA 22161.
2. Test Substance (Col umn 2)- This column lists the
compositi on of tTie" 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 1n 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
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61
TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined In a footnote to the
table.
4. Does EPA have data? (Column 4). This column Indicates one
of three answers:
YES - EPA has data In Us files that completely satisfy
thls 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
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62
T6UIDE-3
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 t requires
that data b~esubmi tted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are those established either as a
result of a previous Data Call-In letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
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63
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Test Use
Data Requirement Substance1/ Patterns
Sec. 158
Product
61-2 -
61-3 -
Analysis
product
62-1 -
Physical
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
.120 Product Chemistry
Identity and Composition
Description of Beginning
Materials and Manufac-
turing Process
Discussion of Formation
of Impurities
and Certification of
ingredients
Preliminary Analysis
of Product Samples
and Chemical Characteristics
Color
Physical State
Odor
Melting Point
Boiling Point
T6AI
T6AI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
All
All
All
Does EPA
Have Data?
3/
3/
3/
3/
3/
3/
3/
3/
B1 bl 1 ographi c Timef rame
Citation Must Additional for
(MRID) Data Be Submitted? Submission2/
3/
3/
3/
3/
3/
3/
3/
3/
YesV
Yes*/
Yes6/
Yes7/
Yes7/
Yes7/
Yes7/,8/
Yes7/,9/
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
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64
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Sec. 158.120 Product Chemistry (cent1
Physical and Chemical
Characteristics icont'd)
63-7 - Density, Bulk Density, or
Specific Gravity
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:
Test
Substance1-/
'd)
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
Use
Patterns
All
All
All
All
All
All
All
Does EPA
Have Data?
3/
3/
3/
3/
3/
3/
3/
Bibliographic
Citation
(MRID)
3/
3/
3/
3/
3/
3/
3/
Must Additional
Data Be Submitted?
Yes7/
Yes7/
Yes7/
Yes7/
Yes7/,10/
Yes7/,H/
Yes7/
Timeframe
for
Submission2/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
64-1 - Submittal of Samples
N/A
N/A
N/A
N/A
No
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65
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.120 Product Chemistry - Footnotes
V Test Substance: TGAI - Technical Grade of the Active Ingredient; PAI - Pure Active Ingredient.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated.
3/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been Introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
4/ Complete Information must be provided regarding the nature of the process (batch or continuous), the relative amounts
of beginning materials and the order 1n 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.
5/ A detailed discussion of all Impurities that are or may be present at X).l%, based on knowledge of the beginning
materials, chemical reactions (Intended and side) In the manufacturing process, and any contamination during and
after production must be submitted.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which
a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each analytical
method used.
7/ Physlcochenrfcal characteristics (color, physical state, odor, melting point, boiling* point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
8/ Data needed if the technical chemical is a solid at room temperature.
9/ Data needed if the technical chemical Is a liquid at room temperature.
1°/ Required if the technical chemical is organic and non-polar.
Required if the test substance Is dlspersible in water.
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66
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Test
Substance1/
Does EPA
Have Data?
Bibliographic
Citation
(MRID)
Must Additional
Data Be Submitted?
Timeframe
for
Submission2/
Sec. 158.125 Residue Chemistry
171-2 - Chemical Identity3/
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism)
- Plants
- Livestock
PAIRA
PAIRA and plant
metabolites
(See Index)
Partially 00054954,
00112690
Partially 00089697
171-4 - Residue Analytical Methods TGAI and metabolites
Yes
171-4 - Storage Stability Data
TEP and metabolites Partially
00036987,
00036989,
00036990,
00089548,
00089559,
00089696,
00113304,
00113306,
00113309,
00113326,
00113334,
00126692,
00147425
00036988,
00113309,
00113320,
00147425
Yes*/
Yes5/,6/
18 Months
18 Months
No
Yes?/
18 Months
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67
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Test Use
Substance*/ Patterns
Bibliographic Timeframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
In Plants
- Crop Field Trials
- Root and Tuber
Vegetables Group
0 Beets, garden TEP
0 Carrots TEP
Partially 00113326
Partially 00113326
Yes9/
18 Months
0 Potatoes TEP
0 Turnips TEP
Leaves of Root and Tuber
Vegetables Group
0 Beet greens TEP
0 Chicory, red (leaves) TEP
0 Turnip tops TEP
Bulb Vegetables Group
o Onions, green
TEP
Partially 00112690
00113306
00113326
Partially 00089555
Partially 00112690
00113326
No
Partially 00089555
00113326
Partially 00089555
00112690
Yes10/
Yes11/
No1*/
No13/
Yes14/
Yes15/
Yes16/
18 Months
24 Months
18 Months
18 Months
18 Months
-------
68
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Sec. 158.125 Residue Chemistry (conf
171-4 - Magnitude of the Residues
- Crop Field Trials (cont'd)
- Leafy Vegetables Group
0 Celery
0 Lettuce
0 Parsley
0 Spinach
- Brassica Leafy
Vegetables Group
0 Broccoli
0 Brussels sprouts
0 Cabbage
0 Cauliflower
o Col lards
0 Kale
0 Mustard greens
Test Use
Substance1/ Patterns
d)
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA
Have Data?
Partially
Partially
No
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Partially
Bibliographic
Citation
(MRID)
00113315
00113315,
00147425
00113304,
00113315
00147425
00089555
00112690
00113315,
00113326
00089555
00113315
00113315,
00113326
Must Additional
Data Be Submitted?
Yes17/
Yes18/
Yesi9/
Yes20/
Yes2i/
No22/
Yes23/
No24/
Yes25/
No26/
Yes27/
Timeframe
for
Submission2/
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
-------
69
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Test Use
Substance^/ Patterns
Bi bli ographic Ti meframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
- Crop Field Trials (cont'd)
- Legume Vegetables Group
0 Beans, succulent TEP
and dried
0 Peas (Pisum spp.) TEP
Foliage of Legume
Vegetables Group
0 Bean vines and hay TEP
0 Pea vines and hay TEP
Fruiting Vegetables
(Except Cucurbits)
Group
o Eggplant TEP
o peppers (Capsicum) TEP
0 Tomatoes TEP
Partially 00044663,
00089555
Partially 00089555,
00147425
Partially 00113316,
00147425
Partially 00112690
Partially 00112690,
00113306
Partially 00112690,
00113306
Partially 00089555,
00112690,
00113329
Yes28/
Yes29/
Yes3(V
Yes31/
Yes35/
18 Months
18 Months
18 Months
18 Months
No32/
Yes33/,34/ 18 Months
18 Months
24 Months
-------
70
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Test Use
Substance1/ Patterns
Bibliographic Timeframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.125 Residue Chemistry f(cont'd)
171-4 - Magnitude of the Residues
- Crop Field Trials (cont'd)
- Cucurbit Vegetables
Group
0 Cucumbers
0 Melons
0 Squash, summer
0 Watermelon
TEP
TEP
TEP
TEP
Partially 00089555
Partially 00113306,
00113318
Partially 00113306
Partially 00113306
Yes37/
Yes38/
18 Months
18 Months
18 Months
18 Months
- Citrus Fruits Group
0 (Grapefruit, Lemons TEP
Oranges, Tangerines)
Pome Fruits
0 Apples
0 Pear
TEP
TEP
Partially 00089696,
00089698,
00113309,
00147425
Partially 00089555,
00112690
Partially 00089555
Yes*3/
18 Months
24 Months
18 Months
24 Months
-------
71
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Test Use
Substance^/ Patterns
Bi bli ographi c Timeframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
- Crop Field Trials (cont'd)
- Stone Fruits
0 Cherries TEP
0 Peaches TEP
0 Plums (fresh prunes) TEP
Small Fruits and
Berries
0 Grapes
0 Raspberries
0 Strawberries
Tree Nuts
0 Walnuts
TEP
TEP
TEP
Partially 00147425
Partially 00089555
Partially 00089555
Partially 00113324
Partially
Partially
00089555
00089555,
00147425,
00113315
No46/
YesSO/
Yes51/
Yes53/
TEP
Partially 00147425
Yes54/
18 Months
18 Months
24 Months
18 Months
24 Months
18 Months
18 Months
18 Months
-------
72
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Test Use
Substance1/ Patterns
Bi bl1ographi c Ti meframe
Does EPA Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission2/
Sec. 158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
- Crop Field Trials (cont'd)
- Cereal Grains
0 Corn (field and TEP
fresh)
0 Sorghum TEP
- Forage, Fodder, and
Straw of Cereal Grains
0 Corn forage and TEP
fodder
0 Sorghum forage TEP
and fodder
- Non-grass Animal Feeds
0 Alfalfa forage TEP
and hay
0 Birdsfoot Trefoil TEP
forage and hay
° Clover forage TEP
and hay
Partially 00089555
Partially 00089555
Partially 00112690
Partially 00089555
Partially
No
00089555,
00112690
Partially 00089555,
OO112690
YesfS/
Yes*6/
Yes"/
Yes61/
Yes62/
Yes63/
Yes6V
18 Months
24 Months
18 Months
24 Months
Yes59/,60/ 18 Months
18 Months
18 Months
18 Months
18 Months
-------
73
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec.
171-4
171-4
171-4
Test Use
Data Requirement Substance1/ Patterns
158.125 Residue Chemistry (cont'd)
- Magnitude of the Residues
- Crop Field Trials (cont'd)
- Miscellaneous
Commodities
0 Artichokes TEP
0 Okra TEP
0 Watercress TEP
- Crops Grown Solely
for Seed
0 Bermuda grass TEP
0 Sesame TEP
- Magnitude of the Residues
in Cooked Food
- Magnitude of the Residues
in Meat/Milk/Poultry/Eggs
Does EPA
Have Data?
Partially
Partially
Partially
No
No
Yes
Partially
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
00147425 Yes65/
00147425 Yes66/
00126692 Yes67/
Yes68/
Yes69/
00036998 No
00113325 Reserved70/
Timeframe
for
Submission2/
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
-------
74
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes
1/ Test Substance: TGAI - Technical Grade of the Active Ingredient; PAI - Pure Active Ingredient; PAIRA - Purified Active
Ingredient, Radiolabeled; TEP - Typical End-Use product; EP - End-Use Product.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
3/ The same chemical identity data required as under 158.120, with emphasis on impurities that could constitute residue
problems. Refer to Product Chemistry Data Requirements tables (A and B).
V Data depicting the uptake, distribution, metabolism, and total terminal residues of [32P] or [14C] mevinphos in three
dissimilar crops (e.g., root crop, oilseed and a leafy vegetable). The identities and quantities of residues in or
on mature plant parts must be characterized in the raw agricultural commodities following foliar application of
formulated mevinphos at a rate sufficiently high to permit residue identification. Residue information must be
confirmed by a method such as GC, HPLC, and/or mass spectrometry. Data representing solvent extraction of mevinphos
residues must also be represented. Representative samples from these studies must also be analyzed using enforcement
methods (Including all FDA Multiresidue Protocols) to ascertain that these methods are capable of adequately recovering
and quantifying all residues of toxicological concerns.
5/ Metabolism studies utilizing ruminants and poultry. Animals must be dosed orally for a minimum of 3 days with either
[32p] or [3_14r,] mevinphos at a level sufficient to make residue identification and quantification possible. Milk and
eggs must be collected twice a day during the dosing period. Animals must be sacrificed within 24 hours of the final
dose. The distribution and identity 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 identifying all residues of toxico-
logical concern.
6/ Data depicting the nature of mevinphos residues in swine are also required if the required metabolism studies with
ruminants and poultry reveal that the metabolism of mevinphos in these animals differs from that in rats.
?/ Data depicting the stability of mevinphos residues of concern in or on a representative oilseed and a representative
root crop. 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 data. Storage conditions for the samples must also reflect those in previously submitted and
currently requested data. The chosen intervals must allow for unforeseen delays in sample storage.
8/ Additional data are not required since data requested for carrots will be translated to beets. However, it should be
noted that if the data requested for carrots are not provided then data on beets are required and must be submitted
within the 18 months tlmeframe set forth for submitting the data for carrots.
-------
75
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
9/ Data depicting mevinphos residues of concern in or on carrots harvested 2 days after the last of multiple foliar
applications of an EC, SC/L, and a D formulation at 0.5 Ib ai/A, using aerial and ground equipment in separate tests.
Each formulation must be represented in a separate test. The registrant must propose a maximum seasonal use rate or
a maximum number of applications per season. The required tests must reflect this maximum number. Tests must be
conducted in California (48%), Michigan (7%), and Texas (9%) which accounted for about 60* of the 1985 U.S. carrot
production (Agricultural Statistics, 1986, p. 151)
10/ Data depicting mevinphos residues of concern in or on potatoes harvested 1 day after the last of multiple foliar
applications of an EC, SC/L, and a D formulation at 0.25 Ib ai/A, and data depicting residues in or on potatoes
harvested 4 days after the last of multiple foliar applications of the 4 Ib/gal EC formulation at 1.0 Ib ai/A.
Ground and aerial equipment must be represented in separate tests. Each formulation must be represented in a
separate test. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. The required tests must reflect this maximum number. Tests must be conducted in Idaho (25%) and Maine
(7%) which accounted for about 60% of the 1985 U.S. potato production and represent the major potato growing
regions if Idaho is representative of California (6%), Oregon (7%), and Washington (15%) (Agricultural Statistics,
1986, p. 164).
Data depicting the potential for concentration of mevinphos residues in potato chips, granules or flakes, wet peel,
and dry peel during the processing of treated potatoes bearing measurable, weathered residues. If the data indicate
a potential for residue concentration in any of these commodities, the registrant must propose an appropriate food/
feed additive tolerance.
12/ Additional data are not required since the data requested for carrots will be translated to turnips. However, it
should be noted that if the data requested for carrots are not provided then data on turnips are required and must be
submitted within the 18 months timeframe set forth for submitting the data for carrots.
13/ Additional data are not required since the data requested for turnip tops will be translated to beet greens.
However it should be noted that if the data requested for turnip tops are not provided then data on beet greens are
required and must be submitted within the 18 months timeframe set forth for submitting the data for turnip tops.
14, Data depicting mevinphos residues of concern in or on chicory harvested 7 days after the last of three foliar
applications of the 4 Ib/gal EC formulation at 1 Ib ai/A, applied with aerial and ground equipment in separate
tests made in a minimum of 10 and 100 gal/A, respectively. Tests must be conducted in California in which this
use is permitted (EPA SLN No. CA860073).
-------
76
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
15/ Data depicting mevlnphos residues of concern In or on turnip tops harvested 3 days after multiple foliar applications
of an EC, SC/L, and a D formulation at 0.5 Ib al/G, to be applied with aerial and ground equipment 1n separate tests.
Each formulation must be represented In a separate test. The registrant must propose a maximum seasonal use rate or
a maximum number of applications per season. Required tests must reflect this maximum number. Tests must be
conducted in California (4%), Florida (10%), Illinois (4%), and Tennessee (17*) which collectively accounted for
about 38% of the 1982 U.S. turnip green acreage (1982 Census of Agriculture. Vol. 1, Part 51, p. 355).
1*Y Data depicting mevinphos residues of concern in or on green onions harvested 1 day following multiple foliar
applications (using ground and aerial equipment in separate tests) of an EC, SC/L, and a D formulation at 0.5 Ib ai/A.
Each formulation must be represented in a separate test. The registrant must propose a maximum seasonal use rate or
a maximum number of applications per season. Required tests must reflect this maximum number. Tests must be
conducted in California (36%), Texas (23%), and New York (4%) which accounted for about 60% of the 1982 U.S. green
onion acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 347).
