GUIDANCE FOR THE
REREGISTRATION OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE PFSDDUCTS
CONTAINING
CYANAZINE
(100101)
CASE NUMBER 066
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
I$SHINGTON, D. C. 20460
December 1984
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TABLE OF CONTENTS
.Introduction ................. ..... 1
,1. Regulatory Position and Rationale ............ L
,1,1. Requirement for Submission of Generic Data ....... -7
,111. Requirement for Submission of Product-Specific
Data .......................... 2C
.IV. Submission of Revised Labeling and Packaging
.Information ....................... 6C
A. Label Contents ................... 60
1. Product Name .................. ^
2. Company Name and Address . ........... 60
:! 3« Net Contents .................. 60
fc.. Product Registration Number ........... 6C
5." Producing 'Establishment
.Registration Number ............... ^~
6 '.Ingredient Statement .............. (:-
6 Pounds Per Gallon Statement ........... ^-.
7. Front Panel Precautionary Statements ...... *p
7A Child Hazard Warning Statements ......... fj
7B Signal Word ................... £:
7C Skull and Crossbones and Word Poison ...... ^1
7D Statement of Practical Treatment ........ ~*
TE Referral Statement ............... 62
8. Side/Back Panel Precautionary Labeling ..... 62
8A Hazard to Humans and Domestic Animals. ..... 62
SB 'Environmental Hazard ......... ..... 62
8C Physical or Cher.ical Hazard ........... 62
9 ............ ;?
IDA Storage and Disposal Block ........... 6:
10B Directions for Use ............... 65
B. Collateral .Information ............... 65
V. .Instructions for Submission ............... 66
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APPENDICES
,11-1 Guide to Bibliography ................................. e*7
,11-2 Bibliography ................. - ..... ^0
,11-3 FJFRA §3(c)(2)(B) Summary Sheet -'EPA Form 8580-1 . . . ??
,11-J) Certification of Attempt to 'Enter .Into an Agreement
with Other Registrants for Development of Data
'EPA Form 8580-2 .............. ....... SO
,1.11-1 Product Specific Data Report ('End-Use Products). . . ^
JV-1 HO CFR 162.10 Labeling Requirements ......... e?
.IV-2 Table of Labeling Requirements ........... s-
,IV-3 Physical/Chemical Hazards Labeling Statement .
. . .
Storage and Disposal -Instructions ^6
11
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide. Act
(FIFRA sec. 3(g), as amended in 1978, directs EPA to reregister
all pesticides as expeditiously as possible. Each registrant
of a manufacturing use product of the active ingredient who
wishes to continue to sell or distribute that product must
apply for reregistration.
To carry out this task, we have established the Regis-
tration Standards program, which will review all pesticide
active ingredients first registered before January 1, 1977.
These pesticides will be reviewed in use clusters which are
prioritized on the basis of a ranking scheme giving preference
to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential 6ut missing
~tudi.es ^h'ich -nay not have been required when the product
was initially registered or studies that are now considered
insufficient, pur reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. Based on the regulatory position,
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 poses no potential
adverse effects to human health or 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 formulated (end use) products that contain
the active ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the public.
EPA has the authority under FIFRA $3(c)(2)(B) to require
that registrants submit data that will answer our questions
regarding the hazard that may result from the intended use
of the pesticide under review. Further, $3(c)(2)(B) provides
that these data are to be submitted by those registrants
who do not qualify for the formulator's exemption [PIFRA
§3(c)(2)(D)). Normally, this means that the registrants who
are responsible for filling the data gaps are the manufacturing
use product producers (basic suppliers of the active ingredient).
However, end use producers will not qualify for the formulator's
exemption if the source of their active ingredient: (1) is
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not registered with EPA, and/or (2) is produced by the regis-
trant's firm, or a firm which has ownership in common with
the registrant's firm. These end use producers can qualify
for the formulator's exemption if they change their-source of
supply to a registered source, provided the source does not
share ownership in common with the registrant's firm. If the
end use product registrant decides to switch sources, a new
Confidential Statement of Formula, EPA Form 8570-4, must be
submitted to the appropriate Product Manager within 90 days
of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the reregistration
requirements of this Guidance Document, please notify the Product
Manager named in the cover letter, within 90 days from the
receipt of this document, that you wish to voluntarily cancel
the registrat ion(s). If you decide to maintain your product
registrations), 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 if you fail to comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you at
any time to submit factual information raising concerns of
possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACIION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's 'Exemption
A. Single Active Ingredient
Products1
These products must be reregis-
tered. To obtain reregistratlon,
labeling, packaging and data
requirements must be satisfied
In accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active -Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described In the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
,11. 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 e variety
of ways, including burner
limited to the Label .Improvement
Program and special Intent
to cancel notices.
* 'End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in ".II"
above. ,If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fall to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
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.1. Regulatory Position and Rationale
A. .Introduction
This Chapter describes the regulatory position of the 'Environmental Protection
Agency, (the Agency), on all manufacturing-use products (MPs) containing
the herbicide cyanazlne as the sole active ingredient. The Agency's position
is based on an evaluation of all registered uses and products containing
cyanazine. This document also considers labeling requirements, tolerances,
"Special Local Needs" (registrations authorized by Section 2Mc) of the
Federal .Insecticide, Fungicide and Rodentlcide Act (FIFRA)), as well as
Federal registrations granted or pending under Section 3 of the FIFRA. .In
addition, this document sets forth the data requirements that must be met to
register MPs covered by this Standard.
•In developing its regulatory position, the Agency determines whether available
data indicate that a pesticide has met or exceeded the risk criteria found in
SectionVi62.11(a) of Title HO of the U.S. Code of Federal Regulations (CFR).
Pesticides meeting these criteria are candidates for a Special Review, an
Intensive risk/benefit analysis which is a modification of the Rebuttable
Presumption Against Registration (RPAR^) process. The Agency's determination
as to whether the criteria have been met or exceeded and the rationale for
any regulatory action are summarized in the regulatory position of this
Standard.
This document addresses registration requirements for MPs containing cyanazine
and their Intermediaries. Cyanazine MPs that differ appreciably from
those described here may require amendments to the Standard. .Issues involving
specific end-use products will not be addressed under this Standard, but
general labeling requirements for formulated products will be discussed in
Section G.
B. Use Profile
.Cyanazine is a pre- or postemergent herbicide registered for use to control
annual grasses and broadleaf weeds In corn, cotton, grain sorghum, winter
wheat, and fallow crop land. Approximately 96% of the total domestic use
is on corn. Cotton (3%) and grain sorghum (<1%) are the second and third
most common uses. Application rates of the single active ingredient range
from 0.6 to 5 Ibs active ingredient per acre. Single active ingredient
formulations Include an 80% wettable powder, 10? and 151 granular forms, a
90% dry flowable form, and a H Ib/gal flowable concentrate. These
formulations may be applied with either ground or aerial equipment. To
activate the herbicide, one and one-half to two inches of moisture
(rainfall or irrigation) are required within 10 days of application. .If
such moisture is not available within the 10-day period, a shallow
incorporation is recommended on labels, with the specific type of equipment
and method of Incorporation determined by site and equipment availability.
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When applied preemergence, cyanazine is applied before, at, or after planting
but before the crop emerges from the soil. If applied postemergence to the
crop and/or at lavbv (the last time machinery can enter the field as is the
case with cotton), crop height restrictions must appear on the labels. The
target weeds will not be controlled if they exceed 1.5 inches in heiaht at
the time of application.
Cyanazine may be formulated for use with fertilizers and/or other herbicides
such as atrazine, butvlate, alachlor, EPTC, metolachlor or dicamba for use
in corn, with norflurazon, MSMA, or dinoseb in cotton, with propachlor or
propazine in grain sorghum, and with atrazine, paraquat, or 2,4-D on wheat
fallow cropland.
C. Background and Description of the Chemical
Cyanazine is the cannon name for the herbicide 2-[f4-Chloro-6-(ethylamino)-
^-triazin-2-yl]amino]-2-methylpropionitrile. The Chemical Abstracts Service
(CAS) number is 21725-46-2 and the EPA chemical code number (also known as
the Shaughnessy number) is 100101. The trade name for cyanazine is BLADEX®,
and the chemical has also been known as SD-15418, Payze, and 2-chloro-4-
[(l-cyano-l-fflethylethyl)amino]-6-(ethylaTnino)-s-triazine. Cyanazine was
first registered in 1971 by the Shell Chemical Company.
Technical cyanazine is a white, crystalline substance with a mild chemical
odor and a melting point of 166.5-167°C. At 23°C cyanazine is soluble in
water up to 160 ppm. At 20°C the w/v solubility is 1.5% in benzene, <10%
in xylene and chlorobenzene, 21.0% in chloroform and methylcyclohexanone,
and 4.5% in ethanol. Cvanazine is stable in sunlight, at temperatures up
to 75° C, and in water in neutral, slightly acidic or sliohtlv basic media.
The other manufacturing use product, a 28.2% flowable intermediate (FT) is
a liquid, but other reouired information has not yet been submitted.
The vapor pressure of cyanazine is 1.6 x 10~9 at 20°C. The molecular formula
is CgHjjClNg. The shelf life of formlated BLADKX® is greater than two years.
Cvanazine. is readily absorbed by roots or foliage, and can be translocated from
the roots' to the leaves. Its mode of action is the inhibition of photosynthesis.
D. Regulatory Position and Rationale
Based on a review and evaluation of all available data and other relevant
information on cyanazine, the Agency has made the following determinations:
1. Cyanazine has been placed into the Agency's Special Review process for / ^
analysis of the risks and benefits of its continued use. The positions L-
stated in this section may be altered when the Special Review process is
ccrnpleted. Section I of this Standard gives the Agency's preliminary
analysis of risks and benefits of continued cyanazine use.
Rationale: The risk criterion listed in 40 CFR Section 162.11 has been
exceeded, because studies have shown that cvanazine produces teratogenic
effects in the Fischer 344 rat and fetotoxic effects in the New Zealand
White Rabbit. An adequate margin of safety may not exist for applicators.
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2. While the data qaps are being filled and the Special Review process is
being completed, currently registered manufacturing-use products containing
cyanazine as the sole active ingredient may be sold, distributed, formulated
and used in the United States, subject to the terms and conditions specified
in this Standard.
Rationale: The evidence now before the Agency does not indicate that the
continued use of cyanazine will pose an imminent hazard. Thus, there is no
basis, at this time, for suspension of cyanazine. In addition, if the ,,
restricted use classification and precautionary labeling requirements are ^
implemented, it is the Agency's judgment that continued use of cvanazine will
not cause unreasonable adverse effects on the environment while the Special
Review is being completed.
Several data gaps exist. However, it is not the policy of the Agency to
cancel or withhold registrations solely because of data qaps. (See Sections
3(c)(2)(b) and 3(c)(7) of FIFRA.) The Aqency will reconsider whether initiation
of suspension or cancellation proceedings is necessary when the Special Review
process is completed, and when the data qaps are filled in response to this
Standard and .the accompanyinq FIFRA 3(c)(2)(b) letters.
3. Data on the potential for secondary exposure will not be required unless the
Special Review conclusions (when completed) show that such concern is warranted.
Rationale: Some potential for secondary exposure exists (i.e. exposure of
farm worker's families through contact with their skin or clothes). This
raises concerns because of cyanazine's apparent potential for causing
teratogenic effects. However, because the Agency is not certain of the
magnitude of the teratogenic risk of cyanazine when exposure occurs through
the dermal route, any regulatory action regarding secondary exposures will be
deferred until completion of the Special Review.
4. Registrants must provide or agree to develop the additional data specified
in Tables A and B of this guidance document, in order to maintain existing
..registrations or to permit new reqistrations of substantially similar
cyanazine MPs.
Rationale: The Agency's data base on cyanazine is not complete. The Aqency
requires the data specified in Tables A and B to complete its analysis of
the risks and benefits associated with continued registration of cvanazine
products.
5. Cvanazine end-use products will be placed in the Restricted rise classification.
Rationale: Cyanazine has been detected in qroundwater and surface waters.
Placinq cyanazine in the Restricted Use classification will insure that it
will only be applied under the supervision of individuals who have received
instruction on following label directions and precautions.
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6. The Agency will require qroundwater and surface water monitoring data from
all registrants. The specific data needs will be spelled out in-a format
which will cover all the triazine compounds (atrazine, simazine, etc). The
first stage reouirement will be specific use data (counties, crops, amounts),
and data on the hydrogeological and cliinatic characteristics for each
location where cyanazine is used. Data which the Agency reouires to assess
cyanazine's leaching potential will be required on an accelerated basis.
Rationale: Cyanazine has been found in groundwater and surface water. Data
requirements will be identical for all the triazine compounds because the
triazine compounds follow similar degradative pathways in soil, and some of the
intermediate breakdown products are identical. Leaching data will be reouired
on an accelerated basis because of proven ability of cyanazine to move into
groundwater, and its apparent potential for producing teratogenic effects.
7. The Agency will require registrants to place certain precautionary statements
on the labels of manufacturinq-use and end-use products containing cyanazine.
The specific language of these statements is given in Section G of this Standard.
Rationale: Because of the teratogenic potential and toxicological prooerties
of cyanazine, .certain precautionary statements are required on labels as a
-, means of minimizing the exposure of humans and non-target wildlife.
8. Existing crop tolerances for cyanazine will be recalculated. The new tolerances
will be based on the combined residue of the parent cyanazine compound and
all metabolites that contain the triazine moiety. Tolerances for meat, milk,
eggs, and poultry may have to be established, if residues are found in these
commodities. If these meat/miIk/eqg/poultry tolerances are established,
they will also include the triazine moiety metabolites. The Aaency will
require data sufficient to allow these recalculations, and new tolerances
will not be granted until the data are reviewed.
Rationale: Metabolites containinq the triazine metabolites may contribute
to or be responsible for some of the toxicoloqical properties of cyanazine.
Therefore; they must be included in the tolerances.
9. Reentry intervals will not be reouired.
Rationale: The Agency has determined, based on the use patterns and available
toxicology data, that the criteria in (S158.140 have not been met. The
characteristics of the method of application (e.g., soil incorporation and/or
drenching, and application at very early plant life stage) will minimize
exposure of workers who enter the fields after application.
E. Criteria for Registration Under This Standard
To be covered by this Standard, products must:
o be a manufacturing use product containing cyanazine as the sole
active inqredient, and
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o bear required labeling and conform to the product composition,
acute toxicitv limits, and use pattern requirements l-isted in
Sections F and G of this document.
The apolicant for registration or rereaistration of products subiect to
this Standard must comply with all terms and conditions described in it.
This includes making a commitment to fill data gaps on a schedule specified
bv the Agency. Applicants for registration under this Standard must follow
the instructions contained in this guidance package and complete and submit
the appropriate forms within the time specified.
F. Acceptable Ranges and Limits
1. Product Composition Standard
Technical grade products must contain at least 94 percent cyanazine as the
sole active ingredient. Each manufacturing-use product formulation
proposed for registration must be fully described with an appropriate
certification of limits. In addition, the active ingredient found in the
manufacturingruse cyanazine products must be substantially similar to that
in currently registered technical products. Any manufacturing-use product
not meeting these requirements will be considered a new product and will
•' not be registered under this Standard.
2. Acute Toxicitv Limits
The Agency will consider registration of technical grade and manufacturing-use
products containinq cvanazine when the appropriate acute toxicitv categories
are no higher than Category II. The labelina of any reqistered products must
bear the appropriate precautionary statements.
3. Use Patterns
To be reqistered under this Standard, manufacturing-use products containinq
cyanazine.must be labeled for formulation into end-use products that are to be
used for the control of grassy weeds or broadleaf weeds in corn, qrain sorghum,
fallow land, winter wheat, or cotton.
G. Required Labeling
All technical grade and manufacturing-use products containinq cyanazine must
bear appropriate labeling as specified in 40 CFR 162.10. Other portions of
the guidance package contain specific information reqardinq label requirements.
In addition, the following specific labeling requirements apply:
1. Use Pattern Statements
Labels of all manufacturing-use products must bear the statement:
"For formulation into end-use herbicide products intended only for use on corn,
grain sorghum, fallow land, winter wheat, or cotton."
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Labels of all formulated products must bear the following statements:
"RESTRICTED USE PESTICIDE: Because cyanazine can leach into groundwater, and
has produced birth defects in laboratory animals, this product may be applied
only by certified applicators or persons under their direct supervision."; and
"Cyanazine is a pesticide which can move (seep or leach) through soil and can
enter groundwater which may be used as drinking water. Cyanazine has been
found in qroundwater as a result of agricultural use. Users are advised not
to apply cyanazine where the water table (ground water) is close to the
surface and where the soils are very permeable, i.e. well drained soils
such as loamy sands. Your local agricultural agencies can provide further
information on the type of soil in your area and the location of ground water."
2. Precautionary Statements
Labels of manufacturing-use products and end^use products (EUPs) must bear
the statements:
a. Hazards to Humans Statements
\ "WARNING: May be fatal if swallowed. Harmful if inhaled or absorbed
through the skin. Causes substantial but temporary eye iniury.
Avoid breathing dust (vapor or spray mist). Avoid contact with skin,
eves or clothing. Do not get in eyes or on clothing. Wear a face
shield. Wash thoroughly with soap and water after handling and before
eating or smoking. Remove contaminated clothing and wash before
reuse.": and
"Use of this product may be hazardous to your family's health. This
product has been determined to cause birth defects in laboratory animals.
