OMR Control No. 2070-0057
Expires 11/89
0-9692 M£THiDA"THlDKJ
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
METHIDATHION
SHAUGNESSY NO. 100301
AS THE ACTIVE INGREDIENT
CAS. NO. 950-37-8
EPA CASE NO. GS0034
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, DC 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 2
A. Description of Chemical
B. Use Profile
III. Agency Assessment 5
A. Summary
B. Toxicological Assessment
C. Ecological Effect
D. Pesticide Incident Reports
E. Human Exposure
IV. Regulatory Position and Rationale 20
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 32
VI. Requirement for Submission of Generic Data 34
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 . . 40
VIII. Requirement for Submission of Revised Labeling 41
IX. Instructions for Submission 41
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
11• LABELING APPENDICES
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
HI. BIBLIOGRAPHY APPENDICES
Guide to Biblioqraphy
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA 53(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for
Development of Data
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i active inqredient
ALK Alkaline Phosphatase
ALT Serum Alanine Aminotransferase
AST Serum Aspartase Aminotransferase
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
EMH Extramedullary Hematopoiesis
EP End-Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weiqht or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
mbyp meat by-product
MPI Maximum Permissible Intake
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MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
MATC Maxium Allowance Toxic Concentration
OES Office of Endangered Species, U.S. Pish and Wildlife
Service
PADI Provisional Acceptable Daily Intake
ppb parts per billion
ppm parts per million
RfD Reference Dose
TEP Typical End-Use Product
TMRC Theoretical Maximal Residue Contribution
iv
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I. INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard, issued in 1983,
the Agency described the available data supporting the regis-
tration of the chemical. The Agency concluded that additional
data were necessary to fully evaluate the pesticide. The
Agency also set out label language which the Agency concluded
at that time were needed to ensure that products containing
the pesticide remained in compliance with FIFRA.
The Agency has since received and reviewed the additional
data and has revised its scientific and regulatory conclusions
in light of those data, other information on the chemical,
and expanded data reguirements promulgated in 1984, in 40 CFR
Part 158, for registration and reregistration of pesticides
under FIFRA.
This revised Registration, which supersedes the 1983
Standard, is the Agency's updated scientific assessment of
the pesticide, and the data needed to support its continued
registration. The Agency has also reassessed the tolerances
for the pesticide; that reassessment is included in this
Registration Standard.
The Agency has reviewed the current labeling for products
containing the pesticide, and has specified label revisions
which are necessary to remain in compliance with FIFRA.
The detailed scientific review, which is not contained
in this document, but is available upon reguest*, focuses on
the pesticide active ingredient. The scientific review pri-
marily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Rased on its
regulatory position, the Agency may prescribe a variety of
^The scientific reviews and use index are available from
National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161 or from the Order Desk (703) 487-4650.
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steps to be taken by reqistrants to maintain their registrations
in compliance with FIFRA. These steps may include;
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-In (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, and B, in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify
the Agency of any information, including interim or 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: [O,O-dimethyl] phosphorodithioate S-ester with
4-(mercaptomethyl)-2-methoxy-delta 2-1,3,4-
thiadiazolin-5-one]
Common name: Methidathion
Trade name: Supracide®, Ultracide®, and Somonil®
EPA Shaughnessy Number: 100301
Chemical Abstracts Service (CAS) Number 950-37-8
Empirical Formula: C6HllN2°4pS3
Description of physical characteristics of chemical
Color: white-transparent
Melting Point: 39-40°C
Odor: Characteristic Organophosphate Odor
Molecular Weight & Formula: 302.3; & C6H11N2O4PS3
Density: 1.495 g/cc
Solubility: Water - 240 ppm @ 20°C
Organic Solvents g/100 ml @ 25°C
Benzene 88
Acetone 91
Methanol 61
Xylene 80
Kerosene 3
Chloroform > 25
Dichloromethane > 25
B. Use Profile
Type of Pesticide: Insecticide/Acaricide
Pests Controlled: A broad spectrum of agricultural insect
and mite pests.
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Registered Uses: Terrestrial food crop use on alfalfa
(including seed crop), almond, artichoke,
cherry, citrus fruits, clover (seed
crop), cotton, grapefruit, lemon,
nectarine, peach, pecan, plum, prune
olive, orange, safflower, sorghum
(forage and grain), sunflower and walnut.
Terrestrial nonfood crop use on tobacco
and ornamental pines (nursery stock).
Predominant Uses; Alfalfa and Citrus
Mode of Activity: Inhibits the enzyme acetyl cholinesterase
Method of Application: Can be applied both aerially and
with ground equipment, including
airblast and hydraulic sprayers.
Formulations: 95.0% Technical
50.0% Intermediate
24.4% Emulsifiable concentrate
Methidathion is registered as a single active ingredient.
Basic Registrant: Ciba-Geigy
Year of Initial Registration: 1974
Pesticide Type: Insecticide/Acaricide
Chemical Family: Organophosphate
Application rates: 0.25 - 10 lb active ingredient per acre
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all the available data relating
to methidathion. 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.
1. Acute Toxicity: Technical methidathion is a highly
toxic pesticide. It is placed in Toxicity Category I by the
oral route and Toxicity Category II by the dermal route.
Technical Methidathion is only mildly irritating to eyes and
skin (Toxicity III and IV, respectively). It is not a dermal
sensitizer and does not produce acute delayed neurotoxicity.
There are no acute inhalation studies for technical methida-
thion. Due to the physical properties of the compound
(solid), no inhalation study is required.
2. Oncogenicity Study: Methidathion fed to Sprague-
Dawley rats did not produce an oncogenic response. Methida-
thion fed to CD-I mice resulted in an increase in both benign
and malignant liver tumors in males only. Based on the
mouse study, the Agency has classified methidathion as a
possible human carcinogen (Group C). However, the evidence
is not strong enough to warrant a quanititative estimation of
risk.
3. Data Base: The toxicology data base for methidathion
is complete, no additional data are required at this time.
4. Adverse Impact on Birds and Aquatic Organisms:
Laboratory data show that methidathion is highly toxic to birds
on an acute oral basis and moderately toxic to birds on a dietary
basis. Methidathion is highly toxic to all aquatic organisms.
Laboratories studies show methidathion may have an adverse
impact on fish, other aquatic organisms and birds. EPA will
reassess the impacts of methidathion use on birds and aquatic
organisms after the required ecological effects and environ-
mental fate data are received and reviewed.
5. Groundwater Contamination: The Agency is unable to assess
the potental for methidathion to contaminate groundwater because
the environmental fate of methidathion is largely uncharacterized.
Preliminary data indicate that methidathion and its degradates may
leach."* Additional data are needed in order for the Agency to
assess the fate of methidathion in the environment and its
potential to contaminate groundwater.
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6. Tolerance Reassessment; The Agency cannot complete a
final tolerance reassessment for methidathion at this time because
plant and animal metabolism, storage stability, and field residue
and processing data are reguired. However, based on available
data for the U.S. population the Average Anticipated residue
contribution (ARC) is 0.000935 mg/kg body weight/day. The
Acceptable Daily Intake (ADI) is 0.001 mg/kg/day based on the
chronic dog feeding study and a 100 fold uncertainty factor.
The ARC occupies 93.5% of the ADI.
The Agency has also determined that certain label restric-
tions and revisions are necessary. Refer to Section IV
for these revisions.
Table 1 lists that data gaps that are covered in this
Registration Standard.
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TABLE I. DATA GAPS
(Please refer to the tables in Appendix I for detailed
information regarding these requirements)
PRODUCT CHEMISTRY (TGAI):
61-2 Manufacturing Process
61-3 Discussion of Formation of Impurities
62-1 Preliminary Analysis
63-7 Specific Gravity
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 ph
63-13 Stability
Product Chemistry (MUPs):
61-1 Product Identity
and Disclosure of Ingredients
61-2 Manufacturing Process
61-3 Discussion of Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Methods to Verify Certified Limits
63-7 Specific Gravity
63-12 ph
63-14 Oxidizing or Reducing Action
63-15 Flanunability
63-16 Explodability
63-17 Storage Stability
63-19 Miscibility
63-20 Corrosion Characteristics
Residue Chemistry;
171-4 Nature of the Residue (Metabolism) Plant and Livestock
171-4 Analytical Methods
171-4 Storage Stability Data
171-4 Magnitude of the Residue in Plants and in Meat/Milk/Eggs
Exposure Assement;
161-1 Hydrolysis
161-2 Photodegradation in water
161-3 Photodegradation in soil
161-4 Photodegradation in air
162-1 Aerobic Soil
162-2 Anaerobic Soil
163-1 Leaching and Adsorption/Desorption
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163-2 Volatility (Lab)
164-1 Dissipation (Soil) (A field leaching study is required
in lieu of a terrestrial field dissipation study)
165-1 Confined rotational crops
202-1 Drift Field Evaluation and Droplet Size Spectrum
Ecological Effects:
70-1 Special Testing (Residue Monitoring)
71-2 Avian dietary LC50 for an upland game bird
71-4 Avian reproduction (waterfowl and upland game bird)
72-1 Freshwater fish LC50 (typical end-use product - both
coldwater and warmwater species)
72-2 Acute LC50 for freshwater invertebrates (typical end-
use products)
72-3 Acute LC50 for Estuarine Organisms
- Fish, Shrimp, and Mollusk (Typical End-Use
Product)
- Mollusk (TGAI)
72-4 Estuarine (Mysid Shrimp) and Aquatic Invertebrate
(Daphnia) life cycle
72-5 Fish Life Cycle
72-6 Aquatic organism accumlation
Nontarget Insect Testing - Pollinators
141-2 Honey Bee Toxicity of Residues
on Foliage
Spray Drift
201-1 Droplet Size Spectrum
202-1 Drift Field Evaluation
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B. TOXICOLOGICA.L ASSESSMENT
1. Acute Toxicity
a. Acute Oral Toxicity: There are sufficient data
available to show that technical raethidathion is highly acutely
toxic by the oral route (the rat LD50 is 46.1 mg/kg).
Methidathion is therefore classified as Toxicity Category I
for the oral route of exposure.
b. Acute Dermal: There are sufficient data are available
to show that technical methidathion is acutely lethal by the
dermal route. The LD50 for rats is 1663 mg/kg, for males
and females combined. Methidathion is therefore classified as
Toxicity Category II for dermal exposure.
c. Acute Inhalation; There are no acute inhalation
studies conducted with technical methidathion; However, a
study is not required due to the physical properties of the
compound (solid). Note: There is an inhalation study for
the 40% end-use product is highly toxic (I) by the
inhalation route.
d. Primary Eye Irritation: There are sufficient data
available to show that technical methidathion is only a
slight eye irritant. Methidathion is classified in Toxicity
Category III for eye irritation.
e. Primary Dermal Irritation: There are sufficient data
available to show that technical methidathion is only a slight
dermal irritant and is therefore classified in Toxicity
Category IV for dermal irritation.
f. Dermal Sensitization: There are sufficient data
available to show that technical methidathion is not a dermal
sensitizer.
g. Acute Delayed Neurotoxicity: There are sufficient
data available to show that technical methidathion did not
produce acute delayed neurotoxicity in the hen.
2. Subchronic Toxicity: There are no satisfactory sub-
chronic oral studies with methidathion. However, subchronic
studies are not required since there are acceptable chronic
feeding studies in both rats and dogs. Therefore, subchronic
oral studies are fulfilled.
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There is an acceptable subchronic dermal 21-day study
with rabbits. A group of 19 New Zealand white rabbits were
treated by dermal exposure for 21 days to 0, 1, 5, or 20
mg/kg/day of raethidathion. The systemic NOEL was 5 mg/kg/day
and the LEL was 20 mg/kg/day based on depressed body weight
and weight gain and a possible treatment-related hypoactivity.
The NOEL for dermal irritation was greater than or equal to
20 mg/kg/day.
A subchronic 90-day dermal study is not required because
the existing acceptable end-uses should not result in repeated
human skin contact for extended periods.
A 90-day subchronic inhalation study is not required
because methidathion does not result in repeated inhalation
exposure at concentrations likely to be toxic.
The acute delayed neurotoxicity study in the hen was
negative. Therefore, a subchronic neurotoxicity study is
not required.
3. Chronic Toxicity: A core minimum chronic dog feeding
study was conducted using an end-product containing 40%
methidathion. Beagle dogs (3/sex/group) were treated with
raethidathion in the diet for 24 months at doses of 0, '4, 16 and
64 ppm. The NOEL was 4 ppm (0.1 mg/kg day) and the LEL was
16 ppm (0.4 mg/kg/day) based ons increased alkaline phosphatase
and SGPT as well as histologic liver alterations including,
pigmentation (porphyrin), serositis, fibrosis, nodularity and
phlebitis. RBC cholinesterase inhibition was only observed
at the high dose. This study was considered to be core-
supplementary in the 1983 Registration Standard for
methidathion. However, after evaluation of additional
information submitted concerning this study, the study has
been upgraded to core-minimum.
There is a core - guideline two-year feeding/oncogenicity
study in the Sprague/Dawley rat (65 rats/sex/group) given
diets containing 0, 4, 40, or 100 ppm of raethidathion technical
(0, .2, 2, or 5 mg/kg/day. The NOEL was 4 ppm (0.2 mg/kg/day).
The LEL was 40 ppm (2 mg/kg/day) based on (males and females).
At this level there were signs of cholinesterase inhibition
including reduced serum, RBC and brain cholinesterase; alopecia;
and neurologic signs. The above mentioned lesions also
occurred at 100 ppm (5 mg/kg/day) along with decreased body
weight gain and water consumption, increased food consumption;
inflammatory skin lesions and focal accumulations of foamy
macrophages in the lungs. There was no indication of oncogenic
potential at any dose level.
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In a core-supplementary feeding study, 5 to 7 Rhesus
monkeys sex dose were treated with 0, 0.25 or 1.0 mg/kg/day
(gavage) for two years. The systemic NOEL was greater than
1 mg/kg/day and the cholinesterase NOEL was 0.25 mg/kg/day.
The cholinesterase LEL was 1 mg/kg/day based on inhibition
of RBC and plasma cholinesterase.
4. Oncogenicity: The rat chronic study previously
described above also adequately assesses the oncogenicity
of methidation. A discussion on the 2-year mouse study is
given below.
Fifty Charles River CD® mice sex group were treated with
either 0, 3, 10, 50 and 100 ppm, respectively, for two years.
There was an additional 120 mice/sex/group sacrificed at
various times during the 18 month chronic phase of the study.
The doses, calculated for the study using body weight and the
weekly compound intake data, were 0, 0.46, 1.6, 7.5 and 16.1
mg/kg/day. The systemic NOEL was 10 ppm (1.6 mg/kg/day).
The LEL was 50 ppm (7.5 mg/ kg/day), based on males only
caused red to orange urine, increased ALT, absolute and
relative liver weight, histologic liver and biliary alterations
including bile duct hyperplasia, biliary stasis,
cholangiofibrosis, gall bladder epithelial hyperplasia,
chronic hepatitis (females only) and decreased RBC
cholinesterase. Signs of toxicity at the high dose (100
ppm), in addition to the above, in males were increased
mortality, increased platelets, leukocytes, AST, ALK and
plasma cholinesterase, decreased brain cholinesterase,
increased absolute and relative spleen weight and spleen
EMH, and decreased hepatic EMH; in females there was
decreased brain cholinesterase, increased histologic liver
alterations (same as males above) and cholecystitis. There
were no treatment-related clinical signs or changes in body
weight, weight gain or food consumption. Oncogenic changes
included a treatment related increased incidence of both
benign and malignant liver tumors only in male mice at the
high dose level of 16.1 mg/kg/day (100 ppm). Based on the
mouse study, the Agency has classified methidathion as a
possible human carcinogen (Group C). The evidence as a
whole (i.e. 1 species, 1 sex, a common tumor; no increase in
proportion of malignant tumors, or apparent shortening of
time to tumor; lack of mutagenicity or structure activity
relationship) is not considered strong enough to warrant a
quantitative estimation of human risk. In addition, the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
Science Advisory Panel (SAP) agreed that the weight of
evidence, for oncogenicity support a Category C designation
for methidathion.
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5- Teratoqeiiicity: There is an acceptable rabbit study
in which groups of 19 New Zealand white rabbits were treated
by oral gavage on days 7 throuqh 19 of gestation with 0, 2,
6 or 12 mg/kg/day of methidathion. The maternal toxicity
NOEL was 6 mq/kg/day and the LEL was 12 mg/kg/day based on
clinical signs typical of cholinesterase inhibition, miosis
and blood in the pan, all of which only occurred during the
treatment period. The developmental NOEL was greater than or
equal to 12 mg/kg/day.
There is an acceptable teratoloqy study in which
groups of 30 Charles River CD rats were treated by oral
gavage on days 6 through 15 of gestation with 0, 0.25, 1.0
or 2.25 mg/kg/day of methidathion. The maternal toxicity
NOEL was i.O irig/kg/day and the LEL was 2.25 mg/kq/day based
on decreased body weight and food consumption during the
treatment period and clinical siqns typical of cholinesterase
inhibition, exophthalmia, raspy respiration and vaginal
bleeding. The developmental NOEL was greater than or equal
to 2.25 mg/kg/day and the LEL was not reached in this study.
