>EPA
United States
Environmental Protection
Agency
Pesticides and
Toxic Substances
(H-7501C)
540/RS-89-052
Registration Standard For
Pesticide Products
Containing METHOMYL
As The Active Ingredient
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OMB CONTROL NO. 2070-0057
Expires 11/89
REGISTRATION STANDARD
(SECOND ROUND REVIEW)
FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
METHOMYL
AS THE ACTIVE INGREDIENT
CAS. NO.: 16752-77-5
OPP Chemical Code 090301
EPA CASE NUMBER 0028
April, 1989
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III.Agency Assessment 4
A. Summary
B. Toxicological Assessment
C. Ecolological Assessment
D. Environmental Fate Assessment
E. Pesticide Incident Reports
F. Tolerance Reassessment
IV. Regulatory Position and Rationale 17
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 29
VI. Requirement for Submission of Generic Data 31
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data .37
VII. Requirement for Submission of Revised Labeling ... .37
VIII. Instructions for Submission 38
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Addresses
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APPENDICES
I. DATA APPENDICES 41
Guide to Tables
Table A
Table B
Table C (if included)
II. LABELING APPENDICES 79
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES 103
Guide to Bibliography
Bibliography
IV. FORMS APPENDICES 126
Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
Form 8580-4 Product Specific Data Report
Form 8570-27 Formulator's Exemption Statement
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TABLE I. Summary of Data Gaps
TABLE II. Summary of Tolerances
111
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GLOSSORY OF TERMS AND ABBREVIATIONS
ADI: Acceptable Daily Intake
a.i.: Active Ingredient
CAS: Chemical Abstract Services (Number)
CSF: Confidential Statement of Formula
EPA: The U.S. Environmental Protection Agency (The Agency)
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide
Act
LC50: 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 volumn of test substance per volumn
of air or water or per weight of feed (e.g., mg/1 or
ppm) .
LD50 Median Lethal Dose- a statistically derived single
dose that can be expected to cause death in 50% of
test animals when administered by the route in-
dicated, expressed as weight of substance per
weight of test animal (e.g., mg/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MIRD: 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
PPM: Parts Per Million
Technical: Active Ingredient as Manufactured
IV
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I. INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued in 1981, the
Agency summarized the available data supporting the registration
of the pesticide and its assessment of those data to determine
whether the pesticide met the "no unreasonable adverse effects"
standard of FIFRA. The Agency concluded that additional data
were necessary to fully evaluate the pesticide, and, as part of
the issuance of the Standard, required that registrants supply
those data. The Standard also set out labeling requirements that
the Agency believed were necessary to ensure that products
containing the pesticide were adequate to protect public health
and the environment while the data were under development.
The Agency has since reviewed the additional data and has
updated and revised its scientific and regulatory conclusions
concerning the pesticide in light of expanded data requirements
promulgated in 1984 as 40 CFR Part 158. The Registration
Standard contains the Agency's updated scientific assessment of
this pesticide and its currently registered uses. As part of its
review, the Agency has reassessed the tolerances for the
pesticide and determined whether they are adequate. The
tolerance reassessment is included in this Registration Standard.
Based on the new data, the Agency has also reviewed the
labeling requirements for the pesticide and is requiring label
revisions.
This revised Registration Standard supersedes the original
Registration Standard in its entirety.
This document contains the following sections:
0 Section II describes the particular pesticide(s)
covered by this Registration Standard, and gives a brief
profile of its usage and composition. Regulatory
history may be provided as well.
0 Section III sets out the Agency's scientific
assessment of the health risks and environmental
characteristics and effects of the chemical, updated
based on data submitted to the Agency under the original
Registration Standard.
1 The scientific reviews and Compendium of Acceptable Uses are
now available from the Freedom Operation Division (H7506C). Write
to Office of Pesticides Program, EPA, Washington, DC 20460.
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0 Section IV explains the regulatory decisions and
conclusions arising from the Agency's assessment, and
the rationales for its decisions. Section V describes
the labeling statements required for products containing
the chemical. These are divided into statements for
manufacturing use products and statements for end use
products.
0 Sections VI, VII, VIII, IX and X describe what
products are subject to the data and labeling
requirements set out in this Registration Standard, and
what is required of registrants to comply with the
requirements.
0 Appendix I contains a series of tables setting out
data requirements for the chemical. The tables identify
which requirements have been satisfied, as well as those
for which gaps remain. A Guide to Tables introduces the
tables.
0 Appendix II is a series of labeling information
sheets, setting out general labeling information that
must be placed on labeling.
0 Appendix III is a bibliography of the data evaluated
by the Agency in its assessment. A Guide to
Bibliography explains how to read and use the
Bibliography.
0 Appendix IV contains the necessary forms to respond to
receipt of the Standard
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, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submission of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. Description of Chemical
The following pesticide chemical is covered by this revised
Registration Standard:
Generic Name: S-methyl N-[(methylcarbamoyl)oxy]-
thioacetimidate
Common Name: Methomyl
Trade Name and
other names: methyl N-[[(methylamino)carbonyl]oxy]-
ethanimidothioate, methyl N-[(methylcar-
bamoyl) oxy]-thioacetimidate, Lannate,
Lanox, and Nudrin
EPA Shaughnessy Number: 090301
Chemical Abstracts Service (CAS) Number: 16752-77-5
Physicochemical Characteristics:
Technical Methoinyl
Color: White
Physical State: Crystalline solid
Melting Point: 73-79 C
Solubility: 5.8 g/100 g water, 100 g/100 g methanol,
72 g/100 g acetone, 42 g/100 g ethanol,
22 g/100 g isopropanol, 3 g/100 g toluene.
(no temperature provided)
Vapor pressure: 5 x 10~5 mm Hg at 25 C
Specific gravity: 1.2946
Octanol/water
partitioning coef: 1.29-1.33° at 20 C and 1.03
(no temp, given)
B. Use Profile
Type of Pesticide: Insecticide
Pests Controlled: Broad range of agricultural insects.
Control of house flies.
Registered uses: Methomyl is registered on a wide range
of field crops, vegetables, fruits, and
ornamentals (refer to Table II for a
listing of tolerances). It is used
in both human and animal premises.
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Predominate Uses: Soybeans, peanuts, cotton, tobacco,
and corn comprised 80% of the total
usage up until 1980. Since then,
notable increases have occurred in
apples and potatoes.
Mode of Activity: Inhibits the enzyme acetyl cholinesterase
Method of Application: Foliar and soil applications
with both ground and aircraft
equipment.
Formulations: Wettable powders, emulsifiable concentrates,
soluble concentrates, granulars, baits, and
dusts.
Basic Registrant: E.I. duPont de Nemours and Company
Year of Initial Registration : 1968
Pesticide Type: Insecticide
Chemical Family: Carbanate
Application rates: 0.1 to 1.5 Ib a.i. per acre
Methomyl is formulated in combination with acephate,
Bacillus thuringiensis var. kurstaki, cryolite, maneb, methyl
parathion, and tricosene. Single active ingredient formulations
consist of 1 to 2% baits, 1 to 5% granulars and dusts, 1%
ready-to-use liquids, 1.8 to 2.4 Ib/gal emulsifiable con-
centrate (EC), 90% wettable powders (WP). Methomyl is usually
foliarly applied using ground equipment or aircraft.
The federal and Special Local Need (24 c's) registrations
for methomyl include the following:
Section 3 registrations - 33 products - 19 companies
Special Local Need Section 24(c) registrations - 199
III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed the available data relating to
methomyl. Based on the available data, the Agency has arrived
at the conclusions summarized below. A detailed discussion
of these points can be found in the remaining sections of the
"Agency Assessment" portion of this Standard.
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1. Acute toxicity: Technical methomyl is highly toxic
to laboratory mammals by.the oral route of exposure and mod-
erately toxic by dermal exposure. The compound is also a
pulmonary irritant.
2. Subchronic Dermal (21 day): The previously submitted
study has been downgraded to supplementary. The Agency is
requiring another 21-day dermal study testing on both abraded
and unabraded skin measuring plasma and red blood cell cholin-
esterase as an additional endpoint.
3. Chronic toxicity; Chronic feeding studies in the
rat and dog show dose-related histopathology effects of the
kidney and spleen. The No Observed Effect Level (NOEL) in
both the rat and dog is 100 ppm or 2.5 mg/kg/day. Methomyl
is not oncogenic in rats or mice.
4. Metabolism: The metabolism of methomyl in plants
has been satisfactorily elucidated. Additional metabolism
studies in both food producing and non-food producing animals
are required. A metabolism study in a food producing animal
(cattle) is required to determine the metabolites present
with particular attention paid to acetamide. Two metabolism
studies, one in the rat and one in the monkey, are required
to determine the potential tissue levels of acetamide, a
suspected oncogen. Acetamide is a known metabolite of thio-
dicarb, a related pesticide that breaks down initially to
methomyl in non-food species.
5. Adverse Impact on Birds and Aquatic Organisrs:
Methomyl may have an adverse impact on fish and other aquatic
organisms and birds. Aquatic and terrestrial field studies
are required to determine the potential risks to these species.
6. Preliminary data indicate a potential groundwater
contamination problem. Groundwater monitoring data are
required.
7. Methomyl meets the toxicity and exposure criteria
defined under the Pesticide Assessment Guidelines, Sub-
division K, for reentry. Reentry intervals of from one to
seven days are being imposed based upon the available data.
These reentry intervals are found in section IV "Regulatory
Position and Rationale" part D. "Labeling". Spray drift and
droplet size spectrum are required to evaluate the droplet
spectra that are associated with actual use patterns.
The Agency has identified the data it believes are
necessary to fully evaluate the human and environmental risks
associated with the use of methomyl. These data must be
submitted in order to maintain registration of products or to
register new products containing methomyl. A summary of these
data gaps appears below in Table I. Please note that this
is only a summary and that complete details must be obtained
by referring to the tables in Appendix I.
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The Agency has also determined that certain label restric-
tions and revisions are necessary. Refer to Section IV.D for
these revisions.
TABLE I.
TOXICOLOGY
82-2 Subchronic Dermal (21 Day)
85-1 General Metabolism
ECOLOGICAL EFFECTS
71-4 Avian Reproduction
71-5 Simulated and Actual
Field Testing-Birds
72-1 Freshwater Fish LC50
warmwater -TEP
coldwater-TEP crops
DATA GAPS
ENVIRONMENTAL FATE
162-3 Anaerobic Aquatic
162-4 Anerobic Aquatic
163-2 Volatility (Lab)
164-2 Aquatic (sediment)
165-4,-5 Accumulation
Studies
Groundwater Monitoring
Reentry Data
RESIDUE CHEMISTRY
171-4 Animal Metabolism
Analytical Methods
Residue Data
PRODUCT CHEMISTRY
Product Chemistry Data
72-2 Acute LC50 Freshwater
Invertebrate-TEP
72-3 Acute LC50 Estuarine and
Marine Organisms
a. Shrimp- TGAI and TEP
b. Fish- TGAI and TEP
c. Mollusk-TGAI and TEP
72-5 Fish Life-Cycle
72-7 Simulated/Actual Field
Testing of Aquatic Organisms or
Residue Monitoring
B. TOXICOLOGICAL ASSESSMENT
Acute Toxicity
a. Acute oral toxicity
Technical methomyl was administered in fasted laboratory
rats of the ChR-CD (Charles River-Caesarian derived/delivered)
strain. The LD50 for male rats is 17 mg/kg and for the females
is 24 mg/kg, with confidence limits of 14-20 and 22-25 mg/kg,
respectively. Based on this study the product was classified
as highly toxic and placed in Toxicity Category I for this
route of exposure.
b. Acute dermal toxicity
Technical methomyl was applied at a dose of 5000 mg/kg to
the intact skin of six male albino rabbits for 24 hours. No
observed toxic effects were noted. On the basis of this study,
the product was placed in Toxicity Category III.
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c. Acute Inhalation Toxicity
Sufficient data are available on the acute inhalation
toxicity of methomyl. The LC50 value for aerosolized methomyl
is 0.3 mg/liter/4 hours in male ChR-CD rats, Toxicity Cat-
egory II. Methomyl was found to be a pulmonary irritant.
d. Acute Delayed Neurotoxicity
The available data show that methomyl does not cause
delayed neurotoxicity. No evidence of leg or wing paralysis
was noted and the pathological examination revealed no
abnormalities.
No data are available for primary eye and dermal irri-
tation or skin sensitization. These data are required.
Subchronic Toxicity
No acceptable subchronic oral studies are available/-
however, adequate chronic feeding studies in both the rat and
dog are available and these were used to evaluate the sub-
chronic toxicity in these species. No additional subchronic
studies are required.
A subchronic study conducted with Charles River CD rats
at doses of 0, 10, 50 125 and 500 ppm produced growth depression
and reduced hemoglobin in rats fed diets containing methomyl
at a concentration of 125 ppm for three months. No adverse
treatment related effects were noted at 50 ppm. This study
and others available to the Agency are not acceptable based
on modern standards of testing.
A three-month Beagle dog study which was conducted at
doses of 0, 10, 100 and 400 ppm reported no evidence of
toxicity in levels up to and including 400 ppm (the highest
concentration tested, HOT). These data are not adequate
because of insufficient reporting of details of animal main-
tenance, lack of statistical analysis, and absence of
histopathologic evaluation.
A 21-day subchronic dermal toxicity study is available
using a 90% soluble concentrate. Methomyl was administered
dermally to New Zealand albino rabbits with intact or abraded
skin at a single dose of 200 mg/kg, 5 days a week, for three
weeks. There were no toxic signs noted in the animals with
intact skin. However, methomyl was absorbed through abraded
skin and caused severe toxic effects (e.g., tremors, labored
breathing, miosis, loss of reflexes and hyperactivity). This
study was considered acceptable in the original methomyl
Registration Standard but is now considered supplementary.
The current Pesticide Assessment Guidelines (see 40 CFR §§
158.20 (d) and 158.70) require a limit dose of 1000 mg/kg on
intact (non-abraded) skin.
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A study using both abraded and unabraded skin which
measures plasma and red blood cell cholinesterase as an
additional endpoint is now required. The abraded skin re-
quirement has been added because the Agency feels that
this study more closely approximates the exposure conditions
experienced by farmworkers.
Chronic Toxicity
Sufficient data are available on the chronic toxicity
of methomyl in both the rodent and non-rodent.
In a twenty-two month feeding study using ChR-CD rats,
methomyl was fed at dietary concentrations of 0, 50, 100,
200, and 400 ppm. No adverse effects were noted at the 50
or 100 ppm levels. In both male and female rats, the
400 ppm level caused compound-related histopathological
alterations in the kidneys, characterized by vacuolation
of the tubular epithelial cells and hypertrophy of the
convoluted tubules. Compound related histopathologic
changes were also seen in the spleen of female rats at
doses of 200 to 400 ppm. The No Observable Effect Level
(NOEL) was set at 100 ppm.
In a twenty-four month ChR-CD rat study, animals were
dosed with technical methomyl at concentrations of 0, 50,
100, and 400 ppm. No treatment-related effects were reported
at levels up to and including 100 ppm. However, at 400 ppm,
erythrocyte counts, hemoglobin levels and henatocrit values
were significantly reduced in females. No significant effects
were found with respect to red blood cell (RBC) or brain
cholinesterase activity; however, plasma cholinesterase activity
was not determined and it is unclear whether animals were
fasted prior to the blood and tissue collection. The NOEL
for this study was 100 ppm.
In a twenty-four month chronic feeding study in the
Beagle dog, four males and four females per dose group were
fed methomyl at concentrations of 0, 50, 100, 400 and 1000 ppm.
Dose-related histopathology was observed in the kidney and
spleen of the 400 and 1000 ppm dose group and in the liver
and bone marrow of the 1000 ppm dose group. The NOEL was 100
ppm.
Oncogenicity
Sufficient data are available on the oncogenic potential of
methomyl.
ChR-CD rats were fed the test material at doses of 0, 50,
100, 200, and 400 ppm for 22 months. The neoplastic lesions in
the high-level test rats were generally comparable with those
of the control animals. No oncogenic effects related to
treatment were noted. These results were corroborated in a
second oncogenicity study where ChR-CD rats were fed methomyl
at the same dietary concentrations as the above study.
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Methomyl was not oncogenic in mice. Mice were fed dietary
concentrations of 0, 50, 75, and 200 ppm. The neoplastic
lesions reported were of the usual type and number observed
in mice of this age and strain and were essentially comparable
in incidence between control and treated groups.
Available animal metabolism data on thiodicarb, a related
insecticide that breaks down initially to methomyl, revealed
the presence of a minor metabolite acetamide. Acetamide has
been characterized as a possible human carcinogen. The Agency
is requiring new animal metabolism studies to allow it to
address its concerns regarding acetamide.
Teratogenicity
Sufficient data are available to assess the teratogenic
potential of methomyl in the rat and rabbit.
Pregnant rats were fed a diet containing 0, 50, 100, and
400 ppm of nethonyl on gestation days 6 through 15. Other
than maternal body weight loss, there were no dose related
effects. Methomyl was neither embryotoxic or teratogenic.
New Zealand White pregnant rabbits were given technical
methomyl at dosages of 0, 2, 6, and 16 mg/kg/day on gestation
days 7 through 19. Methomyl was not embryotoxic or teratogenic.
Reproduction
Sufficient data are available on the reproductive toxicity
of methomyl in the rat.
Methomyl was added to the diets of one month old ChR-CD rats
(male and female) for approximately 3 months at dosage levels
of 0, 50, and 100 ppm. After completion of this initial feeding
study, a reproduction study was conducted with 10 rale and 20
female rats. Offspring fron these adults were bred in groups to
produce ?2^ and ^2B litters. This procedure was follov;ed
with the F2g litter to produce F3A and F3B litters. Ten
male and 10 female weanling rats from the F3g litter (fron
the control and each test group) were subjected to a histo-
pathologic evaluation following necropsy.
Methomyl fed to rats at dietary levels of 50 and 100 ppm
for 3 generations caused no adverse effect on reproduction nor
any gross or histologic evidence of compound-related congenital
abnormalities. The NOEL was 100 ppm.
Mutaqenicity
Sufficient data are available on the mutagenic potential
of methomyl by tests on; 1) gene mutation, 2) structural
chromosome aberrations and 3) other mutagenic mechanisms as
deemed appropriate. No evidence of mutagenicity was noted
in any of the required testing.
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Metabolism
No valid metabolism study is available. Rat and mon-
key metabolism studies are required to assess the tissue levels
of acetamide, a possible human oncogen.
C. ECOLOGICAL ASSESSMENT
Avian Toxicity
An acute oral avian study indicates that methomyl is
highly toxic to upland game birds. The LD50 value for the
bobwhite quail is 24.2 mg/kg.
Subacute dietary toxicity studies on mallard ducks and
bobwhite quail indicate that methomyl is slightly toxic,
with LC50 values of 2883 and 1100 ppm, respectively.
Maximum application rates for methonyl range from 0.125-
0.9 Ibs/acre. Estimated foliar residues calculated from
using the highest application rate (0.9) immediately following
a single application would be 13 to 220 ppm, well below the
LC50 values for the mallard duck and bobwhite quail. Even
after 7 repeat applications of the highest application rate
there is very little risk to avian species on a dietary
basis.
The greatest hazard to avian species is expected to be
from the ingestion of methomyl treated granules. Agency
calculations indicate that the ingestion of as little as 19
granules of 5% granular product can be fatal to small seed
eating birds such as the Grasshopper sparrow. The Agency is
requiring actual field testing with birds to support the use
of 5% granular products.
There are no adequate data for assessing the likelihood
of chronic effects. Experimental data on the effects of
methomyl on avian reproduction are being required.
Aquatic Organism Toxicitv
Acute toxicity data indicate that methomyl is moderately
to highly toxic to both cold and warm water fish species
(LCSO's = 1.6 to 0.5 ppm) and very highly toxic to aquatic
invertebrate species (LC50's = 0.07 to 0.34 ppm). Therefore,
the Agency is particularly concerned about the direct and
indirect hazards that the use of methomyl poses to freshwater
aquatic organisms. The use sites which the Agency considers
of primary concern are: watercress, citrus, cotton, tobacco,
sweetcorn, peanuts amd forest woodlots/plantations, where
direct contamination, drift, runoff or soil erosion of methomyl
to lakes, streams, ponds or other bodies of water and wetlands
may occur.
