GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
TRIPHENYLTINHYDROXIDE
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER GS280
ENVIRONMENTAL PROTECTION AGENCY
OFFICIE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
SEPTEMBER 1984
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TABLE OF CONTENTS
Introduction
I. Regulatory Position and Rationale
II. Requirement for Submission of Generic Data
III. Requirement for Submission of Product-Specific
Data
IV. Submission of Revised Labeling and Packaging
Information
A. Label Contents
1. Product Name
2. Company Name and Address
3. Net Contents
4. Product Registration Number
5. Producing Establishment
Registration Number
6A Ingredient Statement
6B Pounds Per Gallon Statement
7. Front Panel Precautionary Statements
7A Child Hazard Warning Statements
7B Signal Word
7C Skull and Crossbones and Word Poison
7D Statement of Practical Treatment
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals
8B Environmental Hazard
8C Physical or Chemical Hazard
9 Misuse Statement
10A Storage and Disposal Block
10B Directions for Use
B. Collateral Information
V. Instructions for Submission
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APPENDICES
II-l Bibliography 57
II-2 FIFRA 53(c)(2)(B) Sununary Sheet - EPA Form 8580-1 74
II-3 certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6 75
III-l Product Specific Data Report (End-Use Products)
EPA Form 8580-4 76
IV-1 40 CFR §162.10 Labeling Requirements 77
IV-2 Table of Labeling Requirements and Sample Labels 84
IV-3 Physical/Chemical Hazards Labeling Statement 87
IV-5 Storage and Disposal Statements -..88
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
common 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 9 0
days from the receipt of this document, that you wish to
voluntarily cancel the registrations). If you decide to
maintain you 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 Union Carbide Agricultural Products Co., Inc
v. Ruckelhaus, EPA was recently enjoined from implementing in
any way the "mandatory data licensing" aspects of section
3(c)(1)(D) of FIFRA. EPA is assessing the implications of the
injunction for the reregistration process. Because this situ-
ation is currently unresolved, EPA has decided to proceed with
the requirements in the Guidance Document which do not relate
to compliance with the section 3(c)(1)(D) provisions and to
supplemnet the Document with additional guidance when circum-
stances 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 registration (s).
Registrants are reminded that section 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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II. Regulatory Position and Rationale
A. Introduction
This Chapter describes the regulatory position of the Environmental Protection
Agency, hereafter referred to as "the Agency", on all manufacturing-use
products (MPs) containing the fungicide triphenyltin hydroxide (TPTH) as the
sole active ingredient. The Agency's position is based on an evaluation
of all registered uses, and all products containinq TPTH. This document
also considers labeling requirements, tolerances, "Special local Needs"
(registrations authorized by Section 24(c) of the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA)), as well as Federal registrations
granted or pending under Section 3 of the FIFRA. In addition, this document
sets forth the data requirements that must be met to register MPs covered
by this Standard.
In developing its requlatory position, the Agency determines whether available
data indicate that a pesticide has met the risk criteria found in Section
162.11(a) of Title 40 of the U.S. Code of Federal Regulations (CFR).
Pesticides meeting these criteria are candidates for a Special Review, an
intensive risk/benefit analysis which is a modification of the Rebuttable
Presumption Against Registration (RPAR) process. Hie Agency's determination
as to whether the criteria have been met and the rationale for any regulatory
action are summarized in the regulatory position of this standard.
This document addresses registration reauirements for MPs (containing TPTH)
and their intermediaries. TPTH MPs that differ appreciably frcm those
described here may require amendments to the standard. Issues involvinq
specific end-use products will not be addressed under this standard, but
general labeling requirements for same formulated products will be discussed
in Section G.
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B. Use Profile
TPlil is a fungicide registered for use on potatoes, sugar beets, peanuts,
pecan trees, and carrots, and is registered for use as a spider mite suppressant
on peanuts. TPTH is also registered for use on tobacco, and as an industrial
preservative, but is no longer marketed for these two uses. TPTH is currently
being tested (under an Experimental Use Permit) as an active ingredient in
a marine antifouling paint. As of May 1984 petitions were pending for
rice and soybean tolerances.
About 82% of the domestic use of TPTH is on pecans, where it is used to control
a number of foliar diseases. TPTH is applied 6 to 10 times annually, on pecan
trees, starting at the budbreak stage (pre-pollination) and continuing to just
before the shuck split stage at 14 to 21 day intervals. Ground or aerial
equipment may be used.
For control of early leafspot and mites on peanuts, TPTH is applied when
symptoms of the target infestations occur, usually 25 to 60 days after
planting. Applications may continue at 7 to 14 day intervals until 2 to 3
weeks prior to harvest. Overall, 5 to 10 applications may be made per
seauon depending on weather conditions, type and variety of peanuts, amount
of irrigation, and other factors. Applications can be made using ground
equipment, irrigation systems, or by aerial means.
For control of late blight in potatoes, TPTH is applied up to 10 or 12 times
at 5 to 10 day intervals. For control of early blight in the Northwest, 3 to
4 applications may be required on irrigated potatoes. In the Northeast,
late-season applications for late blight also control early blight. TPTH is
applied to potatoes using ground, aerial, or sprinkler irrigation equipment.
Use on carrots and sugarbeets is minor. On carrots, 1 to 4 applications may
be required at 7 to 14 day intervals for adequate disease control. Applications
can be made using ground, aerial, or irrigation equipment. In Idaho, 1 to 3
applications may be needed on sugarbeets under furrow irrigation, with more
required under sprinkler irrigation.
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TPTH formulations include a 47.5% wettable powder, 19.7 and H0% flowable,
and 95 and 96% technical solids for industrial use. TP Hi is applied with
aerial, ground, or sprinkler irrigation equipment at rates of from 1.5 to
12 ounces of active ingredient per acre. The 47-5% wettable formulation is
available in water soluble bags that may be added directly to the spray tank.
C. Background
Triphenyltin hydroxide, a member of the organotin family, is commonly referred
to by the acronym TPTH. TPTH is also known as fentin hydroxide, (British
Standards .Institution, .International Standards Organization), and as
hydroxytriphenyltin. The Chemical Abstracts Service (CAS) number is 76-87-9,
and the 'EPA chemical code number (also known as the Shaughnessy number) is
083601. TPTH is marketed under such names as "Du-ter®", "Duter®", "Haitin®",
"Flo-Tin®", "Brestan H®", "Suzu H®", "TPTH", "TPTOH", "TUbotin®", "0JT-28OO9",
"Supertin", and "Triple Tin". At present there are 7 federally registered
products containing TPTH as the sole active ingredient, 23 state (24(c))
registrations, and two intrastate registrations. One'Experimental Use
Permit has been issued for use of TPTH as one of two active ingredients in
a marine antifouling paint, under the trade name Rabamarine A/F 1000.
TPTH was first developed for agricultural use by the Thompson-Hayward
Agriculture and Nutrition Co., but Thompson-Hayward's interests have been
purchased by Uniroyal, .Inc. Technical TPTH is manufactured in the United States
by M & T Chemicals, and in Amsterdam, Holland by Duphar, .Inc. The American
Hoechst Co. and Uniroyal are currently seeking rice and/or soybean tolerances.
D. Regulatory Position and Rationale
Based on a review and evaluation of all available data and other relevant
information on TPTH, the Agency has made the following determinations:
1. A Special Review of TPTH will be initiated. The Agency will not reregister
any current products or register any new uses of TPTH until the special review
Is completed and the Agency has received a commitment to fulfill all data gaps.
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Rationale: The risk, criterion set forth in §162.11 has been exceeded, because
a study has shown that TPTH produced teratogenic effects at the lowest
dose levels tested. Moreover, farm workers may be exposed to concentrations
of TPTH which could cause unreasonable adverse health effects. When a
Special Review is completed, an assessment of the benefits of TPTH along
with the risk analysis will be published in the Federal Register. Publication
of that Notice will constitute th» Position Document 1 of the Special Review
process.
2. Products containing TPTH, including currently registered products, will be
registered only under the "Restricted Use" classification.
Rationale: TPTH has produced teratogenic effects, as noted above. It also has
potential to produce immunotoxic and perhaps oncogenic effects, and may inhibit
reproduction. TPTH is in Toxicity Category I for inhalation, dermal, and primary
eye irritation exposure routes. Use should be limited to properly trained persons.
3. No new permits will be Issued for experimental use as anti-fouling agents in paints.
Rationale: With its high toxicity to aquatic organisms, TPTH poses too great a
threat to non-target populations.
4. No new tolerances will be Issued until data gaps involving iramunotoxicity,
reproductive effects, teratology, oncogenicity, inhalation toxicity, and
chronic feeding effects are filled and/or problems in the available studies
are resolved to the satisfaction of the Agency.
Rationale: The current data base does not provide sufficient information to
adequately safeguard the public from possible dangers if their dietary intake
of TPTH were increased by the granting of new tolerances.
5« The tolerances for TPTH in root and tuber vegetable crops, potatoes, sugar
beets, carrots, pecans, and peanuts must be revised to include the intermediary
degradation products diphenyltin and monophenyltin hydroxides and oxides,
once the Agency has received sufficient data to allow this revision.
Registrants must submit data that will allow this revision. The tolerances
for meat, milk, poultry, and eggs will also be revised, once the Agency has
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a method of detection and residue data. The Agency requires this information.
.If continued registration on tobacco is desired, the registrants must
submit data regarding the residues on freshly harvested tobacco. (See
T&ble A for generic data requirements.)
Rationale: The intermediate degradation products named above may be the cause
of some of the observed toxic effects of TPTH. There is insufficient data
available to categorize them as innocuous.
5. The Agency will require that certain warnings be placed on the labels of all
formulated products containing TPTH. (See Section G(2) of the standard for
specific labeling requirements.)
Rationale: Because of the high toxicity of TPTH, label warnings are necessary
to protect mixers, loaders, applicators, and others who may be exposed.
6. The required label warnings will include a caution against entering treated
areas for 2H hours after application. Registrants must submit re-entry
data, as noted in the T&ble A. (See Section G(2) of this standard for
specific labeling requirements.)
Rationale: Re-entry data are required because, based on the use patterns
and available toxicity data, the criteria for such requirement in §158.1M0
have been met. The 2^-hour re-entry interval required by this standard
will be used as an interim precautionary measure until the submission and
analysis of the re-entry data.
7. While the data gaps are being filled and the Special Review process is
being completed, currently registered manufacturing-use products containing
TPTH as the sole active ingredient may be sold, distributed, formulated
and used in the United States, subject to the terms and conditions specified
in this standard.
Rationale: The criteria for suspension of product registrations have not been
met. .In addition, with the Imposition of restricted use classification and the
label changes set forth in Section P and G below, at this time it does not ap-
pear that continued use of TPTH during the special review will cause unreasonable
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adverse effects on the environment. Many data gaps exist, but it is not the
Agency's policy to cancel or withhold registration solely because of data gaps.
(See Sections 3(c)(2)(B) and 3(c)(7) of the FIFRA.) When the data gaps
are filled, and the Special Review process is completed, the Agency will
evaluate whether the new data constitute sufficient grounds for initiating
suspension or cancellation proceedings.
E. Criteria for Registration Under This Standard
To be covered by this standard, products must:
o be a manufacturing-use product containing TPTH as the sole
active Ingredient,
o bear required labeling and conform to the product composition,
standard, acute toxicity limits, and use pattern requirements
listed in Sections G and H of this document.
The applicant for registration or reregistration of products subject to
this standard must comply with all terms and conditions described in it.
This Includes making a commitment to fill data gaps on a schedule specified
by the Agency. Applicants 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. Prouuct Composition Standard
Technical grade products must contain at least 95 percent TPTH as the
sole active ingredient. Each manufacturing-use product formulation
proposed for registration or reregistration must be fully described with
an appropriate certification of limits. In addition, the active ingredient
found in the manufacturing-use TPTH products must be substantially similar
to that in currently registered technical products. Any manufacturing-use
product not meeting these requirements will be considered a different
product and will not be registered under this standard.
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2. Acute Toxicity Limits
Because of the high acute toxicity classifications, and other potential
toxicological effects of subchronic and/or chronic exposure, the Agency will
consider registration of products containing TPTH only under restricted use
classification. All labels must bear appropriate precautionary statements.
3. Use Patterns
To be registered under this standard, manufacturing-use products containing
TPTH must be labeled for formulation into end-use products that are to be
used for the control of fungus on peanuts, potatoes, pecan trees, sugar
beets, carrots, and tobacco, or for the control of spider mites on peanuts.
The Fungicide Index for TPTH is attached to this standard as Appendix A.
G. Required Labeling
All technical grade and manufacturing-use products containing TPTH must
bear appropriate labeling as specified in 40 CFR §162.10. Other portions of
the guidance package contain specific information regarding label requirements.
In addition, the following specific labeling requirements apply to technical
and manufacturing-use products:
1. Use Pattern Statements
Labels of manufacturing-use products must bear the statement:
"For formulation into end-use fungicide products intended for use on pecan
trees, peanuts, carrots, potatoes, sugar beets, and tobacco, or insecticide
products intended for use as spider mite suppressants."
Labels of formulated products must bear the statement:
"RESTRICTED USE PESTICIDE: Because of the high acute toxicity of triphenyltin
hydroxide, and its potential for creating teratogenic effects, this product
may be applied only by certified applicators or persons directly under
their supervision."
