&EPA
United SutM
Environmental Protection
Agmcv
Offlo* of
Pwticidw end Toxic Subcuncw
Washington DC 20460
PMticidM
June 1985
Guidance for the Reregistration
of Pesticide Products
Containing Cyhexatin
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CYHEXATIN
AS THE ACTIVE INGREDIENT
101601
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
June 1985
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 58
III. Requirement for Submission of Product-Specific
Data 61
IV. Submission of Revised Labeling and Packaging
Information 61
A. Label Contents 62
1. Product Name 62
2. Company Name and Address 62
3. Net Contents 62
4. Product Registration Number 62
5. Producing Establishment
Registration Number 62
6A ingredient Statement 63
6B Pounds Per Gallon Statement 63
7. Front Panel Precautionary Statements 63
7A Child Hazard Warning Statements 63
7B Signal Word 63
7C Skull and Crossbones and Word Poison 63
7D Statement of Practical Treatment 63
7E Referral Statement 64
8. Side/Back Panel Precautionary Labeling 64
8A Hazard to Humans and Domestic Animals 64
8B Environmental Hazard 64
8C Physical or Chemical Hazard 64
9 Product Classification 65
10 Misuse Statement 67
10A Storage and Disposal Block 67
10B Directions for Use 67
B. Collateral Labeling 67
V. instructions for Submission 68
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APPENDICES
1 1—1 Guide to Bibliography . . . . . . . . . . . . . . . . • 71
11—2 Bibliography . . . . . . . . . , • • • • • • . • • • • 73
11—3 FIFRA §3(c)(2)(B) Summary Sheet — EPA Form 8580—1
11—4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580—2
111—1 Product Specific Data Report (End—Use Products)
Iv—l 40 CFR 162.10 Labeling Requirements
IV—2 Table of Labeling Requirements
IV—3 Physical/Chemical Hazards Labeling Statement
IV—4 Storage and Disposal Instructions
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INTRODUCTION
The Federal Insecticide, Fungicide, and Roderiticide Act (FIFRA
sec. 3(g)) directs EPA to reregister all pesticides as expeditiously
as possible.
To carry out this task, EPA has established the Registration
Standards program, which will review all pesticide products
containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters which
have been ranked to give earliest review 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. EPA’s reassessment
results in the development of a regulatory position, contained in a
Registration Standard, on each pesticide and its uses. The Agency
may require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the pesti-
cide 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
will not result in adverse effects on the environment.
The scientific review, which is not contained in this Guidance
Package 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 were also looking for
potential hazards that may be associated with the end—use
(formulated) products that contain the active ingredient. If we
have serious concerns, we will address end use products as part of
the Registration Standards program and will propose regulatory
actions to the extent necessary to protect the public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to require
registrants to submit data that will answer our questions regarding
the hazard that may result from the intended use of a pesticide.
Although sec. 3(c)(2)(B) provides that all registrants are
responsible for these data, the Agency generally imposes generic
data requirements only on the registrants of the manufacturing—use
products (basic suppliers of the active ingredient). End—use
producers who do not qualify for the formulator’s exemption* are
also required to submit these data.
* The formulator’s exemption applies to a registrant if the source
of his active ingredient(s): (1) is a registered product and (2)
is purchased from a source which does not have ownership in common
with the registrant’s firm.
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An end—use producer who wishes to qualify for the formu-
lator’s exemption may change his source of supply to a registered
source, provided the source does not share ownership in common
with the registrant’s firm. An end—use registrant may do so by
submitting a new Confidential Statement of Formula, EPA Form
8570—4, identifying the registered source of the active ingredient,
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 your decide to request the Agency to cancel the registra-
tion of any of your products subject to the requirements of this
Guidance Document, please notify the Product Manager named in the
cover letter, within 90 days from the receipt of this document.
If you decide to maintain your product registration(s), you must
provide the information described in the following pages within
the timeframes outlined. EPA will issue a notice of intent to
cancel or suspend the registration of any currently registered
product which does not comply with the requirements set forth in
this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible unreason-
able 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 ACTION(S) REQUIRED TO
REGISTRATION STANDARDS PROGRAM MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For the Formulator’s Exemption
A. Single Active Ingredient These products must be reregis—
Products* tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Registra-
tion Standards Guidance Document.
. •I.
B. Multiple Active Ingredient These products will not be
Products 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 Only when additional restrictions
The Formulator’s Exemption or labeling are needed to protect
man or the environment will these
products be subject to the
Registration Standard require-
ments. 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 manu-
facturing—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 “It” 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 contains the Agency’s regulatory position and
rationale on manufacturing—use products containing the pesticide
cyhexatin as a sole active ingredient. The Agency bases its
position and rationale on a consideration of all uses of cyhexatin
appearing on pesticide products registered under Sections 3 and
24(c) of the FIFRA as well as on products authorized for distribu-
tion in intrastate commerce under 40 CFR 162.17. The Agency has
reviewed the known chemical, environmental, and toxicological
characteristics of this pesticide and its established tolerances
for residues in or on food and feed commodities. From thes
considerations the Agency sets forth the data and labeling
requirements that must be met by registrants and applicants for
registration of cyhexatin manufacturing—use products (MPs) in
order for their products to be registered or reregistered under
this Standard. Unique labeling requirements and certain data
needs for end—use products (EPs) containing cyhexatin are also
established by this Standard.
Only those data and labeling requirements for current and future
substantially similar MPs and EPS are addressed here. Applications
to register products that differ appreciably from those described
in this Standard may be subject to additional data and/or labeling
requirements.
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B. Description of Chemical and Use Profile
Cyhexatin is the American National Standards Institute (ANSI)
International Organization For Standardization (ISO), and
British Standards Institute (BSI) approved name for a miticide
produced by Dow Chemical Co., U.S.A., in Germany by Bayer A.G.
and in Taiwan by GENP International.
The chemical name for cyhexatin is tricyclohexyihydroxystannane.
Another name is tricyclohexyltin hydroxide. Trade names in-
clude Acarstin®, Plictran® and Dowco® 213.
Other identifying characteristics and codes are:
Empirical Formula: C 18 H 34 OSn
Molecular Weight: 385
CAS Registry No.: 13121—70—5
ENT Registry No.: 27—395—X
Shaughnessy No.: 101601
Some physical and chemical properties of the 95% technical
cyhexatin product is that it is a white crystalline powder,
nearly odorless, has no true melting point, degrades to bis—
tricyclohexyltin oxide at 121—135°C, decomposes at 228°C and is
soluble at various amounts in organic solvents such as carbon
disulfide, carbon tetrachloride, chloroform, chlorobenzene,
methyl chloride tetrahydrofuran, and toluene. Cyhexatin is
practically insoluble in water.
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The vapor pressure is negligible at 25°C for the pure active
ingredient of cyhexatin. Cyhexatin is stable in aqueous
suspensions with neutral and alkaline pH. Cyhexatin reacts
ionically in the presence of a strong acid to form salts,
and cyhexatin is converted by exposure to UV radiation to
dicyclohexyltin oxide, then to cyclohexylstannoic acid.
There are three products currently registered which contain
cyhexatin as an active ingredient of which one is a technical
cyhexatin product (95%). The other two are 50% wettable powder
formulations. These are all single active ingredient formula-
tions. There are eight intrastate products. Cyhexatin is a
miticide registered for use on almonds, apples, ‘citrus fruits,
hops, macadamia nuts, nectarines, peaches, pears, plums (fresh
prunes), strawberries, walnuts, ornamental plants and greenhouse
grown carnations, chrysanthemums, poinsettias, and roses. Foliar
applications are made when pests first appear and are repeated
as needed; applications to apples, citrus fruits, and pears may
be made with aerial equipment. Apples and walnuts comprise most
of the use of cyhexatin in the U.S.
Tolerances for food/feed items are currently expressed in terms
of combined residues of cyhexatin and its organotin metabolites
(expressed as cyhexatin) (40 CFR 180.144, 21 CFR 561.400, and
21 CFR 193.430).
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C. Regulatory Position and Rationale
Based on a review and evaluation of all available data and other
relevant information on cyhexatin, the Agency has made the
following determinations:
1. All products containing cyhexatin as a sole active ingredient
may continue to be registered for sale, distribution,
reformulation, and use, subject to the terms and conditions
specified in this Guidance Document. Registrants must provide
or agree to develop additional data, as specified in Tables A
and B in order to maintain existing registrations or to
permit new registrations.
Rationale : Under FIFRA, the Agency normally does not cancel
or withhold registration simply because data are missing or
are inadequate (see Sections 3(c)(2)(B) and 3(c)(7) of the
FIFRA) . Rather, issuance of this Standard provides a mechanism
for identifying data needs. These data will be reviewed and
evaluated after they are received and the Agency will determine
at that time whether they will affect the registration(s) of
cyhexat in.
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2. The Agency will not allow any significant new uses* to be
established for cyhexatin until the toxicological and residue
chemistry data deficiencies identified in Table A have been
received and evaluated and the Agency concludes that new uses
are supportable.
Rationale : The Agency is unable to complete a tolerance
reasse’ssment of cyhexatin because of extensive residue
chemistry and toxicology data gaps. The data requested in
Table A are needed for EPA to calculate an acceptable daily
intake (ADI) level of cyhexatin and its metabolites and to
reassess the present tolerances. For a complete discussion
of the tolerance reassessment for cyhexatin, see section G
entitled “Tolerance Reassessment.”
3. The Agency is requiring that existing food additive tolerances
for dried prunes and dried hops be amended and that food
and feed tolerances be proposed and established for wet apple
pumace, citrus oil and molasses and possibly spent hops.
Rationale : Current established food additive tolerances for
dried prunes (4ppm) and dried hops (90 ppm) are considered
* The terminology “significant new use” is defined in 44 FR
27934, May 11, 1979. In the case of a new food or feed use,
the Agency will generally consider as significant an increase
in the Theoretical Maximal Residue Concentration of greater
than 1%.
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inadequate from the Agency’s reassessment of the existing
residue data for these commodities. These data demonstrate
that residues will concentrate at higher factors. These
tolerances must be amended to 7 ppm and 135 ppm, respectively,
unless it can be demonstrated otherwise with additional data.
Also, existing data demonstrate that cyhexatin and its
metabolites concentrate such that food and feed additive
tolerances must be proposed and established for wet apple
pumace, citrus oil and molasses. Required data for spent
hops, after it is received and evaluated, may also demonstrate
the need for a tolerance on this commodity.
4. The Agency is requiring extensive environmental fate and
chemistry data to characterize cyhexatin’s behavior in the
environment, including its potential to leach through soil.
Rationale : At present, only very limited data are available
to assess the environmental fate of cyhexatin or to charac-
terize its potential for contaminating ground water. These
data suggest that cyhexatin leaches slowly. The Agency has
become increasingly concerned about the presence of pesticide
chemicals in ground waters in the United States and has
identified a number of chemicals, including cyhexatin, which
may have the potential to enter ground waters based on factors
such as chemical structure, solubility and use patterns.
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5. The Agency is requiring that labels be revised to require the
use of protective clothing. It is also requiring that data
gaps in the existing exposure and toxicology data base be
filled. Upon receipt and review of the exposure and toxicol-
ogy data, the Agency will determine if field reentry restric-
tions and additional protective clothing requirements are
necessary.
Rationale : Adequate toxicology data are not available to
fully characterize the acute, subchronic and chronic effects
of cyhexatin in humans. Acute oral and eye irritation toxicit’
data are sufficient to categorize the current MP and EP
formulations as Toxicity Category II. Product labeling
precautions inform and instruct applicators to minimize
exposure and therefore acute hazards. The existing toxicology
data base does not include any studies conducted by Industrial
Bio—Test Laboratories, Inc.
Between the years of 1966 and 1981, the Pesticide Incident
Monitoring System (PIMS) report includes 14 humans, 1 domestic
animal and no environmental incidents in which cyhexatin
alone was involved. During that same time, there were 26
human, no domestic animal and 1 environment incidents reported
in which cyhexatin in combination with other pesticides
were involved. Most of the human incidents were agricultural
related and a few were industrial. Circumstances of exposure
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were mixed between the various handling and application
operations (mixing, loading, application, flagging) and
involved different exposures——dermal, inhalation and eye
contact. Usually, the exposures were caused by the lack of
Or improper use of protective clothing, spray drift or spills.
Contact dermatitis was a common effect from dermal exposure.
Because of these reported incidents, it is necessary to
prescribe protective clothing. This requirement is presented
in Section F (Required Labeling).
6. Studies to determine the effects on nontarget avian and
aquatic organisms are being required.
Rationale : Acute toxicity studies indicate that cyhexatin is
highly toxic to birds. Due to this toxicity and the probable
repeated exposure resulting from multiple applications, the
avian reproduction study is now required for cyhexatin. The
fish early—life stage and aquatic invertebrate life—cycle
studies are reserved since the currently existing
environmental fate data are not sufficient for the Agency to
estimate aquatic exposure. In addition, the guideline trigger
for persistence in water cannot be addressed until a valid
study is available. Once the Agency has reviewed these
studies, it will determine if higher tier studies such as
aquatic and avian field studies should be required.
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7. The Agency will impose interim labeling to protect endangered
species, if the generic (cluster) analysis for endangered
species has not been completed in time to impose appropriate
labeling in time for the 1986 growing season. At this time,
no label statements are being imposed.
Rationale : Appropriate labeling for the protection of
endangered species determined to be in jeopardy is being
developed in conjunction with a generic (cluster) approach,
rather than under this Standard. This generic approach,
which entails the analysis of the effects of all pesticides
on endangered species on a crop—by—crop basis, rather than a
chemical—by—chemical approach, is being developed in coopera-
tion with Federal and State enforcement agencies, the Office
of Endangered Species (OES) of the U.S. Fish & Wildlife
Service and the U.S. Department of Agriculture (USDA), using
the extension services, and the National Agricultural Chemical
Association (NACA). Since the cluster approach does not
currently address small crops, those uses will be reviewed
separately by the Office of Endangered Species through
Section 7 consultation. A comprehensive consultation will
require EPA to provide an estimated environmental concentra-
tion (EEC) for the habitats of endangered species. EEC’S are
made available through computer models which require environ-
mental fate data. As shown by the data requirement tables,
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minimal environmental data are available. By agreement with
the Office of Endangered Species, consultation will be delayed
until these data are available.
8. The Agency is requiring that use directions for end—use
products for ground application to pears, peached, plums
(prunes) and nectarines be amended to reflect reductions
of the maximum spray gallonage from 800 to 500 gallons
per acre.
Rationale : Current spray coverage recommendations and
practices for the above orchard crops follow a spray regime
of 300 to 500 gallons per acre to obtain full coverage.
Higher volumes are excessive. A reduction will eliminate
unnecessary and excessive spray dosages and reduce the
environmental impact by reducing runoff which does not
contribute to efficacy.
9. Registrants of end—use products must submit revised labeling
which incorporates the label precautions found in Section F.
Rationale : The Agency believes that label statements
prescribed in this Guidance Document should minimize the
acute hazards associated with the oral, dermal, inhalation
and ocular routes of exposure to users of cyhexatin, and
should minimize the hazards to terrestrial and aquatic
organisms.
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D. Criteria for Registration Under This Standard
To conform to this Guidance Document, products must contain
cyhexatin as the sole active ingredient, bear required labeling,
and conform to the product composition, acute toxicity limits,
and use patterns listed in Sections E and F of this document.
The application for registration or reregistration of
manufacturing—use products subject to this Guidance Document
must comply with all terms and conditions described in it,
including submission of an up—to—date Confidential Statement
of Formula and Certification of Ingredients statement, revised
labeling, commitment to fill data gaps on the schedule specified
by the Agency and, when applicable, offer to pay compensation
as required by 3(c)(l)(D) and 3(c)(2)(D) of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended,
7 U.S.C. 136(c)(l)(D) and 136(c)(2)(D). Registrants of end—use
products who qualify for the Formulator’s Exemption must submit
five (5) copies of draft labeling incorporating the unique label
statements identified in Section F.
E. Acceptable Ranges and Limits
Product Composition Standard
To conform to this Guidance Document, manufacturing—use products
must contain cyhexatin as the sole active ingredient. Each MP
formulation proposed for registration must be fully described
with an appropriate certification of limits, stating maximum
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and minimum amounts of the active and intentionally added inert
ingredients which will be present in products.
Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing—use products containing cyhexatin, provided that
the product labeling bears appropriate precautionary statements
for the acute toxicity category in which each product is placed.
The attached index entry lists all registered uses (and intrastate
label uses*) as well as approved maximum application rates and
frequencies.
F. Required Labeling
All manufacturing—use and end—use cyhexatin products must bear
appropriate labeling as specified in 40 CFR 162.10. In addition
to the above, the following information must appear on the
labeling:
1. Ingredient Statement
The ingredient statement for MPs must list the active ingredient
as:
Cyhexatin (tricyclohexyihydroxystannane) ... .......... ___
* Product uses that appear only on the labels of intrastate products
have not been subject to review under sec. 3 of the FIFRA.