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The Agency's estimated environmental concentrations (EEC's)
indicate that the direct application, runoff, drainage, and
drift of methomyl into both freshwater and marine environments,
when used according to recommended label rates, result in
exposures to aquatic organisms that exceed the lower
aquatic values discussed above.
The Agency is requiring simulated (e.g., mesocosm), and/or
actual field testing, or field monitoring studies to ascertain
the potential impact of methomyl in aquatic environments.
Endangered Species
Sufficient data exists to indicate that the current regis-
tered use patterns of methomyl may pose a hazard to certain
fish, aquatic organisms and insects. The risk levels for birds,
reptiles and mammals are apparently not exceeded. In aquatic
environments, all maximum application rates for various uses
are expected to result in EEC's above the invertebrate LC50 and
above 1/20 of the fish LC50 values for the tested species.
Hazards to Non-Target Insect-Pollinators
The available data indicates that methomyl is highly toxic
to bees. The Agency is requiring a bee caution on all end-use
products (except granulars) intended for outdoor use.
D. ENVIRONMENTAL FATE ASSESSMENT
Under aerobic conditions, methomyl degrades to predominately
CO2 with a half-life of 30-45 days. Methomyl is relatively
stable to hydrolysis under neutral and acidic condtions and
degrades under basic conditions with a half-life of 30 days.
Under anaerobic conditions, although acetonitrile is the
major degradate in the early stages, C02 is the end product,
with total conversion in about 8 days. Methomyl is very mobile
in sandy loam and silty clay loam soils.
There are confirmed detections of methomyl in groundwater
at maximum concentrations of 9 ppb and 1.2 ppb, respectively in
New York and New Jersey (EPA's Pesticide Monitoring Inventory
Data Base). These levels are not expected to produce acute
toxicity effects in humans and therefore, the Agency is not
requiring that a groundwater advisory statement be added to
methomyl labeling. Additional groundwater monitoring data are
required to determine methomyl's impact to ground water.
Although spray drift has been a concern to the Agency, the
requirements for these data were not in place at the time of the
original Registration Standard for methomyl in 1981. The spray
drift requirements are now being imposed.
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E. PESTICIDE INCIDENT REPORTS
Data on occupational illness due to methomyl exposure have
been received by California, which requires that physicians
report all such illnesses to the State. Between 1982 and 1986,
physicians treated an average of 11.8 methomyl poisonings per
year. An additional 5.4 cases per year were reported as due to
skin or eye injuries. Between 1980 and 1886, there were 17
reported hospital-ized cases of occupational methomyl poisoning,
the third highest number for any pesticide in California.
Thirty-nine workers were off the job for a total of 140 days
during this period.
The California data represent a complete count or census
of all occupationally related cases. These data indicate
that methomyl poses a significant hazard to mixers, loaders,
applicators and field workers. From the California census,
there were 0.6 poisonings per 1,000 applications. The average
value for all 54 pesticides used during this period was 0.8,
with a median of 0.4. On the basis of poisonings per pounds
sold, there were 6 occupational poisonings per million pounds.
Tor all pesticides this ratio was 1.3.
Reentry Intervals
Because of the above incident reports, California establish-
ed a reentry interval of two days for citrus, grapes, nectarines
and peaches (California Administrative Code, January 4, 1979,
Article 23, 2479(h), Field Worker Safety). In its original
methomyl Registration Standard, the Agency adopted the two day
reentry interval for these crops following California's example
and requested that additional reentry data be submitted. The
Agency has evaluated the reentry data it has received and lias
concluded that the following reentry intervals are appropriate:
one day for beans, cabbage, roses grown outdoors, and carnations
whether grown outdoors or in a greenhouse; three days for
cotton, nectarines, and citrus; four days for peaches; and
seven days grapes. Additional reentry data are needed for
mint, roses grown in greenhouses, and chrysanthemums grown in
greenhouses or outdoors. Weight/area conversion factors are
required for corn foliage to set an adequate reentry interval
to protect workers during detasseling operations.
F. RESIDUE DATA
The nature of the residue in plants is adequately known.
Methomyl is converted to methomyl oxime which is subsequently
degraded to acetonitrile and carbon dioxide. Methomyl may
also be oxidized to methomyl sulfoxide. Recently available
data on the metabolism of thiodicarb in plants (thiodicarb, a
related pesticide, is metabolized initially to methomyl),
reveal that acetamide will not occur in plants following
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treatment with either thiodicarb or methomyl. Furthermore,
any acetamide formed from acetonitrile is hydrolyzed to acetic
acid and incorporated into natural products.
The nature of the residue in animals is not adequately
understood. The only available ruminant metabolism study
(a goat study) failed to characterize 14C-activity. Also,
the detection of acetamide in a thiodicarb animal metabolism
study raised Agency concerns about the metabolism of methomyl
in animals. Additional animal metabolism studies have been
required in a Sec. 3(c)(2)(B) Notice issued on March 23, 1987.
Although adequate methods for data collection and en-
forcement of tolerances are available (Method I. in the PAM,
Vol. II. and FDA Multiresidue Protocol No. Ill), the Agency
now requires that all FDA multiresidue methods be tested to
determine their adequacy. Therefore, the residues of methomyl
occurring in or on raw agricultural plant commodities must be
subjected to analysis by multiresidue Protocols I, II, and IV.
Also, if the requested data on animal metabolism indicate
that residues of toxicological concern occur in tissues,
milk, or eggs, methods for data collection and enforcement
will be required. Representative samples from the metabolism
studies in which [1-14C] methomyl is used, must be subjected
to analysis using Method I in the PAM, Vol. II.
Residues of methomyl are stable in plant commodities
during long-term storage at near-freezing and sub-freezing
temperatures. The nature of the residue in animals is not
adequately understood. If the requested data on animal
metabolism indicate the presence of residues of toxicolog-
ical concern, data depicting the stability of those residues
in tissues, milk, eggs during frozen storage will be required.
Also, the following conclusions pertaining to tolerances
have been reached:
1. On receipt of the required residue chemistry data for
members of the root and tuber and bulb vegetable groups,
individual tolerances must be established and the current
tolerance for residues in or on "root crop vegetables"
must be revoked.
2. Residue data and a tolerance proposal are required for
dried peas, and the current tolerance for residues in or on
"peas" must be revised to "peas plus pod, succulent" on receipt
of the requirements for dried peas.
3. Residue data and a tolerance proposal (or a feeding
restriction) are required for bean hay.
4. Tolerances (or feeding restrictions) must be proposed
13
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for residues in or on the hay of lentils, peas, and soybeans.
The required data for bean hay will be translated to these
crops.
5. A tolerance (or a feeding restriction) of 10 ppm for
residues in or on lentil forage must be proposed based on
the currently available bean forage data.
6. The use of bean forage and hay data for lentil forage
and hay will require the establishment of a pregrazing
interval of greater than 3 days and a preharvest interval
of greater than 7 days.
7. Toxicological considerations permitting, the tolerance
for residues in grapes must be increased to greater than or
equal to 10 ppm or the PHI must be increased such that residues
will not exceed the established tolerances.
8. Residue data and tolerance proposals (or feeding re-
strictions) are required for sorghum fodder and hay.
9. Additional residue data and tolerance proposals are
needed for the forage and hay of clover which is grown tor
seed.
10. Additional residue data are required tor hops.
F. TOLERANCE REASSESSMENT
Tolerances Issued
Tolerances have been established for methomyl on a
variety of raw agricultural commodities (see 40 CFR 180.253
and Table II). There are no tolerances established for
animal products (meat, milk, poultry and eggs). The need
for these tolerances will depend on the results of the
requested animal metabolism studies.
Additional data are required to support the following
tolerances: apples, chicory leaves, corn grain, corn fodder,
cottonseed, onions (dry-bulb), pears, sugar beet tops, sweet
potatoes, turnip tops and hops. Data depicting the
potential concentration of methomyl residues are required for
the processed commodities of corn grain, citrus, cottonseed,
peanuts, potatoes, sorghum, soybeans, tomatoes, and wheat.
Data depicting the pyrolysis products of methomyl in tobacco
smoke are also required.
14
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Dietary Exposure
The Agency has established a Acceptable Daily Intake
(ADI) at 0.025 mg/kg/day based on a 2-year dog feeding study
(NOEL of 100 ppm) in which histological changes in the kidney
and spleen were noted. The Anticipated Residue Contribution
(ARC) to the human diet was calculated by factoring the published
tolerances by percent of the crops treated. The ARC for the
United States population is 0.006677 mg/kg/day which occupies
26.71?, of the ADI. The two highest calculated exposures were
non- nursing infants less than one year of age (0.018078 mg/kg/
day, 72.3?, of the ADI) and children 1-6 years old (0.010772
mg/kg/day, 43.1?, of the ADI).
14(a)
-------
TABLE II
SUMMARY OF TOLERANCES
Commodity
Beets, garden
Carrots
Chicory
Horseradish
Jerusalem
artichoke
Potatoes
Radishes
Sugar beet roots
Sweet potatoes
Turnips
Beet greens
Sugar beet tops
Turnip tops
Garlic
Onions green
Onions bulb
Celery
Dandelions
Endive (escarole)
Lettuce
Parsley
Spinich
Swiss chard
Broccoli
Brussels sprouts
Cabbage
Cauliflover
Chinese cabbage
Collards
Kale
Mustard greens
Beans, succulent
Beans, dry
Lentils
Peas
Soybeans
Bean forage
Pea vines
Soybean forage
Hay and Straw
Eggplant
Peppers
Tomatoes
Cucumbers
Melons
Squash
Grapefruit
Lemons
Oranges
Tangerines
T
U.S.
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
6.0
0.2
6.0
0.2
3.0
0.2
3 .0
6. 0
5. 0
5.0
6. 0
6. 0
6. 0
3 .0
2. 0
5.0
2.0
5.0
6.0
6.0
6.0
2.0
0.1
0. 1
5.0
0.2
10. 0
10. 0
10.0
0.2
2.0
1. 0
0.2
0.2
0.2
2 . 0
2 .0
2.0
2.0
olerances
Canadian
_
-
-
-
_
0. 1
-
0. 1
-
-
—
-
—
-
-
-
0.5
-
—
2 .0
0. 1
-
-
0. 1
0. 1
5. 0
0. 1
-
-
-
-
0. 1
0.1
-
0. 1
-
-
—
—
-
-
0. 1
-
-
-
1.0
1.0
1. 0
1. 0
(ppm)
Mexican
0. 2
_
-
_
0.2
—
-
—
—
—
—
_
0.2
-
-
3 . 0
-
_
5. 0
-
6. 0
—
3 . 0
—
5. 0
-
—
_
-
-
2.0
0. 1
—
-
0.2
10. 0
-
10. 0
0. 1
0.2
0.2
0.2
0.2
0.2
2.0
2 . 0
2 . 0
2 . 0
(MRL)
Codex
_
_
-
0. 1
_
0.1
_
_
_
_
_
_
0.5
0.5
3 . 0
—
_
5. 0
_
5. 0
_
_
_
5. 0
1.0*
_
_
5. 0*
_
2 . 0*
0. 1*
_
5.0*
0. 1
-
10. 0*
10. 0*
0. 5*
0. 1*
1. 0*
0.5*
0.2*
0.2*
2 . 0*
2 . 0*
2.0*
2 . 0*
-------
TABLE II
SUMMARY OF TOLERANCES (con't)
Commodity
Apples
Pears
Peaches
Blueberries
Grapes
Strawberries
Pecans
Barley, Oats and
Rye grains
Corn grain
Corn, fresh
Sorghum grain
Wheat grain
Forage, hay, and
Straw of barley,
oats and rye
Corn forage and
Fodder
Sorghum forage
Wheat forage, hay
and Straw
Bermuda grass
Bermuda grass hay
Alfalfa
Asparagus
Avocados
Cottonseed
Hops
Mint hay
Peanuts and hulls
Peanut forage
Pomegranates
Watercress
U.S.
1.0
4.0
5.0
6.0
5.0
2.0
0. I
1.0
0. 1
0. I
0.2
1.0
10.0
10.0
1.0
10. 0
10.0
40. 0
10. 0
2. 0
2 . 0
0. 1
7.0
2. 0
0. 1
5.0
0. 2
Tolerances (ppm)
Canadian Mexican
0.5 1.0
- -
-
-
4.0 5.0
-
0.1
— _
0.1
0.1 0.1
0.2
0.1 0.1
-
10. 0
1.0
6.0
-
-
10.0
2.0
-
0.1
-
-
-
-
- -
(MRL)
Codex
2 . 0*
—
5.0*
-
5.0*
—
-
—
-
0 . 2*
0. 1*
10.0*
_
10. 0*
10.0
—
—
10. 0*
2 .0*
-
0. 1
—
0.2*
0. 1*
5. 0*
_
6. 0
a=The U.S., Canadian, and Mexican tolerances and the Codex
Maximum Residue Levels (MRL's) expressed in terms of
residues of methomyl per se.
* These codex MRL's are pending.
# There is a 0.5 ppm codex MRL for peas, shelled.
-------
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on methomyl, the Agency has made
the following determinations:
1. Special Review.
The Agency is not now placing methomyl into Special
Review. The Agency has insufficient information at this time
to determine whether the criteria for initiating Special
Review at 40 CFR §154.7 are exceeded for methomyl use patterns.
Rationale: Laboratory data, theoretical calculations and
modeling indicate that methomyl use patterns could result in
residue levels that would exceed risk criteria for mortality
to non-target birds and aquatic organisms. Avian and aquatic
field studies are required to determine actual residue levels
in the affected environments and to assess the potential
risks to aquatic and avian species. Additionally, the Agency
believes that the restricted use classification for water
soluble bags and the more stringent reentry intervals identified
in this Standard provides increased mixer/loader and fieldworker
protection. The Agency intends, though, to monitor State pest-
icide incidents monitoring systems to determine the effectiveness
of the labeling changes indentified by this Standard and
the necessity of further regulatory actions.
2. Aquatic and Avian Field Testing
The Agency is requiring simulated or actual field test-
ing for both terrestrial and aquatic species.
Terrestrial Species. Actual field testing with birds
is required to support the continued use of 5% granular
end-use products.
Aquatic Species. Aquatic field, mesocosrn, or residue
monitoring studies are required using a typical end-use
product on the following sites: cotton, citrus, tobacco,
sweet corn, watercress and forest woodlots.
Rationale: These studies are needed to assess the risks to
birds and aquatic organisms and to determine whether additional
regulatory actions are warranted.
3. Restricted Use.
In 1978, the Agency, by regulation codified at 40 CFR
§162.31, classified all methomyl products except the 1%
bait and 90% water soluble bag formulations as restricted
use pesticides. The Agency has now determined that the 90%
17
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water soluble bag formulation should also be classified for
restricted use only. To remain in compliance with FIFRA,
label revisions will be necessary which specify that a
certified applicator must be physically present during mixing,
loading and application of this and all other restricted use
formulations.
Rationale: The Agency believes that the high acute toxicity of the
chemical to humans shows the need for a restricted use
classification for the 90% water soluble bag formulation. This
classification and the other precautions discussed below are not
being proposed for the one percent fly bait formulation because the
low exposures resulting from the use of such formulations don't
warrant this classification or additional precautions.
4. Protective Clothing and Equipment
The Agency will continue to require that labels bear
statements requiring the use of protective clothing for
workers reentering treated fields, and this protective
clothing provision has been upgraded. In addition, the use
of human flaggers during aerial application is prohibited
unless they are in enclosed vehicles.
Rat ionale: Because of the high acute toxicity of methomyl,
and the relatively high number of reported poisonings,
specific protective clothing and equipment and the above
prohibition are required to minimize exposure of methomyl to
fieldworkers, applicators and flaggers.
5. Reentry Intervals
In order to remain in compliance with FIFRA, the following
reentry interval directions must be placed on the labels of
all methomyl end use products (except the one percent fly
baits): one day for beans, cabbages, roses grown outdoors,
and carnations whether grown outdoors or in a greenhouse;
three days for cotton, nectarines, and oranges/citrus; four
days for peaches; and seven days for grapes. Because of the
similarity in the crops for which reentry data were provided,
and in the work tasks performed in those crops, a three day
reentry interval is being established for apples, and a one
day reentry interval for alfalfa, asparagus, broccoli, brussel
sprouts, carrots, cauliflower, celery, collards, cucumbers,
lettuce, melons, onions, peanuts, peas, peppers, potatoes,
sorghum, soybeans, summer squash, spinach, sugar beets, tobacco,
and tomatoes. An interim seven day reentry interval is required
for corn and a one day reentry interval is being imposed for
all other crops and use sites not listed above.
Rationale: The 1981 Registration Standard required that
reentry data be submitted and adopted California's two day
-------
reentry interval for citrus, grapes, nectarines, and peaches
as an interim measure. Based upon the reentry data submitted
in response to the 1981 Standard, the Agency is requiring the
above reentry intervals. In cases where additional data are
needed, the Agency has chosen to set the above interim reentry
intervals. Because of the large number of incidents associated
with corn detasseling and other tasks related to corn, an
interim seven day reentry interval is being required for corn.
These interim reentry intervals will remain in effect until
the requested data are received and evaluated. A reentry
interval for the one percent fly baits is not required because
of the low acute toxicity and use patterns which minimize
exposure.
6. Tolerance Revisions
Section 180.253 in 40 CFR will be revised as follows:
a. The current tolerance listing for residues in or on
"leafy vegetables [except beet tops . . ." ] will be revoked
and an individual tolerance of 0.2 ppm for residues in or on
sugar beets will be established.
Rationale: The current tolerances for residues in or on
"leafy vegetables [except beets (tops). . .]" is outdated
and currently covers only residues in sugar beet tops. Other
leafy vegetable crops included under this old crop grouping
have individual tolerances.
b. The tolerances for residues in or on celery, dan-
delions, endive (escarole), lettuce, parsley, spinach, and
Swiss chard will be revoked and replaced with a 6 ppm tolerance
on the crop group, leafy vegetables (except Brassica vegetables!
in 40 CFR 180.34(f ) .
Rationale: The available data support this crop group tolerance
c. The tolerance for residues in or on fruiting
vegetables will be revoked and replaced with an individual
tolerance of 0.2 ppm for residues in or on eggplant.
Rationale: The crop group tolerance of 0.2 ppm for residues
in or on fruiting vegetables is inappropriate. Entries for
tomatoes and peppers currently exist in 40 CFR 180.253 (a) at
1 and 2 ppm, respectively. The established tolerance for
residues in or on peppers is greater than five times that
established for eggplant. Thus, according to 40 CFR 180.34.
(f)(5), a crop group tolerance should not be established.
d. The tolerances for residues in or on grapefruit,
lemons, oranges, and tangerines will be revoked and replaced
with a 2 ppm tolerance on the crop group, citrus fruits in
19
-------
40 CFR 180.34(f).
Rationale: The available data support this crop group tolerance.
e. The established tolerance for residues in alfalfa
will be revoked and replaced with individual tolerances of
10 ppm for residues of methomyl in or on alfalfa forage and
alfalfa hay.
Rationale: Alfalfa forage and hay are considered to be
individual raw agricultural commodities and require separate
tolerances.
f. The designation "N" will be deleted from all
entries where it occurs in 40 CFR 180.253.
Rationale: The term "negligible residue", as defined in 40
CFR 180.1 (k)(i), is no longer used by the Agency in conjunction
with tolerance expressions because NOELs frequently change as
additional data become available.
7. Groundwater Contamination
Groundwater monitoring data are required since the avail-
able data indicated a potential ground water contamination
problem. The Agency has chosen not to include a groundwater
advisory statement on labeling at this time.
Rationale: Methomyl has been detected in two states. Additional
groundwater monitoring data are required to determine methomyl's
impact on groundwater. A groundwater advisory labeling statement
is not warranted because the levels of methomyl detected to date
are not toxicologically significant.
8. Toxicology -Metabolism Studies
The Agency is requiring rat and monkey metabolism studies
to determine the potential tissue levels of acetamide in non-
food producing animals.
Rationale; Acceptable data are not available on the animal
metabolism of methomyl. Previously submitted metabolism
studies do not meet current Agency Guidelines because results
were not reported in sufficient detail, used too few animals
of one sex and did not follow excretion for a sufficient
interval of time. This rat metabolism study was acceptable in
the initial Registration Standard, but now is considered
supplementary. The monkey metabolism study is required be-
cause the Agency needs a study conducted on a species more
closely related to humans in order to assess tissue levels
of acetamide, a possible human oncogen.
20
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9. A subchronic 21-day dermal toxicity study using both
abraded and unabraded skin which measures plasma and red
blood cell chlolinesterase as additional endpoints are
requi red.
