&EPA
United SIMM
Environmental Protection
Agency
Pwicida*
Off f PI of
Pecticidei «nd Toxic SubettnoM
Wathington DC 20460
540-ES-88-06S
Guidance for the
Reregistration of
Pesticide Products
Containing CRYOLITE
as the Active Ingredient
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OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CRYOLITE
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 15096-52-3
OPP SHAUGHNESSY NO. 075101
EPA CASE NUMBER 0087
April, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
I. INTRODUCTION . . 1
II. CHEMICAL COVERED BY THIS STANDARD 4
A. Description of Chemical 4
B. Use Profile 5
III. AGENCY FINDINGS 7
A. Summary 7
B. Health Effects Assessment 9
C. Environmental Characteristics and Effects . . 11
D. Tolerance Reassessment 14
IV. REGULATORY POSITION AND RATIONALE 17
A. Summary of Regulatory Positions and Rationales 17
V. LABELING STATEMENTS AND COMPLIANCE
DATES 20
VI. PRODUCTS SUBJECT TO THIS STANDARD 22
VII. REQUIREMENT FOR SUBMISSION OF GENERIC DATA .... 24
A. What are generic data? 24
B. Who must submit generic data? . .- 24
C. What generic data must be submitted? 25
D. How to comply with DCI requirements 26
E. Procedures for requesting a change
in protocol 29
F. Procedures for requesting extensions
of time 29
G. Existing stocks provisions upon
suspension or cancellation ......... 30
VIII. REQUIREMENT FOR SUBMISSION OF PRODUCT SPECIFIC
DATA 30
IX. REQUIREMENT FOR SUBMISSION OF REVISED LABELING . . 31
X. INSTRUCTIONS FOR SUBMISSION 31
A. Manufacturing-Use Products (Sole Active) ... 31
B. Manufacturing-Use Products (Multiple Active) . 33
C. End-Use Products 34
D. Addresses 35
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APPENDICES
Page
I. DATA APPENDICES ........... ...... .37
Guide to Tables ........... ...... .37
Table A ............ ......... .40
Table B ........... ...... ..... 71
II. LABELING APPENDICES .............. . . 77
Summary of Label Requirements and Table ...... 78
40 CFR 162.10 Labeling Requirements ........ 88
Physical/Chemical Hazards Labeling Statements ... 93
Storage instructions ............... 94
Pesticide Disposal Instructions .......... 95
Container Disposal Instructions .......... 9g
III. BIBLIOGRAPHY APPENDICES .............. 97
Guide to Bibliography ............... 93
Bibliography ................... 100
IV. USE INDEX APPENDIX
V- FORMS APPENDICES
.EPA Form 8580-1 FIPRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter into an
Agreement With other Registrants for
Development of Data
EPA Form 8580-4 Product-Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
EPA Form Certification With Respect to Citation of
Data
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI; Acceptable Daily Intake
a.i.: active ingredient
CAS: Chemical Abstract Services (number)
CSF: Confidential Statement of Formula
EEC: Estimated Environmental Concentration
EPA: The U.S. Environmental Protection Agency (Agency)
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide
Act
LC50: Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals,
expressed as weight or volume of test substance
per volume of air or water or per weight of feed
(e.g., mg/1 or ppm).
LD50: Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of
test animals when administered by the route
indicated, expressed as weight of substance per
unit weight of test animal (e.g., mg/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number) - EPA's
system of tracking studies used in support of
registration.
NPDES: National Pollutant Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs of the U.S. EPA
OES: The Office of Endangered Species, U.S. Fish and
Wildlife Service
111
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PHI: • Preharvest Interval
RfD: Reference Dose. The reference dose is an estimate
of a daily exposure to the human population (including
sensitive subgroups) that is likely to be without an
appreciable risk of deleterious effects during a lifetime.
The Reference Dose is a replacement term for the term
Acceptable Daily Intake (ADI).
IV
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I. INTRODUCTION
This document is a revised Registration Standard for the
subject chemical. In its original Standard issued in 1983,
the Agency summarized the available data supporting the
registration of cryolite and concluded that additional
scientific data were needed to fully evaluate the pesticide.
The Standard required submission of additional data and
included label requirements for manufacturing-use products.
The Agency has since received and reviewed the
additional data and has revised its scientific and regulatory
conclusions in light of the expanded data requirements
promulgated in 1984, at 40 CFR Part 158, for registration
and reregistration of all pesticides.
This revised Registration Standard, which supercedes the
1983 document, is the Agency's updated assessment of the
pesticide and the data needed to support its continued
registration, and includes a review of the labeling
requirements for cryolite.
This document contains the following sections:
Section II describes the particular pesticide covered by this
Registration Standard, and gives a brief profile of its usage
and composition. Regulatory history may be provided as
well.
Section III sets out the Agency's scientific assessment of
the health effects and environmental characteristics and
effects of the chemical, updated based on data submitted to
the Agency under the original Registration Standard.
Section IV explains the regulatory decisions and conclusions
arising from the Agency's assessment, and the rationales for
its decisions.
Section V describes the labeling statements required for
products. These statements are divided into statements for
manufacturing-use products and statements for end-use
products. Compliance dates are also included in this section.
Section VI describes the products subject to this Standard.
Section VTI through Section X contain information on what
pesticide manufacturers and formulators are required to do in
order to comply with this Registration Standard.
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Appendices I through V contain tables setting out data
requirements for the chemical, general label requirements for
pesticide products, a bibliography containing data citations
used in support of data requirements, the use index, and the
necessary forms to respond to receipt of this Standard.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
conclusions from available data in its files pertaining to
the pesticide active ingredient. However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end-use products that
contain the active ingredient. The Agency will apply the
provisions of this Registration Standard to end-use products
if necessary to protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submission of data in support of product
registration; •
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with data requirements may result in
the issuance of a Notice of Intent to Suspend. Failure to
comply with the remaining requirements listed above may
result in the issuance of a Notice of Intent to Cancel.
xThe scientific reviews may be obtained from the
National Technical Information Services (NTIS) / Attn: order
Desk, 5385 Port Royal Road, Springfield, VA 22161
703:487-4650).
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In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a Special
Review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA-has authority under the Data Call-in (DCI)
provisions of FIFRA sec. 3(c)(2)(B) to require that
registrants submit data to answer our questions regarding the
chemical, toxicological, and environmental characteristics
and fate of a pesticide. This Registration Standard lists
the data EPA believes are necessary to resolve our concerns
about this pesticide. These data are listed in Tables A and
B in Appendix I. Failure to comply with the DCI
requirements enumerated in this Registration Standard may
result in issuance by EPA of a Notice of Intent to Suspend
the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submission of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICAL COVERED BY THIS STANDARD
A.
The following chemical is covered by this Registration
Standard:
Common Name: Cryolite
Generic name: Sodium aluminofluoride or sodium
(Chemical) fluoaluminate
Chemical Family: Inorganic fluorine compound
Trade Names: Kryocide and Prokil
Other Chemical
Nomenclature: trisodium hexafluoroaluminate,
sodium hexafluoroaluminate, and sodium
aluminum fluoride
CAS Registry Number: 15096-52-3 or 1344-75-8
EPA Pesticide Chemical Code (Shaughnessy Number): 075101
Empirical Formula: NA3A1F6
Molecular Weight: 210
Chemical/Physical
Characteristics: Cryolite is a naturally occurring
mineral (large deposits occurring in
Greenland and the Urals), or it may be
synthetically produced by the reaction
of aluminum oxide, sodium chloride and
hydrogen fluoride.
Color: white (natural); white to
yellow- brownish white
(synthetic)
Physical state: powder (natural);
glassy powder at
20° C (synthetic)
Odor: none (natural and synthetic)
Melting Point: 1000° C (Merck Index)
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B. USE PROFILE
Type of Pesticide: Insecticide
Year of Initial Registration: 1959
Registered
Uses: Terrestrial food crop use on apples, beans, beets,
broccoli, Brussels sprouts, cabbage, cantaloupes,
carrots, cauliflower, collards, cranberries,
cucumbers, eggplant, grapefruit, grapes, kale,
kohlrabi, kumguats, lemons, lettuce, limes, melons,
mustard greens, oranges, pears, peppers, pumpkins,
radishes, squash, strawberries, tangelos, tangerines,
tomatoes, turnips, and watermelons.
Terrestrial non-food crop use on ornamental trees and
shrubs (including nursery stock).
Pests Controlled: The principal pests controlled on grapes
are omnivorous leafroller, grape
leaffolder, and orange tortrix, as well
as cutworms and other foliar feeders.
The main target pests on head lettuce and
other crops include cabbage looper, beet
armyworm, and corn earworm.
Methods of application: Aerial or ground, foliar appli-
cation as a spray or dust
Application rates: rates ranging from 5 to 78.98 Ib ai/A
(the highest rate is on citrus)
Annual Usage: 4.4 to 4.6 million pounds active ingredient
(1987 estimate)
Predominant Usage: Predominate use is on grapes, which
comprises more than 90% of annual
cryolite usage as a pesticide.
Mode of Activity: Cryolite is primarily a stomach poison,
but can act as a contact poison also.
Formulations: Wettable powders and dusts
U.S. Registrants: Agchem Division of Pennwalt Corp.,
Amvac Chemical Corp., Gowan Co., and
Moyer Products, Inc.
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Number of Registrations: 11 federally registered
end-use products, no technical
products or formulating
intermediates, and
16 "special local need"
registrations issued under FIFRA
section 24(c).
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III. AGENCY FINDINGS
A. SUMMARY
The Agency has reviewed all data currently supporting the
registration of cryolite. Based on the available data, EPA
has reached the following conclusions. The points summarized
below are presented in further detail, in the context of
EPA's science findings and additional data requirements, in
Sections B through D.
1. Technical cryolite is mildly toxic on an acute oral,
dermal, and inhalation basis (Toxicity Category IV, III and
III, respectively).
2. Cryolite does not demonstrate a teratogenic,
fetotoxic, or mutagenic potential.
3. Based on acceptable fish and wildlife toxicity
studies, cryolite is not expected to pose an acute hazard to
nontarget aquatic and terrestrial fauna, including
endangered species. The acute toxicity studies indicate that
technical cryolite is practically nontoxic to birds and bees
and slightly toxic to fish and aquatic invertebrates.
However, aerial application of cryolite at ^ 30 Ib ai/A may
pose a chronic hazard for aquatic invertebrates. Therefore,
an aquatic invertebrate life cycle study is required to
support these uses of cryolite.
4. There are no groundwater concerns identified for
cryolite, based on results of acceptable leaching and
adsorption/desorption studies showing that it has limited
mobility in soil.
5. None of the tolerances for cryolite are adequately
supported. Preliminary residue chemistry data indicate that
tolerance-exceeding levels of fluoride and/or cryolite may
occur in food crops following direct treatment with
cryolite, and that the current tolerances of 7 ppm are, in
most cases, too low. However, residue chemistry data gaps
must be filled before the Agency can determine the adequacy
of current tolerance levels.
6. Based on the results of the residue chemistry data
showing tolerance-exceeding levels of fluoride and/or
cryolite in food crops, there is a possibility that these
residues will also occur in rotational crops, necessitating
the requirement for a confined rotational study. The
requirement for a field rotational crop study is reserved,
pending receipt and evaluation of the confined rotational
crop study.
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7. The Agency has concerns about the potential adverse
health effects of fluoride to bones, as well as the potential
adverse cosmetic effects of fluoride to the teeth of
children, resulting from the pesticidal application of
cryolite. These concerns are based upon findings of
crippling skeletal fluorosis in adults who were chronically
exposed to relatively high levels of fluoride and extensive
epidemiological studies with large populations of children
carried out over the last 40 years.2
The Agency cannot set a reference dose (RfD) for
cryolite until additional data are submitted, specifically, a
rat metabolism (pharmacodynamic) study to quantitate the
bioavailability.of fluoride from cryolite. Information
derived from this study should allow the Agency to establish
a RfD for cryolite.
8. Based upon the results of the subchronic rat feeding
study (NOEL of 50 ppm for stomach lesions for cryolite), and
preliminary residue chemistry data showing that tolerance-
exceeding residues of fluoride and/or cryolite may occur in
food crops, the Agency is requiring long-term toxicity
testing (chronic toxicity, oncogenicity, and reproduction).
As a result of this review, the Agency has determined
that updated environmental hazard label statements are
required for manufacturing-use products and end-use products
in order to remain in compliance with FIFRA. The Agency has
also identified additional data necessary to complete an
evaluation of the human and environmental risks associated
with the use of cryolite as an insecticide. These data must
be developed in order to maintain registrations of existing
products or register any new products containing cryolite.
The Regulatory Position and Rationale section of this
Registration Standard discusses the Agency's position on each
2 In 1986, the Agency's Reference Dose Work Group
established a reference dose of 0.12 mg/kg/day for fluoride.
This RfD is designed to prevent the development of crippling
skeletal fluorosis. The Work Group also established an
additional value of 0.06 mg/kg/day for fluoride. This
additional value is designed to prevent the development of
objectionable cosmetic dental fluorosis in children (the
Agency's Work Group determined that, while dental fluorosis
was not an adverse health effect, it was desirable to supply
the public with information concerning dental fluorosis).
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of the regulatory issues concerning cryolite, and the
Labeling section contains the specific wording required for
each of the labeling revisions.
B. HEALTH EFFECTS ASSESSMENT
Below is an assessment of the human health risks
associated with the insecticide cryolite based upon data
submitted in response to the 1983 Cryolite Registration
Standard, and data previously accepted in support of
registration.
1. Acute Toxicity
There are adequate acute toxicity studies on file for
cryolite.3 Technical cryolite is mildly toxic on an acute
oral, dermal, and inhalation basis. It falls in Toxicity
Category IV for acute oral exposure based on an acute oral
LD5n value of greater than 5 g/kg in the rat. It is in
Toxicity Category III for dermal exposure based on an acute
dermal LD50 value of greater than 2.1 g/kg in the rabbit.
Technical cryolite is in Toxicity Category III for
inhalation exposure based on acute inhalation toxicity values
ranging from greater than 2.06 mg/L to less than 5.03 mg/L.
Technical cryolite is only mildly irritating to the eye
(Toxicity Category III) based on the results of an acceptable
primary eye irritation study using rabbits. No dermal
irritation was reported in rabbits exposed for 24 hours to a
dose of 0.5 g. of 95% technical cryolite, placing cryolite in
Toxicity Category IV for this route of exposure. Results of
an acceptable dermal sensitization study show that technical
cryolite is nonsensitizing by dermal application. No data
are available on the acute delayed neurotoxicity of cryolite
in the hen, but since cryolite is not an organophosphate, (a
compound which has been shown to demonstrate neurotoxicity),
neurotoxicity data are not required.
2. Subchronic Toxicitv
The Agency reviewed dog and rat subchronic (90-day)
feeding studies submitted in response to the 1983 Cryolite
Standard. These studies did not establish No Observed Ef-fect
Levels (NOELs) for fluoride accumulation in the bone.
Fluoride accumulation in the bone occurred at 50 ppm (2.5
mg/kg) in the rat study and 500 ppm (12.5 mg/kg) in the dog
3 Studies submitted in response to the 1983 Standard
included acute oral toxicity and dermal sensitization;
previously accepted data included acute dermal toxicity,
acute inhalation, primary eye, and dermal irritation.
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study, the lowest doses tested. Cryolite NOELs for other
effects were 50 ppm (2.5 mg/kg) in the rat (stomach lesions4
at 5000 ppm) and 10,000 ppm (250 mg/kg) in the dog (decreased
body weight, decreased body weight gain, decreased food
consumption, and a decrease in hematological parameters at
50,000 ppm).
3. Chronic Toxicity Testing
In the 1983 Cryolite Registration Standard, the Agency
required submission of a rat teratology study and
mutagenicity data. Requirements for chronic feeding,
oncogenicity, a teratology study in a second species, and a
reproduction study were reserved pending submission and
review of the data required in the 1983 Standard,
specifically the 90-day subchronic feeding studies, rat
teratology study, mutagenicity studies, and residue data. A
metabolism study was not required, since there were
acceptable data on file to support registration of cryolite
products. Data submitted in response to the 1983 Cryolite
Registration Standard are discussed below.
84-4 - Mutagenicity
Acceptable mutagenicity studies have been submitted to
support registration of cryolite products. Technical
cryolite tested negative for mutagenic activity in a
Salmonella/Microsomal Assay (Ames). It was also negative in
a DNA repair test using Escherichia coli for genotoxic
effects and in a rat in vivo cytogenetics assay for
structural chromosome aberrations. No further testing is
required.
83-3 - Teratogenicity
An acceptable rat teratology study has been submitted to
support registration of cryolite products. In this study,
cryolite was tested in rats at dosage levels of 750, 1500,
and 3000 mg/kg. Cryolite did not demonstrate a teratogenic
potential at doses up to and including 3000 mg/kg, and was
not shown to be fetotoxic. A whitening of the dam teeth in
treated animals was the only change in either dams or fetuses
that was attributable to cryolite treatment. The No Observed
Effect Level (NOEL) for maternal and fetotoxicity is 3000
rog/kg (highest dose tested). Based on the negative findings
in the rat teratology study, coupled with the high dose
levels tested, the Agency is not requiring a rabbit
teratology study.
4 Stomach lesions such as thickened wall, raised focal
area, inflammation, hyperkeratosis, acanthosis.
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New Data Requirements
The Agency is requiring submission of a new rat
metabolism (pharmacodynamic) study. The metabolism study
submitted in 1983 was considered acceptable because it
generally reaffirmed in a qualitative and semiquantitative
way what had been reported in the published literature.
However, since the 1983 Standard was issued, submitted
subchronic rat and dog studies with cryolite showed no NOEL
for fluoride accumulation in bone at the lowest doses tested.
In addition, EPA's Reference Dose (RfD) Work Group, in 1986,
established a RfD of 0.12 mg/kg/day for fluoride (designed to
prevent the development of crippling skeletal fluorosis), and
also established an additional value of 0.06 mg/kg/day for
the adverse cosmetic effect of fluoride in teeth (dental
fluorosis in children). A rat metabolism (pharmacodynamic)
study is required in order to accurately quantitate the
amount of fluoride which would be bioavailable from cryolite.
The Agency expects that the study will provide the
information necessary to establish a reference dose for
cryolite.
The requirements for chronic feeding, oncogenicity, and
reproduction were originally reserved in the 1983 Standard.
These studies are now being required, because of the results
of the subchronic rat feeding study (NOEL of 50 ppm for
stomach lesions for cryolite), and because preliminary
residue chemistry data show that tolerance-exceeding levels
of fluoride and/or cryolite may occur in food crops.
C. ENVIRONMENTAL CHARACTERISTICS AND EFFECTS
1. Ecological Effects
In the 1983 Cryolite Registration Standard, the Agency
required submission of an avian oral LD50 study to support
registration of cryolite products. The Agency had acceptable
ecological effects data for avian LC50, freshwater and
invertebrate LC50/ and honey bee acute data. Requirements
for fish early life stage and aquatic invertebrate life cycle
studies (72-4) were reserved. EPA did not request avian
reproduction (71-4), simulated and actual field testing for
birds and mammals (71-5), acute toxicity to estuarine and
marine organisms (72-3), fish life cycle (72-5), and
simulated or actual field testing (72-7) because, based on
the use data and available toxicology data, the criteria for
requiring these tests were not met or exceeded. An update on
the ecological effects profile is provided below.
