vEPA
United Sum
Environmental Protection
Agency
Off ice of
PwticidM and Toxic SubManow
Washington DC 20460
540/RS-88-086
Pwticictos
Guidance for the
Reregistration of
Pesticide Products
Containing SULFOTEPP
as the Active Ingredient
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OMB Control No. 2070-OOf
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
SULFOTEPP
AS THE ACTIVE INGREDIENT
CASE NUMBER 0338
CAS Registry Number 3689-24-5
EPA Pesticide Chemical Code (Shaughnessy)
Number 079501
SEPTEMBER, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical 4
B. Use Profile 4
III. Agency Assessment 5
A. Summary 5
B. Preliminary Risk Assessment 11
C. Other Science Findings 11
D. Tolerance Reassessment 12
IV. Regulatory Position and Rationale 13
A. Regulatory Positions 13
B. Criteria for Registration 17
C. Acceptable Ranges and Limits 17
D. Required Labeling 19
V. Products Subject to this Standard 23
VI. Requirement for Submittal of Generic Data 25
A. What are generic data? 25
B. Who must submit generic data? 25
C. What generic data must be submitted? 26
D. How to comply with DCI requirements 26
E. Registrant Requests Regarding Data Requirements
and Agency Responses 29
F. Testing Protocols, Standards for Conducting
Acceptable Tests, Guidance on Evaluating and
Reporting Data 29
G. Procedures for requesting a change in protocol . .30
H. Procedures for requesting extensions of time . . .30
I. Data Format and Reporting Requirements 30
J. Existing stocks provisions upon suspension or
cancellation 31
VII. Requirement for Submittal of Product-Specific Data . . .31
VIII. Requirement for Submittal of Revised Labeling 32
IX. Instructions for Submittal 32
A. Manufacturing use products (sole active) 32
B. Manufacturing use products (multiple active) . . .33
C. End use products (sole active) 34
D. End use products (multiple active) 34
E. Intrastate products 343.
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APPENDICES
I. DATA APPENDICES 35
Guide to Tables 36
Table A 38
Table B 55
II. LABELING APPENDICES 61
Summary of label requirements and table 62
40 CFR 156.10 Labeling Requirements 72
Physical/Chemical Hazards Labeling Statements 77
Storage Instructions 78
Container Disposal Instructions 79
Pesticide Disposal Instructions 80
III. BIBLIOGRAPHY APPENDICES 83
Guide to Bibliography 84
Bibliography 86
IV. FORMS APPENDICES 87
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet 88
EPA Form 8580-3 Generic Data Exemption Statement 89
EPA Form 8580-4 Product Specific Data Report 90
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for
Development of Data 91
11
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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 system 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 statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LDso Median lethal dose - a statistically derived single dose
that 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
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
111
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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^, 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.
scientific reviews may be obtained after April 1, 1988
from the National Technical Information Service,
5285 Port Royal Road, Springfield, Virginia 22161
(703-487-4650).
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
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the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICAL(S) COVERED BY THIS STANDARD
A. Description of chemical (s)
The following chemical (s) are covered by this Registration
Standard:
Common name: Sulfotepp
Chemical name: O,O,O',O'- tetraethyl dithiopyrophosphate
CAS Number: 3689-24-5
Sulfotep is the British Standards Institution (BSI) and
International Organization for Standardization (ISO) approved
common name of an acaricide/insecticide registered in the U. S
by Centerchem, Inc., Fuller Systems, Inc., and Plant Products
Corp. The molecular structure is depicted below.
OPP (Shaughnessy) Number: 079501
Empirical Formula: C8H20°5P2S2
Trade names: Bladafume, Dithio, Dithione, and Thiotepp.
Description of physical characteristics of chemical:
Pale yellow liquid with a boiling point of 136-139°C at
2 mm Hg; specific gravity of 1.196 d25/4 °C; solubility
of 25 mg/1 water at room temperature; completely misci-
ble with chloromethane and most organic solvents; a
vapor pressure of 22.6 mPa at 20 °C.
B. Use Profile
Type of Pesticide: Insecticide/Acaricide
First Registration: 1951
Pests Controlled: aphids, mealybugs, spider mites, thrips,
scales, whiteflies
Registered Uses: commercial greenhouses, non-food
Predominant Use(s): azaleas, carnations, chrysanthemums,
geraniums, roses, snapdragons
Mode of Activity: organophosphate, non-systemic, contact
Formulation Types Registered: technical material, ready-
to-use solution, impregnated materials
Method(s) of Application: liquid fog, smoke generating
impregnated materials
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III. AGENCY ASSESSMENT
The Agency has reviewed all data in its files as of
March 8, 1988 supporting the registration of sulfotepp.
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.
A. SUMMARY
The main area of concern is for human exposure to
airborne residues of sulfotepp when used in greenhouses,
since this chemical is known to be highly acutely toxic.
There are major data gaps in the areas of toxicology, en-
vironmental fate, exposure to humans, ecological effects,
and product chemistry.
1. TOXICOLOGY
No data are available that meet the Agency's
Guideline requirements for the toxicity of sulfotepp.
However, data available in the public literature indicate
that sulfotepp is highly toxic. In addition, some data
on human poisonings are available, but there is no conclu-
sive evidence of a significant poisoning problem due to
the pesticide. Studies to fulfill all acute toxicity
requirements are required, including an acute delayed
neurotoxicity study in the hen. Subchronic 21-day dermal
and 90-day inhalation studies are required. A 90-day
neurotoxicity study is reserved depending on the results
from the acute delayed neurotoxicity study. A teratology
study in one species is required and all mutagenicity
studies are required.
2. ENVIRONMENTAL FATE
There are no available environmental fate studies on
sulfotepp. Therefore, groundwater contamination potential
cannot be assessed at this time. Because of toxicological
concerns involving acute hazards (see above), an interim
reentry interval in accordance with the proposed § 170.66
of 40 CFR as it pertains to application of smokes, mists,
fogs and aerosols in greenhouses is being imposed for the
registered uses of sulfotepp. Once adequate data have been
submitted and evaluated, the Agency will reconsider this
issue. The following list summarizes the environmental
fate data requirements for sulfotepp.
Environmental Fate Data Requirements Summary
DEGRADATION STUDIES - LAB
Hydrolysis
Photodegradation - air
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METABOLISM STUDIES - LAB
Aerobic metabolism - soil
MOBILITY STUDIES
Adsorption/desorption studies (batch equilibrium study is
preferred)
Volatility (lab)
Volatility (field) - [reserved]
REENTRY PROTECTION
Air monitoring of toxicologically significant residues are
required for purposes of calculating human exposure (no
actual monitoring of human inhalation exposure is to be
conducted) .
3. ECOLOGICAL EFFECTS
Terrestrial
No data are available for any terrestrial species.
An avian single-dose acute oral LD5Q study and a subacute
dietary LC5Q study using the bobwhite quail are required.
No. data are required for toxic effects on wild mammals or
on honey bees for the existing indoor use patterns.
Aquatic
Freshwater Invertebrates and Fish
The available data indicate that sulfotepp is highly
toxic to the rainbow trout and bluegill sunfish. No data
are available on effects on freshwater invertebrates. The
fish studies only partially fulfill the Agency's data re-
quirements, but may be acceptable if additional data con-
cerning the studies are submitted. An acute LCso study
on aquatic invertebrates is required.
Ecological Effects Data Requirement Summary
The following data are required for the present use pat-
terns:
Avian single-dose oral LDso (bobwhite quail)
Avian dietary LCso in one species (bobwhite quail)
Fish acute LCso
Acute LCso on aquatic invertebrates
4. RESIDUE CHEMISTRY
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There are no registered uses of sulfotepp on agricul-
tural crops. Residue chemistry data are not required to
support the registered uses of sulfotepp on greenhouse
non-food crops, except for chemical identity and directions
for use. These requirements may be met by submission of
the required product chemistry data discussed below.
5. PRODUCT CHEMISTRY
a. PRODUCT IDENTITY AND COMPOSITION
61-1. Product Identity and Disclosure of Ingredients
Sulfotep is the British Standards Institution (BSI)
and International Organization for Standardization
(ISO) approved common name of an acaricide/insecti-
cide registered in the U. S. by Centerchem, Inc.,
Fuller Systems, Inc., and Plant Products Corp. The
molecular structure is depicted below.
S S
II II
O,0,0',0'-tetraethyl dithiopyrophosphate is the chemi-
cal name (International Union for Pure and Applied
Chemistry). Other chemical, common, and trade names
include: tetraethyl thiodiphosphate (9th Collective
Index), tetraethyl thiopyrophosphate (8th Collective
Index), thiodiphosphoric acid tetraethyl ester,
ASP-47, Bayer E 393, Bladafume, Dithio, Dithione,
sulfotepp (Entomological Society of America approved),
and Thiotepp.
Other identifying characteristics and codes are:
Empirical Formula: C8H20°5P2S2
Molecular Weight: 322.3
CAS Registry No.: 3689-24-5
Shaughnessy No.: 079501
Wiswesser Line-Formula Notation*
20PS&O2&OPS&O2&02
U. S. Department of Agriculture: ENT 16 273
* A single-line representation of the structural formula
for organic chemical molecules.
