GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AMITROLE
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE_OF CONTENTS
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 35
III. Requirement for Submission of Product-Specific
Data 38
IV. Submission of Revised Labeling and Packaging
Information 39
A. Label Contents
1. Product Name
2. Company Name and Address
3. Net Contents
4. Product Registration Number
5. Producing Establishment
Registration Number
6A Ingredient Statement
6B Pounds Per Gallon Statement
7. Front Panel Precautionary Statements
7A Child Hazard Warning Statements
7B Signal Word
7C Skull and Crossbones and Word Poison
7D Statement of Practical Treatment
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals
8B Environmental Hazard
8C Physical or Chemical Hazard
9 Misuse Statement
IDA Storage and Disposal Block
10B Directions for Use
B. Collateral Information
V. Instructions for Submission 44
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APPENDICES
I Bibliography
II PIFRA s3(c)(2)(B) Summary Sheet - EPA Form 8580-1
III Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
IV Product Specific Data Report (End-Use Products)
EPA Form 8580-4
V-l 40 CFR §162.10 Labeling Requirements
V-2 Table of Labeling Requirements and Sample Labels
V-3 Physical/Chemical Hazards Labeling Statement
V-4 Storage and Disposal Statements
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
TO fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1, 1977,
These pesticides will be reviewed in use clusters which are
prioritized on the basis of a ranking scheme, giving preference
to pesticides used on food and feed crops. Amitrole is in the
H-7 herbicide cluster for chemicals used on drainage ditches,
rights-of-way, forests and ponds.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the end-use (formulated) products that contain the active
ingredient. If we find serious concerns, we will bring
end-use 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, it is the.Agency's policy
under §3(c)(2)(B) that these data are not required to be
submitted by those registrants who qualify for the formulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that the
registrants who are responsible for filling the data gaps are
the manufacturing-use product producers (basic suppliers of
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the active ingredient). However, end-use producers will not
qualify for the formulator's exemption if the source of their
active ingredient: (1) is not registered with EPA, and/or (2)
is produced by the registrant's firm, or a firm which has
ownership in common with the registrant's firm. These end-use
producers can qualify for the formulator's exemption if they
change their source of supply to a registered source, provided
the source does not share ownership in common with the regist-
rant's firm. If the end-use product registrant decides to
switch sources, a new Confidential Statement of Formula, EPA
Form 8570-4, must be submitted to the appropriate Product
Manager within 90 days of receipt of this Guidance Document.
The chart on the following page shows what is generally
required of those who do and do not qualify for the formulator's
exemption in the Registration Standards program.
If you decide to request the Agency to discontinue the
registration of any of your products subject to the reregistra-
tion requirements of this Guidance Document, please notify
the Product Manager named in the cover letter, within 90
days from the receipt of this document, that you wish to
voluntarily cancel the registration(s). If you decide to
maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined. EPA may issue a notice of intent to cancel
or suspend the registration of any currently registered
product or deny any application for registration of a product
if you fail to comply with the requirements set forth in
this Guidance Document.
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Acting Administrator, EPA was
enjoined from implementing §3(c)(l)(D) of FIFRA. EPA has
decided that as long as this injunction is in effect, it will,
for most pesticides, proceed with the requirements in this
Guidance Document which do not require compliance with the
provisions of §3(c)(l)(D). Despite this decision, EPA will
require current registrants to apply to amend their product
registrations to make changes in the labeling, packaging, or
composition for this chemical. The Agency will supplement
the Document with additional guidance when this litigation
concludes. Failure to comply with the provisions of the
subsequent guidance may also result in issuance by EPA of an
intent to cancel the affected product registration(s).
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products* .
ACTION(S) REQUIRED TO"
MAINTAIN REGISTRATION
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II.
Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B. _^_____
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I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This chapter describes the regulatory position of the
Environmental Protection Agency ("the Agency") on amitrole,
based on an evaluation of all registered manufacturing-use
products (MUP's) containing amitrole as the sole active
ingredient. Future requests for registrations of
substantially similar products will be covered by this
standard. Dissimilar products will require amendments to
the standard. This standard provides the rationale for the
Agency's position, the criteria for registration and also
discusses labeling requirements and tolerances.
In developing its regulatory position, the Agency determines
whether available data indicate that a pesticide has met
the criteria for unreasonable adverse effects found in
Section 162.11(a) of Title 40 of the U.S. Code of Federal
Regulations (CFR). Pesticides meeting these criteria are
candidates for a Special Review, an intensive risk/benefit
analysis which a modification of the Rebuttable Presumption
Against Registration (RPAR) process. The Agency's
determination as to whether any criteria have been met and
its rationale for any regulatory action are summarized in
the regulatory position of this standard.
"Amitrole" is the accepted common name for 3-amino-l,2,4-
triazole recognized by the American National Standards
Institute. Trade and other names for amitrole include
Weedazole®, Amino Triazole Weed Killer®, Cytrol®, Amitrol
T®, Domatol®, Vorox®, Amizole®, X-All®, Ustinex®, AT, ATA,
Aminotriazole 90 and Chempar Amitrole. The Chemical Abstracts
Service (CAS) Registry number is 61-82-5. The Office of
Pesticides Program's internal control number (EPA
Shaughnessy number) is 004401.
B. USE PROFILE
Amitrole is a broad spectrum herbicide effective against a
wide range of monocotyledonous (grasses) and dicotyledonous
(broadleaf) weeds. It was first registered in 1948 for use
on noncrop lands and in 1958 for use on cranberries on a no
residue basis for postharvest application only.
Amitrole is registered for use on a variety of noncrop
sites, including rights-of-way, marshes and drainage ditches,
ornamentals and around commercial, industrial, agricultural,
domestic, and recreational premises. It is formulated into
a soluble concentrate/liquid (2 Ibs/gal), soluble concentrate/
solid (50 and 90%) and pressurized liquids (0.36 and 1%).
Amitrole is not currently registered for use on food crops.
Registrants were notified by EPA on June 16, 1971 that
registrations of all formulations containing amitrole and
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bearing use directions for food crops would be cancelled
because this chemical is a carcinogen in experimental
animals. There are no tolerances for any food crop or
water which will be used for irrigation, drinking, or other
domestic purposes, and to date no new registrations or
establishment of tolerances for amitrole have been requested.
C. REGULATORY POSITION
Based on a review and evaluation of all available data and
other relevant information on amitrole, the Agency has made
the following determinations:
1. Amitrole has oncogenic potential and is a candidate
for special Review. Registrants of amitrole products
are hereby notified that some uses of amitrole may
have met the risk criterion for oncogenicity in 40
CFR 162.11(a). A Notice announcing the Agency's
decision to initiate a Special Review will be
published in the Federal Register.
2. The Agency will not reregister any current products
and it will not register any new products containing
amitrole at this time.
3. Except for homeowner uses, the oncogenic risk
associated with all use patterns and application
techniques of amitrole may be high and their continued
general use may cause unreasonable adverse effects.
Except for homeowner uses, all use patterns and
application techniques are classified as restricted.
4. Registrants must alter labeling, as specified below,
in order to maintain existing registrations or to
permit new amitrole registrations. Labeling must
include a cancer warning statement and a requirement
to use protective clothing to reduce risk during
the period of pivotal data development and Special
Review.
5. Within 90 days after receipt of this Standard,
registrants must: (A) commit to perform all of the
required studies, (B) complete labeling of all
products to-be-released-for-shipment, (C) furnish
all retailers and wholesalers of record with
supplementary labeling for all products in channels-
of-trade, and (D) submit copies of the above labeling
to the Agency as evidence of compliance with this
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Standard. Within 180 days after receipt of this
Standard, registrants must submit all pivotal data
and initiate steps to fulfill the remaining data
requirements. All registrants, regardless of whether
they intend to maintain their registrations, are
required by this Standard to furnish all retailers
and wholesalers of record with supplementary labeling
for all products in channels-of-trade.
6. Manufacturing-use pesticide products containing
amitrole as a sole active ingredient may, after
further review, be registered for sale, distribution,
formulation and use in the United States, subject
to the terms and conditions specified in this standard,
Registrants and applicants with products that do
not conform to this standard must apply to amend the
standard in order to reregister and register,
respectively. Mixtures and end-use products
containing amitrole are covered under this standard
for the purposes of labeling. The use patterns of
the end-use products are considered for purposes
of determining generic data requirements for amitrole.
7. Registrants not qualifying for a formulator exemption
must provide or agree to develop all data specified
in the tables of this standard to maintain existing
registrations or to permit new amitrole registrations.
The Agency may amend this standard or initiate
further regulatory actions after it has reviewed
the submitted data. All data must be generated
according to the Good Laboratory Practices specified
in 48 FR 53946.
8. Some of the required data will permit the Agency
to perform a more accurate exposure assessment and
determine the necessity for further regulatory
action. Specifically, the Agency must be able to
assess the ability of amitrole to penetrate the
skin and the effectiveness of protective clothing.
Due to their pivotal nature, registrants must
initiate and submit these studies and initiate steps
to complete the remaining data specified in the
tables.
9. Food or feed uses of this pesticide will not be
permitted to be registered.
10. End-use product label changes are required.
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D. REGULATORY RATIONALE
Data indicate that amitrole has oncogenic potential. At this
time, the Agency has determined that it will not reregister
existing use patterns of amitrole for the following reasons:
1. Amitrole demonstrated oncogenic potential (thyroid
and liver tumors) in laboratory rodent feeding
studies. Risks associated with dietary exposure
have been eliminated through cancellation of all
food uses in 1971. No further food or feed uses
will be permitted. Risks associated with mixer/
loader/applicator exposure remain.
2. Toxicological data are insufficient to fully evaluate
the hazards associated with dermal and inhalation
exposure to this chemical.
3. Monitoring of workers applying amitrole showed no
apparent changes in thyroid function. While the
sole study on amitrole exposure did not adequately
consider the effects of single or multiple episodic
exposures on thyroid hormones, it did provide some
evidence that brief exposures cause relatively
minor or no effects on human endocrine systems.
4. The use of protective clothing specified in this
standard and the restriction of high risk use
patterns and application techniques of amitrole may
reduce exposure. While it has no adequate data on
the ability of amitrole to penetrate the skin, the
Agency's evaluation of its structure and solubility
indicates that some amitrole may penetrate the
skin. Assuming 100 percent absorption and the
results of the sole exposure study, workers
associated with certain use patterns and application
techniques are theoretically exposed to doses of
amitrole approaching those which cause thyroid
tumors in laboratory animals. It is estimated
that protective clothing may reduce worker exposure
approximately 80 percent or more, based on the
structure and solubility of this chemical. This
exposure reduction is anticipated to significantly
reduce risk during the period of pivotal data
development and permit continued registration under
restricted use.
5. Given the scientific uncertainties associated with
its preliminary analysis, the Agency will consult
with experts in endocrinology and review the results
of the pivotal data prior to deciding on how to
further regulate this chemical. The Agency estimates
that the risks associated with the use of this
chemical for one year (i.e., the time required for
instituting the changes required by this Standard)
are low.
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6. There are no data to estimate re-entry exposure to
individuals entering areas treated with amitrole.
Tne Agency will assess a need for a re-entry interval
after it Has reviewed the environmental and
toxicological data required by this standard.
7. Available data are insufficient to fully assess the
environmental fate of this chemical. A complete
environmental fate assessment, including a review
of the leaching potential of amitrole, will be
performed after the required data is submitted to
the Agency.
8. There are insufficient data to characterize the
toxic effects of the end-use products of amitrole
to aquatic organisms. A complete hazard assessment
will be performed after additional ecological
effects data are submitted to the Agency.
9. Available data on both human and wildlife poisoning
incidents indicate that the majority of cases of
human poisoning cited in the Pesticide Incident
Monitoring System (PIMS) through June, 1981 appear
to be the result of misuse or accident. The PIMS
data provide no information on chronic health effects
from exposure to amitrole.
E. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
All products which contain amitrole are subject to this
standard. The Agency will not consider registration of new
products or reregistration of current products containing
amitrole until it has reviewed the pivotal data required by
this standard.
Should the Agency decide to register and reregister amitrole
products after reviewing the pivotal data, registrants of
products containing amitrole as the sole active ingredient
must either comply with the acute toxicity limits, product
composition, and use pattern requirements listed in Section
F of this document; or submit data and a justification to
amend the standard to encompass such products.
Should the Agency decide to register and reregister amitrole
products after reviewing the pivotal data, applicants for
registration and reregistration of products which contain
amitrole as the sole active ingredient must comply with all
terms and conditions described by this standard, including
commiting to fill data gaps on a schedule agreed to by both
this agency and the applicant, and when applicable, offer-
ing to pay compensation for data to the extent required by
§ 3(c)(l)(D) FIFRA. Applicants for registration under this
standard must follow the instructions contained in this
standard and complete and submit the appropriate forms
within the time specified.
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F. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 90 percent
amitrole 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 manufacturing-use amitrole products must be
substantially similar to currently registered technical
products. Any manufacturing-use product not meeting these
requirements will be considered a new product and will
require an amendment to the standard.
2. Acute Toxicity Limits
Technical grade and manufacturing-use products containing
amitrole in acute toxicity category I, II, III, or IV must
bear appropriate precautionary labeling.
3. Use Patterns
Manufacturing-use products containing amitrole must be
labeled for formulation only into end-use products for use
as herbicides to control grasses and broadleaf weeds in
rights-of-way, marshes and drainage ditches, ornamentals,
and around commercial, industrial, agricultural, domestic,
and recreational premises. The attached index lists all
registered uses for end-use products, which may be formulated
from the manufacturing-use products covered by this standard,
as well as approved maximum application rates and frequency.
Formulations may be applied by using helicopter or ground
equipment, with the specific type of equipment determined
by the conditions of the site and equipment availability.
The Agency classifies all uses patterns and application
techniques, except homeowner uses, as restricted.
G. REQUIRED LABELING
Registrants must complete all label requirements within 90
days from the receipt of this guidance document. Products
to be released for shipment or advertized, products which
have been amended to remove any restricted uses, existing
stocks of products covered by this document, related
brochures, technical pamphlets and similar materials must
be labeled to comply with all label requirements within 90
days after the receipt of this guidance document.
All technical grade, manufacturing-use, and end-use products
containing amitrole must bear appropriate labeling as
specified in 40 CFR 162.10. The following labeling
requirements apply to technical, manufacturing-use, and
end-use products.
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1. Manufacturing-Use Product Statements
a. Use Patterns
Products intended for formulation into end-use products must
bear the following statement:
"For formulation only into end-use herbicide products
intended for noncropland, outdoor use."
"The use of this product may be hazardous to your health.
This product contains amitrole, which has been determined
to cause cancer in laboratory animals. Products intended
for formulation into restricted-use pesticides must
- require on its labeling that a respirator be worn during
mixing and loading. Lightweight waterproof clothing
(jumpsuit [or coverall], boots [or shoes], gloves, and
a wide-brimmed plastic hardhat) must be worn when mixing
and loading all products and when applying all products
to control dense, tall vegetation. Workers applying
this product in all other situations must wear lightweight
waterproof gloves and boots (or shoes). Products
intended for formulation into general-use pesticides
must require on its labeling that waterproof gloves be
worn while handling the product."
All products must bear the following statements:
"Each formulator is responsible for obtaining EPA
registrations for its formulated product(s)."
b. General Warning
"Do not discharge into lakes, streams, ponds, or public
waters unless in accordance with NPDS permit. For
guidance, contact your Regional Office of the EPA."