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71-1 to 71-4 Avian and Mammalian Testing
Based on acceptable laboratory data, technical cryolite
is characterized as practically nontoxic to birds. The acute
oral toxicity value to bobwhite is >2,150 mg/kg. The
subacute dietary toxicity value of technical cryolite is
>10,000 ppm in both the mallard (waterfowl species) and
bobwhite (upland gamebird). A risk assessment for avian
species based on a worst case scenario for ingestion of
grapes indicated no significant acute risk. Based on this
information, it is unlikely that cryolite use poses any
significant acute risks to avian species.
Many of the terrestrial uses of cryolite allow for
multiple applications, which may result in repeated exposure
to birds during the breeding season. There are no chronic
toxicity data upon which to estimate the hazards that
repeated use of cryolite poses to birds. However, because of
cryolite's low avian toxicity as demonstrated in acceptable
acute and subacute dietary studies, and its probable limited
palatability, an avian reproduction study is not required.
72-1 to 72-6 Aquatic Organisms Testing
Based on acceptable laboratory data, technical cryolite
is characterized as slightly toxic to fish and freshwater
invertebrates on an acute basis. The 96-hour acute toxicity
value (LC50) for rainbow trout, a coldwater species, is 47
ppm, and the 96-hour acute toxicity value for bluegill, a
warmwater species, is >400 ppm. Studies conducted with a 50%
active ingredient wettable powder formulation indicate that
the formulation is slightly toxic to bluegill (LC50 >100 ppm)
and rainbow trout (LC50 =42.5 ppm). The 96-hour acute
toxicity value for freshwater invertebrates is >100 ppm for
Daphnia magna and 10 ppm for Daphnia pulex. The fish early
life stage and fish life cycle studies are not required
because (i) the acute toxicity of cryolite to freshwater
organisms is low, (ii) there is only minimal use of cryolite
on crops grown in proximity to water (i.e., citrus and
cranberries), and (iii) the highest estimated environmental
concentration (EEC) based on indirect application of cryolite
is <1% of the lowest acute toxicity value for fish.
Estuarine and marine organism studies are not required
because insignificant concentration is expected in
marine/estuarine waters and cryolite is only slightly toxic
or practically nontoxic to representative freshwater
organisms.
141-1 - Honeybee Acute Toxicity
There is sufficient information to characterize cryolite
as practically nontoxic to honey bees (1.45% mortality at 217
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13
mg per bee). Precautionary labeling for cryolite products is
not required.
New Data Requirements
In the 1983 Cryolite Standard, EPA reserved the
requirement for an aquatic invertebrate life cycle study.
Since then, the Office of Pesticide Programs (OPP) has
developed more realistic models for calculating estimated
environmental concentrations (EECs) when actual field residue
data are lacking. The aquatic EEC resulting from indirect
application (i.e., runoff and spray drift) of cryolite
exceeds the criteria for requiring the life cycle test (i.e.,
>1% of the acute toxicity value for the most sensitive
species) when cryolite is applied aerially at ^30 Ib ai/A.
Therefore, this test is required for cryolite products
allowing for application under these conditions.
4. Environmental Fate
In the 1983 Cryolite Registration Standard, the Agency
required submission of hydrolysis (dissociation) and mobility
(leaching and adsorption/desorption) data. No other
environmental fate studies were required because it was
concluded that due to the nature of the pesticide (naturally
occurring mineral), the usual environmental fate studies
would not yield information useful for regulatory purposes.
The required studies have been received and reviewed and are
discussed below.
161-1 - Hydrolysis (Dissociation)
Cryolite does not hydrolyze, but rather dissociates.
Based on an acceptable study, in which cryolite (purity
97.3%), was added at 200 ppm to buffered solutions at pH 5
and 9 and to unbuffered deionized water at pH 7; 30.9%,
86.6%, and 73.7%, respectively, of the theoretical fluoride
had dissociated from the parent compound. With increasing
pH, an increasing amount of fluoride dissociated from the
test substance. No further testing is required.
163-1 - Mobility (leaching and adsorption/desorption)
Results of acceptable soil column studies indicate that
cryolite is only slightly mobile in soil. For all soil
types, fluoride was detected primarily in the upper 12 cm of
the soil columns. In an ancillary study, sorption
coefficient (K^) values were measured at 1.4 to 6.6 in the
sand soil, 8.1 to 15.1 in the sandy loam soil, 7.9 to 10.7 in
the clay loam soil, and 19.3 to 52.8 in the silt loam soil.
No further testing is required.
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New Data Requirements
Although not required in the 1983 Cryolite Registration
Standard, a confined rotational crop study is now required
because recently submitted residue chemistry data indicate
that tolerance-exceeding levels of fluoride and/or cryolite
will occur in food crops following direct treatment with
cryolite, and hence there is a possibility that residues will
also occur in rotational crops. The requirement for a field
rotational crop study is reserved, pending receipt and
evaluation of the confined study.
D. TOLERANCE REASSESSMENT
1. Tolerances Issued
Tolerances for residues of cryolite in or on raw
agricultural commodities are published in 40 CFR 180.145.
These tolerances were established based upon information
presented at the 1950 Spray Residue Hearings (a public
hearing). Tolerances are expressed in terms of combined
fluorine for residues of the insecticidal fluorine compounds
cryolite and synthetic cryolite and are set at 7 ppm for all
listed commodities.
2. Residue Data
No residue chemistry data have been submitted in
response to the data requirements listed in the 1983 Cryolite
Registration Standard. In 1986, prior to the date the data
were due, the Agency received a petition from a registrant
proposing an exemption from the requirement of a tolerance
for residues of cryolite in potatoes and all the raw
agricultural commodities currently listed in 40 CFR 180.145.
The Agency reviewed the request and, in late 1987, concluded
that an exemption was inappropriate and that the residue
chemistry data submitted in support of the proposed tolerance
exemption did not support the exemption request. Based on
data submitted in the petition, there is ample evidence that
tolerance-exceeding accumulation of fluoride ion and/or
cryolite occurs in or on plants treated with cryolite.
Furthermore, the data indicate that the current tolerances of
7 ppm are, in most cases, too low, and will not cover residue
levels following use at currently registered rates.
Therefore, the data requirements set forth in the 1983
Standard are still required.
An update on the residue chemistry data in support of
cryolite tolerances is as follows:
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15
a. The nature of the residue in plants is not
adequately understood. Although traditional plant metabolism
studies using radiolabeled materials may not be useful or
practical for cryolite (an inorganic material), studies
showing the form of fluoride (cryolite per se or free
fluoride ion) in or on raw agricultural plant commodities
could provide useful information regarding the nature of the
residue as consumed by humans and livestock. Development of
an analytical method for distinguishing between cryolite per
se and free fluoride ion is required. This method must be
used in selected residue trials so that a residue profile
(cryolite per se vs. total fluoride) can be developed.
b. The requirement for livestock metabolism is reserved
pending receipt and evaluation of the rat metabolism
(pharmacodynamic) study.
c. An adequate method is available for enforcement of
tolerances and data collection for residues of cryolite,
expressed in terms of combined fluorine, in or on plant
commodities. The limit of detection for fluorine is 0.1 ppm.
However, analytical methodology for determining the levels
of residues of cryolite per se in plants and animals are
required. The method must distinguish between cryolite and
free fluoride ion. Cryolite is not expected to degrade during
storage because it is a naturally occurring mineral. Storage
stability data are not required.
d. Field trial studies are required for all crops on
which cryolite is registered.
e. Data are required depicting the potential for
concentration of cryolite residues in the processed
commodities of beans (cannery residue), tomatoes (dry
pomace), citrus fruits (pulp, molasses, oil, and juice), and
apples (dry pomace and juice).
f. Data are required for potatoes, because FIFRA
Section 18 emergency exemptions have been issued for >. 3
consecutive years for use of cryolite on potatoes in Maine,
New York, and Rhode Island. The data must be supported by a
tolerance proposal.
g. Tolerances (or feeding/grazing restrictions) must be
proposed and appropriate supporting residue data submitted
for the raw agricultural commodities and feed items - bean
vines and hay.
h. Separate tolerances must be proposed for succulent
and dry beans.
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i. Food/feed additive tolerances must be proposed for
the combined fluorine residues of cryolite and synthetic
cryolite in grape pomace, raisins, and raisin waste, and in
paste, puree and catsup of tomatoes, since residues have been
observed to concentrate in these commodities.
j. Residue data and accompanying use directions must be
submitted for rutabagas, quinces, apricots, peas (succulent
and dried), plums (fresh plums), blackberries, blueberries,
boysenberries, dewberries, loganberries, raspberries,
youngberries, corn, okra, and peanuts, or the Agency will
revoke these tolerances.
k. The following commodity definition changes to 40 CFR
180.145 will be proposed by the Agency:
Current 40 CFR Entry Appropriate
Commodity Definitions
Beets (with or without tops) Beet roots
Beet greens
Radishes (with or without tops) Radishes
Rutabagas (with or without tops) Rutabaga Roots
Turnips (with or without tops) Turnip Roots
• Turnip Tops
Squash Winter Squash
3. Toxicology
There is no reference dose for cryolite. When the
residue chemistry and toxicology data have been submitted
and evaluated, a reference dose can be established and a
tolerance reassessment performed.
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IV. REGULATORY POSITION AND RATIONALE
A. SUMMARY OF REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and
other relevant information on cryolite, the Agency has made
the following determinations:
1. Cryolite is not a candidate for Special Review.
Rationale; No criteria specified in 40 CFR 154.7
have been met or exceeded based on data reviewed by the
Agency for this chemical.
2. The Agency will not approve significant new food
uses5 for cryolite until the Agency has received and
evaluated data sufficient to perform a tolerance assessment.
Rationale; None of the tolerances for cryolite are
adequately supported. Further, the Agency is unable to
establish a reference dose due to a toxicology data gap (rat
pharmacodynamic study). This lack of data prohibits the
Agency from performing a tolerance reassessment. Significant
new food uses will not be granted until these data gaps have
been filled.
3. EPA is requiring an aquatic invertebrate life cycle
study.
Rationale; Aerial application of cryolite at
.>30 Ib ai/A may pose a chronic hazard for aquatic
invertebrates (see Section III.C). Therefore, EPA is
requiring an aquatic invertebrate life cycle study to support
such uses.
4. The Agency is not restricting the use of cryolite
products.
Rationale; Section 3(d)(l)(C) of FIFRA provides
that some or all uses of a pesticide will be classified for
restricted use if the Administrator determines that without
such restriction the pesticide "may generally cause
unreasonable adverse effects in man or the environment."
5 "Significant new use" is defined in 40 44 FR 27934,
May 11, 1979. In the case of a new food or feed use, the
Agency will generally consider as significant an increase in
the Theoretical Maximum Residue Contribution (TMRC) of
greater than 1%.
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The Agency has determined that cryolite does not meet any of
the risk criteria of 40 CFR 162.11, therefore products
containing cryolite do not warrant restricted use
classification.
5. There are no groundwater concerns which necessitate
additional environmental fate/exposure studies at this time.
Rationale; Since cryolite is only slightly mobile
in soil, based upon acceptable leaching and
adsorption/desorption studies, it is not expected to
contaminate groundwater.
6. The Agency is not establishing a longer reentry
interval for agricultural uses of cryolite beyond the
minimum reentry interval (sprays have dried and dusts have
settled).
Rationale; Although there is no scientifically
validated toxicological evidence showing whether cryolite
causes adverse effects to persons entering treated areas,
cryolite has a relatively low acute toxicity (Toxicity
Category III by the inhalation and dermal routes of exposure
and Toxicity Category IV by the oral route of exposure) .
For this reason, the Agency has determined that a longer
reentry interval beyond the minimum established reentry
(sprays have dried and dusts have settled) is not necessary
for this pesticide.
7. The Agency will revise commodity definitions for
certain raw agricultural commodities listed in 40 CFR
180.145.
Rationale; Certain listings in 40 CFR 180.145 are
not appropriate and will be corrected by the Agency (e.g. the
tolerance listing for turnips will be revised to reflect the
appropriate commodity definitions "turnip roots" and "turnip
tops". (See Section D.2.k. of this Standard)
8. The Agency will propose to revoke tolerances
associated with commodities for which there are no registered
uses, unless the registrant submits an application for
registration and accompanying supporting residue data.
Rationale: Tolerances are established for the
following commodities: rutabagas, quinces, apricots, peas
(succulent and dried), plums (fresh prunes), blackberries,
blueberries, boysenberries, dewberries, loganberries,
raspberries, youngberries, corn, okra, and peanuts.These
crops do not have any currently registered uses. Therefore,
applications for registration and supporting residue
chemistry data must be submitted to support these uses, or
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the Agency will propose revocation of the tolerances for
these crops.
9. The Agency is requiring chronic toxicity,
oncogenicity, and reproduction studies to support currently
registered uses of cryolite.
Rationale: The 1983 Registration Standard for
cryolite indicated that the Agency was reserving these
requirements pending receipt and evaluation of a rat
subchronic feeding study, rat teratology study, mutagenicity
data and residue chemistry data. The subchronic rat feeding
study showed a NOEL of 50 ppm for stomach lesions for
cryolite. While residue chemistry data have not been
submitted (see Section HID), the Agency has preliminary
evidence that tolerance-exceeding levels of fluoride and/or
cryolite may occur in or on food crops. Because of the
uncertainty regarding the residues of fluoride or cryolite on
treated food crops, and the 50 ppm NOEL indicated in the
subchronic feeding study, the Agency is requiring these long
term toxicity studies for cryolite.
10. The Agency has identified certain data that will
receive priority review when submitted to the Agency.
Rationale; Certain data are essential to the
Agency's assessment of this pesticide and its uses and/or may
trigger the need for further studies which should be
initiated as soon as possible. The following studies have
been identified to receive priority review as soon as they
are received by the Agency:
Section 158.135 Toxicology
82-2 21-Day Dermal Toxicity
85-1 General Metabolism (pharmacodynamic) Study
Section 158.125 Environmental Fate
161-1 Rotational Crops (Confined)
Section 158.145 Wildlife and Aquatic Organisms
72-4 Aquatic Invertebrate Life Cycle
Section 158.125 Residue Chemistry
171-4 Magnitude of the Residue in Plants
Processing Studies
Residue Analytical Methodology
Plant Metabolism Data
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11. While data gaps are being filled, currently
registered'products containing cryolite may be sold,
distributed, formulated, and used, subject to the terms and
conditions specified in this Standard. However, significant
new food uses will not be registered. Registrants must
provide or agree to develop additional data, as specified in
the Data Appendices, in order to maintain existing
registrations.
Rationale; Even when authorized under FIFRA
sections 3(c)(2)(B) and 3(c)(7) the Agency may elect not to
cancel or withhold registration even though data are missing
or are inadequate. Issuance of this Standard provides a
mechanism for identifying data needs. These data will be
reviewed and evaluated, after which the Agency will determine
if additional regulatory actions are necessary. The Agency
has elected not to consider registration of any significant
new food uses while data gaps are being filled and data
evaluated.
V. REQUIRED LABELING STATEMENTS AND COMPLIANCE DATES
All products must bear appropriate labeling as specified
in 40 CFR 162.10, precautions and warnings listed in thre
Cryolite Use Index (Appendix IV), and below.
Pesticide products containing this pesticide as an
active ingredient may not be released for shipment by the
registrant after June, 1989 unless the product bears amended
labeling that complies with the requirements of FIFRA, as set
out in this Registration Standard.
Pesticide products containing this pesticide as an
active ingredient may not be distributed, sold, offered for
sale, held for sale, shipped, delivered for shipment, or
received (and having been so received) delivered or offered
to be delivered by any person after June, 1990 unless that
product bears amended labeling that complies with the
requirements of this Standard.
A. MANUFACTURING USE PRODUCTS
a. The ingredient statement for MPs must declare the
active ingredient as:
Cryolite: sodium aluminofluoride
b. Labels for MPs must bear the following identifying
phrase directly beneath the product name:
"An insecticide for formulating use only."
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c. In the directions for use, the following statement
must appear:
"Formulators using this product are responsible for
obtaining EPA registration of their formulated product."
d. In the directions for use, the following statement
regarding acceptable use patterns must appear:
"For formulation into end-use insecticide
products intended only for (list acceptable sites)."
NOTE: No use may be included on the label where
the registrant fails to agree to comply with the data
requirements for that use pattern.
e. If detailed instructions for formulating are not
provided on the label, the following statement must appear:
"Refer to attached Technical Bulletin for
formulating and other information."
NOTE: The technical bulletin must be submitted
with the product label for Agency review.
f. The following statements are required to appear
under the "Environmental Hazards" heading:
"Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or public
waters unless this product is specifically identified and
addressed in a National Pollutant Discharge Elimination
System (NPDES) permit. Do not discharge effluent containing
this product to sewer systems without previously notifying
the sewage treatment plant authority. For guidance, contact
your State Water Board or the Regional Office of EPA."
B. END USE PRODUCTS
a. The ingredient statement for EPs must declare the
active ingredient as:
Cryolite: sodium aluminofluoride
1. All products allowing for outdoor use must bear
the following environmental hazards statement:
"Do not apply directly to water or wetlands
(i.e.swamps, bogs, marshes, and potholes). Do not
contaminate water when disposing of equipment washwater."
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VI. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain
requirements for data submission or changes in composition,
labeling or packaging of the product. The applicable
requirements depend on whether the product is a manufacturing
or end use product and whether the pesticide is the sole
active ingredient or one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing-use products containing this
pesticide as the sole active ingredient are subject to:
1. The restrictions (if any) upon use,
composition, or packaging listed in Section IV, if they
pertain to the manufacturing-use product.
2. The data requirements listed in Tables A
and B6.
3. The labeling requirements specified for
manufacturing-use products in Section IV.
4. Administrative requirements (application
forms, Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
B. Manufacturing-use products containing this
6Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to
all products containing the pesticide subject to this
Registration Standard. Table B lists product-specific data
applicable to manufacturing use products. The data in Tables
A and B need not be submitted by a producer who is eligible
for the formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end
use products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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pesticide as one of multiple active ingredients are subject
to:
1. The restrictions (if any) upon use,
composition, or packaging listed in Section IV, if they
pertain to the manufacturing-use product.
2. The labeling requirements specified for
manufacturing-use products in Section IV.
3. The data requirements listed in Table A.
C. End-use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use,
composition, or packaging listed in Section IV if they
pertain to the end-use product.
2. If eligible for the formulator's exemption7,
the data requirements listed in Table C (if included).
3. If not eligible for the formulator's
exemption, the data requirements listed in Table A and the
data requirements listed in Table C ( if included).
4. The labeling requirements specified for end-
use products in Section IV-
D. End-use products containing this pesticide as one
of multiple active ingredients are subject to:
7If you purchase from another producer and use as the
source of your active ingredient only EPA-registered
products, you are eligible for the formulator's exemption for
generic data concerning that active ingredient (Table A) and
product-specific data for the registered manufacturing use
product you purchase (Table B)
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption and
become subject to the data requirements in Table A.