Rationale: The requirement for the 21-day dermal toxicity
studies are being imposed because the present Guidelines
require a limit dose of 1000 mg/kg on intact skin for a dermal
study which does not produce toxic effects. However, since
fieldworkers often work with exposed and "abraded" skin, the
Agency is also requiring a study done with abraded skin.
10. Endangered Species and Bee Caution
The U.S. Fish and Wildlife Service (USFWS) has determined that
certain uses of methomy1, including uses on range and pastureland,
forests, grain crops, soybeans, sorghum and cotton, may jeopardize
the continued existence of endangered species. Fish, other aquatic
organisms and insects are at the greatest risk. A program is being
developed by the Agency to reduce or eliminate exposure of this
chemical to these species. After this program is developed,
the Agency will notify registrants of any additional labeling
that may be required to remain in compliance with FIFRA. A.s
explained below, the labeling requirements affecting met homy 1,
e.g. those listed in PR Notices 87-4 and 87-5, have been
withdrawn.
In addition, a bee caution is now required on all products
except granulars.
Rationale: Methomyl is highly toxic to fish and aquatic
organisms and insects, including bees.
In May 1987, EPA issued PR Notices 87-4 and 87-5 in
response to an OES finding that certain pesticides, including
methomy1, jeopardized the continued existence of endangered
species. Methomyl was omitted from the range and pasture-
land list and the forest list by error. The Agency later
withdrew these PR Notices. The Agency will notity regi-strants of
the labeling requirements and other relevant information to protect
endangered species.
11. Priority Review of Data
The Agency has identified certain data that will receive
priority review when submitted.
Rationale: Certain data are essential to the Agency's
assessment of methomy1. A review of these data may indicate
the need for further studies which should be initiated as
soon as possible (e.g. tiered studies). The following
studies have been identified to receive priority review:
21
-------
158.240 Residue Chemistry
171-4 Nature of the Residue (Metabolism-Livestock and
Poultry) , Meat/Mi Ik/Poultry and Eggs
158.390 Reentry Protection
132-1 Foliar Dissipation (Re-entry)
201-1 Droplet Size and Drift Field Evaluation
158.340 Toxicology
- Birds
82-2 21-Day Dermal Toxicity
85-1 General Metabolism
158.490 Ecological Effects
71-4 Avian Reproduction
71-5 Simulated and Actual Field Testing
72-1 Freshwater Fish Acute Toxicity
72-2 Acute Toxicity - Freshwater Invertebrate - TEP
72-3 Acute Toxicity - Aquatic Estuarine and Marine Organism
72-5 Fish Life Cycle
72-7 Field Testing for Aquatic Organism
158.290 Environmental Fate
162-3 Anaerobic Aquatic
162-4 Aerobic Aquatic
163-2 Volatility (Lab)
164-2 Aquatic (Sediment)
165-5 Accumulation in Aquatic
Groundwater Monitoring
Non-Target Organisms
12. The Agency will not establish any food or
regulations for methomyl until issues concerning
of methomyl are resolved.
feed additive
the metabolism
Rationale: The available data indicate that animals metabolize
methomyl into acetamide which may be oncogenic. The Delaney
Clause of the Federal Food, Drug and Cosmetic Act bars substances
which induce cancer in man or test animals, with exceptions which
may not apply here.
The Agency is requiring the submission of data to determine
whether methomyl residues are indeed converted to acetamide in
animal species that are used for human food and whether humans
are likely to convert methomyl residues to acetamide. The Agency
has issued a policy to address Delaney Clause issues regarding
pesticides that have produced positive oncogenic responses in
chronic animal studies (53 FR 41104, 10/19/88). After metabolism
data are reviewed, the Agency will determine whether and
22
-------
how to apply its Delaney Clause policy to methomyl.
13. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing methomyl may be sold, distrubuted, formulated, and
used, subject to the terms and conditions specified in this
Standard. Additionally, registrants must provide or agree to
develop additional data, as specified in the Data Appendices,
in order to maintain existing registrations.
Rationale: Under FIFRA sections 3(c)(2)(B) and 3(c)(7) the
Agency may elect not to cancel or withhold registrations if
data are missing or inadequate. 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 actions are necessary.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
manufacturing use and end use products must contain this
pesticide, bear required labeling, and conform to the pro-
duct composition, acute toxicity limits, and use pattern
requirements listed in this document.
In order to remain in compliance with FTFRA, registrants
must comply with all terms and conditions described in this
section, including svibmission of product specific data specified
in Appendix I, submission of revised labeling, commitment to
fill data gaps on the schedule specfied by the Agency and,
when applicable, offer to pay compensation as required by
FIFRA sections 3(c)(l)(D) and 3(c)(2)(D), as amended. Reg-
istrants of end use products who qualify for the formulator's
exemption must submit five (5) copies of the draft labeling
incorporating the unique label statements identified in Sec-
tion D of this document. Registrants of end use products
who do not qualify for the formulator's exemption must
comply with the terms and conditions set forth above for
manufacturing-use registrants.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To conform to this Standard, manufacturing-use and end
use products must contain this pesticide ingredient. Each
formulation proposed must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and the intentionally added inert
ingredients. Additionally, all manufacturing-use and end
use products not derived from a registered source must
23
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declare all impurities found at greater than 0.1 percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade,
manufacturing-use, and end-use products containing methomyl
provided that the product labeling bears appropriate precaution-
ary statements for the acute toxicity category in which each
product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the sites and uses listed in the Index in Appendix
III. The Use Index lists all registered uses, as well as
approved maximum application rates and frequencies. However,
no use may be included on the label where the registrant
fails to agree to comply with the data requirements in Table A
for that use pattern.
D. REQUIRED LABELING
All manufacturing-use products and end-use products
must bear appropriate labeling as specified in 40 CFR 162.10,
PR Notices 83-2 and 83-3, precautions and warnings listed in
the Methomyl Use Index (Appendix III), and as indicated below.
Appendix II contains additional information on label specifi-
cations .
Schedule for these Labeling Requirements
No pesticide product containing methomyl as an active
ingredient may be released for shipment by the registrant
after May, 1990 unless the product bears an amended label which
complies with the specifications of the Standard.
No pesticide product containing methomyl as an active
ingredient may be distributed, sold, offered for sale, held
for sale, shipped, delivered for shipment, or received and
(having so received) delivered or offered to be delivered
by any person after May, 1991 unless the product bears an amended
label which complies with the specifications of this Standard.
To remain in compliance with FIFRA, all products must
have appropriate storage and disposal statements on the label.
Refer to Appendix II for the appropriate statements. Ad-
ditionally, the following ingredient statement must appear on
all methomyl product labels:
24
-------
"INGREDIENT STATEMENT
ACTIVE INGREDIENTS:
Methomyl ( S-Methyl-N- [ (methylcarbamoyl)oxy
thioacetimidate]
INERT INGREDIENTS:
MANUFACTURING-USE PRODUCTS
1. The following statements must appear directly beneath the
product name:
"An Insecticide for Formulating Use Only"
"Formulators using this product are responsible for ob-
taining EPA registration of their formulated product"
"For formulation into end-use insecticide products
intended only for (list acceptable sites)"
If detailed instructions for formulating are not provided
on the label, the following statement must appear:
"Refer to attached Technical Bulletin for formulating and
other information."
NOTE: The technical bulletin must be submitted along
with the product label for Agency review.
2. The following environmental hazard statement labeling is
specified for all manufacturing-use products:
"ENVIRONMENTAL HAZARD STATEMENT
This pesticide is toxic to fish. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public waters unless this product is
specifically indentified and addressed in the NPDES permit.
Do not discharge effluent containing this product to sewer
systems without previously notifying the sewage treatment
plant authority. For guidance, contact your State Water
Board or Regional Office of the EPA."
END-USE PRODUCT PRODUCT LABELING
1. The following reentry interval directions must be placed
on the labels of all methomyl end use products (except the
one percent fly baits):
25
-------
"Reentry into treated areas is prohibited for the fol-
lowing time periods after the end of application, unless
personal protective clothing and equipment specified on this
label for early reentry are worn.
25a
-------
Seven days for corn and grapes; four days for peaches;
three days for cotton, nectarines, citrus and apples;
and one day for all other crops and use sites. For early
reentry before sprays have dried or dust have settled,
wear a long-sleeved shirt, long-legged pants, shoes and
socks, chemical resistant gloves, face shield or goggles,
and NIOSH or MSHA approved respirator. For early re-
entry after sprays have dried or dusts have settled, all
the above except the respirator must be worn."
2. Restricted Use Statement
The following restricted use statement must appear on the
front panel of all methomyl end-use products except the one
percent fly baits.
RESTRICTED USE PESTICIDE
Due to High Acute Toxicity to Humans
For retail sale to and use only by certified applicator 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. Commercial certified applicators
must also ensure that all persons involved in these
| activities are informed of the precautionary statements.
I L
3. The following equipment and protective clothing statements
are required for all methomyl end-use products except the one
percent fly baits and these statements must be placed in the
directions for use section of the labeling:
"PERSONAL PROTECTIVE EQUIPMENT
USE ONLY WHEN WEARING THE FOLLOWING PERSONAL PROTECTIVE
EQUIPMENT DURING MIXING/LOADING, APPLICATION, REPAIRING AND
CLEANING OF MIXING, LOADING, AND APPLICATION EQUIPMENT, AND
DISPOSAL OF THE PESTICIDE: longsleeve shirt; long-legged
pants; shoes and socks, chemical resistant gloves; face shield
or goggles; NIOSH or MSHA approved respirator. During equipment
repair and cleaning, the respirator need not be worn.
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. All other protective 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
not be brought back into the cab unless in an enclosure such
as a plastic bag.
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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
USING TOBACCO PRODUCTS, 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 clothing
worn during work must be stored and laundered separately from
protective clothing and household articles. Store protective
clothing separately from personal clothing. 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 heavily contaminated or drenched with methomyl must
be destroyed according to state and local regulations.
HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE ADEQUATELY
DECONTAMINATED.
DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE PROHIBITED."
4. The following protective clothing statements are required
for one percent bait products and these statements must be
placed in the directions for use section of the labeling.
"PERSONAL PROTECTIVE CLOTHING
Use only when wearing the following personal protective
clothing during loading, application, repairing and cleaning
of application equipment, and disposal of the pesticide:
longsleeve shirt; long-legged pants; shoes and socks; gloves.
IMPORTANT! If pesticide coines in contact with skin, wash
off with soap and water.
ALWAYS WASH HANDS, FACE, AND ARMS WITH SOAP AND WATER BEFORE
USING TOBACCO PRODUCTS, EATING, DRINKING, OR TOILETING."
5. Additional labeling statements that are being required
for baits.
"Do not contaminate feed and foodstuffs. Do not apply
where poultry or other animals, especially dogs and young
calves, can pick it up or lick it.
Do not use in edible product areas of food processing
plants, restaurants, or other areas where food is commercially
prepared or processed. Do not use in serving areas when
food is present."
6. The following environmental hazard statements, to be
placed in the environmental hazard section of the label,
are required for all end use products:
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A. Granulars (which include baits)
"This pesticide is toxic to birds. Collect, cover or
incorporate granules spilled on the soil surface. Do not
apply directly to water or wetlands (swamps, bogs, marshes,
and potholes). Do not contaminate water when disposing of
equipment washwaters."
B. Non-Granular
1. Aquatic (Watercress)
"This pesticide is toxic to fish and wildlife. Drift
and runoff from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water
when disposing of equipment washwaters."
2. Terrestrial
"This pesticide is toxic to fish. Do not apply directly
to water or wetlands (swamps, bogs, marshes, and potholes).
Drift and runoff may be hazardous to aquatic organisms in
neighboring areas. Do not contaminate water when disposing
of equipment washwaters."
7. All end use products (except granulars and baits) with
outdoor crop uses must have the following bee caution and
this statement must be placed in the environmental hazard
section of the label.
"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 crops or weeds
while bees are actively visiting the treatment area."
8. If the directions for use include lentils, the following
restrictions must be placed in the directions for use section
of the label.
"Do not allow animals to graze in treated areas for three
days after treatment. Do not harvest crop for seven days
after treatment."
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VI. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product is a manufacturing or end use product and
whether the pesticide is the sole active ingredient or one of
multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2.
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.
B. Manufacturing use products containing this pesticide as one
of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2Data 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 an end-use producer who is eligible for the
generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products. The Agency has decided that, in most cases, it will
not require the submittal of product-specific data for end-use
products at this time. Therefore, most Registration Standards do
not contain a Table C.
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2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the sole active
ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the end use
product.
2. If eligible for the generic data exemption3, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data requirements
listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of multiple
active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the data
requirements listed in Table C.
3. The labeling requirements specified for end use
3If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data exemption for generic data
concerning that active ingredient (Table A) and product-specific
data for the registered manufacturing use product you purchase
(Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in
common with yours, you individually lose the exemption and become
subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end-use
producers lose the exemption, and become subject to the data
requirements in Table A.
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products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). It refers to the
data listed in Table A, which are required to be submitted by
registrants to maintain in effect the regis-tration of products
containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of
a product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having
that formulation type. These are classed as generic data, and
are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's exemption
(FIFRA sec. 3(c)(2)(D) and 40 CFR 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
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
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data.
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply to a
registered source that does not share ownership in common with
your firm. If you choose to change sources of supply, the
Confidential Statement of Formula must identify the new source(s)
and you must submit a Generic Data Exemption Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not yet
been submitted, any new registration will be conditioned upon the
new registrant's submittal or citation of the required data not
later than the date upon which current registrants of similar
products are required to provide such data. See FIFRA sec.
3(c)(7)(A). If you thereafter fail to comply with the condition
of that registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form you
must state which of the following six methods you will use to
comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been formed
which allows you to rely upon the data to be submitted. Such
evidence may be: (1) your letter offering to join in an
agreement and the other registrant's acceptance of your offer,
(2) a written statement by the parties that an agreement exists,
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or (3) a written statement by the person who will be submitting
the data that you may rely upon its submittal. The Agency will
also require adequate assurance that the person whom you state
will provide the data is taking appropriate steps to secure it.
The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or a mechanism
to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data Submitter
Number, as part of your 90-day response. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond concerning the
data ;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of the
consortium); and
e. Identification of the specific data that the consortium
will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to jointly
develop data, but no other registrant has accepted your offer.
You request that EPA not suspend your registration for non-
compliance with the DCI. EPA has determined that, as a general
policy, it will not suspend the registration of a product when
the registrant has in good faith sought and continues to seek to
enter into a data development/cost sharing program, but the other
registrants developing the data have refused to accept its offer.
[If your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Develop-ment
of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must, at a
minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
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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 sec. 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to limit
this commitment. If the other registrant to whom your offer is
made does not accept your offer, and if the other registrant
informs us on a DCI Summary Sheet that he will develop and submit
the data required under the DCI, then you may qualify for this
option. In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share in the
burden of developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply to
your product or its uses, you must provide EPA with a statement
of the reasons why you believe this is so. Your statement must
address the specific composition or use factors that lead you to
believe that a requirement does not apply. Since the Agency has
carefully considered the composition and uses of pesticide
products in determining that a data require-ment applies, EPA
does not anticipate that many waivers will be granted. A request
for waiver does not extend the time-frames for developing
required data, and if your waiver request is denied, your
registration may be suspended if you fail to submit the data.
The Agency will respond in writing to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required to
submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
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original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting the
requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must be
conducted in accordance with applicable Good Laboratory Practices
regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced in
the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (Part 158.70). Please
note, however, that certain OECD standards (such as test
duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be be
modified as appropriate so that the data generated by the study
will satisfy the requirements of Part 158. Normally, the Agency
will not extend deadlines for complying with data requirements
when the studies were not conducted in accord with acceptable
standards. The OECD protocols are available from OECD, 1750
Pennsylvania Avenue, N.W., Washington, D.C. 20006.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use test
procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for 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 submittal of the data,
nor will extensions generally be given to conduct studies due to
submittal of inappropriate protocols. The Agency will respond in
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writing to your request for protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate the
data than is allowed by EPA's schedule, you may submit a request
for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future claim
that there was insufficient time to submit the data. While EPA
considers your request, you must strive to meet the deadline for
submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity or
adequacy of funding, since the Agency believes that with proper
planning these can be overcome. The Agency will respond in
writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including, but
not limited to, requirements referenced or included in this
Notice or contained in PR Notice 86-5 (issued July 29, 1986).
All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the
submittal requirement.
J. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the registrant
is not consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale or
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distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing using
a specific formulated product, and, unlike generic data,
generally support only the registration of that product. All
such data must be submitted by the dates specified in this
Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided that
it will not routinely require product-specific data for end use
products at this time. Therefore, Table C may not be contained
in this Registration Standard; if there is no Table C, you are
not required to submit the data at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data) or"
VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and
its uses. General labeling requirements are set out in 40 CFR
156.10 (see Appendix II - LABELING and SUMMARY). In addition,
labeling language specific to products containing this pesticide
is specified in Section IV.D of this Registra-tion Standard.
Responses to this Registration Standard must include draft
labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in 8-1/2 x
11 files. Draft labeling must indicate the intended colors of
the final label, clear indication of the front panel of the
label, and the intended type sizes of the text.
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If you fail to submit revised labeling as required, which
complies with 40 CFR 156.10 and the specific instructions in
Section IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR 5UBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Document Processing Desk (RS-0023)
Office of Pesticide Programs - H7504C
U.S. Environmental Protection Agency
401 M St., SW
Washington, D.C. 7.0460
A. Hanu_l_ac_tu_r ing Use Products (HUPs) containing the__sjibjec_t
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit lor each product subject to this Registration Standard:
a. Generic Data Exemption Statement (F.PA Form 8580-3),
it applicable, or the "FIFRA Section 3 (c)(?.)(H) Summary
Sheet" (EPA Form 8580-1), with appropriate attachment.1;.
b. Confidential Statement of Formula (EPA Form 85/0 4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
1 52. 80-15?.. 99.
2. Within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1 ) .
b. Five copies of draft labeling, including the
container label and any associated supplemental labeling.
c. Product Specific Data Report (EPA Form 8580-4).
3. Within, the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
4. Within the times set forth in Table B, you must submit
all product specific data.
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B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Five copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit a]l generic data, unless you are eligible for the generic-
data exemption. If for any reason any test is delayed or
aborted so that the schedule cannot be met, immediately notify
the Agency of the problem, the reasons lor the problem, and your
proposed cour.se of action.
4. With in the time frames set forth in Table B, you must
submit all product specific data.
C . En d_Use_JP rgi.lv'.ct.s contaJjiijig, the...subject pest ic ido as so le
active ingredient.
1. Within 90 days from receipt ot this document, you must
submi t:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary Sheet,
with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you must
submit:
a. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
b. Five copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
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that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
4. Within the times set forth in Table C, you must submit
all product specific data.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3 ( c )(?.)( B ) Summary Sheet,
with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Five copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must .submit
all generic data, unless you are eligible tor tho gonerie data
exemption. It for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed
course of action.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 3L,
1988. Unless an application for registration was submitted by
that date, no product may be released tor shipment by the
producer after July 31, 1988.
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I. DATA APPENDICES
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table
'•42
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation .
-* • Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
3. Footnotes (at the end of each table). Self-explanatory.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requi lament
§158, Subpart C Pioduct Chemistry
Product Identity
61-2 - Description of Beginning
Materials and Manufactui ing
PrOCeSS
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TeSt USe DOeS Et
Substance Patterns Have D;
I/
TGAI All NO
TGAI All NO
TGAI All NO
TGAI All NO
TGAI Al 1 NO
TGM Al 1 NO
TGAI All NO
TGAI All NO
Bibliogianhic
Must Additional Time Frame
Data be for
Submitted? 2/ Submission
YES2/
YES3/
YES5/
YES5/
YES5/
YES5,6/
YES5,V
9 Months
9 Months
12 Months
9 Months
9 Months
9 Months
9 Months
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
Test Use Does EPA 3ibl ioqi aphic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
I/ Submitted? 2/ Submission
§158, Subpait C Product Chemistry (Continued)
Physical and Chemical Character istics
(Continued)
63-7
63-8
63-9
63-10
63-11
63-12
63-13
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
coefficient
- PH
- Stability
TGAI
TGAI or PAI
PA I
PAI
PAI
TGAI
TGAI
All NO
Al 1 NO
Al 1 NO
All NO
Al 1 NO
All NO
Al 1 NO
YESV
YESV
YES5/
YES5/
YES5, */
YF,s5,V
YES5/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Complete information must be provided regarding the nature and 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 anil the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition the name and address
of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must
be provided, along with information regarding the properties of each beginning material used to manufacture each
product.