6. Reproduction: There is an acceptable 2 generation
reproduction rat study in which a group of 15 male and 30
female Sprague Dawley (CRLjCD BR) rats were treated with 0,
5, 25 or 50 ppm methidathion in the diet. The parental
systemic NOEL was 5 ppm and the LEL was 25 ppm, based on
tremors and decreased food consumption during lactation, and
decreased ovarian weight. In addition to the above, in the
HDT there was a slight decrease in body weight early in the
Fl growth phase (male and females). The reproductive NOEL
was 5 ppm and and the LEL was 2 5 ppm based on a decreased
mating index and a generalized indication of pup unthrifty-
ness while nursing. In addition to the above, at the HDT
there was an increase in stillbirths and decreased pup
survival at birth and during lactation.
7. Mutagenicity Tests; There is an acceptable gene
mutation test in which methidathion was tested for mammalian
cell point mutation using L5178Y mouse lymphoma cells with
no apparent mutagenic activity.
There is an acceptable chromosomal aberration test with
male albino mice in which there was no evidence of dominant
lethal effects.
Methidathion was tested for the capacity to induce
sister chromatid exchanges in bone marrow cells of Chinese
hamster. The marginal response was considered biologically
relevant in the absence of a clear dose response.
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The requirements for direct DNA damaqe or other testinq
have been satisfied.
9. Metaholism• There is an acceptable metabolism study
characterizing the absorption, distribution and elimination
of methidathion and its metabolites. Methidathion appears
to be rapidly absorbed, metabolized and eliminated. The
primary route of elimination is air, in the form of CO2
(about 38%). The percent eliminated in urine ranged from 30
to 57% dependinn upon dose. The amount eliminated in the
feces ranged from 2 to 10%. There was no evidence of
accumulation in the tissues. In addition to hydrolysis of
the ester bond, the heterocyclic portion was cleaved and
the resulting fragments were further oxidizied to CO2.
The primary urine metabolite appeared to be the sulfoxide ,
with the sulfone and sulfide occuring as secondary urinary
metabolites, depending upon the study. The other metabolites
are present in trace to a few percent of the administered
dose.
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C. ECOLOGICAL EFFECT
1- Avian Toxicity; Methidathion exibits high acute
toxicity to bird's on an acute basis (LD50 -23. 6-33. 2) and
moderate toxicity on a dietary basis (LC50 - mallards =
543 ppm). A dietary toxicity study for an upland qame bird
and avian reproduction studies are required. The dietary
study was not required in the orqinal standard because it
was previously thought that data for the formulated product
could satisfy requirements for the technical grade of the
active ingredient (TGAI). This is no longer considered to
be acceptable. The lack of a requirement for reproduction
studies in the original standard was due to an oversight.
Also, a residue monitoring study is now required because the
estimated environmental concentrations (EECs) exceed the
mallard LCso«
2. Aquatic Organism Toxicity; Methidathion technical
product is highly acutely toxic to all aquatic organisms
(LC50 = 0.7-14 ppb). Additional studies requirinq determina-
tion of the acute toxicity of formulated products to aquatic
organisms have been triqqered because the calculated EECs
exceed the LC50 values. The newly submitted first tier
acute toxicity study for mollusks using the TGAI was not
adequate; this study may be upgraded to "core" by submission
of additional data. A fish life cycle study is required
because the EEC exceeds 1/10 of the no effect level for all
application rates. Estuarine (Mysid shrimp) and aquatic
invertebrate life cycle studies are also required because
the EECs for all uses are at least 2x the LC50 values. An
aquatic residue monitoring study is required because the
calculated EECs are greater than the aquatic LC50 values.
3. Honey Beest There is sufficient information to
characterize methidathion as hiqhly toxic to honey bees.
Because data indicate a high toxicity to bees, additional
data are required to fully assess the toxicity to honey bees
from the registered use patterns.
4. Endangered Species: The Office of Endangered Species
(OES), Dept. of Interior, has determined in their cluster
opinion that the use of methidathion on agricultural crops and
pastureland, 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 spcies.
After this program is developed, the Agency will notify
registrants of any labeling that may be required to remain in
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compliance with FIFRA. As explained below, the labeling
requirements affecting methidathion, i.e. those listed
in PR Notices 87-4 and 87-^5, have been withdrawn.
In May 1987, EPA issued PR Notice 87-4 and 87-5 in response
to an OESA finding that certain pesticides, including
methidathion, jeopardized the continued existence of endangered
species. The Agency later withdrew these PR Notices because
of some technical errors and inconsistencies. When these
deficiencies are corrected, the Agency will notify registrants
with another PR Notice that will state the labeling requirements
and other relevant information to protect endangered species.
5. Environmental Fatet In the 1983 Standard for
methidathion, additional data were required for all
environmental fate topics except aerobic soil metabolism,
terrestrial field dissipation and aged leaching. Also, data
were required for reentry. The Agency has evaluated all the
data submitted in response to the Standard and found that,
with the exception of reentry and unaged leaching, the studies
either did not meet guideline requirements or were resubmissions
of previously submitted, unacceptable data. All previously
accepted studies are no longer considered adequate because
they do not meet current guideline requirements (e.g.,
formation and decline of degradates were not demonstrated).
Extensive data gaps remain-
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D. PESTICIDE INCIDENT REPORTS
No deaths in the U.S. (in 1961, JL969, 1973 and 1974) and
no deaths in California (1965-1977 and 1982-1986) were reported
due to methidathion. From 1971 through 1976, no hospitalizations
were reported in the U.S., or in California between 1980-1986.
In California, physicians treated an average of 4.8
methidathion poisonings each year from 1981 through 1986. In
addition, 2 cases per year were reported as either due to skin
or eye injury. Of the total 41 illnesses reported for this
period, 9 were to applicators, 23 were due to exposure to
residues or drift, and 6 were mixer/loaders.
E. HUMAN EXPOSURE
1. Reentry: To assure a safe reentry interval in regard
to Methidathion EC applications to tree fruits, a 14 day
interval is required when formulations are applied at no
greater than 10.0 lb ai/acre. However, if amounts of
methidathion greater than 10 lbs ai/acre are applied, then a
30 day reentry interval is required.
When methidathion EC formulations are applied at 2 lbs ai/acre
or less to low crops, a 2-day interval is required before
workers reenter the field.
2. Dietary Exposure: The Agency reference dose Acceptable
Daily Intake (ADI) used in the analysis was 0.001 mg/kg/day,
based upon a NOEL of 0.1 mg/kg body weight/day from a 2-year
dog feeding study with a safety factor of 100. This value
has been approved by the Agency Reference Dose Committee.
The Tolerance Assessment System (TAS) routine chronic
analysis was conducted using established tolerance values
given in 40 CFR 180.298 and anticipated residue values for
citrus pulp, citrus juice, citrus oil, and cottonseed oil.
Also, percent crop treated data obtained from Benefits and
Use Division (BUD) were used in an effort to present the most
realistic exposure estimate possible. The potato tolerance
was excluded from the analysis because methidathion is not
registered for use on potatoes in the U.S. For the U.S.
population average, the Anticipated Residue Contribution
(ARC) is 0.000935 mg/kg body weight/day (93.5% of the ADI).
The two most highly exposed population subgroups, non-nursing
infants, and children aged 1 to 6, have ARCs of 0.002313 mg/kg
body weight/day (231.3% of the ADI) and 0.001395 mg/kg body
weight/day (139.5% of the ADI), respectively.
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The primary contributor to residues in the diet of non-
nursinq infants and children aqed ]-6 was milk, at 84.7% and
7.1.2% of the total ARC for these population subgroups,
respectively. Therefore, the Aqency is requestinq processing
data for milk to permit a more reliable estimate of actual
residues consumed. Milk fortified with the sulfoxide and
sulfone metabolites (residues of concern known to occur in
milk) must be subjected to pasteurization and all major
degradation products accounted for and identified.
2. RESIDUE DATA
The metabolism of methidathion in plants is not adequately
understood. A high proportion of the radio-labeled residues
remained unidentified in many of the metabolism studies.
Water-soluble ^^C-metabolites have not been adequately charac-
terized in plants. Also, the refining processes for vegetable
oils can greatly reduce methidathion residues that have con-
concentrated in crude vegetable oils and may form unknown
degradation products. The following additional data are required:
1. Data depicting the total terminal residue of
radio-labeled methidathion applied foliarly
to representative oil seed, citrus, and forage
legume crops (we suggest cottonseed, orange,
and alfalfa). A completely characterized
test substance representative of technical
methidathion used in commercial formulations
(including manufacturing impurities) must be
applied under conditions representing normal
cropping practices and at rates high enough to
result in sufficient radio-labeled residues
for characterization. Sampling intervals
following treatment must include the day of
application. Radio-labeled residues in or
on the respective raw agricultural commodities,
including water-soluble metabolities, must be
characterized and quanitified. Use of multiple
radio-labels (l^C, 32pf 35g) may be necessary
for complete characterization. Representative
samples from these studies must also be analyzed
by the residue analytical methods developed
and/or currently in use (Method I in the PAM,
Vol. II) for tolerance enforcement to ascertain
that the methods are capable of adequately
recovering and quantifying all residues
of concern.
2. Data depicting the nature and distribution of
radio-labeled residues in crude and refined
vegetable oil processed from representative
oil seeds bearing measurable weather residues
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oE radaio-labeled methidathion. Use of
multiple radio-labels (14C, 32p( 35s) may
be necessary for complete characterization.
The various procedures used in commercial
processing must be represented in these
studies.
The Methidathion Guidance Document dated January 13, 1983
concluded that the nature of the residue in animals is adequately
understood. However, the study of C14C]-methidathion metabolism
in cattle which was reviewed for the Guidance Document did not
characterize 14C-residues in tissues. A recently submitted
study of C14c]-methidathion metabolism in a lactating goat also
failed to characterize 14c-residues in milk and tissues.
Furthermore, the poultry metabolism study reviewed for the
Guidance Document did not use radiolabeled methidathion; thus,
the total terminal residue could not be characterized.
The chemical structures of methidation and its known
metabolites in plants and animals were illustrated. The
available data adequately characterized the total terminal
residue of [14C]methidathion in milk. 14C-Activity from
carbonyl-[14C]methidathon fed to dairy cows can be incorporated
into lactose, casein, and glycerol, as well as the methidathion
sulfoxide and sulfone metabolites. Methidathion and its
oxygen analog were not detected in milk.
The following additional data are required:
1. Metabolism studies characterizing the total
terminal residue of methidathion in ruminants
and poultry. Animals must be dosed orally for
a minimum of 3 days with radiolabeled
methidathion at a level high enough to make
residue identification and quantification
possible. Eggs must be collected twice a
day during the dosing period. Test animals
must be slaughtered for tissue analysis
within 24 hours of administration of the
final dose. The distribution and characteri-
zation of residues must be determined in
eggs, liver, kidney, muscle, and fat.
Representative samples from these studies
must also be analyzed using residue
analytical methods developed for tolerance
enforcement to asoectain that
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2. Studies of the metabolism of methidathion in
swine may be required if the metabolism of
methidathion in ruminants and poultry differs
substantially from that in rats.
F. TOLERANCE REASSESSMENT
Tolerances for residues of methidathion in food and feed
commodities are established in 40 CFR 180.298. Tolerances
for residues in or on plant commodities are expressed in terms
of methidathion per se and tolerances for residues in animal
commodities are expressed in terms of methidathion, its 0-analog,
and its sulfoxide and sulfone metabolites. The currently
available data are sufficient to permit the established
tolerances to stand, pending receipt of the required
residue chemistry data. A final tolerance reassessment can-
not be made, however, until all the required residue chemistry
data (metabolism in plants and livestock, storage stability,
and certain field residue and processing studies) have been
received and evaluated.
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IV. REGUATORY POSITION AND RATIONALE
A- REGULATORY POSITIONS AND RATIONALE
Based on review and evaluation of all available data and
other relevant information on methidathion, the Agency has made
the following determinations:
1. Methidathion is not being placed into Special Review
at this time.
Rationale: The available data are limited, and none of the
criteria for initiation of Special Review listed in 40 CFR §
154.7 have been meet. The Agency will reevaluate its position
after the required ecological effects and environmental
fate data are submitted and evaluated.
2. The Agency will not approve new tolerances for
significant new uses1 until the Agency has received data
sufficient to perform a tolerance reassessment.
Rationale: Data gaps exist for plant and animal metabolism,
storage stability as well as for various commodities.
Although the toxicology data base is complete, the lack of
residue data precludes the Agency from conducting a full
tolerance reassment. For these reasons, significant new
uses* will not be granted until these data gaps have been
filled.
3. The Agency is requiring avian and aquatic residue
monitoring studies to assess the impact of methidathion on
avian and aquatic organisms.
Rationale: Methidathion exhibits high acute toxicity to birds
on an acute oral basis and moderate toxicity to birds on a
dietary basis. Based on theoretical calculations, residues
in citrus orchards could be as high as 1100 ppm on long grass
in the understory and 1250 ppm on foliar surfaces. Both of
these values exceed the mallard LC50 (543 ppm). Therefore a
residue monitoring study is required. Methidathion is
highly toxic to aquatic organisms and the intended use patterns
are such that aquatic environments may be exposed to drift and
runoff. Calculated EEC's indicate that methidathion could
be transported to water resulting in concentrations above
aquatic LC50 values. Thus an aquatic residue monitoring
study is required.
a1/
""Significant new use" is defined in 44 FR 27934, May 1, 1979.
In the case of a new food or feed use, the Agency will generally
consider as significant increase in the Theoretical Maximum
Residue Contribution (TMRC) of greater than 1%.
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4. The Agency will continue to classify methidathion as
a restricted use pesticide. Based on terrestial (EECs), the
restricted use triqger is exceeded (calculated EECs are > 1/5
the mallard LC50). Based on calculated EECs for aquatic
ecosystemsr the restricted use trigger is also exceeded
{calculated EECs are all > 1/10 the aquatic invertebrate LC50
Rationale: Restricted Use classification is required when
residues from the various use patterns result in levels
that exceed 1/5 the of the LC50 values for terrestrial wild-
life. Estimated terrestrial residues do meet these criteria.
If the actual residues are below 108 ppm (l/5th the LC50
for mallards) then restricted use wouid be rescinded for
terrestial wildlife. Restricted Use Classification is
required when residues in the aquatic environment exceed
1/10 the the lowest aquatic LC50 (0.72 ppb for Daphnia maqna).
All use patterns with application rates above 1 lb ai/A
should be classified as restricted based upon aquatic
toxicity data. However, if residue monitoring shows that
actual residues are less than 0.72 ppb (l/10th the inverte-
brate LC50)r then restricted use would not be necessary
for aquatic concerns.
5. The Agency is deferring decisions regarding
methidathion's potential for contaminating ground water until
information on its environmental characteristics and fate have
been submitted and reviewed.
Rationale: The Agency is unable to assess the potential for
methidathion to contaminate ground water because the environmental
fate of methidathion is largely uncharacterized. Preliminary
data indicate that methidathion and it degradates may leach.
However, it has not been found in ground water and is not on the
list of pesticides to be monitored in the National Survey of
Pesticides in Ground Water. Additional data are needed to assess
the fate of methidathion in the environment and it potential
to contaminate ground water.
6. In order to remain in compliance with FIFRA, the
following reentry intervals are being imposed at this time
based on the submitted reentry data: 14 days for tree fruit
at < 10 lb ai/A, 30 days for tree fruits > 10 lb ai/A and 2
days for low crops £ 2 lb ai/A.
Rationale: Three reentry studies were submitted in
response to the 1983 Registration Standard. These studies
were reviewed and found to be scientifically valid and
represented human agricultural exposure situtations of both
low dose (0.5 lbs. Al/acre) and high (10 lbs. ai/acre).
These studies contribute to the fulfillment of reentry data
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requirements by providing information on the dissipation of
dislodgeable residues from cotton, alfalfa and citrus leaf
surfaces treated with the 2 lb/gal EC formulation of
methidathion. The data provided are sufficient for the
emulsifiable concentrates, but are not acceptable for
wettable powder, encapsulated, or oil formulations.
7. The Agency is requiring protective clothing for workers
who mix, load or apply methidathion, dispose of methidathion
products, repair and clean contaminated mixing/loading and
application equipment, or reenter treated areas before the
established reentry levels have expired. In addition, the
use of human flaggers during aerial application is prohibited
unless they are in enclosed vehicles.
Rationale; Because of the high acute toxicity of methidathion
protective clothing and equipment and the above prohibition
are required to minimize exposure of methidathion to field-
workers applicators and flaggers.
8. Tolerance Revisions
a. The tolerances for residues in or on meat, milk,
poultry and eggs cannot be evaluated at this time.
Rationale: Because of the need for plant and animal metabolism
data, new analytical methodology and method validation data for
animal commodities, storage stability data, and residue data
for feed items, the tolerances for residues in or on meat,
milk, poultry and eggs cannot be evaluated at this time.
b. The sheep mbyp tolerance (00.5 ppm) in 40 CFR 180.298
(b) is apparently in error and will be changed to 0.05. The
tolerance statement will be amended to specify "combined
residues of methidathion" and its metabolites "expressed as
methidathion", to clarify how residues are to be quantified.