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The above information was obtained from the following
sources: Acceptable Common Names and Chemical Names
for the Ingredient Statement on Pesticide Labels, 4th
Ed., 1979, p. 225; British Crop Protection Council,
The Pesticide Manual - A World Compendium, 7th Ed.,
1980, p. 498; Farm Chemicals Handbook '88, p. C33;
and Analytical Reference Standards and Supplemental
Data; The Pesticide and Industrial Chemicals Reposi-
tory, 1984, p. 98.
The sulfotepp technical products are summarized in
Table 1. Confidential Statements of Formula were not
available in the registration jackets for EPA Reg.
Nos. 8241-5 and 9382-4.
Table 1. Technical sulfotepp products.
Percent Active
95
95
90
EPA Reg. No.
1327-39
8241-5
9382-4
Registrant
Fuller Systems, Inc.
Plant Products Corp.
Centerchem, Inc.
61-2. Description of Beginning Materials and Manu-
facturing Process
No description has been submitted for this topic by
the registrants. The following manufacturing process
was obtained from Marshall Sittig's Pesticide Manu-
facturing and Toxic Materials Control Encyclopedia,
pp. 689-690.
Sulfotep is manufactured by reaction of sulfur
with tetraethylpyrophosphate (TEPP) or O,O-di-
ethyl phosphorochloridothioate and aqueous sod-
ium carbonate in the presence of pyridine.
61-3. Discussion of the Formation of Impurities
No discussion was submitted for this topic by the
registrants.
b. ANALYSIS AND CERTIFICATION OF PRODUCT INGREDIENTS
62-1. Preliminary Analysis
No data were submitted for this topic by the regis-
trants.
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62-2. Certification of Ingredient Limits
Only ingredient limits of the Fuller System, Inc.
95% technical product are known. No data were sub-
mitted for this topic by the other registrants.
62-3. Analytical Methods to Verify Certified Limits
No methods were submitted for this topic by the reg-
istrants .
c. PHYSICAL AND CHEMICAL CHARACTERISTICS
No data pertaining to the physical and chemical
characteristics of any technical product have been
submitted. Summarized in Table 2 are physical and
chemical properties of the PAI obtained from the
British Crop Protection Council, The Pesticide Man-
ual - A World Compendium, 7th Ed., 1980, p. 498.
This information is provided for reference purposes
only.
Table 2. Physical and chemical properties of pure
sulfotepp.
Guidelines Reference
No., 40 CFR 158, Subpt C
Name of Property Description
63-2. Color pale yellow
63-3. Physical state liquid
63-6. Boiling point 136-139°C/2mm Hg
63-7. Specific gravity 1.196 d25/4°C
63-8. Solubility 25 mg/1 water at room
temperature; completely
miscible with chloromethane
and most organic solvents
63-9. Vapor pressure 22.6 mPa at 20°C
Product Chemistry Data Requirements Summary
Product Identity and Composition
Product Identity and Disclosure of Ingredients
Description of Beginning Materials
and Manufacturing Process
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Discussion of Formation of Impurities
Analysis and Certification of Product Ingredients
Preliminary Analysis of Product Samples
Certification of Ingredient Limits
Analytical Methods to Certify Limits
Physical and Chemical Characteristics
Color
Physical State
Odor
Melting Point .
Boiling Point
Density, Bulk Density or Specific Gravity
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partitioning Coefficient
pH
Stability
Oxidizing or Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
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B. PRELIMINARY RISK ASSESSMENT
As previously discussed briefly above, there are no data
available on technical sulfotepp satisfying the basic toxi-
cology requirements of the Guidelines. Therefore, no prelimi-
nary risk assessment is possible at this time. In the absence
of such an assessment, the toxicology summary is presented
below.
1. Toxicology Summary
Sulfotepp is a restricted use pesticide. It is used on
greenhouse nonfood crops (ornamental plants and forest
trees), for ^control of aphids, mealybugs, spider mites,
scales, thrips and whiteflies. In the past, sulfotepp
has been known to be an impurity in the pesticide, Diazi-
non. From the toxicity data on Diazinon, the Agency is
aware that sulfotepp is highly acutely toxic. However,
no data are available on the Technical Product. No toler-
ances exist for sulfotepp. No studies are available for
registered uses. Dat'a required are listed in Tables A and
B in Appendices I, the Data Appendices.
2. ADI Reassessment
An ADI reassessment is not necessary because there
are no approved tolerances for sulfotepp.
C. OTHER SCIENCE FINDINGS
1. Exposure Assessment;
The Agency does not have any exposure data on sulfotepp.
Data are required to do an assessment of exposure under
40 CFR 158.390 and these data are listed in Table A.
The only health statistics available for sulfotepp come
from California. The ratio of poisonings to applica-
tions reported in 1981-1984 was somewhat higher than the
average reported for 54 selected pesticides, but not un-
usually high. This ratio is based on a single poisoning
only (to a chamber fumigator). There was only one other
poisoning in California since 1975, which was listed as
a worker exposed to drift or residue in 1977. Given
these data, there is no conclusive evidence of a signifi-
cant poisoning problem due to sulfotepp.
2. Ecological Effects
a. Ecological Effects Profile
Freshwater fish acute toxicity data indicate that sulfo-
tepp is highly toxic to the rainbow trout [LCso = 1.0
(0.8 - 1.3) ppm] and bluegill sunfish [LCso = 0.36 (0.27
- 0.46 ppm)].
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b. Ecological Hazard Assessment
Sulfotepp is registered only for indoor greenhouse use on
ornamental plants. Ecological hazard assessments are not
performed for indoor uses.
D. TOLERANCE REASSESSMENT
A tolerance reassessment is not necessary since there are
no registered uses for sulfotepp that require tolerances under
FFDCA.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of the limited data avail-
able and other relevant information on sulfotepp the Agency has
made the following determinations:
1. Sulfotepp is not a candidate for Special Review at
this time.
Rationale; Since available data are quite limited, the Agency
is not yet able to make a determination as to whether any of
the criteria specified in 40 CFR 154.7 have been met or
exceeded.
2. Restricted use
The current position stated in 40 CFR 162.31 that all
products containing the active ingredient sulfotepp must
bear labeling for RESTRICTED USE is to be continued,
based on an acute inhalation hazard to humans.
Rationale; There is sufficient information of a collateral
nature based on sulfotepp as an impurity in Diazinon for the
Agency to conclude that sulfotepp is highly acutely toxic to
mammals, and by inference to humans. Data to characterize the
risk are required.
3. Groundwater concerns
The Agency is requiring submission of the minimal studies
needed for determination of the groundwater contamination
potential of sulfotepp. These include laboratory degre-
dation studies on hydrolysis (161-1) and photodegradation
in air (161-4); a laboratory metabolism study for aerobic
soil organisms (162-1);and mobility studies on adsorp-
tion/desorption (163-1), and volatility in the laboratory
(163-2) . The mobility study on volatility in th"efield
(163-3) is being reserved at the present time, but may be
required depending on the results of laboratory studies.
Rationale; Since it is not possible to determine the groundwater
contamination potential without data on the environmental fate
of a pesticide and since the aforementioned studies are required
by the Guidelines for any pesticide used on greenhouse non-food
crops, these studies are necessary in order to fill the data
gaps for the environmental fate of sulfotepp. The laboratory
study on photodegradation in air is being required due to the
high vapor pressure of sulfotepp [1.7xlO~4 mm Hg or 22.6 mPa at
20°C.] and the possibility that fumes may be sensitive to photo-
degradation.
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4. Reentry requirements
The Agency has determined that the present reentry
requirements of from 1.5 hours to overnight, and
ventilation of the greenhouse structure for one or
two hours, are inadequate to fully protect humans
exposed to airborne residues of sulfotepp. An interim
reentry interval in accordance with proposed Subpart F,
§ 170.66 of 40 CFR, as it pertains to application of
smokes, mists, fogs or aerosols in greenhouses is being
imposed for the uses of sulfotepp until adequate data
have been submitted and evaluated.
Rationale: Reentry data are required for sulfotepp under
40 CFR § 158.390. Those data are required by § 158.390 if the
pesticide and its use patterns meet both of certain toxicity and
exposure criteria. Sulfotepp meets these criteria.
In the case of sulfotepp, human exposure monitoring data must
not be submitted. In other cases, human exposure monitoring
data have been accepted when the Registrants chose to submit
those, but the hazard at high levels of airborne sulfotepp resi-
dues could be so great that those data must not be gathered.
Therefore, the Agency is requiring monitoring of toxicologically
significant residues in air over a given time period.
According to the provisions of proposed § 170.66(a), no worker
shall be allowed or directed to enter or remain in a reentry-
restricted area before the reentry interval specified in para-
graph (b) has expired, unless: (1) The worker will have no con-
tact with pesticide residues on treated surfaces or in soil,
water, or air; or (2) The following requirements for early re-
entry workers are met: (i) Personal protective equipment spec-
ified on the pesticide labeling for early reentry activities is
worn; (ii) Duties related to personal protective equipment
specified in § 170.16 are met; (iii) Decontamination provisions
specified in § 170.18 are available; (iv) Training specified in
§ 170.12(b) is given; (v) Any other requirement regarding early
reentry specified on the pesticide labeling is met.