17/ Data depicting mevinphos residues of concern in or on celery. The 2% D, an EC, and A SC/L formulation must be applied
(each in separate tests) at 0.5 and 1 Ib ai/A, and samples must be collected 3 and 5 days, respectively, following
the last of multiple foliar applications. The use of aerial and ground equipment must be represented in separate
tests. The registrant must propose a maximum number of applications per season and the requested data must reflect
this maximum number. Tests must be conducted in California (72%), Florida (18%), and Michigan (9%) which collectively
accounted for about 100% of the 1985 U.S. celery crop (Agricultural Statistics, 1986, p. 154), and represent the major
celery production regions.
18/ Data depicting mevinphos residues of concern in or on head and leaf lettuce harvested 2 and 4 days, respectively,
following multiple foliar applications at 0.5 and 1 Ib ai/A of an EC, SC/L, and the 2% D formulation. Applications
must be made with aerial and ground equipment, in separate tests. The registrant must propose a maximum seasonal use
rate or a maximum number of applications per season. The required tests must reflect this maximum number. Tests must
be conducted in California since this state produced about 70% of the 1985 U.S. lettuce crop (Agricultural Statistics,
1986, p. 159).
19/ Data depicting mevinphos residues of concern in or on parsley harvested 5 and 8 days following the last of three
foliar applications of the 4 Ib/gal EC formulation at 0.5 and 1 Ib ai/A, respectively. Applications by ground and
aerial equipment must be performed in separate tests. Tests must be conducted in California (37%), Florida (14%),
New Jersey (13%), and Texas (14%) since about 80% of the U.S. parsley acreage is located in these states; acreage
figures given parenthetically were obtained from 1982 Census of Agriculture, Vol 1, Part 51, p. 348.
-------
77
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
20 / Data depicting mevinphos residues of concern in or on spinach harvested 4 and 7 days following multiple foliar
applications of an EC, SC/L, and the 2% D formulation at 0.5 and 1 Ib ai/A, respectively. Applications must be
made with aerial and ground equipment in separate tests. Each formulation must be represented in separate tests.
The registrant must propose a maximum seasonal use rate or a maximum number of applications per season. The
required tests must reflect this maximum number. Tests must be conducted in California (24%), Texas (25$) and
New Jersey (6%) which accounted for about 60% of the 1982 U.S. spinach acreage if New Jersey is representative
of New York (5%) and Maryland (3%) (1982 Census of Agriculture, Vol. 1, Part 51, p. 352).
21 / Data depicting mevinphos residues of concern in or on broccoli harvested 3 days after the last of multiple foliar
applications of an EC, SC/L, and a D formulation at 1 Ib ai/A. Applications must be made by aerial and ground
equipment in separate tests. Each formulation must be represented in a separate test. The registrant must propose
a maximum seasonal use rate or a maximum number of applications per season. Required tests must reflect this maximum
number. Tests must be conducted in California which accounted for about 90% of the 1985 U.S. broccoli production
(Agricultural Statistics. 1986, p. 150).
22/ Additional data are not required since the data requested for broccoli will be translated to Brussels sprouts.
However, it should be noted that if the data requested for broccoli are not provided then data on Brussels sprouts
are required and must be submitted within the 18 months timeframe set forth for submitting the data for broccoli.
23/ Data depicting mevinphos residues of concern in or on cabbage harvested 3 days after the last of multiple foliar
applications of an EC, SC/L, and a D formulation at 1 Ib ai/A. Applications must be made with aerial and ground
equipment in separate tests. Each formulation must be represented in a separate test. The registrant must propose
a maximum seasonal use rate or a maximum number of applications per season. Required tests must reflect this
maximum number. Tests must be conducted in Texas (16%), Florida (16%), New York (15%), and Wisconsin (9%) which
accounted for about 70% of the 1982 U.S. cabbage acreage if Wisconsin is representative of Ohio (3%) and Michigan
(3%), and New York is representative of New Jersey (3%) (1982 Census of Agriculture. Vol. 1, Part 51, p. 338).
Additional data are not required since the data requested for broccoli will be translated to cauliflower.
However, it should be noted that if the data requested for broccoli are not provided then data on cauliflower
are required and must be submitted within the 18 months timeframe set forth for submitting the data for broccoli.
25/ Data depicting mevinphos residues of concern in or on collards harvested 3 and 7 days after the last of multiple
foliar applications of an EC, SC/L, and a D formulation at 0.5 and 1.0 Ib ai/A, respectively. Applications must
be made with aerial and ground equipment in separate tests. Each formulation must be represented in a separate
test. The registrant must propose a maximum seasonal use rate or a maximum number of applications per season.
Required tests must reflect this maximum number. Tests must be conducted in Arizona (5%) and Georgia (20%) which
accounted for about 50% of the 1982 U.S. collard acreage if Georgia is representative of Florida (10%) and South
Carolina (9%) and if Arizona is representative of California (3%) (1982 Census of Agriculture. Vol. 1, Part 51,
p. 345).
-------
78
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
26/ Additional data are not required since the data requested for collards will be translated to kale. However, it
should be noted that if the data requested for collards are not provided then data on kale are required and must
be submitted within the 18 months timeframe set forth for submitting the data for collards.
27/ Data depicting mevinphos residues of concern in or on mustard greens harvested 3 days after the last of multiple
foliar applications of an EC, SC/L, and a D formulation at 0.5 Ib ai/A. Applications must be made with aerial
and ground equipment in separate tests. Each formulation must be represented in a separate test. The registrant
must propose a maximum seasonal use rate or a maximum number of applications per season. Required tests must
reflect this maximum number. Tests must be conducted in California (13%), Florida (7*) and Texas (12%) which
accounted for about 60% of the 1982 U.S. mustard green acreage if California is representative of Arizona (12%)
and Florida is representative of South Carolina (6%), North Carolina (5%) and Georgia (5%) (1982 Census of
Agriculture, Vol. 1, Part 51, p. 346).
2°/ Data depicting mevinphos residues of concern in or on beans (one succulent and one dried variety in separate tests)
harvested 1 day after the last of multiple foliar applications of an EC, SC/L, and the 2% D formulation at 0.5 Ib
ai/A, to be applied with aerial and ground equipment in separate tests. Each formulation must be represented in a
separate test. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. Required tests must reflect this maximum number. Tests must be conducted in California (16% dry),
Oregon (18% snap) or Idaho (9% dry), Michigan (7% snap; 24% dry) or Nebraska (16%), New York (12%) and Wisconsin
(35% snap) since these states account for about 60% and 70% of the 1985 U.S. edible dry bean and snap bean crops,
respectively; (Agricultural Statistics, 1986, p. 149 and p. 252).
29/ Data depicting mevinphos residues of concern in or on peas (one succulent and one dried variety in separate tests)
harvested 1 day after the last of multiple foliar applications of an EC, SC/L, and the 2% D formulation at 0.5 Ib
ai/A, to be applied with aerial and ground equipment in separate tests. Each formulation must be represented in a
separate test. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. Required tests must reflect this maximum number. Tests must be conducted in Minnesota (20%) or
Wisconsin (28%) and Washington (17%) which collectively accounted for about 70% of the 1985 U.S. green peas grown
for processing (Agricultural Statistics, 1986, p. 162).
30/ Tolerances must be proposed and data submitted depicting mevinphos residues of concern in or on bean vines and hay
harvested 1 day after the last of multiple foliar applications of an EC, SC/L, and the 2% D formulation at 0.5 Ib
ai/A, to be applied with aerial and ground equipment in separate tests. Each formulation must be represented in a
separate test. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. Required tests must reflect this maximum number. Tests must be conducted in California (16% dry),
Oregon (18% snap) or Idaho (9% dry), Michigan (7% snap; 24% dry) or Nebraska (16%), New York (12%) and Wisconsin
(35% snap) since these states account for about 60% and 70% of the 1985 U.S. edible dry bean and snap bean crops,
respectively; (Agricultural Statistics. 1986, p. 149 and p. 252). Alternatively, the registrant may propose a
label amendment restricting the feeding or grazing of treated bean hay and vines to livestock.
-------
79
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
31/ Data depicting mevlnphos residues of concern in or on pea vines harvested 1 day following the last of multiple foliar
applications of an EC, SC/L, and a D formulation at 0.5 Ib ai/A, to be applied with aerial and ground equipment in
separate tests. Each formulation must be represented in a separate test. The registrant must propose a maximum
seasonal use rate or a maximum number of applications per season. Required tests must reflect this maximum number.
Tests must be conducted in Minnesota (22%) or Wisconsin (28%) and Washington (17%) which collectively accounted for
about 70% of the 1985 U.S. green pea production (Agricultural Statistics, 1986, p. 162). Also, since pea hay is a
raw agricultural commodity, the registrant must propose a tolerance and submit appropriate supporting data.
Alternatively, the registrant may propose a label amendment restricting the feeding or grazing of pea vines and
hay by livestock.
32/ Additional data are not required since the data requested for tomatoes will be translated to eggplant. However,
it should be noted that if the data requested for tomatoes are not provided then data on eggplant are required
and must be submitted within the 18 months timeframe set forth for submitting the data for tomatoes.
33 / Data depicting mevlnphos residues of concern in or on peppers harvested 2 days following multiple foliar applications
(using ground and aerial equipment in separate tests) of an EC, SC/L, and the 2% D formulation at 0.5 Ib ai/A. Each
formulation must be represented in a separate test. Aerial applications must be made in a minimum of 3 gal/A and
ground applications must be made in a minimum of 10 gal/A. Tests must be conducted in California (18%), Florida
(23%), Michigan (3%), New Jersey (7%) and Texas (16%) which collectively accounted for about 67% of U.S. sweet pepper
acreage (1982 Census of Agriculture, Vol.1, Part 51, p. 350). The registrant must propose a maximum seasonal use
rate or a maximum number or applications per season. Required tests must reflect this maximum number.
34/ Data depicting mevlnphos residues of concern in or on peppers harvested 4 days following multiple foliar applications
of the 4 Ib/gal EC formulation at 1 Ib ai/A. Ground and aerial equipment must be represented in separate tests.
Tests must be conducted in California. The registrant must propose a maximum number of applications per season or
a maximum seasonal application rate. Required tests must reflect this maximum. Also, the registrant must amend the
appropriate product labels by deleting the limitations for use on peppers grown for processing.
35/ Data depicting mevlnphos residues of concern in or on tomatoes harvested 1 day following multiple foliar applications
(using ground and aerial equipment in separate tests) of the 2% D formulation and (in separate tests) an EC and a SC/L
formulation at 0.5 Ib a1/A. Aerial applications must be made in a minimum of 3 gal/A and ground applications must be
made In a minimum of 10 gal/A. Tests must be conducted in California (26%) and Florida (47%) which accounted for
about 73% of U.S. fresh market tomato production; California produced about 85% of U.S. tomatoes for processing
(Agricultural Statistics, 1986, p. 172). The registrant must propose a maximum number of applications per season
or a maximum seasonal application rate. Submitted tests must reflect the proposed maximum.
36/ A processing study depicting mevlnphos residues of concern in products (dry pomace, puree, catsup and juice) processed
from tomatoes bearing measurable, weathered residues. If residues concentrate in any product, appropriate food/feed
additive tolerances must be proposed.
-------
80
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
37/ Data depicting mevinphos residues of concern 1n or on cucumbers harvested 1 day following the last of multiple foliar
applications (using ground and aerial equipment 1n separate tests) of the 2% D, 10.3 Ib/gal SC/L, and an EC formulation
at 0.5 Ib ai/A. Each formulation must be represented in a separate test. The registrant must propose a maximum number
of applications per season or a maximum seasonal use rate. Required tests must reflect this maximum rate. Tests must
be conducted in California (11*), Michigan (19%) or Wisconsin (9%), North Carolina (14%), Ohio (9%) and Texas (5%)
since these states collectively accounted for about 70% of the 1985 U.S. cucumber production (Agricultural Statistics,
1986, p. 157).
38/ Data depicting mevinphos residues of concern in or on melons harvested 1 day following the last of multiple foliar
applications (using ground and aerial equipment in separate tests) of the 2% D, SC/L, and an EC formulation at 0.5 Ib
a1/A. Each formulation must be represented in separate tests. The registrant must propose a maximum number of appli-
cations per season or a maximum seasonal use rate. The required tests must reflect this maximum rate. Tests must be
conducted in California (52%) and Texas (21%) which accounted for about 70% of the 1982 U.S. cantaloupe acreage
(1982 Census of Agriculture, Vol. 1, Part 51, p. 339).
Data depicting mevinphos residues of concern in or on summer squash harvested 1 day following the last of multiple
foliar applications (using ground and aerial equipment 1n separate tests) of the 2% D, SC/L, and an EC formulation
at 0.5 Ib ai/A. Each formulation must be represented in separate tests. The registrant must propose a maximum number
of applications per season or a maximum seasonal use rate. The required tests must reflect this maximum rate. Tests
must be conducted in California (15%), Florida (21%), New Jersey (6%) and Texas (7%) which accounted for about 50% of
the 1982 U.S. squash acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 353).
40/ Data depicting mevinphos residues of concern in or on watermelons harvested 1 day following the last of multiple
foliar applications (using ground and aerial equipment in separate tests) of the 2% D, 10.3 Ib/gal SC/L, and an
EC formulation at 0.5 Ib a1/A. Each formulation must be represented in separate tests. The registrant must propose
a maximum number of applications per season or a maximum seasonal use rate. The required tests must reflect this
maximum rate. Tests must be conducted in California (10%), Delaware (20%), Florida (9%) and Texas (24%) which
accounted for about 60% of the 1982 U.S. watermelon acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 357).
41/ Data depicting mevinphos residues of concern in or on representative members of the citrus fruits group (oranges,
grapefruits and lemons) harvested 1 day following multiple foliar applications at 7-day intervals of the 10.3 Ib/gal
SC/L and, In separate tests an EC formulation sprayed to runoff at the maximum proposed Ib ai/100 gal rate. Ground
and aerial equipment must be represented in separate tests. The registrant must propose a maximum number of appli-
cations per season or a maximum seasonal application rate. The requested data must reflect this maximum number.
The registrant must also propose to amend the appropriate product labels to specify a maximum Jb ai/100 gal rate
sprayed to runoff. Tests must be conducted in Florida which accounted for about 70% and 80% of 1984-85 U.S.
orange and grapefruit production, respectively, and in California which accounted for about 80% of the 1984-85
U.S. lemon production (Agricultural Statistics, 1986, p. 198).
-------
81
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
42/ Data .depicting mevlnphos residues of concern In citrus pulp, molasses, oil and juice processed from citrus fruits
bearing measurable, weathered residues, if residues concentrate in any of these processed commodities then an
appropriate food/feed additive tolerance must be proposed.
43/ Data depicting mevlnphos residues of concern in or on apples harvested 1 day following the last of multiple foliar
applications of an EC and the 10.3 Ib/gal SC/L formulations at 3 Ib ai/A, and the 2% D formulation at 1.2 Ib al/A,
using ground and aerial equipment in separate tests. Each formulation must be represented in a separate test. The
registrant must propose a maximum number of applications per season or a maximum seasonal rate for each use. The
requested data must reflect the maximum rate. Tests must be conducted in California (8%), Michigan (14%), New York
(14%) and Washington (26%), which collectively accounted for about 60% of the 1985 U.S. apple production (Agricultural
Statistics, 1986, p. 186).
Data depicting mevlnphos residues of concern in dry apple pomace and juice processed from apples bearing measurable,
weathered residues. If residues concentrate in any of these processed commodities then an appropriate food/feed
additive tolerance must be proposed.
Additional data are not required since the data requested in support of the tolerance for mevinphos residues in or
on apples will be translated to pears. However, it should be noted that if the data for apples are not provided
then data on pears are required and must be submitted within the 18 months timeframe set forth for submitting the
data for apples. Note also that translated data may not be used to support a crop group tolerance.
Additional data are not required since the data requested in support of the tolerance for mevinphos residues in or
on plums (fresh prunes) will be translated to cherries. However, it should be noted that if the data for plums are
not provided then data on cherries are required and must be submitted within the 18 months timeframe set forth for
submitting the data for plums. Note also that translated data may not be used to support a crop group tolerance.
