CASE NUMBER 2 3 4
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
AMITRAZ
AS THE ACTIVE INGREDIENT
106201
ENVIRONMENTAL PROTECTION.AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 56
III. Requirement for Submission of Product-Specific
Data . 59
IV. Submission of Revised Labeling 59
A. Label Contents 60
B. Collateral Information 65
V. Instructions for Submission 66
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APPENDICES
Page
II-l Guide to Bibliography 69
II-2 Bibliography 70
II-3 PIPRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
II-iJ Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2
III-l Product Specific Data Report (End-Use Products)
IV-1 40 CPR 162.10 Labeling Requirements
IV-2 Table of Labeling Requirements
IV-3 Physical/Chemical Hazards Labeling Statement
IV-^ Storage and Disposal Instructions
ii
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. '3(g)) directs EPA to reregister all pesticides
as expeditiously as possible.
To carry out this task, EPA has established the Registration
Standards program, which will review all pesticide products
containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. EPA's reassessment results in the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations,
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we were also looking for potential hazards that may be
associated with the end-use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration Standards
program and will propose regulatory actions to the extent
necessary to protect the public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our questions
regarding the hazards that may result from the intended use
of a pesticide. Although sec. 3(c)(2)(B) provides that all
registrants are responsible for these data, the Agency generally
Imposes generic data requirements only on the registrants of
the manufacturing-use products (basic suppliers of the active
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ingredient) and other producers who do not qualify for the
formulator1s exemption*.
A producer who wishes to qualify for the formulator1s
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm. An end-use registrant
may do so by submitting a new Confidential Statement of
Formula, EPA Form 8570-4, identifying the registered source
of the active ingredient, to the appropriate Product Manager
within 90 days of receipt of this Guidance Document. The
chart on the following page shows what is generally required
of those who do and do not qualify for the formulator's
exemption in the Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document. If you decide to maintain your product
registration(s), you must provide the information described
in the following pages within the tiraeframes outlined. EPA
will issue a notice of intent to or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible unreason-
able adverse effects of a pesticide. You should notify the
Agency of interim results of studies in progress if those results
show possible adverse effects.
* The formulatorrs exemption applies to a registrant if the source
of his active ingredient(s): (1) is a registered product and (2)
is purchased from a source which does not have ownership in common
with the registrant's firm.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION (S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For the Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Registra-
tion 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 restrictions
or labeling are needed to protect
man or the environment will these
products be subject to the
Registration Standard require-
ments. Affected products will be
dealt with in a variety of ways,
including but not limited to the
Label Improvement Program and
special intent to cancel notices.
* End use products of registrants who also produce a manufacturing use
product will not be required to be reregistered provided that registrant
fulfills the requirements specified in the Guidance Document for manu-
facturing-use product(s). Such end-use products will be subject to the
labeling changes required for products in "II" above. If there are no
manufacturing-use products registered by any company end-use products
will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "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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II. REGULATORY POSITION AND RATIONALE
A. Introduction
This chapter contains the Agency's regulatory position on
products containing the pesticide amitraz as the sole active
Ingredient. T.he Agency bases its position and rationale on
a consideration of all uses of amitraz appearing on pesticide
products registered under Sections 3 and 24(c) of the PIFRA as
well as on products authorized for distribution in intrastate
commerce under 40 CFR 162.17. The Agency has reviewed the
known chemical, environmental, and toxicological characteristics
of this pesticide and its established tolerance for residues in
or on pears. From these considerations the Agency sets forth the
the data and labeling requirements that must be met by registrants
and applicants for registration of amitraz products in order
for their products to be registered or reregistered under this
Guidance Document. Unique labeling requirements and certain
data needs for end-use products (EP's) containing amitraz are
also established by this Standard.
Only those data and labeling requirements for current and
future substantially similar MPs and EPs are addressed here.
Future products that differ appreciably from those described
in this Guidance Document may be subject to additional data and/or
labeling requirements.
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B. Description of Chemical and Use Profile
Amitraz is the American National Standards Institute's (ANSI)
acceptable common name for N'-(2,H-dimethylphenyl)-N-[[(2,4-
dimethylphenyl)imino]methyl]-N-methylmethanimidamide. Other
names and code designations are: Estrella, Azadleno, Baam,
Mitac, Taktic, JA 119, Trlazid, Triatox and azaform. The
current Chemical Abstract Service (CAS) registry number for
amitraz is 33089-61-1 and the EPA Shaughnessy number is 106201.
Technical amitraz is a straw colored crystalline solid. Its
melting point is 86-87°C. Amitraz at 25°C is extremely
soluble in xylene (66.6g/100ml) and acetone (50g/ 100ml-) and
relatively insoluble in methanol (2,38g/100ml) and water
«lppm). The empirical formula is C^gH23N3 and the molecular
weight is 293.
Technical amitraz is imported into this country from England
by Nor-Am Chemical Company. This pesticide is not produced
domestically. There are six products currently registered
which contain amitraz as an active ingredient. Two are technical
amitraz products (93%) and the other four are end-use products.
These are all single active ingredient formulations.
Amitraz end-use formulations are an emulsifiable concentrate and
a wettable powder. There are no intra-state registrations for
amitraz. Amitraz is registered to control insects and mites
only on pears. There are proposed tolerances and applications
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for registration for hogs, cattle, apples and citrus. Amitraz
is a restricted-use pesticide and applicators must be certified
or be under the direct supervision of applicators certified
to apply amltraz.
C. Regulatory Background
Amitraz was first registered in 1975 as a 93% technical to be
used in the preparation of experimental miticide/insecticide
formulations. The first application for registration for an
end-use product for use on apples and pears was made in 1976.
In April 1977, before the registration of these uses, the Agency
published in the Federal Register (42 PR 18299) a notice of a
rebuttable presumption against registration (RPAR, and currently
known as a Special Review) of pesticide products containing
amitraz on the basis that araitraz met the risk criteria for
oncogenic effects (40 CPR l62.11(a)(3)(±i)(A). An 80-week mouse
oncogenlclty study showed a significant increase in the incidence
of lymphoreticular tumors in mice.
In January, 1979, the Agency published in the Federal Register
(44 PR 2678-2682) a notice of determination and availability
of Position Document 2/3. This position document presented the
Agency's analysis of the risks and benefits resulting from the
proposed use of amitraz on apples and pears, analyzed the
rebuttals received from Interested parties and proposed a
decision to conclude the RPAR process. The Agency concluded
that there is "weakly positive evidence" that araitraz is a
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positive human carcinogen based on the positive effects
demonstrated in the mouse study although there were questions
raised regarding the reliability of the study. The Agency
also concluded that the proposed use of amitraz on apples and
pears might pose a very small risk of cancer to certain exposed
groups. To determine that risk the Agency conducted a dietary
and occupational risk assessment.
The Agency, in its assessment of dietary and occupational risks
associated with the use on pears, calculated two scenarios for
exposure, one conservative and the other more realistic. The
conservative scenario used the assumptions that: all pears were
treated annually; all fresh and processed pears had residues of
of amitraz at the tolerance level (3.0 ppra); and mixers, loaders
and applicators did not wear protective clothing. These
conservative assumptions led to calculated risks of 9 x 10~6
(10~5) from dietary exposure and 10~** to 10~6 occupational
exposure. The more realistic scenario Included the following
assumptions: only 40-505& of the pear acreage is treated annually,
fresh pears average 1.0 ppm and processed pears average 0.25
of amitraz residues and mixers, loaders and applicators are
required to wear protective clothing. This more realistic
scenario leads to risks of 10~6 for dietary and 10~5 to 10~6
for occupational exposure. In reviewing the benefits and
risks, the Agency determined that there would be significant
benefits from the use on pears with little or no benefits from
the use on apples since there were suitable alternatives.
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After weighing the benefits and risks, the Agency proposed to
issue a conditional registration for four years for use of
amitraz on pears provided that the company agreed to certain
terms and conditions. These were (1) to submit additional
benefits data on pears, (2) submit a new mouse oncogenicity
study and (3) -implement several changes on the proposed
label. The label changes were: classification of all amitraz
products as restricted use; additional precautionary changes
including protective clothing for applicators; and, a 24-hour
reentry interval and a 7-day pre-harvest Interval.
In October, 1979, the Agency published in the Federal Register
(44 PR 59939-59946) a notice of its intent to conditionally
register amitraz for use on pears and not to issue registration
for use on apples. This FR Notice also announced the avail-
ability of Position Document 4. In this notice the Agency
proposed to conditionally register amitraz for use on pears
for four years under section 3(c)(7)(C) of FIFRA with the
conditions that the registrants make the label changes at
registration and additional mouse oncogenicity study and
benefits data be submitted within four years from the date of
registration. This section of FIFRA allows conditional
registration of a pesticide product containing unregistered
active ingredients only if the registration would not cause
unreasonable adverse effects and would be in the public
interest. The Agency determined that the registration of
amitraz for use on pears would not cause unreasonable adverse
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effects and would be in the public interest because it would
result in substantial benefits and very small risks. The
Agency determined that it could not grant registration of
amitraz for use on apples because the requirements of section
3(c)(7)(C) of FIFRA had not been met. The Agency concluded
that this use would result in little or no benefits and would
therefore not be in the public interest. Amitraz was granted a
conditional registration in January, 1980, for four years only
for use on pears. At the same time, the Agency established a
0.0 ppm tolerance for residues of amitraz in or on apples, and
the fat, meat by-products, and meat of cattle, goats, hogs,
horses, and sheep to affect the decision to prohibit the use on
apples. (Waste from processed apples is fed to livestock.)
The conditions under which amitraz was conditionally registered
have been satisfied. The benefits data were reviewed and found
to substantiate the benefits of the use on pears. The new mouse
oncogenicity study was referred to the Agency's Cancer Assessment
Group (CAG) for evaluation. The results of this study show an
increase in the incidence of hepatocellular tumors in female mice
and an increase in lung tumors in male mice. Based on this study
and the first mouse study, CAG has determined that amitraz has
carcinogenic activity in the mouse. The second study did not
appreciably change the Agency's quantitative assessment of the
potency of amitraz from the first mouse study. Based on the
weight of evidence of analysis, CAG concluded that amitraz
should be considered a possible human (a Group "C") carcinogen.
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In reaching this conclusion CAG considered the following
information:
There is no positive epidemiology carcinogenicity data for
amitraz.
The positive carcinogenic effects were found in only one species,
the mouse.
Tumors were discovered mostly in terminally sacrificed groups.
The rat was negative for oncogenic effects at doses as high as
200 ppm.
Also, the mutagenic potential of amitraz has been determined
to be negative in the gene mutation, hostmediated and dominant
lethal test systems. Additional negative studies including
the Ames Bacterial Test, a Mouse Lymphoma Assay, and an
Unscheduled DNA Synthesis in Human Embryonic Cells have been
conducted with amitraz. In addition, several metabolites have
also been tested with their mutagenic potential also reported to
be generally negative. The Agency is not aware of any other
pesticide that is structurally related to amitraz that shows
carcinogenicity. However, the parent compound does metabolize
to substituted anilines, some of which as a class are oncogenic.
The chronic toxicology data base for amitraz is complete. The
toxicological data considered in support of this registration
standard included a 2-year rat feeding/oncogenicity study which
was negative for oncogenic effects with a no-observable-effeet-
level (NOEL) of 200 ppm; a three-generation rat reproduction
study with a NOEL of 15 ppm; rat and rabbit teratology studies
which were negative; and a 2-year mouse oncogenicity study
which demonstrated an increase in the incidence of hepatocellular
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tumors in female mice and increase in lung tumors in male mice.