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2. Precautionary Statements
a. Hazards to Humans Statements
Labels of manufacturing-use and formulated end-use products (EUPs) must
bear the statements:
"DANGER - Fatal if inhaled. Corrosive, causes irreversible eye damage.
May be harmful or fatal if swallowed or absorbed through the skin.
Do not get in eyes, or on skin. Do not breathe dust, vapor, or spray
mist. When handling either products containing TPTH or spray-diluted
mixtures, wear protective clothing (long pants, long sleeve shirt,
impermeable gloves, hat, boots, and a pesticide respirator jointly
approved by the Mining Enforcement and Safety Administration and the
National Institute for Occupational Safety and Health.) When handling
the concentrated products, wear a face shield. Wash thoroughly with
soap and water after handling and before eating or smoking. Remove
contaminated clothing and wash before reuse. Do not enter treated
areas for at least 24 hours after treatment."; and
"The United States Environmental Protection Agency has determined that
triphenyltin hydroxide causes birth defects in laboratory animals.
Exposure to triphenyltin hydroxide during pregnancy should be avoided."
The word "POISON" (in red letters) and a skull and crossbones must appear
in close proximity to the word "DANGER".
b. Statements of Practical Treatment
Labels of manufacturing-use and EUPs must bear the statements:
"If on skin: Wash with plenty of soap and water."
"If Inhaled: Remove victim to fresh air. If not breathing, give artificial
respiration, preferably mouth-to-mouth. Get medical attention."
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"If In eyes: Flush with plenty of water. Call a physician."
"If swallowed: Do not induce vomiting. Drink promptly a large quantity of
milk, egg whites, gelatin solution, or if these are not available, drink
large quantities of water. Call a physician or Poison Control Center."
Environmental Hazard Statement
The following specific statements must appear on the labels of all
manufacturing use products:
"This pesticide is toxic to fish and wildlife. Do not discharge into
lakes, streams, ponds, estuaries, oceans, or public waters unless this
product is specifically identified and addressed in a NPDES permit.
Do not discharge effluent containing this product to sewer systems
without previously notifying the sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of the EPA."
All labels of EUPs intended for outdoor use must bear this statement:
"This pesticide is toxic to fish and wildlife. Do not apply directly
to water or wetlands. Drift or runoff from treated areas may be hazardous
to aquatic organisms in neighboring areas. Cover or incorporate spills.
Do not contaminate water by cleaning of equipment or disposal of wastes."
Disposal Statements
All labels of manufacturing use and EUPs products must bear this statement,
under the heading "STORAGE AND DISPOSAL":
"Do not contaminate water, food, or feed by storage or disposal. Pesticide
wastes are acutely hazardous. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office for
guidance."
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The label of all products (except those intended solely for household use)
must bear the appropriate container disposal statement. See Appendix IV-5.
The required statements listed in this standard must appear on the labels
of all MUPs and EUPs released for shipment after March 30, 1985. After
review of data to be submitted under this standard, the Agency may
impose additional label requirements.
H. Tolerance Reassessment
Tolerances of 0.05 to 0.10 ppm were established several years ago for
residues of TPTH on carrots, sugar beets, pecans, peanuts, potatoes, and in
kidney and liver. A tolerance of 0.40 ppm was established for residues on
or in peanut hulls. The original Acceptable Daily Intake (ADI) for TPTH
has been re-evaluated as part of the pending soybean tolerance petition. The
re-evaluation indicated that an ADI could no longer be determined from the
available data base and that additional tolerances should not be established
until problems related to the chronic feeding, teratology, reproductive
and oncogenicity studies and immunotoxicity potential were resolved, and
some additional data submitted. To date the problems have not been resolved.
There is no valid ADI for TPTH at this time.
Crop group tolerances for the root and tuber vegetable crops and the tree
nuts groups are not appropriate at this time, because data are needed on
the storage stability, and on residue levels of the di- and monophenyltin
oxides and hydroxides in registered crops. Tolerances for meat, milk,
poultry, and eggs will be revised when the problems mentioned above have
been resolved, and registrants have submitted a method of detection and
the appropriate residue data.
The Theoretical Maximum Residue Concentration (TMRC) calculated from existing
tolerances is 0.0106 mg/day, assuming a 1.5 kg diet/day. However, the
inclusion of the intermediate metabolites would Increase the TMRC by an
amount that cannot be assessed at this time. The granting of new tolerances
would have the same effect. The TMRC will be recalculated when the Agency
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receives information on the residue levels of di- and monophenyltin oxides
and hydroxides in registered crops.
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EPA Index of Pesticide Chemicals
TRIPHENYUTIN HYDROXIDE C083601
TYPE PESTICIDE: Fungicide
FORMULATIONS: Tech (95%, 96%); WP (47.5%); FiC (0.5625 lb/gal or 5.1%,
1.875 lb/gal or 19.7%, 4 lb/gal or 40%, 4 lb/gal or 40.5%)
GENERAL WARNINGS AND LIMITATIONS:
Dosages are expressed in units of active ingredient.
Livestock tolerances:
0.05 ppn (negligible residue) in the kidney and liver of cattle, goats,
hogs, horses and sheep.
Definition(s): MAI - multiple active ingredient, ppn - parts per million.
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation
AGRICULTURAL CROPS
General Warnings and limitations: Do not graze dairy or meat animals in
treated areas. Do not add surfactant, spreaders or stickers to sprays.
Oonsult a State Cooperative Agricultural Extension Service regarding
timing recommendations.
Fbr ground application equipment: Mix with water tor a total solution of
10 to 100 gallons per acre..
For aerial application: Mix with water for a total solution of 3 to 20 gallons
per acre.
§?rinkier irrigation application: Sse specific label instructions and
and limitations for this type of use.
Carrot
Alternaria blight
(late blight)
Gercospora leaf
spot
1.9-3.8 02/b.
(47.5% WP)
(1.875 lb/
gal or 19.7%
FIC)
(4 lb/gal or
40% E1C)
(4 lb/gal or
40.5% FIC)
0.1 ppm (negligible residue) /14003AA
14 day preharvest "interval through
3.8 ounces per acre for foliar applic-
ation. Do not use tops as feed for
livestock.
Fbliar application, tee lower rate FBASAAX
in protective schedules or when
disease is light and increase the EMBCCBM
rate as disease severity increases.
Ihe highest rate is used during high
infection periods. Begin application
6 weeks after planting or as soon
as first signs of disease appears.
Continue at 7 day intervals or as
needed for control.
Peanut 0.05 ppm (negligible residue) in or /28015AA
on peanuts
0.4 ppm in or on peanut hulls
14 day preharvest interval through
3.8 ounces per acre for foliar ap-
plication.
Do not allow hogs to feed on peanuts
in treated fields. Hulls frcm treated
peanuts may be used in feed for live-
stock. Do not use vines as feed.
May be applied by ground equipnent,
by aircraft or through sprinkler
irrigation application.
Issued: 04-07-79 11-083601- 1
Revised: 01-23-84
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EPA Index of Pesticide Chanicals
TRIFHENYLTIN HYDROXIDE
Site and Pest
Peanut (continued)
Cercospora leaf
spot
Pecan
Dosages and
Formulation
2.38-3.8 oz/A
(47.5% MP)
(4 lb/gal or
40% F1C)
(4 lb/gal or
40.5% FlC)
or MAI
2.25-3.75
OZ/A
(0.5625 lb/
gal or 5.1%
FlC)
2.38-3.8 oz/A
(1.875 lb/gal
or 19.7% FlC)
Brcwn leaf spot
(cercospora)
Downy leaf spot
(mycosphaerella)
Leaf blotch
Liver spot
(gncmonia)
Powdery mildew
(microsphaera)
Scab (cladosporium)
Sooty mold
0.36-0.71 lb/A
(47.5% WP)
(1.875 lb/gal
or 19.7% FlC)
(4 lb/gal or
40% FlC)
(4 lb/gal or
40.5% FlC)
Tolerance, Use, Limitations
Foliar application. Use the lower FMBCCBM
rate when disease is light, increas-
ing the rate "3s disease severity
increases. Apply for full coverage
to foliage. Use lcwer gallonage in
early season when plants are small
and increase spray volume as plant
size increases. Application should
begin approximately 6 weeks after
planting, or as first sign of leaf-
spot appears. Spray applications
should continue on a 10 to 14 day
schedule.
or MAI
Formulated with sulfur.
Foliar irrigation systan application
only. Application should begin approx-
imately 6 weeks after planting, or as
first sign of leafspot appears. Ap-
plications should continue on a 10
to 14 day schedule. Do not mix with
emulsifiable concentrate or liquid
formulations. See specific label
for other instructions and limit-
ations regarding this type of applic-
ation.
0.05 ppn (negligible residue) /03008AA
Apply through 2.9 pounds per acre for
foliar application. Do not apply
after shucks have started to cpen.
May be applied in combination with
emulsifiable concentrate or wettable
powder insecticides.
Delayed dormant and foliar applic- FMBCCBM
ations. Apply with ground equip-
ment or by aircraft. Make first FMASMCo
application at prepollination stage
when young leaves are unfolding and FCADMCo
second application when small nuts FMBDGAT
are forming. Repeat at 2 to 4 week FFACMBT
intervals as needed. Tto maintain
control, use lower rate for first FEAJCCV
two applications, or until disease FHAKQBg
becanes severe, or during dry
weather. Use higher rate during v«t
weather or during severe disease
infection periods.
Issued: 04-07-79 Revised: 01-23-84
II-083601-2 16
-------
EPA Index of Pesticide Chemicals
Site and Pest
Potato
Early blight
(alternaria)
Late blight
(phytophthora)
Gray mold
(botrytis)
Early blight
(alternaria)
Late blight
(phytophthora)
Sugar beet
Ceroospora
leaf spot
TRIPHENYLTIN HYDROXIDE
Tolerance, Use, Limitations
Dosages and
Formulation
2.38-4.75
oz/A
(47.5% WP)
(4 lb/gal or
40% F1C)
(4 lb/gal or
40.5% F1C)
0.05 ppm (negligible residue)
7__day preharvest interval through
4.75 ounces per acre
May be applied in combination with
emulsifiable concentrate or wettable
pcwder insecticides, hcwever, before
using emulsifiable concentrates it
is suggested that the mixture be
tested for phytotoxic response under
actual use conditions.
Foliar application. Begin treatment
when weather conditions favor disease
development and continue on a 7 day
schedule. Full coverage of foliage
is necessary for best results.
/14013AA
FBAMAAX
FBASPCN
2.85-4.75 Foliar irrigation system application FHADBAW
oz/A only. Irrigation systems must be
(1.875 lb/gal equipped with safety valves or other FBAMAAX
or 19.7% F1C) devices to prevent backsiphoning of
pesticide into water source. Any FBASPCN
irrigation water treated with this
chemical should be held on the treated
areas until it is absorbed by the soil.
It should not be turned into tail water
or fed back into the irrigation system.
Apply when weather conditions are
favorable for disease development and
continue at 7 day intervals.
0.1 ppm (negligible residue) in or /28020AA
on sugar beet roots
14 day preharvest interval through
4.75 ounces per acre. Do not graze
dairy or meat animals in the treated
areas or feed beet tops to livestock.
1.9-4.75 oz/K
(47.5% WP)
(1.875 lb/gal
or 19.7% F1C)
(4 lb/gal or
40% F1C)
(4 lb/gal or
40.5% F1C)
Fbliar application. Apply when leaf
spot symptoms appear or when disease
occurs in the area and repeat at 10
to 14 day intervals.
FMBCCBM
Issued: 04-07-79
Fevised: 01-23-84
II-083601-3
17
-------
EPA Index of Pesticide Chemicals
Site and Pest
Tobacco
Brown spot
(alternaria)
TRIFHENYLTIN HYDROXIDE
Tolerance, Use, Limitations
Dosages and
Formulation
3.09-4 .51
Oz/A
or
0.193-0.294
lb/A
(47.5% WP)
N.F.
Do not use in combination with
atiulsif iable concentrate or oil
spray formulations.
Use limited to Southeastern United
States.
Foliar application. Apply in 40 to
60 gallons of water per acre. Apply
as a full coverage spray beginning
immediately after the first priming
(harvest) and repeat immediately
after each weekly priming.
/26003AA
FMAJAAX
AERIAL AND TANK MIX APPLICATIONS
Aerial Applications
— Refer to
Agricultural Crops
Carrots, Peanuts, Pecans, Potato,
Sugar beets
Issued: 04-07-79 II-083601-4 18
Revised: 01-23-84
-------
EPA Index of Pesticide Chanicals
TRIPHENYLTIN HYDROXIDE
Listing of Registered Pesticide Products by Formulation
95% technical chemical
triphenyltin hydroxide (083601)
047916-00037
96% technical chemical
triphenyltin hydroxide (083601}
037100-00013
47.5% wettable powder
triphenyltin hydroxide (083601)
0U0400-00160 000400-00161 008340-00015 037100-00012 044215-00074
047916-00034
5.1% (0.5625 lb/gal) flowable concentrate
triphenyltin hydroxide (083601) plus sulfur (077501)
001812-00252
19.7% (1.875 lb/gal) flowable concentrate
triphenyltin hydroxide (083601)
000400-00163
40% (4 lb/gal) flowable concentrate
triphenyltin hydroxide (083601)
001812-00244 045115-00014 047916-00035 049085-00001
40.5% (4 lb/gal) flowable concentrate
triphenyltin hydroxide (083601)
000400-00164
State Label Registrations:
MI Reg. No.
