Unhed StttM
Environmental Protection
Agency
Office of
Pesticides and Toxic Subcta
Washington DC 20460
Pesticides
Guidance for the Reregistration
of Pesticide Products
Containing Dipropetryn
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GUIDANCE FOR THE REREGISTRATION
OF PESTICIDE PRODUCTS
CONTAINING DIPROPETRYN
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER 224
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
June 1985
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TABLE OF CONTENTS
Introduction . . . . . . . . . . . . . . . . . • • • • 1
Regulatory Position and Rationale. . . . . . . . . • •
[ • Requ1rern for Submission of Generic Data . . . . . . 16
III. Requirement for Submission of Product—Specific
Data . • . . . . . . . . . . . . . . . . . • • • • • • 20
IV. Submission of Revised Labeling . . . . . . . . . . . . 144
A. Label Contents . . . . . . . . . . . . . . . . . • 14)4
B. Collateral Information Labeling. . . . . . . . . . 50
V. Instructions for Submission. . • • • • • • • • • . . 51
APPENDICES
II— ]. Guide to Bibliography . . . . . . . . . . . . . . . 55
11—2 Bibliography. . . . . . . . . . . . . . . . . . . . 57
11—3 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580—1 . 60
11-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580—2. . . . . . . , . . . . . . . . . . 61
111—1 Product Specific Data Report (End—Use Products) . 62
IV—l 40 CFR 162.10 Labeling Requirements . . . . . . . 64
IV-2 Table of Labeling Requirements. . . . . . . . . . 77
IV—3 Physical/Chemical Hazards Labeling Statement. . . 80
IV—4 Storage and Disposal Instructions . . . . . . . . 81
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INTRODUCTION
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 adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration Standards
program and will propose regulatory actions to the extent neces—
sary to protect the public.
EPA has the authority under FIFRA see. 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 see. 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-n, 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 will
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
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
firm.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulatorts Exemption
A. Single Active Ingredient
Products*
.. .. . . . S S • • • •• • • • . . . . . .. .•I...*•••
B. Multiple Active Ingredient
Products
These products must be reregis—
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
S. • •I• •S• •I•S•. .S . • S ••• •• •• • •I••I
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator’s Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will notbe 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 t 11 tt lose their right to
qualify for the formulator’s exemption and become subject to the
requirements in I-A and B.
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I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory position and
rationale of the Environmental Protection Agency (“the Agency”)
for all registered manufacturing—use products (MPs) containing
dipropetryn as the sole active ingredient. The Agency bases
its position and rationale on an evaluation of all MPs and Section
3, 2 )4(c) and intrastate uses registred for dipropetryn. End—use
products (EPs) are reviewed only when there are no MPs registered
or when the label has been changed significantly from the current
accepted label. Mixtures are included only when there is a
significant change in the label. After briefly describing the
chemical and its uses, this chapter presents the Agency’s regulatory
position and rationale, the criteria for registration, acceptable
ranges and limits, labeling requirements and the current tolerance.
B. DESCRIPTION OF CHEMICAL
Dipropetryn is the accepted common name for the compound: 2-
(ethylthio)_ ) 4,6_bis(isopropylaminO)—S—trlazine , as determined
by the British Standards Institution, International Organization
for Standardization, and the Weed Science Society of America.
Dipropetryn is marketed under the trade name Sancap® and other
names such as: Cototar® and GS—16068. The Chemical Abstracts
Service (CAS) Registry number is 141)47—51—7. The Office of Pesti-
cide Program’s EPA Chemical Code Number is 10)4)401.
Dipropetryn is a crystalline solid at room temperature. The empi-
rical formula is C 11 H 21 N 5 S, and its molecular weight is 255.140.
The melting point is 1014-106°C. Dipropetryn is soluble in aromatic
and chlorinated hydrocarbon solvents; and in water at 20°C (16.0
ppm).
[ Dipropetryn is a triazine type herbicide which selectively con-
trols pigweed and Russian thistle in cotton grown on sandy soils
(sand, loamy sand, and fine sandy loam). Dipropetryn is applied
as a preemergence ground application to cotton. 3
Dipropetryn is absorbed by the roots and readily translocated
through the xylem to the apical meristem. Its mode—of—action
in the weed is inhibition of water photolysis In the photo-
synthesis process.
Dipropetryn was patented by the Nippon Kayaku Corporation (US
Patent No. 3,326,912) in 1967 and was first registered for use
by the Ciba-Geigy Corporation In 1973. Currently, technical
dipropetryn Is being produced in the United States by the Ciba—
Geigy Corporation of Greensboro, N.C.
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Dipropetryn is available as a technical material at 95.0 %
active ingredient for formulation of dipropetryn end—use products.
Dipropetryn is available in wettable powder formulations.
C. REGULATORY POSITION AND RATIONALE
Based on the review and evaluation of all available data and other
relevant Information on dipropetryn the Agency has made the
following determinations:
1. The available data are Insufficient to indicate that any Of
the risk criteria listed in § 162.11(a) of Title 4O of the
U.S.Cocle of Federal Regulations have been met or exceeded
for the uses of dipr’opetryn at the present time.
Rationale: Dipropetryn has low toxicity by the oral, dermal,
and eye Irritation routes of exposure. However, two sub
chronic feeding studies Indicated that dIpropetryn can
cause toxic effects at the higher dose levels.
The 19-week rat feeding study indicated that rats dosed
with dipropetryn at 0.0 ppm, 400 ppm, 1200 ppm and 4000
ppm had renal calculi, varied proliferation of renal
pelvic epithelium, pyelitis and dilation of the renal
pelvis at the 1200 ppm level which is the Lowest Effect
Level (LEL). The No-Observable--Effect--Level (NOEL) Is
400 ppm.
The 1 1 4-week dog feeding study indicated that dogs dosed
with dipropetryn at 0.0 ppm, 40O ppm, 1200 ppm and 000
ppm showed toxic effects at the 1200 and 0O0 ppm levels:
hematopolesis In the spleen; hematopoletic and mononuclear
inflammatory cells In the liver; regenerative tubule
epithellum and dilation in the kidneys; gastritis In the
Intestinal tract; reduction In tissue In lymph nodes; re-
duction In cellularity In bone marrow In males and females
The LEL Is 1200 ppm. The NOEL Is 00 ppm.
There are no chronic toxicology data to determine long term
effects of dipropetryn. Therefore, the Agency will require
the following chronic toxicity data: a 90—day rat inhalation
toxicity study, a chronic toxicity study in both the rat and
dog, an oncogenicity study In both the rat and mouse, a tera-
togenicity study in both the rat and rabbit, a two—generation
rat reproduction study; a general metabolism study in the
rat; the mutageniclty tests: gene mutation in bacteria, gene
mutation In mammalian cells in culture, chromosomal aberration
analysis in mammalian cells In culture, and DNA damage in
mammalian cells in culture.
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The Agency has concerns about the herbicide’s lack of
chronic toxicity data and its use on a food and feed crop
when it is structurally related to cyanazine, a s-triazine
pesticide that may be regulated as a teratogen.
2. The Agency will not allow any significant new uses* to be
established for dipropetryn until the toxicological and
residue chemistry data deficiencies identified in Table A
have been satisfied.
* “Significant new use” is defined in FR 2793i , May
11, 1979. In the case of a new food or feed use, the
Agency will generally consider as significant an In-
crease in the Theoretical Maximum Residue Contribution
of greater than 1%.
Rationale: The Agency is unable to complete a tolerance re-
assessment of dipropetryn because of extensive residue and
toxicology data gaps. EPA needs the data to evaluate the
metabolism of dipropetryn and related metabolite(s) in crops
and animals, storage stability, and chronic studies in ro-
dent and nonrodent species. Any future tolerance granted
for dipropetryn must Include any other triazine moiety
residues with dipropetryn.
In order to determine the dietary Average Daily Intake (ADI),
a combined chronic feeding/oncogenicity study must be
completed.
3. Products which are substantially similar to registered pro-
ducts may be considered for registration, subject to the
terms and conditions specified in this document.
Rationale: The Agency does not think that new registrations of
uses already on the market will increase the risks to the
public from exposure to dipropetryn because use of the
chemical is confined to a specific geographical area.
However, the Agency will not register new products that
would significantly increase exposure until the data gaps
have been filled.
4. The Agency will require MP8 containing dipropetryn to bear
Category III hazard statements and other warning statements
as required in the precautionary labeling under O CFR
162.10.
Rationale: Acute toxicity studies for dipropetryn showed
the following: Toxicity Category III for acute oral, and
Toxicity Category IV for acute dermal and acute inhalation,
and for dermal and primary eye irritation.
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5. Based on available information and the use pattern of dipro-
petryn, the Agency does not expect that dipropetryn will
contaminate ground water. At this time, the Agency has de—
cided not to restrict dipropetryn, nor to include on labeling
a ground water advisory statement. Environmental chemistry
data were requested in May 198L to characterize dipropetryn’s
potential to contaminate ground water; additional Information
Is required by this Standard. If these data reveal that
dipropetryn is mobile or persistent such that contamination
of ground water may occur, the Agency may reconsider these
decisions.
Rationale: Dipropetryn is structurally similar to other s-
triazine herbicides which are known (and have been found)
to leach into ground water. Dipropetryn itself has not
been found in ground water and is used only on cotton in
four high plains states (Texas, Oklahoma, Arizona, and New
Mexico). Moreover, the quantity used has been decreasing
over the last three years. In those States where it is
applied, the ground water table is estimated to be 150—200
feet below the soil surface. Therefore the Agency does not
expect that dipropetryn will contaminate ground water
supplies.
In May 198L , the Agency Issued a Data Call—In Notice requi-
ring the following environmental fate data: hydrolysis
( 161—1); photodegradation in water(161—2), on soil (161—3);
soil metabolism in aerobic soIl (162—1), In anaerobic soil
(162—2); and mobility ( 163-1). Data on photodegradatlon
of dipropetryn on soil surfaces (Accession No. 257328)
were submitted recently by a registrant In response to
the Data Call—In Notice. These data are being reviewed by
the Agency at the present time.
6. The Agency is imposing restrictions on rotational crops.
The extent of the restrictions will be reconsidered when
additional data are received.