In this registration process the Agency has reconsidered the
risks and benefits associated with the use on pears in view of
the reassessment of the data base including the new oncogenicity
study and benefits data. Since the assessment of these data has
not led the Agency to change its opinion of amitraz's oncogenic
potential or benefits, the Agency concludes that the risks and
benefits remain the same for the pear use and that there is no
reason to act against the registration of that use.
D. Regulatory Position and Rationale
Based on a review and evalution of all available data and other
relevant information on amitraz, the Agency has made the
following determinations:
1. All products containing amitraz as a sole active ingredient
may continue to be registered for sale, distribution,
reformulation, and use on pears subject to the terms and
conditions specified in this Guidance Document. Registrants
must provide, or agree to develop, additional data, as
specified in Tables A and B in order to maintain existing
registrations or to permit new registrations.
Rationale; The Agency made a regulatory decision in 1980 to
conditionally register amitraz for use on pears because a
risk/benefit assessment demonstrated that the benefits from
the use outweighed the risks. The Agency has reevaluated that
decision and concludes that the risks and benefits as discussed
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above are substantially the same as those reached in the RPAR
process. The risks have been reassessed using the results of a
second mouse oncogenic study. The dietary risk from consuming
amitraz treated pears is 10~~" and the occupational risk is
between 10"^ and 10"^. These risks are essentially the same as
those that were calculated when amitraz was initially registered
using the first mouse oncogenic study. A current evaluation
of the benefits from the use of amitraz on pears indicates
that the benefits have not changed. No viable alternative
to amitraz for control of the pear psylla has been registered
by the Agency since the original benefits assessment. The
Agency believes that it continues to be in the best interest
of the public to continue the registration of the pear use.
2. The Agency has decided not to issue tolerances for the proposed
use of amitraz on apples and citrus. The Agency will consider
other uses on a case-by-case basis.
Rationale :
The toxicology data base for amitraz is complete except for
a dermal penetration study. The Agency (GAG) has classified
amitraz as a Group "C" carcinogen based on positive effects
demonstrated in two mouse oncogenicity studies coupled with
the negative rat oncogenicity study.
The environmental data base for amitraz is largely incomplete.
However, there are uses which would have minimal impact on
the environment.
There are currently four proposed uses for amitraz pending
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with the Agency. These are apples, citrus, cattle and
swine. Available residue data submitted in support of the
proposed apple and citrus uses indicate that food additive
(409) tolerances for apple pomace and citrus molasses and
pulp must be established. At this time the Agency will
not establish' these food additive tolerances because
of the Delaney Clause within Section 409 of the Federal Food,
Drug and Cosmetic Act. The proposed cattle and swine uses
will be considered. Data supporting these particular uses
are in review.
3. The Agency is requiring environmental fate studies to
characterize amitraz's fate in the environment, including
its potential to leach through soil.
Rationale; Data are not sufficient either to assess the
environmental fate of amitraz or to characterize its leaching
potential for contamination of ground water. The preliminary
data indicate that amitraz may have the potential to leach
through soil. A leaching study (although not adequate by
Agency standards) indicates that amitraz is moderately
mobile in sandy loam, silt loam and clay soils and very
mobile in sandy soils. However, the available data are
insufficient to fully characterize the leaching potential
of amitraz. Additional studies are being required. The
Agency has become increasingly concerned about the presence
of pesticide chemicals in ground waters in the United
States. Although amitraz was not included in the Special
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Data Call-in Notice the Agency issued on March 31, 1984 the
Agency is concerned over the potential of amitraz to leach.
The data required under this Guidance Document will allow
the Agency to characterize the potential of amitraz to
contaminate ground water.
4. All end-use products containing amitraz shall continue to
be classified for restricted use and the restricted use label
statement will be revised to specify that the reason for this
classification is because of the oncogenicity of amitraz and
concern over worker exposure to amitraz. A cancer warning
statement will also be added to manufacturinguse product
labels.
Rationale; The Agency required that all end-use amitraz
products be classified for restricted use when amitraz was
conditionally registered for use on pears in an effort to
reduce worker exposure. Since the Agency is regulating amitraz
as a possible human carcinogen, continuation of the restricted
use statement because o£ its oncogenicity potential is
warranted. In addition, the Agency believes that a cancer
statement will further emphasize the precautions that
must be taken when handling amitraz, especially for the
end-use products.
5. The Agency will continue to require a reentry interval of
24 hours for the pear use of amitraz.
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Rationale; in order to minimize exposure to workers
entering treated areas pending the receipt and evaluation
of reentry data, a 24-hour reentry interval was required
when amitraz was conditionally registered for use on
pears. Because of amitraz1s oncogenic potential, this
reentry interval is being retained. Through this Guidance
Document studies are being required to further evaluate
amitraz's exposure potential. Upon receipt and review of
these data, the Agency may impose a different reentry
interval.
6. The Agency is requiring a study to determine the effects of
amitraz on avian reproduction.
Rationale: Acute toxicity studies indicate that amitraz
is slightly toxic to birds, A one-generation avian
reproduction study, although inadequate, demonstrated that
amitraz would affect avian reproduction at less than 40 ppm.
A NOEL was not established with that study. Therefore, a new
study is being required. Also, sufficient environmental fate
data are not available to permit assessment of avian exposure
to amitraz residues. Based on Agency receipt and review of
the avian reproduction data and the environmental fate data
required by this Guidance Document, the Agency will be able
to determine if amitraz poses a hazard to bird reproduction.
7. The Agency is requiring additional plant metabolism data since
the metabolism of amitraz in plants has not been adequately
described.
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Rationale; Heretofore, the parent compound, amitraz and its
metabolites containing the 2,4-dimethylaniline moiety have
been considered to be the residues of concern in plants.
However, reexamination of existing data indicate that about
60% of the residues were unidentified. Should the required
metabolism data indicate the presence of additional
metabolites of concern, the tolerance definition will have
to be altered accordingly. In addition, the Agency is
concerned over the possibility of amitraz to hydrolyze and
form dimethylamine which has been shown to cause liver
tumors in mice. The Agency cannot determine whether amitraz
does hydrolyze to dimethylamine and if so, the amount, until
the plant metabolism data are submitted.
The Agency is not imposing label statements at this time
with regard to endangered species.
Rationale; The limited available data indicate that technical
amitraz is slightly toxic to birds. Although an avian repro-
duction study indicates a potential chronic hazard to birds
is possible if there is sufficient exposure from the use of
amitraz, the effect on birds including endangered species
cannot be assessed until a new avian reproduction study and
the environmental fate data required by this Guidance Document
are received and evaluated. The available data also suggest
that the estimated residues that could occur in water as a
result of the pear use of amitraz do not result in an endangered
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aquatic species concern. The Agency will address the need
for an endangered species label statement when the environmental
fate and avian reproduction data are received and evaluated.
9. Registrants of end-use products must submit revised labeling
which incorporates the label precautions found in Section G.
Rationale; The Agency believes that the label statements
prescribed in this Standard should minimize the hazards
associated with exposure to users of amitraz and to
aquatic organisms.
Criteria for Registration Under This Standard
To be covered under this Guidance Document products must
contain amitraz the sole active ingredient, bear required
labeling, and conform to the product composition, acute
toxicity limits, and use pattern requirements listed in
Section F of this document.
The application for registration or reregistration of manufac-
turing-use products subject to this Guidance Document must
comply with all terms and conditions described in it, including
submission of an up-to-date Confidential Statement of Formula,
submission of revised labeling, commitment to fill data gaps
on the schedule specified by the Agency and, when applicable,
offer to pay compensation as required by 3(c)(l)(D) and
3(c)(2)(D) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), as amended, 7 U.S.C. 136(c)(l)(D) and 136(c)(2)(D).
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F. Acceptable Ranges and Limits
Product Composition Standard
To be covered under this Guidance Document manufacturing-use
products must contain amitraz as the sole active ingredient.
Each manufacturing-use product formulation proposed for
registration must be fully described with an appropriate
certification of limits, stating maximum and minimum
amounts of the active and intentionally added inert
Ingredients which may be present in products.
Acute Toxlcity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing amitraz provided
that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which each
product is placed.
Use Patterns
To be registered under this Standard, manufacturing-use
products containing amitraz may be labeled for formulation
into other manufacturing-use products or into end-use
products only for the use on pears. The attached index
entry provides the approved maximum application rate and
frequencies.
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G. Required Labeling
All manufacturing-use and end-use araitraz products must bear
appropriate labeling as specified in 40 CPR 162.10. The
guidance document for this Standard contains information on
label requirements.
0 Ingredient Statement
The ingredient statement for manufacturing-use products and
end-use products must list the active ingredient as:
Amitraz: N'-(2,4-dimethylphenyl)-N-[[2,4-dimethylphenyl)=
imino]methyl]-N-meth;ylmethanimidajnide
° Use Pattern Statement
All manufacturing-use amitraz products must state that they
are intended for formulation into other manufacturing-use
products or into end-use products for use only on pears.
0 Precautionary Statements
Statement For Manufacturing-Use Products
1. Labels for manufacturing-use amitraz products must bear
precautionary statements, as specified in 40 CPR 162.10,
reflecting the compound's acute human toxicity. Amitraz
is in Toxicity Category II by the acute dermal route of
exposure.
2. The following statement must be place on the front panel of
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all manufacturing-use amitraz products:
"The use of this product may be hazardous to your
health. This product contains amitraz which has
been determined to cause tumors in laboratory
animals. Use of protective clothing and equipment
can reduce risk."
3. The following revised environmental hazard statement must
appear on all MP labels:
" Environmental Hazards
This pesticide is toxic to fish. Do not discharge
effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water unless this
is specifically identified and addressed in an NPDES
permit. Do not discharge effluent containing this
product into sewer systems without previously notifying
the sewage treatment plant authority in writing. For
guidance contact your State Water Board or Regional
Office of the EPA."
Statements For End-Use Products
1. All end-use products must bear the restricted-use statement:
"RESTRICTED USE PESTICIDE
"Because amitraz has been shown to cause tumors
in laboratory mice, this product may be applied only
by certified applicators or persons under their
direct supervision. Use of protective clothing and
equipment and following the use precautions below
can reduce risk."
2. The reentry statement below must appear in the use directions
of labels of all araitraz products with directions for
use for use on pears:
"Do not reenter treated areas for 24 hours without
protective clothing."
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3. The worker protection statements listed below must appear
as part of the precautionary statements for all end-use
amitraz products:
"During mixing/loading or application wear a protective
suit which has long sleeves and long pants. Wear chemical
resistant gloves; a hat, boots and goggles or face
shield. A helmet with visor may be substituted for the
hat and goggles during aerial application. Mixer/loaders
should also wear a chemical resistant apron when handling
the concentrated product. Wash thoroughly with soap and
water after handling and before eating, urinating, or
smoking. Remove and wash clothing before reuse. Clothing
should be laundered separately from household articles.
Replace gloves frequently. Clothing which has been
drenched and used gloves should'be disposed of in accor-
dance with state or local regulations. Instead of
clothing and equipment specified above, the applicator
can use an enclosed tractor cab or cockpit with properly
filtered air supply."
4. The following environmental hazards statement listed below
must appear on each end-use label in the Environmental
Hazards section:
"This product is toxic to fish. Do not apply directly
to water. Drift and runoff from treated areas may be
hazardous to fish in adjacent sites. Do not contaminate
water by cleaning of equipment or disposal of wastes."