Exposure of women of child-bearing age to cyanazine should be avoided."
b. Statements of Practical Treatment
"If on skin; Wash with plenty of soap and water. Get medical attention."
"If in eyes; Flush with plenty of water. Call a physician."
"If swallowed; Call a physician or Poison Control Center. Drink 1 or 2
glasses of water and induce vomiting by touching back of throat with
finger. Do not induce vomiting or give anythina bv mouth to an
unconscious person."
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c. Environmental Hazard Statement
The following specific statements must appear on the labels of all
manufacturing use products:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public waters unless this product is
specifically identified and addressed in a NPDES permit. Do not
discharge effluent containing this product to sewer systems without
previously notifying the sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of the EPA."
The labels of EUPs intended for outdoor use must bear one of the following
statements, depending on the formulation of the product:
Granular products must bear the statement:
"Do not apply directly to water or wetlands. In case of spills, collect
for use or properly dispose of the granules. Do not contaminate water
by cleaning of eouipment or disposal of wastes."
Non-granular products must bear the statement:
"Do not apply directly to water or wetlands. Do not contaminate water by
cleaning of equipment or disposal of wastes."
The label of all products (except those intended solely for household use)
must bear the appropriate container disposal statement. See Appendix IV-5
of this guidance package.
The required statements listed in this Standard must appear on the labels
of all MUPs and EUPs released for shipment after June 30, 1985. The labels
of all MUPs and EUPs currently in the channels of trade must be modified to
include .all the listed statements by January 1, 1986. After review of
data to be submitted under this Standard, the Agency may impose additional
• label requirements.
H. Tolerance Reassessment
Tolerances ranginq from 0.05 to 0.10 ppm have been established for the
residues of cyanazine in or on certain raw agricultural food commodities
such as corn, cottonseed oil, sorghum, and wheat. (See 40 CFR 1R0.307.)
An acceptable daily intake (ADI) for man was set at 0.006 mgAg/day,
based on a "no observed effect level" (*OEL) of 12 ppm (0.6 ma/kg/day)
and a toxic endpoint of significant reduction in body weight gain noted
in a chronic feeding study in the rat. The customary safety factor of
100 fold was used in setting the ADI. The maximum permissible intake
(MPI) for a 60 kg person was calculated to be 0.360 mg/day.
The theoretical maximum residue contribution (TMRC) to the human diet as
a result of the existing tolerances was set at 0.0175 mg/day/I.5 kg of the
diet, or 4.88% of the MPI. No tolerances were established for residues
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of cyanazine in meat, milk, eggs, or poultry because at the time these
tolerances were first considered, the parent compound was thought to be
the only residue of concern, and it was not present at detectable levels
in feed.
Reevaluation of the chronic feeding study mentioned above revealed major
deficiencies that prevent the continued use of this study as a basis for
the ADI. Since no other acceptable chronic feeding study is available,
the existing ADI cannot be recalculated and must be considered invalid.
Under circumstances such as these, where the ADI cannot be calculated,
a provisional acceptable daily intake (PADI) can be determined based on
a "no observed effect level" aenerated from a subchronic feeding study,
and a margin of safety of 2000 fold. A subchronic 13-week feeding study
in the rats (MRID 00093198) was used to calculate this PADI. In this
study, a NOEL of 25 ppm (1.25 nwAg) was observed, with a toxic endpoint
.of organ to bodyweiqht changes. Therefore the PADI was set at 0.000625
mgAg/day and the maximum permissible intake (MPI) was calculated to be
0.0375:mg/day for a 60 kg person, based on 1.5 kg diet per day. In this
case, althoucrh the TMRC will not be changed, the portion of the MPI
utilized will be increased from 4.RR% under the old ADI to 46.66% under
• the new PADI.
After review of the existing data, the Agency has reason to believe
that some or all of the metabolites which contain the triazine moiety
may contribute to the overall toxicity levels observed. Therefore,
existing crop tolerances for cyanazine will be recalculated. The new
tolerances will be based on the combined residue of the parent cyanazine
compound and all metabolites that contain the triazine moiety. Tolerances
for meat, milk, eggs, and poultry may be established, if residues are
found in animal feed. If these meat/milk/eqg/poultry tolerances are
established, they will also include the triazine moiety metabolites.
The Agency will require data sufficient to allow these recalculations,
and new.tolerances will not be granted until the data are reviewed.
It may be necessary to amend the TMRC, if the contribution to dietary
intake is found to be increased by the inclusion of the triazine metabolites.
If the TMRC is increased, the margins of safety for the teratogenic,
maternal, and fetotoxic effects will be reduced. Further regulatory
action may become necessary at that time, includina changes in the
requlatory positions stated herein, if circumstances warrant.
I. Preliminary Risk and Benefit Analysis for Cyanazine
A. Risk
1. Introduction
The Agency has concerns about teratoqenic and fetotoxic effects that
occurred when cyanazine was fed to experimental laboratory animals. A
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preliminary risk assessment has been conducted and the Agency has
determined that because of the teratogenic effects of cyanazine and
the potential exposure to applicators it meets or exceeds the risk
criterion set forth in CFR 40 162.11.
2. Teratogenicity Studies
A supplementary study (MRID 00091020, Shell Oil Co. 1981) "with Fisher
F-344 rats showed cyanazine teratogenic at 25 mgAg. The no effect
level (NOEL) was 10 mgAa. The teratogenic effects were anaphthalmia
and microphthalmia. Cyanazine also caused fetotoxic effects when fed
to rabbits (Study NO. 221/«1, Shell Oil Co. 1981) at 2 mgAg. The
NOEL for this study was J mg/ko.
3. Dietarv Exposure
Dietary exposures result from use on corn and other crops which are
used for human food and livestock feed. Ninety-six percent of the
cyanazine produced in the United States is applied to corn. A marain of
safety for dietary exoosure to a teratoaen is usually determined based on
. a single serving of a given food commodity. However, the sinale
'•. serving for all raw agricultural conmodities, for which cyanazine
tolerance exist, is very close to the food factor based on the annual
average. Thus the theoretical maxijnum residue contribution of each of
these commodities can be used as an exposure estimate. On this basis,
the marains of safety for the teratogenic and or maternal and fetotoxic
effects can be calculated accordina to the following formula.
MOS = no-observed effect level (mgAg)
Exposure
The Margins of Safety (MOS) based on the no observable effect level
(NOEL) for teratogenic itv and fetotoxicity are as follows:
: Table 1. Crop Margin of Safety (MOS)
for Teratogenicitv and Fetotoxicity
Crop Margins of Safety (MOS)
TeratoaenicitvlFetotoxicitv
Corn 53,300
Cottonseed Oil 90,900
Sorahum 500,000
Wheat 643
530
9,090
50,000
64
Rased on these marains of safety, the Aaencv has determined that the
risk criterion in 40 CFR 162.11 has not been met for dietarv exposure.
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4. Non-Dietary Exposure
The Agency did not have specific data for cyanazine to allow an exposure
assessment to be done. Therefore, a surrogate study was used as a basis
for estimating exposure to cyanazine by agricultural workers. The study
selected was a spray operation safety study from the British Agrichemicals
Association, LtD. (BAAL). The BAAL study assessed human exposure
associated with aqueous dilutions of a liquid 2,4-D herbicide formulation
applied with several different types of agricultural spraying eauipment.
Based on the use patterns of cyanazine and the results of the BAAL study,
two occupational exposures of concern were identified: mixer/loader and
applicator. Because the same person often performs both mix ing /load ing
and application operations, mixer/loader and applicator exposure values
should be added to qet a reasonable worst case exposure figure.
The following table shows estimates for cyanazine exposure for the
completely unprotected agricultural worker. More than 9n* of this
exposure can be eliminated if the workers wear rubber cloves.
..Table 2. Exposure Estimates
' Operation . ' Dermal Exposure Estimates
Mixing/loading (open system) 117 mg/bay/140 acres or 1.95 mg/kg/day
(for a 60 kg woman)
Application 324 ma/10-rhr Day/140 acres
or 5.4 mgAa/day (for a 60 kg woman)
The Marains of Safety (MOS) for applicator, mixer/loader
are shown on the following table and are calculated by the following
formula:
MOS = NOEL (moAg/day)
Exposure (mg/tei/dav)
Table 3. Margins of Safety for Applicator, Mixer/Loader Personnel
Personnel Margin of Safety
Teratoaenicitv I Fetotoxictv
H
Mixer 5.1 I 0.5
Applicator 1.9 I 0.2
These MOS values demonstrate that exposures are likely to be close or
comparable to levels at which effects occur in experimental laboratory
animals. The Aaencv has concluded, based on the above data, that
cyanazine has met the risk criterion set forth in 40 CFR 162.11. Therefore,
the Agency is initiating an RPAR or Special Review for the pesticide.
-13-
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B. Benefits Review
1. .Introduction
The Agency has completed a current benefits review for cyanazlne. The
following information Is preliminary In nature and will be expanded upon as
the need arises. Reference documents utilized for this summary Include:
(1) l^ack A - Biological Data Base For A Current Benefits 'Evaluation of
Cyanazlne Herbicide and (2) Current Benefits Review of Cyanazlne Herbicide.
2. Use Sites
Cyanazlne as a herbicide is federally registered for use on agricultural
sites of corn, cotton and grain sorghum and the terrestrial non-crop site for
fallowland before planting wheat. Cyanazlne is currently used under Section
24(c) as Special Local Need registrations In the following states: Kansas
and Nebraska for use as a tank mix with 2,4-D or paraquat or atrazlne and
2,4-D on grain sorghum; and in Texas for fall-winter weed control on idle
farmland; in Kansas, Nebraska, and Oklahoma for early season weed
control on winter wheat using cyanazlne, 2,4-D or paraquat. An
application for registration and a petition for tolerances for cyanazine
**or use as a. preemergence on soybeans is pending with the Agency.
Research has been completed for adding data to support an early preplant
and post plant direct application of cyanazlne to soybeans, but this data
has not yet been submitted by the registrant.
Of the above mentioned cyanazlne use sites, most use is on corn. For this
reason, this preliminary analysis primarily addresses cyanazlne use on
corn. Ninety-six (96t) percent of total cyanazine use is on corn. The
remaining use is on cotton which represents 3% of the total use and grain
sorghum which accounts for about 1% of the total use. A small quantity of
cyanazlne is used on wheat fallowland.
3. Benefits On Corn
Approximately 4.6 million acres (14 to 16? of the total U.S. corn
acreage) of com were treated in 1982 with cyanazlne as the sole active
Ingredient; in addition, 8.5 million acres are tank mixed with atrazine,
alachlor, butylate, or metolachlor. When mixed with other herbicides, the
cyanazlne use rate drops from a range of 1.2 - 4.8 Ib al/A to a range of
0.4 - 3.6 Ib al/A depending upon the herbicide with which it is tank mixed
and/or formulated with. Ihe cyanazine dosage rate selected also is
dependent upon soil texture and the percent organic matter. -It is applied
to corn as a preemergence or postemergence broadcast application by ground
equipment In the spring. .It may also be applied preemergent through a
center pivot sprinkler Irrigation system. A minimal amount of cyanazlne
«lt) is applied aerially to corn. Growers selected cyanazlne over
other currently available corn herbicides for: (1) Its wide broadleaf and
annual grassy weed control spectrum; (2) the wide number of herbicides it
can be tank mixed with to further increase its weed control spectrum;
(3) its ability to reduce the carryover effect of other triazlne herbicides
on subsequent crops and (4) its lack of crop rotational restrictions.
-14-
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Cyanazlne also provides contact weed control In addition to Its residual
activity on seedling weeds when applied in a no-till or minimal till
situation. .In these situations it is usually applied alone "or with
alachlor or metolachlor. .It is directed into stubble (soybean, small
grains) or stalk ground (corn, sorghum). ,It may also be tank mixed with
2,4-D, or paraquat and dlcamba where heavy crop residues are encountered.
l*. Other Registered Herbicides for Corn
There are a limited number of corn herbicides registered for control of
as wide a spectrum of weeds as cyanazlne. The major alternative is
Atrazlne. Atrazlne Is the most widely used herbicide on corn; however,
residues may carry over in the soil to the next crop and limit the
growers options for rotational crops. Cyanazine because of its short
.•esidual life has no crop rotational restrictions and is often tank
mixed with atrazine to permit a reduction in the amount of atrazlne used
and thus the carryover effect. Cyanazlne is said to provide better
control of some grasses such as fall panicura, crabgrass, and foxtail than
raany:Of the alternative herbicides available. The main problem with
cyanazine is the lower crop tolerance and potential for phytotoxlcity
under certain conditions. Atrazlne is the main alternative to cyanazlne
when it is applied postemergence. Other herbicides which compete with
cyanazine are simazlne, a tank mix of butylate and atrazlne, and package
mixes of metolachlor and atrazlne and atrazine and propachlor. These
alternatives have a smaller weed control spectrum; those mixed with
atrazine still produce a carryover effect. Slmazine is less flexible in
Its application timing than cyanazlne as are tank mixes of butylate and
atrazlne and a package mix of atrazlne and propachlor. The butylate and
atrazlne mixture has regional restrictions which cyanazlne does not. The
package mix of metolachlor and atrazlne (Bleep") also provides less
control of certain broadleaf weeds than does cyanazlne.
5. Other Cyanazine Use Sites
The other cyanazine use sites previously listed are considered "minor"
usage sites In comparison to corn. Nevertheless, cyanazlne may offer
some benefits on these sites.
•In cotton, cyanazine may be applied preemergent, directed early postercergent
or as a layby (late) postemergent directed treatment. .It can be tank mixed
with norflurazon as a preemergent treatment or with MSMA or dlnoseb as a
postemergence directed spray. Both cyanazlne and the tank mix with norflurazon
are recommended as the best treatment for spotted spurge control. Possible
alternatives to cyanazlne use In cotton would be prometryn, fluometuron,
and diuron, however, cyanazlne is registered for control of more weeds
than any of the other three herbicides. Diuron has more rotational crop
restrictions than does cyanazine. Approximately 84 J of the cyanazlne used
on cotton is reported to be applied as a directed postemergence treatment.
The remaining 16% Is applied as preernergent treatments.
-15-
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Cyanazine may be applied to grain sorghum as a preemergent application but
only when tank mixed with propachlor or with propazlne. These tank mixes
cannot be used on sand, sandy loam, loamy sand, and peat or muck soils.
Also these tank mixes have several geographical restrictions because of
possible crop injury under stress conditions. Potential alternatives to
cyanazine include propachlor and atrazlne as a tank or package mix,
ulfenox and propachlor tank mixed, and the package mix of metolachlor
and atrazlne. These alternatives except for propachlor also carry crop
rotational or regional restrictions. The cyanazine tank mixes claim
control of more broadleaf weeds than the other alternatives. Generally
the tank mix of cyanazine and propazlne Is said to give better control
of broadleaf weeds than the cyanazine and propachlor tank mix. However,
cyanazine tank mixes are generally less effective on cocklebur and
raornlngglory, two of the major weed problems in cotton.
-16-
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,11. REQUIREMENT FOR SUBMISSION OF OENERIC DATA
A. This portion of the guidance document is a Notice Issued
under the authority of P-IFRA sec. 3(c)(2)(B) and describes,
in table format, the data required for maintaining the reglstra-
bllity of each product. Additionally, a bibliography (Appendix
.11-2) is Included that identifies that data considered as part
of the data base supporting this standard. 'FPA has determined
that additional generic data described in this Notice must be
submitted to 'EPA for evaluation in order to maintain.in
effect the registratlonCs) of your product(s) Identified as
an attachment to the cover letter accompanying this guidance
document. As required by PJFRA 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 Data1/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at ..the end of this chapter. That table lists the generic
:-.data needed to evaluate the continued reglstrabllity of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
'EPA Approved protocols (such as those contained in the Pesticide
Assessment Guidelines £/ or data collected under the approved
protocols of the Organization for 'Economic Cooperation and
Development (OECD). If you wish not to develop data which
are necessary to support the reregistration of certain uses
appearing in your labeling, you may delete those uses at the
time you submit your revised labeling.
Also for certain kinds of testing (generally ecological
effects), .'EPA requires the test substance to be a "typical
}J Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that Ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
£/ The Pesticide Assessment Guidelines are available In hard
copy or microfiche from the National Technical .Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
17-
-------
formulation," and In those cases 'EPA needs data of that type
for °ach major formulation category (e.g., emulslflable 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; The "typical formulation" data should
not be confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter ,ILI 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 "FIFEA
Section 3(c)(2)(B) Summary Sheet" ['EPA Form 8580-1, Appendix
.11-3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the. requirements of this Notice:
1. (.--a) Notify 'EPA that you will submit the data, and
(b) either submit the existing data you believe will
. satisfy the'requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified In) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of 'Expert Groups to the Chemicals Group,
°rganlzation 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.
3. File with 'EPA a completed "Certification of Attempt to
'Enter .Into an Agreement With Other Registrants for Develop-
ment of Data" CEPA Form 8580-6, Appendix ,LI-4)«/
OR
V FIFRA sec. 3(c)(2)(B) authorizes Joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision If they agree
to Jointly develop data tut fall to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data Jointly.
(Footnote continued on next page)
IS
-------
J|. Request that 'EPA amend your registration by deleting
the uses for which the data are needed. (This option Is
i.ot available to applicants for new products.)
OR
5. Request voluntary cancellation of the reglstratlon(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)
Chemical* Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
.If you think that you will need more time to generate the
required data than Is allowed by'EPA's schedule, you may
submit a request for an extension of time. The extension
request must.be submitted in writing to the Product Manager.