Data depicting mevlnphos residues of concern in or on peaches harvested 1 day following the last of multiple foliar
applications of an EC and the 10.3 Ib/gal SC/L formulations at 2.5 Ib ai/A. Each formulation class must be
represented in a separate test. The registrant must propose a maximum seasonal application rate or a maximum
number of applications per season. The requested data must reflect this maximum. Tests must be conducted in
California (68%), South Carolina (11%) and Michigan (3%) or Pennsylvania (2%) which collectively accounted for
about 80% of the 1985 U.S. peach production (Agricultural Statistics, 1986, p. 211).
48/ Data depicting mevlnphos residues of concern in or on plums harvested one day following the last of multiple foliar
applications of an EC and the 10.3 Ib/gal SC/L formulations at 2.5 Ib ai/A. Each formulation must be represented
In separate tests. The registrant must propose a maximum seasonal application rate or a maximum number of
applications per season. The requested data must reflect this maximum number. Tests must be conducted in
Michigan (22%) and Oregon (49%) which collectively accounted for about 70% of the 1985 U.S. plum and fresh
prunes production (Agricultural Statistics, 1986, p. 218).
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82
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
Data depicting the concentration of mevlnphos residues of concern in dried prunes processed from plums (fresh prunes)
bearing measurable, weathered residues. If the data indicate a potential for concentration of residues during
processing, an appropriate food additive tolerance must be proposed.
Data depicting mevinphos residues of concern in or on grapes harvested 5 days after the last of multiple foliar
applications (using ground and aerial equipment in separate tests) of an EC, the 2% D, and the 10.3 Ib/gal SC/L
formulations at 1 Ib ai/A; and 2 days following applications of these same formulations at 0.5 Ib ai/A. Each
formulation must be represented in separate tests. The registrant must propose a maximum number of applications
per season or a maximum seasonal application rate. The requested data must reflect these rates. The tests must
be conducted in California which accounted for about 90% of the 1985 U.S. grape production (Agricultural Statistics,
1986, p. 206).
Data depicting the potential for concentration of mevinphos residues in raisins, dry pomace, raisin waste, and grape
juice processed from grapes bearing measurable, weathered residues. If the data indicate a potential for concentra-
tion of residues in any of these commodities, an appropriate food/feed additive tolerance must be proposed.
S2/ Data depicting mevinphos residues of concern in or on raspberries harvested 3 days after the last of multiple foliar
applications (using ground and aerial equipment in separate tests) of an EC and the 10.3 Ib/gal SC/L formulation at
0.64 Ib ai/A. Each formulation must be represented in a separate test. The registrant must propose a maximum
seasonal use rate or a maximum number of applications per season. The requested data must reflect this maximum rate.
Tests must be conducted in Oregon (40%) and Washington (40%) which collectively accounted for about 80% of the 1982
U.S. raspberry production (1982 Census of Agriculture, Vol. 1, Part 51, p. 372).
S3/ Data depicting mevinphos residues of concern 1n or on strawberries harvested 1 and 2 days after the last of multiple
foliar applications of an EC, the 2% D, and the 10.3 Ib/gal SC/L formulations at 0.5 and 1.0 Ib ai/100 gal/A,
respectively. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. Tests must be conducted in California which accounted for about 80% of the 1985 U.S. production of
strawberries (Agricultural Statistics, 1986, p. 221).
54/ Data depicting mevinphos residues of concern in or on walnuts harvested 1 day after the last of multiple foliar
applications of an EC and the 10.3 Ib/gal SC/L at 2.5 Ib ai/A. Each formulation class must be represented in
separate tests. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. The required data must reflect the maximum rate. Tests must be conducted in California which accounted
for about 100% of the 1982 U.S. walnut acreage (1982 Census of Agriculture. Vol. 1, Part 51, p. 368).
-------
83
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
Data depicting mevinphos residues of concern in or on sweet corn (kernels plus cobs with husks removed), field corn
grain, and popcorn grain harvested 1 day after the last of multiple foliar applications of an EC, the 10.3 Ib/gal
SC/L, and the 2% D formulation at 0.5 Ib ai/A, to be applied with aerial and ground equipment in separate tests.
Each formulation must be represented in separate tests. The registrant must propose a maximum seasonal use rate
or a maximum number of applications per season. The required tests must reflect this maximum number. Tests on
sweet corn must be conducted in California (10% fresh market), Florida (29% fresh market), Minnesota (26% processing)
and Wisconsin (25% processing). Tests on field corn must be conducted in Iowa (19%), Illinois (16%) and Nebraska
(11%) since these states represent the major U.S. corn grain production region (Iowa, Illinois, Indiana, Minnesota,
Nebraska, and Ohio) and collectively produced about 70% of the 1985 U.S. corn grain crop. Production figures for
corn grain and sweet corn were obtained from Agricultural Statistics, 1986, p. 32 and p. 156, respectively.
A processing study depicting the concentration of mevinphos residues of concern in the following products processed
from field corn grain bearing measurable, weathered residues: starch, crude and refined oil from wet and dry milling,
grits, meal, flour, and grain dust. If residues concentrate in any product, an appropriate food/feed additive
tolerance must be proposed.
57/ Data depicting mevinphos residues of concern in or on sorghum grain harvested 3 days after the last of multiple
foliar applications of an EC, SC/L, and the D formulations at 0.5 Ib ai/A, to be applied with aerial and ground
equipment In separate tests. Each formulation must be represented in separate tests. The registrant must propose
a maximum seasonal use rate or maximum number of applications per season. The required tests must reflect this
maximum number. Tests must be conducted in Arkansas (6%) or Texas (22%) and Kansas (26%) or Nebraska (14%) which
collectively accounted for about 70% of the 1985 sorghum production (Agricultural statistics, 1986, p. 52).
58/ A processing study depicting the concentration of mevinphos residues of concern in flour, starch, and grain dust
processed from sorghum grain bearing measurable, weathered residues. If residues concentrate in any product, an
appropriate food/feed additive tolerance must be proposed.
59/ Data depicting mevinphos residues of concern in or on corn forage harvested 1 day after the last of multiple foliar
applications of an EC, the 10.3 Ib/gal SC/L, and the 2% D formulation at 0.5 Ib ai/A, to be applied with aerial and
ground equipment in separate tests. Each formulation must be represented in separate tests. The registrant must
propose a maximum seasonal use rate or a maximum number of applications per season. The required tests must reflect
this maximum number. Tests on sweet corn must be conducted in California (10% fresh market), Florida (29% fresh
market), Minnesota (26% processing) and Wisconsin (25% processing). Tests on field corn must be conducted in
Iowa (19%), Illinois (16%) and Nebraska (11%) since these states represent the major U.S. corn grain production
region (Iowa, Illinois, Indiana, Minnesota, Nebraska and Ohio collectively produced about 70% of the 1985 U.S.
corn grain crop). Production figures for corn grain and sweet corn were obtained from Agricultural Statistics,
1986, p. 32 and p. 156, respectively.
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84
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
60/ Since corn fodder is a raw agricultural commodity, the registrant must propose a tolerance and submit appropriate
supporting residue data.
61/ Data depicting mevinphos residues of concern In or on sorghum fodder and hay harvested 1 day after the last of
multiple foliar applications (using ground and aerial equipment in separate tests) of an EC, the 10.3 Ib/gal SC/L,
and the 2% D formulation at 0.5 Ib a1/A. Each formulation must be represented in separate tests. The registrant
must propose a maximum seasonal use rate or a maximum number of applications per season. The required tests must
reflect this maximum number. Tests must be conducted in Kansas (36%) or Nebraska (13%) and Georgia (6%) since these
states produced about 60% of the 1985 sorghum crop used for silage and forage; production figures given in parentheses
were obtained from Agricultural Statistics, 1986, p. 52.
62/ Data depicting mevinphos residues of concern in or on alfalfa forage and hay harvested 1 day following the last of
multiple foliar applications, using ground and aerial equipment in separate tests, of an EC, SC/L and the 2% D
formulation at 0.5 Ib a1/A. Each formulation class must be represented in separate tests. The registrant must
propose a maximum number of applications per season or a maximum seasonal application rate for each registered use.
The required tests must reflect this number or maximum rate. The registrant must also propose an appropriate
tolerance for mevinphos residues of concern in or on alfalfa hay. Tests must be conducted in California (8%),
New York (3%) and Wisconsin (12%) which collectively comprised about 50% of the 1985 U.S. alfalfa production if
Wisconsin 1s representative of Iowa (7%), Michigan (6%), Minnesota (7%) and Nebraska (6%) and if New York is
representative of Pennsylvania (3%), (Agricultural Statistics, 1986, p. 242).
Data depicting residues of mevinphos alpha and beta isomers in or on birdsfoot trefoil forage and hay (about 10%
moisture content) following multiple foliar applications of the 4 Ib/gal EC formulation at 0.5 Ib ai/A, using ground
and aerial equipment in separate tests. The registrant must propose a maximum number of applications per season or a
maximum seasonal application rate. The required tests must reflect this number or maximum rate. Tests must be
conducted in New York in which this use is permitted. Alternatively, the registrant may elect to cancel this use
permitted under EPA SLN No. NY810002.
The registrant must propose an appropriate tolerance for mevinphos residues of concern 1n or on clover hay based on
the data requested for alfalfa hay.
65/ Data depicting mevinphos residues of concern in or on artichokes harvested 2 days after the last of multiple foliar
applications (using ground and aerial equipment in separate tests) of the 2% D formulation at 0.25 Ib ai/A, and an EC
and the 10.3 Ib/gal SC/L formulation (each in a separate test) at 1 Ib ai/A. The registrant must propose a maximum
seasonal use rate or a maximum number of applications per season. The requested data must reflect this maximum.
Tests must be conducted in California which accounted for about 100% of the 1982 U.S. artichoke acreage (1982 Census
of Agriculture, Vol. 1, Part 51, p. 335).
-------
85
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.125 Residue Chemistry - Footnotes (cont'd)
Data depicting mevfnphos residues of concern in or on okra harvested 1 day after the last of multiple foliar
applications (using both aerial and ground equipment in separate tests) of an EC and a SC/L formulation at
0.5 Ib ai/A in separate tests. Ground applications must be made in a minimum of 10 gal/A and aerial applications
must be made in a minimum of 3 gal/A. The registrant must propose a maximum number of applications per season or
a maximum seasonal use rate. The requested data must reflect the maximum rate. Tests must be conducted in Georgia
(20%) and Texas (29%) which collectively accounted for about 50% of the 1982 U.S. okra acreage if Georgia is
representative of Florida (9%), (1982 Census of Agriculture, Vol. 1, Part 51, p. 347-348).
Data depicting mevinphos residues of concern in or on watercress harvested 1 day following the last of five foliar
applications (using ground equipment in a minimum of 25 gal/A) at 2-day Intervals of the 4 Ib/gal EC formulation
at 0.5 Ib ai/A. Tests must be conducted in Alabama and Maryland, Pennsylvania, or West Virginia. Alternatively,
the registrant may elect to cancel this use permitted under EPA SLN Numbers AL850007, FL840025, MD850001, PA850003
and WV850002.
Data depicting mevinphos residues of concern in or on Bermuda grass and seed harvested 7 days following the last
of multiple foliar applications of the 4 Ib/gal EC formulation at 1 Ib ai/A using both ground and aerial equipment
1n separate tests. The registrant must propose a maximum number of applications per season or a maximum seasonal
use rate. The required data must reflect these proposals. Alternatively, the registrant may elect to cancel this
use permitted under EPA SLN Number AZ790033.
69/ Data depicting mevinphos residues of concern in or on sesame and sesame seed harvested following the last of multiple
foliar applications of the 4 Ib/gal SC/L formulation at 0.5 Ib ai/A using aerial equipment in a minimum of 5 gal/A.
The registrant must propose a maximum number of applications per season and a pre-harvest interval (PHI). The
requested data must reflect these proposals. Alternatively, the registrant may ele.ct to cancel this use permitted
under EPA SLN Number CA760180.
70/ Presently the nature of the residues in animals is not adequately understood. Upon receipt of the data requested
1n the section "Nature and Residue in Animals", the need for, and the nature of tolerances for mevinphos residues
in livestock and poultry will be assessed.
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86
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data
Requirement
Bibliographic
Test Use Does EPA Citation
Substance!/ Patterns2/ Have Data? (MRID)
Timeframe
Must Additional for
Data Be Submitted? Submission3/
Sec. 158.130 Environmental Fate"
Degradati
161-1 -
on Studies - Lab
Hydrolysis
TGAI or PAIRA A B C D E
No
Yes
9 Months
Photodegradati on
161-2 -
161-3 -
161-4 -
In Water
On Soil
In A1r
TGAI or PAIRA A B C D
TGAI or PAIRA A
TGAI or PAIRA A
No
No
No
Yes
Yes
Yes
9 Months
9 Months
9 Months
Metabolism studies - Lab
162-1 -
162-2 -
162-3 -
162-4 -
Mobility
163-1 -
163-2 -
163-3 -
Aerobic Soil
Anaerobic Soil
Anaerobic Aquatic
Aerobic Aquatic
Studies
Leaching and
Adsorption/
Desorptl on
Volatility (Lab)
Volatility (Field)
TGAI or PAIRA ABE
TGAI or PAIRA A
TGAI or PAIRA CD
TGAI or PAIRA C D
TGAI or PAIRA A B C D E
TEP A E
TEP A E
No
No
No
No
Partially 40157101
No
No
Yes
Yes
Yes
Yes
Yes4/
Yes
Reserved^/
27 Months
27 Months
27 Months
27 Months
12 Months
12 Months
—
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87
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Sec. 158.130 Environmental Fate
Dissipation Studies - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long- Term
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Test
Substance!/
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
T6AI or PAIRA
TEP
Use
Patterns2/
A B
C D
N/A
N/A
A C
A C
A C
C D
A B C D
D
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
Bibliographic
Citation Must Additional
(MR ID) Data Be Submitted?
Yes
Yes
No6/
No?/
Reserved**/
Yes
YesV
Reserved10/
Yes
Yes11/
Tlmeframe
for
Submission3/
27 Months
27 Months
—
—
—
39 Months
—
—
12 Months
12 Months
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88
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data
Sec. 158.
132-1 -
132-2 -
132-3 -
132-4 -
Sec. 158.
201-1 -
202-1 -
Sec. 158.
Requirement
140 Reentry Protection
Foliar Dissipation
Soil Dissipation
Dermal Exposure
Inhalation Exposure
142 Spray Drift
Droplet Size Spectrum
Drift Field Evaluation
75 Special Testing
Test
Substance1/
TEP
TEP
TEP
TEP
TEP
TEP
Use
Patterns2/
A B C D E
A B C D E
A B C D E
A B C D E
ABODE
A B C D E
Does EPA
Have Data?
Yes
Yes
Yes
Yes
No
No
Bibliographi
Citation
(MRID)
00147424
00147424
00147424
00147424
c
Must Additional
Data Be Submitted?
No
No
No
No
Yes
Yes
Timeframe
for
Submission-3/
—
—
—
—
14 Months
14 Months
- Applicator Exposure
TEP
A B C D E
No
Reserved12/
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89
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.130 Environmental Fate - Footnotes
Sec. 158.140 Reentry Protection - Footnotes
Sec. 158.142 Spray Drift - Footnotes
Sec. 158.75 Special Testing - Footnotes
V Test Substance: TGAI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-Use Product
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food;
C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G = Forestry; H = Domestic Outdoor; I = Indoor; N/A = Not Applicable.
3/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
V Acceptable data are needed to provide information on the mobility of aged mevinphos residue in soil.
5/ Field volatility requirement conditional on results of the laboratory study (field volatility requirement is reserved
until acceptable laboratory data are received). If required, the field volatility study will be due within 15 months
after notification of requirement by the Agency.