H. Tolerance Reassessment Summary
U.S. tolerances for residues of amitraz in or on the raw agricul-
tural commodities are as follows (40 CFR 180.287):
3.0 ppm in or on pears
0.0 ppm in or on apples, and the fat, meat by-products,
and meat of cattle, goats, hogs, horses, and sheep
The zero tolerances were established administratively as a result
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of the RPAR as an affirmative action to emphasize the Agency's
decision not to permit the use of amltraz on apples.
Interim Codex Maximum Residue Limits have been established
for amitraz as follows: In or on pome fruits at 0.5 ppm; In
or on oranges at 0.5 ppm; and, in or on the carcase meat of
cattle and pigs at 0.05 ppm, cattle, pig, and sheep meat
by-products at 0.2 ppm and milk at 0.01 ppm. There are no
Canadian or Mexican tolerances established for amltraz. The
metabolism of amitraz in plants has not been adequately
described. Should the required metabolism data indicate the
presence of additional metabolites of concern, the tolerance
definition will be revised accordingly. The available pear
residue data support the established tolerance level for
araitraz residues in or on pears.
There are no finite tolerances established for amitraz residues
on crops involving livestock feed items. At this time, data
pertaining to the metabolism of amitraz in food animals for
purposes of this Registration Standard are not required.
The acceptable daily Intake (ADI) for amitraz is 0.0025 mg/kg/day
based on the 2-year chronic dog feeding study with a no observed
effect level (NOEL) of 10 ppm and a safety factor of 100.
The maximum permitted intake (MPI) (based on a 60 kg person)
is 0.15 mg/day. The published tolerance for pears given a
22
-------
theoretical maximum residue contribution (TMRC) to the daily
diet of 0.0115 mg/day (for an average 1.5kg daily diet) which
accounts for 7.66% of the ADI.
23
-------
EPA Compendium of Acceptable Uses
C106201 AMITRAZ*
TYPE PESTICIDE; Insecticide, Acaricide
FORMULATIONS:
Tech (93Z)
WP (50%)
EC (1.5 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; RESTRICTED USE PESTICIDE. Do not re-
enter treated areas until 24 hours after application unless protective
clothing is worn. Do not tank mix with bordeaux mixtures, detergents,
dodine, ferbam, 1-napthaleneacetic acid (NAA), sulfur, or other highly
alkaline materials. During mixing/loading or application wear a protec-
tive suit which has long sleeves and long pants. Wear chemical resistant
gloves; a hat, boots, and goggles or face shield. A helmet with visor may
be substituted for the hat and goggles during aerial application. Mixer/
loaders should also wear a chemical resistant apron when handling the con-
centrated product. Instead of clothing and equipment specified above, the
applicator can use an enclosed tractor cab or cockpit with properly fil-
tered air supply. Amitraz is toxic to fish. Do not apply directly to
water. Drift and runoff from treated areas may be hazardous to fish in
adjacent sites. Do not contaminate water by cleaning of equipment or
disposal of wastes.
Beneficial Insect Caution:
Amitraz is toxic to predacious mites such as Typhlodromus accidentalis.
Amblyseius fallacis. and stigmaeid mites.
Agricultural Crop Tolerances:
Apples - 0 ppm
Livestock Tolerances;
0 ppm (meat, fat, and meat byproducts of cattle, goats, hogs, horses, and
sheep)
Definition of Terms:
Claims for pest control limited to suppression of population are indicated
by parenthesized pest name.
*N'-(2,4-diraethylphenyl)-N-[[(2,4-dimethylphenyl)imino]methyl]-N-methyl-
methanimidamide
Issued: 10-01-81
Provisional Update: 8-06-85
24
-------
/04003AA
Site and Pest
Pear
EPA Compendium of Acceptable Uses
AMITRAZ
Dosages and Tolerance, Use, Limitations
Formulation(s)
3 ppm
7 day preharvest interval through
1.5 pounds per acre for foliar ap-
plication. Do not apply more than
10.5 pounds per acre during the
growing season.
Do not allow livestock to graze
treated areas. Do not apply emulsi-
fiable concentrate formulation as a
summer spray west of the Rocky Moun-
tains when cool, moist, poor drying
conditions exist or when night tem-
peratures are below the dew point,
as fruit injury may result.
ILAVASA
ITBGAZA
ILAVAYA
ILAVBEA
European red mite
(Codling moth)
(McDaniel spider
mite)
(Twospotted spider
mite)
IRAXALA
ITBGAZA
ILAVAYA
ILAVBEA
Pear psylla
(Codling moth)
(McDaniel spider
mite)
(Twospotted spider
mite)
0.75-0.94
Ib/A
[400 gal/A]
[concen-
trate spray]
or
0.188-0.234
lb/100 gal
(1.5 Ib/gal
EC)
0.75-1.5 Ib/A
[400 gal/A]
[concen-
trate spray]
or
3-6 oz/100
gal [0.75-
1.5 Ib/A]
(50% WP)
(1.5 Ib/gal
EC)
Prebloom and foliar applications.
Apply when the majority of overwin-
tering European red mite eggs have
hatched and repeat as needed.
Prebloom application. Application
must occur during a precise point in
the pest's life cycle. Apply after
eggs have moved into the female pear
psyllas oviduct, but prior to heavy
egg laying. Apply when daily maxi-
mum temperatures exceed 50 F (10.0
C). If weather or orchard condi-
tions do not permit treatment before
heavy egg laying, apply after the
majority of the first generation
eggs have hatched. Consult local
Cooperative Agricultural Extension
Service for more specific timing
information. May be tank mixed with
dormant oil.
Foliar application. Apply when ma-
jority of pests are in the adult or
young nymphal stages of development.
Issued: 10-01-81
25
-------
ILAJAOA
ITBGAZA
ILAVAYA
ILAVBEA
Site and Pest
Pear (continued)
EPA Compendium of Acceptable Uses
AMITRAZ
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
Pear rust mite
(Codling moth)
(McDaniel spider
mite)
(Twospotted spider
mite)
0.75-1.5
Ib/A
[400 gal/A]
[concen-
trate spray]
or
0.188-0.375
lb/100 gal
(1.5 lb/gal
EC)
Prebloom and foliar applications.
Apply when the mites become active
in the spring and repeat as needed.
Issued: 10-01-81
26
-------
EPA Compendium of Acceptable Uses
AMITRAZ
Listing of Registered Pesticide Products by Formulation
&093.0001 93? technical chemical
amitraz (106201)
001023-00058 045639-00051
&050.0006 501 vettable powder
amitraz (106201)
001023-00061
&101.5012 1.5 Ib/gal emulsiftable concentrate
amitraz (106201)
001023-00059 043142-00045
Issued: 10-01-81
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Guideline Citation and Test
Name of Test Substancel
§158.120 Product Chemistry
Product Identity:
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
£*3 Q Phwol f>a1 Q+-Q+-Q
Dj j rnyt>-LOcl.J. oCatc
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TCAI
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines
Status
R
R
CR
R
R
R
R
R
Are Data Footnote
Required Number
Yes No
[X]
[X]
[X]
O
n
[X]
c~]
n
n 3
n t
n 5
[X]
tx]
n
[X]
[XJ 6
Data Must Be
Submitted Within
Time Frames Liste
Below 2
6 Months
6 Months
12 Months
6 Months
28
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Guideline Citation and
Name of Test
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Stability
Test Guidelines
Substance Status
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
R
R
R
R
B
R
R
Are Data Footnote
Required Number
Yes No
[X]
n
n
n
[X]
[X]
[X]
c ]
[X]
[X]
[X]
n
n
n 7
Data must Be
Submitted Within
Time Frames Listed
Below 1
6 Months
6 Months
6 Months
15 Months
Other Requirements;
64- 1 - Submittal of samples
TGAI, PAI
CR
C 3
[X]
29
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.120 Product Chemistry (Continued)
1. TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R * Required; CR » Conditionally Require
2. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date Is .
0 15 Month Due Date is .
3. Details of the manufacturing process Including the relative amounts of beginning materials, description of
reaction conditions, duration of each step of the process and quality control measures for the stabilized
93% technical must be submitted. The name and address of the manufacturer or producer of each starting
material for the stabilized 93% technical must be submitted. In addition, a copy of all available technical
specifications, data sheets, and all other documents by which the manufacturer, producer or supplier of the
beginning material describes its composition and properities must be submitted.
4. A discussion of each impurity believed to be present at >O.I% based on knowledge of any contamination such as
migration of components of packaging materials into the product and contaminants resulting from earlier use
of production equipment to produce other products or substances must be submitted.
5. Five or more representative samples should be analyzed for the amount of active ingredient and each Impurity
present >0.1%. Analysis for nitrosoamine Impurities should include volatile and non-volatile
nitrosoamines.
6. Not required because the 93/& stabilized technical is a solid at room temperature.
7. Insufficient information was provided as to the sensitivity of the 93? staballzed technical to metal ions and
metal, therefore additional data are required.
30
-------
TABLE A
GENERIC DATA
FOR CHEMICAL: AMITRAZ
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)?
Time Frames For Data
Submission 2
§158.125 Residue Chemistry
171-2 - Chemical Identity TGAI
171-3 - Directions for Use
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
- Storage stability
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Pears TEP
PAIRA
PAIRA and Plant
Metabolites
TGAI and Metabolites
TGAI and Metabolites
TCAI and Metabolites
Yes
Yes
Partial
No
Yes
Partial
GS00234015;GS00234016 No
GS00234017 No
00028664;00028666
00055718;GS00234011
GS00234012
Yes3 18 Months
Reserved^
00046030;00051930 No5
00051929;(
Reserved**
00046029;GS00234014 Yes6 15 Months
Yes
00046029;00051717 No
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
1
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)V
Time Frames for Data
Submission .2
§158,125 Residue Chemistry - Continued
171-M - Magnitude of the Residue -
Residue Studies (continued)
— Meat/Milk/Poultry/Eggs
TGAI or Plant
Metabolites
No
Reserved1*
171-5 - Reduction of Residue
171-6 - Proposed Tolerance
171-7 - Reasonable Grounds In
Support of Petition
171-13 - Submittal of Analytical
Reference Standards
Residue of
Concern
Residue of
Concern
PAIRA
No
No
No
Yes
No?
No7
No?
No?
32
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.125 Residue Chemistry - Continued
1. Composition: T3AI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP
Typical end-use product; EP = End-use product.
2. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 15 Month Due Date is .
0 18 Month Due Date is .
3. The available plant metabolism data are not adequate because a large fraction O60/6) of 1J*C-residues recovered
from mature pears was not identified. Data reflecting the distribution and metabolism of l^C-amitraz labeled
in both benzene rings in mature pears harvested 7 days after the last of a series of prebloom and foliar
applications (at least 10) at l.Slb. AI/A is required. It may be necessary to apply exaggerated rates to
obtain sufficient residues for identification. Analyses should include hydrolysis and reextraction of plant
residues and aqueous fractions to determine conjugated 1^-residues of amltraz. l^C amitraz treated pears
should also be analyzed by enforcement "cold" methodology to determine whether conjugated metabolites of
concern are determined by the method and to verify detection of all 2,4-dimethylaniline.
4. There are no finite tolerances established for amitraz residues on crops involving livestock feed items.
Therefore, data are not required at this time.
5. If additional metabolites of toxlcological concern are found then additional validated methods for data
collection and tolerance enforcement will be required.
6. Data are required reflecting the stability of metabolites III, IV, and V in or on pears stored at freezing
temperatures for intervals up to 42 days.