Therefore, these uses may not be added to the label of any product
registered under sec. 3 until the supporting data have been
submitted, reviewed and found to be acceptable.
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2. Use Pattern Statements
All manufacturing—use cyhexatin products must state that they
are intended for formulation into other manufacturing—use
products or end—use products for uses accepted by the U.S.
Environmental Protection Agency. A limiting factor will be
data that supports these use patterns. No use may be included
on the label for which the registrant fails to agree to comply
with the data requirements in either Table A or Table B for
that use pattern. The attached “EPA Index to Registered
Pesticides” entry summarizes all currently acceptable uses for
cyhexatin including sites of application, target pests, dosage
rates, restrictions and limitations, and the method and
frequency of application.
3. Acute Toxicity Precautionary Statements
Labels for manufacturing—use cyhexatin products must bear
statements reflecting the compound’s acute human toxicity.
The acute oral and eye irritation toxicity data are sufficient
to categorize the current MP and EP formulations as Toxicity
Category II. The required precautionary statements associated
with this category are specified in 40 CFR 162.10.
4. Protective Clothing
Because of the reported incidents of dermatitis, the following
protective clothing statements are required for product labels.
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a. Manufacturing—Use Products :
“When handling this product wear chemically resistant
gloves.”
The use of goggles is also required.
b. End—Use Products :
“When mixing, loading, and applying wear chemically
resistant gloves.”
Use of goggles, a mask or pesticide respirator is required.
5. Environmental Hazards Statements
a. The following revised environmental hazard statement must
appear on all MP labels:
“ENVIRONMENTAL HAZARDS
This pesticide is toxic to fish and wildlife. Do not
discharge effluent containing this active ingredient
into lakes, streams, ponds, estuaries, oceans or public
waters unless this product is specifically identified
and addressed in an NPDES permit. Do not discharge
effluent containing this product to sewer systems without
previously notifying the sewage treatment plant authority.
For guidance contact your State Water Board or Regional
Office of the EPA.”
b. For end—use products the environmental hazards statement
shall read:
“ENVIRONMENTAL HAZARDS
This pesticide is toxic to fish and wildlife. Do not
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apply directly to water or wetlands. Drift and runoff
from treated areas may be hazardous to fish in neighboring
areas. Do not contaminate water by cleaning of equipment
or disposal of wastes. Cover or incorporate spills.”
6. EP labels must be revised to reduce the recommended spray
gallonage from 300—800 gallons to 300—500 gallons per acre
for ground application to pears, peaches, plums (prunes) and
nectar ines.
G. Tolerance Reassessment
The adequacy of the established tolerances (40 CFR 180.144,
21 CFR 193.430 and 561.400 and Table I), covering residues of
cyhexatin in crop and animal products cannot be determined at
the present time due to significant data gaps in residue
chemistry and toxicology. The nature of residues in plants
and animals and the chronic toxicity of cyhexatin has not
been adequately described. Available residue data are suffic-
ient to characterize the expected residue levels of cyhexatin
in or on the following raw agricultural commodities (RACs):
hops, macadamia nuts, and strawberries. Additional crop
residue data are required to support the established tolerances
for residues in or on peaches, plums, nectarines, apples,
pears, almonds, almond hulls, walnuts, and citrus fruits.
The adequacy of the tolerances for residues in dried citrus
pulp and dried apple pomace cannot be determined until the
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adequacy of the tolerances for residues in the RACS (apples
and citrus) has been ascertained. Data are available to the
Agency which Indicate that residues in dried prunes concentrate
by a factor of 7 over residues present in the raw agricultural
commodity. The tolerances for residues in dried prunes must
be revised from 1 ppm to 7 ppm to reflect this potential 7X
concentration. Additional data to support the established
tolerance of 30 ppm or a proposal for a tolerance revision
are needed for dried hops; data available to the Agency suggest
that a revision to 135 ppm may be appropriate.
In addition to the conclusions given above regarding established
tolerances, the following requirements pertain to residues in
processed products: (I) after the adequacy of the apple
tolerance is determined, a food additive tolerance at 3x that
of the tolerance for residues in or on apples must be proposed
for residues in wet apple pomace; (11) a food additive
tolerance at 22x that of the tolerance for residues in or on
citrus fruit must be proposed for residues In citrus oil;
(iii) a food and feed additive tolerance at 2x that of the
tolerance for residues in or on citrus fruit must be proposed
for residues in citrus molasses; and, (lv) data are needed to
determine whether residues concentrate in spent hops, a
processed product of fresh hops.
The food and feed additive tolerance mentioned above are
required because data available to the Agency indicate that
residues in processed fruits are greater than residues in raw
agricultural commodities.
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The acceptable daily intake (ADI) for cyhexatin was previously
based on the no observable effect level (NOEL) of 0.75 mg/kg
of the 2—year dog feeding study. However, a recent review of
this Study indicates effects at this level which was also the
lowest tested dosage level. Therefore, without a NOEL this
study is now classified as supplementary and can no longer be
utilized as a basis for an ADI calculation. There are no
other available appropriate studies to the Agency on which
the ADI for cyhexatiri can be based. The Agency has concluded
that the chronic toxicology is inadequate and therefore is
requiring the full complement of studies: chronic feeding,
oncogenicity, reproduction and teratology studies.
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Cyhexatin
TABLE I
SUMMARY OF PRESENT IOLERANCES
Iblerances (p zii)
Camodity United states / Canadab/ Mexico International (ODdex)C/
Almonds 0.5 0.3 — —
Almond Hulls 60.0
Apples 2.0 2.0 2.0
Apple pw ace (dried) 8.0 -— ——
Cattle, fat 0.2
Cattle, kidney 0.5
Cattle, liver 0.5
Cattle, MBYP 0.2
(exec. kidney, liver)
Cattle, meat 0.2 0.5
Citrus fruits 2.0 2.0 2.0
Citrus pulp (dried) 8.0 ——— ——
Goat, fat 0.2
Goat, kidney 0.5
Goat, liver 0.5
Goats, MBYP 0.2
(except kideny, liver)
Goat, meat 0.2 0.5
Hogs, fat 0.2
Hogs, kidney 0.5
Hogs, liver 0.5
Hogs, MBYP 0.2
(exec. kidney, liver)
Hogs, meat 0.2 0.5
Hops 30.0
Hops (dried) 90.0
Horses, fat 0.2
Horses, kidney 0.5
Horses, liver 0.5
Horses, MBYP 0.2
(exec. kidney, liver)
Horses, meat 0.2 0.5
Macadamia nuts 0.5
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Cyhexatin
TABLE I
SUMMARY OF PRESENT IOLER NCES (Con’ t.)
lblerances (pun)
Camnodity United States / Canadab/ Mexico International (Codex)C /
Milk, fat 0.05
(= N in whole milk)
Necatrines 4.0
Peaches 4.0 4.0 5.0
Pears 2.0 2.0 2.0
Plums or Prunes (fresh) 1.0 1.0 2.0
Prunes (dried) 4.0
Sheep, fat 0.2
Sheep, kidney 0.5
Sheep, liver 0.5
Sheep, MBYP 0.2
(exec. kidney, liver)
Sheep, meat 0.2 0.5
Strawberries 3.0 2.0 2.0
Walnuts 0.5 0.3
Note, a = The U.S. tolerance is expressed in terms of residues of cyhexatin and
its organotin metabolites; b = The Canadian tolerance in terms of canbined
residues of cyhexatin D(iflO and CHSA; C = Cocex is for cyhexatin and DCHm.
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TP BLE A
G ERIC DATP Rg UIR 4 N1S F R CfHEXATIN
Data Must
Be
Guideline Citation and
Test
Guidelines
Are Data
Footnote
Submitted
Within
Name
of
Test
Substance
Status
I quired
Yes t’b
Number
TinEframes
Below 2/
Listed
§158.120 Product th nistry
Product Identity :
61-2 — Product Identity and Disclosure 1 A1 R [ X I [ =1 __________ 7 Months
of Ir redients
61-3 - Discussion of Formation of ICAI R [ X I [ 1 __________ 7 Months
Impurities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis ]XAI CR [ ] [ J ___________ 12 Months
Physical and th nical tharacteristics
63-2 - Qlor R [ :j [ J __________
63—3 — Physical State R [ ] [ ] ___________ — —
63-4 - Odor 1 I R [ ) fl __________ 7 Months
63—5 - Melting Point R fl [ ] __________
63—6 — Boiling Point R [ J [ ] __________
23
-------
TABLE A
GF 4ERIC DATA R tJIRE 4 rs FOR CYHE (ATIN
Guideline Citation and
Data must
Be
Nan
of
Test
Test
Substance l
Guidelines
Status
Are Data
Required
Footnote
Number
Sut itted
Tin frames
Within
Listed
§158.120 Product th nistry (Continued)
Physical and theinical tharacteristics
(Continued)
63—7 —
1 AI
63—8
63—9
63—10
63—11
R
Density, Bulk Density, or
Specific Gravity
— Solubility
— Vapor Pressure
— Dissociation constant
— Octanol/water partition
coefficient
[ ]
63—12 — pH
63—13 — Stability
Other Requirements :
64— 1 — Sut nitta1 of samples
lGAIorpAI
PAl
PAl
PAl
R
R
R
R
1)
i=i
[ X]
LX]
[ ]
[ J
[ 1
[ ]
7
7
Months
Months
l AI
1 AI
R
LX]
[ 1
7
Months
1/
‘IGAI
= Technical Grade of the
Active
Ingredient;
CR = Conditionally Required.
PM =
Pure
Active
Ingredient;
R
=
Required;
2/
Data
must be suth itted within
the indicated
Standard (see front
tiimefrarmes
which
begin
on
the
date
of
the
Registration
24
-------
TABLE A
GENERIC DATA REX)UIRF24E SflS FOR CYHEXATIN
t es EPA Have Data
Must Additional Data
i Satisfy This
Be Sub nitted Under
1/
Requirement? (Yes,
Bibliographic
FIFRA § 3(c)(2)(B)?
Data Requirements
Canposition
No, or Partially)
Citation
Timefrarnes For Data
Sut nission 2/
§158.125 Residue the’nistry
171—4 — Nature of Residue (Metabolism)
— Plants PAIRA Partially 00034893, 00080462, 00081491, Yes 3 24 Months
00112208, 00112217, 00040803,
00071437, 00112230, 00065985,
00108766, 00112232, 00065986
00112181, 00112236, 00065987,
00112207, 00112237, 00065991,
00112218, 00065993, 00112220,
00112225
— Livestock PAIRA and Plant Partially 00112187, 00112217 Yes 4 18 Months
Metabol ites
171—4 — Residue Analytical Method
— Plant residues TGAI and Yes 00040803, 00071437, 00112236, Reserved
Metabolites 00065985, 00108766, 00112237,
00065986, 00112218, 00065987,
00112225, 00065991, 00065993,
00112232
— Animal residues B3A1 and Yes 00112207, 00112218, 00112220,
Metabolites 00112230 Reserved
171—4 — Storage Stability Data PAl Partially 00108766, 00112225 Yes 6 13 Months
171-4 — Magnitude of the Residue—
Residue Studies for Each
Food Use
Citrus Fruits Group TEP Partially 00112236 Yes 7 24 Months
25
-------
TABLE A
GENERIC DA TA R OUIREMENIS FOR
es EPA Have Data
1b Satisfy This
1/ I qui rez nt? (Yes,
Cat position No, or Partially)
Data 1 quirements
CYHEXATIN
Must Mditional
Be Sutxnitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Timefran s Fbr Data
Su1znission 2/
§158.125 I sidue theinistry (continued )
171—4 — Magnitude of the Residue —
Residue Studies
Pate Fruits Group
Apples
Pears
Stone Fruits Group
Nectari nes
Peaches
Pl s
all Fruits and Berries
Group
Strawberries
Tree Nuts Group
Alnvnds
Macadamia Nuts
TEP
No
—
Yes 8
24
Months
TEP
Partially
00052033,
00065986,
00112218,
00065984,
00065987,
00112236
00065985,
00112181,
Yes 9
24
Months
TEP
Partially
00052033,
00112181,
00065986,
00112236
00065987,
Yes 1 °
24
Months
TEP
No
—
Yes 1 ’
24
Months
TEP
Partially
00040803
Yes 12
24
Months
TEP
Partially
00040803
Yes 13
24
Months
TEP
Partially
00040803,
00112237
Yes 14
24
Months
TEP
No
—
Yes 15
24
Months
TEP
Yes
00040803
No
‘rEp
io
—
Yes’ 6
24
Months
‘rEP
Partially
00040803,
00112237
Yes 17
24
Months
‘rEP
Yes
00112225
26
-------
TABLE A
GF2 ERIC DF TA REY JIRE 4EN S FOR CYHFXATIN
1/
Data Requirements O nposition
Does EPA Have Data
lb Satisfy This
Require nt? (Yes, Bibliographic
No, or Partially) Citation
Must Mditional Data
Be Suhnitted Under
FIFRA § 3(c)(2)(B)?
Timeframes For Data
Sutrnission 2/
§158.125 Residue themistry (continued)
Walnuts TEP
Yes 00040803, 00112237
Yes 18 24 t4Dnths
Misc. OciriTodities —
— —
No
Hops TEP
Partially 00108766
Yes 19 24 Months
Meat/milk/poultry/eggs TEP
Partially 00112207, 00112230, 00112232 Reserved 20 18 Months
1/ Cnnpos it ion: 1 AI = l chnical grade of the active ingredient; EP = End—use product.
/ Data must be suthiitted within the irxiicated tineframes which begin on the date of the Registration
Standard (see front cover).
27
-------
TABLE A
GENERIC DATA R UIREMENTS FOR CYHEXATIN
§158.125 Residue chemistry (continued )
3/ Data reflecting the distribution and metabolism of ring—labeled [ “ 9 Sn]cyhexatin in a tree fruit
(preferably apples) following foliar application at 3 lb ai/A are required.
4/ Metabolism studies utilizing runinants are needed. Animals must be dosed for 3 days with ring—labeled
[ ll 9 Sn]cyhexatin at a level sufficient to make residue identification possible. Milk must be collected
twice daily during the dosing period. Animals must be sacrificed within 24 hours of the final dose.
The distribution and characterization of residues must be determined in milk, liver, kidney, muscle, and
fat. Metabolism studies utilizing poultry are required. Hens must be dosed with ring—labeled [ l 19 Sn]
cyhexatin for 3 days at a level sufficient to permit residue identification. Eggs must be collected
twice daily during the dosing period. Animals must be sacrificed within 24 hours of the final dose and
residues characterized in eggs, muscle, liver, kidney, and fat.
5/ Should the data which were requested in the section entitled “Nature of the Residue in Plants” and
“Nature of the Residue in Animals” indicate additional metabolites of toxicological concern or that the
methods will not adequately determine all residues of concern, then subnission of additional validated
methods for data collection and tolerance enforcement will be required. The [ -‘ 9 Sn]cyhexatin labeled
samples should be analyzed by both radiocounting techniques and “cold” enforcement methodology to deter-
mine the percent of the total residue measured by the enforcement method.
6/ The available storage stability data are acceptable for plant cam dities; however, no data pertaining
to the stability of cyhexatin residues in animal tissues or products were presented, thus, constituting
a data gap.
7/ Data are needed depicting residues of cyhexatin in or on oranges, grapefruit, and lemons harvested the
same day as the last of six foliar treatments at 10— to 14—day intervals with the 50% WP at 0.1875 lb
ai/100 gal using a spray volume to runoff. Tests must be conducted in FL and CA. Alternatively, must
clarify the total spray volume utilized for data submitted under PP*3F1312 (117973). A food additive
tolerance for citrus oil and citrus n lasses at respective levels of 22x and 2x the residues found in or
on whole citrus must be proposed. Art appropriate feed additive tolerance for citrus nolasses at 2x the
residues found in or on whole citrus must be proposed and, if necessary, a revision of the existing 8 ppTi
feed additive tolerance for residues in dried citrus pulp is required.
8/ Tb establish a pane fruits group tolerance additional data must be submitted for apples and pears.
See footnotes 9 and 10 below.
9/ Information must be provided as to the gal/ Japplication applied in the high—volume ground application
data submitted; alternatively, data must be submitted which reflect residues in or on apples harvested
14 days after the last of four applications at 1.5 lb ai/800 gal/A. Tests must be conducted in all the
major U.S. apple production regions. A food additive tolerance must be proposed for residues in wet
apple panace at 3x that of the accepted tolerance for residues in or on the raw agricultural cam odity
(apples).
28
-------
TABLE A
GE 4ERIC DATA RE) UIREM NTS R)R CYHFXATIN
§158.125 Residue ch nistry (continued )
10/ The available data provide insufficient support for the established tolerance for the following reasons:
(i) gal/A rates were not provided for high—volume ground applications; (ii) the aerial data do not
reflect use of a registered formulation; and (iii) no low—volume ground application data were provided.
In our opinion, the available ULV aerial data for apples may be used to support low-volume ground and
aerial use on pears. Also, since data have been requested reflecting high—volume ground applications
to apples, no additional data reflecting such use on pears are needed. It should be noted, however,
that translated data not be used to support a crop group tolerance.
