££PA
Unrt«dSt«m
EmriroanMntai Protection
Agency
Off lea of
I^Hteld* and Toxic SubtunoM
Washington DC 20460
December 1985
PMicto-i
Guidance for the
Reregistration of
Pesticide Products
Containing
fhion-ancte Ethyl
as t*- * Active Ingredier*
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AS THE ACTIVE INGREDIENT
THIOPHANATE ETHYL
EPA CASE NUMBER: 378
CAS: 23564-06-9
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
DECEMBER 31, 1985
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 13
III. Requirement for Submission of Product—Specific Data . . 30
IV. Submission of Revised Labeling . . . . 34
A. Label Contents . . . . . 35
B. Collateral Information . . . . . . . . . . . . . . . 40
V. Instructions for Submission 41
I .
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APPENDICES
Page
1 1—1 Guide to Bibliography . . 44
11—2 Bibliography . . . . . . . . . . . 46
11—3 FIFRA §3(c)(2)(B) Summary Sheet — EPA Form 8580—1 . 49
11—4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
E P A F 0 rrn 8 5 80 — 2 . . . . . . . . . . . . 50
1 1 1—1 Product Specific Data Report (End—Use Products) . 51
IV—1 40 CFR 162.10 Labeling Requirements 53
IV—2 Table of Labeling Requirements 58
IV—3 Physical/Chemical Hazards Labeling Statement. . . . 61
IV—4 Storage Instructions . 62
P1—5 Pesticide Disposal Instructions . . . . . . . . . 63
IV—6 Container Disposal Instructions . . . . . . . . . . 70
ii
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I NTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA..sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration 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 pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in unreasonable adverse effects on the environ-
ment.
The scientific review, which is not contained in this
Guidance Package but is available from the National Technical
Information Service, concentrates on the technical grade of
the active ingredient and identifies missing generic data.
However, during the review of these data we are also looking
for potential haz-ards that maybe 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
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of the active ingredient) and other producers who do not
qualify for the formulator’s exemption.*
A-producer who wishes to qualify for the formulator’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. A 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 you decide to request the Agency to cancel the regis-
tration 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 may
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
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
*The formulator’s exemption applies to a registrant of an
product 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
f i rm.
2
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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 Regis-
tration Standards Guidance
Document.
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 restric—
The Formulator’s Exemption tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
- of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in “II”
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in “I” above fail to meet the requirements in
I—A and B above, then the registrants in “II” lose their right to
qualify for the formulator’s exemption and become subject to the
requirements in I—A and B.
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I. REGULATORY ASSESSMENT
A. INTRODUCTION
This chapter describes the regulatory position of the
Environmental Protection Agency (“the Agency”) on thiophanate
ethyl. This position is based on an evaluation of the one
manufacturing use product (MP) containing thiophanate ethyl
as the sole active ingredient and the registered thiophanate
ethyl uses. Future requests for registrations of substantially
similar products will be covered by this standard. After
briefly describing the chemical and its uses, this chapter
presents the regulatory position and rationale, the criteria
for registration, the acceptable ranges and limits, and the
labeling requirements for manufacturing use products (MP5) and
end use products (EPs).
B. DESCRIPTION OF CHEMICAL
“Thiophanate” is the common name (British Standards
Institution, International Organization for Standardization) for
diethyl 4,4’—o—phenylene bis [ 3—thioallaphanate]. Trade and
other chemical names for this compound include 1,2—bis [ 3—(ethoxy—
carbonyl)—2—thioureido]benzene, diethyl [ 1 ,2—phenylerte bis
(irninocarbonothioyl)]—bis—(carbamate), Topsin, Cleary’s 3336,
Cercobin, Topsin E, NF—35, and TD—1604. The Chemical Abstracts
Service (CAS) Registry Number is 23564—06—9 and the Office of
Pesticide Program’s Internal Control Number (EPA Shaughnessy
number) is 103401.
Thiophanate ethyl is a broad spectrum systemic fungicide
registered for use on turf (golf courses), roses, flowers,
ornameritals, and shade trees. Technical thiophanate is manu—
factured--by Nippon Soda Co. Ltd., Japan and is marketed in the
United States by Penriwalt Corporation. There are four
formulations of thiophanate ethyl, 2 wettable powders (16.67
percent and 50 percent) and 2 flowable concentrates (1 .09 lb/gal
and 4 lb/gal). Application rates range from 1.36 to 10.9 lbs
ai per acre for turf uses and 0.25 lb to 0.75 lb ai per 100 gallons
for ornamental uses.
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C. REGULATORY POSITION AND RATIONALE
Based on a review and evaluation of the available data
and other relevant information on thiophariate ethyl, the Agency
has made the following determinations.
1 . None of the risk criteria set forth in Title 40
Code of Federal Regulations (CFR) §162.11 have been met or
exceeded by thiophanate ethyl.
Rationale :
a. Thiophanate ethyl is not oncogenic in rats or mice.
A chronic toxicity/oncogenicity study in rats which resulted
in reduced body weight in both sexes, thyroid follicular
hypertrophy in older male rats, and elevated liver weights
and liver—to—body weight ratios in males, indicated a LEL (lowest
effect level) of 1000 ppm (50 mg/kg/day) and a NOEL (no observable
effect level) of 200 ppm (10 mg/kg/day) . Tumors were observed
predominantly in older animals, but there were no statistically
significant increases in their incidences. A mouse oncogenicity
study did not indicate an oncogenic effect for thiophanate ethyl
at doses tested up to 2000 ppm (300 mg/kg/day).
b. Methyl benzimidazole carbamate (MBC), which is a
metabolite of the fungicide thiophanate methyl and a structural
analog of ethyl benzimidazole carbamate (EBC), the metabolite of
thiophartate ethyl, is associated with increased liver tumors in
mice. However, there are no studies available suggesting that
EBC similarly induces tumors in laboratory animals, and
oncogenicity studies with thiophanate ethyl and thiophanate
methyl do not suggest an oncogenic potential similar to that of
MBC for either fungicide. Because of the low potential for human
exposure to thiophanate ethyl from current uses, exposure to EBC
is also expected to be low, even though we do not have data which
show the proportion of thiophanate ethyl that is likely to be
metabolized to EBC. If uses are expanded, thereby increasing
potential human exposure, data to determine the proportion of
thiophanate ethyl that is metabolized to EBC in animals, and data
on the toxicity of EBC may be required to complete a hazard
assessment.
c. Thiophanate ethyl has moderate to low acute toxicity
to humans. Acute toxicity studies indicate Toxicity Category III
for acute inhalation (LC 50 = 6.7 mg/L), acute dermal (LD 50 >
15,000 mg/kg), and primary skin irritation (non—irritating),
and Toxicity Category IV for acute oral (LD5O > 15,000 mg/kg),
and primary eye irritation (non—irritating).
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2. The Agency is requiring the submission of teratology,
mutagenicity, and repeated dermal toxicity studies.
Rationale : Registrants of thiophanate ethyl products were
not previously required to submit the above studies to the
Agency. Teratology studies in two mammalian species are required
to assess the teratogenic potential of thiophanate ethyl.
Mutagenicity studies that evaluate the potential of thiophanate
ethyl to cause gene mutations, chromosomal damage, or other related
effects are also required, and a 21—day dermal toxicity study in
rabbits is required to fully assess the dermal toxicity of
thiophanate ethyl.
3. Since there are no food/feed uses registered for
thiophanate ethyl, plant and livestock metabolism, residue, and
feeding data for thiophanate ethyl are not required at this time.
Rationale : To date there have been no U.S. tolerances or
registrations on food/feed items for thiophartate ethyl. All
currently registered labels contain a restriction prohibiting
grazing on treated turf or feeding clippings to livestock.
In the event that future food uses for thiophanate ethyl
are proposed, all appropriate metabolism, residue, and feeding
data will be required, pursuant to 40 CFR §158.
4 . The Agency is requiring the submission of studies to
fully assess the environmental fate of thiophanate ethyl and the
exposure of human and nontarget organisms to thiophanate ethyl.
Rationale : Registrants of thiophanate ethyl products were
not previously required to submit environmental fate studies.
The following studies are required to fully assess the environ-
mental fate and transport of, and the potential exposure to
thiophanate ethyl: hydrolysis studies; photodegradation studies
in water; aerobic soil metabolism studies; leaching or adsorption/
desorptiort studies; terrestrial field dissipation studies; and
accumulation studies in fish.
5. The Agency may require additional avian toxicity
data depending on the outcome of the required environmental
fate studies.
Rationale : Thiophanate ethyl has an extremely low acute
toxicity to birds. Thiophanate ethyl has an acute oral LD 50 to
bobwhite quail greater than 2510 mg/kg and LC5ij values of
greater than 5620 ppm to both mallard ducks and bobwhite quail.
If after receipt and evaluation of environmental fate data
it is concluded that avian species are subject to significant
or recurrent exposure to thiophanate ethyl and EBC, the Agency
may request a complete avian toxicity battery on EBC and avian
reproduction studies on thiophanate ethyl and EBC.
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6. The Agency is requiring data to evaluate the acute
toxicity of EBC to aquatic species, and to evaluate the
toxicity of thiophanate ethyl and EBC to channel catfish in
particular. Depending on the outcome of the environmental
fate studies, additional aquatic toxicity testing may be
required.
Rationale : Thiophanate ethyl has moderate acute toxicity
to fish and aquatic invertebrates. Thiophanate ethyl has an LC 50
of 2.6 ppm to bluegill sunfish, 2.26 ppm to rainbow trout, and
2.6 ppm to Daphia magna . However, studies performed with the
chemically related compounds, thiophanate methyl and benomyl,
show a toxicity to channel catfish in the “very highly toxic”
range. Furthermore, the primary rnetabolite of both these compounds,
NIBC, is also very toxic to channel catfish. There is reason to
suspect that thiophanate ethyl may be more highly toxic to
ictalurid fishes (catfish family) than to other types of fish,
and therefore, a 96—hour LC 50 on channel catfish using thiophanate
ethyl and EBC is being required. As there are also no data
available to assess the acute aquatic toxicity of EBC, these
data must also be submitted. If after receipt and evaluation of
environmental fate data it is concluded that there may be
significant or recurrent exposure to aquatic habitats, chronic
aquatic testing on both thiophanate ethyl and ethyl benzimidazole
carbamate may be required in order to complete this hazard
assessment.
7. Based on available data, the currently registered uses
of thiophanate ethyl should not result in adverse effects to
endangered species. A formal consultation with the OES (Office of
Endangered Species) may be initiated if data to be generated
indicate risks to endangered species.
Rationale : There are two ictalurid finfishes (catfish
family) on the endangered species list, the scioto madtom and the
yellowfin madtom. If, after the receipt of additional data
thiophanate ethyl proves to be highly toxic to ictalurids
and if significant aquatic exposure seems likely, a formal
consultation with the Office of End.angered Species will be
initiated.
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8. Manufacturing use pesticide products containing
thiophanate ethyl as a sole active ingredient may be registered
for sale, distribution, formulation, and use in the United States,
subject to the terms and conditions specified in the Standard.
Registrants must provide or agree to develop addLtional data,
as specified in the tables, in order to maintain existing
registrations or to permit new thiophanate ethyl registrations.
Rationale : In the absence of evidence indicating that the
use of a pesticide would cause unreasonable adverse effects to
the environment, the Agency can register or allow the continued
registration of a product for which data are missing or inadequate.