2. End-Use Product Statements
a. General Warnings and Limitations
All restricted-use products must bear the following statements:
"Restricted Use Pesticide"
"For retail sale to and application only by certified
applicators or personnel under their direct supervision."
"The use of this product may be hazardous to your health.
This product contains amitrole, which has been determined
to cause cancer in laboratory animals. Wear a respirator
during mixing and loading of all products. Wear
lightweight waterproof clothing (jumpsuit [or coverall],
boots [or shoes], gloves, and a wide-brimmed plastic
hardhat) when applying all products to control dense,
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tall vegetation. Workers applying this product in all
otner situations must wear lightweight waterproof gloves
and boots (or shoes)."
All homeowner products must bear the following statements:
"The use of this product may be hazardous to your health.
This product contains amitrole, which has been determined
to cause cancer in laboratory animals. Wear waterproof
gloves when using this product."
All products must bear the following statements, regardless
of classification:
"Do not allow spray or spray drift to contaminate edible
crops or water intended for irrigation, drinking or
other domestic purposes."
"Do not allow livestock to graze or feed in treated non-
crop areas."
All products intended for nonaquatic uses must bear the
following statement on the label:
"Do not apply directly to water or wetlands. Do not
contaminate water by cleaning of equipment or disposal
of wastes."
All products intended for aquatic uses must bear the following
statement on the label:
"Consult your state Fish and Game Agency before applying
this product to public waters. Permits may be required
before treating such waters."
H. TOLERANCE REASSESSMENT
There are no established tolerances for amitrole in the
U.S.A., Canada, and Mexico. There are no food or feed uses .
in the U.S.A. and residues are not permitted on any food,
feed or water intended for irrigation, drinking, or other
domestic purposes, and to date, no new registrations or
establishment of tolerances for amitrole have been requested.
I. PRELIMINARY ANALYSIS OF CURRENT BENEFITS AND RISKS
1. Current Benefits Review
a. Introduction
The Agency has completed a current benefits review for
amitrole. The review was based on published pesticide data
and preliminary telephone discussions with users and
applicators.
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b. Usage Site of Study
This review summarized the data available on the pesticide
applications on highway rights-of-way. This site was
selected for analysis because it is the site on which the
greatest volume of amitrole (approximately 50 percent of
the annual production) is used and for which data are
available. Lesser amounts of the herbicide are also used
on utility-commercial-industrial-institutional sites with
small amounts also used in forestry, aquatic areas and the
home. Finally, the effectiveness of amitrole on poison ivy
is viewed as particularly important by individuals sensitive
to the toxic effects of this plant. However, the total
volume used on poison ivy is small.
Amitrole is imported and is not produced in the United
States. Currently 500,000 to 800,000 pounds of Active
Ingredient (A.I.) are imported annually. The market for
amitrole has shown little annual fluctuation during the
last ten years. The three major importers are Union Carbide,
American Cyanamid and Aceto Chemical. Amitrole use
represents about 5 percent of the total herbicide used for
vegetation control on highway rights-of-way. It is used
by a large number of state and local agencies on an estimated
100,000 acres at a rate of 2.5 to 4 pounds per acre. Eleven
states, particularly in the west, account for most of its
use.
c. Benefits
Vegetation control on highway rights-of-way is needed in
order to assure (1) safe shoulders for emergency exit from
the roadway (i.e. grass must be long enough to protect the
bank from erosion but short enough so as not to obscure
obstructions), (2) adequate visibility at intersections;
(3) that the roadway is unobstructed by brush or, where
snow melting is important, the tree canopy does not overshade
the road, and (4) weed-free appearance of ornamental plants.
The major role of amitrole is to give non-selective contact
weed control, either alone or in combination with longer-
lasting herbicides, on those parts of shoulders where no
vegetation is desired (e.g. immediately adjacent to the
pavement, or under rails and around sign posts, where
mow ing is difficult).
Benefits from the use of amitrole are associated with its
relatively low cost, broad-spectrum control of growing
plants and the ability to mix it with other low cost,
broad-spectrum residual soil active chemicals. In combination
with other chemicals, low cost broadspectrum control is
obtained both on newly emerged or established broadleafs by
amitrole as well as seasonal control by residual product(s)
with which it is mixed.
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d. Substitutes
Amitrole substitutes are divided into two classes: herbicidal
chemical control and non-herbicidal mechanical control.
1) Herbicidal Control
A limited number of nonselective, broad-spectrum postemergent
substitutes are available for amitrole. These substitutes
may be divided into contact herbicides and residual soil-
active herbicides. The amine salts of dicamba, 2,4-D, MCPP
and glyphosate are substitutes in the first category of
contact herbicides. Glyphosate is as effective as amitrole
in the control of emerged weeds and has little residual
action, is more costly and more corrosive than amitrole and
may lose some of its activity when tank-mixed with residual
herbicides. The amine salts of dicamba, 2,4-D, and MCPP,
while relatively inexpensive, can volatilize in hot weather
and damage sensitive crops and shoulder plants. Additionally,
dicamba can move through soils and damage woody vegetation.
Residual soil-active herbicides offer an advantage of longer
control and lower cost than amitrole. In order to offer
season-long control, these chemicals must be applied early
in the season at high rates, a situation which could result
in off-target movement of the pesticide, vegetation removal
and soil erosion. Additional substitutes may be used, but
not necessarily at lower cost, equal convenience or equal
effectiveness.
2) Non-Herbicidal Control
Controlling brush on highway rights-of-way without herbicides
by manual or mechanical cutting and controlled burning are
high cost alternatives. Non-chemically controlled sites
along guardrails and steep slopes are particularly high
cost and are precisely the areas where amitrole is used.
e. Current Review of the Economic Impacts of
Cancellation on Highway Rights-of-Way
The Agency has estimated that the financial impact of with-
drawing amitrole could account for about a 1 to 3 million
dollar cost increase to users. This estimate is based on
users continuing to use a contact herbicide (specifically
substituting glyphosate for amitrole) in combination with
a residual herbicide.
The Agency's preliminary estimate does not take into account
that some users may elect not to shift to another contact
herbicide but rely entirely on residual herbicides. The
Agency's preliminary information does not permit an estimate
of the extent that users would elect another contact herbicide
in place of amitrole as opposed to relying solely on the
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use of residual pesticides for germination control. The
Agency's current benefit review may change upon receipt of
new information.
2. Preliminary Risk Analysis
a. Introduction
Data indicate that amitrole induces a high incidence of
thyroid tumors in laboratory animals. Amitrole has also
been shown to induce liver tumors in mice at feeding
levels in excess of the maximum tolerated dose; thyroid
carcinomas were evident in conjunction with liver tumors.
Amitrole is a textbook example of a potent antithyroid
agent in laboratory animals. The postulated mechanism of
action is an alteration of the complex feedback mechanism
between two endocrine glands, the thyroid and the pituitary.
Dietary administration of amitrole inhibits peroxidase
activity in the liver and thyroid, causing a subsequent
inactivation of iodide ions in the blood. The lower level
of active iodide ion reduces the level of thyroid hormones
circulating in the blood. The reduced level of thyroid
hormones induces the pituitary to secrete a hormone which
stimulates the thyroid. Prolonged stimulation causes
thyroid enlargement, hyperplasia and, ultimately, tumors.
The Agency's preliminary risk analysis is based on production
data supplied by manufacturers, usage information, estimates
supplied by consumers and worker exposure estimates. Worker
exposure estimates were obtained through surrogate studies
employing other pesticides with uses and application techniques
similar to amitrole and the only exposure study (GS009517)
which specifically used amitrole. The Agency's assumptions
to estimate worker exposure are conservative and tend to
err in the direction of overestimating exposure.
b. Exposure Assumptions
The following assumptions were used to estimate worker
exposure:
1) All workers are unprotected, wearing cotton work
clothes, short-sleeved shirt, without hat, gloves
or respirator, with 15 percent of the body
surface uncovered by clothing.
2) Applicator exposure was calculated from surrogate
data by two possible methods. In the first and
preferred method amitrole exposure varies as a
linear function of the pounds of amitrole active
ingredient expected to be used vs. the pounds of
applied surrogate active ingredient. When no
data were available, applicator exposure was
calculated as a linear function of the duration
of application and the concentration of the
active ingredient in the spray.
14
-------
3) Mixer/loader exposures were estimated from
surrogate data and is proportional to the amount
of amitrole active ingredient vs. the amount of
surrogate active ingredient.
4) Highway tractor (or truck) applicators and forest
helicopter applicators are tended by mixer/loader
personnel. Except for home-use pressurized
aerosols, all other applicators will also be
involved in mixing/ loading operations.
c. Exposure Estimates
The Agency estimated the exposure for each technique of
amitrole application, with the ranges for a particular
technique based on actual field observations. The typical
exposure is based on the average field worker exposure,
while the minimum and maximum values are the lowest and
highest exposures observed in the data. No exposure
estimates were made for re-entry personnel. An exposure
assessment of re-entry personnel will be made upon submission
of data requested by this standard. The following table
summarizes the Agency's exposure estimates for mixers,
loaders and applicators.
15
-------
PRELIMINARY EXPOSURE ESTIMATES
Exposure Situation Minimum Typical Maximum
(mg/kg/dy)*
Utility
Knapsack/Hand-Carry
Applicator
Mixer/Loader
Power Wagon
Mixer/Loader/
Applicator
Industry
Knapsack/Hand-Carry
Applicator
Mixer/Loader
Power Wagon
Mixer/Loader/
Applicator
Railroad
Tanktrain
Applicator
Mixer/Loader
Hy-Rail
Applicator
Mixer/Loader
Forest
Knapsack/Hand-Carry
Applicator
Mixer/Loader
Helecopter
pilot
Mixer/Loader
Highway
Tractor/Truck
Applicator
Mixer/Loader
Home
Aerosol Can
Applicator
7xlO-3
2x10-3
3x10-2
5x10-3
5x10-4
4x10-2
9xlO-3
3xlO-2
3xlO-2
9x10-2
2x10-2
8x10-1
7x10-2
3xlO-2 3X10-1
4xlO~5
8x10-3
4xlO-6
IxlO-4
2x10-4
4x10-2
2xlO-5
4x10-3
5x10-4
9x10-2
5x10-5
2x10-4
2x10-3
2xlO~5
5xlO-3
7x10-3
3xlO~4
7x10-2
IxlO-4
3xlO-2
5xlO-3
3xlO-2
4xlO~4
3x10-4
6x10-2
3xlO~7 1x10-5 2x10-5
*mg/kg/dy (Human Equivalents) =(
Lifetime Exposure =(mg/dy)(dys/y
dose/20)/3
r)/(70kg)(2)(365)
In summary, the Agency has made a preliminary estimate that
dermal exposure, especially from the hands, constitutes
virtually all of the total amitrole exposure. The use of
lightweight waterproof clothing (jumpsuit, gloves, hat and
boots [or shoes]) is expected to reduce dermal exposure.
Despite the minor contribution toward the total exposure, a
respirator is required during mixing/loading operations
until the effects of inhalation exposure can be better defined.
d. Risk Estimates
The Agency cannot, with the available data, accurately predict
the risks involved with the use of amitrole. Quantitative
risk assessments are normally based upon assumptions and,
16
-------
consequently, contain uncertainties. The amitrole risk
assessment contains more uncertainty than usually encountered
because of the lack of information about dermal absorption.
The choice of the most significant assumptions used to calculate
the risks associated with the use of this chemical are
explained in the discussion below which highlights the
principal areas of scientific uncertainty that preclude the
development of a more definitive estimate of risk.
1) Dermal Penetration
Exposure to applicators or spray workers is the major source
of exposure as there are no food uses and other incidental
contact with this chemical would be minimal. Data indicate
that exposure to applicators is almost entirely by the dermal
route. Therefore, dermal penetration is a very important
parameter to estimate worker exposure. No data are currently
available to estimate the extent of dermal penetration. In
the absence of data, the Agency assumes 100 percent dermal
penetration, a worst case scenerio. Realistically, the Agency
feels that much less than 100 percent dermal penetration,
based on the structure and solubility of this chemical.
The effect of dermal penetration on the risk associated with
the use of this chemical is demonstrated by the two estimates
of dermal penetration, 0.1 percent and 100 percent. These
two estimates of dermal penetration represent a worst case
absorption and the lowest value which can be usually be
demonstrated.
2) Risk Assessment Model
The Agency has utilized both the linear one-hit model and the
log-probit model to estimate cancer risk associated with
worker exposure to amitrole. Estimates by both models are
presented in the risk estimate tables. 'The Agency believes
that the log probit model is most appropriate to express the
risk based on the data showing induction of thyroid tumors
and estimates realistic limits of risk, while the one-hit
model provides an upper limit of risk estimation.
Both models demonstrate similar risk estimates at high dose
levels, primarily because the estimated human exposure levels
approach the level of dosing in animal studies. This
convergence of exposure precludes the necessity for extensive
extrapolation at high levels of exposure. The risk estimates
diverge radically, though, at medium and low dose levels.
3) Thyroid Extrapolation
The extrapolation of oncogenic animal data to humans is an
area of uncertainty. Although the Agency has usually
approached extrapolation by adjusting equivalence of exposure
based on surface areas between animals and humans, the amitrole
risk assessment contains additional uncertainties because of
interpretation of data on thyroid effects. It is not known
17
-------
whether a direct comparision can be made between rat and
human thyroids or whether a correction factor should be used.
Regardless of this latter uncertainty, the Agency believes
that the human thyroid can probably withstand a greater insult
than the rat thyroid. It is the Agency's policy to presume
that effects demonstrated in laboratory animals have the
potential to occur in humans. This issue will be carefully
studied during the course of the Special Review for this
chemical.
4) Basis of Risk Estimates
The Agency utilized a study by Johnson et al. (1981)
(GS009504) in its risk estimates because the dietary dosing
schedule was the most representative of the "pulsed" exposures
that are experienced by applicators and the histological
evaluation demonstrated a clear dose-response relationship.
Additionally, this study dosed rats with amitrole at levels
comparable to the highest human exposure estimates.
Dermal absorption was assumed to be 100 percent because no
acceptable dermal absorption data on amitrole are available.
A worker was assumed to weigh 70 kg, have a work exposure of
35 years over a 70 year lifetime, and wear no specialized
protective clothing during mixing/loading/application.
The positive steady dosing oncogenicity studies were not
used for the quantitative risk assessment because that dosing
pattern was less appropriate to the intermittant pattern of
applicator exposure than the pulsed study. These studies
also utilized dosing at levels that are somewhat higher than
the lifetime average doses administered in the pulsed study.
An assessment utilizing the linear model and a steady dose
would produce risk estimates no higher than those based on
the pulsed study. The risk assessment estimates that the
liver oncogenic risk is less than the thyroid oncogenic risk,
based on the linear model. Thus, estimates based on the
linear model are a clear upper limit of worker risk.
Tne following tables, for comparison, demonstrate worker
risk utilizing the linear and log-probit models both applied
to the data showing induction of thyroid tumors. Dermal
absorption estimates of 100 percent and 0.1 percent,
respectively, are used in the following tables.