11/ lb establish a stone fruiE group tolerance additional data must be sutinitted for peaches and plums
(prunes) (see footnotes 13 and 14 below) and for one additional crop member of this group. Data for
cherries are currently under review.
12/ Available data are insufficient for the evaluation of the adequacy of the established tolerance for the
canbined residues for cyhexatin and its organotin metabolites in or on nectarines since no data were
sutxnitted reflecting aerial or IJLV ground application. No additional data reflecting aerial application
will be required since the aerial application data requested for peaches may be translated to nectarines.
However, the following additional data are required:
° Data fran tests (in CA) reflecting low volume (40 gal/A) ground application of the 50% WP at 1.25
lb ai/A at a seasonal maximum of 3 lb ai/A; samples must be harvested on the day of the last
application.
13/ Residue data for peaches in CA and SC receiving aerial treatment of the 50% WP at 1.25 lb ai/A in 15 gal
water, reflecting a seasonal use rate of 3 lb ai/A, and a 1—day PHI are required. Residue data for
peaches are required. Samples must be collected on the day of the last treatment. Also, additional
data fran tests in CA reflecting ULV ground and aerial application of 1.25 lb ai/A in at least 15 gal
water/A, and a seasonal use rate of 3.0 lb ai/A, must be subititted.
14/ Residue data f ran tests in CA, using ground equi inent to apply the 50% WP at 4.5 lb ai/A per season, at
0.1875 lb ai/100 gal of water (dilute spray), and, in separate tests, at 1.25 lb ai/A (40 gal/A) are
required. Samples must be collected iitmediately after the last treatment. Residue data fran CA tests
reflecting aerial application of the 50% WP at 1.25/15 gal/A (using 3 lb ai/A per season), and a 1—day
PHI are required. An appropriate tolerance revision must be proposed for residues in or on dried prunes.
15/ lb establish a nall fruits and berries group tolerance residue data are required for three additional
crop members of this group (blackberry or other Rubus spp., blueberry and cranberry).
16/ m establish a tree nuts group tolerance additional data are needed for a]JnDnds and walnuts (see
footnotes 17 and 18 below) and for an additional representative nut crop (pecans).
29
-------
TABLE A
GENERIC D .TA REI)UIREMF1 1TS FOR CYHE (ATIN
§158.125 1 sidue th nistry (continued )
17/ Residue levels on or in almonds and almond hulls fran trees receiving at least three applications of
— 1.25 lb ai/A of the 50% WP (for a seasonal total of at least 4.5 lb ai/A) by ground ULV application,
with a 0—day PHI are required. These tests must be conducted in CA. Additional data on residues on/in
almond hulls and nuts are required. These data must be fran CA tests reflecting a 1.25 lb al/A use rate,
a seasonal use rate of 4.5 lb ai/A, ULV application by ground equiprent, and no PHI.
18/ The available data are inadequate for the determination of the adequacy of the established tolerance for
— residues of cyhexatin and its organotin metabolites in or on walnuts, since only one test reflecting ULV
application was subnitted (and it did not reflect a 0—day PHI). The required data for ULV ground
application for almonds can be translated to walnuts. These translated data cannot be used to support a
crop group tolerance.
19/ Data reflecting residues in dried hops processed f ran fresh hops bearing measurable weathered residues
are required. Alternatively, the tolerance for residues in dried hops may be revised. If so, we recan—
mend a level of 135 p n (4.5 x 30). Data reflecting residues in spent hops processed f ran fresh hops
bearing measurable weathered residues are required. If residues are found to concentrate in spent hops,
an appropriate feed additive tolerance must be proposed.
20/ The nature of residues in ruminants (including milk) and poultry (including eggs) is not adequately
understood. The adequacy of the established tolerances and of the data sut nitted in support of the
established tolerances cannot be assessed at the present tine. Upon receipt of the data required under
the section “Nature of Residue in Animals,” the adequacy of the available data and the established
tolerances will be assessed.
30
-------
161—4 — In air
MflABOLISM SIUDIES-LAB :
162—1 — Aerobic Soil
162—2 — Anaerobic Soil
)BILITY SIUDIES :
163—1 — Leachir and
Adsorption/Desorption
— Volatility (Lab)
— Volatility (Field)
TABLE A
GENERIC DATA RB UIREME Th FDR CYHEXATIN
tXDes EPA Have Data
Ib Satisfy This
1/ Use 2/ Requirement?
O position Pattern (Yes, No
or Partially)
Data Requirement
Must Additional Data
Be Sut nitted Under
Bib1i raphic
FIFRA § 3(c)(2)(B)?
Citation
Timeframe for Data
Su1mission 3/
§158.130 Envirorunental Fate
DEXRAD TICI SIUDI ES-LAB :
161—1 — Hydrolysis
Photodegradat ion
161—2 — In water
161—3 — on soil
1CJ 1
or
PAIRA
A,B,F
No
Yes 9
Months
IGAI
or
PAIRA
A,B
No
Yes 9
Months
1t AI
or
PAIRA
A
No
Yes 9
Months
113A1
or
PAIRA
A
No
Reserved 4
ICAI
or
PAIRA
A,B,F
No
Yes 27
Months
RA1
or
PAIRA
A
No
Yes 27
Months
‘IT AI
or
PAIRA
A,B,F
No
00034894
00034895
Yes 12
Months
00081485, 0008148
163—2
163—3
ThP
TEP
N/A 4
N/A 4
No
No
31
-------
TABLE A
GENERIC DATA REX)(JIRE 4ENIS FOR CYH (ATIN
IXes EPA Have
Data
Must Additional Data
To Satisfy This
Be Subnitted Under
Data
1 quirement
/
Cc nposition
Use 2/
Pattern
Requiren nt?
(Yes, No
or Partially)
Bibli raphic
Citation
FIFRA § 3(c)(2)(B)?
Timefraitie for Data
Sutznission 3/
§158.130 E)wironmental Fate (continued)
DISSIP ICN S1’UDIES-FIELD :
164—1 — Soil TEP A,B No Yes 27 fvbnths
164-4 - Caiibinat ion and N/A No 5
Tank Mixes
164-5 - Soil, Lang-term TEP A No R eserved 6 —
ACCUMULATION STUDIES :
165-1 — I tational Cr s PAIRA A No Yes 39 Months
(Confined)
165—2 — 1 tational Crops TEP A No Reserved 7 —
(Field)
165—4 — In Fish ‘1 AI or PAIRA A,B No Yes 12 Months
32
-------
TABLE A
G ERIC DATA R JIREME 4TS FOR CYHF (ATIN
§158.130 wironmenta1 Fate (continued )
1/ Canposition: IGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radio-
labeled; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crc ; B = Terrestrial, Non-Food;
C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food;
G = Forestry; H = Dcziestic Outdoor; I = Indoor.
3/ Data must be subnitted within the indicated tin franes which begin on the date of the Registration
Standard (see front cover).
4/ No data are required because cyhexatin has negligible vapor pressure.
5/ This Guidance IXcunent deals only with single active ingredients.
6/ No data are required pending the results of n taboli i and field dissipation studies.
7/ Data may be required, depending upon the results of the confined studies.
33
-------
TABLE A
GFNERIC DATA RE UIRE24FN1’S Ft R CYHE CATIN
Does
EPA Have
Must Mditional Data
Data
lb Satisfy
Be Sub nitted Under
Data
Requiren nt
1/
Canposition
Use 2/
Pattern
This Require—
nent? (Yes,
or Partially)
No
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Sutrnission 3/
§158.140 Reentry Protection
132—1 — Foliar Dissipation A,B No Reserved 3
132—2 — Soil Dissipation TEP A,B Reserved 3
132-3 - Dermal Exposure TEP A,B Reserved 3
132—4 - Inhalation Exposure TEP A,B No Reserved 3
1/ Canposition: TEP = Typical end—use product.
2/ The use patterns are coded as follows: A = 1 rrestrial, Food Crop; B = T rrestrial, Non—Food;
C = Aquatic, Food Crop; D = Aquatic, Non—Food; E = Greenhouse, Food Crop; F = Greenhouse, Non—Food;
G = Forestry; H = EOi stic Outdoor; I = Indoor.
3/ Data to support the establishment of reentry standards are reserved. No reentry intervals are
needed for cyhexatin based on available environmental fate and toxicological data. H ver, if
results of new required toxicity studies indicate potential problems, then studies will be required.
34
-------
1/
Data 1 guir ent canposition
Use 2/
Pattern
TABLE A
GENERIC DATA REX)UIREMENI’S FOR CYHE ATIN
Does EPA Have
Data Tb Satisfy
This Require-
r nt? (Yes, No
or Partially)
Must Mditional
Be Suhiiltted Under
FIFRA
3(c)(2)(B)?
Bibliographic
Citation
§
Timeframe for Data
Sutinission 3/
§158.135 Tbxicology
ACUTE TESTING :
81—1 — Oral Rat
81—2 — Acute Derrnal
81—3 — Acute Inhalation — Rat
81—7 — Acute Delayed
Neurotoxicity — Hen
SUBCHFONIC TESTING :
82-1 - 90-Day Feedir —
I x1ent, Non—rodent
82—2 — 21—Day Dermal
82—3 - 90—Day Dermal
82—4 - 90-Day Inhalation -
Rat
82—5 — 90—Day Neurotoxicity —
Hen/Maninal
TGAI
A,B,F
Yes
]XAI
A,B,F
No
Yes
TG1 I
A,B,F
Yes
00112180
No
1t AI
A,B,F
N/A 4
No
A,B,F
N/A 5
No
I AI
A,BF
No
yes
IGAI
A,B,F
N/AS
No
10A 1
A,B,F
N/A 5
No
9 Months
12 Months
35
-------
§158.135 Toxicology
( continued)
CH1 JNIC TESTING :
83—1 — Chronic Toxicity —
2 species: WxIent
arKi Non—rodent
83—2 — Oncogenicity Study —
2 species: Rat and
Mouse preferred
83—3 — 1 ratcr3enicity —
2 species
83—4 — Reproduction,
2—ge nerat ion
MTN 4ICI1”f TESTING :
84—2 - Gene Mutation
84—2 — thrai saua1 Aberration
84—4 - Other Mechani ns of
Mutagenicity
1/ Use 2/
Data Requirement Q position Pattern
TABLE A
GENERIC DATA REX UIREMENTS FOR CYHEXATIN
r es EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Alditional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Subiiission 3/
Bibliographic
Citation
mAI
A,B,F
No
—
Yes
50
Months
1GAI
A,B,F
No
—
Yes
50
Months
I AI
A,B,F
No
—
Yes
15
Months
IGAI
A, B, F
No
-
Yes
39
Months
It AI
A,B,F
No
Yes
9
Months
]XA1
A,, F
No
Yes
12
Months
ICAI
A, B, F
No
Yes
12
Months
36
-------
TABLE A
GENERIC DATA RD UIRE 4ENI’S FOR CYHD ATIN
Does EPA Have
Must klditional Date
Data To Satisfy
Be Suthiitted Under
Data Requirement
1/
Canposition
use 2/
Pattern
This Require—
ment? (Yes,
or Partially)
No
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Sutxnission 3/
§158.135 Toxicology
(continued)
SPECIAL TESTI 3
85-1 — Ger ra1 Metabolism
PM or PAIRA
A,B,F
Yes
00112206
No
1/ Ccxnposition: IGAI = Technical grade of the active ingredient.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crc , B = Terrestrial, Non—Food; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
H = IXn stic Outdoor; I = Indoor.
3/ Data must be sutinitted within the indicated timefran s which begin on the date of the Registration
Standard (see front cover).
4/ Cyhexatin is neither an organophosphate, nor an analog of the neurotoxic ccinpound, hence, no delayed
neurotoxicity study is required.
5/ Not applicable.
37
-------
TABLE A
GE 4ERIC DATA RB UIREMEN S FOR C HEXkTIN
toes
EPA Have
Must Pdditional
Data
To Satisfy
Data
Be Sutinitted Under
1/
Use 2/
This
Require—
Bibli raphic
FIFRA § 3(c)(2)(B)?
Data
Requirement
Cc position
Pattern
ment?
or Pa
(Yes, No
rtially)
Citation
Tirneframe for Data
Suth ission 3/
S158.145 Wildlife and
Aquatic Organi s
AVIAN AND MAMMALIAN TESTING :
71—1 — Avian Oral LD ItAI A,BF Partially 00112178 Yes 4 9 Months
71—2 — Avian Dietary LC 50
a. ter fowl ‘I GA I A,B No
b. Upland game IGAI A,B,F Partially 00112178 Yes 4 9 Months
71—3 - Wild Man nal Toxicity It A1 A N/A
71—4 - Avian Reproduction A,B No Yes 5 24 Months
71—5 — Simulated and Actual TEP A,B No Reserved 6
Field Testir —
Manmals and Birds
NJIJATIC ORGANISM TESTING :
72—1 — Freshwater Fish LC5o
a. rrnwater 1T AI A,B,F Yes 00003503* No
GS00237001*
b. Goldwater ¶IGAI A,B Yes 00081739* No
TEP A Yes GS00237002* Reserved 7
00081743**
72—2 — Acute LC 50 Freshwater IGAI A,B,F Yes 00003503 No
Invertebrate
72—3 - Acute LC Freshwater ‘IGAI
and Marine Organi us
a. Shrimp A No None Yes 8 12 Months
b. Marine fish A No None Yes 8
C. Oyster A No None Yes 8
38
-------
TABLE A
GENERIC DA TA RD UIREME2,flS OR CYHEXATIN
Data Requirement
1/
Ccznposition
Use 2/
Pattern
Does EPA Have
Data lb Satisfy
This Require—
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must .½iditional Data
Be Sub nitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Sulmiission 3/
§158.145 Wildlife and
Aquatic Organisms (continued)
l AI
A,B
No
-
Reserved 9 !
72—4 — Fish Early Life-Stage
and Aquatic Inverte-
brate Life—Cycle
75-5 — Fish Life—Cycle
IT3AI
A,B
No
-
Reserved l O/
72-6 — Aquatic Organism
Accumulation
l AI, PAl OR
E gradat ion
Product
A,B
N/A
-
-
72—7 — Simulated or Actual
Field Testing—
Aquatic Organisms
TEP
A,B
No
-
Reserved 10 !
1/ Cmpcsit ion: l AI = Technical grade of the active ingredient; PAl = pure ingredient; TEP = Typical end—use product;
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food Crcp; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Dcmestic
Outdoor; I = Indoor.
3/ Data must be suhmitted within the indicated timeframes which begin on the date of the Registration Standard (see
front cover).
4/ The acute LC 50 is only supplemental because the birds were below the minimum age of 10 days. The acute oral LD
is supplemental because the birds were below the minimum age of 16 weeks.
5/ Avian reproduction study is required since repeat applications are allowed.
6/ Preliminary toxicity data indicate cyhexatin is “highly toxic” to birds. However, the lack of certain environmental
fate and ecological effects studies prevent a requirement at this time for field testing. Upon f ency receipt and
review of those studies, this field testing study may be required.
39
-------
TABLE P
GENERIC DATA REOIJIREMENTS FOR CHE 4ICAL CYHEXATIN
§158.145 Wildlife and Aquatic Organi ns (continued )
7/ Pending environmental fate studies needed to develop an estimated environmental concentration.
8/ Acute estuarine and marine studies are required for crc s which are grown in excess of 300,000 acres in coastal
counties. Of the currently registered uses, cotton and citrus meet this requirement.
9/ Fish early life—st& e and aquatic invertebrate life—cycle studies are reserved since the environmental fate data
are not sufficient for canputer n deling. In addition, the guideline trigger for persistence in water cannot be
addressed until a valid study is available.
10/ The requirement for fish life—cycle and simulated or actual field testing, and for aquatic organisms is reserved,
pending the requirement and results of the fish early life—stage and aquatic invertebrate life—cycle studies.
* Study on its own fulfills the requirement.
** Study does not on its own fulfill the requirement.
40
-------
1 /
Data Requirmi nt Canposition
Use 2/
Pattern
ThBLE A
GENERIC DATA RB UIRE 4E TS FOR CYHE ATIN
r es EPA Have
Data 1 Satisfy
This Require—
n nt? (Yes, No
or Partially)
Must Additional Data
Be Suhnitted Under
Biblicx raphic
FIFRA § 3(c)(2)(B)?
Citation
Timeframe for Data
Sut inission 3/
§158.150 Plant Protection
121—1 - TA1 3ET AREA EP B No — No 3 —
PH?ItT IOXICITY
NONTA AREA PIFt”IOIOXICITY:
TIER I
122-1 - Seed Germination! I AI B No - No 3 —
Seedling F rgence
122—1 — Vegetative Vigor IGAI B No — No 3 —
122—2 — Aquatic plant Growth TGAI B No — No 3 —
TIER II
123-1 - Seed Germination/ IG A l B No - No 3 —
Seedling DT rgence
123—1 — Vegetative Vigor .i i B No — No 3 —
123—2 - Aquatic Plant Growth IGAI B No - No 3 —
TIER III
124—1 — rrestria1 Field TEP B No — No 3 —
12 4—2 — Aquatic Field TEP B No — No 3 —
1/ Canposition: ]1AI = i chnical grade of the active ingredient; TEP = 1 ’pical end—use product.
