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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
FENSULFOTHION
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
DECEMBER 22, 1983
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27790
TABLE OF CONTENTS
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 34
III. Requirement for Submission of Product-Specific
Data 60
IV. Submission of Revised Labeling and Packaging
Information 64
A. Label Contents 64
1. Product Name 64
2. Company Name and Address 64
3. Net Contents 64
4. Product Registration Number 65
5. Producing Establishment
Registration Number 65
6A Ingredient Statement 65
6B Pounds Per Gallon Statement 65
7. Front Panel Precautionary Statements 65
7A Child Hazard Warning Statements 66
7B Signal Word 66
7C Skull and Crossbones and Word Poison 66
7D Statement of Practical Treatment 66
7E Referral Statement 66
8. Side/Back Panel Precautionary Labeling 66
8A Hazard to Humans and Domestic Animals 67
8B Environmental Hazard 67
8C Physical or Chemical Hazard 67
9 Misuse Statement 68
10A Storage and Disposal Block 68
10B Directions for Use 68
B. Collateral Information 68
V. Instructions for Submission 69
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APPENDICES
II-l Bibliography
II-2 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
III-l Product Specific Data Report (End-Use Products)
EPA Form 8580-4
IV-1 40 CFR §162.10 Labeling Requirements
IV-2 Table of Labeling Requirements and Sample Labels
IV-3 Physical/Chemical Hazards Labeling Statement
IV-5 Storage and Disposal Statements
Note: Appendices IV-4 and IV-6 are not germane to this
document and are not included.
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain ^registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2)(B) provides that these data are to be submitted by
those registrants who do not qualify for the formulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that
the registrants who are responsible for filling the data
gaps are the manufacturing-use product producers (basic
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suppliers of the active ingredient). However, end-use producers
will not qualify for the formulator's exemption if the source
of their active ingredient: (1) is not registered with EPA,
and/or (2) is produced by the registrant's firm, or a firm
which has ownership in common with the registrant's firm.
These end-use producers can qualify for the formulator's
exemption if they change their source of supply to a registered
source, provided the source does not share ownership in
ccmmon with the registrant's firm. If the end-use product
registrant decides to switch sources, a new Confidential
Statement of Formula, EPA Form 8570-4, must be submitted to
the appropriate Product Manager within 90 days of receipt of
this Guidance Document. The chart on the following page
shows what is generally required of those who do and do not
qualify for the formulator's exemption in the Registration
Standards program.
If you decide to request the Agency to discontinue the
registration of any of your products subject to the reregistra-
tion requirements of this Guidance Document, please notify
the Product Manager named in the cover letter, within 90
days from the receipt of this document, that you wish to
voluntarily cancel the registration(s). If you decide to
maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined. EPA will issue a notice of intent to cancel
or suspend the registration of any currently registered
product if you fail to comply with the requirements set
forth in this Guidance Document.
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved, EPA
has decided to proceed with the requirements in this Guidance
Document which do not relate to compliance with the §3(c)(l)(D)
provisions and to supplement the Document with additional
guidance when circumstances permit. Failure to comply with
the provisions of the subsequent guidance will also result
in issuance by EPA of an intent to cancel the affected product
registrations ).
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory position of the Environmental
Protection Agency (the Agency) on registered manufacturing-use products (MUPs)
containing the insecticide and nematicide fensulfothion. The Agency's position
is based on an evaluation of all registered uses and registered MUPs with
fensulfothion as the sole active ingredient. This position is based on a number
of considerations. Foremost among these is an analysis of fensulfothion based
on the risk criteria found in Section 162.11(a) of Title 40 of the U.S. Code
of Federal Regulations. The Standard also considers labeling requirements,
tolerances, "Special Local Needs" registrations authorized by Section 24(c)
of the FIFRA, as well as Federal registrations granted or pending under Section
3 of the FIFRA. Finally, the Agency sets forth the data requirements that must
be met to register products covered by this document.
This Standard only addresses registration requirements for current or substan-
tially similar future MUPs and their intermediaries. Fensulfothion MUPs that
differ appreciably from those described here may require amendments to the
Standard. End-use products (EUPs) will be registered under the Label Improve-
ment Program.
B. CHEMICAL DESCRIPTION AND USE PROFILE
Fensulfothion is the common name approved by the International Organization
for Standardization (ISO) and the British Standards Institution (BSI) for an
insecticide-nematicide manufactured and registered in Vhe United States by
the MOBAY Chemical Corporation with the chemical names of 0,0-diethyl 0-
[p-(methylsulf inyl) phenyl] phosphorothioate and 0,0-diethyl 0-[4-(methylsulf inyl)
phenyl] phosphorothioate.
Additional names used for fensulfothion include BAY 25141, S-767, and the
the trade names DASANIT and TERRACUR P. The Chemical Abstracts Service
(CAS) Registry Number is 115-90-2 and the EPA Reference Number is 032701.
The empirical formula is CnHj7O4S2P and the molecular weight is 308.3.
The structural formula is as follows:
C2H 0
2 5
C2H5°
The 90% technical material also serves as a manufacturing-use product under
the trade name DASANIT.
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Fensulfothion is an insecticide and nematicide which is Federally registered
for use on the following food/feed crops : bananas, corn (field, pop-, and
sweet), cotton, onions (dry bulb), peanuts, pineapples, plantain, potatoes,
rutabagas, sorghum, soybeans, sugarcane, sweet potatoes, and tomatoes. Fen-
sulfothion formulations are also registered for use on tobacco, citrus seed-
lings, lawns, ornamental turf, ornamental herbaceous plants, ornamental woody
shrubs and vines, and ornamental trees.
Technical fensulfothion is a brown liquid, stable under normal use conditions,
with a boiling point of 138-141°C at 0.01 mm Hg. It is soluble in most organic
solvents except aliphatics. Existing data gaps related to product chemistry
are identified in Table A and Table B.
As of December, 1983, MOBAY Chemical Corporation is the sole manufacturer
of the one single active ingredient technical and manufacturing-use fensul-
fothion product, and the one fensulfothion-disulfoton multiple active
ingredient manufacturing-use product.
Fensulfothion is formulated into the following single active ingredient
products: a 63% (Gib/gallon) emulsifiable concentrate, a 10% granular,
and a 15% granular. Fensulfothion is also formulated at various percentages
with the following other active ingredients: disulfoton, thiram, and pebulate.
End-use products containing fensulfothion as their sole active ingredient
include 5 Section 3 Federal registrations, 20 Section 24(c) Special Local
Need registrations, and 22 Intrastate registrations. End-use products
containing fensulfothion plus other active ingredients include 17 Section
3 Federal registrations, 14 Section 24(c) Special Local Need registrations,
and 5 Intrastate registrations.
Fensulfothion is usually applied as a preplant or at planting soil application.
Postplant topical applications are permitted on a limited number of crops;
these are corn, peanuts, and rutabagas. The topical applications are permitted
in addition to the at planting application. The 10% and 15% granular products
may be used only by commercial growers, applicators and nurserymen, while the
6 Ib/gal. emulsifiable concentrate is a restricted use pesticide.
C. REGULATORY POSITION
Based on a review and evaluation of all available data and other relevant
information on fensulfothion, the Agency has made the following determinations:
1. Manufacturing-use pesticide products containing fensulfothion as a
sole active ingredient may be registered for sale, distribution,
reformulation, and use, subject to the terms and conditions
specified in this Standard.
2. Available data show that three of the criteria listed in Section
162.11(a) of Title 40 of the U.S. Code of Federal Regulations
(RPAR triggers in avian, aquatic, and mammalian categories) may
be met or exceeded by the current uses of fensulfothion specified
in this Standard. Because of this possibility, Tier III data
(field studies) have been requested in this Standard to gather
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qualitative and quantitative data to support the registration
and/or need for special review. Additional gaps in the data
base also preclude conpletion of the Agency's risk assessment.
3. The "Restricted Use" classifications for the following fensulfothion
use patterns will continue: all uses of concentrate solutions 63%
and greater, all emulsifiable concentrates and concentrate solutions
43% and greater with disulfoton 21% and greater, all emulsifiable
concentrates 32% and greater in combination with disulfoton 32%
and greater, and indoor greenhouse use of granular formulations
10% and greater. Current labeling for those products subject to the
"Restricted Use" classification already bear the required "Restricted
Use Only" block on the front panel.
4. Registrants must provide or agree to develop additional data, as
specified in the tables attached to this Standard, in order to
maintain existing registrations or to permit new fensulfothion
registrations.
5. Tolerance reassessment is normally a part of a Registration
Standard review. The Agency is unable to complete its reassess-
ment of fensulfothion tolerances because necessary toxicology
and residue data are not available.
D. REGULATORY RATIONALE
The Agency has determined that it should continue to allow the registration
of fensulfothion after considering the following:
1. Although many of the toxicology studies for technical fensulfothion
were performed prior to 1970 and contain insufficient data for
full evaluation, sufficient information is available to determine
that j^his chemical is in Toxicity Category 1 by oral and dermal
exposure r? Additional required studies, representing gaps due
to missing or incomplete studies are identified in Table A.
Theoretical Maximum Residue Contribution <^JIMRC
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4. The plant and animal metabolites are well studied and understood.
Most tolerances for residues are supported with data, however,
additional data must be submitted to support tolerances for resi-
dues in or on the following commodities: bananas, peanuts, peanut
hulls, plantain, and potatoes (processing data only). The Category
3 classification [40 CFR 180.6(a)] for residues in milk, eggs,
poultry meat, fat or meat by-products of poultry is considered
adequate, i.e. no tolerance are required. In addition, human
exposure to fensulfothion residues via tobacco products and their
smoke has been adequately delineated.
5. [^Available data are insufficient to fully assess the fate of fen-
sulfothion in the environment^/however, based on what is known,
ground water contamination does not appear to be a problem with
this chemical. Data are insufficient to assess the exposure of
humans and non-target organisms to the chemical or its degradates.
6. |_No federal reentry interval had been established for workers entering
fields treated with fensulfothion/] Since the State of California
requires a reentry interval of 7 days for soil applied fensulfothion
to mitigate human-skin contact with residues on wet soil, and since
fensulfothion is a toxicity category I pesticide, the Agency is estab-
lishing an interim reentry interval of seven days when fensulfothion
is applied to soil and 24 hours for all applications of fensulfothion
where agricultural practices will involve hand labor with prolonged,
intimate foliar contact.
The reentry interval will be waived when fensulfothion is applied to
soil if the fieldworkers use impermeable foot-wear and use impermeable
gloves when hand contact with soil will occur. If the soil is dry,
the seven day reentry period will be waived, and the 24-hour reentry
interval will then apply.
The restrictions for soil and foliar application are label requirements.
Refer to the Required Labeling chapter for specific statements.
7. Fensulfothion was developed in 1957 by Bayer Corporation, Germany.
The technical and manufacturing-use product was registered in the
United States on December 29, 1965. Reported pesticide incidents
involving fensulfothion alone between 1966 and 1983 include 25
involving human injury and 4 involving animals. Most of the human
incidents resulted from failure to use safety equipment while
applying fensulfothion. Other incidents were the result of
improper disposal, handling, or storage. Because the incidents
involve occasions of misuse, no additional precautionary state-
ments are necessary at this time to minimize the risk of injury.
8. IThe toxicity of fensulfothion to terrestrial and aquatic non-target
organisms is very highTj Residue calculations indicate that 3
RPAR triggers (mammalian, avian, and aquatic) have been exceeded.
In all cases this Standard has asked for Tier III data (field
studies) to gather qualitative and quantitative data to support
the registration and/or need for special review. Because of
fensulfothion's extensive number of use patterns and its high
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toxicity to wildlife, numerous endangered species have been
identified that could be impacted. In addition, the Agency
has issued a Notice of Proposed Rulemaking on granular pesticides
that proposed restricted use classification for all granular
and fertilizer products containing greater than 2% fensulfothion
(except treatment of plant benches, beds, and potting soil)
because of acute oral toxicity and residue effects on avian
species (Federal Register Vol. 44, No. 149, pp 45219-45224).
The Agency is currently considering various approaches to address
the endangered species concerns for this and other chemicals,
and this Standard may be amended to incorporate the results of
this additional review.
9. {The use of fensulfothion is not permitted on food crops grown in
greenhouses,,} The use on non-food crops grown in greenhouses was
removed from the labeling of the 10% and 15% granular products on
December 10, 1979 by addition of "(OUTDOORS ONLY)" for the sites
benches, beds, and potting soil. Greenhouse non-food, non-foliar
application is currently registered for a 63% emulsifiable concen-
trate with the Restricted Use Only classification.
10. In accordance with FIFRA, the Agency cannot routinely cancel
existing registrations of products or withhold registration merely
for lack of data unless risks are clearly identified from the data
that have been submitted and evaluated. Rather, the publication of
this Standard provides a mechanism for identifying data needs and
for imposing restrictions based on the review of data currently
available. Registration of fensulfothion under this Standard
will allow for the upgrading of labels during the period in
which the required data are being generated.
E. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
All manufacturing-use products which contain fensulfothion as the sole active
ingredient are subject to this Standard and must either comply with the acute
toxicity limits, product composition, and use pattern requirements listed in
Section F of this document or submit data and a justification to amend the
Standard to encompass such products.
The applicant for registration or reregistration of products subject to this
Standard must comply with all terms and conditions described in it, including
a commitment to fill data gaps on a schedule specified by the Agency. Appli-
cants for registration under this Standard must follow the instructions
contained in this Guidance Package and complete and submit the appropriate
forms within the time specified.
F. ACCEPTABLE RANGES AND LIMITS
1. Product Conposition Standards
To be covered under this Standard, manufacturing-use products must contain
at least 90% fensulfothion as the sole active ingredient. The composition
of each manufacturing-use fensulfothion product must be substantially similar
to that in currently registered manufacturing-use products. Any manufacturing
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use product not meeting these requirements will be considered a new product
and will require an amendment to the Standard.
2. Acute Toxicity Limits
The Agency will consider registration of manufacturing-use products con-
taining fensulfothion for any acute toxicity category, provided the labeling
of those products bears appropriate precautionary statements.
3. Use Patterns
To be registered under this Standard, manufacturing-use products containing
fensulfothion may be labeled for formulation only into end-use products for
the following sites (as summarized from the EPA Index to Pesticide Chemicals,
page 13 to page 33 of this document):
a. Terrestrial, Non-Domestic, Food Uses
Bananas, Plantain
Cereal Grains - Corn (field, pop, and sweet), Sorghum
Cotton
Onions (dry bulb)
Peanuts
Pineapples
Root and tuber vegetables - Potatoes, Rutabagas, Sugar Beets,
Sweet Potatoes
Soybeans
Sugarcane
Tomatoes
b. Terrestrial, Non-Domestic, Non-Food Uses
Citrus seedling roots
Lawns
Ornamental turf
Ornamentals - herbaceous perennial, woody shrubs and vines, trees
Tobacco
c. Greenhouse, Non-Food Uses
Ornamentals - non-foliar application only
End-use products formulated from products under this Standard may be con-
centrate solutions, emulsifiable concentrates, or granulars.
