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October 1988
Guidance for the
Reregistration of
Pesticide Products
Containing
TETRACHLORVINPHOS
as the Active Ingredient
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OMB Control No. 2070-0057
Expires November 1989
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
TETRACHLORVINPHOS
AS THE ACTIVE INGREDIENT
[0321]
CAS No.961-11-5
October 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction
II. Chemical(s) Covered by this Standard 3
A. Description of Chemical
B. Use Profile
III. Agency Assessment 6
A. Introduction
B. Health Risk Assessment
C. Ecological Effects
D. Environmental Fate
E. Reported Pesticide Incidents
F. Tolerance Reassessment
G. Summary of Data Gaps
IV. Regulatory Position and Rationale 17
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 27
VI. Requirement for Submittal of Gene.r_i_c_.Da.ta ^ ^ ^ _ - 29-
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Registrant requests regarding data
requirements and Agency responses
F. Test protocols and standards
G. Procedures for requesting a change in protocol.
H. Procedures for requesting extensions of time
I. Data Format and Reporting Requirements
J. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submittal of Product-Specific Data . .
36
VIII. Requirement for Submittal of Revised Labeling ^
IX. Instructions for Submittal 38
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multiple active)
E. Intrastate Products
i
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APPENDICES
I. DATA APPENDICES kl
Guide to Tables 43
Table A
Table B
Table C
II. LABELING APPENDICES 74
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. BIBLIOGRAPHY APPENDICES 98
Guide to Bibliography 99
Bibliography
IV. FORMS APPENDICES
109
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to
Enter
Into an Agreement with Other
Registrants for Development of Data
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GLOSSARY OF TERMS AND ABBREVIATIONS
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.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide
Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statisticallv
derived concentration of a substance that can
be expected to cause death in 50% of test
animals. It is usually expressed as the weight
of substance per weight or volume of water or
feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived
single dose 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.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
111
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NOEL No Observed Effect Level
OPP Office of Pesticide Programs
OES Office of Endangered Species, U.S. Fish and
Wildlife Service
PADI Provisional Acceptable Daily Intake
ppm Parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
iv
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I. INTRODUCTION
EPA has established the Registration Standards program in
order to provide an orderly mechanism by which pesticide products
containing the same active ingredient can be reviewed and
standards set for compliance with FIFRA. The standards are
applicable to reregistration and future applications for
registration of products Containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling into
compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough review
of the scientific data base underlying a pesticide's registration.
The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the
pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide
meets the "no unreasonable adverse effects" criteria of FIFRA. In
its review EPA identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been required
when the product was initially registered or may be needed to
replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product is
not misbranded and that the labeling is adequate to protect man
and the environment.
The detailed scientific review, which is not contained in
this document, but is available upon request,1 focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide active
ingredient. However, during the review of these data the Agency
is also looking for potential hazards that may be associated with
the end use products that contain the active ingredient. The
Agency will apply the provisions of this Registration Standard to
end use products if necessary to protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard, on
the pesticide and each of its registered uses. See Section IV -
1(rhe scientific reviews and Compendium of Uses may be
obtained from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161.
Telephone (703) 487-4650.
1
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Regulatory Position and Rationale. Based on its regulatory
position, the Agency may prescribe a variety of steps to be taken
by registrants to maintain their registrations in compliance with
FIFRA. These steps may include:
1. Submittal of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in the
issuance of a Notice of Intent to Cancel or a Notice of Intent to
Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the pesticide.
If the Agency determines that the risks of the pesticide's use
outweigh the benefits of use, the Agency may propose additional
regulatory actions, such as cancellation of uses of the pesticide
which have been determined to cause unreasonable adverse effects
on the environment.
EPA has authority under the Data Call-in (DCI) provisions of
FIFRA sec. 3(c)(2)(B) to require that registrants submit data to
answer our questions regarding the chemical, toxicological, and
environmental characteristics and fate of a pesticide. This
Registration Standard lists the data EPA believes are necessary to
resolve our concerns about this pesticide. These data are listed
in the Tables A, B, and C in Appendix I. Failure to comply with
the DCI requirements enumerated in this Registration standard may
result in issuance by EPA of a Notice of Intent to Suspend the
affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible
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
submittal 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
Tlie following chemical is covered by this
Registration Standard.
Common Name: Tetractilorvinphos
Generic Name: (Z)-2-chloro-l-(2,4,5-
triclilorophenyl)vinyl dimethyl phosphate
Other Chemical Names: (Z)-2-chloro-l-(2,4,5-
trichloro-phenyl) ethenyl dimethyl phosphate
Trade Names: Stirofos Gardona, Ration, C7MP,
Gardeide.
Chemical Class: Organophrisphate
Empirical Formula: C1QHgCl404P
Molecular Weight : 366.0
Molecular st-0*
CAS Registry NOs.: 22248-79-9 [ (2) -isomer]
22350-76-1 [ (E) -isomer]
961-11-5 (mixed isomers)
OPP Shaughnessy No.: 083701
Year of Initial Registration: 1966
U.S. and Foreign Producers: E.I.duPont de Nemours £
Co. and Fermenta Animal Health Co. (Animal Health
Products).
CI
3
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Physical/chemical properties of tetrachlorvinphos
Color: tan to brown
Physical State: solid
Odor: mild chemical
Melting Point: 93-98 C
Boiling Point: N/A - solid at room
temperature
Bulk Density: 50-55 lb/cu ft
Solubility: 15 ppm in water at 24°C; 40
ppm in chloroform, 40 ppm in dichloromethane,
20 ppm in acetone, and 8 ppm in xylene at 0°C
B. Use Profile
Type of Pesticide: Non-systemic organophosphate
Pests Controlled: Fleas, lice, ticks, ants,
chiggers, mites, itch mite family, chicken mite,
northern fowl mite, filth and manure flies (face
fly, horn fly, house fly, and stable fly), deer
fly, spiders, wasps, gnats, mosquitoes, and
cockroaches.
Registered Uses: Terrestrial nonfood crop use on
recreational areas; Domestic outdoor use on
domestic premises; Indoor use in/on livestock (beef
and dairy cattle, swine, horses, and ponies),
poultry, mink, farm animal buildings, pets (cats
and dogs), pet living quarters, domestic dwellings,
and garbage dumps.
Principal Uses: The major use is for controlling
filth or manure flies associated with livestock
(cattle, swine, horses, mink) and is applied in
the form of mineral blocks and feed additives.
Remaining uses include dusts, wettable powders and
sprays applied to agricultural premises, livestock,
pets and flea collars. Tetrachlorvinphos
impregnated ear tags comprise a small amount of
the formulated a.i.
4
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Mode of Application: contact and stomach poison
Method of Action: Premise treatment by
conventional hydraulic sprayer or low pressure
knapsack; animal treatment by hand dusting (shaker
can, hand duster, grooming brush, dust mitt),
pressurized spray, flea collars, ear tags, dust
bags, oral feed additive, oral mineral block,
backrubber.
Formulations: Dust, granular, pelleted/tableted,
wettable powder, wettable powder/dust, impregnated
material, emulsifiable concentrate, ready-to-use
and pressurized liquid.
Basic Producers: E.I. dupont de Nemours & Co.
Fermenta Animal Health Co.
(livestock products)
Annual Usage: approximately 500,000 lbs. a.i.
5
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III. AGENCY ASSESSMENT
A. INTRODUCTION
The Agency has reviewed all data in Agency files as of
December 17, 1988 supporting the registration of tetrachlorvin
phos. Data received by the Agency after this date have not been
reviewed for the purposes of this standard. This section
discusses the Agency's scientific findings and conclusions based
on these data.
B. HEALTH RISK ASSESSMENT
The Agency has reviewed tetrachlorvinphos data in the areas
of acute toxicity, subchronic and chronic toxicity, oncogenicity,
reproductive effects, mutagenicity, environmental fate and
exposure, and ecological effects. The following assessment is
based on available data.
1. Acute Toxicity
No data are available on the acute oral and dermal toxicity,
primary eye irritation, primary dermal irritation or sensitization
properties of tetrachlorvinphos. Technical tetrachlorvinphos is
not very toxic on an acute inhalation basis. It is in Toxicity
Category III for inhalation exposure based on an acute inhalation
toxicity value (LC5q) of >3.61 mg/L (expressed in gravimetric
concentration) in male and female Sprague-Dawley rats. Sufficient
data are available on the acute delayed neurotoxicity of
tetrachlorvinphos. In hens, it was reported that as a single oral
(capsule) dose of 1.5 g/kg or as multiple oral doses of 300
mg/kg/day for five days, tetrachlorvinphos did not produce
clinical signs of neurotoxicity.
2. Subchronic Toxicity
Data are available to-assess the subchronic oral toxicity of
tetrachlorvinphos. In a subchronic oral toxicity study in which
dogs (3 male and 3 females per treatment group) were fed diets
containing 50, 200, 800, or 3200 ppm (1.25, 5, 20, or 80 mg/kg) of
tetrachlorvinphos the major treatment-related effects were:
(1) statistically significant decrease in hemoglobin and
erythrocytes in male dogs of the high-dose group indicating
normocytic anemia; and (2) statistically significant decrease in
plasma cholinesterase activity in male and female animals of the
800 ppm (80 mg/kg) and 3200 ppm (80 mg/kg). The NOEL was 200 ppm
(5mg/kg) in both sexes for cholinesterase inhibition.
In a subchronic oral toxicity study in which rats (15 male
and 15 females) were fed diets containing 12.6, 50, 200, 800, or
3160 ppm (0,63, 2.5, 10, 40, or 158 mg/kg) of tetrachlorvinphos,
6
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statistically significant depression in plasma cholinesterase was
seen in both sexes of the 800 ppm (40 mg/kg) and 3160 ppm (158
mg/kg) groups. Liver and kidney weights were higher in both sexes
of the high-dose group. In female rats, terminal body weight and
hemoglobin was lower in the 800 (40 mg/kg) and 3160 ppm (158
mg/kg) groups compared to controls. The NOEL was 200 ppm (10
mg/kg) in both sexes for cholinesterase inhibition. Both the rat
and dog subchronic oral toxicity studies are considered to be
supplementary by the Agency because the purity and stability of
tetrachlorvinphos used was not specified.- However, since the
Agency has acceptable rat and dog chronic feeding studies that
suffice to characterize subchronic effects, subchronic oral
toxicity studies are not required. A 90-day neurotoxicity study
is not required, since the acute neurotoxicity was negative in
hens.
3. Developmental Effects
Based on an acceptable rabbit teratology study, in which
eighteen New Zealand White rabbits were administered orally (by
gavage) tetrachlorvinphos at dose levels of 0, 150, 375, or 750
mg/kg on days 6 through 19 of gestation, tetrachlorvinphos was
not teratogenic. Soft tissue variations and skeletal
malformations were comparable between the treated and control
groups. The number of viable fetuses per litter was reduced at
the middle (375 mg/kg) and high (750 mg/kg) dose groups compared
to controls. Maternal toxicity was seen in the high dose group in
the form of reddish vaginal discharge. The fetotoxic No
Observable Effect Level (NOEL) is 150 mg/kg based on a decrease in
number of viable fetuses and the maternal NOEL is 375 mg/kg based
on reddish vaginal discharge. A second teratology study in a
species other than the rabbit is required.
4. Reproduction
Sufficient data are available to assess the potential effects
of tetrachlorvinphos on reproduction. In a rat reproduction study
in which rats (20 female and 10 males per group) were fed diets
containing 0, 100, 333, or 1000 ppm (0,5,16.7, or 50 mg/kg) of
tetrachlorvinphos over a period of three generations, the only
compound related effect seen was the increase in liver size in the
F3jj weanlings in the 50 mg/kg group. No other compound-related
effects were seen in the parents or the litters. A NOEL of 16.73
mg/kg (333 ppm) (for increased liver size in F3^ weanlings) has
been established.
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5. Metabolism
Preliminary data indicate that tetrachlorvinphos is
completely metabolized in dogs and rats and excreted mainly in the
urine and to a lesser extent in the feces as metabolites. Six
metabolites were identified and quantified from rat urine and four
metabolites from dog urine. All metabolites in dog urine were
common to those in rat urine but were quantitatively different.
These studies are inadequate to fully characterize the metabolism
of tetrachlorvinphos due to reporting deficiencies and design
flaws.
6. Mutagenicity
There are no acceptable mutagenicity studies on
tetrachlorvinphos. Studies in all three categories (gene
mutation, structural chromosome aberrations and other genotoxic
tests) are required. Tetrachlorvinphos was positive in a dominant
lethal assay, resulting in the decreased rate of pregnancies and
number of fetal implants in mice. However, no compound related
effects were seen in an in vivo bone marrow assay (Chinese
hamsters) or in a host-mediated (mouse) assay with microorganisms.
These studies are considered by the Agency to be inadequate due to
design and reporting flaws, and a full battery of studies is
required.
7. Chronic Toxicity
Cholinesterase inhibition and reduced weight gains are the
significant toxic effects resulting from chronic exposure to
tetrachlorvinphos. This is based on an acceptable chronic feeding
dog study, in which tetrachlorvinphos was administered in the diet
to six beagle dogs (3 males and 3 females) at 0, 5, 25, 125, and
2000 ppm (0, 0.13, 0.63, 3.13, or 50 mg/kg) for 2 years. Effects
considered to be compound-related were observed at the highest
dose tested (50 mg/kg). These effects included a significant
decrease in plasma cholinesterase activity and a significant
increase in the relative liver and kidney weights in both sexes.
Based on this, the No-Observable Effect Level (NOEL) is 3.13 mg/kg
(125 ppm).
Based on an acceptable chronic toxicity study in the rat, a
NOEL of 6.25 mg/kg (125 ppm) is established for the effects of
cholinesterase inhibition and reduced weight gain. In this study,
male and female rats were fed diets containing 0, 5, 25, 125, or
2000 ppm (0, 0.25, 1.25, 6.25, or 100 mg/kg) of tetrachlorvinphos
for 2 years. A total of 60 male and 60 female rats were used for
the control group; 40 rats/sex for the 5, 25, or 125 ppm (0.25,
1.25, or 6.25 mg/kg) groups; and 20 rats/sex for the 2000 ppm
(100 mg/kg) group. Compound-related effects were seen only in the
high-dose group (100 mg/kg) and consisted mainly of significantly
decreased body weights in both sexes, significantly decreased
plasma cholinesterase activity in male rats, and plasma and
erythrocyte cholinesterase activity in females.
8
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8. Oncogenicity
Based on the Agency's Guidelines for Carcinogen Risk
Assessment, the Agency has classified tetrachlorvinphos as a Group
C (i.e. possible human) carcinogen, with a cancer potency estimate
(Ql*) of 3.1 x 10~3 (mg/kg/day)~1.