6/ There are no forestry uses currently registered for mevinphos.
7/ Combination and tank mixes are not being addressed in this Standard.
8/ Long-term field dissipation studies are conditional on results of the field dissipation study (164-1). The long-term
field dissipation study will be required if the residues of mevinphos and/or its major toxic degradate(s) do not reach
<50 per cent dissipation in soil prior to recommended subsequent application of mevinphos to the same sites utilized
for the field dissipation study. If required, the long-term field dissipation study will be due within 50 months after
notification or the requirement by the Agency.
9/ Field crop rotation data are conditional on results of the confined study (the field crop rotation requirement is
reserved until acceptable confined data are received). If required, the field crop rotation study will be due within
50 months after notification of the requirement by the Agency.
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90
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.130 Environmental Fate - Footnotes (continued)
Sec. 158.140 Reentry Protection - Footnotes
Sec. 158.142 Spray Drift - Footnotes
Sec. 158.75 Special Testing - Footnotes
Irrigated crop data are conditional on results of the laboratory fish accumulation study (the irrigated crop
requirement is reserved until acceptable laboratory fish accumulation data re received). If required, the irrigated
crop study will be due within 39 months after notification of the requirement by the Agency.
An aquatic nontarget accumulation study is required if the water at the treated site is used for irrigation purposes.
Applicator exposure monitoring data may be needed after the Agency establishes the toxicological category of mevinphos.
If required, the study will be due within 24 months after notification of requirement by the Agency.
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91
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Sec. 158.135 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation -
Rabbit
81-6 - Dermal Sensltlzatlon -
Guinea Pig
81-7 - Acute Delayed
Neurotoxldty - Hen
Special- Acute Dermal /ChE
Testing
Subchronlc Testing
82-1 - 90-Day Feeding -
- Rodent
- Nonrodent
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
Test
Substance1/
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns2/
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
Does EPA
Have Data?
No
No
No
No
No
No
No
No
No
No
No
No
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes6/
No?/
No?/
Yes
No8/
Tlmeframe
for
Submission3/
3/15/884/
3/15/884/
3/15/88*/
3/15/88V
3/1 5/88 V
3/15/88*/
6/15/885/
6 Months
—
—
12 Months
—
-------
92
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec.
Data Requirement
158.135 Toxicology (cont'd)
Test
Substance^/
Use
Patterns2/
Does EPA
Have Data?
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Timeframe
for
Submission3/
Subchronic Testing (cont'd)
82-4
82-5
- 90-Day Inhalation
- 90-Day Neurotoxicity -
- Hen
- Mammal
TGAI
TGAI
TGAI
A B C D E
A B C D E
A B C D E
No
No
No
Yes9/
YeslO/
Yes1!/
15 Months
—
—
Chronic Testing
83-1
83-2
83-3
83-4
- Chronic Toxicity -
- Rodent
- Nonrodent
- Oncogenicity -
- Rat
- Mouse
- Teratogenicity -
- Rat
- Rabbit
- Reproducti on
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
No
No
No
No
Yes
No
No
Yes
Yes
Yes
Yes
40201401 No
Yes
Yes
50 Months
50 Months
50 Months
50 Months
—
15 Months
39 Months
-------
93
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Sec. 158.135 Toxicology (cont'd)
Mutageiridty Testing
84-2 - Gene Mutation
84-2 - Chromosome Aberration
84-2 - Other Mechanism of
Mutagenicity
Special Testing
85-1 - General Metabolism
85-2 - Dermal Penetration
Test
Substance1/
TGAI
TGAI
TGAI
PAI or PAIRA
PAI or PAIRA
Use
Patterns2/
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
Does EPA
Have Data?
No
No
No
No
No
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission-*/
9 Months
12 Months
12 Months
24 Months
6/15/885/
-------
94
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.135 Toxicology - Footnotes
V Test Substance: T6AI - Technical Grade of the Active Ingredient; PAIRA - Pure Active Ingredient, Radiolabeled;
TEP - Typical End-Use Product
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food;
C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G = Forestry; H = Domestic Outdoor; I = Indoor; N/A = Not Applicable.
3/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
V The Agency's Data Call-in Notice of September 9, 1987 established the due date for this study as March 15, 1988.
5/ The Agency's Data Call-In Notice of September 9, 1987 established the due date for this study as June 15, 1988.
6/ An Acute Dermal Toxicity study is required which defines NOELs for cholinesterase inhibition (ChE), toxicity, and
lethality. The most sensitive sex, as determined in the guideline acute dermal toxicity study, is to be used in
this study.
7/ This requirement is waived since chronic studies are required.
®/ Not required because of the nature of the exposure pattern. (The existing acceptable end-uses do not involve purposeful
application to human skin or comparaable human exposure to the product and should not result in repeated human skin
contact for extended periods.)
9/ Required to support use of mevinphos in greenhouses.
Requirement is contingent upon results of the acute delayed neurotoxicity study in hens. If required, the study
will be due within 15 months after notification of requirement by the Agency.
If neurotoxic lesions are found in mammalian studies, a subchronic neurotoxicity study in mammals may be required.
If required, the study will be due within 15 months after notification of requirement by the Agency.
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95
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec.
Avian
71-1
71-2
71-3
71-4
Data Requirement
158.145 Wildlife and Aquatic
organi sms
And Mammalian Testing
- Avian Acute Oral
Toxicity
- Waterfowl
- Songbird
- Avian Subacute Dietary
Toxicity
- Upland game bird
- Waterfowl
- Songbird
- Wild Mammal Toxicity
- Avian Reproduction
- Upland game bird
- Waterfowl
Test
Substance^/
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use Does
Patterns2/ Have
A B C D [E]4/
A B
A B C D [E]4/
A B C E
A B
ABC
ABC
ABC
EPA
Data?
Yes
No
Yes
Yes
No
No
No
NO
Bi bl i ographi c
Citation Must Additional
(MRID) Data Be Submitted?
40094601 No
Reserved5/
00022923 No
00022923 Mo
Reserved5/
Yes6/
Yes7/
Yes7/
Timeframe
for
Submission^/
—
—
—
—
—
24 Months
24 Months
24 Months
71-5 - Simulated and Actual
Field Testing for
Mammals and Birds
70-1 - Special Testing -
Residue Monitoring
TGAI
TEP
ABC
A
No
No
Reserved8/ 24 Months
24 Months
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96
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec.
Data Requirement
158.145 Wildlife and Aquatic
Organisms icont'd)
Test
Substance1/
Use Does
Patterns2/ Have
EPA
Data?
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Tineframe
for
Submission-3/
Aquatic Organisms Testing
72-1
72-2
72-3
- Freshwater F1sh Toxicity
Toxlcity
- Warmwater
- Coldwater
- Acute Toxlcity to Fresh-
water Invertebrates
- Acute Toxlcity to
Estuarine and Marine
Organisms
- F1sh
- Shrimp
- Oyster
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
A B C D
A C D
A B C D [E]4/
A C D
A B C D [E]4/
A C D
A C D
A C D
A C D
A C D
A C D
A C D
Yes
No
Yes
No
Yes
No
No
No
No
No
Yes
No
40098001 No
Yes10/
40098001 No
Yes10/
40098001 No
Yes10/
Yes11/
Reserved12/
Yes11/
Reserved12/
40228401 No
Reservedj2/
—
9 Months
—
9 Months
—
9 Months
12 Months
—
12 Months
—
—
— _ —
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97
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Data Requirement
Sec. 158
Aquatic
72-4 -
72-5 -
.145 Wildlife and Aquatic
Organisms (confd)
Organisms Testing (cont'd)
Fish Early Life Stage
and Aquatic Invertebrate
Life Cycle
- Fish
- Invertebrates
Fish Life Cycle
Test
Substance^/
T6AI
TGAI
TGAI
Use Does EPA
Patterns2/ Have Data?
A B C D No
A B C D No
A B C D No
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Yes13/
Yes13/
Reserved14/
Timeframe
for
Submission3/
15 Months
15 Months
—
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing
- Aquatic Organisms
70-1 - Special Testing
- Aquatic Residue
Monitoring
TGAI
TEP
A B C D
A B C D
No
No
TEP
A B C E
No
Yes
Reserved15/
Reserved16/
12 Months
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98
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.145 Wildlife and Aquatic Organisms - Footnotes
VTGAI = Technical Grade of the Active Ingredient; TEP = Typical End-Use Product.
2/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/Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
^/Required to support manufacturing-use product for reformulation into end-use product.
5/Reserved pending the results of the terrestrial monitoring study on avian food items. If required, study will be due
within 9 months after notification of requirement by the Agency.
6/This is a five-day dietary toxicity test with a species of wild mammal. The recommended species is Peromyscus
mam'culatus or Peromyscus leucopus.
^/Required because the label allows repeat applications for all uses.
8/Reserved pending the results of the terrestrial residue monitoring study. If required, study will be due within
24 months after notification of requirement by the Agency.
9/Terrestrial residue monitoring studies are required for the following use sites: alfalfa, apple, and Bermuda grass
grown for seed. Avian and mammalian food items such as forage, insects, and seeds should be sampled.
10/Required to support aquatic food crop use because the pesticide is applied directly to water. Also required to
support all other outdoor crop uses because the EEC exceeds the LC5Q of the technical material to aquatic organisms
(fish or freshwater invertebrates).
^/Required to support use on corn, sorghum, and citrus because of potential exposure of estuarine/marine environments
through runoff, drainage, and drift.
12/ReServed pending the results of acute toxicity testing with technical mevinphos on marine/estuarine organisms. If
required, study will be due within 12 months after notification of requirement by the Agency.
13/Required to support all outdoor crop uses because the acute toxicity of technical mevinphos is less than 1 mg/L (ppm)
to aquatic organisms (fish and aquatic invertebrates) and the EF.Cs exceed 0.01 of the
-------
99
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.145 Wildlife and Aquatic Organisms - Footnotes
^/Reserved pending the results of fish early life stage and aquatic invertebrate life cycle tests. If required, study
will be due within 27 months after notification of requirement by the Agency.
15/Reserved pending results of aquatic residue monitoring study (if required). If required, the simulated or actual field
testing for aquatic organisms will be due within 24 months after notification of requirement by the Agency.
^/Pending the results of the required environmental fate data, aquatic residue monitoring data may be required for the
following use sites: artichoke, watercress, and sewage treatment. If required, acceptable protocols must be submitted
within 6 months after notification of requirement by the Agency. The study is due within 12 months after notification
by the Agency that the protocol is acceptable.
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100
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance1/ Patterns2/ Have Data? (MRID) Data Be Submitted? Submission3/
Data Requirement
Sec. 158.155 Nontarget Insects
NONTARGET INSECT TESTING - POLLINATORS
141-1 - Honeybee Acute Contact
Toxicity T6AI A B
141-2 - Honeybee - Toxicity of
Residues on Foliage TEP A B
141-4 - Honeybee Subacute
Feeding Study Reserved^/ —
141-5 - Field Testing for
Pollinators TEP A B
NONTARGET INSECT TESTING - AQUATIC INSECTS
Reserved7/
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect
Life-cycle Study Reserved7/
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects Reserved7/
NONTARGET INSECT TESTING - PREDATORS AND PARASITES
143-1
thru
143-3 -
Reserved7/
Yes
No
05004151
No
Yes4/
15 Months
No
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101
TABLE A
GENERIC DATA REQUIREMENTS FOR MEVINPHOS
Sec. 158.155 Nontarget Insects - Footnotes
VTest substance: T6AI = Technical Grade of the Active Ingredient; TEP = Typical End-Use Product.
2/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/Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise Indicated.
^/Residual toxidty data are required because data from the acute test indicate high toxicity.
^/Reserved pending development of test methodology.
6/Data reviewed to date do not indicate the need for field testing.
^/Reserved pending Agency decision as to whether the data requirement should be established.
-------
102
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MEVINPHOS
Data Requirement
Sec. 158.120 Product Chemistry,
Product Identity and Composition
61-1 - Product Identity
and Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of
Product ingredients
62-1 - Preliminary Analysis
of Product Samples
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
Test
Substance1/
MP
MP
MP
MP
MP
MP
MP
MP
MP
Use
Patterns
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?
3/
3/
3/
3/
3/
3/
3/
3/
3/
Bibliographic
Citation
(MRID)
3/
3/
3/
3/
3/
3/
3/
3/
3/
Must Additional
Data Be Submitted?
Yes4/
Yes5/
Yes6/
Yes7/
Yes8/
Yes9/
Yesl°/
Yes7/
Yes7/
Timeframe
for
Submission2/
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
-------
103
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MEVINPHOS
Data Requirement
Sec. 158
Physical
.120 Product Chemistry (cont
and Chemical
Test
Substance1-/
'd)
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
(MRID)
Must Additional
Data Be Submitted?
Tlmeframe
for
Submission2/
Characteristics (cont'd)
63-7 -
63-12 -
63-14 -
63-15 -
63-16 -
63-17 -
63-18 -
63-19 -
63-20 -
Density, Bulk Density, or
Specific Gravity
pH
Oxidizing or Reducing
Act1 on
Fl ammabl 1 1 ty
ExplodablHty
Storage Stability
Viscosity
M1sc1b1Hty
Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
3/
Yes7/
Yes7/H/
YeslO/12/
YeslO/13/
YeslO/14/
YeslO/
YeslO/15/
YeslO/16/
Yes^/
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
Other Requirements;
64-1 - Submlttal of Samples
N/A
N/A
N/A
N/A
No
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104
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MEVINPHOS
Sec. 158.120 Product Chemistry - Footnotes
V Test Substance: MP - Manufacturing-Use Product.
2/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
3/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
V The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and
purpose of the active ingredient and each intentionally added inert must be provided. For the active ingredients,
the following must also be provided: the product, common, and trade names; the molecular, structural, and empirical
formulas; the molecular weight or weight range; and any experimental or internally assigned company code numbers.
5/ 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 those materials.
6/ A detailed discussion of all impurities that are or may be present at >0.l%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
7/ 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.
-------
105
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MEVINPHOS
Sec. 158.120 Product Chemistry - Footnotes
8/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at >0.1% (w/w) and each "lexicologically significant" impurity present at <0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and precision
data have been provided. Limits for impurities not associated with the active ingredient need be provided only if
they are considered to be of toxicological significance, regardless of the concentration at which they are present.
Certifications must be submitted on EPA Form 8570 Rev. 2-85.
9/ Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which certified limits are required. Each method must be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
Data required if the test substance is dispersible in water.
Data required if the product contains an oxidizing or reducing agent.
Data required if the product contains combustible liquids.
14/ Data required if the product is potentially explosive.
15/ Data required if the product is a liquid.
16/ Data required if the product is a liquid and is to be diluted with petroleum solvents.
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106
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MEVINPHOS
Data Requirement
Sec. 158.135 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation -
Test
Substance1/
MP
MP
MP
MP
MP
Use
Patterns2/
A B C D E
A B C D E
A B C D E
A B C D E
A B C D E
Does EPA
Have Data?
No
No
No
No
No
Bibliographic
Citation Must Additional
(MRID) Data Be Submitted?
Yes
Yes
Yes
Yes
Yes
Time frame
for
Submission3/
9 Months
9 Months
9 Months
9 Months
9 Months
Rabbit
81-6 - Dermal Sensitization - MP
Guinea Pig
81-7 - Acute Delayed MP
Neurotoxicity - Hen
A B C D E
A B C D E
No
No
Yes
Yes
9 Months
12 Months
Footnotes:
V Test material: MP = Manufacturing-Use Product.