Rationale: It Is the policy of the Agency to impose restric-
tions on planting rotational crops in treated fields, pend-
ing the submission of data. This serves to protect the
public from Impermissable residues of dipropetryn In food or
feed.
7, No endangered species label statements are required.
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Rationale: The Agency has evaluated dipropetryri under the cot-
ton cluster/use patterns for endangered species concerns.
Available data show a low order of toxicity suggesting the
potential hazard to endangered species is low. Therefore,
dipropetryn was not included among the chemicals referred
to the Office of Endangered Species (OES), U.S. Fish &
Wildlife Service, in the cotton cluster. Currently, there
are no Identifiable endangered plants that would be affected
by dipropetryn.
The Agency believes that the conventional labeling for
dipropetryn is adequate to properly inform the users on
how to protect any endangered species.
8. The Agency is not requiring a re-entry Interval for currently
registered uses of dipropetryn at this time.
Rationale: Dipropetryn has low acute toxicity (Category III)
and no known chronic effects at the present time. Addi-
tionally, the preemergence use of dipropetryn on cotton
does not lead to reentry exposure.
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D. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT
To be subject to this guidance document, MPs must meet the fol-
lowing conditions:
1. Contain dipropetryn as the 8ole active ingredient and,
2. Conform to the acute toxicity limits, product compo8itiOfl,
and use pattern requirements listed in Section F of this
document.
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
Technical grade products must contain at least 95.0 percent
dipropetryfl as the sole active Ingredient. Each MP formulation
proposed for registration must be fully described with an appro-
priate certification of limits. In addition, the active ingredient
found in the MPs must be substantially similar to that in currently
registered technical products. Any MP not meeting these require-
ments will be considered a new product and will not be registerable
under this guidance document.
2. Acute Toxicity Limits
The Agency will consider registration of products containing
dipropetryn, provided that the product labeling bear 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 dipropetryri
must be labeled for formulation only into end—use herbicide
products for the commodities listed below. [ The attached index
entry lists all registered uses, as well as approved maximum
application rates and frequencies].
DipropetrYfl, a selective herbicide, Is registered for control
of pigweed and Russian thistle on cotton grown on sandy soils
in Arizona, New Mexico, Oklahoma and Texas. Currently,
dipropetryn is the only preemergence cotton herbicide that can
be used on approximately 315,000 acres of sandy and loamy sand
soils in Texas and Oklahoma. Other available preemergence cotton
herbicides are phytotoxic to cotton on these soil types.
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F. REQUIRED LABELING
All technical grade products, MP5, and EP8 containing dipropetryn
must bear appropriate labeling as specified in ê0 CFR § 162.10.
Other portions of this guidance package contain specific infor-
mation regarding label requirements.
In addition to the requirements stated in ItO CFR § 162.10, the
following information must appear on the labeling of all products
released for shipment after July 30, 1986 and products in the
channels of trade after July 30, 1987 .
1. Ingredient Statement
The ingredient statement for MPs must list the active in-
gredient as:
Dipropetryn: 2—(ethylthio)—Lt,6-bis(isopropylamiflO)
—s—triazine •• •• • .%
2. Manufacturing—Use Product Statements
All products intended for formulation into end-use products
must bear the following statement:
“This pesticide is toxic to fish. 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 dis-
charge 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”.
The following environmental hazard statement must appear
on all EP products:
“Do not apply directly to water. Do not contaminate
water by cleaning of equipment or disposal of wastes.
In case of spiiis, cover or incorporate spills.”
Restrictions on Rotational Crops
“Do not plant food and feed crops in dipropetryn—treated
fields unless dipropetryri is authorized for use on those
crops”.
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G. TOLERANCE REASSESSMENT
Data are not available for calculating the Acceptable Daily
Intake (ADI) for dipropetryn.
The Agency is unable to complete a full tolerance reassessment
because the available dipropetryn toxicology and residue data
do not fully support the established tolerance listed below.
The metabolism of dipropetryn in animals and plants is not
fully understood. Therefore, the Agency is requiring data on the
metabolism of dipropetryn and related metabolite(s) in crops and
animals, and on storage stability. Additional long term rodent
and nonrodent toxicological studies are also required. These data
will be used to assess dietary exposure to dipropetryn and may
lead to revisions in the existing tolerances. The Agency will
not grant any significant pending or new tolerances for
dipropetryn until the data are submitted.
In the United States, tolerances are currently established in ItO
CFR § 180.369 for the combined residues of the herbicide,
dipropetryn: 2(ethylthio)—14,6—bis(isoPrOPyla!flinO)—B-triaZifle,
in or on the following raw agricultural commodity:
Commodity Parts per million
Cottonseeds 0.1
International Tolerances
Presently, there are no tolerances for residues of dipropetryn
on cottonseed in Canada, Mexico, or in the Codex Alimentarius .
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EPA Index to Pesticide Chemicals
DIPROPETRYN*
TYPE PESTICIDE : Herbicide
FORMULATIONS :
Tech (95%)
WP (80%)
GENERAL WARNINGS AND LIMITATIONS : A selective preemergent herbicide
working mainly through root absorption. Irrigation or rainfall after
application will enhance weed control. Should weeds develop, a shallow
cultivation or rotary hoeing may improve weed control. Cotton growing on
alkali soils, caliche outcroppings or where cuts, fills or erosion have
exposed calcareous subsoil may be injured by the chemical. Application
to emerged cotton will cause crop damage. Make broadcast ground applica-
tions in a minimum of 20 gallons of water per acre. Apply by air in a
minimum of 2 gallons per acre.
TINE REQUIRED FOR CONTROL : Not located.
PHYTOTOXICITY TO TARGET WEEDS : Not located.
PHYTOTOXICITY TO CROPS : Not located.
MODE OF ACTION : Inhibition of photolysis of water in photosynthetic pro-
cess.
BROADLEAF WEEDS CONTROLLED :
PAFACBI redroot pigweed
PBDAKBA Russian thistle
*Sancap
2—(ethylthio)—4, 6—bis(isopropylamino)—s—triazine
Issued: 11—02—84 1—104401—i
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EPA Index to Pesticide Chemicals
DIPB.OPETRYN
Site, Dosage Tolerance, Use, Limitations
and Formulation
(lb a.i./A)
AGRICULTURAL CROPS
/28007AA Cotton 0.1 ppm (negligible residue) (cottonseed)
Do not feed treated forage to livestock or graie
treated areas. Rotational crops may be planted 6
months following initial application. Cotton
stalks should be disked or plowed under prior to
planting a rotational crop.
1.2—2.0 Use limited to sandy soils in AZ, NM, OK and TX.
(80% WP) Preemergence. Broadcast or band. Apply to flat—
planted, bedded or furrow—planted cotton. Apply
band only to furrow—planted cotton, not to exceed
the width of the bottom of the furrow. Reduce
dosage in proportion to band area actually treat-
ed. Apply at planting or within 2 days following
planting. If replanting is necessary, do not
make a second application in the, same furrow. A
second band application is recommended for furrow—
planted cotton if the new furrows are formed down
the untreated row middles. Use the lower dosage
on sand soils, a medium dosage on loamy sand, and
the high dosage on fine sandy loams.
AERIAL AND TANK MIX APPLICATIONS
9001500 Aerial Application
Refer to
AGRICULTURAL CROPS
Cotton
Issued: 11—02—84 1—104401—2
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EPA Index to Pesticide Chemicals
D I PROPETRYN
Listing of Registered Pesticide Products by Formulation
95% technical chemical
dipropetryn (104401)
000100—00569
80% wettable powder
dipropetryn (104401)
000100—00522
Issued: 11—02—84 1—104401—3
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EPA Index to Pesticide Chemicals
DIPROPETRYN
Appendix B
Listing of Registration Numbers By Site
AGRICULTURAL CROPS
/28007AA Cotton
000 100—00522
Issued: 11—02—84 1—104401—4
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA 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 Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a “typical
formulation,” and in those cases EPA needs data of that type
11 Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product’s unique composition or specific use. Product—
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
2/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
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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—3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the te8t 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— ) /
*1 FIFRA see. 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)
17
-------
OR
14• Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA’s schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
In EPA’s opinion, joint data development by all regis-
trants subject to a data requirement or a cost—sharing agreement
among all such registrants is clearly in the public interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [ on terms to be agreed upon
or determined by arbitration under FIFRA Section 3(c)(2)(B)(iil)];
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.
18
-------
The extension request 8hould state the reasons why you believe
that an extension 18 appropriate. While EPA considers your
request, YOU mu8t strive to meet the deadline for submitting
the required data.
19
-------
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—14, 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
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
20
-------
TABLE A
GENERIC DATA REQTJIRE7 1ENTS FOR DIPROPETRYN (95 A .1.)
lhta Must Be
Guideline Citation and
Test
Guidelines
Are t ta
Footnote
Submitted Within
Name
of
Test
Substance
Status
Required
Yes No
Number
Time Frames
Below 1/
Listed
§158.120 Product Chemistry
Product Identity :
61—i - Product Identity and Disclosure TGAI R [ ] IX]
of Ingredient
61—2 - Description of Beginning Materials TGAI R IX] [ ] 2 6 Months
and Manufacturing Process
61-3 - Discussion of Formation of TGAI R Li [ ] _____________
Impurities
Analysis and Certification of Product
Ingredients
62-i - Preliminary Analysis TGAI CR [ ] Li 3 12 Months
62—2 - Certification of Limits AI CR [ ] [ TI 3 12 Months
62-3 - Analytical Method for forcement It AI CR [ X] 1] 3 12 Months
of Limits
Physical and Chemical Characteristics
63—2 — Color TGAI R I] [ ] _____________
63-3 - Physical State TGAI R Li [ ] __________
63-l i - Odor TGAI R [ ] [ ] 2 6 Months
63-5 - Melting Point TGAI R Li [ ]
63-6 - Boiling Point TGAI R [ Ti [ 1
21
-------
TABLE A
GENERIC L TA R JIRE24E2fl’S FC1 DIPROPE7flWN (95% A.I.)
t ta Must Be
Guideline Citation ani
Test
Guidelines
Are t ta
Footnote
Suhni tted Within
t e
of
st
Substance
Status
Required
Ye8 No
W,nber
Thne Frames
Below 1/
Listed
§15 . 120 Product nistry (Continued)
Pt8ical Q ical Characteristics
( itinued)
63-7 — Density, &ilk Density, or
Specific Gravity
R c i
63—8 — So lubility
‘1 AI or PA l
R ci
63-9 - Vapor Pressure
63-10 - Dissociation constant
63—11 — Octanol/water partition
coefficient
63—12 — pH
63—13 — Stability
Other Req uirenents :
6i - 1 - Sutinittal of samples
PAl
PA]
PAl
AI
TGAI
6 Munths
6 Munths
TGAI = Technical Grade of the Active Irgredient; PAl = Pure Active Ir redient; H = Required; CR = Conditionally Required
1/ De’ta must be submitted within the Indicated time frame, based on the date of the Guidance t ctxnent.