2) If no producer subject to the generic data
requirements in Table A agrees to submit the required data,
all end use producers lose the exemption, and become subject
to those data requirements.
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1. The restrictions (if any) upon use,
composition, or packaging listed in Section IV if they
pertain to the end-use product.
2. If not eligible for the formulator's
exemption, the data requirements listed in Table A and Table
C (if included).
3. If eligible for the formulator's exemption,
the data requirements listed in Table C (if included).
4. The labeling requirements specified for end-
use products in Section IV.
VII. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the
registration of products containing this active ingredient8.
A. What are generic data?
Generic data pertain to the properties or effects
of a particular active ingredient. Such data are relevant to
an evaluation of all products containing that active
ingredient regardless of whether the product contains other
ingredients (unless the product bears labeling that would
make the data requirement inapplicable).
Generic data may also be data on a "typical
formulation" of a product. "Typical formulation" testing is
often required for ecological effects studies and applies to
all products having that formulation type. These are classed
as generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for
submitting generic data in response to a data request under
8 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
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FIFRA sec. 3(c)(2)(B) (DCI Notice). EPA has decided,
however, not to require a registrant who qualifies for the
formulator's exemption (FIFRA sec. 3(c)(2)(D) and 40 CFR sec.
152.85) to submit generic data in response to a DCI notice if
the registrant who supplies the active ingredient in his
product is complying with the data request.
If you are granted a generic data exemption, you
rely on the efforts of other persons to provide the Agency
with the required data. If the registrants who have
committed to generate and submit the required data fail to
take appropriate steps to meet the requirements or are no
longer in compliance with this data requirements notice, the
Agency will consider that both they and you are not in
compliance and will normally initiate proceedings to suspend
the registrations of both your product(s) and their
product(s) unless you commit to submit and submit the
required data in the specified timeframe. In such cases, the
Agency generally will not grant a time extension for
submitting the data.
If you are not now eligible for a formulator's
exemption, you may qualify for one if you change your source
of supply to a registered source that does not share
ownership in common with your firm. If you choose to change
sources of supply, the Confidential Statement of Formula must
identify the new source(s) and you must submit a Formulator's
Exemption Statement form.
If you apply for a new registration for products
containing this active ingredient after the issuance of this
Registration Standard, you will be required to submit or cite
generic data relevant to the uses of your product if, at the
time the application is submitted, the data have been
submitted to the Agency by current registrants. If the
required data have not yet been submitted, any new
registration will be conditioned upon the new registrant's
submission or citation of the required data not later than
the date upon which current registrants of similar products
are required to provide such data. See FIFRA sec.
3(c)(7)(A). If you thereafter fail to comply with the
condition of that registration to provide data, the
registration may be cancelled (FIFRA sec. 6(e).
C. What generic data must be submitted?
You may determine which generic data you must
submit by consulting Table A. That table lists the generic
data needed to evaluate current uses of all products
containing this active ingredient, the uses for which such
data are required, and the dates by which the data must be
submitted to the Agency.
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D. Hov to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements.
1. You will submit the data yourself.
2. You have entered into an agreement with one or
more registrants to "jointly develop for share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also
provide EPA with documentary evidence that an agreement has
been formed which allows you to rely upon the data to be
submitted. Such evidence may be: (1) your letter offering
to join in an agreement and the other registrant's acceptance
of your offer, (2) a written statement by the parties that an
agreement exists, or (3) a written statement by the person
who will be submitting the data that you may rely upon its
submission. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are
generating or submitting requested data as a task force or
consortium, a representative of the group should request a
Joint Data Submitter Number from the Registration Support and
Emergency Response Branch, Registration Division. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with
whom EPA will correspond concerning the
data ;
c. Identity of the Registration Standard
containing the data requirement;
d. A list of the products affected (from all
members of the consortium); and
e. Identification of the specific data that
the consortium will be generating or
submitting.
The Agency will assign a number to the
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consortium, which should be used on all data submissions by
the consortium.
3. You have attempted to enter into an agreement
to jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the PCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification
of Attempt to Enter into an Agreement with other Registrants
for Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to
the other registrant and proof of the other registrant's
receipt of your offer (such as a certified mail receipt).
Your offer must, at a minimum, contain the following language
or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient]
Registration Standard upon terms to be agreed or
failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit offer to share in the burden of developing the data.
In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by
this Notice in a timely manner. If the other registrant
fails to develop the data or for some other reason would be
subject to suspension, your registration as well as that of
the other registrant will normally be subject to initiation
of suspension proceedings, unless you commit to submit and
submit the required data in the specified timeframe. In such
cases, the Agency generally will not grant a time extension
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for submitting the data.
4. You request a waiver of the data requirement.
If you believe that a data requirement does not (or should
not) apply to your product or its uses, you must provide EPA
with a statement of the reasons why you believe this is so.
Your statement must address the specific composition or use
factors that lead you to believe that a requirement does not
apply. Since the Agency has carefully considered the
composition and uses of pesticide products in determining
that a data requirement applies, EPA does not anticipate that
many waivers will be granted. A request for waiver does not
extend the timeframes for developing required data, and if
your waiver request is denied your registration may be
suspended if you fail to submit the data.
5. You request that EPA amend your registration
by deleting the uses for which the data are needed. You are
not required to submit data for uses which are no longer on
your label.
6. YOU request voluntary cancellation of the
registration of your product(s) for which the data are
needed.
E. Testing Protocols. Standards for Conducting
Acceptable Tests. Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be
conducted in accordance with test standards outlined in the
Pesticide Assessment Guidelines, unless other protocol or
standards are approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are
referenced in the Data Tables, are available from the
National Technical Information Service (NTIS), Attn: Order
Desk, 5385 Port Royal Road, Springfield, VA 22161 (tel: 703-
487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
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with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing
protocol.
If you will generate the required data and plan to
use test procedures which deviate from EPA's Pesticide
Assessment Guidelines or the Reports of Expert Groups to the
Chemicals Group, Organization for Economic Cooperation and
Development (OECD) Chemicals Testing Programme, you must
submit for EPA approval the protocols you propose to use.
You should submit your protocols before beginning
testing, because the Agency will not ordinarily accept as
sufficient studies using unapproved protocols. A request for
protocol approval will not extend the timeframe for
submission of the data, nor will extensions generally be
given to conduct studies due to submittal of inappropriate
protocols.
G. Procedures for recruestinq extensions of time.
If you think that you will need more time to
generate the data then is allowed by EPA's schedule, you may
submit a request for an extension of time. Any request for a
time extension which is made as an initial response to a
section 3(c)(2)(B) request notice must be submitted in
writing to the Product Manager listed at the end of this
section and must be made by the 90-day deadline for response.
Once dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension
before the data submission response deadline as a waiver of
any future claim that there was insufficient time to submit
the data. While EPA considers your request, you must strive
to meet the deadline for submitting the data.
The extension request should state the reasons why
you believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the
timeframe for submission of the data. If EPA denies your
request for a time extension and you do not submit the data
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as requested, EPA may begin proceedings to suspend the
registrations of your products.
H. PR Notice 86-5 and Anv Other Requirements
Referenced or Included Within this Notice.
All data submitted in response to this Notice must
comply with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR Notice 86-5
(issued July 29, 1986).
I. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances. If
you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The
following information must be included in any request for an
existing stocks provision:
1. Explanation of why an existing stocks
provision is necessary, including a statement of the quantity
of existing stocks and your estimate of the time required for
their sale or distribution; and
2. Demonstration that such a provision would
be consistent with the provisions of FIFRA.
VIII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your
registrations in effect. Product-specific data are derived
from testing using a specific formulated product, and, unlike
generic data, generally support only the registration of that
product. All such data must be submitted by the dates
specified in this Registration Standard.
If you have a manufacturing-use product, these data are
listed in Table B. If you have an end-use product, the data
are listed in Table C. As noted earlier, the Agency has
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decided that it will not routinely require product-specific
data for end-use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for
generic data. See Section VI.D, E, F, and G. You should
note, however, that product chemistry data are required for
every product, and the only acceptable responses are options
VI.D.I. (submit data) or VI.D.6. (cancellation of
registration).
Failure to comply with the product-specific data
requirements for your products will result in suspension of
the product's registration.
IX. REQUIREMENT FOR SUBMISSION OF REVISED LABELS
FIFRA requires each product to be labeled with
accurate, complete and sufficient instructions and
precautions, reflecting the Agency's assessment of the data
supporting the product and its uses. General labeling
requirements are set out in 40 CFR 162.10 (see Appendix II -
LABELING and SUMMARY). In addition, labeling requirements
specific to products containing this pesticide are specified
in Section V this Registration Standard. Applications
submitted in response to this notice must include draft
labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific
instructions in Section V, EPA may seek to cancel or suspend
the registration of your product under FIFRA sec. 6.
X. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing-Use Products fMUPs) containing the
subiect pesticide as sole active ingredient.
1. Within 90 days from receipt of this document,
you must submit to the Product Manager in the Registration
Division for each product subject to this Registration
Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1), with appropriate
-------
32
attachments.8
b. Confidential Statement of Formula (EPA
Form 8570-4).
c. Formulator's Exemption Statement (EPA
Form 8570-27), if applicable.
d. Evidence of compliance with data
compensation requirements of FIFRA sec.
3(C)(1)(D). Refer to 40 CFR 152.80 - 152.99.
2. Within 9 months from receipt of this document
you must submit to the Product Manager:
a. Application for Pesticide Registration
/Amendment (EPA Form 8570-1).
b. Two copies of any required product-
specific data (see Table B).
c. Product Specific Data Report
(EPA Form 8580-4).
d. Three copies of draft labeling, as
specified in Section V. including the
container label and any associated
supplemental labeling. 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 files.
The draft label must indicate the intended
colors of the final label, clear indication of
the front panel of the label, and the
intended type sizes of the text.
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
8 If on the Summary Sheet, you commit to develop the
data, present arguments that a data requirement is not
applicable or should be waived, or submit protocols or
modified protocols for Agency review, you must 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 submission
is in addition to responding to the Product Manager, and
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 to the Office of Compliance Monitoring
-------
33
for any reason any test is delayed or aborted so that the
schedule cannot be met, immediately notify the Product
Manager and the Office of Compliance Monitoring of the
problem, the reasons for the problem, and your proposed
course of action.
B. Manufacturing-Use products containing the subject
pesticide in combination with other active
ingredients.
1. Within 90 days from receipt of this document,
you must submit to the Product Manager in the
Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with
appropriate attachments (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA
Form 8570-4).
c. Formulator's Exemption Statement (EPA
Form 8570-27), if applicable.
2. Within 9 months from receipt of this document
you must submit to the Product Manger:
a. Application for Pesticide
Registration/Amendment (EPA Form 8570-1).
b. Three copies of draft labeling, as
specified in Section V, including the
container label and any associated
supplemental labeling. 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 files. The draft
label must indicate the intended colors of
the final label, clear indication of the
front panel of the label, and the intended
type sizes of the text.
3. Within the time frames 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 schedule
cannot be met, immediately notify the Product Manager and the
Office of Compliance Monitoring of the problem, the reasons
for the problem, and your proposed course of action.
C. End-Use Products containing the subject pesticide
as sole active ingredient.
-------
34
1. Within 90 days from receipt of this document,
you must submit to the Product Manager in the Registration
Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet,
with appropriate attachments (EPA Form 8580-
1).
b. Confidential Statement of Formula (EPA
Form 8570-4).
c. Formulator's Exemption Statement (EPA
Form 8570-27), if applicable.
2. Within 9 months from receipt of this document
you must submit to the Product Manager:
a. Two copies of any product-specific data,
if required by Table C (if included).
b. Product Specific Data Report (EPA Form
8580-4 if Table C lists required product-
specific data.
c. Three copies of draft labeling, as
specified in Section V, including the
container label and any associated
supplemental labeling. 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 files.
The draft label must indicate the intended
colors of the final label, clear indication of
the front panel of the label, and the intended
type sizes of the text.
3. Within the time frames 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
schedule cannot be met, immediately notify the Product
Manager and the Office of Compliance Monitoring of the
problem, the reasons for the problem, and your proposed
course of action.
D. End-Use Products containing the subject pesticide
in combination with other active ingredients.
1. Within 90 davs from receipt of this document,
you must submit to the Product Manager in the Registration
Division:
-------
35
a. FIFRA Section 3(c)(2()B) Summary Sheet,
with appropriate attachment (EPA Form 8580-1),
b. Confidential Statement of Formula (EPA
Form 8570-4).
c. Formulator's Exemption Statement (EPA
Form 8570-27), if applicable.
2. Within 9 months from receipt of this document
you must submit to the Product Manager:
a. Two copies of any product-specific data,
if required by Table C (if included).
b. Product Specific Data Report (EPA Form
8580-4), if Table C lists required product-
specific data.
c. Three copies of draft labeling, as
specified in Section V, including the
container label and any associated
supplemental labeling. 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 files.
The draft label must indicate the
intended colors of the final label, clear
indication of the front panel of the
label, and the intended type sizes of
the text.
3. Within the time frames 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
schedule cannot be met, immediately notify the Product
Manager and the Office of Compliance Monitoring of the
problem, the reasons for the problem, and your proposed
course of action.
E. Addresses
The required information must be submitted to the
following address:
William H. Miller
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
-------
36
Washington, D.C. 20460.
The address for submissions to the Office of
Compliance Monitoring iss
Laboratory Data Integrity Assurance Division
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
-------
37
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that
apply to the pesticide in all products, including
data requirements for which a "typical formulation"
is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment
Guidelines, which are available from the National Technical
Information Service, 5285 Prot Royal Road, Springfield, VA
22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used.for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The
following letter designations are used for the given use
patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
-------
38
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor . . . . .. ^
N/A= There are no registered use patterns for which the
data requirement applies.
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates
one of three answers:
YES - EPA has data in its files that completely
satisfy this data requirement. These data may be
cited by other registrants in accordance with data
compensation requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but
such data do not fully satisfy the data
requirement. In some cases, the Agency may possess
data on one of two required species or may possess
data on one test substance but not all. The term
may also indicate that the data available to EPA
are incomplete. In this case, when the data are .
clarified, or additional details of the testing
submitted by the original data submitter, the data
may be determined to be acceptable. If this is the
case, a footnote to the table will usually say so.
NO - EPA either possesses no data which are
sufficient to fulfill the data requirement, or the
data which EPA does possess are flawed
scientifically in a manner that cannot be remedied
by clarification or additional information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the
identifying number of each study. This normally is the
Master Record Identification (MRID) number, but may be a GS
number if no MRID number has been assigned. Refer to the
Bibliography Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6) . This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column e
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not
require its submission because of the unique characteristics
of the chemical; because data on another chemical can be used
-------
39
to fulfill the data requirement; or because the data
requirement has been waived or reserved. Any such unusual
situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column t
requires that data be submitted, this column indicates when
the data are to be submitted, based on the issuance date of
the Registration Standard. The timeframes are those
established either as a result of a previous Data Call-in
letter, or standardized timeframes established by PR Notice
85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory,
-------
Table A
Generic Data Requirements for Cryolite
Data Reouirement
Composition
Does EPA
Have Data to
Satisfy This
Reouirement^
Bibl iographic
Citation
Must Additional
Data Be Submitted
Wider FIFRA Section
3(c)(2)(B)7
Timeframe
For Data
Submission^-/
§158.120 Product Chemistry
Product Identity and Composition
61-2 - Description of Beginning
Materials and Manufacturing
Process
61-3 - Discussion of Formation of
Impurities
Ingredients
:ion of Product
62-1 - Preliminary Analysis of
Product Samples
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
TGAI
TGAI
TGAI
TGAI
TGAI
Partially
Partially
Partially
Partially
Partially
00152192,40193801 Yes3/
00152192,40193801
00152192,00162905,
40193802
00152192,40193803
00152192,40193803
9 months
9 months
Yes^/
12 months
9 months
9 months
40
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Data Requirement
Composition
S158.120 Product Chemistry
Physical and Chemical Characteris
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
Does EPA
Have Data to
Satisfy This
Reouirementi^
Lcs (cont'd)
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
Partially
Partially
No
Partially
Partially
No
No
Must Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3fcH21(Bl? Submission2-/
00152192,40193803
40193803
N/A
00152192,40193803
00152192,40193803
Yes6^
Yes6-/
No
9 months
9 months
9 months
9 months
9 months
41
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Compositj
158.120 Product Chemistry
Physical and Chemical Characteristics can't
63-11 - Octanol/Water Partitioning PAI
Coefficient
63-12 - pH TGAI
63-13 - Stability TGAI
Other Requirements;
64-1 - Submittal of Samples N/A
Does EPA
Have Data to
Satisfy This
No
Partially
Partially
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3fcU2HB>? Submission2-/
NoW
00152192,40193803
40193803
Yes6-/!!/
9 months
9 months
I/ Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted for each pesticide. New requirements have been introduced and previously submitted data must
be updated. Therefore, bibliographic citations for the old data are not applicable. However, data submitted in
response to requests made in the 1983 Registration Standard, dated June 1983, have been evaluated with regard to
their adequacy in meeting the requirements of 40 CFR 158.120.
2/ Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
42
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.120 Product Chemistry
Footnotes (cont'dl
3/ Complete information must be provided for the Pennwalt 96% technical product from
synthetic and natural sources regarding the nature of the process (batch or continuous), the relative amounts of
beginning materials and the order in which they are added, the chemical equations for each intended reaction,
equipment used to produce each intermediate and the final product, reaction conditions, the duration of each step
of the process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, producer, or supplier of each beginning material used in the manufacture of each product must be
provided, along with information regarding the properties of those materials. These requirement have been met for
the Gowan technical product from the synthetic source. However, for the natural source, quality control
procedures must be submitted.
4/ A detailed discussion of all impurities in the Gowan 98% synthetic technical product that are or may be present at
> 0.1% (w/w), based on knowledge of the beginning materials. A detailed discussion of all impurities that are or
may be present at 0.1%, based on knowledge of the beginning materials, chemical reactions (intended and side) in
the manufacturing process, and any contamination during and after production must be submitted for the Pennwalt
96% technical from natural and synthetic sources. These requirements have been satisfied for the Gowan natural
product.
5/ Five or more representative batches of the Gowan and Pennwalt technical products from natural and synthetic
sources must be analyzed for the amount of active ingredient and each Impurity for which certified limits are
required. Complete validation data (accuracy and precision) must be submitted for each analytical method used.
6/ Physicochemical characteristics (color, physical state, odor, melting point, bulk density/density, solubility,
dissociation constant, pH, and stability) as required in 40 CFR 158.120 and more fully described in the Pesticide
Assessment Guidelines, Subdivision D, must be submitted.
7/ This requirement has been satisfied for the Gowan synthetic and natural products.
8/ Data are not required because the technical product is not a liquid at room temperature.
9/ For EPA Registration No. 10163-41, an explanation roust be provided for the significantly different reported water
solubilities of the natural and synthetic sources (23,000 mg/L natural versus 428 mg/L - synthetic).
lO/ Data are not required because the technical product is not organic and nonpolar.
ll/ Data required if the test substance is dispersible in water.