G. REQUIRED LABELING
All manufacturing-use and end-use products containing fensulfothion must
bear appropriate labeling as specified in 40 CFR 162.10. The following
additional statements are required:
1. Use Pattern Statements
All fensulfothion manufacturing-use products must contain one or more of
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the following use pattern statements listed below:
- Terrestrial, Non-Domestic, Food Use on [specify food crops]
- Terrestrial, Non-Domestic, Non-Food Use on [specify non-food sites]
- Greenhouse, Non-Food Uses (Non-foliar application)
2. Precautionary Statements
Labels for all manufacturing-use products containing fensulfothion must bear
statements reflecting the acute human toxicity of the compound. An updated
description of precautionary statements which must appear for each type
of product to be in compliance with 40 CFR §162.10 is included as Appendix
IV-1 in this document.
The following environmental hazard warning statement must appear on all
manufacturing-use product labels:
"This product is toxic to fish and extremely toxic to wildlife. Do
not discharge into lakes, streams, ponds, or public waters unless
in accordance with an NPDES permit. For guidance, contact your
Regional Office of the EPA."
Based on data reviewed by the Agency, the following label revisions are
required for end-use products in this guidance package. The environmental
hazards section should be revised as follows:
"This product is toxic to fish and extremely toxic to wildlife. Use
with care when applying in areas frequented by wildlife. Birds
feeding on treated areas may be killed. Cover, disc, or incorporate
spill areas. Drift and runoff from treated areas may be hazardous
to aquatic organisms in neighboring areas. Do not apply directly
to water or wetlands. Do not contaminate water by cleaning of equip-
ment or disposal of wastes. This product is highly toxic to bees
exposed to direct treatment on blooming crops or weeds. Do not apply
this product or allow it to drift to blooming crops or weeds while
bees are actively visiting the treatment area."
Since a complete assessment of hazards to workers cannot be made at this
time due to insufficient data, reentry precautionary statements as follows
will be required on end-use products until data showing acceptable risk
levels are submitted and evaluated:
"Unprotected workers should not re-enter treated fields until 24
hours after application. Unprotected workers should not re-enter
fields where the soil is wet until 7 days after soil application."
The Agency may impose additional label requirements after the receipt and
review of the data to be submitted under this Standard, and/or the Agency's
review of all nematicide labeling in response to a request from the State
of California to consider, among other things, a 48 hour reentry interval
for applications of nematicides to dry soils.
10
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H. TOLERANCE REASSESSMENT
A sunmary of tolerances for fensulfothion is presented in Table 1. This
table also includes information on Canadian, Mexican, and Codex tolerances
for fensulfothion. The tolerances established in the United States were
derived from data submitted to the Agency•
The tolerances for combined residues of fensulfothion and its cholinesterase-
inhibiting metabolites, as listed in Title 40 of the U.S Code of Federal
Regulations (CFR) Section 180.234, in or on the following commodities are
supported: corn (fresh and grain), corn forage and fodder, cottonseed,
onions (dry bulb), pineapples, rutabagas, sorghum grain, sorghum forage
and fodder, soybeans, sugar beet roots and tops, sugarcane, sweet potatoes,
tomatoes, and meat, fat, and meat by-products of cattle, goats, hogs, horses,
and sheep. Also, the Category 3 classification [40 CFR §180.6(a)] for
residues in milk, eggs, poultry meat, fat, and meat by-products of poultry
is considered adequate, i.e. no tolerances are required.
Additional data are required, however, to determine the adequacy of the
tolerances for residues in or on the following commodities: bananas,
peanuts, peanut hulls, plantain, and potatoes (processing data only).
Tolerances are pending for residues in or on beans (green and dried,
except lima) and bean forage and hay.
The Theoretical Maximum Residue Contribution (TMRC) to the diet, based
on the relevant food factors and tolerances cited in 40 CFR §180.234, is
0.0249 mg/day assuming a 1.5-kg diet. Since some of the tolerances
cannot be assessed presently, a future change in the TMRC may be anticipated.
The current Acceptable Daily Intake (ADI) calculations are based on interpol-
ating a No Observable Effect Level (NOEL) for cholinesterase depression in
rats of 0.35 ppm (0.018 mgAg/day) from the 17 month chronic rat feeding
study when, in fact, no NOEL was actually observed at the lowest dose of
1 ppm. Using a safety factor of 10 (for cholinesterase inhibition) results
in an ADI of 0.0018 mgAg/day and a Maximum Permissible Intake (MPI) of
0.105 mg/day for a typical 60 kg individual. The amount of the ADI used by
the existing tolerances was calculated to be 23.71%.
Since the existing 17 month chronic rat feeding study has been categorized
as Core-Supplementary in this Standard and is required to be repeated, the
previously used NOEL, ADI, and MPI are no longer fully supported by data.
They will, however, be used provisionally on an interim basis until the
new chronic studies are received and evaluated.
11
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TABLE 1. SUMMARY OF PRESENT TOLERANCES FOR FENSULPOTHION
Tolerances (parts per million)
Commodity United States
Bananas
Beets, sugar
Beets, sugar, tops
Cattle, fat
Cattle, MBYP
Cattle, meat
Corn, field, fodder
Corn, field, forage
Corn, fresh (inc. sweet)
(K4CWHR)
Corn, grain
Corn, pop, fodder
Corn, pop, forage
Corn pop, grain
Corn , sweet , fodder
Corn, sweet, forage
Cotton, seed
Goats, fat
Goats, MBYP
Goats, meat
Hogs, fat
Hogs, MBYP
Hogs, meat
Horses, fat
Horses, MBYP
Horses, meat
Onions, dry bulb
Peanuts
Peanuts, hulls
Pineapples
Pineapples, forage
Plantains
Potatoes
Rutabagas, roots
Sheep, fat
Sheep, MBYP
Sheep, meat
Sorghum, fodder
Sorghum, forage
Sorghum, grain
Soybeans
Soybeans, forage
Sugarcane
Sweet potatoes
Tomatoes
0.02
0.05
0.05
0.02
0.02
0.02
1.0
1.0
0.1
0.1
1.0
1.0
0.1
1.0
1.0
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.1
0.05
5.0
0.05
0.05
0.02
0.1
0.1
0.02
0.02
0.02
1.0
1.0
0.1
0.02
0.1
0.02
0.05
0.1
International
Canada Mexico (Codex)
_
-
- -
- -
- -
-
- -
-
0.1
0.1
- -
_ . _
0.1
- -
- -
- -
- -
- -
-
- -
— —
- -
— —
-
- -
0.1
-
-
-
-
— -
0.1
0.1
- -
- -
- -
- -
- -
— —
- -
- -
— —
. - -
-
0.02
-
-
0.02
0.02
0.02
-
-
0.1
0.1
-
-
0.1
-
-
-
0.02
0.02
0.02
-
-
-
—
-
-
0.1
0.05
-
0.05
-
-
0.1
0.1
0.02
0.02
0.02
-
-
—
-
-
—
-
0.1
12
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EPA Index to Pesticide Chemicals
.
C032701 0,0-DIETHYL 0-[p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE*
TYPE PESTICIDE: Insecticide (also refer to Nematicide entry)
FORMULATIONS: Tech (90%); G (10%, 15%); EC (6 Ib/gal, 63%)
GENERAL WARNINGS AND LIMITATIONS;
The 63 percent and 6 pounds per gallon emulsifiable concentrate formula-
tions are RESTRICTED USE PESTICIDES.
Bee Caution;
This product is highly toxic to bees exposed to direct treatment or
residues on crops. Protective information may be obtained from your
State Cooperative Agricultural Extension Service.
Agricultural Crop Tolerances:
Bananas - 0.02 ppm /
Cottonseed - 0.02 ppm
Pineapples - 0.05 ppm
Pineapples, forage - 0.05 ppm
Plantains - 0.02 ppm
Soybeans - 0.02 ppm
Soybeans, forage - 0.1 ppm
Sugarcane - 0.02 ppm
Tomatoes - 0.1 ppm
Livestock and Poultry Tolerances:
Cattle (fat, meat, meat byproducts) - 0.02 ppm
Goats (fat, meat, meat byproducts) - 0.02 ppm
Hogs (fat, meat, meat byproducts) - 0.02 ppm
Horses (fat, meat, meat byproducts) - 0.02 ppm
Sheep (fat, meat, meat byproducts) - 0.02 ppm
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
AGRICULTURAL CROPS
General Warnings and Limitations: Unless otherwise specified, apply
emulsifiable concentrate formulation in sufficient water for thorough
coverage. Do not place treated zones (bands or furrows) closer together
than 6 inches.
*Dasani t
0,0-diethyl 0-[4-(methy Isulf inyDphenyl] phosphorothioate
fensulfothion
Issued: 5-24-82 III-032701-l
13
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EPA Index to Pesticide Chemicals
0,0-DIETHYL 0- [p-(METHYLSULFINYL)PHENY. L] PHDSPHOROTHIOATE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
/28006AA
/15004AA
/15005AA
Corn, Field
Corn, Pop
Corn, Sweet
INAMBHA
Corn rootworms
0.5-1 Ib/A
[with 40
in. row
spacing]
or
0.6-1.2 oz/
1,000 ft row
[with any
row spacing]
(10-15% G)
(6 Ib/gal EC)
0.75-1 Ib/A
[with 40
in. row
spacing]
or
0.9-1.2 oz/
1,000 ft row
[with any
row spacing]
(10-15% G)
(6 Ib/gal EC)
0.1 pptn [grain and fresh corn (in-
cluding sweet corn), kernel plus cob
with husk removed]
1 ppm (fodder, forage)
30 day pregrazing or preharvest in-
terval through 1 pound per'acre for
postplant foliar application. Do
not make' more than 2 foliar applica-
tions during the growing season.
40 day pregrazing or preharvest in-
terval through 1.2 ounces per 1,000
feet of row for basal soil applica-
tion (at cultivation).
Soil application at planting (band).
Apply in a 4 to 6 inch band behind
planter shoe and in front of press
wheel. Apply the low rate for light
to moderate infestations and the
high rate for moderate to severe in-
festations.
Split boot application at planting
(band). Apply emulsifiable concen-
trate formulation with liquid ferti-
lizer as bands 2 inches away from
seed on both sides of planting row.
An additional emulsifier may be
needed with high phosphorous fer-
tilizers.
Soil application at cultivation
(band). Apply uniformly in a 4 to
6 inch band along the row around the
base of the stalks. Apply directly
in front of the cultivating equip-
ment. Consult your local Coopera-
tive Agricultural Extension Service
for proper timing. One application
at cultivation may be made in addi-
tion to 1 emulsifiable concentrate
formulation application at planting,
but do not make more than 2 applica-
tions during the growing season by
any 1 method or combination of
me thod s.
Issued: 5-24-82
III-032701-2
14
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EPA Index Co Pesticide Chemicals
0,0-DIETHYL 0-[p-(METHYLSULFINYL)PH£NYL] PHOSPHOROTHIOATE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
ITBMCCA
Corn, Field cluster (continued)
European corn borer 0.75-1 Ib/A
(10-15% G)
:NAKABA
IOACAHA
Seedcorn beetle
Seedcorn maggot
.NAVAAA
Wireworms
1 Ib/A
[with 40
in. row
spacing]
or
1.2 oz/1,000
ft row
[with any
row spacing]
or
(10-15% G)
0.5-1 Ib/A
[with 40
in. row
spacing]
or
0.6-1.2 oz/
1,000 ft row
[with any
row spacing]
(15% G)
Use limited to Midwest United
States.
Broadcast foliar application. Apply
into whorls approximately 10 days
following maximum moth activity when
egg masses average 1 or more per
plant. A second application may be
needed in 7 to 10 days. Postplant
foliar applications may be made in
addition to soil applications (at
planting or at cultivation). -Claim
for control is limited to second
brood of pest.
Use limited to Midwest United
States.
Soil application at planting (band).
Apply in a 4 to 6 inch band behind
planter shoe and in front of press
whee1.
Soil application at planting (band)
Apply in a 4 to 6 inch band behind
planter shoe and in front of press
whee1.
Issued: 5-24-82
III-032701-3
15
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EPA Index Co Pesticide Chemicals
0,0-DIETHYL 0-[ p-(METHYLSULFINYL)PHENYL] PHDSPHOROTHIOATE
/14011AA
IOACACA
Site and Pest
Onions (dry bulb
onion)
Onion maggot
/28015AA
Peanuts
.TBMBDA
Lesser cornstalk
borer
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.1 ppm (dry onion)
In-furrow soil application (at
planting time) through 0.56 ounce
per 1,000 feet of row.
1 Ib/A
[with 18
in. row
spacing]
or
0.5-0.56 oz/
1,000 ft row
[with any
row spacing]
(10-15% G)
(6 Ib/gal EC)
1 Ib/A
[with 36
in. row
spacing]
or
1.1 oz/1,000
ft row
[with any
row spacing]
(6 Ib/gal EC)
Soil application at planting (in
furrow). Apply evenly in the seed
furrow. Apply emulsifiable concen-
trate formulation in 100 gallons of
water per acre. Do not apply to
green-bunch onions.
0.05 ppm (peanuts)
5 ppm (hulls)
30 day preharvest interval through
1.1 ounces per 1,000 feet of row for
banded soil application (preplant).
65 day preharvest interval through
4.4 ounces per 1,000 feet of row for
double banded soil application (at
pegging).
Do not apply more than 6 pounds per
acre at pegging. Do not apply more
than 7 pounds per acre in any single
crop year.
Do not allow livestock to feed on
vines or hay from treated fields.
Use limted to OK and TX.
Postplant soil application (band).
Apply in 20 to 30 gallons of water
per acre as a basal directed spray.
Repeat as needed but do not make
more than 4 applications during the
growing season. Do not apply basal
directed spray if any spray or gran-
ular application was made at plant-
ing or pegging.
Issued: 5-24-32
III-032701-4
16
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EPA Index to Pesticide Chemicals
0,0-DIETHYL 0-['p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
ITBMBDA
INAMBMA
Site and Pest
Peanuts (continued)
Lesser cornstalk
borer
Southern corn root-
worm
Dosages and Tolerance, Use, Limitations
Formulation(s)
2-4 Ib/A Use limited to AL and GA.