The extension request should state the reasons why you conclude
that an extension is appropriate. While 'EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
(Footnote continued from previous page)
Jn 'EPA's opinion, Joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public Interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, 'EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). 'EPA has concluded that
it is appropriate to exercise its discretion not to suspend In
ways which will discourage duplicatlve testing. Accordingly, If
(1) a registrant has informed us of his Intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs 'EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under F.IFRA
Section 3(c)(2)(B)(lll)]; 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.
19
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,111. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise In Section .1, 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 data1 listed on the
form entitled "Product Specific Data Report" ('EPA Form
8580-4, Appendix ,111-1) to fill "gaps" identified by 'EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), 'EPA has determined that you must submit these
data to 'EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing
Use Products" appearing In Table B permit you to determine
which product-specific data you must submit. This can be
done by'examinlng the entries in the column of those tables
entitled "Must Data By Submitted Under §3(c)(2)(B)."
V Product specific data pertain to data that support the
formulation which Is marketed; it usually Includes product
chejnistry data and acute toxiclty data.
20
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EPA lodes to Pesticide Chemicals
2-((4-^SWRD-6-(ETHYlJ^BO)-S-TRlAZIH-2-TL)AMIHO)-2-METHYLPROPIOIiITRILE* hlOOlOl
TYPE PESTICIDE! Herbicide
FORMULATIONS! Tech (94Z); FI (28.22); G (10Z, 1SZ); HP (SOX);
F1C (4 Ib/gal, 43Z)
GENERAL WARNINGS AND LIMITATIONS: A selective herbicide used on com, cot- *
ton, sorghum and fallow land. Effectiveness depends on adequate moisture
to move the herbicide into the root cone of the veeds. This chemical is
readily adsorbed to soil particles. The degree of adsorption varies with
soil texture, percent organic matter and water content. Dosages are specif-
ic for certain soil textures and percent organic matter. Consult State
Agricultural Cooperative Extension Service for help in determining soil
texture, organic matter content and appropriate rates for local conditions.
Under conditions which delay weed germination, such as low temperature, lack
of soil surface moisture, or when germination extends over a long period,
the effectiveness may be impaired. Supplemental cultural practices or post-
emergence herbicide treatments may be necessary under these conditions.
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Not located.
PHYTOTOXICITY TO CROPS! Not located.
MODE OF ACTION; Absorbed by roots and translocated to the leaves where
it inhibits the Hill reaction of photosynthesis.
BROADLEAF WEEDS CONTROLLED:
annual buttercup
annual groundcherry
black mustard
buffalobur
carpetweed
cocklebur
on chickveed
on groundsel
on lambsquarters
on mallow
on purslane
corn apurry
curly dock
falseflax
florida pus ley
List continued on the next page.
(3PZAAASP
gPBKAFBF
gPEWAlBF
gPADABBA
gPBFDQAA
gPAZAOBB
gPBFCXBK
CPBDAEBA
gPDAAKBB
gPEDADBA
CPAZAMBA
PPEAAHBE
8PBKAGAA
gPEMAZBB
*Cyanazine
.Bladex
Issued: 10-19-79
21
-------
EPA Index to Pesticide Chemicals
2-((4-CHLOSD-6-(ETHYLAMI»0)-S-TRIA2IN-2-YL)AMINO )-2-KETHYLPROPIONIlSILE
BROADLEAF WEEDS CONTROLLED (continued)
hedge mustard
hentrit
ivyleaf aorningglory
jimsonweed
kochia
ladysthumb
lambsquarters
mayweed
Pennsylvania smartweed
pigveed
pineappleveed
plantain
poorjoe
prickly lettuce
prostrate knotweed
prostrate spurge
ragweed;/
redroot pigveed
red tasselflbver
russian thistle
shepherdspurse
smallflower galinsoga
smallflower norningglory
small white morningglory
spiny amaranth
spotted spurge
sunflower
tall morningglory
tall vaterhemp
tansymustard
tarweed
velvetleaf
vild buckwheat
wild mustard
wild radish
wild turnip
8PBRBDBD
gPCOAFBA
9PBGAFBG
0PEWADBD
(3PBDA1BA
9PEAAGBP
8PBDAEAB
9PBFAHBB
CFEAAGBO
9PAAAA5I
gPBFCKBB
gPOXABAA
gPEMACBA
gPBFCEBF
@PEAAGBD
§PBVAGBQ
(3PBFAEAA
§PAFACBI
(3PBFBFBA
9PBDAKBA
gPSKAKBA
gPBFBOBB
gPBGAGBB
(?PBGAFBI
@PAFACBJ
@PBVAGBK
@PBFBUAA
gPAFACBK
@PBRANBB
-------
EPA Index to Pesticide Cheaicals
2-((4-CHLORO-6-(ETHYLAMINO)-S-'niIA2IN-2-YL)AMINO)-2-METHYLPROPIONITRILE
•
GRASSES AND OTHER MDBOCOTS COHTROLLED (continued)
downy brone gPCAATBM
fall panicun gPCACEBD
giant foxtail gPCACTJBA
gooaegrass g?CABIBA
green foxtail CPCACUBF
india lovegrass • gPCABKBH
italian ryegrass gPCABZBA
johnaongrass (seedling) gPCACVBG
junglerice ?PCABHBA
atinkgrass gPCABKBC
wheat (volunteer) fPCADFBA
wild oat CPCAAOBB
witchgrass @PCAC£BC
yellow foxtail gPCACUBD
Issued: 10-19-79
-------
EPA Index to Pesticide Chemicals
2-((4-CHLOBO-6-(ETHYLAMINO)-S-TRIA2IN-2-YL)AMINO)-2-KETHYlJ>ROPIONIc, Linitationi
and Formulation
(Ib a.i./A)
AGRICULTURAL CROPS
General Warnings and Limitations; A rotary hoeing or shallow cultivation
is recommended if rainfall or sprinkler irrigation has not occurred within
10 days after application (4 to 6 days for granular formulations). Mois-
ture should be sufficient to wet the top 1.5 to 2 inches of soil or make
the soil too wet to cultivate. One-half inch of moisture is sufficient
for aost soils. Exact dosages for soil types will vary within the given
range according to soil texture and percent organic natter. Reduce dosage
in proportion to band area actually treated.
Corn
0.05 ppn (grain)
0.05 ppm (fresh corn including sweet corn (kernels
plus cob with husks removed))
0.2 ppm (fodder, forage)
CO state label
Registration Number 000201-05703
RS state label
Registration Number 000201-05704
HT state labels
Registration Number 000201-05701
Registration Number 000201-05702
N8 state label
Registration Number 000201-05700
ND state label
Registration Number 000201-05699
OR state label
Registration Nucber 000201-05698
SD state label
Registration Number 000201-05696
VA state label
Registration Number 000201-05697
WY state label
Registration Number 000201-05907
/2800500
Issued: 10-19-79
-------
EPA Index co Pesticide Chemicals
2-((4-CHLORD-6-(ETHYLAMINO)-S-TRIA2IN-2-YL)AMIRO)-2-METHYLPROPIONITRILE
Site, Dosage
and Formulation
(Ib a.i./A)
Corn (continued)
1.60-3.20
(SOX WP)
Corn, Field
Tolerance, Die. Limitations
Broadcast. Use in early portion of fallow program
prior to planting corn. Apply in IS to 40 gallons
of vater per acre. For spring applications, do not
use more than 2.4 pounds active ingredient per acre.
In the presence of heavy crop residues and stubble,
the effectiveness can be inproved by applying during
or following a stubble mulching operation. Use
higher spray volumes where there are crop residues
on the soil surface. Do not apply to soils with
more than 2 percent organic matter. Do not plant
crops less than 120 days after a spring or sunmer
application, or less than 9 months after a fall
application. May be tank mixed with paraquat di-
chloride for control of existing weeds. Apply this
tank mix with a surfactant, but do not mix with
liquid fertilizers.
0.05 ppo (grain)
0.03 ppm (fresh corn including sweet corn (kernels
plus cob with husks removed))
0.2 ppm (fodder, forage)
Do not make more than 1 application per crop season.
General Information; When preplant applications
have been made, avoid removal of treated soil from
the seed row prior to or during the planting opera-
tion. Liquid fertilizers, if compatible, may re-
place all or part of the water as a carrier for pre-
eoergence applications, except when tank mixed with
paraquat dichloride. Do not use liquid fertilizers
in postemergence applications. Temporary yellowing
of corn may result from postemergence applications,
particularly under cold, adverse, growing condi-
tions. If corn is cultivated, tillage should be
shallow to minimize herbicide dilution in the soil.
Unless otherwise specified, treated fields can be
rotated from corn to other crops. Should the corn
be lost due to adverse weather conditions, the
field can be replanted the sane season with corn
or sorghum. Do not use on peat or muck soil, or
on sand or loamy sand with less than 1 percent
organic matter.
$2800502
4080.0006
19900300
/2800600
Issued: 10-19-79
25
-------
EPA Index to Pesticide Chemicals
2-((4-CHL080-6-(ETHYLAMDIO)-S-TRlA2IN-2-YL)AMINO)-2-METHYLPROPIONIIRILE
Site. Do*age
and Formulation
(Ib a.i./A)
Tolerance. Uae, Limitations
Corn. Field (continued)
1.20-4.00
(80Z VP)
(4 Ib/gal F1C)
0.80-2.00
(80Z WP) .
(4 Ib/gal F1C)
1.20-4-. 05
(101 G)
U5Z C)
(80Z VP)
(4 Ib/gal F1C)
AL atate label
Regiatration Number 038749-10312
TZ atate label
Regiatration Number 000201-05908
Preplant. Broadcast or band. Tank mix vith para- $2800641
quat dichloride. For uae in minimum tillage systems 4080.0006
vbere kill of existing vegetation and residual con- 4104.0014
trol of weeds is required. Apply in IS to 30 gal- 19900300
Ions of water per acre withoground equipment, or in 19001500
a minimum of 4 gallons of water per acre with aerial
applications. Use with a surfactant. Do not apply
this tank mix in liquid fertiliser.
Preplant. Soil incorporation. Broadcast or band. $2800602
Tank mix or sequential treatment with S-ethyl 4080.0006
diisobutylthiocarbamate. Apply as a tank mix and 4104.OOU
incorporate immediately or apply preenergence, 19001500
following preplant incorporated application of 19900300
S-ethyl diisobutylthiocarbamate. Apply in 15 to
30 gallons of water per acre with ground equipment,
or in a minimum of 4 gallons of water per acre with
aerial applications. Incorporate no deeper than
4 inches. Existing stands of quackgrass, yellow
nutsedge, and purple nutsedge must be turned under
and chopped up prior to treatment. Do not use
on corn grown for seed.
Preemergence. Broadcast or band. Apply immediately 19001500
before planting, at planting, or after planting but 4010.000*
before crop emergence. Do not use on peat or muck 6015.000-
soils. Apply the nongranular formulations in 15 to 4080.000<
30 gallons of water per acre with ground equipment, 4104.001«
or in a minimum of 4 gallons of water per acre with
aerial applications.
Issued: 10-19-79
26
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EPA Index to Pesticide Chemicals
2-((4-CHLOEO-6-(ETHYLAMI»0)-S-niIAZIN-2-YL)AMINO)-2-ffiTHYLPROPIONITRILZ
Site. Dotage
•Dd Formulation
(Ib a.i./A)
Tolerance, Use, Limitations
Corn, Field (continued)
0.60-2.66
(80Z WP)
0.60-2.67
(4 Ib/gal F1C)
0.60-2.00
(80Z WP)
(4 Ib/gal F1C)
1.20-4.00
(4 Ib/gal F1C)
0.60-2.67
(4 Ib/gal F1C)
0.60-2.00
(4 Ib/gal F1C)
1.20-2.00
(so: wp)
(4 Ib/gal F1C)
Preemergence. Broadcast or band. Tank mix vith
alachlor. Apply immediately before planting, at
planting, or after planting but before crop emer-
gence. Apply in IS to 30 gallons of water per
acre vith ground equipment, or in a minimum of
4 gallon* of water per acre vith aerial applica-
tions .
Use limited to Western Plains States. Preemergence.
Water application. Broadcast. Apply in center
pivot sprinkler irrigation water after planting,
but prior to crop emergence. Use 0.5 to 1 acre-
inch of water.
Use limited to Western Plains States. Preemergence.
Water application. Broadcast. Inject in combina-
tion with atrazine into center pivot aprinkler irri-
gation water. Apply after planting, but prior to
crop emergence. Use 0.5 to 1 acre-inch of water.
Use limited to Western Plains States. Preemergence.
Water application. Broadcast. Inject in combina-
tion with alachlor into center pivot aprinkler irri-
gation water. Apply after planting, but prior to
crop emergence. Use 0.5 to 1 acre-inch of water.
Postemergence. Broadcast or band. Apply from crop
emergence through the 4-leaf stage before weeds are
1.5 inches high. Do not apply if the fifth leaf is
visible. Apply in 15 to 30 gallons of water per
acre with ground equipment, or in a minimum of 4
gallons of water per acre vith aerial applications.
Use the higher dosage when dry conditions prevail.
Under dry or arid conditions, effectiveness can be
improved by the use of surfactants or emulsifible
vegetable oils. Do not use any type of petroleum
oil. Do not use surfactants or additives of any
kind in applications to corn grown for seed.
19900300
4080.0006
19001500
6104.0014
4080.0006
(104.0014
$2800603
6104.0014
19900300
4104.0014
19900300
6104. OOU
$2800601
4080.000*
6104.001'
19001500
Issued: 10-19-79
27
-------
EPA Index to Pesticide Chemicals
2-((4-CHWRO-6-(ETHYLAMIRO)-S-raiA2IN-2-YL)AMINO)-2-METHYLPROPIONITRIL£
Site. Dosage Tolerance. Use, Limitations
and Formulation
(Ib a.i./A)
Corn. Pop 0.05 ppm (grain) /1500400
0.05 ppm (fresh corn including tweet corn (kernels
plus cob with husks removed))
0.2 ppm (fodder, forage)
Do not make more than 1 application per crop season.
General Information; When preplant applications
have been made, avoid removal of treated toil from
the seed row prior to, or during the planting opera-
tion. Liquid fertilisers, if compatible, may re-
place all or part of the water as a carrier for pre-
emergence applications, except when tank mixed with
paraquat dichloride. Do not use liquid fertilisers,
surfactants or additives of any kind in postemer-
gence applications. Temporary yellowing of the corn
:' may result from post emergence applications, particu-
larly under cold, adverse, growing conditions. If
.. . corn is cultivated, tillage should be shallow to
minimise herbicide dilution in the soil. Unless
otherwise specified, treated fields can be rotated
from corn to other crops. Should the corn be lost
due to adverse weather conditions, the fitld can be
replanted with corn or sorghun during the same sea-
son. Do not use on peat or muck soil, or on sand or
loamy sand with less than 1 percent organic matter.
AL state label
Registration Number 038749-10312
TX state label
Registration Number 000201-05908
Preplant. Refer to Corn, Field for use and limita- $1500441
tion information. S2800641
Preplant and preeaergence. Refer to Corn, Field for $1500402
use and limitation information. S2800602
Use limited to Western Plains States. Preenergence. $1500403
Refer to Corn, Field for use and limitation informs- S2800603
tion.
Postemergence. Refer to Corn, Field for use and $1500401
limitation information. S2800601
Issued: 10-19-79 28
-------
EPA Index to Pesticide Chemicals
2-((A-CHLOBO-6-(ZTHTLAMINO)-S-raiAZIN-2-YL)AMI»0)-2-METBTLPROPIONIIEILE
Site, Dosage
and Formulation
(Ib a.i./A)
Corn, Sweet
Tolerance, Use, Limitations
0.03 ppm (grain) /15005W
0.05 ppm (frtih corn including tweet corn (kernels
plus cob with husks removed))
0.2 ppa (fodder, forage)
Do not make more than 1 application per crop season.
General Information; When preplant applications
have been Bade, avoid removal of treated aoil from
the seed row prior to, or during the planting opera-
tion. Liquid fertilisers, if compatible, may re-
place all or part of the water as a carrier for pre-
emergence applications, except when tank mixed with
paraquat dichloride. Do not use liquid fertilizers,
surfactants or additives of any kind in postemer-
gence applications. Temporary yellowing of the corn
may result from postemergence applications, particu-
larly under cold, adverse, growing conditions. If
corn is cultivated, tillage should be. shallow to
minimize herbicide dilution in the soil. Unless
otherwise specified, treated fields can be rotated
from corn to other crops. Should the corn be lost
due to adverse weather conditions, the field can be
replanted with corn or sorghum during the same sea-
son. Do not use on peat or muck soil, or on sand or
loamy sand with less than 1 percent organic matter.
AL state label
Registration Number 038749-10312
TX state label
Registration Number 000201-05908
Preplant. Refer to Corn, Field for use and limits- $1500541
tion information. S2800641
Preplant and preemergence. Refer to Corn, Field for $1500502
use and limitation information. S2800602
•
Dse limited to Western Plains states. Preemergence. $1500503
Refer to Corn, Field for use and limitation informs- S2800603
tion.
Postemergence. Refer to Corn, Field for use and $1500501
limitation information. S2800601
Issued: 10-19-79
29
-------
EPA ladcx to Pesticide Chemicals
2- ( (4-CHLOK)-6- (ETHYLAMIHO )-8-
-2-KETHTLPROPIORIT»ILZ
Site. Dosage
and Formulation
(Ib a.i./A)
Cotton
0.80-2.00
(80Z WP)
(4 Ib/gal F1C)
0.60-1.00
(80Z VP)
Tolerance, Use, Limitations
O.OS pnm (cottonseed) /2800ZOO
Do not graze or feed foliage fro* created areas
to livestock.