43
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Table A
Generic Data Requirements for Cryolite
Test
Data Requirement Substance
§158.125 Residue Chemistry
171-3 - Directions for Use
171-4 - Nature of the Residue PAIRA
(Metabolism)
- Plants
171-4 - Nature of the Residue PAIRA
(Metabolism)
- Livestock
171-4 - Residue Analytical Methods TGAI
171-4 - Storage Stability TEP or PAI,
Does EPA
Have Data to
Satisfy This
Requirement
No
No .
Partially
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3fcH2HBl?
Yes2*3/
YesV
Reserved5-/
00158001 yes6'7'8/
No§/
Timeframe
For Data
18 months
18 months
15 months
+ Metabolites
171-4 - Magnitude of the
Residue in Plants
- Root and Tuber
Vegetables
- Beets, Garden
- Carrots
- Radishes
TEP
TEP
TEP
No
No
No
YeslQ/
YesU/
YesW
18 months
18 months
18 months
44
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Does EPA Must Additional
Have Data to Data Be Submitted Timef rame
Test Satisfy This Bibliographic Under FIFRA Section For Data
Data Requirement Substance Requirement Citation 3(c)(2)(B)7 Submissionl/
§158.125 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants (cont'd)
- Rutabagas
- Turnips
- Leaves of Root and Tuber
Vegetables
- Beet Greens
- Turnip Tops
- Leafy Vegetables
- Lettuce
- Brassica Leafy Vegetables
- Broccoli
- Brussels sprouts
- Cabbage
- Cauliflower
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
No Yesl2/
No Yesl4/
No Yesi^/
No YesW
Partially 00102979, Yesl2/
00158001
Partially 00158001 Yesi8-/
Partially 00158001 Yesi§/
Partially 00158001 Yes22/
Partially 00158001 Yes^V
45
18 months
18 months
18 months
18 months
18 months
18 months
18 months
18 months
18 months
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Test
Data Requirement Substance
§158.125 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants (cont'd)
- Collards TEP
- Kale TEP
- Kohlrabi TEP
- Mustard Greens TEP
- Legume Vegetables
- Beans TEP
- Peas TEP
- Fruiting Vegetables
- Eggplant TEP
- Peppers TEP
- Tomatoes TEP
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Satisfy This Bibliographic Under FIFRA Section For Data
Requirement Citation 3fcW2HB)? Submissionl/
Partially 00158001 Yes2^/
No Yes23/
No Yes^V
No Yes25/
Partially Yec26 • 27 • 28/
No Yes2-^/
No Yes2S/
Partially 00158001 YesH/
Partially 00158001 Yes^2/
Yes33/
18 months
18 months
18 months
18 months
18 months
18 months
18 months
18 months
18 months
24 months
46
-------
Table A
Generic Data Requirements
for Cryolite (cont'd)
Data
§158.
171-4
Test
Requirement Substance
125 Residue Chemistry
- Magnitude of the
Residue in Plants (cont'd)
, - Cucurbit Vegetables
- Cucumbers TEP
- Melons TEP
- Pumpkins TEP
- Squash TEP
- Citrus Fruits
- Pome Fruits
- Apples TEP
- Pear TEP
- Quince TEP
Does EPA
Have Data to
Satisfy This
Requirement
Partially
Partially
Partially
Partially
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3fcU2HB)?
00158001 YeslV
00158001 Yes^5-/
00158001 Yes26/
00158001 Yes3I/
YesW
Yesll/
Yes42/
Yes43/
Timeframe
For Data
Submissionl/
18 months
18 months
18 months
18 months
18 months
24 months
18 months
24 months
18 months
18 months
Stone Fruits
- Apricots
TEP
No
18 months
47
-------
Table A
Generic Data Requirements
for Cryolite (cont'd)
Test
Data Requirement Substance
§158.125 Residue Chemistry
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Satisfy This Bibliographic Under FIFRA Section For Data
Reouirement Citation 3fcH2HB)? Submissionl/
171-4 - Magnitude of the
Residue in Plants (cont'd)
- Peaches
- Plums (fresh prunes)
- Small Fruits and Berries
- Caneberries
- Blueberries
- Cranberries
- Grapes
- Strawberries
TEP
TEP
TEP
TEP
TEP
TEP
TEP
45/
No Yes
46/
No Yes
No Yes42/
No Yes42/
No Yes42/
Partially 00130741, Yes5-^/
00149815, Yes5-!/
00158001
Partially 00158001 Yes52/
18 months
18 months
18 months
18 months
18 months
18 months
24 months
18 months
Cereal Grains
- Corn TEP
Miscellaneous Commodities
- Okra TEP
- Peanuts TEP
No
No
No
Yes53/
Yes54/
18 months
18 months
18 months
48
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Test
Substance
§158.125 Residue Chemistry
171-4 - Magnitude of the
Residue in Plants (oont'd)
- Miscellaneous Commodities
- Potatoes TEP
Does EPA
Have Data to
Satisfy This
Bibliographic
Citation
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission]
171-4 - Magnitude of Residue in
Meat/MilVPoultry/Eggs
TGAI or Plant
Metabolites
Partially
Partially
00158001
00158001
18 months
18 months
49
-------
Sec. 158.125 Residue Chemistry
Footnotes:
Table A
Generic Data Requirements for Cryolite (cont'd)
I/ Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/ An application for registration and appropriate supporting residue data must be submitted in support of the
established tolerances for the combined residues of cryolite and synthetic cryolite in or on apricots,
blackberries, blueberries, boysenberries, corn, dewberries, loganberries, peanuts, peas, plums (fresh prunes),
quinces, raspberries, rutabagas, and youngberries. Alternatively, the tolerances for residues in or on these
commodities will be revoked.
j/ All pertinent labels must be revised to include a maximum number of applications per season, a repeat-application
interval, and a EHI. Concentrations in gal/A must be specified for all spray applications. In addition, the
conditions under which aerial applications are permitted must be specified for all uses. The residue data used to
support each established tolerance must reflect these specifications.
4/ In the required residue field trials on the following representative crops, cryolite per se and total fluoride
residues must be determined and reported separately: apples, beans (dried and succulent), broccoli, cabbage,
citrus fruits, cranberries, cucumbers, grapes, lettuce, melons, mustard greens, peaches, peppers, radishes,
strawberries, tomatoes, turnips, and turnip greens.
5/ No data have been submitted pertaining to the metabolism of cryolite in ruminants or poultry- The need for such
data will not determined until the study requested by the Toxicology Branch on the metabolism of cryolite by rats
has been evaluated.
fi/ Data validating the ammonium hydroxide/fluoride-specific electrode method for measuring cryolite residues in or on
samples of raw agricultural and processed plant conmodities. This requirement may be partially satisfied by
supplying additional information regarding tests already conducted, specifically the levels at which samples wer«
fortified with cryolite and recovery in ppm. In addition, validation of the method at several levels between 0.!
and 5 ppm is needed. The registrant must also define what acid strength is used to adjust the pH and provide a
more detailed description of the filtration steps.
I/ A specific confirmatory method needs to be developed to ascertain whether fluoride residues at or above the
tolerance of 7 ppm are due to the presence of cryolite.
S/ Data validating the microdiffusion/fluoride-specific electrode method for collecting cryolite residue data on
milk, eggs, and animal tissues. Samples in recovery tests must be fortified with cryolite at levels of 0.2 to £
ppm, as well as 5 to 50 ppm.
S/ Data are not required since cryolite is a naturally occurring mineral and is not expected to degrade during
storage.
107 Data are required depicting the combined fluorine residues of cryolite in or on beets harvested on the day of th<
last of multiple foliar applications of a D formulation at 44.55 Ib ai/A. The registrant must propose a maximum
seasonal use rate, or a maximum number of applications per season. Tests must be conducted in NY, WI, OR, and OX.
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.125 Residue Qiemistrv fcont'dl
ll/ The data required for beets will be translated to carrots. All label amendments required for beets must be
implemented for carrots also.
12/ Data are required depicting the combined fluorine residues of cryolite in or on radishes harvested after the last
of multiple foliar applications, applied through the seedling stage only, of a WP/D formulation applied as a spray
and as dust at 46.5 Ib ai/A using ground and aerial equipment in separate tests. The registrant must propose a
maximum number of applications per season or a maximum seasonal use rate. The registrant must propose a PHI based
on the minimum interval expected between the end of the seedling stage and harvest. Tests must be conducted in FL
and ME.
13/ Currently, there is no registered use for cryolite on rutabagas. Unless the registrant submits and application
for registration (supported by residue data), the tolerance will be revoked. Depending on the use pattern
proposed, it may be possible to translate data from another root crop to assess the tolerance for residues in or
on rutabagas.
14/ Data are required depicting the combined fluorine residues of cryolite in or on turnips harvested after the last
of multiple foliar applications, through the seedling stage only, of a WP/D formulation applied as a dust and as a
spray at 48 Ib ai/A. The registrant must propose a maximum seasonal use rate or a maximum number of applications
per season. In addition, the registrant must propose a PHI based on the minimum interval expected between the end
of the seedling stage and harvest. Tests must be conducted in CA, GA, PA, WA, and TX.
15/ Data are required depicting the combined fluorine residues of cryolite in °r on beet tops harvested on the day of
the last of multiple foliar applications of a D formulation at 44.55 Ib ai/A. The registrant must propose a
maximum seasonal use rate or a maximum number of applications per season. Tests must be conducted in NY, WI, OR,
and TX. The current PHI for beet tops permitting application only through the seedling stage is impractical and
should be deleted from all labels since there is no PHI for beet roots.
16/ Data are requireddepicting the combined fluorine residues of cryolite in or on turnip tops harvested after the
last of multiple foliar applications, through the seedling stage only, of a WP/D formulation, applied as a dust
and as a spray at 48 Ib ai/A, using aerial and ground equipment in separate tests. The registrant must propose a
maximum seasonal use rate or a maximum number of applications per season. A PHI must be proposed based on the
minimum interval expected between the end of the seedling stage and the earliest harvest of turnip tops. Tests
must be conducted in CA, GA, PA, WA, and TX.
IT/ Data must be submitted depicting the combined fluorine residues of cryolite in or on head and leaf lettuce (with
and without wrapper leaves) harvested after the last of multiple foliar applications, applied through the seedling
stage of a WP/D formulation applied as a dust and a spray, in separate tests, at 50 Ib ai/A. Applications must be
made with aerial and ground equipment in separate tests. The registrant must propose a maximum seasonal use rate
or a maximum number of applications per season. In addition, registrants must amend all pertinent labels to
specify a PHI based on the minimum interval expected between the end of the seedling stage and harvest. Tests
must be conducted in CA.
51
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.125 Residue Chemistry fcont'd)
18/ Data must be submitted depicting the combined fluorine residues of cryolite in or on broccoli harvested after the
last of multiple foliar applications, applied prior to the formation of edible portions, of a WP/D formulation
applied as a dust and a spray, in separate tests, at 50 Ib ai/A. Applications must be made with aerial and ground
equipment in separate tests. The registrant must propose a maximum seasonal use rate or a maximum number of
applications per season. The required tests must reflect this maximum number.
In addition, registrants must amend all pertinent labels to specify a PHI based on the minimum interval expected
between formation of the edible portions and harvest. Alternatively, the requirement for spray applications may
be waived if the registrants amend all pertinent labels to limit this use to six applications at 16 Ib
ai/fi/applicatian and to specify a 7-day FHE. Tests must be conducted in CA.
19/ Data required for broccoli will be translated to Brussels sprouts. All label amendments required for broccoli
must be implemented for Brussels sprouts also.
20/ Data are required depicting the combined fluorine residues of cryolite in or on cabbage (with and without wrapper
leaves) harvested after the last of multiple foliar applications of a WP/D formulation applied as a dust and a
spray in separate tests at 50 Ib ai/A, applied before the head formation begins. Applications must be made with
aerial and ground equipment in separate tests. The registrant must propose a maximum seasonal use rate or a
maximum number of applications per season. Required tests must reflect this maximum number. In addition,
registrants must amend all pertinent labels to specify a PHI based on the minimum interval expected between head
formation and harvest. Tests must be conducted in TX, FL, NY, and WI.
21/ Data required for broccoli will be translated to cauliflower. All label amendments required for broccoli must be
implemented for cauliflower also.
22/ Data required for mustard greens will be translated to collards. All label amendments required for mustard greens
must be implemented for kale also.
23/ Data requested for mustard greens will be translated to kale. All label amendments required for mustard greens
must be implemented for kale also.
24/ Data requested for broccoli will be translated to kohlrabi. All label amendments required for broccoli must be
implemented for kohlrabi also.
25/ Data are required depicting the combined fluorine residues of cryolite in or on mustard greens harvested after the
last of multiple foliar applications of a WP/D formulation applied as a dust and a spray in separate tests at 50
Ib ai/A, applied through the seedling stage. Applications must be made with aerial and ground equipment in
separate tests. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. Required tests must reflect this maximum number. In addition, registrants must amend all pertinent
labels to specify a PHI based on the minimum interval expected between the end of the seedling stage and harvest.
Tests must be conducted in CA, FL, and TX.
52
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.125 Residue Chemistry rcont'dl
26/ Data are required depicting the combined fluorine residues of cryolite in or on beans (dried and succulent)
harvested on the day of the last of multiple foliar applications of a WP/D formulation applied as a dust and (in
separate tests) as a spray at 48 Ib ai/A, to be applied with aerial and ground equipment in separate tests. The
registrant must propose a maximum seasonal use rate and maximum number of applications per season. Required tests
must reflect this maximum number. The registrant must propose a tolerance based on the resulting residue data.
Tests must be conducted in (i) CA and OR, or (ii) ID and MI, or (iii) WI, NE, and NY. Separate tolerances for
dried and succulent beans must be proposed.
27/ Data depicting residues in cannery residue prepared from beans bearing measurable weathered residues. If residues
concentrate in this feed item, an appropriate feed additive tolerance must be proposed.
28/ Tolerances must be proposed and supporting residue data submitted for bean vines and hay since they are raw
agricultural commodities of beans. Alternatively, the registrant may propose a label amendment to impose
restrictions on grazing and the feeding of these commodities to livestock. [If data are submitted and tolerances
proposed, no cannery residue data are required.]
29/ There are no registered uses of cryolite on peas. Unless the registrant proposes use directions accompanied by
appropriate supporting residue data, the tolerance will be revoked.
30/ Data requested for tomatoes will be translated to eggplant. All label amendments required for tomatoes must be
implemented for eggplant also.
31/ Data are required depicting residues of cryolite in or on peppers harvested on the day of the last of multiple
foliar applications (using ground and aerial equipment in separate tests) of a WP/D formulation applied as a dust
and as a spray at 48 Ib ai/A, in separate tests. The registrant must propose a maximum number of applications per
season or a maximum seasonal use rate. Required tests must reflect this maximum rate. Tests must be conducted in
CA, FL, MI, NJ, and TX. An appropriate tolerance increase must be proposed.
32/ Data are required depicting residues of cryolite in or on tomatoes harvested on the day of the last of multiple
foliar applications (using ground and aerial equipment in separate tests) of a WP/D formulation applied as a spray
and a dust (in separate tests) at 48 Ib ai/A. The registrant must propose a maximum number of applications per
season or a maximum seasonal use rate. Required tests must reflect this maximum rate. Tests must be conducted in
CA and FL.
33/ Data are required depicting the potential for concentration of residues in dry pomace processed from tomatoes
bearing measurable weathered residues. An appropriate feed additive tolerance covering potential concentration in
both wet and dry pomace must be proposed. Also, when an appropriate tolerance for residues in or on tomatoes is
determined, a food additive tolerance at 2.3X this tolerance must be established for puree, paste, and catsup.
34/ Data are required depicting residues of cryolite in or on cucumbers harvested on the day of the last of multiple
53
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Sec. 158.125 Residue Chemistry fcont'd)
foliar applications (using ground and aerial equipment in separate tests) of a WP/D formulation applied as a dust
and as a spray at 48 Ib ai/A. The registrant must propose a maximum number of applications per season or a
maximum seasonal use rate. The required tests must reflect this maximum rate. Tests must be conducted in CA', MI,
NC, and TX.
35/ Data are required depicting residues of cryolite in or on melons harvested on the day of the last of multiple
foliar applications (using ground and aerial equipment in separate tests) of a WP/D formulation applied as a dust
and as a spray at 48 Ib ai/A. The registrant must propose a maximum number of applications per season or a
maximum seasonal use rate. The required tests must reflect this maximum rate. Tests must be conducted in CA and
TX.
36/ Data requested for melons will be translated to pumpkins. All label amendments required for melons must be
implemented for pumpkins as well.
37/ Data requested for cucumbers and melons will be translated to summer and winter squash, respectively. All label
amendments required for cxicumbers and melons must be implemented for summer and winter squash also.
38/ Data are required depicting the combined fluorine residues of cryolite in or on representative members of the
citrus fruits group, oranges, grapefruits, and lemons, harvested on the day of last of multiple foliar
applications of a WP/D formulation applied as a dust and (in separate tests) as a spray of 78.98 Ib ai/A applied
with ground and aerial equipment in separate tests. The registrant must propose a maximum number of applications
per season for each use. The requested data must reflect the maximum rate. Information regarding tree size and
spacing and the number of gal/A applied must be provided for each test. Tests on grapefruit and oranges must be
conducted in FL. Tests on lemons must be conducted in CA.
39/ Data are required depicting the fluorine residues of cryolite and in or on dried citrus pulp, molasses, oil, and
juice processed from, citrus fruit bearing measurable, weathered residues. If residues concentrate in any of these
processed commodities then an appropriate food/feed additive tolerance must be proposed.
40/ Data are required depicting residues of cryolite in or on apples harvested on the day of the last of multiple
foliar applications (using ground and aerial equipment in separate tests) of a WP/D formulation applied as a spray
and a dust at 48 Ib ai/A. The registrant must propose a maximum number of applications per season or a maximum
seasonal use rate. Required tests must reflect this maximum rate. Information regarding tree size and spacing
and the number of gal/A applied must be provided. The tests must be conducted in MI, NY, and WA.
41/ Data are required depicting combined fluorine residues of cryolite in dry apple pomace and juice processed from
apples bearing measurable, weathered residues. If residues concentrate in either of these processed commodities
then an appropriate food/feed additive tolerance must be proposed.
42/ The data requested for apples may be translated to pears. All label amendments required for apples must be
implemented for pears also.
43/ Currently, cryolite is not registered for use on quinces. The registrant must submit an application for
registration for cryolite on quinces and provide appropriate supporting residue data. Alternatively, the
tolerance for the fluorine residues of cryolite in or on quinces will be revoked.
54
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sc. 158.125 Residue Chemistry (cont'd)
44/ Currently, cryolite is not registered for use on apricots. Unless the registrant sutmits an application for
registration accompanied by appropriate supporting residue data, the tolerance will be revoked.
45/ Data are required depicting residues of cryolite in or on peaches harvested on the day of the last of multiple
foliar applications (using ground and aerial equipment in separate tests) of a WP/D formulation applied as a spra]
and a dust at 48 Ib ai/A. The registrant must propose a maximum number of applications per season or a maximum
seasonal use rate. Information regarding tree size and spacing and the number of gal/A applied must be provided
for each test. Tests must be conducted in CA.