7. Not applicable.
33
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
1
Data Requirement Composition
§158.130 Environmental Pate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradatlon
161-2 - In water TGAI or PAIRA
161-3 - On soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
MDBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Use 2
Pattern
A
A
A
A
A
A
A
A
A
A
A
Does EPA Have
Data To Satisfy
This Require-
ment?
No
No
No
No
No
No
No
No
Partial
No
No
Must Additional Data
Be Submitted Under
Bibliographic PIPRA § 3(c)(2)(B)7
Citation Time Frame for Data
Submission 3
Yes
Yes
Yes
No2*
Yes
Yes
No1*
No"
00114229 Yes5
Yes
Yea
9 Months
9 Months
9 Months
27 Months
27 Months
12 Months
12 Months
15 Months
34
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Data Requirement
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
161-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targ(
1
Composition
Continued
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
Jt TEP
Use 2
Pattern
A
A
A
A
A
A
A
A
A
A
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
No
No
No
No
No
No
No
No
No
No
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3_
Yes
No1*
No1*
No1*
No1*
No1*
No1*
No1*
Yes
Yes
2? Months
12 Months
12 Months
Organisms
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.130 Environmental Fate - Continued
1. Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active Ingredient, radiolabelled;
TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is .
0 12 Month Due Date is .
0 15 Month Due Date is .
0 27 Month Due Date is .
4. Not required based on use pattern.
5. Although this study is scientifically sound, this study does not fulfill this data requirement because of the
following deficiencies: the test soils were not completely characterized; the purity of the test substance was
not reported; the incubation temperature was not reported; degradates were not identified; and values of soil/
water relationships (K^) were not reported. This information must be submitted to upgrade the study or
another study must be conducted.
36
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
1
Data Requirement Composition
§138.133
Toxicology
Use 2
Pattern
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
This Require- Bibliographic FIPRA § 3(c)(2)(B)?
ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3.
ACUTE TESTING:
81-1 -
81-2 -
81-3 -
81-7 -
Acute Oral Toxicity - Rat TGAI
Acute Dermal Toxicity TGAI
- Rabbit
Acute Inhalation Toxicity TGAI
- Rat
Delayed TGAI
Neurotoxiclty - Hen
A
A
A
A
Yes
Yes
Yes
No
00011539 No
00040862 No
00029963 No
No4
SUBCHRONIC TESTING:
82-1 -
82-2 -
82-3 -
82-U -
82-5 -
90-Day Feeding : TGAI
- Rodent, and
- Non- rodent (Dog)
21-Day Dermal - Rabbit TOAI
90-Day Dermal - Rabbit TGAI
90-Day Inhalation: TGAI
- Rat
90-Day Neuro toxic ity: TGAI
- Hen
-Mamnal
A
A
A
A
A
A
A
Yes
Yes
Yes
No
No
No
No
000287 12; 00028715 No5
00028716 No
00029972 No
No
No
No1*
No1*
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission 3.
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - TGAI
2 species:
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
2 species:
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogeniclty - TGAI
2 species:
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal TGAI
Aberration
84-4 - Other Genotoxlc Effects TGAI
A
A
A
A
A
A
A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
00044585
00044586
No
No
00044485 No
00139552;00111886 No
00029959;00029960 No5
00029961 No
00029962 No
00029459;00029953 No5
00029954;00029955 No5
00029957
00029958;GS00234007 No5
38
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Time Frame for Data
Submission .3
§158.135 Toxicology - Continued
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
Yes
85-2 - Dermal Penetration
86-1 - Domestic Animal
Safety
Choice
Choice
A
A
No
Yes
00028685;00028674 No5
00028667;00028675
00028668;00028676
00028671;00041503
00028669; 00041497
00028672;00041499
00041500;00041498
00041501;00028682
GS00234006
Yes 12 Months
00041513;00044591 No5
39
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.135 Toxicology - Continued
1. Compos ition: p/vi = 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; OAcputic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document....
0 12 Month Due Date is .
4. Amitraz is not an organophosphate compound and is not structurally related to a substance that causes delayed
neurotoxicity.
5. All references must be cited to satisfy this data requirement.
40
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
1 Use
Data Requirement Composition Pattern
§158.1HO Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
201-1 - Drift Field Evaluation
Special Testing
Glove Permeability Study
TEP A
TEP A
TEP A
TEP A
TEP A
TEP A
TEP A
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
2 This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? Citation Time Frame for Data
Submission 3
No
No
No
No
No
No
No
Yes ^ 27 Month
No5
No5
No5
No5
No5
Yes 6 6 Months
1. Composition: TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrlal, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatlc, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date is .
0 27 Month Due Date is .
41
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.140 Reentry Protection
§158.1*12 Spray Drift
Special TestingTcontinued)
4. An interim 24-hour reentry interval is being imposed until the foliar dissipation data are received and reviewed
by the Agency.
5. Not required because the criteria that would trigger these requirements have not been exceeded.
6. Because of the oncogenicity potential of amitraz, data are required detailing the permeability and breakthrough
times of materials used in "protective" gloves. Data are required to support liquid amltraz formulations* A
descrlptl of this study can be found in ASTM 739-81- Standard Test Method for Resistance of Protective Materials To
Permeation by Hazardous Liquid Chemicals.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
1
Data Requirement Composition
Use
Pattern
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
2 This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3.
§158.115 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-1
71-5
- Acute Avian Oral Toxicity TGAI
- Avian Subacute Dietary
Toxicity
- Upland Game Bird, and TGAI
U-10181
- Waterfowl TGAI
- Wild Mammal Toxicity TGAI
- Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
- Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mammals, and
- Birds
A
A
A
A
A
A
A
A
A
A
A
Yes
Partial
No
Yes
No
Partial
Partial
No
No
No
No
00030^51 No
00030152 Yesl
Reserved^
00030153 No
No
00072112 Yes6
00072111 No6
Reserved7
Reserved7
Reserved7
Reserved?
9 Months
21 Months
21 Months
43
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
1
Data Requirement Composition
§158.145 Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity
a. Coldwater Fish Species,
b. Coldwater Fish Species
c. Warmwater Fish Species
d. Warmwater Fish Species
72-2 - Acute Toxicity to
Freshwater Invertebrates
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Fish
- Mollusk
- Shrimp
TGAI
TEP
U-40481
TGAI
TEP
TGAI
TEP
U-40481
TGAI
U-40481
TGAI
U-40481
TGAI
U-40481
Does EPA Have
Data To Satisfy
Use 2 This Require- Bibliographic
Pattern ment? Citation
A
A
A
A
A
A
A
A
A
A
A
A
A
A
Yes
Partial
No
Partial
Partial
Yes
No
No
No
No
Yes
No
Yes
No
00030446; 00030445
00030445
00030447; 00030448
00030444
00030447 ;00030448
00030444
GS00234021
-
GS00234022; 00030450
GS00234022;00030450
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission 3
No
Yes9
Reserved5
Ye=8
No8
No
Yes 10
Reserved5
Yes 11
Reserved5
Noll
Reserved5
Noll
Reserved5
9 Months
9 Months
9 Months
12 Months
44
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)7
Time Frame for Data
Submission 3
§158.145 Wildlife and
Aquatic
Organisms - Continued
AQUATIC ORGANISM TESTING
72-3 -
Y2-H -
-
72-5 -
72-6 -
Acute Toxicity to
Estuarine and Marine
Organisms (continued)
- Fish TEP
- Mollusk TEP
- Shrimp TEP
Fish Early Life Stage, TGAI
and
Aquatic Invertebrate
Life-Cycle
Fish - Life-Cycle TGAI
Aquatic Organism TGAI, PAI OR
A
A
A
A
A
A
A
No
No
No
No
No
No
No
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
72-7 - Simulated Field Testing
- Aquatic Organisms
- Actual Field Testing
Degradation
Product
TEP
TEP
No
No
45
Noll
Noll
Noll
Yes
Yes
Reservedl3
Reservedl3
15 Months
15 Months
Reservedl2
Reservedl2
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Wildlife and Aquatic Organisms - Continued
1. Composition: TGAI = Technical grade of the active Ingredient; PAI = pure active ingredient;
TEP = Typical end-use product; U-40481 = degradation product of amitraz
2. The use patterns are coded as follows: A=Terrestrial, Pood Crop; B=Terrestrial, Non-Pood Crop; C=Aquatlc, Pood Crop;
D=Aquatlc, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestlc Outdoor; I=Indoor.
3. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is .
0 12 Month Due Date is .
0 15 Month Due Date is .
0 24 Month Due Date is .
4. The Japanese quail is not a recommended species. A study using the bobwhite quail is required.
5. Available data shows that a degradation product of amitraz (U-40481) is substantially more toxic than the parent.
Testing with this degradation product may be required depending upon requested environmental fate data and the
results of the requested ecological effects studies on amitraz.
6. An NOEL was not established In either the bobwhite or mallard duck study. However, only one avain reproduction
study needs to be repeated, preferably with an upland gameblrd (the bobwhite quail is preferred).
7. Reserved pending receipt of requested environmental fate data and/or the results of the avian reproduction data.
8. The referenced studies do not fulfill guideline requirements because the harlequin fish and the carp are not
recommended test species. Also, in one study the test containers were lined with polyethylene plastic.
9. This study does not fulfill guideline requirements because it is only a 48-hr study instead of the required
96-hour and the test levels were not measured. This study is required because the test results suggest that
amitraz in the 20% EC formulation is more toxic tc fish than technical amitraz.
10. A 48-hour aquatic invertebrate study with the 20% EC is required because test results suggest that amitraz
in the 2Q% EC formulation is more toxic to fish than technical amitraz.
11. Marine/estuarine testing is not required for the pear use. Present data fulfill requirements for oyster and
shrimp, but the estuarine fish study would be required for future uses.
46
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
§158.1U5 Wildlife and Aquatic Organisms - Continued
12. Reserved pending the results of requested environmental fate data
13. Reserved pending the results of the early life stage and aquatic invertebrate life-cycle studies and
requested environmental fate studies.
47
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
1 Use 2 This Require- Bibliographic PIPRA § 3(c)(2)(B)?
Data Requirement Composition Pattern raent? Citation Time Frame for Data
Submission
§158.150
121-1 -
Plant Protection
TARGET AREA EP No
PHYTOTOXICITY
No3
NONTARGET AREA PHYTOTOXICITY
122-1 -
122-1 -
122-2 -
123-1 -
123-1 -
123-2 -
124-1 -
124-2 -
TIER I
Seed Germination/ TGAI No
Seedling Emergence
Vegetative Vigor TGAI No
Aquatic Plant Growth TGAI No
TIER II
Seed Germination/ TGAI No
Seedling Emergence
Vegetative Vigor TGAI No
Aquatic Plant Growth TGAI No
TIER III
Terrestrial Field TEP No
Aquatic Field TEP No
No3
No3
No3
No3
No3
No3
No3
No3
-------
TABLE A
GiiNERIC DATA REQUIREMENTS FOR CHEMICAL: AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission
§158.150 Plant Protection
(continued)
1. Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. fiP = End-use product.
2. The use patterns are coded as follows: A=TerrestriaI> Pood Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; P=Greenhouse> Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3. These data are not required in accordance with §158.150.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR CHEMICAL: AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Time Frame for Data
Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact toxicity TGAI
141-2 - Honey bee - toxicity TEP
of residues on
foliage
141-4 - Honey bee subacute (Reserved)
feeding study
141-5 - Field testing for TEP
pollinators
Yes
No
00074486
No
No
No3
No3
50
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHEMICAL:
AMITRAZ
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have
Data To Satisfy
This Require-
ment?