§ 170.66(b) as proposed, states in (2) that for any pesticide
applied in the form of a smoke, mist, fog or aerosol [in the
greenhouse], the reentry-restricted area shall be the entire
nonporous enclosed area within which the pesticide is applied
until the reentry interval specified on the pesticide labeling
has expired. Since sulfotepp has a vapor pressure such that it
behaves like a fumigant, the Agency is imposing a reentry inter-
val in accordance with § 170.66(b)(1), which states:
For any pesticide identified on the pesticide labeling as a
fumigant, the reentry-restricted area shall be the entire
nonporous enclosed area within which the pesticide is ap-
plied. The reentry interval shall extend until all vapors
have dispersed, as defined by one of the following criteria:
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(i) Two hours of ventilation using fans or other mechanical
ventilation systems.
(ii) Four hours of ventilation using vents, windows or
other passive ventilation systems.
(iii) Eleven hours with no ventilation, followed by one
hour of mechanical ventilation.
(iv) Eleven hours with no ventilation, followed by two
hours of passive ventilation.
(v) Twenty-four hours with no ventilation.
(vi) The air concentration of the fumigant is measured to
be less than or equal to the permissible exposure level
specified on the product labeling.
Since (vi) is not applicable until the registrants have submit-
ted air monitoring data in accordance with § 158.390 to estab-
lish a permissible exposure level for sulfotepp, and (v) would
not allow the present common practice of overnight treatments
of greenhouses to continue during the data-gathering phase, the
Agency proposes to limit the reentry interval options to (i)
through (iv), as described in Sec. IV.D. below.
5. Protective clothing requirements are being imposed as
labeling amendments for all registered products con-
taining sulfotepp for end-use application in commercial
greenhouses, as described in Sec. IV.D. below.
Rationale; Sulfotepp is highly acutely toxic (approx. 5 mg/kg
acute oral LDso to rat according to Pesticide Index - Fourth
Edition, 1969, p. 356, D. E. H. Frear, editor). Although we
do not have a complete toxicological data base or enough in-
formation to allow a preliminary risk assessment to be made,
the early history of use recognized the acute hazard involved
and called for the use of protective clothing. To come into
compliance with FIFRA, uniform wording will be required in
order to standardize the text on current labels.
6. Labeling requirements
The requirements specified in Section IV.D.3. below
and in the Labeling Appendices must be satisfied, as
appropriate, for all products containing sulfotepp,
whether the products are used in the formulation or
manufacture of end-use products containing sulfotepp
or as end-use products for treating greenhouse flower
crops (non-food) of azaleas, carnations, chrysanthemums,
geraniums, roses and snapdragons, applied as liquid fog
or smoke-generating impregnated materials.
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7. Studies that will receive immediate review.
The Agency has identified certain data that will receive
immediate review when submitted.
Rationale; Certain of the data being required by the Agency
are essential to resolve risk concerns, or may trigger the need
for further studies which should be initiated as soon as possi-
ble. The following studies have been identified to receive
immediate review.
40 CFR §158.290 Environmental Fate
161-1 Hydrolysis
161-4 Photodegradation in Air
162-1 Aerobic Soil Metabolism
163-1 Adsorption/Desorption
163-3 Volatility (Lab)
§158.340 Toxicology
81-1 Acute Oral - Rat
81-2 Acute Dermal
81-3 Acute Inhalation - Rat
81-4 Eye Irritation - Rabbit
81-5 Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-7 Acute Delayed Neurotoxicity - Hen
§158.49'0 Ecological Effects
71-1 Avian Single-Dose Oral
71-2 Avian Dietary
72-1 Fish Acute
72-2 Acute LCso Aquatic Invertebrates
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8. Continuation of registration.
While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing sulfotepp may be sold, distributed, formulated
and used. Registrants must provide or agree to develop
additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or
are inadequate (see FIFRA sec. 3(c)(2)(B) and 3(c)(7)).
Issuance of this Standard provides a mechanism for identifying
data needs and labeling changes arising from available data.
Required data will be reviewed and evaluated, after which
the Agency will determine if additional regulatory changes
are necessary.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain sulfotepp, 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 sulfotepp.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and
inert ingredients which are present in products, as well as
impurities found at greater than 0.1%.
2. Acute Toxicity Limits
In order to remain in compliance with FIFRA, the Agency
will require that product labeling of technical grade and
manufacturing-use products containing sulfotepp bear approp-
riate precautionary statements for the acute toxicity category
in which each product is placed.
3. Use Patterns
To remain in compliance with FIFRA, manufacturing-use
products may be labeled for formulation into end-use products
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only for the commodities listed below. The EPA Compendium
of Acceptable Uses1 lists all registered uses, as well as
approved maximum application rates and frequencies.
-Greenhouse non-food use on:
Azaleas
Carnations
Chrysanthemums
Geraniums
Roses
Snapdragons
1 The Compendium may be obtained from the National Technical
Information Service, 5285 Port Royal Road, Springfield,
Virginia 22161 (703-487-4650).
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D. REQUIRED LABELING
In order to remain in compliance with FIFRA, manufacturing
use products (and end-use products, if covered by Standard)
must bear appropriate labeling as specified in 40 C?"R i.'3;S,LO,
Appendix II contains information on label requirements.
:\To pesticide product containing sulfotepp may be released
for shipment by the registrant after September 30, 1989,
unless the product bears an amende."!. 1.aV>ol -.Jhloh o^aplies
with the ee pil-- >iaent:i of. this Standard.
No pesticide product containing sulfotepp may be dis-
tributed, sold, offered for sale, held for sale, shipped,
delivered for shipment, or received and (having been so
received) dell^ere;! o<~ offered to be delivered by any person
a!7tec September 30, 1990, unless the product bears an amended
label which complies with the requirements of this Standard.
The following specific information .uast •i.i>oH-i.r vi the
labelirig in order for prodaoi-.s to re>nain in compliance with
FIFRA:
1. Ingredients Statement
The ingredient statement for MPs irus'r. li.sL ;.1i.» -. .• i '.
ingredient as:
O,O,O' ,O '-tetraec'iyl dithiopyrophosph-iLe
2. Use Pattern Statements
All manufacturing-use products must state f-'n.t fie/
are intended r^r Torinnlation Into end-use products !!:>r
acceptable use patterns. Labeling must specify sites,
which are listed in Use Patterns, Section C.3. However,
no use may be iaolu-.\.*.<\ on the label where the cetji-3 trant
fails to agree to comply with the data requirements Ln
TABLE A for that use pattern.
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3. Precautionary Statements
a. Statements applicable to all products
GENERAL WARNINGS AND LIMITATIONS: Sulfotepp is
classified as a RESTRICTED USE PESTICIDE by Title 40,
Code of Federal Regulations, Part 162, Section 31, on
the basis of its acute inhalation hazard to humans.
b. Statements for Manufacturing-Use Products
ENVIRONMENTAL HAZARDS:
This pesticide is toxic to fish. Do not discharge
effluent containing this product directly into
lakes, streams, ponds, estuaries, oceans, wetlands,
or public waters unless this product is specifically
identified and addressed in a NPDES permit. Do not
discharge effluent containing this product to sewer
systems without previously notifying the sewage
treatment plant authority. For guidance, contact
your State Water Board or Regional Office of the
Environmental Protection Agency.
c. Statements for End-Use Products
RESTRICTED USE:
RESTRICTED USE PESTICIDE
Due to very high acute inhalation toxicity to humans.
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.
General Warnings and Limitations:
Close all greenhouse vents prior to use. Block or
barricade entries and post warning signs. Do not
place generators on wood or other flammable materi-
als as fire hazard may result.
Reentry Statement; Reentry after applying is restric-
ted until one of the following intervals has elapsed:
(1) Two hours of ventilation using fans or other me-
chanical ventilation systems.
(2) Four hours of ventilation using vents, windows or
other passive ventilation systems.
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(3) Eleven hours with no ventilation, followed by one
hour of mechanical ventilation.
(4) Eleven hours with no ventilation, followed by
two hours of passive ventilation.
If necessary to reenter the greenhouse for any reason
during the specified intervals after application,
protective clothing described in the Worker Protection
Statement must be worn. All greenhouses must be posted
during the exposure period and until safe to reenter.
Worker Protection Statement;
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING LOADING,
APPLICATION, EQUIPMENT REPAIR, EQUIPMENT CLEANING, EARLY
REENTRY TO TREATED AREAS, AND DISPOSAL OF THE PESTICIDE.
Wear a protective suit of one or two pieces that
covers all parts of the body except the head, hands, and
feet. Wear chemical-resistant gloves and chemical-resis-
tant shoes, shoe coverings, or boots. Wear goggles and a
pesticide respirator approved by the National Institute
for Occupational Safety and Health (NIOSH) and the Mine
Safety and Health Administration (MSHA) at all times
during application and early reentry to treated areas.
IMPORTANT! Before removing gloves, wash them with
soap and water. Always wash hands, face, and arms with
soap and water before smoking, drinking, eating, or use
of the toilet.