The Agency's decision to classify tetrachlorvinphos as a
Group C carcinogen is based on a finding of significant increases
in hepatocellular adenomas/carcinomas and kidney
adenomas/carcinomas in mice. In rats, there was an increased
incidence of thyroid and adrenal cortical adenomas; however, the
study is considered by the Agency to be equivocal and another
oncogenicity study in the rat must be submitted. A synopsis of
these studies is provided below.
Mouse Study (Hazleton Laboratories). Tetrachlorvinphos was
administered in the diet to groups of 80 male and 80 female B6C3F1
mice at 0, 17.5, 64, 320, 1600, 8000, or 16,000 ppm (0, 2.6, 9.6,
48, 240, 1200, or 2400 mg/kg) for 103 weeks. Control groups
consisted of 160 mice/sex.
In male mice, there was a statistically significant increase
in hepatocellular adenoma/carcinoma combined, at 16,000 ppm (2400
mg/kg) {Highest Dose Tested) with a statistically significant
trend. In female mice, there was a statistically significant
increase in hepatocellular carcinomas at 8000 (1200 mg/kg) and
16,000 ppm (2400 mg/kg), and in combined adenoma/carcinoma at 1600
(240 mg/kg), 8000 (1200 mg/kg), and 16,000 ppm (2400 mg/kg);
adenomas were statistically increased at 16,000 ppm (2400 mg/kg),
only; there was a statistically significant trend for adenoma,
carcinoma and for combined adenoma/carcinoma, as well.
In male mice only, there was also a statistically significant
increase in renal adenoma, carcinoma and adenoma/carcinoma,
combined, at 16,000 ppm (2400 mg/kg); there was also a
statistically significant trend for adenoma, carcinoma and for
combined adenoma/carcinoma, as well.
The Agency has determined that the Maximum Tolerated Dose
(MTD) was achieved or slightly exceeded in this study at the 8000
ppm (1200 mg/kg), based on body weight gain depression (>15%).
There was no significant histopathology at 8000 ppm (1200 mg/kg),
but significant histopathology at 16,000 ppm (2400 mg/kg),
indicative of cellular proliferation (severe liver necrosis) was
present. The liver necrosis was not life-threatening, however, as
survival at this dose (16,000 ppm) was actually enhanced compared
to controls.
9
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Mouse study (Gulf South). In this study, tetrachlor-
vinphos was administered in the diet to groups of 50 male and
50 female B6C3F1 mice at 0, 8000 or 16,000 ppm (0, 1200, or 2400
mg/kg) for 80 weeks (with an additional observation period of 12
weeks). Matched controls (0 mg/kg) consisted of 10 untreated
mice/sex; pooled controls were from bioassays of 4 other test
chemicals (40 males and 40 females).
In male mice there was a statistically significant increase
in hepatocellular carcinoma at both dose levels, with a
statistically significant trend. There was also a liver lesion,
designated as a neoplastic nodule which was statistically
significant in males, at the low dose only, and in females at both
doses with a statistically significant trend. The Agency has
determined that the MTD was achieved or slightly exceeded at 8000
ppm (1200 mg/kg).
Rat study (Gulf South). In this study, tetrachlor-
vinphos was administered in the diet to groups of 50 male and
50 female Osborne-Mendel rats at 0, 4250, or 8,500 ppm (0, 212.5,
or 425 mg/kg) for 80 weeks (with an additional observation period
of 31 weeks). Matched controls (0 mg/kg) consisted of 10
untreated rats/sex; pooled controls were from bioassays of 4 other
test chemicals (45 males and 45 females).
In female rats there was a statistically significant increase
in thyroid c-cell adenoma at 8500 ppm or 425 mg/kg (HTD), with a
statistically significant trend. There was also a statistically
significant increase in adrenal cortical adenoma at the HTD, with
a statistically significant trend. Male rats did not show
treatment related increases in either of these tumors.
Oncogenic Potency
The oncogenic potency (Q^*) was calculated based on data in
the 103-week dietary study on B6C3F1 mice conducted by Hazelton
Laboratories (the liver tumor (carcinoma and/or adenoma) in female
mice illustrates the most sensitive outcomes with dose*increments
of the chemical). The highest dose (16,000 ppm or 2400 mg/kg) was
excluded from the calculations because the Agency determined that
the Maximum Tolerated Dose (MTD) was exceeded at this level. The
Q!* in animal units (mg/kg/day)~l was converted to human
equivalents by means of an interspecies surface area adjustment as
recommended by the Agency's Carcinogen Risk Assessment Guidelines
to account for the difference in body weight and surface area.
The estimated unit oncogenic potency factor, Qi*, in human
equivalents for this chemical is 3.1 x 10"3 (mg/kg/day)~l.
10
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RISK ASSESSMENT FOR ONCOGENICITY AND CHRONIC EFFECTS
1. Dietary Non-Oncogenic Risk
Dietary exposure to tetrachlorvinphos residues may occur as a
result of its use on livestock. Published tolerances exist for
residues of tetrachlorvinphos on meat, milk, and eggs (40 CFR
180.252). The Theoretical Maximum Residue Contribution (TMRC) is
0.0015 mg/kg/day for the U.S. population average. The TMRC
assumes that all meat, milk and eggs contain residues at the
maximum level and that 100% of the site is treated. The
Provisional Acceptable Daily Intake (PADI) was calculated to be
0.03 mg/kg/day based on a 2-year dog feeding study with a No
Observable Effect Level (NOEL) of 3.13 mg/kg (125 ppm) for the
effect of increased relative liver and kidney weights. The
Uncertainty Factor applied was 100 in calculating the PADI to
account for inter-and intraspecies differences (ADI x 100 = NOEL).
The TMRC for the U. S. population average occupies between 2.0 %
(low) and 10 % (high) of the PADI. In no population group
analyzed did the TMRC equal or exceed the PADI.
2. Dietary Oncogenic Risk
Using the Q^* of 3.1 x 10-3 mg/kg/day)-1 and the TMRC, the
dietary oncogenic risk is calculated as follows:
Risk = Exposure x Qi*
= 0.0015 x 0.0031
= 4.7 x 10"6
This dietary risk assessment is most likely overestimated,
since it assumes that all meat, milk and eggs contain residues at
the tolerance level. The Agency has no data on which to adjust
theoretical maximal residues (such as extent of actual usage and
processing effects). However, from 1972-1985, no tetrachlorvin
phos residues were found in livestock (cattle, sheep, goats,
swine, horses, poultry) samples analyzed in USDA's National
Residue Monitoring Program. Both the oncogenic and non-oncogenic
risks are considered to be worst-case estimates.
3. Non-Dietarv Oncogenic Risk
Non-dietary exposure to mixer/loaders and/or applicators can
result from the application of tetrachlorvinphos to livestock,
pets, and agricultural premises. Limited data are available
regarding likely non-dietary exposure resulting from these uses.
1 1
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Thus, the Agency will require such exposure data for
representative uses of tetrachlorvinphos in order to assess the
risks from mixing/loading and/or applying the pesticide. The
following use patterns must be monitored during mixing/loading and
/or application of tetrachlorvinphos for both dermal and
inhalation exposure : feed additive, general indoor and outdoor
sprays (one site each), poultry house spray, and large animal
dusts. Moreover, since the Agency has no data on dermal
absorption of tetrachlorvinphos, a dermal penetration study is
required.
C. ECOLOGICAL EFFECTS
The available studies show that tetrachlorvinphos is
practically non-toxic to avian species, but is highly toxic to
coldwater and warmwater fish. No studies are available for
evaluation of hazard to freshwater aquatic invertebrates from the
use of tetrachlorvinphos and are being required. A discussion of
the ecological effects is set forth below.
1. Terrestrial Organisms
Tetrachlorvinphos is practically non-toxic to birds as
demonstrated by both acute and dietary studies. Acute oral tests
with mallards, pheasant, and chukars resulted in LD50's of >2,000
mg/kg. Dietary studies with mallard, japanese quail, and ring-
necked pheasant resulted in LC50's of >5,000 ppm.
2. Aquatic Organisms
Available acute test results indicate that tetrachlorvinphos
is highly toxic to fish. Acute tests resulted in LC50's of 0.43
ppm to rainbow trout and 0.53-1.0 ppm to bluegill sunfish.
3. Non-target Insects
Data from honey bee acute contact toxicity studies indicate
that tetrachlorvinphos is highly toxic to honey bees (contact LD50
= 1.37 ug/bee), when bees are exposed to direct
treatment. However, toxicity of foliar residues is short-lived,
with bee hazard minimal after three hours.
4. Endangered Species
There are sufficient data to indicate that the currently
registered domestic indoor and outdoor uses of tetrachlorvinphos
are not expected to result in significant concentrations in the
habitat of susceptible aquatic and terrestrial organisms. Thus,
there is no expected risk to endangered species.
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D. ENVIRONMENTAL PROFILE
Available data are insufficient to fully assess the
environmental fate of tetrachlorvinphos.
Preliminary findings from an aerobic soil metabolism study
indicate that under aerobic conditions, 14C tetrachlorvinphos,at
13.4 ppm, degraded with a half-life of <8 days in medium loam
soil. The major degradates were identified as l-(2,4,5-
trichlorophenyl)-2-chloroethan-l-ol and 1-(2,4,5,-
trichlorophenyl)ethan-l-ol. l-Chloroacetyl-2,4,5-trichlorobenzene,
2,4,5-trichloraceto-phenone, and l-(2,4,5-trichlorophenyl)ethane-
diol were also detected. However, this study was not adequate to
fully characterize the aerobic soil metabolism of
tetrachlorvinphos primarily because the soil was not typical of U.
S. soils. There were also deficiencies in the conduct and
reporting of the study.
E. REPORTED PESTICIDE INCIDENTS
As part of its assessment of tetrachlorvinphos, the Agency
reviewed its Pesticide Incident Monitoring System data base
covering a period from 1981 to December 1986. No deaths have been
reported in the U. S. or California due to tetrachlorvinphos. A
national survey of 12 percent of the nations' hospitals found two
observed occupational poisonings from 1974 to 1976, or an
estimated five hospitalized cases per year in the U.S.
California, which requires mandatory reporting of all physician-
treated, occupationally-related cases, has not reported any
incidents of tetrachlorvinphos illness from 1981 through 1986.
During the time period January 1, 1987 to September 1, 1988,
the National Animal Poison Control Center at the University of
Illinois reorded 43 calls concerning potential
tetrachlorvinphos poisoning. Of the 43 calls, 24 involved cats,
13 involved dogs, 4 involved cattle and one each occurred in a
horse and a ferret. Evidence of poisoning was strongest in cats
and dogs which developed symptoms after exposure to flea and tick
preparations including powders, sprays, and collars. The horse
case was judged a doubtful poisoning.
F. TOLERANCE REASSESSMENT
Tolerances for residues of the insecticide tetrachlorvinphos
in or on various raw agricultural commodities are currently
expressed in terms of tetrachlorvinphos per se (40 cfr 180.252).
A feed additive regulation has also been established for
tetrachlorvinphos per se in Section (40 CFR 186.950). Tolerance
revocation procedures (40 CFR 180.7) will be initiated for apples,
field corn, sweet corn and popcorn, fresh corn forage and fodder
alfalfa, cherries, cranberries, peaches, pears, and tomatoes,
since tetrachlorvinphos is no longer registered for these uses.
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The Agency has evaluated the residue chemistry and toxicology
data supporting the tolerances on animal commodities and has
determined that it does not have sufficient data to support the
currently established tolerances for residues of tetrachlorvinphos
in the fat of cattle, goats, hogs, horses, sheep, and in poultry;
in eggs and milk fat, including negligible residues in whole
milk. The Agency will complete a reassessment of the established
tolerances for tetrachlorvinphos after the required residue and
toxicological data are submitted and evaluated.
1. Residue Data
Currently, no tetrachlorvinphos end-use products are
registered for use on any plant commodity; therefore, the
metabolism of tetrachlorvinphos in plants will not be discussed in
this Standard. The nature of the residue of tetrachlorvinphos in
animals is not adequately understood because the available data
pertaining to metabolism in ruminants and poultry do not include
adequate characterization of residues and data were not submitted
reflecting direct animal treatments.
The available data, although inadequate, indicate that 14C-
residues and 32P-residues of tetrachlorvinphos will occur in the
tissues of ruminants and poultry following ingestion of feeds
containing [i4C]-or [32P]- tetrachlorvinphos.
Data gaps exist for animal metabolism, analytical method
validation data, storage stability, as well as the adequacy of
multiresidue procedures. On receipt of the data requested in
these sections of the Registration Standard, the Agency will
assess the adequacy of tolerances for residues in animal
commodities.
Adequate gas liquid chromatographic (GLC) analytical methods
are available for data collection and enforcement pertaining to
residues of tetrachlorvinphos and its low melting isomer SD 13462
in animal commodities and milk. However, the adequacy of the
analytical methods for data collection and enforcement may change
upon receipt of the required animal metabolism data. If
metabolites of concern other than tetrachlorvinphos, per se, are
found in the required metabolism studies, adequately validated
methods for their detection, which may be used for data collection
and tolerance enforcement, will be required.
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There are no Canadian or Mexican tolerances and no Codex MRL
has been established for tetrachlorvinphos residues in poultry fat
and eggs. Therefore, no compatibility questions exist with
respect to the Codex MRL.
2. Toxicology Data
The available toxicity data are sufficient for the Agency to
calculate a Provisional Acceptable Daily Intake (PADI) for
tetrachlorvinphos (0.03 mg/kg/day) based on a 2-year dog study and
using an uncertainty factor of 100. The PADI and TMRC (0.0015
average mg/kg/day) will be reassessed when the data required in
the Standard have been received and reviewed.
G. Other Science Findings (Product Chemistry)
The Agency has noted that tetrachlorvinphos may be
contaminated with tetra- through heptahalogenated dibenzo-p-
dioxins or dibenzofurans. Certain polyhalogenated dibenzo-p-
dioxin or dibenzofuran congeners have been found to be mutagenic,
oncogenic, teratogenic and to cause reproductive toxicity.
Nitrosamines have been found to be oncogenic. Analytic data to
identify and quantify tetra-through heptachlorinated dibenzo-p-
dioxin or dibenzofuran contaminants were required in a Data Call-
in Notice issued in June, 1987.
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H. Summary of Data Gaps for Tetrachlorvinphos
(Refer to Appendix I, Data Tables, for detailed information
and due dates).
Product Chemistry All
Residue Chemistry Metabolism Studies in Livestock
Residue Analytical Methods (animal
residues)
Magnitude of the Residues in Fat of
Livestock
Storage Stability
Environmental Fate Hydrolysis
Photodegradation (in water)
Metabolism Studies (aerobic soil)
Mobility Studies (leaching and
absorption/desorption)
Dissipation Studies (soil)
Dissipation of Residues in Excrement
Toxicology Acute Oral (rat)
Acute Dermal (rat)
Eye Irritation (rabbit)
Dermal Irritation (rabbit)
Dermal Sensitization (guinea pig)
Domestic Animal Safety
21-Day Dermal
Oncogenicity (rat)
Teratology (rat)
Mutagenicity
Ecological Effects—Acute Toxicity to Freshwater Invertebrates
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on tetrachlorvinphos, the Agency has
made the following determinations:
1. Special Review
The Agency is not initiating a special review for
tetrachlorvinphos at this time.