In addition, the words "or on", in reference to the location
of residues, will be deleted.
Rationale: The available data support these changes.
c. The tolerance established for residues of methidathion
on potatoes will be revoked.
Rationale: Currently, no registered products bear the use
for methidathion in or on potatoes. Therefore, an application
to register this use must be submitted together with a promise
to submit the residue data in accordance with the data table or
the tolerance will be revoked.
d. The Agency delete the separate tolerances for methida-
thion residues in or on peaches, pecans, and walnuts from 40 CFR
180.298 (a), as these are now covered by appropriate crop
group tolerances. The Agency recommends that the entry
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"nut" be changed to "tree nut, and nutmeat" in order to
avoid confusion regarding other commodities pertaining to
crops in this crop group (specifically, almond hulls for
which a separate tolerance has been established at a higher
level).
Rationale: The available data support these changes.
9. The Agency has identified certain data which will
receive priority review when submitted to the Agency.
Rationale: Certain data are essential to the Agency's assessment
of methidathion. 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:
158.120 Product Chemistry
61-2 Description of Beginning Materials and
Manufacturing Process
61-3 Discussion of Formation of Impurities
62-1 Preliminary Analysis of Product Samples
158.125 Residue Chemistry
171-4 Nature of residue (Metabolism)
-Plant
171-4 Nature of residue (Metabolism)
-Live stock
171-4 Residue analytical methods
171-4 Magnitude of the residue
-Plant
158.290 Environmental Fate
163-1 Leaching and Adsorption/Desorption
158.490 Wildlife and Aquatic Organisms
70-1 Special Testing
Residue Monitoring
71-2 Avian Subacute Dietary Toxicity
-Upland Game Bird
71-4 Avian Reproduction
-Upland Grame Bird, and Waterfowl
72-1 Freshwater Fish Toxicity
"" -Coldwater Fish and Warmwater Species
72-2 Acute Toxicity to
Freshwater Invertebrates
72-3 Acute Toxicity to EstuarLue and Marine
Organism
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72-4 Early Life Stage
Aquatic Invertebrate
-Daphnia magna
-Shrimp
72-5 Fish life Cycle
72-6 Aquatic Organism
158.155 Nont.arqet Insect
141-2 Honey Bee Toxicity of
Residues on Foliage
10. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end use products (EPs)
containing methidathion may be sold, distributed, formulated
and used, subject to the terms and conditions specified in
this Standard. Registrants must provide or agree to develop
additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale: Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or
are inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for identifying
data needs and labeling changes arising from available data.
Required data will be reviewed and evaluated, after which
the Agency will determine if additional regulatory changes
are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain methidathion, bear required labeling,
and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this document.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain methidathion.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and
inert ingredients which are present in products, as well as
impurities found at greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing methidathion provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the sites and uses listed in the Use Index ( EPA
Compendium of Acceptable Uses) (for availability, see page 1).
The Use Index Compendium lists all federally 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 data requirements
in Table A for that use pattern.
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D. LABELING
In order to remain in compliance with FIFRA, manufacturing
use products (and end-use products, if covered by the Standard)
must bear appropriate labeling as specified in 40 CFR 156.10.
Appendix II contains information on label requirements.
No pesticide product containing methidathion may be
released for shipment by the registrant after September 30,
1989, unless the product bears an amended label which complies
with the requirements of this Standard.
No pesticide product containing methidathion may be
distributed or sold*after September 30, 1990, unless the
product bears an amended label which complies with the
requirements of this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
ALL PRODUCTS
1. Ingredients Statement
The ingredient statement for products must list the
active ingredient ass
ACTIVE INGREDIENT
Methidathion: 0,0-dimethyl phosphorodithioate S-ester
with 4-(mercaptomethyl)-2-methoxy-delta
2-1,3,4-thiadiazolin-5-one %
INERT INGREDIENTS: %
MANUFACTURING-USE PRODUCTS
Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites, which are listed
in Use Patterns, Section C.3. However, no use may be included
on the label where the registrant fails to agree to comply
with the data requirements in TABLE A for that use pattern.
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2• Environmental Hazard Statments
The following revised environmental hazard statement must
appear on all manufacturing product labels:
"This pesticide is toxic to fish and wildlife. Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans or public waters unless ths product is
specifically identified and addressed in an NPDES permit. Do
not discharge this product into sewer systems without previously
notifying the sewage treatment plant authority. For guidance,
contact your State Water Board or Regional Office of U.S. EPA".
END-USE PRODUCT LABELING
1. Restricted Use Statement
The following restricted use statement must appear on
the front panel of all products not intended for or packaged
for use around the house.
RESTRICTED USE PESTICIDE
Due to Aquatic Toxicity and Avian Hazard
"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. Environmental Hazard statements
The following revised environmental hazard statement must
appear on all end-use product labels:
"This pesticide is toxic to fish and wildlife. Do not apply
directly to water or wetlands (swamps, bogs, marshes, and
potholes). Drift and runoff will be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water
when disposing of equipment washwater."
3. Bee Caution Statements
The following bee hazard statement must appear on all
end-use product labels:
"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. Do not apply to corn during the
pollen shed period."
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4. Reentry Statement:
The following statement must appear on the labeling of
all end-use products:
"Do not enter tree fruit areas for 14 days after application
of 10 lb ai/A or less, 30 day? for tree fruits greater than 10 lb
ai/A and 2 days for low crop or egual to 2 lb ai/A or less unless
protective clothing is worn, as described in the product
labeling."
5. Rotational Crop Statements
The following crop rotational statement must appear on all
end-use product for artichokes!
"Do not plant crops other than those crops registered for applica-
tion with methidathion within 1 year after last application".
6. Grazing and Preharvest Statements;
The following grazing statement must appear on all
end-use products labels.
-For alfalfa grown for seed:
"Do not use treated crop for feed or hay or graze treated
fields with livestock".
-For almonds
"Do not allow livestock to graze on cover crops in treated
areas".
-For Apples, apricots, cherries, nectarines, pears,
plum, prunes, and olives:
"Do not graze treated areas or feed cover crops grown in
treated areas to livestock".
-For cotton:
"Do not feed gin waste to livestock or allow livestock to
graze treated cotton plants".
-For grapefruit, oranges, lemons, pecans, safflower, and walnuts".
"Do not allow livestock to graze treated areas."
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-For sunflower:
"Do not graze treated areas or Eeed treated forage to "Livestock".
-For alfalfa:
"10-day preharvest, pregrazing, or prefeeding interval through
1 pound per acre for foliar application".
-For sorghum (forage and grain):
"30-day preharvest, pregrazing interval through 0.5 pound per acre
for foliar application".
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7• Protective Clothing and equipment
The following statements must appear on the label of all
end-use products:
USE ONLY WHEN WEARING THE FOLLOWING PROTECTIVE CLOTHING AND
EQUIPMENT DURING MIXING/LOADING, APPLICATION, REPAIR AND
CLEANING OF MIXING, LOADING, AND APPLICATION EQUIPMENT,
DISPOSAL OF THE PESTICIDE, AND EARLY REENTRY INTO TREATED
AREAS: Protective suit of one or two pieces covering all
parts of the body except head, hands and feet; chemical
resistant gloves; chemical resistant shoes (or chemical
resistant shoe covers or chemical resistant boots); and a
NIOSH OR MSHA approved respirator. In addition, mixer/loaders
must wear a chemical resistant apron and face shield or
goggles.
During equipment repair and cleaning, the respirator need not
be worn. During early reentry after sprays have dried or dust
has settled and vapors have dispersed, the respirator need
not be worn.
IF MIXING/LOADING IS PERFORMED USING A CLOSED SYSTEM, THE
FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT MAY BE WORN AS AN
ALTERNATIVE! long-sleeved shirt and long legged pants;
chemical resistant gloves; chemical resistant apron; shoes
and socks. Goggles or face shield must be worn if the system
is under pressure.
IF APPLICATION IS PERFORMED USING AN ENCLOSED CAB OR COCKPIT,
THE FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT MAY BE WORN
AS AN ALTERNATIVE: long-sleeved shirt and longlegged pants;
shoes and socks. Chemical resistant gloves must be available
in the cab or cockpit and must be worn when exiting. This
clothing is inadequate to protect you during equipment repair
or cleaning, reentry, or pesticide disposal work.
IMPORTANT! If pesticide comes in contact with skin, wash off
with soap and water. Always wash hands, face, and arms with
soap and water before smoking, eating, drinking, or toileting.
AFTER WORK: Before removing gloves, wash them with soap and
water. Take off all work clothes and shoes. Shower using
soap and water. Wear clean clothes. Do not reuse contaminated
clothing. Personal clothing worn during work must be laundered
separately from household articles. Store protective clothing
separately from personal clothing. Clean or launder protective
clothing after each use. Respirators must be cleaned and
filters replaced according to instructions included with the
respirator. Protective clothing and equipment that becomes
heavily contaminated or drenched must be destroyed according
to state and local regulations. HEAVILY CONTAMINATED OR
DRENCHED CLOTHING CANNOT BE ADEQUATELY DECONTAMINATED.
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DURING AERIAL APPLICATION, HUMAN FLAGGERS MUST BE IN A TOTALLY
ENCLOSED VEHICLE.
In addition, it is recommended that all product labels that
carry a DANGER signal work contain the following language:
"The National Pesticide Telecommunication Network
(NPTN) is available for recommendations regarding
management of pesticide poisonings, emergency
treatment, and other information regarding the
toxicity of methidathion. The toll free number
for the National Pesticide Telecommunication Network
is 1-800-858-7378".
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2.
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject tos
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption3, the
data requirements listed in Table B.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A.
2 Data requirements are listed in the two Tables in
Appendix I of the Registration Standard. The Guide to
Tables in the Appendix explains how to read the Tables.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the generic data exemption^, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data reguirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption,
the data requirements listed in Tables A and C.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-reqistered 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 reguirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to the data
requirements in Table A.
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2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). it
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submittinq
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Aqency will consider
4 Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed
in this Registration Standard.
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-35-
that both they and you are not in compliance and will normally
initiate proceedinqs to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Generic Data Exemption
Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submittal or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submittinq the data
yourself. If you use this method, you must state who will
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-36-
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submittal.
The Agency will also reguire adeguate 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 reguested data as a task force or consortium, a
representative of the group should reguest a Joint Data
Submitter Number, as part of your 90-day response. The
reguest 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 reguirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You reguest that EPA not suspend your registration
tor non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may gualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
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-37-
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your reqistration 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 forjwhich the data are needed. You are not required
to submit data for uses which are no longer on your label.
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-38-
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
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.
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-39-
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 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.
1 * Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). All studies must be submitted in the form of
a final report; a preliminary report will not be considered
to fulfill the submittal requirement.
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-40-
J. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a reqistration is
suspended for failure to respond to a DCI request under
FiFRA sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act. The following information must be included in any
request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII« REQUIREMENT for submission of product-specific data
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.l. (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 reqistration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion Standard. Responses to this Registration Standard must
include draft labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the intended
colors of the final labelr clear indication of the front
panel of the label, and the intended type sizes of the text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific instructions
in Section IV.D., EPA may seek to cancel the registration of
your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Methidathion Registration Standard
All submittals in response to this Registration Standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must
be clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration Standard
responses be combined with other types of filings for which
fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. -Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
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-42-
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate attachments.
b. Confidential Statement of Formula (EPA Form 8 570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8 570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
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-43-
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3) ,
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet* with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from receipt of this document you
must submits
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8 580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
D. End Use Products containing the subject active ingredient
as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Witjiin 9 months from the receipt of this document, you
must submit:
Three copies of draft labelinq, including the container
label and any associated supplemental labeling.
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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.
E. Intrastate Products
Applications for full Federal registration of intrastate
products were reguired to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
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DATA APPENDICES
-------
TGUIDE-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI ¦ Technical grade of the active ingredient
PAI « Pure active ingredient
PAIRA » Pure active ingredient, radio labeled
TEP « Typical end use formulation
MP « Manufacturing use product
EP » End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A » Terrestrial, food
B » Terrestrial, non-food
C * Aquatic, food
D » Aquatic, non-food
E ¦ Greenhouse, food
F » Greenhouse, non-food
G ¦ Forestry
H - Domestic outdoor
I Indoor
Any other designations will be defined in a footnote to the table.
-46-
-------
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
<3o~not Fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-47-
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TABLE A
GENERIC DATA REQUIREMENTS TOR METHIDATHION
Data Requirement
Test Use Does EPA Biblioqraphic
Substance^ Patterns Have Data? Citation-*
Part 158.150-158.190
Subpart C - Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI All
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI All
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI All
Physical and Chemical
Character ist ics
63-2 - Color TGAI All
63-3 - Physical State TGAI All
63-4 - Odor TGAI All
63-5 - Melting Point TGAI All
63-6 - Boiling Point TGAI All
63-7 - Density, Bulk Density, or TGAI All
Specific Gravity
Must Additional Time Frame
Data be for
Submitted?* Submission
Partially 00011347.
Partially 00131026, 40079802
Yes
Yes
Yes
Yes
N/A
Partially
00011347, 40079802.
40079802.
00011347.
00011347.
00155944.
Yes"
Partially 00131026, 40079802. Yes5
Yes*
No
No
No
No
No7
Yes
8
6 Months
6 Months
12 Months
6 Months
-48-
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TABLE A
GENERIC DATA REQUIREMENTS FDR METHIC&THION
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance^ Patterns Have Data? Citation^ Data be for
Submitted?^ Submission
Part 158 .'150-158.190
Subpart C - Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-8 - Solubility
TGAI or PAI
All
Yes
00011347, 00131026. No
63-9 - Vapor Pressure
TGAI or PAI
N/A
Partially
00011347. Yes8
6 Months
63-10 - Dissociation constant
TGAI or PAI
N/A
No
Yes8
6 Months
63-11 - Octanol/water partition
coefficient
PAI
N/A
Partially
00131026. Yes8
6 Months
63-12 - pH
TCAI
N/A
Partially
00131026, 00142590. Yes8
6 Months
63-13 - Stability
TGAI
N/A
Partially
00011347, 40079802. Yes8
6 Months
Other Requirements:
64- 1 - Submittal of samples NA N/A N/A - No
1. Because the 95% T also serves as a manufacturing-use product, additional data requirements applicable to
this product are listed in Table B.
2. TGAI = technical grade of the active ingredient. PAI = purified active ingredient.
3. Eight-digit MRID number refer to documents catalogued in the Pesticide Data Management System (PDMS).
Hyphenated numbers refer to product registration jackets for the respective EPA Registration Numbers.
-49-
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TABLE A (continued)
4. Complete information on the manufacturing process for the 95% T (EPA Reg. No. 100-530) must be provided
regarding the nature or the process (batch or continuous), relative amounts of beginning materials,
equipment usecb to product each intermediate and final product, reaction conditions, duration of each step of
the process, purification procedures, and cjuality control measures.
5. A detailed discussion must be submitted for the 95% (EPA Reg. No. 100-530) regarding all inpurities
that are or may be present at _> 0.1%, based on knowledge of the beginning materials, intended and side
chemical reactions in the manufacturing process, and any contamination during and after production. A
discussion regarding the possible carryover of hydrazine from any source in the product is also required.
6. Samples from five or more representative batches of the 95%T (EPA Reg. No. 100-530) must be analyzed
for the active ingredient and each impurity for which a certified limit is required. Complete and detailed
descriptions of the methods used for sample analysis must be submitted, including statements of their
precision and accuracy. The preliminary analysis report should include the identity and quantity of each
ingredient for which analysis is conducted along with the mean and relative standard deviation of the
analytical results. This requirement may be partially fulfilled by submission of satisfactory validation
data for the methods used to generate the available preliminary analysis data.
7. Data are not required because the technical product is a solid at room temperature.
8. As required in the 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines,
Subdivision D, data are required on specific gravity, vapor pressure, dissociation constant, octanol/water
partitioning coefficient, ph, and stability of the 95% T (EPA Reg. No. 100-530). These requirements may be
partially satisfied by supplying quantitative data from tests already conducted in these products and
information regarding methods and parameters (e.g. temperature) used to obtain the available data. Because
the 95% T also serves as a manufacturing-use product, there are additional data requirements pertaining to
physicochemical characteristics which are listed in Table B.
-50-
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Table A
Generic Data Requirements for Methidathion
Data Requirement
Test
Substance*
Does EPA
Have Data?
Bibliographic
Citation^
Must Additional Timeframe
Data Be for
Submitted? Submission^
§158.240 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism) - Plants
PAIRA
(See Index)
Partially
171-4 - Nature of the Residue PAIRA & Plant
(Metabolism) - Livestock Metabolites
Partially
171-4 - Residue Analytical Method
- Plant Residues
- Animal Residues
Partially
TCAI &
Metabolites
TGAI &
Metabolites
00011317,00022903, Yes4'5 18 Months
00022910,00022911,
00060895,00154460,
00154462,05011885,
40127811,40127812
00011317,00011335, Yes6'7 18 Months
00011336,00011936,
00022908,00022909,
00026090,40127821*
00011320,00011322, yes8'9,10,ll 15 Months
00011324,00011326,
00011334,00011337,
00011373,00011722,
00011843,00011844,
00011846,00011852,
00020944,00020945,
00020979,00029229,
00060902,00128127*,
00154474*,05011904,
40127804* ,40127805*,
40127806*,40341001*
-51-
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Table A
Generic Data Requirements for Methidathion (cont'd)
Data Requirement
Test
Substance*
Does EPA
Have Data?
