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C 20460
540/RS-89-034
Guidance for the
Reregistration of
Pesticide Products
Containing DIFENZOQUAT
METHYL SULFATE
as the Active Ingredient
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OMB Control No. 2070-0057
Expires November 1989
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
DIFENZOQUAT METHYL SULFATE
AS THE ACTIVE INGREDIENT
OPP Chemical Number: 106401
GS 0223
CAS (DOCKET) NUMBER : 43222-48-6 (SALT)
December 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Covered by this Standard 4
A. Description of Chemical 4
B. Use Profile 4
III. Agency Assessment 7
A. Summary Science Statement 7
B. Health Effects Assessment 9
.C. Environmental Chacteristics and Effects . . 11
D. Tolerance Reassessment 14
IV. Regulatory Position and Rationale 17
A. Regulatory Positions 17
B. Criteria for Registration 21
C. Acceptable Ranges and Limits. 21
D. Required Labeling 22
V. Products Subject to this Standard 24
VI. Requirement for Submittal of Generic Data 26
A. What are generic data? 26
B. Who must submit generic data? 26
C. What generic data must be submitted?. ... 27
D. How to comply with DCI requirements .... 27
E. Registrant requests regarding data
requirements and Agency responses 28
F. Test protocols and standards 30
G. Procedures for requesting a
change in protocol 31
H. Procedures for requesting extensions of time 31
I. Data Format and Reporting Requirements. . . 31
J. Existing stocks provisions upon suspension or
cancellation 32
VII. Requirement for Submittal of Product-Specific Data . 33
VIII. Requirement for Submittal of Revised Labeling ... 34
IX. Instructions for Submittal 35
A. Manufacturing use products (sole active). . 35
B. Manufacturing use products (multiple active) 35
C. End use products (sole active) 37
D. End use products (multiple active) 37
E. Intrastate Products 38
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APPENDICES
I. DATA APPENDICES 39
Guide to Tables 39
Table A 42
Table B 68
II. LABELING APPENDICES 72
Summary of label requirements and table
40 CFR 156.10 Labeling Requirements 73
Physical/Chemical Hazards Labeling Statements. 82
Storage Instructions 83
Pesticide Disposal Instructions 84
Container Disposal Instructions 85
III. BIBLIOGRAPHY APPENDICES 86
Guide to Bibliography 87
Bibliography 89
IV. FORMS APPENDICES • . 99
EPA Form 8580-1 FIFRA 3(c)(2)(B) Summary Sheet
EPA Form 8580-3 Generic Data Exemption Statement
EPA Form 8580-4 Product Specific Data Report
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other
Registrants for Development of
Data
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a. i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HOT
LC50
LD50
LDT
LEL
MPI
An acceptable daily intake of pesticide residue
based on a complete data base.
Active ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The
estimated pesticide concentration in an
environment, such as a terrestrial or aquatic
ecosystem.
End Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Highest dose tested in a toxicity study.
Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals. It
is usually expressed as the weight of substance per
weight or volume of water or feed, e.g. , mg/l or
ppm.
Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of
the test animals, when administered by the route
indicated (oral : dermal). It is usually expressed
as a weight of substance per unit weight of animal,
e.g., mg/kg.
Lowest dose tested in a toxicity study.
Lowest Effect Level from a toxicity test in
animals.
Maximum Permissible Intake of residues.
111
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MRID Master Record Identification (number). EPA's
system of recording and tracking studies submitted
to the Agency.
MP Manufacturing Use Product
NPDES National Pollutant Discharge Elimination System
NOEL
OPP
PAD I
ppm
RfD
TMRC
No Observed Effect Level from a toxicity study.
Office of Pesticide Programs
Provisional Acceptable Daily Intake is an
acceptable daily intake of pesticide residue that
is based on a limited data base.
Parts per million
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).
Theoretical Maximum Residue Contribution is an
estimate of dietary exposure obtained by
multiplying residue tolerance levels for a given
pesticide by the average daily per capita food
consumption figure, then adding the exposure figure
for each crop. The TMRC is usually expressed in
terms of mg/kg of food.
IV
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing an
active ingredient subject to this Standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:.
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request,^ 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
The scientific reviews and Compendium of Acceptable
Uses may be obtained from the OPP Public Docket. Write to
OPP Public Docket, Field Operations Division (H7506C),
Office of Pesticide Programs, EPA, Washington, D.C. 20460
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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. Submittal 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 these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
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.
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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 the Tables A, B, and
C 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 submittal of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A.Description of Chemical
Difenzoquat is the American National Standards Institute
(ANSI) common chemical name for 1,2-dimethyl-3,5-diphenyl-l
H-pyrazolium. It is marketed under the trade name AVENGE by
American Cyanamid Company. AVENGE contains the methyl
sulfate salt of difenzoquat.
Other identifying characteristics and codes are:
Empirical Formula: dsH2oN2°4s (Salt)
Molecular weight: 360.4 (Salt)
CAS Registry No.: 43222-48-6 (Salt)
OPP (Shaughnessy) No.: 106401 (Salt)
General Description of Chemical
Difenzoquat is a white, odorless, crystalline solid with
a bulk density of 41 lb/cu.ft.. Difenzoquat is soluble in
water; 76.5% at 23°C. It is poorly soluble in most organic
solvents. This chemical is very stable under most conditions.
B. Use Profile
Difenzoquat or AVENGE is a postemergent herbicide for
control of wild oats in alfalfa (seed crop in CA), wheat and
barley. It is readily absorbed by plants and is not
significantly metabolized or further degraded. The exact
herbicidal mode of action of difenzoquat is not currently
understood.
The only pest claim on the end-use products is for-
control of wild oats (Avena fatua) which is one of the most
serious annual weeds in the hard red spring wheat growing
areas of Montana, North Dakota, and Minnesota. Wild oats is
an annual grassy weed with growth habits that out-compete
wheat and barley and create serious yield losses.
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Difenzoquat is applied postemergence broadcast by ground
or aerial equipment when wild oats are in the three to five
leaf stage (tillering). The rates of application range from
0.6 to 1.0 Ibs./acre. This herbicide may be used on all
varieties of barley and certain varieties of wheat. Since
difenzoquat is highly selective in its weed control, it is
usually tank mixed with broadleaf herbicides such as the
amine salts or esters of MCPA (2-methyl-4-chlorophenoxyacetic
acid) or 2,4-D {2,4-dichlorophenoxyacetic acid), metsulfuron
methyl, bromoxynil, or chlorsulfuron.
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Table I. Listing of Registered Products Containing
Difenzoquat Methyl Sulfate
Formulation and
Registration No.