2/ 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/ Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
-------
107
II. LABELING APPENDICES
-------
108
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeli ng. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered in
the upper part of the panel. The name of a product will not be
accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The name
and address should preferably be located at the bottom of the
front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest suitable
unit, e.g., "1 pound 10 ounces" rather than "26 ounces." In
addition to English units, net contents may be expressed in
metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
ment at which the product was produced, and may appear in any
suitable location on the label or immediate container. It must
also appear on the wrapper or outside container of the package if
the EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container-
[40 CFR 162.10(f)]
-------
109
SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
1s required on the front panel. The Ingredients statement must
contain the name and percentage by weight of each active
Ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 162.10(g)]
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 6point 6point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 162.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40CFR 162.10(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 162.10(h ) (1) (i )
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR 162.10(h)(l)(iii)]
-------
110
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning statements must be headed by the appropriate
hazard title. [40 CFR 162.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury-, or damage. [40 CFR 162.10(h ) (2) (i i )]
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.
-------
Ill
SUMMARY-4
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must reflect
this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistrati on. During the
Agency's review of your application, your proposed classification
determination will be evaluated in accordance with the provisions
of 40 CFR 162.11(c). You will be notified of the Agency's
classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in
40 CFR 162.10(h)(l)(1v).
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.
-------
112
SUMMARY-5
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistrati on, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be
assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the label.
Additional worker protection statements may be required in
accordance with PR Notice 83-2, Ma-rch 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and appear
under the heading "Storage and Disposal" in the directions for
use. This heading must be set in the same type sizes as required
for the child hazard warning. Refer to Appendix II, STOR,
PEST/DIS, and CONT/DIS to determine the storage and disposal
instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to protect
the public from fraud and from personal injury and to prevent
unreasonable adverse effects on the environment. [40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product are
termed collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted in
connection with registration of the product. It should be made
part of the response to this notice and submitted for review.
-------
113
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
Z
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
ingredients
statement
pounds/gai ion
statement
Front panel
precauti onary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
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.
way be in metric units in addition to
U.S. units.
Must be m similar type size and run
parallel to other type.
nay 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.
-------
114
SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (cont'd)
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross- "•
bones and word
POISON (In red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/Dack panel
precauti onary
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
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
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
115
SUMMARY-8
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (cont'd)
ITEM
8C
9A
9B
IDA
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
! APPLICABILITY
i OF REQUIREMENT
iAll pressurized
! products, others
Iwith flash
{points under
!150°F
iAi-i restricted
! products
i
i
i
JAll products
i
i
i
!PR Notice 83-Z
lor as determined
by the Agency
IAII products
i
i
i
i
i
1A11 products
i
i
PLACEMENT ON LABEL
KEquiREO
None
Top center
of front
panel
Immediately
f ol 1 owi ng
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
di recti ons
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
includes a statement of tne terms or
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 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
-------
116
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
• tOMESTCANMAU
CAUTION
DMftOMJENTAL HAZARDS
PHYSICAL Oft CHEMCAL
HAZARDS
DMEOTONS FOR USf
Ik* *oMM tf
to •
RE-ENTRY STATEMENT
CMO*
PRODUCT
NAME
AOTNE NQREOCNT:,
MERT MOREDCNT8:,
TOTAL;
100.00%
THIS PRODUCT CONTANS IBS Of PER OAUON
KEEP OUT OF REACH OF CHILDREN
CAUTION
STATEMENT OF PRACTICAL TREATMENT
r SWALLOWED:
FNHALEO=
r M EYES
SEISM PANEL FOR ADOmONAL PRECAUTONARY STATEMENTS
MTOSV:
TOWN. STATE r==
ESTAKJ3HMCNTNO.:
EPAREQMTRATIONNa:
NIT CONTENTS:
STORAGE AND
DISPOSAL
STORAC
DMPOSAL:
WARRANTY STATEMENT
-------
117
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
(I OOMESTC ANMALS)
DANOER
ENVMONMENTAL HAZARDS
PHYSICAL OR CHEMICAL
HAZARDS
I » i ttMw 4
It »
to UM
RE-ENTRY CTATCUENT
STORAGE AND
DISPOSAL
RESTRICTED USE
, PESTICIDE %
(reason for clasnlfytnp)
waTO ARC ow cutr w cotnnto Appuooore or:
.1* WBIR 0a8Cr ««WW»ICM AN) ONLY «* TO06B
wes oarozo BY ne CEWITIEO APPUOOWB
PRODUCT
NAME
ACTM NOREOCNT: .
NERT NOREDIENTS:.
TOTAL
100.00%
THIS PRODUCT COKTAMS 133 Of PER OAUON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
•TATCUENT Of PRACTICAL TREATMENT
> SWALLOWED:
•I
f M EYE3
SEE 8DC PANEL FOR ADOmONAL PRECAUTIONARY STATCMENT3
MFQ
TOWN. STATE
ESTABU9HMENTNO.
EPAREQISTRATIONNO.
NET CONTENTS:
CROP:
CROP:
CROP:
CROP:.
CROP:
WARRANTY STATEMENT
-------
§ 162.8
118
Conditional registration. Any at
plidation for which a preview of scieil-
tific\data is needed, ofjher than an
plication which the]} Agency det
mines may be considc
tionalX registration
(d) of khis section, wilt
application for condit
under KIFRA sec. 3(t
revieweaand acted
in §§ 162)160 through]
(f) Den\
ministrat
reviewed lAider
section if any of the
paragraph «1X2) of I this
not met. or\if therq are
data to make\the
tions.
(1) Notification. | Promptly after
making a determination to deny a reg-
istration, the X Administrator shall
notify the applicant py Certified letter
of the denial of
red for uncoBdi-
Uder paragraph
treated as an
tnal registration
k?) and vAll be
>n as set/forth
162.177.
of registration. Iffhe Ad-
shall deny an application
)h (d? of.this
lents of
:tion are
sufficient
huired/determlna-
set forth the rec
for the detei
tions. if any. whic
in order for the
proved.
(2) Opportunity fj
cant (i) The apj
days from the
certified letter
corrective actioi
(11) The appl
Administrator t£ wit
tion. The
discretion, dc
drawal and
denial in
(fX3) of
(3) FED
the appli
ciency of
the Ad
issue in
rsectic
RCGI
it fails
Ition and shall
id factual basis
and the condi-
lust be satisfied
ion to be ap-
remedy by appli-
it will have 30
receipt of the
the specified
petition the
LW his applica-
tion may, in his
petition for with-
a notice of
witH paragraph
{cation. If
remedy the defi-
on application,
ilnistratoif shall promptly
1C FEDERAL RBOXSTEBUl notice
of denial of registration. Such notice
shall seyt forth the reasons and factual
basis for the denial and shall contain
the name and address of the appucant,
the product name, (the name and; per-
centage by weight of each active
dienc in the product, the proposed
of use. and tljte proposed claabifi-
cafilon.
f4) Hearing rights.
fallowing publica
Within 30
n of the denial
e FEDERAL REGISTER, the applicant
y interested party with the writtei
40 CFR Ch. I (7-1-86 Edition)
Authorization of the {applicant may
lest a hearing pursuant to section
6(\3) .of the Act .and! Part 164 of this
chapter. If no hearing is timely/re-
quested, the denial snail become qffec-
tive at the end of thd 30 days.
6n the
that:
(1) Has been obtiained by
come to his attention; and
(2) Insofar as He is aware.
previously been I submitted
Agency.
cts of the
or man
Such informatioi
not be
published laboi
dent experienceJ
FR 34005, July 26. 19831
or has
not
the
shall include.
to. publishc
ttory studies and
§ 162.10 Labeling requirement*.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the'informa-
tion specified by the Act and the regu-
lations in this Fart. The contents of_a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
122
-------
Environmental Protection Agency
119
162.10
scribed in paragraph (b) of this sec-
tion:
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
-------
§ 162.10
120
40 CFR Ch. I (7-1-86 Edition)
purposes other than as a pesticide or
device;
(iv) A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recpmmended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe," "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling. (1) Except
as provided in paragraph fa.)(6Xll) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to S 162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by •• V or "Sold by to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68* F (20*C)
and shall be expressed in conventional
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units. Le.. "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing - practice. Variation
below a stated minimum, is not pennlt-
ted. In no case shall the average con-
tent of the packages in a shipment Tall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
124
-------
121
environmental Protection Agency
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 establishments 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—<1) 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
§ 162.10
or wrapper. If the size or form of the
package makes it impracticable jto
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text'of the ingredient 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(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(1) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement in a prominent position on
125
-------
§ 162.10
122
40 CFR Ch. I (7-1-66 Edition)
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 ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicologies!
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:
Hazard Indicators
Oral LD»
Inhalation LC».
Dermal L0»
plM aft
-------
123
Environmental Protection Agency
statement 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-
icity. 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 (hX2) 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:
162.10
Size ot label front panel m square
incites
5 and undo*
Above 5 to 10
Above 10 to 15
Above IS to 30
Over 30
Pen
Required
signal
word, all
capitals
6
10
12
14
18
nls
'Keep out
of reach of
children"
6
6
8
10
12
(2) Other required warnings and pre-
cautionary statements. 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 required.]
(ii) 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
127
-------
§ 162.10
124
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 LDM 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 LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Pish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM 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
40 CFR Ch. I (7-1-86 Edition)
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."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flashpoint
Required taxi
(A) PREMURIZEO CONTAINCRS
Flash point at or below 20* F; K there is a flashback at
any valve opening.
Flash point above 20* F and not over 80* F or V the
flam* extension b more than 18 In long at a Distance
of 6 in from the flame.
AM other pressurized container*
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 open flame. Do not puncture or Incinerate container.
Exposure to temperatures above 130* F may cause bursting.
Contents under pressure. Do not use or ston near heat or open
flame. Do not puncture or Incinerate container. Exposure to
temperatures above 130* F may causa bursting.
(B) NONPAEttumzED CONTAINERS
At or below 20* F.
Above 20* F and not over 80* F_
Above 80' F and not over ISO* F.
Extremely flammable. Keep away from fire, sparks, and heated
surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
(I) Directions for Use—41) General
requirements—<1) Adequacy and clar-
ity of directions. 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.
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which 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 bag;
(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.
(Hi) Exceptions to requirement for
direction for use—(.A) Detailed direc-
128
-------
Environmental Protection Agency
125
(.ions for use may be omitted from la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
(/) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products Involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(J) The product will not come into
the hands of tlje general public except
after incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(J) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(.1) There is information readily
available to the formulators on the
composition, toxicity, methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes;
<2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved;
§ 162.10
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) 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 site<8) of application, as for
example the crops. Animals, areas, or
objects to be treated.
(iv) The target pestts) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application. In-
cluding instructions for dilution, if re-
quired, and type
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
129
-------
§162.11
126
40 CFR Ch. I (7-1-86 Edition)
(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 U»e 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(8) excep: 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
orovlsions of (162.KKJK2).
(1) General Use Classification. Pesti-
cide products bearing •directions for
use. 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]
C40 PR 28268. July 3. 1975; 40 PR 32329.
Aug. 1. 1975; 40 FR 36571. Aug. 21. 1975. as
amended at 43 FR 6786. Feb. 9.19781
.11 Criteria for
Niable advene! effect*.
)) [Reserved]
ions of i
Except as
of this
pesticide
tered shall be
if each of the
forth In paragrai
(ill) of this secti<
the product usejtf)
for restricted
the la
(cK3) of thin'section
product use may be
era! use/or the
strlctetr use of the
the risks of
ide. Each of
'set forth below
te product use(s)j
1)
reffisj
(cK4)
i) of a
lously regis-
ter general use
tie criteria set
'(O(lKl) through
met. Otherwise.
be classified
a review of
it \Q paragraph
that the
•i««8lfflM for gen-
Its fnnn unre-
Icide dtttweigh
use oil the
separate
st be appliedXor
to be classifii
130
-------
127
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or 1f there 1s a
flashback at any valve
opening.
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.
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.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container- Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame,
Do not use or store near
heat and open flame.
None required.
-------
128
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Headlng:
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 1n original container and placement 1n
locked storage areas.
-------
129
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 Toxi'city 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
domestic use, containing
Toxic Hazardous Wastes or
Subpart C for a hazardous
disposal statement:
products, except those intended for
active or inert ingredients that are
meet any of the criteria in 40 CFR 261,
waste must bear the following pesticide
"Pesticide
pesticide,
wastes are toxic. Improper disposal of excess
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
domestic use, must
statement:
other products, except those intended for
bear the following pesticide disposal
"Wastes resulting from
disposed of on site
facility."
the use of this product may be
or at an approved waste disposal
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
1n several layers of newspaper and discard 1n trash."
-------
130
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container-
use products must bear one of the following
1. Domesti c
container di sposai statements:
Container Type
Non-aerosol products
(bottles, cans, jars
Non-aerosol products
(bags)
Aerosol
products
Statement
j Do not reuse container
iRinse thoroughly before
; Do
i
not
! Replace
! trash.
reu
ca
Do
se bag.
p and
not
d1
inc
DISC
(bottle, can, jar).
discarding in trash.
ard
oag
In
trasn.
scard containers in
inerate or puncture.
2. All
instructions'!
Container Type
other p roducts
must bear container
based on container type, listed below:
Statement
disposai
Meta I
cental ners
(non-aerosol )
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cyl Inders
iTrlple rinse (or equivalent). Then offer
Ifor recycling or reconditioning, or puncture
land dispose of in a sanitary landfill, or by
[other procedures approved by state and local
! authorities.
iTrlple rinse (or equivalent). Then offer
Ifor recycling or reconditioning, or puncture
land dispose of in a sanitary landfill, or
! 1 nci neration, or, if allowed by state and
llocal authorities, by burning. If burned,
! stay out of smoke.
iTrlple rinse (or equivalent). Then dispose
!of 1n a sanitary landfill or by other
lapproved state and local procedures.
[Completely empty liner by shaking and
jtapplng sides and bottom to loosen clinging
[particles. Empty residue Into application
[equipment. Then dispose of Hner 1n a
[sanitary landfill or by Incineration If
[allowed by state and local authorities.
[If drum is contaminated and cannot be
[reused1/, dispose of 1n 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 wordl ng) .
I/ Manufacturer may replace this phrase with one indicating wnetner
and how fiber drum may be reused.
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131
III. USE INDEX APPENDIX
-------
132
EPA Compendium of Acceptable Uses
c015801 2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS*
TYPE PESTICIDE; Insecticide, Acaricide
FORMULATIONS:
Tech (100%)
D (2%)
EC (1 Ib/gal, 2 Ib/gal, 4 Ib/gal, 25.4%)
SC/L (2 Ib/gal, 4 Ib/gal, 10.3 Ib/gal)
RTU (3.64%, 5%)
GENERAL WARNINGS AND LIMITATIONS: RESTRICTED USE PESTICIDE. 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 appli-
cator's certification. Direct supervision for this product is defined as
the certified applicator being physically present during application, mix-
ing, loading, repair and cleaning of application equipment. Conmercial
certified applicators must also ensure that all persons involved in these
activities are informed of the precautionary statements.
Protective Clothing. Equipment and Work Safety Statements;
The following protective equipment must be worn during mixing/loading, ap-
plication, repair and cleaning of mixing, loading, and application equip-
ment and, disposal of mevinphos: Protective suit of 1 or 2 pieces that
covers all parts of the body except head, hands, and feet; chemical-
resistant gloves; chemical-resistant shoes (or chemical-resistant shoe
coverings or chemical-resistant boots); goggles or face shield; hood or
wide brimmed hat; NIOSH or MSHA approved respiratory protection device.
If mixing/loading is performed using a closed system, the following protec-
tive clothing and equipment may be worn as an alternative: Long-sleeve
shirt; long-legged pants; chemical-resistant gloves; chemical-resistant
apron; shoes and socks. Goggles or face shield must be worn when the sys-
tem is under pressure. All other protective clothing and equipment re-
quired for use with open systems must be available nearby.
Pilots should not assist in mixing and loading operation.