Rationale: Although the Agency has classified
tetrachlorvinphos as a Group C oncogen ( Possible Human
Carcinogen), anticipated dietary exposure to humans and the
associated risk is not high (10 -6). In addition the exposure
analysis and oncogenic risk assessment assume tolerance level
residues would be present. Since processing data or the extent of
tetrachlorvinphos usage have not been used to estimate the actual
residue levels and since pesticide residues on foods as eaten are
often considerably lower than the tolerances, the estimate of
exposure and oncogenic risk (10-6) would be considered a worst
case estimate. The Agency is concerned that potential non-dietary
exposure to mixer/loaders and/or applicators resulting from the
feed additive, agricultural premise, and general indoor/outdoor
uses of tetrachlorvinphos may lead to an oncogenic risk of
regulatory concern. The Agency is unable to conclude at the
present time that the oncogenic risk criteria of 40 CFR 154.7 have
been met. Therefore, the oncogenicity risks of tetrachlorvinphos
will be reassessed upon receipt and evaluation of required
exposure studies, rat oncogenicity study, and dermal penetration
study.
2. Restricted Use
The Agency is not requiring the classification of any of the
uses of tetrachlorvinphos as restricted use at this time.
Rationale: Section 3(d)(1)(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." The Agency has determined that based upon
currently available data, tetrachlorvinphos does not meet any of
the risk criteria of 40 CFR 152.170 and therefore, products
containing tetrachlorvinphos do not warrant restricted use
classification at this time. However, exposure to applicators
for certain uses may pose risks of regulatory concern.
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Upon receipt and evaluation of required exposure studies and a
dermal penetration study the Agency will reassess the requirement
for restricted use classification.
3. Domestic Animal Safety
The Agency will analyze the safety and efficacy data of
tetrachlorvinphos powders, sprays, flea and tick collars, as well
as the feed additive uses to determine if further regulatory
action is warranted.
Rationale: Complaints of animal poisoning incidents have
been reported relating to the use of tetrachlorvinphos. It has
been alleged that tetrachlorvinphos causes illness in dogs, cats,
and horses. It is uncertain if these incidents were due to
misuse, animal stress (heat, exercise), or age or type of dog and
cat or horse treated. As with other organophosphates,
tetrachlorvinphos can inhibit plasma and erythrocyte
cholinesterase activity in animals. Therefore, existing data
submitted in support of tetrachlorvinphos use on animals will be
analyzed to determine if the minimum effective rate is being
recommended and if it demonstrates an adequate safety margin to
animals over its use level. If the data do not demonstrate an
adequate margin of safety to animals when used as directed,
further regulatory actions may be warranted, including labeling
directions, use restrictions or cancellation.
4. Endangered Species Concerns
The Agency is not requiring endangered species restrictions
at this time.
Rationale: The indoor/domestic outdoor uses of
tetrachlorvinphos are not toxic to plants and are relatively
nontoxic to avian wildlife. As a result of these use patterns the
products are not expected to enter the habitat of susceptible
aquatic and terrestrial organisms in significant concentrations.
Because of the apparent lack of exposure of susceptible nontarget
organisms, products registered for indoor and domestic outdoor
uses are not expected to pose a risk to endangered species.
5. Nontaraet Organism Labeling
In order to comply in part to the statutory standard for
continued registration, the Agency has determined that
tetrachlorvinphos products must bear revised and updated labeling
for hazards to nontarget organisms. The specific statements are
given Section IV. B of this Standard.
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Rationale; Available data show that tetrachlorvinphos is
highly toxic to fish. Precautionary label statements relative to
the potential risks posed by tetrachlorvinphos to nontarget
organisms will provide useful information to promote practices to
limit such exposure of nontarget species to this pesticide.
6. Groundwater Concerns
Groundwater and drinking water monitoring are not required
for tetrachlorvinphos at this time.
Rationale: There are no available environmental chemistry
studies with which to adequately assess the groundwater
contamination potential of tetrachlorvinphos. Data for assessing
this potential have been required in this Standard.
7. Reentry Requirements
The Agency is not imposing any reentry statements nor is
requesting that reentry data be submitted.
Rationale; There are no currently registered uses of
tetrachlorvinphos (i.e. outdoor agricultural uses) applied to
crops which utilize hand labor tasks.
8. Protective Clothing
The Agency is requiring protective clothing for workers or
other users who mix, load, and/or apply tetrachlorvinphos
products.
Rationale; Tetrachlorvinphos has been classified by the
Agency as a C(Q*1) (possible human) oncogen. For this reason
protective clothing is necessary to reduce worker exposure during
mixing, loading, and/or applying this pesticide. The
precautionary labeling statements provide specific guidance for
persons handling tetrachlorvinphos and describe the protective
clothing required for handling/applying particular
tetrachlorvinphos products.
9. Environmental Fate Labeling
The Agency is requiring data to show the maximum
concentration of tetrachlorvinphos and its degradation products in
livestock manure at the time such materials are applied to crops
as fertilizer, in the interim, labeling restrictions are being
imposed until the required data is submitted and reviewed by the
Agency.
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Rationale: Currently there are no registered uses of
tetrachlorvinphos on food crops. By definition, the use of
tetrachlorvinphos as a feedthrough for fly control must result in
adequate residues being present in fresh manure to inhibit fly
development. The rate of decline of these residues in the manure
is not known and this use could potentially result in residues of
tetrachlorvinphos being present in or on food crops if the manure
is applied to the land used to grow food crops.
10. Tolerance Revocation
The Agency will revoke tolerances for alfalfa, cherries,
cranberries, apples, corn, peaches, pears, and tomatoes.
Rationale: Currently, there are no registered products
bearing these uses. Available data are insufficient to support
these tolerances.
11. Tolerances and Significant New Uses2
The Agency will not grant any-new tolerances or any significant
new food uses for tetrachlorvinphos until the required residue
chemistry and toxicology data have been submitted and reviewed.
Rationale: The Agency needs additional residue and animal
metabolism data in order to characterize the nature of residues in
animals The Agency also needs method validation, storage
stability, and teratology data before it can perform a tolerance
reassessment for tetrachlorvinphos.
12. Food/Feed Additive Regulations
The Agency will not establish any new food or feed additive
regulations pursuant to Section 409 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) and is deferring action on previously
established food/feed additive regulations.
Rationale: The Delaney Clause in Section 409 of the FFDCA
bars the establishment of food/feed additive regulations for
substances which induce cancer in man or test animals, with
certain exceptions. The Agency is currently developing a position
regarding the Delaney Clause and FIFRA. Once this policy has
been established, the Agency will determine what action is
required for pesticides which have produced oncogenic responses in
animals.
2 "NEW USES" is defined in 40 CFR 152.3 (p). In the case
of a new food or feed use, the Agency will generally consider
as significant an increase in the Theoretical Maximum Residue
Contribution (TRMC) of greater than 1%.
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13. Dioxin/Furan Contamination
The Agency is requiring analytical chemistry data for
tetrachlorvinphos products to evaluate contamination with tetra-
through heptahalogenated dibenzo-p-dioxins or dibenzofurans.
Rationale; Polyhalogenated dibenzo-p-dioxins or
dibenzofurans may be formed during manufacture of
tetrachlorvinphos. The Agency has identified these contaminants
as being toxicologically significant. The Agency does not have
sufficient data to determine the extent and significance of the
contamination.
14. Data Identified for Immediate Review
The Agency has identified certain data that will receive
immediate review when submitted.
Rationale: Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger the
need for further studies which should be initiated as soon as
possible. The following studies have been identified to receive
priority review as soon as they are received by the Agency:
section 158.340 TQXiCQlQqY
83-3 Teratology(Rat)- tolerance
reassessment.
84-2 Mutagenicity (all studies)-
83-2 Oncogenicity-Rat
onocogenicity risk assessment to
applicators.
85-2 21-day Dermal-
section 158.75 Requirement for Additional Data
Other Exposure Data (Dermal and
inhalation)- Oncogenicity risk
assessment.
section 158.240 Residue Chemistry
171-4 Animal Metabolism-Tiered study
Magnitude of the Residues in Fat and
Milk-Tiered study.
st-.orage Stability-Tiered study.
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section 158.290 Environmental Fate
161-1 Hydrolysis-Analysis for ground water
contamination potential.
162-1 Aerobic Soil Metabolism-Analysis for
ground water contamination
potential.
163-1 Leaching and Adsorption/Desorption-
Analysis for ground water contami-
nation potential.
164-6 Dissipation of Residues in Excrement
Tiered study.
15. Continued Registration
While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing tetrachlorvinphos may be sold, distributed,
formulated and used, subject to the terms-and conditions specified
in this Standard. Registrants must provide or agree to develop
additional data, as specified in the Data Appendices, in order to
maintain existing registrations.
Rationale: Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or are
inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7).
Issuance of this Standard provides a mechanism for
identifying data needs and labeling changes arising from available
data. Required data will be reviewed and evaluated, after which
the Agency will determine if additional regulatory actions are
necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain tetrachlorvinphos, bear required
labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in this
section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain this pesticide.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and inert
ingredients which are present in products, as well as impurities.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing this pesticide provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products only
for the use patterns listed below. The EPA Index to Pesticide
Chemicals (for availability, see page 1) lists all registered
uses, as well as approved maximum application rates and
frequencies.
-Terrestrial, non-food
-Indoor
-Domestic outdoor
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D. LABELING
In order to remain in compliance with FIFRA, products must
bear appropriate labeling as specified in 40 CFR 156.10 and this
Standard, or must be revised to conform to those specifications.
Appendix II contains information on label requirements.
No pesticide product containing this pesticide may be
released for shipment by the registrant after October 31, 1989,
unless the product bears an amended label which complies with the
requirements of this Standard. No pesticide product containing
this pesticide may be distributed or sold after October 31, 1990
unless the product bears an amended label which complies with
the requirements of this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the-active
ingredient as:
ACTIVE INGREDIENT
Tetrachlorvinphos: 2-chloro-l-(2,4,5-
triclilorophenyl) viny 1 dimethyl phosphate %
2. Use Pattern Statements
A. MANUFACTURING USE PRODUCTS
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable use
patterns. Labeling must specify sites, which are listed in Use
Patterns, Section C.3. However, no use may be included on the
label where the registrant fails to agree to comply with the data
requirements in TABLE A for that use pattern.
a. Labels for MPs must bear the following identifying phrase
directly beneath the product name:
"An insecticide for formulating use only."
b. In the directions for use, the following statement must
appear:
"Formulators using this product are responsible for obtaining
EPA registration of their formulated product."
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c. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use insecticide products intended
only for (list acceptable sites)."
NOTE: No use may be included on the label where the
registrant fails to agree to comply with the data requirements for
that use pattern.
d. If detailed instructions for formulating are not provided
on the label, the following statement must appear:
"Refer to attached Technical Bulletin for formulating and
other information."
NOTE: The technical bulletin must be submitted with the
product label for Agency review.
e. The following statements are required to appear under the
"Environmental Hazards" heading:
"This pesticide is highly toxic to fish. 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 National Pollutant
Discharge Elimination System (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 the Regional Office of
EPA."
B. END USE PRODUCTS
a. The ingredient statement for EPs must declare the
active ingredient as:
Tetrachlorvinphos: 2-chloro-l-(2,4,5-trichlorophenyl) vinyl
dimethyl phosphate %
1. All products allowing for outdoor use must bear the
following environmental hazards statements:
"This pesticide is toxic to fish. Drift and runoff may be
hazardous to aquatic organisms in adjacent areas. Do not apply
directly to water or wetlands (swamps, bogs, marshes, and
potholes). Do not contaminate water when disposing of equipment
washwater.n
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"This product is highly toxic to bees exposed to direct
treatment on blooming crops or weeds. Do not apply this product
or allow it to drift to blooming crops or weeds if bees are
visiting the treatment area."
2. All products allowing for domestic outdoor use must
bear the following environmental hazards statement:
"This pesticide is toxic to fish. Do not contaminate water
when disposing of equipment washwaters."
3. The following protective clothing statements must
appear on all products allowing for use on livestock, agricultural
premises, feed additives:
For dusts and sprays: " Wear long-sleeved shirt and
pantschemical resistant gloves; shoes and socks." For ear tags:
"wear gloves when applying tags."
4. The following protective clothing statements must
appear on all products allowing domestic use:
For dusts and sprays: "Wear long-sleeved shirt and
pants, shoes and socks."
5. All products allowing for use of tetrachlorvinphos as a
feed additive and/or use on manure (droppings) mus.t. b.e.ar the
following statement:
" Do not use manure/droppings on land where food crops are
to be grown during the current growing season."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submittal or changes in composition, labeling or
packaging of the product. The applicable requirements depend on
whether the product is a manufacturing or end use product and
whether the pesticide is the sole active ingredient or one of
multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B.
3.The labeling requirements specified for manufacturing use
products in Section IV.
4. Administrative requirements (application forms,
confidential statement of Formula, data compensation
provisions) associated with reregistration.
B. Manufacturing use products containing this pesticide as one
of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
3Data requirements are listed in the three Tables in Appendix
I of this Registration Standard. The Guide to Tables in that
Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registration
Standard. Table B lists product-specific data applicable to
manufacturing-use products. The data in Tables A and B need not
be submitted by an end-use producer who is eligible for the
generic data exemption for that active ingredient.
Table C lists product-specific data applicable to end-use
products. The Agency has decided that, in most cases, it will not
require the submittal of product-specific data for end-use
products at this time. Therefore, most Registration Standards do
not contain a Table C.
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C. End use products containing this pesticide as the sole active
ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the generic data exemption,4 the data
requirements listed in Table C.3.
If not eligible for the generic data exemption, the data
requirements listed in Table A and the data requirements
listed in Table C.
4. The labeling requirements specified for end use products
in Section IV.
D. End use products containing this pesticide as one of multiple
active ingredients are subject to:
1. If not eligible for the generic data exemption, the data
requirements listed in Tables A and c.
2. If eligible for the generic data exemption, the data
requirements listed in Table C.
3. The labeling requirements specified for end use products
in Section IV.
4If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you are
eligible for the generic data exemption for generic data
concerning that active ingredient (Table A) and product-specific
data for the registered manufacturing use product you purchase
(Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient, or
acquire your active ingredient from a firm with ownership in
common with yours, you individually lose the exemption and become
subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end-use
producers lose the exemption, and become subject to the data
requirements in Table A.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration standard is a notice issued
under the authority of FIFRA sec. 3(c)(2)(B). It refers to the
data listed in Table A, which are required to be submitted by
registrants to maintain in effect the registration of products
containing this active ingredient.5
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation" of a
product. "Typical formulation" testing is often required for
ecological effects studies and applies to all products having that
formulation type. These are classed as generic data, and are
contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to require
a registrant who qualifies for the formulator's exemption (FIFRA
sec. 3(c)(2)(D) and 152.85) to submit generic data in response to
a DCI notice if the registrant who supplies the active ingredient
in his product is complying with the data request.