000148-05843
WI Reg. No.
000148-05844
Issued: 04-07-79
Revised: 01-23-84
I1-083601-5
19
-------
EPA Index of Pesticide Chemicals
TRIPHENYLTIN HYDROXIDE
Appendix B
Listing of Registration Numbers by Site:
Carrots
000400-00160
008340-00015
047916-00035
Peanuts
000400-00160
001812-00252
047916-00034
Pecans
000400-00160
008340-00015
047916-00035
Potato
000400-00160
008340-00015
047916-00035
Sugar beet
000400-00160
008340-00015
047916-00035
Tobacco
008340-00015
000400-00161
037100-00012
049085-00001
000400-00161
008340-00015
047916-00035
000400-00161
037100-00012
049085-00001
000400-00161
037100-00012
049085-00001
000400-00161
037100-00012
049085-00001
000400-00163
044215-00074
000400-00163
037100-00012
000400-00163
044215-00074
000400-00163
044215-00074"
000400-00163
044215-00074
000400-00164
045115-00014
000400-00164
044215-00074
000400-00164
045115-00014
000400-00164
045115-00014
000400-00164
045115-00014
001812-00244
047916-00034
001812-00244
045115-00014
001812-00244
047916-00034
001812-00244
047916-00034
001812-00244
047916-00034
/014003A;
/28015AA
/03008AA
/14013AA
/28020AA
/26003AA
Issued: 04-07-79
Revised: 01-23-84
I1-083601-6
20
-------
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 registration(s)
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 !/ 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
1/ Generic data pertain to the properties or effects of a
partTcular 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.
21
-------
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 11-3)^/
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)
22
-------
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.
23
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR TPTH
Data Requirement Composition!/
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)?2/
§158.120 Product Chemistry
Product Identity:
61-1 - Product Indentity &
Disclosure of Ingredients
61-2 - Description of the
Manufacturing Process
61-3 - Discussion of Formation of
Unintentional Ingredients
TGAI
TGAI
TGAI
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits
62-3 - Analytical Methods and Data
for Enforcement of Limits
TGAI
TGAI
Yes
Partially
Partially
Partially
No
Partially
00083551
00083551
00083551
No
TH - 46946 ELN
dtd May 3, 1982
Duphar - 37100-13
dtd May 12, 1982
00030265
00086487
Yes 3/
YesV
Ye si/
Yes
Yesl/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TPTH
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition]/ No or Partially) Citation 3(c)(2)(B)?.?/
S158.120 Product Chemistry (continued)
Physical and Chemical Characteristics
63-2 -
Color
TGAI
Yes
00083551
No
63-3 -
Physical State
TGAI
Yes
00083551
No
63-4 -
Odor
TGAI
Yes
00083551
No
63-6 -
Melting Point
TGAI
Yes
00083551
No
63-7 -
Density, Bulk Density, or
Specific Gravity
TGAI
No
—
Yes
63-8 -
Solubility
TGAI
Yes
00083551
No
63-9 -
Vapor Pressure
PAI
Partially
00083551
Yesj
63-10 -
- Dissociation constant
TGAI, PAI
No
—
Yes
63-11 -
- Octanol/water partition
coefficient
PAI
Yes
00093704
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR TPTH
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
§158.120 Product Chemistry
(continued)
63-12 - pH
63-13 - Stability
TGAI, PAI
TGAI
Yes
Yes
00083551
00083551
No
No
1/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient. Choice = Choice of
several test substances determined on a case-by-case basis.
2/ Data nust be submitted no later than June 1, 1985 unless otherwise indicated.
3/ Updated information is needed frcm all manufacturers/registrants.
4/ Updated information giving analyses of five or more representative samples is needed frcm all manufacturers/regis-
trants.
5/ Validation data is requested from all manufacturers/registrants.
6/ Vapor pressure data in quantitative terms is requested.
-------
TABLE A
GENERIC DATA REQUIREMENTS EOR TPTH
Data Requirenents Composition!/
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)?2/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA
Yes
00030252 00030311 No
00030253 00086459
00030254 00086493
00030309 00086494
00030310 00124220 (D-2, D-4, D-5)
- Livestock
PAIRA and plant
metabolites
Yes
171-4 - Residue Analytical Method
- Plant residues
TGAI and
metabolites
Partially
00030250 00080381 No
00030251 00086552
00030313 00086553
00030315 00086554
00030316 00124220 (D-8, D-10, D-ll,
D-13)
00029834 00086472 YesV
00029835 00086473
00030259 00086534
00030272 00086545
00036021 00086561
00036027 00086569
00036029 00086571
00080387 00086601
00086450 00086603
00086452 00124220 (D-14, D-16 to 18,
D-28)
- Animal Residues
TGAI and
metabolites
Partially
See plant citations Yesi/
above.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR TPTH
Data Requirements
Compos i t ioni/
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)?!/
fO
00
§158.125 Residue Chemistry (continued)
171-4 - Storage Stability Data PAI
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group #1 - (Root and Tuber Vegetables Group)
o Crop 1 (Potatoes)
— Crop field trials TEP
o Crop 2 (Sugar Beets)
— Crcp field trials TEP
o Crcp 3 (Carrots)
— Crop field trials TEP
o Leaves of Root and Tuber
Vegetables N/A®/
No
Partially
Partially
Partially
00086492
00086494
00086560
00086544
Yes_5/
Yes§/
Yes 6/
YesZ/
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR TPTH
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)?!/
to
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies (continued)
- Crop Group #2 (Tree Nuts Group)
o Crcp 1 (Pecans)
— Crcp field trials TEP
- Individual Crcps
Peanuts
— Crcp field trials TEP
Tobacco
— Crcp field trials TEP
— Meat/milk/poultry/eggs TGAI
Partially
Partially
No
Partially
00086600
00080383
00080384
00086556
00053415
00080381
Yes?/
Yes!®/
Yes!!/
Yes!!/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TPTH
S158.125 Residue Chemistry
(continued)
1/ Composition: TGAI = Technical qrade of the active inqredient; PAIRA = Pure active ingredient, radiolabelled: TEP =
Typical end-use product: EP = End-use product.
2/ Data must be submitted no later than June 7, 1985 unless otherwise specified.
3/ All existing tolerances should be altered to include the metabolites di- and monophenyltin hydroxides (or oxides).
None of the methods submitted by the registrants is suitable for determination of the collective or separate residues
of TPTH and these two degradates in plants. A method for enforcing a tolerance which includes these two deqradates
is needed.
4/ All existing tolerances should be altered to include the metabolites di- and monophenyltin hydroxides (or oxides).
None of the methods submitted by the registrants is suitable for determination of collective or separate residues of
TPTH and its metabolites, di- and monophenyltin hydroxides (or oxides) in meat, milk, poultry, and eggs. New
methodology must be submitted which includes a base hydrolysis step, which is necessary to free TPTH residues from
coniuqates in meat, milk, poultry, and egqs. Analytical methodology for poultry and eggs is also needed. A method
for enforcing a tolerance which includes these two metabolites is needed.
5/ Data on storage stability of tpth residues in plant and animals have not been submitted. Although same samples are
said to have been stored a -2°C, no information has been furnished on how long these were held in storage before
being analyzed, and none to show whether or not residues were stable during storaae for an unreasonable length of
time (e.q. more than about two months). Data on storage stability must be submitted no later than December 7, 1QSS.
6/ Data are needed on the storage stability and the data and methodoloqy for residues of di- and monophenvl tin hydroxides
(or oxides) in potatoes and sugar beets, and of tetraphenyltin as well, in processed commodities from potatoes and
sugar beets. Data must be submitted no later than June 7, 1986.
7/ Data on the residue storage stability, and the data and methodoloqy for residues of di- and monophenyltin hydroxides
(or oxides) in carrots are needed. Data must be submitted no later than June 7, 1Q86.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TPTH
5158.125 Residue Chemistry
(continued)
8/ Tolerances established for the root form of the root and tuber vegetables, individually or collectively (in the crop
grouping) must be accompanied either by a restriction against the use of the leaves as human food or animal feed
(when practical and appropriate) or by residue data on the leaves (again, individually or as representatives of the
crop qroupinq). [Note: These residue data are in anticipation of a tolerance which should not be established at this
time.1 In the absence of residue data, such restrictions have been made applicable to carrot and suqar beet toos in
the present uses of TPTH vrtiere the restrictions are practical and appropriate. Restrictions are not needed for
carrot tops and the leaves of potatoes because these are neither food nor feed.
9/ Data are needed on the residue storage stability, and the data and methodology for residues of di- and monophenyltin
hydroxides (or oxides) in pecans. [Residue data for the representative crops, almonds and English walnuts, would be
needed for a crop group tolerance, which should not be established at this time.] Data must be submitted no later than
June 7, 1986.
10/ Data and methodology for residues of di- and monophenyltin hydroxides (or oxides) in peanuts will be needed. Data
for tetraphenyltin will be needed for corrmodities processed from peanuts. Data must be submitted no later than
June 1, 1986.
11/ Hie use of TPTH on tobacco does not require a tolerance or an exemption from the requirement of a tolerance, but
data are needed to assess the exposure to residues resulting from the use of the pesticide. For continued
registration, residue data on green freshly-harvested tobacco will be needed. If residues of TPTH and di- and
monophenyltin hydroxide (or oxides) at 0.1 ppm or more are detected, then the pyrolysis products derived from
these residues must be characterized. Data must be submitted no later than June 7, 1986.
12/ Information on residue storage stability, and data and methodology for residue of di- and monophenyltin hydroxides
(or oxides) will be needed. Hie method should be revised or a new method developed to include the determination of
the forementioned metabolites collectivelv with tpth or separately in meat, milk, poultry, and eggs. The new
methodology should also include a base hydrolysis step, which is necessary to free TPTH residues from coniugates in
meat, milk, poultry, and eqgs. Ttie expression of the established tolerance should be changed to include, di- and
monophenyltin hydroxide (or oxides) along with parent TPTH. The required information must be submitted no later
than June 7, 1986.
-------
TABLE A
GENERIC LATA REQUIREMENTS TOR TPTH
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Carpositionl/ Pattern^/ No or Partially) Citation 3(c)(2)(B)?!/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
TGAI
or
PAIRA
A,B
Yes
00093875
NO
Photodegradat ion
161-2 - In water
TGAI
or
PAIRA
A,B
No
—
Yes
161-3 - On soil
TGAI
or
PAIRA
A
No
—
Yes
161-4 - In Air
TGAI
or
PAIRA
n/a!/
No
—
—
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
TGAI
or
PAIRA
A, B
No
—
YesZ/
162-2 - Anaerobic Soil
TGAI
or
PAIRA
A
No
—
YesZ/
162-3 - Anaerobic Aguatic
TGAI
or
PAIRA
n/a5./
No
—
—
162-4 - Aerobic Aguatic
TGAI
or
PAIRA
n/aV
No
—
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TFTH
Data Requirement
Compos i t ionV Pattern?/
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)?V
§158.130 Envirornvental Fate
(continued)
MOBILITY STUDIES;
163-1 - Leaching and TGM or PAIRA
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION SHJDIES-FIELD:
164-1 - Soil
164-2 - Aguatic
164-3 - Forestry
164-4 - Combination and
Tank Mixes
TEP
TEP
TEP
TEP
TEP
A,B
N/Ai/
n/a!/
A,B
n/aY
N/A§/
N/Ai/
Partially^/
No
00099673
Yes
ty
Yes!/
164-5 - Soil, Long-term
TEP
n/aW
-------
TABLE A
GENERIC EftTA REQUIREMENTS FDR TPTH
Data Requirement
Use
Composition!/ Pattern?/
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)?!/
§158.130 Environmental Fate
(continued)
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
N/A11/
n/aV
A,B
N/A5'6/
No
No
YesZ/
Yes
§158.140 Reentry Protection
TEP
A, all/ No
YesZ/
-------
TABEE A
GENERIC DATA REQUIREMENTS FOR TPTH
§158.130 'Environmental Pate
(continued)
V Ccniposition: 1GAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = typical end-use product.
2/ The use patterns are coded as follows: A = Tferrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; 'E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Danestic
Outdoor; .1 = ilndoor
3/ Unless otherwise specified, data must be submitted no later than June 7, 1985.
V No data a^e required because TPTH has a low vapor pressure and low soil mobility.
5/ No data are required because there are no aquatic uses and no irrigation by furrow.
6/ Mobility tests are required for silt loam and sand to fulfill requirements for un-aged samples; aged samples must
, also be tested.
1
7/ Data must be submitted no later than December 7, 1985.
8/ No data are required because there are no forest uses.
9/ This standard addresses only a single ingredient.
10/ Required if total extractable residues exceed 50? of the initial application at the time of next application.
11/ Required when significant residues of concern are detected in the confined study test crops.
12/ An interim 2'4-hour reentry interval is required unless protective clothing is worn.
13/ Preliminary, incomplete data Indicate that the parent compound of TPTH does not leach appreciably; however, the
mobility in silt loam and sand, and the mobility of degradates, remains to be tested.