Product Name
Manufacturer
96% Technical Chemical
EPA Reg. NO. 241-239
AVENGE Technical
Herbicide
American
Cyanamid
Company
31.2% Soluble Concentrate
Liquid (2 Ib./gal)
EPA Reg. No. 241-266
AVENGE Wild Oat
Herbicide
American
Cyanamid
Company
31.8% Soluble Concentrate
Liquid (2 Ib./gal)
EPA Reg. No. 241-250
AVENGE 2AS Wild
Oat Herbicide
62.5% Soluble Concentrate/ AVENGE S Wild
Solid Oat Herbicide
EPA Reg. No. 241-262
American
Cyanamid
Company
American
Cyanamid
Company
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II. AGENCY ASSESSMENT
The Agency has reviewed all data in Agency files as of
June 14, 1988 supporting the registration of difenzoquat.
Data received by the Agency after this date have not been
reviewed for the purposes of this standard. This section
discusses the Agency's scientific findings and conclusions
based on these reviewed data.
A. SUMMARY
The Agency has reviewed all available data for
difenzoquat and determined that there are data gaps in the
areas of residue chemistry, environmental fate, and
toxicology.
A summary of these data gaps appears in Table II. Note
that this list contains only summary information on the data
gaps. More detailed information relating to the issues can be
found in the Data Tables in Appendix I.
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Table II. Summary of Data Gaps for Difenzoguat
Toxicology
Acute Oral Toxicity in one sex (females)
Acute Dermal Toxicity in one sex (females)
Acute Inhalation Toxicity in one sex (females)
Dermal Sensitization
Subchronic Dermal (21-day)
Chronic Toxicity in one species (nonrodent)
Teratogenicity in one species (rat)
Oncogenicity in one species (mouse)
Mutagenicity
(Gene mutation, chromosomal aberration, and direct DNA
damage studies).
Metabolism
Ecological Effects
(None identified)
Environmental Fate
Hydrolysis
Photodegradation in water and on soil
Aerobic and anaerobic soil metabolism
Leaching and Adsorption/Desorption
Volatility (Lab)
Terrestrial field dissipation (soil)
Accumulation rotational crops (confined)
Fish accumulation
Product Chemistry
Product Identity and Disclosure of Ingredients
Description of Manufacturing Process
Discussion of Formulation and Impurities
Preliminary Analysis of Product Samples
Certification of Ingredient Limits
Analytical Methods to Verify Certified Limits
Physical and Chemical Characteristics
Residue Chemistry: Tolerance Reassessment
Nature of the Residue (Metabolism) in Livestock
Residue Analytical Methods
Storage Stability Data
Magnitude of Residue in Plants,
Fat/Meat/Meat Byproducts
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B. Health Effects Assessments
l. Acute Toxicitv
In studies with male rodents difenzoquat is moderately
toxic by the oral route and only slightly toxic via the
dermal route of exposure in rabbits. It has an extremely low
toxicity via the inhalation route of exposure. Difenzoquat
was found to be only slightly irritating to rabbits' eyes and
moderately irritating to abraded skin while non-irritating to
intact skin.
No data on the oral, dermal, inhalation toxicity and
dermal sensitization of difenzoquat in female test animals
available for review. These studies are required.
2. Subchronic Toxicity
In a 21-day subchronic dermal exposure study with
difenzoquat, rabbits were dosed dermal'^for 21 days at doses
of 0.25, 0.5, and 1.0 g/kg. The test material was applied for
six hours a day, five days a week, and half of application
sites were abraded. No toxic signs were exhibited in male
rabbits at 0.5 g/kg level and in female rabbits at 1.0 g/kg
level. Decreased body weight gain was the only toxic effect
noted .in males at'-the 1.0 g/kg level. However, the study
reviewed was judged to be inadequate because it failed to
note basic test parameters such as: application sites; food
consumption; clinical biochemistry tests; organ weights; and
an insufficient number of test animals from the high-dose
group were microscopically examined. A new study is required.
No compound related effects were observed in male and
female dogs in a 90-day oral feeding study. The systemic
NOEL in that study is 2500 ppm (62.5 mg/kg:HDT).
3. Chronic Toxicity
There are no chronic feeding studies conducted with
difenzoquat in non-rodents. This study is required.
The only toxic sign noted in a 2 year chronic feeding study
in rats was a decrease in body weight gain in both sexes at
the 2500 ppm level (125 mg/kg). A systemic NOEL was
established at the 500 ppm level (25 mg/kg) for males and
females.
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4. Developmental Effects and Teratology
Teratogenic, fetotoxic and maternal toxic effects were
not observed in rabbits at the 100 mg/kg level. However, high
mortality and high percentage of animals with resorptions
were observed at the high level (250 mg/kg:HDT).
Difenzoquat was negative for .teratogenicity,
fetotoxicity and maternal toxicity in the rat at the 2500 ppm
(125 mg/kg; HOT) level. However, the test material was
incorrectly administered, thus invalidating the test. No
maternal toxicity was observed at the highest level tested.
Another rat teratology study is required.
§•. Reproduction
In a 3-generation rat reproduction study, the parental
NOEL was equal to or greater than 2500 ppm (125 mg/kg:HDT)
and reproductive/ developmental NOEL was 500 ppm (25 mg/kg).
Decreased body weights of male and female pups at weaning in
all generations and decreased body weights of male and female
pups at birth in the second and third generation,
respectively, were observed at the 2500 ppm level.
6- Oncogenicitv
In a 2-year oncogenicity study in rats, difenzoquat was
administered in the diet at levels of 100 ppm (5 mg/kg), 500
ppm (25 mg/kg), 2500 ppm (125 mg/kg), and 5000 ppm (250
mg/kg). No oncogenic effects were observed at any dose level.
However, the oncogenic potential of difenzoquat in mice
could not be determined because too few animals (tissues)
were examined microscopically at all dose levels and
particularly at the 2500 ppm (375 mg/kg:HDT) level in an 18-
month feeding study. A new mouse oncogenicity study is
required.
6. Mutagenicitv
Insufficient data are available to evaluate the
mutagenicity potential of difenzoquat. The following studies
are required: gene mutation; chromosomal aberration; and
direct DNA damage.
1C
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The only mutagenic study available is a dominant lethal
study. Difenzoquat was judged not to be mutagenic in this
study because of the low incidence of embryonic mortality
when females were mated with treated males as compared with
females mated with untreated males. This study has been
provisionally classified as unacceptable because a positive
control was not reported. This study may be upgraded upon
receipt of information regarding the positive control.
C. Environmental Characteristics and Effects
1. Environmental Fate
The review of the environmental fate data indicates that
difenzoquat is stable to hydrolysis. Difenzoquat is not
likely to leach because it remains bound to soil particles
and thus is not expected to contaminate groundwater.
While the studies available to the Agency have not been
conducted according to the Agency's guidelines they have been
deemed good studies following generally sound scientific
practice. They have been classified as "supplemental"
information on which to base the characterization of the fate
of difenzoquat.