2/ 6 Nonth Ilie 1 te is January 30, 1986 .
/ 12 ! bnth Ilie 1 te is July 30, 1986 .
2 / This canpound does not require the submittal of samples at this time.
AI
H ci
R
R
R 0
R 0
CR
[ -]
[ ]
[ ]
2
2
1
TGAI, PAl
22
-------
TABLE A
GENFJ IC DATA REQUIRE7€NTS FOR DIPROPETRYN
DDes EPA Have 1)ita
Must Additional E Eita
To Satisfy This
Be Submitted Under
1/
Requirenent? (Yes,
Biblic raphic
FIFRA § 3(c)(2)(B)?
E ta
Requirenents
Canposition
No, or Partially)
Citation
Time Frames For t ta
Submission 2/
§158.125 Residue Ch nistry
171—2 — Ch n1cal Identity ill,
171—3 — Directions for Use 13/
171—4 — Nature of Residue (Metabolism)
— Plants PAIRA Partially 00110374, 00110378 Yes 3/ 2 4 Months
- Livestock PAIRA and Plant No Yes 4/5/ 18 Months
Metabolites
171-4 - Residue Analytical Method
— Plant residues I AI and Metabolites Partially 00036732, 00036740 Yes 5/7/ 24 Months
BT
- Animal residues ¶ AI and Metabolites No Yes 7/8/ 18 Months
171—4 — Magniti. 1e of the Residue—
Residue Studies for Each
Food Use
- Crop Group: Miscellaneous
Caiinodities
o Cottonseed
— Processed Food/Feed EP Partially 0011037 14, Yes 9/ 214 Months
GS0224—001
23
-------
TABLE A
GENERIC DATA p EQtJIRF14ENrS 10R DIPROPFTRYN
Data Requirement
1/
Ccinpos Ition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA S 3(c)(2)(B)?
Time Frames for [ ta
Submission _____
§158.125 Residue Chemistry — Continued
l7l— — Magnitude of the Residue —
Residue Studies (continued)
-- MeatJl4ilk/Poultry/Eggs
!ltlAI or Plant
Metabolites
No
Yes 10/11/ 18 Months
- Potable Water
- Fish
- Irrigated Crops
- Food Handling
171-5 - Reduction of Residue
171-6 - Proposed Tolerance
171-7 - Reasonable Grounds in
Support of Petition
EP
EP 1?!
EP
EP
Residue of i V
Concern
Residue of
Concern
No
No
No
No
No
No
No
24
-------
TABLE A
GENERIC DATA REQ(JIRE74EI 1PS FOR DIPROPE IW(N
S158.125 Residue Chemistry — Continued
1/ CanposItion: IIUAI = Technical grade of the active ingredient; PAulA = Pure active ingredient, radiolabelled; TEP =
Typical end-use product; EP = End-use product.
2/ Data must be suheiltted within the indicated time frame, based on the date of the Guidance Ducument.
o 18 Month Due Date Ia January 30, 1987 .
o 214 t bnth Due Date Is July 30, 1987 .
3/ AddItional plant metabolism data are required to reveal the canpiete identity of radioactive residues encountered
in cotton plants resulting fran treatment with radiolabeled dipropetryn.
14/ Metabolism studies utilizing ruminants are required. Animals must be dosed with 111 C ring labeled dipropetryn.
Distribution and characterization of residues must be determined in milk and tissues.
5/ If the additional metabolism data show the presence of new metabolites, then additional methodology data may be
required.
6/ Metabolism studies utilizing chickens are required. Chickens must be dosed with C ring labeled dipropetryn.
7/ When the nature of the dipropetryn residues in plants and animals are adequately understood, the registrant must
suttnit appropriate analytical standards [ successful method trial for dipropetryn] to the Agency.
8/ Depending upon the results of plant and animal metabolism data being required, Method AG-137 or other methodology
which determines this canpound and/ or other constituents of the terminal residue of dipropetryn on cotton will be
required.
9/ If detect ible residues are observed in cottonseed in the metabolism studies and method trials,
processing data will be required for cottonseed. Consult the Agency for appropriate test protocol.
10/ When the metabolism and residue studies becane available, conventional feeding s1 udIes on ruminants will be required.
11/ When the metabolism and residue studies beccine available, conventional feeding studies on chickens will be required.
T / This use is not pending, nor has it been approved for dipropetryn at the present time.
13/ This requirement is not appropriate for dipropetryn at the present time.
T1r/ This requirement has been satisfied.
25
-------
§158.130 Ehvirorinental Fate
DEGRADATION S’IUDIES-LAB :
161—1 — Hydrolysis
Photodegradatlczi
161—2 — In water
161—3 — On soil
161-44 - In Air
ME’TABOLISM S’fiDIES-LAB :
162—1 — Aerobic Soil
162-2 — Anaerobic Soil
162—3 - Anaerobic Aquatic
162—4 — Aerobic Aquatic
MOBILITY SIUDIES :
163—1 - Leaching and
Adsorption/Desorption
163—2 — Volatility (Lab)
163—3 — Volatility (Field)
1/
Use
2/
t ita Requirenent Ccznposltion
Pattern
TABLE A
GENERIC DATA R3 UIRH4EN S FOR DIPROPEfl YN
1)es EPA Have
t ta Tb Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional t ta
Be Submitted Under
Bibliographic
FIF1 A § 3(c)(2)(B)?
Citation
Time Frame for I ta
Submission 3/
‘I AI
or
PAIRA
A
No
-
Yes
9
Months
¶lflAI
or
PAIRA
A
No
-
Yes
9
Months
!It AI
or
PAIRA
A
No
-
Yes
11/
9
Months
TUAI
or
PAIRA
I/
No
¶ AI
or
PAIRA
A
Yes
27
Months
¶1 AI
or
PAIRA
A
Yes
27
Months
¶LWJ
or
PAIRA
10/
No
T AI
or
PAIRA
10/
No
‘RAI
or
PAIRA
Partially
GS022 1 4—002
Yes
5/
12
Months
TEP
TEP
14/
14/
26
No
No
-------
Soil
Aquatic (Sediment)
— Forestry
- Cinbination and
Tank Mixes
164—5 — Soil, rig—term
ACC1MJLATIC* &‘1 JDTh :
165—1 - Rotational Crops
(Confined)
165—2 — Rotational Crops
(Field)
165—3 — Irrigated Crops
165—4 — In Fish
165-5 - In Aquatic Non-Target
0rgani ns
PEP
PEP
PEP
PEP
PEP
PAIRA A
PEP A
PEP
TGAI or PAIRA A
PEP
Yes
10/
10/
9/
6/
10/
No
10/
00036726, 00110378 No
No
No
No
No
1/
Use2/
t .ta Requir nent Canposition
Pattern
TABLE A
GENERIC DATA RBY UIRE?4E1s11’S FOR DIFROPETRYN
1)es EPA Have
t ta ‘lb Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional t ta
Be Sutmrttted Under
Bibl1ogra iic
ML1 1 A § 3(c) (2) (B)?
Citation
Time Frame for t .ta
Sut n1ss1on 3/
§158.130 E ivirorinental Fate - Continued
DISSIPATI S’1 JDIE -FIE [ D :
164—1 —
164—2
164—3
164—4
A
Partially
00103171 Yes 7/8/
Yes 8/
No
Yes
No
39 Months
50 Months
12 Months
27
-------
TABLE A
GENERIC DATA RB UIREMENTS FOR DIPROPETRYN
§158 . 130 Environmental Fate — Continued
1/ Composition: AI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: ATerrestrial, Food Crop; B=Terrestrial, Non—Food; C=Aquatic, Food Crop;
D=Aquatic, Non—Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dctnestic Outdoor; I=Indoor.
3/ Data must be suthiitted within the indicated time frame, based on the date of the Guidance tkcument.
o 9 ltnth Due Date is April 30, 1986 .
o 12 Month Due Date is July 30, 1986 .
o 27 Month Due Date is October 30, 1987 .
o 39 Month Due Date is October 30, 1988 .
o 50 Month Due Date is Sept nber 30, 1989 .
14/ Exposure is not expected to be significant with currently registered use patterns.
5/ Additional data will be required on leaching or adsorptiorVdesorptiofl of dipropetryn degradation products.
/ Results of terrestrial field dissipation data indicate that greater than 50% of applied dipropetryn would dissipate
prior to subsequent application.
7/ Data for nallgraln crops are acceptable; additional data will be required for root crops and leafy vegetables if
these are to be rotated.
8/ For crops rotated on treated areas, any one of the following restrictions will apply:
a. A tolerance must be obtained for the rotated crop,
b. Product label must include a restriction not to plant food and feed crops in dipropetryn-treated fields unless
dipropetryn is registered for use on those crops,
c. Data must be provided to determine time intervals at which rotated crops planted on dipropetryn—treated fields
wil be free of dipropetryn residues.
9/ Data on dipropetryn in combination and tank mixes are not required.
10/ These data requir nents do not apply to current use patterns.
11/ Under the Data CAll-In Notice for Ground Water, photodegradation data were received by the Agency in March
1985 (Accession 257328) and are under review.