-------
TABLE A
GENERIC EftTA REQUIREMENTS FUR TPTH
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition!/ Patterns?/ No or Partially) Citation 3(c)(2)(B)?V
§158.135 Toxicology
ACUTE TESTING:
81-1 - Acute Oral Toxicity - Rat
TGAI
All
Yes
00083557
No
81-2 - Acute Dermal Toxicity
TGAI
All
Yes
00083560
No
81-3 - Acute Inhalation
Toxicity - Rat
TGAI
All
Yes
00083562
NO
81-4 - Primary Eye Irritation
TGAI
All
Yes
00088622
No
81-5 - Primary Dermal Irritation
TGAI
All
Yes
00124210
No
81-6 - Dermal Sensitization
TGAI
All
Partially
00124210
Yes
81-7 - Acute Delayed
Neurotoxicity - Hen
TGAI
N/A*>./
N/A
—
No
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding -
Rodent
Non-rodent (dog)
Non-rodent (guinea pig)
TGAI
TGAI
TGAI
A
A
A
Partially
Partially
Yes
00045837
00086514
00086548
00045831
00065167
00086467
YesV
YesV
No
82-2 - 21-Day Dermal
TGAI
A,IP
No
—
Yes
82-3 - 90-Day Dermal
TGAI
n/a!/
N/A
—
-
82-4 - 90-Day Inhalation
TGAI
A, IP1/
Partially
00124219
Yes®/
82-5 - 90-Day Neurotoxicity-
vv».n
TGAI
n/a£/
N/A
—
-
-------
TABLE A
GENERIC DftTA REQUIREMENTS POR TPTH
Use
Data Requirement Conpositionl/ Patterns^/
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)?V
§158.135 Toxicology (continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
Rodent (rat)
Non-rodent (dog)
83-2 - Oncogenicity Study -
Rat
Mouse
83-3 - Teratogenicity -
rat
hamster
83-4 - Reproduction -
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Genotoxic
Effects
SPECIAL TESTING:
85-1 - General Metabolism
- Immunotoxicity Studies
- Dermal Penetration
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
PAI or PAIRA
TGAI
TGAI
A
A
A
A
A,IP
A,IP
A
All
All
All
A
All
All
Partially
Partially
Partially
Partially
Partially
Yes
Partially
Yes
No
Partially
No
No
No
00046016
00080390
00080391
00046016
00080390
00125261
00086547
00094903
00094904
00086548
00086549
00086551
05016869
Yes?./
Yes?/
YesV
YesV
Yesi£/
No
Yes11/
No
Yesi2/
Ye si?/
Yesl_V
Yes14/
YesJ_V
-------
TAB EE A
GENERIC DATA REQUIREMENTS FOR 1P1H
1/ Composition: Material to be tested is technical grade unless otherwise specified in footnotes. PAI= Pure Active
-Ingredient. PAIRA= Pure Active .Ingredient, Radio-labeled.
2/ The use patterns are coded as follows: A = Tferrestrial, Pood Crop; B = Ibrrestrial, Non-Pood; C = Aquatic, Pood Crop;
D = Aquatic, Non-Pood; 'E = Greenhouse, Food Crop; P = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor;
J = ,Indoor; ,IP = .Industrial Preservative.
3/ Unless otherwise specified, data must be submitted no later than June 7, 1985.
¥/ .Initiation of a chronic feeding study with rodents and submission of an acceptable interim report will eliminate this
requirement. Otherwise, data must be submitted no later than February 7, 1986.
5/ The dog 100-day study was done by .IBT, and has not been validated. .Initiation of a chronic feeding study with dogs
and submission of an acceptable interim report will eliminate the requirement for a 90-day study with dogs. Otherwise,
data must be submitted no later than February 7, 1986.
6/ Data are not required.
7/ The requirement for a 90-day inhalation study relates to the acute inhalation toxicity of this chemical.
¥/ Additional information related to the 90-day inhalation study was requested of the registrant. No reply has been
received. The requested data must be submitted by June 7, 1985. 'If new studies must be run, the results must be
submitted by February 7, 1986.
9/ Where the Agency has requested clarification or explanation of a prior study, such information must be provided no
later than June, 7 1985. 'If new studies must be run, the results must be submitted by December 7, 1988.
10/ The Tbxicology Branch (Hazard 'Evaluation Division) is waiting for the registrant to provide an acceptable defense for
establishing a NOEL for teratogenic/fetotoxic effects in rat fetuses. Such information must be provided by June 7,
1985. 'If new studies must be run, the results must be submitted by December 7, 1985. The Agency will also require
^ postnatal teratology study on rats by gavage, a teratology study on rabbits by gavage, and, depending on the results
of these two studies and the results of the dermal penetration study, may also require a teratology study using the
dermal route of administration. The results of the first two studies must be submitted by December 7, 1985.
11/ Data must be submitted no later than September 7, 1986.
12/ Data must be submitted no later than September 7, 19%5.
13/ Data must be submitted no later than March 7, 1986.
T¥/ Additional data are required to support continued registration of this chemical; data must be submitted no later
than January 7, 1986.
15/ Data must be submitted no later than June 7, 1985.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TPTH
Data Requirement
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Coirpositioni/ Pattern?/ no or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?!/
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Acute Oral Toxicity TGAI
GJ
vo
71-2 - Avian Dietary Toxicity
Waterfowl
Upland Gamebird
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
TGAI
TEP
TEP
TGAI
TGAI
TGAI
TEP
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Acute
Toxicity TGAI
Wannwater Fish
Coldwater Fish
72-2 - Acute Toxicity to TGAI
Freshwater Invertebrates
A,B
A,B
A,B
A,B
A,B
N/A§/
A,B
A, B
A,B
A,B
A,B
Yes
Partially
No
Partially
No
Partially
No
Yes
Partially
Yes
001252741/
00125274-5./
00099092V
000864865/
000990931/
000865731/
000865741/
GSO280261/
000865741/
001252741/
GSO280261/
No
Yes
Yes 6/
Reserved!./
Yes
Yesi/
Reserve d!2./
No
Yes
No
-------
TABLE A
GENERIC EATA REQUIREMENTS FOR TFTH
Use
Data Requirement Composition!/ Pattern?/
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)?!/
§158.145 Wildlife and Aquatic Organisms (continued)
72-3 - Acute Toxicity to TGAI
Estuarine and Marine Organisms
a. Shrimp
b. Marine Fish
c. Oyster
72-4 - Fish Early Life TGAI
Stage and Aquatic
Invertebrate Life-Cycle
a. Fish
b. Aguatic Invertebrate
72-5 - Fish - Life-Cycle TGAI
72-6 - Aguatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing -
&juatic Organisms
TGAI, PAI or
Degradation
Product
TEP
A,B
A,B
A,B
A,B
A,B
A,B
N/A§/
A,B
Partially
Partially
Partially
Yes
Yes
No
Partially
000966331/
000966321/
00096634V
001252741/
001252741/
000865781/
000865791/
000865811/
No
No
No
NO
No
Reserved11/
Reserved^1/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TPTH
§158.145 Wildlife And Aquatic Organisms (continued)
1/ Corposition: 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; C = Aquatic, Food
Crop; D = Aguatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic
Outdoor; I = Indoor
3/ Unless otherwise specified, data mast be submitted no later than June 7, 1985.
4/ Study fulfills Guideline requirements.
5/ Study must be combined with other studies to fulfill Guideline requirements.
6/ Avian dietary study on waterfowl with formulated product is required because when the technical product was used,
the test birds would not eat the test diet in sufficient quantities to produce a valid test result. Apparently
the technical material is extremely unpalatable.
7/ Reserved pending avian dietary results frcm test on technical.
8/ Not applicable at this time.
9/ Avian reproduction studies are required because repeat applications are allowed on all uses and half-life on soil
is over 180 days. Hie results of this study must be submitted no later than June 7, 1986.
10/ Reserved pending results frcm avian dietary reproduction tests and pertinent environmental fate studies.
11/ Reserved pending results from acute coldwater fish test and pertinent environmental fate studies.
-------
TABLE A
GENERIC mTA REQUIREMENTS FDR TPTH
Use
Data Requirement ConpositionV Pattern?/
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)?V
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
Pollinators:
141-1 - Honey bee acute TGAI
contact toxicity
141-2 - Honey bee - toxicity of TEP
residues on foliage
141-4 - Honey bee subacute [Reserved]V
feeding study
141-5 - Field testing for TEP
pollinators
A,B Yes 00018842 No
A, B No - No!/
A,B No - No!/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR TPTH
Use
Data Requirement Composition!/ Pattern?/
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)?V
§158.155 Nontarget Insect (continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to
aquatic insects
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1- NONTARGET INSECT TESTING
thru PREDATORS AND PARASITES
143-3
[Reserved] §/
[Reserved] 6/
[Reserved] §/
[Reserved ].£/
1/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use pattern codes are as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop;
D = Aguatic, 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 June 7, 1985.
4/ Because acute contact test showed low toxicity to honey bees, no further testing is required.
5/ Reserved pending development of test methodology.
6/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This Section 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.
44
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING TFTH
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition!/ No or Partially) Citation 3(c)(2)(B)?2/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of the MP
Manufacturing Process
61-3 - Discussion of Formation MP
of Unintentional Ingredients
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods and Data MP
for Enforcement of Limits
Yes 00083551 No
Partially 00083551 Yes!/
Partially 00083551 Yes3/
Partially 00083551 Yesl/
No — Yes
Partially 00030265 Yes!/
00086487
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING TPTH
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requiremsnt Composition!./ No, Partially) Citation 3(c) (2) (B) ?2/
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
63-7 - Density, Bulk Density, or MP
Specific Gravity
63-12 - pH MP
63-14 - Oxidizing/Reducing Action MP
63-15 - Flammability MP (for
combustible
liquid only)
63-16 - Explodability MP
63-17 - Storage stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP (for
emulsifiable
liquid produ'
Yes 00083551 No
Yes 00083551 No
Yes 00083551 No
No — Yes
Yes 00083551 No
No — Yes
N/A — No
No — Yes
No — Yes
N/A — No
N/A — No
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING TPTH
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition!/ No or Partially) Citation 3(c)(2)(B)?2/
§158.120 Product Chemistry
(continued)
63-20 - Corrosion MP No — Yes
1/ Composition: MP = Manufacturing-use product; Choice = Choice of several test substances determined on a case-by-case
basis.
2/ Data must be submitted no later than June 7, 1985 unless otherwise specified.
3/ Updated information is needed from all manufacturers/registrants.
4/ Validation data is requested from all manufacturers/registrants.
-------
IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies to end-use products only to the
extent described under Section II of this document. Otherwise,
the following information pertains exclusively to manufacturing-
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.
If owners of currently registered products fail to submit
revised labeling and packaging information complying with this
Section and/or Section II, EPA may issue a notice of intent to
cancel the registration under FIFRA §6(b)(l).
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
48
-------
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.
49
-------
Size of Label
on Front Panel
In Square Inches
Signal Word as Re-
quired Minimum Type
Size All Capitals
"Keep Out of Reach
of Children"
as Required
above 5 to 10
above 10 to 15
above 15 to 30
over 30
5 and under
6 point
10 point
12 point
14 point
18 point
6 poi nt
6 point
8 point
10 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 7C. SKULL & CR0SSB0NES 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)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. 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
(h)(2)]
50
-------
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
§162.10(h)(2 ) (ii )]
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-flammability. 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).
51
-------
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
precauti on.
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. PRODUCT CLASSIFICATION: CLASSIFICATION
LABELING REQUIREMENTS AND COMPLIANCE SCHEDULE -
Section 3(d) of FIFRA requires that all pesticide
formulations/uses be classified for either general or
restricted use, and that those uses classified as restricted
be limited to use by certified applicators or persons
under their direct supervision (or subject to such other
restrictions as may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses to be restricted, based either
on a previous classification determination made through
the optional procedures of 40 CFR 162.30 or based on data
already available to the Agency, or (2) indicated certain
formulations/uses to be urestricted, based on data already
available to the Agency, or (3) reserved any classification
decision until appropriate short-term data are submitted.
Uses have not been classified for general use at this
time because such a decision requires an evaluation of
chronic data, most of which has yet to be generated.
The product-specific data required by the standard should
be used by each registrant to make a classification
determination following the criteria of 40 CFR 162.11(c)
(Appendix V-4). The draft label(s) submitted to the
Agency as part of your application should reflect this
determination, and must be consistent with the terms of
40 CFR 162.10 and this guidance package with respect to
label language and format for restricted use products.
(No label changes with respect to classification are
required for products with unrestricted uses.) The
rationale supporting a classification proposal by the
52
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registrant that differs from a classification determination
found in the Standard should be submitted with your
application.
During the Agency's review of your application, your
proposed classification determination will be evluated
in accordance with the provisions of 162.11(c). You
will be notified of the Agency's classification evaluation.
A. Classification Labeling Requirements
1. Unrestricted uses - no label changes with
respect to a classification statement are
necessary for those formulations/uses that
are unrestricted.