Hydrolysis study: This study does not fulfill data
requirements because the test substance and the buffer
solutions were incompletely characterized. However, the data
suggest that difenzoquat is stable to hydrolysis. This study
may be made acceptable if the appropriate information can be
supplied.
Photodegradation studies in water: Two studies are
available. One study is unacceptable because it was done in
pond water. In addition the sampling protocol was inadequate
(sampling was too infrequent and >90% of the difenzoquat
dissipated between the first and second samplings) to
precluding an accurate characterization of the
photodegradation half-life of difenzoquat in water. The
second study is also unacceptable because there were no dark
controls, it was not specified that the solutions were
sterile, and the sampling protocol (sunlight-irradiated
solutions were analyzed at 58 days posttreatment only) was
inadequate to accurately establish the photodegradation of
difenzoquat in aqueous solutions.
I 1
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Photodeqradation studies on soil: One study is
available. This study does not fulfill data requirements
because the natural sunlight, the test substance and test
soil were incompletely characterized. Also the incubation
temperature was too high, ranging from 22-42°C.
Aerobic soil metabolism studies: No data were available
for review.
Anaerobic soil metabolism studies: No data were
available for review.
Leaching and adsorption/desorption study; This study
does not fulfill data requirements because the imaged and
aged portion of the test substance does not fully
characterize the test substance, the description of
incubation conditions during the aging period was inadequate,
and [14C]residues in the soil before and after leaching were
not characterized.
Terrestrial field dissipation studies: Twelve studies
are available. Six studies are unacceptable because they do
not meet EPA Guidelines. Six studies provide supplemental
information that suggests difenzoquat dissipates with a half-
life of 7 to 180 days depending on soil type. These six
studies do not fulfill data requirements because freezer
storage stability data were not provided.
Confined accumulation studies on rotational crops; No
data were available for review.
Laboratory studies of pesticide accumulation in fish: No
data were available for review.
The following data requirements are deferred until the
submission and evaluation of all of the previously identified
environmental fate data requirements: photodegradation in
air, aerobic and anaerobic aquatic metabolism, field
volatility, aquatic field dissipation, forest dissipation,
dissipation for combination products and tank mixes, long-
term field accumulation on irrigated crops, and field
accumulation in fish (laboratory).
Reentry
Reentry data are not required based on current use
patterns of difenzoquat; postemergent applications to wheat
and barley are at a time when workers are not expected to be
in treated fields. Wheat and barley are harvested by machine
and workers are not expected to be exposed to difenzoquat
during harvest.
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2. Ecological Effects
The available data were adequate to fully assess the
potential hazards relating to the ecological effects for
difenzoquat. No adverse effects to birds and mammals from the
currently registered uses of difenzoquat are anticipated.
Difenzoquat is slightly toxic to mallard ducks (LD50 -
10,388 ppm) and bobwhite quail (LD5Q -4640 ppm). Difenzoquat
was found to be slightly toxic to fish (bluegill LC50 - 90.4
ppm and rainbow trout LC50 - 76-99 ppm). Aquatic
invertebrates were found to be the most sensitive test group
to difenzoquat. Technical difenzoquat was found to be
moderately toxic to freshwater invertebrates (Daphnia LC50 -
2.63 ppm).
A worst case scenario model for exposure of aquatic
species would be a direct application to a farm pond using
the maximum application rate applied to wheat and barley, 1
Ib/ai/A. This type of application can be expected to result
in a concentration of 0.061 ppm. This concentration is 43
times lower than the LC5Q for Daphnia (2.63 ppm) .-. Since this
worst case scenario model does not indicate concern for
aquatic invertebrates, additional modeling of runoff and
drift is unnecessary.
Adverse chronic effects on terrestrial and aquatic
species from difenzoquat are not anticipated because of its
low toxicity and use restriction to a single application per
season.
No data relating to nontarget insects are required.
The uses for this herbicide, single postemergent applications
to wheat and barley, do not represent significant exposure
routes for honey bees.
3.Endangered Species
The uses of difenzoquat will have a low potential for
hazard to endangered plant and animal species. These uses,
are not expected to result in difenzoquat entering the
habitat of susceptible aquatic and terrestrial organisms in
significant concentrations. Since the only uses of this
chemical are applications to cultivated crops, difenzoquat is
not expected to have an adverse impact on endangered plant
species. Risks to endangered plant and animal species have
been deemed to be minimal and no additional data are needed.
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D. Tolerance Reassessment
Residue Data
Tolerances have been established on a number of raw
agricultural commodities and in meat, fat, and meat
byproducts (40 CFR 180.369) for difenzoquat at levels ranging
from 0.05 to 20.0 ppm. A Canadian maximum residue limit (MRL)
of 0.1 ppm (negligible residue) has been established for
difenzoquat in or on wheat and barley grain. There are no
Mexican tolerances or Codex MRL for residues of difenzoquat
in or on wheat grain. There are no Canadian or Mexican
tolerances or Codex Maximum Residue Levels (MRL) for
difenzoquat in or on barley or wheat straw. A listing of the
established tolerances and MRLs -is located at the end of this
section.
The Agency has evaluated the residue and toxicology data
supporting the tolerances and reviewed all uses of
difenzoquat. Based on the available data the Agency has
reached the following conclusions:
° The metabolism of difenzoquat in ruminants and poultry
is not adequately understood. The tolrances for
residues in animal commodities cannot be assessed at
this time until the required animal metabolism,
storage stability and method validation studies have
been submitted and reviewed.
° The metabolism of difenzoquat in small grains is
adequately understood. In barley plants difenzoquat
remains almost entirely unmetabolized (96% of
radiolabelled residues consisted of unaltared
difenzoquat). One possible metabolites is 1-methyl-
3,5-diphenyl pyrazole. Other metabolites present in
trace amounts of those found in soil and
photodegradation studies.
° Adequate methods exist for data collection and
enforcement.
° Data adequately support the tolerances for residues
of difenzoquat in barley and wheat grain, and straw.
However, storage stability data are needed to
validate these data.
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Tolerance Assessment System (TAS) Tolerance Reassessment
A Reference Dose (Rfd) was established for difenzoquat
based on a NOEL of 25 mg/kg from a two-year rat feeding
study, using a safety factor of 300 to account for the lack
of a chronic study in the most sensitive species, the dog.
The Rfd is 0.08 mg/kg/day. It is considered a Provisional
Allowable Daily Intake (PADI) because of the data gaps. The
study from which the NOEL is taken is considered of only fair
quality and is given a low confidence rating; the highest
dose tested produced only marginal decrease in weight gain,
but the change was consistent during a significant part of
the study.
Dietary exposure was calculated using the published
tolerances. The TAS Routine Chronic Analysis estimated a
daily intake of 0.000219 mg/kg/day for the average U.S.
population, 0.27% of the RfD. No population subgroup consumed
more than 0.52% of the RfD.