-------
§158, .Subpart C Product^Chemistry (Continued)
3/ A detailed discussion of all impurities that are or nay be present at ^0.1%, based on knowledge of the
beginning materials, chemical reactions (intended and side) in the manufacturing process, and any contamination
during and after production must be submitted. Ttiis discussion must also address the possible formation of
nitrosamine unless the Registrant provides evidence that prcxkict containers are free of nitrosating agents.
4/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used. In addition, unless the Registrant provides evidence that product containers art.1 free of
nitrosating agents, all nitrosamines must be identified and quantified in six samples of each product; two
samples of each must lx^ analyzed shortly after prcxluction, 3 months after pnxluction, and 6 months after
prcxluction. A method sensitive to 1 ppm of N-nitroso contaminants must be used. An upper limit must be provided
and certified for all nitrosamines found.
5/ Physicochemical characteristics (color, physical state, odor, inelting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition ccx?fficient, pll, and stability) as required in 40 CFR
158.120 and more fully described in the Pesticide Assessment Guidelines, SuUiivision D, must be submitted.
6/ Data are needed if the technical chemical is a solid at r
-------
TALLL A
GENERIC DATA REO.U I Rl 1MENTS KIR METHOMYL
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tiunal data
t>e submitted?
Time frame
Lor
submission
158.240 Residue Chemistry
171-2. Chemical Identity1/
171-3. Directions for use^/
171-4. Nature of the residue PAIRA
(Metabolism)
- Plants
171-4. Nature of the residue PAIRA
(Metabolism)
- Ruminants
- Poultry PAIRA
(See Index)
00044069, 00135794,
001586B9, 05008206
PARTIALLY 00063418
NO
NO
YES March 19894a/
YES3,4/ 18 Months
171-4. Residue analytical
methods
171-4. Storage stability
TEP and
metatxDlites
PARTIALLY 00007132, 00009009,
00008837, 00009074,
00085367
PARTIALLY 00007044, 0006J421,
00073259, 00144617,
00126579, 05008453
,6/ March 19894a/
15 Months
171-4. Magnitude of the residue
in plants
Root and Tuber Vegeta-
bles
-Beets TEP
YES
00073259
NO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
158.240 Residue Chemistry (con't
-Carrots
-Chicory
-Horseradish
-Jerusalem artichoke
-Potatoes
-Radishes
-Suqar beet roots
-Sweet potatoes
-Turnips
Leaves of Root and Tubei
Vegetables
- Beet greens
- Chicory leaves
- Sugar beet tops
- Turnip tops
TeSt DOeS EPA
substance have data?
)
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
PEP
YES
YES
YES
YES
PARTIALLY
YES
YES
NO
YES
YES
NO
NO
PARTIALLY
Must addi-
Bibliographic tional data
citation be submitted?
00007837
00009063
(see carrots)
(See potatoes)
00008295, 00008862
(see carrots)
00007004, 00007161,
00008044
(;si--e car tots)
00073259
(also See spinach)
00008362
NO
NO
NO
NO
YES8/
NO
NO
YESV
NO
NO
YESW
YESH/
YES12/
Time frame
for
submission
24 Months
18 Months
18 Months
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
-P
CD
Data Reouiiement
Bulb Vegetables
- Gallic
- Onions
TeSt
substance
TEP
TEP
DOeS EPA
have data?
NO
PARTIALLY
Biblioqiaphic
citation
00007192, 00073261
Must addi-
tional data
be submitted?
YES13/
YES14/
Time fiame
fOL
submission
18 Months
18 Months
Leafy Vegetables
- Celeiy
- Dandelions
- Endive (escaiole)
- LettUCe
TEP
TEP
TEP
TEP
YES
YES
YES
YES
- Paisley
- Spinach
TEP
TEP
YES
YES
00144617
00007136, 00008679 NO
00008803, 00055457
(see spinach) NO
(See lettUCe) NO
00007039, 00007168 NO
00007175, 00007715
00007992, 00008264
00008964
(see spinach) NO
00007001, 00007002 NO
00007003, 00007185
00055457
- Swiss chaid
TEP
YES
(see spinach)
NO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requiiement
Biassica Leafy Vegetables
- Bioccoli
- Biussels spiouts
- Cabbage
- Chinese cabbage
- Cauliflowei
- Col la ids
- Kale
- Mustaid qieens
Lequme Vegetables
- Beans (Phaseolus)
- Lentils
- Peas
TeSt DOeS EPA
substance have data?
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
•PARTIALLY
Must addi- Time fiame
Biblioqiaphic tional data for
citation be submitted? submission
00007604, 00008043
00055457
00008043, 00055457
00007039, 00007168
00007715, 00007928
OOOOB679, 00008964
(See lettUCe)
00007605, 00008043
00055457
00008359, 00008359
00008360
00008361
00007134, 00007135
00007168, 00008264
00008436, 00009154
(see beans)
00007683, 00007999,
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
YES15/ 18 Months
00008154, 00009079
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Recruiteirient
TeSt
substance
DOeS EPA
have data?
Bibliogtaphic
citation
Must addi-
tional data
be submitted?
Time fiame
fOL
submission
- Soybeans TEP
Foliage of Legume
Vegetables Group
- Bean fotage and hay TEP
- Lentil foiage and hay TEP
- Peas vines and hay TEP
Soybean foiage TEP
and hay
Fiuiting Vegetables
(eXCept CuCUlbit) GLOUp
- Eggplant TEP
- PeppeLS TEP
- Tomatoes TEP
PARTIALLY
PARTIALLY
NO
PARTIALLY
PARTIALLY
YES
YES
PARTIALLY
00007008, 00008264,
00008411, 00008602,
00008998, 00009083,
00142925
00007134, 00007168,
00008264, 00009154
00007683, 00007999,
00008145, 00009079
00007008, 00008264,
00008411, 00008602,
00008998, 00009083,
00142925
00007039, 00009000
00006995, 00006996,
00007094, 00009000
00007007, 00007039,
00007094, 00007626,
00008742, 00156940,
05009890
YES16/
110
NO
YES21/
24 Months
YES17/
YES18/
YES19/
18 Months
18 Months
18 Months
18 Months
24 Months
-------
01
ro
TABLE A
GENERIC DATA REQUIREMENT'S FOR METHOMYL
Test Does EPA
Data Requirement substance have data?
Cucurbit Vegetables
Group
- Cucumbers TEP
- Melons TEP
- Squash TEP
Citrus Fruits Group
- Grapefruit TEP
- Lemons TEP
- Oranges TEP
- Tangerines TEP
- Tangelos TEP
YES
YES
YES
YES
YES
PARTIALLY
YES
YES
Must addi- Time frame
Bibliographic tional data for
citation be submitted? submission
00007970, 00009076, NO
00009291
00007970, 00009291, NO
00144827
00007970, 00144827 NO
00007137, 00007140, NO
00009070
00007138, 00009070 NO
00007139, 00009070 YES22/ 24 Months
00007140 NO
00009070 NO
Pome Fruits Group
- Apples
TEP
PARTIALLY 00007077
YES23/
18 Months
- Pears
TEP
PARTIALLY 00063419, 00063421 YES2V
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
Test
substance
DOeS EPA
have data?
Biblioqiaphic
citation
Must addi-
tional data
be submitted?
Time frame
foi
submission
en
CO
Stone Ftuits Gioup
- Peaches TEP
Small Fiuits and Berries
Group
- Blueberries TEP
- GiapeS TEP
- Strawberries TEP
Tree NutS Group
- Pecans TEP
Cereal Grains Group
- Bailey grain TEP
- Coin TEP
- Oat grain TEP
- Rye grain TEP
- Soighum grain TEP
- Wheat grain TEP
YES
YES
PARTIALLY
YES
YES
PARTIALLY
PARTIALLY
PARTIALLY
PARTIALLY
PARTIALLY
PARTIALLY
00038316, 00144827,
00156939, 00007672,
00007832
00008334
00007634, 00007991,
00144827, 00156973
00008847, 00009004
00008919
00007612
00007039, 00007142,
00007659, 00008838
00007612
00007612
00008233, 00009366
00007612, 00156941
NO
NO
YES25/
NO
NO
YES26/
YES27/
YES30/
YES3V
YES32/
18 Months
24 Months
18 Months
24 Months
24 Months
24 Months
24 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
Test
substance
Must addi- Time frame
Does EPA Bibliographic tional data foi
have data? citation be submitted? submission
en
-F
Foiage, Foddei, and
Stiaw of Ceieal Grains
Group
- Barley forage, hay, TEP
and straw
- Corn forage and fodder TEP
- Oat forage, hay, and TEP
straw
- Rye forage and straw TEP
- Sorghum forage TEP
- Wheat forage, hay and TEP
straw
Grass Forage Fodder and
Hay Group
- Bermuda grass TEP
Non-grass Animal Feeds
Group
- Alfalfa TEP
YES 00007612 NO
PARTIALLY 00007039, 00007142, YES33/
00008838, 00073260
YES 00007612 NO
YES 00007612 NO
PARTIALLY 00008233, 00009366 YES34/
YES 00007612, 00156941 NO
YES
YES
00050464, 00078359 NO
00007133, 00007159,
00008039, 00008984
NO
18 Months
18 Months
- Clover
TEP
NO
YES35/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYI,
CJl
en
Data Requirement
Must addi-
Test Does EPA Bibliographic tional data
substance have data? citation be submitted?
Time frame
for
submission
_T_-i«-au.-»i-i-iJ*i--U--M.-ii ii- - --•• • ..--.-- . .. . - ---— — ——.-- — — — — —— . - - i — — _______
Miscellaneous Commodities
- Asparagus
- Avocados
- Cottonseed
- Hops
- Mint
- Peanuts
- Pomegranates
- Watercress
- Tobacco
TEP YES U0008938
TEP YES 00161144
TEP PARTIALLY 00007690, 00007989,
00009075, 00009135,
00009378
TEP PARTIALLY 40056901
TEP YES 00007043, 00007044,
00007996
TEP PARTIALLY 00007081, 00007997,
00009078,
TEP YES 00009002, 00009003
TEP YES (see spinach)
PAIRA PARTIALLY 00007005, 00008453,
NO
NO
YES36/
YES37/
YES3B/
NO
YES 397
NO
NO
YESW
18 Months
24 Months
March 1989
24 Months
18 Months
Magnitude of the Residue
- Meat/Milk/Poultry/ TGAI
Eggs
00008964, 00157373,
05008453, 05013872
PARTIALLY 00008832, 00009365 YES41,42/ April 1990
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MLTHQMYL
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
submission
158.240^Residue Chemistry (con't)
I/ The same chenical identity data are required as under 158.120, with emphasis on impurities that could
constitute residue problems. Refer to Product Chemistry Data Requirements tables.
2/ The maximum number of applications and/or seasonal application rate must be specified on the product
labels for alfalfa, anise, apples, asparagus, avocados, Ixarley, t>eans, beets, Bermuda grass, blueter-
ries, broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, chicory, Chinese cabbage,
collards, field corn, sweet corn, popcorn, cotton, cucumbers, dandelions, eggplant, endive (escarole),
grapefruit, grapes, horseradish, Jerusalem artichoke, kale, lemons, lentils, lettuce, melons, mint,
mustard greens, nectarines, oats, onions, oranges, parsley, pasture grass, peaches, pecans, peppers,
pomegranates, potatoes, ralishes, rye, sorghum, soybeans, spinach, strawberries, summer squash, Swiss
chard, tangelos, tangerines, tomatoes, turnips, watercress, and wheat. These restrictions must be supported
by the available/requested residue data.
3/ Data are required depicting the metabolism of methomy1 in poultry. Animals must be dosed for three days
with [ 1-1 ^C] me thorny 1 at a level sufficient to make residue identification and quantification possible. Eggs
must be collected twice daily during the dosing period. Animals must be sacrificed within 24 hours of the final
dose. The distribution and characterization of residues must te determined in eggs, liver, kidney, muscle,
and fat. Specific analyses for acetamide and acetonitrile must be included. Samples from these studies must
also be analyzed by Method I in the PAM, Vol. II, Pest. Reg. Sec. 180.253 to ascertain that the method
is capable of adequately recovering and quantifying all residues of toxicological concern.
4/ Data depicting the nature of methorny1 residues in swine are also required unless the metabolism of methomy1
in ruminants or poultry does not differ significantly from that in rats.
4a/ These data have teen submitted recently, and are currently in review.
5/ Residues of me thorny1 occurring in or on raw agricultural plant commodities must be subjected to analysis by
multiresidue Protocols I, II, and IV. These Protocols are available from the National Technical Information
Service under Order No. PB 203734/AS.
-------
158.240 Residue Chemistry (con't)
6/ If the requested data on animal metabolism indicate that residues of toxicological concern OCCUL in tissues,
milk, OL eggs, methods foi data collection and enforcement will be requited. We have required, in the "Nature of
the Residue in Animals" section, that LepieSentative samples from the metabolism studies, in which [1-14C]-
methomyl is to be used, be subjected to analyses using Method I in the PAM, Vol. II.
7/ If the requested data on animal metabolism indicate the presence of tesidues of toxicological concein, data
depicting the stability of those Lesidues in tissues, eggs, and milk duting frozen storage will be requited.
8/ Data are required depicting methomyl residues in chips, granules or flakes, and wet and dry potato peel pro-
cessed from potatoes bearing measurable weathered residues. If residues concentrate in any of these processed
commodities, an appropriate food/feed additive tolerance must be proposed. It may be necessary to use
exaggerated rates to obtain measurable residues in the raw agricultural commodity.
9/ Data are required depicting residues in or on sweet potatoes grown in CA and harvested 30 days after the last
of three aerial applicationns with the 90% SC/S formulation at 1 Ib ai/5 gal/A. Alternatively, the 24(c)
registration may be voluntarily cancelled.
10/ Data are required depicting residues in or on chicory leaves harvested 80 days after multiple foliar applica-
tion at 5-day intervals of the 1.8 Ib/gal SC/L formulation at 0.9 Ib ai/A. Tests must be conducted in MA(6%),
NJ(17%), and NY(3%), which collectively accounted for 26% of the 1982 U.S. chicory acreage (1982 Census of
Agriculture, Vol. 1, Part 51, p. 341), and represent the major U.S. chicory growing regions.
ll/ Data are required depicting residues in or on sugar beet tops harvested 7 days after multiple soil and foliar
applications (in the same test) of the 1.5% G and an SC/L or SC/S formulation, respectively, at 0.9 Ib ai/A. For
foliar treatments, both ground and aerial application data (from separate tests) must be provided, if necessary,
an appropriate tolerance increase must be proposed. Also, the 30-day PHI for "tops" must be stricken from the
labels. Tests must be conducted in CA(21%), ID(15%), MN(22%), and WY(5%) which together represent 89% of the U.S.
sugarbeet crop if MN represents MI(10%), NE(5%) and ND(11%).
12/ Data are required depicting residues of methanyl in or on turnip tops harvested 3 days following the last of
two foliar applications of the 90% SC/S formulation at 0.9 Ib ai/A. Ground and aerial equipment must be
represented in separate tests. Tests must be conducted in CA. Alternatively, the registrant may elect to cancel
this use permitted under EPA SLN No. CA770495.
13/ The data required for dry bulb onions will be translated to garlic.
-------
en
CD
158.240 Residue Chemistry (con't)
14/ Data aLe LequiLed depicting Lesidues of methoinyl in OL on diy bulb onions haLVeSted 7 days following
multiple foliaL applications of the 90% SC/S OL a SC/L foimulation at 0.9 Ib ai/A and multiple soil
applications of the 1.25% G foimulation (in the same field tiials) at 0.25 Ib ai/A. Tests must be conducted
(1) CA(28%), (2) NY(9%), and (3) ID(8%) OL OR(15%), states that accounted foi 70% of U.S. onion pioduction for
stOLage, non-stOLage and pLOcessing (AgLicultuLal Statistics, 1986).
15/ Data aLe LequiLed depicting Lesidues in dLied pea seed haLVested 1 day aftei the last of seVeLal soil and
foliaL applications (in the same test) of a G and SC foLmulation, Lespectively, at 0.9 Ib ai/A. Tests must
be conducted in WI(28%) and WA(17%) which togethei LeOLeSent appLoximately 74% of the U.S. pea ciop (foL
pLOcessing) if WI LepLeSents MN(22%) and WA LepLeSents OR(7%) [Agricultural Statistics, 1986, p. 162], A
toleLanCe fOL LeSidUeS in dLied pea Seed must be pLOpOSed.
16/ Data aLe LequiLed depicting the potential foi concentLation of Lesidues in meal, soapstock, caude oil,
Lefined oil, and giain dust pLOCessed fLom soybeans bearing measurable, weatheLed Lesidues. If the data
indicate a potential foL concentLation of Lesidues in any of these processed commodities, an appLOpiiate
fOOd/feed additive toleLanCe mUSt be pLODOSed.
17/ Data aLe LequiLed depicting Lesidues in OL on bean hay haLVested 7 days aftei the last of seVeLal foliaL
and soil applications (in the same test) with a SC and G foLmulation, Lespectively, at 0.9 Ib ai/A. Tests
must be conducted in MI(24%), ND(14%), ID(9%), C0(13%) and CA(16%) which togetheL represent appLoximately 88%
of the U.S. bean pLoduction area if CO LepLeSents NE(12%) [AgLicultuLal Statistics, 1986, p. 252]. FOL
foliaL applications, both gLOund and aerial data, fiom sepaLate tests, must be submitted. The LegistLant
must pLopose a toleLance foL residues of methomyl in OL on bean hay. AlteLnatively, the LegistLant may elect
to amend all peLtinent labels to pLOhibit feeding of hay.
18/ ToleLances foL Lesidues of methomyl in OL on lentil foiage and hay must be pLoposed. Also, a piegLazing
inteLval of 2. 3 days fOL foLage and a pLehaLVcSt inteLval of _> 7 days fOL hay must b_- pLoposed. These
pLegiazing/pLehaLVeSt inteLvals will allow the Registiant to use the available and Lequested data foL otheL
legumes in suppoLt of the pLoposed toleLanceS. A toleLance of 10 ppm should be pLoposed foL foiage. The
appLOpriate toleLance level foL hay will depend on the Lesults of the LequiLed data fOL bean hay.
AlteLnatively, feeding and gLazing LestLictions fOL lentil foLage and hay may be pLoposed.
19/ Since pea hay is a Law agLicultuLal commodity of peas, the LegistLant must pLopose a toleLance foL
Lesidues of methomyl in OL on pea hay. The LequiLed data for bean hay may be tLanslated to pea hay.
AlteLnatively, the LegistLant may elect to amend all peLtinent labels to pLOhibit feeding of hay.
-------
158.240 Residue Chemistry (con't)
20/ Since soybean hay is a raw agiicultuial commodity of soybeans, the registrant must piopose a tolerance
foi residues of methomyl in OL on soybean hay. The required data for bean hay may be translated to soybean hay.
Alternatively, the registrant may elect to amend all pertinent labels to prohibit feeding of soybean hay.
21/ Data are required depicting the potential for concentration of methomyl residues in catsup, juice, puree,
and dry pomace processed from tomatoes bearing measurable, Weathered residues. If concentration occurs during
processing, the registrant must propose an appropriate food/feed additive tolerance.
22/ Data are required depicting methomyl residues in or on dried citrus pulp, citrus juice, molasses, and oil
processed from representative citrus fruit bearing measurable, weathered residues. If residues are found to
concentrate in any of these commodities, an appropriate food/feed additive tolerance must be proposed.
23/ Data are required depicting residues in or on apples harvested 8 days after multiple foliar applications
with an SC formulation at 1.8 Ib ai/400 gal/A. Tests must be conducted in WA(26%), NY(14%), MI(14%), and VA(5%)
which together produce 60% of the U.S. apple crop and represent all major growing regions (Agricultural Statistics
1986, p. 186).
24/ Data are required depicting methomyl residues in or on pears harvested 7 days after a single foliar
application of the 1.8 SC/L or SC/S formulation at 1.8 Ib ai/400 gal/A, to be applied with ground equipment.