[with 36 Soil application at pegging (double
in. row band). Apply uniformly in a 12 to
spacing] 18 inch band over the row at peg-
or ging. Mix the granules into the
2.2-4.4 oz/ soil to a depth of 1 to 2 inches on
1,000 ft each side of the row. For moderate
row to heavy infestations of lesser
[with any cornstalk borer, a second pegging
row spacing] application should be made 18 -to 21
(10% G) days later.
WlOAAAA
Thrips
2-4 Ib/A
[with 36
in. spac-
ing]
or
2.25-4.5 oz/
1,000 ft row
[with any
row spacing]
(10-15Z G)
(6 Ib/gal EC)
Use of granular formulatiojt is
limited to the Southeastern United
States.
Preplant soil application (band).
Apply in a 12 to 18 inch band. In-
corporate into the top 4 to 6 inches
of soil. Plant seed in the center
of the treated band. Claims for
control are limited to reduction of
pests in the early growing season.
3-6 Ib/A use of granular formulation is
(10-152 G) limited to the Southeastern United
(6 Ib/gal EC) States.
Preplant broadcast soil application.
Incorporate into the top 4 to 6
inches of soil. Claims for control
are limited to reduction of pests
in the early growing season.
Issued: 5-24-82
III-032701-5
17
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EPA Index to Pesticide Chemicals
0,0-DIETHYL 0- [p-(METHYLSULFINYL)PHENYL] PHDSPHOROTHIOATE
'14013AA
1NAVAFA
1NAVAGA
:NAVAAA
'14015AA
Site and Pest
Potato
Southern potato
wireworm
Tobacco wireworm
Tuber flea beetle
(larvae)
Wireworas (Cteni-
cera spp.)
Rutabaga
0.4.CADA
Cabbage maggot
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.1 ppm
Broadcast soil application (pre-
plant) through 5 pounds per acre.
2 Ib/A
(10-15% G)
5 Ib/A
(10-15% G)
Preplant broadcast soil application.
Incorporate into top 3 to 4 inches
of soil.
0.1 ppm (roots)
40 day preharvest interval through
2 ounces per 1,000 feet of-row for
banded soil applications (preplant
and postplant.) Do not apply more
than 2.5 pounds per acre. Do not
make more than 4 applications during
the growing season.
1-2 oz/1,000 preplant soil application (band).
ft row Apply in a 4 to 6 inch band prior
[with any to seeding. Incorporate into top 1
row spacing] inch of soil then seed into the cen-
(10-15% G) ter of treated band. Repeat at 28
days after planting using emulsifi-
able concentrate formulation with
the dosage and use instructions
listed below.
1-2 oz/ Postplant soil application (band).
1,000 ft row Apply in a 6 inch band sprayed over
[with any the row immediately after seeding.
row spacing] Apply in not less than 3.5 gallons
(6 Ib/gal EC) of water per 1,000 feet of row.
Repeat at 28 days after planting.
One or 2 repeat applications may be
needed as a drench to wet the crown
of the plant and 3 inches of soil
on both sides of the row.
Issued: 5-24-82
III-032701-6
18
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EPA Index to Pesticide Chemicals
0,0-DIETHYL 0-[p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
/28019AA
Site and Pest
Sorghum
INBPBIA
Phyllophaga white
grubs
'28020AA
:OAXACA
Sugar Beets
Sugarbeet root
maggot
1401SAA
NAVAFA
Sweet Potato
Southern potato
wireworm
Dosages and . Tolerance, Use, Limitations
Formulation(s)
0.1 ppm (grain)
1 ppm (forage, fodder)
Banded soil application (at planting
time) through 1.275 ounces per
1,000 feet of row.
1.03 Ib/A
(with 40
in. row
spacing]
or
1.2-1.275 oz/
1,000
ft row
[with any
row spacing]
(10-152 G)
(6 Ib/gal EC)
Use limited to OK and TX. *
Soil application at planting (band).
Apply granular formulation as a 2
inch band approximately 0.5 inch
above the seed. Apply the emuIsifi-
able concentrate formulation in 20
gallons of water as a 3 to- 4 inch
band. Do not apply directly to the
seed. Claims for control are limit*
ed to suppression of feeding damage.
0.05 ppm (roots and tops)
Banded soil application (at planting
time) through 1.35 ounces per 1,000
feet of row.
1-2 Ib/A Soil application at planting (band).
[with any Apply in a 4 to 6 inch band in 1 of
row spacing] the following ways: Apply in front
or of the planter, incorporate lightly
0.67-1.35 oz/ into the soil with shallow tilling
-1,000 ft row equipment, and plant seed in center
(10-15% G) of treated band; or apply 1 inch or
more above the seed behind the
planter shoe and in front of the
press wheel. Do not allow granules
to directly contact the seed. For
light, sandy soils, use only the
lower dosage.
0.05 ppm
Broadcast soil application (pre-
plant) through 7 pounds per acre.
7 Ib/A Use limited to Southeastern United
(10-152 G) States.
Preplant broadcast soil application.
Incorporate into top 4 to 6 inches
of soil. Claims for control are
limited to reduction of feeding
damage.
Issued: 5-24-32
III-032701-7
19
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EPA Index to Pesticide Chemicals
/26003AA
INAVAAA
0,0-DIETHYL 0-(p-(iMETHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Site and Pest
Tobacco
Wireworms
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
N.F.
Banded soil application (preplant)
through 3 ounces per 1,000 feet of
row.
Broadcast soil application (pre-
plant) through 2 pounds per acre.
3 oz/1,000 Preplant soil application (band).
ft row Apply in a 10 to 12 inch band. In-
[with any corporate into top 2 to 3 inches of
row spacing] soil.
(10-15% G)
(6 Ib/gal EC)
2 Ib/A
(10-15% G)
(6 Ib/gal EC)
Preplant broadcast soil application.
'330100A
'330080A
.NASDUA
^JALAEA
NBPAGA
NBPAZC
NITPANA
ORNAMENTALS
(Lawns and Turf (including ground covers))
Lawns
Ornamental Turf
Billbugs
Chinch bug
European chafer
Japanese beetle
(larvae)
Northern masked
chafer
Do not make application to newly
seeded areas. Treated turf should
not be cut for sod, or sod handled
for 30 days after treatment. Imme-
diately after treatment, drench
grass thoroughly by applying 0.25
to 0.5 inch of water.
1.65-3.35 pt Use limited to FL.
63% EC/25-50 Application to established lawns and
gal/5,000 turf. Use the high rate for bill-
sq.ft bugs.
(63% EC)
4.6-4.7 oz/ Application to established lawns and
5,000 sq. ft turf.
(10-15% G)
4.6-4.7 oz/ Use limited to OH.
5,000 sq.ft Application to established lawns and
(10-15% G) turf.
Issued: 5-24-32
III-032701-8
20
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EPA Index Co Pesticide Chemicals
0,0-DIETHYL 0-[p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Listing of Registered Pesticide Products by Formulation
90% technical chemical
0,0-diethyl 0-[p-(methyIsulfinyDphenyl] phosphorothioate (032701)
003125-00171
10% granular
0,0-diethyl 0-[p-(methy Isulf inyDphenyl] phosphorothioate (032701)
003125-00164 003125-00196
152 granular
0,0-diethyl 0-[p-(methy Isulf inyDphenyl] phosphorothioate (032701)
003125-00213
6 Ib/gal emulsifiable concentrate
0,0-diethyl 0- [p-(me thy Isulf inyDphenyl] phosphorothioate (03270D'
003125-00163
632 emulsifiable concentrate
0,0-diethyl 0-[p-(methy Isulf inyDphenyl] phosphorothioate (032701)
003125-00195
State Label Registrations
CA Reg. No.
009876-04611
GA Reg. No.
003125-07835
ID Reg. No.
003125-07834
OR Reg. No.
003125-07859
TX Reg. No.
000557-09579
000557-09583
000557-09587
000557-09591
WA Reg. No.
003125-07828
003125-07836 006735-08177
000557-09580
000557-09584
000557-09588
000557-09592
000557-09581
000557-09585
000557-09589
000557-09695
000557-09582
000557-09586
000557-09590
Issued: 5-24-82
III-O32701-9
21
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EPA Index to Pesticide Chemicals
a
O,O-DIETHXL O-Cp-fMETHH.SULFIl^PHENYL] PHOSPBDROTHIOATE*
TYPE PESTICIDE: Nematicide (Refer also to Insecticide Index Entry)
PC-EMULATIONS:
G (7.5%, 10%, 13.35%, 15%); EC (3 Ib/gal or 32%,
4 Ib/gal or 43%, 6 Ib/gal or 63%)
GhMKKAL WARNINGS AND LIMITATIONS: Do not use in or near human dewellings.
The enulsifiable concentrate formulations are restricted use pesticides.
Do not treat food crops grown in greenhouses, or apply to plant foliage
other than comercial turf. Wear a pesticide respirator approved by the
Mining Enforcement and Safety Administration and by the National Insti-
tute for Occupational Safety and Health under the provision of 30 CFR
part 11. Wear protective clothing and cotton or natural rubber gloves.
Do not apply with a knapsack or similar equipment that is placed on the
user's body. Keep all unprotected persons out of the operating, area or
vicinity particularly until spray has been thoroughly drenched into or
covered by soil, and all mist has dissipated. The active ingredient
kills nematodes by contact action, and therefore should be mixed thor-
oughly into the soil to obtain maximum control. Dosages are expressed
as weight actual (unless otherwise specified).
Agricultural Crop Tolerance: See listing at individual crop sites.
Also for crops with non-nematicidal uses as follows: 0.05 ppm in or on
beets, sugar and beets, sugar, tops; also pineapple and pineapple forage.
0.1 ppm in or on onions, potatoes, rutabagas roots and sorghum grain.
1.0 ppm in or on sorghum fodder and sorghum forage.
Livestock Tolerances; 0.02 ppm in the fat, meat byproducts, and meat of
cattle, goats, hogs, horses, and sheep
C032701
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
AGRICULTURAL CROPS
General Warnings and Limitations: Where row spacing is extremely narrow,
do not place treated zones (band or furrow) closer together than 6 inches.
Plant in the middle of the band.
Banana
Plantain
0.02 ppm /06002A;
60 day preharvest interval through /06016A?
0.23 ounce per plant.
*Dasanit
fensulfothion
0,0-Diethyl 0-C4—(methylsulfinyljphenyl] phosphorothioate
Issued: 3-24-82
II-II-032701-1
22
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EPA Index to Pesticide Chemicals
O,0-OIETHYL 0-[p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE*
Site and Pest Dosages and Tolerance, Use, Limitations
Foraiulation( s)
Banana (continued)
Burrowing nematode 0.15-0.23 oz/ Use limited to PR. NEJBCBA
Reniform nematode plant Soil application (at-planting). NEHBBBA
Spiral nematodes (15% G) Apply uniformly around the base of NEGABAA
each plant in a 2 to 2.5 foot band
using suitable granular applicator
equipment such as a shaker can.
Mix with covering soil. Repeat at
6 month intervals. Incorporate
post planting by mixing to.a depth
of 2 inches.
Citrus Fruits (seedlings) N.F. /02000D;
Nematodes
4.0-6.0 oz/ RESTRICTED USE PESTICIDE. NABAAAJ
50 gal water Dip treatment on nursery stock.
(6 Ib/gal or Remove soil from roots of plants
63% EC) and immerse only the root systems
into the solution (approximately
575 to 360 ppo: active ingredient).
Allow roots tc soak for 30 minutes
then remove for planting or ship-
ment. Treated plants to be moved
into commercial trade within 1 week
after dipping must bear warning tags
stating appropriate precautions for
this formulation.
2.25-4.5 oz/ RESTRICTED USE PESTICIDE.
25 gal water Containerized plant treatment.
(6 Ib/gal or Apply 0.33 pint of finished solution
63% EC) per 8 inch pot. Do not apply to
dry pots or to plants in a wilted
condition.
Corn, Field 0.1 ppm grain, also for sweet corn, /28006A2
Corn, Pop fresh (kernel, plus cob with husk /15004AP
Corn, Sweet removed). 1.0 ppm forage-fodder /15005AA
At-planting soil application through
2.03 pounds per acre.
Issued: 3-24-82 II-II-032701-2
23
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EPA Index to Pesticide Chemicals
0,0-DISTHYL O-[p-(METHYLSULFINYL)PHENYL] PHOSPHORQTHIOATE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
Corn, Field (continued)
Sting nematodes
Stubby root nematodes
2.2 oz/1,000
ft of row
or
2.03 Ib/A
(using 36
inch row
spacing)
(10.% G)
(15% G)
Cotton
NEBBAAA
NCAABAA
Nematodes
Peanuts
Nematodes
Use limited to Southeastern States.
Soil application (at-planting).
Apply in a 12 inch band over the
row in front of the planter shoe
and incorporate to 3 inches•
Issued: 3-24-82
0.02 ppm cottonseed.
At-planting soil application
through 6.5 pounds per acre.
Do not use foliage for- feed or
forage.
4.0-8.0 oz/ Use limited to Southeastern and Gulf
1,000 ft row States.
or Soil application (at-planting) .
3'.25-6.5 Ib/A Apply in a 12 inch band. Disc or
(using 40 till thoroughly to a depth of 4 to 6
inch row inches.
spacing)
(10% G)
(15% G)
0.05 ppm
Preplant soil application through
6.0 pounds per acre.
Do not feed vines or hay.
2.2-4.4 oz/ Preplant soil application.
1,000 ft row Apply in a 12 to 18 inch band over
or the row, or broadcast. Disc or till
2.0-4.0 Ib/A thoroughly to a depth of 4 to 6
(using 36 inches.
inch row
spacing)
or
3.0-6.0 Ib/A
(broadcast)
(10% G)
(15% G)
II-I1-032701-3
/28007A.
NABAAAA
/28015A;
NABAAAA
24
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EPA Index to Pesticide Chemicals
0,0-DIETHYL O-[p-{METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Site and Pest
P eanuts (continue d)
Plantain (see Banana)
Soybeans
Nematodes (except
cyst nematodes)
Sugarcane
Nematodes
Dosages and Tolerance, Use, Limitations
Ebrmulation(s)
2.25-4.5 oz/ RESTRICTED USE PESTICIDE.
1,000 ft row PrepIant soil application. Apply
or in a 12 to 18 inch band over the
2.03-4.05 row, or broadcast. Disc or till
Ib/A (using- thoroghly to a depth of 4 to 6
36 inch row inches.
spacing)
3.0-6.0 Ib/A
(broadcast)
(6 Ib/gal or
63% EC)
0.02 ppm soybeans, 0.1 ppm soybeans
forage. At-planting soil applica-
tion through 1.3 pounds per acre.
/28023A.
NABABAA
1.0-2.0 oz/
1,000 ft row
or
0.9-1.8 Ib/A
(using 36
inch row
spacing)
(7.5% G)
(10% G)
(15% G)
(3 Ib/gal or
32% EC)
Soil application (at-planting) .