Bibliographic
Citation
Nontarget Insect - Continued
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
11*2-1 - Acute toxicity to
aquatic insects
142-1 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic Insects
143-1 - NQNTARGET INSECT
TESTING - PREDATORS
thru AND PARASITES
143-3
Must Additional Data
Be Submitted Under
PIPRA § 3(c)(2)(B)?
Time Frame for Data
Submission
(Reserved)
(Reserved)
(Reserved)
(Reserved)
1. Composition: TGAI = Technical grade of the active Ingredient; TEP = Typical end-use product.
2. The use patterns are coded as follows: A=Terrestrlal, Food Crop; B=Terrestrlal, Non-Food; C^Aquatic, Pood Crop:
D=Aqautic, Non-Pood; E=Greenhouse, Pood Crop; F=Greenhouse, Non-Pood; G=Porestry; H=Domestlc Outdoor; I=Indoor
3. Due to the low toxicity demonstrated by the honey bee acute toxicity study, no further testing is required.
51
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
AMITRAZ
Guideline Citation and Test
Name of Test Substance
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
6l-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status
R
R
R
CR
R
R
R
R
R
Are Data Footnote
Required Number
Yes No
o
f^Y "1
L^1 _J
CX]
[X]
[X]
[X]
n
n
[X]
[X]
n
n
n
n 2
n
[X]
CX]
n
Data Must Be
Submitted Within
Time Frames Listed
Below 1
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
52
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL:
AMITRAZ
Guideline Citation and
Name of Test
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammabllity
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibllity
63-20 - Corrosion Characteristics
Test
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines
Status
R
CR
CR
CR
R
R
CR
CR
R
Are Data Footnote
Required Number
Yes No
[X] [~]
Cx] T]
[X] [~]
cx] n
fin n
ex] n
ex] H
[X] T]
ex] n
Data Must Be
Submitted Within
Time Frames Listed
Below 1
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
Other Requirements;
6M- 1 - Submittal of samples
MP
CR
n
53
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: AMITRAZ
! 158.120 Product Chemistry (Continued)
MP = Manufacturing-use Product; R = Required; CR = Conditionally Required
1. Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date is .
0 12 Month Due Date is .
0 15 Month Due Date is .
2. An upper limit must be provided (and certified) for amitraz in the stabilized 93% technical product. An
upper and lower limit must be provided (and certified) for the intentionally added inert in the stabilized
93% technical produt. Also, upper limits must be provided (and certified) for each impurity >0.1% (w:w)
in the stabilized 93% technical product. Finally, any nitrosamines must be identified and quantified in
six samples of the 93% stabalized technical; two samples of each must be analyzed shortly after production,
three months after production, and 6 months after production. A method sensitive to 1 ppm of N-nitroso
contaminants must be used. An upper limit must be established and certified for any nitrosamines found
to be present.
54
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHEMICAL: AMITRAZ
1
Data Requirement Composition
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat MP
81-2 - Acute Dermal Toxicity MP
- Rabbit
81-3 - Acute inhalation Toxicity MP
- Rat
81-4 - Primary Eye MP
Irritation - Rabbit
81-5 - Primary Dermal MP
Irritation - Rabbit
81-6 - Dermal Sensitization - MP
Guinea Pig
1. Composition: MP = Manufacturing-use product.
2. Data must be submitted within the indicated time
0 9 Month Due Date is
Does EPA Have Must Additional Data
Data To satisfy Be Submitted Under
This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? Citation Time Frame for Data
Submission 2
Yes 00041539 No3
Yes 00040862 No3
Yes 00029963 No3
No - Yes3 9 Months
No - Yes3 9 Months
No - Yes3 9 Months
frame, based on the date of the Guidance Document.
•
3. Data will support both manufacturing-use products 45639-51 and 129.
-------
REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of PIPRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by PIPRA sec. 3(c)(2)(B),
you are required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Datal/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines _£/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that type
_!/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product's unique composition or specific use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
£/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
56
-------
for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain '"typical formulations" but
not others. Note; "Typical formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "PIPRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. Pile with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data" (EPA Form 8580-6, Appendix II-4)«/
*/ FIPRA sec. 3(c)(2)(B) authorizes joint development of
data b~y two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
57
-------
OR
4. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
In EPA's opinion, Joint data development by all regis-
trants subject to a data requirement or a cost-sharing agreement
among all such registrants is clearly in the public interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIPRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [on terms to be agreed upon
or determined by arbitration under FIFRA Section 3(0)(2)(B)(ill)];
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,
58
-------
The extension request should state the reasons why you believe
that an extension Is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form
8580-4, Appendix III-l) to fill gaps Identified by EPA
concerning your product. Under the authority of PIPRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B—Product-Specific Data Requirements for Manufacturing
Use Products — lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under §3(c)(2)(B)."
IV. SUBMISSION OF REVISED LABELING
Note; This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
PIPRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CPR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
V Product specific data pertain to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
59
-------
If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under PIPRA sec. 6(b)(l).
A. Label Contents
40 CPR 162.10 requires that certain specific labeling
statements appear at certain locations on the ."label. "T?his
is referred to as format labeling. Specific label items
listed below are keyed to Appendix IV-2.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. See Appendix IV-1. [40 CFR
I62.10(d)3
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the -phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CPR I62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container,
See Appendix IV-1. [40 CPR I62.10(f)]
60
-------
Item 6A.._ INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active Ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. See Appendix IV-1. [40 CPR
I62.10(g)]
Item 6B. -POUNDS PER GALLON STATEMENT - For'liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV-1.
[40 CFR I62.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (h)(l)(i)]
Item 70. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CFR 162.10(h)(1) ( i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix IV-1. [40 CFR I62.10(h)(1)(111)]
61
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Item ?E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV- 1. [40 CFR 162 . 10(h) (1) ( iii) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV- 1. [40 CFR 162.10
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. See Appendix IV-1. [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 IV-1. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flamciabllity statement. Precautionary statements relating
to f lammabilit;y of a product are required to appear on the
label if it meets the criteria in Appendix IV-3 . The require-
ment is based on the results of the flashpoint determinations
and flame extension tests required to be submitted for all
products. These statements are to be located in the side/back
panel precautionary statements section, preceded by the
heading "Physical/Chemical Hazards." Note that no signal
word is used in conjunction with the f lammability statements.
2. Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°F (177°C).
62
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c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
ill. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammability specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It may
appear as a substateraent to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9A. RESTRICTED USE CLASSIFICATION - PIPRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
63
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Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification,
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CPR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from ^our
label and submit draft labeling bearing only unrestricted
uses .
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
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Item 9B [There is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be Included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B [There is no Item 10B].
Item IOC. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10D. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from
those accepted in connection with registration of the product.
It should be made part of the response to this notice and
submitted for review.
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Amitraz as an
active ingredient.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the "FIPRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix
II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-l) .
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
text on 8-1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8-1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80-152.99
for latest requirements.
3. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
66
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B. For Manufacturing Use Products containing Amitraz in
combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the "PIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for-Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason any
test is delayed or aborted so that the agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
C. For End Use Products containing Trimethacarb alone or in
combination with other active Ingredients;
1. Within 90 days from receipt of this document, you must
submit the "FIPRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also submit a copy of the
Summary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data generated
in response to this notice. This Information should be submitted
to the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be submitted.)
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l) .
c. Two copies of any required product-specific data.
(Refer to Table C) .
67
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d. Two copies of draft labeling, Including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. Labeling should be either typewritten
text on 8 1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8 1/2 inch files. The draft label
must indicate the intended colors of.-the final -label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance, with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80-152.99
for latest requirements.
3. Within the time frames set forth in Table A. submit all
generic data, unless you are eligible for the formulator's
exemption.
D. For intrastate products containing Amitraz either as
the sole active ingredient or in combination with other
active ingredients
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
registration.
E. Applications and other required information should be
submitted to the following address:
Jay S. Ellenberger Product Manager 12
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
Phone No. (703) 557-2386
The address for submission to the Office of Compliance Monitoring
is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW.
Washington, D.C. 20460
68
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OP 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 OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary Identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OP ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
69
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Appendix II-l (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took It directly
from the document. When a four-digit date Is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
70
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Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00028664 Lewis, O.K. (1970) RD 27 419, Plant Biochemistry Report
No. 1: FM 70 158. (Unpublished study received
April 9, 1980 under 43142-EX1; submitted by Boots
Hercules Agrochemicals Co., -Wilmington, DE;
CDL:099371-A)
00028666 Somerville, L.; Spiers, M.J. (19??) BTS 27 419: Metabolism
in Apple Leaves: AX 72 002. (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted by
Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099371-C)
00028667 Boots Hercules Agrochemicals Company (1970) Fate of
14C-BTS 27 419 Applied to Rats as a Single Oral
Dose: Report No. C 71 Oil. (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099371-D)
00028668 Boots Hercules Agrochemicals Company (1971) Fate of
14C-BTS 27 419 Applied to Rats as a Single Oral
Dose: Report No. C 71 015. (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099371-E)
00028669 Somerville, L. (19??) Fate of 14C-BTS 27 419 Administered
to Rats in Repeated Oral Doses: AX 73011. (Unpub-
lished study received April 9, 1980 under 43142-EX-l;
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099371-F)
00028671 Jones, E.M. (1973) Metabolism 14C-BTS 27 419 in Rats:
F 73010. (Unpublished study received April 9, 1980
under 43142-EX1; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL:099371-H)
00028672 Boots Hercules Agrochemicals Company (197D Fate of
14C-BTS 27 419 Applied to Dogs as a Single Oral
Dose. (Unpublished study received April 9, 1980
under 43142-EX-l; CDL:099371-1)
71
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Appendix II-2
OFFICE OP PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00028674 Hamilton, D.Y.; Somerville, L. (1974) Fate of 14C-BTS
27 419 When Administered at 15 Mg/Kg to Dogs as a
Single Oral Dose: AX 74006. (Unpublished study
received April 9, 1980 under 43142-EX1; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099371-K)
00028675 Somerville, L.; Hughes, K.W. (1973) The Conversion of
BTS 27 419 to BTS 27 271 in the Dog Stomach: AX 73
021. (Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099371-L)
00028676 Taylor, J.; Somerville, L. (1977) The Conversion of
Amitraz to BTS 24 868 in Dog Gastric Juice: AX
77010. (Unpublished study received April 9, 1980
under 43142-EX-l; submitted by Boots Hercules Agro-
chemicals Co., Wilmington, DE; CDL:099371-M)
00028682 Somerville, L. (1973) Fate of 14C-BTS 27 419 When
Administered to Cats as a Single Oral Dose: AX 73
018. (Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Agrochemicals Co.,
Wilmington, DE; CDL:099371-S)
00028685 Hamilton, D.Y. (1976) The Fate of 14C-BTS 27419 (Amitraz)
When Administered to Mice at 100 Mg/Kg as a Single
Oral Dose: AX 76013. (Unpublished study received
April 9, 1980 under 43142-EX1; submitted by Boots
Hercules Agrochemicals Co., Wilmington, DE; CDL:
099371-V)
00028712 Sutton, M.M.; Williams, G.A.H. (1973) BTS 27 419: 90-Day
Toxicity Study in Rats: P71548; C44. (Unpublished
study received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL.-099365-A)
00028715 Shaw, J.W.; Williams, G.A.H. (1972?) BTS 27 419: 90-Day
Chronic Toxicity Study in Mice: TX 74 016; C47.
(Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099365-D)
72
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Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00028716 Patton, D.S.G.; Williams, G.A.H. (19??) BTS 27 419:
90-Day Toxicity Study in Dogs: P71547; C48.
(Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099365~E)
00029^59 Everest, R.P.; Wilcox, P.; McCarthy, J.F. (1979) In vitro
Bacterial Mutagenicity Testing of an Amitraz Sample
Containing 1% BTS 33220. (Unpublished study received
March 5, 1980 under 1023-59; prepared in cooperation
with Boots Company, Ltd., submitted by Upjohn Co.,
Kalamazoo, MI; CDL:241968-D)
00029953 Everest, R.P.; Wilcox, P. (1976) BTS 27 419, BTS 27 271,
BTS 27 919 and BTS 28 369: Mutagenicity Testing in
Bacterial in vitro Systems: Report No. TX 76016.
(Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099368-C)
00029954 Wilcox, P. (1976) BTS 27 419: Mutagenicity Study in the
Intraperitoneal Host-Mediated Assay: Report No. TX
76028. (Unpublished study received April 9, 1980 under
43142-EX-l; submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL: 099368-D)
00029955 Everest, R.P. (1976) BTS 27 419: Mutagenicity Study in the
Male Mouse Perlvisceral Cavity Host-Mediated Assay:
Report No. TX 76056. (Unpublished study received
April 9, 1980 under 43142EX-1; submitted by Boots
Hercules Agrocheraicals Co., Wilmington, DE; CDL:
099368-E)
00029957 Palmer, A.K.; James, P.A. (1977) Dominant Lethal Assay of
Araitraz in the Female Mouse: Report No. TX 77020.
(Unpublished study received April 9, 1980 under
43142-EX-l; prepared by Huntingdon Research Centre,
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099368-G)
00029958 Palmer, A.K.; James, P.A. (1977) Dominant Lethal Assay of
Amitraz In the Male Mouse: Report No. TX 77021.
(Unpublished study received April 9, 1980 under
43142-EX-l; prepared by Huntingdon Research Centre,
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099368-H)
73
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Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00029959 Sutton, M.M. (19??) BTS 27 419: Teratogenicity in the
Rat: Report No. TX 73028. (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted by
Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099368-I)
00029960 Sutton, M.M. (19??) BTS 27 419: Effect on Pregnancy,
Parturition and Care of the Young in Rats: Report
No. TX 73031. (Unpublished study received April 9,
1980 under 43142-EX-l; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099368-J)
00029961 Sutton, M.M. (19??) BTS 27 419: Teratogenicity in the
Rabbit: Report No. TX 73029. (Unpublished study
received April 9, 1980 under 43142-EX-l; submitted by
Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099368-K)
00029962 Sutton, M.M. (19??) BTS 27 419: Multigeneration Feeding
Test in Rats: Report No. TX 73036. (Unpublished
study received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099368-L)
00029963 Berczy, Z.S.; Binns, R.; Newman, A.J. (1972) Acute
Inhalation Toxicity to the Rat of BTS 27419: Report
No. 4971/72/406. (Unpublished study received April
9, 1980 under 43142-EX-l; prepared by Huntingdon
Research Centre, submitted by Boots Hercules Agro-
chemicals Co., Wilmington, DE; CDL:099368-M)
00029972 Sutton, M.M. (1977) BTS 27 419: Three Week Dermal Toxicity
to Rabbits: Report No. TX 73026. (Unpublished
study received April 9, 1980 under 43142-EX-l; submitted
by Boots Hercules Agrochemicals Co., Wilmington,
DE; CDL:099368-V)
00030444 Nissan Chemical Industries, Limited (1972) JA-119 (BTS-27419):
Test on Fish Toxicity. (Unpublished study received
April 9, 1980 under 43142-EX-l; submitted bj Boots
Hercules Agrochemicals Co., Wilmington, DE;
CDL:099369-B)
74
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Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00030445 Fraser, W.D.; Jenkins, G. (1972) The Acute Toxlcities
of BTS 27419 (Tech) and BTS 27419 (20* E/C) to
Rainbow Trout under Continuous Flow Conditions:
4880/72/315. (Unpublished study received April 9,
1980 under 43142-EX-l; prepared by Huntingdon Re-
search Centre, submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099369-D)
00030446 Bentley, R.E. (1975) Acute Toxlcity of Technical Amitraz
to Rainbow Trout (Salmo gairdneri). (Unpublished
study received April 9, 1980 under 43142-EX-l; prepared
by Bionomics, EG&G, submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369-E)
00030447 Fraser, W.D.; Jenkins, G. (1973) The Acute Toxicities of
Technical and Formulated BTS 27419 to Blue Gill
(Lepomis macrochirus): BTS/73H6. (Appendix 4;
unpublished study received April 9, 1980 under 43142-EX-l;
prepared by Huntingdon Research Centre, submitted
by Boots Hercules Agrochemicals Co., Wilmington, DE;
CDL:099369-F)
00030448 Fraser, W.D.; Jenkins, G. (1973) The Acute Toxicities
of Technical and Formulated BTS 27419 to Harlequin
Fish (Rasbora heteromorpha) under Continuous Flow
Conditions: BTS/73117. (Appendix 5; unpublished
study received April 9, 1980 under 43142EX-1; prepared
by Huntingdon Research Centre, submitted by Boots
Hercules Agrochemicals Co., Wilmington, DE; CDL:
099369-G)
00030450 Bentley, R.E. (1973) Acute Toxicity of BTS-27419 Technical
to Grass Shrimp (Palaeomonetes vulgaris) and Fiddler
Crab (Uca pugilator). (Appendix 7; unpublished
study received April 9, 1980 under 43142-EX-l; prepared
by Bionomics, Inc., submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369-D
00030451 Fink, R. (1976) Final Report: Acute Oral LD50-Bobwhite
Quail: Project No. 137-105. (Unpublished study
including unofficial analytical report, received
April 9, 1980 under 43142-EX-l; prepared by Truslow
Farms, Inc., submitted by Boots Hercules Agro-
chemicals Co., Wilmington, DE; CDL:099369-J)
75
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Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00030452 Ross, D.B.: Roberts, N.L. (1973) The Acute Toxiclty
(LC50) of BTS 27 419 to Mallard Duck: BTS/73497.
(Appendix 9; unpublished study received April 9, 1980
under 43142-EX-l; prepared by Huntingdon Research
Centre, submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:099369-K)
00030453 Ross, D.B.; Roberts, N.L. (1973) The Acute Toxicity (LC50)
of BTS 27 419 to Japanese Quail: BTS/73498. (Appendix
8; unpublished study received April 9, 1980 under
43142-EX-l; prepared by Huntingdon Research Centre,
submitted by Boots Hercules Agrochemicals Co.,
Wilmington, DE; CDL:099369-L)
00040862 Sutton, M.M.; Williams, P.A. (1972) BTS 27 419: Acute
Dermal Toxicity to Rabbits: YM72011. (Unpublished
study received October 7, 1974 under 5G1558; submitted
by Upjohn Co., Kalamazoo, MI; CDL:094254-1)
00041497 Upjohn Company (1973) Metabolism of 14C-BTS 27 271 in
Dogs: F73019. (Unpublished study received June 24,
1976 under 6F1817; submitted by Upjohn Co., Kalamazoo.
MI; CDL:096423-N)
00041498 Jones, E.M. (1974) Metabolism of 14C-BTS 27 271 in Dogs,
Part 2-Identification of Metabolites in the Retina
and Choroid of the Eye: F74001. (Unpublished study
received June 24, 1976 under 6F1817; submitted by
Upjohn Co., Kalamazoo, MI; CDL:096423-0)
00041499 Hamilton, D.Y.; Somerville, L. (1973) Fate of 14C-BTS 27 271
When Administered to Dogs as a Single Oral Dose: AX
73 019. (Unpublished study received June 24, 1976
under 6F1817; submitted by Upjohn Co., Kalamazoo,
MI; CDL:096423-P)
00041500 Somerville, L.; Hamilton, D.Y. (1974) Studies on the
Accumulation and Elimination of Radio-Labelled
Residues from Dogs' Eyes following Oral Administration
of 14C-BTS 27 271: AX74013. (Unpublished study
received June 24, 1976 under 6F1817; submitted bj
Upjohn Co., Kalamazoo, MI; CDL:096423-Q)
00041501 Hamilton, D.Y.; Somerville, L. (1974) Fate of 14C-BTS 28 3&9
When Administered at 10 Mg/Kg to Dogs as a Single
Oral Dose: AX74012. (Unpublished study received
June 24, 1976 under 6F1817; submitted by Upjohn Co.,
Kalamazoo, MI; CDL:096423-R)
76
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00041503 Hamilton, D.Y.; Soraerville, L. (1974) Fate of 14C-BTS 27 271
When Administered to Cats as a Single Oral Dose: AX
74 005. (Unpublished study received June 24, 1976
under 6F1817; submitted by Upjohn Co., Kalamazoo,
MI; CDL:096423-U)
00041513 Clegg, D.E. (1973) Residues of BTS27.419 in Animal Tissues.
(Unpublished study received June 24, 1976 under
6F1817; submitted by Upjohn Co., Kalamazoo, MI;
CDL:096423-AH)
00041539 Shaw, J.W. (1973) BTS 27 419: Acute Oral Toxiclty to Male
and Female Rats: TXM 73041. (Unpublished study
received June 24, 1976 under 6F1817; submitted by
Upjohn Co., Kalamazoo, MI; CDL:096419-AE)
00044585 Sutton, M.M.; Offer, J. (1973) BTS 27 419: Carcinogenicity
and Long-Term Toxicity Study in Rats: Report TX 73043.
(Unpublished study received June 24, 1976 under 6F1817;
submitted by Upjohn Co., Kalamazoo, MI; CDL:096417-A)
00044586 Moragan, H.E.; Patton, D.S.G.; Turnbull, G.J. (19??) BTS 27
419: Two-Year Oral Toxicity Study in Dogs: TX 73035.
(Unpublished study received June 24, 1976 under 6F1817;
submitted by Upjohn Co., Kalamazoo, MI; CDL:096415-A)
00044591 Kakuk, T.J.; Weddon, T.E. (1976) U-36059: Safety Evaluation
of Baam 1.5 EC in Dogs Following a Single Topical
Exposure: 527-9610-TJK-76-1. (Unpublished study received
October 7, 1974 under 6F1817; submitted by Upjohn Co.,
Kalamazoo, MI; CDL:096415-K)
00046029 Joos, J.L.; Sigetko, J.; Lee, B.L.; et al. (1980) Baam
(R) WP Insecticide for Pears. (Compilation; unpublished
study received July 25, 1980 under 1023-61; submitted
by Upjohn Co., Kalamazoo, MI; CDL:242996-C)
00046030 Nappier, J.L.; Hornish, R.E.; Lane, R.E. (1976) Total
Residue Method for U-36,059 1,5-Di-(2 ,4-dimeth.ylpheny 1)
-3-methyl-l,3,5triazapenta-l,4-diene in Oranges:
Report No. 315-9760-70. Method dated March 24, 1976.
(Unpublished study received July 25, 1980 under
1023-61; submitted by Upjohn Co., Kalamazoo, MI;
CDL.-242996-D)
77
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00051717 Holifield, E.L.; Bowers, R.C.; Lee, B.L.; et al. (1975)
Residue Data for Baam on Pears. (Unpublished study
received June 24, 1976 under 6F1817; submitted by
Upjohn Co., Kalamazoo, MI; CDL:096422-E)
00051929 Nappier, J>L.; Hornlsh, R.E. (1975) Total Residue Method
for U36,059-..in Apples, Pears and Soils: Report
No. 315-9760-32. Method dated Sepember 26, 1975.
