Erft
540/RS-89-068
United States
Environmental Protection
Agency
Pesticides and
Toxic Substances
(H-7501C)
Registration Standard For
Pesticide Products
Containing COUMAPHOS
As The Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
REGISTRATION STANDARD
(SECOND ROUND REVIEW)
FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
COUMAPHOS
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 56-72-4
OPP Chemical Code 036501
CASE NUMBER 0018
September, 1989
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
I. INTRODUCTION 1
II. CHEMICAL COVERED BY THIS STANDARD 3
A. Description of Chemical 3
B. Data Call-Ins Issued 4
C. Use Profile 5
III. AGENCY FINDINGS 6
A. Current Status and Summary of Data Base. ... 6
B. Health Effects Assessment 9
JC. Environmental Characteristics and Effects . . 12
D. Tolerance Reassessment 15
IV. REGULATORY POSITION AND RATIONALE 24
V. LABELING STATEMENTS AND COMPLIANCE
DATES 27
VI. PRODUCTS SUBJECT TO THIS STANDARD 33
VII. REQUIREMENT FOR SUBMISSION OF GENERIC DATA .... 34
A. What are generic data? . . '. 34
B. Who must submit generic data? 34
C. What generic data must be submitted? 35
D. How to comply with DCI requirements 35
E. Registrant Requests Regarding Data Requirements
and Agency Responses 38
F. Test Protocols and Standards 39
G. Procedures for requesting a change
in protocol 39
H. Data Format and Reporting Requirements ... 39
I. Procedures for requesting extensions
of time 40
J. Existing stocks provisions upon suspension or
cancellation 40
III. REQUIREMENT FOR SUBMISSION OF PRODUCT SPECIFIC
DATA 41
IX. REQUIREMENT FOR SUBMISSION OF REVISED LABELING . . 42
X. INSTRUCTIONS FOR SUBMISSION 43
A. Manufacturing-Use Products (Sole Active) and
(Multiple Active) 43
B. End-Use Products (Sole Active) and
(Multiple-Active) 44
•: •:*=,
1 • T "" r
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APPENDICES
I. DATA APPENDICES 45
Guide to Tables 45
Table A 49
Table B 70
TABLE C 76
II. LABELING APPENDICES 85
Summary of Label Requirements and Table 86
40 CFR 162.10 Labeling Requirements 96
Physical/Chemical Hazards Labeling Statements . . . 105
Storage Instructions 106
Pesticide Disposal Instructions 107
Container Disposal Instructions 108
III. BIBLIOGRAPHY APPENDICES 109
Guide to Bibliography 110
Bibliography 113
IV. FORMS APPENDICES 128
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement With Other Registrants for
Development of Data
EPA Form 8580-4 Product-Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
A Acre
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem.
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
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
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system
of recording and tracking studies submitted to the
Agency.
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
LD,
so
iii
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PADI Provisional Acceptable Daily Intake
ppm parts per million
RfD Reference Dose
TGAI Technical Grade of the Active Ingredient
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
August, 1981, the Agency assessed the available data
supporting the registration of the pesticide to determine
whether the pesticide met the "no unreasonable adverse
effects" standard of FIFRA. The Agency concluded that
additional data were necessary to fully evaluate the
pesticide, and, as part of the issuance of the Standard,
required that registrants supply those data. The Standard
also set out labeling requirements that the Agency believed
were necessary to ensure that products containing the
pesticide were adequate to protect public health and the
environment while the data were under development.
The Agency has reviewed the additional data submitted as
of July 9, 1988 and has updated and revised its scientific
and regulatory conclusions concerning the pesticide in light
of expanded data requirements promulgated in 1984 as 40 CFR
Part 158. The Registration Standard contains the Agency's
updated scientific assessment1 of this pesticide and its
currently registered uses. As part of its review, the Agency
has reassessed the tolerances for the pesticide and 4
determined whether they are adequate. The tolerance "•
reassessment is included in this Registration standard.
The Agency has also reviewed the labeling requirements for
manufacturing-use and end-use products and is requiring label
revisions.
This revised Registration Standard supersedes the
original Registration Standard in its entirety.
This document contains the following sections:
° Section II describes the particular pesticide(s)
covered by this Registration Standard, and gives a brief
profile of its usage and composition. Regulatory
history may be provided as well.
0 Section III provides a summary of the current status
of the data base. It sets out the Agency's scientific
assessment of the health risks and environmental
characteristics and effects of the chemical, which are
updated from the original Registration Standard.
1 The scientific reviews and Compendium of Acceptable Uses
are now available from the Field Operations Division (H7506C).
Write to Office of Pesticides Program, EPA, Washington, DC 20460.
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0 Section IV explains the regulatory decisions and
conclusions arising from the Agency's assessment, and
the rationales for its decisions.
0 Section V describes the labeling statements required
for products containing the chemical. These are divided
into statements for manufacturing-use products and
statements for end-use products.
0 Sections VI, VII, VIII, IX and X describe requirements
for submission of generic data, product-specific data,
and labeling.
0 Appendix I contains a the data tables which describe
data requirements for the chemical. The tables identify
which requirements have been satisfied, as well as those
for which gaps remain.
0 Appendix II contains basic labeling information.
0 Appendix III contains the bibliography. A Guide to
Bibliography explains how to read and use the
Bibliography.
0 Appendix IV contains the necessary forms to respond to
receipt of the Standard
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submission of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common Name: Coumaphos
Chemical Name: 0,0-diethyl 0-(3-chloro-4-methyl-2-oxo-
2H-l-benzopyran-7-yl) phosphorothioate
Chemical Family: Organophosphate
Trade Names: Bay 21/199, Asuntol, Muscatox, Resitox,
Baymix, Meldane, Co-Ral and Negashunt
Other Chemical
Nomenclature: 0-3-chloro-4-methylcoumarin-7-yl
0,0-diethyl phosphorothioate; 3-chloro-7-
di ethoxyphosphino-thi oyloxy-4-
methylcoumarin; 0- (3-chloro-4-methyl-2-
oxo-2H-l-benzopyran-7-yl) 0,0-diethyl
phosphorothioate (Chemical Abstracts,
9th Collective Index); 3,chloro-7-hydroxy-
4-methylcoumarin 0-ester with 0,0-diethyl
phosphorothioate (8th Collective Index);
0,3-chloro-4-methyl-2-oxo-2H-chromen-7-yl
0-0-diethyl phosphorothioate;
[0-(3-chloro-4-methyl-7-coumarinyl)]
0,0-diethyl phosphorothioate; 0,0-diethyl
0-(3-chloro-4-methyl-7-courmarinyl)
phosphorothioate; phosphorothioic acid 0-
(3-chloro-4-methyl-2-oxo-2H-l-benzopyran-
7-yl) 0,0-diethyl ester; 3-chloro-4-
methylumbelliferone, 0-ester with 0,0-
dietyl phosphorothioate; 0,0-diethyl
0-(3-chloro-4-methyluinbelliferone
thiophosphate.
CAS Registry Number: 56-72-4
EPA Pesticide Chemical Code (Shaughnessy Number): 036501
Empirical Formula: C14H16C1O5PS
Molecular Weight: 362.8
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Chemical/Physical Characteristics
of the technical grade:
Color: grey to tan
Physical state: powder to granules
Odor: characteristic sulfur
Melting Point: 90 to 95 °C
Boiling Point: 20 °C at 10"7 mmHg
Solubility: (at 20 °C): g/100 mL at 20 C
acetone 23.82
methylene chloride 6.39
denatured alchohol 0.90
xylenes 0.90
hexanes 0.07
water insoluble at 0.002
octanol 0.13
odorless mineral spirits 0.09
diethyl phthalate 21.50
Vapor Pressure: 1 X 10"7 mmHg at 20 C
Density, Bulk Density, or
Specific Gravity: 30.06 Ib/cu ft.
pH: 7.23 at 1 g/100 mL
Stability: hydrolyzes'slowly under alkaline conditions;
stable under normal storage conditions and
use; incompatible with piperonyl butoxide
Storage Stability: Stable «6% loss) in glass vials up
to 8 weeks at -12 to 50 C, dry and
at pH 4-10, at 83% moisture, exposed
to aluminum, and stainless steel;
stable exposed to sunlight for 4
days.
B. DATA CAT.T.-TTJS
There have been no 3(c)(2)(B) Data Call-in (DCI) Notices
issued for coumaphos since the 1981 Standard.
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C. USE PROFILE
Type of Pesticide: Insecticide/acaricide
Year of Initial Registration: 1958
Registered Uses: Indoor Use2 on beef and dairy cattle;
sheep; goats; horses; swine and
swine bedding
Pests Controlled: Face flies, horn flies, fly larvae, cattle
grubs, ticks (including ear tick), lice,
mites, screwworms, sheep keds and
fleeceworms
Methods of
Application: Dust, spray, dip, pour-on, dust bags and
backrubber oiler
Annual Usage: 264,000 to 525,600 Ibs (1986 estimate)
Predominant Usage: Predominate use is on beef cattle (98%).
A relatively small amount is used on
dairy cattle «2%) and swine (
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III. AGENCY FINDINGS
A. CURRENT STATUS AND SUMMARY OF DATA BASE
The current status of the coumaphos data base and a
summary of major science findings are provided below. The
summarized points are presented in further detail in Sections
11 IB through HID.
1. Most of the toxicology testing requirements for
coumaphos have been satisfied. This includes acute toxicity
testing on registered end-use products. There were no
toxicological concerns identified for this chemical (other
than effects on cholinesterase inhibition). There are four
outstanding data requirements: a structural chromosome
aberration study, a dog chronic feeding study, a 21-day
dermal toxicity study and a reproduction study. For each
study, there is a different reason for why the Agency
considers the requirement to be outstanding [Refer to Section
IIIB]. Below is a summary of the major toxicological science
findings for coumaphos:
a. Technical coumaphos is highly acutely toxic by the
oral and inhalation routes of exposure (Toxicity
Category I and II, respectively) and moderately acutely
toxic by the dermal route of exposure (Toxicity Category
III) based on studies using rats, rabbits and guinea
pigs. Technical coumaphos causes only mild eye and
dermal irritation (Toxicity Category III and IV,
respectively), and is nonsensitizing.
b. End-use products containing coumaphos fall in a
range of Toxicity Categories from I to III through the
various exposure routes.
c. Coumaphos does not produce organophosphate-type
delayed neurotoxicity, based on acute neurotoxicity
testing in hens.
d. The oncogenic potential of coumaphos is
satisfactorily defined. In vitro microbial studies for
gene mutation and DNA damage coumaphos did not cause a
mutagenic response, and when tested in the rat and
mouse, there were no carcinogenic effects noted.
e. Coumaphos is not a developmental toxicant, or
teratogen based on findings in studies utilizing rats
and rabbits.
f. Results of a chronic feeding study using rats show
that cholinesterase (plasma and erythrocyte) is the
primary target of coumaphos. Decreased body weight gain
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is a secondary effect.
g. In a rat metabolism study, coumaphos was rapidly
excreted. There were no dose-related changes in
metabolism or evidence of activation/bioaccumulation.
2. The coumaphos data base for ecological effects
testing is complete, with the exception of one special study.
Based the on results of laboratory studies using birds, fish,
and aquatic invertebrates, technical coumaphos is moderately
acutely toxic to fish and very highly acutely toxic to birds
and aquatic invertebrates. Coumaphos is moderately toxic to
birds on a subacute (dietary) basis. A refined ecological
risk assessment, performed for the livestock use, shows that
aquatic invertebrates may be potentially exposed to hazardous
levels of coumaphos resulting from washing-off of the
material from the backs of newly treated cattle which have
entered a body of water. Aquatic residue monitoring is
required to assess the potential hazards. Due to the
potential for avian exposure resulting from birds feeding on
the backs of cattle and in cattle lots, Tier I avian field
testing is required to assess possible adverse effects to
birds resulting from the livestock treatment.
3. The environmental fate profile for coumaphos is
adequately delineated for the registered use pattern, except
for a groundwater assessment. Coumaphos is relatively
immobile in aged sandy loam soil, based on findings in a
column leaching study. There are no immediate concerns for
groundwater contamination from non-point source application
of coumaphos. However, the potential does exist for
localized, point source contamination in animal treatment
areas (particularly where animals are dipped), and as a
result of associated disposal practices. Due to increased
Agency sensitivity in the area of pesticides and groundwater
contamination, four environmental fate studies are required
so that the Agency can assess coumaphos' potential for point
source contamination of groundwater.
4. Most of the residue chemistry conclusions drawn in
the 1981 Standard have been reversed in this Standard.
Residue chemistry data requirements were not imposed in the
1981 Standard. Since issuance of that Standard, the Agency
has published residue chemistry guidelines (Pesticide
Assessment Guidelines, Subdivision 0, 1982, EPA-540/9-82-023)
and other Federal Register (FR) Notices which provide a more
stringent interpretation of the existing regulations. As a
result of these new guidelines, data are now required in the
area of animal metabolism, storage stability and method
validation. No changes to coumaphos tolerances are indicated
at this time.
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5. The Agency is unable to totally assess the safety of
current tolerances and establish an acceptable daily intake
(ADI) value for coumaphos because of the absence of chronic
toxicity studies (reproduction and dog chronic toxicity), and
outstanding residue chemistry data. However, a preliminary
dietary exposure analysis has been performed for coumaphos.
Based on the results of this analysis, current coumaphos
tolerances are considered to be adequate to protect the
public health [Refer to discussion in Section HID Tolerance
Reassessment 1. When the remaining data requirements have
been fulfilled, the Agency will perform a final reassessment
of coumaphos tolerances.
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B. HEALTH EFFECTS ASSESSMENT
In the 1981 Standard, the Agency required submission of
acute and subacute toxicity studies for technical and
formulated products, a chronic feeding study, teratology and
reproduction studies, mutagenicity studies and a metabolism
study. Based on the Agency's review.and evaluation of the
current toxicity data base, all toxicity data requirements
for registration of products containing coumaphos have been
met, except for a 21-day dermal toxicity study, a non-rodent
chronic toxicity study, a reproduction study, and a
chromosome aberration study [reasons are explained below].
The toxicity profile of coumaphos, based on the results of
acceptable studies, is provided below.
1.' Acute Toxicitv
Technical coumaphos is very highly acutely toxic, based
on a reported oral LD50 of 17 mg/kg in female rats and
greater than 240 mg/kg in male rats [Toxicity Category is I].
Technical coumaphos is moderately acutely toxic by the dermal
route of exposure [Toxicity Category III] based on a reported
LD50 value of greater than 2400 mg/kg in rabbits. In studies
using rabbits, only mild irritation to the eyes [Toxicity
Category III] and very minor irritation of the skin [Toxicity
Category IV] was reported. There was no observable evidence
of dermal sensitization reported in an acceptable dermal
sensitization study using guinea pigs. In an acute
inhalation study, the LC^ dose for a 1-hour exposure was
determined to be 341 mg/nr in female -rats and greater than
1080 mg/m3 in male rats [Toxicity Category is II]. Coumaphos
did not produce organophosphate-type delayed neurotoxicity
when administered orally to hens protected with atropine at
1.5 times the acute LD50 in an acute delayed neurotoxicity
study.
Thirty-six acute toxicity studies were submitted in
support of registration of the end-use products. These
studies were reviewed and found to be acceptable. Coumaphos
end-use products range in toxicity from Toxicity Categories I
through III. Appropriate precautionary statements, for each
of the registered formulation types, are provided in Section
V Required Labeling.
2. Subchronic Toxicitv
Acceptable data are not available on the subchronic oral
toxicity study of coumaphos in dogs. This study is not
required since a chronic feeding study in dogs is required,
and supercedes the need for a subchronic toxicity study. The
previously accepted rat subchronic oral toxicity study is
considered now to be inadequate, since a NOEL was not
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achieved in the study. A new study does not need to be
performed, since there is an acceptable rat chronic toxicity
study on file. In the 1981 Standard, the Agency asked for a
90-day dermal toxicity study to support coumaphos use on dogs
and dog bedding. Label claims for use on dogs/dog bedding
were dropped for the chemical. Hence, no subchronic dermal
testing was performed for this chemical. The Agency is
requiring a subchronic dermal toxicity study now, because
application of coumaphos may result in repeated dermal
exposure. This is especially true for the dust bag uses,
when charging and recharging the bags. A subchronic
neurotoxicity study is not required, since there was no
evidence of neurotoxicity in the acute delayed neurotoxicity
study.
3. Chronic Toxicity/Oncogenicitv Testing
In a rat combined chronic feeding/oncogenicity study,
groups of SPF Wistar rats (50/ sex/group) were administered
0, 1, 5, or 25 ppm (equivalent to 0, 0.07, 0.36, and 1.7
mg/kg/day) coumaphos in the diet for 2 years. Plasma ChE was
inhibited in males and females in the 25 ppm group. Plasma
ChE was also inhibited in females in the 5 ppm group.
Erythrocyte ChE was inhibited in males and females in the 25
ppm group. Brain ChE was not inhibited in any of the groups.
Females in the 25 ppm group exhibited decreased weight gain
when compared to the controls. The NOEL (ChE) derived from
this study is 1 ppm. The NOEL for other systemic effects is
5 ppm (based on a decrease in body weight gain in females).
There was no evidence of oncogenicity noted in the study.
In a mouse oncogenicity study, groups of 50 mice/sex
were administered 10 and 20 ppm (equivalent to 15 mg/kg and
30 mg/kg) of coumaphos in the diet for 103 weeks. A control
group of 25 mice/sex was employed. No toxic/oncogenic
effects were noted in this study.
A chronic feeding study in dogs is needed to complete
the chronic effects testing data base for this chemical.
This requirement was inadvertently omitted from the 1981
Standard.
4. Developmental Toxicitv (Teratogenicity)
In studies utilizing rats and rabbits, coumaphos did not
cause teratogenic or developmental effects. In the rat
teratology study, groups of 50 female Charles River CD BS
rats were administered 0, 1, 5, and 25 mg/kg on days 6 to 15
of gestation. Females in the 25 mg/kg group exhibited
tremors. The maternal NOEL and LEL for this study were 5 and
25 mg/kg (based on the observation of cholinergic effects),
respectively. The developmental NOEL was greater than 25
10
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mg/kg (HDT). In the rabbit teratology study, groups of 17
inseminated rabbits were administered 0, 0.25, 2.0, and 18.0
mg/kg of coumaphos from days 7 to 19 of gestation. Several
rabbits in the 18.0 mg/kg group exhibited signs indicative of
ChE inhibition. The maternal NOEL and LEL for this study was
2.0 and 18.0 mg/kg, respectively. The developmental NOEL was
greater than 18.0 mg/kg (HDT).