For granular formulation: Apply
in a 12 inch band. Disc or till
thoroughly to 4 to 6 inches depth.
For emulsifiable concentrate formula-
tion: Apply as a water emulsion
spray in a 4 to 6 inch band over
the seed furrow behind the planter
shoe and in front of the press wheel.
Do not apply directly on the seed.
Do not cut green crop or use dry vine
for feed or forage.
May be formulated with 0,O-Diethyl S-
[2-(ethylthio)ethyl] phosphorodi-
thioate.
0.02 ppm
At-planting seed piece treatment
through 5.0 pounds per acre.
0.23-0.57 lb/ Ose limited to FL.
1,000 ft row Seed piece treatment. Apply in a
or 12 to 18 inch band in the open
2.0-5.0 Ib/A furrow over the seed pieces at
/25003A5
NABAAAA
(using 5
foot row
spacing)
(10% G)
(15% G)
planting.
Issued: 3-24-82
II-II-032701-4
25
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EPA Index to Pesticide Chemicals
O,O-DIETHYL O-[p-(METHYLSULFINYI,)PHENYL] PHOSPHOROTHIOATE
Site and Pest
Sweet Potato
Nematodes
Dosages and Tolerance, Use/ Limitations
Formulatio n(s)
0.05 ppm
Preplant soil application through
7.0 pounds pec acre.
Tobacco
Nematodes
3.0-7.0 Ib/A
(broadcast)
(10% G)
(15% G)
Root-knot Nematodes
3.0-7.0 Ib/A
(broadcast)
(6 Ib/gal or
63% EC)
Preplant: soil application.' Apply
using the higher rate for fields
with a high population of* nematodes
or a history of serious nematode
damage, then plant in the usual
manner. Disc or till thoroughly to
a depth of 4 to 6 inches.
RESTRICTED USE PESTICIDE.
Preplant soil applications Apply
uniformly using the higher rate for
fields with a high population of
nematodes or a history of serious
nematode damage, then plant in the
usual manner. Disc or till thor-
oughly to a depth of 4 to 6 inches.
6.0-9.0 oz/
1,000 ft row
or
4.0-6.0 Ib/A
(using 48
inch row
spacing)
or
6.0-10.0 Ib/A
(broadcast)
(10% G)
(13.35% G)
(15% G)
Preplant soil application. For row
treatment, apply the lower rate in
a 10 to 12 inch band. Under condi-
tions of high nematode populations,
apply the higher rate in a 16 inch
band. For broadcast treatment, make
application, disc or till thoroughly
to a depth of 3 to 6 inches, then
bed-up over the row and plant as
usual. May be formulated with
S-Pr opyl butylethylthiocarbamate.
/14018.
NABAAA.
NEOBCAJ
/260035
NABAAA*
Issued: 3-24-32
II-II-032701-5
26
-------
EPA Index to Pesticide Chemicals
0,O-DIETHYL O-[p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Site and Pest
Tobacco (continue d)
Tomato
Nematodes
Dosages and Tolerance, Use, Limitations
Pormulation(s)
6.0-9.0 oz/
1,000 ft row
or
4.0-6.0 Ib/A
(using 48
inch row
spacing)
(6 Ib/gal or
63% EC)
9.0 oz/
1,000 ft row
(using 48
inch row
spacing)
or
4.0-6.0 Ib/A
(7.5% G)
(10% G)
(4.0 Ib/gal
or 43% EC)
(3.0 ib/gal
or 32% EC)
RESTRICTED USE PESTICIDE.
Preplant soil application. Apply
at the low rate in a 10 to 12 inch
band. Ohder conditions of high
nematode population pressure, apply
at the high rate in a 16 inch band.
Disc or till thoroughly to a depth
of 4 to 6 inches.
RESTRICTED USE PESTICIDE.
Preplant soil application. Apply
in water emulsion or in liquid
fertilizer or apply granular dry
in a 10 to 12 inch band over the
row or as a broadcast application
before planting. Disc or till
thoroughly to a depth of 4 to 6
inches to insure adequate mixing
in the soil. Plant crop in the
usual manner. Apply only once per
season. Formulated with O,0-Diethyl
S—[2-(ethylthio)ethyl] phosphorodi-
thioate.
0.1 ppm
Preplant soil application through
20.1 pounds per acre.
3.68-7.36 oz/ Preplant soil application. Apply in
1,000 ft row a 12 inch band over the row, or
or broadcast. Disc or till thoroughly
3.16-6.33 lb/ to a depth of 4 to 6 inches.
A (using 38
inch row
spacing)
or
10.0-20.1
Ib/A
(broadcast)
(10% G)
(15% G)
/11005A,
NABAAAA
Issued: 3-24-82
II-II-032701-6
27
-------
EPA Index to Pesticide Chemicals
0,0-OIETHYL O-[p-(METHYLSULFINYL)PHENYL] PHOSPHORTHIOATE
Site and Pest
Tomato (continued)
Dosages and Tolerance, Use, Limitations
Pormulation(s)
3.75-7.12 oz/ RESTRICTED USE PESTICIDE.
1,000 ft row Preplant soil application. Apply
or in a 12 inch band over the row,
3.2-6.25 Ib/A or broadcast. Disc or till thor-
(using 38
inch row
spacing)
or
10.0-20.0
Ib/A
(broadcast)
(6 Ib/gal or
63% EC)
oughly to a depth of 4 to 6 inches <
ORNAMENTALS
(Ornamental Plants (herbaceous plants and bulbs; woody shrubs, trees and
vines))
General Warnings and Limitations: Do not apply to Aucuba species,
begonia, hydrangea, or peony. Do not plant seed in areas treated with
granular formulations until safety to germinating seeds has been
established. Do not apply emulsifiable concentrate to newly seeded
areas until plants have developed good root systems.
Ornamental Herbaceous Perennial
Plants (aloe, butterfly iris,
century plant, chrysanthemum,
cyclamen, easter lily, gladiolus.
Ornamental Woody Shrubs and Vines
(ardisia, azalea, blue mist, bougainvillea,
boxwood, camellia, Chinese hibiscus,
croton, dwarf yaupon, dwarf Japanese holly,
euonymus, eurya, gallberry, gardenia,
holly leaf osmanthus, honeysuckle, Japanese
yew, jasmine, jungleflame, juniper,
mabonia ( California barberry), metrosideros,
natal plus, privet, pyracantha, red leaf
barberry, roses, Surinam cherry,
viburnum, and yew)
/34000AA
Issued: 3-24-82
II-II-032701-7
28
-------
EPA Index to Pesticide Chemicals
O/O-DIETHYL O-[p-(METHYLSULFNYL)PHENYL] PHOSPHOROTHIOATE
Site and Pest
Dosages and Tolerance, Use, L imitations
Fonaulation( s)
ORNAMENTALS (continued)
Ornamental and/or Shade Trees
(American holly/ christmasberry,
cypress/ Japanese plum/ laurel
cherry, magnolia/ and Russian
olive)
/35000;
Nematodes
NABAAA;
1.01 lb/1,000 Preplant soil application to nur-
sq. ft
(10% G)
(15% G)
sery stock. Apply as a treatment
evenly over bed or bench area and
work thoroughly into the soil to a
depth of 4 to 6 inches• Do not
apply to newly seeded areas.
0.94-1.88 lb/ RESTRICTED USE PESTICIDE.
1/000 sq. ft. Soil application to nursery stock.
(6 Ib/gal or As a preplant treatment, apply in
63% EC) sufficient water to distribute the
formulation evenly over beds and
benches. Apply the lower
rate for postplant treatment of
seedlings. If the solution comes
in contact with plant foliage/
rinse immediately with fresh water.
follow this application with addi-
tional water to wet the soil to a
depth of 4 to 6 inches. Repeat
application in 4 to 6 months if
soil becomes reinfested.
(6 Ib/gal or
63% EC)
3.0-6.0 OZ/ RESTRICTED USE PESTICIDE.
60 gal water Dip treatment to nursery stock.
Remove soil from roots and immerse
only the root system into the
solution (375 to 750 ppm active
ingredient). Allow to soak for 30
minutes/ then remove for planting
or shipment. Treated plants to be
moved into commercial trade within
1 week after dipping must bear
warning tags stating appropriate
precautions for this formulation.
Issued: 3-24-82
II-II-032701-8
29
-------
EPA Index to Pesticide Chemicals
0,0-DIETHYL 0-[p-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Site and Pest
ORNAMENTALS (continued)
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.05 oz/
cu. ft soil
(10% G)
(15% G)
3.0 oz/100
gal water
or
0.5 tsp
f ormulation/
2 gal water
(6 Ib/gal or
63% EC)
Preplant soil application to
nursery stock potting soil. Thor-
oughly mix into the soil.
RESTRICTED USE PESTICIDE.
Soil application to containerized
plants. Apply 0.5 pint of finished
solution per 6 inch pot.
Caladium (tubers)
Nematodes
/31047D2
0.75 oz/5.5
gal water
or
2.0 tbls
formulation/
5.5 gal
water
(6 Ib/gal or
63% EC)
RESTRICTED USE PESTICIDE.
Dip treatment to nursery stock
tubers. Soak the tubers for 4 to 6
hours in the solution (approximately
1,000 ppm active ingredient), then
remove and allow to drain dry before
further handling or processing.
Treated tubers to be moved into
commercial trade within 1 week
after dipping must bear warning
tags stating appropriate
precautions for this formulation.
(Lawns and Turf (including ground covers))
General Warnings and L.-imitations; Thorough watering is required for
best results. Consult a State Agricultural Cooperative Extension
Service for timing and initial application. Do not treat newly seeded
areas. Do not cut treated turf for sod nor handle sod for 30 days
after treatment.
Ornamental Turf (commercial turf
such as in cemeteries, golf
courses, and sod farms)
/3300SAA
Issued: 3-24-82
II-II-032701-9
30
-------
EPA Index to Pesticide Chemcials
0,0-DIETHYL O-[p-(M£THYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Site and Pest Dosages and Tolerance, Use, Limitaitons
Formulation(s)
Ornamental Turf (continued)
Nematodes
NABAAAJ
0.23-0.47 lb/ Soil application. Distribute evenly
1,000 sq. ft over the turf area. Immediately
following- treatment, apply 0.25 to
or
10.0-20.1 lb/ 0.5 inch of water to drench the
A (ca)
(10% G)
(15% G)
formulations into the soil.
0.25-0.5 lb/ RESTRICTED USE PESTICIDE.
1,000 sq. ft Use limited to PL.
or Soil application. Apply in 5 to 10
10.8-21.6 lb/ gallons of water. Drench grass
A (ca)
(6 Ib/gal or
63% EC)
thoroughly after treatment by
applying 0.25 to 0.5 inch of water.
Recommended for use on bahiagrass,
bermudagrass, centipedegrass, St.
Augustinegrass and zoysiagrass-
Issued: 3-24-82
II-II-032701-10
31
-------
EPA Index to Pesticide Chemicals
0,0-DIETHYL O-rp-(METHYLSULFINYL)PHENYL] PHOSPHOROTHIOATE
Listing of registered Pesticide Products by Formulation (Nematicides)
7.5% granular
O,O-Diethyl 0-[p-(methylsulfinyDphenyl] phosphorothioate (032701)
plus O,0-Diethyl S- [2-(ethylthio)ethyl] phosphorodithioate (032S01)
003125-00252
10% granular
O,O-Diethyl 0-[p-{methylsulfinyl)phenyl] phosphorothioate (032701)
003124-00164 003124-00196
0,0-Diethyl 0-[p-( methyl sul fin yDphenyl] phosphorothioate (032701)
plus S-Propyl butylethylthiocarhamate (041503)
000476-02146 003125-00291
O/0-Diethyl O-[p-(methylsulfinyl)phenyl] phosphorothioate (032701)
plus O,0-Diethyl S-[2-(ethylthio)ethyl] phosphorodithioate (032501)
003125-00300 003743-00345
13.35% granular
O,0-Diethyl 0-[p—( methyl sul fin yDphenyl] phosphorothioate (032701)
plus S-Propyl butylethylthiocarhamate (041503)
000476-02147 003125-00290
15% granular
0,O-Diethyl 0-[p-(methylsulfinyl)phenyl] phosphorpthioate (032701)
003125-00213
32% (3 Ib/gal) emulsifiable concentrate
0,0-Diethyl O-[p-(methylsulfinyl)phenyl] phosphorothioate (032701)
plus 0,O-Diethyl S-[2-(ethylthio)ethyl] phosphorodithioate (032501)
003125-00279
43% (4 Ib/gal) emulsifiable concentrate
0,0-Diethyl O-[p-(methylsulfinyDphenyl] phosphorothioate (032701)
plus 0,O-DiethylS-[2-(ethylthio)ethyl] phosphorodithioate (032501)
003125-00299
63% (6 Ib/gal) emulsifiable concentrate
0,0-Diethyl O—[p-(methylsulfinyDphenyl] phosphorothioate (032701)
003125-00163 003125-00195
Issued: 3-24-82 II-II-032701-11
32
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EPA Index to Pesticide Chemicals
O,0-DIETHYL O-[p-(METHYLSULFINYL)PHENYL] PHOSPHORQTHIOATE
State Label Registrations
CT Reg. No.
001258-08638
GA Reg. No.
003125-07835
009876-04611
ID Reg. No.
003125-07834
OR Reg. No.
003125-07859
SO Reg. No.
003743-07017
TX Reg. No.
000557-09579
000557-09583
000557-09587
000557-09591
WA Reg. No.
003125-07828
001258-08639
003125-07836
000557-09580
000557-09584
000557-09588
000557-09592
001258-08640
006735-08175
006735-08177
000557-09581
000557-09585
000557-09589
000557-09695
000557-09582
000557-09586
000557-09590
Issued: 3-24-82
II-II-032701-12
33
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix II-l) is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registrations)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data I/ Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2/, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop data
which are necessary to support the registration or
reregistration of certain uses appearing in your labeling,
you may delete those uses at the time you submit your
revised labeling.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
_!/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
2_/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 "Federal Register 53192.
34
-------
type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note; The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-2] for each of your products. On that form you must
state which of the following methods you will use to comply
with the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix II-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of next page)
35
-------
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2 ) (B)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
36
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TABLE A
GENERIC DATA REQUIREMENTS FDR FENSULFDTHION1/
Data Requirement
Composition2/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
TGAI
TGAI
No
No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients TGAI Yes
61-2 - Description of Beginning TGAI No
4/ No
YesV
Yes6/
Yes7/
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
N/A8/
TGAI
TGAI
Yes
Yes
No
N/A
Yes
Yes
GS0107001*
GS0107001*
GS0107001*
GS0107001*
No
No
Yes
No
No
No
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULPOTHIONV
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2) (B)?V
§158.120 Product Chemistry
(continued)
63- 8 - Solubility
63- 9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64- 1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
Partially
No
No
No
No
No
N/A
GS0107001**
GS0107002*a/
YesV
Yes
Yes
Yes
Yes
No
I/ The 90% technical (T), EPA Reg. No. 3125-171, also serves as a manufacturing-use product.