Required tests must be conducted in NY which accounted for ca. 87% of the 1982 U.S. northeastern pear production
1982 Census of Agriculture, Vol. 1, Part 51, p. 364).
25/ The tolerance for residues in or on grapes is too low. The Registrant must either propose a tolerance
revision to _> 10 ppm or_ a higher PHI (must be efficacious and supported by residue data). The acceptability of a
tolerance increase will depend upon toxicological consideration.
26/ Processing data will be translated from the required data for wheat.
27/ Data are required depicting residues of methomyl in or on corn grain harvested on the day of the final
application of treatment schedules that include foliar application of a G formulation at 1 Ib ai/A, applied
using ground and aerial equipment in Separate tests, and multiple foliar applications of the 90% SC/S or a SC/L
formulation at 0.45 Ib ai/A applied by both ground and aerial equipment in separate tests. Tests must be con-
ducted in IL(17%), IA(19%), NE(11%), and MN(8%) which collectively produced ca. 60% of U.S. corn grain in 1985
and represent the major field corn growing regions (Agricultural Statistics, 1986, p. 32). The registrant must
propose a maximum number of applications per Season and this maximum number must be reflected in all residue
data used to support the established tolerance.
-------
a>
o
158.240 Residue Chemistty (con't)
28/ Data ate required depicting the potential foi concentration of residues in commodities processed fiom
coin giain bearing measurable, weatheted residues. Data ate tequited on staich, etude oil, and refined oil
from wet milling; giits, meal, flout, etude oil, and tefincd oil ftom dry milling; and gtain dust. If the
data indicate a potential fot concenttation of tesidues in any of these commodities an apptoptiate food/feed
additive toletance must be ptoposed.
29/ Ptocessing data will be ttanslated ftom the requited data fot wheat.
30/ Processing data will be ttanslated ftom the required data fot wheat.
31/ Data ate tequited depicting the potential for concentration of residues in flout, statch, and gtain
dust ptocessed ftom sotghum gtain beating measutable, weatheted tesidues. If the data indicate a potential
fot concenttation of residues in either of these commodities, an apptoptiate food/feed additive toletance
must be ptoposed.
32/ Data ate tequited depicting the potential fot concenttation of residues in middlings, shotts, and
gtain dust derived ftom wheat gtain beating measutable, weatheted tesidues. If the data indicate a potential
fot concenttation of tesidues in any of these commodities, apptoptiate feed additive tolerances must be
pt oposed.
33/ Data ate tequited depicting tesidues of methoinyl in ot on corn faider harvested 3 days following the
completion of a treatment schedule that includes foliat application of a G formulation at 1 Ib ai/A
and foliat applications of the 2.4 Ib/gal SC/L fotmulation at 0.45 Ib ai/1 gal/A. Sepatate test
data fot aerial and gtound applications must be submitted. Tests must be conducted in IL(17%), IA(19%),
NE(11%), and MN(8%) which collectively produced ca. 60% of U.S. cotn gtain in 1985 and teptesent the majot
field cotn gtowing tegions (Agricultural Statistics, 1986, p. 32).
34/ Data ate tequited depicting tesidues in ot on foddet and hay hatvested 14 days aftet the last of seVetal
foliat applictions of a SC fotmulation at 0.45 Ib ai/A. Tests must be conducted in KS(26%) and TX(22%) which
togethet teptesent 80% of the U.S. sotghum production atea if KS represents M0(ll%) and NE(14%) and TX repre-
sents AR(6%) [Agricultural Statistics, 1986, p. 52]. Toleiances must be ptoposed. Altetnatively, the Re-
gistrant may amend all labels to prohibit feeding of sotghum foddet ot hay to livestock.
-------
158.240 Residue Chemistry (con't)
35/ Data are required depicting residues of methorny1 in or on clover forage and hay harvested inuiediately
following the last of multiple foliar applications of the 90% SC/S formulation at 1 Ib ai/A using Ixjth ground
and aerial equipment in separate tests. The registrant must propose a maximum number of applications pet-
season. The requested data must reflect these proposals. Alternatively, the registrant may elect to cancel
this use permitted under EPA SLN No. CA780127.
36/ Data are required depicting residues in or on cottonseed harvested 15 days after the last of several
foliar treatments using a D formulation at 1 Ib ai/A. Tests must be conducted in CA(23%), MS(12%) and TX(29%)
which together produce 64% of the U.S. cotton crop (Agricultural Statistics, 1986, p. 62). An appropriate
tolerance increase must be proposed.
37/ Data are required depicting concentration of methomy1 residues during processing of cottonseed hulls and
soapstock derived from cottonseed bearing measurable weathered residues. (Exaggerated application rates may
be necessary to obtain these levels on the cottonseed). If concentration occurs during processing, the
registrant must propose appropriate food/feed additive tolerances.
38/ These data were requested in an FR Notice dated Sept. 23, 1987 (52 FR 35730; PP j} 7E3495) .
39/ Data are required depicting methomy1 residues in meal, crude oil, refined oil, and soapstock processed from
peanuts bearing measurable weathered residues. If residues concentrate in any of these processed commodities,
then appropriate food/feed additive tolerances must be proposed.
40/ Pyrolysis products derived from the active ingredient must be characterized in tobacco smoke.
Weathered residues of [14C]methomyl must be used for identification of pyrolysis products.
4I/ Additional animal metabolism data have been requested in this document (see "Nature of the Residue in
Animals" sections for details). Upon receipt of those data the need for and nature of tolerances for
residues of methorny1 in meat, milk, poultry, and eggs will be determined and additional feeding studies
may be required.
42/ These data were required previously through a Data Call-In notice in March 1987.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement Test Use
Substance Patterns
Does EPA Bibliographic
Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission
§158.340 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-7
•)
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
YES 00009227
YES 00007947
YES 00008982
YES 00008827
NO
NO
NO
NO
3 SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent (Rat)
Non-Rodent (Dog)
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
TGAI
TGAI
TGAI A,B,C
E,F,G
I
TGAI
TGAI
NO
NO
NO
NO
NO
NO1/
NO2/
YES3/ 12 Months
NOV
NOV
Rat
82-5 - 90-Day Neuiotoxicity-
Hen/Mammal
TGAI
NO
NO5/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
§158.340 Toxicology (Cont.)
CHRONIC TESTING:
83-1 - Chronic Toxicity -
Rodent (ChR-CD® Rat)
Non-rodent (Beagle Dog)
83-2 - Oncogenicity Study -
o. (ChR-CD® Rat)
(MOUSe)
83-3 - Teratogenicity -
(Rat)
(Rabbit)
83-4 - Reproduction,
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use DOeS EPA
Patterns Have Data?
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
Bibliographic
Citation
00078361
00007091
00078361
00078423
00008621
00131257
00007093
00161887
00161888
05009139
Must Additional Time Frame
Data be for
Submitted? Submission
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Mutagenicity
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.340 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A,B,C
E,F,G
I
86-1 - Domestic Animal Safety Choice
NO
NO
YES6/
NOV
24 Months
CJ)
f
I/ This requirement is waived based on the submission of an acceptable chronic feeding study in the rat.
2/ This requirement is waived based on the submission of an acceptable chronic feeding study in the dog.
3/ Under the first Standard, MRID No. 00009234 was considered satisfactory. However, this Standard is downgrading
this study to supplementary. Guidelines require a limit dose of 1000 mg/kg on intact skin which does not produce
toxic effects. In addition, the Agency is requiring testing on both abraded and unabraded skin measuring plasma
and red blood cell cholinesterase as an additional endpoint.
4/ This study is not required under the existing use patterns.
5/ Since an acute neurotoxicity study is negative for this com(X>und and there is no evidence of neurotoxicity in mam-
malian species, this study is not required.
6/ Guideline studies in the rat and monkey are required to determine potential tissue levels of acetamide in non-food
animals following ingestion of methomyl.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
01
en
Data RequiLeinent Test
Substance
§158.290 Emmonmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydiolysis TGAI OL PAIRA
Photodeqi adat ion
161-2 - In watei TGAI 01 PAIRA
161-3 - On soil TGAI 01 PAIRA
161-4 - In ail TGAI OL PAIRA
METABOLISM STUDIES-LAB:
162-1 - AeLObic Soil TGAI 01 PAIRA
162-2 - Anaeiobic Soil TGAI OL PAIRA
162-3 - Anaeiobic Aquatic TGAI OL PAIRA
162-4 - AeLObic Aquatic TGAI OL PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI OL PAIRA
AdsoLption/DeSOLption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Use Does EPA BibliogLaphic
Patteins Have Data? Citation
A,B,C,E,F YES 00131249
A,B,C YES 00161885
A YES 00163745
NO
A,B,E,F YES 00008568
A YES 00073214
C NO
C NO
A,B,C,E, YES 00044306
F 00161884
A,E,F NO
A,E,F NO
Must Additional Time FLame
Data be foi
Submitted? Submission
NO
NO
NO
ReSeLVedl/
NO
NO
YES 27 Months
YES 27 Months
NO
YES 12 Months
ReSeLVedV
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
en
en
Data Requirement
§158.290 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Continued
TEP A,B YES 00009326
TEP C NO
TEP A NO
TEP A NO
Must Additional
Data be
Submitted?
NO
YES
NO2/
NO3/
Time Frame
for
Submission
27 Months
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-4 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
GROUNDWATER MONITORING
PAIRA A YES
TEP A NO
TEP C NO
TGAI or PAIRA A,B,C YES
TEP NO
TEP A,B NO
00019947
00019947
NO
N04/
YES
NO
YES
YES5/
39 Months
12 Months
27 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
§158.290 Environmental Fate - Continued
I/ These studies may be requited pending lesults of the laboratory volatility study.
2/ Although there are forestry uses, the application is for ground only, therefore this study is not applicable.
3/ These data ate not required because methomyl is not peisistant.
4/ As data showed that methomyl did not accumulate in the confined study, a field study is not needed.
5/ Based on the results of the laboratory studies on mobility, additional data are necessary to determine the impact
of methomyl on ground water. Therefore, snail scale retrospective groundwater field monitoring studies are
being required. This type of study evaluates the impact of past (and current) use of a pesticide on ground water
beneath, and if appropriate, downgradient of fields with known histories of usage and hydrogeologic vulnerability.
A minimum of three field sites will be required. For each site, the study will encompass at least one set of
soil samples (to characterize the soil down to the water table and to locate contaminate plumes from recent
applications) and several water samples from wells installed for the study. Existing wells may also be used
for sampling if properly constructed and they tap appropriate protions of the aquifer. A protocol must be sub-
mitted within 90 days from receipt of this notice prior to initiation of the study. This protocol must also
propose geographic areas (preferably counties) in which appropriate sites will be located. These areas must
01 be typical of the use sites of methomyl and must be hydrogeologically vulnerable. The proposal must include
justification of the proposed area: hydrogeologic vulnerability as evidenced by sandy soils, shallow aquifers
and use patterns as evidenced by sales data. In addition, sampling and laboratory methodology (including
analytical recovery data) must be included for parent methomyl and degradates.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
en
GO
Data Requirement
§158.390 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
131-3 - Dermal Exposure
131-4 - Inhalation Exposure
§158.440 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use
Pattern
A,B
A,B
A,B
A, 8
A,B
A,B
Does EPA Bibliographic
Have Data? Citation
PARTIALLY
NO
NO
NO
NO
NO
Must Additional Time Frame
Data be for
Submitted? Submission
YES1/ 27 Months
NQ2/
NO3/
NO3/
YES4/ 27 Months
YES4/ 27 Months
I/ Data are required for mint, roses grown in greenhouses, chrysanthemums in greenhouses or outdoors and the weight/area
conversion factors (used in the data previously submitted) for corn foliage. For each end-use, the registrant is
required to propose an acceptable reentry interval based either upon data: (a) on dissipation of residues (decline
curve), on human exposure to those residues, and on toxicity of the residues; or (b) on determination of that time
beyond which there are no detectable dislodgeable or inhalable residues remaining in the worder/occupant environment.
If the registrant has reason to believe that an end-use product will not cause exposure to residues, a request for
waiver from this data requirement must be submitted.
2/ Soil dissipation data are requited only for uses where workers will be exposed directly to substantial quant-
ities of soil during their work activities, e.g. for use on potatoes or peanuts where hand harvesting will be
pel formed.
3/ Human exposure monitoring data may be submitted at the registrant's option. However, if dermal exposure data
are submitted, then inhalation data must also be submitted.
4/ The spray drift droplet spectrum and field evaluation may be done together in order to evaluate the droplet
spectrums that are associated with actual field use patterns.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
§158.490 Wildlife and Aquatic
TERRESTRIAL ORGANISMS
71-1 Avian single dose
oial LD5Q
71-2 Avian Dietary LC50
a. upland game bird
b. wateifowl
71-3 Wild Mammal
71-4 Avian Reproduction
71-5 Simulated and Actual
Field Testing for
Mammals and Birds
AQUATIC ORGANISMS
72-1 Freshwater Fish LC50
a. warmwater
b. coldwatei
c. warmwater
d. coldwater
e. warmwater
72-2 Acute LC5Q Freshwater
Invertebrate
TeSt
Substance
Organisms
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
(5% granular )
TGAI
TGAI
TEP
TEP
DEGRADATE
TGAI
TEP
Use
Patterns
A,B,G,I
A,B,G,I
A,B,G
A,B,G
A,B,G
A,B,G
A,B,G,I
A,B,G
A,B,G
A,B,G
A,B,G
A'B'C^G'
DOeS EPA
Have Data?
YES
YES
YES
YES
NO
NO
YES
YES
PARTIALLY
PARTIALLY
YES
YES
PARTIALLY
Bibliographic
Citation
00161886
00062189
00022923
00062189
40094602
40094602
40094602
00077273
40094602
00077272
00009226
00077271
00009061
00019977, 00034016
40094602
Must Additional Time Frame
Data be for
Submitted? Submission
NO
NO
NO
NOV
YES2/ 24 Months
YES3/ 48 Months
NO
NO
YES4/ 9 Months
YES4/ 9 Months
NO
NO
YES4/ 9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
§158
72-3
72-4
72-5
72-6
72-7
.490 Wildlife and Aquatic
Acute LC5Q Estuarine and
Marine Organisms
a. Shrimp
b Fish
c. Mollusk
Fish and Early Life-
Stage Aquatic Invert.
Life-Cycle
Fish Life-Cycle
Aquatic Organism
Accumulation
Simulated/Actual
Test
Substance
Organisms (Cont.
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
TEP
TEP
TEP
Use
Patterns
A,B
A, 8
A,B
A,B
A,B
A,B
A,B
A,B,C,G
A,B,C,G
A,B,C,G
A,t3,C
A,B,C
DOeS EPA
Have Data?
NO
PARTIALLY
NO
NO
NO
NO
YES
YES
NO
YES
NO
Bibliographic Must Additional
Citation Data be
Submitted?
YES5/
00009134 YES5,4/
00009230
YES5
YES5,4/
YES5
YES5,4/
00131255 NO
00131254 NO
YES6/
NO
YES7/
Time Frame
for
Submission
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
27 Months
48 Months
Field Testing of
Aquatic Organisms
or Residue Monitoring
-------
TABLE A
GENERIC DATA REQUIREMENTS EOR METHOMYL
Data Requirement
Test
Substance
Use
Patteins
DOeS EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Fiame
for
Submission
§158.490 Wildlife and Aquatic Organisms (Cont.)
I/ The Agency will use toxicology data to satisfy this requirement.
2/ This study is Lequiied because the use directions call foi lepeat applications.
3/ Actual field testing (Level 1) with buds is requited, as per 40 CFR 158.145, to support the use of end-use
products containing the 5% granular formulation. Initial sites to be tested, based upon application rates and
wildlife usage information include; field corn and sorghum (broadcast applications). The design of the field
study must include appropriate methods such as thorough carcass searching to determine whether there is a
pesticideinduced mortality and, if so, to what extent. Protocols for these field studies must be submitted to
the Agency for review within 90 days from receipt of the standard. A Guidance Document is available, from the
Agency, which outlines an acceptable approach to these studies. The Agency encourages the registrants to consult
with our staff for assistance as needed.
4/ Testing is being required for the emulsifiable concentrate formulation.
5/ Testing is being required in shrimp, fish and mollusk to support cotton, citrus and peanut uses (crops exceeding
300,000 acres in coastal counties).
6/ Test are required because estimated environmental concentrations are equal to or greater than 1/10 of the no-
effect level in the fish early life-stage or invertebrate life cycle test.
7/ Aquatic field studies, mesocosm studies and/or the option to conduct residue monitoring studies are required
for the cotton, citrus, tobacco, sweet corn, watercress and forest woodlot uses. Field studies for other use
patterns are reserved pending an evaluation of the results for these crops and an analysis of their applicability
to support other uses. Study protocols for each study must be submitted to the Agency. For either mesocosm or
actual aquatic field studies, the study design must include appropriate techniques to determine acute mortality
to aquatic invertebrates and effects on productivity and diversity of fish. A protocol for a mesocosm or
full field study must be submitted to the Agency for review within 90 days from receipt of the standard.
A guidance document is available, from the Agency, which outlines an acceptable approach to mesocosm studies.
This document also provides relevant, although general, guidance for full field studies, which, if selected in
place of the mesocosm studies, must include multiple treated ponds and control ponds. The Agency encourages
registrants to consult with the our staff for assistance as needed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission
§158.540 Plant Protection
121-1
- TARGET AREA EP
PHYTOTOXICITY
NO - NO Reserved^/
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER II
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER III
- Terrestrial Field TEP
- Aquatic Field TEP
NO - NO Reserved1/
NO - NO Reserved1/
HO
NO Reserved1/
NO - NO Reserved1/
NO - NO Reserved1/
NO - NO Reserved1/
NO - NO Reserved1/
NO - NO Reserved1
I/ These data are not required in accordance with §158.150.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.590 Nontarqet Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - PREDATORS
143-3 AND PARASITES
TGAI
TEP
(ReSerVed)1/
TEP
(ReSerVcd)3/
(ReSerVed)3/
(ReSerVed)3/
(ReSerVed)3/
A,B,G,H
A,B,G,H
YES
YES
A,B,G,H
NO
05011163
00014715
05000837
NO
NO
NO2/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHOMYL
§158.540 and §158.590 Plant Protection and Nontarget Insect - Continued
I/ Reserved pending development of methodology.
2/ This requirement is imposed on a case-by-case basis. Data reviewed under this standard do not indicate the need
for a field study.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHOMYL
-o
en
Data Requirement Test
Substance
§158, Subpait C - Product Chemistry
Product Identity:
61-1. Product Identity and
Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and
Manufacturing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density or
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
USe
Patterns
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
Does EPA Bibliographic
Have Data?1/ Citation
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Must Additional
Data b«
Submitted?
YES2/
YES3/
YESV
YES5/
YES6/
YES7/
YES8/
YES8/
YES8/
YES8/
Time Frame
for
Submission
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
9 Months
9- Months
9 Months
9 Months
Specific Gravity
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHOMYL
Data Requirement • Test
Substance
Use
Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data?1 Citation Data be for
Submitted? Submission
§158, Subpart C - Product Chemistry (cont.)
63-12 - pH
62-14 - Oxidizing or Reducing Action
62-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-19 -Miscibility
01 63-20 -Corrosion Characteristics
Other Requirements:
64-1 - Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
N/A
ALL
ALL
ALL
ALL
ALL
ALL
ALL
N/A
NO
NO
NO
NO
NO
NO
NO
N/A
YES8,9/ 9 Months
YES8,W 9 Months
YES8, IV 9 Months
YES8,!^/ 9 months
Yes8/ 15 months
YES8,W 9 months
YEs8,14/ 15 months
NO
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
be resubmitted for each pesticide. -New requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
2/ 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 empirica formulas; the molecular
weight or weight range; and any experimental or internally assigned company code numbers.
3/ Complete information must be provided regarding the nature and process (batch or continuous), the relative
amounts of beginning materials and the order in which they arc added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition the name and address
of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must
be provided, along with information regarding the properties of those materials.
-------
§158, Subpatt C - Pioduct Chemistry (cont.)
4/ 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. This discussion must also address the possible formation of nitrosamines unless
the Registrant provides evidence that product containers are free of nitrosating agents and no nitrosating agents
are added during formulation.
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used. In addition, unless the Registrant provides evidence that product containers are free of
nitrosating agents and no nitrosating agents are added during formulation, all nitrosamines must be identified and
quantified in six samples of each product; two samples of each must be analyzed shortly after production, 3 months
after production, and 6 months after production. A method sensitive to 1 ppm of N-nitroso contaminants must be
used. An upper limit must be provided and certified for all nitrosamines found.