If application is performed using an enclosed cab or cockpit, the follow-
ing protective clothing and equipment may be worn as an alternative:
Long-sleeve shirt and long-legged pants; shoes and socks. Chemical-
resistant gloves must be available in the cab or cockpit and must be worn
during entry to and exit from the application vehicle. All other pro-
tective clothing and equipment required for use during application must be
available in the cab and must be worn when exiting the cab into treated
area. When used for this purpose, contaminated clothing may be not be
brought back into the cab unless in an enclosure such as a plastic bag.
This clothing is inadequate for protection during repair and cleaning of
application equipment and early reentry to treated areas.
The use of human flaggers during aerial application of mevinphos is pro-
hibited unless the flaggers are in enclosed cabs.
Before removing gloves, wash them with soap and water. Take off all work
clothes and shoes. Shower using soap and water. Wear only clean clothes
when leaving job—do not wear contaminated clothing. Personal and protect-
ive clothing worn during work must be stored and laundered separately from
household articles. Clean or launder protective clothing after each use.
*mevinphos
phosdrin
Issued: 3-26-87 111-015801-1
Provisional Update: 3-08-88
-------
133
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
GENERAL WARNINGS AND LIMITATIONS (continued)
Respirators must be cleaned and filters replaced according to instructions
included with the respirators. Protective clothing and protective equip-
ment that becomes heavily contaminated or drenched with mevinphos must be
destroyed according to State and local regulations. Heavily contaminated
or drenched clothing cannot be adequately decontaminated.
If pesticide comes in contact with skin, wash off with soap and water and
contact a physician immediately. Always wash hands, face, and arms with
soap and water before smoking, eating, drinking, or toileting.
If handled indoors provide mechanical exhaust ventilation. Keep all un-
protected persons, children, livestock, and pets away from treated area or
where there is danger of drift. Do not rub eyes or mouth with hands.
Reentry Interval;
Reentry into treated citrus groves, grape vineyards, and nectarine and
peach orchards is prohibited for 96 hours (4 days) after the end of appli-
cation, unless the protective clothing specified for early reentry is
worn. Reentry into all other treated areas is prohibited for 48 hours (2
days) after the end-of application, unless the specified protective cloth-
ing for early reentry is worn.
For early reentry into treated areas after sprays have dried, wear pro-
tective suit of 1 or 2 pieces covering all parts of the body except head,
hands, and feet; chemical-resistant gloves; chemical-resistant shoes (or
chemical-resistant shoe coverings or chemical-resistant boots).
For early reentry into treated areas before sprays have dried, wear all
specified protective clothing for an applicator.
For dust formulations and in states that may require more restrictive
reentry intervals, consult State Departments of Agriculture.
Bee Caution;
Mevinphos is highly toxic to bees exposed to direct treatment on blooming
crops or weeds. Do not apply mevinphos or allow it to drift to blooming
crops or weeds while bees are actively visiting the area.
Commodity Tolerances (other than those listed in the text);
Parsley, dehydrated 4 ppm
Definition of Terms;
ii - Exact computation of actual dosage is not possible because of the
lack of weight/volume information on the label. Extrapolation from
other formulations reveals that the dosage from this label appears
to fall within the range shown by formulations with known weight/
volume ratios.
Issued: 3-26-87 111-015801-2
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Site and Pest
134
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
/23001AA
/23003AA
ITBJADA
IRACAAA
INASBWC
ITBCCZA
IVABAAA
IRAFAAA
IQAMARA
ILAAABA
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: Mevinphos is toxic to fish and wild-
life. Drift and runoff nay be hazardous to aquatic organisms in neigh-
boring areas. Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water by cleaning of equip-
ment or disposal of wastes. Apply when pests first appear and repeat as
needed to maintain control. Apply by aircraft in 3 to 10 gallons of
water per acre. For application to fruit and nut crops, apply suffi-
cient finished spray for thorough coverage not exceeding maximum gallon-
age indicated for that crop. Apply in a minimum of 10 gallons of water
per acre by concentrate ground equipment. For field crops and vegetable
crops, apply in 10 to 125 gallons of water per acre when using ground
equipment.
Alfalfa
Clove
Alfalfa caterpillar 0.25 Ib/A
Aphids (21 D)
or
0.125-0.5
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25-0.5 Ib/A
(2* D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Alfalfa weevil
(larvae)
Climbing cutworms
Grasshoppers
Leafhoppers
Lygus. bugs
Mites
Issued: 3-26-87
III-015801-3
-------
Site and Pest
135
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
/28008AA
/13052AA
IRACAAA
ITBCCFA
ITBCCSA
IOAAAEJ
ITBJAHA
1QAMARA
/04001AA
/04003AA
IRACAAA
ILAAABA
Anise. Fennel
Broccoli Raab
Aphids
Armyworm
Cabbage looper
Dipterous leaf-
miners (adults)
Imported cabbage-
worm
Lygus bugs
Aphids
Mites
Tolerance not located.
3 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Do not apply to broccoli raab when
temperatures are above 75 F (23.9
C).
[SLN] SLN - Use limited to CA.
0.125-0.25 Foliar application. Apply in a mini-
Ib/A mum of 10 gallons of water per acre.
(4 Ib/gal EC) Repeat at 5 to 7 day intervals.
[SLN]
0.25-0.5 Ib/A
(4 Ib/gal EC)
0.125-0.25
lb/100 gal
[max 1,200
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.5 ppm
1 day preharvest interval through 3
pounds per acre for foliar applica-
tion of emulsifiable concentrate and
soluble concentrate/liquid formula-
tions (apple and pear).
1 day preharvest interval through
1.2 pound per acre for foliar appli-
cation of dust formulation (apple).
For apple, do not apply under condi-
tions of high relative humidity and
high temperature. Applications of
mevinphos may cause injury to golden
delicious, Staymen and related vari-
eties.
Foliar application.
Issued: 3-26-87
111-015801-4
-------
136
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Site and Pest
Dosages and Tolerance. Use. Limitations
Formulation(s)
Apple cluster (continued)
IVABAAA
IQAMARA
ITBUAPA
Grasshoppers
Lygus bugs
Redbanded leaf-
roller
/04001AA
IRACAAA
ILAAABA
/13018AA
IRACAAA
(apple)
Aphids
Mites
Artichoke
Aphids
ITBLABA
Artichoke plume
moth
/28001AA
Beans
IRACAAA
Aphids
0.25-0.333
lb/100 gal
[max 900
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
1-1.2 Ib/A
(2% D)
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.5-1 Ib/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.125-0.25
Ib/A
(2% D)
(2, 4 Ib/gal
EC)
Foliar application.
1 ppm
2 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Foliar application.
0.25 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
III-015801-5
-------
137
EPA Compendium of Acceptable .Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
IVABAAA
IRAFAAA
INAPAFA
ILAAABA
/28002AA
IRACAAA
ITBCCSA
ITBCCZA
IOAAAEJ
IQALAHA
IVABAAA
ITBJAHA
IRAFAAA
ILAAABA
ITABACA
Site and Pest
Beans (continued)
Dosages and Tolerance. Use. Limitations
Formulation(s)
Grasshoppers 0.25-0.5 Ib/A
Leafhoppers (2% D)
Mexican bean beetle (2, 4 Ib/gal
Mites EC)
(4, 10.3 lb/
gal SC/L)
Beets (including tops)
Aphids
Cabbage looper
Climbing cutworms
Dipterous leaf-
miners (adults)
False chinch bug
Grasshoppers
Imported cabbage-
worm
Leafhoppers
Mites
Saltmarsh cater-
pillar
0.25 Ib/A
(2% D)
or
0.125-0.5
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.5 Ib/A
(2% D)
or
0.25-0.5 Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 ppm (beets', garden (including
tops))
3 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
III-015801-6
-------
138
/22017BA
ILAVANA
ILAJARA
IRANAAA
IRAWAAA
IRABAAA
/23001AA
ITBJADA
IRACAAA
INASBWC
ITBCABA
IVABAAA
IRAFAAA
IQAMARA
ILAAABA
/13005AA
/13006AA
/13007AA
/13008AA
/13009AA
/13011AA
IRACAAA
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Site and Pest
Dosages and Tolerance. Use. Limitations
Formulation(s)
Bermudagrass (seed crop)
Banks grass mite
Bermudagrass mite
Fulgorid plant-
hoppers
Mealybugs
Whiteflies
Birdsfoot Trefoil
Tolerance not located.
7 day preharvest interval through 1
pound per acre. Do not pasture or
use treated crop for feed, food, for-
age, or bedding purposes.
[SLN] SLN - Use limited to CA.
0.75-1 Ib/A Apply in 5 to 10 gallons of water by
(4 Ib/gal EC) aircraft and in 10 to 30 gallons of
water per acre by ground equipment.
1 ppm (forage, hay)
2 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Alfalfa caterpillar [SLN]
Aphids 0.125-0.25
Ib/A
(4 Ib/gal EC)
SLN - Use limited to NY.
Foliar application.
Alfalfa weevil
(larvae)
Cutworms
Grasshoppers
Leafhoppers
Lygus bugs
Mites
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
Aphids
[SLN]
0.25-0.5 Ib/A
(4 Ib/gal EC)
NY810002
0.125-0.25
Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(25.4% EC)**
(4, 10.3 lb/
gal SC/L)
1 ppm
3 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Foliar application.
Issued: 3-26-87
III-015801-7
-------
Site and Pest
139
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
Broccoli cluster (continued)
ITBCCSA
ITBCCZA
IOAAAEJ
IVABAAA
ITBJAHA
IRAFAAA
IQAMARA
ITABACA
Cabbage looper
Climbing cutworms
Dipterous leaf-
miners (adults)
Grasshoppers
Imported cabbage-
worm
Leafhoppers
Lygus bugs
Saltmarsh cater-
pillar
Broccoli Raab
/14003AA
IRACAAA
Aphids
Foliar application. Apply when in-
festations are difficult to control.
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25-0.5 Ib/A Foliar application.
(2% D)
(2, 4 Ib/gal
EC)
(25.4% EC)**
(4, 10.3 lb/
gal SC/L)
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
See Anise, fennel cluster.
0.25 ppm
2 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
0.25 Ib/A
(2% D)
or
0.125-0.5
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application.
Issued: 3-26-87
III-015801-8
-------
140
ITBCCZA
ITBCCZA
IOAAAEJ
IRAFAAA
IQAMARA
ILAAABA
ITABACA
/13002AA
IRACAAA
ITBCCSA
IOAAAEJ
IRACAAA
IQAMARA
ILAAABA
ITABACA
Site and Pest
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
Carrot (continued)
Cabbage looper
Climbing cutworms
Dipterous leaf-
hoppers (adults)
Leafhopper
Lygus bugs
Mites
Saltmarsh cater-
pillar
Cauliflower
Aphids
Cabbage looper
Dipterous leaf-
miners (adults)
Leafhoppers
Lygus bugs
Mites
Saltmarsh cater-
pillar
0.5 Ib/A
(2% D)
or
0.25-0.5 Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
See Broccoli cluster.
1 ppm
3 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
5 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Foliar application.
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25-0.5 Ib/A Foliar application.
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application. Apply when in-
festations are difficult to control.
Issued: 3-26-87
III-015801-9
-------
141
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Site and Pest
ilerv (continued)
Dosages and Tolerance. Use. Limitations
Formulation(s)
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application. Apply when in-
festations are difficult to control.
/05002AA
IRACAAA
ILAAABA
Cherrv. Sour
Aphids
Mites
1 ppm
2 day preharvest interval through
2.5 pound per acre for foliar appli-
cation.
Foliar application.
/13053AA
IRACCUA
/13010AA
IRACAAA
ITBCCSA
ITBCCZA
ITBJAHA
0.25-0.333
Ib/A
[max 750
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Chinese Broccoli (gai Ion) 1 ppm (broccoli)
3 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Do not make more than 3 applica-
tions.
Green peach aphid [SLN] SLN - Use limited to CA.
1 Ib/A Foliar application. Apply in 10 gal-
(4 Ib/gal EC) Ions of water per acre by aircraft
and 100 gallons of water per acre by
ground equipment.
Chinese Cabbage (including napa or 1 ppm (cabbage)
nappa cabbage, bok choy, pak choi, 3 day preharvest interval through
gai choy, and mizunal) 0.25 pound per acre for foliar appli-
cation.
Aphids
Cabbage looper
Climbing cutworms
Imported cabbage-
worm
[SLN]
SLN - Use limited to CA.
0.125-0.25 Foliar application. Apply in a mini-
Ib/A mum of 10 gallons of water per acre
(4 Ib/gal EC) by aircraft or in a minimum of 25
gallons of water per acre by ground
equipment.
(10.3 Ib/gal
SC/L)
Issued: 3-26-87
111-015801-10
-------
Site and Pest
142
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
/13009AA
/13011AA
Collards
Kale
/28005AA
Corn
IRACAAA
ILAAABA
Aphids
Mites
/10010AA
Cucumber
See Alfalfa cluster.
1 ppm
3 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
7 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Refer to Broccoli cluster for additional informa-
tion.
0.25 ppm (corn, grain, field, pop,
sweet (K+CWHR))
1 ppm (forage)
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
0.25-0.5 Ib/A Foliar application.
(2% D)
or
0.125-0.5
Ib/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.2 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
IRACAAA
Aphids
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2,.4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application.
Issued: 3-26-87
111-015801-11
-------
Site and Pest
113
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
IVABAAA
IRAFAAA
ILAAABA
/11001AA
/11003AA
IRACAAA
Cucumber (continued)
Grasshoppers
Leafhoppers
Mites
Eggplant
Aphids
IVABAAA
IRAFAAA
ILAAABA
Grasshoppers
Leafhoppers
Mites
0.25-0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.5 Ib/A
(2% D)
or
0.25-0.5 Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25 ppm
2 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
111-015801-12
-------
144
/02002AA
/02004AA
/02006AA
IRACAAA
ITBCCUA
ITAHABA
ITBCCBA
ITAXAFA
ITBUAGA
ITBUBCA
ITBUALA
/01014AA
IRACAAA
Site and Pest
Grapefruit
Lemon
Orange
Aphids
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.2 ppm (citrus)
1 day preharvest interval through 2
pounds per acre for foliar applica-
tion.
Allow a minimum of 7 days between
treatments.
Citrus cutworm
Pink scavenger
caterpillar
Variegated cutworm
Western tussock
moth (larvae)
Fruittree leaf-
roller
Omnivorous leaf-
roller
Orange tortrix
Grapes
Aphids
0.5-1 lb/200
or more
gal/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
2 lb/1,200
gal/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
1 lb/500
gal/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application.
0.5 ppm
2 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
5 day preharvest interval through 1
pound per acre for foliar applica-
tion.
0.25-0.5 Ib/A Foliar application.
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Issued: 3-26-87
111-015801-13
-------
145
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
IZZZAQA
IRAFAAA
IQAMARA
ILAAABA
ITBUAPA
/13020AA
Site and Pest
Grapes (continued)
Leaffolders
Leafhoppers
Lygus bugs
Mites
Redbanded leaf-
roller
Lemon
Lettuce
IRACAAA
Aphids
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.5-1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
See Grapefruit cluster.
0.5 ppm
2 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
4 day preharvest interval through 1
pound per acre for foliar applica-
tion.
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application.
Foliar application. Apply when in-
festations are difficult to control.
Issued: 3-26-87
111-015801-14
-------
146
ITBCCSA
ITBCCZA
ITBCBOA
IOAAAEJ
IQALAHA
IVABAAA
ITBJAHA
IQAMARA
ILAAABA
ITABACA
IMOAAAA
/10001AA
/10008AA
IRACAAA
Site and Pest
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
Lettuce (continued)
Cabbage looper
Climbing cutworms
Corn earworm
Dipterous leaf-
miners
False chinch bug
Grasshoppers
Imported cabbage-
worm
Lygus bugs
Mites
Saltmarsh cater-
pillar
Thrips
0.25-0.5 Ib/A Foliar application.