5. Reproduction
A reproduction study must be conducted. This study was
originally required in the 1981 Standard. The Agency, in
1984, waived the requirement, agreeing with the registrant
that a study was not needed since there were two acceptable
teratology studies and a metabolism study. Since the purpose
of a reproduction study is to provide information on the
effects of the test substance on gonadal function, estrous
cycles, mating behavior, conception, parturition, lactation,
weaning, and the growth and development of the offspring, the
Agency no longer believes a waiver is appropriate.
Metabolism and teratology studies will not provide
information on the majority of these toxicity endpoints.
Therefore, a reproduction study must be conducted.
6. Mutagenicity
Technical coumaphos did not induce a mutagenic response
in the two tests listed below.
a. Gene Mutation: A Salmonella/microsome study was
conducted. Coumaphos was not mutagenic when tested at
levels up to 12,500 ug/plate with and without metabolic
activation in Salmonella typhimurium strains TA1535,
TA1537, TA100, and TA98.
b. Direct DNA Damage and Repair: A test on Escherichia
coli was conducted. Coumaphos was not mutagenic when
tested at levels up to 5000 ug/plate with and without
metabolic activation.
A previously accepted micronucleus study (00131682) is
considered to be inadequate, since the test substance did not
induce toxic effects in mice and only one dose level was
tested. A new study must be conducted in accordance with the
guidelines published in October 1982 (Subdivision F: Hazard
Evaluation:Human and Domestic Animals, EPA-540/9-82-005).
7. Metabolism
Results of a rat metabolism study showed that coumaphos
labelled on the leaving group (the most acidic group that is
11
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bonded to the phosphorus atom) was rapidly excreted as a
conjugate in the urine. There were no dose-related changes
in metabolism and no evidence of activation or
bioaccumulation noted in this study.
8. Pesticide Incidents/Human Exposure
The Agency's nation-wide survey of hospitals (covering
the period 1977-1982) contained only 1 out of 1,245 cases
related to coumaphos (less than 0.1%). Exposure data are
not required for this chemical. The Agency will evaluate the
need for occupational and nonoccupational exposure data upon
receipt and evaluation of the required toxicology data.
C. ENVIRONMENTAL CHARACTERISTICS AND EFFECTS
1. Ecological Effects
In the 1981 Standard, the Agency required submission of
avian acute and subacute toxicity testing; and a fish acute
LC50. These studies have been submitted, and are adequate to
support registration of products containing coumaphos. All
ecological effects testing requirements for coumaphos have
been met, with one exception [discussed below]. The
ecological effects profile of coumaphos, based on the results
of acceptable laboratory studies, is provided below.
Birds
The acute toxicity of technical coumaphos to birds
ranges from highly to very highly toxic. On a subacute
dietary basis, coumaphos is highly toxic to birds.
Representative LD50 values are 29.4 mg/kg for mallard duck,
7.94 mg/kg for pheasant, and 2.4 mg/kg for bobwhite quail.
Reported avian dietary LC50s are 401 ppm for mallard and 82
ppm for bobwhite quail. Due to the potential for avian
exposure resulting from birds feeding in cattle lots and on
the backs of cattle, Tier I avian field testing is required
to assess possible effects to birds resulting from direct
treatment to livestock. Birds have been killed by feeding on
the backs of cattle treated with other pesticides which were
toxic to birds. In conjunction with this study, samples of
hair and insects from the backs of cattle should be monitored
for residues.
Aquatic Organisms
Technical coumaphos is moderately toxic to freshwater
fish based on reported LC50s for fish of 5.9 ppm in rainbow
trout and 5.0 ppm in bluegill. Technical coumaphos is very
highly toxic to aquatic invertebrates based on a reported
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LC50 of 0.15 ppb in an amphipod, Gammarus lacustris.
There is a potential for exposure to aquatic organisms
resulting from washing-off of the material from the backs of
newly treated cattle which have entered a body of water, such
as a pond or stream. Based on numerical calculations,
application of coumaphos to a herd of 40 cattle at a rate of
0.0130 Ib. ai/100 Ib. of animal results in a concentration
level of 15.9 ppb in 6 feet of water. This assumes that the
cattle move into the water in a short period of time after
application and that about 5% of the applied amount of the
active ingredient is washed off. This concentration level
exceeds the amphipod LC50 of 0.15 ppb. Based on this
assessment, an acute hazard to aquatic invertebrates may
exist. To evaluate the potential risk, a residue monitoring
study is required.
A hazard to aquatic invertebrates may also exist as a
result of improper disposal of spent dipping solution.
Special disposal instructions (in compliance with RCRA) for
used dip solutions resulting from the livestock dip use
pattern are required as specified in Section V, Required
Labeling.
Non-target Insects and Plants
Data requirements for non-target insect testing and-non-
target phytotoxicity testing are not applicable for
coumaphos's indoor use pattern.
2. Environmental Fate
In the 1981 Standard, the Agency required submission of
studies pertaining to aerobic soil metabolism, hydrolysis,
photodegradation, volatility, adsorption/desorption, water
dispersal, leaching, fish accumulation and a special test for
composition and concentration in feces. After issuance of
the 1981 Standard, Bayvet submitted waiver requests for many
of the studies. The Agency agreed to waive requirements for
volatility and composition/concentration in feces, since the
poultry/poultry house claims were dropped. The Agency agreed
to waive requirements for photodegradation and anaerobic soil
metabolism, since it concluded that coumaphos would not reach
soil or water on an area of several acres or more at
detectable levels. The Agency agreed to waive the
requirement for adsorption/desorption, since it determined
that the potential for mobility could be determined from a
column leaching study. Finally , the Agency agreed to waive
the requirement for water dispersal, since were no aquatic
uses for the chemical.
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The Agency has reviewed the studies submitted in
response to the 1981 Standard: hydrolysis (MRID 00159928),
aerobic soil metabolism ( MRID 40518701), fish accumulation
(MRIDs 00115168 and 00150619) and leaching (MRID 00163806 )3.
The column leaching portion of the leaching study is
acceptable and will support registration of products
containing coumaphos. In this study, 30 day-old
t C]coumaphos residues were relatively immobile in a column
(24-cm length) of sandy loam soil. After leaching, the upper
6 cm of the soil column contained 97.93% of the recovered
[ C] residues, the 6 to 12 cm depth contained 1.20%, the 12-
to 24-cm depth contained 0.04%, and the leachate contained
0.40%. The radioactivity in the upper 6 cm of the sandy loam
soil column was characterized as:14C]coumaphos, 95.8% of the
recovered; chlorferone (3-chloro-4- methyl-7-
hydroxycoumarin), 3.1%; the coumaphos oxygen analog (0,0-
diethyl 0-3-chloro-4-methylcoumarin phosphate), 0.2%; and
unidentified organosoluble [14C]residues, 0.9%. The material
balance after leaching was 118.45% of the applied. Based on
this data, coumaphos can be characterized as persistent, but
immobile in sandy loam soils.
The other studies were found to be unacceptable due to
design and reporting flaws. The fish accumulation study and
aerobic soil metabolism study do not need to be repeated. The
Agency no longer considers these studies necessary to support
coumaphos's indoor use pattern. New hydrolysis and
3 MRID 00115168 Lamb, D.W. 1985. Coumaphos 14C accumulation
and persistence of residues in bluegiil. Report No. 71632.
Unpublished study prepared by Mobay Chemical Corporation, Stilwell,
KS, and submitted by Bayvet Division of Cutter Laboratories,
Shawnee Mission, KS.
MRID 40518701 Olson, G., and L. Lawrence. 1987.
Coumaphos—Aerobic soil metabolism study: PTRL Project No. 113.
Unpublished study prepared by the Pharmacology and Toxicology
Laboratory, Lexington, KY.
MRID 00150619 Waggoner, T. 1985. Inclusion of additional
data to coumaphos-[carbon-12] accumulation and persistence of
residues in blugill: Bayvet Report No. 71632. Unpublished study
prepared by Bayvet Division of Miles Laboratories, Inc., Shawnee
Mission, KS.
MRID 00159928 Waggoner, T. 1986a. Hydrolysis of [Carbon
14] coumaphos in sterile buffered aqueous solutions. Report No.
73320. Unpublished study prepared by the Pharmacology and
Toxicology Laboratory, Lexington, KY.
MRID 00163806 Waggoner, T. 1986b. Leaching of aged
residues of [carbon 14]-coumaphos in soil: Mobay Report No. 73431.
Unpublished study prepared by the Pharmacology and Toxicology
Laboratory, Lexington, KY.
14
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adsorption/desorption studies must be conducted to fully
assess coumaphos' potential for contaminating groundwater.
There are no immediate concerns for groundwater
contamination from non-point source application of coumaphos.
However, the potential does exist for localized, point source
contamination in animal treatment areas (particularly where
animals are dipped), and as a result of associated disposal
practices. In order to evaluate the potential for point
source contamination, special studies are required: a
photodegradation study in soil, a photodegradation study in
water, an adsorption/desorption study, a hydrolysis study
and a special retrospective field dissipation study. In the
interim, special labeling requirements for disposal of spent
dipping solutions are imposed (see under Section V, Required
irm.
D. TOLERANCE REASSESSMENT
EPA has reviewed and evaluated the residue and
toxicology data used in support of coumaphos tolerances to
determine whether current tolerances are sufficient to cover
the actual residues resulting from use, and to determine if
tolerances are adequate to protect the public health,
including that of sensitive subpopulations.
Most of the residue chemistry conclusions drawn in the
1981 Standard have been reversed. No residue chemistry data
requirements were imposed in the 1981 Standard. Since
issuance of that Standard, the Agency has published residue
chemistry guidelines (Pesticide Assessment Guidelines,
Subdivision 0, 1982, EPA-540/9-82-023) and other FR Notices
which provide a more stringent interpretation of the existing
regulations. As a result of these new guidelines, data are
now needed in the area of animal metabolism, storage
stability and method validation.
The Agency's findings as a result of this evaluation are
summarized below. The regulatory results of the Agency's
review are set out in Section IV Regulatory Position and
Rationale.
1. Tolerances Issued
U.S. tolerances are established for residues of the
insecticide coumaphos, 0,0-diethyl 0-(3-chloro-4-methyl-2-
oxo-2H-l-benzopyran-7-yl) phosphorothioate, and its oxygen
analog, 0,0-diethyl 0-3-chloro-4-methyl-2-oxo-2H-l-
benzopyran-7-yl-phosphate, in or on raw agricultural products
as follows (40 CFR 180.189):
15
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o 1 ppm in or on meat, fat, and meat byproducts of
cattle, goats, hogs, horses, poultry , and sheep
o 0.5 ppm in milk fat (reflecting negligible residues
in milk)
o 0.1 ppm in eggs5
The Food and Drug Administration (FDA) regulates the use
of Coumaphos Crumbles (0.32% ai) as a top dressing on cattle
feed (21 CFR 520.500) and coumaphos mixed with feed (21 CFR
558.185) administered at 0.00012-0,0002 Ib ai/100 Ib of body
weight.
2. Residue Data
Below is a discussion of the residue chemistry data used
in ..support of coumaphos tolerances.
a. Additional animal metabolism studies, conducted in
ruminants, are required. In the 1981 Standard, the Agency
concluded that the available data were sufficient to assure
that coumaphos residues were adequately delineated based
solely on data from metabolism studies in which poultry and
ruminants were dermally treated with [32P]coumaphos. These
data are no longer considered acceptable because: (i) the
fate of the ring moiety of coumaphos was not determined; (ii)
many metabolites were not conclusively identified or
adequately quantitated; (iii) 32P-activity was not adequately
accounted for in all tissues; and (iv) many studies are from
open literature thus raw data are unavailable. Although the
available data provide some information regarding the
identities and distributions of 32P-residues in meat and
milk, metabolism studies using ring-labeled [14C]coumaphos
are required to adequately characterize the terminal
residues. The molecular structures of coumaphos and its
metabolites identified in animals treated with [32P]
coumaphos are depicted in Table 1.
There are no longer any federally registered uses for
poultry/poultry houses. Therefore, the Agency intends to revoke
the tolerances for poultry and eggs.
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Table l. Coumaphos and Its Metabolites in Animal
Chemical Name Substrate
Common Name
I. 0,0-diethyl 0-(3-chloro-4-methyl-2-oxo-2H-l-
benzopyran-7-yl) phosphorothioate
Milk
Cattle fat,
liver, kidney
Swine fat
Sheep fat
Cattle feces
Egg yolk
(putative)
Poultry feces
Poultry skin
Coumaphos
II. 0,0-diethyl 0-(3-chloro-4-methyl-2-oxo-2H-l-
benzopyran-7-yl) phosphate
Milk
Ruminant tissues
(unspecified)
Egg yolk
(putative)
Poultry feces
Cattle feces
Coumaphos oxygen
analog
III. O-ethyl 0-(3-chloro-4-methyl-2-oxo-2H-l-benzopyran-
7-yl) phosphorothioate
Milk
Ruminant
urine
De-ethylated
coumaphos
17
•: •:*•,
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Table 1, Coumaphos and Its Metabolites in Animal
Chemical Name Substrate
Common Name
IV. 0-ethyl 0-(3-chloro-4-methyl-2-oxo-2H-l-benezopyran-
7-yl) phosphate
Milk
Ruminant
urine
V. 3-chloro-4-methyl-7-hydroxycoumarin
De-ethylated
coumaphos
oxygen analog
Rabbit feces
Cattle tissues1
(putative)
Chlorferrone,
Chlorferone,
Chlorferron
VI. 0,0-diethyl-O-(4-methyl-2-oxo-2H-l-benzopyran-7-yl)
phosphorothioate
Rabbit feces
Cattle tissues1
(putative)
Potasan
VII. diethyl phosphorothionic acid
Milk
Poultry feces
Cattle urine
Diethyl
phosphorothionic
acid
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Table l. CoumaDhos and Its Metabolites in Animal
Chemical Name
Substrate
Common Name
VIII. diethyl phosphoric acid
IX. monoethyl phosphorothioic acid
X. monoethyl phosphoric acid
Milk
Poultry feces
Cattle urine
Diethyl phosphoric
acid
(putative)1
Cattle, goat urine
(putative)
Poultry feces
XI. phosphoric acid
XII. phosphorothioic acid
Monoethyl
phosphoric acid
Milk
Cattle urine,
feces
Phosphoric acid
(putative)1
JThe 1981 Standard identified chlorferron and potasan as
putative metabolites of coumaphos, and did not require
additional methods for the enforcement of the tolerances of
coumaphos and it oxygen analog. However, since the nature of
the residues in animals is not understood, the adequacy of
the available analytical methods can not be ascertained.
Methods to be used for data collection and tolerance
enforcement will be determined upon receipt of the requested
metabolism data.
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b. Additional storage stability data are required. Although
it was concluded in the 1981 Standard that adequate storage
stability data were available, these data reflected storage
of the 25% WP product, not samples of commodities bearing .
coumaphos residues. No data reflecting the storage of meat
or tissues were submitted. Data must be submitted which
conforms to the Pesticide Assessment Guidelines, Subdivision
0.
c. Data are required concerning recovery of coumaphos and the
coumaphos oxygen analog by certain of the Multiresidue
Protocols I-IV, as per FR 51(187)34249.
d. The adequacy of the available data pertaining to residues
of coumaphos and its oxygen analog in animal commodities
cannot be ascertained, since the qualitative nature of the
residue in animals is not adequately understood. Upon
receipt of the requested animal metabolism data, the adequacy
of the established tolerances will be determined. If these
studies reveal the existence of additional residues of
toxicological concern, additional data may be required.
e. The tolerance established by the Canadian government is
0.5 ppm in meat, meat byproducts and fat of cattle, goats,
horses, hogs, poultry, and sheep. This is lower than the
U.S. tolerance due to different methods of setting
tolerances. The Canadian tolerance reflects expected
residues that are statistically determined percentages of the
maximum residues, rather than the maximum residues used in
setting U.S. tolerances. Temporary Codex Maximum Residue
Levels of 1 ppm in poultry and fat of meat of cattle, 0.5 ppm
in fat of meat of sheep, pigs, goats, milk, and milk
products, and 0.05 ppm in eggs are proposed to be revoked due
to a lack of supporting data.
f. Regulatory Incidents: No finding of coumaphos were
reported in 1 sample of meat byproducts; 12 samples of milk,
cream, and cheese; 1 sample of poultry byproduct; 2 samples
of eggs; 8 samples of noodles (likely to contain eggs); or in
numerous samples of plant commodities collected in FDA
domestic and import surveillance from 1986 to 1988.
3. Acute and Chronic Dietary Exposure Analysis
The Provisional Acceptable Daily Intake (PADI) for
coumaphos is 0.0007 mg/kg/day and is based on the 2-year rat
feeding/oncogenicity study NOEL of 0.07 mg/kg/day (based on
plasma cholinesterase inhibition in females) and uncertainty
factor of 100.
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A preliminary dietary exposure analysis, performed for
the registered uses of coumaphos assuming that 100% of the
commodities contained tolerance level residues, resulted in
exposure estimates that exceeded the reference dose.
Consequently, anticipated residue data were developed for
meat and milk. Simple calculations of average and "upper-
bound" anticipated residue levels were not possible due to
limitations in the data base (e.g. residue data dating to
pre-1968, many exaggerated rate studies, dissimilarity in
measuring residue levels from study to study, and lack of
information regarding typical rates of application,
application rates and preslaughter intervals). Because of
these.limitations, a residue decline analysis was performed
for each available residue study to calculate average and
"upperAbound" 95% confidence limit values between zero and 14
days after treatment. The highest average values between
zero and 14 days for each study were used to calculate an
average anticipated residue. The highest 95% confidence
limit (or highest residue level found) between zero and 14
days was determined for each study, and the highest of these
from all studies was used for the "upper-bound" anticipated
residue. High values which appeared to be "outliers" were
excluded from the data sets if the values appeared
unrealistically high because the data sets were small or
because the value was obtained by extrapolation to higher or
lower PHIs for which residue data were not available.