M/ Currently, cryolite is not registered for use on plums. Unless the registrant submits an application for
registration accompanied by appropriate supporting residue data, the tolerance will be revoked.
427 Currently, cryolite is not registered for use on caneberries. Unless the registrant submits an application for
registration accompanied by appropriate supporting residue data, the tolerances for residues of cryolite in or on
blackberries, boysenberries, dewberries, loganberries, raspberries, and youngberries will be revoked.
48/ Currently, cryolite is not registered for use on blueberries. Unless the registrant submits an application for
registration, accompanied by appropriate supporting residue data, the tolerance will be revoked.
49/ Data depicting the combined fluorine residues of cryolite in or on cranberries harvested on the day of the last of
multiple foliar applications of a D and a WP/D formulation at 48 Ib ai/A. Each formulation class must be
represented in separate tests and both dust and spray applications applied using ground and aerial equipment must
be represented. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season. The required tests must reflect this maximum. Tests must be conducted in MA and WI.
5_Q/ The requested test protocols recognize that the registrant may amend pertinent product labels thereby reducing or
eliminating the need for additional residue data. If the registrant wishes to retain the current registrations,
data must be submitted depicting the combined fluorine residues of cryolite in or on grapes harvested after the
last of multiple foliar applications, applied prior.to the formation of the fruit, of a WP/D formulation applied
as a dust and a spray in separate tests at 58.72 and 46.5 Ib ai/A, respectively. Applications must be made with
aerial and ground equipment in separate tests. The registrant must propose a maximum seasonal use rate or a
maximum number of applications per season. The required tests must reflect this maximum number. In addition, the
registrant must amend all pertinent labels to specify a PHI based on the minimum interval expected between fruit
formation and harvest. The tests must be conducted in CA and NY. Alternatively, the requirement for additional
data may be waived if registrants amend all labels to limit this use to two spray applications at 9.6 Ib ai/A or
two dust applications at 15.4 Ib ai/A, and to specify a 30-day PHI.
51/ Food/feed additive tolerances must be proposed for the combined fluoride residues of cryolite and synthetic
cryolite in grape pomace (23X), raisins (10X), and raisin waste (53X). These concentration factors are based on
previously submitted, acceptable residue chemistry data.
55
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.125 Residue Chemistry (cont'd)
52/ Data are required depicting residues of cryolite in or on strawberries harvested on the day of the last of
multiple foliar applications of a WP/D formulation applied as a dust and as a spray at 50 Ib ai/A. Applications
must be made with ground and aerial equipment in separate tests. Each formulation type must be represented in
separate tests. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
season and an appropriate tolerance for residues in or on strawberries. Tests must be conducted in CA.
5_3/ There are not registered uses of cryolite on corn. Unless the registrant submits an application for registration
for the use of cryolite on corn accompanied by appropriate supporting residue data, the established tolerance will
be revoked.
5_4/ Currently, cryolite is not registered on okra. Unless the registrant submits an application for registration
accompanied by appropriate supporting residue data, the established tolerance will be revoked.
55/ Currently, cryolite is not registered for use on peanuts. Unless the registrant submits an application for
registration accompanied by appropriate supporting residue data, the tolerance will be revoked.
5£/ Section 18 emergency exemptions were granted in MA from 1985-1987, in NY from 1984-1987, and in RI from 1984-1987.
Section 18s in a given State for > 3 consecutive years must be considered permanent uses and supported by
tolerance proposals, appropriate residue data, and label amendments. Thus, a proposed section 3 use, residue data
and a processing study in support of such use, and a tolerance are required for potatoes.
5_7_/ Upon receipt of the results of the requested method try-out and the. registered method validation data, and the
residue data requested on feed commodities, the residue data on animal commodities will be evaluated and the need
for additional data and tolerances will be determined.
56
-------
Table A
Generic Data Requirements for Cryolite
Data Requirement
Test
Substance
Sec. 158.130 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies - Lab
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TGAI or PAIRA A,B
TGAI or PAIRA A,B
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A,B
TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA N/A
162-4 - Aerobic Aquatic TGAI or PAIRA N/A
Mobility Studies
163-1 - Leaching and
Adsorption/
Desorption
163-2 - Volatility (Lab)
TGAI or PAIRA A,B
TEP
Does EPA
Have Data to
Satisfy This
Yes
No
No
No
No
No
Yes
No
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3fcH2UBl? Submission^
00142836
00142837
No
NO2/
NO2/
No2/
No2/
No2/
No
No2/
57
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3fcU2UBl? Submissionl^
Sec. 158.130 Envii
163-3 - Volatility (Field)
Dissipation Studies - Field
164-1 - Soil
164-2 - 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
fcont'd)
TEP
TEP
TEP
TEP
TEP
A,B
N/A
N/A
N/A
165-5 - In Aquatic Nontarget
Organisms
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
A
A
A
N/A
A,B
N/A
No
No
NO
No
No
No
No2/
NO?/
Yes3/
Reserved^/
39 Wealths
58
-------
Sec. 158.130 Environmental Fate
Footnotes
Table A
Generic Data Requirements for Cryolite (cont'd)
I/ Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/ No data reviewed; however, no data are required because the chemical and physical properties of cryolite are such
that information derived from conducted studies would not be expected to yield information useful to a regulatory
decision.
3/ Although a confined rotational crop study was not required in the 1983 Cryolite Registration Standard, this study
is now required since data recently reviewed by the Agency show detectable levels of fluorine in primary crops and
hence there is a possibility of fluorine residues occurring in rotational crops. It is recommended that the
registrant submit protocols before conducting the study. A progress report is due 12 months from the issuance of
this Standard and semiannually thereafter.
4/ This requirement is reserved pending the results of the confined rotational crop study.
59
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3 re) (2) (B) ? Submission
Sec. 158.140 Reentry Protection
132-1 - Foliar Dissipation TEP
132-2 - Soil Dissipation TEP
132-3 - Dermal Exposure TEP
132-4 - Inhalation Exposure TEP
Sec. 158.142 Spray Drift
201-1 - Droplet Size Spectrum N/A
201-1 - Drift Field Evaluation N/A
A,B
A,B
A,B
A,B
No
No
No
No
NoV
No!/
No!/
NO!/
I/ Cryolite does not meet the criteria of 40 CFR 158.140 for requiring reentry data (i.e., cryolite has a low
mammalian toxicity and there is no epidemiological evidence of adverse effects to humans).
60
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Data
Sec.
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Requirement
158.135 Toxicology
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation
- Dermal Irritation
- Dermal Sensitization
- Acute Delayed
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use
Patterns
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Does EPA
Have Data to
Satisfy This
Yes
Yes
Yes
Yes
Yes
Yes
No
Bibliographic
Citation
00138096
00128107
00128108
00128106
00128106
00138097
Must Additional
Data Be Submitted
Under FIFRA Section
No
No
No
No
No
No
No2/
Timeframe
for
Submission^
Neurotoxicity
Sunchronic Testing
82-1 - 90-Day Feeding -
(Rodent and Non-Rodent)
82-2 - 21-Day Dermal
TGAI
TGAI
A,B
A,B
Partially
No
0157999 Reserved^/
9 Months
61
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Sec. 158.135 Toxicology
Subchronic Testing (cont'd)
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
Chronic Testing
83-1 - Chronic Testing
- Rodent
- Nonrodent
83-2 - Oncogenicity
- Rat
- Mouse
83-3 - Teratogenicity
- Rat
- Rabbit
TGAI
TGAI
TGAI
N/A
N/A
A,B
No
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
A,B
A,B
A,B
No
No
No
No
Yes
No
62
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FTFRA Section for
Citation 3fcH2HB)? Submission^
Yes5/
Yes5-/
50 Months
50 Months
50 Months
50 Months
00131352
No
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Data
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under EEFRA Section for
Citation 3teW2WBl? Submission^
Sec. 158.135 Toxicology
Chronic Testing (cont'd)
83-4 - Reproduction TGAI A,B
Mutagenicity Testing
84-2 - Gene Mutation TGAI A,B
84-2 - Chromosome Aberration TGAI AfB
84-2 - Other Mechanisms of TGAI A,B
Mutagenicity
Special Testing
85-1 - General Metabolism PAI or PAIRA A,B
No
Yes
Yes
Yes
YesV
39 Months
00128113
00128114
00128115
NO
No
No
NO
Yes7/ 24 Months
(Protocol - 90 Days)
I/ Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/ This test is required only for compounds which are organophosphate inhibitors of cholinesterase, or related to such
inhibitors or metabolites of such inhibitors. Cryolite is not an organophosphate, and therefore, a study is not
required.
3/ At present, cryolite rat and dog subchronic feeding study data gaps exist due to lack of a NOEL upon which an RfD
would normally be established. The presence of fluoride accumulation in the bone, originating from fluoride
disassociation from cryolite, precluded the establishment of an NOEL for cryolite for fluoride accumulation in
animal bones. New subchronic studies are not-being required at this time. However, the registrant is required to
perform a new metabolism (pharmacodynamic) study to accurately quantitate the amount of fluoride which would be
bioavailable from cryolite. The Agency expects that this study will provide the information necessary to establish
a reference dose for cryolite, when expressed in terms of fluoride, that will not exceed the RfD already
established by the Agency RfD Work Group.
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.135 Toxicology
Footnotes (cont'd)
4/ A 21-day dermal toxicity study was not required in the Cryolite Standard issued in 1983; this study is now
required. The EPA Final Guidelines (October 1984) require this study for pesticides which can be expected to
result in human exposure or skin contact. Cryolite meets this criteria.
5/ A progress report is due twelve months from receipt of the Standard. Annual reports are due thereafter.
6/ This study is not required considering the lack of toxicity demonstrated by the compound in the rat teratology
study and minimal toxicity observed in other species.
7/ Although a metabolism study was not required in the Cryolite Standard issued in 1983, the Agency is requiring a rat
metabolism (pharmacodynamic) study due to findings of fluorine accumulation in the bone in the subchronic studies
submitted by the registrant. An acceptable protocol is required three months from receipt of the Standard. A
progress report is due 12 months from receipt of this Standard.
64
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3 (c) (2) (B) ? Submission^
Sec. 158.145 Wildlife and Aquatic Organisms
Avian and Mammalian Testing
71-1 - Acute Avian Oral TGAI A,B
Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
- Upland Game Bird TGAI A,B
and Waterfowl
71-5 - Simulated and Actual TGAI A,B
Field Testing For
Mammals and Birds
Yes
No
No
00125375
No
TGAI
TGAI
TGAI
A,B
A,B
N/A
Yes
Yes
00084001
00084002
No
No
No?/
65
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Data
Sec.
Does EPA
Have Data to
Test Use Satisfy This
Reouirement Substance Patterns Requirement?
158.145 Wildlife and Aouatic Oroanisms (cont'd)
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3fcH2WB)? Submission^
Aquatic Organisms Testing
72-1
72-2
72-3
- Freshwater Fish
Toxicity
- Warmwater TGAI A,B Yes
TEP A,B Yes
- Coldwater TGAI A,B Yes
TEP A,B Yes
- Acute Toxicity to Fresh- TGAI A,B Yes
water Invertebrates
TEP A,B No
- Acute Toxicity to TGAI A,B Partially
40094602,
00147306
00073804
40094602,
00147306
00073804
00147306
40094602
00073805
NO
NO
NO
No
No
NoV
No§/
Estuarine and Marine
Organisms (shrimp,
oyster, and fish)
66
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(cW2HBl?
Timeframe
for
Submission^
Sec. 158.145 Wildlife and Aquatic Organisms
Aquatic Organisms Testing (cont'd)
72-4 - Fish Early Life Stage and
Aquatic Invertebrate
Life Cycle
- Fish TGAI A,B
- Invertebrates TGAI A,B
72-5 - Fish Life Cycle TGAI A,B
72-6 - Aquatic Organism TGAI A,B
Accumulation
72-7 - Simulated or Actual Field
Testing
- Aquatic Organisms TEP A.B
No
No
No
No
Yes?/
15 Months
No
I/ Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/ The Agency is not requiring an avian reproduction study because of the low avian toxicity demonstrated in
acceptable acute oral and subacute dietary toxicity studies and the probable low palatability of cryolite.
3/ Data are not required based on the results of lower tier testing.
4/ This study is not required. Tests describing acute toxicity of cryolite EPs to freshwater invertebrates will
probably not provide significant information for the following reasons: i) results of fish acute toxicity using
TGAI and EP formulations are comparable; ii) the class of inert ingredients that is most often implicated in EP
67
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Sec. 158.145 Wildlife and
Footnotes (oont'd)
products having a higher aquatic toxicity than TGAI products is surfactants. The EPS containing cryolite are
formulated as dusts and wettable powders, and it is unlikely that these formulations would contain surfactants.
5/ The requirement for estuarine and marine organism toxicity is partially satisfied. The Agency is not requiring
further testing because i) normal use of products containing cryolite should not cause significant concentrations
of cryolite in marine and estuarine waters, and ii) cryolite is only slightly toxic to practically nontoxic to
representative freshwater organisms.
6/ The fish early life stage and fish life cycle studies are not required because i) the acute toxicity of cryolite
freshwater organisms is low, ii) there is only minimal use of cryolite on crops grown in the proximity to water
(i.e., citrus and cranberries), and iii) the highest estimated environmental concentration (EEC) based on indirect
application of cryolite is less than 1 percent of the lowest acute toxicity values for a fish (i.e., 42.5 ppm
rainbow trout).
7/ In the 1983 cryolite Standard, EPA reserved the requirement for the aquatic invertebrate life cycle study. Since
then, OPP has developed more realistic mathematical models for calculating estimated environmental concentrations
(EECs) when actual field residue data are lacking. The aquatic EEC resulting from indirect application (i.e.,
runoff and spray drift) of cryolite exceeds the criteria for requiring the life cycle test (i.e., >1% of the acute
toxicity value for the most sensitive species) when cryolite is applied aerially at > 30 Ib ai/A. Therefore, this
test is required for products allowing for application under these conditions.
68
-------
Table A
Generic Data Requirements for Cryolite (cont'd)
Data Requirement
Does EPA
Have Data to
Test Use Satisfy This
Substance Patterns Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3fcW2HB)? Submission^-
Sec. 158.155 Nontarget Insects
NOETTARGET INSECT TESTING - POTTTNATORS
141-1 - Honey Bee Acute' TGAI
Toxicity
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
NONIARGET INSECT TESTING - AQUATIC INSECTS
142-1 - Acute Toxicity to Reserved^/
Aquatic Insects
142-2 - Aquatic Insect Reserved^/
Life Cycle Study
A,B
A,B
A,B
142-3 - Simulated or
Actual Field
Testing for
Aquatic Insects
Reserved^/
Yes
No
00036935
No
No
69
-------
Table A
Generic Data Requirements for Cryolite (oont'd)
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Test Use Satisfy This Bibliographic Under FIFRA Section for
Data Requirement Substance Patterns Requirement? Citation 3 (c) (2) (B) ? Submission^
Sec. 158.155 Nontarcret Insects (cont'd)
NONTARGET INSECT TESTING - PREDATORS AND PARASITES
143-1 Reserved3-/
thru
143-3
I/ Due dates refer to the number of months following receipt of this Registration Standard, unless otherwise
indicated.
2/ Due to the low toxicity demonstrated by the honey bee acute toxicity study, this study is not required.
3/ This requirement is reserved pending development of test methodology and/or decisions as to whether data should be
required.
70
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Cryolite
Data Requirement Composition
§158.120 Product Chemistry
Product Identity and Composition
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of Beginning MP
Materials and Manufacturing
Process
61-3 - Discussion of Formation of MP
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of MP
Product Samples
62-2 - Certification of Ingredient MP
Limits
62-3 - Analytical Methods to Verify MP
Does EPA
Have Data to
Satisfy This
Requirement!^
Partially
Partially
Partially
Partially
Partially
Partially
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3fcW2WBl?
00152192,
00152192,
00152192,
00152192,
40193802
40193801
00152192,
40293802
40193801
40193801
00162905,
40193802
Yes2/
Yes*/
Yes§/
Yes§/
Yes^/
Yes^/
Timeframe
For Data
Submission^/
9 months
9 months
9 months
12 months
12 months
12 months
Certified Limits
71
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Cryolite
Data Requirement Composition
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Satisfy This Bibliographic Under FIFRA Section For Data
Reouirement!/ Citation 3(cW2HB)? Submission2-/
§158.120 Product Chemistry
Physical and Chemical Characteristics
63-2
63-3
63-4
63-7
63-12
62-14
62-15
63-16
- Color
- Physical State
- Odor
- Density, Bulk Density or
Specific Gravity
-PH
- Oxidizing or Reducing Action
- Flammability
- Explodability
(cont'dl
MP
MP
MP
MP
MP
MP
MP
MP
Partially
Partially
Partially
Partially
Partially
Partially
No
No
00152192,40193803 Yes9-'!0/
00152192,40193803 Yes9-'!0/
00152192,40193803 Yes9-'!0/
00152192,40193803 Yes9/
00152192,40193803 Yes9/
00152192 Yes9-'!!/
NoW
Yes9-'!3/
9 months
9 months
9 months
9 months
9 months
9 months
9 months
72
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Cryolite (cont'd)
Data Requirement
ComDosition
Does EPA
Have Data to
Satisfy This
Reouirementl^
§158.120 Product Chemistry
Physical and Chemical Characteristics
63-17 - Storage Stability MP Partially
63-18 - Viscosity MP No
63-19 - Miscibility MP No
63-20 - Corrosion Characteristics MP No
Other Requirements;
64-1 - Submittal of Samples N/A
Must Additional
Data Be Submitted Timef rame
Bibliographic Under FIFRA Section For Data
Citation 3fcH2HBl? Submission2-/
00152192
15 months
NoW
15 months
No
73
-------
Table B
Product-Specific Data Requirements for ManufacturireHJse Products Containing Cryolite (cont'd)
Sec. 158.120 Product Chemistry
Footnotes;
I/ Data submitted in response to requests made in the 1983 Standard by Pennwalt and Gowan have been evaluated with
regard to their adequacy in meeting the requirements of 40 CFR 158.120. Data are required to support
registration of all other products.
2/ Due dates refer to number of months following receipt of the Registration Standard, unless otherwise indicated.
3/ The chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient and each intentionally added inert must be provided. For the active ingredients, the following must
also be provided: the product, common, and trade names; the molecular, structural, and empirical formulas; the
molecular weight or weight range; and any experimental or internally assigned company code numbers.
4/ Complete information must be provided for the Pennwalt technical product from synthetic and natural sources
regarding the nature of the process (batch or continuous), the relative amounts of beginning materials and the
order in which they are added, the chemical equations for each intended reaction, equipment used to produce each
intermediate and the final product, reaction conditions, the duration of each step of the process, purification
procedures, and quality control measures. In addition, the name and address of the manufacturer, producer, or
supplier of each beginning material used in the manufacture of each product must be provided, along with
information regaring the properties of those materials. These requirement have been met for the Gowan technical
product from the synthetic source. However, for the natural source, quality control procedures must be
submitted.