Issuance of this Standard provides a mechanism for identifying
such data needs. Data submitted to fill these gaps will be
reviewed and evaluated. The Agency will then determine if they
will affect registration(s) of thiophanate ethyl.
9. In order to meet statutory standards under FIFRA,
MP labels must bear. a statement regarding discharge to bodies of
water and sewer systems (see Section F. Labeling requirements).
Rationale : These precautions will minimize the discharge
of effluents from manufacturing plants and also meet the
Effluent Guideline requirements
10 . No protective clothing statements or reentry intervals
are required.
Rationale : Thiophanate ethyl has moderate to low acute
toxicity to humans. Acute toxicity studies indicate Toxicity
Category III for acute inhalation (LC 50 = 6.7 mg/L), acute dermal
(LD 50 > 15,000 mg/kg), and primary skin irritation (non—irritating),
and Toxicity Category IV for acute oral (LD 50 > 15,000 mg/kg),
and primary eye irritation (non—irritating).
11. EP labels will be required to bear a revised
environmental hazard statement regarding application to bodies of
water. This statement however, may be subject to further
revisions (see Section F. Labeling requirements).
Rationale : After evaluation of the required environmental
fate data and ecological effects data on the parent compound
and its metabolite EBC, the basic environmental hazard
statement may need to be further revised to protect the
non—target species.
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12. EP labels will be required to maintain the grazing
restriction statement (See Section F. Labeling Requirements).
Rationale : There are currently no established U.S.
tolerances for thiophanate ethyl on food/feed items.
This restriction is neces ary to prevent the occurrence
of secondary residues in meat and milk products.
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D. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT
To be subject to this guidance document, MPs must meet the
following condition:
1 . Contain thiophanate ethyl as the sole active ingredient
and,
2. Conform to the acute toxicity limits, product composition,
and use pattern requirements listed in Section E of this
document.
In order to meet applicable statutory standards under FIFRA,
registration of products subject to this document must comply
with all terms and conditions described in it, including
commitment to fill data gaps on a schedule acceptable to EPA
and consistent with that required of the present registrant.
All registrants and applicants for registration under this
document must follow the instructions contained in this
document and complete and submit the appropriate forms within
the specified time.
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits.
In addition, the active ingredient found in the MP5 must be
substantially similar to that in the currently registered
product. Any MP not meeting these requirements will be
considered a new product and will not be registerable
under this standard.
2. Acute Toxicity Limits
The Agency will consider registration of products containing
thiophanate ethyl, provided that the product labeling bears
appropriate precautionary statements for the acute toxicity
category in which each product is placed.
3. Use Patterns:
To be registered under this standard, MPs containing thiophanate
ethyl must be labeled for formulation only into end-use
fungicide products for use on turf (golf courses), roses,
flowers, ornamentals, and shade trees.
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F. REQUIRED LABELING
All technical grade products, MPg, and EPs containing thiophanate
ethyl must bear appropriate labeling as specified in
40 CFR § 162.10. Other portions of this guidance package contain
specific information regarding label requirements.
In addition to the requirements stated in 40 CER § 162.10, the
following information must appear on the labeling of all products
in the channels of trade after June 30, 1987 .
1 . Ingredient Statement
The ingredient statement for MPs and EPs must list the
active ingredient as:
Thiophanate ethyl: diethyl 4,4’—o—phenylene bis [ thio—
allophanatel , %
2. Precautionary Statements
Manu facturing—tJse Product Statements
All products intended for formulation into EPs must bear
the following environmental hazard statement:
“Do not discharge effluent containing this product directly
into lakes, streams, ponds, estuaries, oceans or public
waters unless this product is specifically identified
and addressed in a National Pollutant Discharge
Elimination System (NPDES) permit. Do not discharge
effluent containing this product into sewer systems without
previously notifying the sewage treatment plant authority.
For guidance, contact your State Water Board or Regional
Office of the Environmental Protection Agency.”
End—Use Product Statements
The following environmental hazard statement must appear
on all EP products:
“Do not apply directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water by cleaning
of equipment or disposal of waste.”
The following feeding/grazing restriction must appear
on all EP products:
“Do not graze treated area or feed clippings to livestock.”
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G. TOLERA ’.1CE REASSESSMENT
To date there have been no U.S. tolerances or registrations
on food/feed items for thiopnanate ethyl.
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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
this 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 Data” 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 registrability 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 Orgaritzation 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, regardles
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.
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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—31 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-
ment of Data” (EPA Form 8580—6, Appendix II_4)*/
/ FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator’s decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
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OR
4 . Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
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 tide offer to the first registrant to share
in the expenses of the testing (on terms to be agreed upon
or determined by arbitration under FIFRA Section 3(c)(2)(B)(iii)];
and (3) the first registrant has declined to agree to enter
into a cost—sharing agreement, EPA will not suspend the
second firm’s registration.
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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.
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TABLE A
GENERIC D ATA R U1REME II FOR ThIOPHANATE ETHYL
Data Must Be
Guideline Citation and
Test
Guidelines
Are Data
Submitted Within
Name
of
Test
Substance
Status
Required
Yes
Reference
Citation
Tine Frames
Below 1/
Liste
§158.120 Product Chemistry
Product Identity:
61-1 —. Identity of Ingredients
61—2 — Description of Beginning Materials
ar i Maruifacturir j Process
61—3 — Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62—1 —
62—2 —
62—3 —
00089068
‘ItAI
TGAI
I 3AI
TGAI
I AI
TGAI
‘IXA I
‘I 3AI
B 3AI
]X AI
R
R
R
R
R
R
R
R
R
R
NA
Preliminary Analysis
Certification of Ingredient
Limits
Analytical Methods to Verify
Certified Limits
Physical and Chemical Characteristics
63-2 — Color
63-3 — Physical State
63-4 - Odor
63—5 —
63—6 —
12 Months
12 Months
6 Months
6 Months
12 Months
El
[ Xl
[ Xl
[ xl
[ Xl
[ X I I
[ 1
III
[ 1
III
[ 1
[ X I
[ I
[ — I I
[ I
[ I
[ 1
(XII
[ Xl
[ Xl
Ix
[ II
Melting Point
Boiling Point
00068776
00068776
00068776
00068776
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TABLE A
GENERIC ( TA R UIREMENTIS FOR THIOPI-IANATE ETHYL
Data ITaist Be
Guideline Citation and
Test
Guidelines
Are Data
Submitted Within
Narr of Test
Substance
Status
Required
Yes ND
Reference
Citation
Tine Fran s Listed
Below 1,
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63—7 — Density, Bulk Density, or
¶IXA1
R
(1 (X l
00068776 —
Specific Gravity
63—8 — Solubility
63—9 — Vapor Pressure
6 3—10 - Dissociation constant
KA 1
¶ AI
TCAI
R
R
R
lx i I I
[ Xi Ii
[ X l (I
6 Months
6 Months
6 Months
63—11 - Octanol/water partition
coefficient
¶R3AI
R
[ ] 11
6 Months
63-12 - p t - I
63—13 — Stability
1XM
‘j1 Aj
R
R
[ ) 11
[ I (Xl
6 Months
0088444
TGAI = Technical Grade of the Active Ingredient; PAl = Pure Active Ingredient; R = Required; CR = Conditionally Required
1/ Data trust be submitted within the indicated tine frane, based on the date of the Guidance [ )Dcunent.
o 6 Month the Date is June 30, 1986
o 12 Month the Date is December 31, 1986
18
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TABLE A
GENERIC DATA RB)UIREMENI 3 I OR ThIOPHANATE ETHYL
Does EPA Have
Data To Satisfy
This Require-
n nt? (Yes, No
or Partially)
B
4J
N/A
4/
N/A
B,F No
4/
N/A
4/
N/A
4/
NI/A
B, F
4/
N/A
4/
N/A
1/
Data Requiren nt Composition
Use 2/
Pattern
Must Additional Data
Be Submitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
-
Tine Fran for Data
Sut üssion 3/
1 AI or PAIRA
B,F Yes
No
ltM
1 AI
UA 1
‘IIAI
§158.130 Environnental Fate
DEY RADATION STIJDI ES-LAB :
16 1—1 — Hydrolysis
Photodegradat ion
161—2 — In water
161—3 — On soil
161—4 — In Air
METABOLISM STUDI ES—LAB :
162—1 — Aerobic Soil
162—2 - Anaerobic Soil
162—3 — Anaerobic Aquatic
162—4 — Aerobic Aquatic
N )BILITY STUDIES :
163—1 — Leachir and
Adsorpt ion/Desorpt ion
163—2 — Volatility (Lab)
163—3 — Volatility (Field)
or PAIRA
or PAIRA
or PAIRA
or PAIRA
or PAIRA
6 Months
6 Months
24 Months
6 Months
Yes
Yes
Yes
ICAI or PAIRA
IGP 1 J or PAIRA
IGAI or PAT RA
TEP
TEP
No
19
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TABLE A
GENERIC DATA REI)UIREMEN S EOR ThIOPHAN TE E FWL
E es
EPA Have
Must Additional Data
Data
To Satisfy
Be Submitted Under
1/
Use 2/
This
Require—
Bibliographic
FII A § 3(c)(2)(B)?
Data
Requirerrent
Composition
Pattern
ment? (Yes,
or Partially)
t’b
Citation
Time Frame for Data
Submission 3/
§158.130 Environmental Fate — Continued
DISSIPATION SIUDIES — FIELD ;
164—1 — Soil TEP B Yes 24 nonths
4 - _I
164—2 — uatic (Sediment) TEP N/A
4/
164—3 — Forestry TEP N/A
164—4 - Combination and 5/
Tank Mixes
4/
164—5 - Soil, Long term TEP N/A
ACCUMULATION SIUDI ES :
165—1 — Rotational Crops 4/
(Confined) PAIRA N/A
165-2 - Rotational Crops 4/
(Field) TEP
4
165-3 — Irrigated Crops TEP WiC
165—4 — In Fish TGAI or
PAIRA B Yes 6 mcnths
165-5 — rn Njuatic n-Target 4/
Organisms TEP N/A
6/
158.140 Reentry Protection
20
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ThBLE t
GENERIC DATA REI UIREMEtSTFS I?’OR ThIOPUAN1 ATE I fHYL
§158.130 Environn ntal Fate — Continued
1/ Canposition: ICAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end—use product.
2/ The use patterns are coded as folk ,s: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; C=I cjuatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Exxnestic C itdoor; I=Indoor.
3/ Data must be sub’nitted within the indicated time frame, based on the date of the Guidance Document.
o 6 Month We Date is June 30, 1986
o 24 Month We Date is December 31, 1987
4/ Not applicable. Data are not required to support current registered uses.
5/ Data requirements for ccznbination products and tank mixes are not addressed in this standard.
6/ The criteria for reentry data requirements as defined in 40 CFR Part 158.140 are not met for this chemical.
21
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U58.135 Toxicology
TABLE A
GENERIC tY TA REOUIREMENTS I OR ThIOPHAMkTE ETF1YL
Does EPA Have
Data Th Satisfy
This Require-
n nt? (Yes, No
or Partially)
5/
00032673 No
6/
No
Yes
7/
No
1/
Data Requireu nt Composition
Use 2/
Pattern
Must Additional Data
Be Subnitted Under
Bibliographic
FII!i A 3(c)(2)(B)?