AFTER WORK, that is, immediately after completing
work with this pesticide, take off all clothing and
shoes. Shower using soap and water. Do not reclothe
with contaminated clothing and shoes. Wash protective
clothing and protective equipment with soap and water
after each use. Respirators must be cleaned and filters
replaced according to the instructions included with the
respirators. Personal clothing worn during use must be
laundered separately from household articles. Clothing
and protective equipment heavily contaminated, so that
routine maintenance with soap and water cannot remove
spilled or undiluted sulfotepp from any drenched non-
chemical-resistant protective suit, must be destroyed
according to State and local regulations. HEAVILY CON-
TAMINATED CLOTHING CANNOT BE ADEQUATELY DECONTAMINATED.
4. Directions for Use
a. Statements for Manufacturing Use Products
The following identifying phrase must appear directly
below the product name:
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"An insecticide for formulating use only."
The following statement must appear in the Directions
for Use section of the label:
"Formulators using this product are responsible for
obtaining EPA registration of their formulated prod-
uct. "
In the Directions for Use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use insecticide products
intended only for greenhouse ornamental flowers:
azaleas, carnations, chrysanthemums, geraniums,
roses, and snapdragons."
b. Statements for End-Use Products
The following statement must appear in the Direc-
tions for Use section of the label for all end-use
products:
"Calculate volume in cubic feet of greenhouse space
to be treated in order to determine amount of prod-
uct required for application. Use only this amount."
The following paragraph or similar wording should
appear in the Directions for Use section for all
end-use products:
"General Application and Use Directions;
Apply in greenhouses with ornamental plants only.
Do not use on edible plants. Turn off all misting
systems. Keep generators a minimum of 2 feet away
from plants. Temperatures in the greenhouse should
be between 70°F to 90°F (21.1°C to 32.2°C). Foli-
age and blooms should be free of moisture and rela-
tive humidity should be low. Soil should be moist
but do not water on the day of application. Do not
apply on rainy or windy days. Pick open blooms be-
fore application."
The following optional wording is recommended for
smoke generator products:
"Where the greenhouse being fumigated is large
enough to require that generators be placed in more
than one walk, it is recommended that one person be
assigned to light the generators in each walk start-
ing at the end farthest from the exit, so that the
fumigation in each walk may start simultaneously and
all persons exit from the house simultaneously."
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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 B2
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data 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 Registra-
tion 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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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section IV.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the generic data exemption^, the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption,
the data requirements listed in Tables A and C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-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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2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for 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
4 Registrations granted after issuance of this Standard will
be conditioned upon submittal or citation of the data listed
in this Registration Standard.
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that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
If you are not now eligible for a generic data exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share 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 form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. If the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submittal or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
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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 con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the DCT~. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
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registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data. The Agency will respond in writing
to your request for a waiver.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
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6. You request voluntary cancellation of the registration
of your product(s) for which the data are neededT
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. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the 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.
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G. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submittal of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols. The
Agency will respond in writing to your request for protocol
approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before
the data submittal response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome. The Agency
will respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986). All studies must be submitted in the form of
a final report; a preliminary report will not be considered
to fulfill the submittal requirement.
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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 consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D through J. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 156.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling language specific to products containing
this pesticide is specified in Section IV.D of this Registra-
tion Standard. Responses to this Registration Standard must
include draft labeling for Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the intended
colors of the final 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 or suspend the
registration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration Standard
must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Sulfotepp Registration Standard
All submittals in response to this Registration Standard
are non-fee items, including 90-day responses, protocols and
waiver requests, data, and revised labeling. Submittals must
be clearly identified as being in response to the Registration
Standard. Under no circumstances may Registration Standard
responses be combined with other types of filings for which
fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
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a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is delayed
or aborted so that the schedule cannot be met, immediately
notify the Agency of the problem, the reasons for the problem,
and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form 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.
-------
-34-
3. Within the time frames set forth in Table A, you must
submit all generic data,unless you are eligiblefor 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).
2. Within 9 months from receipt of this document you
must submit:
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).
-------
-34a-
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.
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.
-------
-------
-35-
I. DATA APPENDICES
-------
-36-
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table
-------
-37-
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
-38-
TABLE A. GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT Sulfotepp. (Continued).
Data Requirement
Test
Substance
Does EPA
have data to
satisfy this Bibliographic
requirement?!./ Citation!/
Must additional
data be submitted
under FIFRA Sec.
3(c)(2)(B)?
Time Frame
For Data
Submission
§158, Subpart C, Product Chemistry
Product Identity and Composition;
61-2 - Description of Beginning TGAI
Materials and Manufac-
turing Process
61-3 - Discussion of Formation TGAI
of Impurities
Analysis and Certification of
Product Ingredients;
62-1 - Preliminary Analysis of TGAI
Product Samples
No
No
No
N/A
N/A
N/A
Yes2/
Yes3/
YesV
6 Months
6 Months
12 Months
(Continued).
-------
TAHI iK A.
-------
-40-
TABLE A. GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT Sulfotepp (Continued).
Does EPA Must additional
have data to data be submitted Time Frame
Test satisfy this Bibliographic under FIFRA Sec. For Data
Data Requirement Substance requirement?!./ Citation!/ 3(c)(2)(B)? Submission
§ 158, Subpart C, Product Chemistry (continued).
Other Requirements;
64-1 - Submittal of Samples N/A N/A N/A No
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. Complete information must be provided regarding the nature of the process (batch or continuous), the relative
amounts of beginning materials and the order in which they are added, the chemical equations for each intended
reaction, equipment used to produce each intermediate and the final product, reaction conditions, the duration of
each step of the process, purification procedures, and quality control measures. In addition, the name and address
of the manufacturer, producer, or supplier of each beginning material 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 submitted.
(Continued).~~~
-------
-MI-
TABLE A. GENERIC DATA REQUIREMENTS FOR THE TECHNICAL GRADE OF THE ACTIVE INGREDIENT Sulfotepp (Continued).
§ 158, Subpart C, Product Chemistry (continued).
FOOTNOTES (Continued):
4. Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for
Which certified limits are required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used.
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 submitted.
6. Data needed if the technical chemical is a solid at room temperature.
7. Data required if the technical product is a liquid 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.
-------
-42-
TABLE A. GENERIC DATA REQUIREMENTS FOR SULPOTEPP.
Data Requirement
Test
substance
Must addi-
Does EPA Bibliographic tional data
have data? Citation be submitted?
Time frame
for
submission
§158, Subpart D
§158.240 Residue Chemistry
171-2 Chemical Identity!/
Directions for use
171-3
171-4
171-4
171-4
171-4
171-4
171-4
Nature of the residue
(Metabolism)
- Plants
Nature of the residue
(Metabolism)
- Livestock
Residue analytical
methods
Storage stability
Magnitude of the residue
in plants
Magnitude of residue in
Meat/Milk/Poultry/Eggs
(See Index)
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
Nq2/
Nq2/
No2/
No!/
1. The same chemical identity data are required as under §158, Subpart C, with emphasis on impurities that could
constitute residue problems. Refer to Product Chemistry Data Requirements tables.
-------
-43-
TAELE A
GENERIC DATA REQUIREMENTS EXDR Sulfotepp
Does EPA have Must additional Time frame
Test Use data to satisfy Bibliographic data be submitted for
Data Requirement Substance Pattern this requirement? citation!/ under FIFRA submission
(Yes, No, Partially) § 3(c)(2)(B)?
§158, Subpart D (Continued)
§158.290 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA F No
Photodegradation
161-2 - In Water TGAI or PAIRA
161-3 - On Soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA F No
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA F No
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
Yes 9 Months
Yes!/ 9 Months
Yes 27 Months
27 Months
27 Months
27 Months
(12 Months - Progress
Report)
(Continued).
-------
-44-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Does EPA have Must additional Time frame
Test Use data to satisfy Bibliographic data be submitted for
Substance Pattern this requirement? citationV under FIFRA submission
• (Yes, No, Partially) § 3(c)(2)(B)?
Data Requirement
§158, Subpart D (Continued)
§158.290 Environmental Fate (continued)
MOBILITY STUDIES;
163-1 - Adsorption/Desorption TGAI
and Leaching or PAIRA
No
Yes3/
12 Months
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
F
F
No
No
Yes!/
Reserved^/
12 Months
To be Determined
FOOTNOTES:
1. EPA Accession Number.
2. Sulfotepp has a high vapor pressure; sulfotepp fumes may be sensitive to photodegradation.
3. The adsorption/desorption (batch equilibrium) study is preferred. This study should also be conducted
with major metabolites found in the aerobic soil metabolism study.
4. The reported vapor pressure of sulfotepp is 1.7x10-4 mm Hg or 22.6 mPa (20°C); sulfotepp is considered
highly toxic.
5. The field studies may be required depending on the results of the laboratory studies.
-------
-45-
TABLE A
GENERIC DATA REQUIREMENTS EDR Sulfotepp
Data
Requirement Test Use Does EPA Bibliographic Must Additional Timeframe.
Substance Patterns Have Data? Citation Data be for
Submitted? Submission
§158, Subpart D (Continued)
§158.