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Table IV. Summary of Tolerances Issued for Difenzoquat
Tolerances (ppm) KRL
Commodities US1Canada2 International3
Barley, grain 0.2 O.l(N)
Barley, straw 20
Cattle, fat 0.05
Cattle, meat 0.05
Cattle, meat byproducts 0.05
Goats, fat 0.05
Goats, meat 0.05
Goats, meat byproducts 0.05
Hogs, fat 0.05
Hogs, meat 0.05
Hogs, meat byproducts 0.05
Horses, fat 0.05
Horses, meat 0.05
Horses, meat byproducts 0.05
Poultry, fat 0.05
Poultry, meat 0.05
Poultry, meat byproducts 0.05
Sheep, fat 0.05
Sheep, meat 0.05
Sheep, meat byproduct 0.05
Wheat, grain 0.05 O.l(N)
Wheat, straw 20
I./ The United States tolerances are expressed as residues of
difenzoquat (calculated as cation).
2/ Canadian MRLs are expressed in terms of residues of
difenzoquat per se.
I/ No Mexican tolerances or Codex Maximum Residue Level (MRL)
have been established for difenzoquat.
N - negligible.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on the review and evaluation of the available data
on difenzoquat, the Agency has made the following
determinations. Where label revisions are imposed, specific
language is set forth in Section C of this Chapter.
1. The Agency will not initiate a Special Review of
difenzoquat.
Rationale: Based on the data available to the Agency,
difenzoquat does not exceed any of the risk criteria for
Special Review specified in 40 CFR 154.7.
2. The Agency is not imposing restricted use
classification on difenzoquat.
Rationale: At present, there is no indication that
difenzoquat meets the criteria for restricted use in 40 CFR
152.170.
3. The Agency is not requiring registrants to place
endangered species labeling on end-use products containing
difenzoquat.
Rationale; The principal use patterns for difenzoquat
are single postemergent applications to barley and wheat. The
low toxicity to fish, mammals, and aquatic invertebrates
combined with the limited use patterns is not expected to
result in any adverse impact on endangered or threatened
species.
Since the only federally registered uses of this
pesticide are applications to cultivated crops, it is not
expected to have an adverse impact on endangered plant
species.
4. The available residue chemistry data are
insufficient to permit the Agency to conduct a full tolerance
reassessment.
Rationale: Data gaps exist for animal metabolism and
magnitude of residue for difenzoquat in ruminants and
poultry.
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5. No new/additional tolerances for feed items treated
with difenzoquat will be issued until the animal data have
been submitted and reviewed by the Agency. Until these data
gaps are filled, the Agency believes that it is prudent not
to issue any new/additional tolerances for difenzoquat.
Rationale: Available animal metabolism and magnitude of
residues in livestock data, are insufficient and/or lacking.
These data deficiencies preclude the Agency from conducting a
full tolerance reassessment.
6. The Agency is not requiring the use of personal
protective clothing or establishment of reentry intervals for
difenzoquat.
Rationale; Based on the available toxicological
information, there are no concerns with human exposure which
would require personal protective clothing and specific field
reentry intervals.
7. The Agency is not requiring the addition of a
groundwater advisory statement to difenzoquat labels.
Rationale: No acceptable environmental fate data are
available to fully assess this issue. The Agency is requiring
the submission of environmental fate data. Refer to Appendix
I, Table A for the specific data requirements. While certain
environmental fate data are lacking, a preliminary review of
the available data indicates that difenzoquat is not
persistent and does not leach. Rather, it remains bound in
nearby soil particles and is not expected to contaminate
groundwater. After a review of the data sufficient to
evaluate groundwater hazards, the Agency will take the
appropriate steps to protect groundwater if necessary.
8. No studies have been identified for priority review.
The Agency will review the studies submitted under this
Registration Standard when it schedules difenzoquat for a
second round review.
Rationale; There are no human health or environmental
concerns that warrant early review of these studies.
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9. Data in support of tolerances on alfalfa hay and seed
must be submitted, and pre-harvest intervals proposed. If the
registrant of this use, permitted only in California under
SLN CA 770540, can demonstrate to the Agency's satisfaction
that treated alfalfa seed and hay will not be used for food
or animal feed purposes, the Agency will consider this use to
be a non-food, non-feed use not requiring the establishment
of a tolerance. The State of California, California
Department of Food and Agriculture (CDFA),' must establish the
following restrictions regarding alfalfa treated with
difenzoquat, as well as provide evidence of ability to
enforce these restrictions.
a. All screenings must be disposed of in such a way that
they cannot be distributed or used for food or feed. The seed
conditioner must keep records of screening disposal for three
-years from the date of disposal and shall furnish the records
to the director of the California Department of Food and
Agriculture upon request. Disposal records shall consist of
documentation from a controlled dump site, incinerator, or
other equivalent disposal cite and shall show the amount of
material disposed of, its grower, and the date of disposal.
b. No portion of the seed alfalfa plant, including but
to limited to green chop, hay, pellets, meal, whole seed, and
cracked seed, may be used or distributed for food or feed
purposes.
c. All alfalfa seed conditioned in the state of
California must be bear a label tag which prohibits the use
of the seed for human consumption or animal feed.
d. No alfalfa seed conditioned in California may be
distributed for human consumption or animal feed.
Rationale: No tolerances have been established for
difenzoquat in or on alfalfa seed and hay. Restrictive
provisions upon the use of treated alfalfa, however, will
permit a determination that tolerances are not necessary.
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10. While data gaps are being filled, currently
registered manufacturing use products (MPs) and end use
products (EPs) containing difenzoquat may be sold,
formulated and used, subject to the terms and conditions
specified in this Standard. Registrant must provide or agree
to develop additional data, as specified in the Data
Appendicies, in order to maintain existing registrations.
Rational; Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data are
missing or inadequate (see FIFRA section 3(c)(2)(B) and
3(c)(7)). The issuance of this Standard provides the
mechanism for obtaining necessary data. The data will be
reviewed and evaluated, after which the Agency will determine
if additional regulatory actions are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Star.dard,
products must contain difenzoquat, bear required labeling,
and conform to the product composition, acute toxicity
limits, and use pattern requirements listed in this
registration standard.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain this
pesticide. Each MP formulation proposed for registration
must be fully described with an appropriate certification of
limits, stating -maximum and minimum amounts of the active
ingredient and inert ingredients which are present in
products, as well as impurities found at greater than 0.1
percent.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing this pesticide
provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category in
which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The EPA Compendium of
Acceptable Uses (for availability, see page 1) lists all
registered uses, as well as approved maximum application
rates and frequencies.
Terrestrial, non-domestic, food uses on:
Barley
Wheat
Alfalfa (seed crop only under SLN in CA)
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D. LABELING
In order to remain in compliance with F1FRA, products
must bear appropriate labeling as specified in 40 CFR 156.10
and this Standard, or must be revised to conform to those
specifications. Appendix II contains information on label
requirements.