If you are granted a generic data exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrants who have committed to generate and
submit the required data fail to take appropriate steps to meet
the requirements or are no longer in compliance with this data
requirements notice, the Agency will consider that both they and
you are not in compliance and will normally initiate proceedings
to suspend the registrations of both your product(s) and their
product(s) unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed in
this Registration Standard.
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If you are not now eligible for a generic data exemption, you
may qualify for one if you change your source of supply to a
registered source that does not share ownership in common with
your firm. If you choose to change sources of supply, the
Confidential Statement of Formula must identify the new source(s)
and you must submit a Generic Data Exemption Statement.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not yet
been submitted, any new registration will be conditioned upon the
new registrant's submittal or citation of the required data not
later than the date upon which current registrants of similar
products are required to provide such data. See FIFRA sec.
3(c)(7)(A). If you thereafter fail to comply with the condition
of that registration to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed to
evaluate current uses of all products containing this active
ingredient, the uses for which such data are required, and the
dates by which the data must be submitted to the Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration Standard,
you must submit to EPA a completed copy of the form entitled
"FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form 8580-1,
enclosed) for each of your products. On that form you must state
which of the following six methods you will use to comply with the
DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
30
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submit the data on which you will rely. You must also provide EPA
with documentary evidence that an agreement has been formed which
allows you to rely upon the data to be submitted. Such evidence
may be: (1) your letter offering to join in an agreement and the
other registrant's acceptance of your offer, (2) a written
statement by the parties that an agreement exists, or (3) a
written statement by the person who will be submitting the data
that you may rely upon its submittal. The Agency will also require
adequate assurance that the person whom you state will provide the
data is taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the final
arrangement between the parties or a mechanism to resolve the
terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data Submitter
Number, as part of your 90-day response. The request must include
the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative of
the consortium, with whom EPA will correspond concerning
the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of the
consortium); and
e. Identification of the specific data that the consortium
will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to jointly
develop data, but no other registrant has accepted your offer.
You request that EPA not suspend your registration for non-
compliance with the DCI. EPA has determined that, as a general
policy, it will not suspend the registration of a product when the
registrant has in good faith sought and continues to seek to enter
into a data development/cost sharing program, but the other
registrants developing the data have refused to accept its offer.
[If your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt to
Enter into an Agreement with other Registrants for Development of
Data" (EPA Form 8580-6. enclosed).
31
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2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must, at a
minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec. 3(c)(2)(B) in
the [name of active ingredient] Registration Standard upon terms
to be agreed or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your offer
is made does not accept your offer, and if the other registrant
informs us on a DCI Summary Sheet that he will develop and submit
the data required under the DCI, then you may qualify for this
option. In order for you to avoid suspension under this method,
you may not later withdraw or limit your offer to share in the
burden of developing the data.
In addition, the other registrant must fulfill its commitment
to develop and submit the data as required by this Notice in a
timely manner. If the other registrant fails to develop the data
or for some other reason would be subject to suspension, your
registration as well as that of the other registrant will normally
be subject to initiation of suspension proceedings, unless you
commit to submit and submit the required data in the specified
timeframe. In such cases, the Agency generally will not grant a
time extension for submitting the data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply to
your product or its uses, you must provide EPA with a statement of
the reasons why you believe this is so. Your statement must
address the specific composition or use factors that lead you to
believe that a requirement does not apply. Since the Agency has
carefully considered the composition and uses of pesticide
products in determining that a data requirement applies, EPA does
not anticipate that many waivers will be granted. A request for
waiver does not extend the timeframes for developing required
data, and if your waiver request is denied, your registration may
be suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
32
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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 regis- tration
of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and Agency
Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such requests
for changes in the requirements do not alter the original
requirements or extend the time allowed for meeting the
requirement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must be
conducted in accordance with applicable Good Laboratory Practices
regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are referenced in
the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (Part 158.70). Please note,
however, that certain OECD standards (such as test duration,
selection of test species, and degradate identification which are
environmental fate requirements) are less restrictive than those
in the EPA Assessment Guidelines listed above. When using the
OECD protocols, they should be 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.
33
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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 amy 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.
34
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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 registrant is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If you
believe that your product will be suspended or cancelled and that
an existing stocks provision should be granted, you have the
burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. The following
information must be included in any request for an existing stocks
provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale or
distribution; and
2. Demonstration that such a provision would be consistent
with the provisions of FIFRA.
35
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing using a
specific formulated product, and, unlike generic data, generally
support only the registration of that product. All such data must
be submitted by the dates specified in this Registration Standard.
If you have a mariufacturing use product, these data are
listed in Table B. If you have an end use product, the data are
listed in Table C. As noted earlier, the Agency has decided that
it will not routinely require product-specific data for end use
products at this time. Therefore, Table C may not be contained in
this Registration Standard; if there is no Table C, you are not
required to submit the data at this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for generic
data. See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.l. (submit data) or
VI.D.6. (cancellation of registration).
Failure to comply with the product-specific data requirements
for your products will result in suspension of the product's
registration.
36
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product and its
uses. General labeling requirements are set out in 40 CFR 156.10
(see Appendix II - LABELING and SUMMARY). In addition, labeling
language specific to products containing this pesticide is
specified in Section IV.D of this 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 IV.D., EPA may seek to cancel the registration of your
product under FIFRA sec. 6.
37
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IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard must
be sent to the following address:
Office of Pesticide Programs
OPP MaiIroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Tetrachlorvinphos Registration Standard
All submittals in response to this Registration Standard are
non-fee items, including 90-day responses, protocols and waiver
requests, data, and revised labeling. Submittals must be clearly
identified as being in response to the Registration Standard.
Under no circumstances may Registration Standard responses be
combined with other types of filings for which fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit for each product subject to this Registration Standard:
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)(1)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you must
submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data (See
Table B).
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling.
38
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d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic Data Exemption Statement (EPA Form 8580-3) , if
applicable, or the FIFRA sec. 3(c)(2)(B) Summary Sheet,
with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you must
submit:
Three copies of draft labeling, including the container label
and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you must
submit all generic data, unless you are eligible for the generic
data exemption. If for any reason any test is delayed or aborted
so that the schedule cannot be met, immediately notify the Agency
of the problem, the reasons for the problem, and your proposed
course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3), if
applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
39
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2.
submit:
Within 9 months from receipt of this document you must
a. Two copies of any product-specific data, if required by
Table C.
b. Product Specific Data Report (EPA Form 8580-4), if Table
C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
D. End Use Products containing the subject active ingredient as
one of multiple active ingredients
1. Within 90 days from receipt of this document, you must
submit:
a. Generic data exemption Statement (EPA Form 8580-3), if
applicable, or the FIFRA Section 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
2. Within 9 months from the receipt of this document, you
must submit:
Three copies of draft labeling, including the container label
and any associated supplemental labeling.
3. Within the times set forth in Table A, you must submit
all generic data, unless you are eligible for the generic data
exemption. If for any reason any test is delayed or aborted so
that the schedule cannot be met, immediately notify the Agency of
the problem, the reasons for the problem, and your proposed course
of action.
40
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E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted by
that date, no product may be released for shipment by the producer
after July 31, 1988.
41
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I. DATA APPENDICES
42
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T-GUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that
apply to the pesticide in all products, including
data requirements for which a "typical formulation"
is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement {Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment
Guidelines, which are available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA
22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The
following letter designations are used for the given use
patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
43
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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
44
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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 6
requires that data be submitted, this column indicates when
the data are to be submitted, based on the date of receipt 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.
45
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TABLE A
RIC DATA. REQUIREMENTS FOR 1
v aj k;!»• lw ic i i; •
Pata Requirement
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional For Data
Substance Patterns Have Data?l (mrid) Data Be Submitted? Submission-
Part 158. Subpart C, PmrtnrTt- Chemistry
Ppvhirt identity and Composition
61-2 - Description of Starting
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Inpurities
TGAI
TGAI
All
Ml
No
No
N/A
N/A
Yesz
Yes3
9 Months
9 Months
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
of Product Samples
TGAI
All
NO
N/A
Yes4
9 Months
Physical and Chemical Characteristics
63-2 - Color
TGAI
All
NO
N/A
Yes5
9 Months
63-3 - Physical State
TGAI
All
NO
N/A
Yes5
9 Months
63-4 - Odor
TGAI
All
NO
N/A
Yes5
9 Months
63-5 - Melting Point
TGAI
All
NO
N/A
Yes5 ®
9 Months
63-6 - Boiling Point
TGAI
All
NO
N/A
Yes7
9 Months
46
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TABLE A
GENERIC DMA REQUIREMENTS FOR TE7ERACHLCKVINFHQS
Data Requirement
Test
Substance
Use
Patterns
Does EPA.
Have Data?-!
Bibliographic
Citation1
(MRID)
Timeframe
Must Additional for
Data Be Submitted? Submission^/
Part 158. Subpart C. Prnrtivt- Chemistry (cont'd)
Physical and Chemical
rhararfpristics (cont'd)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octano1/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
64-1 - Submittal of Samples
TGAI
All
No
N/A
Yes5
9 Months
TGAI or
PAI
All
NO
N/A
Yes5
9 Months
Tffil or
PAI
All
NO
N/A
Yes5
9 Months
TGAI or
PAI
All
NO
N/A
Yes5
9 Months
PAI
All
NO
N/A
Yes5
8
9 Months
TGAI
All
NO
N/A
Yes5
9
9 Months
TGAI
All
NO
N/A
Yes5
9 Months
N/A
N/A
N/A
N/A
No
a
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TABLE A
GENERIC DATA REQUIREMENTS FOR TEHIWMjCRVINEHOS
Part 158. Subpart C. Prarinr* Chemistry - Footnotes
1 Not applicable. Although product chemistry data may have been sutmitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2 Complete information must be provided regarding the nature and process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures, in addition the name and
address of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each
product must be provided, along with information regarding the properties of those materials.
3 A detailed discussion of all impurities that are or may be present at >=0.1%, based on knowledge of the beginning
materials, chemical reactions {intended and side) in the manufacturing process, and any contamination during and
after production must be sutmitted.
4 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation datd (accuracy and precision) must be sutmitted for each
analytical method used. In addition, specific data have been required from registrants on June 15, 1987,
regarding the identity of all halogenated dibenzo-p-dioxins and dibenzofurans occurring in each technical
product, analytical methods for their detection and quantitation, and certification of limits of these contaminants.
5 Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CFR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be sutmitted.
6 Data required if the technical chemical is a solid at room tenperature.
7 Data not required because technical tetrachlorvinphos products are solids at room temperature.
8 Data required if the technical product is organic and nonpolar.
9 Data required if the test substance is dispersible in water.
18
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TABLE A
GENERIC DATA REQUIREMENTS FOR TE3RACHLCKVINFHQS
Data Requirement
Bibliographic
Test Use Does EPA Citation Must Additional
Substance Pattern Have Data? (MRID) Data Be Submitted?
Timeframe
for
Sutmission-
Sec. 158.PPgifhiP Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of the Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Methods
- Animal Residues
TGAI
PAIRA
PAIRA
H, I
H, I
N/A
H, I
TGAI and H, I
metabolites
No
Yes
NO
Partially
Partially
(See Use Index)
YesJ
No
00116020,
00117354,
00120147,
00120204
00038458,
00077812,
00077814,
00077816,
00115939,
00116020,
00116553,
00117329,
00117340,
00117351,
00117354,
00117389,
00118265,
00120147,
00120200,
00120205,
No^
Yes-
18 Months
Yes3,4
18 Months
49
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TABLE A
GENERIC DMA REQUIREMENTS FOR TEHRACHIjQRVINFHOS
Data Requirement
Bibliographic Timeframe
Test Use Does ETA Citation Mast Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? gufcmisgiQn
sec. 158.240 mpwrimry t™*'™
171-4 - Residue Analytical Methods
- Animal Residues
(cont'd)
00120206,
00120229,
00130705,
00133913,
05004211,
40530101
171-4 - Storage Stability Data
FAI and Pare H, I Partially
00117329,
00117354,
00117361,
00117389,
00133913
Yes5/
18 Months
171-4 - Magnitude of the Residues
- Magnitude of the
Residues in Meat,
Milk, Poultry,
and Eggs
- Fat of Cattle, Goats,
Hogs, Horses, and
Sheep
TGAI
H, I Partially
00038458,
00115939,
00117298,
00117339,
00117354,
00117389,
Reserved
50
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TABLE A
GENERIC DMA REQUIREMENTS FOR TE3RACHjORV]1IPHQS
Sec. 158.2AO Jfogirtng ChPmHgj-ry - FrafnntPS
1 Refer to Product Chemistry Data Requirements tables (A and B).
2 There are no plant uses currently registered for tetrachlorviriphos.
3 Metabolism studies reflecting direct animal treatments using cattle, poultry, and swine. Animals must be sprayed daily
for 28 days and in separate tests, orally dosed for 3 days (cattle and swine only), using [14C-ring] tetrachlorvinphos
at a rate sufficiently high to permit adequate characterization of residues in muscle, fat, liver, kidney, milk,
and eggs. Eggs and milk must be collected twice daily throughout the treatment period and animals must be sacrificed
within 24 hours of the final application or dosing. Representative samples frcan these tests must be analyzed using all
current and proposed enforcement methods (including FDA multiresidue protocols I-IV and Method I in the EAM, Vol. II,
Pest. Reg. Sec. 180.252) to ascertain that the methods are capable of accurately quantifying all residues of
toxicological concern.
4 If metabolites of concern other than tetrachlorvinphos per se are found in the required metabolism studies, adequately
validated methods for their detection, which may be used for data collection and tolerance enforcement, will be
required.
5 Uie storage intervals and conditions of samples (including samples from previously sutmitted studies) used to support
all established tolerances for residues of tetrachlorvinphos must be sutmitted. These data must be accompanied by
data depicting the percent decline in residues of tetrachlorvinphos at the times and under the conditions specified.
Additional stability studies are not required for milk fat stored at 0°C up to 31 days and animal fat stored at roam
tesmperature up to 11 days. In laboratory tests using fortified samples, the pure active ingredient and pure
metabolites must be used.
6 Hue nature of the residue in animals has not been adequately described. If the requested metabolism studies
indicate the presence of additional residues of toxicological concern in animal commodities, data depicting the
stability of such residues in storage will be required.
7 On receipt of the requested animal metabolism data, the adequacy of the available data regarding the magnitude
of the residue in animal products will be determined and, if necessary, additional data will be required.