18
-------
PRELIMINARY RISK ESTIMATE RANGES
(100 % Dermal Absorption)
Exposure Situation Model Type
Log-Probit One-Hit
Utility
Knapsack/Hand-Carry
Applicator <10~8-10-3 10-2->10~l
Mixer/Loader <10~8 10-3-10-2
Power Wagon
Mixer/Loader/
Applicator 10-8->lQ-l 10-2->lO-l
industry
Knapsack/Hand-Carry
Applicator <10~8-10-4 10-2->lO~l
Mixer/Loader <10-8->10~1 10-3->10-l
Power Wagon
Mixer/Loader/
Applicator <10-8->lO-l 10~2->10-1
Railroad
Tanktrain
Applicator <10~8 10-4-10-3
Mixer/Loader <10~8-10~3 10-2-10-1 10-3->10-1
way
Tractor/Truck
Applicator <10~8 10-5-1Q-3
Mixer/Loader <10-8_io-5 iQ-2-10-1
Home
Aerosol Can
Applicator
-------
PRELIMINARY RISK ESTIMATE RANGES
(0.1 % Dermal Absorption)
Exposure Situation
Log-Probit
Model Type
One-Hit
Utility
Knapsack/Hand-Carry
Applicator
Mixer/Loader
Power Wagon
Mixer/Loader/
Appl icator
Industry
Knap sack /Hand-Carry
Applicator
Mixer/Loader
Power Wagon
Mixer/Loader/
Appl icator
Railroad
Tanktrain
Applicator
Mixer/Loader
Hy-Rail
Applicator
Mixer/Loader
Forest
Knap sack /Hand-Carry
Applicator
Mixer/Loader
Helecopter
Pilot
Mixer/Loader
Highway
Tractor/Truck
Appl icator
Mixer/Loader
Home
Aerosol Can
Applicator
<10-8
<10-8
<10-8
<10-8
<10-8
<10-8
<10-8
<10-8
<10-8
<10~8
<10-8
<10-8
<10-8
<10-8
<10-8
<10~8
<10-8
10-5-1Q-4
10-6-10-5
10-4-10-3
10-5-1Q-4
10-6-10-4
10-4-10-3
10-7-10-6
10-5-10-4
10-8-10-7
10-7-10-5
10-6-10-5
10-7-10-4
10-7-10-6
10-6-10-3
10-8-10-6
10-5-10-4
10-9-10-8
Ranges indicate minimum and maximum exposures
There is wide variation in risk estimation. These variations
depend on the model used to estimate risk and the percent
of dermal absorption used in the exposure estimates. The
Agency has made a preliminary estimate that a high risk may
be associated with all uses, except for the homeowner use.
Homeowner risk is estimated to be low because exposure is
estimated to be one hour per year and the chemical is
applied as a targeted (non-fogging) spray.
Despite the potential for high risk, the Agency believes
that restriction of all uses patterns and application
techniques (except homeowner uses) and the use of protective
clothing will reduce exposure 80 percent and reduce risk
20
-------
associated with the use of this chemical during the period
of pivotal data development. The exposure associated with
the homeowner use will be reduced by the use of waterproof
gloves.
The Agency's preliminary analysis of the effects of
restricting all use patterns and application techniques,
except the homeowner use, coupled with the use of protective
clothing indicates that exposure and, hence, risk will be
reduced for all use patterns and application techniques
except the power wagon application of amicrole.
3. Conclusions
The Agency has determined that amitrole may have exceeded
the oncogenicity risk criteria for Special Review.
The Agency has made a preliminary determination that the
costs of cancellation to be a 1 to 3 million dollar cost
increase to users, while the benefits of continued use are
to provide for the safe use of highways. The Agency has
made a preliminary determination that the risk associated
with some uses is high. Restriction of all uses, except
the homeowner use, and labeling will mitigate risk during
the period of pivotal data development and Special Review.
The Agency considers the establishment of the dermal
absorption of amitrole and the effectiveness of protective
clothing to be pivotal in its future risk assessment.
Pending further review, registration of new products and
reregistration of current products containing amitrole
cannot be permitted until the Agency has reviewed these
pivotal data.
21
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
§158.120 Product Chemistry
Product Identity
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Unintentional Ingredients
Analysis and Certification of Product
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-7 - Density, Bulk Density, or
Specific Gravity
V
Composition
TGAI
TGAI
Ingredients
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data
To Satisfy This
Requirement? ( Yes ,
No or Partially)
I/
Partially
No
No
Yes
Yes
Yes
Yes
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?When?
00052653 00052652 Yes/6 months
Yes/6 months
Yes/6 months
00052652 No
00052652 No
GS009514 No
00052652 No
Yes/6 months
V Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
2/ Details of the laboratory synthesis procedures are given. However, details of the actual manufacturing procedures
presently being used needs to be supplied by all registrants.
22
-------
TABLED
GENERIC DATA REQUIREMENTS FDR AMITRDLE
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.120 Product Chemistry (cont'd)
63- 8 - Solubility TCAI OR PAI
63- 9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Other Requirements
64- 1 - Submittal of samples
PAI
PAI
PAI
1GAI
TGAI
Choice
Partially
No
No
No
Yes
Yes
No
2/
00052652
00033124
00069171
00052652
00052652
Yes/6 months
Yes/6 montfts
Yes/6 months
Yes/6 months
No
No
Yes/6 months
\/ Composition: TGAI = Technical grade of the active ingredient; PAI
several test substances determined on a case-by-case basis.
2/ Solubilities in quantitative terms are needed.
23
= Pure active ingredient; Choice = Choice of
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
PHOTODEGRADATION;
161-2 - In water
161-3 - On soil
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
TGAI or PAIRA B,D,G,H
TGAI or PAIRA B,D,G
TGAI or PAIRA G
TGAI or PAIRA B,G,H
TGAI or PAIRA D,G
TGAI or PAIRA D
No
No
No
Partially"
No
No
3/
00036962
00027115
00033127
00089104
Yes/6 months
Yes/6 months
Yes/6 months
Yes/24 months
Yes/24 months
Yes/24 months
V 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=Terres trial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Studies 00036962, 00033127, 00089104 , and 00027115, partially satisfy the aerobic soil metabolism data require-
ments by providing data on the rate of degradation of amitrole in several soil types. No data were provided on the
formation and decline of degradation products of amitrole in aerobic soil other than ^cx (00027115).
24
-------
TABLED
GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
V Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?Wnen?
§158.130 Environmental Fate (cont'd)
MOBILITY STUDIES;
163-1 - Leaching and TGAI or PAIRA B,D,G,H
Adsorption/Desorption
Partially
3/
00032045 00044017
Yes/6 months
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-5
- Soil
- Aquatic (Sediment)
- Forestry
- Soil, Long-term
TEP
TEP
TEP
TEP
B,G,H
D
G
B,D,G,H
No
No
No
No
Yes/24 months
Yes/24 months
Yes/24 months
I/
Reserved
Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radio-labelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=<3reenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3_/ These soil thin layer chromatography studies fulfill the rapid leaching part of the mobility data requirement for the
noncrop use patterns by providing information on the movement (Rf values) of amitrole on sand, sandy loam, silt loam,
clay loam, and silty clay loam thin layer plates. To totally satisfy the mobility data requirements the following
studies are required. 1) A mobility study to assess the leaching potential of amitrole and its degradates after the
pesticide has been aged in sandy loam soil or a soil representative of the use area. This will satisfy the data
requirement for noncrop use patterns. 2)A batch equilibrium (adsorption/desorption) study on a sandy soil or a soil
representative of the domestic use area. This will satisfy the data requirement for the domestic outdoor use pattern.
3) A batch equilibrium (adsorption/desorption) study on one aquatic sediment obtained from a representative aquatic
use area. This will satisfy the data requirement for the aquatic noncrop use pattern. 4) A soil thin layer chromato-
graphy, soil column, or a batch equilibrium (adsorption/desorption) study on a soil representative of the use area
(forest). This will satisfy the data requirement for the forestry use pattern.
4/ The requirement for Dissipation: Long Term Studies is reserved depending upon the results of the Field Dissipation Study
25
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR AMITROLE
Data Requirement
V Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.130 Environmental Fate (cont'd)
ACCUMULATION STUDIES;
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
SPECIAL EXPOSURE STUDIES:
- Protective Clothing
Effectiveness
- Exposure Study
TEP
TGAI or PAIRA
TEP
TEP
TEP
D
B,DrG
D,G
B,D,G
B,D,G
No
Yes
No
No
Partially
00061349
GS009517
4/
Yes/24 months
No
NcT
Yes/6 months
No
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=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3_/ Accumulation studies in aquatic non-target organisms are required to support aquatic non-food and forestry
use patterns. However, the accumulation studies for non-target organisms are waived because the data from the
laboratory fish accumulation study did not show a potential for residues of amitrole to accumulate in bluegills.
V This study only evaluated worker exposure. A study to evaluate the effectiveness of the protective clothing is
required. The Agency should be contacted for protocol review.
26
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TABLED
GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
Composition"
Use 2/
Patterns
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)?When?
§158.135 Toxicology
ACUTE TESTING
- Rat
81-1 - Oral
81-2 - Dermal LD50
81-3 - Inhalation LC50 - Rat
81-4 - Primary Eye Irritation
81-5 - Primary Skin Irritation
81-6 - Dermal Sensitization
81-7 - Acute Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING
82-1 - 90-Day Feeding -
Rodent only
82-3 - 90-Day Dermal _
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
B,D,G,H
B,D,G,H
B,D,H
B,D,G,H
B,D,G,H
B,D,G,H
B,D,G,H
TGAI
TGAI
B,D,G,H
B,D,G,H
Yes
Yes
Yes
Partial
No
No
No
Yes
Partially
00063598
00063599
GS009502
000063599"
5/
00052658 00082174
00052643 00063601
00028434 00063598
GS009517
No
No
No
Yes/6 months
Yes/6 months
Yes/6 months
I/
No
No
Yes/24 months
I/ Composition: TGAI = Technical grade of the active ingredient.
~2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquaticf Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Amitrole is not structurally related to a known neurotoxin nor does it inhibit cholinesterase.
T/ The study indicated that an unprotected worker could receive dermally 20.4 mg/kg/day of amitrole under test conditions.
Medical monitoring of thyroid function was not assessed for a sufficient time period. Thyroid function must be
monitored in the required study. Also, the ability of this chemical to be absorbed dermally must be quantified.
5/ The scoring system and eye irritation scores were not reported. These data must be provided or the test must be rerun.
27
-------
TABLE A.
GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
V Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.135 Toxicology (cont'd)
82-4 - 90-Day Inhalation - Rat TGAI B,D,G,H
CHRONIC TESTING
83-1 - Chronic Toxicity - TGAI B,D,G,H
2 species: Rodent
and Non-rodent
83-2 - Oncogenicity Study - TGAI B,D,G,H
2 species: Rat and
Mouse preferred
83-3 - Teratogenicity -
2 species TGAI B,D,G,H
83-4 - Reproduction -
2-generation TGAI B,D,G,H
Partially
Yes
GS009502 GS009517
00061351 00061348
00082176 GS009503
00061340 GS009504
GS009505 GS009520
yes/24 months
No
Yes
00061351
00082176
00061340
GS009505
GS009520
00061348
GS009503
GS009504
GS009518
No
Partially"
Yes
3/
GS009506 GS009507
GS009506
Yes/24 months
No
I/ Composition: TGAI = Technical grade of the active ingredient.
TT/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=domestic Outdoor; I=Indoor.
_3/ The two available studies were incomplete in reporting and design. The teratology study in mice (GS009506) did not
measure the water consumption of the animals (amitrole was fed to the animals in the drinking water). The study in
rats (GS009507) did not have visceral or skeletal examination of the fetuses.
V Thyroid function must be monitored in this study.
28
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR AMITROLE
Data Requirement
Composition"
V
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.135 Toxicology (cont'd)
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
TGAI
TGAI
TGAI
B,D,G,H
B,D,G,H
B,D,G,H
Yes
I/
V
Yes
PAI or PAIRA B,D,G,H
I/
- Dermal Absorption Study PAIRA
BfD,G,H
Yes"
Yes
No
3/
00052661
00052660
00052665
00052662
00052646
00052648
00079923
00052647
00052649
05020819
05020822
GS009508
GS009509
00052659 00052645
00052644 GS009510
GS009511
No
No
No
No
Yes/6 months
V Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aqautic, Food Crop;
D=Aquatic, Non-Food; E<5reenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ The citations apply to all mutagenicity testing.
4/ Contact the Agency for specific data requirements and protocol review.
29
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR AMITROLE
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LD$Q TCAI
71-2 - Avian Dietary IC$Q TGAI
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish
TGAI
B,D,G,H
B,D,G,H
BfD,G,H
No
Yes
Yes
5/
72-2 - Acute IC$Q Freshwater
Invertebrates
72-3 - Acute LCso Estuarine
and Marine Organisms
TEP
TGAI
TEP
TGAI
TEP
D
B,D,G,H
D
D
Partially
/
Partially"
No
No
No
00022923
6/ 6/
00025435 00069192
V I/
GS009519 GS009515
I/
GS009516
I/
00024959
6/ 6/
GS009519 00017800
0500149
Yes/24 months
No
No
Yes/24 months
Yes/24 months
Yes/24 months
Yes/24 months
Yes/24 months
I/ Composition: TGAI = Technical Grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=*Terrestrial, Food Crop; B=Terrestrial, Non-Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ The formulated product tested was not representative of products used to control aquatic vegetation.
T/ The test was not performed according to the recommended procedures. Recommended test procedures call for testing
the first instar stage as opposed to the mature stage of the organism. The former are generally more sensitive
than the latter.
5/ This study fulfills Guideline requirements and supports registration.
6/ This study does not fulfill Guideline requirements.
30
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TABLE A
GENERIC DATA REQUIREMENTS FOR AMITROLE
Data Requirement
Composition"
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?When?
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact LDc;o
TGAI
B,D,G,H
Yes
00036935
No
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop:
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
31
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING AMITROLE
Data Requirement
Composition"
V
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)?When?
§158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation of
Unitentional Ingredients
MP
MP
MP
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
MP
MP
MP
Yes
Partially"
No
No
No
Partially"
2/
00052653 00052652
00052653 00052652
3/
00063956
No
Yes/6 months
Yes/6 months
Yes/6 months
Yes/6 months
Yes/6 months
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
- Color
- Physical State
- Odor
- Density, bulk density, or
specific gravity
MP
MP
MP
MP
Yes
Yes
Yes
No
00052652
00052652
GS009514
No
No
No
Yes/6 months
I/ Composition: MP = Manufacturing-use product.
"2/ Details of the laboratory synthesis procedure are given. However, details of the actual manufacturing
presently being used have not been supplied by any of the registrants.
3_/ Descriptions and validation data for analytical methods used must be submitted by each registrant.
procedures
32
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TABLED
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING AMITPOLE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
V Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition No or Partially) Citation 3(c)(2)(B)?When?
§158.120 Product Chemistry (cont'd)
63-12 - pH MP No Yes/6 months
63-14 - Oxidizing or reducing
63-15
63-16
63-17
action
- Flammability
- Explodability
- Storage Stability
MP
MP
MP
MP
No
No
No
No
Yes/6 months
Yes/6 months
Yes/6 months
Yes/6 months
V Composition: MP = Manufacturing-use product; Choice = Test substance choice determined on a case-by-case basis.
33
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING AMITROLE
Data Requirement
Composition
V
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/When?
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LDso - Rat
81-2 - Dermal 11)50
81-3 - Inhalation ££50 - Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
MP
MP
MP
MP
MP
MP
Yes
Yes
Yes
Partially"
No
No
4/
00063598
00063599
GS009502
00063599
No
I/
3
3/
No
I/
No
Yes/6 months
Yes/6 months
Yes/6 months
I/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted within 8 months.
3/ This is based on the assumption that the manufacturing-use products are similar in composition to the technical product
originally tested.
4/ The scoring system was not reported. Either the scoring system and scores should be forwarded or the test should be
redone unless the pH is less than 2 or greater than 11.5; and the product will be classified Toxicity Category I on
the basis of potential eye and dermal irritation effects.