6/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at ^0.1% (w/w) and each "toxicologically significant" impurity present at <0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g.,
sample analysis using validated analytical procedures, quantitative estimate based on amounts of ingredients used,
o etc.). 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.
7/ 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 certi-
fied limits.
8/ Physicochemical characteristics (color, physical state, odor, specific gravity, pH, oxidizing or reducing action,
flammability, explodability, storage stability, viscosity, miscibility, and corrosion characteristics) as required
in 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
9/ Data required if the test substance is dispersiblc in water.
10/ Data required if the product contains oxidizing or reducing agents.
ll/ Data required if the product contains combustible liquids.
12/ Data required if the product is potentially explosive.
13/ Data required if the product is a liquid.
14/ Data required if the product is a liquid and is to be diluted with petroleum solvents.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHOMYL
-o
CO
Data
§158.
ACUTE
81-1
81-2
81-3
81-4
81-5
81-6
Requirement Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
/I
340 Toxicoloqy
TESTING:
- Acute Oial Toxicity - Rat MP2/ All Partial ly 00009227
- Acute Deimal Toxicity MP All . Partially 00007947
- Rabbit
- Acute Inhalation Toxicity MP All Partially 00008982
- Rat
- Primary Eye Irritation MP All NO
- Rabbit
- Primary Dermal Irritation MP All NO
- Rabbit
- Dermal Sensitization - MP All NO
Guinea Pig
Must Additional
Data be
Submitted? I/
YES1/
YES1/
YES1/
YES1/
YES1/
YES1/
Time Frame
for
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
I/ Data are adequate to support registration of MP products containing 90% TGAI. Data are required for all other
MP formulations.
2/ Formulation intermediates are also included in the category of manufacturing-use products.
-------
II. LABELING APPENDICES
79
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will not
be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The
name and address should preferably be located at the bottom of
the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number
and the required identifying phrase must not appear in such a
manner as to suggest or imply recommendation or endorsement of
the product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA 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 156.10(f)]
80
-------
SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR
156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40CFR 156.10(h) (1) (i) ]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON. [40 CFR 156.10(h)(1)(i)
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR I56.l0(h)(1)(iii)]
-------
' SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel.
[40 CFR 156.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning statements must be headed by the appropriate
hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10 (h) (2) ( i) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h) (2) (ii) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on
the results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is used
in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation) .
In the Registration Standard, the Agency has (I) 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.
82
-------
SUMMARY-4
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must reflect
this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed
classification determination will be evaluated in accordance
with the provisions of 40 CFR 162.11(c). You will be notified
of the Agency's classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in
40 CFR 156.10(h)(1)(iv).
b. Directly below this statement on the front panel, a
summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use. If
you do so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your label
and submit draft labeling bearing only unrestricted
uses.
-------
SUMMARY-5
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be
assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item IDA. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and appear
under the heading "Storage and Disposal" in the directions for
use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-------
SlIMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
IABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warninq)
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 ON IABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
. of label text
Front panel
Front panel
immediately
before or
following
Req. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warninq
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . , "
"Distributed by . . .." etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
GO
un
-------
SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
8
8A
8D
IABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Env i ronmen ta 1
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicitv
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON IABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Knvi ronmen tal hazards include bee
caution where applicable.
00
en
-------
SUMMARY-8
LABELING REQUIREMENTS OF TiiE FIFRA. AS AMENDED (cont'd)
ITEM
8C
9A
9B
10A
10B
IOC
TARFJ, ETFMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°T
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aqency
All products
All products
PLACEMENT ON IABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
siqnal 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
-------
CO
CD
PMCAUTXXAJIY ITATIUIWTI
HAZARD* TO HUUAMI
II OOUimC AMMAU]
IMVmOMUCKTAL HAZAftM
PHYICA1 OM CHCUCAl
HAZAAM
OftlOTOM* POU UU
I • «
*• *
KI4NTKY (TATIUCWT
STORAGE AND
' DISPOSAL
•TOAA04
04POIAI
RESTRICTED USE
PESTICIDE
for
PRODUCT
NAME
ACTWf N(}KCDCNT:
HIM NO«D«NTJ.
TOTAL
*
t
100 00*
THIS PRODUCT COMTAJNJ L*S OP PIN OUIOH
KEEP OUT OF REACH OF CHILDREN
DANGER—POISON
•TATUIfNT OP PRACTCAL TKCATUCNT
>IWAUOWfO:
M IVII
•II IOC PANIL POA AOCXTONAL PRCCAUTIONAMY ITATIUCNT8
TOWM.ITATIS==
IITAIU9HMINT NO. =
IPA M04TNATIOM NO.
NIT COKTINTI:
WAMUNTYITATIUINT
-------
OD
UJ
PAICAUnQNAHY STATIUEWTt
HAZARD* TO HUUAN*
.A DOUlfTC ANMALf
CAUTION
IMVmONUCMTAL HAZAAOC
PHYttCALOMOHfUCAL
HA2AMM
OMOnOMS IKM UM
Ik*
k •
M-CNTHY fTATIUENT
PRODUCT
NAME
AOTVI HOACDCMT:
MAT
TOTAL;
10000%
THM PRODUCT CONTAIU LM Of Pi* OAUON
KEEP OUT OF REACH OF CHILDREN
CAUTION
•TATCUINT OF PRACTICAL TRCATUEMT
MlYf• :
Ml Id f ANIL FOR AOOfTJONAL PRCOAUnONAIIY •TATIUINTt
TOWN. ITATI '
MTAK4HUINT NO.
I*A RfOMTRATlON HO.
Mil CONTiNTt
CHOT;
CAOPi
CHOP:.
STORAGE AND
DISPOSAL
•TQiuai —
OMPOlALs
WAMUNTYfTATIUINT
-------
§ 162.8
40 CFft Ch. I (7.1-66 Edition)
(fe) Conditional registration. Any ap/
plidation for which aflreview of sciej(-
tifiddata is needed, other than an
plication which theji Agency deter-
mines may be considered for uncoMdi-
tional\ registration Under paragraph
(d) of this section, will be treated as an
application for conditional registration
under KIFRA sec. 3(B<7) and vnll be
reviewed and acted upon as set/forth
in §§ 162A160 through[l62.177.
(f) Denial of registration, 'tfhe Ad-
ministrator shall deny an application
reviewed under paragraph (d3 of this
section if any of the} requirements of
paragraph idX2) of j this section are
not met. or\if there are Insufficient
data to make\the required Ale termina-
tions.
(1) Notification. I Proinptly after
making a determination to deny a reg-
Adrfiiniiftrator shall
t by ^rtified letter
istratlon, the
notify the appli
of the denial of
set forth the re
for the detennin
tions, if any, whl
In order for the re
proved.
(2) Opportunity f\
canL (i) The app
days from the
certified letter
corrective actlo
(ii) The appli
Administrator
tion. The A
discretion, deriy and petl
drawal and proceed jbo
Ltion and shall
id factual basis
and the condl-
lust be satisfied
kration to be ap-
remedy by appli-
t will have 30
receipt of the
the specified
petition the
w his appllca-
ator\may. In his
on for with-
a notice of
denial In accordant
licatlon,
promptly
notice
ttion, SucA notice
>ns and Vactual
and shall contain
adc
of the applicant,
f-oduct name. I the name and per-
?e by weight of each active Uagre-
in the product, the proposed)
of use. and the proposed clt
ion.
Hearing rights. Within 30
fallowing publication of the denial
ic FEDERAL REGISTER, the applicant 6j
any interested party with the written
Authorization of the (applicant may
lest a hearing pursuant to section
6(b) of the Act and Part 164 of Lrtts
chanter. If no heating is timely/re-
quested, the denial snail become e/fec-
tive lit the end of thd 30 days.
(g) ^Disposition on material sjibmit-
ted with the appZtcajion. The test data
and other information submitted with
an application shall become d part of
the official file of the Agenc/ for that
application or registration. ./Except as
provided ay section 10 of the Act,
within 30 dkys after the registration of
a pesticide, the dati callflti for in the
registration statement together with
such other scientific ULformation as
the Administrator (deems relevant -to
his decision snail pe/nade available
for public InspecXioi
(48 PR 34004. July
0 16££ D«U to be rftnished by appUcant
(a) An applican
registration, or
tration under
furnish data /as
Agency to de
plication may/be
Part.
(b) An applican
?r registration, re-
lent of a regls-
3(0(5) shall
mired by the
le whether his ap-
his applic
tion regan!
ad
ppro
under this
shall "submit with
ion any facti
erse
infonna-
:ts of the
the environment or man
pesticide
that:
(1) Has be«n obtained by
come to his attention: and
(2) Insofar as I e Is aware.
previously been
Agency.
Sucn Informatioi
shiul not be limi
submitted
or has
not
.the
shall Include, \but
,ed to, publishedXor
Ipubllflhed laboratory studies and
fdent experience
L48 FR 34005, July
0 \3ftSi Labeling requiremenU.
(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 Part. 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-
90
-------
Environmental Protection Agency
162.10
in paragraph (b) of this sec-
tion:
(ii) The name and address of the
producer, registrant, or person for
u-hom produced as prescribed in para-
graph (c) of this section;
«iii) The net contents as prescribed
m paragraph (d) of this section:
The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classiflcation(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text In other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably bo cxpocted to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. if it is a part of the package as
customarily distributed or sold.
(ii) Tank cart and other bulk con-
tainers— nrfcfog and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car. tank truck or
other mobile or portable bulk contain-
er. a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve. • >
(5) False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
9 162.15. is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pes-
tlcldal claims. Examples of statements
or representations in the labeling
which constitute mis branding include:
(i) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement-
concerning the effectiveness of the
product as a pesticide or device.
(Ill) A false or misleadinp statement
about the value of the product for
9 1
-------
162.10
40 CFR Ch. I (7-1-66 Edition)
purposes other than as a pesticide or
device;
(iv) A fals«? or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended 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;
(vli) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser.
(vlli) 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"
U 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 fts 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 permit-
ted. In no case shall the average con-
tent of the packages in a shipment Tail
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the Lime of
92
-------
environmental Protection Agency
§ 162.10
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 ahall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement.
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable Jio
place the ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
(li) 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(cX6).
(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 Jia-
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
3
-------
§ 162.10
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 lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxiclty 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 CD.
Inhalation LC«. .
Darmal LD»
Ey» affacts
Stun affect*
f ^ ^ t
ToUcJty catagorias
1
Up to and tockcftng 90
me/ kg.
Up to and indudng 2
mg/Mar.
Up to and Indudtog 200
mg/kg.
CQfTQtbffr oom»MJ
opActty not n&fm&9
«MMn7day*.
Cort^t
H
From SO fwj 500 mg/kg..
Rom 2. ttru 2 mg/Mar —
Pram 2OO flvu 2000
ComaaJ opacity
fa»arat»i wufwi 7
dij^, biNaJkjn
parnatlng tor 7 day*.
Sa
-------
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
S>re cX UO* IrorM p«n«4 n u)u*r«
«cf»«*
S and undo*
Abova 5 to 10
Abov* 10 10 tS
Abova IS to 30
Ovor 30 _
Ports
Aaqurod
*
-------
§ 162.10
40 CFR Ch. I (7-1-86 Edition)
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 LC« of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active Ingredient
with an avlan 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
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 flammabll-
ity or explosive characteristics of the
pesticide are required as follows:
tart
(A)
COWTAJMOtS
FlMfi port at or Mow 20* F;
any vaNa opanng.
to a flaaftoack at
Ftaah pom abova 20* F and not ovar 80* F or * tfta
ftama axtanaun to mora than 18 m long at • iJaiiu_a
Of 6 In from tha Aama.
Ai othar praaaunzad contanam
Extramary flammabta. Comants unoar pruaura. Kaap away from
flr*. apart*, and haatad aurtaoaa. Do not puncture or lrx*n«aia
oornaaiar. Expoaura to tamparnna abova 130* F may cauaa
burclng.
Rammabto. Contanta unoar prim**. Kaap away from haai.
•parka, and opan flama. Do not pmaur* or InooanUa oontalnar.
Expoau» to iampamff«a abov* 130* F may cauaa burcftng.
Contanti unbar praaaura. Oo not uaa or nor^ naar haat or opan
llama. Oo not punctura or Indnarata oontMnar. Expoaur* to
tamparia^aa abov« 130* F may cauaa twtlng.
(B)
Ai or balowZO* F.
Abova 20* F and not o«w KT F
Abova 80* F and not ovar ISO* F
Extramary Aammabta. Kaap away from *ra. aparfca. and haatad
F^ammabia. Kaap away from naat and opan flama.
Oo not uaa or atom naar haat or opan flama.
(1) Directions for U»e—(1) General
requirement*—4i) Adequacy and clar-
ity of direction*. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
(11) Placement of 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 drcular""and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(Ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
96
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Environmental Protection Agency
§ 162.10
(.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
-------
§162.11
40 CFR Ch. I (7-1-S6 Edition)
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(O) [Reserved]
nable adrenel effect*.
[Reserved]
(c)
for
Except as
of this
pesticide p:
tered shall be
if each of th
forth in paragra
\ew
a-
registrations.
ivlded ih paragraph (cX4)
n, a si «dflc >ose
-------
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
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.
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I or
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
101
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1- Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(baas)
Aerosol products
Do not reuse container (bottle, can, jar) .
Rinse thorouqhly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2- All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities .
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/ , dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording) .
-• *• A.
and how fiber drum may be reused.
102
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III. BIBLIOGRAPHY APPENDICES
10
-------
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and
its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study." In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the
published article from within the typically larger volumes
in which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for a further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
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.
104
-------
b. Document Date. When the date appears as four
digits with no question marks, the Agency took it
directly from the document. When a four-digit
date is followed by a question mark, the
bibliographer deduced the date from evidence in
the document. When the date appears as (19??),
the Agency was unable to determine or estimate the
date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing Parentheses. For studies submitted to
the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the EPA accession number of the
volume in which the original submission of
the study appears. The six-digit accession
number follows the symbol "CDL," standing for
"Company Data Library." This accession
number is in turn followed by an alphabetic
suffix which shows the relative position of
the study within the volume. For example,
within accession number 123456, the first
study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-
AA.
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methorny1 Standard
MRID CITATION
00006995 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Bell Peppers Resulting from the Application of
Nudrin. a California Study: TIR-24-240-75. (Unpublished study
received Jun 29, 1976 under 201-347- CDL.-232402-A)
00006996 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Green Peppers Resulting from the Application of
Nudrin, an Iowa Study TIR-24-268-75. (Unpublished study re-
ceived Jun 29, 1976 under 201-347; CDL-232402-B)
00007001 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Spinach Resulting from the Application of Nudrin
from Modesto, California: TIR-24-137-75. (Unpublished study in-
cluding TTR-24-280-75, received Jun 29, 1976 under 201-347; CDL:
232402-1)
00007002 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Spinach Following Application of Nudrin from
Yakirra, Washinaton: TIR-24-147-74. (Unpublished study received
Jun 29, 1976 under 201-347; CDL:232402-J)
00007003 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Spinach Resulting from the Application of Nudrin,
a Tennessee Study: TIR-24-363-75. (Unpublished stu^y received
Jun 29, 1976 under 201-347; CDL:232402-K)
00007004 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Suqar Beets Following Application of Nudrin from
Williams, California: TIR-24-177-74. (Unpublished study includ-
ing TIR-24-1S4-74 and TIP-24-247-74, received Jun 29, 1976 under
201-347: CDL.-232402-L)
00007005 Shell Chemical Company (1975) 1975—Residue Data for Nudrin
Insecticide in Tobacco Leaves Resulting from the Application of
Nudrin from Rocky Ptn., North Carolina: TIR-24-217-75. (Unpub-
lished study received Jun 29, 1976 under 201-347; CDL:232402-M)
00007007 Shell Chemical Company (1975) 1975—Residue Data for Nudrin
Insecticide in Tomatoes Resulting from the Application of Nudrin
from Homestead. Florida: TTR-24-118-75. (Unpublished study re-
ceived Jun 29, 1976 under 201-347; CDL:232402-0)
00007008 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Soybeans Resulting from the Application of Nudrin
from Tallasee, Alabama: TTR-24-103-75. (Unpublished study re-
ceived Jun 29, 1976 under 201-347; CDL:232402-P)
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
HP. ID CITATION
00007039 E.I. du Pont de Nemours & Company (1972) Residue Data. (Unpub-
lished study received Jan 22, 1973 under 352-370: CDL:101340-A)
00007043 Wellman, D.: Kiigemagi, U.; Terriere, L.C. (1971) Residues of
Methomyl in Peppermint Hay and Oil. (Unpublished study received
Jun 13, 1972 under 3E1303; prepared by Oregon State Univ., Dept.
of Agricultural Chemistry, submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:092205-C)
00007044 Wellman, D. ; Cooley, E.J.• Kiigemani, U.: Terriere, L.C. (1972)
Residues of Methomyl in Mint Hay and Oil. (Unpublished study
received Jun 13, 1372 under 3E1303: prepared by Oregon State
Univ., Dept. of Agricultural Chemistry, submitted by Inter-
regional Research Project No. 4, New Brunswick, N.J.; CDL:
092205-D)
00007077 E.I. du Pont de Nemours & Company (1971) Residue Data: Methomyl—
Apples. (Unpublished study received Mar 5, 1974 under 3F1308;
CDL:092222-A>:)
00007081 E.I. du Pont de Nemours and Company (1971) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl (Un-
published study received Apr 26, 1971 under 1F1153; CDL-
090951-F)
00007091 Busey, W.M. (1968) Final Report: Two-year Dietary Administration—
Dogs: Project No. 201-165. (Unpublished study includina adden-
dum, received Jun 5, 1969 under 9F0314- prepared by Hazleton
Laboratories, Inc., submitted by E.I. du Pont de Nemours & Co.,
. Inc., Wilmington. Del.- CDL:091405-A)
00007093 Kundzin, M. (1968) Three-Generation Reproduction Study: Lannate
Methomyl Insecticide: Final Report: Project No. 201-166. (Un-
published study received Jun 5, 1969 under 9F0814; prepared by
Hazleton Laboratories, Inc., submitted by E.I. du Pont de
Nemours & Co., Inc., Wilmington, Del.; CDL:091405-C)
00007094 E.I. du Pont de Nemours & Company (1969) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Jun 5, 1969 under 9F0814; CDL:091405-D)
00007132 Shell Development Company (1975) Residue Determination of
Nudrin Insecticide in Crops: GLC-Flame Photometric Detector
Method: Modesto Method Series. Method MMS-R-427-1 dated May
1975. (Unpublished study received Jun 29, 1976 under 201-34"?;
CDL:232400-C)
107
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomvl Standard
MPID CITATION
00007133 Shell Chemical Company (1976) 1974—Residue Data for Nudrin
Insecticide in Alfalfa Resulting from the Application of Nudrin,
a Colorado Study: TIR-24-199-74. (Unpublished study received
Jun 29, 1976 under 201-347: CDL:232400-F)
00007134 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Snap Beans Following Application of Nudrin from
Modesto, California: TIR-24-151-74. (Unpublished study in-
cluding TTR-24-163-74, TIR-24-213-74, TIR-24-271-74 and TIR-24-
117-75, received Jun 29, 1976 under 201-347; CDL:232400-G)
00007135 Shell Chemical Company (1976) 1974—Residue Data for Nudrin
Insecticide in Pinto Beans Resulting from the Application of
Nudrin, a Colorado Study: TIR-24-200-74. (Unpublished study in-
cluding TIR-24-265-75, received Jun 29, 1976 under 201-347;
CDL:232400-I)
00007136 Shell Chemical Company (1975) 1975—Residue Data for Nudrin
Insecticide in Celery Pesultina from the Application of Nudrin
from Lake Harbour, Florida: TIP-24-123-75. (Unpublished study
received Jun 29, 1976 under 201-347; CDL:232400-M)
00007137 Shell Chemical Company (1975) 1975—Residue Data for Mudrin
Insecticide in Grapefruit Resulting from the Application of
Nudrin from Weslaco, Texas: TIP-24-155-75. (Unpublished study
includina TIP-24-159-75 and TIR-24-161-75, received Jun 29, 1976
under 201-347; CCL:232400-0)
00007138 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Lemons from Fort Pierce, Florida- TIP-24-268-74.