Citation
-
Time Frau for Data
Su ission 3/
ICA I
TGAI
TGAI
ICA I
lY AI
1 AI
B, F
B, F
B, F
B, F
B, F
B, F
ACUTE TESTIt C :
81—1 — Acute Oral Toxicity — Rat
81—2 — Acute Dermal Tbxicity
— Rabbit
81—3 — Acute Inhalation Toxicity
— Rat
81—4 — Eye Irritation — Rabbit
81—5 — Dermal Irritation — Rabbit
81—6 — Dermal Sensitization —
Guinea Pig
81—7 — Acute Delayed
Neurotoxicity — Hen
SUBCHF ONIC TESTIM :
82—1 — 90-Day Feeding
— Rodent, and
— Non-rodent (Dog)
82-2 — 21—Day Dermal — Rabbit
82-3 — 90—Day Dermal — Rabbit
Yes
00089070
tb
Yes
00089070
tb
Yes
00098045
Yes
00098046
tb
Yes
00098047
No
Yes
00089070
TGAI B,F
‘I AI
TGAI
TGAI
AI
4/
No
B, F
B, F
B, F
B, F
6 Months
22
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§158.135 Tbxicology — Contiruied
SUBCURONIC TE STI (Cont’ d.) :
82—4 — 90—Day Inhalation:
— Rat
82—S — 90—Day Neurotoxicity:
— Henfllammal
CHRONIC TESTI1 C :
83—1 — Chronic Toxicity—
2 species:
— Rodent, and
— Non—rodent (Dog)
83—2 — Oncogenicity —
2 species:
— Rat (preferred), and
- Maise (preferred)
83—3 — Teratogenicity —
2 species:
— Rat
— Rabbit
83-4 — Reproduction - Rat
2—generation
TABLE A
GENERIC DATA REI)UIREMENIS Ft)R ¶IHIOPHANATE E’TI-IYL
Does EPA Have
Data To Satisfy
This Require—
ment? (Yes, ND
or Partially)
Yes
Yes
9/
No
/
Data Requirerrent Composition
Use 2/
Pattern
Must Additional Data
Be Subnitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Time Frarre for Data
Sut ission 3/
8/
TGAI
B,F
No
4/
1 AI
B,
F
ND
ND
Yes
ND
00032673
No
6/
No
Yes
00032673
Yes
00032674
R3AI
AI
1 AI
TGAI
P3A1
AI
AI
B, F
B, F
B, F
B, F
B, F
B, F
B, F
9 Nonths
9 Months
23
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§158.135 Thxicology — Continued
MtJTN3ENICITY TE TI
84—2 — Gene Mutation (An s Test)
84—2 — Structural Chron somal
Aberration
84—4 — Other Genotoxic Effects
SPECIAL TE TI
85—1 — General Metabolism
85—2 — Dermal Penetration
86—1 — Domastic Animal
Safety
6 Months
6 Months
Yes 6 Months
10/
Mo
11/
Mo
12/
Mo
/
Use
2/
Data Requiremant Composition
Pattern
TABLE A
GENERIC DATA REOUIREMENTS DR THIOPHANP TE E HYL
Does EPA Have
Data To Satisfy
This Require—
mant? (Yes, Mo
or Partially)
Must AddtEional Data
Be Subnitted Under
Bibliographic
FIFRA § 3(c)(2)(B)?
Citation
Tima Frait for Data
Su nission 3/
l 3AI
B,
F Mo
Yes
IXAI
B,
F
Yes
I CAI
B,
F
PAl or
PAIRA
B, F
Mo
Choice
B,F
Mo
24
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TABLE (
GENERIC DATA REX)UIREMENIS FOR THIOPUANATE ETHYL
§158.135 lbxicolocjy — Continued
1/ Canposition: PAl = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case— ’—case basis.
2/ The use patterns are coded as fo1lci s: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; C=Aquatic, Food Crop;
D=Pquatic, Non—Food; E=Greenhcuse, Food Crop; F=Greenhouse, Non—Food; G=Forestry; H=Danestic C jtdoor; I=Indoor.
3/ Data must be sub’nitted within the indicated time franb , based on the date of the Guidance t)Dcument....
o 6 Month the Date is June 30, 1986
o 9 Month ihe Date is September 30, 1986
4/ Test material is not an organophosphate or degradation pro&*ct thereof, and it is not structurally related to a
kno4n acute delayed neurotoxic substance.
5/ Satisfied by chronic rodent studies.
6/ Not required to support registration for non—food uses.
7/ No direct application to the skin or prolonged dermal exposures are expected with uses of thiophanate ethyl.
8/ Repeated inhalation exposure to toxic concentrations is not likely under normal use conditions.
/ Not expected to result in human exposure over a portion of the human lifespan which is significant in terms of
— frequency of exposure, magnitude of exposure, or the duration of exposure.
10/ Only required in conjunction with chronic feeding or oncogenicity studies which are not required for this use
pattern.
11/ Thiophanate ethyl has noderate to lo acute toxicity to humans and its limited use pattern will not result in
a significant amount of dermal exposure.
12/ The likelihood of dcii stic animal exposure to thiophanate ethyl is minimal.
25
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1/
Ccxnpos it ion
1 AI
5/
EBC
l AI
5/
EBC
N/A
Use
Pattern
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
ND
6/
Reserved
ND
6/
Reserved
ta Requirement
TABLE A
GENERIC DATA REOUIREMEN S FOR NIOPHANATE ETHYL
Lbes EPA Have
Data To Satisfy
This Require-
ment? (Yes, ND
Bibliographic
Citation
. 58.145 Wildlife and
cjuatic Organisms
AVIAN AND MAMMALIAN TESTIt
71—1 — Acute Avian Oral Toxicity
71—2 — Avian Subacute Dietary
Toxicity
- Upland Game Bird, and
— Waterfc zl
71—3 - Wild Maninal Toxicity
ND
7/
TGAI
B,
F
Yes
4/
00085643
TEP
B,
F
Yes
00050517
5/
EI
B,F
B,
7/
F
Yes
00079196
B,F
ND
B,
F
Yes
00079197
B,F
ND
6/
Reserved
26
------- An error occurred while trying to OCR this image.
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TABLE A
GENERIC DT TA REOUIREMENIS EOR T1-IIOPHANPtTE ETFFWL
Does
EPA Have
Must Additional Dat
Data
To Satisfy
Be Subnitted Under
)ata
Requirenent
1/
Composition
Use 2/
Pattern
This Require—
nent? (Yes,
or Partially)
No
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Tine Frane for Data
Su inission 3/
U58.145 Wildlife and
P uatic Organisms — Continued
7/
72-2 - Acute Toxicity to TGAI B, F Yes 00079200 N D
Fresh iater Invertebrates 5/
EBC B, F Yes 9 Months
12/
72-3 - Acute Toxicity to TGAI B
Estuarine and Marine
Organisms
6/
72-4 — Fish Early Life Stage, IOAI B Reserved
and 5/ 6/
— Aquatic Invertebrate EBC B Reserved
Life—Cycle
13/
72—5 - Fish - Life—Cycle TGAI B No
6/
72—6 — Aquatic Organism B Reserved
A ccunuilation 5/
EBC B ND Reserved
6/ 14/
72—7 — Simulated or Actual TEP B Reserved
Field Testir j for
Aquatic Organisms
28
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TABLE A
GENERIC DATA R OUIREMEt I1’S FOR TI-IIOPHANATE Efl’HYL
§158.145 Wildlife and lcjuatic Organi n — Continued
1/ Ccuiposition: ‘IGAI = Technical grade of the active ingredient; PAl = pure active ingredient;
TEP = Typical end—use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, n—Food Crop; C=Aquatic, Food Crop;
D=Aquat ic, Isbn-Food; E=Greenhouse, Food Crop; F=Greenhouse, tsbn— Food; G=Forestry; H=Domest ic Outdoor; 1= Indoor.
3/ Data must be subnitted within the indicated time frame, based on the date of the Guidance Document.
° 9 Month [ lie Date is September 30, 1986
4/ Although this study exists and is acceptable, currently there are no requirements for formulated product testing.
5/ EBC is the primary metabolite of thiophanate ethyl.
6/ Pending review of environmental fate data by EAB.
7/ Study is required to support the MP formulated into these end use products.
8/ Pending review of environmental fate data and subsequent lower tier EER data, e.g., studies on EBC.
9/ Only one fish study, either on a coldwater or a warm ater fish, is required to support the MP formulated
into these end use products.
10/ A 96—hour LC test performed on the channel catfish using the parent compound thiophanate ethyl is required.
(Chemically related compounds have been shown to be very highly toxic to channel catfish.
11/ Two 96—hour LC tests, the standard 96—hour LC test performed on bluegill sunfish, and a second
— LC test performed on channel catfish. The second study is required because chemically related compounds
have been sbown to be very highly toxic to channel catfish.
12/ Product not intended for direct application to marine or estuarine environment.
13/ Product not intended for direct application to water.
14/ Residue nonitoring with caged catfish.
29
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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—4, 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).”
/ Product specific data pertain to data that support the
!ormulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
30
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TABLE B
PL )DUCF SPECIFIC DATA REX)UIREMENI’S L0R MANUFAC1IJRII’&-WE PIODUCIS ffAININ ThIOPIIANATE muyL 2 /
Data Must Be
Guideline Citation and
Test
Guidelines
Are Data
Reference
Submitted Within
r ama
of
Test
Substance
Status
R uired
Yes
Citation
Tine Framas
Below 1/
Listed
§158.120 Product Chemistry
Product Identity :
61—1 — Product Identity and Disclosure MP R [ =1 IX] 00089068
of Ingredients
61—2 — Dascription of Beginning Materials MP R L x ] [ 1 ___________ 12 Months
and Manufacturing Process
61—3 - Disoission of Formation of NP R i ii LI ___________ 12 Months
Impurities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis R LX] ____________ 6 Months
62—2 — Certification of Limits NP R fl ___________ 6 Months
62—3 — Analytical Methods to Verify MP R [ X I 1] ___________ 12 Months
Certified Limit
31
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TABLE B
PRODUCt’ SPECIFIC DATA REZ)UIREMENI’S I t)R MAF RJFAC’11JRfl&-WE PRODUCt’S COI fl ’AINIt’ 3 ThIOPU NNr 1 ( fl’UYL 2 /
Data Must Be
uideline Citation and
Test
Guidelines
Are Data
Footnote
Submitted Within
Jaiie
of Test
Substance
Status
Required
Yes t b
Number
Tine Frau s
Belc i 1/
Listed
158.120 Product Chemistry (Continued)
hysical and Chemical Characteristics
63-12 - pt-I MP CR ( 1 11 ___________ 6 Months
Other Requiren nts :
64— 1 — Submittal of samples MP CR [ X l ii 3 6 Months
MP = Manufacturing—use Product; R = Required; CR = Conditionally Required
1/ Data must be submitted within the indicated tine frari , based on. the date of the Guidance E)Dcument.
o 6 Month the Date is June 30, 1986
o 12 Month the Date is December 30, 1986
2/ The technical (T) also serves as a manufacturing—use product.
3/ If needed, the Agency will request the samples.