34
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix I) is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registration(s)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data V Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted2/. Any
necessary studies must be conducted in accordance with
acceptable protocols, examples of which are contained
in EPA's Pesticide Assessment Guidelines-^/, and, for the
most part, in the approved protocols of the Organization
for Economic Cooperation and Development (OECD). If
you wish not to develop data which are necessary to
support the registration or reregistration of certain
uses appearing in your labeling, you may delete those
uses at the time you submit your revised labeling.
I/ 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)
2/ U.S. EPA, 1982. Pesticide Registration; Proposed Data
Requirements - Part 158. FEDERAL REGISTER of November 24, 1982
(47 FR 53192).
_3/ U.S. EPA, 1983. Pesticide Assessment Guidelines, National
Technical Information Service, Springfield, VA.
35
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Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note; The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix III)*/
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
(Footnote continued at bottom of next page)
36
-------
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed.
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
"and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA will consider your request, you remain subject to the
deadlines for submitting the required data until EPA
grants your request.
(Footnote continued from previous page)
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
37
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III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix IV) to
fill "gaps" identified by EPA concerning your product. Under the
authority of FIFRA Section 3(c)(2)(B), EPA has determined that
you must submit these data to EPA in order to register or reregister
your product(s). All of these data must be submitted not later
than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
38
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IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
V-l an V-2], as indicated by the following paragraphs of this
chapter of the guidance document.
You must submit the revised labeling set forth in this guidance
package within 90 days of receipt of this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix V-l) requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and F (Appendix V-2).
Item 1. PRODUCT NAME - The name, brand, or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading. See Appendix
V-2. [40 CFR §162.10(b)]
Item 2. COMPANY NAME, ADDRESS AND PHONE NUMBER - The name,
address and phone number of the registrant or distributor is
required on the label. The name and address should preferably
be located at the bottom of the front panel or at the end of
the label text. See Appendix V-2. [40 CFR §162.10(c)]
Item 3. AVERAGE NET CONTENTS - An average net content
statement is required on all labels. The preferred location
is the bottom of the front panel immediately above the company
name and address, or at the end of the label text. The average
net contents must be stated in terms of weight, expressed as
avoirdupois pounds and ounces, and stated in terms of the
39
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largest suitable unit, i.e., "1 pound 10 ounces" rather than
"26 ounces." In addition to the required units specified,
net contents may be expressed in metric units. See Appendix
V-2. [40 CFR §162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix V-2.
[40 CFR Sl62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-2. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
nominal percentage by weight of each active ingredient and
the total percentage by weight of all inert ingredients as
indicated in your certification of limits. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix V-2. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
40
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Size of Label
on Front Panel
in Square Inches
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 - All labels are
required to have the statement "KEEP OUT OF REACH OF CHILDREN"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix V-2. [40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix V-2.
[40 CFR S162.10 (h) (l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. See Appendix V-2. [40 CFR
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix V-2. [40 CFR §162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix V-2. [40 CFR §162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix V-2. [40 CFR §162.10
41
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Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions taken to avoid
accident, injury or damage. See Appendix V-2. [40 CFR §162.10
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix V-2. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix V-3. The requirement is based on the results
of the flashpoint determinations and flame extension
tests required to be submitted for all products.
These statements are to be located in the side/back
panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flam-
mability statements.
2. Criteria for declaration of non-flammability . The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163 . 61-8 (c ) ( 13 )
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163.61-8(c) (13) (ii ) ;
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c) (13) (i) .
42
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3. Declaration of non-flammability. Products which meet
the criteria for non-FlammabilTty specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
Chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix V-2. [40 CPR §162.10(1)(2)(ii)].
Item 10A. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. Make certain that the statement you use
pertains specifically to your product. These instructions
must be grouped and appear under the heading "Storage and
Disposal" in the directions for use. This heading must be
set in the same type sizes as required for the child hazard
warning. Refer to Appendix V-4 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix V-2. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other graphic printed matter which is referred to
on the label or which is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
in connection with registration of the product. It should be
made part of the response to this notice and submitted for review.
43
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Robert Taylor (PM 25)
Phone No. (703)-557-1800
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1 and revised labeling. Refer to Appendix
II with appropriate attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III).
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
Note; If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed,
notify the Product Manager listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1).
44
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APPENDIX I
-------
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and
its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered/ will be included. .
2. UNITS OP ENTRY. The unit of entry in this bibliography is
called a "study". In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the
published article from within the typically larger volumes
in which they were submitted. The resulting "studies"
generally have a distinct title (or at least, a single
subject), can stand alone for purposes of review, and can be
described with a conventional bibliographic citation. The
Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OP ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier", or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number" which
has been used to identify volumes of submitted studies; see
paragraph 4(d}(4) below.for a further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all HRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier.
(MRID), each entry consists of a citation-containing
standard elements followed, in the case of materials
submitted to EPA, by a description of the earliest Known
submission. Bibliographic conventions used reflect the
standards of the American National Standardq Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as
author. As a last resort, the Agency has shown the
first toown submitter as author.
-------
b. Document Date. When the date appears as four digits •
with no question narks/ the Agency took it directly
from the document. When a four-digit date is followed
by a question mark/ the bibliographer deduced the date
from evidence in the document*. When the date appears
as (19??), the Agency was unable to determine or
estimate the date of the document.
c. Title. In some cases it has been necessary for Agency
bibliographers to create or enhance a document title.
Any such editorial insertions are contained between
square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past/ the trailing parentheses include
(in addition to any self-explanatory text) the
following elements describing the earliest known
submission:
(1) Submission Date. Immediately following the word
•received1 appears the date of the earliest known
submission.
(2) Administrative Number.' The next element/
immediately following the word 'under1, is the
registration number/ experimental permit number/
petition number/ or other administrative number
associated with the earliest known submissions
(3) Submitter. The third element is the submitter/
following the phrase 'submitted by'. When
authorship is defaulted to the submitter/ this '
element- is 'omitted.
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
tne symbol 'CDL1/ 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 123456-2; and the 27th/ 123456-AA.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the Standard
MRID CITATION
GS009518 Alexander, N.M. (1959) Antithyroid Action of 3-amino-l,2,4 tria-
zole. Journal of Biological Chemistry 243:148-150.
00033124 American Chemical Paint Company (1955) Weedazol: H-60. (Unpub-
lished study received Jun 9, 1955 under 264-68; submitted by
Union Carbide Agricultural Products Co., Ambler, PA.; CDL:
001845-A)
00063956 American Cyanamid Company (1957) Crop Residue Data: Corn, soy-
beansm apples, cranberries. (Compilation; unpublished study
received Mar 18, 1957 under 241-37; CDL:222312-E)
00089104 American Cyanamid Company (1959) Aminotriazole Residues in Soil.
(Compilation; unpublished study, including published data,
received May 16, 1960 under 241-37; CDL-.120214-A)
00069171 American Cyanamid Company (1961) The Name, Chemical Identity, and
Composition: Amino Triazole Weedkiller®: 3-amino-l,2,4-tria-
zole. (Unpublished study received Nov 18, 1959 under 241-37:
CDL:231111-G)
00036935 Atkins, E.L.; Greywocd, E.A.; MacDonald, R.L. (1975) Toxicity of
Pesticides and other Agricultural Chemicals to Honey Bees.
Laboratory Studies. University of California, Division of
Agriculture Science Leaflet 2287. 38 pp.
00052643 Babish, J.G. (1977) Triiodothyronine (T-3) and Thyroxine (T-4)
levels in male rats consuming amitrole (3-amino, 1-2-4-triazole)
in their diets for four weeks followed by a four-week recovery
period; laboratory No. 5539. (Unpublished study received Sep
22, 1980 under 264-135; prepared by Food and Drug Research Lab-
oratories, Inc., submitted by Union Carbide Agricultural Products
Co., Ambler, PA.; CDL:243310-A)
00063601 Bagdon, R.E.; Shaffer, C.B.; Vidone, L.B. (1956) Aminotriazole:
Acute and Subacute Toxicity: Report No. 56-29. (Unpublished
study receeived Feb 26, 1957 under 241-37; submitted by Ameri-
can Cyanamid Co., Princeton, N.J.; CDL:222312-J)
00052662 Bamford, D.; Sorsa, M.; Gripenberg, U.; et al. (1976) Mutagenicity
and Toxicity of Amitrole. III. Microbial Tests. Mutation Re-
search 40:197-202. (Also in unpublished submission received
Sep 22, 1980 under 264-135; submitted by Union Carbide Agri-
cultural Products Co., Ambler, PA.; CDL:243309-M)
GS009517 Baugher, D.G.; Bookbinder, M.G.; Blundell, M.S. (1982) Medical
Monitoring and Assessment of Exposure of Workers Applying
Amitrole to Utility Rights-of-Way. (Unpublished study rec-
eived Nov 18, 1982; prepared by Dynamac Corporation; submitted
by Union Carbide Agricultural Products Company, Inc., Research
Triangle Park, NC.)
-------
05020819 Bignami, M.; Aulicino, F.; Velcich, A.; Carere, A.; Morpurgo, G.
(1977) Mutagenic and Recombinogenic Action of Pesticides in
Aspergillus nidulans. Mutation Research 46(6):395-402.
00069192 Bond, C.E.; Lewis, R.H.; Fryer, J.L. (1960) Ibxicity of Various
Herbicidal Materials to Fishes. Pages 96-101, in Transactions
of the 1959 Seminar of Biological Problems in Water Pollution.
By Robert A. Taft Engineering Center. Cincinnati, Ohio: U.S.
Public Health Service. (Technical Report W60-3; published
study; CDL:230691-H)
GS009505 Bionetics Research Laboratories, Inc. (1968) Evaluation of Car-
cinogenic, Teratogenic, and Mutagenic Activities of Selected
Pesticides and Industrial Chemicals. Vol. I: Carcinogenic
Study. Report No. NCI-DCCP-CG-1973-1-1. (Prepared by Bionetics
Research Laboratories, Inc., Bethesda, MD., prepared for
National Cancer Institute, Inc., MD., August 1968; U.S. Depart-
ment of Commerce, NTIS No. PB-223 159)
00052646 Brusick, D. (1975) Mutagenic Evaluation of Compound: 3-amino-l,2,4-
triazole: 99.4%:LBI Project 12547. (Unpublished study received
Sep 22, 1980 under 264-135; prepared by Litton Bionetics, Inc.,
submitted by Union Carbide Agricultural Co., Ambler, PA*;
CDL.-243310-D)
00052649 Brusick, D. (1975) Mutagenic Evaluation of Compound: 3-amino-l,2,4-
triazole: Ammonium Thiocyanate: LBI Project No. 2547. (Unpub-
lished study received Sep 22, 1980 under 264-135; prepared by
Litton Bionetics, Inc., submitted by Union Carbide Agricultural
Products Co., Ambler, PA.; CDL:243310-G)
00052648 Brusick, D. (1975) Mutagenic Evaluation of Compound: 3-amino-l,2,4-
triazole: Final Report In Vitro Cellular Transformation in BALB/
3T3 Cells: LBI Project No. 2549. (Unpub lished study received
Sep 22, 1980 under 264-135; prepared by Litton Bionetics, Inc.,
submitted by Union Carbide Agricultural Products Co., Ambler,
PA.; CDL:243310-F)
05020822 Carere, A.; Ortali, V.; Cardanone, G.; Ibrracca, A.M.; Raschetti,
R.; (1978) Microbiological Mutagenicity Studies of Pesticides
In Vitro. Mutation Research 57(3):277-286.
GS009502 Cox, G.E.; Re, T.A. (1978) Inhalation Toxicity Study with 3-amino-
1,2,4-triazole (Amitrole) in Adult Fischer 344 Rats. Lab No.
5492. (Unpublished study prepared by Food and Drug Research
Laboratories, Inc., submitted by Union Carbide)
00017800 Crosby, D.G.; Tucker, R.K. (1966) Toxicity of Aquatic Herbicides
to Daphnia magna. Science 154(0ct 14):289-291. (Also in un-
published submission received Mar 17, 1976 under 38329-2; sub-
mitted by Cosolidated Chemical Co., Denver, Col.; CDL:225259-K)
-------
GS009509
00063599
GS009510
GS009511
00063598
00052658
GS009506
00044017
00022923
00061349
GS009504
Dunkel, V.C. (1979) Collaborative Studies on the Salmonella/
Microsome Mutagenicity Assay. Journal Association of Analytical
Chemistry 62(4):874-882.
Elsea, J.R. (1954) Acute Dermal Application: Acute Eye Applica-
tion. (Unpublished study received Feb 26, 1957 under 241-37;
prepared by Hazelton Laboratories, submitted by American Cyan-
amid Co., Princeton, NJ; CDL:222312-H)
Fang, S.C.; George, M.; Chang Yu,
l,2,4-triazole-5-C14 by Rats.
Chemistry 12(3):219-223.
T. (1964) Metabolism of 3-amino
Journal of Agricultual Food
Fang, S.C.; Khanna, S.; Rao, A.Y. (1966) Further Study on the
Metabolism of labeled 3-amino-l,2,4-triazole (ATA) and its
Plant Metabolites in Rats. Journal of Agricultural Food
Chemistry 14(3):262-265.
Fogleman, R.W. (1954) Final Report: Acute Oral Administration -
Mice; Acute Oral Administration - Dogs; Pharmacodynamics - Dogs;
Subacute Feeding - Rats. (Unpublished study received Feb 26,
1957 under 241-37; prepared by Hazelton Laboratories, submitted
by American Cyanamid Co., Princeton, NJ; CDL:222312-G)
Fregly, M.J. (1968) Effect of Aminotriazole on Thyroid Function
in the Rat. Toxicology and Applied Pharmacology 13:271-286.
(Also in unpublished submission received Sep 22, 1980 under
264-135; submitted by Union Carbide Agricultural Products Co.,
Ambler, PA; CDL:243309-I)
Gaines, T.B.; Kimbrough, R.D.; Linder, R.E. (1973) The Toxicity of
Amitrole in Rats. Toxicol. Appl. Pharmacol. 26:118-129.
Helling, C.S. (1971) Pesticide Mobility in Soils: II. Applications
of Soil Thin-Layer Chromatography. Soil Society of America
Proceedings 35:737-748. (Also in unpublished submission receiv-
ed May 5, 1975 under 464-323; submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:221997-S)
Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scient-
ific 'Report - Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
Iwan, G.R. (1978) l^C-Amitrole, Bluegill Sunfish, Lepomis
macrochirus, Bioaccumulation Study. (Unpublished study received
Sep 22, 1980 under 264-135; submitted by Union Carbide Agricult-
ural Products Co., Ambler, PAf; CDL:243311-A)
Johnson, W.D.; Becci, P.J.; Parent, R.A. (1981) Lifetime Feeding
Study of Amitrole in Fischer 344 Rats. Laboratory No. 5651.
(Unpublished study prepared by Food and Drug Research Labor-
atories, Inc.; submitted by Union Carbide Agricultural Products
Co., Ambler, PA)
-------
GS009519 Johnson, W.W.; Finley, M.T. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. U.S. Dept. of the
Interior, Fish and Wildlife Service Resources Publication No.
137, 98 pp.