Biblioqraphic
Citation^
Must Additional Timeframe
Data Be for
Submitted? Submission^
§158.240 Residue Chemistry
171-4 - Storage Stability
171-4 - Magnitude of the Residue
Residue Studies for
Each Food Use
- In Plants
- Root and Tuber
Vegetables
- Potatoes
- Citrus Fruits
TEP and
Metabolites
Mandarins
Pome Fruits
Stone Fruits
TEP
TEP
Partially
Partially
Partially
TEP Partially
TEP Partially
TEP Partially
00011843,00060902,
00154474,40127802*,
40341001*
00014404
00011323,00011425,
00011426,00027999,
00029221,00029227,
00029228
00011323
00012593,00020946
00011641
00011921
00012594
00012596
00012598
00012600
00012603
00020946
00020948
,00011642,
,00012593,
,00012595,
,00012597,
,00012599,
,00012601,
,00012604,
,00020947,
,00020949,
YeS12 »13
Yes12,14
Yes15,12,24
Yes^'^'^
Yes^'^4
Yes^'^4
18 Months
18 Months
18 Months
18 Months
18 Months
18 Months
-52-
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Table A
Generic Data Requirements for Methidathion (cont'd)
Must Additional Timeframe
Data Be for
Submitted? Submission^
Data Requirement
Test
Substance*
Does EPA
Have Data?
Bibliographic
Citation^
S158.240 Residue Chemistry
171-4 - Magnitude of the Residue in Plants (cont'd)
- Stone Fruits (cont'd)
- Tree Nuts
- Cereal Grains
- Sorghum
Forage, Fodder, and Straw
of Cereal Grains
- Sorrjhum Forage and
Fodder
TEP
TEP
Partially
Partially
TEP
Partially
00020950
00020952
00020954
00020956
00020958
00020962
00020967
00020971
,00020951,
,00020953,
,00020955,
,00020957,
,00020959,
,00020965,
,00020970,
00011640,00011769,
00020946,00036942
00011303,00011304,
00011305,00014382,
00014383,00014384
00011303,00011304,
00011305,00014382,
00014383,00014384
yes12,24
Yes^2f24
Yesl?
yes12,24
18 Months
18 Months
24 Months
18 Months
-53-
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Table A
Generic Data Requirements for Methidathion (cont'd)
Must Additional Timeframe
Test Does EPA Bibliographic Data Be for
Data Requirement Substance*- Have Data? Citation^ Submitted? Submission-*
§158.240 Residue Chemistry
171-4 - Magnitude of the Residue in Plants (cont'd)
- Nonqrass Animal Feeds
- Alfalfa
TEP
Partially
00011318,00012575
yes12,18,24
18
Months
- Clover
TEP
Partially
00011318
Yes
18
Months
Grass Forage, Fodder
and Hay
Partially
00011321
Yes20
18
Months
Miscellaneous Ccnmodities
- Artichokes
TEP
Partially
00011764
Yes21
18
Months
- Cottonseed
TEP
Partially
00115199,40127804
Yes12'2^
Yes22
18
24
Months
Months
- Mangoes
TEP
Partially
00011474
Yes12'2^
18
Months
- Olives
TEP
Partially
00011456
yes12,24
18
Months
- Safflower
TEP
Partially
00038279,00038280
Yes12'2^
18
Months
- Sunflower
TEP
Yes12,2^
18
Months
- Tobacco
TEP
Partially
00011856
Yes12,23,24
18
Months
-------
Table A
Generic Data Requirements for Methidathion (cont'd)
Data Reguirement
Test
Substancej
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Timeframe
for
Submission
§158.240 Residue Chemistry
171-4 - Magnitude of Residue in
Meat/Milk/Poultry/Eggs
- Milk, Fat, Meat, and
Meat Byproducts of
Cattle, Goats, Hogs,
Horses, and Sheep
TGAI or Plant
Metabolites
Partially
00022574,00078342,
00128127
Yes25'2®
18 Months
- poultry and Eggs
TGAI or Plant
Metabolites
Partially
00011314
Yes2^
18 Months
1 Test substance: TCAI = Technical Grade of the Active Ingredient: PAI = Purified Active Ingredient; PAIRA =
Purified Active Ingredient, Radiolabeled; TEP = Typical End-Use Product; EP = End-Use Product.
2 Asterisks indicate references submitted since completion of the Methidathion Residue Chemistry Chapter dated
September 15, 1983 or otherwise reviewed in this FRSTR* Other references listed here were reviewed in the
interim Residue Chemistry Chapter.
3 Data must be submitted within the indicated timeframe, based on the date of this Guidanoe Document.
4 Data depicting the total terminal residue of radiolabeled methidathion applied foliarly to representative oil
seed, citrus, and forage legume crops (we suggest cottonseed, orange, and alfalfa). A completely characterized
test substance representative of technical methidathion used in commercial formulations (including manufacturing
impurities) must be applied under conditions representing normal cropping practices and at rates high enough
to result in sufficient radiolabeled residues for characterization. Sampling intervals following treatment
must include the day of application. Radiolabeled residues in or on the respective raw agricultural commodities,
including water-soluble metabolites, must be characterized and guantified. Use of multiple radiolabels (14C,
P» S) may be necessary for complete characterization. Representative samples from these studies must
also be analyzed by the residue analytical methods developed and/or currently in use (Method I in the PAM,
Vol. II) for tolerance enforcement to ascertain that the methods are capable of adequately recovering and
guantifying all residues of concern. To avoid unnecessary repetition of residue studies, these metabolism
studies should be completed and submitted for review prior to initiation of reguired residue studies.
5 Data depicting the nature and distribution of radiolabeled residues in crude and refined vegetable oil processed
from representative oil seeds bearing measurable residues of radiolabeled methidathion. Use of multiple radio-
labels (14C, 32P, 35S) may be necessary for conplete characterization. Ttie various procedures used in cam-
wet cva.Y kus*. be Te&ceaer&sA Vn tirese stvx&ies.
-------
Table A
Generic Data Feauirements for Methidathion (cont'd)
SI58.240 Residue Chemistry Footnotes (cont'd)
6 Metabolism studies characterizing the total terminal residue of methidathion in ruminants and poultry. Animals
must be dosed orally for a mininwn of 3 days with radiolabeled methidathion at a level high enough to make
residue identification and quantification possible. Eggs must be collected twice a day during the dosing
period. Test animals must be slaughtered for tissue analysis within 24 hours of administration of the final
dose. Th^ distribution and characterization of residues must be determined in eggs, liver, kidney, muscle,
and fat. Representative sanples from these studies must also be analyzed using residue analytical methods
developed for tolerance enforcement to ascertain that the methods are capable of adequately recovering and
identifying all residues of concern.
7 Studies of the metabolism of methidathion in swine may be required if the metabolism of methidathion in
ruminants and poultry differs substantially from that in rats.
8 Residues analytical methods must be developed and validated which will quantify residues of methidathion and
its oxygen analog, sulfoxide, and sulfone metabolites in meat, poultry, and eggs with combined limits of
detection of 0.05 ppm.
9 Additional validation data must be submitted for GLC/FPD method AG-335 to determine its adequacy in recovering
residues of methidathion and its oxygen analoq, sulfoxide, and sulfone metabolites in milk with a combined
limit of detection of 0.03 ppm (the tolerance level).
10 Residues of methidathion occurring in or on raw agricultural commodities must be subjected to analysis by PAM
Vol. I Method No. 242.2 (Multiresidue Protocol IV). In addition, residues of the oxygen analog, sulfone, and
sulfoxide metabolites of methidathion occurring in meat, milk, poultry, and eggs must be subjected to analysis
by Multiresidue Protocols I through IV available fran the National Technical information Service under Order
No. PB 203734/AS.
11 Hie nature of the residue in plants and in animals is not adequately understood. If the metabolism studies
requested in the sections "Nature of the Residue in Plants" and "Nature of the Residue in Animals" reveal the
presence of additional metabolites of concern in or on plant antj/or animal commodities, additional validated
methods for data collection and tolerance enforcement will be required.
12 Information regarding sample storage conditions and time intervals stored for all previously submitted data
that have been tentatively accepted in support of established tolerances and processing requirements (refer
to in PP#4F1513). This information must be accompanied by data depicting the storage stability of methidathion
residues in a representative sample from each crop group and in each miscellaneous crop under the storage
conditions and for the storage intervals specified. (Certain previously submitted stability data may be used
to partially satisfy this data requirement.)
13 All residue data required in this FRSTR must be accompanied by information regarding sanple storaqe conditions
and intervals stored and data depicting the stability of all residues of concern under the storage conditions
and for the time intervals specified. For additional guidance on conducting storage stability studies, the
registrant is referred to an August 1987 Position Document on the Effects of Storage on Validity of Pesticide
Residue Data available from NTIS under Order No. PB 88112362/AS.
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Table A
Generic Data Requirements for Methtdathion (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
14 Use directions and appropriate supporting residue data for potatoes must be submitted. Otherwise, the
established tolerance for residues in or on potatoes will be revoked. {Depending on the use directions
proposed, the available residue data may support the established tolerance).
15 The registrant roust propose an appropriate food additive tolerance for residues of methidathion residues of
concern in citrus oil. The available processing data would support a tolerance of 400 ppm based on the current
tolerance level for residues in raw fruit, toxicological considerations permitting.
16 Hie reqistrant must propose use directions for mandarins. Data depicting residues in or on a mandarin-type
citrus fruit (e.g., tangerines) from tests conducted in California where approximately 50 percent of all
tangerines are produced (Agricultural Statistics, p. 198, 1986) must be submitted. The use regimen must
reflect proposed label instructions. Also, if the proposed use directions indicate higher rates and/or a
lower PHI than currently registered for otter citrus crops, additional data may be required for Florida also.
17 Data depicting the potential for concentration of methidathion residues of concern in flour, starch, and qrain
dust processed from sorghum grain bearing measurable weathered residues. If residues concentrate in any of
these processed cawnodities, appropriate food/feed additive tolerances must be proposed.
18 Data depicting methidathion residues of concern in or on alfalfa forage and hay harvested 14 days follcwinq
the last of multiple foliar applications of the 2 lb/gal EC formulation at 1 lb ai/application. One stubble
and one foliar application must be made per cutting, each in 2 qal of water/A by aerial equipment. Tests must
be conducted in Idatfio and Wisconsin which represent the north western and north central States, respectively.
The registrant must propose a maximum seasonal use rate or maximum number of applications per season, which is
reflected in the data requested above.
19 The data available and requested for alfalfa will be translated to assess the tolerance for residues on
methidathion per se in or on clover.
20 Data depictinq methidathion residues of concern in or on forage and hay of the representative corrmodities
Bermuda grass, blue qrass, and brcme grass or fescue qrown in mixed stands with alfalfa and treated with at
least one stubble and one foliar application of the 2 lb/gal EC formulation at 1 lb ai/A per cutting using
ground equipment (in 10 gal of water/A) and aerial equipment (in 2 qal of water/A) in separate tests. Samples
must be harvested 14 days following the last application. The number of applications must reflect the proposed
maximum seasonal use rate for alfalfa and its mixtures. Tests must be conducted in ID(1%) or MT(2%) or OR(4%)
or WA(1%); KS(5%) or M0(8%) or 0K(5%) or 1X(11%); Ky(5S) or TN(4%); AL(2%) or GA(2%) or MS(2%); IA(2%) or
NE(3%) or f«(3%) or ND{3%) or SD(3%); and NY(4%) or PA(4%), which represent ca. 70 percent of 1985 U.S. hay
production (other than alfalfa) (Agricultural Statistics 1986, p. 243).
21 Data depicting methidathion residues of concern in or on artichokes harvested at the PHI following eiqht foliar
applications at 14-day intervals of the 2 lb/qal EC formulation at 1 lb ai/A/application. Ttte reqistrant must
propose label amendments establishing an appropriate PHI that is reflected in the requested data. Tests must
be conducted in California, which is the major artichoke growing region.
22 Data depicting the potential for concentration of methidathion residues of concern in meal, hulls, soapstock,
crude oil, and refined oil processed from cottonseed bearing measurable weathered residues. If residues
concentrate in any of these processed products, appropriate food/feed additive tolerances must be proposed.
-57-
-------
Table A
Generic Data Requirements for Methidathion (cont'd)
S158.240 Residue Chemistry Footnotes (cont'd)
23 The pyrolysis products derived frcm radiolabeled methidathion must be identified and quantified in tobacco
smoke. Multiple radiolabels (14C, 32P, 35S) may be required to accurately identify all pyrolysis products.
24 On receipt of the required data regarding the nature of the residue in plants, additional residue data may be
required.
25 The metabolism of methidathion in animal tissues has not been adequately defined. Upon receipt of the data
requested in the sections "Nature of the Residue in Animals," "Nature of the Residue in Plants," "Residue
Analytical Methods," "Storage Stability Data," and "Magnitude of the Residue in Plants," the adequacy of
tolerances for methidathion residues in livestock will be reassessed, and additional data may be required.
26 Raw milk fortified with the sulfoxide and sulfone metabolites must be subjected to pasteurization. All residues
and deqradation products remaining after pasteurization must be accounted for and characterized. It may be
necessary bo use the l4C-radiolabel to adequately fulfill this data requirement.
27 The metabolism of methidathion in animal tissues has not been adequately defined. Upon receipt of the data
requested in the sections "Nature of the Residue in Animals," "Nature of the Residue in Plants," "Residue
Analytical Methods," "Storage Stability Data," and "Maqnitude of the Residue in Plants" the adequacy of
tolerances for methidation residues in poultry will be reassessed and additional data may be required.
-58-
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Table A
Generic Data Requirements for Methidathion
Data Requirement
Test Use
Substance'- Patterns^
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data Be
Submitted?
Timeframe
for
Subnissior
§158.290 Environmental Fate
Degradation Studies - Lab:
161-1 - Hydrolysis
PAIRA
A,B
No
—
Yes3
9 Months
Photodeqradation
161-2 - In Water
PAIRA
A,B
No
—
Yes3
9 Months
161-3 - On Soil
PAIRA or TGAI
A,B
No
—
Yes3
9 Months
161-4 - In Air
PAIRA or TGAI
A,B
NO
—
Yes3
9 Months
Metabolism Studies - Lab:
162-1 - Aerobic Soil
PAIRA
A,B
No
—
Yes3
27 Months
162-2 - Anaerobic Soil
PAIRA or TCAI
A,B
NO
—
Yes3
27 Months
162-3 - Anaerobic Aquatic
PAIRA or TGAI
—
NO
—
No4
27 Months
162-4 - Aerobic Aquatic
PAIRA or TGAI
—
NO
—
NO4
27 Months
Mobility Studies:
163-1 - Leaching and PAIRA
Adsorption/Desorption
A,B
Partial
00158529
Yes5
12 Months
163-2 - Volatility (Lab)
TEP
A,B
No
—
Yes
12 Months
163-3 - Volatility (Field)
TEP
A,B
No
-
Reserved^
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Table A
Generic Data Requirements for Methidathion (cont'd)
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Substance^ Patterns^ Have Data? Citation Submitted? Submission^
Data Requirement
SI58.290 Environmental Fate
Dissipation Sjtudies - Field:
164-1 - Soil
164-2 - Aquatic (Sediment)
TEP
TEP
A,B
No
No
Yes7
No4
27 Months
164-3 - Forestry TEP —
164-4 - Combination and TEP
Tank Mixes
164-5 - Soil, Long-Term TEP A,B
Accumulation Studies:
165-1 - Rotational Crops PAIRA A
(Confined)
165-2 - Rotational Crops TEP A
(Field)
165-3 - Irrigated Crops TEP —
165-4 - In Fish PAIRA/IGAI A,B
165-5 - In Aquatic Nontarget TEP —
Organisms
No
No
No
No
No
No
NO
No
No4
No8
Reserved9
Yes
Reserved10
No4
ReservedH
No4
39 Months
50 Months
-60-
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Table A
Generic Data Requirements for Methidathion (cont'd)
5158.290 Environmental Fate Footnotes
1 Composition: TGAI = Technical Grade of the Active Ingredient; PAIRA = Pure Active Inqredient, Radiolabeled; TEP =
Typical End-Use Product.
2 The use patterns are coded as follows: A = Terrestrial Food Crop; B = Terrestrial Nonfood; C » Aquatic, Food Crcp;
D = Aqua tip Nonfood; E * Greenhouse, Food Crop; F = Greenhouse, Nonfood; G » Forestry; H * Domestic Outdoor;
_I = Indoor.
3 Volatile compounds should be trapped, and those accounting for 10% of the aonlied amount should be identified.
4 Not required because methidathion has no registered aquatic or forestry uses.
5 Additional data are required on the nobility of aqed methidathion in soil.
6 These data may be required, dependinq on the results of a laboratory volatility study.
7 In place of a terrestrial field dissipation study, a field leaching study is required. The registrant should
first ask for guidance from the Exposure Assessment Branch's Ground Water Team. After receiving guidance on
how to proceed, a protocol should be submitted to the Ground Water Team for approval.