Central Information; Do not use on aoils containing
less than 1 percent organic matter. In fields where
•oil texture changes from coarse to fine, do not use
the fine soil dosage on medium or coarse soil areas,
or the medium soil dosage on coarse soil areas. Ex-
ceeding recommended dosages for the aoil texture can
result in yellowing or stunting of the crop and may
result in stand reduction. Should the cotton be
lost due to adverse weather conditions, the field
can be replanted to cotton or soybeans. Post emer-
gence applications may follow a preeaergence appli-
cation. On sandy loams, make 1 preemergence and
1 posteaergence application. On other aoil types,
make 1 preeaergence and 2 posteaergence applica-
tions.
AL state label
Registration Number 038749-10312
Use limited to AL, AR, GA, LA, MS, MO, NC, OR, SC, $2800702
TN and TX. Preeaergence. Broadcast or band. May 4080.0006
be used alone or in sequential treatment following 4104.0014
preplant incorporated application of 4-(methylsul- 19900300
fonyl)-2,6-dinitro-N,N-dipropylaniline or triflura-
lin. Apply, in 15 to 30 gallons of water per acre,
at planting, or after planting but before crop has
emerged. Do not use on sand and loamy sands con-
taining more than 70 percent sand.
Use limited to AL, AR, GA, LA, MS, MO, NC, OR, SC, 19900300
ft) and TX. Posteaergence. Directed spray. Apply 4080.0006
in IS to 40 gallons of water per acre after cotton
is 6 inches high. On sandy loaa soils do not apply
before cotton is 12 inches high. Direct the spray
to the base of cotton plants to cover emerged weeds
beneath the cotton. Weeds should not be more than
2 inches high. Do not allow spray to atrike the
cotton leaves, as injury will result. Use with a
surfactant. When dry or arid conditions exist, use
the higher rates. May be tank mixed with monosodium
acid methanearsonate. Apply the tank mix before
cotton reaches the first bloom stage.
Issued: 10-19-79
-------
EPA Index to Pesticide Chemicals
2-((4-CHLOBD-6-(rTHYLAMIHO)-S-TRIA2Ili-2-YL)AMllJO)-2-METHYlPEOPIOHinLILE
Site, Dosage
and Formulation
(Ib a.i./A)
Cotton (continued)
0.80-1.60
(80Z WF)
Sorghum
liaued: 10-19-79
Tolerance, Use, Limitations
Die limited to AL, AR, CA, LA, MS, HD, FJC, OK, SC,
TN and TX. Layby application. Directed spray. 4080.0006
Apply in 15 to 40 gallons of water per acre after
cotton is 12 or »ore inches high. Direct spray to
the base of cotton plants to cover emerged weeds
beneath the cotton. Weeds should not be more than
2 inches high. Do not allow spray to strike the
cotton leaves, as injury will result. Use with a
surfactant.
0.05 ppo (grain, fodder, forage) /2801900
General Information; Apply tank mixes once per crop
season. If replanting of sorghum is necessary, it
should be done in previously treated soil without a
second application.
AL state label
Registrstion Number 038749-10312
CO state label
Registration Number 000201-05703
KS state label
Registration Number 000201-05704
MT state labels
Registration Number 000201-05701
Registration Number 000201-05702
Nl state label
Registration Number 000201-05700
NM state label
Registration Number 000201-10248
ND state label
Registration Number 000201-05699
OR state label
Registration Number 000201-05698
TX state labels
Registration Number 000201-10187
Registration Number 000201-10188
SD state label
Registration Number 000201-05696
VA state label
Registration Number 000201-05697
VY state label
Registration Number 000201-05907
•31.
-------
XPA Index to Pesticide Chemical•
2-((A-CHLOK>-6-(ETHYLAMIHO)-S-TRIAZIIi-2-YL)AMIHO)-2-HETHYLPSOPIONIT2ILE
Sit*. Dosage
and Formulation
(Ib a.i
Sorghum (continued)
0.80-1.20
(BOX VP)
0.96-1.60
(SOX WP)
1.60-3.20
(80Z WP)
Sorghum (grain crop)
Issued: 10-19-79
Tolerance, Use. Limitations
Die limited to KS, OK and IX. Preemergence. Broad- $2801902
cast or band. Tank mix with propazine. Apply in &080.0006
20 to 30 gallons of water per acre, at planting or 19900300
after planting, but before crop and weeds emerge.
Do not use on peat, muck, aand, loamy aand or sandy
loam soils.
Dse limited to states cast of the Rocky Mountains. 19900300
Preemergence. Broadcast or band. Tank mix with 4080.0006
2-chloro-N-isopropylacetanilide. Apply in 20 to
30 gallons of water per acre, at planting or after
planting, but before crop and weeds emerge. Treated
fields may be rotated from sorghum to other crops.
Do not use on peat, muck, sand or loamy aand soils.
Broadcast. Use in early portion of fallow program 19900300
prior to planting sorghum. Apply in 15 to 40 gal- &080.000(
Ions of water per acre. For spring applications,
do not use more than 2.4 pounds active ingredient
per acre. In the presence of heavy crop residues
and stubble, the effectiveness can be improved by
applying during or following a stubble mulching
operation. Use higher spray volumes where there
are crop residues on the soil surface. Do not
apply to soils with more than 2 percent organic
matter. Do not plant crops less than 120 days
after a spring or sumer application or less than
9 months after a fall application. May be tank
mixed with paraquat dichloride for control of exist-
ing weeds. Apply this tank mix with a surfactant,
but do not mix with liquid fertilizers.
O.OS ppm (grain, fodder, forage) /2A00600
General Information; Apply tank mixes once per crop
season. If replanting of sorghum is necessary, it
should be done in previously treated soil without a
second application.
AL state label
Registration Number 038749-10312
-------
EPA Index to Pesticide Chemicals
2-((4-CHL08D-6-(ETHTLAMIHO)-S-raiAZ»-2-YL)AMniO)-2-METHYLPEOPIOBITiILE
Site. Dos*ie
and Formulation
(Ib a.i./A)
Tolerance, Dae, Limitations
Sorsjhum (grain crop) (continued)
0.80-1.20
(80X WP)
Use limited to KS, OR and TX. Preemergence. Broad- $2400602
cast or band. Tank mix vitb propazine. Apply in 6080.0006
20 to 30 gallons of vater per acre, at planting or 19900300
after planting, but before crop and vceds emerge.
Do not use on peat, muck, aand, loamy aand or sandy
loam aoils.
0.96-1.60
(80Z WP)
Wheat
Use limited to states east of the Rocky Mountains. 19900300
Preemergence. Broadcast or band. Tank mix vitb 4080.0006
2-chloro-N-isopropylacetanilide. Apply in 20 to
30 gallons of vater per acre, at planting or after
planting, but before crop and veeds emerge. Treated
fields may be rotated from sorghum to otber crops.
Do not use on peat, muck, aand or loamy aand aoils.
0.1 ppm (grain, green forage, straw) /2806500
AL state label
Registration Number 038749-10312
CO state label
Registration Number 000201-05703
KS state label
Registration Number 000201-05704
KT state labels
Registration timber 000201-05701
Registration Number 000201-05702
KB state label
Registration Number 000201-05700
ND state label
Registration Number 000201-05699
OR atate label
Registration Number 000201-05698
SD state label
Registration Number 000201-05696
WA atate label
Registration Number 000201-05697
WY atate label
Registration Number 000201-05907
Broadcast. Refer to Corn for use and limitation $2806502
information. S2800502
Issued: 10-19-79
33
-------
EPA Index to Pesticide Chemicals
2-((4-CHLOKD-6-(ETHYl^MIFO)-S-TRlAZIH-2-TL)AMIHO)-2-HETHYLPROPICWI
-------
EPA Index to Ptiticide Cbaicalf
2- ( U-CHLOBD-6- (ETHYLAMDJO )-S-TRIAZCT-2-YL)AMIHO M-KETBYLPROPIOHITRILE
Site. Potlie
•nd Formulation
(Ib a.i./A)
Toltrance, Die, Limitation*
AERIAL AND TAKE MIX APPLICATIONS
Aerial Application
— Refer to
Tank Mix
AGRICULTURAL CROPS
Corn (Field), Corn (Pop), Con (Sweet)
Refer to
AGRICULTURAL CROPS
Con, Con (Pield), Con (Pop), Con (Street), Cotton,
Sorghin, Sorghun (grain crop), Wheat
AGRICULTURAL PREMISES
Fallow Land
Itiued: 10-19-79
35
-------
IPA Index to PtBticide Cheaictli
2-((4-CHLOBO-6-(ETHTL4MDJO)-S-TtIAZIH-2-YL)AMIHO)-2-HETHYLPROPIONIT»ILE
*
Lifting of Regie tertd Pesticide Product* by Formulation
•
941 technical cheaical " :
2- ( (4-chloro-6-(ethyla«ino)-i-tria«iB-2-yl )anino)-2-
•ethylpropionitrile (100101)
000201-00298
ino)-2-
28.21 foraulation intermediate
2-((4-chloro-6-(ethyl«mino)-i-triaiin-2-yl
•ethylpropionitrile (100101)
000201-00380
101 granular
2-((4-chloro-6-(ethylanino)-i-triarin-2-yl)amino)-2
•ethylpropionitrile (100101)
000201-00280
4094.0001
*
&228.2002
4010.0004
151 granular
2-U4-cbloro-6-(«tbylasuino)-i-triaxin-2-yl)
•ethylpropionitrile (100101)
000201-00332
ino)-2-
601 vet table powder
2-((4-chloro-6-(ethylaoino)-«-triazin-2-yl )anino)-2-
•ethylpropionitrile (100101)
6015.0004
*
4080.0006
*
000201-00279
000201-05696
000201-05700
000201-05907
000201-10248
000201-00374
000201-05697
000201-05701
000201-05908
038749-10312
000201-00379
000201-05698
000201-05703
000201-10187
000201-00382
000201-05699
000201-05704
000201-10188
•4 Ib/gal flovable concentrate
2-((4-chloro-6-(ethylamino)-a-triazin-2-yl)amino)-2-
nethylp'ropionitrile (100101)
00020Ir00281 000201-00404
431 flovable concentrate
2-((4-chloro-6-(ethylamino)-»-triatin-2-yl)anino)-2-
•ethylpropionitrile (100101)
000201-05702
&104.0014
t
4243.0014
I»sued: 10-19-79
-------
GENERIC DATA REQUIREMENTS FOR CYANAZINE (94% TECHNICAL)
Data Requirement
Composition!/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?2/
S158.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Impurities
TGAI
TGAI
TGAI
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis of TGAI
Product Samples
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
Yes
Partially
Partially
Partially
Yes
Yes
00093184
GS0066-02
GS0066-03
GS0066-03
GS0066-03
GS0066-05
GS0066-06
GSO066-08
00093184
GSO066-01
GS0066-07
00093184
GS0066-01
GS0066-07
No
Yes4/
YesV
No '
NO
-------
:ABLB A
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Data Requirement Composition!/
$158.120 Product Chemistry (continued)
63-4 - Odor TGAI
63-5 - Melting Point TGAI
"
63-6 - Boiling Point N/A4/
V>J \
00 63-7 - Density, Bulk Density, or
Spec i tic Gravity TGAI
63-8 - Solubility TGAI or PAI
63-9 - Vapor Pressure PAI
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes .
Yes
-
No
Yes
Yes
Bibliographic
Citation
00093184
GS0066-01
GS0066-07
00093184
GS0066-01
GS0066-07
-
-
00093184
GSOO 66-01
GS0066-07
00093184
GS0066-01
GS0066-07
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?2/
No
No
-
Yes
No
No
63-10 - Dissociation constant
PAI
No
Yes
-------
GENERIC DATA REQUIRI
E A
FOR CYANAZINE
Data Requirement
Compos itioni/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?2/
SI58.120 Product Chemistry
(continued)
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
pther Requirements;
64- 1 - Submittai of samples
PAI
TGAI
TGAI
No
No
Yes
00093184
GS0066-01
GS0066-07
Yes
Yes
No
N/A
I/ Composition:
TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient.
several test substances determined on a case-by-case basis. .
Choice = Choice of
2/ Data must be submitted no later than six months after publication of this Standard, unless otherwise indicated.
3/ Information is required on the details of the manufacturing process, such as the purities of the starting materials,
description of the reaction conditions, any quality control measures used for the technical and the flowable
intermediate products, and the name and address of the manufacturer or producer of the starting materials.
4/ Information is required on any impurities believed to be present at >0.1%, based on knowledge of the beginning
materials, all possible chemical reactions, and any contamination.
5/ Data is required on analysis of five or more representative samples of. the 94% technical (and the 28.2% flowable
intermediate - see Table B) for the amount of active ingredient and each impurity present for which a certified limit
is required. Data must include a description of the analytical methods used in the analysis of the unintentional
ingredients present at >0.1%, other than the nitrosamines.
-------
tBLE A
GENERIC DATA RHQUIREMENTS FOR CYANAZINE
Data Requirements
Composition!/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
- Livestock
PAIRA
Partially
GS0066-09
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)?2/
SI 58. 125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA -Yes 00022775
00022853
GS0066-08
No
Yea2/
o
,171-4 - Residue Analytical Method
- Plant residues
- Animal Residues
TCAI and
metabolites
TGAI and
metabolites
Partially
No
00015609
00022270
00022786
00023132
00023828
00023829
00044453
GS0066-10
GS0066-11
Yes!/
Yea4/
-------
GENERIC DATA REQUIREMENTS POR CYANA2INE
Data Requirements
Compos i t iorxV
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use^/
Crop Group 1 - Legume Vegetables
, Crop 1 (Soybeans)
— Crop field trials TEP
Crop Group 2 - Cereal Grains Group
Crop 1 (Corn)
— Crop field trials
Crop 2 (Grain Sorghum)
— Crop field trials
Crop 3 (fcheat)
— Crop field trials
TKP and
metabolites
TEP and
metabolites
TEP and
metabolites
N/A2/
Partially
Partially
Partially
GS0066-15
GS0066-16
GS0066-17
00044420
GS0066-18
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?2/
$158.125 Residue Chemistry (continued)
171-4
- Storage Stability Data
PAI and Partially
metabolites
00022792
00026435
Yea5/
Yes§/
-------
GENERIC DATA REQUIREMENTS FDR CYANAZINB
Data Requirement
Composltionl/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.125 Residue Chemistry (continued)
Crop Group 2 (Cereal Grains) (continued)
Crop 4 (Forage, Fodder and Straw of
Cereal Grains Group)
t\>
— Crop field trials
Crop 5 (Grain Sorghum forage
and fodder)
— Crop field trials
TEP and
metabolites
TEP and
metabolites
Crop 6 (Viieat forage and straw)
— Crop field trials
Miscellaneous Commodities
— Cottonseed
TEP and
metabolites
TEP and
metabolites
— Meat/mi Ik/poultry/eggs . TGAI or plant
metabolites
Partially
Partially
Partially
Partially
Partially
GS0066-16
GS0066-17
GS0066-19
00044432
GS0066-18
GS0066-21
00093192
00022792
00022795
00022796
00023869
GS0066-09
Yes6/
Yea6/
Yes6/
Yes§/
Reserved!/
-------
1 GENERIC DATA REQUIREMENTS FOR CYANAZINE
S158.125 Residue Chemistry
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP »
Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than six months after publication of this Standard, unless otherwise indicated.
3/ Additional metabolism data depicting more clearly the nature of the final residues in poultry and ruminants utilizing
cyanazine are required.
4/ Registrants must submit validation data for the methods used to determine plant metabolites and animal residues, if
necessary.
5/ If additional metabolites of concern are found, then registrants must submit storage stability data on such
metabolites (in plants and animals, if necessary).
6/ At present, cyanazine tolerances are expressed in terms of the parent compound only. Data including the qualitative
' and quantitative information on all metabolites containing the triazine moiety must be submitted for corn, cotton,
sorghum, and wheat.
7/ Cyanazine is not currently registered for use on soybeans, but a petition is pending. Data on the residues of parent
compound and metabolites containing the triazine moiety must be submitted to support a registration for use on
soybeans.
8/ These data requirements will depend on the outcome of the animal metabolism studies. If data are required, it will be
in the form of poultry and ruminant feeding studies at three concentrations, as per the Residue Chemistry Guidelines.
In addition to feeding the animals the parent compound, major plant metabolites must be fed at appropriate levels.