32
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TABLE B
P [ )DUer SPECIFIC DP TA RB UIREMENTS JR MANUFACTURII’&-WE P )DUC1’S CflNTAINI CHEMICAL THIOPHANATE fl-1YL
Data Requiremant
L/
Composition
Does EPA Have
Data To Satisfy
This Require—
mant? (Yes, ND
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Subnission
§158 .1 35 Toxicology
ACUTE ThSTIFSC
81—1 — Acute Oral Toxicity — Rat
MP
Yes
00089070
ND
81—2 — Acute Dermal Toxicity
- Rabbit
MP
Yes
00089070
ND
81—3 — Acute Inhalation Toxicity
— Rat
MP
Yes
00098045
ND
81-4 — Primary Eye
Irritation — Rabbit
MP
Yes
00098046
ND
81—5 - Primary Dermal
Irritation — Rabbit
MP
Yes
00098047
ND
81—6 — Dermal Sensitization —
Guinea Pig
MP
Yes
00089070
ND
1/ Composition: MP = Manufacturing—use product.
33
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IV. SUBMISSION OF REVISED LABELING
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 40 CFR 162.10 (see
Appendix IV—1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See AppendixlV—2). Applications submitted in response to
this notice must include draft labeling for Agency review.
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 the registration
under FIFRA sec. 6(b)(1).
34
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A. Label Contents
40 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. [ 40 CFR
162 .10 (d)]
Item 4 • EPA REGISTRATION NUMBER — The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase “EPA Registration No.,” or “EPA
Reg. No.” The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV—l.
[ 40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER — The EPA establishment
number, preceded by the phrase “EPA Est.” is the final estab—
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
See Appendix IV—l. [ 40 CFR 162.10(f)]
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
35
-------
placed in the body of other text. See Appendix 1V—l. [ 40 CFR
162 .10 (g))
Item 6B. POUNDS PER GALLON STATEMENT — For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS — Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word “Keep Out of Reach
on Front Panel Minimum Type Size of Children”
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
“Keep Out of Reach of Children” must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV—1.
[ 40 CFR162.lO(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV—l.
[ 40 CFR 162.10 (h)(l)(i)1
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. [ 40 CFR l62.lO(h)(l)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
[ I, and III. See Appendix IV—l. (40 CFR 162.l0(h)(l)(iii)1
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. [ 40 CFR l62.lO(h)(l)(iii)]
36
-------
iii. The flashpoint of the non—volatile liquid
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.
4 . 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 submit any information and
rationale with your application for reregistration. During
the Agency’s review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency’s classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. Front panel statement of restricted use classification.
37
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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. (40 CFR 162.10
(h) (2)1
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. [ 40 CFR 162.10
(h) (2) ( i) I
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non—target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV—1. [ 40 CFR
162 .10 (h) (2) (ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement . Precautionary statements relating
to flammability of a product are required to appear on the
label if it meets the criteria in Appendix IV—3. The 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 statém nts.
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).
C. A “non—flammable aerosol” is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
38
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a. The statement “Restricted Use Pesticide” must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 162.1O(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: “For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator’s Certification.”
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may “split” your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 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.
39
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Item bC. 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—4, IV—5, and IV-6 to determine the storage and 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
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix P1—1. (40 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.
40
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VI. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Thiophanate
ethyl as sole 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 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 to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570—4.
b. Product Specific Data Report, EPA Form 8580—4
(Appendix 111—1).
C. Two copies of any required product—specific data
(See Tables B).
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 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)(1)(D). Refer to 40 CFR 152.80—152.99
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
41
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met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing use Products containing Thiophanate ethyl
in combination with other active ingredients
1 . Within 90 days from receipt of this document, you must
submit the 11 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 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 Thio hanate ethyl 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 8570—4.
b. Product—Specific Data Report, EPA Form 8580—4
(Appendix 111—1), if applicable (if Table C lists required
product—specific data).
42
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c. Two copies of any required product-specific data,
if applicable (if Table C lists 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. 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.
3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for the formulator’s
exemption.
D. For intrastate products containing Thiophartate ethyl
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. Addresses
Applications and other required information should be
submitted to the following address:
Product Manager 21
Registration Division (TS—767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone o. (703)
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN—342)
Environmental Protection Agency
401 NI St., SW.
Washington, D.C. 20460
43
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Appendix 11—1
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a “study.” In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
“studies” generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted ‘also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by “Master Record Identifier,” or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six—digit “Accession Number”
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine—character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4 . FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
44
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Appendix 11—1 (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four—digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
C. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self—explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
“received.”
(2) Administrative Number. The next element,
immediately following the word “under,” is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase “submitted by.” When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six—digit accession number follows
the symbol “CDL,” standing for “Company Data
Library.” This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456—A; the second, 123456—
B; the 26th, l23456—Z; and the 27th, 123456—AA.
45
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APPENDIX 11—2
OFFICE OF PESTICIDE P XRAMS
R ISTRATION STANDARD BIBLIO3RkPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Thiophanate Ethyl
MRID Citation
00032673 Noguchi, T.; Mashincto, Y.; Makita, T.; et al. (1971) Chronic Oral
Tbxicity Studies of Thiophanate, Diethyl 4,4’—O—phenylene bis
3—thioallophanate in Sprague—Dawley Strain Rats. (Unpublished
study received Jun 27, 1980 under 4581—336; prepared by Nippon
Soda Co., Ltd. in cooperation with Nara Medical Univ., Second
Dept. of Pathology, submitted by Penriwalt Corp., Agchem Div.,
King of Prussia, Pa.; CDL:242740—B)
00032674 Fiashinoto, Y.; Makita, T.; Nishibe, T.; et al. (1972) i xico1ogical
Evaluation of Thiophanate (X): The Final Report on the Carcino-
genesis Studies of Thiophanate, Diethyl 4,4’-o-phenylenebis (3—
thioallc’phanate), in Mice of C57BL Strain for Full Life Span.
(Unpublished study received Jun 27, 1980 under 4581—336; pre-
pared by Nippon Soda Co., Ltd. in cooperation with Nara Medical
Univ., Second Dept. of Pathology, submitted by Pennwalt Corp.,
Agchem Div., King of Prussia, Pa.; CDL:242740—C)
00050517 Shellenberger, T.E. (1971) Letter sent to Paul Sartoretto dated
Mar 4, 1971: An acute toxicological evaluation of Cleary 3336
fungicide with adult mallard ducks. (Unpublished study received
Mar 4, 1971 under unknown admin. no.; prepared by Gulf Soith
Research Institute, submitted by W.A. Cleary Corp., Sonerset,
N.J.; CDL:104612—B)
00068776 Pennwalt Corporation (19??) Product Chemistry—Data Requirenents:
[ Thiophariatel. (Unpublished study received Mar 3, 1978 under
4581—336; CDL:233302—A)
00079196 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report:
Eight—day Dietary LC50——Bob zhite Quail: Project 1 }z. 110—125.
(Unpublished study, including letter dated Mar 20, 1981 fran
A.O. Landskov to Bernalyn M 3aughey, received Jun 10, 1981 under
4581—336; prepared by Wildlife International, Ltd. and Washing-
ton College, submitted by Pennwalt Corp., Philadelphia, Pa.;
CDL:24 5301—C)
00079197 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report:
Eight—day Dietary LC5O——Mallard t ick: Project sb. 110—126. (Un-
published study received Jun 10, 1981 under458l—336; prepared
by Wildlife International, Ltd. and Washington College, submit-
ted by Pennwalt Corp., Philadelphia, Pa.; CDL:245301—D)
46
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APPENDD( 11—2
OFFICE OF PESTICIDE PI XPAt4S
R ISTRATION STANDARD BIBLICXRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Thiophanate Ethyl
MRID Citation
00079198 LeBlanc, GA.; Sousa, J.V. (1981) Acute Toxicity of Topsin E Fungi-
cide to Rainbo. , Trait (Saln gairdrieri): Report *BW-81—3—
843. (Unpublished study, including letter dated Apr 9, 1981
frau A.O. Landskov to Bernalyn McGaughey, received Jun 1981
under 4581—336; prepared by EG & G, Bionamics, submitted by
Pennwalt Corp., Philadelphia, Pa.; CDL:245301—E)
00079199 LeBlanc, G.A.; Sousa, J.V. (1981) Acute Toxicity of Topsin E Fungi-
cide to Bluegill (L.epom.is rnacrochi us): Report BW-81—2—835.
(Unpublished study, including letter dated Apr 9, 1981 fran A.O.
Landskov to Bernalyn McGaughey, received Jun 10, 1981 under
4581—336; prepared by EG & G, Bionauics, submitted by Pennwalt
Corp., Philadelphia, Pa.; CDL:245301—F)
00079200 LeBlanc, G.A.; Surprenant, D.C. (1981) Acute Toxicity of Topsin E
Fungicide to the Water Flea (Daphnia magna): Report #BW-81—
2—814. (Unpublished study, including letter dated May 21, 1981
fran A.O. L.anskov to Bernalyn M 3aughey, received Jun 10, 1981
under 4581—336; prepared by EG & G, Bioncmics, submitted by
Pennwalt Corp., Philadelphia, Pa.; CDL:245301—G)
00085643 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report:
Acute Oral Lr50—Bob Jhite Quail: Project b. 110—127. (Unpub-
lished study, including letter dated Mar 20, 1981 fran A.O.
Landskov to Bernalyn McGaughey, received Jun 10, 1981 under
4581—336; prepared by Wildlife International, Ltd. and Washing-
ton College, submitted by Pennwalt Corp., Philadelphia, Pa.;
CDL: 24 530 1—B)
00088444 Pennwalt Corporation (19??) Chemical and Physical Properties of
Topsirt E and Topsin M. (Unpublished study, including letter
dated Dec 8, 1971 fran R.E. Carlson to J.L. Sandeno, received
Feb 9, 1973 under 4581—288; CDL:007463—A)
00089068 Pennwalt Corporation (19??) Introduction: [ Topsin and Topsin M).
(Unpublished study received Jan 12, 1971 under 4581—278; CDL:
007453—A)
00089070 Hashinoto, Y.; rlakita, T.; Mori, T.; et al. (1970) Toxicological
evaluations of thiophanate: (I) Acute and subacute toxicity of a
new fungicide, thiophanate (active ingredient of NF—35), 1,2—
bis—(ethoxy carbonyl—thioureido)—benzene. Pharmacometrics 4 (1):
5—21. (Also in unpublished submission received Jan 12, 1971
under 4581—278; submitted by Pennwalt Corp., Philadelphia, Pa.;
CDL :00 74 53—D)
47
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APPENDIX 11—2
OFFICE OF PESTICIDE Pl X3RAMS
R ISTRATION STANDARD BIBLI RAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard For Thiophanate Ethyl
MRID Citation
00098045 Collins, C.J.; Breckeriridge, C.; Broxup, B.; et al. (1981) The
Acute Toxicity of Inhaled Topsin E Technical in the Albino Rat:
Project b. 81197. (Unpublished study received Apr 1, 1982
under 4581—336; prepared by Bio—Research Laboratories Ltd.,
Canada, subrtitted by Pennwalt Corp, Philadelphia, Pa.; CDL:
2471 28—A)
00098046 Bier, C,B.; Bran ell, S.; Procter, B.G. (1981) Primary Eye Irri-
tation Study in Albino Rabbits Administered Test Article Top-
sin (R) E Technical: Project 50110. (Unpublished study re-
ceived Apr 1, 1982 under 4581—336; prepared by Bio-Research
Laboratories Ltd., Canada, su nitted by Pennwalt Corp., Phila-
delphia, Pa.; CDL:247128—B)
00098047 Bier, C.B.; Reuben, 4.A.; Procter, B.G. (1981) Primary Dermal
Irritation Study in Albino Rabbits Administered Test Article
T sin (R) E Technical: Project . 50111. (Unpublished study
received Apr 1, 1982 under 4581—336; prepared by Bio-Research
Laboratories Ltd., Canada, su uitted by Pennwalt Corp., Phila-
delphia, Pa.; CDL:247128—C)
48
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O7.—O 57
(E .t r- _.13 /SE )
•P REGISTRATION NO
FIFRA SECTION 3(C)(2)(b) SUMMARY SHEET
PRODUCT NAME
APPLICANT’S NAME DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit “generic” data imposed by the FIFRA section 3(C)(2)(B) notice contained in tne referenced
Guidance Document. I am responding in the following manner
U 1. I will submit data in a timely manner to setisfy the following requirements. If the test procedures I will use deviate tram (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Exoert Groups to me Chemicals Group, DECO
Chemicals Testing Programme, I enclose the protocols that I will use
02. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by.