8 This data requirement is not being imposed at this time.
9 These data may be required, depending on the results of the field leaching study.
10 These data may be reguired, depending on the results of the confined rotational crop study.
11 Registrant should first submit an octanol/water partition coefficient (K^).
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Table A
Generic Data Requirements for Methidathion
Data Requirement
1
Composition"
§158.340 Toxicology
ACUTE TESTING t
81-1 - Acute Oral - Rat
81-2 - Acute Dermal
81-3 - Acute Inhalation - Rat
81-4 - Eye Irritation - Rabbit
81-5 - Dermal Irritation -
Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
81-7 - Acute Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING;
82-1 - 90-Day Feeding
- Rodent
- Nonrodent
TCAI
TGAI
TCAI
TGAI
TCAI
TGAI
TGAI
Use 2
Patterns
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bi bliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3{c)(2){B)3
A
A
A
A
Yes
Yes
NO
Yes
Yes
Yes
Yes
00139328
00139326
00159199
00159200
00137599
00011704
No
No
No4
No
NO
No
No
TGAI
TGAI
A
A
No
No
NOjj
NO"
82-2 - 21-Day Dermal
TGAI
Yes
40079R-04
NO
-62-
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Table A
Generic Data Requirements for Methidathion (cont'd)
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)3/
Data Requirement
Composition
Use 2
Patterns
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
S158.340 Toxicology
SUBCHRQNIC TESTING (cont'd)
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
CHRONIC TESTING;
83-1 - Chronic Toxicity
- Rat
- Dog
- Monkey
83-2 - Oncogenicity Study
- Rat
- Mouse
83-3 - Teratogenicity
- Rat
- Rabbit
83-4 - Reproduction
TGAI
TCAI
TGAI
TCAI
TGAI
TGAI
TCAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
A
A
A
No
No
NO
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
00160260
00011839
00011819
00160260
00157457
400798-07
400798-08
400798-09
400798-10
400798-11
400798-12
No6
No**?
NoB
No
No
No
No
No
No
No
No
-63-
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Table A
Generic Data Requirements for Methidathion (cont'd)
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Use 2 Requirement? (Yes, Bibliographic
Patterns No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)3/
S158.340 "toxicology
MUTAGENICITY TESTING;
84-2 - Gene Mutation
TGAI
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING;
85-1 - General Metabolism
TGAI
TGAI
PAI or PAIRA
Yes
Yes
Yes
Yes
00078329
00084010
00078330
00078331
00060642
00078332
00011351
00078334
00078335
401278-18
401278-19
00026090
05016720
00011451
05012174
No
No
No
-64-
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Table A
Generic Data Requirements for Methidathion (cont'd)
5158,340 Toxicology Footnotes
1 Composition: TGAl = Technical Grade Active Ingredient; PAI « Pure Active Ingredient: PAIRA = Pure Active
Ingredient, Radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.
2 The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Pood Crop; D « Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood: G » Forestry; H =
Domestic Outdoor; I = Indoor; IP = Industrial Preservative.
3 Unless otherwise specified, data must be submitted no later than 6 months after publication of this standard.
4 This study is not required because of physical properties of the technical compound.
5 This requirement is waived based on the submission of an acceptable chronic feeding study.
6 This study is not required because existing acceptable end-uses should not result in repeated human skin contact.
7 This study is not required because existing acceptable end-uses should not result in repeated inhalation exposure.
8 This study is not required because there is no evidence of acute delayed neurotoxicity.
-65-
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Table A
Generic Data Requirements for Methidathion
Must" Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Data Requirement Substance* Patterns^ Have Data? Citation Submitted? Submission
SI58.390 Reentry Protection
132-1 - Foliar Dissipation
TEP
A,B
Yes
Footnote No. 3
No
132-1 - Soil Dissipation
TEP
A,B
—
No
133-3 - Dermal Exposure
TEP
A,B
Yes
00134029
No
133-4 - Inhalation Exposure
TEP
A,R
Yes
00134029
No
1 TEP = Typical End-Use Product.
2 A = Terrestrial Food Crop Uses; B = Terrestrial Nonfood Uses.
3 This requirement has been satisfied by MRID Nos. 00134029, 00131095, and 00131096.
-66-
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TABLE A
Genetic Data Requirements for Methidathion
Must Additional Timeframe
Test Use Does EPA Bibliographic Data Be for
Data Requirement Substance^ Pattern^ Have Data? Citation Submitted? Submission
Si58.440 - Spray Drift
201-1 - Droplet Size Spectrum TEP A,B No Yes3 12 Months
202-1 - Drift Field Evaluation TEP A,B No Yes3 12 Months
1 TEP = Typical End Use Product
2 A = Terrestrial Pood Crop; B = Terrestrial Non-Food;
3 The spray drift droplet spectrum and field evalution may be bone together in order to evaluate the
drop spectrums that are associated with actual field use patterns.
-67-
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIDMHION
Data Requirement
S158.490 - Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
Test Use Does EPA Bibliographic
Substance 1 Pattern^ Have Data? Citation-'
Must Additional
Data be
Submitted?
Time Frame
for
Submission
70-1 - Special Testing TEP
-Residue Monitoring
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Subacute Dietary TCAI
Toxicity
- Upland Game Bird, and
- Waterfcwl
71-3 - Wild Marrmal Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testinq
- Birds TEP
- Actual Field Testing
- Birds TEP
A
A
A
A
A
NO
Yes
NO
Yes
No^
No
No
NO
No
00157347
00011944
Yes4
No
Yes
NO
NO
Yes
Yes
24 Months
Reserved5
Reserved^
9 Months
24 Months
24 Months
-68-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR METHIDATION
Data Requirement
Test Use Does EPA Biblioqraphic
Substance* Pattern^ Have Data? Citation^
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.490 - Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
Freshwater Fish Toxicity
- Ooldwater Fish Species,
and
TGAI
TEP
&
A
A
Yes
No
40098001
No
Yes
9 Months
- Warmwater Fish Species
TGAI
TEP
&
A
A
Yes
No
40098001
No
Yes
9 Months
Acute Toxicity to
Freshwater Invertebrates
TGAI
TEP
&
A
A
Yes
No
00011350
No
Yes
9 Months
Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
TGAI
TEP
&
A
A
Yes
No
00157350
No
Yes
12 Months
- Mollusk
TGAI
TEP
&
A
A
Partially
No
40079815
Yes6
Yes8
12 Months
12 Months
- Shriirp
TGAI
TEP
&
A
A
Yes
No
00157350
No
Yes
12 Months
-69-
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TABLE A. GENERIC DATA REQUIREMENTS TOR MEIHIDATHION (Continued)
Data Requirement Test Use Does EPA Bibliographic Must additional Time Frame
Substance* Pattern2 Have Data? Citation-' Data be for
Submitted? Submission
72-4
- Fish Early Life Stage,
and
- Aquatic Interbertebrate
TGAI
A
Yes
00157353
No
a. - Daphnia magna
1GAI
A
Partially
00157352
Yes ^
15
Months
b. - Shrimp
TGAI
A
Partially
00157351
Yes9
15
Months
72-5
- Fish life Cycle
TGAI
A
No
Yes10
27
Months
72-6
- Aquatic Organism
TGAI
A
NO
Yes**
12
Months
72-7
- Simulated Field Testing
- Aquatic Organisms
TEP
A
NO
Reserved*2
- Actual Field Testing TEP A No
-Aquatic Organisms
-70-
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TABLE A
GENERIC DATA REQUIREMENTS FOR METHIDMTON
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substanee 1 Pattern^ Have Data? Citation-' Data be for
Submitted? Submission
Sec.158.150 Plant Protection Testing
122-1 - Seed germ in./ TGAI A No
seeding emerq.
Vegetative TGAI A No
vigor
122-2 - Aquatic Plant TGAI A No
growth
1. TGAI = Technical Grade Active Inqredient; TEP = Typical End-TJse Product.
2. A = Terrestial Fcod Crop.
3. No requirement currently exists
4. Residue monitorinq studies are required and include following sites: almonds and citrus. If these uses are
dropped, then residue monitoring on additional sites may be required.
5. Actual field testing with birds and mammals is reserved, as per 40 CFR 158.145, to support the registration of
TEP containinq methidathion. This will be required unless the actual residues are significanly below the current
level of concern (mallard LC50 = 543 ppn). The design of the field study should be commensurate with the latest
Guidance Docunent.
6. Maybe upgraded to core pending reevaluation of requested data.
7. Required to support registration on all crop uses because EEC's on technical methidathion exceed the LC50
for all aquatic species.
8. Required to support all use on citrus because of potential exposure of estuarine/marine environments though
runoff and drift
9. Data was received for reevaluation for potential upqrade to core, but was not sufficient to upgrade.
10. Because the EEC's feu: exoeed the MATC for fish early life stage test, this test need to be done.
No*3
No13
No13
-71-
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TABLE A. GENERIC DftTA REQUIREMENTS FOR METHIDATHION (Continued)
11. This test was to be done as part of the data requirements for FAB, but their data indicates a minimal
potential for bioaccumulation of the parent or it oxygen analoq, the principal cholinesterase inhibitors.
12. Actual aquatic field testing is reserved, as per 40CFR 158.145, to support the registration of TEP containing
methidathion on crops where use rate exceeds 0.5 lb ai/A. If the actual measured residues are siqificantly
below the level of concern (1/2 Daphnia LC50 » 3.6 ppb then this may be rescinded. The field test should follow
the guidance of Mesocosm Testing Procedures.
13. This chemical, methidathion, is used on food crops as an insecticide and does not pose a threat to plants.
-72-
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Table A
Generic Data Requirements for Methidathion
Data Requirement
Test
Substance1
Use Does EPA Bibliographic
Pattern^ Have Data? Citation
Must Additional* * Time Frame
Data Be for
Submitted? Submission
SI58.590 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey Bee Acute
Contact Toxicity
141-2 - Honey Bee - Toxicity
of Residues on
Foliage
141-3 - Honey Bee Subacute
Feeding Study
141-4 - Field Testing for
Pollinators
NOWTARGET 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
TGAI
TEP
Yes
No
00036935
No
Yes-
15 Months
(Reserved)^
TEP
No
No5
(Reserved)6
(Reserved)6
(Reserved)**
-73-
-------
Data Requirement
Table A
Generic Data Requirements for Methidathion (cont'd)
Must Additional Time Frame
Test Use Does EPA Bibliographic Data Be for
Substance^ Pattern^ Have Data? Citation Submitted? Submission
§158.155 Won target Insect
143-1 - NONTARGET INSECT (Reserved)6
thru TESTING - PREDATORS
143-3 AND PARASITES
1 Composition: TCAI = Technical grade of the active ingredient; TEP - Typical end-use Product.
2 Hie use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Acruatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; F = Greenhouse, Nonfood; G = Forestry; H =
Domestic Outdoor; I = Indoor.
3 As data fran the acute contact test indicate high toxicity, residual toxicity testing is required.
4 Reserved pending development of test methodology.
5 Data reviewed to date do not indicate a need for field testing.
6 Reserved pending Agency decision as to whether the data requirement should be established.
-74-
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MCTHIEHATHION
Data Requirement
Test Use Does EPA Bibliographic
Substance^ Pattern Have Data? Citation^
Part 158.150-158-190
Subpart C - Product Chemistry Data
Product Identity:
61-1 - Product Identity and MP
Disclosure of
Inqredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Inqredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Must Additional
Data be
Submitted?
All
All
All
Partially
Partially
00131026, 00142590.
40079802.
Yes-
All Partially 00011347, 00131026. Yes4
All Partially 00131026, 40079802. Yes5
00131026, 40079802. Yes6
Yes'
All Partially 00131026, 40079802. Yes8
Time Frame
for
Submission
6 Months
6 Months
6 Months
12 Month
12 Months
12 Months
Continued, footnotes follow
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACIURING-USE PRODUCTS CONTAINING METHIDATHION
Data Requirement
Test Use Does EPA Bibliographic
Substance1 Pattern Have Data? Citation2
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Part 158.150-158.190
Subpart C - Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
All
All
Yes
Yes
00131026.
00131026.
NO
NO
63-4 - Odor MP All Yes 00131026.
63-7 - Density, Bulk Density, or MP All Partially 00131026.
Specific Gravity
63-12 - pH MP All Partially 00131026.
63-14 - Oxidizing or Reducing MP All Partially 00131026.
Action
63-15 - Flammability MP All Partially 00131026.
63-16 - Explodability MP All Partially 00131026.
63-17 - Storage Stability MP All Partially 00131026.
No
Yes9
Yes9
Yes9
Yes9
Yes9
Yes9
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
Continued, footnotes follow
-76-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING METHIDATHION
Data Requirements Test Use Does EPA Bibliographic Must Additional Time Frame
Substance1 Pattern Have Data? Citation^ Data be for
Submitted? Submission
Part 158.150-158-1%
Subpart C - Product Chemistry Data (Continued)
Physical and Chemical Characteristic (Continued)
63-18 - Viscosity
MP
All
Yes
00131026
NO
63-19 - Miscibility
MP
All
Partially
00131026
YesV0
6 Months
63-20 - Corrosion Characteristics
MP
All
Partially
00131026
Yes9
15 Months
Other Requirements;
64- 1 - Submittal of samples
N/A
N/A
N/A
n/a
NO
1. MP = manufacturing-use product.
2. Eight-digit MRID nunber refer to documents catalogued in the Pesticide Data Management System (PMSD6).
Hyphenated numbers refer to product registration jackets for the respective EPA Registration Number.
3. For each manufacturing-use product the product name, chemical name (Chemical Abstracts Index of
Nomenclature or other well defined name), nominal concentration, upper and lower certified limits, Chemical Abstracts
Service (CAS) Registry Number, and purpose of each active ingredient and each intentionally added inert ingredient
nust be provided. The name and upper certified limit must also be provided for each impurity or group of impurities
for which a certified limit is required. The information on ingredient limits must be submitted on EPA Form 8570-4
(Rev. 2/85).
4. Ccnplete information must also be provided for the 50% FI (EPA Reg. No. 100-567) regardirq the nature of the
manufacturing process (batch or continuous), equipment used, and quality control measures. See Table A for
additional data requirements pertaining to the 95% T (EPA Reg. No. 100-530).
5. A detailed discussion must be submitted for each manufacturing-use product regarding all impurities that
are or may be present at _>0.1%, based on knowledge of the beginning materials, intended and side chemical
reactions in the manufacturing process, and any contamination during and after production. A discussion
regarding the possible carryover of hydrazine from any source in the product is also required.
-77-
-------
TABLE B. (Continued).
6. Sanples from five or more representative batches of the 95% technical product mast be analyzed for the
active ingredient ami each inpurity for which a certified limit is required. Conplete and detailed de-
scriptions of the methods used for sanple analysis must be submitted, including statements of their preci-
sion and accuracy. Hie preliminary analysis report should include the identity and quantity of each ingre-
dient for which analysis is conducted along with the mean and relative standard deviation of the analytical
results.
7. Upper and lower limits for the active ingredient and each intentionally added inert and upper limits for
each impurity present at 0.1% (w/w) and each additional "taxicologically significant" inpurity that may be
present at <0.1% must be certified for each manufacturing-use product. An explanation of how each certified
limit was established (e.g. sanple analysis using a validated analytical procedure, quantitative estimate
based on the amounts of ingredients used, etc.) must be provided, along with information on the accuracy and
precision of the procedures used. Limits for inpurities 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 8570-4 Rev. 2/85. These requirements
may be partially satisfied for the 95% T (EPA Reg. No. 100-530) by submission of precision and accuracy data
for the methods used to establish the certified limits.
8. For each manufacturing-use product, analytical methods nust be provided to determine the active ingre-
dient and each impurity and intentionally added inert for which a certified limit is required. Each method
nust be accompanied by validation studies indicating its accuracy and precision. These methods must be
suitable for enforcement of certified limits. Diis requirement may be partially satisfied for the 95% T by
submission of validation data demonstrating the precision and accuracy of the available analytical methods.
9. As required in the 40 CFR 158.120 and more fully described in the Pesticide Assessment Guidelines,
Subdivision D, data are required on specific gravity, pH, oxidizing/reducing action, flanmability,
explodability, storage stability, and corrosion characteristics for the 95% T (EPA Reg. No. 100-530). Data
are also required-tan specific gravity, pH, oxidizing/reducing action, flanmability, explodability, storage
stability, miscibility, and corrosiveness for the 50% FI (EPA Reg. No. 100-567). ttiese requirements may be
partially satisfied by supplying quantitative data from tests already conducted in these products and
information regarding methods and parameters (e.g., tenperature) used to obtain the available data.
10. Data required if the product is a liquid and is to be diluted with petroleum solvents.
-78-
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SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labelinq
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The reqistration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Req. No." The reqistration 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 identifyinq phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Aqency.