The calculated values reflect those expected from
chronic (based on average residues) and acute (based on
highest residue found or 95% confidence limit) exposure.
The analysis did not take into account reduction in
residues from cooking or percent of animal treated data,
since data in either area were unavailable. The Agency
considered the total toxic residue to include coumaphos and
its oxygen analogue as described in the tolerance expression,
since the metabolism of coumaphos is not considered
adequately understood. Due to a wide range of residues found
in beef fat, residue data were weighted by the approximate
percent of each type of application made to beef cattle based
on the best available data (approximately 60% dust and 40%
spray or dip) in calculating the "upper-bound" value.
21
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Anticipated Residues for Coumaphos for Use in
Calculating Chronic and Acute Exosure
Anticipated Residue(ppm)
Commodity
Average Upper Bound
Beef (and horse), -lean meat without removable
fat 0.03 0.05
, fat 0.15 0.40
, liver (and meat by-products) 0.10 0.10
, kidney 0.04 0.04
Goat, lean meat without removable fat 0.04 0.20
, fat 0.50 1.0
, liver (and meat by-products) 0.03 0.03
, kidney 0.02 0.03
Hog, lean meat 0.03 0.20
, fat 0.06 0.60
, liver (and meat by-products) 0.02 0.02
, kidney 0.02 0.02
Sheep, lean meat without removable fat 0.05 0.25
, fat .0.50 1.0
, liver (and meat by-products) 0.03 0.08
, kidney 0.04 0.09
Milk 0.006 0.02
Chronic Exposure Analysis
The chronic dietary exposure analysis was performed
using average anticipated residue values. The Anticipated
Residue Contribution (ARC) for the United States population
is calculated to be 0.000127 mg/kg/day, occupying 18.2% of
the PADI. The two highest calculated exposures for the
population subgroups are children 1 to 6 years of age [ARC
occupies 33.6% of the PADI] and children 7 to 12 years of age
[ARC occupies 25.6% of the PADI].
Acute Exposure Analysis
The acute dietary exposure analysis was performed using
11 upper-bound" anticipated residues. The analysis was used to
estimate the distribution of single-day exposures for the
overall U.S. population average and certain population
subgroups (male, female, children and infants). The acute
dietary exposure to coumaphos is compared to the NOEL for ChE
inhibition of 5 mg/kg body weight from an acute toxicity rat
study [acute toxicity endpoint = inhibition of
cholinesterase; LEL = 5 mg/kg body weight]. The margin of
22
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safety (MOS) for acute exposure is calculated as the ratio of
the NOEL to the estimated exposure5. Results of these
calculations indicate that acute exposure to coumaphos is not
expected to result in an MOS less than 500 for any TAS
population group.
The Agency is unable to totally assess the safety of
current tolerances and establish an acceptable daily intake
(ADI) value for coumaphos because of the absence of chronic
toxicity studies (reproduction and dog chronic toxicity), and
outstanding data in the area of animal metabolism, method
validation and storage stability. When the required data
have been submitted and evaluated, the Agency will perform a
final reassessment of coumaphos tolerances.
For example, the estimated MOS for the average U.S.
consumer is calculated as:
MOS = NOEL / EXPOSURE (ARC)
(5 mg/kg) / 0.000798 mg/kg body weight
= 6300 (Approximately)
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IV. REGULATORY POSITION AND RATIONALE
A. SUMMARY OF REGULATORY POSITIONS AND RATIONALES
Based on a review and evaluation of all available data
and other relevant information on coumaphos, the Agency has
made the following determinations:
1. The Agency is not initiating a Special Review for this
chemical.
Rationale; No Special Review concerns were identified
for this chemical by the Agency during its review of the
current data base.
2. The Agency is classifying coumaphos 11.6% EC and 42%
flowable concentrate end-use products as restricted use due
to acute oral hazards.
Rationale; Section 3(d)(l)(c) of FIFRA provides that
some or all uses of a pesticide will be classified for
restricted use if the Administrator determines that without
such restriction the pesticide "may generally cause
unreasonable adverse effects in man or the environment."
Because of the high acute oral toxicity of the 11.6% EC and
42% flowable concentrate formulations, the Agency is
classifying these products as restricted-use.
3. The Agency will approve new food/feed tolerances for
coumaphos on a case-by-case basis.
Rationale; Based on the results of a preliminary
dietary exposure analysis, the Agency believes that current
coumaphos tolerances are adequate to protect the public
health. The Anticipated Residue Contribution (ARC)
represents only 18.2% of the PADI for the U.S population
average. However, data are lacking in the area of animal
metabolism, method validation, storage stability, and chronic
toxicology (dog chronic toxicity and reproduction).
Therefore, if an applicant submits a petition for a new food
or feed use, the Agency will consider the request on a case-
by-case basis. Such evaluation will include the incremental
contribution to the anticipated residues.
4. Environmental fate testing is required to evaluate
coumaphos' potential for impacting groundwater or surface
water resulting from point source application.
Rationale; There are no immediate concerns for
groundwater contamination from non-point source application
of coumaphos. However, the potential does exist for
24
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localized, point source contamination in animal treatment
areas (particularly where animals are dipped), and as a
result of associated disposal practices. Four environmental
fate studies (adsorption/desorption, retrospective field
dissipation study, hydrolysis, and photodegradation) are
required to assess coumaphos's potential for contaminating
groundwater.
5. Labels bearing directions for use on goats and sheep must
be amended to specify a preslaughter interval (PSI) of 3
days.
Rationale The 15 day preslaughter interval
established for goats and sheep is considered inappropriate.
Agency policy is that a PSI greater than 3 days is not
practical or enforceable, because livestock can be
transferred quickly from an owner who has applied the
pesticide to one who is not* aware of the animal's treatment
history.
6. Coumaphos product labels must bear revised and updated
labeling that accurately reflects hazards to nontarget
organisms. Refer to Section V for the wording of these
statements.
Rationale; Label statements are required since
laboratory data show that coumaphos is highly to very highly
toxic to birds, very highly toxic to aquatic invertebrates
and moderately toxic to fish.
7. A special aquatic residue monitoring study is required.
Rationale; Results of laboratory testing, in
conjunction with theoretical monitoring, indicate that
aquatic invertebrates may be potentially exposed to hazardous
levels of coumaphos as a result of washing-off of the
material from the backs of newly treated cattle which have
entered a body of water, such as a pond or stream. A residue
monitoring study is required in order that the Agency may
assess the risk to aquatic invertebrates resulting from
direct animal treatment.
8. A special avian Level I field study is required.
Rationale; Results of laboratory testing indicate that
this chemical is very highly acutely toxic to birds and
moderately toxic on a subacute (dietary) basis. Due to the
potential for avian exposure resulting from birds feeding in
cattle lots and on the backs of cattle, Tier I avian field
testing is required to assess possible effects to birds
resulting from direct treatment to livestock.
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9. The Agency is requiring protective clothing statements
for coumaphos products falling in Toxicity Category I and II.
Rationale: Coumaphos is a cholinesterase inhibitor.
Protective clothing is necessary to reduce exposure to
individuals (including dip tank workers) who mix, load,
and/or apply coumaphos products.
10. The Agency will revoke the poultry and egg tolerances.
Rationale; Coumaphos is no longer federally registered
for use on poultry or in poultry houses. Therefore, the
Agency will revoke the tolerances for poultry and eggs.
11. End-use product labels must specify a maximum single
application rate expressed in terms of amount of active
ingredient per animal, a maximum seasonal application rate or
number of applications permitted per season, and a minimum
interval between applications.
Rationale; Some of the end-use product labels do not
contain restrictions on use as described above. For those
products which do not contain directions for use specifying a
maximum single application rate expressed in terms of (1)
amount of active ingredient per animal; (2) a maximum
seasonal application rate or number of applications permitted
per season; and (3) a minimum interval between applications,
revised labeling must be submitted.
12. There are no inconsistencies between the U.S. tolerances
and Codex Maximum Residue Levels (MRLs).
Rationale; Temporary Codex MRLs established for
coumaphos residues in animal products are proposed to be
revoked due to a lack of supporting data. Therefore, no
questions of compatibility exist with respect to the U.S.
tolerance and Codex MRLs.
13. The Agency has identified certain data that will
receive priority review when submitted to the Agency.
Rationale; Certain data are essential to the
Agency's assessment of this pesticide and its uses and/or may
trigger the need for further studies which should be
initiated as soon as possible. The following studies have
been identified to receive priority review as soon as they
are received by the Agency:
Fish and Wildlife
70-1 Aquatic Residue Monitoring Data
26
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71-5 Simulated or Actual Field Testing With Mammals and
Birds
Environmental Fate
158.75 Special Retrospective Field Dissipation study
161-1 Hydrolysis
161-2 Phot©degradation Study in Water
161-3 Photodegradatiuon Study in Soil
163-1 Adsorption/Desorption Study
13. While data gaps are being filled, currently registered
products containing coumaphos may be sold, distributed,
formulated, and used, subject to the terms and conditions
specifred in this Standard. However, significant new uses
will not be registered. Registrants must provide or agree to
develop additional data, as specified in the Data Appendices,
in order to maintain existing registrations.
Rationale; Even when authorized under FIFRA
sections 3(c)(2)(B) and 3(c)(7) the Agency may elect not to
cancel or withhold registration even though data are missing
or are inadequate. Issuance of this Standard provides a
mechanism for identifying data needs. These data will be
reviewed and evaluated, after which the Agency will determine
if additional regulatory actions are necessary. The Agency
has elected not to consider registration of any significant
new food uses while data gaps are being filled and data
evaluated.
V. REQUIRED LABELING STATF-MKKfTS AND COMPLIANCE DATES
All products must bear appropriate labeling as specified
in 40 CFR 156.10 and below.
Pesticide products containing this pesticide as an
active ingredient may not be released for shipment by the
registrant after November, 1990 unless the product bears
amended labeling that complies with the requirements of
FIFRA, as set out in this Registration Standard.
Pesticide products containing this pesticide as an
active ingredient may not be distributed, sold, offered for
sale, held for sale, shipped, delivered for shipment, or
received (and having been so received) delivered or offered
to be delivered by any person after November, 1991 unless
that product bears amended labeling that complies with the
requirements of this Standard.
A. MANUFACTURING USE PRODUCTS
1. The ingredient statement for MPs must declare the
27
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active ingredient as:
"0,0-diethyl 0-(3-chloro-4-methyl-2-oxo-
2H-l-benzopyran-7-yl) phosphorothioate.
2. Labels for MPs must bear the following identifying
phrase directly beneath the product name:
"An insecticide for formulating use only."
3. In the directions for use, the following statement
must appear:
"Formulators using this product are responsible
for obtaining EPA registration of their formulated product."
4. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use insecticide products
intend«3 only for (list acceptable sites)."6
5. If detailed instructions for formulating are not
provided on the label, the following statement must appear:
"Refer to attached Technical Bulletin for
formulating and other information."
6. The following statements are required to appear
under the "Environmental Hazards" heading:
"This pesticide is toxic to birds, fish and
aquatic invertebrates. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans,
or public waters unless this product is specifically
identified and addressed in a NPDES Permit. Do not discharge
effluent containing this product to sewer systems without
previously notifying the sewage treatment plant authority.
For guidance, contact your state Water Board or Regional
Office of the EPA."
B. END USE PRODUCTS
The Use Index (EPA Compendium of Acceptable Uses) (for
availability see Section I) lists all federally-registered uses of
coumaphos, as well as approved maximum application rates and
frequencies. No use may be included on the label where the
registrant fails to agree to comply with the data requirements for
that use pattern.
28
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1. The ingredient statement for EPs must declare the
active ingredient as:
"0,0-diethyl 0-(3-chloro-4-methyl-2-oxo-
2H-l-benzopyran-7-yl) phosphorothioate "
2. The following statements are required to appear
under the "Environmental Hazards" heading for all EP
products:
"This pesticide is toxic to birds, fish and
aquatic invertebrates. Do not contaminate water when
disposing of equipment washwater or rinsate."
3. Coumaphos 11.6% EC and 42% flowable concentrate
formulations must bear the following restricted-use
statement:
"RESTRICTED USE CLASSIFICATION
Due to acute oral hazards
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."
4. All products intended for direct animal treatment to
sheep and goats must bear the following statement:
"Do not treat within three days of slaughtering."
5. All EP products in Toxicity Category I or II (except
those formulated as aerosol products) must bear the following
worker protection clothing statements:
"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; long-sleeved shirt and
long-legged pants; chemical resistant gloves; chemical
resistant shoes (or chemical resistant shoe covers or
chemical resistant boots). In addition, mixers/loaders and
dip tank workers must wear a chemical resistant apron and
face shield or goggles, and a NIOSH/MSHA approved respiratory
protection device."
6. Labels for all EP products (except those bearing
direction for livestock dip treatment and those formulated as
aerosol products) which are assigned to Toxicity Category I
on the basis of oral or dermal toxicity, skin or eye
irritation potential, or Toxicity Category I or II on the
basis of acute inhalation toxicity must bear the following
pesticide disposal statements in accordance with PR Notices
83-3 and 84-1.
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"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 directions,
contact your State Pesticide or Environmental Control Agency,
or the Hazardous Waste representative at the nearest EPA
Regional Office for guidance."
7. Labels for products formulated as aerosols may bear
the following pesticide disposal:
"Replace cap and discard containers in trash.
Do not incinerate or puncture."
8. All products allowing for use as a livestock dip
treatment must contain the following disposal statements:
"Used dip solutions must be disposed of in
accordance with the Resource Conservation and Recovery Act
(RCRA). If the applicator generates more than 1000 kg of
used dip solution per month or more than 1000 kg used dip
solution in combination with other hazardous waste, the
material must be treated as a hazardous waste subject to
subpart C of RCRA. Any user who wishes to treat, store or
dispose of hazardous waste must obtain a permit to serve as a
hazardous waste facility pursuant to RCRA."
9. Each end-use product label must be revised to
reflect the appropriate signal word and set of precautionary
statements assigned to it based on the results of acceptable
acute toxicity testing:
11.6% EC
"PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
DANGER —POISON (skull and crossbones)
Fatal if swallowed. May be fatal if inhaled. Do not breathe
vapors or spray mist. Avoid contact with skin, clothing or
eyes. Wash thoroughly with soap and warm water after
handling. Wash contaminated clothing with soap and hot water
before use."
3% Spray
"PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS 6 DOMESTIC ANIMALS
DANGER
Corrosive. Can cause irreversible eye damage. Do not get in
eyes. Wear safety glasses or goggles.
Harmful if swallowed, inhaled or absorbed through skin.
Avoid breathing spray mist. Avoid contact with skin and
clothing."
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4% Pour-On
••PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
WARNING
May be fatal if swallowed or inhaled. Do not breathe vapors
or spray mist. Avoid contact with skin, clothing or eyes.
Causes moderate eye irritation."
25% WP
"PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
WARNING
May be fatal if swallowed or inhaled. Do not breathe dust or
spray mist. Causes moderate eye irritation. Avoid contact
with eyes, skin, or clothing."
42% Flowable
"PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
DANGER — POISON (skull and
crossbones)
Fatal if swallowed or absorbed through the skin. Do not
breathe spray mist. Do not get in eyes, on skin, or on
clothing. Wash thoroughly with soap and warm water after
handling. Wash contaminated clothing with soap and hot water
before use."
1% .0.5% D
"PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION
Harmful if swallowed, inhaled, or absorbed through skin.
Avoid breathing dusts. Avoid contact with eyes, skin, and
clothing."
5% D
"PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
WARNING
May be fatal if swallowed, inhaled or absorbed through the
skin. Avoid contact with skin or eyes. Avoid breathing
dusts."
10. For the liquid formulations, the following STATEMENT OF
PRACTICAL TREATMENT is required:.
"STATEMENT OF PRACTICAL TREATMENT
31
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If swallowed - Call a physician or Poison Control Center
immediately. If possible, vomiting should be induced under
medical supervision. Drink one or two glasses of water and
induce vomiting by touching the back of throat with finger.
Do not induce vomiting or give anything by mouth to an
unconscious person.
If inhaled - Remove victim to fresh air. Apply artificial
respiration if indicated. Get medical
attention if victim displays signs of
poisoning.
If on skin - Remove contaminated clothing and wash affected
areas with soap and water.
If in eyes - Flush eyes with plenty of water. Call a
physician immediately."
11. For the dust and wettable powder formulations, the
following STATEMENT OF PRACTICAL TREATMENT is required:
"STATEMENT OF PRACTICAL TREATMENT
If swallowed - Call a physician or Poison Control Center
immediately. Drink one or two glasses of water
and induce vomiting by touching the back of throat
with finger. Repeat until vomit fluid is clear.
Do not induce vomiting or give anything by mouth to
an unconscious person.
If inhaled - Remove victim to fresh air. Apply artificial
respiration if indicated. Get medical attention
if victim displays signs of poisoning.
If on skin - Remove contaminated clothing and wash affected
areas with soap and water.
If in eyes - Flush eyes with plenty of water. Call a
physician immediately."
11. Revised labeling must be submitted for those products
which do not contain directions for use specifying a maximum
single application rate expressed in terms of: (1) amount of
active ingredient per animal; (2) a maximum seasonal
application rate or number of applications permitted per
season; and (3) a minimum interval between applications,
revised labeling must be submitted.
32
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VI. PRODUCTS SUBJECT TO THIS STANDARD
All products containing the pesticide identified in
Section II.A. are subject to certain requirements for data
submittal or changes in composition, labeling or packaging of
the product. The applicable requirements depend on whether
the product is a manufacturing use product or an end use
product.
All products are subject to this Registration Standard
as follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient or in combination with another
active ingredient(s) are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to
the manufacturing use product.
2. The data requirements listed in Tables A and B .
3. The labeling requirements specified for
manufacturing use products in Section V.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
C. End use products containing this pesticide as the sole
active ingredient or in combination with another active
ingredient(s)are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption , the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section V.