00082176 Keller, J.G. (1959) Final Report: Two-year Chronic Feeding - Rats,
(Unpublished study received Dec 20, 1958 under PP0210; prepared
by Hazelton Laboratories, submitted by American Cyanamid Co.,
New York, N.Y.; CDL:090236-F)
00028434 Keller, J.G. (1960) Final Report: 28-day Dietary Feeding Study -
Rats. (Unpublished study received Aug 9, 1960 under unknown
admin, no.; prepared by Hazelton Laboratories, Inc., submitted
by Union Carbide Agricultural Products Co., Ambler, PA.; CDL:
106983-A)
00052665 Knickerbocker, M.; Stevens, K.R. (1978) A Study to Determine the
Potential of Amitrole to Induce Dominant Lethal Mutations in
HA (ICR) Mice: Laboratory No. 5502. (Unpublished study receiv-
ed Sep 22, 1980 under 264-135; prepared by Food and Drug Research
Laboratories, Inc., submitted by Union Carbide Agricultural Pro-
ducts Co., Ambler, PA; CDL:243310-H)
00052660 Laamanen, I.; Sorsa, M.; Bamford, D.; et al. (1976) Mutagenicity
and Toxicity of Amitrole. I. Drosophila Tests. Mutation Re-
search 40:185-190. (Also in unpublished submission received
Sep 22, 1980 under 264-135; submitted by Union Carbide Agri-
cultural Products CO., Ambler, PA; CDL:243309-A)
00052644 MacDonald, C.M.; Pullinger, D.H. (1976) A Pharmacokinetic Study
to Compare Head Only and Whole Body Inhalation Methods of
cl^Amitrole Exposure: Project No. 291/1. (Unpublished study
received Sep 22, 1980 under 264-135; prepared by Hazelton Lab-
oratories Europe, Ltd., submitted by Union Carbide Agricultural
Products Co., Ambler, PA; CDL:243310-B)
00027115 MacRae, I.C.; Alexander, M. (1965) Microbial Degradation of Selec-
ted Herbicides in Soil. Journal of Agricultural and Food Chem-
istry 13(l);72-75. (Also in unpublished submission received
Jul 19, 1978 under 201-403; submitted by Shell Chemical Co.,
Washington, D.C.; CDL:234475-H)
00024959 McCann, J.A. (1972) Fenavar: Toxicity to Rainbow Trout: Test No.
478. (U.S. Agricultural Research Sevice, Pesticides Regulation
Div., Animal Biology Laboratory, unpublished report.)
GS009516 McCann, J.A. (1976) Amitrole (90%): Toxicity to Bluegill Sunfish:
Test No. 1060. (U.S. Environmental Protection Agency, Pesticide
Regulation Division, Animal Biology laboratory, unpublished
report.)
GS009515 McCann, J.A. (1976) Amitrole (90%): Toxicity to Rainbow Trout:
Test No. 1052. (U.S. Environmental Protection Agency, Pesticide
Regulation Division, Animal Biology Laboratory, unpublished
report.)
-------
00052661 Meretoja, T.; Gripenberg, U.; Bamford, D.; et al. (1976) Muta-
genicity and Toxicity of Amitrole. II. Human Lymphocyte
Culture Tests. Mutation Research 40:191-196. (Also in unpub-
lished submission received Sep 22, 1980 under 264-135; submitted
by Union Carbide Agricultural Products Co., Ambler, PA; CDL:
243309-L)
00052647 Prince, H.N. (1977) Ames Salmonella/Microsome Mutagen Assay: GBL
7515; Laboratory No. 5634. (Unpublished study received Sep 22,
1980 under 264-135; prepared by Gibraltar Biological Laborator-
ies, Inc., for Food and Drug Research Laboratories, Inc., sub-
mitted by Union Carbide Agricultural Products Co., Ambler, PA;
CDL:243310-E)
00079923 Rashid, K.A. (1974) Mutagenesis Induced in Two Mutant Strains of
Salmonells typhimurium by Pesticides and Pesticide Degradation
Products. Master's Thesis, Pennsylvania State Univ., Dept. of
Entomology. (Unpublished study received Feb 23, 1978 under
100-551; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
232925-A)
00032045 Reichert, B.L.; Knoll, B.A. (1979) CL 217,300: Determination of
Mobility in Soil: Project No. 0420. (Unpublished study rec-
eived Jun 11, 1980 under 241-260; submitted by American Cyan-
amid Co., Princeton, N.J.; CDL:099457-C)
05001497 Sanders, H.O. (1970) Toxicities of Some Herbicides to Six Species
of Freshwater Crustaceans. Journal of the Water Pollution
Control Federation 42(8):1544-1550.
GS009521 Shah, P.V. and Gutrie, F.E. (1977) Dermal Absorption, Distribution
and the Fate of Six Pesticides in the Rabbit. Pesticide
Management and Insecticide Resistance; Academic Press, NY, pgs.
547-554.
GS009508 Simmon, V.F.; Rosenkranz, H.S.; Zeiger, E.; Poirier, L.A. (1979)
Mutagenic Activity of Chemical Carcinogens and Related Compounds
in the Intraperitoneal Host-Mediated Assay. Journal National
Cancer Institute 62:911-918.
00052653 Snelson, J.T. (1974) Amitrole: Joint FAO/WHO Meeting of Experts on
Pesticide Residues 1974: Document PB 227. (Draft monograph:
Australia, Dept of Agriculture, unpublished study: CDL:243309-D)
00061351 Steinhoff, D.; Boehme, K. (1979) Aminotrazole (Amitrole) Cancero-
genesis Test with Oral Administration to Rats: Report No. 8450.
(Translation: unpublished study received Sep 22, 1980 under 264-
135; prepared by Bayer, AG, W. Germany, submitted by Union Car-
bide Agricultural Products Co., Ambler, PA; CDL:243312-A)
-------
00061340 Steinhoff, D.; Boehme, K.; Lorke, D.; et al. (1978) Aminotrazole
(Amitrole) Carcinogenicity Study on Orally Dosed Golden Ham-
sters: Report No. 7521. (Unpublished study received Sep 22,
1980 under 264-135; prepared by Bayer, AG, W. Germany, submitted
by Union Carbide Agricultural Products Co., Ambler, PA; CDL:
243314-A)
00061348 Steinhoff, D.; Boehme, K.; Lorke, D.; et al. (1978) Aminotrazole
(Amitrole) Carcinogenesis Study with Oral Administration to
Mice: Report No. 8490. (Unpublished study received Sep 22,
1980 under 264-135; prepared by Bayer, AG, W. Germany, submitted
by Union Carbide Agricultural Products Co., Ambler, PA; CDL:
243313-A)
GS009520 Steinhoff, D.; Weber, H.; Mohr, U.; Boehme, K. (1983) Evaluation of
Amitrole (Aminottriazole) for Potential Carcinogenicity in Orally
Dosed Rats, Mice, and Golden Hampster. Toxicology and Applied
Pharmacology 69:161-169.
00033127 Sund, K.A.; Gordon, P.M.; Walworth, B.L. (1955) Agricultural Ap-
plications and Soil Residue Studies of 3-amino-l,2,4-triazole.
(Unpublished" study received Oct 11, 1955 under 264-68; submitted
by Union Carbide Agricultural Products Co., Ambler, PA; CDL:
001848-A)
00025435 Swabey, Y.H.; Schenk, C.F. (1963) Report on Algicides and Aquatic
Herbicides, (pp. 8-13 only; unpublished study received Mar 12,
1969 under OF0996; prepared by Ontario, Water Resources Commis-
sion, Laboratory Div., Biology Branch, submitted by Geigy Chem-
ical Corp., New York, N.Y.; CDL:091713-B)
00036962 Thiegs, B.J.; Kaufman, D.D. (1965) Data in Support of the Proposed
Use of Dowpon® Grass Killer for Summer Treatment of Perennial
Grasses in Small Grain Stubble. (Unpublished study including
published data, received Jan 26, 1970 under 464-164; prepared
in cooperation with the U.S. Agricultural Research Service,
Crops Research Div., submitted by Dow Chemical U.S.A., Midland,
Mich.; CDL:022950-A)
GS009507 Tjalve, H. (1974) Fetal Uptake and Embryogenetic Effects of Amino-
triazole in Mice. Archives of Toxicology 33:41-48.
00052659 Tjalve, H. (1975) The Distribution of Labelled Aminotiazole in
Mice, Toxicology 3:49-67. (Also in unpublished submission
received Sep 22, 1980 under 264-135; submitted by Union Carbide
Agricultural Products Co., Ambler, PA; CDL:2433092-J)
00052645 Turner, D.M.; Gilbert, C.M. (1976) Evidence of metabolism of C14
Amitrole in the Rat after Inhalation Administration: Project No.
291/lA. Supplementary Rept., May 1976. (Unpublished study re-
ceived Sep 22, 1980 under 264-135; prepared by Hazelton Labor-
atories Europe, Ltd., submitted by Union Carbide Agricultural
Products Co., Ambler, PA; CDL:243310-C)
-------
00082174 Vidone, L.B.; Shaffer, C.B. (1958) Report on Aminotriazole: 32-day
Repeated Feeding to Rats: Comparision of Effects of 1000 ppm
Fed on Alternative Days with 500 ppm Fed on Consective Days:
Report No. 58-4. (Unpublished study received Dec 20, 1958 under
PP0210; submitted by American Cyanamid Co., New York, N.Y.; CDL:
090236-D)
GS009514 Weed Science Society of America (1979) Herbicide Handbook.
4th edition. Weed Science Society of America, Champaign, 111.
GS009503 Weir, R.J. (1958) Chronic Oral Administration - Beagle Dogs. (Un-
published study prepared by Hazelton Laboratories, submitted by
Union Carbide Agricultural Products Co., Ambler, PA)
00052652 World Health Organization (1974) Amitrole: Joint Meeting of the
FAO Working Party of Experts on Pesticide Residues and the WHO
Expert Committee on Pesticide Residues: Rome, 2-11 December, 1974:
FAD/RES/74.4C. (Extracted from V. 7 1974, IARC Monographs on the
Evaluation of the Carcinogenic Risk of Chemicals to Man; English
only, unpublished study, CDL:243309-C)
-------
INDEX OF CITATIONS USED IN THE DATA REQUIREMENTS CHARTS
REFERENCES LISTED IN NUMERICAL ORDER
MRID
00017800
00022923
00024959
00025435
00027115
00028434
00032045
00033124
00033127
00036935
00036962
00044017
00052643
00052644
00052645
00052646
00052647
00052648
00052649
00052652
00052653
00052658
00052659
00052660
00052661
00052662
00052665
00061340
00061348
00061349
00061351
00063956
00063598
00063599
00063601
00069171
00069192
00079923
00082174
00082176
00089104
05001497
05020819
05020822
GS009502
GS009503
GS009504
GS009505
AUTHOR
Crosby, D.G.; Tucker, R.K. (1966)
Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975)
McCann, J.A. (1972)
Swabey, Y.Hi; Schenk, C.F. (1963)
MacRae, I.C.; Alexander, M. (1965)
Keller, J.G. (1960)
Reichert, B.L.; Knoll, B.A. (1979)
American Chemical Paint Company (1955)
Sund, K.A.; Gordon, P.M.; Walworth, B.L. (1955)
Atkins, E.L.; et al. (1975)
Thiegs, BB.J.; Kaufman, D.D. (1965)
Helling, C.S. (1971)
Babish, J.G. (1977)
MacDonald, C.M.; Pullinger, D.H. (1976)
Turner, D.M.; Gilbert, C.M. (1976)
Brusick, D. (1975)
Prince, H.N. (1977)
Brusick, D. (1975)
Brusick, D. (1975)
World Health Organization (1974)
Snelson, J.T. (1974)
Fregly, M.J. (1968)
Tjalve, H. (1975)
Laamanen, I.; et al
Meretoja, T.; et al
Bamford, D.; et al.
Knickerbocker,
Steinhoff, D.;
(1976)
(1976)
(1976)
M.; Stevens, K.R. (1978)
et al. (1978)
Steinhoff, D.; et al. (1978)
Iwan, G.R. (1978)
Steinhoff, D.; et al. (1979)
American Cyanamid Company (1957)
Fogleman, R.W. (1954)
Elsea, J.R. (1954)
Bagdon, R.E.; Shaffer, C.B.; Vidone, L.B. (1956)
American Cyanamid Company (1961)
Bond, C.E.; Lewis, R.H.; Fryer, J.L. (1960)
Rashid, K.A. (1974)
Vidone, L.B.; Shaffer, C.B. (1958)
Keller, J.G. (1959)
American Cyanamid Company (1959)
Sanders, H.O. (1970)
Bignami, M.; et al. (1977)
Carere, A.; et al. (1978)
Cox, G.E.; Re, T.A. (1978)
Weir, R.J. (1958)
Johnson, W.D.; Becci, P.J.; Parent, R.A. (1981)
Bionetics Research Laboratories, Inc. (1968)
-------
MRID AUTHOR
GS009506 Gaines, T.B.; Kimbrough, R.D.; Linder, R.E. (1973)
GS009507 Tjalve, H. (1974)
GS009508 Simmon, V.F.; et al. (1979)
GS009509 Dunkel, V.C. (1979)
GS009510 Fang, S.C.; George, M.; Chang Yu, T. (1964)
GS009511 Fang, S.C.; Khanna, S.; Rao, A.Y. (1966)
GS009514 Weed Science Society of America (1979)
GS009515 McCann, J.A. (1976)
GS009516 McCann, J.A. (1976)
GS009517 Baugher, D.G.; et al. (1982)
GS009518 Alexander, N.M. (1959)
GS009519 Johnson, W.W.; Finley, M.T. (1980)
GS009520 Steinhoff, D.; Weber, H.; Mohr, U.; Boehme, K. (1983)
GS009521 Shah, P.V. and Gutrie, F.E. (1977)
-------
APPENDIX II
-------
No.
F1FHA SECTION 3(C)(2)(B) SUMMARY SHEET
6PA REGISTRATION NO.
PRODUCT NAME
APPUCANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
WWi respact to tha requinmant tn submit "janarie" dattimposad by tna F1FRA action 3(C)(2MB) notict containad in tha refxanad
Guidanes Qocumant, I am responding in tna fallowing mannar.
D1. I wilt submit data in i timary mmnir to atisry tt>« following requirammts. If thi tan proctdum I will ua dwins from (or an nor
aiBcifiid in) tfn fliqistntion Guidrtintt ortna Proncais eonttimd iff ttm Ripora of Export Groups to *» ChuntcaJj Group, 0 ECO
Chamieai* Toting Prognmmt, I mdon tht protoenk-tRit I will use
Cl I hm wroTBd intn an aqrwrnmtwrth on* or mort othir ugauum undar F1FHA action 3(C)(2(B)(ii) to awry the following data
nquirrnneRO. Tlia too, and any rtquind protoeois, will IM aibmittad to EPA by:
'NAME OF OTHER REGISTRANT
1_J 1 I sndoa a eampiattd "Cartiflcation of Attampt to Entar Into an Agriamant with Other fleqatrams for Oaveiopment of Data" with
mpact to tha following data, requirements
. I reouast that you amand my registration by daieting tha following uaa (this option is not available to applicants for new products):
D 5. I rtquast voluntary eancallation of tha registration of this product (This option is not availabia to applicants for naw products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8880-1 (10-82)
-------
APPENDIX III
-------
OMB fioon * Ho. 20004468 (ExoinK 12-31-33i_
(To quatify, eam'fyA^
1. 1 am duly authorized
merits of a Notice- un
to submit data cancer
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
fourinmsi FOR DEVELOPMENT OF DATA
to represent the following firm(s) who are subject to the require-
der F1FRA Section 3(c)<2)(B) contained in a Guidance Document
nirtg the active ino/edienti
NAME Of «RM
aUIOANCE DOCUMENT DATE
ACTIVE INOR6OIENT
EPA COMPANY NUMBER
(This firm or grouo of •firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if tMeasiary. However, my firm would prefer to enter
into an agreement with one or mom other registrants to develop, jointly, or to share in th» oat of developing, the following required
items 'or data:
f *
1 My firm has offered in writing to anarinto sudran agreement. Capias of tiie offers an attadied.Tlin offer w«» irrevocable and included an offer to be
oound by an arbitration dtcsion under FiFHA Section 3(d(2)(B)(iii) if final agreement on all turn could not be readied otherwise. This offirwas made
to me following firm(s) on die following date(x):
NAME OP FIRM
*
*
DATE OF OFTCR
^.