(Unpublished study received December 18, 1975 under
1023-EX-34; submitted by Upjohn Co., Kalamazoo,
MI; CDL:094993-D)
00051930 Upjohn Company (1975) Comparison of the Analytical Residue
Procedures for U-36,059 and U-40,48l (Used in 1973
and 197^) with the Degradative Procedure (Used in
1975). (Unpublished study received December 18, 1975
under 1023-EX-34; submitted by Upjohn Co., Kalamazoo,
MI; CDL:094993-E)
00055718 Sommerville, L.; Nicholson, J.E. (1977) BTS 27 4l9--Metabolism
in Apples, Variety Cox's Orange Pippin. (Unpublished
study received October 7, 1974 under 5G1558; submitted by
Upjohn Co., Kalamazoo, MI; CDL:094250-C)
00072411 Fink, R.; Beavers, J.B. (1980) Final Report: One-generation
Reproduction Study—Mallard Duck: Project No.
137-113. (Unpublished study received April 9, 1981
under 43142-EX-l; prepared by Wildlife International,
Ltd., submitted by Boots Hercules Agrocheraicals
Co., Wilmington, DE; CDL:244830-A)
00072412 Fink, R.; Beavers, J.B. (1980) Final Report: One-generation
Reproduction Study—Bobwhite Quail: Project No.
137-112. (Unpublished study received April 9, 1981
under 43142-EX-l; prepared by Wildlife International,
Ltd., submitted by Boots Hercules Agrochemicals
Co., Wilmington, DE; CDL:244831-A)
00074486 Atkins, E.L.; Kellum, D. (1980) Effect of Pesticides on
Apiculture: Maximizing the Effectiveness of Honey
Bees as Pollinators: Project No. 1499. 1980 annual
rept. (Unpublished study received June 8, 1981 under
241-259; prepared by Univ. of California—Riverside,
Citrus Research Center and Agricultural Experiment
Station, Dept. of Entomology, submitted by American
Cyanamid Co., Princeton, N.J.; CDL:070l48-G)
78
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
00111886 Barnett, R.; Crowley, J.j Lessel, B.; et al. (1976)
BTS 27 419: 80-Week Carcinogenicity Study In
Mice: Report No. 76059. Final report.
(Unpublished study received June 24, 1976 under
6F1817; prepared by Boots Co., Ltd., submitted
by Upjohn Co., Kalamazoo, MI; CDL: 096416-A)
00114299 Leake, C.; Somerville, L.; Lines, D.; et al. (1982) The Leaching
of Amitraz in Four Soil Types Using Soil T.L.C.: METAB/82/
(Unpublished study received Septmber 8, 1982 under 45639-49
prepared by FBC, Ltd., England, submitted by BFC Chemicals,
Inc., Wilmington, DE; CDL:2483l8-B)
00139552 Colley, J.; Dawe, S.; Heywood, R.; et al. (1983)
Amitraz: 104 Week Tumorisenicity Study in Mice:
HRC Report No. BTS 153/8262/A; T233. Final Report.
(Unpublished study received January 5, 1984 under
1023-59; prepared by FBC, Ltd., England, submitted
by Upjohn Co., Kalamazoo, MI; CDL:252098-A; 252099;
252100; 252101; 252102)
79
-------
Appendix II-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amltraz Standard
GS00234006 Nor-Am Chemical Company and The Upjohn Chemical
Company (1984) New Data Submitted in Support
of Registrations of Mitac, Baam and Taktic:
Volume 1 of 3. (Unpublished study received
May 7, 1984 under 45639-49 and 1023-59;
submitted by Nor-Am Chemical Company, Wilming-
ton, DE and The Upjohn Company, Kalamazoo, MI;
CDL:253130)
GS0023400? Nor-Am Chemical Company and The Upjohn Chemical
Company (1984) New Data Submitted in Support
of Registrations of Mitac, Baam and Taktic:
Volume 2 of 3• (Unpublished study received
May 7, 1984 under 45639-49 and 1023-59;
submitted by Nor-Am Chemical Company, Wilming-
ton, DE and The Upjohn Company, Kalamazoo, MI;
CDL:25313D
GS00234011 McGibbon, A.S.; Kelly, I.D. (1984) Metabolism of
[I4c] amitraz in pears (an interim report).
(Unpublished study received May 2, 1984 under
PP#2F2705/2H5353; submitted by FBC Limited,
Saffron Walden, Essex England; CDL:253132)
GS00234012 McGibbon, A.S.; Kelly, I.D. (1984) The metabolism
pf [I4c] amitraz in lemons under greenhouse
conditions (an interim report). (Unpublished
study received May 2, 1984 under PP#2f2705/
2H5353; submitted by FBC Limited, Saffron
Walden, Essex England; CDL:253132)
GS00234014 Staten, F.W.; Thornton, A.M. (1975) Frozen stability
of U-36,059 miticide and a metabolite, U-40,48l.
Report No. 315-9760-29. (Unpublished study
received April 22, 1975 under PP#5Gl623; submitted
by Upjohn Company, Kalamazoo, MI; CDL:094642)
GS00234015 Nor-Am Chemical Company (1980) Confidential Statement
of Formula for Amitraz Insecticide for
Manufacturing Use Only. In EPA Registration
Jacket 45639-51
GS00234016 The Upjohn Company (1974) Confidential Statement of
Formula for U-36,059 Technical. In EPA Registra-
tion Jacket 1023-58
80
-------
Appendix 11-2
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Amitraz Standard
GS00234021 Douglas, M.T.; Pell, I.B.; North, J.C. (1982) The
Acute Toxicity of Amitraz to Daphnia magna.
(Unpublished study received April 9, 19oO
under 45639-EUP-l; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369)
GS000234022 Sleight, B.H. (1973) Acute Toxicity of BTS - 27419
to Atlantic Oysters (Crassostrea Virginica).
(Unpublished study received April 9, 1980
under ^5639-EUP-l; submitted by Boots Hercules
Agrochemicals Co., Wilmington, DE; CDL: 099369)
81
-------
Appendix II-3
OMB Approval No. 2000-0458 {Expires 12-31-83)
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
PRODUCT NAME
APPLICANTS NAME
Guidance Document, 1 tm responding in tht following manner
EPA REGISTRATION NO.
DATE GUIDANCE DOCUMENT ISSUED
a contained in the referenced
D 1. 1 will submit dan in a timely manner to satisfy the following requirementv If ttit test procedures 1 will u*a deviate from (or are not
specified in) thi Rigistmion Guidelines or ttia Protocols contained in trie Reports of Expert Groups to the Chemicals Grout), OECD
Chemicals Tasting Programme, 1 enclose the protocols that 1 will use:
O2. 1 have anttrad into an agreement with one or more other registrants under FIFRA stction 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
Q 3. 1 enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
rttpact to the following data requirements:
D 4. 1 request that you amend my registration by deleting the following uses (this option is not available to applicants for new products).
D 5. 1 request voluntary cancellation of the registration of this product. (This option is not available
REGISTRANTS AUTHORIZED REPRESENTATIVE SIGNATURE
to applicanti for rww products.)
DATE
EPA Form 8680-1 (1042)
-------
Appendix 11-4
OMB Aooronl No. 20004468 (Exoint: 12-31-831
(To nullify, etrtlfvALL four famt)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3{c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
IPA COMPANY NUMSER
(Thit firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such in agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following datets):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(cl(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8580-6 (10-82)
-------
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC DATA REPORT
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
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
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
Appendix III-l (continued)
Registration
Guideline No.
63-13
63-W
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Planmability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID#
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
APPENDIX IV-1
ents, ratheY than to the
end-use product: and
(3) Existing tolerances,
regulations. \exemDtio
clearances issued unde
Food. Drug, and Cosme
(e) If the applicant
lety of the
'ood additive
and other
the Federal
ic Act.
ows that any
item of data he, submnted under this
section was generatedroy (or at the ex-
pense of) anotheii pe^on who original -
ly submitted the
predecessor. USD
ary 1. 1970. to su;
for registration,
permit, or amen
use to an existin,
reregistratlon (
and the ori
reached writ!
to EPA (or its
on or after Janu-
>ort an application
xpertmental use
nt adding a new
.tion, or for
ess the applicant
daU\submitter have
ment on the
amount and thfe terms V>f payment of
any compensation thatXmay be pay-
able under FIKHA section
3(cKlKDKll)/w1th regard to approval
of the application), the applicant shall
submit to EPA a statement that he
has furalaned to each such, identified
original data submitter
(DA notification of the applicant's
intent to Apply for registration. Includ-
ing the Proposed product nam*
(2) An7 offer to pay the penfcn com-
pensatipn. with regard to the approval
of the/application, to the extant re-
quired by FEFRA sections 3(cHlXD)
and3/cX2XD);
(3/An identification of the ite^n(s)
of d&ta to which the offer applies;
(/) An offer to commence nerotia-
tlq(hs to ascertain the amount and
of compensation to be paid; and
A 5) The applicant's name, adc
id telephone number.
other
Chapter I—Environmental Protection Agency
it obtained the data from anothe
(identify); applicant copied dall
frtm a publication: applicant obtained
a oppy of the data from EPA).
(«) The applicant shall submit ytth
his VpplJcation a statement that KFA.
in iu evaluation of the propertiea/effi-
cacyAand safety of the formulated
end-use product, may not consider any
data is supporting the application,
except the following data:
(1) Tne data the applicant has sub-
mitted t* EPA under paragraph (b) of
this section:
(2) Otner data pertalnin'g to the
safety of ihe product's actkCe ingredi-
§ 162.10
If the applicant's product co/
any active ingredient other
that are present solely because
incorporation into the pro/uct.
formulation, of one or/more
pesticide pioducts
from another producer.
then theXapplicant shall aW comply
with 1162y-5 as to such acflve ingre-
dient, andVhe application/shall con-
tain an acknowledgment that for pur-
poses of FXF1LA section ttcXIXD) the
application nUes on (tpd any result-
ing registrationXshouldroe regarded as
if it were based to the/Administrator's
consideration of) yiefollowing data:
(1) All data submitted or specifically
cited by the applppnt in support of
the registration;
(2) Each otheyitedi of data in the
Agency's files wnich:
(i) Concerns Ae properties or effects
of any such active ingreoVnt: and
(11) Is oneybf the types >of data that
EPA would/equire to be submitted for
scientific jertew by EPA IfUhe appli-
cant sou/ht the initial registration
under BTFRA Section 3
-------
; urio
(tv> The product registration
number as prescribed In paragraph (e)
of thin section:
(v) The producing establishment
number M prescribed In paragraph (f)
of this section:
et In 0-polnt or tarter type:
Claims a* to thp safpty of the
pesticide or Its Ingredients. Including
statements surh as "safe." "nonpolson-
oils." "nonlnjnrloiis." "harmless" or
"nonloxlc to humans and pel"" with
or without surh a qualifying phrase as
"whpn used as directed": and
.
Arn.:fi.\ iv-i
(cont tmied}
5 167.10
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the Inrtel shall he ron
sldered as the name nnri addres* of 'he
producer. If the registrant's name ap
pears on the label and Ihp registrant Is
not the producer, or If I lip name of Ihp
person for whom the pesticide wsj«
produced appears on the Inbel. II must
be quallflpd by appropriate wording
such as "Parkpd for • • V "Olslrlbul
pd by ' * '." or "Sold by In show
that the namp Is nol Mint of the pro-
ducer.