33
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VII. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the
registration of products containing this active ingredient.3
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 resppnsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 40 CFR 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is
complying with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer
in compliance with this data requirements notice, the Agency
will consider that both they and you are not in compliance
and will normally initiate proceedings to suspend the
registrations of both your product(s) and their product(s)
unless you commit to submit and submit the required data in
the specified timeframe. In such cases, the Agency generally
will not grant a time extension for submitting the 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
34
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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 requirement
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also
provide EPA with documentary evidence that an agreement has
been formed which allows you to rely upon the data to be
submitted. Such evidence may be: (1) your letter offering to
join in an agreement and the other registrant's acceptance of
your offer, (2) a written statement by the parties that an
35
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agreement exists, or (3) a written statement by the person
who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom EPA will
correspond concerning the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of
the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittal by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the DCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
36
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[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 sec.
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 requirement applies, EPA does not anticipate that
many waivers will be granted. A request for waiver does not
extend the time-frames for developing required data, and if
your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the
registration of your product (s) for which the data are
37
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needed.
E. Registrant Requests Regarding Data Requirements and .
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 requi^d 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
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.
38
:*.
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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.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting ("or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR Notice 86-5
(issued July 29, 1986). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
39
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J. Existing stocks provision upon suspension or
cancellation
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the
. egistrant 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.
40
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VIII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your
registrations in effect. Product-specific data are derived
from testing using a specific formulated product, and, unlike
generic data, generally, support only the registration of that
product. All such data must be submitted by the dates
specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for
generic data. See Section VII. You should note, however,
that product chemistry data are required for every product,
and the only acceptable responses are: 1) submit data; or 2)
cancellation of registration.
Failure to comply with the product-specific data
requirements for your products will result in suspension of
the product's registration.
41
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IX. 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 Registration Standard. Responses to this
Registration Standard must include draft labeling for Agency
review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the
intended colors of the final label, clear indication of the
front panel of the label, and the intended type sizes of the
text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section V, EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
42
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X. INSTRUCTIONS FOR SUBMITTAL
All submittal in response to this Registration Standard
must be sent to the following address:
Document Processing Desk RS-CASE 0018
Office of Pesticide Programs H7504C
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Coumaphos Registration Standard
A. All Manufacturing Use Products (MUPs) - Sole Active
Ingredient and Multiple Active Ingredient
1. Within 90 days from receipt of this document,
you must submit for each product subject to this
Registration Standard:
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
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to
40 CFR 152.80-152.99.
2. Within 1 Year from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Three copies of any required product-specific
data (See Table B).
c. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
43
f
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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.
B. End Use Products Containing the Subject Pesticide as
Sole Active Ingredient. or in Combination With Another
Inaredient(s). "
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 i Year from receipt of this document you must
submit:
a. Three copies of any product-specific data, if
required by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Five copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible
for the generic data exemption. If for any reason
any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Agency of the
problem, the reasons for the problem, and your
proposed course of action.
44
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I. DATA APPENDICES
45
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TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements for
the pesticides covered by this Registration Standard.
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.
R contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158. The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information service,
5285 Prot 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 cc lumn 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
-------
TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA' have data? (Column 4).- This column indicates one
of three answers:
YES - EPA has data in its files that completely satisfy
this data requirement. These data may be cited by
other registrants in accordance with data compensation
requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such
data do not fully satisfy the data requirement. In
some cases, the Agency may possess data on one of two
required species or may possess data on one test
substance but not all. The term may also indicate that
the data available to EPA are incomplete. In this
case, when the data are clarified, or additional
details of the testing submitted by the original data
submitter, the data may be determined to be acceptable.
If this is the case, a footnote to the table will
usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional
information.
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 e 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
47
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TGUIDE-3
have the data, EPA will not require its submission because of the
unique characteristics of the chemical; because data on another
chemical can be used to fulfill the data requirement; or because
the data requirement has been waived or reserved. Any such
unusual situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column t requires
that.data be submitted, this column indicates when the data are
to be submitted, based on the issuance date of the Registration
Standard. The timeframes are those established either as a
result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
'9 48
.'2'-
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49
Table A
Generic Data Requirements for Coumaphos
Test
tData Requirement Substance
Part 158 , Subpart C - Product Chemistry
Product Identity and Composition
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data
Submission
61-2 - Beginning Materials and
Production Process
TGAI
Partially
61-3 - Formation of Impurities TGAI Partially
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis TGAI Partially
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density,
or Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Yes
Yes
Yes
Yes
Yes
00110596
00110596
00110596
00110596
00110596,00021999
00110596
00110596,00021999
00021981
00110596
Yesl/
NO
NO
No
Mb
No
NO
1 Year
1 Year
2 Years
63-8 - Solubility
TGAI or PAI
Yes
00110596
NO
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50
Table A
Generic Data Requirements for Coumaphos (cont'd)
Data Requirement
Does -EPA
Have Data to
Test Satisfy This
Substance Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data
Submission
Part 158, Subpart C - Product Chemistry (cont'd)
Physical and Chemical Characteristics (cont'd)
63-9 - Vapor Pressure TGAI or PAI
63-10 - Dissociation Constant TGAI or PAI
PAI
63-11 - Octanol/Water Partitioning
Coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Other Requirements
64-1 - Submittal of Samples TGAI
Yes
No
No
Yes
Partially
No
00005193
00110596
00021981,00141225
No
Yes4-/
No
Yes^/
1 Year
1 Year
1 Year
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51
Table A
Generic Data Requirements for Coumaphos (cont'd)
Part 158, Subpart C - Product Chemistry Footnotes
I/Tor the 90% T (EPA Registration No. 11556-11), the following information must be provided: (i) a description of
the procedures used to assure consistent composition of the substance produced (quality control methods); (ii) the
name and address of the producer of each starting material and information concerning its composition; (iii) a
flow chart of the chemical equations of each intended reaction occurring at each step of the process and of the
entire process; and (iv) a description of any purification procedures (including procedures to recycle starting
materials, intermediates or the substance produced).
2/For the Bayvet 90% T (EPA Registration No. 11556-11), a discussion regarding the origin of the following potential
impurities must be provided: the possible degradation of ingredients in the product after production,
postproduction reactions between the ingredients in the product, possible contamination from packaging materials
or production equipment, and process control, purification, and quality control measures.
3_/Five or more representative samples must be analyzed for the amount of active ingredient and each impurity present
at 0.1% or greater. If the product is produced by a batch process, five separate batches should be represented in
preliminary analyses. 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. Based on the preliminary analysis, a statement of the composition
of the technical grade and active ingredient must be provided.
4/As required by 40 CTR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D,
Guidelines Reference Nos. 63-2 through 63-13, data must be submitted on physicochemical characteristics
(dissociation constant, octanol/water partition coefficient, and stability). There are additional data
requirements listed in Table B pertaining to physicochemical characteristics of those technical products which are
also manufacturing-use products.
5/Data on octanol/water partition coefficient are required if the technical chemical is organic and nonpolar.
6,/If samples are needed, the Agency will request them.
-------
52
Table A
Generic Data Requirements for Coumaphos
Data Reouirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2HB)?
Timeframe
For Data
Submission
158.240 - Residue Chemistry
171-4 - Nature of the Residue
(Metabolism)-Plants
171-4 - Nature of the Residue
(Metabolism) -Animals
171-4 - Residue Analytical
Methods
171-4 - Storage Stability Data
171-4 - Magnitude of Residue in
Plants
PAIRA and
Plant
Metabolites
PAIRA and
Plant
Metabolites
N/A
Partially
TGM and Partially
Metabolites
TEP and Partially
Metabolites
N/A
00005392,00005402,
00005450,00005454,
05004087,05004483,
05012748
00005195,00005289,
00005342 ,'00005438
00005341,00073248
Yes2/
1 Year
1 Year
1 Year
-------
53
Table A
Generic Data Requirements for Coumaphos (cont'd)
Does EPA
Have Data to
Test Satisfy This Bibliographic
Data Reouirement Substance Reouirement? Citation
158.240 - Residue Chemistry
171-4 - Magnitude of Residue in TGAI and Partially 00005042,00005047,
Meat and Milk Plant 00005048,00005051,
Metabolites 00005056 ,00005074 ,
00005080,00005081,
00005082,00005235,
00005293,00005295,
00005330,00005331,
00005333,00005339,
00005393,00005399,
00005400,00005441,
00005447,00005448,
00005451,00005453,
00005456,00005479,
00005480,00005483,
00005485,00005489,
00005493,00005510,
00005822,00005830,
00005832,00005833,
00005834,00021731,
00021732,00060807
Must Additional
Data Be Submitted Timef rame
Under FIFRA Section For Data
3(c)(2)(B)? Submission
Reserved^/
-------
54
Table A
Generic Data Requirements for Coumaphos (cont'd)
Sec. 158.240 Residue Chemistry Footnotes
I/Metabolism studies, conducted using t C] -benzene-ring labeled coumaphos and characterizing total terminal residue of
coumaphos in ruminants are required. Animals must be dosed dermally with [14C] -benzene-ring labeled coumaphos at
levels sufficient to make residue identification and quantification possible. Milk must be collected twice a day
during the dosing period, and test animals must be sacrificed within 24 hours of the final dose. The distribution
and identities of residues must be determined in milk, liver, kidney (ruminants only), muscle, and fat.
Representative samples from the required metabolism studies must also be analyzed using a suitable confirmatory method
such as MS or HPLC, and using accepted enforcement methods to ascertain that these methods will recover and quantify
all metabolites of concern. Should the metabolism of coumaphos in ruminants and/or poultry differ significantly from
that in rats, swine metabolism data may also be required.
2/Representative animal tissue samples bearing residues of coumaphos and its oxygen analog must be subjected to
multiresidue protocol III from PAM Vol. I, Appendix II. Multiresidue protocols I to IV are available from the
National Technical Information Service under Order No. PB 203734/AS. The nature of the residues in animals is not
understood. If the metabolism studies requested in the section "Qualitative Nature of the Residue in Animals" reveal
the presence of additional metabolites of concern, additional validated methods for data collection and tolerance
enforcement will be required.
3./The sample storage conditions and intervals must be supplied for all required and previously submitted residue data
for animal commodities. Storage stability data in support of previously submitted residue data are required for only
those samples deemed to be useful for tolerance assessment. Data are also required which depict the decline in levels
of coumaphos residues of concern in commodities stored under the range of conditions and for the range in intervals
specified. Fortified meat samples must be analyzed immediately after harvest or fortification and again after
storage intervals that represent actual residue sample storage conditions and allow for reasonable unforeseen delays
in sample analysis. In laboratory tests using fortified samples, the pure active ingredient and pure metabolites must
be used. 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 NITS under Order
NO. PB 88112362/AS.
4/The qualitative nature of the residue in animals is not adequately understood; therefore, the adequacy of the
available data pertaining to residues of coumaphos and its oxygen analog in meat and milk cannot be ascertained. On
receipt of the requested metabolism data, the adequacy of the established tolerances will be determined. If these
studies reveal the existence of additional residues of toxicological concern, additional data may be required.
-------
55
Table A
Generic Data Requirements for Coumaphos
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission
158.290 - Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradat ion
161-2 - In Water
161-3 - On Soil
161-4 - In Air
MEIM3QLISM STUDIES - LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
TGAI or PAIRA I
TGAI or PAIRA I
TGAI or PAIRA I
TGAI or PAIRA N/A
TGAI or PAIRA N/A
TGAI or PAIRA N/A
TGAI or PAIRA N/A
TGAI or PAIRA N/A
NO
NO
NO
NO
1 Year
1 Year
1 Year
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56
Table A
Generic Data Requirements for Coumaphos (cont'd)
Does EPA Must Additional
Have Data to Data Be Submitted Timef rame
Test Use Satisfy This Bibliographic Wider FIFRA Section For Data
Data Reouirement Substance Pattern Reouiremant? Citation 3(c)(2)(B)? Submission
158.290 - Environmental Fate (cont'd)
MOBILITY STUDIES;
163-1 - Leaching and Adsorption/ TGAI or PAIRA
Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
DISSIPATION STUDIES - FIELD;
164-1 - Soil TEP
164-2 - Aquatic (Sediment) TEP
164-3 - Forestry TEP
164-4 - Combination and Tank TEP
Mixes
164-5 - Soil, Long-Term TEP
ACCIMJIATiasr STUDIES;
165-1 - Rotational Crops PAIRA
(Confined)
165-2 - Rotational Crops TEP
I Partially 00163806 Yes^/ 2 Years
N/A
N/A
N/A No No5-/
N/A
N/A
N/A
N/A
N/A
N/A
-------
57
Table A
Generic Data Requirements for Coumaphos (confd)
Data Requirement
Test
Substance
Use
158...29Q Environmental Fate (cont'd)
ACCUMULATION STUDIES; (cont'd)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 In Nbntarget Organisms
158.440 Sorav Drift
201-1 Droplet Size Spectrum
201-1 Drift Field Evaluation
158.75 - Other
Groundwater Monitoring
TEP
TGAI or EAIRA
TEP
TEP
TEP
TEP
N/A
N/A
N/A
N/A
N/A
Does EPA
Have Data to
Satisfy This
Requirement?
No
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c) (2) (B)? Submission
No
Yes2/
-------
58
Table A
Generic Data Requirements for Coumaphos (cont'd)
Data Reouirement
Does EPA
Have Data to
Test Use Satisfy This
ance Pattern Requirement?
158.140 - Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
TEP
TEP
TEP
TEP
40 CFR 158.75 Applicator Exposure Monitoring
231 - Estimation of Dermal
Exposure
- Indoor Site TEP
232 - Estimation of Inhalation
Exposure
- Indoor Site TEP
233 - Estimation of Dermal
Exposure
- Indoor site TEP
N/A
N/A
N/7V
N/A
No
No
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(C) (2) (B)?
NO
'Reserved^/
Reserved^/
Reserved^/
-------
59
Table A
Generic Data Requirements for Coumaphos (cont'd)
Sec. 158.290 and 158.390 Environmental Fate Footnotes
I/Die 1981 Standard required submission of a hydrolysis study. This study was reviewed and found to be inadequate due to
design and reporting flaws. Normally no study is required because of coumaphos's general indoor use pattern (CFR 40
Part 158.290, App. A, Use Pattern Index). However, because point source contamination might arise at animal
treatment sites, this study is required in order to evaluate the potential of coumaphos to impact on ground or
surface water.
2/Nbrmally no study is required because of coumaphos's general indoor use pattern (CFR 40 Part 158.290, App. A, Use
Patternlndex). However, because point source contamination might arise at animal treatment sites, this study is
required in order to evaluate the potential of coumaphos to impact on ground or surface water. Due to recurring
problems that other registrants have encountered in interpreting this guideline, the registrant for coumaphos
should submit a protocol before initiating the two studies. Among the issues that the registrant should be
advised of are the following: 1) in a soil photodegradation study where microbial degradation is significant
(i.e., on soil), continuous (24 hour) exposure to an artificial light source will invalidate the results; 2) a
comparison must be made between any artificial light source and natural light (in terms of intensity, spectral
distribution, and exposure time).
3/The 1981 Coumaphos Registration Standard required submission of an aerobic soil metabolism study. The study
submitted (MRID 4018701) was reviewed and found to be inadequate due to design and reporting flaws. However,
the Agency has determined that this study is not needed to support coumaphos's indoor use pattern.
4/Normally no study is required because of coumaphos's general indoor use pattern (40 CFR Part 158.290, App. A.
Use Pattern Index). However, because point source contamination might arise at animal treatment sites, this
study is required in order to evaluate the potential of coumaphos to impact on ground or surface water. This
study must be conducted according to the guideline for a batch equilibrium adsorption/desorption study using
the parent and two major degradates, chloroferone and HQL 5461, as test substances.
5/A study submitted (MRID 00115166) was reviewed and determined to be unacceptable due to design and reporting
flaws. This study is not required to support the presently registered use.
-------
60
Table A
Generic Data Requirements for Coumaphos (cont'd)
Sec. 158.290 and 158.390 Environmental Fate Footnotes
cont'd
5/The 1981 Coumaphos Registration Standard required submission of a fish accumulation study. The study submitted (MRID
00115168, 00150619) was reviewed and found to be inadequate due to design and reporting flaws. However, the Agency has
determined that this study is not needed to support coumaphos's indoor use pattern.
2/Because point source contamination might arise at animal treatment sites, this study is required in order to
evaluate the potential of coumaphos to impact on ground or surface water. This study is intended as a
retrospective study to assess the dissipation of coumaphos under typical use conditions.
The protocol for this field study should be designed to retrospectively evaluate the dissipation of coumaphos
at a minimum six major use areas in the continental United States including at least one site involving a
sandy soil over a shallow water table. The study should also include analysis of water samples from nearby
existing wells. Core samples from these use sites must be measured to a depth to fully define the extent of
leaching of the parent and major degradates.
Prior to initiating this special study, the registrant should conduct a briefing for the staff of EFGWB
discussing the actual use practices for application and disposal of coumaphos, the sites proposed for
retrospective investigation and provide a draft protocol for branch review. Further testing is
reserved pending results of the retrospective study.
S/The Agency will evaluate occupational and nonoccupational exposure data requirements upon submission and
review of the toxicology data.
-------
61
Table A
Generic Data Requirements for Coumaphos
Data
158
Requirement
.340 - Toxicoloqv
Test
Substance
6
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
tinder FIFRA Section
3(c)(2)(B)?
Timeframe
For Data
Submission
ACUTE TESTING
81-1
81-2
- Acute Oral - Rat
- Acute Dermal - Rat
TGAI
TGAI
I
I
Yes
Yes
00110597
00110598
No
No
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
TGAI
TGAI
TGAI
TGAI
Yes
Yes
Yes
Yes
00110601
00110599
00110600
00110602
No
No
No
NO
- Hen
TGAI
Yes
00115167
NO
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62
Table A
Generic Data Requirements for Coumaphos (cont'd)
Data
158.
Requirement
340 - Toxicoloav (cont'd)
Test
Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Reouirement?
Mist Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3(cH2)(B)? Submission
suBCHRasnc TESTING »
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding
- Rodent
- Nbnrodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation
- 90-Day Neurotoxicity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
I
I
I
I
I
I
No
No
No
N/A
N/A
N/A
Nb™'
Nb*'
Yes3-/ i Year
83-1 - Chronic Testing
- Rodent
- Nbnrodent
TGAI
TGAI
I
I
Yes
No
40836001
No
Yes^/
4 Years
(12 Months -
Progress
Report -
Semi annually
thereafter)
-------
63
Table A
Generic Data Requirements for Coumaphos (cont'd)
Data Requirement
158.340 - Toxicolooy (cont'd)
SUBCHRCMIC TESTING (cont'd)
83-2 - Oncogenicity
- Rat
- Mouse
CHRONIC TFHL'JJlG
83-3 - Teratogenicity
- Rat
- Mouse
Does EPA
Have Data to
Test Use Satisfy This
Substance Pattern Reouirement?