NAME OF OTHER REGISTRANT
03. I enclose a completed “Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data” with
respect to the following data requirements:
04. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
0 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT’S AUTHOR IZED REPRESENTATIVE SIGNATURE DATE
EPA Form 85801 (1082)
-------
0MB Approval 2070—0057 (expires 5/31/86)
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, ce rify Jj four items) FOR DEVELOPMENT OF DATA
(This firm or group of firms is referred to below as “my firm”.)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
1. I am duly
authorized to
represent the following firm(s) w
ho are subject
to the require-
ments of a
to submit d
Notice under
ata concernin
FIFRA Section 3(c)(2)(B) contained in a Guida
g the active ingredient
nce Document
NAME OF FIRM
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. Thus offer was made
to the following firm(s) on the following date(s)’
NAME OF FIRM DATE OF OFFER
However, none of those firm(s) accepted my offer.
4 My firm requests that EPA not suspend the registration(s) of my firm’s product(s). if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA wilt promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPEDNAME SIGNATURE OATE
I
mn r. .. tO4
-------
Appendix 111—1
PRODUCT SPECIFIC DP TA REPOR1’
EPA Registration o. Guidance Document for_________
Date
1
Registration
Guideline t .b.
Name of Test
Test not
required
for my
product
listed
above
(check
belc )
I am complying with
data requirements by
(For EPA Use Only)
Accession Numbers
Assigned
Citing MRID
Suthüt—
ting
Data
(At—
tached)
§ 158 .20
PRODUCT
CHEMISTRY
___________
61—1
Identity of
ingredients
61—2
Staten nt of
caiipos it ion
61—3
Discussion of
formation of
ingredients
62—1
Preliminary
analysis
62—2
Certification of
1 irnits
62—3
Analytical rt thods
for enforcert nt
1 imits
63—2
Color
63—3
Physical state
63—4
Odor
__________
63—5
Melting point
63—6
Boiling point
63—7
Density, kxilk—
density, or
specific_gravity
63—8
Solubility
63—9
Vapor pressure
63—ID
Dissociation
constant
63—11
Octariol/water
part it ion
coefficient
63—12
pH
51
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Appendix 111—1 (continued)
Registration
Guideline b.
Name of Test
Test not
required
for my
product
listed
above
(check
bel )
I am complying with
data requirements
(For EPA Use Only)
Accession Nuxtters
Assigned
Citing MRID#
Sut nit—
ting
Data
(At—
tached)
63—13
Stability
63—14
Oxidizing/reducing
react ion
63—15
Flair nability
63—16
E lodability
63—17
Storage stability
63—18
Viscosity
63—19
Miscibility
63—20
Corrosion
characteristics
63—21
Dielectric break—
d in voltage
§158.135
it ucoux
81-1
Acute oral LD-50,
rat
81—2
Acute dermal
ED-SO
81—3
Acute inhalation,
LC—5O_rat
81-4
Primary eye
irritation, rabbit
81—5
Primary dermal
irritation
81—6
Dermal sensitiza-
tion
[ _______
52
-------
uuii& Lor shall den &n application
reviewed under p aragrap (d) of this
section if any of the requiz-em of
paragraph (d)(2) of this section are
not met, or if there are insufficient
data to make the required determina-
tions.
(fl Not ification. Promptly after
making a determination to deny a reg.
istration, the Administrator shall
notify the applicant by certified letter
of the denial of registration and shall
set forth the reasons and factual basis
for the determination and the condi.
tions, if any, which must be satisfied
in order for the registration to be ap•
proved,
(2) Opportunity for remedy by app! I-
cant. (I) The applicant will have 30
days from the date of receipt of the
certified letter to take the specified
Corrective action.
(ii) The applicant may petition the
N’) Administrator to Withdraw his applica-
In tion. The Adminstrator may, in his
discretion deny any petition for with-
drawal and proceed to issue a notice of
denial in accordance with paragraph
(f)(3) of this section,
(3) FEDEL L REGISTER publication jf
the applicant fails to remedy the defi-
ciency of his registration application.
the Administrator shall promptly
issue In the Fm m j REGISTER a notice
of denial of registration Such notice
shall set forth the reasons and factual
basis for the denial and shall contain
the name and address of the applicant,
the product flame, the name and per.
ceritage by weight of each active ingre-
dient in the product, the proposed pat-
terns of use, and the proposed classifi-
cation.
(4) Rearing rights. Within 30 days
following publication of the denial In
the FEDERAL REGISTER, the applicant or
any interested party with the written
authorization of the applicant may re-
quest a hearing pursuant to section
6(b) of the Act and Part 164 of these
regulatio It no hearing is timely re-
quested. the denial shall become effec-
ttve at the end of the 30 days.
(g) DZ3pO itt fl of matenal submit-
ted with the application The test data
and other information submitted with
an application shall become a part of
the official file of the Agency for that.
92
auon. . :p(
provided by section 10 of the Aa
within 30 days after the registratfofl
a pesticide, the data called for in lb
registration statement together altI
such other scientific information
the Administrator deems relevant k
his decision shall be made availa
for public inspection.
(48 FR 34004, July 26. 1983)
0 162.8 Data to be furnished by appiIe
(a) An applicant for regis ra o
registration, or amendment of a regl
tration Under FIFRA sec. 3(c)(5) shal
furnish data as required by thi
Agency to determine whether his a
plication may be approved under thh
Part.
(b) An applicant shall submit with
his application any factual informi
tion regarding adverse effect.s of lb
pesticide on the environment or mas
that.
(I) Hg been obtained by him orha&
come to his attention; and
(2) Insofar as he is aware, has n
previously been submitted to lb
Agency.
Such information shall include, bui
shall not be limited to, published ot
Unpublished laboratory studies and as
cident experience.
[ 48 FR 34005. July 26, 19831
0 162.10 LabelIng requirements
(a) Generaj—(1) Contents of the
label, Every pesticide products shall
bear a label containing the informs
tion specified by the Act and the regu
lations in this Part. The contents of a
label must show clearly and prorni
nently the following-
(i) The name, brand, or trademark
under which the product is sold as pre
scribed in paragraph (b) of this sec
Lion;
(ii) The name and address of the
producer registrant, or person for
whom produced as prescribed in para
graph (C) of this section;
(lii) Th net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section;
r) Th producing edblishment
cumber as prescribed in paragraph (f)
ci this section;
i An ingredient statement as pre-
Kilbed in paragraph ( ) of this sec-
1 lion;
(iii) Warning or precautionary state-
enLs as prescribed In paragraph (h)
ol this section;
(viii) The directions for use as pre-
ibed in paragraph (I) of this section;
and
(lx) The use classification(s) as pre-
rlbed in paragraph (J) of this section.
(2) PromInence and legibility. (I) All
voids, statements, graphic representa-
lions, designs or other information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
Iii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded,
(3) Language to be used. All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing
(4) Placement of Label—(i) General,
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, “se-
curely attached” shall mean that a
iabel can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
L.fled to such OU.4de wrapper or ..on-
tamer, if it is a part of the package as
customarily distributed or sold.
( II) Tank cars and outer bulk con-S
talners—(A) Transportation. While a
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189, concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers,
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve. -
(5) False or misleading statements.
Pursuant to section 2(q)( IXA) of the
Act, a pesticide or a device declared
subject to the Act pursuant to
* 162.15, is misbranded if its labeling is
false or misleading in any particular
including both pesticidal and non-pea-
ticidal claims. Examples of statements
or representations in the labeling
which constitute misbranding include:
(I) A false or misleading statement
concerning the composition of the
product;
(ii) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(iii) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(lv) A false or misleading comparison
with other pesticides or devices;
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contains two or more principal active
93
-------
§ 162.10
ingredients it the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading Im-
pression to the purchaser;
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
Li ç) Claims as to the safety of the
pesticide or its ingredients, in ludlng
statements such as “safe.” “nonpoison-
ous.” “noniniurlous,” “harmless” or
“nontoxic to humans and pets” with
or without such a qualifying phrase as
“when uzed as directed”; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) “Contains all natural Ingredi-
ents”;
(B) “Az ong the least toxic chemi-
cals known”
(C) “Pollution approved”
(6) FInal printed labeling. (I) Except
as provided In paragraph (a)(OXII) of
this section, final printed labeling
must be submitted and accepted prior
tq . 5 registratlon. However, final printed
‘ iSeUng need not be submitted until
att label texts 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 glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(ii) Baa not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to 182.8(b)(4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and addres of the
40 CFR Ch. I (7-1-85 EditIon)
producer. If the registrant’s name ap
pears on the label and the registrant Is
not the producer, or If the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as “Packed for ‘ ‘ ,“ “Distribut
edby’ • ,“or”Soldby “toshow
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con
tents. (1) The net weight or measure
of content shall be exclusive of wrap
pers or other materials and shall be
the average content unless explicltb
stated as a minimum quantity.
(2) If the pesticide Is a liquid, the
net content statement shall be in
terms of liquid measure at 68’ F (20’Cl
and shall be expressed in conventional
American units of fluid ounces, pint-i.
quarts, and gallons.
(3) If the pesticide Is solid or semi-
solid, viscous or pressurized, or Is $
mixture of liquid and solid, the net
content statement shall be in terms ol
weight expressed as avoirdupob
pounds and ounces.
(4) In all cases, net content shall bi
stated In terms of the largest suitable
units, i.e.. “1 pound 10 ounces” rathee
than “28 ounces.”
(5) In addition to the required uniti
specified, net content may be ex
pressed in metric units.
(8) Variation above minimum con
tent or around an average is permissi-
ble only to the extent that It repre
senta deviation unavoidable in good
manufacturing practice. Varlatlot
below a stated minimum Is not permit
ted. In no case shall the average cos
tent of the packages in a shipment fit
below the stated average content.