2/ Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient
3/ Data must be submitted no later than 6 months from the date of this Standard.
4/ Data on the manufacturing-use technical, EPA Reg. No. 3125-171, included with a confidential ingredient
statement for EPA Reg. No. 3125-213 dated December 16, 1974 submitted by Chemagro Agricultural Division,
MOBAY Chemical Corporation and received by EPA January 9, 1975.
5/ The Manufacturing process for the 90% technical must be submitted. This must include the name and address of the
manufacturer or producer of each starting material, the purities of starting materials and intermediates and
descriptions of the reaction conditions, any purification steps, and quality control measures.
38
-------
6/ A discussion is required for each inpurity believed to be present at greater than 0.1%, based on knowledge
of the beginning materials, all possible chemical reactions, and any contamination.
7/ Five or wore representative samples should be analyzed for the amount of active ingredient and each impurity
present for which a certified limit is required.
8/ Not required because the 90% technical is a liquid at room temperature.
9/ Solubility data should be submitted that is expressed in terms of g/100 ml of solvent at 20°C (68°F) or in
terms such as ppm (mgAg)- This data should also indicate the temperature at which the test was performed.
* Study on its own fulfills Guideline requirements.
** Study must be combined with other studies to fulfill Guideline requirements.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be compensable.
39
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TABLE A
GENERIC DATA REQUIREMENTS FDR FENSULFOTHION
Data Requirements
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
PAIRA
- Livestock
171-4 - Residue Analytical Method
- Plant residues
Yes
PAIRA and plant
metabolites
TGAI and metabolites
Yes
Yes
GS0107003**
GS0107004**
GS0107005**
GS0107006**
GS0107006**
GS0107007**
00094326**
GS0107005**
GS0107006**
GS0107008**
GS0107009**
GS0107010**
GS0107011**
GS0107012**
GS0107013**
GS0107014**
GS0107015**
GS0107016**
GS0101017**3/
GS0107018**
GS0107019**3/
GS0107020**
GS0107021**a/
GS0107022**3/
No
No
No
40
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULPOTHION
Data Requirements
Compos it ionV
Does EPA Have Data
To Satisfy This
Requ i rene nt? (Yes,
No, or Partially)
Bibliographic
Citat ion
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Residue Analytical Method (continued)
- Animal residues TGAI and metabolites
Yes
171-4 - Storage Stability Data
PAI
Partially
GS0107005**
GS0107006**
GS0107008**
GS0107009**
GS0107010**
GS0107015**
GS0107021**a/
GS0107020**3/
No
Yes3/
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group #1 - Root and Tuber Vegetables4/
o Crop 1 - Potatoes
— Crop field trials TEP
— Processed Food/Feed
o Crop 2 - Rutabagas
— Crop field trials
TEP
TEP
Yes
No
Yes
GS0107008**
GS0107018**
GS0107016*
No
Yes5/
No
41
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TABLE A •
GENERIC DATA REQUIREMENTS FOR FENSULFOTHION
Data Requirement
Compos itionV
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group #1 - Root and Tuber Vegetables (continued)
o Crop 3 - Sugar Beets
— Crop field trials TEP
— Processed Food/Feed
o Crop 4 - Sweet Potatoes
— Crop field trials
TEP
Yes
Yes
TEP
Yes
Crop Group #2 - Leaves of Root and
Tuber Vegetable Group6/
o Crop 1 - Sugar Beet Tops
— Crop field trials
TEP
Yes
Crop Group #3 - Bulb Vegetables Group7/
o Crop 1 - Onions (dry bulb)
— Crop field trials TEP
Yes
GS0107005**
GS0107015**
GS0107018**
GS0107005**
GS0107015**
GS0107018**
GS0107020*3/
GS0107005**
GS0107015**
GS0107023*
No
No
No
No
No
42
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TABLE A '
GENERIC DATA REQUIREMENTS FDR FENSULPOTHION
Data Requirement
CompositionV
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Sufcmitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?2/
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group #4 - Legume Vegetables Group**/
o Crop 1 - Soybeans
— Crop field trials TEP Yes
- Crop Group #5 - Foliage of Legume Vegetables GroupV
o Crop 1 - Soybean Forage
— Crop field trials TEP Yes
— Processed Food/Feed TEP Yes
- Crop Group #6 - Fruiting Vegetables (except cucurbits) GrouplV
o Crop 1 - Tomatoes
— Crop field trials TEP Yes
— Processed Food/Feed TEP Yes
- Crop Group #7 - Cereal Grains Group12/
o Crop 1 - Corn (grain, fresh: sweet, pop-, field [K+CWHR])
— Crop field trials TEP Yes
— Processed Food/Feed
TEP
Yes
GS0107019*3/
GS0107019*a/
GS0107019*9/
GS0107008*
GS0107008*
GS0107008**
GS0107020**3/
GS0107008**
GS0107020**9/
No
No
NoW
No
NO
43
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULPOTHION
Data Requirement
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group |7 - Cereal Grains Group^V (continued)
o Crop 2 - Sorghum
— Crop field trials TEP
— Processed Food/Feed TEP
- Crop Group #8 - Forage, Fodder,
and Straw of Cereal Grains Group!5/
o Crop 1 - Corn forage and fodder
— Crop field trials TEP
o Crop 1 - Sorghum forage and fodder
— Crop field trials TEP
- Crop Group #9 - Miscellaneous Commodities
o Crop 1 - Bananas
— Crop field trials TEP
Yes
Yes
Yes
Yes
GS0107022*3/
GS0107022*a/
GS0107008**
GS0107020**3/
GS0107022*a/
No
NoW
No
No
Partially
GS0107012**
YesW
44
-------
TABLE A '
GENERIC DATA REQUIREMENTS FOR FENSULPOTHION
Data Requirement
Coupes it ionV
Does EPA Have Data
To Satisfy This
Requirenent? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?2/
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group #9 - Miscellaneous Commodities (continued)
o Crop 2 - Cottonseed
— Crop field trials TEP
— Processed Food/Feed TEP
o Crop 3 - Peanuts and Peanut hulls
— Crop field trials TEP
— Processed Food/Feed TEP
o Crop 4 - Pineapples (fruit and forage)
— Crop field trials
— Processed Food/Feed
o Crop 5 - Plantains
— Crop field trials
o Crop 6 - Sugarcane
— Crop field trials
— Processed Food/Feed
TEP
TEP
TEP
TEP
TEP
Yes
Yes
Partially
No
Yes
Yes
Partially
Yes
Yes
GS0107019*3/
GS0107019*3/
GS0107005**
GS0107022**3/
GS0107014*
GS0107014*
GS0107012**
GS0107018*
GS0107018*
No
No"/
YesW
YesW
No
N020/
No
45
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULFOTHION
Data Requirement
Composition!/
Does EPA Have Data
To Satisfy This
Requ i renent ? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group #9 - Miscellaneous Commodities (continued)
o Crop 7 - Tobacco
— Crop field trials
- Milk/poultry/eggs
- Cattle (meat, fat, MBYP)
TEP
TGAI or plant
metabolites
TGAI or plant
metabolites
Yes
Yes
Yes
00094326**
GS0107021**a/
GS0107025**3/
GS0107010**
GS0107021**3/
GS0107024**
GS0107010**
GS0107021**a/
GS0107024**
No
No
- Goats (meat, fat, MBYP)
- Hogs (neat, fat, MBYP)
- Horses (meat, fat, MBYP)
TGAI or plant
metabolites
TGAI or plant
metabolites
TGAI or plant
metabolites
Yes
Yes
Yes
GS0107010**
GS0107021***/
GS0101024**
GS0107010**
GS0107021**a/
GS0101024**
GS0107010**
GS0107021**3/
GS0101024**
No
No
No
- Sheep (meat, fat, MBYP)
TGAI or plant
metabolites
Yes
GS0107010**
050107021-*a/
GS0101024**
No
46
-------
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radi©labelled;
TEP = Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than January 1987.
3/ Storage stability data pertaining to fensulfothion residues in animal tissues are required.
4/ A crop group tolerance is not appropriate at the present time because residue data are required for two additional
members of this crop group (carrot and radish).
5/ Field treated potatoes containing 0.1 ppm residues of fensulfothion and its cholinesterase-inhibiting metabolites
must be processed to determine residues in dried potatoes and potato chips and granules.
6/ A crop group tolerance is not appropriate at the present time because residue data are required for one additional
member of this crop group (turnip leaves).
7/ A crop group tolerance is not appropriate at the present time because residue data are required for one additional
member of this crop group (garlic, leek, or shallot).
8/ A crop group tolerance is not appropriate at the present time because residue data are required for several
additional members of this crop group (dried and succulent beans and peas).
9/ A crop group tolerance is not appropriate at the present time because residue data are required for two additional
members of this crop group (forage and hay of beans and peas - any variety of each).
10/ Since residues were nondetectable in soybeans, food/feed additive tolerances are not required for residues in
processed products of soybeans (oil, meal, or soapstock).
ll/ A crop group tolerance is not appropriate at the present time because residue data are required for one additional
members of this crop group (peppers).
12/ A crop group tolerance is not appropriate at the present time because residue data are required for two additional
members of this crop group (rice and wheat).
13/ Food/feed additive tolerances are no required for processed products of corn because fensulfothion residues were
nondetectable (<0.05 ppm) in treated corn.
14/ Food/feed additive tolerances are not required for processed products of sorghum grain since residues were non-
detectable «0.05 ppm) in treated sorghum.
15/ A crop group tolerance is not appropriate at the present tine because residue data are required for one additional
member of this crop group (wheat)
16/ Field trials conducted in Ecuador and either Honduras, Nicaragua, Guatemala, or Costa Rica using 15% formulations
at 0.23 oz ai/plant.
17/ Since residues were nondetectable in cottonseed, food/feed additive tolerances are not required for residues in
processed products of cottonseed (oil, meal, or soapstock).
18/ Field trials are required from sites in Texas or Oklahoma using the 6 Ib/gal EC formulation at 1.1 oz ai/1,000 feet
of row (1 lb ai/A with a 36-inch row spacing) for four postplant basal-directed band soil applications. Sampling
should include peanuts and hulls harvested 30 days after the final treament. A fractionation study to determine
residues in peanut meal, oil (crude and refined), and soapstock is also required. If residues in excess of that
established for the raw agricultural commodity are found, then food/feed additive tolerances must be proposed for
these processed products.
47
-------
19/ Since residues were nondetectable in treated pineapples, food/feed additive tolerances are no required for
residues in the processed products of pineapples (bran and juice).
20/ The additional banana data requested (see footnote 16 above) will be translated to support the tolerance for
residues in or on platains, therefor no additional data are specifically required for plantain.
21/ Since residues were nondetectable in treated sugarcane, food/feed additive tolerances are not required for
residues in processed products of sugarcane.
22/ Category 3 classification [40 CFR §180.6(a)] - no tolerance required
* Study on its own fulfills Guideline requirements.
** Study must be combined with other studies to fulfill Guideline requirements.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be compensable.
48
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULFOTHION
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Composition!/ Pattern^/ NO or Partially)
TGAI or PAIRA A,B No
TGAI or PAIRA A,B No
TGAI or PAIRA A Yes
TGAI or PAIRA A No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2) (B)?3/
Yes
Yes
00094370*3/ No
No
162-1 - Aerobic Soil
TGAI or PAIRA
A,B
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
TGAI or PAIRA
TGAI or PAIRA
Yes
No
00044926**a/
00044930*3/
00073059*b/
00094359**3/
No
Yes
No
49
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TABLE A
GENERIC DATA REQUIREMENTS FDR FENSULPOTHION
Use
Data Requirement
Composition^/ PatternV
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?V
§158.130 Environmental Fate
(continued)
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
TGAI or PAIRA
163-1 - Leaching and TGAI or PAIRA
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
A,B
A
A,B
Yes
No
No
00044925**3/
00044927**a/
00068214*a/
00079144**9/
00094363**a/
No
No
Yes
Yes
DISSIPATION STUDIES-FIELD;
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
TEP
TEP
TEP
A,B
No
TEP
A,B
No
Yes
No
No
No
NoV
50
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FENSULFOTHION
Use
Data Requirement Composition!/ Pattern2/
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c)(2)(B)?3/
§158.130 Environmental Fate
(continued)
ACCUMULATION STUDIES:
165-1 -
165-2 -
165-3 -
165-4 -
165-5 -
§158.140
132-1 -
132-1 -
133-3 -
133-4 -
Rotational Crops PAIRA A
(Confined)
Rotational Crops TEP A
(Field)
Irrigated Crops TEP
In Fish TGAI or PAIRA A,E
In Aquatic Non-Target TEP
Organisms
Reentry Protect ion V
Foliar Dissipation TEP A,B
Soil Dissipation TEP A,B
Dermal Exposure TEP A,B
Inhalation Exposure TEP A,B
No - Yes
Partially 00094369**a/ Yes5/
- No
Partially GS0107021**3/ Yes6/
- No
No - Yes
No - Yes
No - Yes
No - Yes
51
-------
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; OForestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted no later than January 1987.
4/ Based upon aerobic soil metabolism data and terrestrial field dissipation studies demonstrating that less
than 50% of the fensulfothion initially applied would be present when a subsequent application would be
made, the requirement for this test is waived.
5/ A study is needed showing fensulfothion accumulation in field rotational crops grown in sandy loam and
treated with a granular formulation.
6/ A study is needed to characterize residues and to show total residues of fensulfothion in edible and
visceral tissues on days 0 - 21 of accumulation period and days 1 - 14 of depuration period.
7/ For each crop, the registrant is required to propose an acceptable reenty interval based on one of the following:
(a) the longest (most restrictive) interval for fensulfothion [The most restrictive general reentry interval for
for fensulfothion is the 24-hour interval established by the State of California. The most restrictive reentry
interval for soil-applied fensulfothion is the seven-day interval established by the State of California.]; or
(b) data on dissipation of foliar and/or soil residues of fensulfothion (decline curve), on human exposure to
those residues, and on toxicity of fensulfothion; or
(c) determination of that tine beyond which there are no detectable, dislodgeable residues remaining in the
worker environment.
* Study on its own fulfills Guideline requirements.
** Study must be combined with other studies to fulfill Guideline requirements.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be compensable.
b/ Studies submitted by DCW Chemical USA. These studies may be compensable.