TGAI I Yes
*
TGAI I Yes
TGAI I Yes
TGAI I Yes
Must Additional
Data Be Submitted
Bibliographic Ifiider FIFRA Section
Citation 3(c)(2HB)?
40836001 , 05009938 No
05009938 NO
00131684 NO
00131683 NO
Timeframe
For Data
Submission
83-4 - Reproduction
- 3-Generation
TGAI
No
Yes5/ 4 Years
(12 Months -
Progress
Report;
Semiannually
thereafter)
-------
64
Table A
Generic Data Requirements for Coumaphos (cont'd)
Data Requirement
Test
Substance
Use
Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timeframe
For Data
Submission
158.340 - Toxicology (cont'd)
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI I Yes 00131680 No
84-2 - Chromosome Aberration TGAI I No Yes6-/ 1 Year
84-4 - Other Mechanisms of
of Mutagenicity TGAI I Yes 00131681 No
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA I Yes 01155611 No
85-2 - Domestic Animal Safety Choice I Yes 00138251 No?/
I/This study is not required since an adequate chronic toxicity/oncogenicity study in rats has been submitted.
2/A chronic feeding study in dogs is required and supercedes the requirement for a 90-^day feeding study.
JEhis study is required since the use of coumaphos (especially with dust bag applications when charging and recharging the
bags) may result in dermal contact.
4/The Agency overlooked the requirement for a dog chronic toxicity study in the 1981 standard.
5/Although this requirement was waived in 1984, the Agency now believes a reproduction study is needed in order to provide
information on the effects of the test substance on the gonadal function, estrous cycles, mating behavior, conception,
parturition, lactation, weaning, and growth and development of the offspring.
fz/The micronucleus study (MRID 00131682) is no longer considered valid since the test substance did not induce toxic
effects in mice and only one dose level was tested.
J/Domestic animal safety testing on horses; used to support the 42% flowable concentrate (EPA reg. No. 11556-98).
-------
65
Table A
Generic Data Requirements for Coumaphos
Data
158.
Requirement
490 - Wildlife and Aouatic
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
- Avian Oral 11)50
- Avian Dietary IJCso
a. Waterfowl
b. Upland Game Bird
- Wild Mammal Toxicity
- Avian Reproduction
a. Waterfowl
b. Upland Game Bird
Test
Substance
Organisms
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA
Have Data to
Use Satisfy This Bibliographic
Pattern Requirement? Citation
I Yes 00160000
I Yes 00022923
Yes 00022923
N/A
N/A
N/A
Must Additional
Data Be Submitted Timef rame
Under FIFRA Section For Data
3(c)(2HB)? Submission
No
No
No
71-5 - Simulated or Field Testing
Birds and Mammals
TEP
No
Yesl/
3 Years
(Acceptable
Protocol-
90 Days)
-------
66
Table"" A
Generic Data Requirements for Coumaphos (cont'd)
Data
158.
Requirement
Test
Substance
490 - Wildlife and Aouatic Oraanisms (cont
Does EPA
Have Data to
Use Satisfy This Bibliographic
Pattern Reouirement? Citation
'd)
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission
AQUATIC ORGANISM TttbTJJJG
72-1
72-2
72-3
.
72-4
72-4
- Acute Toxicity Freshwater
a. Warmwater
b. Coldwater
- Acute LCso Freshwater
Invertebrates
- Acute LC50 Estuarine
- Fish
- Shrimp
- Mollusk
- Fish Early Life Stage
- Aquatic Invertebrate Life
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TGAI
I Yes 40098001
N/A
I Yes 40098001
N/A
Yes 05009242
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
No
No
No
Cycle
-------
67
Table A
Generic Data Requirements for Coumaphos (cont'd)
Does EPA Most Additional
Have Data to Data Be Submitted Timef rame
Test Use Satisfy This Bibliographic Under FIFRA Section For Data
Requirement? Citation 3(c)(2)(B)?
158.490 - Wildlife and Aquatic Organisms (cont'd)
72-5 - Fish Full Life Cycle TGAI N/A
72-6 - Aquatic Organism
72-7 - Simulated or Actual TEP N/A w"
Field Testing Aquatic
Organisms
Special Testing Requirements
70-1 Monitoring - Aquatic TEP I No Yes^/ 3 Years
Invertebrates and Residues (Acceptable
Protocol-
90 Days)
I/ Field testing for avian effects is required to support the livestock use. This testing involves multiple field (>8)
treatment and searching for dead birds. For design guidance, see Terrestrial Field Studies Guidance Document
(Fite, et. al. 1988). The registrant must submit a protocol within 90 days and complete the testing and submit a final
, report within three years. The livestock must be treated with 0.04 Ib a.i./lOO Ib. At least 100 head of cattle must
be treated at each of the eight sites. Sites must be chosen where a large number of birds regularly feed on and annoy
treated cattle. Samples of hair and insects from the backs of cattle should be monitored.
2/ Monitoring of aquatic invertebrate mortality and residues must be conducted for the direct animal treatment use on
livestock.
-------
68
Table A
Generic Data Requirements for Coutnaphos^
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Pattern Requirement?
Bibliographic
Citation
Most Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission
158.540 - Plant Protection Testing
MOSflARGEr AREA PHYTQTOXICITY
TIER I
122-1 - Seed Germination/Seedling
Emergence
'2-l - Vegetative Vigor
122-2 - Aquatic Plant Growth
- Algae Testing
- Vascular Plants
TIER II
123-1 - Seed Germination/Seedling
Emergence
123-2 - Aquatic Plant Growth
- Algae Testing
- Vascular Plants
TIER III
124-2 - Terrestrial and Aquatic
Field Studies
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
N/A
N/A
N/A
N/A
N/A
TEP
N/A
N/A
N/A
-------
69
Table A
Generic Data Requirements for Coumaphos
Does EPA. Must Additional
Have Data to Data Be Submitted Timef rame
Test Use Satisfy This Bibliographic Under FIFRA Section For Data
Data Requirement _ Substance Pattern Requirement? Citation _ 3(c)(2)(B)? _ Submission
158.590 - Nbntarget Insects
INSECT TESTING - pnr.T;n\|ArTX3RS
141-1 - Honey Bee Acute Toxicity TGAI N/A
141-2 - Honey Bee - Toxicity of TEP N/A
Residues on Foliage
141-4 - Honey Bee Subacute Feeding TEP N/A
Study
141-5 - Field Testing for TEP N/A
' Pollinators
KENIARGET INSECT TESTUSE - AQUATIC INSECTS
142-1 - Acute Toxicity to Aquatic N/A
Insects
142-2 - Aquatic Insect Life Cycle N/A
Study
142-3 - Simulated or Actual Field N/A
Testing for Aquatic Insects
EOnARGET INSECT TESTTM3 - PRFTWTTIRS AND PARASITES
143-1 N/A
thru
143-3
-------
70
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Coumaphos
Test
Data Requirement Substance
Part 158 . Subcart C - Product Chemistrv
Product
61-1 -
61-2 -
Identity and Composition
Product Composition
Beginning Materials and
Production or
Formulation Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
62-1 -
62-2 -
62-3 -
Physical
63-2 -
63-3 -
Preliminary Analysis
Certified Limits
Enforcement Analytical
Methods
. and Chemical Characteristics
Color
Physical State
MP
MP
Does EPA
Have Data to
Satisfy This Bibliographic
Reouirement? Citation
Partially 00110596
Partially 00110596
MP Partially 00110596
Inoredients
MP
MP
MP
MP
MP
Partially 00110596
Partially 00110596
Yes 00110596
Yes 00110596
Yes 00110596
Must Additional
Data Be Submitted Timef rame
Under FIFRA Section For Data
3(c)(2)(B)? Submission
YesV
Yes2/
Yes3-/
Yes^/
Yes5-/
Yes6/
No
No
1 Year
1 Year
1 Year
2 Years
2 Years
2 Years
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71
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Coumaphos (cont'd)
Data I
Part ]
Physic
62-4
63-7
63-12
62-14
62-15
63-15
63-17
63-18
63-19
63-20
Test
Requirement Substance
L58. SubDart C - Product Chemistrv (cont
:al and Chemical Characteristics
- Odor
- Density, Bulk Density
or Specific Gravity
-EH
- Oxidizing or Reducing
Action
- Flamnability
- Explodabilty
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Satisfy This Bibliographic Under FIFRA Section For Data
:'d)
Yes 00110596 , No
Yes 00110596 NO
Yes 00110596 No
jjo yes7 « 8/
No No9/
Mr\ Vac* / a JLJL/
LvLJ •*• Cij •••n™1™'
Partially 00110596,00117974 Yes7-/
.No Nblfi/
No Nol2/
No Yes7-/
1 Year
2 Years
1 Year
2 Years
2 Years
-------
72
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Coumaphos (cont'd)
Data Requirement
Does EPA
Have Data to
Test Satisfy This
Substance Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(0 (2MB)?
Timeframe
For Data
Submission
Part 158. Subpart C - Product Chemistry (cont'd)
Analysis and Certification of Product Ingredients (cont'd)
Other Requirements
64-1 - Submittal of Samples No
-------
73
Table B
Generic Data Requirments for Coumaphos (cont'd)
Part 158r Subpart C - Product Chemistry Footnotes
v;; l/£or the Bayvet 90% T (EPA Registration^). 11556-11) certified limits in accordance with section 158.175 and
-•*'- nominal concentrations for the active ingredient and each impurity, and the chemical name of each impurity. For
the Bayvet .25% FI (EPA Registration No. 11556-20), the chemical/common name and CAS Registry Number of each inert
ingredient in the product.
2/For the 90% T (EPA Registration No. 11556-11), the following information must be provided: (i) a description of
the procedures used to assure consistent composition of the substance produced (quality control methods); (ii)
the name and address of the producer of each starting material and information concerning its composition; (iii)
a flow chart of the chemical equations of each intended reaction occurring at each step of the process and of the
entire process; and (iv) a description of any purification procedures (including procedures to recycle starting
materials, intermediates or the substance produced). For the 25% FI the following information must be provided:
(i) the name and EPA Registration Number of the EPA-registered product and information concerning the identity of
each inert ingredient; (ii) a description of the conditions (e.g., temperature, pressure, pH, humidity) that are
controlled during each step of the process; and (iii) a description of the procedures used to assure consistent
composition of the substance produced (quality control methods).
3/For the Bayvet 90% T (EPA Registration No. 11556-11), a discussion regarding the origin of the following
potential impurities must be provided: the possible degradation of ingredients in the product after production,
postproduction reactions between the ingredients in the product, possible contamination from packaging materials
or production equipment, and process control, purification, and quality control measures. For the Bayvet 25% FI
(EPA Registration No. 11556-20), a discussion must be provided for each impurity associated with the active
ingredient which the registrant has reason to believe may be present in the product at a level equal to or
greater than 0.1% (w/w) based on the possible carryover of impurities present in the registered product which
serves as the source of the active ingredient, the possible carryover of impurities present in the inert
ingredients in the product, possible reactions occurring during the formulation of the product, postproduction
reactions between any of the product's active ingredients and any other component of the product or its
packaging, and possible contamination from packaging materials or production equipment.
4/For each manufacturing-use product produced by an integrated system, the registrant must provide preliminary
analyses of five or more representative samples of the each technical grade of the active ingredient (TGAI)
contained in the product to identify all impurities present at 0.1% or greater of the TGAI. If the product is
produced by a batch process, at least five separate batches should be represented. The preliminary analysis
should be conducted at the point in the production process after which no further chemical reactions designed to
produce or purify the substance are intended. Complete and detailed descriptions of the methods used for sample
analysis must be submitted, including a statement of their precision and accuracy. The preliminary analysis 1
-------
74
Table B
Generic Data Requirments for Coumaphos (cont'd),
Part 158. Subpart C - Product Chemistry Footnotes (cont'd)
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. Based on the preliminary analysis, a
statement of the composition of the TGAI must be provided.
5/For the Bayvet 90% T (EPA Registration No. 11556-11) the registrant must provide an explanation as to how the
proposed upper and lower certified limits for the active inert ingredient were established (e.g., sample analysis
using a validated analytical procedure, quantitative estimate based on the amounts of ingredients used, etc.),
since these limits differ from the standard certified limits determined by the Agency according to 40 CFR
158.175(b)(2). For the 25% FI (EPA Registration No. 11556-20) the registrant must submit a statement of
agreement that the certified limits of the ingredients will be maintained. The registrant must propose certified
limits for ingredients in the 25% FI if those limits would differ from those determined in accordance with 40 CFR
158.175(b)(2). Information on the accuracy and precision of any analytical procedures used must also be
provided. In addition, certifications must be submitted on EPA Form 8570-4 (Rev. 2/85).
5/Analytical methods which are suitable for enforcement purposes must be provided for each active ingredient and
each other ingredient or impurity that is determined to be toxicologically significant. Suitability of submitted
methods for enforcement purposes shall be determined from statements of method accuracy and precision which'must
be provided for the analytical methods submitted by Bayvet Corporation and described in MRID No. 00110596.
2/As required in 40 CFR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D,
Guidelines Reference Nos. 63-2 through 63-20, data must be submitted on physicochemical characteristics of each
manufacturing-use product (oxidizing or reducing action, explodability, storage stability, and corrosion
characteristics). Additional data requirements regarding physicochemical properties of manufacturing-use
products which contain only the TGAI are listed in Table A, "Generic Data Requirements for the Coumaphos
Technical Grade of the Active Ingredient."
5/Data are required on oxidizing/reducing potential' if the product contains an oxidizing or reducing agent.
2/Data are hot required on flammability since the products do not contain combustible liquids.
iQ/Data on viscosity are not required since the products are not liquids.
11/Data are required if the product is potentially explosive.
12/Data on miscibility are not required since the products are not emulsifiable liquids to be diluted with petroleum
solvents.
samples are needed, the Agency will request them.
-------
75
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Coumaphos
Data
Test
Reouirement Substance
158.340 - Toxicology
Does EPA
Have Data to
Satisfy This Bibliographic
Reouirement? Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Oral - Rat Mpi/
- Dermal MP
- Inhalation - Rat MP
- Primary Eye Irritation
- Rabbit MP
- Primary Dermal Irritation MP
- Dermal Sensitization MP
Yes
Yes
Yes
Yes
Yes
Yes
00110597
00110598
00110601
00110599
00110600
00110602
No
No
No
No
No
No
JL/Formulation intermediates are included in the category of manufacturing-use products.
-------
76
Table C
Product Specific Data Requirements for -End-Use Products Containing Coumaphos (25% WP)
Does EPA .
Have Data to
Satisfy This
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFPA Section For Data
Irritation
- Rabbit
81-5 - Primary Dermal TEP
Irritation - Rabbit
81-6 - Dermal Sensitization- TEP
Guinea Pig
Yes
Yes
00110606
00110608
Q^-yi
O\L>V_* •
158.340 Toxicology
Acute Testing
81-1
81-2
81-3
81-4
- Acute Oral - Rat TEP
- Acute Dermal Toxic ity TEP
- Rabbit
- Acute Inhalation
Toxicity TEP
- Rat
- Primary Eye TEP
I Yesw- 00110603 No
I Yes 00110604 No
I Yes 00110607 NO
I Yes 00110605 No
No
No
-------
77
Table C
Product Specific Data Requirements for End-Use Products Containing Coumaphos (11.6% EC)
Data Reouirement
Does EPA
Have Data to
Test Use Satisfy This
Must Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3(c) (2) (B)? Snhnyi ssion-
Sec.
158 . 340 Toxicology
...2V •
Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral - Rat TEP
- Acute Dermal Toxic ity TEP
- Rabbit
- Acute Inhalation
Toxicity TEP
- Rat
- Primary Eye TEP
Irritation
- Rabbit
- Primary Dermal TEP
Irritation - Rabbit
- Dermal Sensitization- TEP
I Yes 00112832 No
I Yes 00112833 No
w-
I Yes 00112836 NO
I Yes 00112834 No
I Yes ' 00112835 NO
I Yes 00112837 NO
Guinea Pig
-------
78
Table C
Product Specific Data Requirements for End-Use Products Containing Coumaphos (0.5%, 1% and 5% D)
Data Requirement
Test Use
Substance Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Must Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Submission-
Sec. 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
TEP
81-2 - Acute Dermal Toxicity TEP
- Rabbit
81-3 - Acute Inhalation
Toxicity TEP
..... - Rat
81-4 - Primary Eye TEP
Irritation
- Rabbit
81-5 - Primary Dermal TEP
Irritation - Rabbit
81-6 - Dermal Sensitization- TEP
Guinea Pig
I
I
Yes
Yes
Yes ,
Yes
Yes
Yes
00110609
00112816
00112820
00112818
00112817
00112819
NO
NO
NO
NO
NO
NO
NOTE: Data are not available for the 0.5% and 5% dust formulations. The toxicity categories assigned to the 0.5%
and 5% formulations are based upon data generated for the 1% formulation. If the registrant wishes to challenge
the classification of the 0.5% or 5% formulations, acute oral and inhalation studies must be submitted.
-------
79
Table C
Product Specific Data Requirements for End-Use Products Containing Coumaphos (3% Spray)
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Sec. 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
TEP
81-2 - Acute Dermal Toxicity TEP
- Rabbit
81-3 - Acute Inhalation
Toxicity TEP
- Rat
81-4 - Primary Eye TEP
Irritation
- Rabbit
81-5 - Primary Dermal TEP
Irritation - Rabbit
81-6 - Dermal Sensitization- TEP
Guinea Pig
I
I
Yes
Yes
Yes
Yes
Yes
Yes
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)?