2. Restricted uses - Pesticide products bearing
directions for use for formulations/uses
classified restricted shall bear statements
of restricted use classification on the front
panel as described below:
a. Front panel statement of restricted use
classification.
i. At the top of the front panel of the
label, set in type of the same minimum
sizes as required for human hazard
signal words (see table in 40 CFR
162.10(h)(1)(iv), and appearing with
sufficient prominence relative to
other text and graphic material on
the front panel to make it unlikely
to be overlooked under customary
conditions of purchase and use, the
statement "Restricted Use Pesticide"
shall appear.
ii. Directly below this statement on the
front panel, a summary statement of
the terms of restriction shall appear.
If use is restricted to certified
applicators, the following statement
is required: "For retail sale to and
use only by Certified Applicators or
persons under their direct supervision
and only for those uses covered by the
53
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Certified Applicator's Certification."
If, however, other regulatory restric-
tions are imposed, the Administrator
will define the appropriate wording
for the terms of restriction by
regulation.
3. Some But Not all Uses Restricted - If you
determine that some uses should be classified
RESTRICTED and some uses should be unrestricted,
several courses of action detailed below are
available:
i. You may delete all RESTRICTED uses and
submit a draft label of the registration
of your product to reflect only those
uses that are unrestricted.
ii. Unrestricted uses may appear on a RESTRICTED
label, but not vice versa. Therefore ,
you have the option of using a RESTRICTED
USE label bearing all of your directions
for use. If you choose this option, you
may not distinguish those uses that are
not restricted from those which are RESTRICTED.
iii. You may register two separate products
with identical formulations, one containing
only unrestricted uses, and the other
RESTRICTED uses. To do so, submit two
applications for reregistration, each
containing all forms and necessary labels.
Both applications should be submitted
simultaneously. Note that the product
names will be assigned separate registration
numbers.
B. Compliance Schedules
1. Unclassified uses - None.
2. Restricted uses - The compliance schedule for
restricted use products is as follows:
54
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No product with a use classified for restricted use under
this Standard may be released for shipment by the registrant
or producer after one year from the date of issuance of
this Standard, unless such product bears the restricted-
use classification. All products still in channels of
trade after two years from the date of issuance of this
Standard must be labeled for restricted use.
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.
55
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Product Manager 21 (Henry M. Jacoby)
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency-
Washington, D.C. 20460
Telephone: 703/557-1900
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 0570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III-1).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms
to the requirements of this guidance document and the
results of the short-term data, the registrant may
submit such labeling. (End-use product labeling
needs to comply specifically with the instruction in
Section II of this guidance document.) The labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for
stortage in 8-1/2 x 11 inch files. The draft label
must indicate the intended colors of the final label,
clear indication of the front panel label, and the
intended type sizes of the text.
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.
After the Supreme Court has ruled on the Monsanto Decision,
you will be informed as to when you must submit your Application
for Amended Pesticide Registration (EPA Form 8570-1) and the
associated data support information.
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APPENDIX II-l
Guide to Use of This Bibliography
1. Content of Bibliography: This bibliography contains citations of all the
studies reviewed by EPA in arriving at the positions and conclusions stated
elsewhere in the Standard. The bibliography is divided into two sections:
(1) citations that contributed information useful to the review of the chemical
and that are considered to be part of the data base supporting registrations
under the Standard, and (2) citations examined and judged to be inappropriate
for use in developing the Standard. This second part of the bibliography
exists in the Agency's files and does not accompany this Standard. Interested
parties may request a copy from the Agency. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its
predecessor agencies in support of past regulatory decisions, and the published
technical literature.
2. Units of Entry: The unit of entry in this bibliography is called a "study".
In the case of published materials, this-corresponds closely to an article.
In the case of unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the published
article from within the typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be described with a
conventional bibliographic citation. The Agency has attempted also to unite
basic documents and commentaries upon them, treating them as a single study.
3. Identification of Entries: The entries in this bibliography are sorted by
author, date of the document, and title. Each entry bears, to the left of the
citation proper, an eight-digit numeric identifier. This number is unique to
the citations, and should be used at any time specific reference is required.
This number is called the "Master Record Identifier", or "MRID". It is not
related to the six-digit "Accession Number" which has been used to identify
volumes of submitted data; see paragraph 4(d)(4) below for a further
explanation. In a few cases, entries added to the bibliography late in the
review may be preceded by an eight-character temporary identifier. This is
also to be used whenever specific reference is needed.
57
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4. Form of the Entry: In addition to the Master Record Identifier (MRID),
each entry consists of a bibliographic citation containing standard elements
followed, in the case of materials submitted to EPA, by a description of the
earliest known submission. The bibliographic conventions used reflect the
standards of the American National Standards Institute (ANSI), expanded to
provide for certain special needs. Some explanatory notes of specific
elements follow;
a. Author: Whenever the Agency could confidently identify one, the
Agency has chosen to show a personal author. When no individual was
identified, the Agency has shown an identifiable laboratory or
testing facility as author. As a last resort, the Agency had shown
the first known submitter as author.
b. Document Date: When the date appears as four digits with no question
marks, the Agency took it directly from the document. When a four
digit date is followed by a question mark, the bibliographer deduced
the date from evidence in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of
the document.
c. Title: This is the third element in the citation. In some cases it
has been necessary for Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between
square brackets.
d. Trailing Parentheses: For studies submitted to the Agency in the
past, the trailing parentheses include (in addition to any self-
explanatory text) the following elements describing the earliest
known submission:
(1) Submission Date: Immediately following the word 'received'
appears the date of the earliest known submission.
58
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(2) Administrative Number: The next element, immediately following
the word 'under1, is the registration number, experimental
permit number, petition number, or other administrative number
associated with the earliest known submission.
(3) Submitter: The third element is the submitter, following the
phrase 'submitted by'. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification: The final element in the trailing
parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six
digit accession number follows the symbol 'CDL', standing for
"Company Data Library". This accession number is in turn
followed by an alphabetic suffix which shows the relative
position of the study within the volume. For example, within
accession number 123456, the first study would be 123456-A; the
second 123456-B; the 26th, 123456-Z, and the 27th 123456-AA.
59
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00018842 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-501.
(Unpublished study received May 8, 1971 under 1F1174; Prepared by
Univ. of California — Riverside, Dept. of Entomology, submitted
by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-8)
00029834 Cannizzaro, R.D. (1979) Determination of Triphenyltin Hydroxide Re-
sidues in Rough Rice by Gas Chromatography/Mass Spectrometry Promim.
Method no. 28 dated Feb. 26, 1979. (Unpublished study received Mar 28,
1980 under 0F2340; submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL:099345-B)
00029835 Cannizzaro, R.D. (1979) Determination of Triphenyltin hydroxide Re-
sidues in Rice Process Fractions (Brown Rice, White Rice, Hulls, Bran,
Polishings, and Straw) by Gas Chromatography/Mass Spectrometry Promim.
Method no. 31 dated Feb 28, 1979. (Unpublished study received Mar 28,
1980 under 0F2340; submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL:099345-C)
00030250 Ackerman, M.E.; Granata, S.V.; Tapprich, B. (1976) The Determination
of Carbon-14 Labeled Residues Due to TPTH following Oral Administration
of Rice Foliage Containing Residues from the labeled Fungicide to
Lactating Goats: ADC Project if270. (Unpublished study received Mar 28,
1980 under 0F2340; prepared by Analytical Development Corp., submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099343-A)
00030251 Moring, S.; Nye, D. (1978) Identification of 14C-TPTH'Residues in
Weathered Rice Folage and Their Bioavailability to Rats Via Single
Oral Dose: Project 780316. Final Rept. (Unpublished study received Mar 28,
1980 under 0F2340; prepared by Stoner Laboratories, Inc., submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099343-B)
00030252 Granada, S.V.; Mulkey, N.S. (1976) Metabolism and Residue Method
Development for TPTH in Rice and Soybeans: ADC Project f1/221.
(Unpublished study received Mar 28, 1980 under 0F2340; prepared by
Analytical Development Corp., submitted by Thompson-Hayward Chemical
Co., Kansas City, Kans.; CDL:099343-C)
-------
00030252 -vargo, J.P., Jr.; Wilkes, L.C.; Mulkey, N.S. (1977) Fate of 14C-
Triphenyltin hydroxide (Du-ter) following Application to Rice: ADC
Project #221. Includes methods dated Jun 27, 1977. (Unpublished
study received Mar 28, 1980 under 0F2340; prepared by Analytical Develop-
ment Corp., submitted by Thompson-Hayward Chemical Co., Kansas City,
Kans.; CDL:099343-D)
00030254 Danhaus, R.G. (1976) Field Metabolism and Environmental Study—1976
(Rice Treated with 14C-TPTH): ADC Project #278. (Unpublished study
received Mar 28, 1980 under 0F2340; prepared by Analytical Development
Corp., submitted by Thompson-Hayward Chemical Co., Kansas City,
Kans.; CDL:099343-E)
00030259 Thompson-Hayward Chemical Company (1970) Fentin acetate; Fentin
chloride; Fentin hydroxide. (Unpublished study received Mar 28, 1980
under 0F2340; prepared in cooperation with Farbwerke Hoechst, A.G. ,
N.V. Philips-Duphar and National Institute of Public Health, Plant
Protection Service; CDL:099342-A)
00030265 Douglas, G. (1978) Assay Method for Triphenyltin hydroxide in Tech-
nical and Formulated Products. Method No. A-93 dated Jan 13, 1978.
(Unpublished study received Mar 28, 1980 under 0F2340; submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.j CDL:099342-G)
00030272 Cannizzaro, R.D. (1979) Determination of Triphenyltin hydroxide Res-
idues in Irrigational Crops (Wheat, Barley, Kidney Beans, Radish
Tops, Beet Tops, Swiss Chard, Radishes) by Gas Chromatography/Mass
Spectrometry Promim. Method no, 30 dated Feb 28, 1979. (Unpublished
study received Mar 28, 1980 under 0F2340; submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL:099345-E)
00030309 Danhaus, R.G. (1976) Field Metabolism and Environmental Study—1976
(Soybeans Treated with 14C-TPTH): ADC Project #278. (Unpublished
study received Mar 28, 1980 under 0F2340; prepared by Analytical
Development Corp., submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL:099344-D)
61
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00030310 Danhaus, R.G. (197 6) Field Metabolism and Environmental Study—197 6
(Soybeans Treated with 113 Sn-TPTH): ADC Project #290. (Unpublished
study received Mar 28, 1980 under 0F2340; prepared by Analytical
Development Corp., submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL:099344-E)
00030311 Danhaus, R.G. (1977) Field Metabolism and Residual Behavior of Radio-
labeled Triphenyltin hydroxide in Soybeans: ADC Project //278/290.
(Unpublished study received Mar 28, 1980 under 0F2340; prepared by
Analytical Development Corp., submitted by Thompson-Hayward Chemical
Co., Kansas City, Kans.; CDL:099344-F)
00030313 Smith, K.S.; Merricks, D.L. (1976) Triphenyltin hydroxide Tissue
Residue and Metabolism Study in Poultry. (Unpublished study received
Mar 28, 1980 under 0F2340; prepared by Cannon Laboratories, Inc.,
submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:099344-H)
00030315 Smith, K.S.; Merricks, D.L. (1977) Triphenyltin hydroxide Metabolism
in Dairy Cows. (Unpublished study received Mar 28, 1980 under 0F2340;
prepared by Cannon Laboratories, Inc., submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL:099344-J)
00030316 Moring, S.; Nye, D.E. (1978) Structure Elucidation of 14C-Labeled
Residues in Tissues of a Cow Exposed to 14C-TPTH for Nine Days:
Project #771672. Final rept. (Unpublished study received Mar 28, 1980
under 0F2340; prepared by Stoner Laboratories, Inc., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099344-K)
00036021 Thompson-Hayward Chemical Company (1972) Clean-Up Procedure for the
Colorimetrie Residue Determination of Triphenyltin Compounds in Rice.
Method no. A-128-A dated Mar 24, 1972. (Unpublished study received May 3,
1973 under 3G1393; CDL: 095436-J)
62
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00036027 Thompson-Hayward Chemical Company (1973) Determination of Triphenyltin
hydroxide as Inorganic Tin in Pre-cleaned Residues. Method no. A-77 D
dated Apr 4, 1973. (Unpublished study received May 3, 1973 under 3G1393;
CDL:095436-Q)
00036029 Thompson-Hayward Chemical Company (1973) Confirmation of Triphenyltin
hydroxide in Milk by Thin Layer Chromatography. Method no. A-332 dated
Mar 29, 1973. (Unpublished study received May 3, 1973 under 3G1393;
CDL:095436-R)
00045831 Baran, J. (1966) Report to Thompson-Hayward Chemical Company: 100-Day
Subacute Oral Toxicity of Technical Triphenyl tin hydroxide—Beagle
Dogs: IBT No. C4343. (Unpublished study received Dec 2, 1966 under
unknown admin, no.; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:109464-A)
00045837 Wolf, C. (1966) Report to Thompson-Hayward Chemical Company: 90-Day
Subacute Oral Toxicity of Triphenyltin hydroxide—Albino Rats:
IBT No. 84634. (Unpublished study received Dec 29, 1966 under
unknown admin, no.; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Thompson-Hayward Chemical Co., Kansas City,
Kans.; CDL:109459-A)
00046016 Til, H.P. (1966) Long-Term Feeding Studies with Triphenyltinhydroxide
(TPTH) in Albino Rats; Progress Report: Report No. R-2295. (Unpublished
study received Nov 22, 1966 under unknown admin, no., prepared by
Central Institute for Nutrition and Food Research, submitted by ?;
CDL:109466-A)
00053415 Bruggemann, J.; Barth, K.; and Niesar, K.H. (1964) Experimental Studies
Of The Occurence of Triphenyltin-acetate Residues in Beet Leaves, Beet
Leaf Silage, Animals Fed Therewith and Their Excretion Products.