2/ The use patterns are coded as follows: A = rrestria1, Food Crop; B = i rrestrial, Non—Food Crop; C = Aquatic, Food
Crop; D = Aquatic, Non—Food; E = Greenhouse, Food Crop; F = Greenhouse, Non—Food; G = Forestry; H = Danestic aitdoor;
I = Indoor.
3/ These data are not required because it is believed there is no phytotoxicity problem with cyhexatin.
41
-------
TABLE A
GE2 ERIC DATA RB iJIREMFNTS FOR CYHEXATIN
t)es
EPA Have
Must Additional Data
Data
To Satisfy
Be Suthiitted Under
Data
Requirement
1/
Cci position
Use 2/
Pattern
This Require—
nent? (Yes,
or Partially)
No
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Su iission 3/
§158.155 Nontarget Insect
NONTA1 3ET INSEO TESTING -
POILINNIORS :
141—1 — Honeybee acute i AI A,B Yes 00018842 No
contact LD 50
141-2 - Honeybee — toxicity TEP A,B No No 3 !
of residues on
foliage
141-4 - Honeybee subacute Reserved 4 !
feeding study
141—5 — Field testing for TEP A,B No 3 !
pollinators
42
-------
TABLE A
GENERIC DATA RD UIRE24E TS OR CYHE CATIN
1/
Data Requir ent Canposition
Use 2/
Pattern
Does EPA Have
Data TO Satisfy
This Require—
n nt? (Yes, No
or Partially)
Bib1io raphic
Citation
Must Additional Data
Be SuLxnitted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
SuL znission 3/
§158.155 Nontarget Insect (continued)
NON AI 3ET INSECT TESTING —
PQUATIC INSECTS:
142—1 — Acute toxicity to (Reserved)
aquatic insects
—
—
-
Reserved 5 /
142—2 — Aquatic insect (Reserved)
life—cycle study
—
—
-
R eserved 5 /
142—3 — Simulated or actual (Reserved)
field testing for
aquatic insects
—
—
-
lReserved 5 /
143—1 — NONTM 3ET INSECT (Reserved)
TESTING — PREDAIORS
thru AND PARASITES
143—3
—
—
-
Reserved 5 /
1/ Canposition: I AI = Technical grade of the active ingredient; TEP = Typical end—use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop;
D = Aqautic, Non—Food; E = Greenhouse, Food Crop; F = Greenhouse, Non—Food; G = Forestry; H = iX nestic Cxitdoor;
I = Indoor.
3/ As the data fran the acute contact study indicate low toxicity, no further testing is required.
4/ Reserved pending develo nt of test n thodology.
5/ Reserved pending Agency decision as to whether the data requiren nt should be established.
43
-------
TABLE B
P1 DWCT SPECIFIC DATA REQUIREMENTS FOR MANUFACIURING-USE P1 )CUC S (XNFAINING CYHDATIN
Tricyclohexylhydroxystann e— 464—451
Guideline Citation and
Test
Guidelines
Are
Data
Nan
of
Test
Substance 1
Status
1 qu
Yes
ired
No
Timaf
Must
rames
Be Sulinitted
Listed
Within
Below 2
§158.120 Product th nistry
Product Identity :
61—1 - Product Identity and Disclosure MP R [ ) [ ] 6 Months
of Ingredients
61—2 — Dascription of Beginning Materials MP R ( ] [ ] 6 Months
and Manufacturing Process
61—3 - Discussion of Formation of MP R [ 1 [ ] 6 Months
Impurities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis MP CR [ ] EJ 12 Months
62—2 — Certification of Limits MP R [ X I [ ) 12 Months
62—3 — Analytical Methods to Verify MP R [ I [ 1 12 Months
Certified Limit
Physical and th ical tharacteristics
63—2 — Color MP R ( ) [ ] 6 Months
63—3 — Physical State jp R [ ) [ 1 6 Months
63—4 - Ckior MP R [ XI Li 6 Months
: : : : : : : :::;:: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :‘: : :
44
-------
TABLE B
P1 DWC SPECIFIC DATA RgXJIREM NrS FOR MANUFACIURING—USE PI )DUCI’S C AINING CYHEXATIN
Tricyclohexylhydroxystannane_ 464—451
Guideline Citation and
st
Guidelines
Name
of st
Substance’
Status
Are Data
Required
Yes
Data Must
Timeframes
Be Sut!nitted Within
Listed Below 2
§158.120 Product th rtistry (continued)
Physical and th nica1 Characteristics
( Continued )
63—7 - Dansity, Bulk Dansity, or MP R [ ] (1 6 Months
Specific Gravity
6 3—12 — pH MP CR [ ] [ =1 6 Months
63—14 — Oxidizing or Reducir MP CR ( ] [ ] 6 Months
Action
63—15 — Flazrii ability MP CR [ ] [ ] 6 Months
63—16 — Explodability NP R [ ] [ ] 6 Months
63—17 — Storage Stability MP R E ] [ ] 15 Months
63—18 — Viscosity NP CR [ ) [ ] 6 Months
63—19 — Miscibility MP CR E ] [ ] 6 Months
63—20 — Corrosion Characteristics NP R E ] [ 1 15 Months
Other Requirements :
64— 1 — Suhnittal of samples M1 CR [ 1 [ ]
1/ MP = Manufacturir —use Product; R = Required; CR = Conditionally Required.
2/ Data must be suLinitted within the indicated timeframes which begin on the date of the Registration Standard (see
front cover).
45
-------
TABLE B
P1 DEXJCF SPECIFIC DATA RFX (JIR 4E flS RDR MANUFACTURING-USE PI DDUC’1S (XN AINING CYHEXATIN
Tricyclohexyihydroxystannane— 464—451
Data I quiren nt
1/
(Xrnpc ition
I es EPA Have
Data Tb Satisfy
This I quire—
nent? (Yes, No
or Partially)
Bibliographic
Citation
Must £ 1ditional Data
Be Sut ititted Under
FIFRA § 3(c)(2)(B)?
Timeframe for Data
Sut nission 3/
§158.135 Ibxicology
AQfl TESTING:
81—1 — Acute Oral — Rat
MP
Yes
00080464
No
81—2 — Acute Dermal
tiP
No
-
Yes 9 t .tnths
81—3 — Acute Inhalation — Rat
NP
Yes
00112180
No
81—4 — Primary Eye
Irritation — Rabbit
M I ’
Yes
00112183
No
81—5 — Primary Dermal
Irritation
NP
Yes
00112215
No
81—6 — Dermal Sensitization
NP
Yes
00081748
No
1/ Canposition: MP = Manufacturir —use product.
2/ Data must be sulxnitted within the indicated tin franes which begin on the date of the Registration Starxlard (see front
cover).
46
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EPA Index to Pesticide Chemic.als
101601 CYHEXATIN*
TYPE PESTICIDE : Acaricide
FORMULATIONS :
Tech (95%)
wP (50%)
GENH .AL WARNINGS AND LIMITATIONS : Apply when pests first appear and re-
peat as needed to prevent buildup of damaging populations. If all life
stages of mites are present at the time of application, a repeat applica-
tion shou.ld.be considered in 10 to 14 days. Thorough coverage of foliage
and fruit is essential for adequate control.
Agricultural Crop Tolerances :
Macadamia Nuts — 0.5 ppm
Lives tock Tolerances :
Cattle (fat, meat, meat byproducts excluding kidney and liver) — 0.2 ppm
Cattle (kidney and liver) — 0.5 ppm
Goats (fat, meat, meat byproducts excluding kidney and liver) — 0.2 ppm
Goats (kidney and liver) — 0.5 ppm -
Hogs (fat, meat, meat byproducts including kidney and liver) — 0.2 ppm
Hogs (kidney and liver) — 0.5 ppm
Horses (fat, meat, meat byproducts including kidney and liver) — 0.2 ppm
Horses (kidney and liver) — 0.5 ppm
Milk (fat) — 0.05 ppm
Sheep (fat, meat, meat byproducts excluding kidney and liver) — 0.2 ppm
Sheep (kidney and liver) — 0.5 ppm
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
T RESTRIAL FOOD CROP
General Warnings and Limitations : Do not tank mix with petroleum distil-
late (dormant or summer oils) or apply in the same growing season as vary-
ing degrees of foliar and fruit injury will occur to almond, nectarine,
peach, plum, strawberry, and walnut.
*p ljctran
tn cyclohexylbydroxystannane
tricyclohexyltin hydroxide
Issued: 10—28—83 1 1 1—101601—i
47
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EPA Index to Pesticide Chemicals
CYHEXATIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s )
]30 0lkA Almond 0.5 ppm (almonds, walnuts)
33009AA Walnut 60 ppm (almond hulls)
No preharvest interval through 1.5
pounds per acre for foliar applica—
t ion.
Do not apply more than 3 pounds per
acre during the growing season.
Do not feed or allow livestock to
graze on cover crops growing in
treated areas.
LAVASA European red mite 0.125—0.1875 Foliar application.
LAVBAA Pacific spider mite lb/lOO gal
LAVBEA Twospotted spider [ 300—800
mite gal/A]
or
0.5—1.25 lb/A
(50% WP)
O4001AA Apple 2 ppm (apple)
8 ppm (dried apple pomace)
14 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication.
Do not make more than 3 applications
or apply more than 3 pounds per acre
during the growing season by air-
craft.
Do not apply more than 6 pounds per
acre during the growing season by
ground equipment.
Do not feed or allow livestock to
graze on cover crops growing in
treated areas.
LIAJAXA Apple rust mite 0.125—0.1875 Foliar application. Apply when
LAVASA European red mite lb/lOU gal mites are active, at or soon after
LAVAYA McDaniel spider [ 300—800 petal fall. Apply lower per acre
mite gal/A] rate by aircraft in a minimum of 5
LAVBAA Pacific spider mite or gallons of water or higher per acre
LAVBBA Schoene spider mite 0.5—1 lb/A rate by low volume ground equipment.
LAVBEA Twospotted spider or
mite 0.5—1.5 lb/A
LAVALA Yellow spider mite (50% WP)
Issued: 10—28—83 111—101601—2
48
-------
EPA Index to Pesticide Chemicals
CYHEXATIN
Site and Pest
Dosages and
Formulation ( s )
Tolerance, Use, Limitations
0200 DAA
Citrus Fruits (including grape-
fruit, lemon, lime, orange, and
tangerin€ )
or
1—2 lb/A
(50% wP)
2 ppm (citrus)
8 ppm (dried citrus pulp)
No preharvest interval through 3
pounds per acre for foliar applica—
ti on.
Do not feed or allow livestock to
graze on cover crops growing in
treated areas.
Do not apply petroleum distillate
(dormant or summer oils) within 28
days before or after application of
cyhexatin in FL or within 56 days
in other areas. Time applications
to avoid feather growth and new
growth flushes that have not hard-
ened off since a pimpling type of
injury will occur to new foliage.
In AZ and CA, do not apply to bear-
ing trees during the period between
the appearance of first blooms and
until the fruit has hardened off,
normally about mid—August, because
of possible injury to the fruit.
Do not apply to lemon when yellow
fruit is present.
Issued: 10—28—83
111—101601—3
LAVARA
Citrus
red mite
0.125—0.1875
Foliar
application.
Per
acre rate
LA.JBCA
Citrus
rust mite
lb/l00 gal
may be
applied
by aircraft in a
LAVBAA
Pacific
spider mite
[ 800—1600
minimum
of 10
gallons
of
water
or
LAVAKA
Texas
citrus mite
gal/A)
by low
volume
ground
equipment.
49
-------
EPA Index to Pesticide Cnemicals
CYHEXATIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s )
O8OLUAA Hops 30 ppm (hops)
90 ppm (dried hops)
21 day preharvest interval through
1.97 pounds per acre for foliar ap-
plication.
Do not apply more than 4.5 pounds
per acre during the growing season.
Do not feed hop cones or refuse to
livestock.
LAVBEA Twospotted spider 0.5—0.875 Foliar application. For concentrate
mite lb/lOO gal applications, use first per acre
[ 150—225 rate for first application and se—
gal/A] cond per acre rate for second and
or third applications.
1.1 lb/150
gal/A
or
1.75 lb/ 225
gal/A
(50% WP)
05003AA Nectarine 4 pp
Q5( t Peach No preharvest interval through 1.5
05 A pounds per acre for foliar applica-
tion.
Do not apply more than 3 pounds per
acre during the growing season.
Do not feed or allow livestock to
graze on cover crops growing in
treated areas.
LAVASA European red mite 0.125—0.1875 Foliar application.
LAVAYA McDaniel spider lb/100 gal
mite [ 300—800
LAVBAA Pacific spider mite gal/A)
LAJA.IA Peach silver mite or
LAVBEA Twospotted spider 0.5—1.25
mite lb/A
(50% wP)
Issued: 10—28—83 111—101601—4
50
-------
EPA Index to Pesticide Chemicals
CYHEXATIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s )
04003AA Pear 2 ppm
14 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication.
Do not make more than 3 applications
or apply more than 3 pounds per acre
during the growing season by
aircraft.
Do not apply more than 5 pounds per
acre during the growing season by
ground equipment.
Do not apply cyhexatin and petroleum
distillate (dormant or summer oils)
as a tank mix or separately within
28 days of each other because of
possible injury to the fruit.
Do not feed or allow livestock to
graze on cover crops growing in
treated areas.
.LAJAXA Apple rust mite 0.125—0.1875 Foliar application. Apply when
.LAVASA European red mite lb/l00 gal mites are active, at or soon after
McDaniel spider [ 300—800 petal fall. Apply lower per acre
mite gal/A) rate by aircraft in a minimum of 5
.LAVBAA Pacific spider mite or gallons of water or higher per acre
LAJAOA Pear rust mite 0.5—1 lb/A rate by low volume ground equipment.
LAVBBA Schoene spider mite or
LAVBEA Twospotted spider 0.5—1.25
mite lb/A
IAVALA Yellow spider mite (50% Wi ’)
05006AA Plum (Prune ) 1 ppm (fresh prunes)
4 ppm (dried prunes)
No preharvest interval through 1.5
pounds per acre for foliar applica—
t ion.
Do not apply more than 3 pounds per
acre during the growing season.
Do not feed or allow livestock to
graze on cover crops growing in
treated areas.
Refer to Nectarine cluster.
Issued: 10—28—83 11 1—101601—5
51
-------
EPA Index to Pesticide Chemicals
CYHEXATIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s )
OlOl6AA Strawberry 3 ppm
1 day preharvest interval through
1.25 pound per acre for I oliar ap-
plication.
LAVBEA Twospotted spider 0.375—0.5 ib! Foliar application. Apply a minimum
mite 100 gal of 0.75 pound per acre per applica—
[ 150—250 don. Apply higher rates in plant—
gal/A) ing with dense foliage or to prolong
(50% WP) the interval between applications.
In CA and FL, it will sometimes be
desirable to apply at 7 to 14 day
intervals during periods of intense
mite pressure.
T .RESTIAL NON—FOOD OP
( Ornamentals )
32000AA Ornamental Plants
310 7CA Apply to the foliage only of
3 ‘A chrysanthemums (prebloom) and
3. . . A poinsettias (prebract) to avoid
34120CA possible injury to blossoms and
bracts.
LAVDE.A Twospotted spider 0.125—0.1875 Foliar application.
mite lb/100 gal
(50% WP)
GREENHOUSE NON—FOOD CROP
( Ornamentals )
31057CA Carnation
3].065CA Chrysanthemum
3115 9CA Poinsettia
3412OCA Rose
Refer to T .RESTIAL NON—FOOD CROP, (Ornamentals)
Ornamental Plants.
Issued: 10—28—83 111—101601—6
52
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EPA Index to Pesticide Chemicals
CYHEXATIN
Site and Pest Dosages and Tolerance, Use, Limitations
Formulation(s)
AflUAL, MOTHPROOFING AND TANK MIX APPLICATIONS
)0 1500 Aerial Application
AAAAA
Ref er to
T .RESTRIAL FOOD CROP
Apple, Citrus Fruits, Pear
Issued: 10—28—63 111—101601—7
53
-------
EPA Index to Pesticide Chemicals
CYHEXATIN
Listing of Registered Pesticide Products by Formulation
95 .utJOl 95% technical chemical
cyhexatin (101601)
000464—00451
)50.0006 50% wettable powder
cyhexatin (101601)
000239—02414 000464—00393
99999 State Label Registrations
CA Reg. No.
000239—05851 000464—06840 010965—09999 010965—10000
035296—05819
WA Reg. No.