[40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 156.10(g)]
-79-
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active inaredient
must be indicated on the label. ingredient
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
tionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum t£oe
size requirements for various size labels. minimum type
Size of Label
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Siqnal Word
Minimum Type Size
All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
Minimum Type Size
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
-Keep Out of Reach of Children" must be located on ta
panel above the signal word except where contact with children
during distribution or use is unlikely. (40 CFR 156.10(h)(lt(ii)]
Item SIGNAL WORD - The signal word (DANGER warmtmp
X U 5eauir!d on the panel tae!!?a?;iy S'
the child hazard warning statement. [40 CFR 156.10 (h)(1)< i)]
Item 7C. SKULL & CROSS BONES AND WORD "PriTcr»M" n. .
assigned a toxicity Category I on the basis o il' 2" pr?ducts
or inhalation toxicity, the word "Poison" shall dermal,
label in red on a background of distinctlv mnt aPP©ar on the
the skull and crossbones shall appear in color and
the word POISON. [40 CFR 156.10(h)(1)(i)] proximity to
Item 7D. STATEMENT OF PRACTICAL TREATMFNt * * .
of practical treatment (first aid or other) shall statement
the label of pesticide products in toxicitv 2aHL ^r °n
II, and III. [40 CFR 156.10(h) (1) (iii)] Categones
Item 7E. REFERRAL STATEMENT - The stafon. „
(or Back) Panel for Additional Precautionary * S£d?
required on the front panel for all product Statements is
required precautionary statements appeal on a11
[40 CFR 156.10(h)(1)(iii)] appear on the front panel.
Item 8. SIDE/BACK PANEL PRECAUTIONARY LARPrtm,
precautionary statements listed below mu«?fr ~
on the label under the heading "PRECAUTIONARY STATEMENTS6"
The preferred location is at the ton of .. CEMENTS.
panel preceding the directions for°Ss°f and b?C" ,
that these statements be surrounded hv a u Preferred
of the three hazard warning elements 1^°^ °utline- Each
appropriate hazard title. I^CfHsLIo")? 2)??^ bV the
-80-
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are reauired 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 ) J
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 damaqe. [40 CFR 156.10(h)(2)(ii)J
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relatinq to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labelinq 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 headinq
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for rereqistration. Durinq
the Agency's review of your application, your proposed classi-
fication determination will be e-^ "Mated in accordance with
the provisions of 40 CFR 152.166 » . You will be notified of
the Agency's classification decision.
-81-
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard siqnal 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 (includinq 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 distinquish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labelinq bearinq only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearinq
restricted uses. To do so, submit two applications for
rereqistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for user directly beneath the heading of that section.
-82-
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20CF; 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
€ 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.
Reouired 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 incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
83
-------
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 storaqe 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, sunliqht,
friction, or contaminating substances or media.
2. Physical reauirements of storage which miqht adversely
affect the container of the product and its ability to
continue to function properly. Requirements miqht include
positioninq of the container in storaqe, storaqe 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.
84
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, mast bear explicit instructions about pesticide disposal. The
statements listed belcw 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 inqredients that are Acute Hazardous
Wastes or are assiqned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Cateqory 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 quidance."
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 frcm 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."
85
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trashy
Non-aerosol products
(baqs)
Do not reuse bag. Discard bag in trash.
Aerosol products
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)
Triple rinse (or equivalent). Then offer I
for recycling or reconditioning, or puncture!
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities. _
Plastic containers
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.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shakinq 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
reused1, dispose of in the same manner.
Paper and
plastic bags
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.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
86
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BIBLIOGRAPHY APPENDICES
87
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RIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Aqency, 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
NRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
88
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no guestion marks, the Agency took it directly
from the document. When a four-digit date is followed
by a guestion mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third «lement 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.
89
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00011303 "IVeedy, B.; Kahrs, R. (1974) Summary: Methidathion (GS-13005)—Sor-
ghum: Results of Tests on the Amount of Residue Remaining, In-
cluding a Description of the Analytical Methods Used: Report
No. GAAC-74025. Summary of studies 094012-B through 094012-K.
(Unpublished study received Jun 4, 1974 under 4F1512; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094012-A)
00011304 Dupre, G.D. (1974) Summary of Residue Analyses: Test No. AG-A 2186;
Project No. 303016. (Unpublished study received Jun 4, 1974 un-
der 4F1512; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:094012-B)
00011305 Turner, W.E. (1972) Residue Report: AG-A No. 2439; Project
No. 303016. (Unpublished study received Jun 4, 1974 under
4F1512; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
094012-C)
00011314 Kahrs, R.A.; Mattson, A.M. (1969) Residues Found in Eqqs and Tis-
sues of Chickens Fed Three Levels of GS-13005 in Their Diet for
Four Weeks: Report No. GAAC-69036. (Unpublished study including
letter dated Feb 2, 1968 frcm K. Morgareidge to Jack R.
Forsythe, received May 7, 1970 under 0F0892; prepared in coop-
eration with Food and Drug Research Laboratories, Inc., sub-
mitted by Geigy Chemical Corp., Ardsley, N.Y.; CDL:091539-D)
00011317 Dupuis, G.; Esser, H.O.; Mucke, W. (1969) The Metabolic Behavior of
the Insecticide GS13005: GAAC-69023. (Unpublished study re-
ceived May 5, 1970 under 0F0892; submitted by Geigy Chemical
Corp., Ardsley, N.Y.; CDL;091538-B)
00011318 Mattson, A.M.; Kahrs, R.A. (1969) Determination of GS-13005 Resi-
dues in Field Treated Forage: Report No.: GAAC-69042. (Unpub-
lished study received May 5, 1970 under 0F0892; submitted by
Geigy Chemical Corp., Ardsley, N.Y.; CDL:091538-G)
00011320 Kahrs, R.A.; Kanuk, M.J. (1969) Determination of Residues of GS-
13005 in Alfalfa by Gas Chromatography Employing Flame Photo-
metric Detection. Method no. AG-105 dated Jun 20, 1969. (Un-
published study received May 5, 1970 under 0F0892; submitted by
Geigy Chemical Corp., Ardsley, N.Y.; CDL:091538-K)
00011321 Mattson, A.M.; Kahrs, R.A. (1969) Dissipation of Residues of GS-
13005 in Forage Grasses: GAAC-69026. (Unpublished study re-
ceived May 5, 1970 under OF0892; submitted by Geigy Chemical
Cbrp., Ardsley, N.Y.; CDL:091538-M)
90
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supportinq
Registrations Under the Methidathion Standard
MRID CITATION
00011322 Gemma, A.A.; Kahrs, R.A.; Mattson, A.M. (1969) Behavior of GS-13005
in FDA Multiple Residue Detection Method: GAAC-69029. (Unpub-
lished study received May 5, 1970 under 0F0892; submitted by
Geigy Chemical Corp., Ardsley, N.Y.; CDL:091538-N)
00011323 Mattson, A.M.; Kahrs, R.A. (1969) Residues of GS-13005 and Its Oxy-
gen Analog in Citrus Fruit and Citrus Fractions: GAAC-69028.
(Unpublished study received May.5, 1970 under 0F0892; submitted
by Geiqy Chemical Corp., Ardsley, N.Y. j CDL:091538-0)
00011324 Kahrs, R.A.? Kanuk, M.J. (1969) Determination of Residues of GS-
13005 in Citrus by Gas Chromatography Employing Flame Photo-
metric Detection. Method no. A3-106 dated Jun 23, 1969. (Un-
published study received May 5, 1970 under 0F0892; submitted by
Geiqy Chemical Corp., Ardsley, N.Y.; CDL:091538-O)
00011326 Kahrs, R.A.; Kanuk, M.J. (1969) Determination of Residues of GS-
13005 in Cotton Seed and Cotton Seed Fractions by Gas Chromato-
graphy. Method no. AG-107 dated Jun 27, 1969. (Unpublished
study received May 5, 1970 under 0F0892; submitted by Geiqy
Chemical Corp., Ardsley, N.Y.; CDL:091538-T)
00011334 Kartuk, M.J.; Kahrs, R.A. (1969) Determination of GS-13005 and Seme
of Its Metabolites in Milk by Gas Chromatography, Method no.
AG-98 dated Mar 28, 1969. (Unpublished study received May 7,
1970 under 0F0892; submitted by Geigy Chemical Corp., Ardsley,
N.Y.; CDL:091540-F)
00011335 V9bod, N.F. (1969) Isolation and Confirmation of the Identity of 2-
Methoxy-4-methylsulfonylmethyl-1,3,4-thi ad iazol-5(4H)-one As a
Metabolite in Milk of a Cow Fed GS-13005: GAAC-69025. (Unpub-
lished study received May 7, 1970 under 0F0892? submitted by
Geigy Chemical Corp., Ardsley, N.Y.; CDL:091540-G)
00011336 Cassidy, J.E.; Wood, N.F.; Lasker, K. (1969) Methods for the Isola-
tion and Determination of 14C in Natural Products in Milk—
Glycerol, Lactose, and Casein. Method no. AG-103 dated Jun 5,
1969. (Unpublished study received May 7, 1970 under 0F0892;
submitted by Geigy Chemical Corp., Ardsley, N.Y.; CDL:091540-H)
00011337 Kahrs, R.A.; Kanuk, M.J. (1969) Determination of GS-13007 in Cow
Milk by Thin Layer Chromatography. Method no. AG-104 dated Jun
23, 1969. (Unpublished study received May 7, 1970 under 0F0892;
submitted by Geigy Chemical Corp., Ardsley, N.Y.j CDL:091540-K)
91
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD RIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00011347 Ciba-Geigy Corporation (1977) Chemical Data Section for Methida-
thion. (Unpublished study received Jun 28, 1977 under 100-530;
CDL:230756-A)
00011350 Vilkas, A.G. (1976) Acute Toxicity of Supracide Technical to the
Water Flea Daphnia magna Straus: AES Proj. #7614-500. (Unpub-
lished study received May 17, 1977 under 100-501; prepared by
Union Carbide Corp., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:096136-A)
00011351 Fritz, H. (1976) Mouse, Dominant Lethal Study. (Unpublished study
received May 17, 1977 under 100-501; prepared by Ciba-Geigy,
Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
096137-A)
00011373 Rolla, H.M.; Kahrs, R.A. (1972) Determination of Residues of GS-
13005 in Potatoes and Tomatoes by Gas Chromatography Employing
Flame Photometric Detection. Method no. AG-199 dated Jun 14,
1972. (Unpublished study received Nov 10, 1972 under 3F1323;
submitted by Ciba-Geigy Corp., Ardsley, N.Y.; CDL:092270-F)
00011425 Ragsdale, D. (1974) Residue Report: AG-A No. 3118 A; Project
No, 303035. (Unpublished study received Sep 27, 1974 under
5F1555; submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:
094463-D)
00011426 Taylor, J.B. (1974) Residue Report: AG-A No. 3161; Project
No, 303035. (Unpublished study received Sep 27, 1974 under
5F1555; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
094463-E)
00011451 Wbod, N.F.; Lasker, K. (1969) Desmethyl GS-13005 and Other Metabo-
lites in the Urine of Rats Fed GS-13005-5-Carbony1-14C: Report
No.: GAAC-69037. (Unpublished study received Oct 1, 1969 under
0F0892; submitted by Geigy Chemcial Corp., Ardsley, N.Y.; CDL:
091535-AP)
00011456 Houseworth, L.D. (1977) Residues of Methidathion in or on Olives
Resulting from Single Applications of Methidathion with or with-
out Nonphytotoxic Oils: Report No. ABR-77013. (Unpublished
study received Jul 19, 1977 under 100-501; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:096256-A)
00011474 Thompson, N.P.; Witkonton, S.; Sartain, D. (1976) Mangoes: Methi-
dathion and Its Toxic Metabolite GS 13007. Undated method.
(Unpublished study received Mar 3, 1979 under 9E2194; prepared
by Univ. of Florida, Institute of Food and Agricultural Science,
Pesticide Research Laboratory, submitted by Interregional Re-
search Project No. 4, New Brunswick, N.J.; CDL:098200-B)
92
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00011640 Tweedy, B.G. (1974) Summary: Methidathion (GS-13005): Peaches, Pe-
cans and Walnuts: Results of Tests on the Amount of Residue Re-
maining, Including a Description of the Analytical Methods Used:
Report No: GAAC-74028. Surnnary of studies 094033-B through
094033-K. (Unpublished study received on unkncwn date under
4F1522; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
094033-A)
00011641 Dupre, G.D.; Hiddleson, L. (1974) Surnnary of Residue Analyses: Bio/
dynamics, Inc. No. 73033. (Unpublished study received on un-
known date under 4F1522; prepared in cooperation with Bio/dyna-
mics, Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:094033-B)
00011642 Dupre, G.D.y Christensen, M.D. (1974) Summary of Residue Analyses:
Bio/dynamics, Inc. NO. 73033. (Unpublished study received on
unkncwn date under 4F1522; prepared in cooperation with Bio/
dynamics, Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:094033-C)
00011704 Sachsse, K.; Ullmann, L. (1977) Acute Oral Toxicity and Neurotoxic-
ity Study of Technical GS-13005 in the Domestic Fowl (Gallus
domesticus): Project No.: Siss 5927. (Unpublished study re-
ceived Jul 25, 1978 under 100-501; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:097230-A)
00011722 Fox, R.W. (1975) Residue Report: AG-A No. 3625; Project No. 303901.
(Unpublished study received Jul 13, 1977 under 100-501; sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:096250-Q)
00011764 TV*eedy, B.G. (1977) Supracide 2E—Artichokes: Residues Ob-
served Including the Analytical Methods Used from California
Field Trials: Report No.: ABR-77026. Sunmary of studies 096253-
B through 096253-D. (Unpublished study received Jul 19, 1977
under 100-501; submitted by Ciba-Geiqy Corp., Greensboro, N.C.;
CDL:096253-A)
00011769 Kahrs, R.A. (1977) Methidathion—Walnuts: Residues Resulting from a
Dormant or Delayed Dormant Plus Two Foliar Applications of
Supracide 2E: Surnnary of Residue Data: Report No.: ABR-
77019. Sunmary of studies 230873-B through 230873-E. (Unpub-
lished study received Jul 20, 1977 under 100-501; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:230873-A)
93
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supportinq
Registrations Under the Methidathion Standard
MRID CITATION
00011819 Coulston, F.; Golberg, L.; Fabian, R.J. (1971) Two-Year Safety E-
valuation Study in Rhesus Monkeys with GS 13005. (Unpublished
study received Jul 2, 1972 under 2G1210; prepared by Albany
Medical College, Institute of Experimental Pathology and Toxi-
cology, submitted by Ciba-Geigy Corp., Ardsley, N.Y.; CDL:
091033-1)
00011839 Johnston, C.D. (1967) GS 13005 Safety Evaluation by Two-Year Feed-
ing Studies in Rats and Dogs: Final Report. (Unpublished study
received Aug 5, 1967 under 8F0648; prepared by Woodard Research
Corp., submitted by Geigy Chemical Corp.; Ardsley, N.Y.; CDL:
091127-A)
00011843 Mattson, A.; Kahrs, R. (1966) The Determination of GS-13005 in
Plant Materials by Gas Chromatography. Method dated Dec 15,
1966. (Unpublished study received Aug 5, 1967 under 8F0648;
submitted by Geigy Chemical Corp., Ardsley, N.Y.; CnL:091126-B)
00011844 Insler, M.; Mattson, A. (1966) Determination of GS-13007 in Forage
Crops by Thin Layer Chromatography. Method dated Dec 15, 1966.
(Unpublished study received Aug 5, 1967 under 8F0648; submitted
by Geigy Chemical Corp., Ardsley, N.Y.; CDL:091126-C)
00011846 Murphy, R.T.; Kahrs, R.A.; Mattson, A.M. (1966) Gas Chromatographic
Method for the Detection of Residues in the Milk of a Cow Fed
Radioactive GS-13005. Method dated Dec 15, 1966. (Unpublished
study received Aug 5, 1967 under 8F0648; submitted by Geigy
Chemical Corp., Ardsley, N.Y.? CDL:091126-F)
00011852 Kahrs, R.A.; Mattson, A.M. (1967) Analytical Method for the Detec-
tion of Residues of GS-13005 in Cotton Seed and Cotton Seed
Fractions. Method dated Jun 30, 1967. (Unpublished study re-
ceived Aug 5, 1967 under 8F0648; submitted by Geigy Chemical
Corp., Ardsley, N.Y.; CDL:091126-M)
00011856 Ciba-Geigy Corporation (1970) Supracide 2E Tobacco Residue
Sunmary. Summary of studies 101092-B through 101092-F. (Unpub-
lished study received Dec 21, 1971 under 100-501; CDL:101092-A)
00011921 Dupre, G.D.j Davidson, W.E. (1974) Summary of Residue Analyses:
Bio/dynamics, Inc. No. 73033. (Unpublished study received on
unknown date under 4F1522; prepared in cooperation with Bio/
dynamics, Inc., submitted by Ciba-Geigy Corp., Greensboro, N.C.?