(Unpublished study submitted Feb 7, 1968 under 8F0700 by Thompson-
Hayward Chemical Co., Kansas City, Kans.; CDL:105279-B)
63
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00065167 Baran, J. (1966) Report to Thompson-Hayward Chemical Company: 90-Day
Subacute Oral Toxicity of Technical Triphenyl Tin Hydroxide—Beagle
dogs: IBT-C3964. (Unpublished study received Mar 17, 1966; Mar 29,
1966 under unknown admin, no.; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Thompson-Hayward Chemical Co.,
Kansas City, Kans.; CDL:109460-A)
00080381 Herok, J.; and Gotte, H. (1964) Radiometric Metabolic Balance Studies
With Triphenyltinacetate (TPTA) In The Milk Sheep" (Unpublished study
submitted Feb 7, 1968 under 8F0700 by Thompson-Hayward Chemical Co.,
Kansas City, Kans.; CDL:091218-F)
00080383 Thompson-Hayward Chemical Company (1968) The Results of Tests on
the Amount of Residue Remaining, Including a Description of
Analytical Method. Summary of Studies 091218-1 and 091218-L.
(Unpublished study received Feb 7, 1968 under 8F0700; CDL:091218-H)
00080384 Upton, E.T. (1967) Residue Analysis of Peanuts Treated with Du-ter
Fungicide: Report No. R-650. (Unpublished study received Feb 7, 1968
under 8F0700; submitted by Thompson-Hayward Chemical Co., Kansas City,
Kans.; CDL:091218-I)
00080387 Thompson-Hayward Chemical Company (1968) Detection of Triphenyltin
Compounds in Peanuts by Thin Layer Chromatography. Method no.
A-184 dated Jan 24, 1968. (Unpublished study received Feb 7, 1968
under 8F0700; 091218-L)
00080390 Til, H.P.; Feron, V.J.; Dr Groot, A.P. (1970) Chronic Toxicity
Study with Triphenyltinhydroxide in Rats for Two Years: Rapport
No. R-3138. (Unpublished study received on unknown data under
8F0700; prepared by Centraal Instituut voor Voedingsonderzoek,
Netherlands, submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL:091218-0)
64
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00080391 Til, H.P.; Feron, V.J. (1968) Chronic (Two-year) Toxicity Study
with Triphenyltinhydroxide (TPTH) in Beagle Dogs: Rapport No.
R-2717. (Unpublished study received on unknown date under 8F0700;
prepared by Centraal Instituut voor Voedingsonderzoek, Netherlands,
submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:091218-P)
00083551 Thompson-Hayward Chemical Company (1979) General Chemistry: Duter
(R) Fungicide. (Unpublished study received Oct 18, 1979 under
148-689; CDL:099046-A)
00083557 Cooper, D.; Terrell, Y. (1978) Acute Oral LD50: Laboratory No. 7E-
8297. (Unpublished study received Oct 18, 1979 under 148-689;
prepared by Cannon Laboratories, Inc., submitted by Thompson-
Hayward Chemical Co., Kansas City, Kans.; CDL:099049-B)
00083560 Imlay, P. (1978) Acute Dermal LD50: Laboratory No. 7E-8289. (Unpub-
lished study received Oct 18, 1979 under 148-689; prepared by
Cannon Laboratories, Inc., submitted by Thompson-Hayward Chemical
Co., Kansas City, Kans.; CDL:099049-F)
00083562 Davidson, D.; Cannon, L.; Taylor, B., Jr. (1978) Acute LC50 Inhalation
Study of Technical TPTH: Laboratory No. 7E-8305. (Unpublished study
received Oct 18, 1979 under 148—689; prepared by Cannon Laboratories,
Inc., submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:099049-J)
00086450 Stewart, T. (1979) Determination of Triphenyltin Hydroxide Residues
in Soybeans and Soybean Folinage by Gas Chromatography/Mass Spectrometry
PROMIN. (programmable Multiple Ion Monitoring). Analytical method no.
29 dated Sep 5, 1979. (Unpublished study received Oct 18, 1979 under
148-689; submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:099056-B)
65
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00086452 Thompson-Hayward Chemical Company (1979) Determination of Triphenyltin
Hydroxide Residues in Soybean Processe Fractions (Meal, Hulls, Soapstock,
Oils) by Gas Chromatograp'ny/Mass Spectrometry PROMIN (Programmable
Multiple Ion Monitoring). Analytical method no. 34 dated Sep 5, 1979.
(Unpublished study received Oct 18, 1979 under 148-689; CDL:099056-D)
00086459 Wargo, J.P., Jr.; Mulkey, N.S.; Wilkes, L.C.; et al. (1977) Fate of
14C-triphenyltin Hydroxide (Du-ter) following application to Soybeans:
ADC Project #221: Phase Two. (Unpublished study received Oct 18, 1979
under 148-689; prepared by Analytical Development Corp., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099048-B)
00086467 Verschuuren, H.G.; Kroes, R.; Van Esch, G.J. (1965) Semi-chronic
Investigation as to the Toxicity of Triphenyltinhdroxide in Guinea
Pigs: Report No. 33/65 Tox. (Unpublished study received Oct 18,
1979 under 148-689; prepared by National Institute of Public Health,
Dept. of Biological Toxicology, The Netherlands, submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099050-C)
00086472 Thompson-Hayward Chemical Company (1969) Analytical Method for
Formulations Containing Triphenyltin Hydroxide. Method A-93-A dated
Oct 13, 1969. (Unpublished study received Aug 25, 1972 under 3F1315;
CDL:094302-C)
00086473 Logan, W.K. (1970) Supplemental Triphenyltin Hydroxide (TPTH) Residue
Anaylsis of Peanuts: Report No. R 852. Includes method nos. A197D
dated Oct 22, 1970. A 136 D dated Nov 20, 1970 and A 77 B dated Oct
15, 1970. (Unpublished study received Ja.n 12, 1970 under 8F0700;
submitted by Thompson-Hayward Chemical Co., Kansas City, Kans.;
CDL:096449-A)
00086486 Taylor, R.E. (1966) Letter sent to Edwin T. Upton dated Jul 11, 1966
Acute oral toxicity studies with Du-ter W-50—bobwhite quail.
(Unpublished study, including letter dated Aug 26, 1966 from R.E.
Taylor to Edwin T. Upton, received Jul 11, 1966 under unknown admin,
no.; prepared by Harris Laboratories, Inc., submitted by Thompson-
Hayward Chemical Co., Kansas City, Kans.; CDL:132246—A)
66
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00086487 Thompson-Hayward Chemical Company (1965) Analytical Metric Tri-
phenyltin hydroxide and Its Formulations. Method no. A-40 dated
Apr 9, 1965. (Unpublished study received Apr 20, 1965 under 148-689;
CDL:119188-B)
00086492 Thompson-Hayward Chemical Company (1965) Du-ter Residues in Potatoes.
Summary of studies 122620-B and 122620-C. (Compilation; Unpublished
study received Jan 27, 1652 under unknown admin, no.; CDL:122620-A)
00086493 Herok, J.; and H. Gotte. (1963) Radiometric Investigations of the
Behavior of Triphenyltin Acetate in Plants and Animals. (Submitted
June 6, 1966 under 496 by Thomson-Hayward. CDL:090570-M)
00086494 Houtman, A.C.; De Wilde, P.C.; De Vries, C. (1964) Residues Investigatioi
of Triphenyltin Sn 113 in Potato Plants: Report nos. 56646/5/64;
56655/55/64; 56656/52/64. (Unpublished study received Jan 27, 1965
under unknown admin, no.; submitted by Thompson-Hayward Chemical Co.,
Kansas City, Kans.; CDL:122620-C)
00086514 Verschuuren, H.G.; Van Esch, G.J.; Arnoldussen, A. (1962) Semi-chronic
Investigation as to the Toxicity of Triphenyltinhydroxide in rats:
Report No. Tox. 161/62. (Unpublished study received Jul 31, 1967
under 6F0496; prepared by National Institute of Public Health, The
Netherlands submitted by Thompson-Hayward Chemical Co., Kansas City,
Kans.; CDL:090570-B)
00086534 Thompson-Hayward Chemical Company (1967) Detection of Triphenyltin
Hydroxcide in Potatoes by Thin Layer Chromatography. Method no. A-154
dated Nov 22, 1967. (Unpublished study, including method A-154 dated
Jul 21, 1967 and letters dated Jul 21, 1967 from L.S. Da Atley to
James B. Lamb; Oct 6, 1967 and Nov 22, 1967 from E.T. Upton to Bart
Puma, received Nov 27, 1967 under 6F0496; CDL:092784—A)
00086544 Logan, W.K. (1972) Triphenlytin Hydroxide (TPTH) Residues Analysis
of Carrots Treated with Du-ter (R) Fungicide: Report No. R-902.
(Unpublished study received Aug 22, 1972 under 3F1315; CDL:094301-E)
67
-------
00086545 Thompson-Hayward Chemical Company (1972) Detection of Triphenyltin
Compound in Carrots and Onions by Thin-layer Chromatography. Method
No. A-303 dated May 9, 1972. (Unpublished study received Aug 22,-1972
under 3F1315; CDL:094301-H)
00086547 Ravert, J.; Parke, G.S.E. (1976) Investigation of Teratogenic and
Toxic Potential of Technical Triphenyltin Hydroxide: Laboratory
No. 6E-524. (Unpublished study received Oct 18, 1979 under 148-689;
prepared by Cannon Laboratories, Inc., submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL:099051-A)
00086548 Til, H.P.; Feron, V.J.; De Groot, A.P. (1967) Reproduction Study with
Triphenyltinhydroxide in Three Generations of Rats: Rapport No. R-2476.
(Unpublished study received Oct 18, 1979 under 148-689; prepared by
Centraal Instituut voor Voedingsonderzoek TN0, The Netherlands, sub-
mitted by Thompson-Hayward Chemical C., Kansas City, Kans.; CDL:099052-A)
00086549 Til, H.P.; Feron, V.J.; De Groot, A.P. (1968) Observations on a Possible
Effect of TPTH on Testicular Development in Rats: Rapport No. R-2620.
(Unpublished study received Oct 18, 1979 under 148-689; prepared by
Centraal Instituut voor Voedingsonderzoek TNO, The Netherlands, submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099052-B)
00086551 Bryant, H.E. (1976) Screening Triphenyl Tin Hydroxide (Alfa 71117)
in the Ames Salmonella typhimurium Mutagenicity Assay, (Unpublished
study received Oct 18, 1979 under 148-689; submitted by Thompson-
Hayward Chemical Co. Kansas City, Kans.; CDL:099052-D)
00086552 Smith, K.S. (1976) Triphenyl Tin Hydroxide Tissue: Residue and Metabolism
Study In Poultry: Laboratory No. 5E-5493. (Unpublished study received Oct 18,
1979 under 148-689; prepared by Cannon Laboratories, Inc., submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099052-E)
00086553 09901207S. (1976) Triphenyl Tin Hydroxide Tissue: Residue and Metabolism
Study in Swine: Laboratory No. 5E-5492. (Unpublished study received Oct 18,
1979 under 148-639; prepared by Cannon Laboratories, Inc., submitted
by Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099052-F)
68
-------
00086554 Smith, K.S. (1977) Triphenyl Tin Hydroxide Metabolism in Dairy Cows:
Laboratory No. 6E-529. (Unpublished study received Oct 18, 1979 under
148-689; prepared by Cannon Laboratories, Inc., submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL:099052-G)
00086556 Thompson-Hayward Chemical Company (1970) Summary of TPTH Residue Analysis—
Peanuts. (Unpublished study received Apr 7, 1971 under 9F0841; CDL:091451-A)
00086560 Thompson-Hayward Chemical Company (19??) Summary: Triphenyltin Hydroxide.
(Unpublished study received Jul 18, 1968 under 9F0841; CDL:091451-F)
00086561 Thompson-Hayward Chemical Company (196 9) Detection of Triphenyltin Compound
in Sugar Beets by Thin Layer Chromatography. Method no. A-217 dated
Mar 3, 1969. (Unpublished study received on unknown date under 9F0841;
CDL:091451-H)
00086569 Thompson-Hayward Chemical Company (1969) Clean-Up Procedure for the
Colorimetric Residue Determination of Triphenyltin Compounds in Sugar
Beets and Sugar Process Samples. Method no. A-74 dated Feb 14, 1969.
(Unpublished study received Jun 2, 1969 under 9F0841; CDL:093544-J)
00086571 Thompson-Hayward Chemical Company (1970) Clean-Up for the Colorimetric
Residue Determination of the Triphenyltin Hydroxide in Meat, Fat and
Meat Byproducts. Method no. A-197-C dated Jan 7, 1970. (Unpublished
study received Jn 12, 1970 under 9F0841; CDL:091451-O)
00086573 Fink, R. (1975) Final Report: Two-generation Reproduction Study—
Mallard Duck: Triphenyltin Hydroxide (TPTH): Project No. 116-101.