-------
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Data Requirement
Composition!/ Pattern?/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under PIFRA Section
Citation 3(c)(2)(B)?l/
SI58.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
\
161-4 - In air
METABOLISM STUDIES-LABt
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA N/A
TGAI or PAIRA N/A
No
No
No
No
Partially
No
No
No
00022853 00044431
00023212 00093202
00027862
Yes
Yes
Yes
No!/
YesV
Yes5/
NoV
NoV
-------
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Data Requirement Compos itiorxV Pattern?/
$158.130 Environmental Fate
(continued)
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA A,B
Adsorption/Desorption
163-2 - volatility (Lab) TEP A,B
163-3 - Vblatility (Field) TEP A,B
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP A,B
164-2 - Aquatic TEP N/A
164-3 - Forestry TEP N/A
164-4 - Combination and A,B
Tank Mixes
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Partially
No
No
Partially
No
No
Yes
•
00071228
05017166
05018132
-
-
00026261 00064604
00026264 00064605
00063847 00064606
-
-
00023820
00027093
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Yes7/
Noi/
NoV
Yes§/
NQ§/
NoV
No?/
164-5 - Soil, Long-term
TKP
A,B
No
-------
TW^PIT
10
GENERIC DATA REQUIREMENT? FOR CYANAZINE
Does EPA Have Data Must Additional
To Satisfy this Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Compos it ioni/ Pattern2/ No or Partially) Citation 3(c) (2)(B)?!/
SI 58. 130 Environmental Fate
ACCUMULATION STUDIES:
165-1 - Rotational Crops PAIRA A No
(Confined)
165-2 - Rotational Crops TEP A Yes
(Field)
165-3 - Irrigated Crops TEP N/A No
165-4 - In Fish TGAI or PAIRA A,B Yes
165-5 - In Aquatic Non-Target TEP N/A No
Organisms
SI 58. 140 Reentry Protection TEP A No
Monitoring of Surface and TEP A,B No
Noil/
00023716 00064604 No
00026261 00064605
00063847 00064606
No
GS0066-08 No
No
No!2/
Yea!!/
Ground Miter
-------
TAJ
11 GENERIC DATA REQUIREMENTS FDR CYANAZINE:
S158.130 Environmental Fate
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: .A = Terrestrial, Food Crop; B ^Terrestrial, Non-Food; C = Aquatic, Food
Crop; D = Aquatic, Non-Pood; E = Greenhouse, Food Crop; F = Greenhouse, Non-Pood; G « Forestry; H = Domestic
Outdoor; I = Indoor •
3/ Unless otherwise indicated, data must be submitted no later than six months after publication of this Standard.
4/ No data are required because cyanazine has a very low vapor pressure.
5/ The submitted studies lack data on the material balance between the parent compound and its degradates. Data must
he submitted no later than 24 months after publication of this Standard.
, 6/ No data are required because cyanazine does not have any aquatic, forestry, or aquatic impact uses.
f^-
-J
7/ An aged soil study of degradates is needed to fill the data requirements under this section.
B/ In the submitted studies, sampling depth was only 6 inches. Cyanazine has been found in ground water. Therefore,
registrants mist submit studies in which samples were taken beyond the leaching depth. Data must be submitted no
later than 24 months after publication of this Standard.
9/ No data are required because this standard deals only with single active ingredient products.
10/ No data are required because cyanazine dissipates rapidly in the environment.
ll/ No data are required because field data showed no accumulation in rotated crops.
/'\2f No data are required because cyanazine does not meet the criteria set forth in Subpart K. Workers reentering
\s treated fields are not expected to be exposed to significant amounts of residue, based on the registered use patterns.
J_3/ The rationale for requiring these data is given in the registration standard text. Data must be submitted within
18 months after the publication of this Standard.
-------
12
TABHBPT
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes
Data Requirement Composition!/ Patterns2/ NO or Partially)
Must Additional
Data Be Submitted
, Bibliographic Under FIFRA Section
Citation 3(c)(2) (B)?l/
$158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
- Rat
- Primary Eye Irritation -
Rabbit
- Primary Dermal Irritation
- Dermal Sensitization
- Acute Delayed
Neurotoxicity - lien
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
N/A
Yes
Yes
Yes
Yes
Partially
Yes
No
00026424 No
00026425 No
000227?« NO
00026427 No
00026428 Yes
00026428 No
NOV
SUBCHRON1C TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent,
Non-rodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
N/A
N/A
N/A
Yes
Yes
No
No
No
00093193 No
00093199 No '
NoV
NoV
NoV
Rat
82-5 - 90-Day Nuurotoxicity-
•• 'Maniivjl
TGAI
N/A
No
NoV
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13
IJL,H^
TABLE
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Data Requirement
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Composition!/ Patterns?./ No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
§158.135
83-1 -
83-2 -
83-3 -
83-4 -
Toxicology (continued)
CHRONIC TESTING:
Chronic Toxicity - TGAI A
2 species: Rodent
and Non-rodent
Oncogenicity Study - TGAI A
2 species: Rat and
Mouse preferred
Teratogenicity - TGAI A
2 species
Reproduction - TGAI A
2-generation
No
Partially
Partially
No
Yes6/
00100503 YesV
00125660 Yes§/
ObCrUOJL.b
Yesl/
MUTAGENICITY TESTING
84-2 -
84-2 -
84-2 -
Gene Mutation TGAI A
Chromosomal Aberration TGAI A
Other Genotoxic TGAI A
No
Partially
No
Yesl°/
00023836 Yea!!/
Yea!?/
Effects
-------
14
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Data Requirement
Use
Composition!/ Pattern2/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(cM2)(B)?
§158.135 Toxicology (continued)
SPECIAL TESTING;
85-1 - General Metabolism
85-2 - Dermal Absorption
PAI or PAIRA
TEP
All
Yes
No
00032348
00022856
No
Yesll/
I/ Composition: TGAI = technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
% ingredient, radiolabelled; Choice = Choice of several test'substances determined on a case-by-case basis.
TEP = Typical end-use product.
2/ Possible use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Pood; C = Aquatic, Pood
Crop; D = Aquatic, Non-Food; E = Greenhouse, Non-Food; G *» Forestry; H = Domestic Outdoor; I = Indoor.
Unless otherwise specified, data must be submitted no later than six months after the publication of this Standard.
-------
15 GENERIC DATA REQU IREjeTCS HOR CYANAZINE
Si SB. 135 Toxicology
(continued)
4/ Data are not required, because cyanazine is not known to have toxic effects to neurological systems.
5/ Requirement is contingent upon the outcome of the worker exposure analysis.
6/ Testing is required in both rats (3-year study) and dogs (2-year study). Data from the dog study nust be submitted no
later than two years after the publication of this Standard. Data frcm the rat study must be submitted no later than
three years after the publication of this Standard.
7/ Testing is required in the rat. Testing should be performed according to a modified protocol to include plant
metabolites and to investigate possible nitrosamine formation. Data must be submitted no later than three years after
the publication of this Standard
8/ Testing is required in the Fischer 344 rats. Data must be submitted no later than one year after the publication of
this Standard.
9/ Testing is required. The Agency prefers data submissions based on the Fischer 344 rat. Data must be submitted no
later than twenty months after publication of this Standard.
1Q/ Testing is required in microbiological systems (Ames assay), and in mammalian cells (mouse lymphoma L5178Y; or CHO,
ItGPRT locus). Data is required on both the parent compound and plant metabolites.
ll/ Testing is required in an in vitro system (SCE in CHO cells or cells or other mammalian cell lines); and in an in vivo
system (dominant lethal test in rodents). Data must be submitted no later than twelve months after the publication of
this Standard. Data is required on both the parent coipound and plant metabolites.
12/ Testing is required for DMA repair in mammalian cells, using both the parent compound and plant metabolites.
13/ Registrants have been sent a S3(c)(2)(B) letter requiring submission of this data no later than July 1, 1985.
-------
KJ
\
16
GENERIC DATA REQUIREMENTS FOR CYANAZINE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Compos itioni/ Pattern?/ No or Partially) Citation 3(c)(2) (B)?3/
S158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI A,B Partially
71-2 - Avian Dietary Toxicity TGAI A,B No
71-3 - Wild Manmal Toxicity TGAI A,B No
71-4 - Avian Reproduction TGAI A,B No'
71-5 - Simulated and Actual TEP A,B No
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Acute Toxicity
- Freshwater Fish TGAI A,B Yes
72-2 - Acute LC50 Freshwater TGAI A,B Partially^/
GS0066-22 Reserved!/
GS0066-23
Yes
No
Reserved*/
No
GSO 28026 (Johnson & No
Finley)
GS028026 Yes
Invertebrates
72-3 - Acute U:$Q Estuarine
and Marine Organisms
TGAI
A,B
Yes
00093206
No
-------
17
TABCE A
GENERIC DATA REQUIREMENTS BOR CYANAZINB
Data Requirement
Use
Composition!/ Pattern2/
Does ERA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)?3/
S15B.145 Wildlife and Aquatic Organisms (continued)
72-4 - Fish Early Life TGAI A,B No
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish - Life-Cycle TGAI A,B No
72-6 - Aquatic Organism TGAI A,B No
Accumulation
72-7 - Simulated or Actual TGAI A,B No'
Field Testing -
Aquatic Organisms
No
No
No
No
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient) TEP = Typical end-use
product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B » Terrestrial, Non-Pood; C = Aquatic, Food
Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic
Outdoor; I = Indoor
3/ Unless otherwise specified, data must be submitted no later than six months after publication of this Standard.
4/ Reserved pending evaluation of the results of guidelinge citation 71-2.
5/ Mature organisms were used in the submitted study. Another study, using the more sensitive immature stages, must be
submitted.
-------
18
GENERIC DATA REQU
FOR CYANAZINE
Data Requirement
Use
Composition!/ Pattern2/
Does. EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under PIFRA Section
No, or Partially) .Citation 3(c)(2)(B)?3/
S15B.155 Nontarget Insect
NONTARGET INSECT TESTING -
Pollinators:
141-1 - Honey bee acute
contact toxicity
141-2 - Honey bee toxicity of
residues on foliage
141-3 - Wild bees important in
alfalfa pollination-
toxicity of residues
on foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for
pollinators
TGAI
TEP
TEP
TEP
TEP
Yes
No
No
00006652
No
No
No
No
No
IReservedI*/
No
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19
GENERIC DATA RBQU
FOR CYANAZINE
Data Requirement
Use
Composition!/ Pattern?/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?3/
VJt
vn
5158.155 Nontarget Insect (continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to TGAI
aquatic insects
142-2 - Aquatic insect TGAI
life-cycle study
142-3 - Simulated or actual TGAI
field testing for
aqua tic i nsects
143-1- NONTARGET INSECT TESTING TGAI
thru PREDATORS AND PARASITES
143-3
No
No
No.
No
iReservedlV
iReservedji/
IReserved)*/
I Reserved) i/
I/ Composition: TGAI = Technical grade of the active ingredient; TEP » Typical end-use product.
2/ The use pattern codes are as follows: A = Terrestrial, Food Crop} B = Terrestrial, Non-Food; C =» Aquatic, Food Cropj
D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H =• Domestic Outdoor;
I = Indoor.
3/ Data must be submitted no later than six months after publication of this Standard, unless otherwise indicated.
4/ Reserved pending decision as to whether data requirements should be established.
-------
20
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING CYANAZINE (94% TECHNICAL)!/
Data Requirement Composition?/
§158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of Product
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
MP
MP
MP
Ingredients
MP
MP
MP
MP
MP
MP
MP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes
Partially
Partially
Partially
Partially
Partially
Yes
Yes
Yes
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
Refer to Product No
Chemistry Chapter
Yea4/
YeaV
YesV
YeaZ/
Yes§/
No
No
No
Yes
specific gravity
-------
21
TAHTE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CYANA2INB (94% TECHNICAL)
Data Requirement
Composition!/
Does EPA Have: Data
To Satisfy This
Requirement? (Yes,
No, Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
$158.120 Product Chemistry (continued)
63-12 - pH MP
63-14 - Oxidizing/Reducing Action MP
63-15 - Flammability MP
63-16 - Explodability MP
63-17 - Storage stability MP
63-18 - Viscosity N/A9/
63-19 - Miscibility N/A?/
Other Requinnents;
64-1 - Submittal of samples N/A
No
No
No
No
No
N/A
N/A
N/A
Refer to Product
Chemistry Chapter
Yes
Yes
Yes
Yes
Yes
No
No
No
I/ The 94% technical also serves as a manufacturing-use product.
2/ Composition: MP = manufacturing-use product.
3/ Data must be submitted no later than six months after publication of this Standard, unless otherwise indicated.
4/ Information is required on the details of the manufacturing process, such as the purities of the starting materials,
description of the reaction conditions, any quality control measures used for the technical and the flowable
intermediate products, and the name and address of the manufacturer or producer of the starting materials.
5/ Information is required on any impurities believed to be present at >0.1%, based on knowledge of the beginning
materials, all passible chemical reactions, and any contamination.
6/ Data is required on analysis of five or more representative samples of the 94% technical for the amount of active
ingredient and each impurity present for which a certified limit is required. Data must include a description of the
analytical methods used to analyze the unintentional ingredients present at >0.1%, other than the nitrosamines.
T/ Upper and lower limits must be provided (and certified) for the active ingredient and each intentional added
ingredient in the 94% technical, and limits must be provided for all impurities associated with the active ingredient.
8/ Data must be provided on a quantitative method to determine the unintentional ingredients (if >0.1%).
9/ Not required, because the 94% technical is a solid at room temperature.
-------
22
PRDDOCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING CYANAZINE (28.2% PI)
VJl
CW
Data Requirement Compositionl/
$158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Impurities
Analysis and Certification of Product
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
MP
MP
MP
Ingredients
MP
MP
MP
MP
MP
MP
MP
t l
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes
Partially
No
Partially
Partially
Partially
No
Yes
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?2/
Refer to Product No
Chemistry Chapter
Yeal/
YeaV
YesV
Yes6/
Yes!/
Yes
No
Yes
Yes
specific gravity
-------
23
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CYANAZINB (28.2% FI)
Data Requirement
CcnpositionV
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
S158.120 Product Chemistry (continued)
63-12 - pH MP
63-14 - Oxidizing/Reducing Action MP
63-15 - Flammability MP
63-16 - Explodability MP
63-17 - Storage stability MP
63-18 - Viscosity MP
63-19 - Miscibility MP
3 Other Requirements;
64-1 - Submittal of Samples N/A
No
No
No
No
No
No
No
N/A
Refer to Product
Chemistry Chapter
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
I/ Composition: MP = Manufacturing-use product; Choice = Choice of several test substances determined on a case-by-case
basis; FI = Flowable Intermediate
2/ Data must be submitted no later than six months after publication of this Standard unless otherwise specified.
3/ Information is required on the details of the manufacturing process, such as the purities of the starting materials,
description of the reaction conditions, any quality control measures used for the technical and the flowable
intermediate products, and the name and address of the manufacturer or producer of the starting materials.
4/ Information is required on any impurities believed to be present at >0.1%, based on knowledge of the beginning
materials, all possible chemical reactions, and any contamination.
5/ Data is required on analysis of five or more representative samples of the 28.2% flowable intermediate for the amount
of active ingredient and each impurity present for which a certified limit is required. Data must include a
description of the analytical methods used in the analysis of the unintentional ingredients present at >1.0%, other
than the nitrceamines.
6/ Upper and lower limits must be provided (and certified) for the active ingredient and each intentional added
ingredient in the 28.2% flowable intermediate, and limits nust be provided for all impurities associated with the
active ingredient.
7/ Data must be provided on a quantitative method to determine the unintentional ingredients (if >0.1%).
-------
,IV. SUBMISSION OF REVISED LABELING .INFORMATION
Note: This section applies to end use products only to the
extei.t described In Section .1 (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FJFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and Its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix ,IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix JV-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 and/or Section I, 'EPA may Issue
a notice ;pf intent to cancel the registration under FJFRA
sec. 6(b)(l).
: •. : A. Label Contents
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items
listed below are keyed to Appendix JV-2.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
In tj
-------
size and style similar to other print on that part of the
label on which It appears and roust run parallel to It. The
registration number and the required Identifying phrase -must
not »ppear In such a manner as to suggest or Imply recommendation
or endorsement of the product by the Agency. See Appendix JV-1.
[40 CFR I62.10(c)]
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 JV-1. [40 CFR l62.10(f)]
Jtem 6. .INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel and must contain the name and
percentage, by weight of each active Ingredient and the total
percentage' by weight of all inert ingredients. The preferred
location Is immediately below the product name. The 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 JV-1. [40 CFR l62.10(g)]
•Item 6A. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active Ingredient
must be indicated on the label.
Jtem 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
on Front Panel
in Square Jnches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word as Re-
quired Minimum Type
Size All Capitals
6 point
10 point
12 point
14 point
18 point
"Keep Out of Reach
of Children"
as Required
6 point
6 point
8 point
10 point
12 point
.Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix JV-1.
[40 CFR I62.10(h)(l)(ii)]
Jtem 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) Is required on the front panel immediately below
the child hazard warning statement. See Appendix JV-1.
[40 CFR 162.10 (h)(l)(i)]
a
-------
-Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxiclty Category .1 on the basis of oral, dermal,
or Inhalation toxiclty, the word "Poison" shall appear on the
label In red on a background of distinctly contrasting color and
the Lkull and crossbones shall appear In Immediate proximity to
the word POISON. See Appendix JV-1 . [HO CFR I62.10(h) (1) (1 ) ]
.Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products In toxiclty Categories .1,
.II, and -III. See Appendix JV-1. [HO CFR I62.10(h) (1 ) (111 )]
Jtem TE. 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 JV-1. [HO CFR I62.10(h) (1) (111)]
Jtem 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label .under the heading "PRECAUTIONARY STATEMENTS."
The preferred location Is at the top of the side or back
.panel preceding' the directions for use, and It Is preferred
'that these statements be surrounded by a block outline. 'Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix JV-1. [HO CFR 162.10
Jtem 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 JV-1. [HO CFR 162.10
Jtem 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 JV-1. [HO CFR
Jtem 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammablllty statement. Precautionary statements relating
to f lammabllity of a product are required to appear on the
label if it meets the criteria in Appendix JV-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.