00112821
00112822
00112825
00112824
00112823
00112826
NO
No
NO
NO
NO
NO
-------
80
Table C ,
Product Specific Data Requirements for End-Use Products Containing Coumaphos (4% Pour-On)
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Sutmission-
Sec. 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
TEP
81-2 - Acute Dermal Toxicity TEP
- Rabbit
81-3 - Acute Inhalation
Toxicity TEP
- Rat
81-4 - Primary Eye TEP
Irritation
- Rabbit
81-5 - Primary Dermal TEP
Irritation - Rabbit
81-6 - Dermal Sensitization- TEP
Guinea Pig
I
I
Yes
Yes
Yes
Yes
Yes
Yes
00112827
00112827
00112830
00112828
00112829
00112831
NO
NO
No
NO
No
NO
-------
81
Table C
Product Specific Data Requirements for Bid-Use Products Containing Coumaphos (42% Flowable)
Data Requirement
Test
Sec. 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
TEP
81-2 - Acute Dermal Toxicity TEP
- Rabbit
81-3 - Acute Inhalation
Toxicity TEP
- Rat
81-4 - Primary Eye TEP
Irritation
- Rabbit
81-5 - Primary Dermal TEP
Irritation - Rabbit
81-6 - Dermal Sensitization- TEP
Guinea Pig
Does EPA
Have Data to
Use Satisfy This
Patterns Re
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Submission-
I
I
I
I
I
I
Yes 00026376 ,00026377
00026379,00026371
Yes 00026375 ,00026378
00026372
Yes 00026374
Yes 00026370
Yes 00026373
Yes 00082524
NO
Nb
No
No
NO
Nb
82-2 - 21-Day Dermal Toxicity TEP
Yes
00117106
Nb
-------
82
Table C
Product-Specific Data Requirements for End-Use Products Containing Coumaphos
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
Timef rame
For Datal/
Submission
Part 158, Subpart C - Product Chemistry
Product Identity and Composition
61-1 - Product Identity and EP
Yes 1 Year
'Disclosure of Ingredients
61-2 - Description of Beginning EP
Materials and
Manufacturing Process
61-3 - Discussion of Formation of EP
Impurities
Yes
Les
Yes
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of EP
Product Samples
62-2 - Certification of EP
Ingredient Limits
62-3 - Analytical Methods to EP
Verify Certified Limits
Yes
Yes
Yes
00110596
00110596
00110596
00110596
00110596
00110596
No
NO
No
NO
No
NO
-------
83
Table C
Product-Specific Data Requirements for End-Use Products Containing Coumaphos (cont'd)
Data Requirement
Part '
Does EPA. Must Additional
Have Data to Data Be Submitted Timef rame
Test Satisfy This Bibliographic Under FIFRA, Section For Data
Substance Requirement? Citation 3(c)(2)(B)? Submission
L58 . SubDart C - Product Chemistry
Physical and Chemical Characteristics (cont'd)
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
62-14
62-15
63-16
63-17
63-18
- Color
- Physical State
- Odor
- Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
00110596
00110596
00110596
00110596
00110596
00110596
00110596
00110596
00110596,00117974
00110596
NO
NO
NO
No
No
NO
NO
NO
NO
NO
63-19 - Miscibility
EP
Yes
00110596
No
-------
84
Table C
Product-Specific Data Requirements for End-Use Products Containing Coumaphos (cont'd)
Data Requirement
Test
Substance
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
l&ider FIFRA Section
3(cH2HB)?
Timeframe
For Datal/
Submission
Part 158. Subtart C - Product Chemistry
Physical and Chemical Characteristics (cont'd)
63-20 - Corrosion Characteristics EP
Other Requirements
64-1 - Submittal of Samples N/A
Yes
00110596
NO
NOTE: Data contained in MRID 00110596 satisfies product-specific data requirements for end-use formulations
containing 3% spray, 4% pour-on, 11.6% EC, 42% flovable, 0.5% D, 1% D, 5% D, and 25% WP.
-------
II. LABELING APPENDICES
85
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will not
be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and.address of
the reg-istrant or distributor is required on the label. The
name and address should preferably be located at the bottom of
the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest
suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number mua^t be set in type of a size and style
similar to other print on that part of the' label on which it
appears and must run parallel to it. The registration number
and the required identifying phrase must not appear in such a
manner as to suggest or imply recommendation or endorsement of
the product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of the
package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or
container. [40 CFR 156.10(f)]
86
-------
SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR
156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
< • *
Item 7A. CHILD1 HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement.
[40CFR 156.10(h)(l)(i)].
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON.
[40 CFR 156.10(h)(1)(i)].
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A Statement Of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR 156.10(h)(1)(iii)]
87
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I56.l0(h)(l)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS.11 The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s)" of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on
the results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is used
in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA S6C. 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.
88
-------
SUMMARY-4
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed
classification determination will be evaluated in accordance
with the provisions of 40 CFR 162.11(c). You will be notified
of the Agency's classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 156.10(h)(1)(iv).
b. Directly below this statement on the front
panel, a summary statement of the terms of
restriction must appear (including the reasons for
restriction if specified in Section I). If use is
restricted to certified applicators, the following
statement is required: "For retail sale to and use
only by Certified Applicators or persons under
their direct supervision and only for those uses
covered by the Certified Applicator's
Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses
that are unrestricted, but you may not distinguish
them on the label as being unrestricted.
89
-------
SUMMARY-5
b. You may delete all restricted uses from your
label and submit draft labeling bearing only
unrestricted uses.
c. You may "split" your registration, i.e.,
register two separate products with identical
formulations, one bearing only unrestricted uses,
and the other bearing restricted uses. To do so,
submit two applications for reregistration, each
containing all forms and necessary labels. Both
applications should be submitted simultaneously.
Note that the products will be assigned separate
registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
90
-------
SUMMARY-6
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the
directions for use. This heading must be set in the same type
sizes as required for the child hazard warning. Refer to
Appendix II, STOR, PEST/DIS, and CONT/DIS to determine the
storage and disposal instructions appropriate for your
products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. [40
CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and
submitted for review.
91
-------
SUMMARY-7
LABELING REQUIREMENTS OF TOE FIFRA, AS AMENDED
VO
^ffjf^f
ITEM
1
2
„
3
4
5
6A
6B
7
7A
7B
i
..-
LABEL ET^WFWT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. Nb.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warnina)
Signal word
1
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage is
given as Ibs.
ai/unit area
All products
All products
All products
PLWFtyFWT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
CN LABEL
i EKhl'MHKP
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
immediately
before or
following
Rea. No.
Inmediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
;
cxMflBwrs
If registrant is not the producer, must
be qualified by "Packed for . . . ,"
"Distributed by . . . f" etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel tQ other typet
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
- .-:--#/»-
*.:• VW
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
i ,
-------
StMftRY-8
LABELING REQUIREMENTS OF THE FIFRAf AS AMENDED (cont'd)
Tmcm*
7C
7D
7E
8
8A
8B
y^RFJ. FT,fiWFTJr
Skull & cross-
bones and word
POISCN (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF RtJU^ I ^F^FTJT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT
REOUIp^n
Front panel
Category I;
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
CN LABEL
PPFTFPPF0
Both in close
proximity to
signal word
Front panel
for all
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
i 1
g •} ••&
Must be grouped under headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where arolicable.
VD
CO
-------
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M4CAUIIOMAIIV flAIIUCNII
HAIAH04 1O HUMAN!
<• OOMf•IIC AMUAUI
DAMMN
•MVMOMUtMfM. HAZAMO*
STORAGE AND
DISPOSAL
KTGJUA*
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CMOP:
RESTRICTED USE
PESTICIDE
_.. . (.reaaon for
«Mt ifcj TO MO W< 0
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OKMO ki IM curuito
PRODUCT
NAME
ACTVI MOMICMINf:
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WAHAAMIV tfAlKAMMt
-------
40 C5K Ch. I (7-1-37 Edition)
ISU
§ 8B.10 Labeling requirements.
(a) General—<1) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
96
-------
scribed in paragraph (b) of this s,ec-
uon;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section:
(iii) The net contents as prescribed
in paragraph (d) of this section:
(iv) The product registration
number as prescribed in paragraph (e)
of this section:
(v) The producing establishment
number as prescribed in paragraph (f)
of this section:
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pre-
scribed in paragraph (i) of this section:
and
(tx) The use ciassification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs^ or
graphic matter on the labeling) and
expressed in such terras as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type:
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
-protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car. tank truck or
other mobile or portable bulk contain-
er. a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. 'When pesticide prod-
ucts are stored in bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use. shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) false or misleading statements.
Pursuant to section 2(q)(lXA> of the
Act. a pesticide or a device declared
subject to the Act pursuant to
§ 162.15. is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pes-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(i) A false or misleading statement
concerning the composition of the
product:
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device:
(iii) A false or misleading statement
about the value of the product for
97
-------
162. tO
40 C?R Ch. I (7-1-37 Edition)
purposes oiher than as a pesticide or
device:.1
( iv ) A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous." "nomnjunous." "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed": and
(x) Non-numerical and/ or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed, labeling, (i) Except
as provided in paragraph (a)(6Xii) of
this section, final printed labeling
must be submitted and accepted pnor
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label. •
(2) No name, brand, or trademark
may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by ' * V or "Sold by to show-
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall he
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68* P (20'O
and shall be expressed in conventional
American units of fluid ounces, pints.
quarts, and gallons:
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units. i.e.. "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
98
-------
Environmental Protection Agency
registration shall appear on the label.
preceded by the phrase "EPA Regis'-
tration No.." or the phrase "EPA Reg.
jfo." The registration number shall be
set in type of a size and style similar to
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents: and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
-------
§ 162.10
40 CFR Ch. I (7-1-37 Edition)
the label: "Not for sale or use after
[date]."
(ii) The product must mee^all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warning* and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazard indicators
Oral LO......
| Tonetv categories
i i ii
UO to ana including £0
mg/kg.
innaiauon (.Cm. — Ue to ana inauamg 2
From JO trvu 500 mg/kg..
III 1 IV
From 500 tnru 5000 mg/
kg.
Greater man
kg.
Prom 2 tnru 2 mg/ liter — Prom 2. tnru 20 mg/iiter . Greater :nan
mg/ liter I
Dermal LD» .... Uo to and inducing 200 ' From 200 thru 2000 J From 2.000 tnru 20.000 ... Greater man
mg/kg. !
Eye efiecss ', Corrosro*; corneal
Skm effects
ooacny not reveroeie
•nrnn 7 days.
^~—t -tnuj
TJVTIW»TW -
Comeal ooaory
reverneie «intn 7
Says: mtation
perilling lor 7 flay*.
Severe imuuon at 72
i rtoun.
1
NO cemeal ooacity:
imtatan revernoie
•nrwi 7 oay*.
Moderate imuuon at 72
No irritation.
Mild or sugnt
hours. 72 nour*.
' 1 !
5000 Tig/
20 mg/ liter
20.000
irmaoofl at
(i) Human hazard signal word—(A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicty
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in "immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) •Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicant to be extremely remote.
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(Hi) Statement of practical treat-
ment—
-------
Environmental Protection Agency
§ 162.10
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
basis of oral, inhalation or dermal tox-
icity. The Agency may. however.
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (h)(l)(iii)(A) of
this section. The applicant may. how-
ever. include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Points
Sat of laow front oantl m souart Reomrtd
mcn«j signal
; woro. an
, caoiiais
5 ana urwtf ; 6
Abovt 5 to 10 10
ABOIM TO It) 15 , .„ .„.,
12
A**?** 15 10 30 .._.,.„ ,....,._...,. 1*
Q»Mr 30
18
"Kt«0 Out
of '«acn ot
eniiorei
6
6
8
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard :o Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hasard to humans and domestic
animals. (A) Where a hazard exists Co
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropnate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Tonotv
caitoory
Precautionary staitmwits ay tonoty category
I
Oral, innaianon. or otrmal towofy
ana «yt toeai tfltcw
(poisenaual rf iw«ilo»«q [mnaitd or aosorotd
tnrougn stun). Do net Drum* vaoor [Oust or lerav
mstl. Oo net 9«t in tyt*. on van. or on aetnmg
(From santt stattmtnt « pracacai treatment rt»
qwtd.1.
May ot fatal A swaiiowtd (mnaitd or attorotd
inrouon int stun). Oo not Drtatnt »aoors (oust or
spray rnsil. Oo net gtt « tyts. on skin, or on
doming. fAcorocnatt first aid stattmtnts rtourtd.].
Harmful if nraiiovtd (infiaMd or aosoroM tnrougn tnt'
sun]. Avoid attaining vapors (dust or spray mail.
A»oio comae: win smn [tycs or aemnq]. CAppr>
pnait first aid SUItmtnt rtouirta.l.
(N« pctcaubonary suitmtnts rtowrtd.]
Corroswt. taustt ty« and stun damaqt Cor sun
(ntaoonl. Oo not gtt in tyn. on sun. or on
emtntng.. W«ar goggtts or fact snwid and rviootr
omvta vntn Handling. Harmful or 'atai if swauowte.
CAoeroonatt first aid stattmtnt rtcuwed.l
Camtt «*t {and sun] irmation Oo not 9M in tyts.
on sun. or on oetnmg. Hvmru rf swauowtd. CAp-
proonatt tnt aid stattmtnt rtqurtd.1
Avoid contact witn sum. ty«s or dottwig. in cast of
contact tfnmtdiaitiy fhisn ty«s or sum «*iin pttnry of
Gtt mtcicai antntion if mutton ptrsists.
[No ortcauuonary stattmtnts rtourtd.]
(ii) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropnate precau-
tions to avoid potential accident.
injury or damage. Examples of the
101
-------
§ 162.10
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD« of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Pish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LD» of 100
mg/kg or less, or a subacute dietary
LC» of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
40 CFR Ch. I (7-1-37 Edition)
pesticide may result in fatality to
„• birds, fish or mammals, the statement
1 "This pesticide is extremely toxic to
wildlife (fish)" is required.
* (E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Fiasn po«*t'
Required text
(A) PtCSSumZEO
point n or awov 20* ?: if tnere i» a flasneact at Extreme-* flammaote Contents unoer pressure Keep it»ar *-om
r»e. spams. ana nested sunaces. Do not sunc-we or -nencriti
container Exposure to temperatures JDove 130* f may '-"•"
any var»e opening.
Fiasn pomt aoove 20* F ana not over SO* f or rf me ; Ramma-ne Content* under pressure. Keeo away from neat.
'lame extension ii more man ifl *> «nq at a aiiance i scarxs. and open (lame. Oo not puncture or .nenenjie esmarer
ot 6 .n irom tne name.
All otner pressurized containers..
Exposure to temoerarures afiove 130* f may ouise aunanq.
Contents under pressure. 3d not use or store near -
-------
Environmental Protection Ag«nc>jJiS>
lions for use may be omitted frbni-la-
beling of pesticides which are intended
for use only by manufacturers of prod-
ucts other than pesticide products* in
their regular manufacturing processes.
provided that:
(11 The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type
-------
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) [Reserved]
(£) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(P) Other pertinent information
which the Administrator determines
to-be necessary for the protection of
man and the environment.
ijl-Statement of Use Classification.
By October 22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (j) (1) and (2: of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s). both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of 5162.10(j)<2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use
-------
Criteria
PHYSICAL-CHEMICAL HAZARDS
*A
Reouired Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
C.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Oo not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame.
Do not use or store near
heat and open flame.
None required.
105
-------
STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Headinot
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement.of container within the storage area,
proper opening and^closing procedures (particularly for
opened containers),' and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
106
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I pr
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
^ "Pesticidefwastes are toxic. Improper disposal of excess
pesticide, 'spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only, must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
107
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T
-
CONT/DIS-l
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 }Do not reuse container (bottle, can, jar). ,
2(bottles, cans. 1ars)lRinse thorouahlv before discarding in trash.'
INon-aerosol products {Do not reuse bag,
Ilbaas)
Discard bag in trash.
{Aerosol products
{Replace cap and discard containers in
!trash. Do not incinerate ^r 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
'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,
istav 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 shaking and
{tapping sides and bottom to loosen clinging
{particles. Empty residue into application
{equipment. Then dispose of liner in a
{sanitary landfill or by incineration if
{allowed by state and local authorities.
{If drum is contaminated and cannot be
'reused^/, dispose of in the same manner.
Paper and
plastic bags
{Completely empty bag into application
,equipment. Then dispose of empty bag in
I 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).
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
108
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III. BIBLIOGRAPHY APPENDICES
109
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Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and
its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
\
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study." In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the
published article from within the typically larger volumes
in which they were submitted. The resulting "studies"
generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for a further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
110
-------
a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
identified, the Agency has shown an identifiable
laboratory or testing facility as author. As a
last resort, the Agency has shown the first
submitter as author.
b. Document Date. When the date appears as four
digits with no question marks, the Agency took it
directly from the document. When a four-digit
date is followed by a question mark, the
bibliographer deduced the date from evidence in
the document. When the date appears as (19??),
the Agency was unable to determine or estimate the
date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing Parentheses. For studies submitted to
the Agency in the past,, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately
following the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is
the registration number, experimental use
permit number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." When authorship is defaulted to the
submitter, this element is omitted.
Ill
-------
(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.
112
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.
4,
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos standard
MRID Citation
00005042 Chemagro Corporation (1971) Chemagro Corporation Residue Experiment
Nos. AH 70G-810, AH 71G-818: Report No. 30331. (Unpublished
study received Oct 29, 1971 under 11556-4; submitted by Bayvet,
Shawnee Mission, Kans.; CDL:010122-F)
00005047 Chemagro Corporation (1967) Chemagro Corporation Residue Experiment
No. KC-201-66D: Report No. 20652. (Unpublished study received
Dec 15, 1967 under 11556-19; submitted by Bayvet, Shawnee Mis-
sion, Kans.; CDL:014008-D)
00005048 Chemagro Corporation (1967) Chemagro Corporation Residue Experiment
No. KC-300-66H: Report No. 20964. (Unpublished study received
Dec 15, 1967 under 11556-19; submitted by Bayvet, Shawnee
Mission, Kans.; CDL:014008-E)
00005051 Chemagro Corporation (1968) Chemagro Corporation Residue Experi-
ment No. ?: Report No. 23942. (Unpublished study received Jul
23, 1970 under 11556-16; submitted by Bayvet, Shawnee Mission,
Kans.; CDL.-007188-A)
00005056 Chemagro Corporation (1963) Chemagro Corporation Residue Experiment
No. KC-215-63D: Report No. 12541. (Unpublished study including
letter dated Jan 22, 1964 from G.G. Stetson to G.M. Downard, re-
ceived Jan 28, 1964 under 11556-21; submitted by Bayvet, Shaw-
nee Mission, Kans.; CDL:025715-A)
00005074 Anderson, C.A. (1959) Co-Ral Residues in Goat Tissues: Report
No. 4008. (Unpublished study received Sep 11, 1959 under 11556-
21; prepared by Chemagro Corp., submitted by Bayvet, Shawnee
Mission, Kans.; CDL:011001-A)
00005080 Chemagro Corporation (1969) Synopsis of Analytical and Residue In-
formation for Spray Application of Co-Ral to Dairy Cattle.