CDL:094033-D)
94
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00011936 Cassidy, J.E.; Murphy, R.; Mattson, A.M. (1967) The Metabolic Fate
of 5-Carbonyl-14C GS-13005 When Given to a Cow. (Unpublished
study received Aug 5, 1967 under 8F0648; submitted by Geigy
Chemical Corp., Ardsley, N.Y.; CDL:091126-E)
00011944 Beavers, J.B. (1979) Final Report: Eight-Day Dietary LC50—Mallard
Duck: Project No. 108-168. (Unpublished study received May 9,
1979 under 100-501; prepared by wildlife International, Ltd.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:238486-A)
00012575 TVraedy, B.G.; Kahrs, R.A. (1977) Supracide 2E—Alfalfa
Residues Observed and Metabolism Data Including the Analytical
Methods Used: Report No.: ABR-77023. (Unpublished study re-
ceived Jul 13r 1977 under 100-501; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:096248-A)
00012593 Ross, J.A.y Kahrs, R.A. (1977) Residues of Methidathion in or on
Deciduous Fruit Resulting from Dormant or Delayed Dormant Appli-
cations with or without Oil: Report No.: ABR-77008. Sunmary of
studies 227647-B through 227647-M. (Unpublished study received
Jan 25, 1977 under 100-501; submitted by Ciba-<3eigy Corp.,
Greensboro, N.C.; CDL:227647-A)
00012594 Christensen, M.D. (1977) Residue Report: AG-A No. 4224; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:227647-B)
00012595 Macjgiore, F.; Christensen, M.D. (1977) Residue Report: AG-A
No. 4225; 2nd Report; Project No. 303060. (Unpublished study
received Jan 25, 1977 under 100-501; prepared in cooperation
with Bio/dynamics, Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:227647-C)
00012596 Zaccaria, J.J. (1977) Residue Report: PG-h No. 4234; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:227647-D)
00012597 Zaccaria, J.J. (1977) Residue Report: A3-A No. 4235; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:227647-E)
95
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00012598 Tranmel, K.; Higgins, E.R. (1977) Residue Report: AG-A No. 4294;
2nd Report; Project No. 303060. (Unpublished study received Jan
25, 1977 under 100-501; prepared in cooperation with Bio/dynam-
ics, Inc., submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:
227647-F)
00012599 Tramnel, K.; Higgins, E.R. (1977) Residue Report: AG-A No. 4295;
2nd Report; Project No. 303060. (Unpublished study received Jan
25, 1977 under 100-501; prepared in cooperation with Bio/dynam-
ics, submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:
227647-G)
00012600 Zaccaria, J.J. (1977) Residue Report: AG-A No. 4321; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:227647-H)
00012601 Zaccaria, J.J. (1977) Residue Report: AG-A No. 4322; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:227647-I)
00012603 Christensen, M.D. (1977) Residue Report: AG-A No. 4367; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Bio/dynamics, Inc.,
submitted by Ciba-Geiqy Corp., Greensboro, N.C.; CDL:227647-K)
00012604 Christensen, M.D. (1977) Residue Report: AG-A No. 4368; 2nd Report;
Project No. 303060. (Unpublished study received Jan 25, 1977
under 100-501; prepared in cooperation with Agricultural Advi-
sors, Inc. and Bio/dynamics, Inc., submitted by Ciba-Geigv
Corp., Greensboro, N.C.; CDL:227647-L)
00014382 tXipre, G.D. (1974) Summary of Residue Analyses: Test No. AG-A 2604
I, II, III (3-IR-1-72): Project No. 303016. (Unpublished study
received Jun 4, 1974 under 4F1512; prepared in cooperation with
Bio/dynamics, Inc., submitted by Ciba-Geiqy Corp., Greensboro,
N.C.; CDL:094012-D)
00014383 Djpre, G.D. (1974) Summary of Residue Analyses: Test No. A3-A 2646
I, II, III (MW-IR-4-72) Second Report; Project No. 303016. (Un-
published study received Jun 4, 1974 under 4F1512; prepared in
cooperation with Bio/dynamics, Inc., submitted by Ciba-Geiqy
Corp., Greensboro, N.C.; CDL:094012-E)
96
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OFFICE OF PESTICIDfi PRDGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00014384 Dupre, G.D. (1974) Sunmary of Residue Analyses: Test No. AG-A 2689
(4-IR-11-72); Project No. 303016. (Unpublished study received
Jun 4, 1974 under 4F1512; prepared in cooperation with Bio/dy-
namics, Inc., submitted by Ciba-Geiqy Corp., Greensboro, N.C.;
CDLj094012-G)
00014404 Mattson, A.M. (1972) Sumnary: GS-13005—Terra toes and Potatoes:
Results of Tests on the Amount of Residue Remaining, Including a
Description of the Analytical Methods Used: Report No. GAAC-
72105A. Sunmary of studies 092270-C through 092270-F, 092270-H
through 092270-P, 092270-U and 092270-V. (Unpublished study
received Nov 10, 1972 under 3F1323; submitted by Ciba-<3eigy
Corp., Ardsley, N.Y.; CDL:092270-T)
00020944 Kahrs, R.A. (1979) Determination of Residues of Methidathion and
Its Metabolites GS-13007, GS-28369, and GS-28370 in Animal Tis-
sue by Gas Chromatography Employing Flame Photometric Detection.
Method no. AG-334 dated Jan 9, 1979. (Unpublished study re-
oeived Aug 21, 1979 under 100-501; submitted by Ciba-<3eigy
Corp., Greensboro, N.C.; CDLs098923-M)
00020945 Kahrs, R.A. (1979) Determination of Methidathion and Some of Its
Metabolites in Milk by Gas Chromatography. Method no. AG-335
dated Jan 9, 1979. (Unpublished study received Aug 21, 1979
under 100-501; submitted by Ciba-Geiqy Corp., Greensboro, N.C.;
CDL:098923-N)
00020946 Kahrs, R.A. (1979) Residues of Methidathion in or on Deciduous
Fruit and Nuts: Report No. ABR-79048. (Unpublished study re-
ceived Aug 21, 1979 under 100-501; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:098925-A)
00020947 Ross, R.H. (1979) Methidathion (Supracide 2E: Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with Michigan State Univ., Horti-
culture Research Station and En-Cas Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-B)
00020948 Saario, C.A.; Kapreilian, H. (1979) Methidation (Supracide 2E):
Project No. 303089. (Unpublished study received Aug 21, 1979
under 100-501; prepared in cooperation with En-Cas Laboratories,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-C)
97
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OFFICE OF PESTICIDE PROGRAMS
REGISrRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00020949 Saario, C.A.; Kaprielian, H. (1979) Methidation (Supracide 2E):
Project No. 303089. (Unpublished study received Auq 21, 1979
under 100-501; prepared in cooperation with En-Cas Laboratories,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-D)
00020950 Luke, J.E. (1979) Methidathion (Supracide 2E): Project No. 303089.
(Unpublished study received Aug 21, 1979 under 100-501; prepared
in cooperation with En-Cas Laboratories, submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:098925-E)
00020951 Christensen, M.D.; Wineinger, H. (1979) Methidathion (Supracide
2E): Project No. 303089. (Unpublished study received Aug 21,
1979 under 100-501; prepared in cooperation with En-Cas Labora-
tories, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
098925-F)
00020952 Christensen, M.D.; Lagorio, A. (1979) Methidathion (Supracide 2E):
Project No. 303089. (Unpublished study received Aug 21, 1979
under 100-501; prepared in cooperation with En-Cas Laboratories,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-G)
00020953 Wittie, R.L. (1979) Methidathion (Supracide 2E): Project
No. 303089. (Unpublished study received Aug 21, 1979 under
100-501; prepared in cooperation with En-Cas Laboratories, sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-H)
Zaccaria, J.J. (1979) Methidathion (Supracide 2E): Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-1)
Zaccaria, J.J. (1979) Methidathion (Supracide 2E): Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-J)
Zaccaria, j.j. (1979) Methidathion (Supracide 2E): Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-K)
Zaccaria, J.J. (1979) Methidathion (Supracide 2E)s Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corn>., Greensboro, N.C.; CDL:098925-L)
00020954
00020955
00020956
00020957
98
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00020958 Schnappinqer, M.G.; Drake, C. (1979) Methidathion (Supracide
2E): Project No. 303089. (Unpublished study received Aug 21,
1979 under 100-501; prepared in cooperation with Virginia Poly-
technic Institute and State Univ. and En-Cas Laboratories, sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-M)
00020959 wittie, R.L. (1979) Methidathion (Supracide 2E): Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501? prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-N)
00020962 Zaccaria, J.J. (1979) Methidathion (Supracide 2E): Project
No. 303089. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp. / Greensboro, N.C.; CDL:098925-0)
00020965 Higgins, E.R.; Trammel, K. (1979) Methidathion (Supracide 2E):
Project No. 303089. (Unpublished study received Aug 21, 1979
under 100-501; prepared in cooperation with En-Cas Laboratories,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-T)
00020967 Wittie, R.L. (1979) Methidathion (Supracide 2E): Project
No. 303060. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-V)
00020970 Wittie, R.L. (1979) Methidathion (Supracide 2E): Project
No. 303060. (Unpublished study received Aug 21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-Y)
00020971 Christensen, M.D. (1979) Methidathion (Supracide 2E): Project
No. 303060. (Unpublished study received Aug*21, 1979 under 100-
501; prepared in cooperation with En-Cas Laboratories, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:098925-Z)
00020979 Kanuk, M.J. (1973) Determination of Residues of GS-13005 and Its
Metabolites GS-13007, GS-28369, and GS-28370 by Gas Chromatogra-
phy Employing Flame Photometric Detection. Method no. AG-240
dated Feb 23, 1973. (Unpublished study received Aug 21, 1979
under 100-501; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDLs098925-AH)
00022574 Kahrs, R.A. (1979) Residues of Methidathion and Its Oxygen Analog
GS-13007 in Tissues and Milk of Lactating Dairy Cows Resulting
from the Feeding of Methidathion: Report No.: ABR-79094. Sum-
mary of studies 098923-M and 098923-N. (Unpublished study in-
cluding ADC project no. 481 and addendum, received Aug 21, 1979
under 100-501; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL: 098923-L)
99
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00022903 Thomas, R.D.; Cassidy, J.E. (1974) Metabolism of delta-14C-GS-
13005 in Artichokes: Report No. GAAC-74092. (Unpublished study
received Feb 27, 1975 under 4F1450; submitted by Ciba-Geiqy
Corp., Greensboro, N.C.; CDL:093863-C)
00022908 Cassidy, J.E. (1969) The Identities and Residue Levels of Metabo-
lites of S- [(2-Methoxy-5-oxo-delta 2-1,3,4-thiadiazolin-4yl-
5-14C) roethyl]o,o-dimethyl phosphorodithioate (Carbonyl 14C
GS-13005) in Milk and Tissues of a Cow Fed This Pesticide—
a Plateau Study: Report No. GAAC-69024. (Unpublished study re-
ceived May 7, 1970 under 0F0892; submitted by Geigy Chemical
Co., Ardsley, N.Y.; CDL:091540-C)
00022909 Polan, C.E.; Chandler, P.T. (1969) Metabolism of S [(2-Methoxy-
5-oxo-delta 2-1,3,4-thiadiazolin-4-yl) methyl]o,o-dimethy 1
phosphordithioate (GS-13005) by By Lactating Cows. (Un-
published study received May 7, 1970 under 0F0892; submitted by
Geigy Chemical Co., Ardsley, N.Y.; CDL:091540-Q)
00022910 Cassidy, J.E.; Tracey, B.A. (1973) Desmethyl GS-13005 in Tomatoes
Treated with delta 14C-GS-13005: Report No. GAAC-73049. (Un-
published study received Jul 2, 1973 under 3F1323; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:092270-A)
00022911 Cassidy, J.E.; Ryskiewich, D.P.; Murphy, R.T. (1968) Metabolism of
S-[(2-Methoxy-5-oxo-delta 2-1,3,4-thiadiazolin-4-yl)methyl]o,
o-dinethyl phosphorodithioate (Supracide) in Alfalfa: Report
No. GAAC-68008A. (Unpublished study received Jul 13, 1977 under
100-501; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
096249-A)
00026090 Esser, H.O.; Muller, P.W. (1966) Metabolism of GS 13005, a new in-
secticide. Experientia 22(36):16. (Also in unpublished sub
mission received August 5, 1967 under 8F0648; submitted by Geigy
Chemical Co., Ardsley, N.Y.; CD:091128-AE)
00027999 Holt, B.E. (1978) Methidathion (Supracide 2E + Oil): AG-A 4754 I,
II. (Unpublished study received Aug 21, 1979 under 100-501;
prepared in cooperation with En-Cas Laboratories, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098924-L)
00029221 Holt, B.E. (1978) Methidathion (Supracide 2E + Oil): A3-A 4756 I-
II-III. (Unpublished study received Aug 21, 1979 under 100-501;
prepared by En-Cas Laboratories, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:098924-H)
100
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00029227 Gaqnon, S.A.; Teuber, A. (1977) Residue Report: A3-A No. 4598.
(Unpublished study received Aug 21, 1979 under 100-501; submit-
ted by Ciba-Geigy Corp., Greensboro, N.C.; CDLt098924-P)
00029228 Gagnon, S.A. (1978) Methidathion (Supracide: 2E + Oil): AG-A
4721 I. (Unpublished study received Aug 21, 1979 under 100-501;
prepared by En-Cas Laboratories, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:098924-0)
00029229 Kanuk, M.J.; Gemma, A. (1973) Determination of Residues of GS-
13005 and Its Metabolite GS-13007 in Sunflower by Gas Chroma-
tography Employing Flame Photometric Detection and Thin-Layer
Chromatography. Method no. AG-247 dated May 14, 1973. (Unpub-
lished study received Aug 21, 1979 under 100-501; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:098924-T)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00036942 Mattson, A.M. (1975) Sunmary: Methidathion (GS-13005) Alnonds:
Results of Tests on the Amount of Residue Remaining, Including
a Description of the Analytical Method Used: Report No. GAAC-
75047. Surtmary of studies 096100-C through 096100-E. (Unpub-
lished study received May 24, 1976 under 100-501; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:096100-B)
00038279 Carlson, E.C. (1976) Results of Tests Concerning the Amount of
Residues of Methidathion Remaining in or on Safflower Seeds,
Including a Description of the Analytical Method Used. Includes
undated method entitled: Total safflower seeds extraction and
cleanup for Supracide. (Unpublished study including environmen-
tal toxicology report nos. 3521, 3522, 3525..., received Aug 12,
1977 under 7E1999; prepared in cooperation with Univ. of Cali-
fornia—Davis, Dept. of Entomology, submitted by Interregional
Research Project No. 4, New Brunswick, N.J.; CDL:097443-B)
00038280 Christensen, M.D.; Carlson, E.C. (1975) [Residue Report: Safflower
Seeds: Methidathion]: AG-A No. 3511-A. (Unpublished study in-
cluding submitter sunroary, received Aug 12, 1977 under 7E1999;
prepared in cooperation with by Univ. of California and Geigy
Research Laboratories, submitted by Interregional Research
Project No. 4, New Brunswick, N.J.; CDL:097443-D)
101
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00060642 Simmon, V.F.; Poole, D. (1977) Final Report: In vitro and in vivo
Microbiological Assays of Six Ciba-Geigy Chemicals: SRI Project
LSC-5686. (Unpublished study received Dec 29, 1977 under 100-
542; prepared by Stanford Research Institute, submitted by Citaa-
Geigy Corp., Greensboro, N.C.; CDL:232550-B)
00060895 Roger, J.C.; Cassidy, J.E. (1972) Metabolism of GS-13005 on Orange
Crops: Report No. GAAC-72018. (Unpublished study received
Aug 2, 1972 under 2F1229; submitted by Ciba-Geiqy Corp., Ard-
sley, N.Y.; CDL:091080-C)
00060902 Mattson, A.M.; Kahrs, R.A. (1967) Analytical Method for the Detec-
tion of Residues of GS-13005 in Citrus Products. Method dated
Jun 30, 1967. (Unpublished study received Aug 2, 1972 under
2F1229; submitted by Ciba-Geigy Corp., Ardsley, N.Y.; CDL:
091079-H)
00078329 Ami, P. (1980) Salmonella/Mammalian-microsame Mutagenicity Test
with GS 13 005. (Test for Mutagenic Properties in Bacteria):
No. of Experiment 79/1556. (Unpublished study received Aug 13,
1981 under 7F1983; prepared by Ciba-Geigy, Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070213-D)
00078330 Satou, S.; Kimura, Y.; Yamamoto, K.; et al. (1980?): In vitro
Microbial Assays for Mutagenicity Testing of DMTP (Methi-
dathion): Project No. NRI-79-2884. Final rept. (Translation;
unpublished study, including letter dated May 29, 1980 from
G. Voss and K. Kikawa to G. Dupuis, received Aug 13, 1981 under
7F1983; prepared by Nomura Research Institute, Japan,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070213-F)
00078331 Ami, P. (1980) Intrasanguine Host-mediated Assay with S. ty-
phimurium with GS 13 005: (Test for the Demonstration of Point
Mutations in Bacteria in vivo): No. of Experiment 801494.
(Unpublished study received Aug 13, 1981 under 7F1983; prepared
by Ciba-Geigy, Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070213-G)
00078332 Strasser, F.F. (1980) Point Mutation Assay with Mouse Lymphoma
Cells: Host-mediated Assay with GS 13 005: (Test for Mutagenic
Properties in Mammalian Cells): No. of Experiment 801495.