000464-06841
Issued: 10—28—83 111—101601—8
54
-------
A Index to Pesticide Chemicals
CYH ATIN
Appendix B
Listing of Registration Numbers by Site/Pest and Formulation
T .RESTRIA.L FOOD CROP
030 O1AA Almond
IAVASA European red mite
LAVBAA Pacific spider mite
LAVBEA Twospotted spider mite
(50% WP)
000239—02414 000464—00393
0400i.AA Apple
LAJAXA Apple rust mite
LAVASA European red mite
LAVAYA McDaniel spider mite
LAVBAA Pacific spider mite
LAVBBA Schoene spider mite
LAVBEA Twospotted spider mite
LAVAEA Yellow spider mite
(50% Wi’)
000239—02414 000464—00393
O2 0 00AA Citrus Fruits (including grapefruit, lemon, lime, orange, and tangerine )
IT ‘A Citrus red mite
L Citrus rust mite
Pacific spider mite
LAVAXA Texas citrus mite
(50% wP)
000239—02414 000464—00393
08020AA Hops
LAVBEA Twospotted spider mite
(50% Wi’)
000239—02414 000464—00393
05003AA Nectarine
LAVASA European red mite
LAVAYA McDamiel spider mite
LAVBAA Pacific spider mite
LA.JAIA Peach silver mite
LAVBEA Twospotted spider mite
(50% WP)
000239—02414 000464—00393
Issued: 10—28—83 111—101601—9
55
-------
EPA Index to Pesticide Chemicals
CYHEXATIN
Appendix B
Listing of Registration Numbers by Site/Pest and Formulation (continued)
5004AA Peach
AVASA European red mite
AVAYA McDaniel spider mite
AVBAA Pacific spider mite
LAJAIA Peach silver mite
AVBEA Twospotted spider mite
(50% WP)
000239—02414 000464—00393
)4003AA Pear
L.AJAXA Apple rust mite
LAVASA European red mite
LAVAYA McDaniel spider mite
LAVBAA Pacific spider mite
LAJAOA Pear rust mite
LAVBBA Schoene spider mite
LAVBEA Twospotted spider mite
IAVAEA Yellow spider mite
(50% WP)
000239—02414 000464—00393
05( Plum (Prune )
I A European red mite
McDaniel spider mite
JAVBAA Pacific spider mite
IAJAIA Peach silver mite
IAVBEA Twospotted spider mite
(50% Wp)
000239—02414 000464—00393
0 1016AJ 1 , Strawberry
LAVBLA Twospotted spider m±te
(50% W i’)
000239—02414 000464—00393
)3009A.A Walnuts
LAVASA European red mite
LAVBAA Pacific spider mite
LAVBEA Twospotted spider mite
(50% WP)
000239—02414 000464—00393
Issued: 10—28—83 111—101601—10
56
-------
EPA Index
Listing of Registration Numbers
‘ RESTRIAL NON—FOOD CROP
( Ornamental s )
320U)AA Ornamental Plants
LAV A Twospotted spider mite
(50% WP)
000239—02414 000464—00393
to Pesticide Chemicals
CYHEXATIN
Appendix B
by Site/Pest and Formulation (continued)
GREENHOUSE NON—FOOD CROP
( Ornamentals )
31057CA Carnation
LAVBEA Twospotted spider mite
(50% wP)
000239—02414 000464—00393
31065CA Chrysanthemum
LAVBEA Twospotted spider mite
(50% WP)
000239—02414 000464—00393
3 1159CA Poinsettia
LAVBEA Twospotted spider mite
(50% WP)
000239—02414 000464—00393
Rose
Twospotted spider mite
(50% w )
00023 9—02 4 14
Issued: 10—28—83
1 1 1— 10 160 1— il
34 12OCA
IAVBEA
57
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REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data -described
in Table A 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
tnis guidance document. As required by FIFRA sec. 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 Datal! Must be Submitted . You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued reglstrabllity of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained In the Pesticide
Assessment Guidelines 2/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
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 type
1/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product’s unique composition or specific 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 Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
58
-------
for each major formulation category (e.g., emulsifiable concen-
trates, 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 : “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 III 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
11-3] 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
Pesticide Assessment 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.
OR
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.
OR
3. File with EPA a completed “Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop—
men of Data” (EPA Form 6580—6, Appendix Il—U’!
*1 FIFRA Sec. 3(c)(2)(B) authorizes joint development of
data y 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 fall to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
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OR
L . 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.)
OR
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.
(Footnote continued from previous page)
In EPA’S opinion, joint data development by all regis-
trants subject to a data requirement 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 unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion 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 should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant 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)(1i1)j;
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.
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The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to 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—Li, Appendix 111—1) to fill gaps identified by EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B—-Product-Specific Data Requirements for Manufacturing
Use Products——lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled “Must Data By Submitted
Under §3(c)(2)(B).”
IV. SUBMISSION OP REVISED LABELING
Note : This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 1 0 CFR 162.10 (see
Appendix IV-l) and are summarized for products containing
this active Ingredient as part of this Guidance Document
(See Appendix IV—2). Applications submitted in response to
this notice must include draft labeling for Agency review.
•/ Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
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If you fail to submit revised labeling Information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel tne registration
under FIFRA sec. 6(b)(l).
A. Label Contents
L 0 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling . Specific label Items
listed below are keyed to 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.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS — A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., “1 pound 10 ounces” rather than
“26 ounces.” In addition to English units, net contents may
be expressed in metric units. See Appendix IV—l. [ 0 CFR
162.10(d)]
Item . 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.
[ L 0 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 number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV—l. [ LW CFR 162.10(f)]
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Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active Ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV—l. [ 140 CFR
162.l0(g)J
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word “Keep Out of Reach
on Front Panel Minimum Type Size of Children”
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 114 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
“Keep Out of Reach of Children” must be located on the front
panel above the signal word except where contact with children
during distribution or use Is unlikely. See Appendix IV—l.
[ 140 CFR 162.1O(h)(1)(11)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel Immediately below
the child hazard warning statement. See Appendix IV—1.
[ 140 CFR 162.10 (h)(l)(I)J
Item 7C. SKULL & CROSSBONES AND WORD “POISON” - On products
assigned a toxicity Category I on the basis of oral, dermal,
or Inhalation toxicity, the word “Poison” shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in Immediate proximity to
the word POISON. See Appendix IV—l. [ 140 CFR 162.l0(h)(1)(1)J
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV—1. [ 140 CFR 162.10(h)(l)(iii)J
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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—l. [ iO CFR 162.lO(h)(1)(iii)J
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading “PRECAUTIONARY STATEMENTS.”
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV—l. [ LW CFR 162.10
(h) (2)J
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS — Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix IV—l. [ 140 CFR 162.10
(h)(2)(i)J
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV—l. [ LW CFR
162.1O(h)(2)(ii)J
Item BC. 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 require-
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, preceded by the
heading “Physical/Chemical Hazards.” Note that no signal
word is used in conjunction with the flammability statements.
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 flashpoint
greater than 350°F (177°C).
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c. A “non—flammable aerosol” Is one which meets the
following criteria:
1. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non—volatile 1-Iquid
component is greater than 350°F (177°C).
3. Declaration of non—flammability . Products which
meet the criteria for non—flammability specified
above may bear the notation “non—flammable” or “non-
flammable (gas, liquid, etc.)” on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
i4 Other physical/chemical hazard statements . When
chemistry data 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 9A . RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) Indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
,reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must suDmit any information and
rationale with your application for reregistration. During
the Agency’s review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 4O CFR 162.11(c). You will be notified of
the Agency’s classification decision.
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A. Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement “Restricted Use Pesticide” must
appear at the top of the front panel of’ the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 4O CFR 162.].0(h)(l)(jv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: “For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator’s Certification.”
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete- all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may “split” your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
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B. Compliance Schedules
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 tr e date of
issuance of this Standard, unless such product beers 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 9B [ There is no Item 9B].
Item 9C. MISUSE STATEMENT — All products must bear the
misuse statement, “It is a violation of Federal law to use
this product in a manner inconsistent with its labeling.”
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 1OA. REENTRY STATEMENT — If a reentry interval
has been established by the Agency, It must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83—2, March 29, 1983.
Item lOB [ There is no Item 1OBJ.
Item 1OC. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading “Storage and Disposal” in the directions
for use. This heading must be set In the same type sizes as
required for the child hazard warning. Refer to Appendix
IV—1i to determine the disposal instructions appropriate for
your products.
Item 1OD. DIRECTIONS FOR USE — Directions for use must
be stated in terms which can be easily read and understood by
tne 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— ] .. [ 110 CFR 162.10]
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from
those accepted in connection with registration of the product.
It should be made part of the response to this notice and
submitted for review.
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (name of
pesticide) as an active ingredient .
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the “FIFRA Section
3(c)(2)(B) Summary Sheet” EPA Form 8580-1. Refer to Appendix
11—3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exern tion, present arguments that a
data requirement Is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summar T Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. WIthin 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570- is.
b. Product Specific Data Report, EPA Form 8580—Li
(AppendIx 111—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, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) 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 storage in 8—1/2 x 11 inch files. The draft
label must indicate the intended colors of the final laDel,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR 152.80—152.99
(enclosed) for latest requirements.
3. Within the times set forth In Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
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B. For Manufacturing Use Products containing (name of pesticide)
in combination with other active ingredients
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 11-3 with appropriate attapiiments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. WIthin the times set forth In Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
C. For End Use Products containing (name of pesticide) alone
or In combination with other active ingredients :
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 11—3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 857O— l.
b. Product—Specific Data Report, EPA Form 8580— 4
(Appendix 111—1).
c. Two copies of any required product—specific data.
(Refer to Table C).
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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, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8 1/2 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.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to A4Q CFR 152.80—152.99
(enclosed) for latest requirements.
3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for tne formulator’s
exemption.
D. For intrastate products containing (name of pesticide)
either as the sole active ingredient or in combination
with other active ingredients
These products are being called In for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
registration.
E. Applications and other required information should be
submitted to the following address:
Product Manager
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20 460
Phone No. (703)
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN—3 1 42)
Environmental Protection Agency
01 M St., SW.
Washington, D.C. 201160
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Appendix 11—1
Guide to Use of This Bibliography
1. TENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data su nitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections fran other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a “study.” In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials subedtted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article fran within the typically larger
volumes in which they re suLii i tted. The result i rx
“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 ccirmentaries upon them, treating them as a
single study.
3. I NTIFICA ION OF ENTRIES. The entries in this bibliography
are sorted numerically by “Master cord Identifier,” or
MRID, number. This nt nber is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six—digit “Accession Number”
which has been used to identify volumes of sthnitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine—character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
su riitted to EPA, by a description of the earliest known
sutinission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
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Appendix Il—i (continued)
a. Aut PDL. Whenever the Agcicy could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first su initter as author.
b. D c .rnent E te. When the date appears as four digits
with no question marks, the Agency took it directly
fran the docut nt. When a four—digit date is followed
by a question mark, the bibliographer deduced the
date fran evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or est imate the date of the document.
C. Title. In sane cases, it has been necessary for
Agency bibliographers to create or enhance a doctzrent
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies subnitted to the
Agency in the past, the trailing parentheses include
(in addition to any self—explanatory text) the fol-
lowing elements describing the earliest known subnission:
(1) Su nission E te. The date of the earliest known
sul:xnission appears ixwnediately following the word
received.
(2) Administrative Number. The next element,
IniTediately following the word under, is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known su niss ion.
(3) Sukxnftter. The third element is the su rnitter,
following the phrase Nsuhnitted by. b en
authorship Is defaulted to the subiutter, this
element is anitted.
(4) Vblune Identification (Accession Numbers). The
final element in the trailing parentheses
Identifies the EPA accession number of the volume
in which the original sulrnission of the study
appears. The six—digit accession number follows
the symbol ‘CDL, standing for Canpany ta
Library. TM 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—M.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
MRID CITATION
0018842 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-
7501. (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-B)
00034893 Smith, G.N.; Fischer F.S.; Axelson, R.J. (197O) The Volatilization
nd Pho odecomposition of Plictran (R) Miticide. (Unpub-
lished study received Jul 20, 1970 under 0F1005; submitted by
Dow Chemical U.S.A., Midland, Mich.; CDL:091734—B)
00034894 Smith, G.N.; Axelson, R.J.; Schiesser, L.H. (1970) The Loss of
Plictran (R) Miticide from Various Soils. (Unpublished Study
received Jul 20. 1970 under 0F1005; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:091734-D)
00034895 Whitney, W.K.; Hummel, R.A.; Bartel, J. (1966) Leaching Tests with
Dowco 213 in Soil. (Unpublished study received Jul 20, 1970
under 0F1005; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:091734—E)
00034896 Smith, G.P4.; Fischer, F.S.; Axelson, R.J. (1970) The Fate of Tn-
cyclohexyltin hydroxide in Fish Tanks Containing Water, Plants,
Soil, and Fish. (Unpublished study received Jul 20, 1970 under
0F1005; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
091734—F)
00040803 Getzendaner, M.E.; Corbin, H.B.; Stewart, D.,; et al. (1973) Resi-
dues of Tricyclohexyltin hydroxide on Apples and Pearsi. In-
cludes method ACR 73.2 dated May 1, 1973. (Unpublished study
received May 23, 1973 under 3F1400; prepared in cooperation with
N & T Chemicals, Inc. and others, submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:091962—B)
73
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
MRID CITATION
00052033 Komblas, K.N. (1969) Determination of Residues of Plictran Acari—
dde on Apples and Pears in Italy. (Translation; unpublished
study received Mar 10, 1969 under 9G0815; prepared by Societa
Italo—Americana Produtti Antipararassitari, Italy, submittea by
Dow Chemical U.S.A., Midland, Mich.; CDL:093133—J)
00065984 Dow Chemical U.S.A. (1969) Summary and Conclusions: Plictran.
(Unpublished study received Jul 20, 1970 under 0F1005; CDL:
091735-A)
00065985 Getzendaner, M.E. (1968) A Review of Residue Information on Tn—
cyclohexyltin Hydroxide. Includes method dated Jul 18, 1967;
method no. V—Or-47 dated May 2, 1966; method no. V-Or-48 dated
May 2, 1966; method no. V-Dr-51 dated Aug 15, 1966. (Unpub-
lished study received Jul 20, 1970 under 0F1005; CDL:091735—8)
00065986 Getzendaner, M.E.; Corbin, ILB. (1969) Inorganic and Organic Tin
Compounds in or on Apples and Pears from Field Applications of
Plictran (R) Miticide. (Unpublished study received Jul 20,
1970 under 0F1005; prepared in cooperation with H & I Chemicals,
Inc., submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
091735—D)
00065987 Getzendaner, M.E.; Corbin, H.B. (1969) Inorganic and Organic Tin
Residues in or on Apples and Pears from Field Applications of
Plictron (R) Miticide. (Unpublished study received Jul 20,
1970 under 0F1005; prepared in cooperation with H & T Chemicals,
Inc., submitted by Dow Chemical U.S.A., Midland, Filch.; CDL:
091735—E)
00065991 Corbin, H.B. (1970) Separation and determination of trace amounts
of tin present as organotin residues on fruits. Journal of the
Association of Official Analytical Chemists 53(1):140—146. (Al-
so in unpublished submission received Jul 20, 1970 under 0F1005;
submitted by Dow Chemical U.S.A., Midland, Filch.; CDL:091735-I)
00065993 H & T Chemicals, Incorporated (19??) Recovery of Total Tin from
Apple with Arsenic Present: TA-6—1 with Arsenic Elimination
Modification. (Unpublished study received Jul 20, 1970 under
0F1005; submitted by Dow Chemical U.S.A., Midlanc, Filch.; CDL:
091735—K)
74
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
MRID CITATION
00071437 Norton, E.J. (1980) Organotln Residues in Pecan Nutmeats and Shells
after Treatment with Plictran SOW Miticide. (Unpublished study
received Mar 19, 1981 under 464-393; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:099953—A)
00080462 Smith, G.N.; Axelson, R.J. (1969) Radiotracer Evaluation of the Up-
take of Tricyclohexyltin Hydroxide from Various Soils by Bean,
Radish, and Corn Plants. (Unpublished study received Jun 5,
19 9 under 9F0815; submitted by Dow Chemical Co., Indianapolis,
md.; CDL:091406-L)
00080464 Wazeter, F.X.; Buller, R.H.; Geil, R.G.; et al. (1968) Acute Oral
Toxicity Study in the Wistar Rat: 221—031. (Unpublished study
received Jun 5, 1969 under 9G0815; prepared by International
Research and Development Corp., submitted by Dow Chemical Co.,
Indianapolis, md.; CDL:091406—N)
00080472 Starnes, C.J. (1966) Stability of Tricyclohexyihydroxy Tin to Sun-
lamp Exposure: AL No. S—66—648. (Unpublished study received Jun
5, 1969 under 9G0815; submitted by Dow Chemical Co., Indianapo-
lis, md.; CDL:091406—X)
00081485 Smith, G.N.; Fischer, F.S.; Axelson, R.J. (1968) The Volatilization
and Photodecompositlon of Plictran (R) Miticide. (Unpublished
study received Jun 5, 1969 under 9G0815; submitted by Dow
Chemical Co., Indianapolis, md.; CDL:091406—AH)
00081487 Whitney, W.K.; Kenaga, E.E. (1966) Bioassay Experiments To Deter-
mine the Volatility of Tricyclohexyltin Hydroxide. (Unpublished
study received Jun 5, 1969 under 9G0815; submitted by Dow Chemi-
cal Co., Indianapolis, md.; CDL:091406—AJ)
00081491 Smith, G.N. (1969) A Simple Method for Combusting Tissues for Tin—-
Sn 119 Analysis. (Unpublished study received Jun 5, 1969 under
9GO815; submitted by Dow Chemical Co., Indianapolis, md.; CDL:
091406-AN)
00081739 Batchelder, T.L. (1967) Acute Fish Toxicity of Tricyclohexyltin
Hydroxide to Three Species of Fish. (Unpublished study received
Jun 6, 1969 under 9G0815; submitted by Dow Chemical Co., Indian-
apolis, md.; CDL:091407-F)
75
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
MRID CITATION
00081743 DuddIes, G.A. (1968) The Acute Fish Toxicity of Cyclohexyl Stannoic
Acid. (Unpublished study received Jun 6, 1969 under 9G0815;
submitted by Dow Chemical Co., Indianapolis, InC.; CDL:091407-K)
00081748 Laker, T.L.; Elsea, J.R.; Ede, H. (1966) Repeated Insult Patch Test
on M—2527 and Cloth Material TE98-S.E..U.3501: Report Q—246.