(Unpublished study includina TIP-24-157-75, received Jun 29,
1976 under 201-347; CDL:232400-P)
00007139 Shell Chemical Company (1975) 1975—Residue Data for Nudrin
Insecticide in Oranges Following Application of Nudrin from
Modesto, California- TIR-24-115-75. (Unpublished study in-
cluding TIR-24-158-75, received Jun 29, 1976 under 201-347;
CDL:232400-R)
00007140 Shell Chemical Company (1975) 1975—Residue Data for Nudrin
Insecticide in Tangerines Following Application of Nudrin from
Modesto, California: TIR-24-114-75. (Unpublished study received
Jun 29, 1976 under 201-347; CDL:232400-T)
10 8
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00007142 Shell Chemical Company (1976) 1974—Residue Data for Nudrin(R)
Insecticide in Sweet Corn Resulting from the Application of
Nudrin, an Illinois Study: TIR-24-181-74. (Unpublished study
including TIR-24-186-75, TIR-24-311-75 and TIR-24-329-75,
received Jun 29, 1976 under 201-347: CDL:232400-AAA)
00007159 E.I. du Pont de Nemours and Company (1973) Methomyl Residues—
Alfalfa. (Unpublished study received May 11, 1973 under 352-
342: CDL:008508-A)
00007161 E.I. du Pont de Nemours and Company (1973) Supplemental Data Sup-
porting the Use of Lannate Methomyl Insecticide on Sugar
Beets/ Summary of studies 008509-B through 008509-G. (Unpub-
lished study received May 15, 1973 under 352-342- CDL:008509-A)
00007163 E.I. du Pont de Nemours and Company (1973) Data Supporting the
Aerial Use of Lannate Methomyl Insecticide and Lannate L
Methomyl Insecticide. (Unpublished study received May 24,
1973 under 352-342; CDL:008511-A)
00007175 E.I. du Pont de Nemours & Company (1971) Methomyl Residue Data:
Lettuce. (Unpublished study received Jan 12, 1971 under 352-
342; CDL:106655-E)
00007185 E.I. du Pont de Nemours and Company (1971) Data Supporting the Use
of Lannate on Spinach. Summary of studies 003029-3 throuah
003029-D, 003029-F through 003029-1, and 003029-K through
003029-0. (Unoublished study received Nov 16, 1971 under 352-
342; CDL:003029-A)
00007192 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate Methomyl Insecticide and Lannate L Methomyl
Insecticide on Onions. Summary of studies 026715-B throuah
026715-D, 026715-G through 026715-N. (Unpublished study re-
ceived Jul 30, 1974 under 352-370; CDL:026715-A)
00007604 Shell Chemical Company (1976) 1976—Residue Data for Nudrin
Insecticide in Broccoli Resulting from the Application of
Nudrin, a California Study: TIR-24-100-76. (Unpublished study
received Jun 29, 1976 under 201-347; CDL:232400-U)
00007605 Shell Chemical Company (1976) 1976—Residue Data for Nudrin
Insecticide in Cauliflower Resulting from the Application of
Nudrin, a California Study: TTR-24-105-76. (Unpublished study
received Jun 29, 1976 under 201-347; CDL:232400-V)
109
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00007612 E.I. du Pont de Nemours & Company (1975) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Apr 8, 1975 under 5F1615; CDL.-094495-B)
00007626 E.I. du Pont de Nemours & Company (1974) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Apr 8, 1975 under 5F1616: CDL:094496-B)
00007634 E.I. du Pont de Nemours and Company (1973) Results of Tests on the
Amount of Residue Remaining on Treated Crops- Methomyl. (Un-
published study received on unknown date under 4F1437; CDL:
093331-A)
00007659 E.I. du Pont de Nemours and Company (1967) Results of Tests on the
Amount of Residue Remaining on Treated Crop: Methomyl. (Un-
published study received Dec 28, 1968 under 8F0677; CDL:
091184-A)
00007672 E.I. du Pont de Nemours and Company (1972) Results of Tests on the
Amount of Residue Remainino on Treated Crops- Methomyl. (Un-
published study received Sep 1, 1972 under 2F1246- CDL:091770-A)
00007683 E.I. du Pont de Nemours and Company (1972) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Lannate. (Un-
published study received Sep 2, 1972 under 2F1247; CDL:091771-A)
00007690 E.I. du Pont de Nemours and Company (1973) Data Supporting the Use
of Lannate Methomyl Insecticide on Cotton. Summary of
studies 003043-B through 003043-U. (Unpublished study received
Mar 1, 1973 under 352-342: CDL:003043-A)
00007715 WARF Institute, Incorporated (1973) Residue Summary—WARF Data.
(Unpublished study including WARF Institute nos. 3020936-69 and
3020936-0952, received Apr 5. 1973 under 201-347; submitted by
Shell Chemical Co., Washington, D.C.: CDL:001053-G)
00007832 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate and Lannate L Methomyl Insecticide on Nectarines.
Summary of studies 009332-B through 009832-E. (Unpublished
study received Mar 4, 1974 under 352-342; CDL:009832-A)
00007837 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate Methomyl Insecticide and Lannate L Methomyl
Insecticide on Carrots. Summary of studies 028450-B through
028450-G. (Unpublished study received Dec 20, 1974 under 352-
342; CDL-028450-A)
110
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MPID CITATION
00007928 E.I. du Pont de Nemours and Company (1967) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Feb 3, 1968 under 8F0681; CDL:091188-A)
00007947 Dashiell, O.L. (1971) Acute Skin Absorption LD50 Test in Rabbits:
Haskell Laboratory Report No. 340-71. (Unpublished study re-
ceived Sep 1, 1972 under 2F1245; submitted by E.I. du Pont de
Nemours & Co., Inc., Wilmington, Del.; CDL:091769-B)
00007970 E.I. du Pont de Nemours & Company (1972) Results of the Tests on
the Amount of Residue Remaining on Treated Crops: Methomyl.
(Unpublished study received Feb 22, 1972 under 2F1245: CDL:
095111-E; 091769)
00007989 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Cottonseed from Portland, Arkansas: TIP-24-254-
74. (Unpublished study including TIR-24-119-75, received Jun
29, 1976 under 201-347; CDL:232401-A)
00007991 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Grapes from Modesto, California: TIR-24-161-74.
(Unpublished study received Jun 29, 1976 under 201-347; CDL:
232401-1)
00007992 Shell Chemical Company (1975) 1975—Residue Data for Nudrin
Insecticide in Lettuce Resulting from the Application of Nudrin
from Arvin, California: TIR-24-214-74. (Unpublished study re-
ceived Jun 29, 1976 under 201-347; CDL:232401-J)
00007996 Kiigemaqi, U.; Bottom, S.L.- Deinzer, M.L. (1976) Analysis of Mint
Hay and Oil for Methomyl. (Unpublished study received Jun 29,
1976 under 201-347; prepared by Oregon State Univ., Dept. of
Agricultural Chemistry, submitted by Shell Chemical Co., Wash-
ington, D.C.; CDL:232401-O)
00007997 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Peanuts from Pontotox, Texas: TIR-24-241-74.
(Unpublished Study received Jun 29, 1976 under 201-347; CDL:
232401-0)
00007999 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Peas Following Application of Nudrin from Modes-
to, California: TTP-24-126-74. (Unpublished study including
TIR-24-154-75 and TIR-24-165-75, received Jun 29, 1976 under
201-347; CDL:232401-U)
111
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MPID CITATION
00008039 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Alfalfa Following Application of Nudrin from
Reno, Nevada: TTR-24-142-74. (Unpublished study including TIR-
24-153-74, TIR-24-166-74, TIR-24-167-74, TIR-24-175-74 and TIR-
24-803-74, received Mar 31, 1975 under 201-347; CDL:115269-AP)
00008043 E.I. du Pont de Nemours & Company (1968) Recovery Studies: Metho-
myl—Leafy Vegetables. (Unpublished study received Mar 31, 1975
under 201-347; submitted by Shell Chemical Co., Washington,
D.C.; CDL:115269-AY)
00008044 E.I. du Pont de Nemours and Company (1972) Data Supporting the Use
of Lannate Methomyl Insecticide on Sugar Beets. Summary
of studies 003036-B through 003036-1,"003036-K through 003036-P,
and 003036-R through 003036-T. (Unpublished study received Mar
6, 1972 under 352-342; CDL:003036-A)
00008145 E.I. du Pont de Nemours and Company (1974) Data Supporting the Use
of Lannate Methomyl Insecticide and Lannate L Methomyl Insecticide
on Corn. Summary of studies 023294-A through 023294-G and
023294-1 through 023294-0. (Unpublished study received Mar
5, 1974 under 352-342; CDL:023294-A)
00008154 E.I. du Pont de Nemours & Company (1974) Supplemental Data Support-
ing the Use of Lannate and Lannate L Methomyl Insecticides
on Peas. Summary of studies 023301-B through 023301-G and
023301-1 through 023301-L. (Unpublished study received Mar 5,
1974 under 352-342; CDL:023301-A)
00008233 E.I. du Pont de Nemours & Company (1974) Sum-nary of Residues on
Sorghum and Lannate Yethomyl Insecticide for Control of South-
western Corn Borer and Corn Earworm on Grain Sorghum. Summary
of studies 009653-B, 009653-D through 009653-F, 009653-1 through
009653-K, 009653-M, and 009653-O through 009653-Q. (Unpublished
study received Dec 20, 1974 under 352-342; CDL:009653-A)
00008264 E.I. du Pont de Nemours & Company (1971) Supplemental Information:
Methomyl. (Unpublished study received Jun 16, 1971 under
1F1021; CDL:091071-A)
00008295 E.I. du Pont de Nemours and Company (1969) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Jan 21, 1970 under OF0886; CDL:
091530-L)
112
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00008334 E.I. du Pont de Nemours & Company (1976) Methomyl Residue Data-
Summary: Blueberry: Table 1. (Unpublished study received Mar
15, 1978 under 352-342? CDL:096959-D)
00008359 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Collard
Greens: IR-4-PR 143. (Unpublished study received Dec 8, 1977
under 8E2030; prepared by Virginia Truck and Ornamentals Re-
search Station in cooperation with Virginia Polytechnic Insti-
tute and State Univ., and U.S. Dept. of Agriculture, Vegetable
Insect Laboratory, submitted by Interregional Research Project
No. 4, New Brunswick, N.J.; CDL:097378-F)
00008360 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Kale Greens:
IP-4-PR *43. (Unpublished study received Dec 8, 1977 under
8E2030; prepared by Virginia Truck and Ornamentals Research Sta-
tion in cooperation with Virginia Polytechnic Institute and
State Univ., and U.S. Dept. of Agriculture, Vegetable Insect
Laboratory, submitted by Interregional Research Project No. 4,
New Brunswick, N.J. ; CDL:097378-G)
00008361 Hofmaster, R.N. (1976) Methomyl (Lannate) Residues on Mustard:
IR-4-PR #43. (Unpublished study received Dec 8, 1977 under
8E2030; prepared by Virginia Truck and Ornamentals Research Sta-
tion in cooperation with Virginia Polytechnic Institute and
State Univ., and U.S. Dept. of Agriculture, Vegetable Insect
Laboratory, submitted by Interregional Research Project No. 4,
New Brunswick, N.J.: CDL:097378-H)
00008362 Hofmaster, P.N. (1976) Methomyl (Lannate) Residues on Turnip
Greens: IR-4-PR #43. (Unpublished study received Dec 8; 1977
under 8E2030; prepared by Virginia Truck and Ornamentals Re-
search Station in cooperation with Virginia Polytechnic Insti-
tute and State Univ., and U.S. Dept. of Agriculture, Vegetable
Insect Laboratory, submitted by Interregional Research Project
No. 4, New Brunswick, N.J.; CDL:097378-I)
00008411 E.I. du Pont de Nemours and Company (1974) Supplemental Data Sup-
porting the Use of Lannate Methomyl Insecticide and Lannate
L Methomyl Insecticide on Soybeans. Summary of studies
023303-B through 023303-0, 023303-T through 023303-V, 023303-Y,
023303-AA and 023303-AC through 023303-AH. (Unpublished
study received Mar 4, 1974 under 352-342; CDL:023303-A)
11
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MPID CITATION
00008436 E.I. du Pont de Nemours and Company (1974) Data Supporting the Use
of Lannate Methomyl Insecticide and Lannate L Methomyl
Insecticide on Succulent Beans. Summary of studies 009841-C
through 009841-G and 009841-1 through 009841-AE. (Unpublished
study received Mar 4, 1974 under 352-342; CDL:009841-A)
00008453 Fowler, B. (1972) Lannate—Small White Beans Lygus Control. (Un-
published study received Mar 4, 1974 under 352-342: prepared by
Soilserv, Inc., submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.: CDL.-009841-AA)
00008568 Harvey, J., Jr. (1977) Degradation of 14C-Methomyl in Flanagan Silt
Loam in Eiometer Flasks. (Unpublished study received Feb 23,
1977 under 352-342? prepared in cooperation with Univ. of
Delaware, Soil Testing Laboratory, submitted by E.I. du Pont de
Nemours & Co., Wilminaton, Del.; CDL.-096026-B f
00008602 E.I. du Pont de Nemours & Company (1976) Residue Data: Methomyl
Soybeans. (Unpublished study received Jun 15, 1977 under 352-
342; CDL:230630-M)
00003621 Rogers, A.S.; Culik, R.; Wood, R.A.; et al. (1973) Oral Teratogenic
Study in Rats with Lannate (INfX-1179): Haskell Laboratory
Report No. 498-78. (Unpublished study received Oct 18, 1973
under 352-342; submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del.; CDL:097449-A)
00008679 E.I. du Pont de Nemours and Company (1972) Residue Data- Methomyl—
Aerial Application. (Unpublished study received Apr 5, 1972
under 352-342; CDL:023289-A)
00008742 E.I. du Pont de Nemours & Company (1971) Data Supporting Registra-
tion of Lannate Methomyl Insecticide for Use on Tomatoes. (Un-
published study received May 26, 1971 under 352-342; CDL:
003025-A)
00008803 E.I. du Pont de Nemours & Company (1969) Lannate Methomyl
Residues—Celery. (Unpublished study received Jul 22, 1970
under 352-342; CDL:003020-A)
00008827 Krauss, W.C.; Stula, E.F. (1967) Oral LD50 and Delayed Paralysis
Tests (Hens): Haskell Laboratory Report No. 161-67. (Unpub-
lished study received Dec 12, 1967 under 352-342; submitted by
E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:050420-B)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00008832 E.I. du Pont de Nemours and Company (1967) Methomyl Livestock
Feeding Studies: Milk and Meat. (Unpublished study received Dec
28, 1968 under 8F0671; CDL:091179-B)
00008837 Pease, H.L. (1968) Selectivity of Methomyl Residue Procedure. (Un-
published study received Dec 28, 1968 under 8F0671; submitted by
E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:
091179-G)
00008838 E.I. du Pont de Nemours & Company (1968) Residue Data: Methomyl—
Leafy Vegetables. (Unpublished study received Dec 28, 1968 un-
der 8F0671: CDL:091179-H)
00008847 E.I. du Pont de Nemours and Company (1974) Residue Studies: Metho-
myl. Summary of studies 096079-C throuah 0^6079-G. (Unpub-
lished study received Apr 19, 1977 under 352-342; CDL.-096079-B)
00008862 5.I. du Pont de Nemours and Company (1976) Data Supporting the Use
of Lannate Methomyl Insecticide and Lannate L Methomyl
Insecticide on Potatoes. (Unpublished study received Apr 15,
1976 under 352-342; CDL:224068-A)
00008919 E.I. du Pont de Nemours and Company (1976) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Sep 21, 1976 under 352-342; CDL:
095289-B)
00008938 E.I. du Pont de Nemours & Company (1975) Results of Tests on
the amount of Residue Remaining on Treated Crops: Summary of
studies 094852-G and 094352-L. (Unpublished study received
Jul 10, 1975 under 6F1654; CDL:094852-B)
00008964 E.I. du Pont de Nemours & Company (1971) Residue Data. (Unpub-
lished study received Jan 31, 1972 under 352-361; CDL:003094-D)
00008982 Foster, G.V., Jr. (1966) Acute Inhalation Toxicity (Progress Re-
port): Haskell Laboratory Report No. 73-66. (Unpublished study
received Dec 2, 1968 under unknown admin, no.; submitted by E.I.
du Pont de Nemours & Co., Wilmington, Del.? CDL:106664-E)
00008984 E.I. du Pont de Nemours & Company (1970) Methomyl on Alfalfa.
(Unpublished study received Apr 27, 1971 under 1F1159; CDL:
090952-A)
115
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supportina
Registrations Under the Methomyl Standard '
MRID CITATION
00008998 E.I. du Pont de Nemours and Company (1979) Residue Data. (Unpub-
lished study received Apr 10, 1979 under 352-342; CDL:238156-A)
00009000 E.I. du Pont de Nemours & Company (1969) Residue Analyses: Egg-
plant. (Unpublished study received Mar 26, 1979 under 352-342;
CDL:237887-B)
00009002 LaRue J; Dibble, J. (1975) Lannate Methomyl Insecticide: Pome-
granates. (Unpublished study including letter dated Sen 18,
1975 from J.H. Stoner to Alvin Barbar, received Mar 26, 1979
under 352-342; prepared by Univ. of California, Agricultural
Experiment Station in cooperation with Stoner Laboratories,
Inc., submitted by E.I. du Pont de Nemours & Co.; Wilmington,
Del.; CDL:237887-D)
00009003 E.I. du Pont de Nemours & Company (1975) Methomyl Residue Analy-
ses—Pomegranate. (Unpublished study received Mar 26, 1979
under 352-342; ODL:237887-E)
00009004 E.I. du Pont de Nemours and Company (1979) Residue Data. (Unpub-
lished study received Apr 10, 1979 under 352-342; CDL:098215-A)
00009009 Pease, H.L.; Kirkland, J.J. (19??) Determination of Methomyl Resi-
dues Using Microcoulometric Gas Chromatography. Undated method.
(Unpublished study received Dec 11, 1967 under 8F0671; submitted
by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:
092971-C)
00009061 Schneider, P.W., Jr. (1976) 96-Hour LC50 to Bluegill Sunfish:
Haskell Laboratory Report No. 710-76. (Unpublished study
received Jun 21, 1979 under 352-342; submitted by E.I. du Pont
de Nemours & Co., Wilmington, Del.; CDL:238781-A)
00009063 E.I. du Pont de Nemours & Company (1977) Residue Data. (Unpub-
lished study received May 16, 1979 under 352-342; CDL:238519-B)
00009070 E.I. du Pont de Nemours and Company (1972) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Mar 24, 1972 under 2F1254; CDL:
095333-C)
11!
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MP.ID CITATION
00009074 Pease, H.L. (1969) Modification of the Published Gas Chromatogra-
phic Method for Determination of Methomyl Residues: Use of a
Flame Photometric Detector. Method dated Jul 17, 1969. (Un-
published study received Jan 21, 1970 under OF0886; submitted by
E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:
091530-N)
00009075 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Cottonseed Resulting from the Application of
Nudrin to Cotton Plants, a Texas Study: TIR-24-207-75. (Unpub-
lished study including TIR-24-208-75, received Jun 29, 1976 un-
der 201-347; CDL:232401-B)
00009076 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Cucumbers Following Application of Nudrin from
Modesto, California: TIR-24-150-74. (Unpublished study includ-
ing TIR-24-244-74, received Jun 29, 1976 under 201-347; CDL:
232401-D)
00009073 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Peanuts Resulting from the Application of Nudrin,
a Georgia Study: TIR-24-261-75. (Unpublished study including
TIR-24-308-75, received Jun 29, 1976 under 201-347; CDL:
232401-R)
00009079 Shell Chemical Company (1976) 1975—Residue Data for Nudrin
Insecticide in Dry Peas Resulting from the Application of Nu-
drin, a Washington Study: TIR-24-197-75. (Unpublished study in-
cluding TIR-24-219-75 and TIP-24-264-75, received Jun 29, 1976
under 201-347; CDL:232401-X)
00009083 Shell Chemical Company (1975) 1974—Residue Data for Nudrin
Insecticide in Soybeans Following Application of Nudrin from
Painter, Virginia: TIR-24-269-74. (Unpublished study received
Mar 31, 1975 under 201-347; CDL:115269-AT)
00009134 Sleight, B.H., III (1973) Bioassay Report Submitted to E.I. DuPont
de Nemours & Company, Newark, Delaware: Acute Toxicity of H-
7946, MR-581 to Grass Shrimp (Palaemenetes vulgaris), Pink
Shrimp (Penaeus duorarum) and Mud Crab (Neopanope texana).