28
-------
TABLE A
GENERIC DATA RE UI1 ’1ENTS FOR DIPROPETRYN
E ta
¶Lk Satis
fy
Be Submitted Under
This
Require—
Bibliographic
FIFRA § 3(c)(2)(B)?
t .ta
Requir nent
1/
Ccznposltion
Use
Pattern
ment? (Yes,
or Partially)
No
Citation
Time Prame for De.ta
Submission 3/
§158.135 ToxIcology
ACIJIE TES’TING :
81—1 — Acute Oral Toxicity ‘ AI A,B Yes 00O7037 4 No
—Pat
81—2 — Acute Dermal Toxicity ‘It AI A,B Yes 00070375 No
- Rabbit
81—3 - Acute Inhalation Toxicity TGAI A,B Yes 00070377 No 4/
— Pat
81-4 — Primary Rye Irritation P AI A,B Yes 00034098 No
81—5 — Primary Skin Irritation TGAI A,B Yes 00070375 No
81-6 - Derinal Sensitization ¶ AI A,B Yes 00110376 No
81-7 - Delayed 9X AI A,B 5/ No
Neurotoxicity - Hen
SUBC}IRONIC TESrING :
82—1 — 90—Day Feeding :
— Rodent, and ‘11 AI A,B Yes 00070371 No
- Non—rodent (I)g) TGAI A,B Yes 00070372 No
82-2 - 21-Day Derrnal - Rabbit ‘It AI A,B 14/ No
82-3 - 90-Day Dermal - Rabbit ‘It AI A,B 14/ No
29
-------
§158.135 Toxicology — Continued
82—1 — 9O—t y Inhalation:
— Rat
82—5 — 9O—t y Neurotoxicity:
- Hen
—M.qnim i].
CHRONIC TESTING :
83—1 — Chronic Toxicity —
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 — c cogenicity -
2 species:
— Rat (preferred), and
— Mouse (preferred)
83-3 - Toratogenicity -
2 species:
— flat
— Rabbit
83—14 - Reproduction - Rat
2—generation
1/ Use 2/
1 .ta Requir nent Canposltion Patterri
T BIE A
GENERIC DATA RFJ UIRFWRTS FOR DIPROii n YN
Does EPA Hav
I .ta To Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional t ta
Be Submitted Under
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Time Frame for t ta
¶LT AI
A,B
i’io
-
Yes 6/ 15 Months
¶I’GAI
A,B
15/
No
¶L AI
A,B
15/
No
!Lt AI
¶ AI
A,B
A,B
No
No
-
-
Yes
Yes
7/8/
7/8/
50
50
Months
Months
‘I AI
A,B
No
-
Yes
7/9/
50
Months
AI
A,B
No
-
Yes
7/9/
50
Months
X AI
A,B
No
Yes
10/
15
Months
fl3AI
A,B
No
Yes
10/
15
Months
P3AI
A,B
No
30
-------
158.i35 Toxicology - Continued
M [ YPAGFNICITY L TI
811—2 — Gene Mutation (Ames I st)
81 1—2 — Structural Chranosanal
Aberration
81i-li — Other Genotoxic Erfects
SPECIAL TF TflG
85-i - Genera]. Metaboli&n
85-2 - Dermal Penetration
86—i — L imestic Animal
Safety
1/ Use 2/
t ta Requiranent Ccinposition Pattern
TABLE A
GENERIC DATA RE UIREME1 I1’S FOR DI OPETRYN
DDes EPA Have
De.ta To Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional t .ta
Be Submitted Under
Bibliographic
Citation
FIF’RA § 3(c)(2)(B)?
Time Frame for De.ta
¶ AI
A,B
r
-
Yes 12/ 9 Months
¶ AI
A,B
No
-
Yes
12/
12
Months
‘It AI
A,B
No
-
Yes
12/
12
Months
PAl or PAIRA
A,B
Yes
13/
211
Months
Choice
No
thoice
31
-------
TABLE A
GENERIC DATA RE7 UIRE74ENI’S FOR DIPROPE RYN
Ccinposition: PAl = Pure active ingredient; PAIRA = Pure active ingredient, radio
test substances dete mined on a case-by-case basis.
The use patterns are coded as follows: A=Terrestri-al, Food Crop; B=Terrestrial,
I)=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry;
time frame, based on the date of the
labelled; Choice = Cho
Non—Food; C=Aqautic,
H=Dctnestic Outdoor;
Guidance Document....
ice of several
Food Crop;
I=Iridoor.
t ta must be sul:xnitted within the
o 9 ? bnth Die t .te is April 30, 1986
o 12 !.bnth Die t te is July 30, 1986
o 15 !tnth Die Lute is October 30, 1986.
o 2 4 ! bnth Die Dite is July 30, 1957
o 39 Wnth Die t .te is October 30, 1988
o so Wnth Die t .te is Sept nber 30, 1959.
/ The acute (11 hour) inhalation toxicity study is considered to be adequate for the acute test.
5/ Dipropetryn is not an organo *iosphate , nor is it known to cause delayed neurotoxicity.
/ Discolored spleens formed in all dosage levels in the acute inhalation toxicity study indicate that a
90-day inhalation study in the rat is required.
7/ The Agency will require interim reports on the chronic studies. (The registrant should consult the Agency to
determine the interim reporting dates for the chronic toxicity studies).
8/ Qwonic toxicity studies in both the rat and in dog are required.
9/ ( icogenicity studies in both the rat and in mouse are required.
10/ Teratology studies in both the rat and rabbit are required.
11/ A two generation reproduction study in the rat is required.
12/ The following mutagenicity data are required:
a. In vitro mananalian cell point mutation [ L5178Y (TK), or CHO (HGPRT), or W9 (HGPRT)] tests,
b. In vitro cytogenetic damage: both cbrcinosanal aberration and SCE (in CHO cells, or human lymphocytes, or other
rodent/human cell lines/strains tests,
c • In vitro/in vivo primary hepatocyte repair for UDS testing both in vivo and in vitro exposure of cells to
Dipropetryfl,
d. In vivo cytogenetics test for chranosomal aberrations using bone marrow preparations of rats,
e. Dcinlnant lethal test in rats or mice.
13/ A general metaboliani study of the rat is required.
Till The guidelines and uses indicate that these data are not required.
15/ Dita are not required, unless there are indications from other tests or literature which may require data fran
this study.
S158.135 Toxicology - Continued
1/
2/
3/
32
-------
TABLE A
GEN IC DATA R UIRE74E IPS FOR DI} OPE’PRYN
Does EPA Have
Be Submitted Under
tata Th Satisfy
FU HA S 3(c)(2)(B)?
Data
1iequir nent
1/
Canposition
Use 2/
Pattern
This Require—
ment? (Yes,
or Partially)
No
Bibliographic
Citation
Time Frame for Data
Submission 3/
§158 . 1140 Reentry Protection
132-1 - Foliar Dissipation ‘]EP No 14/ No
132-1 - Soil Dissipation No i/ No
133-3 - Dermal &poeure ‘IEP No li/
133-14 - Inhalation posure ‘IEP No 14/
§158.1142 Spray Drift
201-1 - Droplet Size Spectrum No ‘s/ No
201-1 - Drift Field Evaluation ‘IEP No 14/ No
1/ Ccmposition: ‘lEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non—Food; E=Greenhouse, Food Crop; F=Greerthouse, Non-Food; G=Forestry; H=Danestic C*itdoor; 1= Indoor.
3/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document.
° 27 Month Due Date is not applicable .
l / sed on the criteria cited in 140 CPR § 158.1140, re—entry data are not required for dipropetryn.
33
-------
S158.1’45 Wildlife arxl
Aquatic Organisms
AVIAN AND MANMALIAN TF TING
71—1 - Acute Avian Oral Toxicity
71-2 — Avian Subacute Dietary
Toxicity
— Upland Game Bird, and
— Waterfowl
Wild irinal Toxicity
Avian Reproduction
- Upland Game Bird, and
— Waterfowl
71-5 - Simulated Field Testing
- Manina.ls, and
- Birds
— Actual Field Testing
- Maxmnals, and
- Birds
9 Months
9 Months
1/
Use
2/
Data Requir nent Canposit ion
Pattern
TABLE A
GENERIC DATA RE U R NE S FOR DIPROPETRYN
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Be Submitted Under
Bibliographic
FJJ F A § 3(c)(2)(B)?
Frame for Data
Citation
Submission 3/
71—3 —
71— 4 —
TGAI
A
Partially 00070378 Yes 9
¶ AI
A
No
Yes
AI
A
I b
Yes
‘1t AI
A
5/
No
mAI
A
5/
¶ AI
A
5/
A
5/
A
5/
No
1EP
No
TEP
No
TEP
A
5/
No
‘IEP
A
5/
No
34
-------
- Coidwater Fish Species
72-2 — Acute Ibxicity to
Freshwater Invertebrates
72-3 - Acute lbxicity to
Eatuarine and Marine
Organi
- Marine Fish
- Mollusk
- r1inp
72 — I l - Fish Early Life Stage,
and
— Aquatic Invertebrate
Life—Cycle
72—5 — Fish — Life—Cycle
1/ Use 2/
t .ta Requir iient Canposition Pattern
TABLE A
GENERIC DATA R UIRH€NTS FOR DIPROPE RYN
tbes EPA Have
t ta ¶lb Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Must Additional t ta
Submitted Under
FIFRA § 3(c)(2)(B)?
Citation
Time Frame for t ta
Submission 3/
§158.1115 Wildlife aj j
Aquatic Organisms - Continued
AQUATIC OfiGANISM PE. TING
72—1 — Freshwater Fish ‘lbxicity
- Wannwater Fish Species,
I AI
A
N o6/
-
No
PEP
A
Yes
00070379
No
¶ AI
A
?b6/
-
No
PEP
A
Yes
00070379
No
¶I AI
A
No
-
Yes
9Months
TE?
A
No
Reserved
4/
AI
A
No
Reserved
4/
¶ AI
A
No
Reserved
1/
AI
A
No
Reserved
4/
AI
A
No
Reserved
14/
AI
A
No
Reserved
14/
T AI
A
Reserved
LI!
35
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TABLE A
GENFRIC DATA RE UIRH4ENTS FOR DLPROPF rRYN
tbes
EPA Have
&ist Additional t ta
L ta
‘lb Satisfy
Fe Sut*nitted Under
t ta
Requirenent
1/
Canposition
Use 2/
Pattern
This Require—
ment? (Yes,
or Partially)
I &
Bibliographic
Citation
FIFRA § 3(c)(2)(B)?