(Unpublished study, including letter dated Sep 26, 1966 from
K.J. Olson to G.E. Lynn, received Jun 6, 1969 under 9G0815;
prepared by Hill Top Research, Inc., submitted by Dow Chemical
Co., Indianapolis, md.; CDL:091407—P)
00108766 Interregional Research Project F o. 4 (1973) Plictran: Residues
in Hops. (Compilation; unpublished study received Jun 7, 1973
under 3E1405; CDL:093758—B)
00112178 Shellenberger, T. (1971) Acute Toxicological Evaluations of Dowco
213 and Plictran 50W Miticide with Bobwhite and Japanese Quail:
GSRI Project No. NC—471. Final rept. (Unpublished Study re-
ceived Dec 6, 1971 under 464—393; prepared by Gulf South
Research Institute, submitted by Dow Chemical U.S.A., Midland,
MI; CDL:003643—B)
00112180 Leong, B.; Jersey, C. (1972) Acute Inhalation Toxicity of Plictran
50W Mitlcide. (Unpublished study received Feb 14, 1973 under
464-470; submitted by Dow Chemical U.S.A., Midland, MI; CDL:
003678-B)
00112181 Getzendaner, H. (1973) A Study of Residues of Tin in Apples and
Pears from Applications of Plictran Miticide as a 2% Dust by
Helicopter: GHC 625. (UnpublIshed study received Feb 14, 1973
under 464—470; submitted by Dow Chemical U.S.A., Midland, MI;
CDL :003678—C)
00112183 Rampy, L.; Keeler, P. (1973) Acute.iye Irritation Studies Conducted
on Trichyclohexyltin Hydroxide. (Unpublished Study received Nov
6, 1973 under 464—393; submittedby Dow Chemical U.S.A., Mid-
land, MI; CDL:050104-A)
00112187 Dow Chemical Co. (1969) Full Reports of Investigations Made with
Respect to the Safety of the Pesticide Chemical: Tricyclohexyl-
tin Hydroxide. Summary of Studies 091408—B through 091408-N,
091737-A through 091737—C, 091406-K, 091737-E. and 091406-1
through 091406-N. (Compilation; unpublished study received Jun
6, 1969 under 9G0815; CDL:091408-A)
76
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
MRID CITATION
00112206 Dow Chemical Co. (1970) Tin Content of Tissues of Rats and Dogs Fed
Varying Miounts of Tricyclohexyltin Hydroxide in the Daily Diet
for Two Years. (Unpublished study received Jul 20, 1970 under
0F1005; CDL:091737-B)
00112207 Dow Chemical Co. (1970) Study of Tin Residues in Dairy Products
and Tissue from Cattle Fed Tricyclohexyltin Hydroxide. (Compi-
lation; unpublished study received Jul 20, 1970 under 0F1005;
CD t : 091737-C)
00112208 Smith, G.; Taylor, Y. (1970) The Absorption and Translocation of
Plictran Miticide and Its Decomposition Products in Bean and
Corn Plants. (Unpublished study received Jul 20, 1970 under
0F1005; submitted by Dow Chemical Co., Indianapolis, IN; CDL:
091737-E)
00112215 Wazeter, P.; Buller, R.; Geil, R.; et al. (1969) 21 Day Dermal
Study in Albino Rabbits: Pllctran M-3180: 221—064. (Unpub-
lished study received Jul 20, 1970 under 0F1005; prepared by
International Research and Development Corp., submitted by Dow
Chemical Corp., Indianapolis, IN: CDL:091738—J)
00112217 Dow Chemical Co. (1970) Full Reports of Investigtions Made with
Respect to the Safety of the Pesticide Chemical: Tricyclohexyl-
tin Hydroxide. Si.mimary of studies 091407—L, 091408—B through
091408—N and 091738—B through 091738-J. (Unpublished study re-
ceived Jul 20, 1970 under 0F1005; CDL:091743—A)
00112218 Dow Chemical Co. (1972) Study: Tricyclohexyltin Hydroxide Residue
in Meat, Fat, and Meat Byproducts-—Dairy Cattle. (Compilation;
unpublished study received on unknown date under 0F1005; CDL:
091744-A)
00112220 Dow Chemical Co. (1972) Study: Tricyclohexyltin Hydroxide Residue
In Meat & Milk. (Compilation; unpublished study received on
unknown date under 0F1005; CDL:093315—A)
00112225 Interregional Research Project No. 4 (1975) The Results of Tests
on the Amount of Tricyclohexyltin Hydroxide Residue Remaining
in or on Macadamia Nuts, Including a Description of the Analyt-
ical Methods Used. (Compilation; unpublished study received
Nov 20, 1975 under 6E1706; CDL:097367—A)
77
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
MRID CITATION
00112230 Dow Chemical U.S.A. (1975) Residues: Tricyclohexyltin Hydroxide in
or on Crop and Animal Products. (Compilation; unpublished
study received Jun 11, 1975 under 5F1641; CDL:097475-C)
00112232 Dow Chemical U.S.A. (1976) Study: Plictran SOW Residue on Grapes
and Raisins. (Compilation; unpublished study received Feb 17,
1976 under 5F1641; CDL:097508—A)
00112236 Dow Chemical U.S.A. (1975) Performance and Residue Data: Aerial Ap-
plicati on of Plictran 50W Miticide on Apples, Pears, Citrus.
(Compilation; unpublished study received Apr 10, 1975 under 464-
393; CDL:220007-A)
00112237 Dow Chemical U.S.A. (1975) Residue Data in Support of Concentrated
Applications of Plictran 50W Miticide on Stone Fruits and Nuts.
(Compilation; unpublished study received Apr 28, 1975 under
464-393; CDL :220413-A)
00138963 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chern-
cals to Fish and Aquatic Invertebrates. By U.S. Fish and Wild-
life Service. Washington, D.C.: USFWS. (Resource publication
137; also in unpublished submission received Feb 6, 1984 under
239-2424; submitted by Chevron Chemical Co., Richmond, CA; CDL:
252355—C)
78
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyhexatin Standard
GS-00237001 Dow Chemical Co. 1971. Determination of small amour ts of
organotin in macertaed fruit. Method No. TA-2-3 [ Submitted
under PP#3F1312 (117973).]
GS-00237002 Dow Chemical Co. 1971. Determination of small amounts of tin
in fruit. Method No. TA—6-2. [ Submitted under PP#3F1312
(117973).)
GS-00237003 Dow Chemical Co. 1971. Determination of total and organic
tin on orange oil. Method No. TA-19. [ Submitted under
PP#3F1312 (117973).]
GS—00237004 Dow Chemical Co. 1972. Trace organotin in the presence of
inorganic tin. Method No. TA-29. [ Submitted under PP#3F1312
(117973).)
GS—00237005 Dow Chemical Co. 1972. Gas chroinatographic method for the
determination of tricyclohexyltin hydroxice in organge
juice. Method No. ACR 72.11. [ Submitted under PP#3F1312
(117973)].
GS-00237006 Kovacs, M. 1972. Methoa trail on GLC confirmatory method for
Plictran in liver; in correspondence file of PP#3F1005.
GS-00237007 Makhijani, G. 1971. Report on method tryout for Plictran; in
correspondence file of 0F1005.
GS—00237008 Makhijani, G. 1973. Report on method trial for Plictran in meat
and milk; in correspondence file of PP#0F1005.
GS-00237009 Seibert, E. 1971. Method tryout for Plictran on apples; in
correspondence file of PP#OF100S.
79
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Appendix 11—3
0MB ADDrovelNO 2XX -O4 8 fEZD,res 12 3 .&
EPA REGiSTRATION NO
F )FHA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANTS NAME DATE GUIDANCE DOCUMEr T ISSUED
With respect to the lequniment to wbmrt ‘g,neric’ data impoead by the FIFRA ciion 3(C)(2)(B) notice contained in the referenced
Guidance Document, I sin responding in the following manner.
0 1. I will wbmit data in s timely manner to estirfy the following requirements. If the test procedures I wifl uu deviate from (or are not
specified in) the Regietrition Guideknes or the Protocols contained in the RepDrts of Expert Groups to the Chemicali Group DECO
Chemicals Testing Programme. I enclose the protocols that I will uw
02. I have entered mto in agreement with ore or mote other regotrunu under F IF RA section 3(C)(2)(B)(ii) to satisfy the following Cats
requirements. The tests. and any required protocols, will be ibmnt,d to EPA by:
NAME 0
F OTHER REGISTRANT
03.
i enclose a completed C,nification 01 Attempt to Enter Into an Agreement wiTh Other Registrants for Development of Date ’ with
respect to the following date requirements:
04. I request inst you emend my rigotmion by deleting the following us (this option a riot available to applicants for new produru).
05. I request volunu.ry cancellation of the registration o this product (Thu option a not svsilable to applicants for now products.)
REGISTRAP4V& AUTHORIZED REPRESENTATIVE SIGNATURE DATE
EPA P01 1 118580.1 (1082)
-------
Appendix 111—1
PROLXJCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for_________
Date ____
Registration
Guideline No.
Name of Test
‘Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Only)
Accession N .m bers
Assigned
Citing P ID#
Suthiit—
ting
Data
(At—
tached)
l58.2O
P DUC T
C ,flsThY
61—1
identity of
ingredients
61-2
Statement of
c position
61-3
Discussion of
formation of
ingredients
62—1
Pre1iminar ’
ana. lysis
62—2
Certification of
limits
62—3
AnalytIcal methods
for enforcement
limits
63—2
Color
63—3
Physical state
63— 4
Odor
63—5
tè] ting point
63—6
Boiling point
63—7
Density, bulk—
density, or
specific gravity
63—8
Solubility
63—9
Vapor pressure
63—10
Dissociation
constant
63—U
Octanol/water
partition
coefficient
6S—12
-------
Appendix 111—1 (continued)
Acute dermal
LD-50
I
Registration
Guideline No.
Name of Test
Testnot
required
for my
product
listed
above
(check
below)
I sin complying with
data requirements by
(For EPA Use 0n]. )
Accession Numbers
Assigned
Citing t ID#
Submit-
ting
Data
(At—
tached)
63—13
Stability
63 —114
0xidiz i ng/redUCin
reaction
63—15
Flanrnability
63—16
Explodability
63—17
Storage stability
63—18
Viscosity
63—19
Miscibility
63—20
Corrosion
cha.racterlstics
63—21
Dielectric break—
down_voltage
S158 .135
t)XIC0I.OGY
81-1
Acute oral LD-50,
rat
81—3
Acute innaIation,
LC—50 rat
81 —14
Primary eye
irritation, rabbit
81—5
Primary dermal
irritation
81—6
Dermal sensitiza-
tion
-------
APPENDIX IV—1
Chops. ’ l.— .InvIro,im. ifc Prof.eflon A .i cy
t obtained the data from anoth
(identify). applicant copied da
I m a publication. applicant ob d
a py of the data from WA).
The applicant shall submit th
his plicatlen $ atement that A.
th I valuatlon of the properties elfi-
esey. and safety of the form ated
e d• e product, may not conil T &ItY
data supporting the app tion.
eacept he following data
e data the applicant sub-
mitted A under ti (b) of
thusecU n.
(2)0 rdata tothe
safety of e product’s act e ingredi-
enu. rathe than to the ety of the
end-use uct. and
(3) IzUfl tolerances. ood additive
.Tegulitlona, xemptio and other
clearances ed unde the Federal
Food. Dnag. Cca=e c Act.
(C) 11 the ap licant owa that any
Item of data h sub ted under this
section was gen d y (or at the c x-
pense of anothe pe on who original-
ly submitted the to A (or iti
predecessor. VSD on Cr alter Janu-
ary 1, 1970, to eta rt an application
for reg1 tzsUon . apeilmenta) use
permit, or amen nt adding a new
use to an e tion. or for
ycreglzti%UOn ( the applicant
and the data submitter have
ycached wn ent on the
amount and terms I payment of
any corn on that may be pay-
able ond coction
$(CXIXDXU) with to approval
of the sppli Uon). the licarat shall
submit to A a atcrn I that be
has I ed to cash identified
original subrnltter
(1) A WicaUon of the plicant’s
intent to pply for registrstio Includ-
tog the pivduet narn
(2) offer to pay the corn-
pensa u. with rep.rd to the proval
of tb application. to the t re-
q by F AA sections 34c )(D)
and cX2XD);
(3 An Ident cation of the 1 (a)
of 411a to which the offer applies:
(f) An oiler to commence nego a-
tI s to ascertain the amount d
s ms of compensation to be paid. d
/(5) The applicant’s name,
dnd telephone number.
162 )0
11 the applicant’s product cc
any active Ingredient other
th that arc present solely e
of Incorporation into the p uct,
d formulation. of one or more
other pesticide p uci.s
p d from another oducer,
then the applicant shall comply
withill astosuch velng ’re
dient. and e applicatlo shall con-
tain an ledgment t for pur-
poses of section cX1XD) the
application es on ( d any result-
tog reglztratio thoul regarded as
lilt were based tb M iv ilt7,tor’s
consideration of) e oliowlng dat&
(1) All data su ted or apeciflesily
cited by the app t In support of
the regts atlon.
(2) Lath 0th 1 of data to the
Agency’s flies w ch:
(1) Concerns e pro ‘tles or effects
of any such ye lngved nt: and
(11) La one I the typesӍif data that
A would ulre to be m m1tt.d for
scientific view by A Lf\ .he appli-
cant ht the Initial r4lstrstlon
under bectlon 3(cX ) of a
produ with composition and’ ntend-
ed identical to those propoè d for
the plicants product. ondet the
di requiroments In effect on\the
di D’A approves the app1les ts
i application. \
3, t and of ? ‘RA. as am.nL%.& \
V.8.C. 13$ i S c)
($4 FR 37153. IIM 11. lYlE
• 3 1 2J0 a IIag ,iqubwenta.
(a) Oearrol—(1) Contents of Vi i
labeL Lvery pesticide products shall
bear a label oonti iMng the Inlorma-
sion specified by the Act and the regu-
MUons In this Pasl. The contents of a
label must show dwiy and prorni-
ucatly the fdflowInr
(I) The name, brand, or ‘ademark
under which the product is sold as pre-
scelbed to paragraph (b) of this sec
(U) The name and addrom of the
producer. regizDanX. or person for
wham produced as presalbed In pars-
graph (c) of this aeeUon
( U I) The net contents as proscribed
to paragraph (4) of this section
-------
1d2.lO
(lv) The product registration
number as prescribed In paragraph (e)
of this section:
(vi The producing establishment
number is prescribed in parajrsph (I)
of this section;
(vi) An Ingredient statement as Pre-
scribed in paragraph (g) of this sec-
tion:
(vii) Warning or precautionary state.
menu as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pro-
scribed in paragr*ph (I) of this section:
and
ix) The use claseificatlon(s) as pie-
scribid in paragraph (j) of this section.
(3) Prominence and teglbUEty ( I) All
worm. statements. graphic representa-
tions. design. or other Information re-
quired on the libeling by the Act or
the regulations in this part must be
ciesily legible to a person with normal
vision. and must be placed with such
conspicuousness (is compared with
other words, statements. designs, or
graphic matter on the libeling) and
eapres.ed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom.
ary condiUons of purchase and use.
(Ii) All required label tent must:
(A) Be set in I-point or larger type
(B) Appear on a clear contesaUng
background; and
(C) Not be obscured or crowded.
(I) L.agwogc to be seed. Au required
label or labeling text shall appear in
the b gilsh language. However, the
Agency may require or the applicant
may propo.e additional text in other
languages as Is considered necemory to
protect the public. When additional
test in another language is necemary.
all labeling requirements will be ap.
piled equally to both the bigilsh and
other-language versions of the label-
ing.