4. My firm requests that EPA not suspend the registration^) of my firm's produces), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
m» whether my firm must submit data to avoid suspension of its registration^) under F1FRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.} I give EPA permission to disclose this statement upon request.
TYP8O NAME
SIGNATURE
OATH
-------
APPENDIX IV
-------
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document 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
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Stability
Oxidiz ing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRIDt
Miscibility
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LI>-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
-------
APPENDIX V-l
-------
1142.10
cacy, and safely of the formulated
end-use product, may not coiulder any
data as supporting Ilia application.
except the following data:
(I) The data |ho applicant liaa sub-
mitted to EPA under paragraph (b) pi
fhls section;
(3) Other data pertaining to (he
aafety of the producl'a active Ingredi-
ent*, rather than to the aafety of the
end-use product; and
(3) Existing tolerancea. food additive
regulations, exemption*, and other
clearance* loaned under the federal
Food. Drug, and Cosmetic Act.
(el If the applicant knows ihat any
Item of data lie submitted under thuj
section wan generated by (or at the ex-
pense of) another person who orlglna)-
jy submitted the data t,P EPA (or It*
predecessor. USDA) on or after Janu-
ary 1, 1070. to support an application
for registration, experimental uso
permit, or amendment adding a, new
use to an existing registration, or for
rcregldtratlon (unless the applicant
and the original data submitter |iave
reached written agreement on the
amount and the tenni of payment of
any compensation that may be pay-
able under PIP11A aect|pi»
3(D>;
(3) An Identification of the |tem(a)
of data to which the offer applies;
(4) An offer to commence negotia-
tions to ascertain the amount and
terms of compensation to be paid; and
(6) The applicant's name, address.
and telephone number.
(f) If the applicant's product con-
tains any active Ingredient other than
those llmt are present solely because
of the Incorporation Into the product.
dijrlng formulation, of one Of more
other registered pesticide products
purchased from another producer.
then the applicant *|ial| also comply
fill* 40—fro(«ctlop of Envlronptan|
with | m 0 6 aa to such active Ingredi-
ent, and the application ahall contain
an acknowledgment that for purposes
of PIPHA section 3(c)(|MD) the appli-
cation relies on (and any resulting reg-
istration should bo regarded as If ft
were based on the Adnilnlstialor'* con-
sideration of) the following data:
(|) All data submitted or specifically
cited by the applicant In support of
fhe registration; and
(3) Bach other Item of data In the
'Agency's files which:
(|) Concerns the properties or effects,
of any suc|i actjve Ingredient; and .
(II) Is one of tile types of data, that
EP4 would require to be submitted for
scientific review by EPA If the appli-
cant sought the lnlf|a| registration
under PIFRA flection l(c)(6) of a
product with composition and Intend-
ed uses Identical to those proposed for
the applicant's product, under the
data requirement* In effect on the
date EPA approve* the applicant's
present application.
(See*. 1. f. and 31 of FlFflA. M amend*), 1
P B O. Ill elugt
IU fit HftM. M.f II. |S7»]
| 111 !• Labeling rHulr«mcff|f.
(a) General-(I) Content* oj f/»«
label. Every pesticide product* *hal|
bear a label containing the Informa-
tion specified by the Act and the regu-
lation* In this Part. The content* of a
label must show clearly *nd promi-
nently the following: .
(!) The name, brand, or trademark
under which the product I*, sold a* pre-
scribed In paragraph (b) of this sec-
tion;
(II) The name and address of the
producer, registrant, or person for
whom produced a* prescribed In para-
graph (c) of llila section;
(III) The net contents a* prescribed
In paragraph (d) of this section;
(!v) The product registration
pumber aa prescribed In paragraph (e)
of this section;
(v) The producing establishment
(lumber a* prescribed |n paragraph (f)
of this aecl Ion;
(vl) An Ingredient statement aa pre-
scribe*! |r| paragraph (g) of this tec-
lion;
er
— |6n. v|roru«aii|«d Pr0|«t (Ion Ag»ncy' tf lei. 10
proprlate provisions of 40 CPU I'ujls
(10-180. concerning the transportation
of hazardous Jnalt rials, and specifical-
ly those provisions concerning the .la-
beling, (narking and placarding of haz-
'
Chapl
(vll) Warning or precautionary state-
ments as prescribed In paragraph ill)
of this section: >
(*lll) The directions for use M pre-
scribed In paragraph (I) of thh) section;
•lid
' (Ix) The use classification^) aa pre-
scribed |n paragraph (J> of this *ectlon.|
(3) Prominence and leplbUUif. (I) A|l
words, statements, graphic representa-
tions, designs or other Information re-
quired on the labeling by the Act of
the regulation* |n thin part must be
clearly legible to a person w|||i normal
vision, and must be placed with such,
consplciiousnea* (as compared wilt)
Pther words, aiafemenla. designs, or
graphic matter on the labeling) and
expressed hi such terms M to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and W«-,
(II) All required label lent must: <|
(A) Be set |ri d point or larger type;
(B) Appear on a clear contrasting
background; and
(Ol Not be obscured or crowded.
I)) Language to be \tted. All required
label or labeling texj. s|ial| appear In
the English language. Ifowever. the
Agency may require or the applicant
nisy propose additional (ext In other
languages aa Is considered necessary fa
protect the public. When additional
(ext In another language la necessary,
all labeling requirement*) will be ap-
plied equally |o both the English and
other language versions of the label-
ing.
(4) Placement oj Label—t\t QeneraL
The label ahall appear on or be secure-
ly attached to the Immediate contain-
er of the pesticide product, for pur-
poses of this Section, and the niU-
prand .ig provision* of the Act. "*e-
eurely attached" shall mean that •
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of uae. If the lin-
piedlate container Is enclosed within a
wrapper pr outside container through
which the label cannot be clearly read,
jhe |abe| must also be aecnrely at-
tached to such outside wrapper or con-
tainer; If It |a a part of f lie package a*
customarily distributed pr sold.
(Ill Tank cart anil other bulk con-
(A) Tranipor/ufioM. While *
product la |n transit, the ap-
ardous piate'rlala and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered -pesticide product la trans
ported In a (auk cur. tank truck or
other mobile'or portable hulk contain-
er, a copy of the accepted label must
be attached to t|ie shipping paper*.
and left with t|iu consignee at Ilio lime
pf delivery.
(B) Storage. When pesticide prod-
ucts are stored In bulk containers.
whether mobile or stationary, which
feniali) In the custody of Hie uucr. a
copy of the label of labeling, Including
all appropriate direction* for use. shall
be securely attached to the container
In the Immediate vicinity of tin: ills
Charge control valve.
(B) false or mlileadtno ttatementt.
Pursuant to section 3«j)(|MA) of the
Act, a pesticide of o device declared
•iibject to the Act pursuant to 1103.16.
I* mlsbranded If Its labeling la false or
misleading In any particular Including
both pestlcldal and non pcstlcldul
claim*. Examples of statement* or rep-
resentations In the labeling which con-
stitute inlsbrandlng Include:
(|) A false or misleading statement
concerning the composition of the
product;
(II) A false or misleading statement
concerning the effectiveness of the
product a* a pesticide or device;
(III) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device;
(Iv) A false or misleading comparison
with other pesticides or devices;
(y) Any statement directly or indi-
rectly Implying that (lie pesticide or
device la recommended or endorsed by
any agency of the Federal (luvcrn-
ment;
(vl) The name of a pesticide which
contain* two or more principal active
Ingredient* If the name suggests one
or more but not all such principal
active Ingredients, even though the
pomes of the other Ingredient* are
si tiled elsewhere In the labeling;
-------
1142.10
(vll> A true statement used In such ft
way ma to |lv« a (aloe or misleading Im-
pression to Uio purchaser;
label disclaimers which negate
or detract from Ubcllng statements re-
quired under the Act and these regula-
tions;
(Ix) Claims as to the safely of the
pesticide or Ita Ingredient*. Including
statements such aa "safe." "nonpolson-
ous." "nonlnjiirlous." "harmless" Of
"nontoxlo to human* anil pel*" with
or without such a qualifying phrase as.
"when used aa directed"; am)
. ._ . _ M..w».»wl« , Klllf
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural Ingredi-
ents";
Name, brand, or trademark. (I)
The name, brand, or trademark under
which the pesticide product la sold
shall appear on the front pane) of the
label.
(3) 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 a* an addi-
tional name pursuant to | !03.l(bM|).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant'* name ap-
pears on the label and the registrant Is
I not the producer, or If the name of the
I person for whom the pesticide waa
produced appears on t|ie label. It must
IllU 4Q—f rotation of f nvlfonmanf
ba qualified by appropriate wording
such aa "Packed for • t V "Plstrllnit
ed by » • V or "Bold by • • »" to show
that the name hi not that of the pro-
ducer. •
(d) Net weight-or meature oj con-
tenti. (I) The net weight or measure
of content shall ba exclusive of wrap-
pers or other material* and ahal) be
the average content unlesa explicitly
stated as a minimum quantity.
(3) If the pesticide I* a liquid, the
net content statement shall ba In
terms of liquid measure at 88* ft* (30*C)
and ihall he expressed In conventional
American unit* of fluid, ouncea, p|nU,
quarts, and gallon*.
(»If the pesticide hi solid or aemlso-
lid. viscous or pressurized, or U a mix-
ture of liquid and solid, the not con-
tent statement shall be |n terms of
Weight expressed a* avoirdupois
pounds and ounce*.
(4) In all case*, net content shall be
stated In term* of the largest suitable
imlts. I.e., "I pound |0 ounces" rather
than "34 ounces."
(6) In addition to the required units ''
specified, net content may be ex-
pressed In metric unit*.
(0) Variation above minimum con-
tent er around an average I* permissi-
ble only to the extent that It repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a staled minimum la not permit-
ted. |n no case shall the average con-
tent of the package* In a shipment fall
below the stated average content.
(o) product reglttrallon number.
The registration number assigned to
the pe«tlc|de product at the time of
registration shall appear on the label.
preceded by the phraae "BPA Regis-
tration NO.," or the phrase "KPA Reg.
No." The registration number shall be
set In type of a size and style similar to
oilier print on that part of the label
on which It appear* and shall run par-
allel to It. The registration number
and the required Identifying phrase
•hall not appear In such a manner as
|o suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) producing ettabllthinenti regli-
(ration nuntber. The producing estab-
lishment registration number preced-
ed by the phrase "|fiPA Bat.", of ||i«
Chapter f—favlraninfn|al frof««fl<
final establishment at which |h« proli.
pet was produced may appear In anv
suitable location on the |abel or'|n,","a
dlale container. It miist appear fin Ilia
wrapper or outside container of the
package If the BPA eslabllshmen reg
Ulrsl on number on the Immediate
container cannot be clearly re«d
through such wrapper or container
^tngrallent ,tatement~n> Oentr-
al The label of each pesticide product
must bear a statement which conUIn*
the name and percentage by weight of
each active Ingredient, the total
ecnlftrn hu ujuioi.i „« .1. > . : •
fi 162 10
. s * 'lwl "l-
ents; and If the pesticide contains ar-
senic In any form, a statement of the
percentage, of Mai and water so ,,bht
arsenic calculated a* elemental „
«"«'««Ua,u must La
_ T , .»..«••? mf9
designated by the term "active Ingredi-
ents" and the Inert Ingredient* by tin*
Icrm "Inert Ingredients." or the sliigu"
jar forms of these term* when appro-'
prlaie. Both term* shall he |n Hie
same type size, be aligned |o t|>e aame
margin and be equally prominent. Tl«e
statement "Inert Ingredient*, none" I*
pot required for pesticide* which eon-
• lain |0tt percent active lngred|ei)La.
Unleu the Ingredient statement la a
complete analysis of the pesticide, the
Icrm "analysis" shall not be used M •
heading for the Ingredient statement
<3) Poiltlon o/ Ingredient *tateinef\L
(I) The Ingredient statement |* nor-
mally required on the front panel of
the label, ff there I* an ouUlde con-
tainer or wrapper through which thp
Ingredient statement cannot be clearly
read, the Ingredient statement mns|.
also appear on *uc|i outside container
pr wrapper. If the size or form of the
package make* It Impracticable to
place I he Ingredient statement on the
front panel of the label, permission
l»ay be granted for the Ingredient
f I element to appear elsewhere.
(ID The lent of the Ingredient state
went must run parallel with other
Icxt on the panel on which It appears.
and must be clearly distinguishable
from and must not be placed <» Hie
My of other text-
ill «-— • -r
be the'
K-rVBrJ! "i^f h/one, fo,
™ *na «he«ilcal fiame. The
common name may be used alone only
(f jl I* well Known. If no common name
iaa been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name ha* been accepted as a common
name-by the Administrator under the
authority of Section 3fi pose a
hazard to man or the environment.
(h) Warning* and precautionary
Statement*, flequlred warnings and I
precautionary statements concerning
ihe general area* of toxlcologlcal '
hazard Including hazard to children,
environmental htfeurd, and physical or
chemical hazard full Into two i;roni>s:
-------
9 ua.14
those required on ilio front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement,
type size, and prontjnence arc given
below.
(I) llequircit front panel sfafemeiif*.
With the exception of the child
fill* 40—frotocljan «l f nvlr0nmihif
hazard warning statement, the text re-
quired on the front pane) ol the lapel
la determined by the Toxlclty Catego-
ry of the pesticide. The category U M-
algned on the basis of the highest
hazard shown by any of the Indicator*
In the table below:
»
_t
OidlO.. Ity»» •«• IncUSim M f«w«tOSw>MOuia/ka f ion 600 »uu Moo •«/ Oi«*tM *>M tooa M/
«•/!«. ' k» >•
f HMI * SMI «*o/*«.... fiO*« «nU20«ylM. Of*M« |l«t M we/MM.
IV u *«i b**M*>0 too f iu» too s»u soao _ fioMt.ooasinigo.aoo.. o»Mi«f «w> 20.000
Nakiktilan.
Catioiki*. cam*(«<% not i«»*ia«* Irmulaa •! l|
M»d«aU tllUSMI *l If
-t-
<|) Human haaard tional word—(A)
. faxtctty Catepory I. All pesticide prod-
ucts meeting the criteria of Toilclty
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition If the product waa assigned to
Toxlclty Category I on the basis of IU
oral. Inhalation or dermal toxlclty Toiictlv Category II Al| pes|l-
clde producta meeting the criteria of
Toxlclty Category II ahall bear on the
front panel the signal word "Warn-
ing."
(C) ToxMty Category Iff. All pesti-
cide producU meeting the criteria of
Toxlclty Category III ahall bear on
the front panel the digital word "Cau-
tion."
(D) Toxtcttv Category IV- All pesll-
clde producla meeting the criteria of
Toxlclty Category IV ahall bear on the
front panel the signal word "Caution."
If U) I'J« of tlgnal word*. Uue of any
Ignal wprd(s) associated with a higher
Toxlclly Category la not permitted
except when the Agency determine*
that such labeling la necessary to pre-
vent unreasonable adverse effects oij
man or the environment. In no case
ahall more t|ian one human hazard
algna.1 word appear on the front panel
of a label.