,340 Toxicology
ACUTE TESTING: " '
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat TGAI F No
- Acute Dermal Toxicity - TGAI F No -
Rabbit
- Acute Inhalation Toxicity - TGAI F No -
Rat
- Eye Irritation - Rabbit TGAI F No -
- Dermal Irritation - Rabbit TGAI F No -
- Dermal Sensitization - TGAI F No -
Guinea Pig
- Acute Delayed TGAI F No -
Neurotoxicity - Hen
Yes 9 months
Yes 9 months
Yes 9 months
Yes 9 months
Yes 9 months
Yes 9 months
Yes 12 months
(Continued).
-------
-46-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data
§158,
§158.
Requirement
Subpart D (Continued)
340 Toxicology (continued)
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timefrarne
for
Submission
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding -
Rodent
Non-rodent
- 21-Day Dental - Rabbit
- 90-Day Dermal - Rat
- 90-Day Inhalation - Rat
- 90-Day Neurotoxicity
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
F
F
F
F
F
F
No
No
NO
No
No
No .
*
NbV
Nql/
Yes
Nb2/
Yes
[ Reserved ]3_/
12 months
15 months
(Continued).
-------
-47-
TART.F. A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data
§158,
§158.
Requirement
Subpart D (Continued)
340 Toxicology (continued)
Test Use Does EPA Bibliographic Must Additional
Substance Patterns Have Data? Citation Data be
Submitted?
Timeframe
for
Submission
CHRONIC TESTING:
83-1
83-2
83-3
83-3
83-4
- Chronic Toxicity -
Rodent
Non-Rodent
- Oncogenicity Study -
Rat
Mouse
- Teratogenicity - Rat
- Teratogenicity - Rabbit
- Reproduction - Rat
TGAI F No No2/
TGAI F No - No2/
TGAI F No - No2/
TGAI F No - No2/
TGAI F NO - Yes!/
TGAI F No Yes!/
TGAI F No No2/
15 months
15 months
(Continued, footnotes follow).
-------
-48-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data Requirement Test Use
Substance Patterns
§158, Subpart D (Continued)
§158.340 Toxicology (continued)
MUTAGENICITY TESTING:
84-2 - Gene Mutation (Ames Test) TGAI F
84-2 - Chromosomal Aberration TGAI F
84-4 - Other Mechanisms of TGAI F
Mutagenicity
SPECIAL TESTING:
85-1 - General Metabolism PAI or PAIRA F
86-1 - Domestic Animal Choice F
Safety
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
" «
No - Yes
No - Yes
No - Yes
No - Nq2/
No - No2/
Timeframe
for
Submission
9 months
12 months
12 months
(Continued, footnotes follow).
-------
-49-
TABLE A
GENERIC DATA REQUIREMENTS FDR Sulfotepp
§158, Subpart D (Continued)
§158.340 Toxicology (continued)
FOOTNOTES:
1. This study is not required because there is no oral exposure and because of requirements for subchronic
dermal and inhalation studies.
2. This study is not required under the existing use patterns.
3. This study is reserved until the results of the acute delayed neurotoxicity study become available. If the
results of the acute study are positive in the hen, then this study is required.
4. A teratology study in one species is required.
-------
-50-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional Timeframe
Data be for
Submitted? Submission
§158, Subpart D (Continued)
§158.390 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.440 Spray Drift
201-1 - Droplet Size Spectrum
202-1 - Drift Field Evaluation
TEP
TEP
TEP
TEP
TEP
TEP
F
F
No
No
No
Yes!/
Reserved^/
Reserved^/
27 months
1. The registrant is required to propose an acceptable reentry label statement based upon airborne residue
levels measured after observing the proposed label conditions, on estimated human exposure to those residues,
and on toxicity (No Observed Effect Level) of Sulfotepp. Human exposure should be estimated from the levels
of the airborne residues assuming a respiration rate of 60 liters/minute. Data from monitoring of actual human
inhalation exposure must not be gathered.
2. Reserved until all the toxicity data requirements are fulfilled.
-------
-51-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data
§158,
§158.
Requirement Test
Substance
Subpart D (Continued)
490 Wildlife and Aquatic Organisms
Use Does EPA Bibliographic Must Additional
Patterns Have Data? Citation Data be
Submitted?
Timeframe
for
Submission!/.
AVIAN AND MAMMALIAN TESTING:
71-1
71-2
71-3
71-4
71-5
- Acute Avian Oral Toxicity TGAI
- Avian Subacute Dietary
- Upland Game Bird TGAI
- Wild Mammal Toxicity TGAI
- Avian Reproduction TGAI
- Simulated and Actual TEP
Field Testing for
Mammals & Birds
F No - Yes!/
F No - Yes!/
F No - No!/
F No No!/
F No - No!/
9 months
9 months
(Continued, footnotes follow).
-------
-52-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data Requirement
Test Use Does EPA Bibliographic Must Additional Timeframe
Substance Patterns Have Data? Citation Data be for
Submitted? Submission!/.
§158, Subpart D (Continued)
§158.490 Wildlife and Aquatic Organisms (Continued)
AQUATIC ORGANISM TESTING; , ;
72-1 - Freshwater Fish Toxicity
- Coldwater Species
72-2 Acute Toxicity
to Freshwater
Invertebrates
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
TGAI
TGAI
TGAI
PartiallyV 00104043
No
No
Yes!/
Yes
Nbl/
9 months
9 months
72-4
72-4
72-5
72-6
72-7
- Fish Early Life Stage
- Aquatic Invertebrate
Cycle
- Fish Full Life-Cycle
- Aquatic Organism
Accumulation
- Simulated or Actual
Field Testing for
Aquatic Organisms
TGAI
Life TGAI
TGAI
TGAI,PAI or
Degradation Product
TEP
F
F
F
F
F
No
No
No
No
No
Nq2/
No!/
No!/
Nb2/
No2/
(Continued, footnotes follow).
-------
-53-
TART.F, A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
§158, Subpart D (Continued)
§158.490 Wildlife and Aquatic Organisms (continued)
FOOTNOTES:
1. Data must be submitted no later than [9 months from receipt of Guidance Package], unless
otherwise indicated. . ;
2. As per 40 CFR 158.490, data are not required for this indoor, greenhouse use pattern.
3. Only testing with one species (bobwhite quail) is required for this use pattern.
4. Only testing with one species (rainbow trout) is required for this use pattern.
5. Certain information, such as the amount of solvent used; whether control contained solvent and, if so, how much;
photoperiod; time and location of water quality measurements; fish behavior, including signs of toxicity other
than mortality; were not reported. If this information was recorded and can be reported to the Agency, it is
possible that these studies nay be upgraded.
-------
-54-
TABLE A
GENERIC DATA REQUIREMENTS FOR Sulfotepp
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
§158, Subpart D (Continued)
§158.590 Nontarget Insects
NONTARGET INSECT TESTING - POLLINATORS;
141-1 - Honey Bee Acute Contact TGAI
Toxicity
141-2 - Honey Bee - Toxicity of TEP
Residues on Foliage
141-4 - Honey Bee Subacute
Feeding Study
141-5 - Field Testing for TEP
Pollinators
No
No
No
Must Additional Timeframe
Data be for
Submitted?!/ Submission
No
No
No
1. Ecological Effects Branch, Hazard Evaluation Division, has determined that no data are required on sulfotepp and
honey bees, as sulfotepp is registered only for indoor use.
-------
-55-
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Sulfotepp.
Does EPA
have data to
Test satisfy this Bibliographic
Data Requirement Substance requirement?!/ Citation!/
§ 158, Subpart C, Product Chemistry
Product Identity and Composition
61-1 - Product Identity and Disclosure MP
of Ingredients
61-2 - Description of Beginning Mater- MP
ials and Manufacturing Process
61-3 - Discussion of Formation of MP
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product MP
Samples
62-2 - Certification of Ingredient MP
Limits
62-3 - Analytical Method to Verify MP
Certified Limits
•
No N/A
No N/A
No N/A
No N/A
No N/A
No N/A
Must additional
data be submitted
under FIFRA Sec.
3(c)(2)(B)?
•
Yes!/
Yes!/
Yes!/
YesV
Yes!/
•t /
YesZ/
Time Frame
For Data
Submission
6 months
6 months
6 months
12 months
12 months
12 months
(Continued).
-------
-56-
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Sulfotepp.
Does EPA
have data to
Test satisfy this Bibliographic
Data Requirement Substance requirement?!/ Citation!/
§ 158,
Must additional
data be submitted
under FIFRA Sec.
3(c)(2)(B)?
Time Frame
For Data
Submission
Subpart C, Product Chemistry (Continued)
Physical and Chemical Characteristics
63-2 -
63-3 -
63-4 -
63-7 -
63-12
63-14
63-15
63-16
63-17
Color
Physical State
Odor
Density, Bulk Density or
Specific Gravity
- pH
- Oxidizing or Reducing Action
- Flaimability
- Explodability
- Storage Stability
MP
MP
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
• : Yes8/
Yes8/
Yes8/
Yes8/
Yes8,!/
Y«&10/
Yes8'!!/
Yes8,!2/
Yes8'!!/
6 months
6 months
6 months
6 months
6 months
6 months
6 months
6 months
15 months
(Continued).
-------
-57-
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING Sulfotepp (continued).
Data Requirement
Test
Substance
Does EPA
have data to
satisfy this Bibliographic
requirement?!/ Citationi/
Must additional
data be submitted
under FIFRA Sec.
3(c)(2)(B)?