Time Frame for t .ta
SubmissIon 3/
§158.1115 Wildlife arxl
Aquatic Organisms - Continued
72—6 — Aquatic Organism TGAI, PAl OR
Accixnulation t gradation
Product
- Crustacean A Reserved LI!
- Fish A Reserved LI!
- Insect Nym A ND Reserved LI!
- Mollusk A ND Reserved LI!
72-7 - Simulated Field Testing
- Aquatic Organisms ¶IEP A Reserved 1 1/
— Actual Field Testing
-Aquatic Organisms ‘ lEP A Reserved LI!
36
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TABLE A
GENF IC DATA RE UIRF7IEW1 FOR DIF 0PEPRYN
§158.1145 Wildlife and Aquatic Organisms - Continued
1/ Cc*nposition: 1 AI = Technical grade of the active ingredient; PAl = pure active ingredient;
PEP = ¶ [ rp1cal end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Fbod Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Fkiod Crop;
D=Aquatic, }bn-lkod; E=Greenhouse, Fbod Crop; F=Greenhouse, NDn-Fbod; G Forestry; H=Dcinestic Outdoor; I=Iridoor.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
° 9 Wnth 1)ie Date is April 30, 1986
14/ Requir nents are pending receipt and review of envirorinental fate data In conjunction with the use on cotton.
5/ The low avian toxicity data and limited use pattern for dipropetryn indicate that data are not required.
Li Data for the PEP, (80 WP) will satisfy this requir nent. Any changes in the formulation will require submission
of additional data.
37
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TABLE A
GENBRIC DATA RE UIR IIEI 1rS FOR DIPROPF RYN
L es
EPA Have
Must Additional t .ta
L .ta
To Satisfy
Submitted Under
1/
Use 2/
This
Require—
Bibliographic
FIFRA § 3(c)(2)(B)?
t ta
Requir nent
Canpositlon
Pattern
ment? (Yes,
or Partially)
ND
Citation
Time Frame for t ta
Submission 3/
§158.155 Nontarget Insect
NOMTARGEYP INSECT TES’PING —
POLLINAWRS :
141—1 — Honey bee acute
contact toxicity fl3AI A Yes 00066708 No
141—2 — Honey bee — toxicity ‘IEP A li/ No
of residues on
foliage
141—k - Honey bee subacute (Reserved) 5/
feeding study
141-5 — Field testing for ‘IEP A 14/ No
pollinators
M)WTARGE P INSECT TESTING -
AQUATIC INSECTS :
142—1 — Acute toxicity to (Reserved) 6/
aquatic insects
142—1 — Aquatic Insect (Reserved) 6/
life—cycle study
1142—3 - Simulated or actual (Reserved) 6/
field testing for
aquatic insects
1143-1 - NON ARGET INSECT (Reserved) 6/
thru TESTING - PREDA ’ IORS
143—3 AND PARASITES
38
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TABLE A
GENERIC DATA RE UIRE74EN1”S FOR DIPROPETRYN
ft58.155 Nontarget Insects
1/ Canposition: ¶L AI = Technical grade of the active ingredient; PEP = ¶ [ rpical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; CAquatic, Food Crop:
D=Aqautic, Non—Food; E=Greenhouse, Food Crop; F=Greenhouse, Non—Food; G=Forestry; H=Dcmestic Cxitdoor; I=Indoor.
3/ t ta must be submitted within the indicated time frame, based on the date of the Guidance t)cument.
° 9 Wnth tXie t te is not applicable .
14/ No additional data required because the data shows dipropetryn to be relatively non-toxic to bees.
5/ Reserved pending development of test methodology.
/ Reserved pending Agencys’ decision as to thether data requir nent should be established.
39
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TABLE B
PRODUCT SPECIFIC DATA RE) UIRE 4EI’.1rS FOR MANUFACTURING-USE PRODUCTS CONTAINING DIPROPE’mYN
t ta Must Be
Guideline Citation and
Test
Guidelines
Are tO.ta
Fbotnote
Submitted Within
Name
of
Test
Substance
Status
Required
Yes No
Number
Thne Frames Listed
Below 1/
2
§158.120 Product Ch nistry
Product Identity:
61—1 — Product Identity and Disclosure
of Ingredients
61—2 — t scription of Beginning Muterlals
and Manufacturing Process
61—3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62—1 — Preliminary Analysis
62—2 — Certification of Limits
62—3 — Analytical Methods to Verify
Certified Limit
Physical and Ch nica1 Characteristics
63-2 — Color
63-3 — Thysical State
63—a — Qior
63—5 — Melting Point
63—6 — Boiling Foint
NP
R
[ K]
[ ii]
NP
R
U
[ K]
NP
CR
[ K]
c i
NP
R
[ ]
[ iii ]
NP
R
[ KJ
[ 1J
NP
R
1=]
[ K]
NP
R
[ Ti ]
[ K]
NP
R
[ K]
[ ii]
NP
R
[ _]
[ ]
NP
R
[ _]
[ ]
3
3
3
6
12 Menths
12 Menths
12 Mentha
6
2
40
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T BIE B
PRODUCT SPECIFIC DATA RW IJIRF2’1ERPS PCI MANUFACTURING—USE PRODUCTS COI ITAINING DIPROPE R1N (95% A.1.)
E .ta !4ist Be
Guideline Citation ard st Guidelines Are t ta Footnote Sulinitted Within
Name of Test &tbstance Statu$ Required Number Time Frames Listed
Yes No Below 1/
§158.120 Product Ch nistry (Continued)
Physical and Chanical Characteristics
(Continued)
63—7 — Density, Bulk Density, or
Specific Gravity
NP
R
[ TI
[ ]
63—12—pH
NP
R
[ Ti
[ ]
63-11
- Oxldizirg or ReducirE
NP
CR
[ ]
[ TI
Action
63—15
- Flammability
NP
CR
[ ]
[ Ti
63-16
- &plodabil ity
NP
R
[ X]
[ Ti
63-17
- Storage Stability
NP
R
[ J
[ Ti
63—18
— Viscosity
NP
H
[ Ti
[ J
63-19
— Miscibility
NP
H
[ TI
[ ]
63—20
— Corrosion Characteristics
NP
R
[ TJ
1]
Other
Requiranents:
— Sulinittal of s nples
NP
CR
[ TI
[ ]
61t— 1
6 T’ bnths
6 Months
6 Months
15 Months
2
2
2
11
5
41
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMEI’ZTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DIPROPETRYN (95% A.1.)
§ 158.120 Product Chanistry
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
1/ Data must be submitted within the indicated time frame, based on the date of the Guidance DDcllnent.
2/ 6 Month 1)ie Date is January 30, 1986 .
3/ 12 Month J)ie Date is July 30, 1986 .
7- / 15 Month JXie Date is October 30, 1986 .
5/ This canpound does not require the submittal of samples at the present time.
42
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMEI\YrS FDR MANUFACTURING-USE PRODUCTS COWPAINING DIPROPETRYN
tbes EPA Have Must Additional t ta
E ta ‘lb Satisfy Be Submitted Under
1/ This Require— Bibliographic FIFRA § 3(c) (2) (B)?
t ta Requlr9nent Canposition ment? (Yes, No Citation Time Frame for L .ta
or Partially) Submission 2
§158.135 Toxicology
ACtJI’E TESTING
81—i — Acute Oral Toxicity NP Yes 00070374 No
— I: .t
81—2 — Acute Dermal Toxicity NP Yes 00070375 No
— Rabbit
81—3 - Acute Inhalation Toxicity NP Yes 00070377 No
— i: t
81—Is - Primary Rye Irritation MP Yes 00034098 No
— Rabbit
81—5 - Primary Derinal Irritation NP Yes 00070375
— Rabbit
81—6 — Der nal Sensitization NP Yes 00110376 No
- Guinea Pig
§158.135 Toxicology - Continued
1.1 Ccznposition: NP = Manufacturing-use product.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Docixnent.
9 Month 1)ie Date is not applicable
43
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IV. SUBMISSION OF REVISED LABELING
Note : This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-l) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
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).
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 labeli . 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)]
44
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Item LI. 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
riot appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-l.
[ k0 CFR 1 6 2.lO(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. [ 110 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
placed In the body of other text. See Appendix IV—1. [ 110 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 1 4 point 10 point
over 30 18 point 12 point
45
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Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
“Keep Out of Reach of Children” must he located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix P 1—i.
[ Lb CFR 162.l0(h)(l)(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)]
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 l62.1O(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV—1. [ 40 CFR l62.iO(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement “See Side
(or Back) Panel for Additional Precautionary Statements” Is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV—1. [ 40 CFR 162.10(h)(1)(Iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements 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)].
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) (1)]
46
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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. [ i O CFR
162.lO(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 statements.
2. Criteria for declaration of non—flammability . The
following criteria will be used to determine if a product
Is non-flammable:
a. A “non-flammable gas” is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A “non—flammable liquid” is one having a flashpolnt
greater than 350°F (177°C).
c. A “non—flammable aerosol” is one which meets the
following criteria:
1. The flame extension is zero inches;
II. There is no flashback; and
Iii. The flashpoint of the non—volatile 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.
47
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L . 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 statement8
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 Po8ition 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 4O CFR 162.11(c). You will be notified of
the Agency’s classification decision.
A. Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement “Restricted Use Pesticide” must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table In 4O CFR 162.1O(h)(1)(Iv).
48
-------
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.
B. Compliance Schedules
No product with a use classified for restricted use
under this Standard may be released for shipment by the
registrant or producer after one year from the date of
issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
Item 9B [ There Is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement, “It is a violation of Federal law to use
this product In a manner inconsistent with Its labeling.”
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
49
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Item 1OA. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83—2, March 29, 1983.
Item lOB [ There is no Item lOB].
Item lOC. 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— 1 4 to determine the disposal instructions appropriate for
your products.
Item 1OD. DIRECTIONS FOR USE — Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV—l. [ 4O 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.
50
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing (dipropetryn)
as an active ingredient .