(Unpublished study received Oct 18, 1979 under 148-689; prepared
by Truslow Farms, Inc., submitted by Thompson-Hayward Chemical Co.
Kansas City, Kans.; CDL:099053)
69
-------
00086574 Reinert, H.K.; Parke, G.S.E. (1975) Static 96 Hour Toxicity Study
of Thompson Hayvard Chemical Company Sample TH-TPTH in Bluegill
Sunfish, Rainbow Trout and Fathead Minnows: Laboratory Nos. 5E-
6443-A through C. (Unpublished study received Oct 18, 1979 under 148-689;
prepared by Cannon Laboratories, Inc., submitted by Thompson-Hayward
Chemical Co. Kansas City, Kans.; CDL:099053-G)
00086578 Grigarick, A.A.; Benson, J.M.; Way, M.O. (1977) Effect of Du-ter on
Invertebrates Found in a Rice Field and Its Drain Ditch. (Unpublished
study received Oct 18, 1979 under 148-689; prepared by Univ. of
California — Davis, Entomology Dept. , submitted by Thompson-Hayward
Chemical Co., Kansas City, Kans.; CDL:099053-K)
00086579
Butte County (California), Mosquito Abatement District (1976) Effect
of a Du-ter Treatment for Gambusia affinis in Rice, (Unpublished
study; CDL:099053-L)
00086581 Grigarick, A.A.; Meyer, R.P.; Zalom, F.G. (1977) Effect of a Du-ter
Treatment on Aquatic Invertebrates in Rice Paddies, 1977. (Unpublished
study received Oct 18, 1979 under 148-689; prepared by Univ. of
California-Davis, Dept. of Entomology, submitted by Thompson-Hayward
Chemical Co. Kansas City, Kans.; CDL:099053-N)
00086600 Thompson-Hayward Chemical Company (1969) Results of Tests on the Amount
of Residue Remaining, Including a Description of the Analytical Method:
Du-ter. (Compilation; unpublished study, including report no. R-769,
received May 13, 1970 under 0F0900; CDL:091554-B)
00086601 Thompson-Hayward Chemical Company (1969) Clean-up Procedure for the
Colorimetric Residue Determination of Triphenyltin Compounds in Pecans.
Method no. A-168 dated Sep 2, 1969. (Unpublished study received May 13,
1970 under 0F0900; CDL:091553-C)
00086603
Thompson-Hayward Chemical Company (1969) Detection of Triphenyltin
Hydroxide in Pecans by Thin Layer Chromatography. Method no. A-179
dated Sep 5, 1969. (Unpublished study received May 13, 1970 under
0F0900; CDL:091554-E)
70
-------
00088622 Imlay, P.; Parke, G.S.E. (1977) Primary Eye Irritation: Laboratory
No. 7E-8299. (Unpublished study received Oct 18, 1979 under
148-689; prepared by Cannon Laboratories, Inc., submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:099049-H)
00093704 Corbin, H.B. (1976) The Partitioning of bis(Tributyltin) Oxide
(TBT0), Tributyltin Fluoride (TBTF), Triphenyltin Hydroxide
(TPTH), Triphenyltin Fluoride (TPTF), and Tricyclohexyltin
Hydroxide (TCTH) between n-Octanol and Water: R-1150-M. (Unpublished
study received Jan 15, 1982 under 46197-1; prepared by M & T Chemicals,
Inc., submitted by Kansai Paint Co., Ltd., Rahway, N.J.; CDL:246589-A)
00093875 Soderquist, C.J.; Crosby, D.G. (1980) Degradation of Triphenyltin Hydroxide
in water. Journal of Agricultural and Food Chemistry 28(1):111-117;
submitted by Kansai Paint Co., Ltd., Rahway, N.J.; CDL:246606-D)
00094903 Carlton, B.D.; Connell, M. M. (1981) Final Report on Evaluation of
the Teratogenicity of Triphenyltin Hydroxide (TPTH) in the Sprague-Dawley
Rat: Project No. N0723-0200. (Unpublished study received Mar 2,
1982 under 148-689; prepared by Battelle, submitted by Thompson-
Hayward Chemical Co. Kansas City, Kans.; CDL:070696-A)
00094904 Carlton, B.D.; Howard, M. (1982) Final Report on the Evaluation
of the Teratogenicity of Triphenyltin Hydroxide (TPTH) in the Syrian
Golden Hamster: Project No. N0723-0100. (Unpublished study received
Mar 2, 1982 under 148-689; prepared by Battelle, submitted by Thompson-
Hayward Chemical Co. Kansas City, Kans.; CDL:070697-A)
00096632 Ward, G.S. (1982) Acute Toxicity of Triphenyltin Hydroxide to Sheepshead
Minnows (Cyprinodon variegatus): Report No. BP-82-1-7. (Unpublished
study received Mar 16, 1982 under 5204-69; prepared by EG&G Bionomics,
submitted by M & T Chemicals, Inc., Rahway, N.J.; CDL:246999-A)
00096633 Ward, G.S. (1982) Acute Toxicity of Triphenyltin Hydroxide to
Mysid Shrimp (Mysidopsis bahia): Report No. BP-82-3-19. (Unpublished
study received Mar 16, 1982 under 5204-69; prepared by EG&G Bionomics,
submitted by M & T Chemicals, Inc., Rahway, N.J.; CDL:246998-A)
71
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00096634 Ward, G.S. (1982) Acute Toxicity of Triphenyltin Hydroxide to Eastern
Oysters (Crassostrea virginica): Report No. BP-82-2-10. (Unpublished
study received Mar 16," 1982 under 5204-69; prepared by EG&G Bionomics,
submitted by M & T Chemicals, Inc., Rahway, N.J.; CDL: 246997-A)
00099092 Fink, R. (1972) Final Report: Eight-day Dietary LC50— Mallard
Duck.: Triphenyltin Hydroxide (Technical): Project No. 553-105.
(Unpublished study received Feb 27, 1973 under 148-689; prepared by
Environmental Sciences Corp. , submitted by Thompson-Hayward Chemical Co.
Kansas City, Kans.; CDL:120342-F)
00099093 Fink, R. (1972) Final Report: One-generation Reproduction Study —
Bobwhite Quail: Project No. 553-106: Technical Triphenyltin Hydroxide.
(Unpublished study received Apr 4, 1973 under 148-689; prepared by
Environmental Sciences Corp., submitted by Thompson-Hayward Chemical Co.
Kansas City, Kans.; CDL:120342-H)
00099673 Helling, C. (1975) Soil mobility of three Thompson-Hayward pesticides.
Interim rept. U.S. Agricultural Research Service, Pesticide Degradation
Laboratory; (Unpublished study; CDL:09646-F)
00124210 American Hoechst (1981) Acute Dermal Toxicity of HOE 29664 Active
Principle in Male Rabbits. Hoechst Aktiengesellschaft, #229/81;
(Unpublished study received Jan 19, 1983 under 8340-15; CDL:071364,
Tab C-5).
00124219 Cannon Laboratories (1979) 90-Day Inhalation Toxicity Study of Technical
TPTH. Report No. 7E-8305. (Unpublished study received Jan 19, 1983
under 8340-15; CDL:071366, C-12)
00124220
American Hoechst (1983) Summary of Data Presented; (Unpublished
studies received Jan 20, 1983 under 3F2823; submitted by American
Hoechst; CDL:071370-XA)
-------
00125261
Cannon Laboratories (1979) 18-month Carcinogenicity Study of Technical
TPTH 96.3% (Lot No. SWRAM-1K) in CD1 Mice. Study #6E-725. (Unpublished
study received Jan 19, 1983 under 8340-15; CDL:071367, Tab C-13.)
00125274 Booth _et_ _al. (1980) Acute Oral Toxicity of Du-ter to Bobwhite Quail.
(Unpublished report prepared by Brigham Young University for
Thompson-Hayward Chemical Co. CDL:249309, Sec. I—11)
Suprenant, D.C. and G.A. LeBlanc (1982) Acute Toxicity of Triphenyltin
Hydroxide (TPTH) to the Water Flea (Daphnia magna). (Unpublished study
prepared by EG&G Bionomics, Inc., Wareham, MA for American Hoechst Corp.,
CDL:249309 Sec. I)
Suprenant, D.C. al. (1982) The Chronic Toxicity of Triphenyl Hydroxide
(TPTH) to the Water Flea (Daphnia magna). (Unpublished report prepared
by EG&G Bionomics, Inc. for Thompson-Hayward Agriculture & Nutrition Co.,
Inc., CDL:249309 Sec. I)
Wilson, B.F. et al. (1982) The Toxicity of Triphenyltin Hydroxide (TPTH)
to the Fathead Minnow (Pimephales promelas) embryos and larvae.
(Unpublished study prepared by EG&G Bionomics for Thompson-Hayward
Agriculture & Nutrition Co., Inc., CDL:249309 Sec. 1-7)
Booth, G.M. et al. (1980) Acute Oral Toxicity of Technical Triphenyltin
Hydroxide and Du-ter to Mallard Ducks. (Unpublished report prepared by
Brigham Young Univ. for Thompson-Hayward Chemical Co., CDL:249309,
Sec. 1-10)
Received Jan 19, 1983 submitted by American Hoechst Corp. under 8340-15.
05016869 Epstein, S.; Arnold, E.; Andrea, J.; Bass, W; and Bishop, V. (1972)
Detection of Chemical Mutagens by the Dominant Lethal Assay in the
Mouse. Toxicol. Appl. Pharmacol. 2^: 288-325.
GS028026 Johnson W.W. and M.T. Finley (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates, U.S. Fish & Wildlife
Service Publication No. 137. 98 pp.
73
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APPENDIX II-2
OMB Approval No. 2000-0465 (Expires 12-31-331
EPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
G 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, QECO
Chemicals Testing Programme, I enclose the protocols that I will usa:
O 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
G 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
~ 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
O 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
EPA Form 3680-1 410-82)
74
-------
APPENDIX II-3
0M8 Aaorovai No. 2000-0468 f Expires: 12-31-S3)
— CERTIFICATION CF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
m ALL fob development of data
1 | am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT OATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
fThis firm or group of firms is referred to below as "my firm".)
2 My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
" into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. MY firm has offered in writing to enter into such an agreement. Copies of the offer? are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(8)(iii) if final agreement on all terms could not bt reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OP FIRM
S^/ever. none of those firm(s) accepted my offer.
i i iiimf »ha« CDA nrtt rMic
DATE OF OFFER
4 My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
' have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
rn« whether my firm must submit data to avoid'suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
do«s not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
rv>*D
NAME
Form 8880-6
(10-82)
SIGNATURE
7^
DATE
-------
Acpendix :il-l
PTODUCr SPECIFIC CKEA .REPORT
3% Hegistraticn Ho. Guidance Document ccr
Date
Regis tratioi
Guideline Mo.
Name of Test
Test not
required
far my
product
listed
above
(cSecic
belcw)
I am carolying with
data reauirements bv
(Par EPA Use Only)
Accession Numbers
Assigned
Citing MRID*
Su emit-
ting
Data
(At-
tached)
S1S8.20
PJOHICT
CTEMSTOT
61-1
Identity at
inaredients
£1-2
Statement or
ccnccsiticn
£1-3
Discussion oc
formation of
inqredients
-------
§ 162.10
Title 40—Protection of Environment
§ 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
38
77
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Chapter I—Environmental Protection Agency
§ 162.10
whom produced as prescribed in para-
graph (c) of this section:
(iii) The net contents as prescribed
in paragraph (d) of this section:
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph if)
of this section;
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion;
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(viii) The directions for use as pre-
scribed in paragraph Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General.
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, ' se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a part of the package as
customarily distributed or sold.
-------
§ 162.10
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi> The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(viiU Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe,'' "nonpoison-
ous," "noninjurious." "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents";
-------
Chapter I—Environmental Protection Agency
§ 162.10
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(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.
(ii) 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 proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authorit y 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
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) 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.
41
GO
-------
§ 162.10
Title 40—Protection of Environment
(7) Inert ingredients. The Adminis-
trator may require the name of any-
inert ingredienus) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or the environment.
(hi Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
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 nuy
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Hazara ^caters --
Tonicity categories
IV
Oral Up to ana including e.Q Prom SO thru 500 mg/kg From 500 thru 5000 mg, Greater than 5000 mg/
mg/kg *9 *9
inhalation LC»» Up to ana including 2 : From 2 thru 2 mg/Mer ., From 2 thru 20 mg'iiter Greater than 20 rng/Mer
mg/liter
Dermai i-D« up to ana including 200 From 200 thru 2000 ... From 2.000 thru 20.000 Greater than 20.000
mg/Wg
Eye ejects 1 Corrosive, corneal Corneal opacity No corneal opacity. No irritation
opacity not reversioie reversible within ? irritation reversiO'e
within 7 days days, irritation within 7 days
; persisting for ? days
Shm ejects Corrosive 1 Severe irritation at 72 Moderate irritation at 72 Mild or slight -mtation at
hours hours 72 hours.