(e) Product registration numbc’
The registration number assigned ii
the pesticide product at the time d
registration shall appear on the Jabd
preceded by the phrase “EPA Regla
tration No.,” or the phrase “EPA Rt
No.” The registration number shaU bi
set In type of a size and style simllatv
other print on that part of the labs
on which It appears and shall run psi
allel to It. The registration numbe
and the required Identifying phru
- shall not appear in such a manner
to suggest or Imply recommendatl
Environmental Protection Agency
or endorsement of the product by the
‘tgency.
if) Producing establishments regis-
tration number. The producing estab-
lishment seglstratiogi number preced-
ed by the phrase “EPA Est.”, of the
final establishment at which the prod-
uct was produced may appear In any
suitable location on the label or tninie-
diate container. It must appear on the
a ’rapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
aL The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
eats, and if the pesticide contains ar-
lenic in any form, a statement of the
rcentages of total and water-soluble
usenic calculated as elemental ar-
senic. The active ingredients must be
4esignated by the term “active Ingredi-
ails’ and the inert Ingredients by the
term “inert ingredients,” or the singu-
ke forms of these terms when appro-
Pilate Both terms shall be in the
wine type size, be aligned to the same
n&rgln and be equally prominent. The
Ic.atement “Inert. Ingredien(s, none” Is
• required for pesticides which con-
slis 100 percent active ingredients.
L’nless the Ingredient statement is a
axaplete analysis of the pesticide, the
erm “analysis” shall not be used as a
z adIng for the ingredient. stktemerit.
Ill Position of Ingred ient statement.
A The ingredient statement is nor-
asily required on the front panel of
t e label If there Is an outside con-
a,. ’er or wrapper through which the
eijred tent. statement cannot be clearly
a .1, the Ingredient statement must
so appear on such outside container
ii %rapper. If the size or form of the
3a.tsge makes it impracticable to
315ce the ingredient statement on the
ot panel of the label, permission
aaj be granted for the ingredient
g.susnent to appear elsewhere.
.ai The text of the ingredient state-
aidnt must run parallel with other
is on the panel on which it appears,
aiw must. be clearly distinguishable
§ 162.10
from and must not be placed in the
body of other text,
(3) Names to be used In Ingredient
statement. The name used for each in-
gredient shall be the accepted
con)mon name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
If It is well known, If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accept-ed as a common
name by the Administrator under the
authority of Section 25(c)(8),
(4) Statementj of percentages. The
percentages of ingredients shall be
stated In terms of weight-to-weight,
The sum of percentages of the active
and the inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as “22-25%.” If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement- of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the ingredient
statement,
(5) Accurac j of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(8) Deterioration, Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: “Not for sale or use after
(date).”
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(1) Inert ingredients, The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredlent(r,) may pose a
hazard to man or the environm”-’t,
-------
40 CFR Ch. I (7-1-85 EditIon) Environmental Protection Agency
§ 162.10
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of toxicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
Ci) Human hazard signal word—(A)
Ti city Category I. All pesticide prod.
ucta meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word “Danger.” In ad-
diUon if the product was assigned to
Toxicity Category I on the basis of its
&al, inhalatiop or dermal toxicity (as
stI,nct from akin and eye local ef-
fects) the word ‘Poison” shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the wot’d “poison.”
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word “Warn-
ing.”
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category Ill shall bear on
the front panel the signal word “Cau-
tion.”
(D) Toxicity Category IV, All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word “Caution.”
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
type size, and prominence are given
below.
(1) Required front panel statement&
With the exception of the chili
hazard warning statement, the text.re
quired on the front panel of the label
Is determined by the Toxicity Catego
ry of the pesticide. The category is a
signed on the basis of the highes
hazard shown by any of the indicaton
in the table below.
that such labeling is necessary to pie
vent unreasonable adverse effects a
man or the environment. In no cu
shall more than one human hazul
signal word appear on the front pa
of a label.
(ii) Child hazard warning. Every pa
ticide product label shall bear on tki
front panel the statement “keep outs
reach of children.” Only In ca
where the likelihood of contact wtu
children during distribution, mark5
tog, storage or use is demonstrated t
the applicant to be extremely renida
or If the nature of the pesticide lsstd
that it is approved for use on infam
or small children, may the Adminiuui
tor waive this requirement.
(lii) Statement of practical trr
ment—(A) Toxicity Category I I
statement of practical treatment (fis
aid or other) shall appear on the fr
panel of the label of all pesticides hi
ing into Toxicity Category I on l
basis of oral, Inhalation or dermal I
Icity. The Agency may, howe c
permit reasonable variations in
placement of the statement of prig
cal treatment is some reference
as “See statement of practical lx
rnent on back panel” appears on
front panel near the word “Poison”
and the skull and crossbones,
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described In paragraph (h)(l)(iIl)(A) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section If they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
dent prominence relative to other
front panel text, and graphic material
to make them unlikely to be over-
oked under customary conditions of
pirchase and use. The following table
shows the minimum type size require-
aent .s for the front panel warning
u ,stements on various sizes of labels:
S Environmengaj hazards. Where a
awd exists to non target organisms
usluding humans and domestic ani-
aa. s.. precautionary statements are re-
stating the nature of the
§ 16210
Size of label trool panel Si S4 iWI
RO JVOd
I
“Keep out
0
5andunder - ..
AbovuSt olO . ..
AbOve l OtoIS . ...
Abovel5toll0 . .
Over3O ,
6
tO
12
14
53
6
6
6
10
12
(2) OCher required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
“Precautionary Statements” and
under appropriate subheadIngs of
‘Hazard to Humans and Domestic Ani-
mals,” “Environmental Hazard” and
“Physical or Chemical Hazard.”
U) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements, These
statements must be modified or ex-
panded to reflect specific hazards.
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the circum-
Hazard Sidicetars
Toxicity categories
I
II
Ill
I v
Oral ID ,, . ,.
Inhalation LC,,
Up (0 and Vicb,jduig 50
mg/kg.
Up to and h- ,ckirkng 2
mg/ tier
From 50 lIeu 500 mg/k9
From 2 1 1ev 2 mg/tiles
From 500 5ev 5000 mg/
kg -
From 2 thu 20 mg/titer
20,000
Greator than 5000 mg
kg
Greater then 29 mg/b
Greater than 20,000
DerTrrai ID..
Up to and Wicluding 200
mg/kg.
From 200 lIeu 2000
corned opadty
No Irr Itation
Eye effects
ConOsIeo. corned
opacity not severable
s4thn 7 days.
Corneel opacity
reversible withIn 7
days. Siltation
persisting far 7 days
IrritatIon reversible
wIthin 7 days
Irritation 72
Mdd or slight Irilibel
Skin eflects
Co rro& ire_ ,,...
Severe Vitiation at 72
harts
hours
72 hours
S
! _
by toxicity category
Oral inhalation, or derinal losicity
.
and aye local etlects
..
Fatal (poisonous) d swallowed (inhaled or absorbed
through akin) Do not breathe vapor (dust or spray
mist] Do not got In eyes on skin, or on clothing
(Front panel statument of practical treatment re.
qilired
May be fatal IS sweflowed (inflated or absorbed
though tho skin) Do riot breathe vapors (dust or
spray mist) Do not gel in ayes, on skin, or on
clothing (Appropriate Iest aid Statements required I
Haimlul IS swallowed (inflated or absorbed through the
she) Avoid breathing vapors (dust or spray mist)
Avoid contact with skin (eyes or Clothing) (Appro-
pilate first aid statement roqutred)
(No precautionary statornents required I
Corrovvo. causes eye and skin damage (or skin
&rntahori) Do not gel Vi 6105. On SkI II, or on
clothing Wow goggles or lace shield and rubber
gloves when handling harmful or fatal Ii swallowed
(Appropriate first aid statement required)
Causes eye (arid Skin) Irritation Do not gel Vi eyes,
on skin, or on clothing Harmful IS swallowed lAp-
propriate tlrsl aid statement required I
Avoid coniacl with skin, eyes or clothing In case of
contact Immediately flush eyes or skin with plenty of
water Get medical attention if k’jitadon persists
(No precautionary Statements requIred I
I
OR
-------
40 CFR Ch. 1(7.1-85 EditIon) Environmental Protection Agency
§ 162.10
§ 162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDw of
100 or less, the statement “This Pesti-
cide Is Toxic to Wildlife” is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC,. of 1 ppm or less.
the statement “This Pesticide is Toxic
to Fish” Is required.
(C) If a pesticide Intended for out-
door use co talna an active Ingredient
with an avian acute oral L I D , 0 of 100
mg/kg or less, or a subacute dietary
LC . of 500 ppm or less, the statement
“This Pesticide is Toxic to Wildlife” is
required.
(D) It either accident history or field
studies demonstrate that use of the
er below 20’
1 - bOv. 20’ F end not over 80’ F,
‘ Ahoy. 80’ F and ret over 150 F
(i) Directions for Use—(1) General
requ lrements—(i) Adequacy and cZar-
lti, of di recUons. Directions for use
must be stated in terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
pirections may appear on any portion
of the label provided that they are
conspicuouS enough to be easily read
by the user of the pesticide product.
irections for -‘se may appear on
pesticide may result in fatality to
birds, fish or mammals, the statement
“This pesticide is extremely toxic to
wildlife (fish)” is required.
(E) For uses involving foliar applies
tion to agricultural crops, forests, or
shade trees, or for mosquito abate
ment treatments, pesticides toxic to
pollinating insects must bear appropri
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution “Keep out of lakea
ponds or streams. Do not contaminate
water by cleaning of equipment or dis
posal of wastes.”
(iii) physical or chemical hazardi
Warning statements on the flammabU
ity or explosive characteristics of Ihi
pesticide are required as follows:
printed or graphic matter which so
companies the pesticide provided t)u
(A) If required by the Agency, su
printed or graphic matter is securt l
attached to each package of the peju
- ‘ id ’e, r ’ placed within the ouLsi
wrapper or bag;
(B) The label bears a reference U
the directions for use in accompafl)lrI
leaflets or circularS, such as “See $
rections in the enclosed circular:” id
(C) The Administrator determine
that it is not necessary for such dirt
tions to appear on the label.
(iii) Exceptions to requirement is
direction for use—(A) Detailed dint
tions for use may be omitted from
beling of pesticides which are intend
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
(1) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products Involved.
(at Adequate information such as
technical data sheets or bulletins, is
ivailable to the trade specifying the
type of product involved and its
proper use in manufacturing process-
(3) The product will not come into
the hands of the general public except
alter incorporation into finished prod-
ucts; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fect.s on man or the environment,
(B) Detailed directions for use may
le omitted from the labeling of pesti-
dde products for which sale is limited
to physicians, veterinarians, or drug-
jists, provided that:
(1) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such dIrections are not necessary
to prevenl unreasonable adverse et-
(ects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
P deral Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
omitted from the labeling of pesti-
dde products which are intended for
e only by formulators In preparing
esticides for sale to the public, pro-
v ded that:
U) There is information readily
sn iabie to the formulators on the
mmposition, toxicity, methods of use,
çpiicable restrictions or limitations,
uS effectiveness of the product for
esticlde purposes;
(2) The label clearly states that the
Xoduct is Intended for use only in
aanulacturing, formulating, mixing,
ii repacking for use as a pesticide and
cecifles the type(s) of pesticide prod-
tru involved,
iii The product as finally manufac-
nd. formulated, mixed, or repack-
td Ls registered: and
An
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment,
(2) Content,g of Directions for U3e.
The directions for use shall include
the following, under the headings “Di-
rections for Use”:
Ci) The statement of use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the heading “Directions
for Use.”
(ii) Immediately below the state-
ment of use classification, the state-
ment “It is a violation of Federal law
to use this product in a manner incon-
sistent with Its labeling.”