-------
TABLE A
GENERIC DATA. REQUIREMENTS FOR TEIIBACHU^tt/INPHOS
Data Requirement
Bibliographic Timeframe
Test Use Does EPA Citation Most Actional for
Substance Patterns Have Data? (MRID) Data Be Submitted? gutarussion^Z-
Sec. 158.240 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residues
- Magnitude of the
Residues in Meat,
Milk, Poultry,
and Eggs (Cont'd)
- Fat of Cattle, Goats,
Hogs, Horses, and
Sheep (Cont'd)
- Milk
- Poultry Fat and Eggs
KM
00118265,
00120200,
00120206
H, I Partially 00117298,
00117354,
00117389,
00118265,
00120206,
05006630
TGAI
H, I Partially
00084189,
00117340,
00120225,
00120227
Reserved
Reserved
51
-------
TABLE A
GENERIC DATA. REQUIREMENTS PGR TEHEACHLCRVINPHOS
Bibliographic Timeframe
Test Use Does EPA citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission-
Data Requirement
Sec. 158.290 Environment
TYHjrartal-inn frt-nrHph - T^h
161-1 - Hydrolysis EAIRA
phm-rriPcrrarlai-inn
161-2 - In Water PAIRA
161-3 - On soil EAIRA
161-4 - In Air EAIRA
Metabolism studies - Lab
162-1 - Aerobic Soil PAIRA
162-2 - Anaerobic soil EAIRA
162-3 - Anaerobic Aquatic EAIRA
162-4 - Aerobic Aquatic EAIRA
Mobility Studies
163-1 - Leaching and PAIRA
Adsorption/
Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
B, H
B, H
N/A
N/A
B, H
N/A
N/A
N/A
B, H
N/A
N/A
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Yes
Yes
NoJ
NoJ
Yes
No
NO
NOJ
Yes 2
N0J
N0J
9 Months
12 Months
27 Months
12 Months
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEHKACHLQRVINFHOS
Data Requirement
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (NRXP) Data Be Submitted? gyitmission
Sec. 158.290 Environmental Fate (continued)
Dissipation sht^as - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-Term
164-6 - Dissipation of Residues
in Excrement
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organism
TEP
TEP
TEP
TEP
TEP
PAIRA.
TEP
TEP
TGAI OR PAIRA
TEP
B, H
N/A
N/A
N/A
N/A
I
N/A
N/A
N/A
N/A
N/A
NO
NO
NO
No
No
No
No
No
No
No
NO
Yes
No
N0J
No-
Reserved4
Reserved-
Reserved53
No5b
No1
No1
No1
27 Months
90-days f<
Protocol
27 Months for
Final Report
54
-------
TPJ3LE
GENERIC IMA REQUIREMENTS FOR TEHRACHDCRVINPHOS
Data Requirement
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Sutmission-
Sec. 158.290 Environmental Fate (continued)
Sec. 158.390 Reentry Protection
132-1 - Foliar Dissipation TEP
132-2 - Soil Dissipation TEP
132-3 - Dermal Exposure TEP
132-4 - Inhalation Exposure TEP
Sec. 158.75 Requirement for frVKHon;^
- Other Exposure Data TEP
Sec. 158.440 Sorav Drift
201-1 - Droplet Size Spectrum TEP
202-1 - Drift Field Evaluation TEP
N/A
N/A
N/A
N/A
B, H, I
N/A
N/A
No
NO
No
No
No
No
NO
NO1
NO1
No1
Nol
Yes6
NoJ
NoJ
90-Days for
Acceptable
Protocol
18 Months for
Final Report
55
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEJIRACHLQRVINEHQS
Sec. 158.290 Elrviranmental Fate - Footnotes
sec. 158.390 Reentry Protection - Footnotes
Sec. 158.440 Spray Drift - Footnotes
1 Study not required based on the registered use patterns.
2 Batch equilibrium (adsorptian/desorption) required for the domestic outdoor uses.
3 Canbinatian and tank mixes are not being addressed in this Standard.
4 ^ang-term field dissipation data requirement is deferred pending receipt of acceptable field dissipation
data (164-1). If required, the long-term field dissipation study will be due within 50 months after
notification of the requirement by the Agency.
5 Analysis of manure (droppings) frcm the feed-additive use is required at zero time, l and 2 weeks, 3,4 and 6 months
under feed lot conditions. Parent and degradate decline curve is also required.
5a Contingent on the findings of the residue analysis of excrement study.
5b Contingent on finding residues of concern in the confined crop rotation study.
6 Dermal and inhalation exposure data for mixer/loaders and/or applicators are required to support the feed additive
use, large animal dust use, poultry house use, and general spray indoor and outdoor use (the registrant must choose
at least one representative indoor and outdoor site frcm a list including agricultural premises, animal spray sites,
recreational areas, and manure piles; the registrant should provide justification for choosing a particular site).
Studies should be conducted according to the Agency's Pesticide Assessment Guidelines, Subdivision U, Applicator
Monitoring. Protocals for conducting such studies must be submitted for Agency approval.
56
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEHRACHLQRVINFHQS
Test
Data Requirement
Use
Substance
Dose EPA
Patterns
Bibliographic Timeframe
Citation Must Additional for
Have Data? (MRID) Data Be Submitted? Submission-
Sec. 158.340 Toxicology
Acute Testing
81-1 - Acute Oral - Rat
- Acute Dermal - Rat
- Acute Inhalation - Rat
81-2
81-3
81-7
- Acute Delayed
Neurotoxicity - Hen
Subchronic Testing
82-1 - 90-Day Feeding -
- Rodent
- Nonrodent
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
B, H, I
B, H, I
B, H, I
B, H, I
H, I
H, I
No Yes
No Yes
Yes 00138933 NO
Yes 00077801
Partially 00043487,
00120199
Partially 00043488
NO
NO
NO'
9 Months
9 Months
57
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEHRACHIXIRVINFHQS
Data Requirement
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? gutmission-
Sec. 158.340 Toxicology (cont'd)
Subchronic Testing (cont'd)
82-2 - 21-Day Dermal TGAI
82-3 - 90-Day Dermal TSVI
82-4 - 90-Day Inhalation TGAI
82-5 - 90-Day Neurotoxicity TStf
Chronic Testing
83-1 - Chronic Toxicity -
- Rodent TStf
- Nanrodent TGAI
83-2 - Oncogenicity -
- Rat TGAI
B, H, I
B, H, I
B, H, I
B, H, I
B, H, I
B, H, I
B, H, I
NO
NO
NO
NO
Yes 00112525
Yes 00077819
Yes 00117443
Yes
NO-
No-
No
NO
NO
Yes5»5a
12 Months
50 months
- Mouse
TGAI
B, H, I
Yes 00117443, No
00126039
58
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEXRAOtt£KVINFHOS
Data Requirement
Bibliographic Timeframe
Test Use Does ETA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission-
Sec. 158.340 Toxicology (cont'd)
Chronic Testing (cont'd)
83-3 - Teratogenicity -
- Rat
- Rabbit
83-4 - Reproduction
Mutagenicity Testing
84-2 - Gene Mutation
84-2 - Chromosome Aberration
84-2 - Other Mechanism of
Mutagenicity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Special Testing
85-1 - General Metabolism PAI or PAIRA
85-2 - Domestic Animal Safety E3?
85-3 - Dermal Absorption EM or PAIRA
H, I
H, I
H, I
B, H, I
B, H, I
B, H, I
H, I
H, I
H, I
Yes
Yes
Yes
Partially
Partially
No
00127831
00077802
00072172
00072171,
00082160
Partially 00077805
Partially
No
Reserved1
No
No
Yes
Yes
Yes
Yes
Reserved 7
Yes
9 Months
12 Months
12 Months
24 Months
12 Months
59
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEIRACHLQKVINFHOS
Sec. 158.340 Toxicology - Footnotes
1 This requirement is waived based an the submission of an acceptable chronic feeding study in the rat.
2 This requirement is waived based on the submission of an acceptable chronic feeding study in the dog.
3 Study not required based on the registered use patterns.
4 Since an acute neurotoxicity study in hens was negative this study is not required.
5 The Agency has determined that an additional oncogenicity study in rats is required.
Available studies had design deficiencies ( # of animals used was inadequate; use of pooled controls versus concurrent
controls).
5a Registrant who conduct chronic feeding and/or oncogenicity studies should inform the Agency in writing of the dosage level
planned and their reasons for believing that the highest dose approaches or equals the Maximum Tblerated Dose observed in
or range finding studies, and must also consult with the Agency to determine that the appropriate dosage levels are being
chronic feeding and/or oncogenicity studies. If ETA subsequently determines that the study was conducted using a
dosage rate that was too low to assess long-term effects, the study may be deemed not to satisfy the data requirements.
6 Data submitted in response to the December, 1984 Comprehensive Data Call-in were not received in time to be included in th
reviewed for this Standard. Therefore, no determination has been made as to the adequacy of this data satisfying the data
Should the data be found unacceptable after Agency review a new study will be required under Section 3(c) (2) (B).
7 The Agency has received adverse effects/incidents concerning the use of tetrachlorvinphos
on domestic animals (dogs, cats and horses). The Agency is re-examining all studies
concerning the toxicity and efficacy of this product to determine if additional data,
labeling or other action is warranted regarding the continued registration of this product.
60
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEHRAOfljCiRVINFHOS
Data Requirement
Bibliographic Timeframe
Test Use Does EPA. citation Mast Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission-
Sec. 158.490 Wildlife and Aquatic
Organisms
Avian And Manmalian Testing
71-1 - Avian Acute Oral
Toxicity TGAI
71-2 - Avian Subacute Dietaa
Toxicity TGAI
71-3 - Wild Mairmal Toxicity TGAI
71-4 - Avian Reproduction TGAI
71-5 - Simulated and Actual
Field Testing for
Mammals and Birds TEP
Aquatic Organisms Testing
72-1 - Freshwater Fish Acute
Toxicity TGAI
72-2 - Acute Toxicity to Fresh-
water Invertebrates TGAI
B, H, I2
B, H, I2,3
B, I
B, I
B, I
B, H, I2,3
B. H, P
Yes 00160000
Yes 00022923
NO
NO
NO
Yes 40098001
NO
NO
NO
NoJ
NoJ
NoJ
No
Yes
9 Months
61
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TETOACHLOKVINFHQS
Data Requirement
Bibliographic Timeframe
Test Use Does EPA citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission-
Sec. 158.490 Wildlife and aquatic Organisms (cont'd)
aquatic Organisms Testing (cont'd)
72-3
72-4
- Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Shrimp
- Oyster
- rish Early Life Stage
and Aquatic Invertebrate
Life Cycle
- Freshwater
- Estuarine
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
TEP
B
B
B
B
B
B
B
B
B
B
NO
NO
No
No
No
No
No
No
No
No
NO1
NO1
NO1
NO1
NO1
NO1
NoJ
NoJ
NO
NOJ
62
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TEIRAafli3?VINEHQS
Bibliographic Timeframe
Test Use Does ETA Citation Must Additional for
Data Requirement Substance Patterns Have Data? (MRID) Data Be Submitted? Submission-
Sec. 158.490 Wildlife and Aquatic Organisms (cont'd)
Aauatic Organisms Testing (cont'd)
72-5 - Fish Life Cycle TCAI B No No1
HP B NO NO1
72-6 - Aquatic Organism
Accumulation TEP B No No1
72-7 - Simulated or Actual
Field Testing
- Aquatic Organisms TEP B No No1
63
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TEHRACHXJRVINPHQS
Sec. 158.490 Wildlife and aquatic Organisms - Footnotes
1 Study not required based on the registered use patterns.
2 Study required to support the manufacturing use product reformulated into end-use products.
3 Only one species need be referenced.
64
-------
TABLE A
GENERIC DMA REQUIREMENTS FOR TE33*ACHIXKVINFHQS
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data? (MRID) Data Be Submitted? Submission-
Ttat-a Rpcmi remnent
Sec. 158.590 Nantarqet Insects
NCMrARGET INSECT TESTING - POT,17
BS
141-1 - Honeybee Acute Contact
Toxicity TGAI
141-2 - Honeybee - Toxicity of
Residues an Foliage TEP
141-4 - Honeybee Subacute
Feeding Study Reserved1
141-5 - Field Testing for
Pollinators TEP
KCMmRGET INSECT TESTCKC - AQUATIC INSECTS
142-1 - Acute Toxicity to
Aquatic Insects Reserved3
142-2 - frjuatic Insect
Life-cycle Study Reserved3
142-3 - Simulated or Actual
Field Testing for
Aquatic Insects Reserved3
NrTJTAPf^TT TTJSFTT TESTING - PREDATORS AND PARASITES
B, H
B, H
Yes
Yes
00036935
05000837
NO
NO
B, H
No
NO^
143-1
thru
143-3 -
Reserved3
65
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TE3RACHLQRVINPH0S
Sec. 158.590 Nantarcret Insects - Footnotes
1 Reserved pending development of test methodology.
2 Available data do not indicate the need for field testing.
3 Reserved pending Agency decision as to whether the data requirement should be established.
66
-------
TABLE B
PRCQXJCT-SPECIFIC DATA REQUIREMENTS FCR MANUFACTORIN3-USE PRODUCTS CONIAINING TEHKACHLQRVINFHOS
Data Requirement
Part 158. Subpart C. Pr^Ff rhCTngtry
Product Identity and Composition
61-1 -
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance- Patterns Have Data?^ (MRID)^ Data Be Suftnitted? Submission
Product Identity
and Disclosure of
Ingredients
61-2 - Description of starting
Materials and Manufac-
turing Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of
Prnrtnri- ingredients
62-1 - Preliminary Analysis
of Product Samples
MP
MP
MP
All
All
All
NO
NO
NO
N/A
N/A
N/A
Yes'
Yes-
Yes ¦
6 Months
6 Months
6 Months
MP
All
NO
N/A
Yes-
12 Months
62-2 - Certification of
Ingredient Limits
MP
All
NO
N/A
Yesc
12 Months
62-3 - Analytical Methods
to Verify Certified
Limits
MP
All
NO
N/A
Yes'
12 Months
67
-------
Data Requirement
TABLE B
HOXJCT-SPECIFIC DMA REQUIREMENTS FCR MANUFACTURING-USE PRODUCTS CCNIAINING TEHRACHLORVINPHCS
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance- Patterns Have Data?^ (MRID)^ Data Be Submitted? Submission
Part 158. Subpart C. Product Chemistry
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flaircnability
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
NO
NO
NO
NO
NO
NO
NO
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes*
Yes£
Yes1
Yes1
Yes8,9
Yes8,10
Yes8,
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
68
-------
TABLE B
HOXJCT-SPECIFIC DATA. REQUIREMENTS FOR MANUF7\CIURING-USE PRODUCTS COSTCAINING TETOACHLORVINFHCS
Bibliographic Timeframe
Test Use Does EPA Citation Must Additional for
Substance Patterns Have Data?^ (MRID)2 Pata Pe Submitted? gubpiissjon
Data Requirement
Part 158. Subpart C. Tyyhv>i- rh^m-ioi-ry (cant'd)
Physical and Chemical
Characteristics (cont'd)
63-16 - Explodability
MP
All
NO
N/A
Yes8»^
9 Months
63-17 - Storage Stability
MP
All
NO
N/A
Yes6
15 Months
63-18 - Viscosity
MP
All
NO
N/A
Yes8,13
9 Months
63-19 - Miscibility
MP
All
NO
N/A
Yes8,X4
9 Months
63-20 - Corrosion Characteristics
MP
All
NO
N/A
Yes1
15 Months
Other Requirements:
64-1 - Submittal of Samples
N/A
N/A
N/A
N/A
NO
15
69
-------
TART.F! B
H03UCT-SPEEIFIC DMA REQUIREMENTS FOR MANUFACIURING-USE PRCDUCTS CONTAINING TE3RACHL0RVINFHCS
Part 158. Subpart: C. Ppvtum- fhemistrv - Footnotes
1 Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined
that these data must be resubmitted for each pesticide. New requirements have been introduced and previously
submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2 The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and
purpose of the active ingredient and each intentionally added inert must be provided. For the active ingredients,
the following must also be provided: the product, common, and trade names; the molecular, structural, and empirical
formulas; the molecular weight or weight range; and any experimental or internally assigned company code numbers.