5/ A detailed discussion of all impurities in the Gowan 98% synthetic technical product that are or may be present at
> 0.1% (w/w), based on knowledge of the beginning materials. A detailed discussion of all impurities in the
Pennwalt 96% technical from both natural and synthetic sources that are or may be present at > 0.1% (w/w), based
on knowledge of the beginning materials, chemical reactions (intended and side) in the manufacturing process, and
any contamination during and after production. These requirements have been met for the Gowan natural product.
6/ Five or more representative batches of the Gowan and Pennwalt technical products from natural and synthetic
sources must be analyzed for the amount of active ingredient and each impurity for which certified limits are
required. Complete validation data (accuracy and precision) must be submitted for each analytical method used.
74
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Cryolite (cont'd)
Sec. 158.120 Product Chemistry
Footnotes (cont'd)
7/ Upper and lower limits for the active ingredient and upper limits for each impurity present at > 0.1% (w/w) and
each "toxicologically significant" impurity present at < 0.1% (w/w) in the technical products of Gowan (98%) and
Pennwalt (96%) from natural and synthetic sources must be provided and certified. Also, an explanation of how
each certified limit was established must be provided (e.g., sample analysis using validated analytical
procedures, quantitative estimate based on amounts of ingredients used, etc.). Limits for impurities not
associated with the active ingredient need be provided only if they are considered to be of toxicological
significance, regardless of the concentration at which they are present. Certifications must be submitted on EPA
Form 8570 (Rev. 2-85).
8/ Analytical methods must be submitted for distinguishing cryolite from fluorine-containing impurities (e.g.,
chiolite). Also, methods for detection of each toxicologically significant Impurity for which a certified limit
is required must be submitted. Each method must be accompanied by validation studies indicating precision and
accuracy. These methods must be suitable for enforcement of certified limits.
9/ Physicochemical characteristics (color^ physical state, odor, specific gravity, pH, oxidizing and reducing action,
explodability, storage stability, and corrosion characteristics) as required in 40 CFR 158.120 and more fully
described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
10/ This requirement has been satisfied for the Gowen synthetic and natural products.
ll/ Data required if the product contains oxidizing or reducing agents.
12/ Data are not required because the product contains no combustible liquids.
13/ Data required if the product is potentially explosive.
14/ Data are not required because the product is not a liquid.
15/ Data are not required because the product is not a liquid and is not to be diluted with petroleum solvents.
75
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Cryolite
Data
Sec.
Requirement
158.135 Toxicology
Test
Substance
Use
Patterns
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(cH2HB)?
Timeframe
for
Submission^/
Acute Testing
81-1
81-2
81-3
81-4
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation
- Eye Irritation -
MP2/
MP
- Rat MP
Rabbit MP
A,B
A,B
A,B
A,B
Partially
Partially
Partially
Partially
00138096
00128107
00128108
00128106
Yes3/
Yes3/
Yes3-/
Yes3-/
9 Months
9 Months
9 Months
9 Months
81-5 - Dermal Irritation
- Rabbit MP
81-6 - Dermal Sensitization
- Guinea Pig MP
A,B
A.B
Partially
Partially
00128106
00138097
Yes3/
Yes3-/
9 Months
9 Months
I/ Due dates refer to number of months following receipt of the Registration Standard, unless otherwise indicated.
2/ Formulation intermediates are also included in the category of manufacturing-use products.
3/ Data are adequate to support registration of products containing 95 percent and above pure cryolite. Data are
required to support registration of all other products.
76
-------
77
II. LABELING APPENDICES
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78
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
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
test. The net contents must be expressed in the largest suitable
unit, e.g., "l pound 10 ounces" rather than "26 ounces." In
addition to English units, net contents may be expressed in
metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
ment 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.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
-------
79
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 162.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40CFR 162.10(h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON. [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. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
-------
80
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. [40 CFR 162.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury/ or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on the
results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel precautionary
statements section, preceded by the heading "Physical/Chemical
Hazards." Note that no signal word is used in conjunction with
the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3 (d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
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
-------
81
Agency|s review of your application, your proposed classification
determination will be evaluated in accordance with the provisions
of 40 CFR 162.11(c). You will be notified of the Agency's
classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in
40 CFR 162.10 (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 your label
and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
simultaneously. Note that the products will be
assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
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82
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. 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 II, STOR,
PEST/DIS, and CONT/DIS to determine the storage and disposal
•instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue 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,, [40 CFR 162.10]
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.
-------
PfKCAUTONAIIV tfATEUCNTt
HAZAMM TO HUMANS
• ooucfncANMAts
CAUTION
BWVKMUIMTAL MAZAMM
fHVMAtOJIOMMnAt
HAZAMM
OMCCnOIMPOftUM
• b • ***• tf
b •
ro
oo
PRODUCT
NAME
AOTWt MOftCOCMT:.
MCHT tMWOKMTt:.
TOTAL:
10000ft
THMPflOOUOTCONTAffM LM OF KNOAUON
KEEP OUT OF REACH OF CHILDREN
CAUTION
•TATEUDIT OF ffUCTCAL THKATMENT
rONSKM:
Ml M* FANit KM AOOmONAL PMEOAUnONANV STATf UCNT«
ISTAMNMMINT MOX
MA MOWflUTION Na
STORAGEAND
DISPOSAL
•TOUAOI:
WAMMNTV CTATtMOIT
-------
HAZANM TO HUMAN*
It OOMf tIC ANMALS)
OANOCM
ENVmONMfNT At HAZARDS
• * «JMMM * r*** »» »
oo
STORAGE AND
DISPOSAL
RESTRICTED USE
PESTICIDE
(reason for claanlfylnp.)
O «w wt CHU w cornnco Amjonora ox
w OI"KT ""WVMK* »» on.» ro* wose
n THE comrtn Amjoaaci
PRODUCT
NAME
ACTWI NOflCDCNT:
Mf NT MQKtMNTl:,
TOTAL:
10000%
TH» PRODUCT CONTAMS LM Of PfHOAU.ON
KEEP OUT OF REACH OF CHILDREN
DANGER —POISON
tTATIMtNT 9f PHACTCAL THCATUCNT
» SWALL
MI toe PANO. ran AO
M. FMCAUTIOMANV •TATCMCNT*
ItTAMJSHMCNT NO.
IPA MC04TNATION NO.
NtT OONTINTt:
CHOP:
CHOP:
CKOF:
cut*-..
WARRANTY VTATB4CNT
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pou nds/ga 1 Ion
statement
Front panel
precautionary
statements
Keep Out of Reach
ot 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 tront
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 tor . . .,"
"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 ot
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.
-------
SUMMARY-7
ITEM
7C
7D
7E
8
8A
BB
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement ot
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, 11, 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.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
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 tlash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of t ront
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
tor use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix 11 guide
PHYS/CHEM
includes a statement of the terms of
restriction. The words ' "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
tor use.
Reter to Appendix II guides STOR,
CONT/DIS, and PEST/D1S for further
information and required statements.
May be in metric as well as U.S. units
oo
-------
§ 1*2.8
(e) Conditional registration. Any ap-
plication for which a review of sclen-J
title data Is needed, other than an ap
plication which the Agency detej
mines may be considered for uncona
tlonal registration under paragraph
(d) of this section, will be treated as/an
application for conditional registration
under FIFRA sec. 3(c)<7) and wUl be
reviewed and acted upon as set^orth
In il M2.160 through 162.177.
(f) Denial of registration. Tile Ad-
mlnlstrktor shall deny an application
reviewed, under paragraph (d/of this
section 1\ any of the requirements of
paragraph (d)(2) of this section are
not met, W If there are Insufficient
data to majie the required ybetermlna-
tlons.
(1) WolvAcation. Promptly after
making a determination It deny a reg-
istration, trie Administrator shall
notify the applicant by Certified letter
of the denial at registration and shall
set forth the reasons and factual basis
for the determination/ and the condi-
tions. If any. wrUch must be satisfied
oo In order for the \egl/tratlon to be ap-
co proved.
(2) Opportunity Wr remedy by appli-
cant (I) The applicant will have 30
days from the da/eXof receipt of the
certified letter tf t\ke the specified
corrective actlony
(li) The applicant Aay petition the
Administrator w withdraw his applica-
tion. The Administrator may. In his
discretion, deny any petition for with-
drawal and proceed to LsAue a notice of
denial In accordance wltyi paragraph
(f )(3) of this/section.
(3) FEDERAL REGISTER publication. If
the applicant falls to re men y the defi-
ciency of nla registration application,
the Administrator shall \promptly
issue In the FEDERAL REGISTE)[ a notice
of denial of registration. Such notice
shall self forth the reasons and\ factual
basis for the denial and shall Vontaln
the name and address of the applicant,
the product name, the name ana per-
centage by weight of each active Vigre-
dlenl In the product, the proposeckpat-
terrts of use, and the proposed claaplfl-
cat/on.
1) Hearing rights. Within 30 davs
following publication of the denial \n
FEDERAL REGISTER, the applicant <
liny Interested party with the wrlttef
40 CFR Ch. I (7-1-87 Edition)/
Authorization of the applicant may
qViest a hearing pursuant to section
6(h) of the Act and Part 164 of this
chapter. If no hearing Is timely/re-
quested, the denial shall become effec-
tive at the end of the 30 days.
(g) Disposition of material sftbmit-
ted with the application. The test data
and othW Information submitted with
an application shall become a part of
the official file of the Agenc/ for that
appllcatloti or registration. ^Except as
provided ov section 10 of the Act,
within 30 days after the registration of
a pesticide, we data callra for In the
registration statement together with
such other scientific Information as
the Administrator dee/ns relevant to
his decision shall be/made available
for public Inspection.*
C48 PR 34004. July
8 162.8 DaU to be fnished by applicant
(a) An applicant for registration, re-
registration, or amendment of a regis-
tration under FTFRA kec. 3(c)(5) shall
furnish data /as required by the
Agency to determine Whether his ap-
plication maybe approved under this
Part.
(b) An applicant shall Vubmlt with
his application any factual Informa-
tion regamlng adverse effects of the
pesticide yon the environment or man
that:
(1) Hals been obtained by hlAj or has
come uf his attention; and
(2) Insofar as he Is aware, hVs not
previously been submitted to\ the
Agency.
Suofh Information shall Include.
shAll not be limited to, published yr
u/publlshed laboratory studies and i
Kdent experience.
[48 PR 34005. July 26. 1983)
B 162.10 Labeling requirement*.
(a) General—(1) Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following:
(I) The name, brand, or trademark
under which the product Is sold as pre-
f nvironmontol Protection Agoncy
scribed In paragraph (b) of this sec-
tion;
(II) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of this section;
(III) The net contents as prescribed
In paragraph (d) of this section;
(iv) The product registration
number as prescribed In paragraph (e)
of this section:
(v) The producing establishment
number as prescribed In paragraph (f)
of this section;
(vl) An Ingredient statement as pre-
scribed In paragraph (g) of this sec-
tion;
(vll) Warning or precautionary state-
ments as prescribed In paragraph (h)
of this section;
(vill) The directions for use as pre-
scribed In paragraph (I) of this section;
and
(Ix) The use classification^) as pre-
scribed In paragraph (J) of this section.
(2) Prominence and legibility. (I) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
consplcuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed In such terms as to render It
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(II) All required label text must:
(A) Be set In 6-point or larger type;
(B) Appear on a clear contracting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear In
the English language. However, the
Agency may require or the applicant
may propose additional text In cither
languages as Is considered necessary to
protect the public. When additional
text In another language Is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(I) General.
The label shall appear on or be secure-
ly attached to the Immediate contain-
S 162.10
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act, "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the Im-
mediate container Is enclosed within a
wrapper or outside container through
which the label cannot be clearly read,
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It Is a pan of the package as
customarily distributed or sold.
(II) Tank can and other bulk con-
tainer*—
-------
00
§ 162.10
purposes other than as a pesticide or
device;
(Iv) A false or misleading comparison
with other pesticides or devices;
.
(4) Statements of percentage*. The
percentages of Ingredients 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 "22-25%." If
the uses of the pesticide product are
expressed as weight of active Ingredi-
ent per unit area, a statement of the
weight of active Ingredient per unit
volume of the pesticide formulation
shall also appear In the ingredient
statement.
(5) Accuracy of itated 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
present.
(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 chances'
chemical composition significantly.
the product must bear the following
statement In m. prominent position on
-------
o
cr»
§ 162.10
the label: "Not for sale or use after
[date]."
(ID The product must meet all label
claims up to the expiration time Indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
Inert Ingredient(s) to be listed In the
Ingredient statement If he determines
that such tngredlent(s) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard Including hazard to children,
environmental hazard, and physical or
40 CW Ch. I (7-147 Edition)
chemical hazard fall Into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
Is determined by the Toxlclty Catego-
ry of the pesticide. The category Is as-
signed on the basis of the highest
hazard shown by any of the Indicators
In the table below:
Ore) ID.
Inhalation LC»
Dermal ID.
EyeeNecta
Skin effect!
1
Up to and ndudvig 50
mg/kg.
Up to and inckirJng .2
mg/Mar
Up lo and Inducing ZOO
mg/kg.
wrthm7 d»yl.
TafcMyc
N
From SO thru 500 mg/kg
From .2 thru 2 mg/Mer
From 200 tvu 2000
Cornea) opacity
daya; Inflation
perOtng lor 7 daya.
Severe irritation al 72
houra.
alegoriea
III
From 500 ttni 5000 mg/
kg
From 2 thru SO mg/Mer...
From 2.000 ttni 20.000....
within 7 daya.
Moderate Mlaaon al 72
noun.
IV
Qraelar nan 5000 mg/
kg
Qrealer man 20 rag/Her.
Greater man 20.000.
Nokmaten.
Mild or afcghl trrilalion al
72 hours.
(I) Human hazard signal word—
-------
§ 162.10
hazard statements and the circum-
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use cqntalns an active Ingredient
with a mammalian acute oral LD>e of
100 or less, the statement "This Pesti-
cide Is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active Ingredient
with a fish acute LCU of 1 ppm or less.
the statement "This Pesticide is Toxic
to Pish" Is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avlan acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide Is Toxic to Wildlife" Is
required.
(D) If either accident history or field
studies demonstrate that use of the
40 CFR Ch. I (7-1-87 Edition)
pesticide may result In fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating Insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabll-
Ity or explosive characteristics of the
pesticide are required as follows:
Flash point
Requited lent
(A) PRESSURIZED CONTAINERS
Flash point it or below 20* f. rt thara is • flashback al
any valve opening.
Flash poml above 20* F and ml over 80' F or it the
feme extension it more than 18 in long al a distance
of 6 in from the flame.
Extremely flammable. Contents under pressure. Keep away from
lire, sparks, and hasted surfaces. Do not puncture or Incinerate
container. Eiposure to lempeialuree above 130* F may cause
bursting.
Flammable. Contents under pressure. Keep away Irom heat.
spsrks. and open flame. Do not puncture or incinerate container.
Eiposure to temperatures above 130* F may cause bursting.
Contents under pressure. Do not use or store near heal or open
flame. Do not puncture or Incinerate container. Enposure 10
temperatures above 130* F may esuM bursting.
(B) NONPRESSUHIZED CONTAINERS
Al or below 20* F..
Above 20' F and not over 60' F
Above BO* F and not over ISO* F
Extremely flammable. Keep away horn Hre, sparks, and healed
surfaces.
Flammable. Keep away Irom heal and open llama.
Do not use or store near hoot or open flame.
(i) Directions for Use—(1) General
requirements—(1) Adequacy and clar-
ity Of directions. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal Injury and to prevent
unreasonable adverse effects on the
environment.
(11) Placement of directions for use.
Directions may appear on any portion
of t*»e label provided that they are
_ ^SP™*0"0"" M»OUK*\ to toe easily read
»..,Tfl» «*"» V.-..,- M «— ^^_^,^,rtc Droduct.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
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
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that It Is not necessary for such direc-
tions to appear on the label.
(ill) Exception* to requirement for
--.v ~-^«_.«—« tiirec-
Environmental Protection Agency
lions for use may be omitted from la-
beling of pesticides which are Intended
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(I) The label clearly shows that the
product is Intended for use only In
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate Information such as
technical data sheets or bulletins. Is
available to the trade specifying the
type of product Involved and its
proper use in manufacturing process-
es;
(J) The product will not come Into
the hands of the general public except
after Incorporation Into finished prod-
ucts; and
(4) 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 labeling of pesti-
cide products for which sale Is limited
to physicians, veterinarians, or drug-
gists, provided that:
(1) The label clearly states that the
product Is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is Information readily
available to the formulators on the
composition, toxiclty, methods of use,
applicable restrictions or limitations,
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product Is Intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts Involved:
§ 162.10
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged Is registered; and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall Include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed In 162.10(J) immedi-
ately under the heading "Directions
for Use."
(II) Immediately below the state-
ment of use classification, the state-
ment "It Is a violation of Federal law
to use this product In a manner Incon-
sistent with its labeling."
(Ill) The slte(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl) The method of application, in-
eluding Instructions for dilution. If re-
quired, and type(s) of application ap-
paratus or equipment required. ,
(vli) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(vlii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(Ix) Specific directions concerning
the storage and disposal of the pes.ti-
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 same minimum sizes
as required for the child hazard warn-
ing. (See Table In 5 162.10(h)(l)(iv))
(x) Any limitations or'restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required Intervals between ap-
plication and harvest of food or feed
crops.
(B> WotatlonaJ crop restrictions.
-------
§162.11
(C) Warnings as required against use
on certain crops, animals, objects, or
In or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who Is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who Is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Use Classification.
By October 22. 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraphs (j) (1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use(s) except that, if a product
has both restricted use(s) and general
use(s), both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of {162.10(j)(2).
(i) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or Implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
40 CFR Ch. I (7-1-87 Edition)
slflcatlon on the front panel as de-
scribed below:
(I) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as required
for human hazard signal words (see
table In § 162.10(h)U)(lv». and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction Imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement Is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If,
however, other regulatory restrictions
are imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
(40 PR 28268. July 3. 1975: 40 FR 32320.
Aug. 1. 1975; 40 FR 36571. Aug. 21. 1975. as
amencted at 43 FR 5786. Feb. 9. 1978)
§ 162.11 Criteria Tor determination! of un-
reasonable adverse effects.
(a)-(b) [Reserved]
(c) Use classification—(I) Classifica-
tion criteria for new registrations.
Except as provided In paragraph (c)(4)
of this section, a specific use(s) of a
pesticide product not previously regis-
tered shall be classified for general use
If each of the applicable criteria set
forth in paragraph (cKIKi) through
(III) of this section is met. Otherwise,
the product use(s) shall be classified
for restricted use unless a review of
the labeling pursuant to paragraph
(c)(3) of this section indicates that the
product use may be classified for gen-
eral use or the benefits from unre-
stricted use of the pesticide outweigh
the risks of unrestricted use of the
pesticide. Each of the separate criteria
as set forth below must be applied for
the product use(s) to be classified
Environmental Protection Agency
unless the formulation, packaging, or
method of use of the product can rea-
sonably be expected to eliminate the
route of exposure. New data submitted
to support classification must conform
to the specifications of the Registra-
tion Guidelines.