Time Frame
For Data
Submission
§158, Subpart C, Product Chemistry (Continued)
Physical and Chemical Characteristics (continued)
63-18 - Viscosity MP
63-19 - Miscibility MP
63-20 - Corrosion Characteristics MP
Other Requirements;
64-1 - Submittal of Samples N/A
No
No
No
N/A
N/A
N/A
N/A
N/A
Yes8,14/
Yes§/
6 months
6 months
15 months
No
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, 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, 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.
(Continued).
-------
-58-
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Sulfotepp (continued).
§158, Subpart C, Product Chemistry (Continued)
FOOTNOTES, continued:
4. A detailed discussion of all impurities that are or nay be present at _>0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and
after production must be submitted.
5. Five or more representative samples must be analyzed' for the amount of active ingredient and each impurity for
which certified limits are required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used.
6. Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at ^0.1% (w/w) and each "toxicologically significant" impurity present at <0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must be provided (e.g.,
sample analysis using validated analytical procedures, quantitative estimate based on amounts of ingredients used,
etc.). Limits for impurities not associated with the active ingredient need be provided only if they are
considered to be of toxicological significance, regardless of the concentration at which they are present.
Certifications must be submitted on EPA Form 8570 Rev. 2-85.
7. Analytical methods must be provided to determine the active ingredient, and each toxicologically significant
impurity and intentionally added inert for which certified limits are required. Each method must be accompanied by
validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of certi-
fied limits.
8. Physicochemical characteristics (color, physical state, odor, 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 submitted.
9. Data required if the test substance is dispersible in water.
10. Data required if the product contains any oxidizing or reducing agents.
(Continued).
-------
-59-
TABLE B. PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Sulfotepp (continued)
§158, Subpart C, Product Chemistry (Continued)
FOOTNOTES, continued:
11. Data required if the product contains combustible liquids.
12. Data required if the product is potentially explosive.
13. This test for long term storage stability must be under warehouse conditions.
14. Data required if the product is a liquid.
15. Data required if the product is a liquid and is to be diluted with petroleum solvents.
-------
-60-
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING Sulfotepp
Data Requirement Test
Substance
§ 158, Section D
§ 158.340 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat MP
81-2 - Acute Dermal Toxicity MP
- Rabbit
81-3 - Acute Inhalation Toxicity MP
- Rat
81-4 - Primary Eye Irritation MP
- Rabbit
81-5 - Primary Dermal Irritation MP
Use
Patterns
F
F
F
F
F
Does EPA
Have Data?
No
No
No
No
No
Bibliographic Must Additional
Citation Data be
Submitted?
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission
9 months
9 months
9 months
9 months
9 months
- Rabbit
81-6 - Dermal Sensitization
- Guinea Pig
MP
No
Yes
9 months
-------
-61-
II. LABELING APPENDICES
-------
-62-
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 text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 156.10(d)J
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-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 156.10(f)J
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)J
-------
-63-
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
• »
5 and under . 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out- of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 156.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on thie basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 156.10(h)(1)(i)J
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 156.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR I56.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(h)(2)].
-------
-64-
SUMMARY-3
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)J
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 156.11(c). You will be notified of
the Agency's classification decision.
-------
-65-
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 156.10(h)(l)(iv)
. *
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
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 simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-------
-66-
SUMMARY-5
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 use 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.
-------
-67-
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFFA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds /gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
imnediately
before or
following
Reg. No.
Inmediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Imnediately
below child
hazard
warning
COMMENTS
If. registrant is not the producer, must
be qualified by "Packed for . • . . , "
"Distributed by. . .,"etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
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-68-
SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, SB, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
-69-
suiWARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Inmediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Inmediately
after misuse
statement
Intnediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
|t DOMESTIC ANNALS)
DANGER
ENVMONMENTAL HAZARDS
PHYSICAL ON CHEMCAl
HAZARDS
OMfCTONS POR USE
B *
k •
RE-ENTRY fTATfMENT
* Apple**)
STORAGE AND
' DISPOSAL
STORAGE-
D0POSAL
CROP:
CROP:
RESTRICTED USE
PESTICIDE %
(reason for clasnifytnr)
ICM WtUL Wui TO MtD CBt OrtJf BY CBRIPICO APPUCKKM OR
RRSGNS UWCX THEIR DIRECT WRXVUION AW) ONLY KM THQ6B
uses owtno IT THB coaineo APPUCAJDR-I cotrxriorioN
CROP:
PRODUCT
NAME
ACTIVE MOREDCNT:
MERT NQREDCNT8:
TOTAL:
100.00%
CROP:
THIS PRODUCT CONTAMS IBS OP PER GALLON
KEEP OUT OF REACH OF CHILDREN
DANGER -POISON
•o
I
STATEMENT OF PRACTICAL TREATMENT
CROP:
r SWALLOWED:
* WHALED=
SEE SCC PAWL POR ADDITIONAL PRECAUTIONARY STATEMENTS
WARRANTY STATEMENT
MFOSY =
TOWN. STATE ==
ESTABLISHMENT NO. =
EPA REOflTRATXTN NO.
NIT CONTENTS:
-------
fMCAUnONAftV tTATEMCNTS
NAZAAMTOHUUAN*
ftDOMEfnCANMAU
CAUTION
DMRONUENTAL HAZAKtt
fMYWALOHCHEUCAL
HA2AMM
MtfCTOMt FM UM
h • *MM d
h a
M-iMTKY KTATCMCHT
PRODUCT
NAME
ACTWt MOMEOCNT: ,
MfRT MQIUOCNTt:,
TOTAL:
100.00%
THtt PftOOUCT CONTAftt LM OT KHQAUON
KEEP OUT OF REACH OF CHILDREN
CAUTION
•TATEUKNT Of PRACTICAL mCATUCNT
rtWAUOWfO:
«««0« 'AN*L KM AOOmONAL PfttCAUTKMAItY STATEUCNTS
UFO IV
TOWN. ITATl
ISTAMJ3HMCNT NO.
IPA RtOOTRATION NO.
NIT CONTENT*:
STORAGE AND
DISPOSAL
•KMAOC:
WARRANTY STATEMENT
-------
-72-
I—fnvtrwiiiienfeil Protection Agency
§ 16X10
at obtained the data from anothq
(Identify); applicant copied
a publication; applicant
py of the data from EPA).
The applicant shall submit
a statement that
Devaluation of the proc
Land safety of the formV
product, may not <
supporting the appl
,e following data:
data the applicant,
l EPA under:
end-
data
except
(1)
mitted
thissectii
(2)
safety of
ents, rathe
end-use
(3)
regulations,
clearances
Food. Drug.
(e) If the ap
Item of data b
section was
pense of) anoth
ly submitted the
predecessor. USD.
ary 1. 1970. to
for registration.
permit, or
use to an e:
rereglstration (
and the on
reached writ
sub»
(b) of
data
i product's
than to the
and
tolerances.
ixemptio;
ed unde:
O
it
to the
tre ingredl-
iety of the
food additive
and other
the Federal
Act.
that any
ted under.this
iy (or at the ex-
who original-
to EPA (or Its
on or after Janu-
irt an application
ptperimental use
t adding a new
tratlon. or for
the applicant
data \submltter have
it on the
amount and th*e terms W payment of
any compensation that \rnay be pay-
able under FIFRA section
3 156.10 in Volume 53, page
15991 of the Federal Register, dated May 4, 1988, and is
referred to by its new designation throughout this docu-
ment.
-------
(Iv) The proouc* !«••.-.-~-.
number a* prescribed In paragraph (e)
of this secMon. a a a.^^.^^^^.*
(v) The producing eitabmhrneni
number a* prescribed In paragraph (I)
of thta section;
(vl) An Ingredient statement•* pre-
scribed In paragraph (g) of Mil* *ec-
Unn*
(vil) Warning or precaullonary state-
ment* as prescribed In paragraph tn>
of this section;
(vlll) The direction* for use as pre-
scribed In paragraph (I) of Ihto section:
"ax) The use clas*lflc»llon(s) a* pre- (
scribed In paragraph (J) of Ihto *ertlon.
(2) Prominence and legibility. (I) All
words, statements, graphic representa-
llons. designs or olher Informallon re-
quired on Ihe labeling by Ihe Act or
the regulations In thta part must be
clearly legible to a person wllh normal
vision, and must be placed with such
consplcnousnen (as compared wllh
olher words, slalemenls. design*, or
graphic matter on the labeling) and
expressed In s»ich term* as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(II) All required label text must:
(A) Be sel In 0 point or larger type:
(B> Appear on a clear conlrasllng
background: and
(C) Nol be obscured or crowded.
(3) Language to be toed. All required
label or labeling text shall appear In
the English language. However. Ihe
Agency may require or Ihe applicant
may propose additional text In other
languages as to considered necessary to
protect the public. When additional
text In another language to necessary.
all labeling requirement* will be ap-
plied equally to both Ihe English and
other-language version* of the label-
i) Placemen* of Label-it) OtneraL
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 mta-
brandlng 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
whteh the label cannot be clearly read.
Ihe label must also be securely at-
tached to such outside wrapper or con-
tainer. It It ta a part of the package as
customarily distributed or sold.