(II) Child hazard warning, livery pes-
ticide product label ahall bear on the
front panel the statement "keep out of
reach of children." Only In cases
where the likelihood of contact with
children during distribution, market-
ing, storage or Use la demonstrated by
the applicant to bo extremely remote.
or U the nature of the pesticide Is such
that It Is approved for use on Infants
or small children, may the AdmlnUlra-
for waive this requirement.
(Ill) Statement oj f radical treat-
ment—(Al Tojficity Category I. A
statement of practical treatment (llrw
aid or other) shall appear on the front
Kanel of the label of all pesticides fall-
ig Into Toxlclty Category I on Ifc*
basis of oral, Inhalation or dermal !oi-
Idly. The Agency may. however.
permit reasonable variations In tn«
placement of the statement of practi-
cal treatment Is some reference «ucn
as "Bee statement of practical trc"
ntcnt on back panel" appears on •'"
Chapter I — fnvlranm«q|<>|
front panel near the word "Poison"
and the skull and croaaponea.
(0) Other toxjclty categories The
statement of practical treatment U not
required on the front panel except aa
described In paragraph (liMINIUMA) of
t)ils section. The applicant may. how-
ever, (nclude such a front panel state-
ment at his option- fllalenienU of
practical treatment are. however, re-
quired elsewhere on t|io (abel In
accort| with paragraph (li)(2) of this
tecflpn. If they do not appear on th*
front panel. '
(|v) Placement a,ntt promfn«nc«. A||
Hie require front panel wanting state-
ments, shall be groupet) together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to wake them, unlikely to he over-
look ecj under customary conditions of
purcliase apd use. The following table
•how* the mln|i|ium type size requlre-
nienU for the front panel warnljig
statement*, on various sizes of labels:
p«ncy
10
ar
P4MO*
PlMttt
M
I*
a
ta
u
f 91 Other required wamlngt and pre-
cautionary ttalament*. The warnings
and precautionary statements as re-
quired below ahall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humana and Domestic Ani-
mals." "environmental Hazard" and
''Physical or Chemical Hazard."
i (I) flaiartt to humans and dometlio
\ animal*. (A) \Vi\ere a hazard exists to
. humans of domestic animals. pr<;cuti-
(lonary staleinenta are required Indi-
cating t|te particular hazard, the
routefa) of exposure and the precau-
tions (o he taken to avoid accident.
Injury or <|amage. The' precautionary
paragraph ahall be Immediately pin-
Ceded by the appropriate hazard ulgnal
word.
(lit The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to tcfleet specific hazards.
.. Mn k* Ul«l S «W**IMW| Ik4wl*d <* «Lxnl>«»l *U
•blMMAl* iMMrwl |.
. IhimU k *M*IMV*« |k4ul«l ai »fc»nrt>»l »xough Sw
»Wn| AvuU k•! *U
tlilwwnl i«t**J |
• INa (••uukanuy «blMiu IM^M! | ,
«Ut lul-
Uttonl Do not aM *» •»••. «a «fcln. a> •*> *>-
kig W»«« B°ei^«« o> !•£• MiluU tiul ii<4i«
BtovM «4i~l lumSng ll*i*iul pal kt m«,
on am. « on dowry HumU V >»*M.wi lV
piufHteU ti*l «lil >UI*uMiil mi***! I
AMMd catiuct wUi tUn. *y«» w clull^ig hi MM al
cunud tmn*Jal«ly Smli *^*t « >ilA »«ii |4*ily
«f ~»U. O4l HHukcd MlonSWi S liihlkM Mf-
-------
I 1*3-10
lions to avoid potential accldenf.
Injury or damage. Example* of the
hazard statement* and (he circum-
stance* under which they are required,
follow:
(A) If a pesticide Intended for out-
door line contalna an active Ingredient
with a mammalian acuta oral f .p- of
100 or less, the atalemenl "Thta Pestl-
clde la Toxld to Wildlife" la required..
esllclde U Toxic
|o Hall" la required.
.. of 100
mg/lig or lesa. or a aubacute dietary
I/!., of 600 ppm or lea*, the statement
'Tl»ls I'eallclde la Tox|o to Wildlife" la
required.
fill* 40—ffoUcllon of! Environment
hrU) required.
(&) For i|»e» Involving foliar applica-
tion to agricultural cfopa. forest*, or
ahade treea. or for mosquito abate-
ment treatment*, pesticide* tox|c to
pollinating Insect* must bear approjirl-
ate label cautions.
'(F) For all outdoor uaea other than
aquatic application* the label must
bear the eaullon "Keep put of lake*.
ponds or atreama. |)o not contaminate
Water by cleaning pf equipment or dls-.
poaal of wastes."
(Ill) fhvitcal or cltemlcal hasaidt.
Warning statement* on the f lammabll-
Ity or explosive characteristic* of the
pesticide are required a* f ollowa;
' |A| fWtaaiMUM> CUHIMHtH*
fIa4i puM al at batM W F. S Iwa k> a fcuifcaU al f «b«iMly lamiulila. Cuniantt undaf ataaama. lUap amy ken fca.
any kalna auanlng ayaita. ami fcaalad autlaCM Ou not puncha-a Of ktdnwala aoniaU
ai. E«puaK« k> Iao4>a away from haal. apaika.
law* anlonalon la anna (Man |4 k (u^ al f abiaflcf and c«Mn IUM Ou iwn punca.ua at kuJftwala conUktaf-f
cJ • li torn Via tuna to UnyMiluM aboua tio'FiMycauaalMulir
AS adMf piatcuriiad coniafciaia .. Camanla undw |M*«4uia Ou nol baa of aluia
•ama. Oo not ourcWa or liidnafala coiilalitaf
paialuita abowa 11ft" f May cauaa butting.
(I) NO
ICO CllMIAIHtll*
AUM W f (ml am MM «0- F
Aim.* M- F ud nol Ov« |la* f
xny kan •>•
kOM |M«| and QIMA f am^
pa ao4 UM o> IKK* AMI toal Of cp«k lama.
and l»*Ud »»
(I) Dlreciloiu /or f/M- Placement tj iHrcclloni /or uic.
Dlrectlona may appear on any portion
of the label provided thai they ar*
conaplcuoua enough to bo eaully re«4
by l|io uuer of the peatlclde product-
Dlreclloiu (or uae may appear tin
printed or graphic matter which ac
compunlea the peat|clda provided tli»fc
l
leulleU or circular!, auch M "See d
recllonn In the enclosed, circular:" *»
fo r«aufr0>neiif for
/or |»e—(A) lletalled dlreo-
(loita for liae may be pmltted; from |a-
pellng of peotlcldea which are lntende<|
for uae pnly by maoufacturerii of prod-
UcU other than penllclde producU In
fhelr regular inaniifacti|rli>8 propeiwea.
jirpyl4e4 Mlgt:
(J) The label clearly s|iow* f|iat thp
product Is Intended for uae pnly In
manufActurlng processes and apeclfle*
jhe type(*l of product* Involved.
(1) Adequate Information *uc|| a*
technical data aheel* or bulletins. I*
available to the trade specifying the
type of product Involved and II*
' proper use In manufacturing process-
es
(J) The product will not coma Into
the hand* of the general public except
after Incorporation Into finished prc-d.-
ucU; and,
<4> The Administrator determine*
that auch direction* are not necessary
to prevent unreasonable adyerap ef-
fects on man or the environment.
Ip) Detailed direction* for use. may
be omitted from the labeling of pestf-
clde product* for which sole Is limited
to physician*, veterinarian*. Pf drug-
ibis, provided that:
(f) The label clearly states that thp
product I* for use only by physlclaua
Pr veterinarian*;
41) The Administrator determine*
t|iat such directions are hot necessary
to prevent unreasonable adverse ef-
fect* on man or the environment; and
4J) The product b also a drug and
regulated under the provision* of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed direction* for use may
be omitted from the labeling of pesti-
cide products which are Intended for
u«e only by formtilator* In preparing
pesticides for sale to the public, pro-
tided that:
ff) There Is Information readily
available to the formulator* on the
toiii|mauii>n. toxlclty. methods of use.
•uplkable restrictions or limitation*.
it} The |abe| cfearly stale* that the
product hi Intended for use only In
|tianufacti|r|ng. formulating, mixing.
or repacking for use a* a pesticide and
specifies the lype(s) of pesticide prod
[ iicls involved;
' (|) The product a* finally manufac-
tured, formulated, mixed, or repack-
aged Is registered; and
44) The Administrator determines
tliaf such directions are not necessary
to prevent unreasonable adverse ef-
fecta on man or the environment.
<)) Cuittenlt a/ Utrecllont far U»e.
T|ie direction* for use shall Include
the following, under the headings "Di-
rection* for Use":'
<|) The atatement of use classifica-
tion as prescribed In Ida. 104J) Immedi-
ately under t!»e heading "Dlrectlona
for Use."
(II) Immediately below the state-
ment of use classification, the state-
ment "It I* a violation of Federal law
to use this product In a manner Incon-
sUtent with Its labeling."
(Ill) The slices) of application, as for
example the crops, animals, area*, or
objects to be treated.
• (Iv) The target pest(s) associated
wllli each site.
(v) The dosage rate associated with
each site and pest.
(vO.The method of application. In-
cluding Instructions for dilution,. If re-
quired, and. type(s) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
result* without causing unreasonable
adverse effects, on the environment.
(vlll) Specific limitations on reentry
to area* where t|ie |M>stlclde has been
applied, meeting the requirement*
concerning reentry provided by 40
C'FR Part 170.
4lx) Specific directions concerning
the dtorage and disposal of the pesti-
cide and It* container, meeting the re-
quirement* of 40 CMC Fart 166. These
Instructions shall be groti|»ed and
appear under the heading "Storage
and ptsposu|." This heading must be
-------
1 142.1 T
S0t lit type Of the SUM minimum Sizes
a* required for the child hazard w*rn-
JaKSeeTaole in i lailtthXlXivu
(x) Any up^<»««;<. and appear-
ir^y with. •"f*|'***pg prominence relative
to other rjax »*H cnphxc rmffr*^! on
panel- to otaJce It "^mf«iy to
mar only t» appitod under
be orerlootoed. imder customary condi-
tions of purchase and use. the state*
nj»ff "Sescricted. TJse Pesticide"
Which l^lft- >rtm
section: and anail be marketed as aepm-
products- wttii dlff eresc
only for general usetaj and the other
beartnr directions for restricted useia)
exeecc.tfaat.lf a. produce baa bocir re-
stricted osets; and feneraiuaeia;. both
of these uses may appear on » product
landed for restricted- uaeu. Such prod*
acctahaU be-fflibjectto the provisions:
of i IB3.10CJX2X
(1} GcnmL Us* Oaaifleattan. ?estt>
dd«- products- h««^Tiy directions: for
TBiafiF classified general T*^aP be la-
beled with the fxact words- "CeneraL
only for those uses covered by the C&r-
Applicator's- ^wflf^'*t^rm_ " If,
other- iaii"|a*
-------
APPENDIX V-2
-------
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER TO THE SAMPLE LABELS FOLLOWING)
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
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
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size 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.
-------
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
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, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
i
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
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 above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-------
PRODUCT
NAME
CAUTION
General Use Pesticide
RESTRICTED USE
PESTICIDE
PRODUCT
NAME
KEEP OUT OF REACH OF CHUJHEN
OANGEH^-aOISON
• «
Reatrieted Use Pesticide
-------
APPENDIX V-3
-------
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
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 flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
APPENDIX V-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 headino
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 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 might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
-------
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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:
-------
"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.
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.
-------
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients/ (no inerts):
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic' acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanbx
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
-------
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
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
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c ,d ]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-DiChlorobenzene
p-DiChlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
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
-------
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl 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
Trichloromonofluoromethane (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12 )
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
-------
EPA Index co Pesticide Chemicals •
AMITHOLE*
TYPE PESTICIDE; Herbicide
FORMULATIONS; Tech (902, 95?); WP (152, 252); ?1C (0.33 Ib/gal, 12);
SC/L (0.3 Ib/gal, 2 Ib/gal); SC/S (502, 902); PrL (0.362, 12)
CE^RAL WARNINGS AMD LIMITATIONS: For use as general weed killer in non-
crop areas. Do not allow spray or spray drifc co contaminate edible
crops, or water which will be used for irrigation, drinking or other do-
mestic purposes. Do not apply to water where fish are present. No resi-
due in crops is permitted. Soil persistence: 2 to 4 weeks.
TIME REQUIRED FOR CONTROL: Ten days to 3 weeks.
PHYTOTOXICITY TO TARGET WEEDS: Albinism in developing foliage; senescence
in mature leaves, wilting.
PHYTOTOXICITY TO CROPS; Not 1'ocated.
MODE OF ACTION: Disrupts chioroplast development; inhibits regrowth from
buds; general growth inhibition; interferes with metabolism of nucleic
acid precursors.
CQBIBE
3FAV3B
ADABBA
AZALAA
AZAAAC
3FATAA
ZLAOAA
:QAA,«
3FDQAA
AZA033
3FDHAA
IAAKAA
:
-------
EPA Index to Pesticide Chemicals
A.MITROLE
' 3ROADLZAF ME2DS CONTROLLED (continued)
PA.HAAA3 milkweed (a)
PSGAAA3 morninggLory
P3FAJ3N mugworc
P9KAAAC mustard
PFFARAA pennywort
PAAAABI pigweed (a)
PDXASAA plantain
PFMAFB3 puncturevine
PAAAA3P purslane
P3FAZAA ragweed
?BI
-------
EPA Index to Pesticide Chemicals
A.MI1ROLE
GRASSES AKD OTHER MONOCOTS CONTROLLED (continued)
PCACI3C witchgrass
(a) at 2 pounds active ingredient per acre.
(b) at 4 pounds active ingredient per acre.
(d) at 8 pounds active ingredient per acre.
(1) suppression only.
PDMACAA
PBWAFBS
PACABBC
PAYAE3C
PELAPAA
. PAYACAA
PCQBPSA
PCQBQAA
PBWAFCN
PAHABBI
PAHA3BJ
PENAC3A
PELATBL
PAHA3AA
.PELAT30
PDMAC3A
PSWAF3B
PFDABAA
PCACJAA
PAAAACt
PECA3BA
WOODY PLANTS CONTROLLED;
ash
bear oak
bigleai maple
buckbrush
cherry
honeysuckle
kudzu
locust
northern red oak
poison ivy
poison oak
pricklyash
salnonberry
sumac
western dewberry
white ash
white oak
(f)
(g)
(g)
(f)
(b)
(e)
(e)
(f)
(g)
(f)
(g)
(h)
(h)
(e) at 2 pounds active ingredient per 100 gallons.
(f) at 3 pounds active ingredient per 100 gallons,
(g) at 4 pounds active ingredient per 100 gallons.
(h) at 6 pounds active ingredient per 100 gallons.
AQUATIC WEEPS CONTROLLZ3:
cattail
phragmites
tules
waterhvacinth
(k)
(i)
(i) at 1 to 1.5 pounds active ingredient per acre.
(j) at 6 to 10 pounds active ingredient per acre.
(k) at 8 to 20 pounds active ingredient per acre.
NONFLOMERISG PIJUNTS CONTROLLED: '
PSTA3BC scouringrush (=)
(c) a: 6 pounds active ingredient per acre.