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(Iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, If re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and Jts container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading “Storage
and Disposal.” This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing. (See Table in 162.10(h)(1)(iv))
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [ Reserved)
Flash point I ReQuired taxi
(A) PRESSURIZED CONTAINERS
Flaah point at or below 20’ F, if there si flashback at Extremely (lammabis Contents under prealure Keep s cs i er
any wahe opontng tile. sp&kI, and heated au,IaCOs Do not puncture or r . ww
container Exposure to temperatura$ above 130’ F may cs a
bureUnO
Flash point sbOv 20’ F end not over 80’ F or If the Flammable Contents under pressure Keep away (torn he
(tame extenalon Is mph than IS in long at a distanCe sparks. wid open flame Do not punCture 01 InCInerate COfitWI
in from the flame Exposure to temperatures above 133’ F may cause la.rIs
AS other pressurized containers Contents under pressure Do not use or stole near heat or
flame Do not puncture or Inctnerale container Exposes a
tsmpersiwel shove 130’ F may cause burstIng
(8) NOorPO 1LSSURIZED CONTAINERS
1 Extremely flammable Keep away from fire. sparks, and le
turlaces
Flammable Keep away (Torn heat end open flame
Do not use or store rear heat or open flame
-------
40 CFR Ch. 1(7-1-85 EdItion) Environmental Protection Agency
§ 162.11
162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide. unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessarY for the protection of
man and the environment.
(I) Statement of Use ClasslfLcatZOfl-
By October 22, 19’16. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
jn paragraphs U) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others f r restricted use
shall be separately labeled accordinS
to the labeling standards set forth in
this subsectiOn, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
(piovisiOfls of 162.10(i)(2).
...,J1) General Use CiassifacatlOfl. Pesti-
crde products bearing directions for
use(s) classified general shall be la-
beled with the exact words “General
Classification” immediatelY below the
heading “Directions for Use.” And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) RestriCted Use ClassifIcatiOn.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict-
ed use classificatiOn. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table in 162.l0(h)(1)(iV)), and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment “Restricted Use Pesticide’ shall
appear.
(B) Directly below this statement on
the front panel. a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
appllcatOrc, the following statement Is
required: “For retail sale to and use
only by Certified Applicators or per
Sons under their direct supervision and
only for those uses covered by the Cer
titled Applicator’s certification.” If,
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. (Reservedi
(40 FR 28288, July 3, 1975; 40 FR 32329
Aug. 1, 1075; 40 FR 36571, Aug. 21. 1975. i
amended at 43 FR 5786, Feb 9. 19781
162.11 CriterIa for determinations of un-
reasonable adverse effects.
(a) Criteria for Issuance of Notice of
Intent to Deny Registration, Cancd
Registration, or to I-fold a HeariflQ—
(I) Presumption. (I) A rebuttable P1 ’ t ’
sumption shall arise that a notice ol
intent to deny registration pursuant tc
section 3(c)(6) of the Act, a notice at
intent to cancel registration pursuani
to section 6(b)(l) of the Act, or I
notice of intent to hold a hearing Is
determine whether the registratiOr
should be cancelled or denied, as ap
propriate, shall be Issued, upon a de
termination by the Administrator tlu
the pesticide meets or exceeds any c i
the criteria for risk set forth in pan
graph (a)(3) of this section. Upon su
determination, the Administr&t
shall issue notice by certified mail u
the applicant or registrant, as the cu
may be, stating that the applicant S
registrant has the opportunitY 11
submit evidence in rebuttal of su*
presumption in accordance with pa.”b
graph (a)(4) of this section. The apc b
cant or registrant shall have forty 1:4
(45) days from the date such notice is
sent to submit evidence in rebuttal of
the presumption; provided, however,
that ins- good cause shown the Admin-
istrator may grant an additional sixty
(60) days in which such evidence may
be submitted.
(ii) At any time an applicant or reg-
istrant may petition the Administrator
to withdraw his application or termi.
nate his registration, The Administra-
tor may, in his discretion, deny any pe-
tition for withdrawal or for termina-
tion and proceed in accordance with
these regulations.
(2) Rebuttal of Presumption. The
party seeking new or continued regis-
tration may rebut the presumption
arising under paragraph (a)(1) of this
section by sustaining the affirmative
burden or proof set forth in paragraph
(a)(4) of this section. After review of
the evidence submitted In rebuttal of
the presumption, the Administrator
shall determine in accordance with
paragraph (4) of this 162.11(a)
whether the applicant or registrant
has sustained his affirmative burden
and shall issue notice of such determi-
nation in accordance with paragraph
( i R S) of this section,
(3) Risk Criteria. A rebuttable pre-
suniption shall arise if a pesticide’s
ingredient (s), metabolite(s), or degra-
dition product(s) meet or exceed any
of the following criteria for risk, as in-
dicated by tests conducted with the
animal species and pursuant i.e the
lest protocols specified In the Regis.
tzation Guidelines, or by test results
otherwise ava llable. In making this de-
termination the Agency will take Into
consideration the type of effect, the
st.a (Lstical significance of the findings
and whether the tests were conducted
accordance with the material re-
4uiremenls for valid tests as recog-
a ztd by experts in the field.
III Acute toricnty—(A) Hazard to
Ihmarss and Domestic, Animals (1)
liii an acute dermal LID, 0 of 40 mg/kg
u less as formulated, or
‘h Has an acute dermal LD , 0 of 6 g/
tj or less as diluted for use in the
2. em of a mist or spray, -
Has an inhaiatioi LC., of 0.04
nj l:ter or less as formulated
,Bj Ha.nard to lViiduife. (fl Occurs as
I rtsi4ue immediately following appli-
cation in or on the feed of a mammali-
an species representative of the spe-
cies likely to be exposed to such feed
in amounts equivalent to the average
daily Intake of such representative
species, at levels equal to or greater
than the acute oral LID,, measured in
mammalian test animals as specified
in the Registration Guidelines.
(2) Occurs as a residue immediately
following application in or on vian
teed of an avian species, representative
of the species likely to be exposed to
such feed in amounts equivalent to the
average daily intake of such represent-
ative species, at levels equal to or
greater than the subacute dietary LC,,
measured in avlan test animals as
specified in the Registration Guide-
lines.
(3) Results in a maximum calculated
concentration following direct applica-
tion to a 6-inch layer of water more
than V , the acute LC, , for aquatic or-
ganisms representative of the orga-
nisms likely to be exposed as measured
on test animals specified in the Regis-
tration Guidelines.
(ii) Chronic Toxicity, (A) Induces on-
cogenic effects in experimental mam-
malian species or In man as a result of
oral, inhalation or dei-rnal exposure: or
induces mutagenic effects, as deter-
mined by snultitest evidence,
(B) Produces any other chronic or
delayed toxic effect in test animals at
any dosage up to a level, as deter-
mined by the Administrator, which is
substantially higher than that to
which humans can reasonably be an-
ticipated to be exposed, taking into ac-
count ample margins of safety: or
(C) Can reasonably be anticipated to
result in significant local, regional, or
national population reductions in non-
target organisms, or fatality to mem-
bers of endangered species.
(iii) Lack of Emergency Treatments.
Has no known antidot.al, palliative, or
first aid treatments for amelioration
of toxic effects in man resulting Iron,
a single exposure,
(4) Burden of Proof. Upon finding in
accordance with paragraph (1) of this
§ 162.11(a) that notice pursuant to sec
tions 3(c)(6) or 6(b)(l) of the Act, or
notice of Intent to hold a hearing to
determine whether the registration
should be cancelled or denied, as ap-
In’
-------
APPENDIX P1-2
LABELII C REI)UIREMEN1S OF ThE FIFRA, AS AMENDED
ITEM
LABEL ELEMENF
APPLICABILITY
OF RE )UIRE,4EN
P [ ACE IENF ON LABEL
CC1 1MENI
RB UIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Ccii pany 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
4
EPA Reg. No.
All products
None
Front panel
Must be in similar type size and run
parallel to other type.
5
EPA Est. No.
All products
All products
None
Front panel,
inmediately
before or
following
Reg._No.
May appear on the container instead of
the label.
6A
Ingredients
staterr nt
Front panel
Inmediately
follc iing
product_name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
a i/unit area
Front panel
Directly belo ,
the main
ingredients
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
7B
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
All products
All products
Front panel
Front panel
Above signal
word
Ininethately
below child
Note type size requirements.
Note type size requirements.
hazard
warning
-------
APPENDIX ]V—2 (continued)
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
ITEM
LABEL ELEMENT
APPLICABILITY
OF REX?tJIRFJ4EFTF
REIYJIRED
PLACEMENT ON LABEL
PREFERRED (X 1MENI’S
7C
Skull & cr s—
bones and word
POISON (in red)
All products
which are Cat—
egory I based
on oral, der-
mal, or inhala-
tion_toxicity
Front panel
.
Both in
proximity to
signal word
7D
Staterr nt of
practical
treatn nt
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statenw nt
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statemant
Front panel
8
Side,kack panel
precautionary
staten nts
All products
t’bne
Top or side
of back panel
preceding
directions
for_use
Must be grouped under the headings
8A, SB, and 8C; preferably blocked.
BA
Hazards to
humans and
dci stic
animals
-
All products
in Categories
I, II, and III
tsbne
Sa as above
Must be preceded by appropriate
word.
Environn ntal hazards include bee
SB
Environmantal
hazards
All products
NDne
Sama as above
caution where applicable. —
-------
APPENDIX P1-2 (contirued)
bC Storage and
disposal block
In the
directions
for use
irm d lately
before
specific
directions
for use or
at the end of
directions
for use
ITE 4
LABEL EL 1E 4
APPL ICABI LIlY
OF REX)UIREMENT
PLAC 1ENT ON LABEL
COIMEN1’S
REX)UIRED
PREFERRED
8C
Physical or
chemical
hazards
All pressurized
products, others
with flash
points under
150°F
ne
Sane as above
9A
Restricted
block
All restricted
products
Top center
of front
panel
Preferably
blocked
Includes a statenent of the terms of
restriction. The words “tESTRICTED USE
PESTICIDE” must be sane type size as
signal word.
9C
Misuse
statement
All products
Iim ediately
following
heading of
directions
for use
lOA
Reentry
statement
All
cholinesterase
inhibitors
In the
directions
for use
linrediately
after misuse
statement
All products
Must be set apart and clearly distin-
guishable frczn fr other directions
for use.
1OD
Directions
for use
All products
one
1 ’bne
May 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
CONTAI NERS
II. Non—Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
61
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-4
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading :
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
“STORAGE AND DISPOSAL.”
Storage Instructions :
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross—contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
62
-------
Appendix IV—5
PESTICIDE DISR AL IL SThUCrIO
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, “ tX) not contaminate water, food, or feed by storage or disposal.”
2. Except those products intended solely for da stic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes (see list in 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 inhalation toxicity
must bear the following pesticide disposal statement:
“Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance.”
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Ibxic Hazardous Wastes
(see list in this Appendix) or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide disposal
statement:
“Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance.”
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
“Wastes ?esulting fran the use of this product may be disposed of on
site or an approved waste disposal facility.”
5. Products intended for dai stic use only must bear the following
disposal statement: “Securely wrap original container in several layers
of n spaper and discard in trash.”