(4) PIecemeal of Lsbel—4i) 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 8cctlon. and the mis-
branding provisIons of the Act. ‘.e-
cutely attached” shall mean that a
libel can reasonably be expected to
remain .1 fixed during the foreseeable
condlUons and perIod of use If the lm
mediate container is enclosed within a
Till. 40— ’Pr.l.ction .f Environment
wrapper or outside container through
which the libel cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it Is a part of the package as
customarily distributed or sold,
(ii) Task cars and other bulk con-
(a men — IA) Tronsporlalion. Whiie a
pesticide product is in transit, the ap-
propriate provIsions of 49 CFR Parts
170-i Sa, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the li-
beling, marking and piscarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. in addition, when r, ey
registered pesticide product Is trans-
ported In a tank car, tank truck or
other mobile or portable bulk contain.
c i . a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the Ume
of delivery.
(B) Stom When pesticide prod-
ucts axe stored in bulk container,,
whether mobile or stationary, which
remain In the custody of the user, a
copy of the label of labeling. including
all appropriate directions for use, shall
be securely ittarhed to the container
in the immediate vicinity of the di .-
charge control valve.
(1) False or misleading statements.
Pursuant to section 2(QNIXA) of the
Act, a pesticide or a device deciared
subject to th Act pursuant to
S 162 I I, is misbranded if lie labeling is
false or misleading in any psiticula,
including both pestkldal and non-pee-
Ucidal claims. xampios of statements
or rspresentaUosw In the labeling
which constitute misbranding include:
Ii) A false or misleading statement
concerning the composition of the
product;
fill A false or misleading statement
concerning the effectivenem of the
product is a pesticide or device:
(iii) A false or misleading statement
about the value of the product for$
purposes other than as a pesticide or
device; a
(Iv) A false or misleading comparison
with other pesticides or device.;
(vi Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Oovern-
ment:
(vi) The name of a peath-ide which
contains two or more principal srtive
ingredien if the name suggests one
or more but not all such prIncipal
active ingredien even though the
names of the other Ingredients are
stated ekewhpre in the labeling:
(vii) A true statement used in such a
way as to give a lake or miilrading Im-
pression to the purchaser,
(viii) label dlsclsim,,-x which negate
or detract from labeling statements re-
qumired lander the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its Ingredients including
statements such ax ‘sale” “nonpoison-
ous,” “noninjuariomas,” “harmnlenu” or
“nontoxic to humans and pets’ with
or without such a qualifying phrase as
‘when used a s 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.
cnta”;
(H) “Among the least toxic chemi-
cals known”
(C) “Pollution approved”
(I) Final printed labeling (I) xcept
ax provided in paragraph (a)(lMii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label text, have been provision-
ally accepted by the Agency,
(Ii) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk.
screened directly onto lila or metal
containers or large bag or drum labels,
8uch reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or lredema.*, U)
The name, brand, or tradema,t under
which the pesticide product is sold
shall appear on the front panel of the
tabel
(2 No name, brand, or trademark
may appear on the label which:
(I) Is false or misleading, or
1i has not been approved by the
Admlni trathr through registration or
supplemental registration as an addl-
tloamai name pursuant to 5162 6(bk4)
* 162.10
(c) Name and addrevu of producer,
registrant, or person for whom pro-
duced An unqualified name and ad-
dress given on the label shall be con
sldered as the name and address of lb..
producer, If the registrant’s name ap
pears on the label and the regisi rant is
not the producer, or liii . name of ihe
person for whom liar pestI cide was
produced appears on (lie label, ii mua t
be qualified by approprIate wording
such as “Packed for • ‘ “Di lribuL
edby • •.“or”5oldby
that the name lx nfl ilial of hue pro-
ducer
(d) Net weight or mnruuur, of con
tent. (I) The net wrl Iul or measuare
of content shall be ewclu ive of wrap
per, or other materials and shall be
the average content •uiilcs, explfritiv
stated as a minimum QuantIty
(2) If the pestIcIde ha a liquId, the
net content statement shall be in
terms of liquid measure at IS’ f? (20C 1
and shall be expressed Ifl convenhional
American units of fluid ounces, pints,
quarts, and gallons,
(3) If the pesticide is solid or semiso-
lid, viscous or preeauarl,ed, or is a mix.
ture of lIquid and solid, the net con
tent statement shall be In terms of
weIght expressed as avoirdupois
pounds and ounces
(4) In all cases, net content shall he
stated In terms of the largest suitable
units, I... “1 pound 10 ounces” rather
than “36 ounces.”
(5) In addition to the required units
specified, net content may be ex-
pressed in metric Units
( I) Variation above minimum con.
tent or around an average Is prrmlssi-
ble only to the extent that it repre-
sents deviation unavoidable In good
manufacturing practice. VarIation
below $ stated minimum Is not permit-
ted, In no case shall the average con-
tent of the packages in a shipment (all
below the staled average content.
(5) Product rvgi,tratior. number.
The registration number assigned to
the pesUcide product at the time of
registration shall appear on the label,
preceded by the phrase “FPA flegk-
tration No.,” or the phrase “PPA Ileg
No.” The registration number shall be
set in type of a site and style similar SO
other print on that part of the libel
on which it appears and llall nail par
Oa.phsr I—Environ .s.nt. Protection Agency
API’I,’Jl’l x iv—t
(con F Inueci)
-------
162.10
slid to IL 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 estoblfahmenta ie$s-
(muon ,iumber. The ‘producing estab-
lIshment registration number preced-
ed by the phrase “FPA Let.”, 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 LPA establishment reg-
istration number on the Immediate
container cannot be. clearly read
through such wrapper or container.
(g) Ingredient •tatemenl—(I) Oener-
oL The label of each pesticide product
must bear a statement which contains
the name end percentage by weight of
each active lngredienL the total per-
centage by weight of all inert ingredi-
eMs, 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 ti-tm “active ingredi-
ents” nd the Inert ingredient.i by the
term “ineit Ingredient .,” or the stalls-
lar forms of these terms when appro-
pilate. Both terms shall be in the
same type size, be aiIgn d to the same
margin and be equally prominent. The
statement “Inert ingredIents, none” i i
not required for pesticide, 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 U a
heading for the ingredient statement.
(2) Post I ton of ingredtenf atetemessl.
(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. 1* the else 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
Tilt. 40__Prsiedl .n .( ta. knss.wi
lii) The test 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) Homes to be vied fit Ingredient
i lefrmenL The name used for each in-
gredient shall be the accepted
common name, if there I, one, fol-
lowed by the chemical name. The
common name may be used alone only
lilt is well known. If no common name
has been establl hed, the chemical
name alone shall be used. in no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section I5(cMO).
14) Stotemeiela of percestaget 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.
Percentile. shall not be esp.essed by
a range of value. such as “22-25%-’ II
the uses of the pesticide product are
as weight of active inv’edl-
ent per unit area, a statement of the
weight hi active Ingredient per unit
volume of the pesticide formulation
shall also appear in the Ingredient
statement-. _____
(5) Accvweg of staled p esInpes.
The petcentales given shall be a. pre-
cise as gmsslble reflecting good manu-
facturing practice. If there may be un-
avoidable variation between tnsnu lie-
turing batches, (is. value stated for
each . th. Ingredient shall be the
lowest ,, , itage which nay be pres-
ent.
( ) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requtrements
(I) In cases where it is detennhwd
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
Idatel.”
(II) The product must meet all label
claims U to the expiration time mdl-
rated on the label.
(7) men fn redf,nts The Adminis-
traior may require the name of any
Inert lngrectic,ilqsi to be listed in the
ingredient statement If he determines
that such ingredit-nUs) may pose a
hazard to man or the environment.
(h) War,ifnga end pr,cauflonnry
statements Required warnings and
precautionary statements concerning
the general areas of toxIcologIcal
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fail into two groups
those required on the front panel of
the labeling and those which may
(i) Hu,nan hazard signal rord—(A)
Toxicity Category I. All pesticide prod-
ucts meeting the criteria of Toalcity
Category I shall bear oq the front
panel the signal word “Danger.” in ad-
dition if the product was assigned to
Toxicity Category I on the baids of it.
oral, Inhalation or dermal toxicity as
distinct from skin and eye local ef-
fect.) the word “Poison” shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbone, shall appear in immedIate
proximity to th. word “poison.”
(8) Ths leity Category II. All pesti.
dde products meeting the criterIa of
Toxicity Category II shall bear on the
front panel (he signal word ‘Warn.
(C) Toxicity Category Ii!, All peetl
dde products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word “Cau-
tion,”
(Dl Tozidty Category IV, All pesti-
cide products meeting the criteria of
Tnslcily Category IV shall bear on the
front panel Ih signal word “Caution,”
(F’.) f p of ,lø,oI isnnfj Use of any
sienal wordis ) ssorlaiq’d wiih a higher
162.10
appear elsewhere perlflr require.
menis concerning content, placement,
type size, and prominence are given
below.
(I) Required front pni,.1 ,Votem,ni,
With the exerplion of Ihe child
hazard warning datement. lie tq’rl no.
qutred on the Ironi panel of (1w label
is determined by the To iclty Cateii,
ry of the pesticide The rairsory is as
signed on the basis of ihe highest
hazard shown by any of the indlrnlnr .i
in the table below’
so mm , . mi —
I .
— m rI ,... a.
C S em m coo to
P — em r i b
PS
Toxicity Category lx not permitted
except when the Asinry determines
that such labeling ix necessary to pre
vent Unreasonable adverse el feeLs on
man or the envIronment, In no case
shall more than one human hazard
signal word appear on the front panel
of a libel,
(Ii) C ri1d hazard warning Lvery 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 wills
children during distribution, market
ing, storage or use I . demonstrated by
the applicant to be extremely remote,
or if the nature of the pesticide i 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) lbxfcflp Category I A
statement of pruetiral treatment (first
aid or Other) shall appear on the front
panel of the label of all pe’ tirides fall.
ing into Toxicity Cair’unry I on the
buls of oral, inhalation or dermal lot.
icity. The Agency may, however,
permit reasonable vsniatlnns in liii.
placement of t’ie tmt. m”ni nt s ’ ’ ii
Ompto, I—Fnvlronmesdol Pretadion Agency
.‘l I.NDIX tV—I
(cont inued)
dtO
b t _ k&, _ . LC_
-
5— _
. U
. to
Sb
Sb ‘d b u* 1 tie
c_ —
i v
, , , ..v C
too .w em
P
—
, —
S .. .. bi a ,
—
1 5
-------
* 162.10
cat treatment is some reference such
a.i “See statement of practicel treat-
ment on back panel” appears on the
front panel near the word “Poison”
and the skull and crossbones.
(8) Other (ozfcUp catrgor(eL The
statenwnt of practical treatment is not
required on the front panel except as
de’ cribed in paragraph (hMIM 1 1IXA) of
this section. The applicant may. how.
ever, include such a front panel stat.-
ment at his option. Stati ”m,nLe of
practical treatment are, however, re-
quired elsewhere on the label In
accord with parspvsph (hfll) of Ibis
section l they do not appear on the
front panel.
(iv) Placement asd prw’iinewce. All
the require front panel warning state.
ments shall be grouped together on
the label, and shall appear with soUl-
dent prominence relaUve 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
.how, the minimum type else require.
menla for the front panel warning
stst.IT,efl(s on various sises of labels:
(ii) Eneiprrnmei.tat haterda. Where a
hazard e*iete to non tarict organtem.
excludIng humans and domestic ani-
mals, precautionary atatpmi’nta are re-
quired stating the nature of the
hazard and the appropriate pm-au-
lions to avoid potential accident,
me b 5 —
,
P0w
qà,d
-
-v
iI
øns
-— — -
——
—
-- is
— —.—
S
•0
i i
,.
is
S
S
S
is
i
(2) Other rvquf red waral.,gs and pro-
autlonerp statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
Precautionary Statements” and
under appropriate subheadings of
‘Hazard to Humans and Domestic Ani-
mals.” ‘i tvlronmentai lIarard” and
“Physie l or ChemIcal Hazard,”
(ii Hazard to humans and domestic
animals, (Al Where a bawd 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 seeldent,
injury or damage. The precauUor ,ry
parageiph shall be Immediately pre-
ceded by the appropriate bawd signal
word.
(8) The following table depict , typi-
cal precautionary statements, These
statements must be modified ‘ ex-
panded to reflect eduIe hana .
injury Or damage. xaznple. of the
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use cnntainj an active ingredient
wil h a mammalian acut, oral iD ., of
100 or less, the statement “This Pesil-
dde Is Toxic to Wildlife” is requi d.
(8) If * pesticide intended for out.
door use contains an active ingredient
with a fish acute ic., of I ppm or less,
the statement “This Ppsticide Ix Toxic
to Flqh” Lu required.
(C) If a pesticide Intended for oUt-
door use contains an active Ingredient
with an asian anal, oral [ fl .. of tOO
mg/kg or 1cm, or a subacute dietary
[ C. of 300 ppm or lq’ss, the zlt*tcmen t
“This Vr’slinidq. is Toxfr to Wildlife” is
required.
I D) If either accident hIstory or field
uituidles demonstrate that use of the
pesticide may rru,lt in f t Iity to
birds, fish or mammais. the statement
, — — .0 so- r a I es
1 ” • ‘ I• a
pnv* 4 _ .
(I) Dfrrelfon, f t c U,e—.(l) General
Pegsfrom,,,f,. ,. ,ii) Adequacy and eta ,.
Up of di,vetio,ss, Directiom for use
must be stated In terms which can be
easily read and understood by the
average person likely to use or to so.
pervise the use of the pesticide. When
followed, directions must be adequa
to protect the public from fraud and
from personal injury an4 to prevent
unreasonable adverse effect, on the
environment
(i i) Ptacen,,,, of direegfo Jb’ use,
Directions neay appear on soy portion
of the label provided that they are
eonuqiien enough to be easily read
by the ‘user of the pestiu -ft e product
Directions for use may appear on
printed nr graphic mailer which ac
rompanirs the pislieMe provided that-
* 162,10
“This pesticide is extremely to*lc to
wildlife (fish)” Is requ,i,ed
( ) Pot uses Involving foilar applies.
lion to agricultural crops, forest., or
shade trees, or for mosqu,iio ab*te
ment treatments, twstlcides ask- to
pollinating insects must bear arapropri
te label CsUtion .
IF) For all outdoor uses other than
aquatic applicatin, the label must
bear the caution “Keep out of Iake ,
ponds or stream.,. Do not cnnisminaf .
water by cleaning of Pquilp,npnt or dls
posal of wsstm --
(Ill) 1’h tfr t or chemical ho,u,,,q,
Warning statep , n on th flammahll.
it)’ or explosive rha,arteristles of the
pe tltJde are required as Inilnw,
(A) If required by the Asency, such
Printed o s graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag:
(8) The label bear, a referenc, to
the direction, for us ’ in accompanying
leaflets or circular,, such as “See di-
rection, in the enclosed circular’” and
(C) The AdminIstrate, determines
that It Is not necessary for such dIne-
lions to appear on the label.
(iii) tzcepflons t v’equtremewf for
direction Jbr V ie— IA) Detailed direr-
(Ion, for use nay be omitted from Ia
beling of pesticides which are intended
for use only by manu,fsrtu,,,-s of prod
uc L a other than pc-sf lnide pruwiiu -iq In
their regular manuufa -t airing prm -u -s,ipq
provided that
Till. 40— .Pr.s.dl.. •V
O,ep,., i— nvlra,nm.n Pro , $l Ag.ncy
Al ’ .l.tlDtX tv—I
(cont inued)
-- -----—-
——_____I____
(Al P ni, .i, 0
raw — a a a so- r • , a . a a-. _ u . daa, as i... _ a—
— was., d ie. wr., .o s . ._ , . .. , ._
c .ws . , . a w... a., uw
P . . . — . . 5 .w as.,
waIt — wa a,.. a, ‘o ai as.. sas.. .., c
a a . .. . . in- r
a, ‘0a. 0w 5.0a ‘as..
.0 — r
________________________________________ in- P .
m ea
a 50w P- — _..._ Iw.. isa- aw a, _ a
‘P — .0 C,, ._ __ Paas,,u _ a , I . .. d
soot. , ad .0 use’ c — — as 0w a
,
‘- ‘a -v
is,,.*__, U55 W
G IiL .L&. a
me — -
I______
, 5 — l d — .A .,J
5 i 0wL a, .0 a se
east a, i S u 1 b qe. as a as 0wa
Itiad — 0 pas0w I0w ,, . .a a-
a-i .mi ,
=- , a d 0w seu s I . 0w
m — — ot as a a
a --
- a...a._ 0
I
• - - .i ub d . *...t.s
5 5a 0w) a, .0 bse I .
a-., pa,) a, i ,ui 5. as as
— . i.o as a
so a a 0w - 0__,,.&
U
0w* Ii , ,a-..4_ *0 SW)
. ._.,..-..j eoss. a... ,t.. . st.. a,
0 5) -- L..m , u o a-., . i
05, twa. c*0* I t
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‘
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as0w S—. , se... 0w .