62
-------
2. Criteria for declaration of non-flammabllity. The
following criteria will be used to determine If a product
Is non-flammable: .- -
a. A "non-flammable gas" Is a gas (or mixture of gases)
that will not Ignite when a lighted match Is placed
against the open cylinder valve.
b. A "non-flammable liquid" Is one having a-flashpoint
greater than 350°P (177°C).
c. A "non-flammable aerosol" Is one which meets the
following criteria:
1. The flame extension Is zero Inches;
11. There Is no flashback; and
111. The flashpoint of the -non-volatile liquid
component Is greater than 350°P (177°C).
3. Declaration of non-flammablllty. Products which
meet the criteria for non-flamraablllty specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. ,It may
appear as a substatement to the Ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an Inordinately large type
size) In any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammablllty, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of exploslvlty, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
.Item 9. PRODUCT CLASSIFICATION - Section 3(d) of P.IPRA
requires that all pesticide formulations/uses be classified
for either general or restricted use, and that those uses
classified as restricted be limited to use by certified
applicators or persons under their direct supervision (or
subject to other restrictions that may be imposed by regulation).
.In the Registration Standard, the Agency has (1) Indicated
certain formulations/uses to be restricted, based either on a
previous classification determination made through the optional
procedures of HO CPR 162.30 or based on data already available
to the Agency, or (2) reserved any classification decision until
appropriate data are submitted.
63
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The Regulatory Position and Rationale states whether
products containing this active Ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you wish to propose that your product should not be
classified for restricted use, you must submit any Information
and rationale with your application for rereglstratlon.
During the Agency's review of your application, your proposed
classification determination will be evaluated in accordance with
the provisions of HO CPR I62.11(e). You will be notified of
the Agency's classification decision.
A. Classification Labeling Requirements
1. All Uses Restricted - Pesticide products bearing
directions for use for formulations or uses classified
restricted shall bear statements of restricted use classi-
fication on the front panel as described below:
a. The statement "RESTRICTED USF PESTICIDE,"
must appear 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
1*0 CFR I62.10(h)(l)(lv).
i
b. Directly below this statement on the front
panel, a summary statement of the terms of restric-
tion 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."
2. Some But Not all Uses Restricted - If the Regula-
tory Position and Rationale states that some uses are
classified for restricted use and some uses are unclassified,
several courses of action are available:
a. You may label the product for restricted use.
If you do so, you may include those 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 unres-
tricted uses.
64
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c. You may "split" your registration, I.e.,
register two separate products with Identical formula-
tions, one containing only unrestricted uses, and
the other restricted uses. To do so, submit two
applications for rereglstratlon, each containing all
forms and necessary labels. Both applications should
be submitted simultaneously. Note that the product
names will be assigned separate registration numbers.
B. Compliance Schedules
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, JO A. 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-l< to determine the disposal instructions appropriate for
your products.
.Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other graphic printed matter which is referred to
on the label or which is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
In connection with registration of the product. .It should be
made part of the response to this notice and submitted for
review.
65
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V. .INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows: 1.
Robert Taylor
Product Manager
registration Division (TS-767C)
Office of Pesticide Programs
'Environmental Protection Agency
Washington, D.C. 20160
Phone No. (703) S57'1 80°
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "PIPRA Section 3(c)(2)(B) Summary Sheet" 'EPA
Form 8580-1. Refer to Appendix .11-3 with appropriate
attachments.
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, 'EPA Form 8570-^.
b. Product Specific Data Report, 'EPA Form 8580-U
(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 specif-
ically with the instructions in Section .II (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 raockup 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 PIPRA sec. 3(c)(l)(D). Refer to PR Notice 8H-1| (enclosed)
for latest requirements.
3. Within the times set forth in Table A. all generic data
must be submitted.
Note; If for any reason any required test is delayed or
aborted so that meeting the agreed submission time will be
-delayed, notify the Product Manager.
66
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Guide to Use of This Bibliography
1. Content of Bibliography: This bibliography contains citations of all the
studies reviewed by EPA in arriving at the positions and conclusions stated
elsewhere in the Standard. The bibliography is divided into two sections:
(1) citations that contributed information useful to the review of the chemical
and that are considered to be part of the data base supporting registrations
under the Standard, and (2) citations examined and judged to be inappropriate
for use in developing the Standard. This second part of the bibliography
exists in the Agency's files and does not accompany this Standard. Interested
parties may request a copy fron the Agency. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its
predecessor agencies in support of past regulatory decisions, and the published
technical literature.
2. Units of Entry: The unit of entry in this bibliography is called a "study".
In the case of published materials, this corresponds closely to an article.
In the case of unpublished materials submitted to the Agency, the Agency
has sought to identify documents"at a level parallel to the published
article frcm within the typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review, and can be described with a
conventional bibliographic citation. The Agency has attempted also to unite
basic documents and ccnmentaries upon them, treating them as a single study.
67
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11
3. Identification of Entries: The entries in this bibliography are sorted by
author, date of the document, and title. Each entry bears, to the left of the
citation proper, an eight-digit numeric identifier. This number is unique to
the citations, and should be used at any tune specific reference is required.
This number is called the "Master Record Identifier", or "MRID". It is not
related to the six-digit "Accession Number" which has been used to identify
volumes of submitted data; see paragraph 4(d)(4) below for a further
explanation. In a few cases, entries added to the bibliography late in the
review may be preceded by an eight-character temporary identifier. This is
also to be used whenever specific reference is needed.
4. Pom of the Entry: In addition to the Master Record Identifier (MRID),
each entry consists of a bibliographic citation containing standard elements
followed, in the case of materials submitted to EPA, by a description of the
earliest known submission. The bibliographic conventions used reflect the
standards of .the American National Standards Institute (ANSI), expanded to
provide for certain special needs. Some explanatory notes of specific
elements follow;
a. Author: Whenever the Agency could confidently identify one, the
Agency has chosen to show a personal author. When no individual was
identified, the Agency has shown an identifiable laboratory or
testing facility as author. As a last resort, the Agency had shown
the first known submitter as author.
: b. Document Date: When the date appears as four digits with no question
marks, the Agency took it directly fron the document. When a four
digit date is followed by a question mark, the bibliographer deduced
the date fron evidence in the document. When the date appears as
(19??), the Agency was unable to determine or estimate the date of
the document.
68
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iii
c. Title: This is the third element in the citation. In sane cases it
has been necessary for Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between
square brackets.
d. Trailing Parentheses: For studies submitted to the Agency in the
past, the trailing parentheses include (in addition to any self-
explanatory text) the following elements describing the earliest
known submission:
(1) Submission Date: Immediately following the word 'received'
appears the date of the earliest known submission.
(2) Administrative Number: The next element, immediately following
'.the word 'under', is the registration number, experimental
permit number, petition number, or other administrative number
associated with the earliest known submission.
(3) Submitter: The third element is the submitter, following the
phrase 'submitted by'. Vften authorship is defaulted to the
submitter, this element is omitted.
(4) \tolume Identification: The final element in the trailing
parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six
digit accession number follows the symbol 'CDL', standing for
"Company Data Library". This accession number is in turn
followed by an alphabetic suffix which shows the relative
position of the study within the volume. For example, within
accession number 123456, the first study would be 123456-A; the
second 123456-B; the 26th, 123456-Z, and the 27th 123456-AA.
69
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IV
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cyanazine Standard
00006652 Atkins, E.L.; GreywxxJ, E.A.; Macdonald, R.L. (1973) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees:
Laboratory Studies. Rev. By Univ. of California, Dept. of
Entomology. Riverside, Calif.: U.C. (Agricultural Extension
M-16; also in unpublished submission received Nov 17, 1975 un-
der 359-620; submitted by Rhone-Poulenc, Inc., Monmouth Junc-
tion, N.J.; CDL.-223344-A)
00015609 Shell Development Company (1976) Residue Determination of Bla-
dex (R) Herbicide in Crops and Soil: GLC-Electron Capture De-
tector Method. Method MMS-R-202-4 dated Apr 1976. (Unpublished
study received Oct 20, 1978 under 100-583; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:235359-S)
00022270 Shell Development Company (1973) Residue Determination of
Bladex (R) Herbicide in Crops: GLC-Alkali Flame lonization De-
tector. Method MMS-R-218-4 dated Mar 1973. (Unpublished study
received Jul 2, 1979 under 476-2157; submitted by Stauffer Chem-
ical Co., Richmond, Calif.; CDL:238817-F)
00022775 Beynon, K.I.; Stoydin, G.; Wright, A.N. (1972) The breakdown of the
Triazine herbicide Cyanazine in wheat and potatoes grown under
indoor conditions in treated soils. Pesticide Science 3(? ):
379-387. (Also in unpublished submission received Jan 7, 1976
under 6F1729; submitted by Shell Chemical Co., Washington, D.C.;
CDL:094884-G)
00022786 Shell Development Company (1975) Residue Determination of the Chlo-
ro and Hydroxy acid Metabolites of Bladex (R) Herbicide in Wa-
ter, Soil, and Crops: GLC-Alkali Flame lonization Detector.
Method MMS-R-357-3 dated Oct 1975. (Unpublished study received
Jan 7, 1976 under 6F1729; CDL:094884-AH)
00022792 Shell Chemical Co. (1979) Report Nos. TIR-22-106-77 and TIR-22-106-78.
received July 18, 1979 under 9F2232 submitted by Shell Chemical
(Ace. No. 098395-D-6 and 7) titled "Residues of 14C in Milk and
Tissues from Cows Fed SD 33104-1^ by J.C. Potter.
Shell Chemical Co. (1979) Storage Stability of Frozen Residue Samples.
Received July 18, 1979 under 9F2232 (Ace. No. 098395-D-12)
70
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00022795 Potter, J.C.; Arnold, D.L. (1977) Residues of 14C in Milk and
Tissues from Cows Fed SD 33104-14C: TIR-22-106-78. Including
four undated methods. (Unpublished study received Jul 18, 1979
under 201-279; submitted by Shell Chemical Co., Washington,
D.C.; CDL:098395-Q)
00022796 Potter, J.C. (19??) Residues of 14C in Milk and Tissues from Cows
Fed SD 31224-14C: TIR-22-106-77. Including six undated meth-
ods. (Unpublished study received Jul 18, 1979 under 201-279;
submitted by Shell Chemical Co., Washington, D.C.; CDL:098395-R)
00022798 Shell Chemical Company (19??) Storage Stability of Frozen Residue
Samples. (Unpublished study received Jul 18, 1979 under 201-
279; CDL:098395-X)
00022853 Beynon, K.I.; Stoydin, G.; Wright, A.N. (1972) The breakdown of the
Triazine herbicide Cyanazine in soils and maize. Pesticide
Science 3(? ):293-305. (Also in unpublished submission received
Oct 7, 1977 under 100-566; submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:231969-A)
00022856/; Crayford, J.V.; Hutson, D.H. (1972) The metabolism of the herbi-
cide, 2-Chloro-4-(ethylaniino)-6-(l-cyano-l-tnethylethylamino)-
:S Triazine in the rat. Pesticide Biochemistry and Physiol-
ogy 2(? ):295-307. (Also in unpublished submission received Oct
7, 1977 under 100-566; submitted by Ciba-Geigy Corp., Greens-
boro, N.C.; CDL:231969-E)
00023132 Shell Chemical Company (19??) A Study of the Possible Interference
of Other Pesticides with the Analytical Methods for SD 15418,
SD 20262, SD 20258 and SD 31222-D. (Unpublished study including
TIR-26-113-73, received Jul 18, 1979 under 201-279; CDL:
098395-W)
00023212 Shell Chemical Company (1970) Table of Radiolabelled Components
from Bladex Metabolism Study. (Unpublished study received Jul
1, 1971 under unknown admin, no.; CDL:221995-Q)
00023716 'Zimdahl, R. (1974) Residue Data for Bladex in Wneat and Straw:
TIR-24-107-70. (Unpublished study including TIR-24-104-70, TIR-
24-120-70, TIR-24-126-72...and data found in 094884-AI, received
Dec 10, 1974 under 201-379; prepared in cooperation with Colora-
do State Univ., submitted by Shell Chemical Co., Washington,
D.C.; CDL:028277-E)
••71
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VI
00023820
00023828
00023829
00023869
00026261
00026264
00026424
00026425
00026427
Shell Development Company (1975) Dissipation of Bladex (R) Herbi-
cide and Sutan in Soil following Application of Bladex, Sutan,
or a Tank Mix of Bladex and Sutan: TIR-24-134-74. - (Unpublished
study including FSDS no. A-10063, received Jan 6, 1976 under
476-2180; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:224370-J)
Shell Development Company (1970) Residue Determination of Bladex
Herbicide in Corn: GLC-Cesiutn Bromide/Flame Detector Method.
Method MMS-R-218-2 dated Aug 1970. (Unpublished study re-
ceived Mar 28, 1973 under 3G1377; CDL:095516-H)
Shell Development Company (1973) Residue Determination of Bla-
dex (R) Herbicide in Crops: GLC-Alkali Flame lonization Detec-
tor. Method MMS-R-218-3 dated Feb 1973. (Unpublished study
received Mar 28, 1973 under 3G1377; CDL.-095516-I)
Shell Chemical Company (1970) 1970 Residue Data for Bladex Herbi-
cide in Chicken Tissue and Eggs from Hens Fed This Chemical.
(Unpublished study received Jul 1, 1971 under unknown admin.
no.; CDL:221995-AP)
Shell'Chemical Company (1970?) Dissipation of Residues in Soil:
Rate of Dissipation. (Unpublished study received Jul 1, 1971
under unknown admin, no.; CDL:221995-B)
Shell Chemical Company (1971) Soil Residue Data for Bladex.
published, study received Sep 23, 1971 under OF0998; CDL:
094492-A)
(Un-
Young, S.M.; Adamik, E.R. (1979) Acute Oral Toxicity Study in Rats
with SD 15148 (Technical Bladex (R) Herbicide): Code 16-8-0-0:
Project No. WIL-1223-78. (Unpublished study received Jan 10,
1980 under 201-281; submitted by Shell Chemical Co., Washington,
D.C.; CDL:099198-B)
Young, S.M.; Adamik, E.R. (1979) Acute Dermal Toxicity Study in
Rabbits with SD 15418 (Technical Bladex (R) Herbicide): Code
16-8-0-0: Project No. WIL-1223-78. (Unpublished study received
Jan 10, 1980 under 201-281; submitted by Shell Chemical Co.,
Washington, D.C.; CDL:099198-C)
Young, S.M.,;Adamik, E.R. (1979) Acute Eye Irritation study in Rabbits
with SD 15418 (Technical BLADEX* Herbicide): Code-16-8-0-0: Project
No. WIL-1223-78. (Unpublished study received Jan 10, 1980 under 201-
281; submitted by Shell Chemical Co., Washington, DC; CDL:099198-E)
.72
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vii
00026428 Young, S.M.; Adamik, E.R. (1979) Delayed Contact Hypersenisitivity
Study in Guinea Pigs with SD 15418 (Technical BLADEX* Herbicide):
Code 16-8-0-0: Project No. WIL-1223-78. (Unpublished Study received
Jan 10, 180 under 201-281; submitted by Shell Chemical Co., Washington,
D.C.;CDL:099198-F)
00026435 Mancniller, R.L. (1979) Determination of Bladex (R) Herbicide Sta-
bility in Peanuts following Storage at -20° C for 18 Months:
TIR 24-265-77C. (Unpublished study received Jan 10, 1980 under
201-281; submitted by Shell Chemical Co., Washington, D.C.; CDL:
099198-Q)
00027093 Shell Chemical Company (1976) Dissipation of Bladex (R) Herbicide
and Sutan in Soil following Application of Bladex, Sutan Plus,
or a Tank Mix of Bladex and Sutan Plus: TIR-24-134-74. (Unpub-
lished study including FSDS No. A-10063, received Apr 22, 1976
under 201-279; CDL:224067-B)
00027862 Beynon, K.I.; Stoydin, G.; Wright, A.N. (1972) A Comparison of the
breakdown of the Triazine herbicides Cyanazine, Atrazine, and
>: Simazine in Soils and in Maize. Pesticide Biochemistry and
Physiology 2(? ):153-161. (Also in unpublished submission re-
ceived Jul 17, 1978 under 100-541; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:234455-B)
00032348 Shell Chemical Company (1969) Metabolism. (Unpublished study re-
ceived Jun 5, 1969 under 9G0844; CDL:095023-G1
00044420 Shell Chemical Company (1974) Residue Data Developed from the Use
of Bladex (R) Herbicide on Sorghum. (Unpublished study re-
ceived on unknown date under 5F1532; CDL:094155-E)
00044431 Shell Chemical Ccmpany (1970) Metabolian: Plants and Soil.
(Unpublished study received on unknown date under 5F1532; CDL:
094156nJ)
00044432 Shell Chemical Ccmpany (1973) Bladex Herbicide in Grain: TIR-24-
148-72A. (Unpublished study including TIR-24-118-72A, TIR-24-
: 118-73A and TIR-24-150-73A, received on unknown date under
5F1532; CDL:094156-M)
00044453 Shell Development Ccmpany (1969) Determination of SD 15418 Residues
in Corn Kernels and Other Corn Tissues, Oats and Soil: GLC-Elec-
tron Capture Method. Method MMS-R-202-2 dated Oct 1969. (Un-
published study received Jun 5, 1969 under 9G0844; CDL:093140-F)
00063847 Shell Chemical Ccmpany (1970) Summary of Information Regarding
SD 15418 Residues on Corn. (Compilation; unpublished study re-
ceived on unknown date under OF0998; CDL:091722-A)
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viii
00064604 Shell Chemical Company (1970) Residue Data by Isotope Dilution Pro-
cedure for Compound XII and XIII in Soybeans (Follow-up Crop).