52
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULFOTHION
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Compos it ion1/ Pattern2/ No or Partially) Citation 3(c)(2)(B)?3/
§158.135 Toxicology
ACUTE TESTING:
81-1 - Oral LD5Q - Rat TGAI A,B,F Yes
81-2 - Dermal LD5Q TGAI A,B,F Yes
81-3 - Inhalation LC50 - Rat TGAI A,B,F No
81-7 - Acute Delayed TGAI A,B,F Partially
Neurotoxicity - Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding -
Rodent, Non-rodent TGAI A,B,F Partially
82-2 - 21-Day Dermal TGAI N/R
82-3 - 90-Day Dermal TGAI N/R
82-4 - 90-Day Inhalation - TGAI A,B,F No
00072976*9/ No
00072976*9/ No
Yes4/
00094259** Yes
00094336** YesV
00094258
No
No
Yes6/
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal
TGAI
A,B,F
No
Provisional^/
53
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FENSULPOTHION
Data RequIrene nt
CompositionV
Use
Pattern^
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)?
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
§158.135 Toxicology (continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
2 species: Rodent
and Non-rodent
83-2 - Oncogenicity Study -
2 species: Rat and
Mouse preferred
TGAI
TGAI
A,B,F
A,B,F
Partially
Partially
00052974**
00052971
00052974**
Yes8/
YesV
83-3 - Teratcgenicity -
2 species
83-4 - Reproduction,
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Domestic Animal Safety
TGAI A,B,F
TGAI A,B,F
TGAI A,B,F
TGAI A,B,F
TGAI A,B,F
PAI or PAIRA A,B,F
N/R
Partially
Partially
Partially
No
Yes
Yes
00049568a/
00094915**9/
00047706**
05021578**
-
05021578*
00044918*3/
YesW
Yes
YeslV
Yes
No
No
No
54
-------
I/ Conposition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient, radio-labelled
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; F=Greenhouse, Non-Food
3/ Acute toxicology data nust be submitted no later than 6 months from the date of this Standard. All other toxicology
data must be submitted no later than January 1987.
4/ The requirement for an acute rat inhalation study may be waived if the registrant agrees to place fensulfothion
in Toxicity Category 1.
5/ 2 species required
6/ Required for tobacco use (minimum 21 day inhalation exposure).
7/ Provisional depending on the results of 81-7, Acute delayed neurotoxicity - hen.
8/ 2 species required
9/ 2 species required
10/ 2 species required; additional data has been requested for 00094915 on January 21, 1982.
ll/ A gene mutation assay using mammalian cells in culture is required.
* Study on its own fulfills Guideline requirements.
** Study must be combined with other studies to fulfill Guideline requirements.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be compensable.
55
-------
TABLE' A '
GENERIC DATA REQUIREMENTS FDR FENSULFOTHION
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirenent? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition1/ Pattern2/ No or Partially) Citation 3(c)(2)(B)?3
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Avian Oral LD5Q TGAI A,B,F
- Avian Dietary LC50 TGAI
a. Waterfowl A,B
b. Upland game A,B,F
- Wild Mammal Toxicity TGAI N/A9/
- Avian Reproduction TGAI A
- Simulated and Actual TEP A,B
Field Testing -
Mammals and Birds
Yes
Yes
Yes
N/A9/
No
No
05003191**
05008363**
00094233*3/
00094233*a/
-
-
—
No
No
No
N/A9
Yes4/
Yes5/
AQUATIC ORGANISM TESTING
72-1
- Freshwater Fish LC5Q
a. Warmwater TGAI A,B,F
b. Coldwater TGAI A,B
a. Warmwater TEP A
b. Coldwater TEP A
Yes
Yes
Yes
Yes
00078526**3/
05014941**
00078526**3/
GS0107026**
00078526**9/
05014941**
00078526**9/
No
No
No
No
GS0107026**
56
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TABLE A
GENERIC DATA REQUIREMENTS FOR FENSULFOTHION
Data Requirement
OctnpositionV
Use
Pattern2/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.145 Wildlife and
Aquatic Organisms
(continued)
AQUATIC ORGANISM TESTING (continued)
72-2 - Acute LCso Freshwater TGAI
Invertebrates
72-3 - Acute LC5Q Estuarine
and Marine Organisms TGAI
a. Shrimp
b. Marine fish
c. Oyster
72-4 - Fish Early Life Stage
and Aquatic Invertebrate
Life-Cycle TGAI
72-5 - Fish Life-Cycle TGAI
A,B,F
A,B
A,B
A,B
A,B
A,B
No
Partially
Partially
Partially
No
No
00037809**
00037809**
00037809**
Yes
Yes6/
Yes6/
Yes6/
Yes7/
Reserved8/
72-6 - Aquatic Organism
Accumulation
TGAI,PAI or
Degradation
Product
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TEP
A,B
No
Reserved8/
57
-------
I/ Composition: TGAI - Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop;
C=Aquatic, Food Crop; D=Aquatic, Non-food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food;
G=Forestry; H=Domestic Outdoor I=Indoor.
3/ Data must be submitted no later than January 1987.
4/ Avian reproduction study is required since repeat applications are allowed on corn and the half-lifes on soil
indicate persistence ranging from 96 hours to 2640 hours.
5/ Field studies are required due to the very high acute toxicity to birds and maitinals demonstrated by laboratory
studies and field incidents which relate bird mortality to the use of fensulfothion. At this time two fullscale
field monitoring studies are required: One for the use of granular product on field corn and another on the use of
the 6 Ibs/A spray concentrate of field corn. Depending on the results of the first two studies, further testing
on additional crops may be necessary.
6/ Acute estuarine and marine studies are indicated for crops which are grown in excess of 300,000 acres in coastal
counties. The following fensulfothion uses meet this requirement: cotton, corn, soybean, sorghum, and turf.
7/ Fish early life-stage and aquatic invertebrate life-cycle studies are required since the SWRRB - EXAMS model
indicates fensulfothion will transport to water, the LC5Q for bluegill is less than 1 mg/1, and the fensulfothion
half-life in water is greater than 4 days.
8/ The requirement is reserved pending review of the fish early life-stage and aquatic invertebrate life-cycle studies.
9/ Not applicable at this time.
* Study on its own fulfills Guideline requirements.
** Study must be combined with other studies to fulfill Guidelines.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be compensable.
58
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FENSULPOTHION
Data Requirement
CompositionV
Use
Pattern2/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be submitted
Under FIFRA Section
3(c)(2)(B)?
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact
141-2 - Honey bee - toxicity
of residues on
foliage
141-4 - Honey bee subacute
feeding study
TGAI
TEP
[Reserved]
A,B
A,B
Yes
Yes
00049254*3/
00074043*
No
No
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product,
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food
* Study on its own fulfills Guideline requirements.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be compensable.
59
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix III-l)
to fill "gaps" identified by EPA concerning your product. Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B) . "
jV Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
60
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FENSULFOTHIONV
Data Requirement
§158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation
of Impurities
Analysis and Certification
of Product Ingredients:
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
Compos it ion 2/
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes
No
No
No
Partially
No
Yes
Yes
No
Yes
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c) (2)(B)?3/
4/ No
YesV
Yes6/
Yes7/
4/ Yes8/
YesV
GS0107001* No
GS0107001* No
Yes
GS0107001* No
specific gravity
61
-------
Data Requirement
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING FENSULFOTHION1/
Does EPA Have DataMust Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
Composition2/ No or Partially) Citation 3(c)(2)(B)?3/
§158.120 Product Chemistry
(continued)
63-12 - pH
63-14 - Oxidizing or reducing
action
63-15 - Flaimability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
Other Requirements
64- 1 - Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
N/A
No
No
No
No
Yes
No
No
N/A
GS0107002*3/
Yes
Yes
Yes
Yes
No
Yes
Yes
No
I/ The 90% technical (T),EPA Reg. No. 3125-171, also serves as a manufacturing-use product.
2/ Composition: MP = Manufacturing-use product.
3/ Data must be submitted no later than 6 months from the date of this Standard.
4/ Data on the manufacturing-use technical, EPA Reg. No. 3125-171, included with a confidential ingredient
statement for EPA Reg. No. 3125-213 dated December 16, 1974 submitted by Chemagro Agricultural Division,
MOBAY Chemical Corporation and received by EPA January 9, 1975.
5/ The manufacturing process for the 90% technical must be submitted. This must include the name and address of the
manufacturer or producer of each starting material, the purities of starting materials and intermediates and
descriptions of the reaction conditions, any purification steps, and quality control measures.
62
-------
6/ A discussion is required of each inpurity believed to be present at greater than 0.1%, based on knowledge
of the beginning materials, all possible chemical reactions, and any contamination.
7/ Five or more representative samples should be analyzed for the amount of active ingredient and each impurity
present for which a certified limit is required.
8/ The identities and upper limits of the individual impurities present at greater than 0.1% (w/w) should be submitted.
9/ Quantitative methods to determine the active ingredient and impurities present at greatere than 0.1% by weight
are required.
* Study on its own fulfills Guideline requirements.
a/ Studies submitted by MOBAY Chemical Corporation. These studies may be cortpensable.
63
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IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
IV-1 an IV-2], as indicated by the following paragraphs of this
chapter of the guidance document.
You will be informed later when you must submit the revised
labeling set forth in this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix IV-1) requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix IV-2).
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. See Appendix
IV-1. [40 CFR §162.10(b)]
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.
See Appendix IV-1. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. 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
stated in terms of weight, expressed as avoirdupois pounds
64
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and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. See Appendix IV-1. [40 CFR
§162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CFR §162.10(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 registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix IV-1. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and 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 ingredient
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. See Appendix IV-1. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
65
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Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
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 - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix IV-1. [40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR §162.10 (h)(1)(i)]
Item 1C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal 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. See Appendix IV-1. [40 CFR
§162.10(h)(l)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR §162.10(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.
See Appendix IV-1. [40 CFR §162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as 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. See Appendix IV-1. [40 CFR §162.10
66
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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 taken to avoid
accident, injury or damage. See Appendix IV-1. [40 CFR §162.10
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix IV-3. 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 flam-
mability statements.
2. Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163. 61-8( c) ( 13 )
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163. 61-8 (c ) ( 13 ) ( i i ) ;
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c) (13) (i).
67
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3. Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix IV-1. [40 CFR §162.10(1) (2 ) (ii)]
Item 10A. 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. Make certain that the statement you use
pertains specifically to your product. 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 IV-5 for the latest specific
storage and disposal product label statements.
Item 10B. 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. See
Appendix IV-1. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other 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,
68
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
George T. LaRocca (Product Manager 15)
Phone No. (703) 557-2400
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1. Refer to Appendix II-2 with appropriate
attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III-l) .
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
Note; If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed,
notify the Product Manager listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1)
and the revised labeling set forth in this guidance package.
69
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Appendix II-l
BIBLIOGRAPHY
00044918 Everett, L.J. (1968) Rat Metabolism of P32 Labeled Dasanit: Report
No. 23441. (Unpublished study received Jul 20, 1976 under
3125-163; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:095238-1)
00044925 Houseworth, L.D.; Tweedy, B.C. (1973) Report on Parent Leaching
Studies for (R) Dasanit: Report No. 37182. (Unpublished study
received Jul 20, 1976 under 3125-163; prepared in cooperation
with Univ. of Missouri, Dept. of Plant Pathology, submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:095238-P)
00044926 Houseworth, L.D.; Tweedy, B.C. (1974) The Metabolism of (R) Dasanit
in Soil: Report No. 39220. (Unpublished study received Jul 20,
1976 under 3125-163; prepared in cooperation with Univ. of
Missouri, Dept. of Plant Pathology, submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:095238-R)
00044927 Tweedy, B.C.; Houseworth, L.D. (1974) Leaching of Aged Residues of
Dasanit-Et-l-14C in Sandy Loam Soil: Report No. 40565. (Un-
published study received Jul 20, 1976 under 3125-163; prepared
in cooperation with Univ. of Missouri, Dept. of Plant Pathology,
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:
095238-S)
00044930 Takase, I.; Yoshinoto, Y. (1975) The Metabolic Behaviour of Fen-
sulfothion in Flooded Soil: Report No. 1037(RA; Report No. 46133.
(Unpublished paper presented at the Annual Meeting of Japan
Applied Entomology and Zoology; Aug 1974; unpublished study
received Jul 20, 1976 under 3125-163; prepared by Agricultural
Chemicals Institute, Japan, submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:095238-V)
00047706 Doull, J. ; Root, M.; DiGiacomo, R.; et al. (1967) Effect of Bayer
25141 in the Diet on the Reproduction and Lactation of Mice:
Report No. 20720. (Unpublished study received Dec 30, 1968
under 9F0789; prepared by Univ. of Chicago, Toxicity Laboratory,
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:
093097-D)
00049254 Atkins, E.L., Jr.; Anderson, L.D. (1967) Toxicity of Pesticides and
Other Agricultural Chemicals to Honey Bees: Laboratory Studies.
By Univ. of California—Riverside, Dept. of Entomology. River-
side, Calif.: UC, Agricultural Extension Service. (M-16; sub-
mitter report no. 22259, also In unpublished submission received
Mar 22, 1976 under 3125-71; submitted by Mobay Chemical Corp,
Kansas City, Mo.; CDL:224114-K)
00049568 Ladd, R. (1971) Report to Chemagro Corporation: Teratogenic Study
with Dasanit Technical in Albino Rabbits: IBT No. J9028; Report
No. 30169. (Unpublished study received Jul 1, 1972 under
2F1209; prepared by Industrial Bio-Test Laboratories, Inc., sub-
mitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:091031-E)
-------
00052971 Doull, J.; DiGiacomo, R.; Root, M.; et al. (1966) Chronic Oral
Toxicity of Bayer 25141 to Dogs: Report No. 19587. (Unpublished
study received Mar 24, 1967 under unknown admin, no.; prepared
by Univ. of Chicago, Toxicity Laboratory, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:118739-B)
00052974 Doull, J.; DiGiacomo, R.; Root, M.; et al. (1966) Chronic Oral
Toxicity of Bayer 25141 to Rats: Report No. 19294. (Unpublished
study received Mar 24, 1967 under unknown admin, no.; prepared
by Univ. of Chicago, Toxicity Laboratory, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:118739-F)
00068214 Thornton, J.S.; Hurley, J.B.; Obrist, J.J. (1976) Soil Thin-layer
Mobility of Twenty Four Pesticide Chemicals: Report No. 51016.