Summary of studies 006078-B through 006078-G. (Unpublished
study received Feb 20, 1970 under 11556-21; submitted by Bayvet,
Shawnee Mission, Kans.; CDL:006078-A)
00005081 Chemagro Corporation (1969) Chemagro Corporation Residue Experiment
No. KC-201-68D: Report No. 24216. (Unpublished study receiver1
Feb 20, 1970 under 11556-21; submitted by Bayvet, Shawnee Mis-
sion, Kans.; CDL:006078-G)
113
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00005082 Industrial Bio-Test Laboratories (1974) Chemagro Division of Bay-
chem Corporation Residue Experiment: AH-74A-929: Report
No. 40709. (Unpublished study received Jun 20, 1974 under
11556-21; prepared for Baychem Corp., submitted by Bayvet,
Shawnee Mission, Kans.; CDL:009815-A)
00005193 Chemagro Corporation (1957) Co-Ral (Formerly Bayer 21/199) for
Experimental Use Only. (Unpublished study received Jul 1, 1957
under unknown admin, no.; submitted by Bayvet, Shawnee Mission,
Kans.; CDL:124847-A)
00005195 Anderson, C.A. (1958) A Photofluofbmetric Method for the Determina-
tion of Co-Ral (Bayer 21/199) Residues in.Animal Tissues: Report
No. 2216. Method dated Aug 13, 1958. (Unpublished study re-
ceived Feb 27, 1976 under 11556-EX-3; prepared by Chemagro
Corp., submitted by Bayvet, Shawnee Mission, Kans.; CDL:
224167-E)
00005235 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment
No. KC-214-63D: Report No. 12786. (Unpublished study received
Jun 8, 1964 under 11556-25; submitted by Bayvet, Shawnee Mis-
sion, Kans.; CDL:102326-B)
00005289 Adams, J. (1964) A Quantitative Method for the Determination of
Residues of Co-Ral (0-[3-Chloro-4-methyl umbelliferone] 0,0-
Diethyl phosphorothioate) and Chlorferron (3-Chloro-4-methyl-7-
hydroxycoumarin) in Animal Tissues and Milk: Report No. 13656.
Method dated May 6, 1964. (Unpublished study received Aug 18,
1966 under 7F0612; submitted by Chemagro Corp., Kansas City,
Mo.; CDL:090796-K)
00005293 Chemagro Corporation (1966) Chemagro Corporation Residue Experiment
No. KC-3400-66D: Report No. 17971. (Unpublished study received
Aug 18, 1966 under 7F0612; CDL:090796-Q)
00005295 Chemagro Corporation (1966) Chemagro Corporation Residue Experiment
No. KC-3401-66H: Report No. 18522. (Unpublished study received
Aug 18, 1966 under 7F0612; CDL:090796-S)
00005330 Chemagro Corporation (1963) Chemagro Corporation Residue Experiment
No. KC-201-63D: Report No. 10923. (Unpublished study received
on unknown date under PP0306; CDL:090321-D)
114
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the coumaphos Standard
MRID Citation
00005331 Chemagro Corporation (1961?) Synopsis of Analytical and Residue
Information on Co-Ral: (Milk). Summary of studies 090321-F
through 090321-H. (Unpublished study received Sep 4, 1961 under
PP0306; CDL:090321-E)
00005333 Chemagro Corporation (1960) Residue Report: Report No. 5515. (Un-
published study including report nos. 5533 and 5534, received
Sep 4, 1961 under PP0306; CDL:090321-H)
00005339 Chemagro Corporation (1967) Chemagro Corporation Residue Experiment
No. KC-201-67D: Report No. 20599. (Unpublished study including
report nos. 20651, 20663 and 20677, received Mar 18, 1968 under
1F0306; CDL:092586-B) "
00005341 Chemagro Corporation (1963) The Effect of Storage at 40: on CoRal
Residues in Milk: Report No. 11212. (Unpublished study received
on unknown date under 1F0306; CDL:092586-F)
00005342 Adams, J.M. (1963) A Quantitative Method for the Determination of
Residues of Co-Ral (0-(3-Chloro-4-methyl umbelliferone) 0,0-
Diethyl phosphorothioate) and Chlorferron (3-Chloro-4-methyl-7-
hydroxycoumarin) in Animal Tissues and Milk: Report No. 7165.
Rev. (pp. 1-6 only; unpublished study received on unknown date
under 1F0306; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:092586-G)
00005392 Chemagro Corporation (1959) Synopsis of Metabolic, Analytical,
Residue, and Taste Data on Co-Ral. Summary of studies 090326-B
through 090326-U. (Unpublished study received Oct 8, 1959 under
1F0306; CDL:090326-A)
00005396 Gronberg, R.R. (1958) Co-Ral Residues in Cattle Tissues: Report
No. 2409. (Unpublished study received Oct 8, 1959 under 1F0306;
prepared in cooperation with U.S. Agricultural Research Service,
submitted by Chemagro Corp., Kansas City, Mo.; CDL-.090326-E)
00005399 Gronberg, R.R. (1958) Co-Ral Residues in Cattle Tissue: Report
No. 2556. (Unpublished study received Oct 8, 1959 under 1F0306;
prepared in cooperation with Science Service Laboratory, Live-
stock Insect Section, submitted by Chemagro Corp., Kansas City,
Mo.; CDL:090326-1)
115
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00005451 Anderson, C.A. (1959) Co-Ral Residues in Chicken Tissues: Report
No. 4323. (Unpublished study received Mar 10, 1961 under
PP0299; prepared in cooperation with Clemson Univ., Dept. of
Entomology, submitted by Chemagro Corp., Kansas City, Mo.; CDL:
090337-U)
00005453 Anderson, C.A. (1959) Co-Ral Residues in Chicken Tissues: Report
No. 4421. (Unpublished study received Mar 10, 1961 under
PP0299; prepared in cooperation with McGill Univ., McDonald
College, Dept. of Poultry Husbandry, submitted by Chemagro
Corp., Kansas City, Mo.; CDL:090337-W)
00005454 Dourrough, H.W.; Brady, U.E., Jr.; Timmerman, J.A.; Arthur, B.W.
(1959) Magnitude and Nature of Residues in Tissues and Eggs of
Poultry Receiving 32P Co-Ral Mixed in the Feed: Progress Re-
port: Report No. 4425. (Unpublished study received Mar 10, 1961
under PP0299; prepared by Alabama Polytechnic Institute, Dept.
of Zoology-Entomology, submitted by Chemagro Corp., Kansas City,
Mo.; CDL:090337-X)
00005456 Chemagro Corporation (1960) Residue Report: Report No. 6102. (Un-
published study received Mar 10, 1961 under PP0299; CDL:
090337-AA)
0,0005479 Gronberg, R.R. (1958) Co-Ral Residues in Cattle Tissues: Report
No. 2409. (Unpublished study including report no. 2447a, re-
ceived Feb 14, 1961 under PP0299; prepared in cooperation with
U.S. Dept. of Agriculture, submitted by Chemagro Corp., Kansas
City, Mo.; CDL:090320-AH)
00005480 Chemagro Corporation (1960) Residue Report: Report No. 6101. (Un-
published study received Mar 10, 1961 under PP0299; CDL:
090337-AK)
00005483 Chemagro Corporation (1959?) Synopsis of Analytical and Residue
Information for Cattle, Swine, and Poultry Tissues (Co-Ral—Feed
and Salt Additives). Summary of studies 090319-U through
090319-Y and 090319-AA through 090319-AC. (Unpublished study
received Feb 11, 1964 under PP0299; CDL:090319-U)
00005485 Chemagro Corporation (1962) Chemagro Corporation Residue Experi-
ment ?: Report No. 8300. (Unpublished study received Feb 11,
1964 under PP0299; CDL:090319-W)
117
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00005400 Anderson, C.A. (1959) Co-Ral Residues in Hog Tissues: Report
No. 4009. (Unpublished study received Oct 8, 1959 under 1F0306
submitted by Chemagro Corp., Kansas City, Mo.; CDL:090326-0)
00005402 Robbins, W.E.; Hopkins, T.L. ;. Darrow, D.I.; Eddy, G.W. (1959) Stud
ies with P32:-Bayer 21/199 sprayed on cattle. Journal of
Economic Entomology 52(2):214-217. (Report no. 4168; also in
unpublished submission received Oct 8, 1959 under 1F0306; sub-
mitted by Chemagro Corp., Kansas City, Mo.; CDL:090326-R)
00005438 Thornton, J.S. (1968) Determination of Co-Ral in Eggs by Thermioni
Emission Flame Gas Chromatography: Report No. 22052. Method
dated Feb 20, 1968. (Unpublished study including report no.
22053, received Jun 14, 1968 under 8F0678, submitted by Chemagr
Corp., Kansas City, Mo.; CDL:091185-C)
00005441 Chemagro Corporation (1961) Chemagro Corporation Residue Report:
Report No. 6101. (Unpublished study including report nos. 6102
6104, 6141-6142, 7155-7156, 7159, 7166 and 7248, received Jun
14, 1968 under 8F0678; CDL:091185-G)
00005447 Anderson, C.A. (1959) Co-Ral Residues in Chicken Tissues: Report
No. 3869(b). (Unpublished study received Mar 10, 1961 under
PP0299; prepared in cooperation with Univ. of California—River
side, Dept. of Entomology, submitted by Chemagro Corp., Kansas
City, Mo.; CDL:090337-K)
00005448 Anderson, C.A. (1959) Co-Ral Residues in Chicken Tissues and Eggs:
Report No. 4010. (Unpublished study received Mar 10, 1961 unde
PP0299; prepared in cooperation with Univ. of California—River
side, Agricultural Experiment Station, submitted by Chemagro
Corp., Kansas City, Mo.; CDL:090337-N)
00005450 Dourrough, H.W.; Brady, U.E., Jr.; Timmerman, J.A.; Arthur, B.W.
(1959) Magnitude.and Nature of Residues in Tissues and Eggs of
Poultry Dusted with 32P Co-Ral: Progress Report: Report
No. 4209. (Unpublished study received Mar 10, 1961 under
PP0299; prepared by Alabama Polytechnic Institute, Dept. of
Zoology-Entomology, submitted by Chemagro Corp., Kansas City,
Mo.; CDL:090337-T)
116
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00005489 Chemagro Corporation (1963) Chemagro Corporation Residue Experiment
No. EC-212-62D: Report No. 11358. (Unpublished study received
Feb 11, 1964 under PP0299; CDL:090319-AA)
00005493 Chemagro Corporation (1961) Chemagro Corporation Residue Experiment
No. ?: Report No. 7167. (Unpublished study received on unknown
date under PP0229; CDL:092579-C)
00005510 Chemagro Corporation (1968) Recovery of Co-Ral from Milk: Report
No. 2269.7. (Unpublished study received Feb 20, 1970 under
11556-21; submitted by Bayvet, Shawnee Mission, Kans.; CDL:
102084-E)
00005822 Chemagro Corporation (1963) Chemagro Corporation Residue Experiment
No. KC-203-63D: Report No. 11449. (Unpublished study received
Jul 9, 1963 under 11556-21; submitted by Bayvet, Shawnee Mis-
sion, Kans.; CDL:025716-A)
00005830 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment
No. KC-200-64D: Report No. 13875. (Unpublished srtudy received
Jun 4, 1965 under 11556-16; submitted by Bayvet, Shawnee
. Mission, Kans.; CDL:126094-B)
Q0005832 Chemagro Corporation (1964) Chemagro Corporation Residue Experi-
ment No. KC-202-63D: Report No. 12866. (Unpublished study
received Dec 21, 1967 under 11556-11; submitted by Bayvet, Shaw-
nee Mission, Kans.; CDL:121477-E)
00005833 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment
No. NC-202-63D: Report No. 12867. (Unpublished study received
Dec 21, 1967 under 11556-11; submitted by Bayvet, Shawnee Mis-
sion, Kans.; CDL.-121477-F)
00005834 Chemagro Corporation (1964) Chemagro Corporation Residue Experiment
No. ?: Report No. 13100. (Unpublished study received Dec 21,
1967 under 11556-11; submitted by Bayvet, Shawnee Mission,
Kans.; CDL:121477-G)
00021731 Chemagro Corporation (1966) Chemagro Corporation Residue Experiment
No. KC-201-67D: Report No. 19,351. (Unpublished study received
on unknown date under PP0306; CDL:098412-F)
118
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the coumaphos Standard
MRID Citation
00021732 Chemagro Corporation (1966) Chemagro Corporation Residue Experiment
No. KC-200-67D: Report No. 19,234. (Unpublished study received
on unknown date under PP0306; CDL:098412-G)
00021981 Chemagro Corporation (1964) Co-Ral Parasiticide. (Unpublished
study received Oct 8, 1968 under unknown admin, no.; submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL:006897-A)
00021999 coberly, R.D. (19??) Co-ral: 0,0-Diethyl-0-(3-chloro-4-methyl-7-
coumarinyl) phosphorothioate. (Unpublished study received Oct
8, 1968 under unknown admin, no.; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:006897-AI)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report) •
00026370 Shmidl, J.A.; Kohlenberg, M.L. (1979) Eye Irritation Evaluation for
Bay Vb 9328 Flowable: Report No. 70643. (Unpublished study
received Jan 4, 1980 under 11556-98; submitted by Bayvet, Shawne*
Mission, Kansas; CDL:241573-D)
00026371 Shmidl, J.A.; Kohlenberg, M.L. (1979) Oral-LDSO - Evaluation for Ba:
Vb 9328 Flowable 50% in Rats: Report No. 70714. (Unpublished
study received Jan 4, 1980 under 11556-98; submitted by Bayvet,
Shawnee Mission, Kans; CDL:241573-E)
00026372 Shmidl, J.A.; Kohlenberg, M.L. (1979) Dermal Ld50 - Evaluation
for Bay Vb 9328 Flowable in Rabbits: Report No. 70838.
(Unpublished study received Jan 4, 1980 under 11556-98;
submitted by Bayvet, Shawnee Mission, Kans.; CDL:241573-F)
00026373 Shmidl, J.A.; Kohlenberg, M.L. (1979) Primary Dermal Irritation
Evaluation for Bay Vb 9328 Flowable: Report No. 70988.
(Unpublished study received Jan 4, 1980 under 11556-98; submitte
by Bayvet, Shawnee Mission, Kans.; CDL:241573-G)
f
00026374 Nelson, D.L. (1979) Bay Vb 9328 50% Flowable Acute Inhalation
Toxicity to Rats: Report Nc. 71091. (Unpublished study includin
submitting company summary, received Jan 4, 1980 under 11556-98;
prepared by Mobay Chemical Corp., submitted by Bayvet, Shawnee
Mission, Kans.; CDL:241573-H)
119
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00026375 Shmidl, J.A.; Kohlenberg, M.L.; Hiley, C.A. (1979) Dermal LD50
Evaluation for Bay Vb 9328, Lot No. R76-17-109 in Male Rabbits:
Report No. 71181. (Unpublished study received Jan 4, 1980 under
11556-98; submitted by Bayvet, Shawnee Mission, Kans.; CDL:
241573-1)
00026376 Shmidl, J.A.; Hiley, C.A.; Kohlenberg, M.L. (1979) Oral LD50 -
Evaluation for Bay Vb 9328 Flowable, Lot No. R76-17-109, in
Female Rats: Report No. 71190. (Unpublished study received
Jan 4, 1980 under 11556-98; submitted by Bayvet, Shawnee Mission,
Kans.; CDL:241573-J)
00026377 Shmidl, J.A.; Hiley, C.A.; Kohlenberg, M.L. (1979) Oral LD50 -
Evaluation for Bay Vb 9328 Flowable, Lot No. C76-17-151, in
Female Rats: Report No. 71289. (Unpublished study received
Jan 4, 1980 under 11556-98; submitted by Bayvet, Shawnee Mission,
Kans.; CDL:241573-K)
00026378 Shmidl, J.A.; Hiley, C.A.; Kohlenberg, M.L. (1979) Dermal LD50 -
Evaluation for Bay Vb 9328 Flowable, Lot No. C76-17-151, in
Male Rabbits: Report No. 71352. (Unpublished study received
Jan 4, 1980 under 11556-98; submitted by Bayvet, Shawnee Mission,
Kans.; CDL:241573-L)
00026379 Shmidl, J.A.; Kohlenberg, M.L. (1979) Oral LD50 - Evaluation for Bay
Vb 9328 Flowable, Lot No. C76-17-151, in Male Rats: Report No.
71395. (Unpublished study received Jan 4, 1980 under 11556-98;
submitted by Bayvet, Shawnee Mission, Kans.; CDL:241573-M)
0060807 Anderson, C.A. (1959) Co-ral Residues in Sheep Tissues: Report
No. 3665. (Unpublished study including letter dated Apr 16,
1959 from G.M. Williams to R.D. Radeleff, received Apr 21, 1959
under 11556-21; prepared by Chemagro Corp., submitted by Bayvet
Shawnee Mission, Kans.; CDL:124731-A, 124742)
00073248 Mobay Chemical Corporation (1967) Synopsis of Analytical and Re-
sidue Information for Dust Application to Cattle. (Compilation;
unpublished study received Dec 15, 1967 under 3125-209; CDL:
102328-A)
00082524 Hixson, E.J.; Delphia, K.L.; Lamb, D.W.; et al. (1980) Dermal
Sensitization of Bay Vb 9328 Flowable: Report No. 71898.