(Unpublished study received Nov 15, 1970 under OF0998; CDL:
091725-A)
00064605 Shell Chemical Company (1970) Residue Data by Isotope Dilution Pro-
cedure for Compound XII and XIII in Sugarbeets (Follow-up Crop).
(Unpublished study received Nov 15, 1970 under OF0998; CDL:
091725-B)
00064606 Shell Chemical Company (1970) Residue Data for Bladex and Compounds
XII and XIII in Oats (Follow-up Crop). (Unpublished study re-
ceived Nov 15, 1970 under OF0998; CDL:091725-C)
00071228 Lee, P.W. (1979) Determination of the Mobility of SD 9129, SD 6120,
SD 14114, SD 12011, SD 15418, SD 45328 and Selected Reference
Pesticides by Soil Thin-layer Chrcnatography: TIR-22-125-79.
(Unpublished study received Jan 22, 1981 under 201-157; submit-
ted by Shell Chemical Co., Washington, D.C.; CDL:099891-M)
00091020 Lu, C.C.; Tang, B.S.; Chai, E.Y.; et al. (1981) Technical Bla-
'' dex (R) (SD 15418) Teratology Study in Rats: Project No. 61230.
(Unpublished study received Jan 4, 1982 under 201-279; submitted
by-Shell Oil Co., Washington, D.C.; CDL:070584-A)
00093184 Shell Chenical Company (1970) Summary of Basic Data for Technical
Bladex (TM) Herbicide. San Ramon, Calif.: Shell. (Techni-
cal data bulletin ACD: 70-203; also unpublished submission
received Feb 28, 1975-under 5F1599; CDL:094364-B)
00093192 Shell Chemical Company (1974) Residue Data Developed frcm the Use
of Bladex (R) Herbicide on Cotton. Includes methods MMS-R-218-
4 dated Mar 1973 and MMS-R-202-3 dated Oct 1969. (Compilation;
unpublished study, including TIR-24-113-73, TIR-24-175-72, TIR-
24-195-72..., received Feb 28, 1975 under 5F1599; CDL: 094363-Q).
00093193 Shell Chemical Company (1969) Toxicology Summary: SD 15418.
' Summary of studies 091460-B through 091460-1. (Unpublished
study received Oct 17, 1969 under 9G0844; CDL:091460-A)
00093199 Walker, A.I.T.; Stevenson, D.E. (1968?) The Toxicity of the S-
Triazine Herbicide DW 3418: 13 Week Oral Toxicity Experiment
in Dogs: Group Research Report TLGR.0016.68. (Unpublished study
received Oct 17, 1969 under 9G0844; prepared by Shell Research,
Ltd., England, submitted by Shell Chemical Co., Washington,
D.C.; CDL:091460-G)
00093202 Shell Chemical Company (19??) Metabolism of SD 15418 in Corn and
Soil. (Unpublished study received Oct 17, 1969 under 9G0844;
CDL:091460-J)
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ix
00093206 Shell Chemical Company (1968) Toxicity of SD 15418 to Sheepshead
Minnow and Various Subjects. (Compilation of reports by U.S.
Pish and Wildlife Service, Bureau of Commercial Fisheries/
Biological Laboratory; unpublished study; CDL:091460-N)
00099198 Great Lakes Biochemical Conpany, Incorporated (19??) Slow Release
Algimycin PLL-C. (Unpublished study received Jan 30, 1974 under
7364-26; CDL:009692-C)
00100503 Gellatly, J.B.M.; Hend, R.W.; Cole, P.N.; et al. (1981) A TWo Year
Feeding Study of Bladex in Mice: Group Research Report
SBGR.81.171. (Unpublished study received Apr 7, 1982 under 201-
279; prepared by Sittingboume Research Centre, England, sub-
mitted by Shell Chemical Co., Washington, D.C.; CDL:247295-A;
247296; 247297; 247298)
00125660 Dix, K.; Cassidy, S.; Daniel, D.; et al. (1982) Teratology Study in
New Zealand Vhite Rabbits Given Bladex Orally: SBGR.82.357.
(Unpublished study received Feb 1, 1983 under 201-279; prepared
by Shell Research Ltd., Cng., submitted by Shell Chemical Co.,
Washington, DC; CDL:071382-A)
05017166 Majka, J.T. , et al (1977) Adsorption, nobility, and .01 of 01
degradation of cyanazine and diuron in soils. Weed V33200 Science
25(5):401-406.
05018132 Majka, J.T. (1976) Adsorption, mobility and 01 of 01 degradation
of Cyanazine and Diuron in Soils. V33907.
GSC066-01* Shell Chemical Co. (1969) Product Chemistry Data - Section A;
Received June 6, 1969 under 9G0844 (Ace. No. 116126-A)
GSC066-02 Shell Chemical Co. (1970) Technical Data Bulletin entitled "Summary of
Basic Data for Technical Bladex Herbicide". Received Jan 17, 1975
GSC066-03 Shell Chemical Co. (1975) Confidential Statement of Formula for EPA
Reg. No. 201-380; Received Jan 17, 1975
GS0066-04 Shell Chemical Co. (1977a) Determination of nitrosc—bladex and
nitrosoatrazine in technical bladex herbicide. Report No.
TIR-24-701-77-B. Submitted by Shell Chemical Co. in a letter
(dated 5/2/77) from E.L. Hobson of Shell to R.J. Hummel of the EPA
Nitrosanine Panel. Includes a description of the analytical method.
GSC066-05 Shell Chemical Co. (1977b) Determination of N-nitrosodimethylamine,
N-nitrosodiethylamine, and N-nitrosodi-n-propylanine in technical
bladex herbicide. Report No. TIR-24-701-77. Submitted by Shell
Chemical Co. in a letter (dated 2/16/77) from E.L. Hobson of Shell
to M.H. Rogoff of EPA. Includes a description of the analytical method,
.I1)
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GS0066-06* Shell Chemical Co. (1972) Technical Data Bulletin - Sunnary of Basic
Data for Technical Bladex* Herbicide; received Jan 10, 1980
under OG2314 (Ace. No. 099198) submitted by Shell Chemical Co.
Agric. Div., San Ramone, CA
GS0066-07 EPA (1976) Cyanazine EPA-1. In EPA Manual of Chemical Methods for
Pesticides and Devices. EPA, OTS.
GSCX)66-08* Shell Chemical Co. (1969) Metabolisn of SD 15418 in Corn and Soil.
Received June 6, 1969 under 9G0844 Section C-II (Ace. No. 116124)
submitted by Shell Chemical Co. Agric. Div., San Ranone, CA
GS0066-09* Shell Chemical Co. (1969) Milk Cow Experiments. Received June 6, 1969
under 900844 Section C-II (Ace. No. 116124) submitted by Shell
Chemical Co. Agric. Div, San Ratnone, CA
GS0066-10* Shell Chemical Co. (1970) Determination of Residues of DW 3418
Triazine Herbicide in Crops and Soils - Gas Liquid Chronatographic
Method WAMS-63-2. Received Nov 18, 1970 under OP0998 (Ace. No.
116738, Tab 5); submitted by Shell Chemical Co.
GSC066-11* EPA (1971) Report on Method Tryout for Bladex (SD 15418) on Corn
Grain (Ace. No. 116735) under 3G1377
GSCC66-15* Shell Chemical Co. (1974) Report Nos. TIR-24-162-72, TIR-24-163-72,
and TIR-24-170-71 in Section D of 5E1565 (Ace. No. 119044-D)
received Jan 11, 1974 under 5E1565
GS0066-16* Shell Chemical Co. (1970) Section D of OF0998 (Ace. Nos. 116738
and 116740.) Received Nov 18, 1970
GSC066-17* Shell Chemical Co. (1969) Section D of 9G0844 (Ace. No. 116123-D)
received Dec 9, 1969
GSC066-18 Shell Chemical Co. (1976) Project Nos. TIR-26-189-73, TIR-24-126-72
I, II, III, and IV, -189-73 I, II, III, and IV, -129-75 I, II,
III and IV, -127-72 A, B, and C, -107-70, -120-70, and -104-70.
received Jan 22, 1976 under 6F1729 (Ace. No. unknown - none on
petition jacket)
GS0066-19* Shell Chemical Co. (1975) Report Nos. TIR-24-162-72, TIR-24-163-72,
and TIR-170-71 in Section D of 5E1565 (Ace. No. 119044) received
Nov 1, 1974
GS0066-21* Shell Chemical Co. (1969) 1968 Residue Data for Oats Grown in Soil
Treated with SD 15418 in 1967 from University of Minnesota
Plots and Residue in Oats Grown in Soil Treated in 1967, fron
University of Missouri Plots, Page Nos. 00118 and 00119 of
OF0998, submitted by Shell Chemical Co. received Nov 18, 1970
(Ace. No 116738)
76
-------
XI
GS0066-22 Tucker, R.K. (1968) USDI Fish and Wildlife Service, Denver, Colorado,
letter dated Oct. 25, 1968 fee. No. 91460, pp 178-180.
GS0066-23 Tucker, R.K. (1968) USDI Fish and Wildlife Service, Denver, Colorado,
letter dated Oct. 28, 1968, Ace. No. 91460, pp 182-183.
77
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II-3
PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
.1. Products That Do Not Qualify
For The Pormulator'a "Exemption
A. Single Active .Ingredient
Products*
These products oust be reregis-
tered. To obtain rereglstratlon,
labeling, packaging and data
requirements oust be satisfied
In accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active .Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active Ingredient under
review, as described In the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's 'Exemption
Only.when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, Including but not
limited to the Label .Improvement
Program and special Intent
to cancel notices.
• 'End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified In the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products In MI"
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 fall to meet the requirements in
I-A and B above, then the registrants in MI" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in .I-A and B. _^__^
78
-------
J_L=_3_J_cnnt 1
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
Pf LICANTI NAME
DATE GUIDANCE DOCUMENT ISSUED
With rwpin to thi rtquirtmtnt to ubmrt "fintrie" dni impo»d by thi FIFRA 0010113(C)(2KB) notici conttiwd in ttM rtfwwcid
Guidtnct Document. I im r«ponding in thi following mnvwr.
01. I will aibmit Oatt In • tinnly mtnnw to «t«fy thi following nquinmtna If thi tut prKtduw I will tin dtviitt from (or mt not
ipicifwd in) thi Rtgatntion Cutdtlinii or tht Protocoli eonttintd in thi Riports d Exptn Group* to thi Crwmieali Group, OECD
Chwnicali T«ting Prognmmi, I «neloJi thi protocols thtt I will u»:
D 2. I h«vt tnnrid into in •grwmtnt with or* or more other ngBtrirtti undtr FIFRA Mction 3(C)(2)(B)(ii) to witty thi following dm
itquirtmtnn. Thi tuts, ind tny rtquind protocols, will b< tubmimd to EPA by:
NAME OF OTHER REGISTRANT.
D 3. I melon i complmd "Cinrfication of Antmpt to Ermr Into in AgrMmtnt with Othtr Rigamnti for Dtvtlopmim ol Oiu" with
rvpict to thi following dra rtquirfrnmts:
LJ4. I rtquBt thit you imind my rtginrttion by diliting thi following UKS (this option a not ivtiiatut to iDpucints 4ot nt* products
D 5. I rtquvt volumtrv uncillition of thi ngittntion of thii product. (This option is not iviiliblt to tpplicints for ntw produca.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Farm KW-1 (10*21
79
-------
II-4
UMO M
(To gut iffy.
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOft DEVELOPMENT OF DATA
1. I am duly authorized to represent the following frnn(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(e)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
OUIDANCt OOCUMCNT OATi
ACTIVf IMOMPIINT
NAMf OFFIftM
•FA COMFAMY NUMBER
(Thu firm or group of firms It referred to below as "my firm".)
2. My firm it willing to dtvtlop and submit tht data as raquirad by that Notice, H nacauary. Howevar. my firm would prefer to enter
into an aoraemam with one or more other rafittranu to develop jointly, or to thare in the oort of developing, the following required
Hems or data:
3. My firm to offend in .writing to enter into auch an aeraament Copies of ttii offart an attached. That offer wai irravoeable and included en offer to bi
bound by an artrnriori dectson under FlFRA Section 3(c)(2HB)(iii) H final aoreemeni on all tarmi could not be reached etherwiat. This offer wu med<
to tfte fallowing firm(i) on the fallowing dated):
NAME OF FIRM
DATE OF OFFER
However, none of thcit firm(i) accepted my offer.
4. My firm requests that EPA not suspend the ragistration(s) of my firm's product(s), if any of the firms named in peregriph (3) ibov
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inforr
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statemer
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
DATE
EPA Form
110421
80
-------
Appendix ,111-1
•EPA Registration No,
PRODUCT SPECIFIC DAT* REPORT
Guidance Docunent for_
Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-
-------
Appendix .111-1 (continued)
Registration
Guideline No.
67-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21 '
§158.135
'. TOXICOLDGY
81-1
81-2
81-3
Bl-«
81-5
81-6
Name of lest
Stability
Oxldiz ing/reducing
reaction
Flannabllity
'Explodablllty
Storage stability
Viscosity
Misclblllty
Corrosion
characteristics
Dielectric break-
• down voltage
•
Acute oral ID-50,
rat
Acute dermal
LD-50
Acute inhalation,
1£-50 rat
Primary eye
Irritation, rabbit
Primary dermal
Irritation
Dermal sensltiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I an complying with
data requirements by
Citing MRIT*
Submit-
ting
Data
(At-
tached)
(For 'E?A Use Only)
Accession Nirfcers
Assigned
82
-------
Appendix
Ch«s»ter I— tnvire-nnientel Protection Agency
at obtained the dau from toothy
firfc (identify): applicant copied
from a publication: applicant obt
a CMy of the dau from EPA).
(dyThe applicant thai] submit
his application a statement that
in luivaluatlon of the property
caey. mnd safety of the form\|
end-usi product, may not eonsU
dau ai supporting the appl£ation.
except tae following dau.
(1) ThV dau the applicant fas sub-
9A under
dau pe:
e product's ac
than to the
cu and
tolerances.
xemptions
mJtted to1
this sect!
(2) Oth
safety of
ents, rathe:
tad-use pi
(3)
regulations.
clearances Isited unde
Food. Drue, ani Coame
(e) If the applicant
Item of dau he\su
section was genelated
pense of) anothe\pe
ly submitted the
predecessor. USD.
ary 1, 1970. to sup]
for registration,
permit, or aaen
use to an exist:
reregistratiOB (
and the ort
reached writte,
amount and t
Fh (b) of
to the
ingredi-
fety of the
additive
and other
the Federal
Act.
ows that any
ted under this
y (or at the ex
in who original-
to EPA (or lu
'on or after Janu-
n an application
xpertmenul • use
nt addinf a new
1 Istratlon, or for
the applicant
dauXsubmltur have
agreement on the
termsYof payment of
any compensation than may be pay-
able unde/ Pin\A section
3(cxixDxil)Ak-ith regard to approval
of the application), the applicant shall
submit to KPA a suiemVn thai he
has furnisrjed to each sue* identified
original day* submitter:
(1) A DfU/ication of the Lpplicant's
intent to Apply for registration, includ-
ing the oroposed product:
(2) An/offer to pay the pertpn com-
pensatlin. with regard to the feproval
of the/application, to the exfcm re-
Quired/by FXFRA sections 3
and 3/CX2XD);
(3)/An identification of the
to which the offer applies^
An offer to commence negvtia-
to ascertain the amount \nd
of compensation to be pud:
fS) The applicant's name.
i telephone number.
(V> I/ the applicant's product ton-
any active Ingredient other /har.
thoe4 that are present solely botause
of th*^ Incorporation into the pioduct.
^formulation, of one o/ more
lured pesticide
from another Producer.
Applicant shall apo comply
-S as to such a/tive ingre-
le application shall con-
jwledgment/hat for pur-
sectional ex ixD) the
reHes on <^id any result-
di
other
purchs
then
with 11623
dient. and
tain an
ptun of
application
ihoul
be rerarded as
Administrator's
ollowint dau.
ted or specifically
t in support of
of dau in the
Ing reglstratiot
if it were based
consideration of )3
(1) AUdausut
died by the app)j
the registration; i
(2) Each othe/itei
Agency s files wAich:
(I) Concerns Ae properties or effecu
of any such sJtive ingredient: and
(11) Is one/f the typeApf dau that
EPA would/equire to be s\bmltied for
scientific Btttew by EPA 11 the appli-
cant soufht the initial rWutration
under HtTRA Section 3(clu) of a
produeywith composition anl Intend-
ed userIdentical to those propped for
the applicant'j product, undar the
dau/reQuiremenu In effect oft. the
daur EPA approves the applicant's
present application.
(
>. I. and « of PmiA. u amcadt
(44 PR niSJ.
n.
I 1(2.10 Lab«lin( rrquirtmenu.
(a) Oeiur*;— <1> Contents of Vie
labtL Cvery pesticide products shall
bear a label conuininf the informa-
tion specified by the Act and the regu-
lations in this Pan. The content! of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this
section:
(il) The name and address of the
producer, registrant, or person for
whom produced as prescribed in pan-
graph (O of this section:
(ill) The net contents as prescribed
In paragraph (d) of this section:
83
-------
§ ltt.10
Ufa 40—Pre-tectle-n »t Environment
(tr) The product registration
number u prescribed in paragraph (e)
of this section:
(T) The producing establishment
number u prescribed in paragraph of this section.