(Unpublished study received Jul 11, 1977 under 3125-315; submit-
ted by Mobay Chemical Corp., Kansas City, Mo.; CDL:230908-I)
00072976 DuBois, K.P.; Raymund, A.B. (1962) The Acute Toxicity of Bayer
25141 to Mammals: Report No. 8567. (Unpublished study received
Jul 1, 1972 under 2F1209; prepared by Univ. of Chicago, Dept. of
Pharmacology, submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:091031-E)
00073059 Miles, J.R.W.; Tu, C.M.; Harris, C.R. (1979) Persistence of eight
organophosporus insecticides in sterile and non-sterile mineral
and organic soils. Bulletin of Environmental Contamination and
Toxicology 22:312-318. (Also In unpublished submission received
Jun 27, 1979 under 464-448; submitted by LTW Chemical U.S.A.,
Midland, Mich.; CDL:238974-A)
00074043 Johansen, C.; Hutt, R. (1963) Bee Poisoning Investigations, 1963.
(Unpublished study received Feb 8, 1966 under unknown admin.
no.; prepared by Washington State Univ., submitted by Shell
Chemical Co., Washington, D.C.; CDL:128498-F)
00078526 Lamb, D.W.; Roney, D.J. (1972) Acute Toxicity of (R) Dasanit Tech-
nical, Dasanit 15% Granular and Dasanit 6 Ibs/gal Spray Con-
centrate to Bluegill and Rainbow Trout: Report No. 34034. (Un-
published study received Jul 31, 1972 under 3125-213; submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL:120480-BB)
00079144 Sinmons, C.E. (1981) Leaching Characteristics of (R) Dasanit on
Aged Soil: Report No. 45654. Rev. (Unpublished study received
Jun 26, 1981 under 3125-163; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:245312-A)
00094233 Lamb, D.W.; Jones, R.E. (1973) Toxicity of (R) Dasanit- (R) Di-
syston and Dasanit-Tilliam to Bobwhite Quail and Mallard Ducks:
Report No. 38462. (Unpublished study received Jan 25, 1974
under 3125-252; submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL:025811-F)
-------
00094258 Boot, M.; Taitel, C.; Doull, J. (1964) Subacute Oral Toxicity of
Bayer 25141 in Male and Female Dogs: Submitter 13608. (Un-
published study received on unknown date under 7F0600; prepared
by Univ. of Chicago, Dept. of Pharmacology, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:090773-W)
00094259 Kimmerle, G.; Grundmann, E. (1965) Neurotoxic Studies with S 767
Active Ingredient: Submitter 16496. (Translation; unpublished
study, including 17166 and letter dated Feb 18, 1965 from G.
Kimmerle to Dr. Schrader, received on unknown date under 7F0600;
prepared by Farbenfabriken Bayer AG, West Germany, submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:090773-Y)
00094326 Mobay Chemical Corporation (1966) Synopsis of Metabolic, Analyti-
cal, Residue, and Flavor Information on Bay 25141 Treated
Tobacco. Includes methods dated Mar 5, 1964 and Jun 16, 1966
Summary of studies 101760-C and 007107-D, (Compilation; unpub-
lished study received Aug 23, 1966 under 3125-163; CDL:101760-A)
00094336 Root, M.; Taitel, C.; Doull, J. (1964) Subacute Oral Toxicity of
Bayer 25141 to Male and Female Rats: submitter 14243. (Unpub-
lished study received Jun 22, 1965; Feb 7, 1966 under 3125-EX-
101; prepared by Univ. of Chicago, Dept. of Pharmacology, sub-
mitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:126969-C)
00094359 Puhl, R.J. (1977) The Aerobic and Anaerobic Metabolism of (R) Da-
sanit-ring-UL-14C in Soil: Report No. 48436. Rev. (Unpub-
lished study received Jun 20, 1979 under 3125-163; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:241183-D)
00094363 Puhl, R.J.; Hurley, J.B. (1978) Soil Adsorption and Desorption of
(R) Dasanit-ring-UL-14C: Report No. 66740. (Unpublished
study received Jun 20, 1979 under 3125-163; submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:241183-J)
00094369 Thornton, J.S.; Morris, R.A. (1979) Residues of (R) Dasanit and
Metabolites in Field Rotational Crops: 67265. Summary of stud-
ies 241183-D, 241183-K through 241183-O and 091421-D. (Unpub-
lished study received Jun 20, 1979 under 3125-163; submitted
by Mobay Chemical Corp., Kansas City, Mo.; CDL:241183-P)
00094370 Obrist, J.J.; Thornton, J.S. (1979) Photodecomposition of (R) Da-
sanit Applied to a Soil Surface: 67266. (Unpublished study
received Jun 20, 1979 under 3125-163; submitted by Mobay Chem-
ical Corp., Kansas City, Mo.; CDL:241183-Q)
00094915 Machemer, L. (1978) S 767 (Fensulfothion, the Active Ingredient
of Terracur P and Dasanit): Study of Embryotoxic and Terato-
genic Effects on Rabbits after Oral Administration: Bayer Report
No. 7745; Mobay ADC Report No. 66533. (Unpublished study re-
ceived Aug 20, 1981 under 3125-171; prepared by Bayer AG, West
Germany, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:246223-A)
-------
05003191 Schafer, E.W., Jr.; Brunton, R.B.; Lockyer, N.F.; De Grazio, J.W.
(1973) Comparative toxicity of seventeen pesticides to
the Quelea, house sparrow, and red-winged blackbird.
Toxicology and Applied Pharmacology 26(1):154-157.
05008363 Hudson, R.H.; Haegele, M.A.; Tucker, R.K. (1979) Acute oral and
percutaneous toxicity of pesticides to mallards: correlations
with mammalian toxicity data. Toxicology and Applied
Pharmacology 47(3):451-460.
05014941 Pickering, Q.H.; Henderson, C. (1966) The acute toxicity of some
pesticides to fish. Ohio Journal of Science 66(5):508-513.
05021578 Simmon, V.F. (1979) "In Vitro" Microbiological Mutagenicity and
Unscheduled DMA Synthesis Studies of Eighteen Pesticides.
Research Triangle Park, N.C.: U.S. Environmental Protection
Agency, Health Effects Research Laboratory. (EPA-600/1-79-041;
available from: NTIS, Springfield, VA; PB80-133226)
GS0107001 Chemagro Corporation (1966) Formilators Manual for DASANIT
(BAY 25141) Granular Formulations (Received March 27, 1967
under EPA Reg. No. 3125-171)
GS0107002 Chemagro Agricultural Division, MOBAY Chemical Corporation (1977)
Product Chemistry Update: Data from Document No. AS-77-1047,
Report No. 34837 (Unpublished study received July 13, 1977
under EPA Reg. No. 3125-163: RGB 230936)
GS0107003 Benjamini, E., R. L. Metcalf and T. R. Fukuto (1959) The
chemistry and mode of action of the insecticide 0,0-diethyl
0-p methylsulfinylphenyl phosphorothionate and its analogues.
J. Econ. Entomol. 52(1): 94-98.
GS0107004 Benjamini, E., R. L. Metcalf and T. R. Fukuto (1959) Contact
and systemic insecticidal properties of 0,0-diethyl 0-p-
methylsulfinylphenyl phosphorothionate and its analogues.
J. Econ. Entomol. 52(1): 99-102. (Also in unpublished sub-
mission received August 7, 1967 under PPI7F0600; submitted
by Chemagro Corporation; RGB 115053)
GS0107005 Chemagro Corporation (1966) DASANIT Analytical and Residue
Information on Treatment of Peanuts and Sugar Beets-Volume 1
(Unpublished study received June 13, 1969 under PP#9F0838;
RGB 116098)
GS0107006 Chemagro Corporation (1968) Petition for Tolerances: DASANIT
(formerly BAY 25141) in or on Corn (Sweet, Popcorn), Potatoes,
and Tomatoes (Unpublished study received January 7, 1969
under PP#9F0789; RGB 115880)
GS0107007 Avrahami, M. and I. L. Gernert (1973) Distribution, metabolism,
and excretion of 32p-labelled fensulfothion in sheep.
N. Z. Journal of Experimental Agriculture 1:197-202.
-------
GS0107008 Chemagro Corporation (1967) DASANIT Analytical and Residue
Information on Corn, Potatoes, and Tomatoes (Unpublished study
received April 6, 1967 under PP#7F0600; RGB 115059)
GS0107009 Chemagro Corporation (1967) Supplement No. 1 to a Brochure
entitled DASANIT Analytical and Residue Information on Corn,
Potatoes, and Tomatoes (Unpublished study received August 7,
1967 under PP#7F0600; RGB 115053)
GS0107010 Chemagro Corporation (1967) Supplement No. 2 to a Brochure
entitled DASANIT Analytical and Residue information on Corn,
Potatoes, and Tomatoes (Unpublished study received November
27, 1967 under PP#7F0600; RGB 115058)
GS0107011 Eidelman, M. (1967) Report on method tryout for PP#7F0600
(Memorandum prepared by Laboratory Investigations Section,
PB, DFSA, Food and Drug Administration dated September 5, 1967
and filed under PP#7F0600; RGB 115055)
GS0107012 Chemagro Corporation (1967) DASANIT Analytical and Residue
information on Bananas (Unpublished study received January
10, 1968 under PP#8E0696; RGB 115515)
GS0107013 Chemagro Corporation (1968) Determination of Residues of
DASANIT in corn by thermionic Gas Chromatography (Unpublished
study received May 26, 1969 under PPI9F0820: RGB 116846)
GS0107014 Chemagro Corporation (1969) DASANIT Analytical and Residue
Information on Pineapple (Unpublished study received April 2,
1969 under PP#9F0820; RGB 116029)
GS0107015 Chemagro Corporation (1968) DASANIT Analytical and Residue
Information on Treatment of Peanuts and Sugar Beets-Volume 2
(Unpublished study received June 13, 1969 under PPI9F0838;
RGB 116094)
GS0107016 Chemagro Corporation (1966) BAY 25141 Metabolic, Analytical,
Residue, and Flavor Information - Treatment of Rutabagas
(Unpublished study received April 26, 1966 under PP#9E0853;
RGB 116157)
GS0107017 Chemagro Corporation (1969) Report No. 25464: Determination
of Residues of DASANIT in cured tobacco by thermionic emission
gas chromatography (Unpublished study received November 11,
1975 under PPI6F1702)
GS0107018 Chemagro Corporation (1969) DASANIT Analytical and Residue
Information on Sugar Cane (Unpublished study received November
14, 1969 under PP#OF0905; RGB 116366)
GS0107019 Chemagro Corporation (1972) DASANIT Analytical and Residue
Information on Cotton and Soybeans (Unpublished study received
November 18,1971 under PPI2F1209; RGB 117626)
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GS0107020 Chemagro, Division of Baychem Corporation (1972) DASANIT
Analytical and Residue Information on Corn and Sweet Potatoes
(Unpublished study received May 1, 1972 under PP#2F1260; RGB
117796)
GS0107021 Chemagro Agricultural Division, MOBAY Chemical Corporation (1975)
DASANIT Residue Chemistry on Snap Beans, Kidney Beans, and Navy
Beans (Unpublished study received November 11, 1975 under
PP#6F1702; RGB 095238)
GS0107022 Chemagro Agricultural Division, MOBAY Chemical Corporation (1975)
DASANIT - DI-SYSTON Analytical and Residue Information on Pea-
nuts and Sorghum (Unpublished study received July 15, 1975 under
PP#6F1655)
GS0107023 Chemagro Corporation (1967) BAY 25141 Metabolic, Analytical and
Residue Information on Dry Onions (Unpublished study received
May 2, 1967 under PP#7F0600; RGB 115057)
GS0107024 Chemagro Corporation (1968) Petition for Tolerances: DASANIT
(formerly BAY 25141) in or on Corn (Sweet, Popcorn), Potatoes,
and Tomatoes-continuation (Unpublished study received January
7,1969 under PP#9F0789; RGB 115878)
GS0107025 Chemagro Corporation ((1972) Identification of DASANIT residues
in cured tobacco. Chemistry study, pages 187-198. (Unpublished
study received November 11, 1975 under PP#6F1702)
GS0107026 McCann, J. (1977) Beltsville EPA Fish Study with Fensulfothion
on Salmo gairdneri , Test No. 1096 (EPA Animal Biology Lab
report dated May 16, 1977 under EPA Reg. No. 3125-171)
-------
APPENDIX H-2
CM3 ^eoravni No.
F1FHA SECTICN 3(C)(2){B) SUMMARY SHE57
£?A REGISTRATION .MO.
PflCCUCT NAME
DATE GUJOANCS COCJMENT ISSUES
With ranact to tilt nqutmnmt a suomrt -gentric" data imoaad by tna rIFHA action 3(Q(2}(8) notiea camainid in tfta la/aiancad
Sutdmei Oocumm. I am rtaondinq in tfi« following mtnntr.
C 1. I vrtl sufcmrt data in • nrntiy m«nnw TO sansfy tn« fatlowinq rwnurtmtnti If •?!• mt srwtauns I will us divim from (or an rnn
JOMfitd in) m« flwjBtntion Guid«in« or ait Protocati cantaintfl in flit fltocra of tsowt Grauos to ttit CJjtmtcaui Qrouo, OEC3
CwnioU Tonnq Pragrvnmi. 1 andoa tni pmocds aat I wiil ua:
I fa« tmtTBd into inajmnnntwrta an» or mort otrnrmpanna untUr F1F3A action 3(C}(2)(B)(ii] to army 3Jt following dsts.
nquinffim& Th« tna, and any raquind protneaa, vwU bi njomtttta to e?A by:
NAME OP OTHEH REGiSTHANT
I_i3. I mam • eamaintd "Carnffation of Attwnorw intsr into airAgnwntmwnn Otnir fl»qumim for Oavcoomint of Qaa" witn
nsetctta oil foilovwnij data ftquuanttm:
I nqutn wit you untnd my nqanroon gy diininq tht fm/ovwnq usn (tftis option a not avaiUel* to aopiicsnts for naw proaueoj:
t_> & I nfluat voiuncuy cancultaon of ma nqmraton of -tftii praduo. (This option is not naitaeia to aooiicann far naw praeucaJ
flEGJSTTIAMTS AUTHCfllZSS SEPflESSNTATIVE
SIGNATUflE
OATS
CT* ANIH 8530-1 110-CJ
-------
AEPSSDEC I--3
OMB Aoorovat A/o. 2QQO-Q4Ga
CERTIFICATION OF ATTEMPT TO ENTH3
INTO AN AGSEHMENTWITH OTHE3 REGISTRANTS
(Towtlilv.anifvAt^fvurK*™) FOR DEVELOPMENT OF DATA
1. 1 am duly aumorized to reoresem tfte following firm(s) who an subject a tfit require-
ments of a Notict under F1F3A Section 3(a(2)(8) contained in a Guidance Document
to submit cata concerning tn« activ« ingredient:
MAMS Of F1BM
•
<3UtOAMCS 3CCUMCNT 3A73
ACTlVt INQH«OI«NT
EPA COMPANY NUMBER
V
(This firm or grouo of firms is referred to c«iow as "mv firm".)