(2% D)
or
0.125-0.5
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application. Apply when in-
festations are difficult to control.
Melons (including cantaloupes,
honeydew melons, muskmelons, and
watermelons)
Aphids
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.5 ppm (melons (including canta-
loupes, honeydew melon, and
nruskmelon, determined on the
edible portion with rind re-
moved))
(watermelon)
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
111-015801-15
-------
147
ITBCCSA
ITBCCSA
IOAAAEJ
IQALAHA
IVABAAA
IRAFAAA
IQAMARA
ILAAABA
ITABACA
/10008AA
ITAAAIA
/08027AA
IRACAAA
ITBCABA
ITAAAOA
ILAAABA
/13021AA
/28022AA
IRACAAA
Site and Pest
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.25-0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
;lons (continued)
Cabbage looper
Climbing cutworms
Dipterous leaf-
miners (adults)
False chinch bug
Grasshoppers
Leafhoppers
Lygus bugs
Mites
Saltmarsh cater-
pillar
(Watermelons)
Rindworms (includ-
ing cabbage loop-
er, cutworms,
saltmarsh cater-
pillar, and tobac- (10.3 Ib/gal
co budworm) SC/L)
0.25 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
Foliar application.
Mint
Tolerance not located.
30 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Aphids
Cutworms
Loopers
Mites
0.5 Ib/A Foliar application.
(2 Ib/gal EC)
Mustard Greens
Turnips (including tops)
Aphids
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(25.4% EC)
(4, 10.3 lb/
gal SC/L)
1 ppm (mustard greens, turnip
tops)
0.25 ppm (turnips)
3 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
111-015801-16
-------
Site and Pest
148
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
Mustard Greens cluster (continued)
ITBCCSA
IOAAAEJ
IQALAHA
IVABAAA
ITBJAHA
IRAFAAA
ILAAABA
/15015AA
IRACAAA
ITBCCZA
ITBCBOA
IQAQACA
ILAAABA
ITBCATA
/14011AA
Cabbage looper
Dipterous leaf-
miners (adults)
False chinch bug
Grasshoppers
0.25-0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(25.4% EC)
Imported cabbage- (4, 10.3 lb/
worm
Leafhoppers
Mites
Okra
Aphids
Climbing cutworms
Corn earworm
Green stink bug
Mites
Velvetbean cater-
pillar
gal SC/L)
0.125-0.5
Ib/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25-0.5 Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Onions (including green onions)
0.25 ppm (onions (green))
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
ITBCCZA
IMOAAAA
Climbing cutworms
Thrips
0.25-0.5 Ib/A Foliar application.
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
See Grapefruit cluster.
Issued: 3-26-87
111-015801-17
-------
149
/05004AA
705005AA
Site and Pest
Peach
Plum
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
1 ppm
1 day preharvest interval through
2.5 pounds per acre for foliar appli-
cation.
For peach, 4 day reentry interval
for any activity requiring substan-
tial contact with the treated foli-
age.
IRACAAA
ILAAABA
Aphids
Mites
IVABAAA
IQAMARA
ITBUAPA
Grasshoppers
Lygus bugs
Redbanded leaf-
roller
/28016AA
IRACAAA
Aphids
0.125-0.25
lb/100 gal
[max 750
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25-0.133
lb/100 gal
[max 750
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application.
See Apple cluster.
0.25 ppm (peas)
1 ppm (pea vines)
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
111-015801-18
-------
150
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
ITBCCZA
IVABAAA
IRAFAAA
ILAAABA
/11003AA
Site and Pest
Peas (continued)
Climbing cutworms
Grasshoppers
Leafhoppers
Mites
Peppers
IRACCUA
Green peach aphid
/14013AA
Potato
IRACAAA
Aphids
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.25-0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25 ppm
2 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
4 day preharvest interval through 1
pound per acre for foliar applica-
tion.
If the crop is to be grown for proc-
essing do not apply more than 0.5
pound per acre per application.
0.5-1 Ib/A Use limited to CA.
(4 Ib/gal EC) Foliar application. For organo phos-
phate resistant green peach aphids.
Refer to Eggplant for additional use information.
6.25 ppm
1 day preharvest interval through
0.25 pound per acre for foliar appli-
cation.
4 day preharvest interval through 1
pound per acre for foliar applica-
tion.
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC) ,
(10.3 Ib/gal
SC/L)
Foliar application.
Issued: 3-26-87
111-015801-19
-------
151
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
IVABAAA
IRAFAAA
ILAAABA
IRACCUA
/01006AA
IRACAAA
Site and Pest
Potato (continued)
Grasshoppers
Leafhoppers
Mites
Green peach aphid
Raspberry
Aphids
ITBUAGA
IRAFAAA
ILAAABA
ITBUALA
Fruittree leaf-
roller
Leafhoppers
Mites
Orange tortrix
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.25 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 Ib/A
(4 Ib/gal EC)
1 ppm
3 day preharvest interval through
0.64 pound per acre for foliar appli-
cation.
0.125-0.25
lb/100 gal
[max 200
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25-0.32 lb/
100 gal
[max 200
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application.
Issued: 3-26-87
111-015801-20
-------
152
Site and Pest
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
/13003AA
Red Chicory (tops) Radicchio
IRACCUA
Green peach aphid
/15026BA
Sesame (seed crop)
IRACAAA
/28019AA
IRACAAA
Aphids
Sorghum
Aphids
ITBCBOA
ITAAAMA
Corn earworm
Webworms
0.5 ppm (chicory, red (tops) (also
known as radicchio))
7 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Do not make more than 3 applica-
tions.
[SLN] SLN - Use limited to CA.
1 Ib/A Foliar application. Apply in 10 gal-
(4 Ib/gal EC) Ions of water per acre by aircraft
and 100 gallons of water per acre by
ground equipment.
Tolerance not located.
This use pattern is expired and the
state agency requested it remain so.
No preharvest interval through 0.5
pound per acre.
[SLN] SLN - Use limited to CA.
0.5 Ib/A Apply by aircraft only in a minimum
(4 Ib/gal EC) of 5 gallons of water per acre. Ap-
ply at the flower stage.
1 ppm (grain, forage)
3 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(4 Ib/gal EC)
(4, 10.3 lb/
gal SC/L)
0.5 Ib/A
(2% D)
or
0.25-0.5 Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application.
Issued: 3-26-87
111-015801-21
-------
153
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
ITBCCOA
Site and Pest
Sorghum (continued)
Fall armyworm
/13024AA
Spinach
IRACAAA
ITBCCSA
ITBCCZA
IOAAAEJ
IQALAHA
IVABAAA
ITBJAHA
IRAFAAA
I LAMB A
ITABACA
Aphids
Cabbage looper
Climbing cutworms
Dipterous leaf-
miners (adults)
False chinch bug
Grasshoppers
Imported cabbage-
worm
Leafhoppers
Mites
Saltmarsh cater-
pillar
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 ppm
4 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
7 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Foliar application.
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25-0.5 Ib/A Foliar application.
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application. Apply when in-
festations are difficult to control.
1 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application. Apply when in-
festations are difficult to control.
Issued: 3-26-87
111-015801-22
-------
154
/10013AA
IRACAAA
ITBCCSA
ITBCCZA
IOAAAEJ
IQALAHA
IVABAAA
IRAFAAA
IQAMARA
ILAAABA
ITABACA
/01016AA
IRACAAA
ILAAABA
Site and Pest
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
Squash. Summer
Aphids
Cabbage looper
Climbing cutworms
Dipterous leaf-
miners (adults)
False chinch bug
Grasshoppers
Leafhoppers
Lygus bugs
Mites
Saltmarsh cater-
pillar
Strawberry
Aphids
Mites
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25-0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Foliar application.
0.25 Ib/A
(2% D)
or
0.125-0.25
lb/100 gal
(2,. 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
1 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
2 day preharvest interval through 1
pound per acre for foliar applica-
tion.
Foliar application.
Issued: 3-26-87
111-015801-23
-------
155
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Site and Pest
Dosages and Tolerance. Use. Limitations
Formulation(s)
Strawberry (continued)
IVABAAA
IQAMARA
ITABACA
ITBUBWA
Grasshoppers
Lygus bugs
Saltmarsh cater-
pillar
Strawberry leaf-
roller
Foliar application. Apply when in-
festations are difficult to control.
1 Ib/A
(2% D)
or
1 lb/100 gal
[max 100
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
0.25-0.5 Ib/A Foliar application.
(2% D)
or
0.25-0.5 lb/
100 gal
[max 100
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
1 Ib/A
(2% D)
or
1 lb/100 gal
[max 100
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
Foliar application. Apply when in-
festations are difficult to control.
Issued: 3-26-87
111-015801-24
-------
156
Site and Pest
/11005AA
IRACAAA
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
f
0.2 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Aphids
IVABAAA
IRAFAAA
ILAAABA
Grasshoppers
Leafhoppers
Mites
0.25 Ib/A
(2% D)
or
0.125-0.25
Ib/A
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
0.25-0.5 Ib/A
(2% D)
(2, 4 Ib/gal
EC)
(4, 10.3 lb/
gal SC/L)
Foliar application.
/03009AA
Turnips (including tops)
Walnut
IRACAAA
Aphids
0.125-0.25
lb/100 gal
[max 1,000
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
See Mustard Greens cluster.
0.25 ppm (determined on the nut
meats with shell removed)
1 day preharvest interval through
2.5 pounds per acre for foliar appli-
cation.
Foliar application.
Issued: 3-26-87
111-015801-25
-------
157
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Site and Pest
Walnut (continued)
ITBUAGA Fruittree leaf-
roller
1LAAABA Mites
ITANAWA Omnivorous looper
ITBUALA Orange tortrix
Dosages and Tolerance. Use. Limitations
Formulation(s)
0.25 lb/100
gal
[max 1,000
gal/A]
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
/31003AA
IRACAAA
IQAMARA
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
Ornamental Flowering Plants
(field grown)
Make 1 application per year.
Aphids
Lygus bugs
[SLN] SLN - Use limited to CA.
0.25 Ib/A Foliar application. Apply in a mini-
(4 Ib/gal EC) mum of 10 gallons of water per acre
by aircraft only.
Issued: 3-26-87
111-015801-26
-------
158
/13020CA
IRACAAA
ITBCCSA
ITBCCZA
ITBCBOA
IOAAAEJ
IQALAHA
IVABAAA
ITBJAHA
IQAMARA
ILAAABA
ITABACA
IMOAAAA
Site and Pest
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
GREENHOUSE FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: Apply in a closed greenhouse (close
all doors, windows, and ventilators). Lock or barricade all entrances,
post warning signs, and take whatever precautions are necessary to pre-
vent unprotected humans and domestic animals from entering the treated
area. The operator must wear a full face mask of a type found adequate
for mevinphos protection.
Lettuce
Aphids
Cabbage looper
Climbing cutworms
Corn earworm
Dipterous leaf-
miners (adults)
False chinch bug
Grasshoppers
Imported cabbage-
worm
Lygus bugs
Mites
Saltmarsh cater-
pillar
Thrips
0.48-1.167
lb/50,000
sq.ft
(2, 4 Ib/gal
EC)
(10.3 Ib/gal
SC/L)
1 ppm
10 day preharvest interval through
1.167 pounds per 50,000 square feet
for foliar application to greenhouse
grown plants.
Foliar application to greenhouse
grown plants. Apply when the green-
house ventilators can remain closed
for 2 hours without endangering the
crop from high temperatures. Keep
the ventilators closed tightly for a
minimum of 2 hours. If the applica-
tion is made in the late afternoon,
the greenhouse can be kept closed
all night. Ventilate for 1 hour to
render the air safe for reentry.
Issued: 3-26-87
111-015801-27
-------
Site and Pest
159
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Dosages and Tolerance. Use. Limitations
Formulation(s)
AQUATIC FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: Mevinphos is toxic to fish and wild-
life. Effluent may be hazardous to aquatic organisms. Do not contami-
nate water by cleaning of equipment or disposal of wastes.
/13027AA
Watercress
IRACAAA
Aphids
2 ppm
1 day preharvest interval through
0.5 pound per acre for foliar appli-
cation.
Do not make more than 5 applica-
tions.
Do not apply to a bed not in full
growth or without adequate canopy
cover.
[SLN] SLN - Use limited to AL, FL, MD, PA,
0.5 Ib/A and WV.
(4 Ib/gal EC) Foliar application. Apply in 25 to
125 gallons of water per acre by
ground equipment. Apply when pests
first appear and repeat at 2 to 7
day intervals.
AQUATIC NONFOOD
(Aquatic Sites)
/65026MA Sewage Disposal Plants
IOBCAAC Moth flies
(larvae)
IOBCAAH Moth flies
(pupae)
0.35 Ib actu- Water treatment. Apply to the sew-
al age flowing to trickling filters.
or
1 gal of
3.69% RTU
or
1 gal of 52
RTU/100 gal
of sewage/
minute
(2 Ib/gal EC)
(3.69X, 5X
RTU)
Issued: 3-26-87
111-015801-28
-------
160
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Site and Pest Dosages and Tolerance. Use. Limitations
Formulation(s)
Sewage Disposal Plants (continued)
0.05 Ib actu- Water treatment. Apply to sewage in
al flooded trickling filters. Close
or the gate from the filter to the sec-
18 fl.oz of ondary clarifier and raise the sew-
3.64% RTU age level in the filter to the rock
or surface. Add at a number of points
18 fl.oz of around the sides of the filter. Al-
5% RTU/100 low the arms of the filter to make
gal of sew- several revolutions for distribution
age of the material. The contact period
(2 Ib/gal EC) is governed by the extent of the in-
(3.64%, 5% festation, however, a minimum of 5
RTU) hours is required. At the end of
the contact period, the filter can
be returned to normal operation by
opening the gate from the filter to
the secondary clarifier.
AERIAL. MOTHPROOFING AND TANK MIX APPLICATIONS
9001500 Aerial Application
AAAAAAA
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
All sites
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
All sites
Issued: 3-26-87 111-015801-29
-------
161
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Listing of Registered Pesticide Products by Formulation
&299.9901 100% technical chemical
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801)
000352-00455 002498-00079*
*jacket currently unavailable for review
&002.0003 2% dust
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801)
000279-01364 000279-01624* 000352-00472 001202-00119**
001526-00418* 001812-00104 002459-00090* 0*05481-00249
005905-00297 009859-00181** 044317-00013*
*jacket currently unavailable for review
**cancelled
^suspended
&101.0012 1 Ib/gal emulsifiable concentrate
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801); endosulfan (079401) plus xylene (086802)
034704-00187* 051036-00056***
*jacket currently unavailable for review
***no pm listing, unavailable for review
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801); endosulfan (079401) plus xylene range
aromatic solvent (086803)
000279-02220***
***no pm listing, unavailable for review
&102.0012 2 Ib/gal emulsifiable concentrate
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus petroleum distillate (063503)
000201-00177* 002459-00091* 005481-00218
*jacket currently unavailable for review
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus xylene (086802)
000352-00474 005905-00298 040831-00083
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus xylene range aromatic solvent (086803)
000279-01227*
//suspended
4104.0012 4 Ib/gal emulsifiable concentrate
2-carbornethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801)
000352-00471 002935-00167 005481-00113 006973-00012
Issued: 3-26-87 111-015801-30
-------
162
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Listing of Registered Pesticide Products by Formulation (continued)
4 Ib/gal emulsifiable concentrate (continued)
(000201-00289)M AL850007 CA760180 CA780079 CA800180
CA810003 CA860063 CA860073 FL840025
PA850003 WV850002
^transferred to 000352-00471
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus aromatic petroleum derivative solvent
(006501)
001526-00390* 010163-00051* 040831-00083 040831-00112*
051036-00052*
*jacket currently unavailable for review
(001526-00390) AZ790033
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus aromatic petroleum distillate (006601)
001202-00259**
**cancelled
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus petroleum distillate (063503)
000279-01452** 000279-01692*
**cancelled
^suspended
(000279-01452) AZ790015
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus xylene (086802)
000352-00471 001202-00261** 002749-00110** 007001-00100
010163-00009** 011656-00026 034704-00087 034704-00169
040831-00084
**cancelled
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus xylene range aromatic solvent (086803)
000682-00023* 005905-00228 005905-00308
*jacket currently unavailable for review
&225.4012 25.4% emulsifiable concentrate
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus petroleum distillate (063503)
001812-00082*
*jacket currently unavailable for review
Issued: 3-26-87 111-015801-31
-------
163
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Listing of Registered Pesticide Products by Formulation (continued)
&102.0015 2 Ib/gal soluble concentrate/liquid
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus aromatic petroleum derivative solvent
(006501)
009859-00144**
**cancelled
&104.0015 4 Ib/gal soluble concentrate/liquid
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801)
001202-00258** 005481-00114* 010226-00010
*jacket currently unavailable for review
**cancelled
2-carbornethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus isopropyl alcohol (047501)
006023-00033 010163-00049
&110.3015 10.3 Ib/gal soluble concentrate/liquid
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801)
000352-00473 005481-00161 010163-00050**
**cancelled
(000201-00291)## CA810003
##transferred to 000352-00473
&203.6416 3.64% liquid-ready to use
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus aromatic petroleum derivative solvent
(006501)
002270-00697
&205.0016 5% liquid-ready to use
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus aromatic petroleum distillate (006601)
007234-00128
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus petroleum distillate (063503)
010827-00027
2-carbomethoxy-1-methylvinyl dimethyl phosphate, alpha isomer and
related compounds (015801) plus xylene (086802)
003624-00160*
*jacket currently unavailable for review
Issued: 3-26-87 111-015801-32
-------
9999999
164
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Listing of Registered Pesticide Products by Formulation (continued)
State Label Registrations
AZ Reg. No.