No pesticide product containing this pesticide may be
released for shipment by the registrant after December 31,
1988, unless the product bears an amended label which
complies with the requirements of this Standard.
No pesticide product containing this pesticide may be
distributed or sold after December 31, 1988, unless the
product bears an amended label which complies with the
requirements of this Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. Ingredients Statement
The ingredient statement for products must list the
active ingredient as:
ACTIVE INGREDIENT
difenzoquat methyl sulfate %
INERT INGREDIENTS %
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. Labeling must specify sites, which are listed
in Compendium of Acceptable Uses. However, no use may be
included on the label where the registrant fails to agree to
comply with the data requirements in TABLE A for that use
pattern.
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3. Precautionary Statements:
Environmental Hazard Statements
a. Statements for Manufacturing-Use Product
"Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public water
unless this product is specifically identified and addressed
in a NPDES permit. Do not discharge effluent containing this
product into sewer systems without previously notifying the
sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
b. Statements for End-Use Products
"Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate water when
disposing of equipment washwaters."
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V. 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 submittal 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 B.2
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 pesticide as
one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2Data 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 an end-use producer who is
eligible for the generic data 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 submittal 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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2. The labeling requirements specified for
manufacturing use products in Section IV.
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 generic data exemption,
3e data requirements listed in Table C.
3. If not eligible for the generic data exemption,
the data requirements listed in Table A and the
data requirements listed in Table C.
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:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
•*If you purchase from another producer and use as the
source of your active ingredient only EPA-registered
products, you are eligible for the generic data 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 the data requirements in Table A.
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VI. 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 ingredient.4
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 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 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.
Registrations granted after issuance of this Standard
will be conditioned upon submittal or citation of the data
listed in this Registration Standard.
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If you are not now eligible for a generic data
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 Generic Data
Exemption Statement.
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
submittal 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.
D. How to comply with DCI 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 (or 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
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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
submittal. 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, as part of your 90-day response. 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 th-at the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals 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 DCI. 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).
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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 your 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
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. The Agency will
respond in writing to your request for a waiver.
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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 regis-
tration of your product(s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
changes, or time extensions must be submitted in writing.
The original requirement remains in effect unless the Agency
has notified you in writing that it has agreed to a change in
the requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the requirement.
F. Test Protocols and Standards
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. All testing mus-t
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are
referenced in the Data Tables, are available from the
National Technical Information Service (NTIS), Attn: Order
Desk, 5285 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
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
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G. Procedures for requesting a change in test 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 submittal
of the data, nor will extensions generally be given to
conduct studies due to submittal of inappropriate protocols.
The Agency will respond in writing to your request for
protocol approval or change.
H. Procedures for requesting extensions of time-.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before the
data submittal 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. The Agency will
respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
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). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
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J. 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 for the
registrant 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.
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VII. 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
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 through J. 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.
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VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
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 156.10 (see Appendix II -
LABELING and SUMMARY). In addition, labeling language
specific to products containing this pesticide is specified
in Section IV.D of this Registration Standard. Responses to
this Registration Standard must include draft labeling for
Agency review.
*
Labeling must 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. Draft labeling 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.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section IV.D., EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration
Standard must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
Attn: Difenzoquat Registration Standard
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential .Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
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c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course o'f 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:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form
8580-1) .
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you
must submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
C. Knd Use Products containing the subject pesticide as
sule active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
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b. confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if
required by Table C.
b. Product Specific Data Report (EPA Form 8580-4), if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the.problem, and your proposed course of action.
D. End Use Products containing the subject active
ingredient as one of multiple active'ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
37
-------
E. Intrastate Products
Applications for full Federal registration of intrastate
products were required to be submitted no later than July 31,
1988. Unless an application for registration was submitted
by that date, no product may be released for shipment by the
producer after July 31, 1988.
-------
I. DATA APPENDICES
TGUIDE-1
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 substante.
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:
l. 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
39
-------
TGUIDE-2
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
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. Biblioqraphic 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
40
-------
TGUIDE-3
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
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.
41
-------
Table A
Generic Data Requirements for Products Containing Difenzoquat
Data Requirement
Test
Substance^
Part 158.190. Subpart C. Product
Chemistry
Does EPA
Have Data to
Satisfy This
Requirement?
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3(c)(2UB)? Submission
Product Identity and Composition
61-1 - Product Identity and MP
Disclosure of Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufac-
turing Process
61-3 - Discussion of Formation TGAI
of Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
of Product Samples
62-2 - Certification of Ingredient MP
Limits
62-3 - Analytical Methods to Verify MP
Certified Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
Yes-3-/
No2-/
No2-/
No2-/
Wo2-/
No2-/
No2-/
No2-/
Yes6-/
9 Months
9 Months
9 Months
12 Months
12 Months
12 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for Products Containing Difenzoquat
Data Requirement
Part 158.190, Sobpart C, Product Chemi
Physical and Chemical
Characteristics (cont'd)
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
63-11 - Octanol/Water Partitioning
63-12 - cH
Does EPA
Have Data to
Test Satisfy This
Substance^ ' Requirement
Stry (cont'd)
TGAI NO2-/
TGAI NO2-/
TGAI No2-/
TGAI N62-/
TGAI or PAI No2-/
TGAI or PAI NO2-/
TGAI or PAI No2-/
PAI No2-/
TGAI No2-/
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section for
Citation 3(c)(2)(B) submission
Yes9/ 9 Months
Yes9/ 9 Months
NbV
Yes9/ 9 Months
Yes9/ 9 Months
Yes9/ 9 Months
Yes9/ 9 Months
Ass/ 9 Months
Yes3/ 9 Months
-------
Part 158.190. Suboart C. Product Chemistry (cont'd)
Physical and Chemical
Characteristics (cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64-1
- Stability
- Oxidizing or Reducing
Agent
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements:
- Submittal of Samples
TGAI • No2/
MP No2/
MP No2/
MP No2/
MP No2/
MP No2/
MP NO2/
MP NO2/
N/A N/A
Yes2/ 9 Months
Yes^' 9 Months
No2»H/ 9 Months
Yes2»12/ 9 Months
Yes^/ 15 Months
No2«13y 9 Months
No^ ' l^/ 9 Months
Yes^/ 15 Months
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PRODUCTS CONTAINING DIFENZOQUAT
Part 158.190, Subpart C, Product Chemistry - Footnotes
^/ Because the 96% T is also a manufacturing-use product, product chemistry data requirements applicable to both
technical and manufacturing use products are covered in this table .
2/ Although product chemistry may have been submitted in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
-2/ 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 code numbers.
4/ complete information must be provided 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 must be provided, along with information regarding
the properties of each beginning material used to manufacture each product.
5/ 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.
Ł/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which a
a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each analytical
method used. Specific analyses for the potential impurity, hydrazine, must be included.