3 Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration
of each step of the process, purification procedures, and quality control measures. In addition, Specific data
have been required from registrants an 6/15/87 regarding the identity of all halogenated di-benzo-p-dioxins and
dibenzofurans occurring in each technical product, analytical methods for their detection and quantitation, and
and certification of limits of these contaminants.
4 A detailed discussion of all imparities that are or may be present at >0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
5 Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which
a certified limit is required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used.
6 Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at >0.1% (w/w) and each "toxicologically significant" impurity present at <0.1% (w/w) must be
provided, certified, and validated by sample analysis using analytical procedures for which accuracy and precisian
data have been provided. Limits for impurities not associated with the active ingredient need be provided only if
they are considered to be of toxicological significance, regardless of the concentration at which they are present.
Certifications must be submitted on EPA Form 8570 Rev. 2-85.
70
-------
TABLE B
FRIXOCT-SPECIFIC DATA. REQUIREMENTS FOR MANUETKHURING-USE PRODUCTS CCWIAINING TE^RACHLCfRVINFHOS
Part 158. Subpart C. Prnrhint chemistry - Footnotes (continued)
7 Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally artripri inert for which certified limits are required. Each method must be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
® Ehysicochemical characteristics as required in 40 CFR 158.190 and more fully described in the Pesticide Assessment
Guidelines, Subdivision D, must be submitted.
9 Data required if the test substance is dispersible in water.
10 Data required if the product contains an oxidizing or reducing agent.
11 Data required if the product contains combustible liquids.
12 Data required if the product is potentially explosive.
13 Data required if the product is a liquid.
14 Data required if the product is a liquid and is to be diluted with petroleum solvents.
15 If samples are needed, the Agency will request then.
71
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CCWIAINING TEIRACHLQKVINPHOS
Data Requirement
Test
Substance^
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
(MRID)
Must Additional
Data Be Submitted?
Timeframe
for
Sutmissioi
Sec.
158.340 Taxicoloav
Acute Testina
81-1
- Acute Oral - Rat
MP
H, I
No
Yes
9 Months
81-2
- Acute Dermal - Rat
MP
H, I
No
Yes
9 Months
81-3
- Acute Inhalation - Rat
MP
H, I
Yes
00138933
NO
81-4
- Eye Irritation - Rabbit
MP
H, I
No
Yes
9 Months
81-5
- Dermal Irritation -
Rabbit
MP
H, I
No
Yes
9 Months
81-6
- Dermal Sensitization -
Guinea Pig
MP
H, I
NO
Yes
9 Months
81-7
- Acute Delayed
Neurotoxicity - Hen
MP
H, I
Yes
00077801
No
72
-------
TABLE B
PRODUCT-SPECIFIC IMA REQUIREMENTS FOR MANUFACTURING-USE HRQDUCTS CCMEAINIISE TE3RACHLQRVINFH0S
Sec. 158.340 Ttaxicoloov - Footnotes
1 Test material: MP = Manufacturing-Use Product.
2 Due dates refer to the number of months following the registrant's receipt of this Registration Standard, unless
otherwise indicated.
75
-------
LABELING APPENDICES
74
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered in
the upper part of the panel. The name of a product will not be
accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The name
and address should preferably be located at the bottom of the
front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end of
the label test. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
ment at which the product was produced, and may appear in any
suitable location on the label or immediate container. It must
also appear on the wrapper or outside container of the package if
the EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container. [40 CFR
156.10(f)]
75
-------
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
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word Keep Out of Reach
Minimum Type Size of Children"
All Capitals Minimum TYP
-------
SUMMARY-3
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel. [40 CFR
156.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning statements must be headed by the appropriate
hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on the
results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel precautionary
statements section, preceded by the heading "Physical/Chemical
Hazards." Note that no signal word is used in con-junction with
the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
77
-------
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 not
restricted, but you may not distinguish them on the label as
being unrestricted.
b. You may delete all restricted uses from your label
and submit draft labeling bearing only unrestricted uses.
78
-------
SUMMARY-5
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one bearing
only unrestricted uses, and the other bearing restricted uses.
To do so, submit two applications for reregistration, each
containing all forms and necessary labels. Both applications
should be submitted simultaneously. Note that the products will
be assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the
label. Additional worker protection statements may be required
in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and appear
under the heading "Storage and Disposal" in the directions for
use. This heading must be set in the same type sizes as required
for the child hazard warning. Refer to Appendix II, STOR,
PEST/DIS, and CONT/DIS to determine the storage and disposal
instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to 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.
79
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SUTWARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
1
ITEM 1 IARFT. FT.FMFMT
APPLICABILITY
OF REEUIREMENI
PLACEMENT CN LABEL 1
REQUIRED 1 PREFERRED 1
1 | Product name
1
All products
Front panel | Center front |
1 panel 1
2 | Company name
| and address
1
All products
None | Bottom front | If registrant
| panel or end j be qualified
1 of label text 1 "Distributed
3 | Net contents
1
1
All products
None | Bottom front | May be in met
| panel or end j U.S. units.
1 of label text 1
4 | EPA Reg. No.
1
All products
None | Front panel | Must be in si
1 1 parallel to o
5 | EPA Est. No.
1
1
1
1
All products
None | Front panel | May appear on
j imnediately | the label,
j before or j
j following j
1 Rea. No. 1
6A | Ingredients
I statement
1
All products
Front panel | Iirmediately | Text must run
j following | on the panel.
1 product name 1
6B | Pounds/gallon
j statanent
1
1
Liquid products
where dosage is
given as lbs.
ai/unit area
Front panel | Directly below |
j the main j
| ingredients j
1 statanent 1
7 | Front panel
j precautionary
1 statements
All products
Front panel | | All front pan
j j must be group
1 1 blocked.
7A | Keep Out of Reach
j of Children
j (Child hazard
1 warnina)
All products
Front panel | Above signal | Note type siz
j word j
1 1
1 1
7B | Signal word
1
1
1
All products
Front panel | Imnediately | Note type siz
| below child j
j hazard j
1 warnina 1
80
-------
SUMMARY-7
TARFT.TTJj REQUIREMENTS OF THE FIFRA. AS AMENDED (cant'
ITEM
| APPLICABILITY
LABEL ELEMTOT1 I OF RfclXl IHFMFNT
PLACEMENT CM LABEL 1
REQUIRED 1 PREFERRED 1
7C
Skull & cross- | All products
bones and word j which are Cat-
POISCN (in red) j egory I based
I on oral, der-
j mal, or inhala-
1 tion toxicity
Front panel | Both in close |
j proximity to j
j signal word j
1 1
1 1
1 1
ID
Statement of | All products
Practical j in Categories
Treatment or j I, II, and III
First Aid j
1
1
1
1
1
1
Cateaorv I: 1 Front oanel 1
Front panel | for all |
unless refer-j j
ral statement | |
is used. j |
Others: 1 1
Grouped with | |
side panel j j
precautionaryj j
statements. 1 1
7E
Referral | All products
statement j where pre-
j cautionary
j labeling
j appears an
j other than
1 front nanel
Front panel | |
1 1
1 1
1 1
1 1
1 1
1 1
8
Side/back panel | All products
precautionary j
statements j
1
1
None | Top or side | Must be group
j of back panel j 8A, 8B, and 8
j preceding |
j directions j
1 for use 1
8A
Hazards to | All products
humans and j in Categories
domestic j I, II, and III
animals 1
None | Same as above I Must be prece
j j word.
1 1
1 1
8B
Environmental I All products
None | Same as above | Environmental
1 1 caution where
81
-------
SUNfflARY-8
TABFT.TTJn RBOUXREMENTS OF THE FIFRA. AS AMENDED (cant'
| APPLICABILITY |
PLACEMENT CN LABEL
ITEM
1 LABEL FT.FMFTvrr
1 OF REQUIREMENT 1
REBUIRED
1 PREFERRED
8C
| Physical or
|All pressurized |
None
| Same as above
| Refer to Appe
| chemical
I products, others |
1
| PHYS/CHEM
| hazards
|with flash |
1
1
| points under |
1
1
I1502f 1
1
9A
I Restricted
|A11 restricted |
Top center
I Preferably
I Includes a st
I block
|products |
of front
| blocked
j restriction.
1
1 1
panel
1
| PESTICIDE" im>
1
1 1
1
1 sianal word.
9B
I Misuse
|A11 products |
Inmediately
1
I Required stat
j statement
1 1
following
1
j "It is a v
1
1 1
heading of
1
| to use th
1
1 1
directions
1
j inconsist
1
1 1
for use
1
10A
| Reentry
|PR Notice 83-2 |
In the
| Inmediately
| statement
jor as determined j
directions
j after misuse
1
bv the Aaencv 1
for use
1 statement
10B
| Storage and
|A11 products |
In the
I Inmediately
I Must be set a
j disposal block
1 1
directions
j before
j guishable fro
1
1 1
for use
j specific
j for use.
1
1 1
I directions
j Refer to Appe
1
1 1
| for use or
I CCNT/DIS, and
1
1 1
| at the end of
| information a
1
1 1
I directions
1
1 1
1 for use
IOC
| Directions
|A11 products |
None
I None
| May be in met
1 for use
1 1
1
82
-------
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HHMmMMUUI
PESTICIDE ,
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83
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0t
PRODUCT
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MM
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TOTAL.
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KEEP OUT OF REACH OF CHILDREN
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ITAIIHMTtf HVCnULIMAIUM
riNMUMO:
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84
-------
40 cm Oi. I (7-147 KdHton)
• 1U.1Q L*S«linc r»*ulr General-* 1> ConUnU of ttu
labeL Every pesticide products shall
bear a label containing the lnforma-
tlon specified by the Act and the refu-
tations in ***** Pvt. The contents of &
libel must show clearly tad promi-
nently the f«*'\.»lng:
(1) The name. brand. or trademark
under which the product Is sold as pre-
scribed ui paragraph (b) of this sec-
tion:
of this section:
The product registration
number u prescribed in paragraph to
of this section:
of this sec-
tion:
(vil) Warning or precautionary state-
menu as p»escribed la paragraph (h)
of this section:
(rltn The directions for use as pre-'
scribed la paragraph (I) of this section;
and
as pre-
scribed In paragraph (]) of this section.
(2) Pro'iintnc* and Ugibihty. m All
words, statements, graphic represents-
uens. designs or other Information re-
quired on the labeling by the Act or
the regulations In this part must be
dearly legible to a person with normal
vision, and must be placed with such
consplcuousneas (as compared with
other words, statements, designs, or
mphic matur on the labeling) and
espnesed la such urns as to render it
likely to be read and understood by
the ordinary Individual under custom-
try conditions of purchase and use.
(U) All required label text mute
(A) Be set to t-petnt or larger type:
(B) Appear oa a dear contrasting
fromunit; and
(C) Not be obscurid or crowded.
(S) Lnemam to bt ass* All required
MM or lahellng test ahall appear in
the teglish language. However, the
Agency may require or the applicant
Bay propose additional test la other
tanguacM as Is considered necessary to
protect the public When additional
tist in another language Is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
lac.
(4) Maermgnt of Labti—<1> Onwrol
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 me 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 padtage as
customarily distributed or sold.
(U) Tank can and oOur bulk con-
tainer*— false or misleading ttaUmnU.
Pursuant to section ftqxiKA) of the
Act. a pestidds or a device declared
subject to the Act pursuant to
111X15. la mlsbraadsd If Its labeling Is
false or misleading to any particular
including both pestuirtal aad non-pes-
tlcidal claims Examples of statements
or representations to the labeling
which constitute misbranding include:
(l) A false or misleading statement
concerning the ram position of the
product;
-------
scribed in paragraph of this sec-
tion.
(id The n*">e and address of the
producer. rutstrant. or person for
whom produced ai prescribed In para-
graph of this aection;
all) The net contenu as prescribed
In paragraph (d) of this aection:
(lv) The product registration
number aa prescribed In paragraph <•>
of this aection;
(v) The producing establishment
number as prescribed In paragraph The directions for use as pre-
scribed In paragraph (I) of this section:
and
dx) The use classifications) as pre-
scribed in paracraph (J) of this section.
(3) Prominent* and legibility. (I) All
words. statement*, graphic represents,
ttens. designs or other information re-
Quired on the labeling by the Act or
the regulations in this part must be
dearly legible to a person with normal
vision, and must be placed with such
conspicuousneas (as compared with
other words, statements, designs, or
graphic matter oo the labeling) and
expressed in such terms aa to render it
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(11) All required label Uxt muse
(A) Be set Is t-point or larger typo:
necessary,
all labeling requirements will be ap-
pllad squally to both the English and
other-language versions of the label-
lag.
(4) Micnmi of Label—t\) OeneraL
Tho laboi 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" ahaU mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. U the im-
mediate container la enclosed within a
wrapper or outside container through
which the label cannot be dearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer. if It Is a part of the package u
customarily distributed or sold.
(11) Tan* ears and other bulk con-
tainers—< A) Transportation. While a
pesticide product Is in transit, the ap-
propriate previsions of 49 C7R 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 baste Federal
requirements. Ih addition, when any
registered pesticide product Is trans-
ported In a tank ear. 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 dlrectiona for use. shall
be securely attached to the container
In the Immediate vicinity of the dis-
charge control valve.
it) false or mttMdtnp liaimmu
Pursuant to section KqxlXA) of the
Aet. a psstlclds or a device declared
subject to the AA pursuant to
11(3.19. to atobranded If Its labeling Is
false or misleading In any particular
Including both posftrtdil end non-pes-
Ucidal claims. Examples of statements
or representations In the labeling
which constitute misbranding include:
(I) A (alga 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;
(Ul> A false or misleading statement
about the value of the product for
86
-------
purposes other than u a pesticide or
dm ice.