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the “FIFRA Section
3(c)(2)(B) Summary Sheet” EPA Form 8580—i. 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— 14.
b. Product Specific Data Report, EPA Form 8580—14
(Appendix 111—1).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short—term data, you may submit such labeling. End use
product labeling must Comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
text on 8—1/2 x 11 Inch paper or a mockup of the labeling
suitable for storage in 8—1/2 x 11 inch files. The draft
label must Indicate the intended colors of the final 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 140 CFR 152.80—152.99
(enclosed) for latest requirements,
51
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3. Within the times set forth in Table A , you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator’s exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
B. For Manufacturing Use Products containing (dipropetryn)
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 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 (dipropetryn) 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.)
52
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2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 857O— 4.
b. Product—Specific Data Report, EPA Form 8580- 14
(Appendix 111—1).
c. Two copies of any required product—specific data.
(Refer to Table C).
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8 1/2 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(1)(D), Refer to 140 CFR 152.80—152.99
(enclosed) for latest requirements.
3. Within the time frames set forth in Table A , submit all
generic data, unless you are eligible for the formulator’s
exemption.
D. For intrastate products containing (Dipropetryn)
either as the sole active ingredient or in combination
with other active ingredients
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
registration.
E. Applications and other required information should be
submitted to the following address:
Robert Taylor
Product Manager
Registration Division (TS—7670)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., S.W.
Washington, D.C. 20460
Phone No. (703) 557—1800
53
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The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-3 1 42)
Environmental Protection Agency
4O1 M St., S.W.
Washington, D.C. 20)460
54
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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’ t 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 Z (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.
ii. 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.
55
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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.
( ) 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 l23L 56, the
first study would be l23! 56—A; the second, 1231456—
B; the 26th, l23 1456—Z; and the 27th, 123 1 456—AA.
56
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the De.ta Base Supporting
Registrations Under the Dipropetryn Standard
MRID CITATION
00034098 Fink, R.J. (1973) Final Report: Draize Eye Irritation Study——Rab-
bits: Project No. 1483—116. (Unpublished study received Jun 8,
1973 under 100—522; prepared by Hazieton Laboratories, Inc.,
submitted by Ciba—Geigy Corp., Greensboro, N.C.; CDL:000560-B)
00036726 Austin, D.A.; Turner, W.E.; Richarson, C. (1972) GS—16068——Soil
Dissipation: Report No. GAAC—72092. (Unpublished study received
Dec 15, 1972 under 2F1284; submitted by Ciba—Geigy Corp.,
Greensboro, N.C.; CDL:092178—C)
00036732 Richardson, C.; Turner, W.E. (1971) Residue Report: Wheat: AG—A
No. 2235 1,11. (Unpublished study including AG—A no. 2245 1,11,
received Dec 15, 1972 under 2F128 1 4; submitted by Ciba—Geigy
Corp., Greensboro, N.C.; CDL:092178-I)
00036740 Rolla, H.M.; Lewis, D. (1971) Determination of GS—16068 in Cotton
Forage, Cottonseed, and Cottonseed Fractions by Gas Chromatogra-
phy Employing Flame Photometric Detection. Method no. AG—15 1 4
dated Apr 2, 1971. (Unpublished study received Dec 15, 1972
under 2F128 1 1; submitted by Ciba—Geigy Corp., Greensboro, N.C.;
CDL: 092178—Q)
00066708 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect
of Pesticides on Apiculture: Project No. 1499; No. 2177. An-
nual rept. (Unpublished study, including submitter suninary,
received Aug 8, 1971 under 1(11055; prepared by Univ. of Cali-
fornia——Riverside, Dept. of Ehtomology, Div. of Economic Ehto—
mology, submitted by Thompson Hayward Ch nical Co., Atlanta,
Ga.; CDL:091888—H)
00070371 Fink, R.J.; Voelker, R.W., Jr. (1971) Final Report: 19—week Dietary
Administration—-Rats: Project No. 110—145. (Unpublished study
received May 1, 1972 under 2G1186; prepared by Hazleton Labora-
tories, submitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:
090998—B)
00070372 Fink, R.J.; Voelker, R.W., Jr. (1971) Final Report: 14—week Dietary
Administration--Dogs: Project No. 110—146. (UnpublIshed study
received May 1, 1972 under 2G1186; prepared by TRW, Inc., sub-
mitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:090998—C)
57
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MRID CITATION
00070374 Fink, R. (1970) Final Report: Acute Oral——Rats: Project No. 110—
139. (Unpublished study received May 1, 1972 under 2G1186; pre-
pared by ‘NW, Inc., submitted by Ciba—Geigy Corp., Ardsley,
N.Y.; CDL:090998—E)
00070375 Fink, H. (1970) Final Report: Acute Dermal—--Rabbits: Project
No. 110—140. (Unpublished study received May 1, 1972 under
2G1186; prepared by TRW, Inc., submitted by Ciba—Geigy Corp.,
Ardsley, N.Y.; CDL:090998—F)
00070377 Hidd nen, J.W. (1971) Final Report: Acute Inhalation Exposure——
Rats: Project No. 110—147. (Unpublished study received May 1,
1972 under 2G1186; prepared by TRW, Inc., submitted by Ciba—
Geigy Corp., Ardsley, N.Y.; CDL:090998—H)
00070378 Gough, B.J.; Shellenberger, T.E. (1971) Letter sent to Joe Marrus
dated May 13, 1971: Acute toxicological evaluations of GS—16068
with bobwhite quail and mallard ducks. (Unpublished study re-
ceived May 1, 1972 under 2(11186; prepared by Gulf South Research
Institute, submitted by Ciba-Geigy Corp., Ardsley, N.Y.; CDL:
090998—I)
00070379 Heina ann, J.M. (1971) Final Report: Acute Fish Toxicity Study——
Freshwater (Static): Project No. 110—143. (Unpublished study
received May 1, 1972 under 2G1186; prepared by TRW, Inc., sub-
mitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:090998—J)
00103171 Hermes, P.; Knaak, J. (1972) The Uptake of Aged delta—1 1 4C-GS-
16068 and Metabolites in Rotation Wheat and the Degradation of
GS—16068 in Soil (Greenhouse): Report No. GAAC-72037. (Unpub-
lished study received Jun 10, 1982 under 100—631; submitted by
Ciba-Geigy Corp., Greensboro, NC; CDL:070915-H)
001103714 Ciba—Geigy Corp . (1971) Petition for a Negligible Residue Tolerance
of 0.1 ppm in Cottonseed for the Herbicide ... GS—16068. (Com-
pilation; unpublished study received Oct 13, 1972 under 2F12814;
CDL: 091820—B)
00110376 Saunders, H. (1972) Landsteiner Sensitization of GS—16068 Tech.,
99.3% GS—16068 in Guinea Pigs: Contract No. 120—1526—52. Final
rept. (Unpublished study received Jun 15, 1972 under 2F12814;
prepared by Affiliated Medical E iterprise8, Inc., submitted by
Ciba Geigy—Corp., Ardsley, NY; CDL:095916—A)
00110378 CIba-Geigy Corp. (1974) Fate of Dipropetryn In the Envirorinent——
Additional Information: Report No. GAAC-74074. (Compilation;
unpublished study received Oct 10, 1974 under 2F1284; CDL:
095930—A)
58
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OFFICE OF PESTICIDE PROGRAMS
REI3ISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the E ta Base Supporting
Registrations Under the Dipropetryn Standard
CITATION
GSO22 4—OO]. U.S. Departhient of Agriculture (1983) Agricultural Statistics
III. Oilseeds, F ts, and Oils: Cottonseed. 112—116.
GSO22 1 —OO2 Murray, D.S.; Santelmann, P.W..; Davidson, J.M. (1975) Compa-
rative Adsorption, Desorption, arid Mobility of Dipropetryn
and Pranetryn in Soil. J. Agric. Food Chem. 23: 578—582.
59
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0MB Approval No. 2000-0468 Appendix 11—3
IEPA REGISTRATION NO.
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPUCANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit eneric” data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner
0 1. I Will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, QECO
Chemicals Testing Programme, I enclose the protocols that 1 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 tmEPA by:
NAME OP OTHER REGISTRANT
03. I encloecompl.t.d ‘Cartifkatlon of Attmupttn Enter IntoenAgreemuitwith Other Registrant.torDeveiopmentof D.ta”with
respect to the following data r,qulrsmsnt.
04. I request that you emend my registration by deleting the following uses (this option is not available to applicants for new product.):
Os. I request voluntary cancellation of the registratIon of this product. (This option is not available to applicants for new products.)
60
REGISTRANTS AUTHORIZED REPRESENTATIVE SIGNATURE DATE
EPA Ponn 5880.1 (10.82)
-------
Appendix 11—4
0MB AoDrovaI No. 2000-c1468 (Expires: 12-31-83)
CERTIFICATION OF ATTEMPT TO ENTER - - -
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, ce rif’?J 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:
GUIDANCE DOCUMENT DATE
1. I am duly
ments of a
to submit d
authorized to
Notice under
ata concernin
represent the following firm(s) who are subject to the require-
FIFRA Section 3(c)(2)(B) contained in a Guidance Document
g the active ingredient:
NAME OF FIRM
ACTIVE INGREDIENT
EPA COMPANY NUMBER
3. My firm has offered in writing to inter into such an agreement. Copia, of the offers are attached. That offer wee irrevocable and included en offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(Ili) If final agreement on all terms could not be reached otherwise. This offer wee mad.
to the following firm(s) on the following data(s):
NAME OP FIRM
DATE OF OFFER
iFowever, none of those finn(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 will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2HB). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
i . .1
TYPED NAME
DATE
SIGNATURE
-------
Appendix 111—1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. _______________Guidance Document for Dipropetryn
Date
I —
Registration
Guideline No. Name of Test
Testnot
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use Odly)
Accession Numbers
Assigned
Citing MRI1
Submit—
tin,g
Data
(At—
tached)
§ 158.20
PRODUCT
CHEMISTRY
61—1
Identity of
ingredients
61—2
Statement of
composition
61—3
Discussion of
formation of
ingredients
62—1
Preliminary
analysis
62—2
Certification of
limits
62—3
Analytical methods
for enforcement
1 units
63—2
Color
63—3
Physical state
63— 4
Odor
63-5
Melting point
63—6
Boiling point
63—7
Density, bulk—
density, or
specific_gravity
63—8
Solubi lity
63-9
Vapor pressure
6 3—10
Dissociation
constant
6 3—11
Octanol/water
partition
coefficient
63—12
pH
62
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Appendix 111—1 (continued)
I
Registration
Guideline No. Name of Test
¶t st not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
(For EPA Use ly)
Accession Numbers
Assigned
Citing MRID#
SuL nit-
ting
t ta
(At-
tached)
63—13
Stability
63—14
Oxidizing/reducing
reaction
63—15
Flamnability
63—16
Explodability
63—17
Storage stability
63—18
Viscosity
63—19
Miscibility
6 3—20
Corrosion
characteristics
63—21
Dielectric break-
down voltage
l58.135
¶L XIC0LOGY
81—1
Acute oral LD—50,
rat
81—2
Acute dermal
LD-50
81—3
Acute Inhalation,
LC—50_rat
81-4
PrImary eye
Irritation, rabbit
81-5
PrImary dermal
irritation
81—6
Dermal sensitiza-
tion
63
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Chapter 1——Environmental Protection Agency
§162.10 Labeling requirements.