2/ Upper and lower limits for the active ingredients and each intentionally added inert, and upper limits for each
impurity present at > 0.1% (w/w) and each "toxicologically significant" impurity present at <0.1% (w/w) 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. Certification must be submitted on EPA form
8570-4 Rev. 2-85.
-------
TABLE A.
GENERIC DATA REQUIREMENTS FOR PRODUCTS (XNTAINING DIFENZOQUAT
Part 158.190. Subpart C, Product Chemistry - Footnotes (cont'd)
Ł/ Analytical methods most be provided to determine the active ingredient, and each toxicologically significant impurity
Each method must be accompanied by validation studies indicating its accuracy and precision. These methods must be
suitable for enforcement of certified limits.
2/ AS required in the 40 CFR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D,
quantitative data are required on color, physical state, odor, melting point, specific gravity, solubility, vapor
pressure, dissociation constant, octanol/water partitioning coefficient, pH, and stability. Because the 96% T is also a
manufacturing-use product, quantitative data are also required on oxidizing/reducing action, expodability, storage
stability, and corrosion characteristics.
Data on boiling point are not required because the 96% T is a solid at room temperature.
Data on flammability are not required because the 96% T is not a combustible liquid.
Data are required if the product contains potentially explosive ingredients.
Data on viscosity are not required because the 96% T is a solid.
Data on miscibility are not required because the. 96% T is a solid.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIFENZOQUAT
Data Requirement
Test
substance
Does EPA
have data?
Bibliographic
citation
Must addi-
tional data
be submitted?
Time frame
for
Submission1
158.240 Residue Chemistry
171-2. Chemical Identity
171-3. Directions for use
171-4. Nature of the residue
(Metabolism)
- Plants
171-4. Nature of the residue
(Metabolism)
- Livestock
171-4. Residue analytical
methods
171-4. Storage stability
PAIRA
(See Index)
Yes
PAIRA and Partially
plant metabo-
lites
TGAI and
metabolites
TEP and
metabolites
Partially
No
00037957. 00037958.
00042200.
00110347.
00004614. 00004630.
00037959. 00038488.
00052480. 00052481.
NO
Yes2'3
Yes4'5'6
Yes'
18 months
15 months
18 months
(Continued)
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR DIFHSTZOQUAT (Continued) .
Test
Data Requirement substance
171-4. Magnitude of the residue
in plants
Cereal Grains
-Barley TEP
-Processed Barley
-Wheat TEP
-Processed Wheat
Forage, Fodder, and
Straw of Cereal Grains
- Barley Straw TEP
- Wheat Straw TEP
Must addi- Time frame
Does EPA Bibliographic tional data for
have data? citation • be submitted? sutmission1
•
Partially 00004610. 00004611. Yes7 18 months
00004612. 00004613. Yes8 24 months
00005567. 00052478.
00060117. 00060118.
00108772. 00110331.
00110349. 00110355.
Partially .00004637. 00004641. Yes7 18 months
00004647. 00004648. Yes9 24 months
00004652. 00004653.
00004654. 00004655.
00004656. 00004657.
00004658. 00004659.
00004660. 00060111.
00110347. 00110349.
Partially (see Barley Grain Yes7 18 months
listing)
.Partially (See Wheat Grain Yes7 18 months
listing)
(Continued).
-------
TABLE A. GENERIC DATA REQUIREMENTS FOR DIFENZOQUAT (Continued).
Data Requirement
Test Does EPA
substance have data?
Must addi-
Bibliographic tional data
citation be submitted?
Time frame
for
sutmission1
Crops Grown Solely for
OO6O
- -Alfalfa TEP No
171-4. Magnitude of residue in
Meat/Mi Ik/Poultry/Eggs
Milk, Fat, meat, and TGAI or plant Partially 00052481.
meat by-products of metabolites
cattle, goats, hogs, and
sheep
Yes
10
Yes
11
18 months
18 months
Poultry and eggs
TGAI or plant Partially . 00037959.
metabolites
Reserved11 18 months
1. Data must be submitted within the indicated time frame, based on the date of this Guidance Document.
2. Metabolism studies characterizing the total terminal residue of difenzoquat in milk, eggs and the
tissues of ruminants and poultry. Animals must be dosed orally for a minimum of 3 days with 3-pyrazolyl-
[14C]difenzoquat fed in the diet at a level sufficient to make residue identification and quantification
possible. Eggs and milk must be collected twice a day during the dosing period. Animals must be
slaughtered within 24 hours of the final dose. The distribution and identity of residues must be determined
in eggs, milk, liver, kidney, muscle, and fat. Representative samples from these studies must also be
analyzed using Method II in the PAM, Volume II to ascertain that the method is capable of adequately
recovering and identifying all residues of concern.
3. If the metabolism of difenzoquat in ruminants or poultry differs significantly from that in the rat,
swine metabolism studies may be required.
-------
TABLE A. Footnotes (continued).
4. Validation data are required for method M-504 to determine recovery efficiency from poultry tissue
samples fortified at the tolerance level pf 0.05 ppn.
5. The nature of the residue in livestock has not been adequately described. If the metabolism studies
required in the "Nature of the Residue in Animals" section reveal the presence of additional metabolites of
toxicological concern, additional validated methods for data collection and tolerance enforcement will be
required.•
6. Representative plant samples and samples of meat and poultry bearing residues of difenzoquat must be
analyzed by multiresidue protocols I and III, which are available from the National Technical Information
Service under Order No. PB 203734/AS.
7. The sample storage conditions and intervals must be supplied for all required and previously submitted
residue data for plant and animal commodities. Storage stability data in support of previously submitted
residue data are required only for those samples deemed to be useful in evaluation of the tolerance. Data
are also' required which depict the decline in difenzoquat residue levels in commodities stored under the
range of conditions and for the range in intervals specified. Crop samples bearing measurable weathered
residues or fortified with difenzoquat and fortified meat, milk, and egg samples must be analyzed
immediately after harvest or fortification and again after storage intervals that represent actual residue
sample storage conditions and allow for reasonable uhforseen delays in sample analysis. For additional1
guidance on conducting storage stability studies, the registrant is referred to an August 1987 "Position
Document on the Effects of Storage on Validity of Pesticide Residue Data" available from NTIS under order
no. PB88112362/AS.
8. The processing data requested for wheat will be translated to determine the potential for concentration
of residues in milled products and grain dust of barley.
9. Data depicting the potential for concentration of difenzoquat residues in milled products (bran, flour,
middlings, and shorts) and grain dust processed from wheat grain bearing measurable weathered residues.
Exaggerated field use rates may be needed to obtain these residues. If residues concentrate in any of these
products, appropriate food/feed additive tolerances must be proposed.