Issued: 12-01-31 1-00^401-3
-------
Sice, Dosage
and Fomulaeion
(la a.i./A)
AGRICULTURAL PREMISES
660000A Uncultivated Agricul-
cural Areas
EPA Index Co Pesticide Chemicals
AMITROL2
Tolerance, Use, Limieaeions
General Information; Unculcivaced agricultural
areas include farm buildings, fencerows, storage
areas, etc.
1.SO-5.M)
(50-90" SC/S)
2.00-8.00
(2 Ib/gal SC/L)
2.00-6.00 lb/
100 gal
(2 Ib/gal SC/L)
(50-902 SC/S)
Broadcast or spot treatment. Apply in enough
water for adequate coverage; double che spray vol-
ume in Che interaountairi states. The specific
dosage is determined by the weeds to be con-
trolled. May be tank mixed with atrazine; or
diuron; or simazine.
Woody plant control. Broadcast or spot treatment.
Thoroughly spray all foliage and stems to the
ground line from the time the foliage is fully
developed until plants begin to go dormant.
ORNAMENTALS
2514UA
25019AA
25021AA
25021DA
302 6AA
5025DA
*
5040AA
•ioQSAA
-0-3AA
50&AAA
5G
-------
SPA Index co Pesticide Chemicals
3509OAA
35090DA
34102AA
3il02DA
35106AA
35106DA
35107AA
35107DA
351I3AA
351130A
33211AA
35119AA
34L37AA
34137DA
35227AA
35127AA
25127DA
35130AA
35130DA
35000DA
Sice, Dosage
and Fonnulation
(Ib a.i./A)
AM1TROLZ
Tolerance, Use, Limitations
American Beech cluster (continued)
Norway Spruce
Norway Spruce
(nursery stock)
Oleander ~
Oleander (nurserv
Red Pine
Red Pine (nursery
stock)
Red Spruce
Red Spruce (nursery
. stoeic)
Scotch Pine
Scotch Pine (nursery
stoeic)
Silver Maple
Sycamore
Viburnum
Viburnum (nursery
scock) """
White Ash =r~
White Soruce
White Spruce (nursery
scock)
Yew
Yew (nurserv scock)
0.90-1.05
(902 SC/S)
(2 Ib/gal SC/L)
(is:
Directed spray. Apply to small weeds in spring or
early summer in 80 to 100 gallons of water, to wee
_the foliage thoroughly. Cut or mow tall weeds to
the ground line, remove cuttings and spray re-
growth 1 or 2 weeks later. Reapply when any re-
growth is 6 to 12 inches tall. May be tank mixed
wicn simazine.
May be formulated with simazine.
Ornamental Hardwoods
(nursery stock)
3.00-8.13
(2 Ib/gal SC/L)
(50-90S SC/S)
D.irected spray for chrysanthemum control. Apply
in 100 gallons water when weeds are ^ to 6 inches
tall. Keep spray off hardwood stock.
Issued: 12-01-31
1-004^01-5
-------
Sire, Dosage
and "oroulation
(Ib a.i./A)
33010AA Ornamental Lavns
•»•»
(0.36-12 PrL)
0.53 Ib a.i./
5,000 sq.ft
(2 ib/gal SC/L)
32000AA Ornamencal Planes
0.90
(902 SC/S)
32000DA Ornamental Planes
Tnursery stock.)
0.90
(90Z SC/S)
EPA Index Co Pesticide Chemicals
AMITROLZ
Tolerance, Use, Limitations
Spec CreaCment Co individual weed clumps. Spray
target weeds only. Dig up created quackgrass co a
depth of 1 Co 6 inches 2 weeks afcer application.
Lawn renovation. Apply in late summer co early
fall when planes are actively growing in 25 co 30
gallons of water. Water heavily if no rain falls
within 3 to 7 days. Dig, rotovate or plow 10 co
14 days after application and reseed. Keep spray
off desirable vegetation.
Directed spray. Apply co weeds in plantings in-
median scrips. Tank mix with sinasine. Where
johnsongrass or bermudagrass is a problem, may be
cank mixed with diurbn; or monuron.
Directed spray. Tank mix with simazine.
RIGHTS -OF -i
i'OUOA Right s-o f-Vay
1.80-5.40
(50-90: SC/S)
2.00-8.00
(2 Ib/gal SC/L)
.'Broadcast or spot treatment. Apply in enough
water for adequate coverage; double Che spray vol-
ume in tne ineermountain states. Tne spcefic dos-
age is decermerid by cne weeds to be controlled.
May be Cank mixed with acrazine; bromacil; diuron;
monuron; simazine; atrazine ana sodium 2,3,o-tri-
chlorophenylacetate; bromacil and 2,<*-dichloro-
phenoxyacetic acid esters or amines; bromacii and
diuron; bromacil and sodium 2,3,6-trichloro-
phenylacetate; or bromacil and diuron and 2,4-di-
cfalorophenoxyacetic acid esters or amines.
Issued: 12-01-31
1-004401-6
-------
Sice, Dosage
and Formulation
(Ib a.i./A)
EPA Index to Pesticide Chemicals
AMITROLE
Tolerance, Use, Limitations
Rights-of-Vay (continued)
1.00-2.00
(252 WP)
broadcast or spot creacnent. Apply in 20 Co 100
gallons of water. Use the higher dosage for pro-
longed control or when weeds are 6 to 3 inches
tall.
Formulated with linuron.
l.i9-2.97
(0.33 Ib/gal F1C)
670110A
2.00-6.00 Ib/
100 gal
(2 Ib/gal SC/L)
(50-902 SC/S)
Paved Areas
1.98-2.97
(0.113 Ib/gal F1C)
Broadcast or spoc treatment. Apply in 100 gallons
of water. Use the lower dosage where annual rain-
fall is less than 15 inches and the higher dosage
where annual rainfall is between 15 to 20 inches.
Formulated with ammonium 2,3,6-trichiorophenyl-
acetate and atrarine.
Woody plant control. Broadcast or spot treatment.'
Thoroughly spray all foliage and stems to the
ground line from the time the foliage is fully
developed uncii planes begin co go dormanc.
Prepaving treatment. Destroy existing weed
growth, grade and level area to be surfaced.
Apply in at least 300 gallons of water per acre.
Apply asphalt or cement cover as soon as possible.
Formulated with ammonium 2,3,6-trichlorophenyl-
acetate and atrazine.
COMMERCIAL AND INDUSTRIAL PREMISES
jTOCOOA N'oncroa Areas
1.30-5.40
(50-902 SC/S)
2.00-4.00
(2 Ib/gal SC/L)
General Information:
ing lots, tank farms
fencerows, etc.
Noncrop areas include park-
lumber yards, storage areas,
Broadcast or spot treatment. Apply in enough
water for adequate coverage; double the spray vol-
ume in the intermountain states. The specfic dos-
age is determined by the weeds to be controlled.
May be tank mixed with atrazine; bromacil; diuron;
karbutilate; monuron; simazine; atrazine and
sodium 2,3,6-trichlorophenylacecate; bromacil and
2,4-dichlorophenoxyacetic acid esters or amines;
or bromacil and sodium 2, j, 6-crichlorophenyi-
acetate.
Issued: 12-01-31
1-004401-7
-------
iTOHOA
Sice, Dosage
and Formulation
(lb a.i./A)
EPA Index co Pesticide Chemicals
AMITROLS
Tolerance, Use, Limitations
Noncrop Areas (continued)
1.49-2.97
(0.33 Ib/gal rlC)
3.96
(0.44 Ib/gal F1C)
0.90-3.00
(0.3 Ib/gal SC/L)
2.00-6.00 lb/
100 gal
(2 ib/gal SC/L)
(50-902 SC/S)
Payed Areas
1.98-2.97
(0.33 Ib/gal F1C)
Broadcast or spoc treatment. Apply in 100 gallons
of water. Use the lover dosage where annual rain-
fall is less Chan 13 inches and the higher dosage
where annual rainfall is between 15 Co 20 inches.
Formulated with ammonium 2,3,6-trichlorophenyl-
acetate and aerazine.
Broadcast or spoc treatment.
gallons of water.
Formulated with simazine. '
Apply in ac lease 50
Broadcast or spoc treatment. Apply in 20 Co 100
gallons of water.
Formulated with dimethylamine brooacil and
dime thy lamine 2,3,6-Cri'chlorophenylacecace.
Woody plane control. Broadcast or spot treatment.
Thoroughly spray all foliage and seems to che
ground line from che time che foliage is fully
developed uncil planes begin eo go dormant.
?r«paving treatment. Descroy existing weed
growth, grade and level area co be surfaced.
Apply in ac lease 300 gallons of wacer per acre.
Apply asphalt or cement cover as soon as possible.
Formulated with ammonium 2,3,6-trichlorophenyl-
acetate and aerazine.
_. rTOOOOA
DOMESTIC DWELLINGS, MEDICAL FACILITIES AND SCHOOLS
Noncroo Areas
(0.36-15 PrL)
1 pt product/
1-2 gal
General Information; Noncrop areas include areas
along walks, fencerows, buildings, pacios, and
driveways, etc.
Spot treacmenc co individual weeds. Spray target
weeds only. Dig up created quackgrass to a deptn
of 5 to 6 inches 2 weeks after application.
*
Spot treatment. Apply using a sprayer or watering
can.
Issued: 12-01-81
1-004401-3
-------
EPA Index Co Pesticide Chemicals
AMITROLZ
Sice, Dosage
and Formulation
(Ib a.i./A)
(12 EC)
Tolerance, Use, Limitations
FOREST, CHAPARRAL. NONAGRICULTURAL AND WASTELANDS
30126AA American Seech
3012"AA American Elm
30119AA Arborvitae
3012SAA Balsam Fir
30039AA Douglas-Fir
30077AA Eastern Hemlock
30129AA Fraser Fir
30050AA Juniper
30130AA Norway Spruce
30103AA Red Pine
30125AA Red Spruce
30113AA Scotch Pine
30131AA Silver Maple
30066AA Svcamore
30132AA Vhite Ash.
•30108AA White Spruce
30073AA Yew
0.90-1.05
(902 SC/S) '
(2 Ib/gal SC/L)
(152 WP)
Directed spray in forest plantations.. Apply to
small weeds in spring or early summer in 80 to 100
gallons of water, to wet the foliage thoroughly.
Cut or mow tall weeds to tfce ground line, remove
cuttings and spray regrowth 1 or 2 weeks later.
Reapply when any regrowth is 6 to 12 inches tall.
May be tank mixed with siiaazine.
Mav be formulated with simazine.
:5012MB
;5033MB
AQUATIC AREAS
General Warnings and Limitations: Do not allow spray or drift to contami-
nate water which will be used for irrigation, drinking or other domestic
purposes. Do not apply to water where fish are present.
(Moving Water)
Drainage Canals
Drainage Ditches
Marshes
6.00
(2 ib/gal SC/L)
Cattail control in North Central and Eastern
States. Broadcast after catkins are fully devel-
oped until frost. Do not disturb treated plants.
Spot treat any regrowth. Apply in 300 gallons o:
water by ground and in 10 gallons of water by
aerial eauioment.
Issued: 12-01-81
1-004401-9
-------
Size, Dosage
and Formulation
(Ib a.i./'A)
EPA Index to Pesticide Chemicals
AMITROLS
Tolerance, Pse, Limitations
Drainage Canals cluster (continued) ,
8.00-10.00
(2 ib/gal SC/L)
Cattail control in Southwestern and Western
States. Broadcast after catkins are fully devel-
oped until frost. Do not disturb created plants.
Spot treat any regrowen. Apply the lower dosage
in 400 gallons of water by ground and the higher
dosage in 15 gallons of water by aerial equipment.
Cattail control. 'Broadcast after catkins are
fully developed until frost. Do not disturb
treated plants. Spot treat any regrowth. Apply
in 300 to 400 gallons of water by ground and in
15 gallons of water by aerial equipment.
Cattail, phragmites and tules control. Broadcast.
Use the higher dosage in flooded sites and the
lower dosage in nonflooded sites. Tan* mix with
sodium dalapon.
Phragmites control in North Central and Eastern
States. Broadcast after plants are 30 inches tall
until early fruiting stage. Apply in 100 gallons
of water by ground and in 5 to 10 gallons of water
by aerial equipment.
Phragmites control in the Atlantic coast region.
Broadcast after plants are 30 incnes tall until
early fruiting stage. Apply the lower dosage in
300 gallons of water by ground and in 5 gallons of
water by aerial equipment to nonflooded sites.
Apply the higher dosage in 300 gallons of water by
aerial equipment to flooded sites.
1.00-1.50 Wacerhyacinch control in the Southeastern States.
(2 Ib/gal SC/L) Broadcast in April to wet tne weeds and the shoots
under the plants thoroughly. Apply in 200 gallons
of water by ground and in 5 gallons of water by
aerial equipment.
7.20-9.90
(90S SC/S)
1.80-4.50
(902 SC/S)
8.00
(2 Ib/gal SC/L)
15.&0-2Q.OO
(2 Ib/gal SC/'L)
Drainage.Ditches
See Drainage Canals cluster.
(Marshes, Estuaries, Sh'orelines)
Marsnes See (Moving Water), Drainage Canals cluster.
(Adjacent eo Water)
Di:;h 3anks See (Moving Water), Drainage Canals cluster.
Issued: 12-01-31 1-004401-10
-------
Site, Dosage
and Formulaeion
(Ib a.i./AJ
EPA Index to Pesticide Chemicals
AMITROL2
Tolerance, Use, Limitations
AERIAL AND TANK MIX APPLICATIONS
'001500
Aerial Applicaeions
•900300
Tank Mix
Refer Co
AQUATIC AREAS
All sices
Refer Co
AGRICULTURAL PREMISES
All sices .
ORNAiMENTALS
American Beech cluscer, Oroaraencal Planes,'Orna-
mental Planes (nursery stock)
RIGHTS-OF-WAY
Righcs-of-Way
COMMERCIAL AND INDUSTRIAL PREMISES
Noncrop Agricultural Areas
FOREST, CHAPARRAL. NONAGRICULTURAL AND WASTELAND
All sites
AQUATIC AREAS
All sices
Issued: 12-01-31
1-004401-11
-------
EPA Index co Pesticide Chemicals
AMITROLE
Listing of Registered Pesticide Produces by Formulation
90* technical chemical
amitrole (004401)
000241-00222 000264-00238 002749-00071 00931S-00017
95Z technical chemical
amitrole (004401)
007173-00093
15% vee table powder
amicrole (004401) plus siaazine (080807)
000264-00124
25* weccable powder
amicrole (004401)' plus linuron (035506)
000264-00246
0.33 Ib/gal f lovable concentrate
amicrole (004401), atrazine (080803) plus ammonium 2,3,6-crichloro-
phenylacetate (082606)
000264-00172
0.44 Ib/gal flovable concentrate
amicrole (004401) plus simazine (080807)
000264-00196
1* flovable concentrate
amicrole (004401) plus simazine (080807)
000264-00156
0.3 Ib/gal soluble concentrate/liquid
amicrole (004401), dimechylamine bromacil (012304) plus dimetnylamine
2,3,6-crichlorophenylacecace (082605)
000254-00244
2 Ib/gal soluble eoncentrace/1 iouid
amicrole (004401)
000264-00060 000264-00135 000264-00226 002749-00137
010337-00005
502 soluble concentrate/solid
amicrole (004^01)
000264-00063 002749-00216
902 soluble concentrate/solid
amicrole (0044Q1)
000241-00057 000241-00168 000264-00119 002749-00073
007173-00142 009319-00011
0.35" pressurized liouid
amicrole (.004401)
007701-00032
Issued: 12-01-31 1-004401-12
-------
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f,/ of 2
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UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
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