(a) General--(l) Contents of the label . Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(1) The name, brand, or trademark under which the product Is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(Iii) The net contents as prescribed In paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
Ce) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(lx) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility . (i) All words, statements,
graphic representations, designs or other Information required 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, state-
ments,, 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 customary conditions of purchase
and use.
(ii) 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 applied equally to both the English and
other-language versions of the labeling.
(Li) Placement of Label—-(I) General . The label shall appear
on or be aecureI attached to the Immediate container of the
64
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pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, “Securely attached” shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable Conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk contalners——(A) Transportation .
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170—189, concerning the transportation
of hLzardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, 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 products 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 discharge control
valve.
(5) False or misleading statements . Pursuant to section
2(q)(1)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling Is
false or misleading In any particular including both pesticida ].
and non—pesticidal 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;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device Is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredIen 5 if the name suggests one or more but
not all such principal active ingredients even though the names
of the other Ingredien are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading Impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
65
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as “safe,” “nonpoisonous,” “noninjurious,”
“harmless” or “nontoxic to humans and pets” with or without such
a qualifying phrase as “when used as directed”; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) “Contains all natural ingredients”;
(B) “Among the least toxic chemicals known”
(C) “Pollution approved”
(6) Final printed labeling . (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally 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 microfilm reproduction quality.
(b) Name, brand, or trademark . (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § l62.6(b)C 4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant’s name appears 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 ***,“ “Distributed by
or “Sold by to show that the name Is not that of the
producer.
(d) Net weight or measure of contents . (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(14) In all cases, net content shall be stated In terms of the
largest suitable units, i.e., “1 pound 10 ounces” rather than
“26 ounces.”
66
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(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average i
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number . The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase “EPA Registration
No.,” or the phrase “EPA Reg. No.” The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which It appears and shall run parallel to
It. The registration number and the required identifying phrase
shall not appear in such a manner as to Suggest or Imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number . The producing
establishment registration number preceded by the phrase “EPA
Est.”, of the final establishment at which the product was produced
may appear in any Suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement——(1) General . The label of each
pesticide product must be a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water—soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term “active
ingredients” and the inert ingredients by the term “inert
ingredients,” or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement “Inert Ingredients,
none” is not required for pesticides which contain 100 percent
active ingredients. Unless the Ingredient statement is a complete
analysis of the pesticide, the term “analysis” shall not be used
as a heading for the ingredient statement.
(2) Po jt1onof 1ngredien statement. (I) The Ingredient
statement Is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes It impracticable to place
the Ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which It appears, and must be
clearly distinguishable from and must not be placed In the body
of other text.
67
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(3) Names to be used in ingredient statement . The name used
for each ingredient shall be the accepted common name, if there
is one, followed 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 proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(Li) Statements of percentag . The percentages of ingredients
shall be stated in terms of weight_to_Weight. The sum of per-
centages 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 ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages . The percentages given
shall be as precise as possible reflecting good manufactUring
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) DeterioratiOn . Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(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 U to the expiration
time indicated on the label.
(7) Inert ingredients . The Administrator may require the name
of any inert ingredient(s ) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements . Required warnings
and precautionary statements concerning the general areas of
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 requirements ncerning content,
placement, type size, and prominence are given below.
(1) Required front panel statemer’t . With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
68
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Hazard Indicators I Toxicity categories
I I II ill [ iv
Oral LP 50 Up to and From 50 thru From 500 thru Greater than
Including 500 mg/kg 5000 mg/kg 5000 mg/kg
I 50mg/kg
Inhalation LC 50 Up to and From .2 thru From 2 thru Greater than
I including 2 mg/liter 20 mg/liter 20 mg/liter
I .2 mg/liter I
I I
Dermel LD 50 Up to and From 200 From 2,000 thru Greater than
including thru 2000 20,000 20,000
200 mg/kg
I
I
I
I
1
I
Eye effects
I
I
Corrosive; Cornea? opacity No cornea? opacity; No irritation
cornea? opacity I reversible irritation
not reversible within 7 days; reversible
within 7 days irritation wIthin 7 days
persisting for
I 7days
Skin effects
I
Corrosive
Severe irritation
at 72 hours
I
I
Moderate Irritation
at 72 hours
I
Mild or slight
irritation at
72hours
I
I
I
(i) Human hazard signal word.——(A) Toxicity Category I . All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word “Danger.” In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word “Poison” shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word “poison.”
(B) Toxicity Category II . All pesticide products meeting the
criteria of Toxicity Cate ry II shall bear on the front panel
the signal word “Warning.”
(C) Toxicily Category III . All pesticide products meeting the
criteria of Toxicity Category III shall bear on the front panel
the signal word “Caution.”
(D) Toxicity Category IV . All pesticide products meeting the
criteria of Toxicity Category IV shall bear on the front panel
the signal word “Caution.”
69
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(E) Use of sig na1 words . Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning . Every pesticide product label shall
bear on the front panel the statement “keep out of reach of
children.” Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment——(A) Toxicity
Category I . A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as “See statement of
practical treatment on back panel” appears on the front panel
near the word “Poison” and the skull and crossbones.
(B) Other toxicity categories . The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iil)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required 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 required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Points
Required
signal word,
all capitals
“Keep out
of reach of
Children”
5andunder. . . . . .
Above 5 to 10 . . . . . . . . . .
Abovel0tol5 •1S•S•••
Abovel5to3O .... .. .. ..
Over 30 . . . . . . . . . . . . .
6
10
12
14
18
6
6
8
10
12
70
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification . By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(i) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall he separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, If a product has both 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
provisions of § 162.1O(j)(2).
(1) General Use Classification . Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words “General Classification” immediately below the
heading “Directions for Use.” And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement 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 classification on the front panel as described
below:
(i) Front panel statement of restricted 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.lO(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement “Restricted Use
Pesticide” shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction Imposed as a precondition
to registration shall appear. If use Is restricted to certified
applicators, the following statement is required: “For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator’s certification.” If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation.
(k) Advertising. [ Reserved]
[ 4O FR 28268, July 3, 1975; O FR 32329, Aug. 1, 1975; 4O FR
38571, Aug. 21, 1975, as amended at 143 FR 5786, Feb. 9, 1978]
71
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(2) Other required warnings and precautionary statements . The
warnings and precautionary statements as required below shall appear
together on the label under the general heading “Precautionary
Statements” and under appropriate subheadings of “Hazard to Humans
and Domestic Animals,” “Environmental Hazard” and “Physical or
Chemical Hazard.”
(i) Hazard to humans and domestic animals . (A) 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. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
J
Toxicity
category
Precautionary statements by toxicity category
I
I
[ Oral, inhalation, or dermal toxicity
Skin and eye local effects
I
I . . . Fatal (poisonous) if swallowed [ inhaled or
absorbed through skin?. Do not breathe
vapor [ dust? or spray mist?. Do not get
in eyes, on skin, or on clothing [ Front
panel statement of practical treatment
required.?.
Corrosive, causes aye and skin damage [ or
skin irritation?. Do not get in eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal if swallowed.
[ Appropriate first aid statement required.?
II . . . May be fatal if swallowed [ inhaled or
absorbed through the skin?. Do not breathe
vapors [ dust or spray misti. Do not get in
eyes, on skin, or on clothing. IAppropriate
first aid statements required.?.
Causes eye land skin? irritation. Do not
get in eyes, on skin, or on clothing.
Harmful if swallowed. [ Appropriate first
aid statement required.?.
II I . . .
Harmful if swallowed linhaled or absorbed
through the skin?. Avoid breathing vapors
[ dust or spray mist?. Avoid contact with
skin [ eyes or clothing?. [ Appropriate
first aid statement required.?.
Avoid contact with skin, eyes or clothing.
In case of contact iemediately flush
eyes or skin with plenty of water. Get
medical attention if irritation persists.
1V . . .
[ No precautionary statements required.?. I [ No precautionary statements required.?.
— I
(ii) Environmental hazards . 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
72
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD 50 of 100 or less, the
statement “This Pesticide is Toxic to Wildlife” is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC 50 of 1 ppm or less, the statement
“This Pesticide is Toxic to Fish” is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD 50 of 100 mg/kg or less, or
a subacute dietary LC 50 of 500 ppm or less, the statement “This
Pesticide is Toxic to Wildlife” is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement “This pesticide is extremely toxic to
wildlife (fish)” is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution “Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes.”
(iii) Physical or chemical hazards . Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
I I
Flash point Required text
(A) PRESSURIZED CONTAINERS
I
Flash point at or below 20°F; If there is a
flashback at any valve opening.
I
Flash point above 20°F and not over 80°F or If
the flame extension Is more than 18 In. long
at a distance of 6 in. from the flame.
All other pressurized containers . . . . . . . .
I
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.
J Flammable. Contents under pressure. Keep away
J from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure tol
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 tempera—
tures above 130°F may cause bursting. I
(B) NONPRESSURIZED CONTAINERS
At or below 20°F . . . . . . . . . . . . . . . .
Above 20°F and not over 80°F . . . . . . . . . .
Above 80°F and not over 150°F . . . . . . . . .
Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
73
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(i) Directions for Use——(1) General requirements——Cl) Adequacy
and clarity of directions . Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to 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.
(11) Placement of directions for use . Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as “See directions In
the enclosed circular.” and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use——(A )
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products In their regular manu-
facturing processes, provided that:
(1) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, Is available to the trade specifying the type of
product Involved and its proper use in manufacturing processes;
(3) The product will not come into the hands of the general
public except after incorporation into finished products; and
( ) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(1) The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
74
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(2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
c)4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use . The directions for use
shall include the following, under the headings “Directions for
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading “Directions for Use.”
(ii) Immediately below the statement of use classification,
the statement “It is a violation of Federal law to use this
product in a manner inconsistent 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, including Instructions for
dilution, if required, and type(s) of applic&tion apparatus or
equipment requrled.
(vii) The frequency and timing of applications 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 110 CFR Part 170.
(Ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
110 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 warning (See Table in 162.1O(h)(1)(jv),)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application 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]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically 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
applicator who is physically present.
75
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification . By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(1) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both 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
provisions of § 162.1O(j)(2).
(1) General Use Classification . Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words “General Classification” immediately below the
heading “Directions for Use.” And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement 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 classification on the front panel as described
below:
(1) Front panel statement of restricted 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.lO(h)(l)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement “Restricted Use
Pesticide” shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: “For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator’s certification.” If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation.
(k) Advertising. [ Reserved]
[ L O FR 28268, July 3, 1975; 4O FR 32329, Aug. 1, 1975; IO FR
38571, Aug. 21, 1975, as amended at 143 FR 5786, Feb. 9, 1978]
76
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APPENDIX IV-2
LABELING REQUIRE7V1EWI OF THE FIFRA, AS AMENDED
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIREMENT
PLACEMENT ON LABEL
COMMENTS
REQUIRED
PREFERRED
1
Product name
All products
Front panel
Center front
panel
2
Cc*npany name
and address
All products
None
Bottan 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
Bottcm 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
None
Front panel,
l irinediately
before or
following
Reg._No.
May appear on the container instead of
the label.
6A
Ingredients
statement
All products
Front panel
Iiiinediately
following
product_name
Text must run parallel with other text
on the panel.
6B
Pounds/gallon
statement
Liquid products
where dosage
given as lbs.
al/unit area
Front panel
Directly below
the main
Ingredients
statement
7
Front panel
precautionary
statements
All products
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
Keep (lit of Reach
of’ Children
(Child hazard
warnthg)
All products
Front panel
Above signal
word
Note type size requirements.
7B
Signal word
All products
Front panel
Iriinediately Note type size requirements.
below child
hazard
warning
1!
-------
APPENDIX IV-2 (continued)
ITEM
LABEL ELEMENT
APPLICABILITY
OF REQUIRE €NT
PLACEMENT ON LABEL
COMME ’TPS
REQUIRED
PREFERRED
TC
Skull & cross—
bones and word
POISON (In red)
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
Front panel
Both in close
proximity to
signal word
7D
Statement of
practical
treathent
All products
in Categories
I, II, and III
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
for all.
7E
Referral
statement
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
Front panel
8
Side/back panel
precautionary
statements
All products
None
Top or side
of back panel
preceding
directions
for_use
Must be grouped under the headings in
8A, 83, and 8C; preferably blocked.
8A
Hazards to
h inans and
dcinestic
animals
All products
in Categories
I, II, and III
None
Same as above
Must be preceded by appropriate signal
word.
8B
F virorinental
hazards
All products
None
Same as above
ivirorrnental hazards include bee
caution where applicable.
78
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APPENDIX IV-2 (continued)
ITE 4
- LABEL ELE 4E??T
APPLICABILITY
OF 1JtR Et fP RFJ UIRED PBEP RRED COWEW2S
None Same as above
BC
Thysicel or
chemical
hazards
-
All pressurized
products, others
with flash
points under
150°F
center
Preferably
Includes a statement of the terms Ôf
9A
Restricted
block
All restricted
products
¶Ibp
of front
panel
Ijyinediately
blocked
restriction. The ‘ rds “F FSThICTED USE
PESTICIDE” must be same type size as
signal_word.
9C
Misuse
8tatement
All products
.
following
heading of”
directions
for use
In the
) mnediatelY
1OA
Reentry
statement
AU
choUnesterase
inhibitors -
directions
for use
In the
after misuse
statement
] miediately
tist be set apart and clearly distin-
lOC
Storage and
disposal block
All products
directions
for use
None
before
specific
directions
for use or
at the end of
directions
for use
None
guishable fran fran other directions
for use.
W r be in metric as l1 as U.S. units
1OD
Directions
for use
All products
79
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Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non—Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
80
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Appendix IV- 1 4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not Include the heading
“STORAGE AND DISPOSAL.” The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Required type size
Size of label for the heading
front panel In STORAGE AND DISPOSAL
square Inches (all capitals)
10 and under . . . . . . . . . . . . . . .6 point
Above 10 to 15 . . . . . . . . . . . . . .8 point
Above 15 to 30 . . . . . . . . . . . . . 10 point
Over 30 . . . . . . . . . . . . . . . . . 12 p o In t
Storage and disposal Instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions :
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and Its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
Including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
81
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Appendix IV—4
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide Is leaking or has been
spilled, and precautions to minimize exposure if damage occurs.
5. ( eneral precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement In
locked storage areas.
B. Pesticide Disposal Instructions :
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, ‘To not contaminate water, food,
or feed by storage or disposal.”
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the “Acutely Hazardous” Commercial Pesticide
Products List (RCRA “E” List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute Inhala-
tion toxicity must bear the following pesticide disposal
statement:
“Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance.”
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the “Toxic” Commercial Pesticide Products
List (RCRA “F” List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
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Appendix IV- 1 4
(continued)
“Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance.”
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
“Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility.”
3. Products intended for domestic use only must bear the
following disposal statement: “Securely wrap original
container in several layers of newspaper and discard in
trash •“
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, Jars)
Do not reuse container (bottle, can, Jar).
Rinse thoroughly before discarding In trash.
Non-aerosol products
(bags)
Do not reuse bag. Discard bag in trash.
Aerosol products
Replace cap and discard containers in
trash. Do not incinerate or puncture.
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Appendix IV— 1 4
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
!/ Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
Metal
containers
(non—aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, If allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused!, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
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Appendix IV- 2 1
(continued)
Pesticides that are hazardous wastes under 140 CFR 261.33(e) and (f)
when discarded.
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients, (no inerts) :
Acrolein
Aidicarb
Aid r in
Allyl alcohol
Aluminum phosphide
Lt —Aminopyrid me
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbr’ n disulfide
p-Ohio roanil me
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-14 , 6-dinitrophenol
Die 1 d r in
0,0-Diethyl S— [ 2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0—pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
1 4,6—Dinitro—o—cresol and salts
14, 6-Dinitro-o—cyclohexylphenol
2,14 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
F am phu r
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Met horny 1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
85
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Appendix IV- 1
(continued)
“ Acutely Hazardous” Commercial Pesticides (RCRA “E” List)
Active Ingredients continued :
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
O,O,C,O—Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
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Appendix IV-L
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Acetone
Acrylonitrile
Am i t role
Benzene
Bis (2—ethyihexyl )pthalate
Cacodylic acid
Carbon tetrachioride
Chioral (hydrate)
Chiordane (technical)
Chlorobenzene
—Chloro—m—cresol
Oh 10 ro form
o—Chlorophenol
Lt Ch1oro o to1uidine hydrochloride
C reosote
Cresylic acid
Cyclohexane
(kepone, chiordecone)
l,2—Dibromo—3—chloropropane (DBCP)
Dibutyl phthalate
S—3,3-(Dichloroallyl dilsopropyithiocarbamate (diallate, Avadex)
o—Dlch lorobenzene
p—Dich lorobenzene
Dichiorodifluoromethane (Freon 12 )
3,5—Dlchloro—N—(l,1—dlrnethyl—2--propyny l) benzamlde (pronamide,Kerb)
Dichioro diphenyl dichioroethane (DDD)
Dichioro diphenyl trichioroethane (DDT)
Dichiorethyl ether
2, 1 —Dich1orophenoxyacetjc, esters and salts (2,L _D)
1, 2—flichioropropane
1 ,3—Dichioropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 14,14’ —dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichioride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachiorocyclopentadlene
Hexachloroethane
Hydrofluoric acid
87
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Appendix IV— 1 4
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Active Ingredients :
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2’—Methylenebis (3,14,6-trichlorophenol) (hexachiorophene)
Methylene chloride
Methyl ethyl ketone
)4—Methyl—2—pefltaflOfle (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p—Nitrophenol
Pentachioroethane
PentachloronitrobeflZefle (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0—diethyl, methyl ester
Propylene dichioride
Pyridine
Resorcinol
Saf role
Selehium disulfide
Silvex
1,2, 14,5—TetrachlorobeflZefle
1,1, 2, 2—Tetrachioroethafle
Tetrachioroethylene
2,3, 4, 6—Tetrachiorophenol
Thiram
Toluene
1,1 , 1—Trichioroethane
Trichioroethylefle
Trichloromonofluoromethane (Freon il®)
2,4, 5—Trichloropheflol
2 ,14 , 6—Trichiorophenol
2,14,5—TrichiorophefloXyacetiC acid (2,LI,5—T)
Xylene
88
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Appendix IV-L
(continued)
“ Toxic” Commercial Pesticide Products (RCRA “F” List)
Inert Ingredients :
Acetone Formaldehyde
Acetonitrile Formic acid
Acetophenone Isobutyl alcohol
Acrylic acid Meleic anhydride
Aniline Methyl alcohol (methanol)
Benzene Methyl ethyl ketone
Ch].orobenzene Methyl methacrylate
Chloroform Naphthalene
Cyclohexane Saccharin and salts
Cyclohexanone Thiourea
Dichiorodifluoromethane (Freon 12 ) Toluene
Diethyl phthalate 1,1, l—Trichloroethane
Dimethylamlne 1,1, 2—Trichioroethane
Dimethyl phthalate Trichiorofluoromethane (Freon li®)
l, 1 —Dioxane Vinyl chloride
Ethylene oxide Xylene
89
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