10 Data depicting difenzoquat residues in or on alfalfa hay and seed following a single foliar application
of'the 2 Ib/gal SC/L formulation at 1 Ib ae/A in 5 gal of water/A. Plants must be sprayed at the 5-leaf
stage. Tests must be conducted in King's County, CA where this use is permitted by EPA SLN No. CA770540. A
- - - fnr residues in/on hay and
-------
TABLE A. Footnotes (continued).
11. The nature of the residue in livestock is not adequately understood. On receipt of the required
livestock metabolism, storage stability, and method validation data, the adequacy of available feeding
studies and established tolerances will be determined.
c_n
-------
Table A
Generic Data Requirements for Difenzoquat
Data Requirement
Test Use
Substance Pattern
Does EPA
Have Data to
Satisfy This
Requirement?
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(cM2)(B)?
Timeframe
for
Submission
Sec. 158.290 Environmental Fate
Degradation Studies -
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Soil
161-4 - In Air
Metabolism Studies -
162-1 - Aerobic Soil
162-2 - Anaerobic Soi
162-3 - Anaerobic
Aquatic
162-4 - Aerobic
Aquatic
_Lab.
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
Lab
TGAI or PAIRA A
1 TGAI or PAIRA A
TGAI or PAIRA N.A.
TGAI or PAIRA N.A.
Partially
-
No
Partially
No
NO
NO
NO.
No
00036788 Yes1/ 9
Yes 9
00036788 Ye&i/ 9
No
Yes 27
Yes 27
No*/
No^/
Months
Months
Months
Months
Months
,
Ul
Mobility Studies
163-1 - Leaching and TGAI or PAIRA A
Adso rpti on/Deso rpt i on
Partially
00043775
12 Months
-------
Table A
Generic Data Requirements for Difenzoquat (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 Data
Citation 3(c)(2HB)? Submission
Sec. 158.290 Environmental Fate (cont'd)
163-3 - Volatility (Field) TEP
Dissipation Studies - Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-Term
No
TEP
TEP
TEP
TEP
A
N.A.
N.A.
N.A.
' Partially
No.
No
No
00045626
00045627
00045628
00045629
00045631
00045632
Yes^/
27 Months
No5-/
No2-/
TEP
No
In
-------
Table A
Generic Data Requirements for Difenzoquat (cont'd)
Data Requirement
Sec. 158.290 Environmental
Accumulation Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aouatic Nontarqi
Test
Substance
Fate (cont'd)
PAIRA
TEP
TEP
TGAI or PAIRA
3t TEP
Use
Patterns
A
A
N.A.
A
A
Does EPA
Have Data to
Satisfy This
Requirement?
NO
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
Yes6-/
Reserved6-/
No5/
Yes
No?/ •
Timeframe
For Data
Submission
39 Months
12 Months
Organisms
-------
Table A
Generic Data Requirements for Difenzoquat (cont'd)
Does EPA Must Additional
• Have Data to Data Be Submitted Timeframe
Use Satisfy This Bibliographic Under FIFRA Section For Data
Data Requirement Composition Patterns Requirement? Citation * 3(c)(2)(B)? Submission
Sec. J.58.390 Reentry Protection
132-1 - Foliar Dissipation TGAI N.A. No
132-1 - Soil Dissipation TGAI N.A. No
133-3 - Dermal Exposure TGAI N.A. No
133-4 - Inhalation TGAI N.A. No
Sec. 158.440 Spray Drift
202-1 Drift Field Evaluation TGAI A . No
202-1 Drift Size Spectrum TGAI A No
Ground Water Monitoring TGAI A No
LD
U1
•
»5/
uo5/
No*'
No™'
NO
NO
Reserved^/
-------
Table A
Generic Data Requirements for Difenzoquat (cont'd)
Sec. 158.290 Environmental Fate
Footnotes
I/ Additional data are required. This study does not fulfill the data requirements because the test substance and buffer
solutions were inconpletely characterized. This study may be made acceptable if appropriate information can be supplied.
2/ This data requirement is not being imposed at this time.
3/ This data will be required if the compound has a vapor pressure of 10~7 Torr or greater.
4/ These data may be required, pending examination of laboratory volatility data.
5/ These data are not required based on current use patterns because there is no anticipated human exposure.
6/ The soil metabolism data necessary for correct interpretation of rotational crops studies are not available. With
properly done metabolism studies and an acceptable confined rotational crop study, the field studies may not need to be
be repeated.
2/ These data are reserved. The requirements may be imposed if validated short term dissipation studies indicate the need
for longer studies.
8/ These studies may be made acceptable if satisfactory freezer storage stability data are submitted. Otherwise they will
need to be repeated.
%/ These data are reserved. Currently available information indicates that difenzoquat will-not migrate to groundwater.
Ln
-------
Table A
Generic Data Requirements for Difenzoquat
Data
§158.
Test
Requirement Substance
,340 Toxicology
Use
Pattern
Does EPA Have Data
To Satisfy Require-
ments? {Yes, No, Bibliographic
or Partially) Citation
Must Additional
Data Be Submitted Time Frame
Under FIFRA Section for
3(c)(2)(B)? Submission
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral - Rat
- Acute Dermal
- Acute Inhalation - Rat
- Eye Irritation - Rabbit
- Dermal Irritation -
Rabbit
- Dermal Sensitization -
Guinea Pig
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
A
A
A
A
A
A
A
Partially 00041883
Partially 00041883
Partially 00045641
Yes ' 00041883
Yes — '
No
No
Yes1/
Yes2/
Yes3/
No
No
Yes
NoV
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING
82-1
- 90-Day Feeding
- Rodent
- Nonrodent
TGAI
TGAI
A
A
No
Yes 00037922
No5/
No
-------
Table A
Generic Data Requirements for Difenzoquat
Data Requirement
§158.340 Toxicology
SUBCHRONIC TESTING (cont'd)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
CHRONIC TESTING
83-1 - Chronic Toxicity
- Rodent
- Nonrodent
83-2 - Oncogenicity Study
- Rat
- Mouse
83-3 - Teratogenicity
- Rabbit
83-4 - Reproduction
cn
CO
Test
Substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Does EPA Have Data
To Satisfy Require-
Use ments? (Yes, No,
Pattern or Partially)
A Partially
A No
A No
A No
A Yes
A No
A Yes
A Partially
A Partially
A Yes
A Yes
Bibliographic
Citation
00041893
—
—
—
00036710
00036710
00037923
00037925
00144522
00144521
00037924
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B)?