. - a-* I
—-
115. —. . sd I - — —
115. ._s...,... - L di
-------
162.10
(1) The label clearly show, that the
product i Intended for use only in
manufacturing p , cesaes and specifies
the type(s) of products involved.
(2) Adequate information such as
teehnicai data sheets or bulletins, Is
available to the trade specifying the
type of product Involved and it.
proper use In manufacturing proceos-
es
(3) The ptoduct will not come Into
the hands of the general public eseept
after incorporation into finished prod-
ucts: and
(4) The Administrator determine,
that such directions are not nee mary
to prevent unreasonable adverse ci-
feds on man or the environment.
(8) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians. or drug-
guts, provided that:
1 The label clearly stetes that the
product is for use oniy by physicians
or veterinatlsiw
(2) The Administrator detennirwe
that such directions are not neceesar7
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 tie
Federal Food. Drug knd 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:
(fl Thor. is Information readily
available to the formulators on the
composition, tosklty, methode of use,
applicable restrictions or limitations,
and effectivene of the product for
pesticide urpoc
(2) The label clearly states that the
product Is intended for use only in
manufacturing, formulating, mining,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
uct. involved;
(3 The product as finally manulac-
tured, formulated, mixed, or repack-
aged is registered: and
(4) The Admini’d.rator determines
that such dlrection are not necessary
to prevent trnreL’innahie adver’e ef-
fects on man or the environment.
till. 40—Pr.t .d$ .n .f Eavka.ussnt
(2) C ’oilLenha of Directions Jbr U.v
The directions fat use shall include
the following, under the headings “Di-
rections for Use”
(I) The statement of use cismiflea-
tion as v, , , ,...ibed in 1 12 10(1) immedl-
ately under the heading “Directions
for Use.”
(ii) Immediately below the state-
ment of use elabslfleafton, the state-
ment “It is a violation of Federal law
to use this prodittt in a manner incon-
statent with its labeling.”
till) l ’he site(s) of application, as fur
example the craps, animals, ares., or
objects to be treated.
(iv) The target pest(s) aomdated
with each site.
(v) The dosage rate smoclated 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-
piicatlcns necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Bpecif I c limitations on reentry
to areas where the pesticide his been
applied, meeting the requirements
concerning reentry provided by 40
CPR Part 170.
(Ix) Apedfle direcUobe coiicetiilni
the stotage and of the pesti-
cide end its eontainer, meeting the ,e-
quirement. of 40 CFR Part Ii i. These
instructions shall be grouped and
appear under the heading “Storage
and DISposaL” This heading must be
set in Ippe of the same minimum sons
as required for the child hsm,d warn’
ing (See Table I I I lI3.10(hNIXivL)
(5) Any limitatlotu or restrictions on
use required to prevent unreasonable
adverse effects, such sr
(A) Required Intervals between sp
plicatlon and harvest of toed or feed
crops,
(B) flotaUor ial emp restrictions.
(C) Warnings as requIred against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) IReservedi
(P ) P’er restricted use pesticides, a
statement that the pestidde may be
applied under the direct supervision of
a certif led applicator who is not phys ’
irally present at the ‘ii.. of appileaUon
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
(F) Other pertinent information
which the Adminkirai.nr determines
to be necessary for the protecUon of
roan and the environment.
(j) . 1afrmnet of I1 u3 (/trcflos,
fly October 22, 1971, all pesticide prod-
uct must bear on their labels a state-
ment of uw ciassilleation as described
in paragraphs (jxl) anti (2) of this sec-
Lion. Any pesticid, product for which
some uses are classified for general use
and others for restricted us, shall be
separately labeled according to the Ia-
brling standardq t forth in this sub-
section, and shall be marketed as reps-
nile product. with different re.iqtra.
Lion numbers, one bearing directione
only for general usr(s and the other
bearing direction.s for restricted Use(s)
except that, If a produrt has both re-
stricted usnsp and general use(s), both
of these tues may appear on a product
labeled for restricted use. 8uch prod-
ucts shall be subject to the provisions
of I lI2lO(jx21.
(I) General Use Ctuuflflceflon. Pesti-
cide products bearing directions for
use(s) classified general shall be I.-
beied with the exact words “Oeneial
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 (or Use will be
considered a false or misleading state.
merit under the statutory definitions
of misbranding.
(2) Restricted tire Claufjkeflo*.
Pesticide products bearing direction
for me(s) classified restricted shall
beat statements of restricted use clu-
silication on the front panel as do-
acribed below:
(I) Front pon f at sternest of restrict-
ed sue ClOJJfJ7c tIoa, (A) At the top of
the front panel of the label, set in type
of the same minimum luIzes as required
for human hazard signal words (see
table In 1162 iO(hkiXiv)), arid appear-
ing wiih siulfiriprit prominence relative
to oi her teil ajuii graphic material on
Ar”i.NuIx IV—1
(ront Inued)
16211
the front panel to make ii. lmnlikeip to
b. overlooked under -sullomar, rondi
tions of purchase anti use, (he talr.
merit “Restricted 11w Pesticide’ shall
appear
Ui) Directly below this statement on
the front panel. a summary statement
of the terms of restriction imposed as
• precondition to registration shall
appear If use hi rest rirted in rertilied
applicators, the following stai.’mrnl is
required. “For retail sale to and i,u ’
only by Certilled Appiientnrs or per
eons under their direct .suitw ’ivislnn and
only for those uses covered by itie (‘er
tilled Applicator’s rrrlillrallnn ‘ If,
however, other reruuialory restrictions
are Imposed, the Adminislratnr wiii
define the appropriate wording (or Ihr
terms of restriction by regu,isi ion
(k) Advertising iReservedl
i40 PR 2528$, July 3. i SIS, 40 P11 32128,
Auu, I. lWlS; 40 PR 35 7l, Aue Si, IS IS
ampnded at 43 PR alas. 5p1 C, IC7RI
15211 ,ft,,$. is, dpt ,,isatkm. ale -
reaam,abl, sd.,vi, effects,
( P CrIteria jbr l a s wine, of Not I of
tnt I to Dens RestslreUon, C nes -I
R ratios, or to Ibid a II sq—
(I) e’nptlon, (I) A rebutta e pee.
sumpti shall arise that a tlce of
intent eny registration ant to
section 3 Mi) of the Act, notice of
intent to I registra pursuant
tosection bMl)of Actors
notice of in I to hol a hearinc to
determine w er e registration
should be lied denied, as ap.
propriate, shall ued, upon a de-
termination by t dmlnlstrator that
the pesticide mee or ese ,eds any of
the criteria for k I forth in para-
graph (aMP) of is tion, Upon such
detenninat the Administrator
shall Issue by ified mall to
the sppli or regietra I, as the case
may be, ing that the ppik-snt or
registrant has the o tunity to
submit idence in rebut of such
r’esum on in accordance th para-
graph M4) of this section e appli-
cant registrant shall have I ty live
(Ii) aye Irohi the dale such n l ee Ii
to submit evidence in rebiui I of
I Dresumption provided, how Pr,
at for good cause shown the Ad n
trator may grant an additional u. y
chapter I—Inviromsentai Protection Agency
-------
PRODUCT
PWTSCN. On CHVUCII. NJ f’ 1 /I E
Attibi .IOntO NT ______________
P1$t PIOnID(N1S ______________
O CflONS On
• b • IOOOO
• e •
P OOUCt CONtA I (11 On PI GALlON
______ KEEP OUT OF REACH OF CHILDREN
(jj* DANGER —POISON
•ta,1vUi, On PnACICAL t U,U,N,
itonaot I*AUO*l
_____ r
OnIPOSAL ____________ ON I
‘,t,is
m
U! !Cl PANVL Pon At NM. P*,C&sit SdA v SIAVIMINT$
UIOUy - X
-
( )llI*StI$MutHt NO __________
•P* nfc 3 naTow NO 4
NEt CONTENtS ______________
Pfl(CAUI NA V SVAttMtNTl
N&ZARDI tO NUWANI
IS &ItStC £N*iALSJ
ENvVIOnflflNt*& N&1A)InI
RESTRICTED USE
PESTICIDE
Per null iii . Ii • v i i •sIy by t,rtIlI,4 ipplitil.,,
in penI. i •id•r thur dirsti •vp.r.I,I.. . d •IiIy I.,
II oi, sees cs,.n.d by Iki C.rISII.d ippliceleri ( irtItI.
1.1 liii .
l INt v t*?EUtN?
.
STORAGE AND
DISPOSAL
cI’
-------
APPU4DIX IV-2
LABELDfl REQUIREMEI4TS OF ThE FIFRA, AS PJ4E2’IDI ])
ITE?4
LABEL ELEZlE 1T
APPLICABILITY
OF RI U1RF1 ThT
PLACE 4EWI’ ON LABEL
COMMENTS
REQUIRED
PREF RED
1
Product name
All products
Front panel
Center front
panel
2
Company name
and 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
i
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
EPA Eat. No.
All products
None
Front panel,
Inrnedlately
before or
following
Reg._No.
May appear on the container Instead of
the label.
6A
Ingredients
statement
All products
Front panel
Ininedlately
following
product_name
Text must run parallel with other text
on the panel.
613
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
al/unit area
Front panel
Directly below
the main
ingredients
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped to ether, preferably
blocked.
7A
Keep Out of Reach
oC Children
(Child hazard
warning)
All products
Front panel
Above signal
word
Note type size requirements.
7 13
Signal word
All products
Front panel
I______________
Irrmediately Note type size requirements.
below child
hazard
warning I
-------
APP 40IX EV-2 (continued)
ITFM
LABEL EL I4FN
APPLICABILIIY
OF REQU1RE24EN
PLACF2IENI2 ON LABEL
COMMENFS
REQUIRED
PREFB2 RED
7C Skull & cross-
bones and word
POISON (in red)
I
All products
which are Cat-
egory I based
on oral, der—
inal, or inhala—
tion toxicity
Front panel
Both in close
proximity to
signal word
70
Statement of
practical
treatment
All products
in Categories
I, II, and lit
Category I:
Front panel
unless refer-
ral statement
18 used.
Others:
Grouped with
side panel
precautionary
statements.
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
direct ions
for_use
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
8A
Hazards to
hununs and
domestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
SB
Environmental
hazards
All products
None
Same as above
Environmental hazards Inc 1.’jde bee
caution where applicable.
-------
APPE2’1DIX IV-2 (continued)
fF74
LABELS ELE14 2 T
APPLICABILITf
0? RF/ U1RE74 Nr
PLJtCFI1E ’IT ON LABEL
COMME2 S
RE U1RED
PREFEBRED
BC
Physical or
chemical
hazards
All pressurized
products, others
with flash
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 terms of
restriction. The words “RESITIIC’PED USE
PESTICIDE” must be same type size as
8ignal word.
90
Misuse
statement
All products
Irnnediate ly
following
heading of
directions
for_use
1OA
Reentry
statement
All
cholinesterase
inhibitors
In the
directions
for use
Irm edlately
after misuse
statement
1OC
Storage and
dieposal block
All products
In the
directions
for use
Irrinediately
before
specific
directions
for use or
at the end of
directions
for_use
Must be set apart and clearly distin-
guishable from from other directions
for use.
1OD
Directions
for_use
All products
None
None
M&y be in metric as well as U.S. units
-------
Appendix IV—3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non—Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°?
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
Appendix IV-L
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and dispo,.sal 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:
Required type size
Size of label for the head1n
front panel in STORAGE AND DISPOSAL
square inches (all capitals)
10 and under .6 point
Above 10 to 15 . . . . . . . . 8 point
Above 15 to 30 . . . . . . . . . . . . . 10 point
Over3O 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions :
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
-------
Appendix IV-
(continued)
Lj• Instructions on what to do if the container is damaged in
any 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 pesticid es
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 ingred,ients
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, 140 CFB
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
Appendix IV-L$
(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 Ofrice
for guidance.”
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
“Wastes resulting from the use of’ this product may be
disposed of on site or at an approved waste disposal
facility.”
3. Products intended for domestic use only must bear the
following disposal statement: “Securely wrap original
container in several layers of newspaper and discard In
trash.”
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
Non—aeroso i. products Do not reuse container (bottle, can, jar).
( bottles, cans, jars) Rinse thoroughly before discarding In trash .
Non—aerosol products Oo not reuse bag. Discaro bag .n trash.
( bags ) _______________________________________________
Aerosol products Replace cap and discard containers in
_____________________ trash. Do_not_Incinerate_or_puncture.
-------
Appendix IV-L3
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
1/ Manufacturer may replace this phrase with one Indicating
whether and how fiber drum may be reused.
Metal
containers
(non—aerosol)
Triple rinse (or equivalent). --Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Tnen offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
Incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then cispose
of in a sanitary landfill or by other
approved_state_and_local_procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue Into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum Is contaminated and cannot be
reused ],_dispose_of_in_the_same_manner.
Paper and
plastic bags
Completely empty bag Into application
equipment. Then dispose of empty bag In
a sanitary landfill or by Incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out_of_smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
-------
AppendIx IV-14
(continued)
Pesticides that are hazardous wastes under 14Q CFR 261.33(e) and (f)
when discarded.
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients, (no inerts) :
Acrolein
A ldicarb
Aidrin
Allyl alcohol
Aluminum phosphide
1 1-Aminopy ridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p—Ch loroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2—Cyclohexyl—Z ,6—dinitrophenol
Die 1 d r in
0,0—Diethyl S— [ 2—ethylthlo)ethyl] phosphorodithioate
(disulfoton, Di—Syston)
0,0-Diethyl 0—pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethy]. O—p—nitropheny]. phosphorothioate (methyl parathion)
Ai,6—Dinltro—o—cresol and salts
ii ,6—Dinitro—o—cyclohexylpnenol
2, Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphu r
Fluoroacetamide
Heptachior
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomy ].
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV- 4
(continued)
“ Acutely Hazardoustt Commercial Pesticides (RCRA “E” List)
Active Ingredients continued :
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
O,O,O,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
-------
Appendix IV-Li
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Acetone
Acrylonitrile
Amit role
Benz ene
Bis (2—ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachioride
Chloral (hydrate)
Chiordane (technical)
Chlorobenzene
—C1 loro--w—creso1
Chloroform
o-Chlorophenol
l—Chloro—o—toluidj.ne hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro_l,3,z1_metheno....2H_cyclobuta [ cd]_pefltalefl 2 one
(kepone, chiordecone)
l, 2 —Dibromo—3—chloropropane (DBCP)
Dibutyl phthalate
S—3,3—(Dichloroallyl diisopropylthlocarbamate (diallate, Avadex)
o—Dlchlorobenzene
p—Dlch lorobenzene
Dichiorodifluoromethane (Freon 12 c)
3,5—Dichloro—N—(l,1—djmethy l_2_propyny l) benzamide (pronarnide,Kerb)
Dichioro diphenyl dichioroethane (DDD)
Dichloro diphenyl trlchloroethane (DDT)
Dichiorethyl ether
2, I—Dichlorophenoxyacetjc, esters and salts (2,Li—D)
1, 2—Dichloropropane
l,3—Dichloropropane (Telone)
Dlmethyl phthalate
Ethyl acetate
Ethyl LI,ki ‘—dichlorobenzjlate (chlorobenzllate)
Ethylene dibromide (EDB)
Ethylene dichioride
Ethylene oxide
Formaldehyde
Furfura].
Hexachlorobenzene
Hexachlorocyc ] .open tadjene
Hexachloroethane
Hydrofluoric acid
-------
Appendix IV-L4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2’—Methylenebls (3,11,6—trichiorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
1l—Meth #l—2—pentar1one (methyl isobutyl ketone)
Naphthalene
Nltrobenzene
p—Ni trophenol
Pentachloroethane
Peritachloronitrobeflzefle (PCNB)
Pentaclorophenol
Phenol
Phosphorodithloic acid, 0,0—diethyl, methyl ester
Propylene dichioride
Pyridine
Resorcinol
Saf role
Selenium disulfide
Silvex
1,2,11 , 5—Tetrachlorobenzene
1,1,2, 2—Tetrachloroethane
Tetrachloroethylene
2,3,11 ,6—Tetrachlorophenol
Thiram
Toluene
1,1, l—Trlchloroethane
Trichioroethylene
Trichloromonofluoromethane (Freon il®)
2,11, 5—Trichiorophenol
2,11, 6—Trichiorophenol
2,LI,5—Trichlorophenoxyacetic acid (2,11,5—T)
Xylene
-------
Appendix IV-J4
(continued)
“ Toxic” Commercial Pesticide Products ( CRA “F” List)
Inert Ingredients :
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cy clohexanone
Dichiorodifluoromethane (Freon l2 )
Diethyl phthalate
Dime thy lamine
Dimethyl phthalate
1 , 1—D1oxane
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-Trichioroethane
1,1, 2—Trichloroethane
Trichiorofluoromethane (Freon 11
Vinyl chloride
Xylene
------- |