(ID Tan* cars and other buOc con-
tainers—(A) Transportation. While a
pesticide product to In transit, the ap-
propriate provisions of 4f CFR Part*
170-IR9. concerning Ihe transportation
of hazardous materials, and specifical-
ly those provision* concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
i rylng them, define the baste Federal
requirement*. In addition, when any
registered pesticide product to trans-
ported In a lank car. lank Iruck or
olher mobile or portable bulk contain-
er, a copy of the accepted label mu«t
be attached to the shipping papers.
and left wllh the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are *tored In bulk container*.
whether mobile or stationary, which
remain m the custody of the user, a
copy of the label of labeling. Including
•II appropriate directions for use. shall
be securely attached to the container
In Ihe Immediate vicinity of Ihe dis-
charge control valve.
(5) FalM or militating statement*.
Pursuant to section 2(qXlXA) of Ihe
Act. a pesticide or a device declared
•ubjed to Ihe Art P«rsu»nt to
1162.15. ta mtabranded If It* labeling to
false or misleading In any particular
Including bolh pesllcldal and non-pes-
tlcldal claims. Example* of statement*
or representations In the labeling
which conslllule mtobrandlng Include:
(DA false or misleading statement
concerning the composition of the
product:
(II) A false or misleading statement
concerning the effectiveness of the
product aa a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as • pesticide or
device:
(Iv) A false or misleading comparison
with other pesticides or devices:
(v) Any statement directly or Indi-
rectly Implying lhat the pesticide or
device ta recommended or endorsed by
ment;
(vl> The name of a pesticide which
eontalrw two or more principal active
Ingredient* If the name suggests one
or more but not all such principal
active Ingredient* even though the
names of the other Ingredients are
stated elsewhere In the labeling;
(vll) A true statement lined In such a
way as to give a false or misleading Im-
pression to the purchaser;
fvlll) Label disclaimers which negate
or detract from labeling statement* re-
quired under the Act and thrwe regula-
tions;
It*) Claims as to the safety of the
pesticide or Ha Ingredlenti. Including
statements such as "safe." "nonpolson-
ous." "nontnjtirlous." "harmless" or
"nontoxlc to humans and pet*" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural Ingredl-
enU";
(B) "Among the least toxic chemi-
cals known"
name ana address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant Is
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label. It mint
be qualified by appropriate wording
such as "Packed for • • V ••Dblrlbul-
ed by • • V or "Sold by to show
that the name Is not that of the pro-
ducer,
(d) Hft weight or memturr of ron-
tentt. (I) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide Is a liquid, the
net content statement shall he In
terms of HquM measure at 6ft' P (TOT)
and shall be expressed In conventional
American units of fluid ounces, pints.
quarts, and gallons.
(.1) If the pesticide Is solid or semlso-
lid. viscous or pressurized, or Is a mix-
ture of liquid and solid, the nrl con-
tent statement shall be In trrms of
weight expressed as avolrdiipnl* I
pounds and ounces. [j
(4) In all cases, net content shall be (
stated In terms of the largest suitable
units. I.e., "I pound 10 ounces" rather
than "20 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(0) Variation above minimum con-
tent or around an average Is prrmlssl-
ble only to the extent that It rrprr-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the lime of
registration shall appear on the Ishrl.
preceded by the phrase "EPA flcgls-
tratlon No.." or the phrase "EPA flrg.
No." The registration number shall or
set In type of a sire and style similar to
other print on that part of the labrl
on which It appears and shall run par-
28
-------
I U2.M
allel to It The registration number
and the required Identifying phrase
•hall not appear m such a manner •»
to suggest or Imply ictommendatlen
or endorsement of the product by the
Agency.
(f) Producing estoMlshmenc* regit-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est". of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
totratlon number on the Immediate
container cannot be clearly read
through such wrapper or container.
(f) Ingrfdlmt «tof*ment-O) Gener-
al. The label of each pesticide product
mwt bear a statement which contain*
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all Inert Ingredi-
ent*: and If the pesticide contains ar-
nenk In any form, a statement of the
percentage* of total and water-soluble
arsenic calculated as elemental ar-
senic. The active Ingredient* must be
designated by the term "active Ingredi-
ents" and the Inert Ingredient* by the
term "Inert Ingredient*." or the singu-
lar forms of these terms when appro-
priate. Both term* shall be In the
same type size, be aligned to the same
margin and be equally prominent The
statement "Inert Ingredient*, none" to
not required for pesticide* which con-
tain 100 percent active Ingredient*.
Unless the Ingredient statement to a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading lor the Ingredient statement
(2) Position of ingredient itatemtnL
(I) The Ingredient statement to nor-
mally required on the front panel of
the label. If there to an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
atoo appear on such outside container
or wrapper. If the she or form of the
package makes It Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear etoewhere.
mi*
(ID The teat of the mgredVnl state-
ment must run parallel wHh other
text on the panel on which H appears.
and must be clearly distinguishable
from and must not be placed In the
body of other tent.
(3) Name* to be tuerf t« ingredient
statement The name used lor each In-
gredient shall be the accepted
common name. If there to one. fol-
lownl by the chemical name. The
common name may be used atone only
If It to well known. If no common name
has been established, the chemical
name alone shall be used. In now**
will the use of a trademark or propri-
etary name be permitted unleas *uch
name has been accepted as a common
name by the Administrator under the
authority of Section 2S(eX«>.
<«) Statement* of percentages. The
percentages of Ingredient* •hall be
•Uted In terms of wetghHo-welght
The sum of percentages of the active
and the Inert Ingredients shall be 100.
percentages shall not be expressed by
a range of values such as "22-2S%." If
the uses of the pesticide produetare
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight ol active Ingredient per unit
volume of the pesticide formulation
shall also appear m the Ingredient
statement
(5) *cc«r«c» of state*1 percent****
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value slated for
each active Ingredient shall be the
lowest percentage which may be pres-
(0) Deterioration. Pesticides which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where It to determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement m a prominent position on
the label: "Hot for sale or use after
I date)." .. ...
(II) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(7) Inert ingredient*. The Adminis-
trator may require the name of any
I frotsctUm Aasaicy
5 16? 10
Inert IngredlenUs) to be listed In the
Ingredient statement If he determine*
that such IngredtenUs) may pose a
hazard to man or the environment
(h) Wanting* end precautionary
statement*. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard Including hazard to children.
environmental hazard, and physical or
chemical hazard fall Into two group*;
those required on the front panel of
the labeling and thane which may
appear elsewhere. Specific rrquiv-i:
ments concerning content placement.
type state, and prominence are given
(I) Rewind, front panel statements.
With the exception of the cl>li,;
hazard warning statement the text re -
qulred on the front panel of the label
t» determined by the Toxlrlly Cnlcico
ry of the pesticide. The category h a*
signed on the barfs of the hliclie*l
hazard shown by any of the Indicator*
m the table below.
(I) Human hazard lipnoJ toor*1— ToxMtf Cateponr IV. All pesti-
cide products meeting the criteria of
Toxlclty Category IV shall bear on the
front panel the signal word "Caution."
(E) Vie of liffnol word*. Use of any
signal wonMs) associated with a higher
Toxlclty Category to not permitted
except when the Agency determine*
that such labeling to necessary to pre-
vent unreasonable adverse effect* on
man or the environment In no ca*e
shall more than one human hazard
signal word appear on the front panel
of a label.
(II) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach oJ children." Or.iy In rsisjf.
where the likelihood of contact with
children during distribution, market
Ing. storage or use to demonstrated liy
the applicant to be extremely remote.
or If the nature of the pesticide I* such
that It to approved for use on Infant*
or small children, may the Administra-
tor waive thb requirement
(III) Statement o/ practical treat
menf—
-------
M "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other (oxJctt* cofepoHet. The
statement of practical treatment Is not
required on the front panel except as
described In paragraph (hXlXlllXA) 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 If a pesticide Intended for out-
door use contains an active Ingredient
with a mammalian acute oral LD- of
(B) If a pesticide. Intended lor out-
door use contains an active Innrcdlent
with a fish acute LG» of I ppm or Ims,
the statement "This Pesticide Is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active Ingredient
with an avlan acute oral LD. of KM)
mg/kg or less, or a subacule dietary
LCM of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
to to>n|Mrcta^v* ibvM I.W F
Cni<«m» uratar pmw« OB not w* o» Mom now hmi w
Aw* Do ml pixclno 01 >«J»«n
M «ho»« IW F may OHM* l»i>««no
Mxn* IW r ontf ml o*M IW r .
no CotmuMnw
*! cvwwn^f •MivmMii ItcNp twvf wntn %•, npuHni. •nn
I mrtao*
1 rinnmiWi KM* fwff ftvii rxol *n« opm •••»•
I OB no! IKO «r Mm C>M> two) or opm ••«•
(I) rXrrcHon* for t/»e-(l) Oenerof
rr4«irement>— Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are Intended
for use only by manufacturers of prod
uct* other than pesticide produrU In
their regular manufacturing processes.
provided that:
—3
Ul
I
-------
{ 147.10
(1) The label clearly shows thai the
product to Intended for use only In
manufacturing processes and specifies
the type<«) of producU Involved.