(I) Domestic applications. A pesti-
cide use(s) intended for domestic ap-
plication will be a candidate for gener-
al use classification If the pesticide
formulation:
(A) Has an acute dermal LDM greater
than 2.000 mg/kg;
(B) Has an inhalation LCM greater
than 2 mg/llter;
(C) Causes no corneal opacity, or
causes eye Irritation reversible within
7 days or less;
(D) Causes no more than moderate
skin irritation within 72 hours;
(E) Has an acute oral LDU greater
than 1.5 g/kg for the formulation as
diluted for use; and
(F) Causes, under conditions of label
use or widespread and commonly rec-
ognized practice of use. only minor or
no discernible subacute. chronic, or de-
layed effects on man or other nontar-
get organisms from single or multiple
exposures to the product Ingredient(s),
their metabolite(s), or degradation
product(s).
(II) Nondomestic applications. A pes-
ticide use(s) intended for nondomestlc
application will be a candidate for gen-
eral use classification If the pesticide
formulation:
(A) Has an acute dermal LDH greater
than 200 mg/kg;
(B) Has an acute dermal LD.. greater
than 16 g/kg for the formulation as di-
luted for use as a mist or spray;
(C) Has an Inhalation LDM greater
than 0.2 mg/liter;
(D) Is not corrosive to the eye or
causes corneal opacity reversible
within 7 days:
(E) Is not corrosive to the skin and
causes no more than severe skin Irrita-
tion within 72 hours; and
(F) Causes under conditions of label
use, or widespread and commonly rec-
ognized practice of use. only minor or
no discernible subacute, chronic, or de-
layed toxic effects on man or other
nontarget organisms from single or
multiple exposures to the product
§ 162.11
Ingredient(s). their their metabolite(s),
or degradation product(s).
(Ill) Outdoor applications. A pesti-
cide use(s) intended for outdoor appli-
cation will be a candidate for general
use classification If it meets the appli-
cable set of criteria set forth Immedi-
ately above for either domestic or non-
domestic application, as appropriate,
and If the pesticide:
(A) Occurs as a residue immediately
following application in or on the feed
of a mammalian species representative
of the species likely to be exposed to
such feed In amounts equivalent to the
average dally Intake of such represent-
ative species, at levels less than !4 the
acute oral LDH, measured In mammali-
an test animals as specified In the Reg-
istration Guidelines.
(B) Occurs as a residue Immediately
following application in or on the feed
of an avian species representative of
the species likely to be exposed to
such feed in amounts equivalent to the
average daily Intake of such represent-
ative species, at levels less than V4 the
subacute dietary LCM measured in
avian test animals as specified in the
-------
93
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
C.
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 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate 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.
-------
94
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of the
label under the heading STORAGE AND DISPOSAL. Products intended
solely for domestic use need not include the heading "STORAGE AND
DISPOSAL."
Storage Instructions:
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure while
opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been spilled,
and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides during
storage to prevent cross-contamination of other pesticides,
fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
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95
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 that are
Acute Hazardous Wastes or are assigned to Toxicity Category I on
the basis of oral or dermal toxicity, or Toxicity Category I or
II on the basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions, contact
your State Pesticide or Environmental Control Agency or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR 261,
Subpart c for a hazardous waste must bear the following pesticide
disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by use
according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. 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."
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96
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
(Non-aerosol products |Do not reuse container (bottle, can, jar).
I (bottles, cans. Jars) I Rinse thoroughly -before discarding in trash.
[Non-aerosol products
I(baas)
I Do not reuse bag. Discard bag in trash.
.1
I,
|Aerosol products
(Replace cap and discard containers in
I trash. Do not incinerate or puncture.
2a All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Metal
containers
(non-aerosol)
Plastic containers
-
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Statement
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,
stav 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, stay
out of smoke.
Return empty cylinder for reuse (or
similar wordincn .
and how fiber drum may be reused.
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97
III. BIBLIOGRAPHY APPENDICES
-------
98
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in arriving at
the positions and conclusions stated elsewhere in the Standard.
Primary sources for studies in this bibliography have been the body
of data submitted to EPA and its predecessor agencies in support
of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they
have been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study." In the case of published materials, this
corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from
within the typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title (or at
least a single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic citation.
The Agency has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or MRID,
number. This number is unique to the citation, and should be
used at any time specific reference is required. It is not related
to -the six-digit "Accession Number" which has been used to
identify volumes of submitted studies; see paragraph 4(d) (4)
below for a further explanation. In a few cases, entries added
to the bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID) , each entry consists of a citation containing standard
elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for certain special
needs.
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
-------
99
date is followed by a question mark, the
bibliographer deduced the date from evidence in
the document. When the date appears as (19??),
the Agency was unable to determine or estimate the
date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing Parentheses. For studies submitted to
the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission Date. 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.
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100
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cryolite Standard
MRID Citation
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975)
Toxicity of Pesticides and Other Agricultural
Chemicals to Honey Bees: Laboratory Studies.
By University of California, Dept.of Entomology?:
UC, Cooperative Extension. (Leaflet 2287;
published study.)
00073804 McCann, J.A. (1972) Cryolite 50 Dust: Bluegill (Lepomis
macro:chirus): Test No. 443. (U.S. Agricultural
Research Service, Pesticides Regulation Div.,
Animal Biology Laboratory; unpublished study;
CDL:129759-A)
00073805 Heitmuller, T. (1975) Acute Toxicity of Kryocide to Pink
Shrimp (Penaeus duorarum) and Fiddler Crabs
(Ucapugilator). (Unpublished study received Mar 4,
1975 under 1202-297; prepared by Bionomics—EG
& G, Inc., submitted by Puregro Co., Los Angeles,
Calif.; CDL:222201-A)
00084001 Fink, R. (1975) Final Report: Eight-day Dietary LC50—
Bobwhite Quail: Project No. 110-103. (Unpublished
study received Mar 4, 1975 under 1202-297; prepared
by Truslow Farms, Inc., submitted by Puregro Co.,
Los Angeles, Calif.; CDL:222203-A)
00084002 Fink, R. (1975) Final Report: Eight-day Dietary LC50--
Mallard Ducks: Project No. 110-104. (Unpublished
study received Mar 4, 1975 under 1202-297; prepared
by Truslow Farms, Inc.,submitted by Puregro Co.,
Los Angeles, Calif.; CDL:222203-B)
00102979 California (1980) Lettuce: Efficacy of Kryocide. (Unpublishe
study received April 19, 1982 under CA 81/90; CDL:247554-A)
00125375 Schroeder, R.; Hogan, G. (1982) A Pilot Rat Reproduction
Study with Bolero Technical (SX1381): Project No.
82-2614. Final rept. (Unpublished study received
Jan 31, 1983 under 239-2431; prepared by Bio/dynamics,
Inc., submitted by Chevron Chemical Co., Richmond,
CA; CDL:249467-A)
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101
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cryolite Standard
MRID Citation
00128106 Ralston Purina Co. (1981) Acute Oral Toxicity—Method,
Summary, Pathology; Primary Dermal Irritation—
Method, Summary; Primary Eye Irritation—Method,
Summary: Kryocide Insecticide NB84-146-2B: Rats,
Rabbits: RT Lab No. 880531. (Unpublished study
received Feb 10, 1983 under 4581-116; submitted
by Agchem Div., Pennwalt Corp., Philadelphia, PA;
CDL:071392-A)
00128107 Hansen, K.; Mills, V.; Beck, L.; et al. (1981) Acute
Dermal Toxicity Study: Kryocide Insecticide (N.B.
84-146-2B): Rabbits: Project No. 1685-C; Project
No. 1136. Rev. rept. (Unpublished study received
Feb 10, 1983 under 4581-116; prepared by Elars
Bioresearch Laboratories, Inc. and Westpath Labor-
atories, Inc., submitted by Agchem Div., Pennwalt
Corp.Philadelphia, PA; CDL:071392-B)
00128108 Mecler, F.; Knapinski, P. (1981) Acute Inhalation
Toxicity Study in Rats: Kryocide 96W Insecticide
(NB 84-103-4): LBI Project No. 22098. Final rept.
(Unpublished study received Feb 10, 1983 under
4581-116; prepared by Litton Bionetics,Inc.,
submitted by Agchem Div., Pennwalt Corp., Phila-
delphia, PA; CDL:071392-C)
00128113 Putman, D.; Parmar, A.; Schechtman, L. (1981) Activity of
Kryocide in the Salmonella/Microsomal Assay for
BacterialMutagenicity: MA Study No. T1693.102.
Final rept. (Unpublishedstudy received Feb 10,
1983 under 4581-116; prepared by Microbiological
Assoc. and Genetic Toxicology Testing Service,
submitted by Agchem Div., Pennwalt Corp., Phila-
delphia, PA;CDL:071392-1)
00128114 Putman, D.; Moore, W.; Schechtman, L. (1981) Activity
of T1693 in a DNA Repair Test Using Escherichia
coli: MA Project No. T1693.104 Final rept.
(Unpublished study received Feb 10, 1983 under
4581-116; prepared by Microbiological Assoc. and
Genetic Toxicology Testing Service, submitted by
Agchem Div-,Pennwalt Corp., Philadelphia, PA:
CDL:071392-J)
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102
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cryolite Standard
MRID Citation
00128115 Putman, D.; Moore, W.; Schechtman, L. (1981) Activity of
T1693 in the in vivo Cytogenetics Assay in Rodents:
MA Study No. T1693.112. Final rept. (Unpublished
study received Feb 10, 1983 under 4581-116; pre-
pared by Microbiological Assoc. and Genetic Toxi-
cology Testing Service, submitted by Agchem Div.,
Pennwalt Corp., Philadelphia, PA; CDL:071392-K)
00130741 Gowan Co. (1981) Study—Residue: Flourine on Grapes
and Raisins). (Compilation; unpublished study
received Aug 9, 1983 under 10163-41; CDL:251073-A)
00131352 Harris, S.; Holson, J.; Barnett, W.; et al. (1983) Final
Report for a Tertology Study of Kryocide Insecicide
in Albino Rats: PNW/SAI 1182008. (Unpublished
study received Aug 10,1983 under 4581-116; prepared
by Science Applications, Inc.,submitted by Agchem
Div., Pennwalt Corp., Philadelphia, PA; CDL:250968-D)
00138096 Hazleton Laboratories America, Inc. (1983) Acute Oral
Toxicity—Method, Summary, Pathology—Raw Data
Attached: Kryocide: RT Lab No. 814515. (Unpublished
study received Dec 29,1983 under 4581-116; submitted
by Agchem Div., Pennwalt Corp.Philadelphia, PA;
CDL:252071-A)
00138097 Hazleton Laboratories America, Inc. (1983) Dermal
Sensitization Study in Guinea Pigs—Closed Patch
Technique: Kryocide: RT Lab No. 814516. (Un-
published study received Dec 29, 1983 under
4581-116; submitted by Agchem Div., Pennwalt
Corp.Philadelphia, PA; CDL:252071-B)
00142836 Dykeman, R. (1985) The Hydrolysis of Synthetic Cryolite
(Kryocide Insecticide): Project No. WT-5-85. Un-
pulished study prepared by Agchem Div. Pennwalt
Corp. 16 p.
00142837 Dykeman, R. (1985) The Leaching of Synthetic Cryolite
(Kryocide Insecticide) in Soil Columns: Project
No. WT-4-85. Unpublished study prepared by Agchem
Div. Pennwalt Corp. 32 p.
00149815 Nigh, E. (1985) Letter sent to W. Miller dated January
22, 1985: Cryolite .on grapes. Prepared by Gowan
Co. 2 p.
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103
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Cryolite Standard
MRID Citation
00147306 Bailey, H. (1984) (Static Acute Studies of Kryocide
Insecticide with Rainbow Tout (Salmo gairdneri),
Bluegill Sunfish (Lepomis macrochirus), and Daphnia
magna):Project LSC:7632. Upublished study prepared
by SRI International. 25 p.
00152192 Gowan Co. (1983) [Chemical and Physical Properties of
the Active Ingredient Sodium FluoaluminateJ.
Unpublished compilation. 17 p.
00157999 Hagen, C.; Strouse, J. (1986) 90-Day Dietary Study in
Dogs with Kryocide: Final Report: Project No.
WIL-75007. Unpublished study prepared by Wil
Research Laboratories, Inc. 563 p.
00158001 Carlson, R.; Keckemet, 0. (1986) Results of Tests on the
Amounts of Residue Occurring in Crops and Animal
Products from Use of Kryocide Brand Synthetic
Cryolite. Unpublished study prepared by Pennwalt
Corp. 276 p.
00162905 Gardner, W. (1986) Analytical Studies of Cryolite:
Report No. 680110. Unpublished study prepared
by Technology of Materials. 15 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute
Toxicity of Chemicals to Fish and Aquatic Inver-
tebrates: Resource Publication 137. US Fish and
Wildlife Service, Washington, D.C. 106 p.
40193801 Wada, T. (1987) Prokil Cryolite 96: Product Chemistry:
Product Identity and Composition. Unpublished
compilation prepared by Central Glass Co., Ltd.
17 p.
40193802 Wada, T. (1987) Prokil Cryolite 96: Product Chemistry:
Analysis and Certification of Product Ingredients.
Unpublished compilation prepared by Central Glass
Co., Ltd. 7 p.
40193803 Wada, T. (1987) Prokil Cryolite 96: Product Chemistry:
General Provisions for Physical and Chemical
Characteristics Testing. Unpublished compilation
prepared by Central Glass Co.,Ltd. 4 p.
-------
EPA Compendium of Acceptable Uses
CRYOLITE
TABLE OF CONTENTS
Site Name
TERRESTRIAL FOOD CROP 2
(Agricultural Crops) 2
TERRESTRIAL NONFOOD CROP 13
(Ornamental Plants and Forest Trees) 12
Apple 2
Beans 2
Beets 3
Broccoli 3
Brussels Sprouts 3
Cabbage 3
Cantaloupe 3
Carrots 4
Cauliflower 2
Collards 4
Cranberry 4
Cucumber 5
Eggplant 5
Grapefruit 5
Grapes 6
Grapes (raisins) 7
Grapes (table) 7
Grapes (wine) 7
Kale 8
Kohlrabi 8
Lemon 5
Lettuce 9
Lettuce (head) 9
Lettuce (seedling) 10
Lime 5
Melons 4
Mustard (greens) 4
Orange 5
Ornamental Shade Trees (including nursery stock) 13
Ornamental Trees (including nursery stock) 13
Ornamental Woody Shrubs (including nursery stock) 13
Peach 2
Pear 2
Peppers 10
Pumpkin 11
Radish 11
Squash 11
Strawberry 11
Tangelo 5
Tangerine 5
Tomato 12
Turnips 4
Watermelons 3
FRSTR Date: 9-15-87 III-075101-i
Provisional Update: 3-25-88
104
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EPA Compendium of Acceptable Uses
CRYOLITE*
TYPE PFSTTrTDK: Insecticide
FORMULATIONS;
D (30%, 35%, 40%, 45%, 46%, 48%, 50%, 72%, 96%)
WP (84.5%)
WP/D (93%, 96%)
GENERAL WARNINGS AND LIMITATIONS: Do not use cryolite in combina-
tion with lime or compounds containing free lime.
Worker Protection Statement; Written or oral warnings must be
given to workers who are expected to be in a treated area or in an
area about to be treated with cryolite. When oral warnings are
given, warnings shall be'given in a language customarily understood
by workers. Oral warnings must be given if there is reason to
believe that written warnings cannot be understood by workers.
Written and oral warnings must include the following information:
CAUTION—Area treated with cryolite on (date of application). Do
not enter without appropriate protective clothing until dusts have
settled.
Enviornmental Hazards Statement;
Do not apply directly to water or wetlands (i.e. swamps, bogs,
marshes, and potholes). Do not contaminate water when disposing of
equipment washwater.
Bee Caution;
This product is highly toxic to bees exposed to direct treatment or
residues on crops. Protective information may be obtained from
State Cooperative Agricultural .Extension Service.
Agricultural Crop Tolerances (other than those listed in the text):
Apricots 7 ppm
Blackberries 7 ppm
Blueberries (huckleberries) 7 ppm
Boysenberries 7 ppm
Corn 7 ppm
Dewberries 7 ppm
Loganberries 7 ppm
Nectarines 7 ppm
Okra 7 ppm
Peaches 7 ppm
Peanuts 7 ppm
Peas 7 ppm
Plums (fresh prunes) 7 ppm
Quinces 7 ppm
Raspberries 7 ppm
Rutabagas (with or without tops) 7 ppm
Youngberries 7 ppm
*sodium aluminofluoride
FRSTR Date: 9-15-87 III-075101-1
Provisional Update: 3-25-88
105
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Site and Pest
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulation(s)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations; Apply dust formulations pre-
ferably when plants are dry- Remove excess residues on edible
portions of fruit and vegetables by washing, brushing or other
effective means. Do not apply to corn. Dosages given on range
should be applied appropriately depending on plant size and in-
sect population. Per acre rates may be applied by aircraft.
Repeat as needed unless otherwise specified. Consult State Co-
operative Agricultural Extension Service as the number and timing
of treatments may vary according to local conditions.
/04001AA
/04003AA
/05004AA
ITBGAZA
INASACA
INASCWA
ITAXAIC
IVAOAAA
INASAVA
/28001AA
INAMARA
ITASAEA
ITBCBOA
INAMEIA
INAMADA
INAPAFA
Apple
Pear
Codling moth
Flea weevils
Fuller rose
beetle
Gypsy moth
(larvae)
Katydids
Plum curculio
Beans
24-48 Ib/A
(96% D)
(93-96% WP/D)
7 ppra (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
Foliar application.
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar "appli-
cation.
Bean leaf 12.24-48 Ib/A Foliar application. Repeat at 14
beetle (50-96% D) day intervals as needed.
Bean leafroller (93-96% WP/D) May be formulated with parathion.
Corn earworm
Diabrotica bee- [MAI]
ties (includ- 5-15 Ib/A
ing cucumber (40% D)
beetles)
Flea beetles
Mexican bean
beetle
FRSTR Date: 9-15-87 III-075101-2
106
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EPA Compendium of Acceptable Uses
. CRYOLITE
Site ar>d Pest
Dosages and Tolerance. Use
Formulationfs)
300 5 AA
J006AA
300 7 AA
J008AA
3011AA
3012AA
BCCSA
IBCCZA
JCBOA
4MBIA
IWAFC
IMADA
IJAHA
ICCQA
H02AA
I0008AA
J001AA
H012AA
JCCFA
IJCCSA
MBIA
DA
'BMAUA
MfA
0002AA
AAFAA
Broccnli
Brussels
Cabbage
Cauliflower
Sprouts
Cabbage looper
Climbing cut-
worms
Corn earworm
Diabrotica bee-
tles (includ-
ing cucumber
beetles)
Diamondback
moth (larvae)
Flea beetles
Imported cab-
bageworm
Yellowstriped
armyworm
Cantaloupe
Watermelons
Armyworm
Cabbage looper
Diabrotica bee-
tles (includ-
ing cucumber
beetles)
Flea beetles
Melonworm
Pickleworm
Limitations
7 ppra (combined fluorine)
Do not apply after edible parts
start to form on broccoli and
brussels sprouts; or after heads
form on cabbage; or after seed-
ling stage on cauliflower through
48 pounds per acre for foliar ap-
plication.