(Unpublished study received Oct 20, 1981 under 11556-98; submitted
by Bayvet, Shawnee Mission, Kans.; CDL:246071-A)
120
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00110596 Bayvet (1981) Product Chemistry: [Coumaphos]. (Compilation; un-
published study received on unknown date under 11556-4; CDL:
248200-A)
00110597 Shmidl, J. ; Rainey-, L. ; Kohlenberg, M. (1981) Oral LD50 Evaluation
for Coumaphos Compound: Report No. 72212. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-B)
00110598 Shmidl, J. ; Kohlenberg, M.; Rainey, L. (1981) Dermal LD50 Eval-
uation for Coumaphos Technical Compound: Report No. 72216.
(Unpublished study received on unknown date under 11556-4; sub-
mitted by Bayvet, Shawnee Mission, KS; CDL:248200-C)
00110599 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Eye Irritation Eval-
uation for Coumaphos Technical in Rabbits: Report No. 72213.
(Unpublished study received on unknown date under 11556-4; sub-
mitted by Bayvet, Shawnee Mission, KS; CDL:248200-D)
00110600 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Primary Dermal Irri-
tancy of Coumaphos Technical to Rabbits: Report No. 72205.
(Unpublished study received on unknown date under 11556-4;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-E)
00110601 Sangha, G,; De Jong, M.; Lamb, D.; et al. (1982) Acute Inhalation
Toxicity Study with Coumaphos Technical in Rats: Study No. 81-
041-14, Report No. 72398. (Unpublished study received on un-
known date under 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL:248200-F)
00110602 Shmidl, J.; Kohlenberg, M.; Hess, L. (1982) Dermal Sensitization
Evaluation of Coumaphos Technical in Guinea Pigs: Report
No. 72452. (Unpublished study received on unknown date under
11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-G)
00110603 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation
for Co-Ral 25% Wettable Powder: Report No. 72207. (Unpublished
study received on unknown date under 11556-4; submitted by Bayvel
Shawnee Mission, KS; CDL:248200-H)
0110604 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Dermal LD50 Eval-
uation for Co-Ral 25% Wettable Powder in Rabits: Report
No. 71804. (Unpublished study received on unknown date under
11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-1)
121
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
* Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00110605 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Eye Irritation Eval-
uation for Co-Ral 5% Wettable Powder: Report No. 71755. (Un-
published study received on unknown date under 11556-4; submitted
by Bayvet, Shawnee Mission, KS; CDL:248200-J)
00110606 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Primary Dermal
IrritationEvaluation for Co-Ral 25% Wettable Powder: Report No.
71756. (Unpublished study received on unknown date under 11556-4;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-K)
00110607 Sangha, G.; De Jong, M.; Lamb, D.; et al. (1982) Acute Inhalation
Toxicity Study with Co-Ral 25% Wettable Powder in Rats: Study
No. 81-041-15; Report No. 724904. (Unpublished study received on
unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL:248200-L)
00110608 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization
Evaluation for Co-Ral 25% Wettable Powder in Guinea Pigs: Report
No. 72453. (Unpublished study received on unknown date under
11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-M)
00110609 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Oral LD50 Evaluation for
Co-Ral 1% Dust: Report No. 71802. (Unpublished study received on
unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL.-248200-N)
00112816 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Dermal LD50 Evaluation
for Co-Ral 1% Dust in Rabbits: Report No. 71825. (Unpublished
study received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-0)
00112817 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Primary Dermal Irri-
tation Evaluation for Co-Ral 1% Dust: Report No. 71944.
(Unpublished study received on unknown date under 11556-4;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-P)
00112818 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Eye Irritation Eval-
uation for Co-Ral 1% Dust: Report No. 71945. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-Q)
122
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00112819 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization
Evaluation for Co-Ral 1% Dust in Guinea Pigs: Report No. 72331.
Unpublished study received on unknown date under 11556-4; submitt*
by Bayvet, Shawnee Mission, KS; CDL:248200-R)
00112820 Sangha, G.; De Jong, M.; Lamb, D. (1982) Acute Inhalation Toxicity
Study with Co-Ral 1% Dust in Rats: Study No. 81-041-17; Report No
72397. (Unpublished study received on unknown date under 11556-4
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-S)
00112821 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Oral LD50 Evaluation f
Co-Ral 3% Spray Foam: Report No. 72106. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-T)
00112822 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Dermal LD50 for Co-Ral
3% Spray Foam: Report No. 72110. (Unpublished study received on
unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL:248200-U)
00112823 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Primary Dermal Irri-
tation Evaluation for Co-Ral 3% Spray Foam: Report No. 72102.
(Unpublished study received on unknown date under 11556-5;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-V)
00112824 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Eye Irritation Eval-
uation for Co-Ral 3% Spray Foam: Report No. 72191. (Unpublished
study received on unknown date under 11556-4; submitted by Bayvet
Shawnee Mission, KS; CDL:248200-W)
00112825 Sangha, G.; Lamb, D.; Mallicoat, D.; et al. (1981) Acute Inhalation
Toxicity of Co-Ral 3% Spray Foam Wound Treatment: Study No. 81-04
05; Report No. 72323. (Unpublished study received on unknown dat
under 11556-4; submitted by Bayvet, Shawnee Mission, KS;
CDL:248200-X)
00112826 Shmidl, J.; Kohlenberg, M.; Hess, L. (1982) Dermal Sensitization
Evaluation for Co-Ral 3% Spray Foam Concentrate in Guinea Pigs:
Report No. 72455. (Unpublished study received on unknown date
under 11556-4; submitted by Bayvet, Shawnee Mission, KS;
CDL:248200-Y)
123
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00112827 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation
for Co-Ral 4% Pour-on: Report No. 72229. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-Z)
00112828 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1980) Eye Irritation Eval-
uation for 4% Co-Ral Pour-on: Report No. 71634. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-AB)
00112829 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Primary Dermal Irri-
tation Evaluation for Co-Ral Pour-on: Report No. 71635. (Un-
published study received on unknown date under 11556-4; sub-
mitted by Bayvet, Shawnee Mission, KS; CDL:248200-AC)
00112830 Sangha, G. ; Lamb, D.; Mallicoat, D.; et al. (1982) Acute Inhala-
tion Toxicity Study with Co-Ral 4% Pour-on in Rats: Study No.
81-041-18; Report No. 72403. (Unpublished study received on
unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL:248200-AD)
00112831 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization
Evaluation for Co-Ral 4% Pour-on in Guinea Pigs: Report No. 72454.
(Unpublished study received on unknown date under 11556-4;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AE)
00112832 Shmidl, J. ; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation for
Co-Ral Emulsifiable Livestock Insecticide: Report No. 72228.
(Unpublished study received on unknown date under 11556-4;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AF)
00112833 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal LD50 Evaluation
for Co-Ral E.L.I, in Rabbits: Report No. 72328. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-AG)
00112834 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Eye Irritation Eval-
uation for Co-Ral 11.6% ELI in Rabbits: Report No. 72101.
(Unpublished study received on unknown date under 11556-4;
submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AH)
124
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00112835 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Primary Dermal Irri-
tation for Co-Ral 11.6% Emulsifiable Livestock insecticide:
Report No. 72100. (Unpublished study received on unknown date
under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:
248200-AI)
00112836 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization
Evaluation for Co-Ral 11.6% Emulsifiable Livestock Insecticide in
Guinea Pigs: Report No. 72332. (Unpublished study received on
unknown date uner 11556-4; submitted by Bayvet, Shawnee Mission,
KS; CDL:248200-AJ)
00112837 Sangha, G.; Grocki, T.; Lamb, D.; et al. (1982) Acute Inhalation
Toxicity Study with Co-Ral Emulsifiable Livestock Insecticide in
Rats: Study No. 81-041-16; Report No. 72402. (Unpublished study
received on unknown date under 11556-4; submitted by Bayvet,
Shawnee Mission, KS; CDL:248200-AK)
00115167 Kruckenberg, S. (1981) Acute Delayed Neurotoxicity of Coumaphos in
Hens—81-Chicken-02: [Submitter] 72206. (Unpublished study re-
ceived Sep 23, 1982 under 11556-11; prepared by Kansas State
Univ., Veterinary Medical Center, Dept. of Pathology, submitted
by Bayvet, Shawnee Mission, KS; CDL:248397-A)
00117106 Shmidl, J.; Hess, L.; Kohlenberg, M. (1982) Subchronic 21-Day
Dermal Toxicity Study Conducted in Rabbits for a Coumaphos
Flowable Formulation: Report No. 72462. (Unpublished study
received Oct 1, 1982 under 11556-98; submitted by Bayvet, Shawnei
Mission, KS; CDL:248450-A)
00117974 Bayvet (1982) [Coumaphos: Chemical Study]. (Compilation; unpub-
lished study received Nov 3, 1982 under unknown admin, no.;
CDL:248781-A)
00131680 Herbold, B.; Lorke, D. (1981) Asuntol—Salmonella/Microsome Test To
Investigate the Point-mutagenic Effect: Pharma Report No. 10188;
72321. (Unpublished study received Oct 18, 1983 under 11556-11;
prepared by Bayer AG, W. Ger., submitted by Bayvet, Shawnee Mis-
sion, KS; CDL:251532-A)
125
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
00131681 Herbold, B.; Lorke, D. (1983) Asuntol—Pol Al Test on Escherichia
coli To Investigate DNA-damaging Effects: Pharmaceutical Report
No. 11689 (E) ; 72688. (Unpublished study received Oct 18, 1983
under 11556-11; prepared by Bayer AG, W. Ger., submitted by Bay-
vet, Shawnee Mission, KS; CDL:251532-B)
00131683 Clemens, G.; Hartnagel, R. (1983) Study of the Toxicity of Couma-
phos: II. Teratology (Segment II) Study in the Rabbit: Report
No. 6; 72642. (Unpublished study received Oct 18, 1983 under
11556-11; prepared by Miles Laboratories, Inc., submitted by
Bayvet, Shawnee Mission, KS; CDL:251532-D)
00131684 Clemens, G.; Hartnagel, R. (1983) Study of the Toxicity of Couma-
phos: III. Teratology (Segment iD^tudy in the Rat: Report
No. 8; 72754. (Unpublished study received Oct 18, 1983 under
11556-11; prepared by Miles Laboratories, Inc., submitted by
Bayvet, Shawnee Mission, KS; CDL:251532-E)
00138251 Kohlenberg, M.; Barker, L.; Shmidl, J. (1984) Safety Evaluation
for the Use of Coumaphos Flowable on Horses: Bayvet Report No.
72829. (Unpublished study received Feb 23, 1984 under 11556-98;
submitted by Bayvet, Shawnee Mission, KS; CDL:252989-A)
00141225 Campbell, L., Gay, J. (1984) Stability of Coumaphos Grade 1. Un-
published study prepared by Bayvet Div. Miles Laboratories, Inc.
7 p.
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of toxicity of
pesticides to wildlife: Second edition. US Fish and Wildlife
Service: Resource Publication 153. 91 p.
00163806 Waggoner, T. (1986) Leaching of Aged Residues of .-Carbon 14:-Cou-
maphos in Soil: Mobay Report No. 73431. Unpublished study pre-
pared by Pharmacology & Toxicology Research Laboratory. 51 p.
01155611 Leeling, J.L.; Ryerson, B.A.; Helmes, R.J. (1983) General Metabolism
Studies With Coumaphos 14C in the Rat. Bayvet Report No. 72821.
(Unpublished Study Prepared by Bayvet AG, Submitted by Mobay
Corporation.)
05004087 Krueger, H.R.; Casida, J.E.; Niedermeier, R.P. (1959) Bovine
metabolism of organophosphorus insecticides Metabolism and
residues associated with dermal application of Co-Ral to rats,
a goat, and a cow. Journal of Agricultural and Food Chemistry
7(3):182-188.
126
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARDS BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Coumaphos Standard
MRID Citation
05004483 Kaplanis, J.N.; Hopkins, D.E.; Treiber, G.H. (1959) Dermal and
oral treatments of cattle with phosphorus-32-labeled Co-Ral.
Journal of Agricultural and Food Chemistry 7(7):483-486.
05009242 Sanders, H.O. (1969) Toxicity of Pesticides to the
Crustacean Gammarus lacustris:. Washington, D.C.: U.S.
Bureau of Sport Fisheries and Wildlife. (U.S. Bureau of Sport
Fisheries and Wildlife technical paper 25)
05009938 National Cancer Institute (1979) Bioassay of Coumaphos for
Possible Carcinogenicity. Washington, D.C.: United States
Department of Health, Education and Welfare, Public Health
Service. (NCI Carcinogenesis technical report series no. 96;
DHEW publication no. (NIH) •79-1346)
05012748 Kasimov, D.D. (1969) Metabolism ko-rala v organizme krolikov i
krupnogo rogatogo skota. Co-ral metabolsim in rabbits and cattle.
Trudy, Wsesoyuznyi Naucho-Issledovatel'skii institut Veterinarnoi
Sanitarrii. Trransactions, All-Union Scientific Research Institut
of Veterninary Sanitation. 32:379-387.
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): 579 p.
40836001 Eiben, R. (1988) Coumaphos: Studies on Chronic Toxicity and Carcin-
ogenicity in Wistar Rats: Administartion with Feed for 24 Month-
s: Report No. 17131: Study No. T2020064. Unpublished Mobay stu-
dy 73797 prepared by Bayer AG Institute of Toxicology. 2252 p.
127
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IV. FORMS APPENDICES
128
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EPA Form 8580-1
OMB!? Approval NO. 2070-0057
Expires 11/30/89
PIFHA SECTION 3ICH2HBI SUMMARY SHEET
(PA Ate
-------
EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
(To qtmMy. etnify ALL four rttmtl
CERTIFICATION OF ATTEMPT TO CNTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I tin duly authorised to represent ttit following firmdl who art subject to the require-
ments of • Notice under FIFRA Section 3(cl(7)(81 contained in a Guidance Document
to uitxnn dlU concerning the act've ingredient:
GUIOAMCI OOCUMCNT OAT(
ACT IVI IMQHCOItMT
NAMC Of *MttH
CFA COMPANY NUMBER
(This firm or group of firms u referred to below as "my firm".)
2. My firm as willing to develop ond submit the dan as required by that Notice, if necetMry. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to there in the co*t o< developing, the following required
items or data:
3. My firm h« offered in wntinf to trar into audi an aanement, Copiei of tht offert tn merited. That offer w«i imvocabl* tnd included tn oHtr to b«
•ound by an arbnmion dxnion under FIFMA Section 3(cl(2)(BHiii} M final •anement on ell ami could not be rteched otnenMH. Th« oH*f w« m«d«
to 0>« following firm(t) on ttit tollewin| oateil):
MAMC Of PIMM
OATIOFOFFCft
However, none of thote firm(i| aeeepted my offer
4. My firm requertt mat EPA not suspend the regiftration(t) of my firm's product(s). if any of the firms named in paragraph (3) above
nave agreed to submit the dm lined in paragraph (2) above in accordance with the Notice. I gnderttand EPA will promptly inform
RM whether my firm mutt cibmit dan to tvotd suspension of its regmrstion(s) under FlFRA Section 3(c)(2)(Bl. (This natement
doe* not apply to applicant! for new producn.) I give EPA permiuion to disdoia this lutement upon reqwext.
rv»io NAMC
OATf
130 •
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US environmental Protection Agency Registration itanaa/a tor: t?A registration Numoer
Wasnmgton. DC 20460
V>cFA Product Specific
Data Reoort
Registration
Guideline No.
Sec. 153.120
Product
Qiemistrv
51-t
51-2
51-3
52-1
52-2
52-3
53-2
53-3
53-i
53-5
53-5
53-T
53-3
53-3
Testing not 1 am complying witn
required for my Data Reouirements bv -
product listed
Name of Test above Ctjng MR |Q No.
Oeelf ce/owl
Identity of Ingredients
Statement of comoosition
Discussion of formation of ingredients
pf«nminarv analysis !
Certification of limits
Analytical metfiocs for enforcement limits
Color
Suominmg Data
(Artacnoa)
(Chock ooiow)
Physical state
Caor 1
Melting somt '
Soiling aotnt 1
Censitv. 2uiK-<3ensitv. or soecific gravity i
Soiuoiiitv
Vacor areuure
53- ! 0 Ci ssocation constant
53-11 i Ccranot /water sarMion coefficient i
53-12 3H I
53-13 ! Siaoiiirv
53-14
53-iS
53-15
53-17
53-18
53-19
53-20
53-21
Sec. 158.135
Toxicolocv
31-1
81-2
810
31-»
81-5
81-6
Cudizina/reducing reaction
Rammaoititv
Eiotodaoilirv
Sloraae staoiiitv
Viscosity
MlSClOllitV
Corrosion C^arac:8ns1lC3
Cielectnc Sreaxdcwn voltage i
Acute oral toxicity. rat
Acute dermal taxioty. raooit
Acute mnalatton toxietv. rat 1
Primary eve irritation, raooit 1
Primary dermal itntanon
Dermal sensittzation
Fofrp Afloroved
CMS *2Q7C-0057
Expires 11-30-S9
(For EPA Use
Only)
Accession
numoers
assioned
Certification
! certify that the statements ! have made on this form anr1 all attachments thereto are
true, accurate, and complete. 1 acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Name ana Title Signature
Date
EPA Form 4580-4 (H«v. S-38) Prewiou* eamon i* oosotew.
131
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OMB Approval No. 2070-005
Expiration Date 11/30/89
GENERIC EM3\ EXEMPTION STATEMENT
EPA Product Registration Number: ^
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the product
contains the active ingredient solely as the result of the incorporation into the product
of another product which contains that active ingredient, which is registered under FIFRA
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidental Statement of Formula (CSF) for the above-identified
product is attached to this statement. Tnat formula statement indicates, by conpany name,
registration number, and product name, the source of the subject active ingredient in IT/
firm's product, or
Tne CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source*s) of the above named active ingredient in my product(s) is/are
and their registration number (s) is/are .
Ply firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understani, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings made
in this Statement, my firm's product's registration may be suspended under FIFRA Section
3(C)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet requirements or are no longer in
ccnpliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in compliance and will normally initiate proceedings to suspend the
registrations of my firm's product(s) and their product(s), unless my firm commits to
submit and submits the required data in the specified time frame. I understand that, in
such cases, the Agency generally will not grant a. time extension for submitting the data.
Registrant's authorized representative:.
(Signature
Dated:
(Typed)
EPA Form 8570-27
•U.S.GOVERNMENTPUWTTNCOFFICE ! ti>. (i 7«es/g»iSk
132
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