(2) Adequate Information such as
technical data sheeU or bulletins, to
available to the trade specifying the
type of product Involved and Its
proper use In manufacturing process-
13) The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucU: and
(«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fect* on man or the environment.
Detailed directions for use may
be omitted from the labellnc o(, !*•«•
clde producU for which sale to limited
to physicians, veterinarians, or drug-
gist*, provided that:
U> The label clearly state* thai the
product to for use only by physicians
or veterinarians;
(« The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment: and
13) The product to also a drug and
regulated under the provisions of the
Federal Pood. Drug and Cosmetic Act.
Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formulators In preparing
pesticides for sale to the public, pro-
vided that:
(J) There to Information readily
available to the formulators on the
composition, toxlclty, methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes;
(*) The label clearly states that the
product Is Intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the typeis) of pesticide prod-
ucU Involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged to registered; and
(¥) The Administrator determines
that such directions are not necessary
>_ .....ii.ni. unreasonable adverse el-
40
•itlwl Fr*t«tcM*n Af «my
5U7.1I
(1) Content* of Wrectloiu /or Vte.
The directions for use shall Include
the following, under the headings Di-
rections for Use":
(I) The statement of use classifica-
tion as prescribed In IM.IWJ) Immedl-
•tely under the heading "Directions
for Use." . .
(M) Immediately below the state-
ment of use classification. the state-
ment "It to a violation of Federal law
to use this product In a manner Incon-
sistent with Its labeling."
(Ill) The slt« of application ap-
paratus or equipment required.
The frequency and timing of ap-
plications necessary to obtain effective
result* without causing unreasonable
adverse effects on the environment.
Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirement*
concerning reentry provided by 40
CFR Part 170.
(lx> Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirements of 40 CFR Part 165. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set In type of the same minimum S!MS
as required for the child hazard warn-
ing For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
* certified applicator who to not phys-
- •- ---- « -• •»-- -i»» nt •nnllratlon
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who to physically present.
(F) Other pertinent Information
which the Administrator determines
to be necessary for the protection of
man and the environment.
Statement of Vie Classification.
By October 22. 197*. all oestlrlde prod
nets must bear on their labels a state-
ment of use classification as described
In paragraphs (JX I) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general IMC
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth In this sub-
section, and shall be marketed us sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted usrts)
except that. If a product has both re-
stricted uscXs) and general usets). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucU shall be subject to the provisions
of 1l«2 KXJX2).
(I) Oenrrol Ute Classification. Pesti-
cide producU bearing directions for
usc(s) classified general shall be la-
beled with the exact words "General
Clarification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggrsU or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained In the Directions for Usq will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Uif Classification.
Pesticide producU bearing direction
for use classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(I) Front panel if a foment of restrict-
ed use classification. At the top of
the front panel of the label, set In type
of I he same minimum slr.es as required
for human hazard signal words (see
table In I 16J IO(hXlMlv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make It unlikely to
be overlooked under customary rondl-
lions of purchase and use. the state-
ment "Restricted Use Peitllrlile" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to reglsl ration shall
appear. If use Is restricted to ecrHMed
applicators, the following statement Is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under thrlr direct supervision nnd
only for those uses covered by the Or-
lifted Applicator's certlflratlon." If.
, however, other regulatory reslrlel.lons
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulal Inn.
(k) Advertising, f Reserved I
140 FR MISS. July 3. I»7B; 40 FR
AII*. I. i«»; 40 rn SSMI. AW*, it. ir?». «
amriMfeil at 43 PR 97SS. Frb ». IW7S)
• If Z.11 CriUrla for rfrtrrmlni
•M« aawror »ff«H-U.
(a)V7rtf«-Ha /or f**N«inc«> of Nnti/r of
lnte.n\.to Deny Registration, (jdncrl
Registration, or to HoM a HeitriiiQ •
(I) rre.s\mptton. (I) A rebutta/ile pre
sumpllorKshall arise thai a/ntlrc of
Intent to oeny regtolrallon nnrsnanl to
section 3(c\9> of Ihe Acl.yh notice of
Intent to cancel registration pursuant
to section WtoXl) of Otc Art. or a
notice of Intent to hohf a hearing to
determine whether Vnc registration
should be canceled
proprlate. shall
termination by lhe
the pesticide mee
the criteria for
graph (aX3) of )hls
determination
shall Issue
r denied, as up-
urd, upon a de-
dmlnlstralor Iliat
exceeds any of
t forth In para
ion. Upon such
the Admlnlstrator
by ceVlflcd mall to
the applicant or registrant, as the rase
may be. stating thai the itopllcant or
registrant/has the opportunity to
submit evidence In rrbiiUnV of such
presumption In accordance wVh para-
graph ifcX4) of this section. Th\ appli-
cant or registrant shall have forty five
(46) inays from the dale such noftlrr Is
senlr to submll evidence In rebullaJ of
In/ presumption; provided. howeVr,
tWmt for good cause shown the Ailin)
Hrator may grant an additional slxf)
en
I
-------
Criteria
-77-
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 808F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
-78-
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.
-------
-79-
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, iars)
Non-aerosol products
(bags)
Aerosol products "
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke. _____
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application |
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused.!, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
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)
i/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
-80-
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 disp
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardo
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 stateme
"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 lay«
of newspaper and discard in trash."
-------
-81-
PEST/DIS-2
POOS
P070
POU4
POOS
P006
POOS
P010
P011
P012
P021
P022
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with*RCRA I and CAS »
140 CFR 261.33(e)J
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide \
4-Aminopyridine (Avitrol)
Arsenic acid *
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
O,0-Diethyl S-[2-ethylthio)ethyl]
phosphorodithioate (disulfoton)
O,O-Diethyl 0-pyrazinyl
phosphorothioate (Zinophos*)
Dimethoate .
O,0-Dimethyl O^p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexachlorohexahydro-exo,exo-
dimethanonaphthalene (Isodrin)
Hydrocyanic acid
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
OctamethyIpy rophosphoramide
(OMPA, schradan)
Parathion
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P044
P071
P047
P034
P020
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
-------
-82-
PEST/DIS-3
Strychnine and salts <- « P108 57-24-9
4 ~ 60-41-3
0,0,0,0-Tetraethyl P109 3689-24-5
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill 107-49-3
Thallium sulfate P115 7446-18-6
Thiofanox P045 39196-18-4
Toxaphene P123 8001-35-2
Warfarin'(>0.3%) \ P001 81-81-2
Zinc phosphide (>10%) P122 1314-84-7
50 ACTIVES
-------
-83-
III. BIBLIOGRAPHY APPENDICES
-------
-84-
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the 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 explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
-85-
BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no 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 fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element, •
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
-------
-86-
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Sulfotepp Standard
MRID CITATION
00104043 Allen, R. (1975) Toxicity of Dieldrin to Bluegill
Sunfish and Rainbow Trout. (Unpublished study
received July 16, 1975 under 9386-10; submitted
by Vinings Chemical Company, Atlanta, Georgia;
CDL: 223094-B)
-------
-87-
IV. FORMS APPENDICES
-------
-88- OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
E
•A REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFHA section 3(C)(2)(B) notice contained in th- referenced
Guidance Document. I am responding in the following manner
D 1. I will submit data fa a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group. OECO
Chemicals Testing Programme. I enclose the protocols that I will use:
D2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)
-------
OMB Approval No. 2070-0057
-89- Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative: ^
(Signature)
Dated:
(Typed)
EPA Form 8580-3
-------
US Environmental Protection Agency Registration Standard for
Washington. DC 20460
AFPA Product Specific
^ DataReoort
Registration
Guideline No.
Sec. 158. Sub
Product
Chemistry
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158. 340
Toxicology
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
>art C
Identity of Ingredients
Statement of .composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
Analytical methods for enforcement limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-density, or specific gravity
Solubility
Vapor pressure
Dissociation constant
Octanol/water partition coefficient
PH
Stability
Oxidizing/reducing reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
of Subpart D
Acute oral toxicity, rat
Acute dermal toxicity, rabbit
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitization
Testing not
required for my
product listed
above
(Check below)
EPA Registration Number
1 am complying with
Data Requirements by -
Citing MR ID No.
Submitting Data
(Attached)
(Check below)
»
Form Approved
OMB #2070-0057
Expires 11-30-89
(For EPA Use
Only)
Accession
numbers
assigned
-
Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or imprisonment or both under applicable law.
Typed Name and Title
Signature
Date
EPA Form 8580-4 (Rev. 5-88) Previous edition is obsolete.
-------
-91-
OMB Approval No.
Expires 11/30/89
2070-0057
fTo qufltfy. certify ALL four /tarns)
CERTIFICATION Of ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(8) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT OATC
ACTIVE INGREDIENT
NAMC OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm H willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the off«rs ut attached. That offer was irrevocable and included in offer to b«
bound by an arbitration decision under FIFRA Section 3(c)(2)(8)(iii) if final agreement on all terms could not be reached otherwise. This offer wis m*d«
to tne following firmd) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(tl accepted my offer.
4. My firm requests that EPA not suspend the registration(sj of my firm's product(s). if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration^) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicant* for new products.) I give EPA permission to disclose this statement upon request.
TVPCO NAME
EPA Form 8SOO-8
SIGNATURE
OATE
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