(d) Net v>eiaht or mra.iurr nf ron
tentt. (1) The net weight or measure
of content shall be exclusive of wrap
pers or other materials and shall t>p
the average content unless explicit Iv
stated an a minimum quantity.
(2) If the pesticide Is a liquid, the
net content statement shall be In
terms of liquid measure at. «•• F (20"O
and shall be expressed In convent lonal
American unit* of fluid ounce*, pint.s.
quarts, and gallons.
(3) If the pentldde Is solid or semlsn.
lid, viscous or preasiirteed. or Is * mix-
ture of liquid and solid, the net con-
tent statement shall be In terms of
weight expressed as avoirdupois
pound* and ounces.
(4) In all cases, net content shall he
stated In term* of the largest suitable
units. I.e.. "1 pound 10 ounce*" rather
than "M ounce*."
(5) In addition to the required units
specified, net content may be ex-
pressed In metric units.
(«) Variation above minimum con-
tent or around MI average Is permissi-
ble only to the extent that It repre-
sent* deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum Is not permit-
ted. In no e*M shall the average eon-
tent of the packages In a shipment fall
below the stated average content.
(e> Product rtftttratlon number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis.
tratlon No.," or the phrase "EPA Reg.
No." The registration number shall be
set In type of • flee and style similar to
other print on that part of the label
on which It appears and shall run par-
-------
§ I«MO
•lie) to It. The registration number
mnd the required Identifying phrase
shall not appear In such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
.
M> Statement* of percentage*. The
percentages of Ingredient* shall be
stated In terms of welght-to-welght.
The sum of percentages of the active
and the Inert Ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-38%.' If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the Ingredient
statement.
(5) ^ccuroeir of •fated percentage*.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be pres-
ent.
(6) Deterioration. Pesticides which
change In chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
I date )."
(It) The product must meet all label
claims up to the expiration time Indi-
cated on the lahrl.
(7) fnert \narr
-------
§ 163-10
eel treatment U some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity cateporie*. The
statement of practical treatment Is not
required on the front panel except us
described In paragraph »5 to 10.
AtXK* 10 M IS .
Abov* 15 to 30
O«- 30
eoMrl
(Hot**)
•WTJ. «
LJ"***
«
10
It
u
1*
-KM* Oil
otmcxo'
CMlMri
«
•
*
10
1}
(2) Otttrr required ttximlngj and pre-
cautionary ttatemmti. The warnings
and precautionary statements an re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and !
"Physical or Chemical Hazard."
(I) ffoxanf to humans and domtttlc
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required Indi-
cating the particular hazard, the
route(8) of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be Immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depict* typi-
cal precautionary statement*. These
statement* must be modified o* e-
panded to reflect specific hazards.
tin^i iMi). OB net brwfw »«rw (ram a
•Hal. Do rvt fM ta «rn. on rt*i or on
(Ma prxamomrr «W«
Sirfe 0*0* vyv l
tJLi«»^ MT »«« ff
I AMTCpMiK M M MNKMrf !*«•«)>
(II) Knvtronmenlal horortlj. Where a
hazard exist* to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
Injury or damage. Examples of the
hazard statement* and the circum-
stance* under which they are required
follow:
(A) If a pesticide Intended for out-
door one contain* an active Ingredient
with a mammalian acute oral LD« of
Chapter I—Environmental Protection Agency
Al , I.UDIX IV-1
(rent Inued)
$167.10
100 or less, the statement "This Penll-
clde Is Toxic to Wildlife" I* required.
(B) If a pesticide Intendrd for out-
door use contains an active Initrrdlpnt
wllh a fish ncute LC» or 1 ppm or loss.
the stnlcmrnt "This Pesticide Is Toxic
to Fish" Is required.
tx*5« j1 paM ••»<>• 7T r Mr) nal c
"This pesticide Is extremely toxic to
wildlife (fish)" Is required.
For uses Involving foliar appllc*
lion to agricultural crops, forests, or
shade trees, or for mooquHo abate
ment treatment*, pesticides toxic to
pollinating Insects moil bear apprnprl
Rte label cautions.
For all oulrloor uses other than
aquatic applications the label must
bear the caution 'Kf-cp out of lakes.
ponds or streams Do not contaminate
water by cleaning of equipment or rtK
posal ot wastes.'
(Ill) rhvical or chcmtcnf hn?ar<*«
Warning statements on the flammabll
IIy or explosive rlinracteristics ol ll Mr**.*!)* rfwoo^*
IW f f**«v «H«^« t»**fr*Q.
fM fWM Wl n* ^lor* MMr >WM| o* nfwn
*r>owr« in
Al or Mo» TO* r
Abov* JO- r rmrj nol r»w W F_
Do not u»« rjr MOT*
MMT hM« or rwm H
(l> /MrecHon* Aw We—fl) General
rtqvtrtmtnti—tt) Adrquacr and ctar-
f<» o/ dfrrcHon*. Directions for use
must be stated In terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud and
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
(II) Placrmrnt of direction* for vae.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pestlcffte product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, sitch
printed or graphic matter Is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag:
(B) The label bears a reference to
the directions for use In accompanying
leaflet* or circulars, such as "See di-
rection* In the enclosed circular-" and
1C) The Administrator determines
that It Is not necessary for such direr
tlons to appear on the label.
(Ill) Ezceptfonj fo requirement /or
dfrecffon /or use—(A) Detailed dlree-
ttons for use may be omitted from la
bellng of pesticides which are Intended
for use only by manufacturers of pr<«1-
ucts other than pesticide products In
their regular manufacturing processes.
provider! that:
-------
5 IM.10
(/) The label clearly nhows that the
product la Intended for use only In
manufacturing processes and specifies
the lype(s> of products Involved.
(*) Adequate information such as
technical data sheet* or bulletins. Is
available to the trade specifying the
type of product Involved and Ha
proper use In manufacturing process-
es;
(J) The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts: and
(*) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labellni of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
(/) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
The target pest(s> associated
with each site.
(v) The dosage rate associated with
each site and pest.
(v|> The method of application. In-
cluding Instructions for dilution. If re-
quired, and typefs) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(»lll) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning; reentry provided by W
CFR Part 170.
(lx> Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirements of 40 CFR Part 165. These
Instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set In type of the came minimum shies
as required for the child hacard warn-
ing (See Table In f lertOOiXIXIv).)
(x) Any limitations or restriction on
use required to prevent unreasonable
advene effects, such as:
(A) Required Intervals between ap-
plication and harvest of food or feed
crop*.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) tReserved)
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the nil* of application
but nonetheless available to thr
person .applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically presrnt.
(F) Othrr pertinent Information
which the Administrator determines
to be necessary for the protection of
man and thr environment.
(J) Stalrmrnt of f/.«r CT«.w(/fcoffon.
ny October 22. 1970. all pesticide prod-
ucts must, bear on their labels a state-
ment of use classification as described
In paragraphs (Jx I) and (2) of this sec-
tion. Any pesticide product for which
some IISPS arc classified for general tisp
and others for restricted use shall be
scpnrslely Inbclcd according to the la-
beling standards set forth In this sub-
section, and shall be marketed as scpa-
rnle products with different registra-
tion numbers, one bearing directions
only for general uge(s) and the other
besrlng directions for restricted inwKs)
except that. If a product has both re-
stricted nse(s) and general use(s). both
of these uses may appear on a product
labeled for restricted use. Such prod-
ucts shall be subject to the provisions
of | I«2.10,
(I) Ctnrral (Jtr C7o-'.t(/lcaffon. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Clnss(flcatlon" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses eon-
Ulned In the Directions for Use will be
considered a fslse or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Rfttrlrtrtt Vir CTanVTcatton.
Pesticide products bearing direction
for use(«) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(I) Front panrt itatrment of rettrict-
fit nsf classification. (A) At the top of
the front panel of the label, set In type
of the same minimum sizes an required
for human hazard signal words of th> Act. or a
notice of Intent to how a hearlnw to
determine
should be
propriat*. shall
termination by
the pesticide n.
the criteria for
graph (aX3) of
determl
•hall to
theappi
may be.
retMrani
submit
[e registration
dented, as ap-
jued. upon a dp-
tdmlnlstrator that
or exceeds any of
Met forth In para-
Is sVtkm. Upon such
the\ Administrator
, See by certified mall to
or registrant, as the case
, :tnft that theVtippllcanl or
r has the opportunity to
•Idence In rebtiltXl of such
pregunyllon In accordance tyh para
graph/WX4) of this section. TTie appll
cant^- registrant shall have foVty five
(*8K/Oay» frohi the date such notice Is
sent to submit evidence In rebutlal of
presumption; provided, however.
for good cause shown the AdM4
Tstrator may grant an additional six
-------
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Appendix IV-1
-------
Pf«f CAU1ONAMV B1A1CMENT9
MA7ABDS TO HUMANS
II OOUfMC AN1MAISI
OANQEM
On
MA1AHOS
use
STOnAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
For r»t»U i»U l» md oit •«'» ky ttMIHH
tr f«riB"l wndfr f-rlr dlrtct iup«r«lil(K md ant|r ft'
thoif »t»l tovrrtd t>jr tht CtrtUlril »ppllc«tort Certlfl-
citlon, .
PRODUCT
NAME
ACTht WOKf 0»NT »
WtflT »«a*f DCKT9 \
TOtAl 10000%
TI419 WK3DUCT CONTAM9 US Of PEA OAU.ON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
SIAtfMfNf Of f^AC'CAl. IRJATUfNT
9K* PAMtt rO« ACOmONH HltCAUTVlNAMT If ATCUCMTS
irr
MO
Nf T CONTfNTI:
7o
It
CNOF
CMOP
WAMUMTV «r»TtM€Mr
5
a.
-------
APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
H
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precaut ionary
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.
-------
APPENDIX IV-2 (continued)
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
OP 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
f rontjpanel .
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.
-------
APPENDIX IV-2 (continued)
HEM
8C
9A
9C
10A
IOC
10D
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°P
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMEMT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
FKKf'liKKliD
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 frcm from other directions
for use.
May be in metric as well as U.S. units
-------
Appendix IV-3
Criteria
PHYSICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°P; 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 not over BO°F.
C. Flashpoint over 80°P
and not over 150°F.
D. Flashpoint above
15>0°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or Incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
Appendix IV-i|
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal Instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE £ND 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.
-------
Appendix IV-4
(continued)
M. 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:
-------
3.
Appendix IV-4
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact jour 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."
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
(bottleSj 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.
-------
Appendix IV-4
(continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
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.
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.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
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, sta^
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.
-------
Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CPR 26l.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "Er> List)
Active Ingredients, (no inertsj;
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-Cyclohexy1-4,6-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
Endrln
Pamphur
Pluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
-------
Appendix IV-4
(continued)
"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
Jj-Chloro-m-cresol
Chloroform
o~Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresyllc acid
Cyclohexane
Decachlorooctahydro-l,3>4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
l,2-Dibrorao-3-chloropropane (DBCP)
Dlbutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dlchlorodifluoromethane (Preon 12®)
3,5-Dlchloro-N-(l,l-dimethyl-2-propynyl) benzaraide (pronamide,Kerb)
Dlchloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dlchlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,i»'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
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Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active In&redientsT
Isobutyl alcohol
Lead acetate
Llndane
Malelc 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
Pyrldine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4, 5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thirara
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichlororaonofluoromethane (Preon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
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Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluororaethane (Preon 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
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