> A false ~ misleading comparison
»ith other pesticides or devices:
(v> Any statement dlrectJy or Indi-
rectly implying that the pesticide or
device u recommended or endorsed by
any agency of the Federal Govern-
ment;
(vt> The name of a pesticide which
contains two or more principal active
ingredient* if the name suggests one
or more but not all such principal
active ingredients even though %jihe
names of the other Ingredients are
luted 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.
(villi Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
Claim* as to the safety of the
pesticide or Its Ingredient*. Including
statement* such as "safe,'1 "oonpoison-
out." "noninjurlou*." "harmless" or
"nontoxic to humans and pets" with
or without rach a qualifying phrase a*
"when used a* directed"; and
(x) Non-numerical and/or compara-
tive statements oa the *afety of th«
product, including but not limited to:
(A) "Contains all natural Ingredi-
ents":
(B) Among the least toxic chemi-
cals known"
"Pollution approved"
<•> final printed tabsling. (I) Except
as provided in paragraph (axtxil) of
this Mellon. Qztal printed labeling
must be submitted and accepted prior
to registration. However. Qnai printed
labeling aood not be suhmlttod until
draft label texts have been provision*
ally accepted by the Asoney.
Clearly lagfbte reproductions or
photo nducUav wtll bo aoosptsd for
khdi saeh aa umm ellk-
gutotuod directly onto tins or soul
oootalnm or iarte ba« or drum labels,
¦uefe reproductions must bo of micro*
flfan reproduction quality.
Mama, brand. or frodemortt <1)
Tbo nam*, brand, or trertsimrtt under
which the psstidds product la sold
ahall appear oa tbo front panel of the
label.
(2) No name, btand. or trademark
may appear on the label which.
tl) Is false or misleading, or
(il) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to 1l«2.«
-------
registration ihall appear on the label,
preceded >./ the phrase "EPA Refl*-
tration No.." or the phrase "CPA Reg.
No." The registration number shall be
•el 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
•hall not appear In such a manner aa
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing estabiithmtnU rtgti-
(ration number. The producing estab-
lishment registration number preced-
ed by the phrase "CPA Cat.", 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 CPA establishment reg-
istration number on the Immediate
container eannot bo clearly read
through such wrapper or container.
-------
the label: "Not for sale or uk after
(date!"
(ID The product must meet all label
claim* up to the expiration time Indi-
cated on the '-bel.
<7) Inert «»0redicnU. The Adminis-
trator may require the name of any
inert Ingredienus) to be lifted in the
Ingredient abatement IX he determines
that iuch Ingredient! i> may pose a
hazard to man or the environment.
Warning* and precautionary
ttaUmenU. Required warnings and
precautionary statements concerning
the general areas of toxicologtcsJ
hasard including hazard to children,
environmental hasard. and physical or
chemical hazard fail 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 pan*I ttatcmenU.
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
hasard shown by any of the Indicators
In the table betow:
T—II
¦ ! • | ¦
IV
DmiC.
WlMXMlK 1 W •«. 100 «•/>«
T»4
V» « M IUWI I *•«¦> J OK 1
*%/mm \
u»>e mm wan KB 'rvr> no wm JOOD
100 An* MOB wq/
H
hwm t M ID aiva*
>foi LOOOmv 20000
Otmtm »KP WOO mgi
H
Onav *>an 30 W|f—
Gtmvm nw JO 000
n ROM
mmrntm* \ m*
1 ""***
no**
tu Human hasard nana! word—4A)
Toxicity Category /. All pesticide prod-
ucts meeting the criteria of Toxicity
Category 1 shall bear on the front
panel the signal tord Danger, lo ad-
dition if the product was assigned to
Toxicity Category I on the basis of lu
oral. Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Mm" shall appear
In red oq a background of distinctly
contrasting color and the skull and
croasbones shall appear la Immedlste
proximity to the word "poison."
Toxicity Category j. a
89
-------
guiement of practical treatment (first
aid or other: ''.ill appear on th« front
panel of the label of all pesticides fall-
ing into Toxicity Category I on the
Df«u 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 croesbones.
(B) Othrr toxicity categories. The
statement of practical 'reatraent Is not
required on the front panel except as
described In paragraph (hxlxuixA) 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 <2> of this
section 11 they do not appear on the
front panel.
(lv) Macwmmt and prominence. AH
the require front panel aarning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
from panel lexi and of exposure and the precau-
tions to be taken to avoid accident,
injury or damage- The precautionary
paragraph ihili be tnune^uiel} pre-
ceded by the appropriate hazard signal
word.
(B) The (allowing table depicts typl.
eal precautionary itatefrents These
statements must be modified or ex-
panded to reflect specific hazards.
(U) favfammmiai hatards. Where a
hazard exists to non target organisms
excluding human* and domestic ani-
mals. precautionary statements are re-
quired staring the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage, examples of the
90
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hasard statements ind the drcurn-
Mtnca under vblcii they we required
follow:
(A) If a pahwdde Intended for out-
door use contains an active ingredient
with a iw»»wm«naw acute oreJ LD» of
100 or leas, the statement "This Pesti-
cide Is Toxic to Wildlife" is required.
II s pesticide Intended for out-
door use contains an active incredient
with a fish acute LC. of 1 ppm or lets,
the statement "This Pesticide Is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active incredient
with an avian scute oral LDm of 100
tag/kg or leas, or a subacute dietary
VC-n of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
(O) If either scddent history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammali. the statement
"This peatidde is extremely toxic to
wildlife (fish)" Is required.
The label bear
the directions f or um la i
leaflets or circular*, such
rectloas la the tnclOMd circular"
(C) The Administrator determines
that It Is not neeeoeary for such direc-
tion* to appear an the label.
(Ill) IiwiHoiu lo muirwmmt for
directum far mm-(A) Detailed dlrec-
91
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Uona for uae may be omitted from li-
beling of pesticides which are Intended
for uae only by ~ oufacturen of prod-
uct* other than pesticide product! in
their regular manufacturing prooesaea.
provided that*
<;> The label dearly shows that the
product la intended for use only in
manufacturing processes and cped/ies
the typecs) of products involved.
(2) Adequate Information such as
technical data aheeta or bulletins, la
available to the trade specifying the
type of product involved and lu
proper uae In manufacturing proeeaa-
ea;
< J) The product will not cone Into
Uw hands of the general public except
after incorporation Into finished prod-
ucts: and
<*> The Administrator determines
that such directions art not air—»ry
to prevent unreasonable advene ef-
fects on man or the environment.
(B) Detailed directions for uae may
be omitted from the labeling of peotf-
dde products for which sale Is limited
to physicians, veterinarians, or drug-
gists. provided that:
(1) The label clearly states that the
product is for use only by physicians
or veterinarians:
<2) The Administrator determines
that such directions art not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(2) The product to also a drug and
regulated under the previsions of the
Menl Food. Drug and Cosmetic Act.
Detailed direction (or use may
be omitted tram the of pesti-
cide products which are Intended for
use only by formulate!* ta preparing
new id dee (or sale to the public, pro-
ndidUtti:
(I) There Is Information readily
•nibble to tho formulatora on the
toaoagtuon. tosktty. methods a( use.
¦Wilh.slils rmuteUdM or limitations.
vttfjedNM of tho product for
<2) The label eloarly states that the
Moduet It Intended (or uae only la
manufacturing, formulating, mixing.
* repacking (or use as a pesticide and
^oetfles the type of application, as for
example the crops. "«¦»«'« areas, or
objects to be treated.
(lv) The target pestfs) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl) The method of application. In-
cluding instructions for dilution, if re-
quired. and type of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without eauslng unreasonable
adverse effects on the environment.
(vtii) Specific limitations on reentry
to areas whore the pesticide has been
applied, meeting tho requirements
concerning reentry provided by 40
CPU Part 170.
Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirements of 40 CFR Part 185. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." ThU heading must be
set in type of the same minimum sues
as required (or the child haaard warn*
Ing. (flee Table in I lSXlOthMlxlvl)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects. such as:
(A) Required intervals between ap-
plication and harvest of food or (eed
crops.
(B> Rotational crop restrictions.
92
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(C) Warnings u required against use
on eerum crops. animals. object*. or
la or adjacent tc .ertain areas.
CD) [Reserved]
(X) 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
penon applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically present.
(F> Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Utt Clamrtcarton.
By October 22. 1976. all pesticide prod-
ucts must bear on their labels a state*
ment of use classification as described
la paracraphs (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 separaie~=producta=«tth^-diffefent-
rectitrauon numbers, one bearing di-
rections only for general use and
the other bearing directions for re-
stricted use except that. If a product
has both restricted use and general
usrts). both of these uses may appear
en a product labeled for restricted use.
Such products shall be subject to the
provisions of I lg2.10(]X2).
(1) General Um Oautfleotion. Ptsti-
ctds products bearing directions for
usees) classified general shall be la-
beled with the exact words "Oeneral
Classification" Immediately below the
has ding "Directions for Use." And ref-
erence to Um general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
bsyopd thoss puiposss and uses con-
tained in the Directions for Cse will be
oooslderod a false or misleading state-
ment under the statutory definitions
of nUbnadtag.
(3) JbiMM Um Ctaaeiflcation.
Pestlcids products bearing direction
for use Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
t*rms of restriction by regulation.
(fci Advert la Inf. tRwgrvedl
140 FR 3S3SS. July 1. 1973. 40 FR 12329.
Aug i. irrs. «o pr 3«s7i. Aug. >i. ins. ss
intended si 43 PR S7SS. Prt. 9.19?S1
93
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FHYS/CHEM-1
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required r.ahpi Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame.
Do not use or store near
heat and open flame.
None required.
94
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading:
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
95
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or feed
by storage or disposal."
2. Except those products intended solely for domestic use, the
labels of all products that contain active ingredients that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I or
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
96
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type Statement
|Non-aerosol products |Do not reuse container (bottle, can, jar).
I(bottles, cans. iars)lRinse thoroughly before discarding in trash.
|Non-aerosol products |Do not reuse bag. Discard bag in trash.
I (bags) I
|Aerosol products |Replace cap and discard containers in
| I trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
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 arrowed^by state ana
local authorities, by burning. If burned,
stay out of smoke
t
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
Paper and
plastic bags
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused-^-/, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording).
/ Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
97
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III. BIBLIOGRAPHY APPENDICES
98
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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.
99
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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,"
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.
100
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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.
101
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tetrachlorvinphos Standard
MR ID CITATII'^
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)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. 8y University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00038458 Schultz, D.R.; Rawn, D.T.; DeKay, D.E. (1973) Residues of SD 8447
1n Biopsy Fat Samples from Pigs Fed 400 and 800 PPM Stirofos in
the Ration: TIR-26-005-73. (Unpublished study received Jun 27,
1980 under 0H5269; prepared by Shell Development Co., submitted
by Diamond Shamrock Agricultural Chemicals, Cleveland, Ohio;
COL: 242780-G)
00038485 Plccirillo, V.J.; Smith, J.M. (19??) Toxicology: Summary and Eval-
uation. (Unpublished study received Jan 21, 1976 under 5G1566;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:095050-A)
00043487 Stevenson, D.E.; Ferrlgan, L.W. (1965) The Sub-acute Toxicity of
the Halophenyl vinyl phosphate Insecticide SO 8447 to Rats: Re-
port No. R(T)-l-65. (Unpublished study received Feb 25, 1966
under unknown admin, no.; prepared by Shell Research, Ltd., Eng-
land, submitted by Shell Chemical Co., Washington, O.C.; CDL:
107943—IC)
00043488 Walker, A.I.T.; Hunter, C. (1965) The Sub-acute Oral Toxicity of
the Halophenyl vinyl phosphate Insecticide SE 8447 to Oogs: Re-
port No. R(T)-6-65. (Unpublished study received Feb 25, 1966
under unknown admin, no.; prepared by Shell Research, Ltd.,
England, submitted by Shell Chemical Co., Washington, O.C.; CDL:
107943-L)
00072171 Crlpps, R.E.; Doak, S.; Whltebread, C.; et al. (1974) Toxicity
Studies with Gardona: Effect of Gardona on Micro-organisms 1n
the Host-mediated Assay and in vitro: Group Research Report
TLGR.0066.74. (Unpublished study received Mar 30, 1979 under
201-407; prepared by Shell Research, Ltd., England, submitted by
Shell Chemfcal Co., Washington, D.C.; CDL:237921-C)
102
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data 8ase Supporting
Registrations Under the Tetrachlorvinphos Standard
MR 10 CI TAT 10?:
00072172 Dean, B.J.; Van der Pauw, C.L.; Stevenson, D.E. ( 1976) Toxicity
Studies with Gardona: Dominant Lethal Assay in Male Mice after
Single Oral Doses or 5 Daily Oral Doses of Gardona: Group Re-
search Report TLGR.0069.76. (Unpublished study received Mar 30,
1979 under 201-407; prepared by Shell Research, Ltd., England,
submitted by Shell Chemical Co., Washington, D.C.; CDL:237921-0)
00077801 Brown, V.K.; Ferrigan, L.W.; Hunter, C.G. (1965) Detnyell nation
Studies with the Insecticide SD 8447: Tox 8/65. (Unpublished
study received May 23, 1967 under 8G0665; prepared by Shell Re-
search Ltd., England, submitted by Shell Chemical Co., Washing-
ton, D.C.; CDL:091166-L)
00077802 Eisenlord, G.; Loquvam, G.S.; Nemenzo, J.; et al. ( 1966) Results of
Reproduction Study of Rats Fed Diets Containing SD 8447 Insecti-
cide over Three Generations: Report No. 28. (Unpublished study
received May 23, 1967 under 8G0665; prepared by H1ne Labora-
tories, Inc., submitted by Shell Chemical Co., Washington, D.C.;
COL:091166-M)
00077805 Hutson, D.H.; Akintonwa, D.A.A.; Griffiths, M,H.; et al. (1966) The
Metabolism of 2-Ch1oro-l-(2',4',5'-trichlorophenyl)v1nyl Dimeth-
yl Phosphate (SD 8447) 1n the Dog and Rat: Research Report R(T)-
9-66. (Unpublished study received May 23, 1967 under 8G0665;
prepared by Shell Research Ltd., England, submitted by Shell
Chemical Co., Washington, D.C.; COL:091166-P)
00077812 Shell Development Company (1966) Residue Determination of SD 8447
and Its Low-melting Isomer SD 13462 in Agricultural Crops: GLC
Electron Capture Method. Analytical method MMS-71/66 dated
Jan 21, 1966. (Unpublished study received May 23, 1967 under
860665; COL:091166-At)
00077814 Shell Development Company (1966) Residue Determination of SO 8447
and Its Low-melting Isomer SD 13462 in Agricultural Crops: GLC
Phosphorus Detector Method. Analytical method MMS-80/66 dated
Oec 1966. (Unpublished study received May 23, 1967 under
860665; C0L:09U66-AG)
00077816 Shell Development Company (1967) Residue Determination of Acid
Hydrollzable Conjugate Metabolites from SO 8447 Treated Crops:
6LC Electron-capture method. Analytical method MMS-85/67 dated
Apr 1967. (Unpublished study received May 23, 1967 under
860665; COL:091166-AI)
103
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tetrachlorvtnphos Standard
MR ID CITATIC..