(Unpublished study received May 6, 1976 under 352-
342; prepared by Bionomics, Inc., submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del.; CDL:224073-AI)
117
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MR-ID CITATION
00009135 E.I. du Pont de Nemours and Company (1974) Supplemental Data Sup-
porting the Use of Lannate Methomyl Insecticide and Lannate
L Methomyl Insecticide on Cotton. Summary of studies 023305-C
through 023305-O and 023305-0 through 023305-R. (Unpublished
study received Mar 5, 1974 under 352-342; CDL: 023305-A)
00009154 E.I. du Pont de Nemours & Company (1974) Data Supporting the Use of
Lannate Methomyl Insecticide and Lannate L Methomyl Insecticide
on Dry Beans. Summary of studies 023304-D through 023304-H,
023304-J through 023304-M, 023304-O through 023304-AB.
(Unpublished study received Jul 16, 1974 under 352-342; CDL:
023304-A)
00009226 McCain, J.C. (1971) Final Report: Acute Fish Toxicity Study—Static
Freshwater: Project No. 201-254. (Unpublished study received
May 5, 1977 under 352-342- prepared by Hazleton Laboratories,
Inc., submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:229714-A)
00009227 Sherman, H. (1966) Oral LD50 Test: Haskell Laboratory Report
No. 210-66. (Unpublished study received May 5, 1977 under 352-
342: submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:229715-A)
00009230 Bentley, P.E. (1973) Acute Toxicity of H-8385 to Grass Shrimp
(Palaemonetes vulgaris) and Fiddler Crab (Uca pugilator).
(Unpublished study received *ay 5, 1977 under 352342; prepared
by Bionomics, Inc., submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.: CDL:229718-A)
00009291 E.I. du Pont de itemours and Company (1976) Data Supporting Use of
Lannate Methomyl Insecticide and Lannate L Methomyl Insecticide
on Cucurbits. Summary of studies 227340-3 through 227340-S.
(Unpublished study received Jun 29, 1976 under 352342;
CDL:227340-A)
00009326 E.I. du Pont de Nemours & Company (1971) Methomyl Decomposition in
Muck Soil—A Field Study. (Unpublished study received May 5,
1977 under 352-342; CDL:229711-F)
00009365 Sherman, H. (1972) Chicken and Egg Study: Haskell Laboratory Report
No. 55-72. (Unpublished study received Sep 7, 1972 under
3F1307; submitted by E.I. du Pont de Nemours & Co., Inc., Wil-
mington, Del.; CDL:092221-C)
113
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00009366 E.I. du Pont de Nemours & Company (1971) Results of Tests on the
Amount of Residue Remaining on Treated Crops: Methomyl. (Un-
published study received Sep 7, 1972 under 3F1307; CDL:092221-D)
00009378 E.I. du Pont de Nemours and Company (1976) Data Supporting Use of
Lannate D Methomyl Insecticide and Lannate 5-D Methomyl
Insecticide on Cotton. Summary of studies 226190-B through
226190-W. (Unpublished study received Sep 28, 1976 under 352-
380; CDL:226190-A)
00014715 Sakamoto, S.S.; Johansen, C.A. (1971) Toxicity of Orthene to Honey
Bees (Apis mellifera): Alfalfa Leaf Cutter Bees (Megachile
rotundata); Alkali Bees (Norrua melanderi); Bumble Bees (Bombus
auricomus). (Unpublished study received Jun 21, 1972 under
239-EX-61: prepared in cooperation with Washington State
Univ., Entomology Dept., submitted by Chevron Chemical Co.,
Richmond. Calif.: CDL:22350S-AT)
00019947 Harvey, J., Jr. (1977?) Crop Rotation Study with 14C-Methomyl in
the Greenhouse. (Unpublished study received Jan 19, 1978 under
352-342; submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:232720-A)
00019977 Goodman, N.C. (1978) 48-Hour LC502 to Daphnia magna: Haskell
Laboratory Report No. 165-78. (Unpublished study received May
22, 1978 under 352-342; submitted by E.I. du Pont de Nemours &
Co., Wilmington, Del.; CDL:233993-8)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00034016 Goodman, N.C. (1978) 48-Hour LC502 to Daphnia magna: Report
No. 400-78. (Unpublished study received Nov 20, 1978 under 352-
390; submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL:236581-K)
119
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OFFICE OF PESriCIDE PROGRAMS
REGISTRATION STANDAPD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Yethomyl Standard
MPJD CITATION
00038316 E.I. du Pont de Nemours & Company (1973) Residue Data: Methomyl—
Peaches. (Unpublished study received Jun 24, 1976 under 352-
342; CDL:226818-C)
00044069 Feung, C.S.: Chancey, E.L.; Holsing, E.L. (1977) Metabolism of UC
45650 in Cotton Plant: File No. 23484. (Unpublished study re-
ceived Sep 10, 1980 under 264-341; submitted by Union Carbide
Agricultural Products Co., Ambler, Pa.; CDL:099600-G)
00044306 Khasawinah, A.M.; Holsing, G.C. (1976) UC 51762 Pesticide: Mobility
on Soil Thin-Layer Chromatograms: File No. 22754. (Unpub-
lished study received Sep 10, 1930 under 264-341; submitted by
Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:
099602-J)
00050464 Interregional Research Project Number 4 (1976) Grounds in Support
of Petition: Methomyl. (Reports by various sources; unpub-
lished study including published data, received Mar 9, 1977 un-
der 7E1933; CDL:097262-G)
00055457 E.I. du Pont de Nemours and Company, Incorporated (1973) Results
of Tests on the Amount of Residue Remaining on Treated Crops.
(Unpublished study received Apr 16, 1974 under 4F1448; CDL:
093860-A; 093859)
00062139 Heath, R.G.; Spann, J.W. : Hill, E.F.; et al. (1972) Comparative
Dietary Toxicities of Pesticides to Birds. By U.S. Fish and
Wildlife Service, Patuxent Wildlife Research Center. Wash-
ington, D.C.: USFWS. (Special scientific report—wildlife
no. 152; Printing Office, Washington, D.C.; 1971 0—460-531:
published study; CDL:092011-V)
00063418 Harvey, J., Jr. (1976?) Metabolism of 14C-Methomyl in the La eta t-
ing Goat: Document No. A1R-22-80. (Unpublished study received
Mar 18, 1931 under 352-342; submitted by E.I. du Pont de Nemours
& Co., Wilmington, Del.; CDL:099952-A)
00063419 Interregional Research Project Number 4 (1979) Summary of Residue
Chemistry Data. (Unpublished study received Jan 15, 1981 under
1E2465; CDL:099385-A)
00063421 Leeper, J.R. (1980) Letter sent to Mark E. Burt dated Sep 16, 1980
Methomyl residue tests on pears. (Unpublished study, includ-
ing PR no. 1563, received Jan 15, 1981 under 1E2465; prepared by
Cornell Univ., New York State Agricultural Experiment Station,
Dept. of Entomology, Entomology-Plant Pathology Laboratory, sub-
mitted by Interregional Research Project No. 4, New Brunswick,
N.J.; CDL:099885-C)
120
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00073214 Harvey, J., Jr. (1977) Decomposition of 14C-Methomyl in Flooded
Anaerobic Soils. (Unpublished study received Mar 27, 1979 under
352-342; submitted by E.I. du Pont de Nemours & Co., Wilmington,
Del.; CDL-237906-A)
00073259 Kiigemagi, U.; Cheng, J.C.; Deinzer, M.L. (1977) Analysis of Table
Beets and Beet Foliage for Methomyl. (Unpublished study re-
ceived May 15, 1979 under 352-342; prepared by Oregon State
Univ., Dept. of Agricultural Chemistry, submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:238518-A)
00073260 E.I. du Pont de Nemours & Company (1978) Data Supporting Registra-
tion of Lannate LV Insecticide on Crops. (Compilation; unpub-
lished study received Nov 29, 1978 under 352-EX-95; CDL:
236560-A)
00073261 E.I. du Pont de Nemours & Company (1976) Data Supporting the Use of
Lannate Methomyl Insecticide and Lannate L methomyl Insecticide
on Onions. (Unpublished study received Jan 12, 1979 under
9E2164; submitted by Interregional Research Project No. 4,
New Brunswick, N.J.? CDL:097756-A)
00077271 McCann, J.A. (1971) Lannate Methomyl: Toxicity to Rainbow Trout
(Salmo gairdneri): Test No. 474. (U.S. Agricultural Re-
search Service, Pesticides Regulation Div., Animal Biology Labo-
ratory, unpublished study)
00077272 McCann, J.A. (1971) Lannate Methomyl: Toxicity to Rainbow Trout
(Salmo gairdneri): Test No. 427. (U.S. Agricultural Re-
search Service, Pesticides Regulation Div., Animal Biology Labo-
ratory, unpublished study)
00077273 McCann, J.A. (1971) Lannate Methomyl: Toxicity to Bluegill
(Lepomis macrochirus): Test No. 351. (U.S. Agricultural Re-
search Service, Pesticides Regulation Div., Animal Biology Labo-
ratory, unpublished study)
00078359 Interregional Research Project Number 4 (1979) Summary of Residue
Data for Methomyl in or on Forage Grasses and Forage Legumes.
(Unpublished study received Oct 1, 1979 under OE2276; CDL:
099025-A)
00078361 Kaplan, A.M.; Hostetler, K.H.; Dilworth, T.; et al. (1981) Long-
term Feeding Study in Rats with S-Methyl N-(Methylcarbamoyl)
oxy-thioacetimidate (Methomyl; INX-1179): Haskell Laboratory
Report No. 235-81. Final rept. (Unpublished study received
Aug 28, 1981 under 1H5320; submitted by E.I. du Pont de Nemours
& Co., Inc., Wilmington, Del,; CDL:070242-A)
121
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
00078423 Hazleton Laboratories America, Incorporated (1981) Final Report
104-week Chronic Toxicity and Carcinogenicity Study in Mice:
Project No. 201-510. (Unpublished study received Aug 28, 1981
under 1E2556; submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.: CDL:070247-C; 070246; 070241)
00085367 Eidelman, M. (1968) Letter sent to George Beusch dated Sep 16,
1968: PP I8P0671, 8F0677, 8F0681; Method trial for Methomyl,
S-Methyl-N-(methylcarbamoyl)oxy thioacetimidate. (U.S. Food
and Drug Administration, Methods Investigation Section,
Pesticide Branch, DFCT, unpublished study)
00126579 Interregional Research Project No. 4 (1979) Methomyl/Sugarcane/
PR1396. (Compilation; unpublished study received Mar 28,
1983 under 352-342; CDL:071435-A)
00131249 Friedman, P. (19??) Hydrolysis of l-14C-methomyl: Document No. AMR-
109-83. (Unpublished study received Oct 3, 1933 under 352-366;
submitted by E.I. du.Pont de Nemours & Co., Inc., Wilmington,
DE; CDL:251424-B)
00131254 Britelli, M.; Muska, C. (1982) Chronic Toxicity of Methomyl to
Daphnia magna: Haskell Laboratory Report No. 46-82; MR No. 0581-
930. (Unpublished study received Oct 3, 1983 under 352-366;
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
DE; CDL:251426-B)
00131255 Driscoll, R.; Muska, C. (1982) Early Life Stage Toxicity of Metho-
myl to Fathead Minnow: Haskell Laboratory Report No. 528-82: MR
No. 0581-930. (Unpublished study received Oct 3, 1983 under
352-366; submitted by E.I. du Pont de Nemours & Co., Inc., Wil-
mington, DE; CDL:251426-C)
00131257 Feussner, E.; Christian, M.; Lightkep, G.; et al. (1983) Embryo-
Fetal Toxicity and Teratogenicity Study of Methomyl in the Rab-
bit: Study No. 104-005. Final rept. (Unpublished study re-
ceived Oct 3, 1983 under 352-366; prepared by Argus Research
Laboratories, Inc., submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, DE; CDL:251427-B)
00135794 Union Carbide Corp. (1978) Full Reports on the Nature and Magnitude
of Residues of the Pesticidal Chemical and its Metabolites: UC
51762. (Compilation; unpublished study received Nov 17, 1978
under 1016-EX-52; CDL:097647-A)
122
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MPID CITATION
00142925 E.I. du Pont de Nemours and Co., Inc. (1985) Du Pont Lannate LV In-
secticide: [Residue in Soybeans]. Unpublished compilation. 44 p.
00144617 Interregional Research Project No. 4. (19??) The Results of Tests
on the Amount of Methonyl Residues Remaining in or on leeks.
Unpublished compilation. 64 p.
00144827 Shell Chemical Co. (1983) Methomyl ... Residue Data on Cucurbits,
Grapes, Nectarines, Peaches and Peppers. Unpolished compila-
tion. 179 p.
Q0156939 Enviro-Bio-Tech, Ltd. (19??) Peaches - Methomyl Residue Data. Un-
published study prepared by E. I. du Pont de Nemours. 34 p.
00156940 Enviro-Bio-Tech, Ltd. (19??) Greenhouse Tomatoe - Methomyl Residue
Data. Unpublished study prepared by E. I. du Pont de Nemours.
41 p.
00156941 Enviro-Bio-Tech, Ltd. (19??) Wheat (Small Grains) - Methomyl
Residue Data. Unpublished study prepared by E. I. du Pont de
Nemours. 51 p.
00157373 E. I. du Pont de Nemours and Co., Inc. (1986) Experimental Proce-
dures for Data Collection Supporting the Use of Methomyl on To-
bacco. Unpublished compilation. 40 p.
00158689 Bull, D. (1974) Fate of Methomyl on cotton.
mology 3(4) :723-724.
Environmental Ento-
00161144 Interregional Research Project Mo. 4 (1978) The Results of Tests
on the Amount of Methomyl Residue Remaining on or in Avocados
Including a Description of the Analytical Method Used. Unpub-
lished compilation. 31 p.
00161884 Priester, T. (19??) Batch Equilibrium (Adsorption/desorption) and
Soil Thin-layer Chromatography Studies with Methomyl: Document
No. AMR-174-84. Unpublished study prepared by E.I. du Pont de
Nemours and Co., Inc. 44 p.
00161885 Harvey, J. (19??) Photolysis of [1-Carbon 14] Methomyl: Document
No. AMR-121-83. Unpublished study prepared by E. I. du Pont de
Nemours and Co., Inc. 14 p.
00161886 Beavers, J. (1983) An Acute Oral Toxicity Study in the Bobwhite
with H-15,000: Final Report: Project No.: 112-142. Unpublished
study prepared by Wildlife International Ltd. 15 p.
12
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methorny1 Standard
MRID CITATION
00161887 McCooey, K. (1984) CHO/HGPRT Assay for Gene Mutation: [Ethanimido-
thioic acid N-[[(methylamino)carbonylJoxy]-methyl ester]: Has-
kell Laboratory Report No. 556-83: Revised Copy. Unpublished
study prepared by Haskell Laboratory. 12 p.
00161888 Cortina, T.? Farrow, M.; Padilla-Nash, H. (1984) In vivo Bone Mar-
row Chromosome Study in Rats: H# 15,000: Final Report: HLQ-63-
84: MR-4581-124. Unpublished study prepared by Hazleton Bio-
technologies Corp. 46 p.
00163745 Swanson, M. (1986) Photodegradation of [1-Carbon 14]Methomyl on
Soil: Document No. AMR-611-86. Unpublished study prepared by
E.I. du Pont de Nemours and Co., Inc. 25 p.
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide
residues to four kinds of bees. Environmental Entomology
1(3) :393-394.
05008206 Harvey, J., Jr.; Reiser, R.W. (1973) Metabolism of methonyl in
tobacco, com, and cabbage. Journal of Agricultural and Food
Chemistry 21(5):775-783.
05008453 Leidy, P.B. ; Donvanski, J.J. ; Haire, P.L. ; Sheets, T.J. (1977)
Effects of weathering and flue-curing on methomyl residues on
tobacco. Archives of Environmental Contamination and
Toxicology 5(2):199-206.
05009139 Sinroon, V.F.; Mitchell, A.D.; Jorgenson, T.A. (1977) Evaluation of
Selected Pesticides as Chemical Mutagens: In Vitro and In Vivo
Studies. Research Trianale Park, N.C.- U.S. Environmental
Protection Agency, Health Effects Research Laboratory. (EPA
report no. FTA-600/1-77-023; available from: NTIS, Springfield,
VA: PB-268 647)
05009890 Krueger, H.R.; Lindquist, R.K.; Mason, J.F.: Spadafora, R.R.
(1973) Application of methomyl to greenhouse tomatoes:
greenhouse whitefly control and residues in foliage and fruits.
Journal of Economic Entomology 66(5):1223-1224.
05013872 Tappan, W.B.; Wheeler, W.B.; Lundy, H.W. (1973) Methomyl residues
on cigar-wrapper and flue-cured tobaccos in Florida. Journal
of Economic Entomology 66(1) :197-198.
124
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methomyl Standard
MRID CITATION
05011163 Harris, C.R.; Svec, H.J. (1969) Laboratory studies on the contact
toxicity of some insecticides to honeybees. Proceedings of
the Entomological Society of Ontario, Vol. 100 (pgs. 165-167)
40056901 O'Neal, F. (1979) Summary: Magnitude of the Residue of Methomyl
in Hops: Laboratory Report I.D.; DPX-1179 Hops Residue 5/79-1.
Unpublished study prepared by E.I. du Pont de Nenours & Co.,
Inc. 16.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
125
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IV. FORMS APPENDICES
125
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OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(C)(2)(8) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "oenene" data imposed by ttw FIFRA sBction 3(0(2)18) notice contained in the referenced
Guidance Document. I am responding n the following manner
D 1. I will submit data in a tunery manner to satofy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocohcontained in the Reports of Expert Groups to the Chemuis Group. OECO
Chemicals Testing Programme. I enclose the protocols that I will toe:
D 2. I have entered into an agreement wrth one or more other regatrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirement!. The tests, and any required pojtocoh. will be eubmmed to EPA by:
NAME OF OTHER REGISTRANT
D3. I enclose I completed "Ceftrficaiion of Attempt to Enter Into in Agreement with Other Registrants for Development of Data" with
respect to me following data requirement!.
O 4. I request that you amend my registration by deleting the following met (this option • not available to applicants for new products):
D S. I request voluntary cancellation of the registration of thfi product. (This option is not available to applicanu for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
EPA FOTB 8680-1
SIGNATURE
DATE
127
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Data Recort
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ACCSSJ
numc
assign
Certification
I csrtfy that the statements I have made on this farm and ai! attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishacle by fine or impnscnment cr both under applicable law.
fyp*d Nam* ana Tits*
Cat*
£PA form 4480-4
Prwvioua •cunon
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OMB Approval No.
Expires 11/30/89
2070-0057
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(cl(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm of group of firms is referred to below as "my firm" I
2. My firm is willing to d*velop 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, or to share m the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)dn) il final agreement on all terms could not be reKhed otherwise. This offer was made
to trie following firm(s) on the following date(s)
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(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 must 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 disdose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form SS80-6
129
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CMB Approval No. 2070-0057
Expiration Date 11/30/89
(2HERIC DftXA EXEMPTION STATEMENT
ERA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product icfcrf-ified above, I
certify that:
(1) I nave read and am familiar with the terms of the Notice from ERA dated
cmcerning a requirement for submission of "generic" data on the active
ingredient _ _^ named under FIFRA Section 3 (c) (2) (B) .
(2) My firm requests that ERA not suspend the registration of our product, despite
air lack of intent to submit the gareric data in question, on the grounds that the product
cmtains the active ingredient solely as the result of the ircorporaticn into the product
of another product viiich cmtains that active ingredient, which is registered under FIFRA
Section 3, and which is purchased by us from another
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by ccmpany name,
registratim nurber, and product name, the source of the subject active ingredient in my
firm's product, or
dated on file with ERA is oorplete, currart and accurate and
contains the iriformaticn requested on the current CSF Form 8570-4. The registered
scurce(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 aaiti'LiitjiL to the registration prior to changing the source
of the active ingredient in our product.
(4) I inaerstard, and agree on behalf of my firm, that if at any time any portion of
this Statanent is no longer true, or if my firm fails to corply with the undertakings made
in this Statanent, 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 en the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have cxxmtitted to cjenerate and submit the
required data fail to take appropriate steps to meet requirements or are no longer in
compliance with this Notice's data reqioiranents, 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)
ERA Form 8570-27
130
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