(i) Human hazard signal word—(A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity fas
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category 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
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing. storage or use is demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(iii) 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 Toxicity Category I on the
42
31
-------
Chapter I—Environmental Protection Agency
§ 162.10
basis of oral, inhalation or dermal tox-
icity. The Agency may. however,
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
iB) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (h )< 1M iii)(A > of
this section. The applicant may, how-
ever. include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (h)<2> of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Size of label from panel m square
mcnes
5 ana under
Above 5 to '0
Above 10 to 15
Above 15 to 30
Over 30
Required
Signal
wora. ail
capitals
6 !
10
12
14
18
"Keeo out
of reaen ut
Children
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements a.s re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Human.s and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans arid 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.
i 0«iCTV
CAiegory
Precautionary statements by toxicity category
Orai. irhaiation. or dermai toxicity Skin ana eye local effects
Patai -poisonous) '¦ swatiowe-j (inhaled or absorbed
through skm] Do not breatre vaoor (dust or spray
mist J Do not get in eyes on s*in. or on clothing
(Front panel statement ct practical trealment re-
quired ] '
May be fatal d contact with skm (eyes or clothing) (Appro-
priate first aid statement required ]
(No preca^t'Onary statements 'equired ] .
Corrosive, causes eye and s*m damage for skir.
irritation] Do not gel m eyes on skin, or on
clothing Wear goqgies or face shield and rubber
gloves when nandimg Harmful or fatal if swaiiowod.
(Appropriate first aid statement required 1
Causes eye (and skm) irritation Do not get m eyes
on skin, or on ciothmg Harmful if swallowed (Ap-
propriate first aid statement required ]
Avoid contact with skin eyes or clothing in case of
contact immediately flush eyes or skm with plentv of
water Get medical attention if irritation persists
(No precautionary statements required J
-------
§ 162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD« of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC,. 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,0 of 100
mg/kg or less, or a subacute dietary
LCso of 500 ppm or less, the statement
"This Pesticide is Toxic to WildJife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
Title 40—Protection of Environment
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."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash point I Required text
(A) Pressurized Containers
Flash point at or below 20' F. if there is a 'lashoac* at Extremely fiammaole Contents under pressure Keep away lfom
any valve opening. 'ire. sparks, and heated surfaces Do not puncture or incinerate
container. Exposure to temperatures above 130 F may cause
bursting.
Flash point above 20' F and not over riO* F or <1 the Ffammaofe Contents under pressure Keeo awav om hear
flame extension is more man 18 m long at a distance sparks, and open flame Do not puncture or ncmeraie container
of 6 ove 20' F and noJ over 80' F Flammable. Keep awav from neat and open flame
Above 80* F and not over 150' F ! Do not use or store near heat or open flame
(i) Directions for Use—( 1) General
requirements—(i) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, 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 pesticide 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.
(iii) Exceptions to requirement for
direction for use—(.A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
S3
-------
Chapter I—Environmental Protection Agenty
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(1) 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:
(J) 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:
(1) There is information readily
available to the formulators on the
composition, toxicity, 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
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Dirccticms 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 162.10cj) 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."
(iii) 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.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) 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(h)< D(iv).)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops,
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
45
84
-------
§ 162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(P) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22. 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (jXl) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards set forth in this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use(s) and the other
bearing directions for restricted use(s)
except that, if a product has both re-
stricted usc(s) and general use(s). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
of § 162.10(j)(2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
Title 40—Protection of Environment
of the same minimum sizes as required
for human hazard signal words (see
table in § 162.10(h)< l)(iv)), and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved!
(40 FR 28268. July 3. 1975; 40 FR 32329.
Auk. 1. 1975; 40 FR 36571. Aug. 21. 1975, as
amended at 43 FR 5786. Feb. 9, 19781
§ 162.11 Criteria for determinations of un-
reasonable adverse effects.
fa) Criteria for Issuance of Notice of
Intent to Deny Registration. Cancel
Registration, or to Hold a Hearing—
(1) Presumption, (i) A rebuttable pre-
sumption shall arise that a notice of
intent to deny registration pursuant to
section 3(c)(6) of the Act, a notice of
intent to cancel registration pursuant
to section 6(b)(1) of the Act, or a
notice of intent to hold a hearing to
determine whether the registration
should be cancelled or denied, as ap-
propriate, shall be issued, upon a de-
termination by the Administrator that
the pesticide meets or exceeds any of
the criteria for risk set forth in para-
graph (a)(3) of this section. Upon such
determination, the Administrator
shall issue notice by certified mail to
the applicant or registrant, as the case
may be, stating that the applicant or
registrant has the opportunity to
submit evidence in rebuttal of such
presumption in accordance with para-
graph (a)(4) of this section. The appli-
cant or registrant shall have forty-five
46
85
-------
APPEND IX IV-2
LABELING REQUIREMENTS OF TOE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Company name
arid address
All products
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . .
"Distributed by. . etc.
3
Net contents
All products
None
Bottom front
panel or end
of label text
May be in metric units in addition to
U.S. units
4
EPA Est. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
EPA Reg. No.
All products
None
Front panel,
immediately
before or
following
Reg. No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Immediately
following
product name
Text must run parallel with other text
on the panel.
6B
Pounds/ga1Ion
statement
Liquid products
where dosage
given as lbs.
ai/unit area
Front panel
Directly below
the main
ingredients
statement
7
Front panel
precaut ionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep Out of Reach
of Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
1
Immediately
below child
hazard
warning |
Note type size requirements.
-------
APPENDIX IV-2 (continued)
APPLICABILITY
PLACEMENT ON LABEL
ITEM
LABEL ELEMENT
OF REQUIREMENT
REQUIRED
PREFERRED
COMMENTS
7 C
Skull & cross-
bones and word
POISON (in red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word
7D
Statement of
practical
treatment
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precaut ionary
statemepts.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for use
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
8A
Hazards to
hunans and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
Environmental
hazards
All products
None
Same as above
Environmental hazards include bee
caution where applicable.
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
8C
Physical or
chemical
hazards
All pressurized
products, others
with £lash
points under
150°F
None
Same as above
9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statement of the terns of
restriction. The words "RESTRICTED USE
PESTICIDE" nust be same type size as
signal word.
9C
Mi suse
statement
All products
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
10A
Re-entry
statement
All
cholinesterase
inhibitors
In the
directions
for use
Immediately
after misuse
statement
IOC
Storage and
disposal block
All products
In the
directions
for use
Immediately
before
specific
directions
for use or
at the end of
directions
for use
Must be set apart and clearly distin-
guishable from fran other directions
for use.
10D
U.S.
Directions
for use
All products
None
None
May be in metric as well as U.S. units
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
Required Label Statement
A.
B.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
Flashpoint above 20°F
and not over 80®F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
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.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150#F.
D. Flashpoint above
150°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 and open flame.
None required.
3',1
-------
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:
1
1 Required type size |
1 Size of label
1 for the heading 1
1 front panel in
I STORAGE AND DISPOSAL |
1 square inches
1 (all capitals) 1
110 and under
1
I Above 10 to 15
1 Above 15 to 30
lOver 30
1
1
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.
90
-------
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 wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
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:
91
-------
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 Disoosal 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
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
Aerosol products
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type Statement
1 Metal
1 containers
1(non-aerosol)
1 Triple rinse (or equivalent). Then offer |
1 for recycling or recCnditioning, or puncture|
1 and dispose of in a sanitary, landfill, or byj
1 other procedures approved by state and local|
1 authorities. |
i Plastic containers
1 Triple rinse (or equivalent). Then offer |
I for recycling or reconditioning, or puncture!
I and dispose of in a sanitary landfill, or |
1 incineration, or, if allowed by state and |
1 lo.cal authorities, by burning. If burned, |
1 stay out of smoke. |
I Glass containers
1 Triple rinse (or equivalent). Then dispose |
1 of in a sanitary landfill or by other j
1 approved state and local procedures. |
92
-------
Appendix IV-5
(continued)
Container Type Statement
1 Fiber arums
I with liners
1
1
1
1
I
1
1 Completely empty liner by shaking and 1
1 tapping sides and bottom to loosen clinging 1
1 particles. Empty residue into application 1
1 equipment. Then dispose of liner in a 1
1 sanitary landfill or by incineration if 1
1 allowed by state and local authorities. 1
1 If drum is contaminated and cannot be 1
1 reused^, dispose of in the same manner. 1
|Paper and
|plastic bags
1
1
1
1
1 Completely empty bag into application 1
I equipment. Then dispose of empty bag in 1
1 a sanitary landfill or by incineration, 1
1 or, if allowed by State and local 1
1 authorities, by burning. If burned, stay 1
1 out of smoke. 1
I Compressed gas
I cylinders
1 Return empty cylinder for reuse (or 1
1 similar wording). 1
^¦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.
93
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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
Endothai1
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
94
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Appendix IV-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCPA "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,O-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).
95
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Appendix IV-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List.)
Active Ingredients:
Acetone
Aerylonitrile
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
5-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dichloropropane
1.3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,41-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocy.clopentadiene
Hexachloroethane
Hydrofluoric acid
96
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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
2,21-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitropheno1
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Fhosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
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
97
-------
Appendix IV-5
{continued)
"Toxic" Commercial Pesticide Producrts (RCRA "F" List.)
Inert. Ingredients :
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1.1.1-Trichloroethane
1.1.2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
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ATTACHMENT A
PRODUCTS AFFECTED BY THIS
REREGISTRATION PROCESS
Following is a list of your products affected hy this reregistration
process. If this list is incomplete or inaccurate in any wav, please
notify the Product Manager (PM) identified in the letter.
Du-ter Fungicide 05R43 (TH)
Du-ter Funqicide 05R44
Du-ter Fungicide PF-47
Du-ter Fungicide
Du-ter Flowable-30
Du-ter Flowable 640 Fungicide
00160
onifi.i
00163
00164
(ITR)
Super Tin 4L Guardian Flowable Fungicide
Super 16 Sulfur-tin Flowable Fungicide
00244
00252
(GR)
Brestan H 47.5 WP Fungicide
00015
(AH)
Du-ter Fungicide
tpth Technical
00012
00013
(DU)
Vito Spot Funqicide
00074
(KV)
Ida, Inc. Flo-tin 4i,
00014
(ID)
Triple Tin Funaicide
Triple Tin 4L
Vancide KS Industrial Preservative
00034
00035
00037
(WI)
Aqmark 4-Tin Triphenvltin Hydroxide Flowable Fungicide
00001
(AG)
th = ThomDSon-Hayward Chemical Co.? tjR = Unircyal Chemical: gr = Griffin
Corporation; AH = American Hoechst Corporation: DU = Duphar, B.v.:
KV = Kaw Valley Warehousing Co., Inc.: ID = Ida, Inc.: WI = Wesley Industries
Inc.: AG = Aqmark
09
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ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT
The information attached will allow reqistrants with pesticide products
containina the above inaredient to contact one another reaardinq ioint
data development or sharing the cost of data development under section
3(c)(2)(B) of the FIEFA. ^his information includes the followinq: EPA
Req. No., company name, company address, active inqredient, percentaqe
of active inqredient, and type of formulation, such as Manufacturinq-nse
Product (MP), Technical Product (TP), Wettable Powder (WP), and
Emulsifiahle Concentrate (EC).
Product Name
%active
TVpe Formulation Pea.No.
Du-ter Funaicide
Du-ter Eunqicide
47.5
47.5
WP
WP
Reqistrant: Thompson-Hayward Chemical Company
5200 Speaker Road
Kansas City, KS 66106
05843
05844
Du-ter Funqicide PB-47
47.5
WP
00160
Du-ter Funqicide
47.5
WP
00161
Du-ter Flowable-30
19.7
FC
00163
Du-ter Flowable 640
Funqicide
40.5
FC
00164
Registrant: Uniroyal Chemical
Division of Uniroyal,
74 Amity Road
Bethany, CT 06575
Tnc.
Super Tin 4^ Guardian
Flowable Funqicide
Super 16 Sulfur-tin
Flowable Funqicide
40.0 FT
5.1 (40.0% sulfur) FC
Reqistrant: Griffin Corporation
ATTN. Linda C. Elliot
P.O. Box 1847
valdosta, GA 31601
00744
00252
Brestan H 47.5
WP Funqicide
47.5
WP
Reqistrant: American Hoechst Corporation
Rt 702-206 N.
Summerville, N.J. 08876
0001 5
100
-------
Product Name
% active
Tvpe Formulation Rea.No.
Du-ter Fungicide
tpth Technical
47.5
96.0
WP
Tp
nooi2
00013
Registrant: Duphar, B.V.
????????
vito Spot Fungicide 47.5 WP 00074
Registrant: Kaw Vallev Warehousing Co., Inc.
P.O. Box 285
Lansing, KS 66043
Ida, Inc. Flo-tin 4L 40.0 FC 00014
Registrant: Ida, Inc.
Box 9483
24R7 Pennsylvania St.
Memphis, TN 38109
Triple Tin Fungicide
47.5
WP
00034
Triple Tin 4L
40.0
PC
00035
Vancide KS Industrial
Preservative
95.0
TP
00037
Reaistrant: Wesley Industries, Tnc.
P.O. Box 456
Montrose, AL 36559
Aqmark 4-Tin Triphenvltin
Hydroxide Flowahle
Fungicide 40.0 FC 00001
Registrant: Agmark
105 Cherry Creek Dr.
Valdosta, GA 31601
1C1
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