2. My firm is willing to aev«4co and submit 3ie data as required by mat Notica. if necBssarv. However, my firm would arefer to «nrer
into an atn'eem«n witn on* or more otner registrants OT develop jointly, or to snare in me cost of developing, tna following reduirea
rams or OXCK
3. My firm has orfand in vwrrnnq to amar irrta sue) an aqmntent. Caoits of till offtn an attached. That offer VMS irrevocaole and indudid an offer TO os
Bound by an arohrsoon caeiaan unaer riF3A 3«cnan j(o(U(8J(iii} if final agreement on ail aims could not Se nacned amerwta. This ofnjr w« maaa
to the foilowinq firmiii an tne failovmnq aatttsj:
NAME Of P'RM
OATS OF OFFS3
owever,
of mesa •irmisi J
SSTN mv 3fr»r.
4. My firm requests ~ar E?A not suscena me reqistrationis) of my firm's oraouctli). if any of tne firms named in saracraon (3) acov<* •
have acreed to sucmit na data Hired in paraqracn !2) aoove in accsrcanca witn tr» Notice. I uncerstand EPA wiil cromonv inform ;
ma wnetner .TW firm .nust submit sata to avoid'susaension sf its registration!]) uncer riFRA S«c=on 3(cH2)(S). ,This ststement j
does not aooiy ta aociicsnts fcr new srocucts.j I give £?A permiiaon "jo diseosa 7119 luietnau upon request. •
NAMC
SJGNATUM*
PAT8
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
Guidance Document for_
Date
Registration
Guideline No.
$158.20
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
$158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Ttest
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
Dis sociation
constant
Octanol/vater
partition
coefficient
pH
Stability
Oxidizing/reducing
react ion
Flamability
Explod ability
Storage stability
Viscosity
Miscibilitv
Corrosion
character ist ics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID*
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
APPENDIX IV-1
Chapter I—Environmental Protection Agency
§ 162.10
oy (or at the ex-
an who original-
to EPA (or its
it obtained the data from anothe
(identify); applicant copied day
frbm a publication; applicant obtain/d
a copy of the data from EPA).
(«) The applicant shall submit
his application a statement that
in its evaluation of the properties/effi-
cacyAand safety of the formolated
end-use product, may not consider any
data as supporting the application,
except the following data:
(1) The data the applicant has sub-
mitted ts EPA under paragraph (b) of
this section;
(2) Other data pertaining to the
safety of toe product's active ingredi-
ents, rather than to the sqffety of the
end-use product; and
(3) Existing tolerances,/ood additive
regulations, ^exemptions/ and other
clearances issued undey the Federal
Pood, Drug, and Cosmetic Act.
(e) If the applicant Knows that any
item of data hdk submitted under this
section was generated/
pense of) anothen pei;
ly submitted the\
predecessor, USDA)/on or after Janu-
ary 1, 1970, to supeort an application
for registration, /experimental use
permit, or amendment adding a new
use to an existing registration, or for
reregistration (unless the applicant
and the original dataXsubmitter have
reached written agreement on the
amount and thre terms W payment of
any compensation thatXmay be pay-
able under FIFMA section
3(c)(l)(D)(ii)/with regard\to approval
of the application), the applicant shall
submit to EPA a statement that he
has fumisned to each such, identified
original data submitter:
(DA notification of the applicant's
intent toyapply for registration, includ-
ing the broposed product namq
(2) An offer to pay the persbn com-
pensatipn, with regard to the approval
of the/application, to the extent re-
quired by FIFRA sections 3(cHD(D)
and 3/c)(2)(D);
(3V An Identification of the ite\n(s)
of dfrta to which the offer applies;
(f) An offer to commence negotia-
tions to ascertain the amount and
of compensation to be paid; and
/(5) The applicant's name, adc
id telephone number.
f) If the applicant's product coy
any active ingredient other th
those that are present solely
of thY incorporation into the product,
durina formulation, of one or/more
other ^registered pesticide products
purchased from another producer,
then theXapplicant shall alsif comply
with § 162v>-5 as to such active ingre-
ic application/shall con-
Dwledgment that for pur-
section ttcXIXD) the
ad any result-
regarded as
dient,
tain an acb
poses of
application relies on
ing registratiorXshoulc
if it were based oui the/Administrator's
consideration of)\he/ollowing data:
(1) All data submitted or specifically
cited by the appu)aant in support of
the registration; i
(2) Each otlWitedi of data in the
Agency's files wliich:
(i) Concerns *ne properties or effects
of any such aotive ingredient; and
(ii) Is oneyof the typesVf data that
EPA would/eQuire to be submitted for
scientific review by EPA iAthe appli-
cant sought the initial registration
under ^IFRA Section 3(c)?6) of a
producy with composition andVntend-
ed use/identical to those proposed for
the iCppllcant's product, undeX the
data/requirements in effect on\the
date EPA approves the applicant's
present application.
s. 3, 6, and 25 of FIFRA, as amended, ^
U.S.C. 138e/jee.)
C44 PR 27953, May 11, 1979]
§ 162.10 Labeling requirements.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(iii) The net contents as prescribed
in paragraph (d) of this section;
-------
§ 162.10
(Iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed In paragraph (f)
of this section;
(vl) An Ingredient statement as pre-
scribed In paragraph (g) of this sec-
tion;
(vll) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(vlll) The directions for use as pre-
scribed in paragraph (1) of this section;
and
(Ix) The use classlflcatlon(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility. (I) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
consplcuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ID All required label text must:
(A) Be set in 6-polnt or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) QeneraL
The label shall appear on or be secure-
ly attached to the Immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
Title 40—Protection of Environment
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if It is a part of the package as
customarily distributed or sold.
(11) Tank cars and other bulk con-
tainers—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported In a tank car, tank truck or
'other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain In the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(l)(A) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
§ 162.15, Is misbranded if its labeling is
false or misleading in any particular
Including both pestlcidal and non-pes-
ticidal claims. Examples of statements
or representations In the labeling
which constitute mlsbrandlng include:
(1) A false or misleading statement
concerning the composition of the
product;
(11) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(ill) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device; i
(Iv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or Indi-
rectly implying that the pesticide or
device is recommended or endorsed by
Chapter I—Environmental Protection Agency
APPENDIX IV-1
(continued)
§ 162.10
any agency of the Federal Govern-
ment;
(vl) The name of a pesticide which
contains two or more principal active
ingredients If the name suggests one
or more but not all such principal
active Ingredients even though the
names of the other Ingredients are
stated elsewhere In the labeling;
(vll) A true statement used In such a
way as to give a false or misleading Im-
pression to the purchaser;
(vill) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or Its Ingredients, including
statements such as "safe," "nonpolson-
ous," "noninjurious." "harmless" or
"nontoxlc to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural ingredi-
ents";
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling. (I) Except
as provided in paragraph (a)(6)(il) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(11) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product Is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(I) Is false or misleading, or
(ID Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label, It must
be qualified by appropriate wording
such as "Packed for * * *," "Distribut-
ed by • * V or "Sold by to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68° F (20"C)
and shall be expressed In conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide Is solid or semiso-
lid, viscous or pressurized, or is a mix-
ture of liquid and solid, the net con-
tent statement shall be In terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated In terms of the largest suitable
units, I.e., "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average Is permissi-
ble only to the extent that It repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no case shall the average con-
tent of the packages In a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label,
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number shall be
set In type of a size and style similar to
other print on that part of the label
on which It appears and shall run par-
-------
§ 162.10
allel to It. The registration number
and the required identifying phrase
shall not appear In such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or Imme-
diate container. It must appear on the
wrapper or outside container of the
package If the EPA establishment reg-
istration number on the Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(I) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active Ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert Ingredients by the
term "Inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" Is
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement.
(I) The Ingredient statement Is nor-
mally required on the front panel of
the label. If there Is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the Ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it Impracticable to
place the Ingredient statement on the
front panel of the label, permission
may be granted for the Ingredient
statement to appear elsewhere.
Title 40—Protection of Environment
(11) The text of the Ingredient state-
ment must run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each In-
gredient shall be the accepted
common name. If there Is one, fol-
lowed by the chemical name. The
common name may be used alone only
if It Is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be pres-
ent.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(1) In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
[date]."
(II) The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
Chapter I—Environmental Protection Agency
APPENDIX IV-1
(continued)
§ 162.10
inert Ingredient(s) to be listed In the
Ingredient statement If he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxlcological
hazard Including hazard to children,
environmental hazard, and physical or
chemical hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxiclty Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the Indicators
In the table below:
Oral LD.. .
Inhalation LC«
Darmal ID-
Eye effects
Skin effects
Toxicity categories
1
Up to and including 50
mg/kg.
Up to and including .2
mg/liter.
Up to end including 200
mg/kg.
Corrosive; comeal
opacity not reversible
within 7 days.
II
From 50 Ihru 5OO mg/kg..
From .2 thru 2 mg/liter
From 200 thru 2000
Comeal opacity
reversible within 7
days; irritation
persisting for 7 days.
Severe irritation at 72
III
From 500 thru 5OOO mg/
From 2. thru 20 mg/liter...
From 2,000 thru 20.000....
No corneal opacity;
within 7 days.
Moderate Irritation at 72
hours.
IV
Greater than 5000 mg/
Greater than 20 mg/liter.
Greater lhan 20.000.
No irritation.
Mild or slight irritation at
72 hours.
(I) Human hazard signal word—(A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxiclty
Category I shall bear on, the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of Its
oral, inhalation or dermal toxlcity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in Immediate
proximity to the word "poison."
(B) Toxicity Category H. All pesti-
cide products meeting the criteria of
Toxiclty Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxiclty Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxiclty Category Is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ID Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
Ing, storage or use Is demonstrated by
the applicant to be extremely remote,
or If the nature of the pesticide Is such
that It is approved for use on Infants
or small children, may the Administra-
tor waive this requirement.
(Ill) Statement of practical treat-
ment—(A) Toxicity Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing Into Toxiclty Category I on the
basis of oral, Inhalation or dermal tox-
lcity. The Agency may, however,
permit reasonable variations In the
placement of the statement of practi-
-------
§ 162.10
cal treatment Is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described In paragraph (hXlKiilHA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(Iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Till* 40—Protection of Environment
Size of label front panel In square
Inches
Above 5 to 10
Above 10 to IS
Ovei 30
Pot
Required
signal
word, an
capitals
6
10
12
14
18
nts
"Keep out
of reach ol
Children
6
6
e
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
ToxWty
category
IV....
Precautionary statements by toxtdty category
Oral. Inhalation, or dermal loxtdty
Fatal (poisonous) H wallowed (Inhaled or absorbed
through skin]. Do not breathe vapor [dust or spray
mtoU. Do not get In eyes, on skin, or on dothlng
[Front panel statement of practical treatment re-
quired.].
May be fatal If swallowed (Inhaled or absorbed
through the skin]. Do not breathe vapors (dust or
spray mist]. Do not gel In ayes, on skin, or on
doming. (Appropriate first aid statements required.].
Harmful If swallowed (Inhaled or absorbed through the
skin]. Avoid breathing vapors [dust or spray mist].
Avoid contact with skin (eyes or clothing]. (Appro-
priate flrsl aid statement required.].
[No precautionary statements required.]
Skin and eye local effects
Corrosive, causes eye and sMn damage (or skin
Irritation). Do not get ki eyes, on skin, or on
clothing. Wear goggles or lace shield and rubber
Qlovos wixwi nsnoWng. Hsnufut or fctat H Bwflnowoo.
(Appropriate first aid statement required.]
Causes eye [and skin] Irritation. Do not get In eyes,
on skin, or on clothing. Harmful H swallowed. (Ap-
prop)late first an statement required.]
Avoid contact with skin, eyes or clothing. In case of
contact Immediately flush eyes or skin with plenty of
watoi. Get medical attention If Irritation persists.
(No precautionary statements required.]
(11) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage. Examples of the
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active Ingredient
with a mammalian acute oral LD,, of
Chapter I—Environmental Protection Agency
APPENDIX IV-1
(continued)
§ 162.10
100 or less, the statement "This Pesti-
cide Is Toxic to Wildlife" Is required.
(B) If a pesticide intended for out-
door use contains an active Ingredient
with a fish acute LC»0 of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" Is required.
(C) If a pesticide Intended for out-
door use contains an active ingredient
with an avian acute oral LD,» of 100
mg/kg or less, or a subacute dietary
LCjo of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result In fatality to
birds, fish or mammals, the statement
"This pesticide Is extremely toxic to
wildlife (fish)" Is required.
(E) For uses Involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20" F; if there is a flashback al
any valve opening.
Flash point above 20' F and not over 80* F or if the
flame extension is more than 18 in long at a distance
of 6 in Irom the flame.
Ad other pressurized containers
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 open 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 heal or open
flame. Do not puncture or Incinerate container. Exposure to
temperatures above 130" F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
At or below 20" F..
Above 20" F and not over W F
Above 80' F and not over ISO* F..
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 or open flame.
(I) Directions for Use—11) General
requirements—(.1) Adequacy and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the
average person likely to use or to su-
pervise 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.
(II) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pestlcl&e product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use In accompanying
leaflets or circulars, such as "See di-
rections In the enclosed circular:" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are Intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
-------
§ 162.10
(J) The label clearly shows that the
product Is Intended for use only in
manufacturing processes and specifies
the type(s) of products Involved.
(2) Adequate Information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product Involved and its
proper use In manufacturing process-
es;
(3) The product will not come Into
the hands of the general public except
after Incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product Is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) 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:
(7) There Is 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;
(2) 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 type(s) of pesticide prod-
ucts involved;
(3) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
«() The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
Title 40—Protection of Environment
(2) Contents of Directions for Use.
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 162.10(J) immedi-
ately under the heading "Directions
for Use."
(II) Immediately below the state-
ment of use classification, the state-
ment "It Is a violation of Federal law
to use this product in a manner Incon-
sistent with Its labeling."
(Hi) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl) The method of application, In-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vil) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) 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 sizes
as required for the child hazard warn-
ing (See Table in § 162.10
-------
APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. 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,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
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
jparallel 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.
-------
APPENDIX IV-2 (continued)
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
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 toxic ity
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, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
APPENDIX IV-2 (continued)
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
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
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
Appendix IV-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
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." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. 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.
-------
Appendix IV-5
(continued)
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.
B. 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 word ing
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal 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."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
t Appendix IV-5
(continued)
"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."
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."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
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. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
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.
Metal
containers
(non-aerosol)
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.
-------
Appendix IV-5
(continued)
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
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^ , disjapse of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke .
Return empty cylinder for reuse (or
similar wording).
^-Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
-------
Appendix IV--5
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts);
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S- [2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4, 6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(l,1-dimethy1-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1f2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
-------
Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4, 6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methy1-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
S i 1 ve x
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
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