00077819 Doyle, R.L.; Teske, R.H.; Elsea, J.R. ( 1968) Two-year Dietary Ad-
ministration of SD 8447 to Dogs: P-99A. (Unpublished study re-
ceived Aug 17, 1968 under 9F0739; prepared by Hill Top Research,
Inc., submitted by Shell Chemical Co., Washington, D.C.; CDL:
091273—A)
00082160 Dean, B.J.; Senner, K.R. (1974) Toxicity Studies with Gardona:
Chromosome Studies on Bone Marrow Cells of Chinese Hamsters
after Two Daily Oral Doses of Gardona: Group Research Report
TIGR.0062.74. (Unpublished study received Feb 6, 1976 under
201-225; prepared by Shell Research, Ltd., England, submitted by
Shell Chemical Co., Washington, D.C.; COL:223348-D)
00084189 Ivey, M.C.; DeVaney, J.A.; Ivie, G.W. (1981) Residues of Stirofos
(Rabon) 1n Eggs of Laying Hens Treated for Northern Fowl
M1te Control by Dipping. (U.S. Dept. of Agriculture, Science
and Education Administration, Agricultural Research, Veterinary
Toxicology and Entomology Research Laboratory; unpublished stud-
y; CDL:245949-A)
00091657 Anderson, L.D.; Atkins, E.L., Jr. ( 1966) 1965 Research on the
Effect of Pesticides on Honey Bees: Submitter 17923. (Unpub-
lished study received Jan 18, 1968 under 3125-143; prepared by
Univ. of California—Riverside, Entomology Dept., submitted by
Mobay Chemical Corp., Kansas City, Ho.; CDL:00563S-T)
00112525 Walker, A.; Hunter, C. (1967) The Oral Toxicity of the Halophenyl
Vinyl Phosphate Insecticide Gardona (SD 8447): Two Year Oral
Experiment 1n Rats: Research Report R(T)-9-67. (Unpublished
study received Aug 17, 1968 under 9F0739; prepared by Shell Re-
search Ltd., Eng., submitted by Shell Chemical Co., Washington,
DC; CDL:091274-0)
00115939 Shell Chemical Co. ( 1972) Residue Data 1n Reply to EPA's July 10,
1972 Letter of Special Review for Clovap EC Insecticide. (Com-
pilation; unpublished study received Sep 20, 19 7 2 under 201-244;
C0L:000948-A)
00116020 Shell Chemical Co. (1970) Residue Data Oeveloped from the Use of
Oalry Cattle: Rabon. (Compilation; unpublished study received
Jan 19, 1970 under IF 1090; CDL:090850-B)
00116553 Shell Chemical Co. (1971) The Results of Tests on the Amount of
Residues Remaining, Including a Description of the Analytical
Methods Used: Gardona. (Compilation; unpublished study re-
ceived Oct 12, 1972 under 2F1281; C0l:091818-B)
104
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Oata Base Supporting
Registrations Under the Tetrachlorvinphos Standard
MR ID CITATION
00117298 Miller, R.; Gordon, C. (19??) Effect of feeding Rabon to dairy cows
over extended periods. Journal of Economic Entomology 66(1):
135-138. (Also m unpublished submission received Oct 17, 1973
under 201-359; submitted by Shell Chemical Co., Washington, DC;
CDL:050006—G)
00117329 Shell Chemical Co. (1969) Gardona: Residues tn Milk and Other
Subjects. (Compilation; unpublished study received on unknown
date under 9F0805; CDL:093114-C)
00117339 Shell Chemical Co. (1969) Residue Oata Developed from the Use of
Rabon on Livestock. (Compilation; unpublished study received
Dec 13, 1970 under IF 1121; CDL:093431-C)
00117340 Shell Chemical Co. (1969) Residue Data for Rabon Metabolites in
Chicken Tissues and Eggs from California. (Compilation; un-
published study received Dec 1, 1969 under 9F0835; CDL:093538-A)
00117351 Shell Chemical Co. (1971) Analytical Methods for the Determination
of the Pesticide Chemical: Gardona. (Compilation; unpublished
study received Aug 6, 1971 under 2F1187; CDL:093510-C)
00117354 Shell Chemical Co. (1973) Residue Data: SD-8447. (Compilation;
unpublished study received Oct 17, 1973 under 201-359; CDL:
101173—A)
00117361 Shell Chemical Co. (1975) Rabon Oral Larvlcide Self-fed Supplement:
Label Application. (Compilation; unpublished study received
Jul 22, 1975 under 201-392; COL: 22099 2-A)
00117389 Shell Chemical Co. (1978) Rabon: Residues in Tissue, Milk, and
Fat of Cattle. (Compilation; unpublished study received Mar
30, 1979 under 201-407; C0L:237924-A)
00117443 U.S. National Institutes of Health (1978) Bloassay of tetrachlor-
v1nphos for possible carcinogenicity. By National Cancer Insti-
tute, 01 v. of Cancer Cause and Prevention, Carcinogenesis Pro-
gram, Carcinogen Bloassay and Program Resources Branch. Be-
thesda, MO: USNIH. (NCI-CG-TR-33; CAS No. 961-11-5; OHEW publi-
cation no. (NIH)78-833; published study; COL:2389 26-A)
00118265 Tennessee (1975) Residue Oata in Support of the Use of Rabon
Insecticide Cattle Ear Tags. (Compilation; unpublished study
received Apr 12, 1979 under TN 79/1; CDL: 238024-8)
105
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARO BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tetrachlorvinphos Standard
MR ID CITATION
00120147 Shell Chemical Co. ( 1967) Determination of Gardona Residues in
Various Products. (Compilation; unpublished study received Jun
12, 1968 under 9F0739; CDL:091275-A)
00 1 20199 Walker, A.; Hunter, C. ( 1968) The Toxicity of the alpha Isomer
of the Halophenyl Vinyl Phosphate Insecticide Gardona: 13 Week
Oral Experiment in Rats: Group Research Report TLGR.0022.68.
(Unpublished study received Apr 27, 1969 under 9F0804; prepared
by Shell Research Ltd., Eng., submitted by Shell Chemical Co.,
Washington, DC; CDL:091388-A)
00120200 Shell Chemical Co. (1968) The Residue Data Developed from Test
Plots Including a Description of the Analytical Methods Used:
Gardona Insecticide. (Compilation; unpublished study received
Apr 27, 1969 under 9F0804; CDL:091388-8)
00120204 Shell Chemical Co. (1969) [Determination of Residues of SD 8447 and
Rabon in Goats and Poultry]. (Compilation; unpublished study
received Apr 27, 1969 under 9F0804; CDL:091387-A)
00120205 Shell Chemical Co. (1968) The Results of Tests on the Amount of
Residues Remaining, Including a Description of the Analytical
Methods Used: Rabon. (Compilation; unpublished study received
Apr 26, 1969 under 9F0805; CDL:091389-A)
00120206 Shell Chemical Co. (1969) The Results of Tests on the Amount of
Residues Remaining, Including a Description of the Analytical
Methods Used: Rabon. (Compilation; unpublished study received
Apr 26, 1969 under 9F0805; CDL:091390-A)
00120225 Yadava, C. (1969) An Investigation of the Toxicology and Residues
of Rabon In Poultry. Doctoral dissertation, Univ. of Massa-
chusetts. (Unpublished study received Oct 4, 1969 under 9F0835;
submitted by Shell Chemical Co., Washington, OC; CDL:091439-C)
00120227 Shell Chemical Co. (1969) The Results of the Amount of Residues
Remaining, Including a Description of the Analytical Method:
Rabon. (Compilation; unpublished study received Oct 4, 1969
under 9F0835; CDL:091439-G)
00 120 229 Shell Chemical Co. ( 1969) Rabon Insecticide on Poultry. (Unpub-
lished study received Oct 5, 1969 under 9F0835; C0l:091440-B)
106
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tetrachlorvinphos Standard
MR ID CITATION
00126039 Hazleton Laboratories Anerica, Inc. (1980) 103-week Chronic Feeding
Study in Mice: SD-8447 and Original SD-8447. Final rept.
(Unpublished study received Jul 31, 1980 under unknown admin,
no.; submitted by Shell Chemical Co., Washington, DC; CDL:
24 29 7 6—A; 2429 7 7)
00127831 Laveglia, J.; Kllleen, J.; Ignatoski, J. ( 1982) A Teratology Study
1 n Rabbits with DS-36779: Document No. 57 2-5TX-82-0007-003.
(Unpublished study received Apr 13, 1983 under unknown admin,
no.; submitted by Diamond Shamrock Agricultural Chemicals,
Cleveland, OH; COL:249988-A)
00130705 Ralston Purina Co. (1969) Residue Data Developed from the Use of
Dairy Cattle. (Compilation; unpublished study received Jun 17,
1983 under 602-301; CDL:251028-A)
00133913 Shell Chemical Co. (1973) Summary--Residues: Toxicity of SD 8447
in Cattle and Other Mammals. (Compilation; unpublished study
received Dec 20, 1974 under 4H5047; CDL:223244-B)
00138933 Coate, W.; Zoetls, T.; Hardy, R. ( 1983) Acute Inhalation Toxicity
Study in Rats: Ralston Purina Residual Livestock Insecticide:
Project No. 2200-105. Final rept. (Unpublished study received
Jan 31, 1984 under 602-301; prepared by Hazleton Laboratories
America, Inc., submitted by Ralston Purina Co., St. Louis, MO;
COL: 2S2343-C)
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984) Handbook of toxicity of
pesticides to wildlife: Second edition. US F1sh and Wildlife
Service: Resource Publication 153. 91 p.
05000837 Johansen, C.A. (1972) Toxicity of field-weathered Insecticide
residues to four kinds of bees. Environmental Entomology
1(3):393-394.
05004211 Bowman, M.C.; Beroza, M. (1967) Temperature-programmed gas
chromatography of 20 phosphorus-containing insecticides on 4
different colunns and Its application to the analysis of milk
and corn silage. Journal of the Association of Official
Analytical Chemists 50(6):1228-1236.
05006630 Oehler, 0.0.; Eschle, J.L.; Miller, J.A.; Claborn, H.V.; Ivey,
M.C. (1969) Residues in milk resulting from ultra-low-volune
sprays of malathlon, methoxychlor, coumaphos, ronnel, or
Gardona for control of the horn fly. Journal of Economic
Entomology 62(6): 1481-1483.
107
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Tetrachlorvinphos Standard
MR ID CITATION
40098001 Mayer, F.; Ellersleck, 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): 1-36.
40152701 Ford.W.;Killeen, J. (1987) A Teratology Study in Rats with Technical
Rabon: Project ID: 1019-003; 85-0074. Unpublished study prepared
by Ricerca, Inc. in cooperation with Argus Research Laboratories, Inc.
and Test Substance Analysis Laboratory. 298 p.
108
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IV. FORMS APPENDICES
EPA Form 8580-1 OMB Approval No. 2070-0057
1*09
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Expires 11/30/89
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA Form 8580-6 0MB Approval No. 2070-0057
Expires 11/30/89
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
110
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GMB approval No.
2070-0057
Expires 11/30/89
PRODUCT SPECIFIC EMA REPORT
EPA Reg. No. Date
111
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Guidance Document for
Registration
Guideline No.
Name of Test
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements bv
Citing MRID
Number or
EFA Accession
Number
Submit-
ting
Data
(At-
tarhern
(For EFA Use Only)
Accession Numbers
Assigned
Subpart C
PRODUCT
CHEMISTRY
61-1
Identity of
ingredients
61-2
Statement of
composition
61-3
Discussion of
formation of
ingredients
62-1
Preliminary
analysis
62-2
Certification of
limits
62-3
Analytical methods
for enforcement
limits
63-2
Color
63-3
Physical state
63-4
Odor
63-5
Melting point
63-6
PQUiflq ppiflt
63-7
Density, bulk-
density, or
specific gravity
63-8
Solubility
63-9
Vapor pressure
63-10
Dissociation
constant
63-11
Octanol/water
partition
coefficient
63-12
_gL
EPA Form 8580-4
CMB Approval No*.
2070-005
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC IMA REPORT (cont'd)
Date
Guidance Document for.
1 \ '?
-------
Registration
Guideline No.
|Test not| |
j required! I am complying with j
Ifor mv Idata reauirements bv 1
| product | Citing MRID | Submit-1
I listed | Number or I ting j
jabove |efa Accession j Data j(For EPA Use Only)
j(check j Number j(At- jAccession Numbers
Name of Test 1below) 1 1tached) lAssianed
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
II II
II II
II II
II II
63-13
Stability II II
63-14
Oxidizing/reducing | | | |
reaction i i II
63-15
Flanmabilitv II II
63-16
ExDlodabiiii-Y II II
63-17
Storaae l ity II II
63-18
Viscositv II II
63-19
Miscibilitv II II
63-20
Corrosion | | | |
characteristics II II
63-21
Dielectric break- | | | |
down voltaae i 1 II
Sec. 158.340
TOXICOLOGY
II II
II II
81-1
Acute oral | I I I
toxicity, rat 1 j i 1
81-2
Acute dermal | | | |
toxicity r rabhit- i 1 II
81-3
Acute inhalation, | | | |
toxicity, rat II 1 i
81-4
Primary eye I I I I
irritationr rahhiti i i i
81-5
Primary dermal | | | |
irritation i 1 i 1
81-6
Dermal sensitiza- | | | |
tion. II II
81-7
Acute Delayed | | | |
neurotoxicity, henl 1 II
EPA Form 8580-4 (cont'd)
113
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CMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC EMA EXEMPTION SEMEMENT
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 sutmission of "generic" data on the active
114
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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 sutmit 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 fran another producer.
(3) An accurate Confidental Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company name,
registration number, and product name, the source of the subject active ingredient in my
firm's product, or
The CSF dated an file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statanent is no longer true, or if my firm fails to ccnply 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 ccsimitted to generate and submit the
required data fail to take appropriate steps to meet requirenents or are no longer in
compliance with this Notice's data requirements, the Agency will consider that both they
and my firm are not in compliance and will normally initiate proceedings to suspend the
registrations of my firm's product(s) and their product(s), unless my firm coarmits to
sutmit 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 sutmitting the data.
Registrant's authorized representative:
(Signature
Dated:
(Typed)
EPA Form 8570-27
115
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