(Unpublished study received Aug 13, 1981 under 7F1983; prepared
by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:070213-H)
102
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00078334 Hool, G.? Langauer, M.; Loos, H.; et al. (1980) Nucleus Anonaly
Test in Somatic Interphase Nuclei of Chinese Hamster: Test
No. 80-0437. (Unpublished study received Aug 13, 1981 under
7F1983; prepared by Ciba-Geiqy, Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:070213-J)
00078335 Hool, G. (1980) Sister Chromatid Exchange-study in Somatic Cells,
Bone Harrow, GS 13 005, Chinese Hamster: Dosage 17, 34, 68
mgAq: No. of Experiment 801489. (Unpublished study received
Aug 13, 1981 under 7F1983; prepared by Ciba-Geigy Ltd., Switz-
erland, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
070213-K)
00078342 Kahrs, R.A. (1979) Residues of GS-28370 and GS-28369 in Tissues and
Milk of Lactating Dairy Cows Resulting from the Feeding of
Methidathion: ABR-79095. (Unpublished study received Aug 13,
1981 under 7F1983; submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:070213-V)
00084010 Arni, P. (1980) Salronell**/Marrtnalian-Microsome Mutagenicity Test
with GS 13 005s (Test for Mutagenic Properties in Bacteria):
No. of Experiment 801488. (Unpublished study received Aug 13,
1981 under 7F1983; prepared by Ciba-Geigy, Ltd., Switzerland,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:070213-E)
00115199 Ciba-Geigy Corp. (1977) Supracide—Cotton: Residues Observed in
Cottonseed from Multiple Applications: Report No. ABR-77062.
(Compilation; unpublished study received Aug 15, 1977 under 100-
501; CDL:231269-A)
00128127 Ciba-Geigy Corp. (1983) Supracide 2E—Alfalfa: Proposed Animal
Product Tolerances. (Compilation? unpublished study received
Feb 15, 1983 under 100-501? CDLt071401-A)
00131026 Ciba-Geigy Corp. (1982) [Chemistry of Technical Methidathion].
(Compilation; unpublished study received Sep 1, 1983 under
100-530; CDL:251155-A)
00134029 Hensley, J. (1981) Supracide Marker Exposure and Dislodgeable Resi-
due Studies in Cotton: Report No. EIR-80002. (Unpublished study
received Dec 12, 1983 under 100-617; submitted by Ciba-Geiqy
Corp., Greensboro, NC; CDL:072224-J)
00137599 Cannelongo, B.; Sabol, E.; Sabol, R.; et al. (1984) Guinea Pig Skin
Sensitization: [Supracide Technical FL 830958]: Project
No. 3152-83. (Unpublished study received Feb 14, 1984 under
100-567; prepared by Stillmeadow, Inc., submitted by Ciba-Geigy
Corp., Greensboro, NC; CDL:252432-A)
103
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00139326 Fritz, H. (1976) Reproduction Study on GS 13005 Tech.—Rat (Test
for Teratogenic or Embryotoxic Effects): Experiment No. 227564.
(Unpublished study received Jun 6, 1977 under 100-530; prepared
by Ciba-Geigy Ltd., Switz., submitted by Ciba-Geigy Corp.,
Greensboro, NC; CDL:230346-C)
00139328 Bathe, R. (1973) Acute Oral LD50 of Technical GS-13005 in the Rat:
Project No. Siss 2929. (Unpublished study received Jun 6, 1977
under 100-530; prepared by Ciba-Geigy Ltd., Switz., submitted by
Ciba-Geiqy Corp., Greensboro, NC; CDL:230346-F)
00142590 Ciba-Geigy Corp. (1983) Ciba-Geigy Technical Methidathion: Methida-
thion 505: Response to Product Chemistry Contents in EPA Letter
of December 1, 1983. Unpublished study. 2 p.
00154460 Sinoneaux, B.; Cassidy, J. (19??) Identification of a Major Metabo-
lite of GS-12956 (RH) in Tomatoes and Characterization of This
Metabolite in Greenhouse Grcwn Peas: Report No. ABR-80019. Un-
published study prepared by Ciba-Geigy Corp. 25 p.
00154462 Szolics, I.; Sirnoneaux, B.; Cassidy, J. (1981) Metabolism of 2-
Delta-Carbon-14-methidathion in Field Grown Artichokes: Re-
port No. ABR-80052. Unpublished study prepared by Ciba-Geigy
Corp. 26 p.
00154474 Ciba-Geigy Corp. (1985) Analytical Methodology and Residue Data
for GS-13005 and GS-13007. Unpublished compilation. 247 p.
00155944 Ciba-Geigy Corp. (1986?) Technical Methidathion: Density. Unpub-
lished study. 1 p.
00157347 Beavers, J. (1979) Acute Oral LD50 - Mallard Duck: Methidathion
Technical: Final Report: Project No. 108-169. Unpublished study
prepared by Wildlife International Ltd. 17 p.
00157350 Ward, G. (1981) Acute Toxicity of Supracide to Mysid (Mysidopsis
bahia) and Sheepshead Minnow (Cyprinodon variegatus) Report No.
BP-84-4-34: Project Nos. 1781.8001.001 and 1781.8001.002. Un-
published study prepared by Springborn Bionomics, Inc. 35 p.
104
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
00157351 Surprenant, D. (1985) Chronic Toxicity of Supracide to Mysid Shrimp
(Mysidopsis bahia): Report No. BW-85-3-1748: Project No. 1781-
8001. Unpublished study prepared by Springborn Bionomics, Inc.
33 p.
00157352 Forbis, A.; Cantrell, C. (1984) Chronic Toxicity of Supracide to
Daphnia magna under Flow-through Test Conditions: ABC Final Rep-
ort #31328. Unpublished study prepared by Analytical Bio-Chem-
istry Laboratories, Inc. 25 p.
00157353 McAllister, W.j Franklin, L. ? Knox, V. (1984) Early Life Stage Tox-
icity of Supracide to Fathead Minnows (Pimephales promelas, Raf-
inesque) in a Flow-through System: Final Report #31330. Unpub-
published study prepared by Analytical Bio-Chemistry Labora-
tories, Inc. 30 p.
00157457 Sagartz, J. (1986) TWo Year Dietary Oncogenicity Study in Mice:
Methidathion Technical:382-087. Unpublished study prepared by
International Research and Development Corporation. 2911 p.
00158529 Burkhard, N. (1980) Adsorption and Desorption of Methidathion (Sup-
racide, Ultracide) in Various Soil Types: Project Report 08/80.
Unpublished study prepared by Ciba-Geigy Ltd., Agricultural Div.
11 p.
00159199 Sachsse, K. (1973) Irritation of Technical GS-13005 in the Rabbit
Eye: Project No. Siss 2929. Unpublished study prepared by Ciba-
Geigy Ltd. 4 p.
00159200 Sachsse, K. (1973) Skin Irritation in the Rabbit after Single
Application of Technical GS-13005: Project No. Siss 2929. Unpub-
lished study prepared by Ciba-Geigy Ltd. 3 p.
00160260 Yau, E.; McMartin, D.; Zaidi, I.; et al. (1986) Methidathion:
2-year Oral Oncogenicity and Toxicity Study in Albino Rats
(MIN 832001): Toxicology/Pathology Report 86061. Unpublished
study prepared by Ciba-Geigy Corp. 1988 p.
05011885 Bull, D.L. (1968) Metabolism of 0,O-dimethyl phosphorodithioate
S-ester with 4-(mercaptcniethyl)-2-methoxy-delta 2-1,3,4-
thiadiazolin-5-one (Geigy GS-13005) in plants and animals.
Journal of Agricultural and Food Chemistry 16(4):610-616.
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supportinq
Registrations Under the Methidathion Standard
MRID CITATION
05011904 Eberle, D.O.; Hoermann, W.D. (1971) Fate of
S-[ (2-irethoxy-5-oxo-delta 2-1,3,4-thiadiazolin-4-yl)methyl !-0,
O-dimethyl phosphorodithioate (Supracide) in field-qrcwn
agricultural crops and soil. Journal of the Association of
Official Analytical Chemists 54{1):150-159.
05012174 Dupuis, G.; Muecke, W.; Esser, H.O. (1971) The metabolic behavior
of the insecticidal phosphorus ester GS-13005. Journal of
Economic Entomology 64(3):588-597.
05016720 Esser, H.O.; Muecke, W.; Alt, K.O. (1968) Der Abbau des
Insektizides GS 13005 in der Ratte Strukturaufklaerung der
wichtigsten Metabolite (1) [Degradation of the insecticide GS
13005 in rats Structural elucidation of the major metabolites
(1)] Helvetica Chimica Acta 51(3):513-517.
40079802 Gale, T. (1986) Methidathion: Analytical Short Report [Product
Chemistry Data] Study No. ASGSR-86-18. Unpublished compilation
prepared by Ciba-Geiqy Corp. 15 p.
40079804 Schiavo, D. (1986) Methidathion: 21-day Dermal Toxicity Study in
Rabbits: MIN No. 852128: Laboratory Study No. 86019. Unpub-
study prepared by Ciba-Geigy Corp. 149 p.
40079807 Infurna, R. (1986) Methidathion: A Dose Range-finding Study in
Pregnant Rats: MIN No. 852171: Laboratory Study No. 86028. Un-
published study prepared by Ciba-Geigy Corp. 247 p.
40079808 Infurna, R. (1987) Methidation: Teratology Study in Rats: M.I.N.
862164: Laboratory Study No. 86172. Unpublished study prepared
by Ciba-Geigy Corp. 399 p.
40079809 Wallace, P. (1986) Methidathion: Dose Range-finding Teratology in
Rabbits: Laboratory Study No. MIN 852223. Unpublished study
prepared by Ciba-Geigy Corp. 13 p.
40079810 Giknis, M. (1987) Methidathion: Teratology Study in Rabbits: MIN
852202: Laboratory Study No. 86131. Unpublished study prepared
by Ciba-Geigy Corp. 338 p.
40079811 Salamon, C. (1986) Methidathion: TVfo-generation Reproduction Study
in Rats: Laboratory Study No, 450-1713. Unpublished study pre-
pared by American Biogenics Corp. 570 p.
106
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Methidathion Standard
MRID CITATION
40079812 Salamon, C. (1987) Methidathion: TVo-generation Reproduction Study
in Rats: [Final Report]: Laboratory Study No. 450-2125. Unpub-
lished study prepared by American Biogenics Corp. 971 p.
40079815 Surprenant, D. (1986) Methidathion: Acute Toxicity of Supracide
SOS Technical to Embryos-Larvae of Eastern Oysters (Crassostre*
virginica): Bionomics Study #1781.1285.6125.514: Laboratory
Study No. BW-86-10-2150. Unpublished study prepared by Spring-
born Bionomics, Inc. 26 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Inter-
pretation and Data Base 410 Chemicals and 66 Species of Fresh-
Water Animals. US Fish & Wildlife Service; Resource Publica-
tion (160):l-36.
40127802 Bade, T. (1987) Residue Stability of Methidathion and GS-13007 in
Corn (Forage, Fodder, Grain), Corn Grain Fractions (Crude Oil,
Soapstock), Cottonseed, Cottonseed Fractions (Crude Oil, Refined
Oil, Soapstock), Alfalfa Forage and Alfalfa Hay under Freezer
Storage Conditions: (Storage Stability): Laboratory/Study No.
ABR-86101. Unpublished study prepared by Ciba-Geigy Corp. 72
p.
40127804 Bade, T. (1987) Residues of Methidathion and GS-13007 in Cottonseed
and Cottonseed Fractions following Applications of Supracide 2E
to Cotton: (Magnitude of the Residue in Field Crop Trails and
Processed Food and Feed): Laboratory/Study No. ABR-86126. Un-
published study prepared by Ciba-Geiqy Corp. 32 p.
40127805 Bade, T. (1986) Determination of Methidathion (GS-13005) and GS-
13007 Residues in Corn Grain and Corn Fodder: (Residue Analyti-
cal Method): Laboratory/Study No. AG-477A. Unpublished study
prepared by Ciba-Geigy Corp. 19 p.
40127806 Bade, T. (1985) Determination of Methidathion (GS-13005) and GS-
13007 Residues in Corn Grain Fractionation Samples (Residue
Analytical Method): Laboratory/Study No. AG-464. Unpublished
study prepared by Ciba-Geigy Corp. 19 p.
40127811 simoneaux, B. (1980) Isolation and identification of the major
polar metabolites of methidathion in tomatoes. Aqricultural and
Food Chemistry 28:1221-1224.
40127812 Chopade, H.; et al. (1981) Studies on residues and the metabolic
pathway of methidathion in tomato fruit. Pesticide Science
12:17-26.
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 Methidathion Standard
MRID CITATION
40127818 Szolics, I. (1987) Disposition of Methidathion in the Rat: (General
Metabolism): Laboratory/Study No. ABR-86122. Unpublished study
prepared by Ciba-Geiqy Corp. 241 p.
40127819 Chopade, E.y Dauterman, W. (1981) Studies on the in vitro metabo-
lism of methidathion by rat and mouse liver. Insecticide Bio-
chemistry and Physiology 15:105-119.
40127821 Simoneaux, B. (1987) Metabolism of :Carbon 14: (Carbonyl) Labeled
Methidathion in a Goat: (Nature of Residue—Metabolism): Labora-
tory/Study No. ABR-86112. Unpublished study prepared by Ciba-
Geiqy Corp. 21 p.
40341001 Biehn, W. (1987) Methidathion—Magnitude of Residue on Kiwifruit,
Including a Description of the Analytical Method Used: Laborato-
ry Project ID: PR-2701. Unpublished study prepared by Univ. of
California. 25 p.
108
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.
EPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data impoiad by tha FiFRA taction 3(C)(2)(B) notice containad in tha referenced
Guidanca Document, I am responding in tha following mannar.
Oi. 1 will submit data in a timaly mannar to aitisfy tha following requirements. If thi tait procadurat I will u«a daviata from (or ara not
specified In) tha Ragiitretion Guidelines or tha Protocols containad in tha Raporti of Expert Group* to tha Chamicali Group, OECO
Chamicali Tasting Programme, I andota tha protocols that I will usa:
O 2. I hava antared Into an egreement with ona or mora othir registrants undar FIFRA taction 3(C)(2)(B)(ii) to satisfy tha following data
requirements. The tests, and any required protocols, will bs tubmhted to EPA by:
NAME OF OTHER REGISTRANT
~ 3. I enclose e completed "Certification of Attempt to Enter Into en Agreement with Other Registrents for Development of Date" with
respect to the following deta requirements:
^34. I request thet you emend my registration by dilating tha following ums (this option is not available to eppllcsnts for new products):
~ S. I request voluntary cancalletion of tha registration of this product (This option is not eviilable to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8680-1 (1042)
109
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OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the reaistrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data ori the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the qeneric data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is reqistered under FIFRA Section 3, and which is purchased by
us frcm another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not reqistered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakinqs made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required qeneric data. If the reqistrant(s) who have conruitted
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data reguirements,
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:
(Siqnature)
Dated:
(Typed)
EPA Form 8580-3
110
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No. Date
Guidance Document for
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
§158.120
PRODUCT
CHEMISTRY
61-1
Identity of
ingredients
61-2
Statement of
composition
61-3
Discussion of
fornation of
inqredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcement
limits
63-2
Color
63-3
Physical state
63-4
Odor
63-5
Melting point
63-6
Boilinq point
63-7
Density, bulk-
density, or
specific qravity
63-8
Solubility
63-9
Vapor pressure
63-10
Dissociation
constant
63-11
Octanol/water
partition
coefficient
63-12
PH
111
-------
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(FDr EPA Use Only)
Acoessioo Numbers
Assigned
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
63-13
Stability
63-14
Oxidizing/reducing
reaction
63-15
Flammability
63-16
Explodability
63-17
Storage stability
63-18
Viscosity
63-19
Miscibility
63-20
Corrosion
characteristics
63-21
Dielectric break-
down voltage
§158.135
TOXICOLOGY
81-1
Acute oral
toxicity, rat
81-2
Acute dermal
toxicity, rabbit
81-3
Acute inhalation,
toxicity, rat
81-4
Primary eye
irritation, rabbit
81-5
Primary dermal
irritation
VO
1
CO
Dermal sensitiza-
tion
112
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Form Aj>pfOv»d OMB NO 2070-0057. E»pU« n-XlM.
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items) 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(c)(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 or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
« That nffor was irrevocable and included an offer to be
3 My firm has offered in writing to enter into such an agreement. Capies of the offers a[e att®.c _ w not be reached otherwise. This offer was made
bound by an arbitration decision under F1FRA Section 3{c)(2)lB)(iii) if find agreement on ail terms could
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
"However, none of those firm(st accepted my offer.
4 My firm requests that EPA not suspend the registration(s) of my firm's oroduct(s) if .k * ~ TT~ . ,,, „. „
have agreed to submit the data listed in paragraph (2) above in accordance 2 the NoZJ I J7 7ra9raPhJ3). a.bove
me whether my firm must submit data to avoid suspension of its rejto?,tto„«,Ider wow» P,TP 7! ° ,
does not apply to applicants for new products.) I give EPA permission to disclose this statement ^pon'request statement
TYPED NAME
EPA Form I
SIGNATURE
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