10.13-48 Ib/A Foliar application.
(50-96% D) May be formulated with naled,
(93-96% WP/D) parathion, malathion, or metho-
myl.
[MAI]
8-25 Ib/A
(40-50% D)
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
10.13-48 Ib/A Foliar application.
(50-96% D) May be formulated with naled,
(93-96% WP/D) parathion, or malathion.
[MAI]
10-25 Ib/A
(35-50% D)
(Cantaloupe)
Leafhoppers [MAI] Foliar application.
9.2-18.4 Ib/A Formulated with malathion.
(35-46% D)
FRSTR Date: 9-15-87
III-075101-3
107
-------
/28073AA
Site and Pest
Carrots
INASCCA
'13009AA
'13021AA
'28022AA
M4014AA
ITBCCSA
ITBCCZA
•-TBCBOA
LTBWAFC
:NAMADA
:TBJAHA
LTBCCQA
'01010AA
TBMAGA
NASAJA
LTBCCTA
TAXAIC
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulation(s)
7 ppm (combined fluorine (roots
and tops))
No preharvest interval through
28.8 pounds per acre for foliar
application.
Vegetable
weevil
Cauliflower
Collards
Mustard (greens)
Turnips
Cabbage looper
Climbing cut-
worms
Corn earworm
Diamondback
moth (larvae)
Flea beetles
Imported cab-
bagewonn
Yellowstriped
armyworm
Cranberry
12.24-28.8
Ib/A
(50-72% D)
Foliar application.
See Broccoli cluster.
7 ppm (combined fluorine)
Do not apply after the seedling
stage through 48 pounds per acre
for foliar application.
23.25-48 Ib/A Foliar application.
(50-96% D)
(93-96% WP/D)
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
Cranberry
fruitworm
Cranberry
weevil
False armyworm
Gypsy moth
(larvae)
23.25-48 Ib/A Foliar application.
(50-96% D)
(93-96% WP/D)
FRSTR Date: 9-15-87
III-075101-4
108
-------
0010AA
TBCCFA
NAMACA
GAMBIA
AMADA
BMAUA
BMAWA
1001AA
AMADA
200 2 AA
2004AA
200 5 AA
2006AA
2007AA
2008AA
ACABA"
BCCUA
BUAGA
ASCWA
BUBFA
AOAAA
BUALA
BHADA
BCCBA
Site and Pest
Cucumber
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulationfs)
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
Armyworm
Cucumber bee-
tles
Diabrotica bee-
tles (includ-
ing spotted
cucumber bee-
tle and
striped cucum-
ber beetle)
Flea beetles
Melonworm
Pickleworm
Eggplant
10-48 Ib/A Foliar application.
(50-96% D) May be formulated with naled,
(93-96% WP/D) parathion, or malathion.
[MAI]
10-25 Ib/A
(35-50% D)
Flea beetles
12.24-28.8
Ib/A
(50-72% D)
Grapefruit
Lemon
Lime
Orange
Tangelo
Tangerine
Black scavenger 7.68-48 Ib/A
caterpillar (50-96% D)
Citrus cutworm (93-96% WP/D)
Fruittree leaf-
roller
Fuller rose
beetle
Garden tortrix
Katydids
Orange tortrix
Orangedog
Variegated cut-
worm
7 ppm (combined fluorine)
No preharvest interval through
28.8 pounds per acre for foliar
application.
Foliar application.
7 ppm (combined fluorine (citrus
fruits))
No preharvest interval through
78.98 pounds per acre for foliar
application.
Foliar application.
FRSTR Date: 9-15-87
III-075101-5
109
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EPA Compendium of Acceptable Uses
CRYOLITE
/01014AA
Site and Pest
Grapes
ITBCABA
ITBMATA
ITBUBCA
ITBXACA
Cutworms
Grape leaf-
folder
Omnivorous
leafroller
Western grape-
leaf skeleton-
izer
Dosages and Tolerance. Use,
Formulationfs)
Limitations
24-48 Ib/A
(96% D)
(93% WP/D)
or
8.45-10.14
Ib/A
(84.5% WP)
or
5.76-7.68
Ib/A
[25-200
gal/A by
ground
equipment]
or
7.68 Ib/A
[20 gal/A
by heli-
copter]
or
9.6-19.2 Ib/A
[dust]
(96% WP/D)
[SLN][MAI]
5-8.33 Ib/A
(30-45% D)
7 ppm (combined fluorine)
Do not apply after fruit starts
to form through 48 pounds per
acre for foliar application. Do
not make more than 2 applications
per year.
Foliar application. Make first
application just before the
fruits start to form and again
about August 1 to control later
broods.
SLN - Use limited to CA.
Foliar application. Make first
application just before the
fruits start to form and again
about August 1 to control later
broods.
Formulated with sulfur.
FRSTR Date: 9-15-87
III-075101-6
110
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EPA Compendium of Acceptable Uses
CRY6LITE
/01014AA
'01014AA
Site and Pest
Grapes (raisins)
Grapes (table)
Dosages and Tolerance. Use. Limitations
Formulationf s")
7 ppra (combined fluorine)
Dp not apply after fruit starts
to form through 9.6 pounds per
acre (SLN-CA) for foliar applica-
tion. Do not make more than 2
applications per year.
ITBCABA
[TBMATA
1TBUBCA
:TBXACA
Cutworms
Grape leaf-
folder
Omnivorous
leafroller
Western grape-
leaf skeleton-
izer
:TBUALA
Orange tortrix
'01014AA
Grapes (wine)
ITBCABA
:TBMATA
.TBUBCA
•-TBXACA
Cutworms
Grape leaf-
folder
Omnivorous
leafroller
Western grape-
leaf skeleton-
izer
[SLN]
5.76-7.68
Ib/A
[25-200
gal/A by
ground]
or
7.68 Ib/A
[20 gal/A
by heli-
copter]
(96% WP/D)
[SLN][MAI]
6-13.5 Ib/A
(30-45% D)
SLN - Use limited to CA.
Foliar application. Make first
application just before the
fruits start to form and again
about August 1 to control later
broods.
SLN - Use limited to CA,
Foliar application.
Formulated with sulfur.
[SLN] SLN - Use limited to CA.
5.76-9.6 Ib/A Foliar application. Apply by
(96% WP/D) ground equipment.
[SLN][MAI]
9-13.5 Ib/A
(45% D)
[SLN]
5.92-6.76
Ib/A
[25-200
gal/A]
(84,5% WP)
or
SLN - Use limited to CA.
Foliar application.
Formulated with sulfur.
7 ppm (combined fluorine)
Do not apply after fruit starts
to form through 9.6 pounds per
acre (SLN-CA) for foliar applica-
tion. Do not make more than 2
applications per year.
SLN - Use limited to CA.
Foliar application. Make first
application just before the
fruits start to form and again
about August 1 to control later
broods.
FRSTR Date: 9-15-87 III-075101-7
111
-------
Site and Pest
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulation(s)
Grapes (wine) (continued)
5.76-7.68
Ib/A
[25-200
gal/A by
ground]
or
7.68 Ib/A
[20 gal/A
by heli-
copter]
(96% WP/D)
[SLN][MAI]
6-13.5 Ib/A
(30-45% D)
•TBUALA
Orange tortrix
SLN - Use limited to CA.
Foliar application. Make first
application just before the
fruits start to form and again
about August 1 to control later
broods.
Formulated with sulfur.
[SLN] . SLN - Use limited to CA.
5.76-9.6 Ib/A Foliar application. Apply by
[not less
than 50
gal/A by
ground
equipment]
(96% WP/D)
[SLN][MAI]
9-13.5 Ib/A
(45% D)
ground equipment. Allow spray to
dry before reentering field.
'13011AA
'13012AA
.RACAAA
TBCCFA
TBCCSA
:TBCCZA
TBWAFA
:NAMADA
Kale
Kohlrabi
Aphids
Armyworm
Cabbage looper
Climbing cut-
worm
Diamondback
moth (larvae)
Flea beetles
[MAI]
10 Ib/A
(40% D)
SLN - Use limited to CA.
Foliar application.
Formulated with sulfur.
7 ppm (combined fluorine)
Do not apply after seedling stage
through 10 pounds per acre (MAI)
for foliar application.
Foliar application.
Formulated with parathion.
FRSTR Date: 9-15-87
III-075101-8
112
-------
Site and Pest
:BJAHA
ASCCA
B020AA
BCAVA
BCCSA
BCCZA
BCBOA
BCABA
3028AA
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulationfs)
Kale cluster (continued)
Pest list continued from previous page.
Imported cab-
bageworm
Vegetable
weevil
Lemon
Lettuce
BCCNA
Alfalfa looper
Cabbage looper
Climbing cut-
worms
Corn earworm
Cutworms
Lettuce (head)
Beet armyvorm
[MAI]
8 Ib/A
(40% D)
Refer to Broccoli cluster for additional pest
and use information.
See Grapefruit cluster.
7 ppm (combined fluorine)
Do not apply after the seedling
stage through 48 pounds per acre
for foliar application.
10-48 Ib/A Foliar application.
(50-96% D) May be formulated with one or a
(93-96% WP/D) combination of: naled, para-
thion, malathion, or methorayl.
[MAI]
10-25 Ib/A
(35-50% D)
7 ppm (combined fluorine)
Do not apply after the seedling
stage through 23 pounds per acre
(MAI) for foliar application.
[MAI]
11.5-23 Ib/A
(46% D)
Foliar application.
Formulated with methomyl,
FRSTR Date: 9-15-87
III-075101-9
113
-------
EPA Compendium of Acceptable Uses
CRYOLITE
Site and Pest
Dosages and Tolerance
Formulationf s)
Use. Limitations
/13028AA
Lettuce (seedling)
IRACAAA
ITBCBEA
ITBCCSA
ITBJAHA
728017AA
IRACAAA
ITBUBCA
Aphids
Armyworra
Cabbage looper
Imported cab-
bageworm
Lime
Mustard (greens)
Orange
Peach
Pear
Peppers
Aphids
[SLN][MAI]
12.5 Ib/A
(50% D)
[MAI]
6 Ib/A
(40% D)
7 ppm (combined fluorine)
Do not apply after the seedling
stage through 12.5 pounds per
acre for foliar application
(SLN).
SLN - Use limited to AZ.
Foliar application to seedling.
Formulated with parathion.
See Grapefruit cluster.
See Collards cluster.
See Grapefruit cluster.
See Apple cluster.
See Apple cluster.
7 ppm (combined fluorine)
No preharvest interval through <
pounds per acre for foliar applrj
cation.
Foliar application.
Formulated with parathion.
Omnivorous
leafroller
INASAGA
ITBRAJA
[SLN] SLN - Use limited to CA. j
7.68-9.6 Ib/A Foliar application. Apply in 5
(96% WP/D) to 10 gallons of water per acre
by aircraft or in 20 gallons of
water per acre by ground equip-
ment. Apply thoroughly. Begint!
application at first bloom.
Pepper weevil 12.24-48 Ib/A Foliar application. Apply at
Tomato hornworm (50-96% D) first fruit set and repeat up ti
(93-96% WP/D) 5 times at 5 day intervals.
FRSTR Date: 9-15-87
111-075101-10
114
-------
Site and Pest
0011AA Pumpkin
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulation(s)
7 ppra (combined fluorine)
3 day preharvest interval through
20.7 pounds per acre (MAI) for
foliar application.
[BQADA
4014AA
Squash vine
borer
Radish
IJ012AA
I&QADA
Squash
Squash vine
borer
6AA
Strawberry
BUBCA
BGADA
Omnivorous
leafroller
Strawberry
leafroller
[MAI]
12-20.7 Ib/A
(35-48% D)
Foliar application. Apply twice
a week to stems and vines at base
of plants.
Formulated with malathion.
7 ppm (combined fluorine (with or
without tops))
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
Refer to Collards cluster for additional infor-
mation.
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
[MAI]
14-18.4 Ib/A
(35-48% D)
Foliar application.
Formulated with malathion.
Also refer to Cantaloupe cluster for additional
information.
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation.
12.5-48 Ib/A
(50-96% D)
or
7.68-9.6 Ib/A
[spray]
or
24-48 Ib/A
[dust]
(93-96% WP/D)
Foliar application.
FRSTR Date: 9-15-87 III-075101-11
115
-------
Site and Pest
EPA Compendium of Acceptable Uses
CRYOLITE
Dosages and Tolerance. Use. Limitations
Formulationf s)
NAMDJA
11005AA
Strawberry (continued)
Strawberry leaf 12.5-28.8
beetles Ib/A
(50-72% D)
Taneelo
Tangerine
Tomato
NBGAAA
TBCCSA
NAMADA
TBCBOA
TBRAJA
TAMANA
Blister beetles 12.5-48 Ib/A
Cabbage looper (50-96% D)
Flea beetles (93-96% WP/D)
Tomato fruit-
worm [MAI]
Tomato hornworm 9.6-25 Ib/A
Tomato pinworm (35-50% D)
Turnips
Watermelons
Foliar application.
See Grapefruit cluster.
See Grapefruit cluster.
7 ppm (combined fluorine)
No preharvest interval through 48
pounds per acre for foliar appli-
cation. Apply when plants are
first set out and repeat as need-
ed.
Foliar application.
Foliar application.
May be formulated with one or a
combination of: naled or mala-
thion.
See Collards cluster.
See Cantaloupe cluster.
FRSTR Date: 9-15-87 III-075101-12
116
-------
OOOAA
OOODA
5000AA
5000DA
4004AA
4004DA
BGAZA
IASACA
iSCWA
iXAlC
HOAAA
ISAVA
EPA Compendium of Acceptable Uses
CRYOLITE
Site and Pest
Dosages and Tolerance. Use
Formulation(s)
Limitations
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
Ornamental Shade Trees
(including nursery stock)
Ornamental Trees (including
nursery stock)
Ornamental Woodv Shrubs
(including nursery stock)
Codling moth
Flea weevils
Fuller rose
beetle
Gypsy moth
(larvae)
Katydids
Plum curculio
23.25-48 Ib/A Foliar application. Per acre
(96% D) rates may be applied by aircraft
(93-96% WP/D)
01500
iAAAA
AERIAL. MOTHPROOFING AND TANK MIX APPLICATIONS
Aerial Application
Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
All Sites
TERRESTRIAL NONFOOD CROP
(Ornamental Plants and Forest Trees)
All Sites
FRSTR Date: 9-15-87 III-075101-13
117
-------
V. FORMS APPENDICES
118
-------
OMB Approval No.
Expires 11/30,39
2070-0057
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
Wrtti tmptct n tfw rtqumnmt to aibar!
GuMMCi OocuoMnt. I tm raojondmi M
•VtteFIFNA
3(C)(2)(8) not**
Ol. I
u.lf DM MI
• •*• N«»«ra •( Expot 6fM»t M OM
tor r« aoi
Greue. OECO
Dl IIMMvraradimew
TfW MiB^ MH WV
** FIFHA i
• EM fcy:
NAME OF OTHER REGISTRANT
Q 3. I OTdOT • funfttut "ttntiatim tt Aranft to Enor Into M Arvomm nitti OttNr Ko«ionmi lor OwotooiMm o< Ota" »i'h
r«9«et to KM toilomnf tea i
•ONATUMC
DATE
119
-------
OMB A-pproval No. 2070-0057
Expires 11/30/89
(To gutlifY. certify ALL fourrttmtl
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(s) who are subiect 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:
NAME OP PIMM
(This firm or group of firms is referred to below as "my fi
2. My firm is willing to develop and
into an agreement with one or nw
items or data:
OUIOANCt OOCUMCNT DATE
ACTIVf INOMf OICNT
EPA COMPANY NUMBER
rm".)
submit the data as required by that Notice, if noeesaary. However, my firm would prefer to enter
re other registrants to develop jointly, or to shore m the coat of developing, the following required
3. My firm has offered in wntins; to enter into such an agreement Copies of tha offers art attached. That offer was irrevocable and included an offer to b«
bound by on arbitration decision under FIFRA Section 3(e)(2)(B)(iii) if fine) agreement on all ttrmi could not be reached ottenma. This offer was mads
to tnt followmf firm(s) on tha following doted):
MAM* OP PIMM
However, none of those firm(sl accept
ad my offer.
OATS OF OMCM •
4. My firm request* that EPA not suspend the registration's) of my firm's productlsl. 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. 1 understand EPA will promptly inform
mo whether my firm must submit data to avoid suspension of its registrations) under FIFRA Section 3(cM2)(BI. (This statement
doe* not apply to applicant! (or new products.) 1 grve EPA permission to disclose this statement upon requect.
TTPIO NAME
SIONATUMI DATE
EPA Form
120
-------
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
S158.120
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
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
121
-------
Registration
Guideline No.
63-13
63-14
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
Elammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
.
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, 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
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
122
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and an familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the oroduct contains the active ingredient solely as the result of the
incorooration into the product of another product which contains that active
ingredient, which is registered under FIFPA Section 3, and which is purchased by
us from another producer.
(3) An accurate confidental statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
___-^_^_—____i^__—_ and their registration number (s) is/are ___^^___—__
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any tine any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the reauired generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
retirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm coanits to submit and submits
the reauired data in the specified tiae frame. I understand that, in such cases,
the Agency generally will not grant a tiae extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated: _
(Typed)
123
-------
2070-0060
CERTIFICATION WITH RESPECT TO CITATION OF DATA
EPA File Symbol/Reg. No. _ Date of aoolication
Name of Product
Applicant's Name and Address
1. This application is supported by all data submitted or cited in the
application. In addition, if cite-all options are indicated, this application
is supported by all data in the Agency's files that concern the properties
or effects of this product or of any other product that is identical or
substantially similar, and that is one of the types of data that would be
required to be submitted if this application sought the initial registration
of a product of identical or similar composition and intended uses under
the data requirements in effect on the date of approval of this application.
2. Z certify that, for each Study cited in support of this application
for registration that is an exclusive use study, I have obtained the
written permission of the original data submitter to cite that study*
3. I certify that, for each study cited in support of this application
for registration that is not an exclusive use study:
I have obtained the written permission of the original data submitter
to cite that study? or
I have notified in writing the companies who have submitted data I have
cited to suooort this application and have offered to: (a) Pay compensation
for those data in accordance with section 3(c)(l)(D) and 3(cH2MD) of
the Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence
negotiations to determine which data are subject to the compensation
requirement of FIFRA and the amount and terms of compensation due, if
any. The companies I have notified are: (Check one)
( ] All companies listed on the Pesticide Data Submitters List for
all active ingredients contained in my product (Cite-all method or
cite-all option under Selective Method). (Also sign the General
Offer to Pay Statement below.)
( ] Those companies who have submitted the studies which I have
cited (Selective method)
Signatore
Title
General Offer to Pay» I hereby offer and agree to pay compensation to
other persons, with regard to the approval of this application, to the
extent required by FIFRA sec. 3(c)(l)(D) and 3(c)(2)(D).
Date Signature
Title
EPA Form (April 1985) 124
• u. s. covCM«t»T 0*i«u*c orncc:i»«T.sia..::j.s
------- |