(3) Prominence and Uvibility. (i) All
words, statements, traphlc representa-
tions. designs or other information re-
quired on the labeling by the Act or
the retaliations in this pan must be
clearly legible to a person with normal
vision. and must be placed with such
eonspicuousnes* (as compared with
other words, statement*, designs, or
graphic matter on the labeling) and
expressed in such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(U) All required label ten must:
(A) Be set in e-polnt or larger .type:
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) Lanffvaoe to 6e tued. All required
label or labeling text thai] appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as U considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirement* will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Laoet— <1) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if U ls a pan of the package as
customarily distributed or sold.
(U) Ton* can and other bulk con-
tainers— Transportation. While a
pesticide product Is in transit, the ap-
propriate provisions of 49 CFR Pans
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank ear. tank truck or
other mobile or portable bulk contain
er. a copy of the accepted label must
be attached to the shipping papers
and left with the consignee at the um<
of delivery.
(B) Storage. When pesticide prod
ucts are stored in bulk containers
whether mobile or stationary, which
remain in the custody of the user, i
copy of the label of labeling. Includini
all appropriate directions for use, siial «••'•><>«•••"••:<*
be securely attached to the contalne:
in the ImmedlaTe vicinity of the dis
charge control valve.
(5) false or misleading statement:
Pursuant to section 2(qxixA) of th
Act. a pesticide or a device declare:
subject to the Act pursuant i
1162.15.1s misbranded Lf its labeling i
false or misleading In any panicula
including both pesticidsJ and non-pe.1
ticidal claims. Examples of statement
or representations in the labeUr.
which constitute miibrandinj Includ-
(I) A false or misleading statemer
concerning the composition of th
product:
(U) A false or misleading statemer
concerning the effectiveness of th
product as a pesticide or device:
(ill) A false or misleading statemer
about the value of the product fc
purposes other than as a pesticide <
device:
(Jv) A false or misleading compartsc
with other pesticides or devices:
(v) Any statement directly or inc
rectly implying that the pesticide c
device is recommended or endorsed t
84
-------
Chapter I—Environmental Protection Af tncy
any Mency of the Federal Govern-
ment;
(vi) The name of a pesticide which
contain* two or more principal active
Ingredients if the name suggests one
or more but not all such principal
active ingredient! even thouch the
names of the other ingredients are
staud elsewhere in the labclinr.
(vli) A true statement used in such a
way as to five a false or mlsleadinc im-
pression to the purchaser.
(Till) Label disclaimers which netate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoUon-
oua." "nonlnjurious." "harmless" or
"nontoxlc to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
<*) Non-numerical and /or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural Ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
"Pollution approved"
(6) Final printed labeling. (1) Except
as provided in paragraph (aX6xii> of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(11) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Nome, 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 addi-
tional name pursuant to I 162.6<4).
-------
I U110
Title 40—Preteetien ef Invirenment
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner at
to fullest or imply recommendation
or endorsement of the product by the
Afency.
(f) Predttfinf ettablltHmenti rtyH-
{ration number. The producing estab-
Ushment registration number preced-
ed by the phrase "EPA tit.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
Istralion number on the immediate
container cannot be dearly rtad
through such wrapper or container.
<|> Inyrtditnt ttttgmgnt—U) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents: and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total aad water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients crust be
deticnated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredlenti," or the slnru-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type sixe, be aliened to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
tens "analysis" shall not be uaed as a
headini for the ingredient statement.
(2) Petition o/ inffTtditnt itAtrmrni.
(1) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
rtad. the ingredient statement must
also appear on such outside container
or wrapper. If the sixe or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Atam«i to 6c wed in \nprtd\mt
itAtemtnl The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no ease
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cx6)..
(4) StattnenU o/ percentage!. The
percentages of ingredients shall b«
stated in terms'of weight-to-wei|ht
The sum of percentages of the active
and the Inert ingredients shall be 100
Percentages shall not b« expressed b>
a range of values such as "22-25?*." L
the uses of the pesticide product an
expressed as weight of active ingredi
ent per unit area, a statement of th<
weight of active ingredient per uni
volume of the pesticide formulatioi
•hall also appear in the ingredaen
statement.
<5> Jecvrocy of Itaua percmtaffv
The percentages given shall be as prt
dae as possible reflecting good mam
facturtnt practice. If there may be ux
avoidable variation between manufax
turini batches, the value staled to
each active insredier.'. shsUl be th
lowest percentage which may t
present.
(6) £etrrtorarion. Pesticides whic
change in chemical composition iti
niflcantly must meet the following Ii
belini requirements:
(1) In eases where it is determine
that a pesticide formulation chang<
chemical composition significant;
the product must bear the- followir
statement in a prominent position c
the label: "Not for sale or use aft-
[date]."
(U) The product must meet all 1st
claims up to the expiration tune inc
caied on the label.
<"J> Mm inpredimu. The Adaiin.
trator may require the name of a:
86
-------
er I—|flvir«A«itnfsl Pr»f»die-n Af onry
f U2.10
Inert inrredfenKs) to be lilted in the
tarredient statement if he determine*
that such iniredienus) may pose a
hazard to man or the environment.
(h) Warning* and prrcauttonary
itctmenu. Required warnings and
precautionary ttaumenu concerninf
the general areas of toxicoloffical
hazard tncludinc hazard to children.
environment^ hazard, and physical or
chemical hazard (all into two groups:
thoac required on the front panel of
the t»»>»M*t and those which may
appear elsewhere. Specific require-
menu concerninf content, placement.
type size, and prominence are riven
below.
(1) JUcvind front pane/ H&trmfnti
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
to determined by the Toxiclty Catego-
ry of the pesticide. The caterer? is u-
signed on the baals of the highest
hazard shown by any of the indicator!
in the table below:
so *•* so w* MO «»/«i. *•» see *» MOO •»/
(1) Hvmcn Hattrt rtgncl v>erd—(A)
ToncUv CaUpory /. All pesticide prod-
uct* mectinr the criteria of Toxidty
Cat*fory I ahall bear on the front
panel the sirrval word "Danrer." In ad-
dition if the product wu aatirned to
Toxicity Category I on the basis of Its
oral, inhalation or dermal toxicity (as
distinct from akin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
croasbones shall appear in immediate
proximity to the word "poison."
(B) Tancity Category /;. All pesti-
cide products meeting the criteria of
Toxicity Cawrory XI shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicitv Category ///. All pesti-
cide produeu meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word •Cau-
tion."
Tarieitv Catepory IV. All pesti-
cide produeu meeting the criteria of
Toxicity Cat*gory IV shall bear on the
front panel the signal word "Caution."
(£) VM of Hffnal vord*. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vtnt unreasonable advene effect* on
man or the environment. In no ease
ahall more than one human hazard
aignal word appear on the front panel
of a label.
(11) Cntirf tarard wanttap. Every pes-
ticide product label ahall bear on the
front panel the statement "keep out of
reach of children." Only in cisn
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonr.rv.ed by
the applicant.to be extremely remote.
or if the nature of the pesticide is such
that It is approved for use on i&fanu
or small children, may the Administra-
tor waive this requirement.
(ill) Statrmtnt of practical trtat-
mrnt—(A) Tanruv Coupon' /• A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
ing into Toxicity Category I en the
basis of oral, inhalation or dermal tox-
Idty. The Agency may. however.
permit reasonable variations in the
87
-------
f U110
TftU 40—Prc-tt-ctUn »f Invire-nmtnt
placement of the statement of practi-
cal treatment it Borne reference such
w "See statement of practical treat-
ment on beck panel" appears on the
front panel near the word "Poison"
and the skull and croosbones.
(B) Other toxiciti cittyortt*. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hxixUlXA) of
this section. The applicant may. how-
ever. Include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph of this
section if they do not appear on the
front panel.
dv) PUcrmtnt end prominence. All
the require front panel wamlnf state-
menu shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
show the minimum type size require-
ment* for the front panel warning
statements on various sizes of labels:
IMi
I » • 10_
10 » II.
lit »10.
X.
t
16
11
u
IS
1C
1*
12) Otfifr rtuvirtd icormnw and pre-
cautionary itAttmtnts. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the generaJ heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Human* and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(1) //atari to Aumau and tfomoMc
animals. (A) Where a hazard «xisu to
humans or domestic animal*, precau-
tionary statements are required indi-
cating the particular hazard, the
routers) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicu typi-
cal precautionary statement*. These
statement* must be modified or ex-
panded to reflect specific hazard*.
•*• «• Mr •*<•«• If mr
De *m f* •» •»•» v MT • v
• te» we 4ne -vcnv
''J V !C4 '
•c ;
«w! Oc nat tntf*
"•: Oc «i
•V* (•>• •»] runofi Oe "0 *r r rm
(U) Inrironmental tuuiarAt. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau
tions to avoid potential accident
injury or damage. Examples of th
hazard statement! and the circus
-------
CHo'*r I—Invlr»nwtnt«l Pre-tertien Afltncy
U2.U
stances under which they are required
follow:
(A) If t pesticide intended for out-
door use contains to active ingredient
with a mammalian acute oral LDH of
100 or leu, the statement "This Pesti-
cide Is Toxic to Wildlife" Is required.
(B> If a pesticide intended for out-
door use contains an active tnfredient
with a fish acute LC. of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avlan acute oral LD. of 100
mg/kg or leu. or a subacute dietary
LCm 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 UM of the
pesticide may result In fauiity u
birds, fiah or mammal*, the statement
"This pesticide is extremely toxic u
wildlife (fish)" is required.
(X) for uses involving foliar applies
tlon to agricultural crop*, forau. or
•hade trees, or for mosquito abate
nent treatments, pesticide* toxic u
pollinating insects must bear approph
aU label cautions.
•»
OB "• KXC&r* • »«•»
<3P- » «*r MM
(i) DtrecftoTu for Use—(\
rrcwtrrmmti—(1) AAeyuaev and el&r-
iti of direciiofu. Directions for use
must be stated in term* which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud ar.d
from personal Injury and to prevent
unreasonable advene effect* on tr.e
environment.
(U) flactmtnt of dinetioni for tat.
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 msuer whic.u. t-
companie* the pesucide provided in*
(A) If reqoired by the Agency, sue
printed or graphic matter is secure:
attached to eacn package of the pea:
cide. or placed rithin the ouuic
wrapper or bag:
(B) The labei bean a reference t
the directions for use in accompanyir.
leaflets or circulars, such a* "S«« d
reetion* in the enclosed circular:" ar.
(C) The Administmor determin<
that it is not necessary for such dire
Uon* to appear on the label.
(ill) fxceprtofu to rtruirtmmt /<
direction for ia*—
-------
11*2.10
THtt 40—Fre-teellen *f Invire-nment
for UK only by manufacturers of prod-
ueu other thin pesticide produeu in
their regular manufacturing processes.
provided that
(7) The label clearly shows thai the
product U intended for use only in
manufacturing processes and specifies
the type<») of produeu Involved.
(21 Adequate Information such as
technical data abeeu or bulletins, is
available to the trade specifying the
type of product involved and it*
proper use in manufacturing process-
es;
(J) The product will not come into
the hands of the general public except
after incorporation into finished prod-
uct*; and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
Hsu, provided that:
U> The label dearly states that the
product is for use only by physicians
or veterinarians;
(7) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fecu on man or the environment: and
The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vil) The frequency and timing of ap-
plications necessary to obtain effective
rtsulu without causing unreasonable
advene effecu on the environment.
(rill) Specific limitations on reentry
to areas where the pesticide has beer.
applied, meeting the requirement!
concerning reentry provided by 4C
CFR Pan 170.
-------
Qtepter I—lnvir«n«ental Protection Agency
11411
(I) For mulcted use pesticides. a
statement Uut the pesticide m»y be
applied under the direct supervision of
• a certified ippllcator who is net phys-
ically present at the site of application
but nonetheless available to the
person applying the pestidde. unless
the Agency has determined that the
pestidde aar only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
»f environment.
(J) Statemtnt of Vtt CIout/teaMon.
By October 33, 1919. all pestidde prod-
ucts must bear on their labels a state-
ment of us* dasslfleatioD as described
to paragraphs (JXl) and (2> of this
section. Any pestidde product for
which some uses are classified for gen-
era! use and others for restricted use
shall be separately labeled according
to the labeling standards set forth tn
thto subsection, and shall be marketed
as separate products with different
registration number*, one bearing di-
rection* only for general used) and
the other bearing directions for re-
stricted use except that, tf a product
has both restricted use*^
bear sutcmeats of restricted use clas-
sification on the front panel as de-
scribed below.
(1) front pone! ttattmnt of rutnet-
9d «*e eJosft/lcerion. (A) At the top of
the front panel of the label, set in type
of the same minimum itzti as require
for human hazard signal words (se
table in 1162.1
the front panel to make it unlikely t
be overlooked under customary condJ
tions of purchase and use. the stau
men; "Restricted Use Pesticide" aha:
appear.
r ths
eeeds any c
h tn pan
Upon sue
tratc
eertlf ie mail t
e eai
c
t
rtbuttaJ of lye
prtsjflBptlon in accordance with
(aX4) of this section. The
or registrant shall have forty-flv
set
this secti
the
by
registrant.
thai the
the
evidence tn
91
-------
APPENDIX -IV-2
lABFUNn RFPUIRFMFiriS OP THE PIPRA, AS AMBNDFD
JTFM
]
2
3
1
5
6A
6n
I *
7
7A
7B
IABEL 'EEJ5MENT
Product name
Company name
and address
Net contents
'EPA 'Est. No.
'EPA Reg. No.
•Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OP RKJUIRFMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
al/unlt area
All products
All products
All products
NACrttfTJT
RFOUIRFI) .
Pront panel
None
None
None
None
Pront panel
Pront panel
Pront panel
Pront panel
Pront panel
6N LABEL
PRFFERRED
Center front
panel
Bottom Trent
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Pront panel,
Immediately
before or
following
Reg. No.
.Tinned lately
following
product name
Directly below
the main
Ingredients
statement
Above signal
word
.Tinned lately
below child
hazard
warning
COMMENTS
i — —
.If registrant Is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
Hay be In metric units In addition to
U.S. units
Must be In similar type sice and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel .
All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
t
-------
APPENDIX JV-2 (continued)
JTTOI
7C
7D
7F
8
FA "
BB
lABEL'EHMENT
Skull & cross-
bonea and word
POISON (In red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
'Environmental
hazards
APPUcAblUW
OP REQUIREMENT
products
which are Cat-
egory .1 based
on oral , der-
mal , or Inhala-
tion toxlclty
All products
In Categories
.1, ,11, and .lit
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
In Categories
.1, .11, and -III
All products
PLACFMFNT ON LABEL
WWJIWt)
Front panel
Category .1 :
Front panel
unless refer-
ral statement
Is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
FHMTHHtl)
Both In close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
' -
Must be grouped under the headings In
8A. 8D, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
•thvlronmental hazards Include bee
caution where applicable.
10
CO
-------
APPENDIX -IV-2 (continued)
JTO1
He
9A
9C
10A
IOC
10D
r ^-
LABEL 'ECB1ENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OP RHJUIRBIFNT
All pressurized
products, others
with Flash
points under
150°P
All restricted
products
All products
All
chol Inesterase
Inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Ibp center
of front
panel
.timiedlately
following
statement of
classifica-
tion or
ahead of
directions
for use
.In the
directions
for use
.In the
directions
for use
None
PREFERRED
Same as abpve
Preferably
blocked
.Immediately
after misuse
statement
.Imned lately
before
specific
directions
for use or
at the end of
directions
for use
None
OdflENTS
.Includes a statement of the terms of
restriction. The words "RESTOICTTO USE
PESTICIDE" must be same type size aa
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be In metric aa well as U.S. units
VO
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
,1. 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 PRESSURISED
CONTAINERS
.II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
L>. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
"Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or Incinerate
container. "Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or Incinerate
container. 'Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or Incinerate
container. 'Exposure to
temperatures above 130°F
may cause bursting.
'Extremely f lamir.able . 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.
95
-------
Appendix IV-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 sixe listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under € point
Above 10 to 15 . . .8 point
Above 15 to 30 10 point
Over 30. 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements night 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*
96
-------
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. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions!
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, 'Do not contaminate water, food,
or feed by .storage or disposal.'
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
97
-------
Appendix IV-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)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
98
-------
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary 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.
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
99
-------
(continued)
Pesticides that are hazardous wastes under 40 CFR 2€1.33(e) and (f)
when discarded.
•Acutely Hazardous" Coamercial Pesticides (RCRA "E* LisV)
Active Ingredients, (no inert*)t ~
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aainopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl) phosphorodithioate
(dis.ulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Oinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexahethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
100
-------
Appendix IV-4
(continued)
"Acutely Haxapdous" Coroercial Pesticides (RCRA *E* List)
, Activt Ingredients continued;
Phenylmercuric acetate (PMA) ,
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
(sulfotepp)
101
-------
Appenoix iv
(continued)
•Toxic* Coaaercial Pesticide Product! (RCRA "F* Lilt)
Active Ingredientt;
Acetone .- . ^
Acrylonitrile "*
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclphexane
Decachlorooctahydro-l,3,4-aetheno-2H-cyclobutalc,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbaraate (diallate, Avadex)
o-DiChlorobenzene
p-DiChlorobenzene
Dichlorodifluoromethane (Freon 12*)
3,5-Dichloro-N-{l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DOD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
102
-------
Appendix IV-4
(continued)
•Toxic* Corogrcial Pesticide Products (RCRA *P* Li»t)
Active Ingredients*
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (aethyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichlororaonofluoromethane (Freon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
103
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