001202-05003
002935-06555
011656-05720
CA Reg. No.
000201-05967
001202-05093
005905-04435
006973-03579
007001-07718
010972-05300
011656-05971
034704-05804
001202-05011
002935-06571
011656-05745
000201-05968
002935-06669
006023-03034
006973-03580
007001-07719
011369-08809
034704-04720
034704-05806
001526-03811
005905-07952
011656-05749
001202-05044
005481-07501
006973-03554
006973-04409
007001-07748
011656-04795
034704-04730
001526-03812
007001-04376
011656-05972
001202-05046
005481-07512
006973-03578
007001-07695
007001-07749
011656-05865
034704-05797
FL Reg. No.
009782-03649 032928-05924
IL Reg. No.
002270-03069
KS Reg. No.
002270-03070
MO Reg. No.
002270-05608
NY Reg. No.
038655-10414
OR Reg. No.
001871-08940 001871-08941
TX Reg. No.
010827-03427
033722-03276 037854-08292
Issued: 3-26-87
111-015801-33
-------
165
EPA Compendium of Acceptable Uses
2-CARBOMETHOXY-1-METHYLVINYL DIMETHYL PHOSPHATE,
ALPHA ISOMER AND RELATED COMPOUNDS
Appendix A-1
Listing of Active Ingredient(s) Found in Combination with the Report
Chemical
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
079401 endosulfan
— Use Common Name
Issued: 3-26-87 111-015801-34
-------
166
IV. BIBLIOGRAPHY APPENDICES
-------
167
Guide to Use of This Bibliography
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and
its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, 1n those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study." In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the
published article from within the typically larger volumes
1n which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It 1s not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for a further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary Identifier number is also to be used whenever
specific reference 1s needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, In the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
168
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 following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element 1s the
submitter, following the phrase "submitted
by." When authorship is defaulted to the
submitter, this element Is omitted.
-------
169
(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.
-------
170
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevinphos Standard
MRID CITATION
00022923 Hill, E.F.; Heath/ R.G.; Spann, J.W.; et at. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00036987 Shell Chemical Corporation (1956) Analytical Methods for the Deter-
mination of OS 2046 Residues in or on Agricultural Crops. Sum-
mary of studies 092358-D and 092358-E. (Unpublished study re-
ceived Jun 5, 1956 under PP0078; CDL:092358-B)
00036988 Shell Chemical Corporation (1956) Stability of OS 1046 Residues in
Frozen Crops. (Unpublished study received Jun 5, 1956 under
PP0078; CDL:092358-C)
00036989 Shell Development Company (1956) Determination of OS2046 in Agri-
cultural Products and Animal Tissues: Enzyme Inhibition—Spec-
trophotometric Method. Method ARMS-C-12/56 (Tentative) dated
May 15, 1956. (Unpublished study received Jun 5, 1956 under
PP0078; CDL:092358-D)
00036990 Casida, J.E. (19??) Enzymatic Determination of OS 2046 in Agricul-
tural Crops: Enzyme Inhibition—delta pH Method. (Unpublished
study received Jun 5, 1956 under PP0078; prepared by Univ. of
Wisconsin, submitted by Shell Chemical Co., Washington, D.C.;
CDL:092358-E)
00036998 Shell Chemical Corporation (1957) Practicable Methods for Removing
Excessive Residues of Phosdrin Insecticide. (Unpublished study
received Apr 15, 1957 under PP0123; CDL:092404-F)
00044663 Stauffer Chemical Company (1963) Summary of Phosdrin Residues on
Green Beans. (Unpublished study received Dec 9, 1966 under
476-1460; CDL:101405-A)
00054954 Spencer, E.Y.; Robinson, J.R. (1960) Metabolism of the systemic in-
seoticide 0,0-Dimethyl 1-carbomethoxy-1-propen-2-yl phosphate
(Phosdrin) in the pea plant. Journal of Agricultural and Food
Chemistry 8(4):293-295. (Also In unpublished submission re-
ceived Jun 14, 1977 under 2498-79; submitted by Black Hawk Chem-
ical Corp., Los Angeles, Calif.; CDL:230743-H)
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171
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevinphos Standard
MRID CITATION
00089548 Casida, J.E.; Gatterdam, P.E.; Niedermeier, R.P.; et at. (1957)
Residues and Toxicity Associated with Feeding Phosdrin Insec-
ticide to Dairy Cattle. Progress rept. Mar 27, 1957. (Unpub-
lished study received Apr 15, 1957 under PP0123; prepared by
Univ. of Wisconsin, Depts. of Entomology and Dairy Husbandry,
submitted by Shell Chemical Corp., New York, N.Y.; CDL:090154-J)
00089555 Shell Chemical Corporation (1957) Phosdrin-(TM) Insecticide Resi-
dues in or on Raw Agricultural Commodities. (Unpublished study
received Apr 15, 1957 under PP0123, CDL:090154-V)
00089559 Shell Chemical Corporation (1957) Determination of Anticholines-
terase in Plant and Animal Tissues. Method dated Mar 1957.
(Unpublished study received Apr 15, 1957 under PP0123; CDL:
090154-Z)
00089696 Shell Chemical Company (1961) Supplement to Section D—Pesticide
Petition 288. (Unpublished study received Jun 25, 1961 under
PP0288; CDL:090310-A)
00089697 Casida, J.E.; Gatterdam, P.E.; Knaak, J.B.; et al. (1958) Bovine
metabolism of organophosphate insecticides. Subacute feeding
studies with 0,0-dimethyl 1-carbomethoxy-1-propen-2-yl phos-
phate. Journal of Agricultural and Food Chemistry 6(9):658-
662. (Also In unpublished submission received Jun 25, 1961
under PP0288; submitted by Shell Chemical Corp./ New York, N.Y.;
CDL:090310-B)
00089698 Shell Chemical Company (1961) Residues in or on Citrus Resulting
from the Application of Phosdrin Insecticide to the Foliage,
(Unpublished study received Jun 25, 1961 under PP0288; CDL:
090310-D)
00112690 Shell Chemical Co. (1956) The Results of Tests on the Amount of
Residue of the Pesticide Chemical OS 2046 Remaining, Including
a Description of the Analytical Methods used. (Compilation;
unpublished study received Aug 13, 1956 under PP0078; CDL:
090108-1)
00113304 Shell Chemical Co. (1969) Phosdrin: Residues in Spinach. (Com-
pilation; unpublished study received Sep 25, 1970 under 201-289;
CDL:023150-A)
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172
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevinphos Standard
MRID CITATION
00113306 Shell Chemical Corp. (1960) Phosdrin: Residues in Eggplant and
Other Crops. (Compilation; unpublished study received Dec 7, 1959
under PP0235; CDL:092512-A)
00113309 Shell Chemical Corp. (1958) Phosdrin: Residues in Oranges and
Other Crops. (Compilation; unpublished study received on unknown
date under PP0200; CDL:098743-A)
00113315 Shell Chemical Co. (1962) Phosdrin: Residues in Strawberries and
Other Crops. (Compilation; unpublished study received Apr 22,
1963 under unknown admin, no.; CDL:119520-A)
00113316 Berneking, A.; Lau, S.; Stanford, J. (1962) Beta-naphthol and
Phosdrin Insecticide Residues on a Field Crop: Special Project
SD-62-15. (Unpublished study received May 29, 1963 under un-
known admin, no.; submitted by Shell Chemical Co., Washington,
DC; CDL:119869-A)
00113318 Shell Chemical Co. (1958) Phosdrin: Residues in Melon. (Com-
pilation; unpublished study received Jun 1, 1958 under unknown
admin, no.; CDL:125002-A)
00113320 Shell Chemical Co. (1962) Phosdrin: Residues in Milk and Other
Subjects. (Compilation; unpublished study received Jan 29,
1957 under unknown admin, no.; CDL:125010-A)
00113324 Shell Chemical Corp. (1957) Determination of Phosdrin Insecticide
Residues in Grapes following Application of This Toxicant.
(Unpublished study received Mar 19, 1958 under unknown admin.
no.; CDL: 125021-A)
00113325 Shell Chemical Co. (1960) Phosdrin: Residues in Grass and Other
Subjects. (Compilation; unpublished study received Aug 22,
1960 under unknown admin, no.; CDL-125022-A)
00113326 Shell Chemical Co. (1957) Phosdrin: Residues in Beets and Other
Crops. (Compilation; unpublished study received Jun 27, 1958
under unknown admin, no.; CDL:125023-A)
00113329 Shell Chemical Co. (19??) Residues in or on Tomatoes Resulting
from the Application of Phosdrin Insecticide to the Foliage.
(Unpublished study received Apr 21, 1959 under unknown admin.
no.; CDL:125028-A)
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173
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mevinphos Standard
MRID CITATION
00113334 Shell Development Co. (1964) Determination of Phosdrin Insecticide
in Crops and Animal Products: Analytical Method MMS-6/64. (Un-
published study received Jul 1, 1964 under unknown admin, no.;
CDL:129696-A>
00126692 Interregional Research Project No. 4 (1982) The Results of Tests
on the Amount of Mevinphos Residues Remaining in or on Water-
cress, Including a Description of the Analytical Method Used.
(Compilation; unpublished study received Mar 28, 1983 under
201-289; CDL:071506-A)
00147424 Shell Oil Co. (1985?) Determination of an Acceptable Exposure Level
(AEL); CDislodgeable and Total Residues; Reentry Intervals].
Unpublished study. 7 p.
00147425 Shell Oil Co. (1985) Residue Decline of Phosdrin Insecticide on
Various Agricultural Crops. Unpublished compilation. 218 p.
05004151 Stevenson, J.H. (1968) Laboratory studies on the acute contact
and oral toxicities of insecticides to honeybees. Annals of
Applied Biology 61(3):467-472.
40094601 Hudson, R.H.; Tucker, R.K.; Haegele, M.A. (1984) Handbook of Toxicity
of Pesticides to Wildlife. USDI Publication 153, Washington, DC,
90 p.
40098001 Mayer, F.L., Jr. and M.R. Ellersieck (1986) Manual of Acute
Toxicity: Interpretation and Data Base for 410 Chemicals
and 66 Species of Freshwater Animals. U.S. FWS Resource
Publication 160.
40157101 Warren, J. (1987) Soil/Sediment Adsorption/Desorption of [Carbon
143-Mevinphos: ABC Final Rept. #35285. Unpublished study pre-
pared by ABC Laboratories, Inc. 261 p.
40201401 Schroeder, R.; Daly, I. (1987) Mevinphos— A Teratology Study in
Rats with Mevinphos: CFinal ReportD: Laboratory Project ID.
85-3009; 85-3008. Unpublished study prepared by Bio/dynamics,
Inc. 564 p.
40228401 Mayer, F.L. (1986) Acute Toxicity Handbood of Chemicals to Estuarine
Organisms. USEPA, ORD, Gulf Breeze, FL. p. 139.
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174
V. FORMS APPENDICES
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175
Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
FIFKA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
Attach separate page with a list of the data requirements your company
agrees to satisfy.
ED 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(CM2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
Attach list of data reouirements
CH 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
ED 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
ED 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1 (10-82)
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176
OMB Approval No.
Expires 11/30/89
2070-0057
(To qutUfy. certifyALt, fourframe/
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
. I am duly authorized to reprtMm the following firm(c) who arc subject to the require-
ment* of • Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
QUIOANCC OOCUMCNT OATC
ACTIVE INOHCOICNT
NAME OF FIRM
CPA OOMPAMV NUMBER
(Thit firm or group of firms it referred to below at "my firm".!
2. My firm a willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, <* to share in the cost of developing, the following required
hems or data:
3. My firm hat offered in writing to tnttr into such an agreement Copies of the offers are iniched. That offer w*t irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all termt could not be reached otherwise. This offer was made
to the following firm(s) on the following dltels):
NAME OF FIMM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the regittration(s) of my firm's product(s). if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm mutt submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIONATUNI
OATE
EPA Form
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177
OMB Approval No.
2070-0057
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Sec. 158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
I
Name of Test
Identity of
ingredients
Statement of
compositi on
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
63-3 Physical state
63-4 Odor
63-5 Melting point
63-6 Boiling point
63-7 Density, bulk-
density, or
specific gravity
63-8
63-9
Solubi lity
Vapor pressure
63-10 Dissociation
constant
63-11 Octanol/water
partition
coefficient
63-12 pH
Test not
required | I am complying with
for my |data requirements by
product (Citing MRID |Submit-
listed Number or Iting
above EPA Accession Data • (For EPA Use Only)
(check Number (At- | Accession Numbers
below) tached) Assigned
EPA Form 8580-4
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178
OMB Approval No.
2070-0057
Expires 11/30/89
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT (cont'd)
Date
Guidance Document for
Regi strati on
Guideline No.
Sec. 158.120
PRODUCT
CHEMISTRY
(cont 'd)
63-13
63- 14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stabi lity
Oxi dizing/reducing
reacti on
F lammabi lity
Explodabi lity
Storage stabi lity
Viscosity
Miscibi lity
Corrosion
characteristi cs
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
i rritati on
Dermal sensitiza-
ti on,
81-7 \ Acute Delayed
I neurotoxi city, hen
Test not
requi red
for my
product
listed
I above
(check
I be low)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
EPA Form 8580-4 (cont'd)
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179
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product/ despite
our lack of intent to submit the generic data in question, on the grounds that the product
contains the active ingredient solely as the result of the incorporation into the product
of another product which contains that active ingredient, which is registered under FIFRA
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company name,
registration number, and product name, the source of the subject active ingredient in my
firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are
and their registration number (s) is/are .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings made
in this Statement, my firm's product's registration may be suspended under FIFRA Section
3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet requirements or are no longer in
compliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in compliance and will normally initiate proceedings to suspend the
registrations of my firm's product (s) and their product (s), unless my firm commits to
submit and submits the required data in the specified time frame. I understand that, in
such cases, the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature
Dated:
(Typed)
EPA Form 8570-27
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