63
-------
Appendix IV-5
(continued)
P TICIDE ACIT/E fl REDIE Tt’S THAT ARE ACtJI’E ftkZARCOUS WASTES
I. PESTICID ON THE “E” LIST (with RCRA * and CAS *
(40 CFR 261 .33(e)]
Acrolein £003 107—13—1
Aldicarb £070 116-06-3
A].drin £004 309—00—2
Allyl alcohol £005 107—18—6
Alumir .Im phosphide £006 1302-45—0
4—Aminopyridine (Avitrol) £008 504—24—5
Arsenic acid £010 7778—39—4
Arsenic pentoxide £011 130 3—28—2
Arsenic trioxide £012 1327—53—3
Calcium cyanide £021 592—01—8
Carbon disulfide £022 75—15—0
p—Chloroaniline £024 106—47—8
Cyanides (soluble cyanide salts £030
not otherwise specified)
CyanQ en chloride £031 506—77—4
Dieldrin £037 60—57—1
o ,O-Diethyl S— (2—ethy lthio) ethyl] £039 298-04—4
phcsphorodithioate (disulfoton)
0,0-Diethyl 0-pyrazinyl £040 297—97—2
phosphorothioate (Z inophos®)
Dirrethoate £044 60—51—5
O,O-Di.ITethyl o-p-nitrophenyl £071 298-00-0
phosphorothioate (methyl parathion)
4 ,6—Dinitro-o-creSOl and salts £047 534—52—1
4 ,6—Dinitro-o-cyclohexylphenOl £034 131—89—5
Dinoseb £020 88—85—7
Erdosulfari £050 115—29—7
Eridothall £088 129—67—9
Endrin £051 72—20—8
Farrphur £097 52-85—7
Fluoroacetamide £057 640—19—7
Heptachior £059 76—48—8
Hexachiorohexahydro-exo , exo- £069 465-73—6
din thanonaphthalene (Isodrin)
Hydrocyanic acid £063 74—90—8
4ethamyl £066 16752—77—5
alpha-Naphthylthiourea (ANIU) £072 86—88—41
Nicotine and salts £075 54—11—5
OctanethylpyrophOSphOrarfl ide £085 152—16-9
(OMPA, schradan)
Parathion £089 56-38—2
Phenylirercuric acetate (PMA) £092 62—38—4
Phorate £094 298-02—2
Potassium cyanide £098 151—50—8
Propargyl alcohol P102 107—19—7
Sodium azide P105 26628—22—8
Sodium cyanide P106 14 3—33—9
Sodium fluoroacetate £058 62—74—8
64
-------
E—2
Strychnine and salts P108 57—24—9
60—41—3
Q,O,O,0 -Tetraethyl P109 3689—24—5
dithiopyrcphosphate (sulfotepp)
Tetraethyl pyrophosphate P111 107—49—3
Thallium sulfate P115 7446—18—6
Thiofanox O45 39196—18—4
Toxaphene P123 8001—35—2
Warfarin 0.3%) )01 81—81—2
Zinc phosphide (>10%) P122 1314—84—7
50 AC1’IVES
II. PESTICIDES DERIVED F M TRI-, TETRA-, AND PENTACHLO PHENDLS
(40 CFR 261 .31]
2—Chioroethyl 2— (2 ,4 ,6—trichloro— F027 5324—22—1
phenoxy) ethyl ether
Dehydroabietylannoniurn F027 35109—57—0
pentachlorophenoxide
Erbon E027 136—25—4
0-ethyl 0-(2,4 ,5—trichlorophenyl)
ethy1p sphonothioate EU 27 327—98—0
2 ,2 ‘—Methylenebis E027 70—30—4
(3 ,4 ,6—trichlorc henol)
(Hexachlor hene)
—Potassium salt of E027 67923—62—0
—Sodium salt of E027 3247—34—5
——Disodium salt of E027 5736—15—2
Pentachiorophenol F U27 87—86—5
—Potassium salt of EU27 7778—73—6
—Sodium salt of E027 131—52—2
—Zinc salt of EU27 2917—32—0
—Zinc salt of N-alkyl E027
(C 16 —C 18 )—1 ,3—propartediarnine
—Pentachlorcphenyl laurate E027 3772—94—9
Potassium trichioropheriate (2,4 ,6) F027 2591—21—1
Potassium trichlorophenate (2,4,5) E027 35471—43—3
Silvex E U27 93—72—1
——2—Butoxyethyl ester E027 19398—13—1
—Butoxypolypropoxypropyl ester EU 27 53404—07—2
—Butoxypropyl ester E027 25537—26—2
——Diethanolairilne salt E027 51170—59—3
—Diisoprcpanolamine salt F027 53404—09—4
—Din thylamine salt E027 55617-85-1
—Dipropylene glycol isobutyl E027 53535—26—5
ether ester
——Ethanolarnine salt F027 7374—47—2
——2—Ethyihexyl ester F027 53404—76—5
—Isooctyl ester F027 53404—14—1
65
Appendix IV-5
(continued)
-------
E— 3
——Isopropanolamine salt P027 53404—13—0
—Monohydroxylalumiruim salt P027 696 22—82—8
—Polypropoxypropyl ester P027 83562—66—7
—potassium salt P027 2818—16—8
—Propylene glycol isobutyl F027 53466—84—5
ether ester
——Sodium salt P027 37913—89—6
—Triethanolamine salt P027 17369—89—0
——Triethylainine salt P027 53404—74—3
—Triisoprcpanolamine salt F027 53404—75-4
—Tripropylene glycol isobutyl P027 53535—30—1
ether ester
Sodium 2—(2,4 ,5—trichlorophenoxy) F027 3570—61—4
ethyl sulfate
TetrachlorcphenOlS P027 25167—83—3
_Alkylalnine*amine salt (as in P027
fatty acids of cocoru.it oil)
——Potassium salt P027 53535—27—6
—Sodium salt P027 25567—55—9
2,4,5—Trichiorophenol P027 95—95—4
2 ,4 ,6—Trichlorophenol P027 88—06—2
2 ,4 ,5—Trichlorophenol salt of P027 53404—83—4
2 ,6—bis [ (din thylaxnino)rt thyl]
cyclohexanone
2,4 ,5—Trichlorcphenol, sodium salt P027 136—32—3
2,4 ,6—Trichlorophenol, sodium salt P027 3784—03—0
2 ,4 ,5—Trichloropherloxyacetic acid P027 93—79—8
—A].kyl C—12 amine salt P027 53404—84—5
—Alkyl C—13 amine salt P027 53404—85—6
—A.lkyl C—14 amine salt P027 53535—37—8
— N, N-diethylethanolamine salt P027 53404—86—7
—Dist thy1ainine salt P027 6369—97—7
—N,N-dinethyllinoleylalnine salt P027 53404—88—9
—N,N-diirethyloleylanhine salt P027 53404—89—0
——N-oleyl—1 ,3—propylene P027 53404—87—8
diamine salt
—Sodium salt P027 13560—99—1
—Triethanolamine salt P027 3813—14—7
—Triethylainine salt P027 2008—46—0
—Alkyl (C3H7 - C7H9) ester P027
——Amyl ester P027 120—39—8
——Butoxyethoxypropyl ester P027 1928—58—1
—2—Butoxyethyl ester P027 2545-59—7
—— itoxypropyl ester P027 1928—48—9
——Butyl ester P027 93—79—8
——Dipropylene glycol isob.ityl P027 53535—31—2
ether ester
——2—Ethyihexyl ester P027 1928—47—8
—Isob.ityl ester P027 4938—72—1
66
Appendix IV-5
(continued)
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E—4
—Isopropyl ester F027 93—78—7
——Propylene glycol isobutyl E027 53466—86—7
ether ester
——Tripropylene glycol isobutyl E027 53535—32—3
ether ester
4— (2 ,4 , 5—Trichlorcpherioxy) b ityric FO 27 9 3—80—1
acid (2,4,5—TB]
2— (2,4 ,5-Trichlorophenoxy)ettiyl O27 69633-04—1
hydrogen sulfate [ 2,4,5—TES]
1,4’ ,5’—rrichloro—2’—(2 ,4 ,5— E027 69462—14—2
trichlorophenoxy)
rr thanesulfonanilide [ Edolan U]
67
Appendix IV-5
(continued)
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PESTICIDES THAT ARE (IC HP ZAR1YJUS WASTES
PESTICIDES 0t1 THE “F” LIST (with RCRA * and CAS *
(40 CFR 261 .33(f)]
Acetone 1002 67—64—1
Acrylonitrile 1009 107—13—1
Amitrole 1011 61—82—5
Benzerie 1019 71—43—2
Bis(2—ethy lhexyl)phthalate 1028 117—81—7
Cacodylic acid U136 75—60—5
Carbon tetrachioride 11211 56—23—5
Chioral (hydrate) 1034 302—17—0
(chioroacetaldehyde)
Chiordane, technical 1036 57—74—9
Chlorobenzene 1037 108—90—7
4—Chloro-m-cresol 1039 59—50—7
Chloroform 1044 67—66—3
o-Chlorophenol 1048 95-57—8
Creosote 1051 8021—39—4
Cresylic acid (cresols) 1052 1319—77—3
Cyclohexane 1056 110—82-7
Cyclohexanone 1057 108—94—1
Decachlorooctahydro-1 ,3,4-rnetheno- 1J142 143-50—0
2H—cyclobuta [ C ,dl —pentalen—2—one
(Kepone, chiordecone)
1 ,2—Dibraro-3—chlorcprcpafle (DBCP) 1066 96—12—8
Dilutyl phthalate 1069 84—74—2
S—2 ,3—(Dichloroallyl diisopropyl— 1062 2303—16-4
thiocarbamate) (diallate,Avadex)
o-Dichlorobenzene 1070 95—50—1
p-Dichlorobenzene 1072 106—46—7
Dichlorodifluor T thafle 1075 75-71—8
(Freon 12®)
3 ,5—Dich1oro- - (1, l—dii thyl—2— 11192 23950—58—5
propynyl) benzarnide
(pronamide, Kerb®)
Dichioro diphenyl dichioroethane 1060 72—54-8
(DDD)
Dichioro dipheriyl trichioroethane 1061 50—29—3
(DrYr)
Dichioroethyl ether 1025 1191—17—9
2,4—DichiorophenoxyacetiC, 11240 94—75—7
salts and esters (2,4—D)
1 ,2—Dichloropropane 1083 8003—19—8
1 ,3—Dichloropropene (Telone) 1084 54 2—75-6
Diit thyl phthalate 11102 131—11—3
Epichlorohydrin 1041 106—89—8
(1—chloro-2 ,3—epoxypropane)
Ethyl acetate 11112 141—78—6
Ethyl 4 ,4 ‘—dichlorobenzilate 1038 510—15—6
(chlorobenzilate)
6E
Appendix IV-5
(continued)
-------
F—3
2,4 ,5—Trichlorophefloxyacetic acid U232 93—76—5
(2,4 ,5—T)
[ acute waste per 261 .311
Warfarin (<0 .3%) U248 81—81—2
Xylene t3239 1330—20—7
Zinc phosphide (<10%) tJ249 1314—84—7
83 T C IVES
69
Appendix IV-5
(continued)
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Appendix IV-6
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Non—aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Non—aerosol products
(bottles, cans, jars)
Do not reuse container (bottle, can, jar).
Rinse thorouahlv before discardinc in trash.
Aerosol products
Replace cap ana aiscar containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
1/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
Container Type Statement
Container Type Statement
Metal
containers
(non—aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landf.ill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused 1 , 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)
7C
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