Yes6/
NO?/
NoŁ/
No9/
No
Yes
No
Yesio/
YeslV
No
No
Time Frame
for
Submission
9 Months
50 Months
50 Months
15 Months
-------
Table A
Generic Data Requirements for Difenzoquat
Data Requirement
Composition
Does EPA Have Data
To Satisfy Require-
Use ments? (Yes, No,
Pattern or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted Time Frame
Under FIFRA Section for
3(c)(2)(B)? Submission
§158.135 Toxicology
MUTAGENIC TESTING
84-2 - Gene Mutation TGAI
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
TGAI
A
A
No
No
No
Yes
00030577
Yes
9 Months
12 Months
12 Months
85-1 - General Metabolism PAI or PAIRA
85-2 - Domestic Animal Safety Choice
A
A
No
No
— Yes
NoW
24 Months
c_n
-------
Table A
Generic Data Requirements for Difenzoquat
§158.340 Tbxicology Footnotes
I/The existing study is inadequate because only male rats were tested. A study with female rats is required.
~2/1he existing study is inadequate because only male rabbits were tested. A study with female rabbits is required.
I/The existing study is inadequate because only male rats were tested and concentration of the test material in the
~~ inhalation chamber and the size of particles were not determined. A full study is required.
4/This study is not required because Difenzoquat is not an organophosphate.
"5/Ihe acceptable 2-year rat study available fulfills this requirement.
6/The existing study is inadequate because of deficiencies in experimental procedures.
"7/TMs study is not needed because the existing acceptable end-uses should not result in repeated human skin contact
~~ for extended periods.
8/This study is not needed because the existing acceptable end-uses should not result in repeated inhalation exposure.
9/This study is not required because an acute delayed neurotoxicity study is not required.
10/The available study is inadequate.
IT/The existing study has deficiencies in experimental procedures and does not satisfy the regulatory requirement.
l2/TV>e existing study can be upgraded from Unacceptable to Acceptable by submitting appropriate positive control data.
Is/Considering the use pattern, these data are not required.
-------
Table A
Generic Data Requirements for Difenzoquat
Data Requirement
Sec. 158.1490 -Wildlife and
Avian and Mammalian Testing
Test Use
Substance Pattern
Aquatic Organisms
Does EPA Have
Data to Satisfy
This Require-
ment?
No, Partially)
Must Additional
Data Be Submitted
Bibliographic ' Under FIFRA
Data
Citation 3(c)(2)(B)?
Timeframe
Section For
Submission
71-1 -Avian Acute Oral Toxicity
- Upland game bird
71-2 - Avian Dietary LC50
- Upland Game Bird
- Waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
- Upland Game Bird
- Waterfowl
TGAI A
TGAI A
TGAI A
TGAI A
TGAI A
TGAI 'A
TGAI A
Yes
Yes
Yes
No
No
No
No
00058830 NO
00052458 No
00037928 No
»!/
NO
NO
NO
71-5 - Actual Field Testing
for Birds and
Mammals
TEP
A
No
No
-------
Table A
Generic Data Requirements for Difenzoquat (cont'd)
Does EPA Have
Data "to Satisfy
This Require-
Test Use ment? (Yes, Bibliographic
Data Requirement Substance Pattern No. Partially) citation
Sec. 158.490 Wildlife and Aquatic Organisms
Aquatic Organism Testing
72-1 - Freshwater Fish LC50
- Warmwater TGAI A Yes 00037926
TEP A Yes2/ 00037927
- Coldwater TGAI A Yes 00037926
TEP A Yes2-/ 00037927
72-2 - Freshwater
Invertebrate LC50 TGAI A Yes 00057909
72-3 - Estuarine and Marine TGAI A No
Must Additional
Data Be Submitted Timeframe
Under FIFRA Section For Data
3(c)(2)(B)? Submission
No
No
No
NO
Organisms
0\
72-4 - Fish Early Life Stage
and Invertebrate
Life Cycle
- Freshwater
- Fish
- Invertebrates
TGAI
TGAI
A
A
NO
No
NO
No
-------
Table A
Generic Data Requirements for Difenzoquat
Data Requirement
Test
Substance
Does EPA Have
Data to Satisfy
This Require-
Use ment? (Yes,
Pattern No. Partially)
Must Additional
Data Be Submitted Timeframe
Bibliographic Under FIFRA Section For Data
Citation 3(c)(2)(B)? Submission
72-5 - Fish Life Cycle
72-6 - Aquatic Organisms
Accumulation
72-7 - Simulated or Actual
Field Testing
-Aquatic Organisms
TGAI
TGAI
TEP
No
No
No
Mb
No
No
Sec. 158.540 Plant Protection
121-1 - Target Area
Phytotoxicity
TEP
No
Nontaraet area Phvtotoxicitv
Tier I
122-1 - Seedling Germination
Seedling Emergence
TGAI
No
122-1 - Vegetative Vigor
TGAI
No
NC4/
O\
122-2 - Aquatic Plant Growth TGAI
NO
-------
Table A
Generic Data Requirements for Difenzoquat
Does EPA Have
Data to Satisfy Mist Additional
This Require- Data Be Submitted Timeframe
Test Use ment? (Yes, Bibliographic Under FIFRA Section For Data
Data Requirement Substance Pattern No. Partially) Citation 3(c)(2HB)? Submission
Tier II
123-1 - Seedling Germination/
Seedling Emergence TGAI A No No
123-2 - Aquatic Plant Growth TGAI A No No
TIER III
124-1 - Terrestrial Field TEP A No No
I/ The rat LD50 = 270
2/ The studies on Avenge 2A-S (32%ai) would fulfill Guideline requirements for that TEP, however, there is no
requirement for these data at this time.
_3_/ Not currently a requirement.
4/ Phytotoxicity testing is not required because difenzoquat has a negligible vapor pressure and is strongly absorbed
to soil particles.
-------
Table A
Generic Data Requirements for Difenzoquat
Does EPA Must Additional
Have Data to Data Be Sutmitted Timeframe
Test Use Satisfy This Bibliographic Under FIFRA Section For Data
Data Requirement Substance Patterns Requirement? Citation 3(c)(2)(B)? Submission
Sec. 158.590 Nontarget Insects
NCNP^RGCT INSECT TESTING - POLLINATORS
141-1 - Honey Bee Acute TGAI A, No
Contact LD50
141-2 - Honey Bee - Toxicity TEP A No No2/
Residues on
Foliage
141-4 - Honey Bee Subacute Reserved^/
Feeding Study
141-5 - Field Testing for TEP A Nb No2/
pollinators
NCNTARGET BISECT TESTING - AQUATIC INSECTS
142-1 - Acute Toxicity to TEP A No No2/
Aquatic Insects
142-2 - Aquatic Insect TEP A No No2/
Life Cycle Study
142-3 - Simulated or TEP A Nb No2/
Actual Field
Testing for
Aquatic Insects
O\
cn
-------
Table A
Generic Data Requirements for Difenzoquat
Does EPA Must Additional
Have Data to Data Be Submitted Timeframe
Test Use Satisfy This Bibliographic Under FIFRA Section For Data
Data Requirement Substance Patterns Requirement? Citation 3(c)(2HB)? Submission
MI7IARGET INSECT TESTING - PREDATORS AND PARASITES
143-1 Reserved^/ A No No
thru
143-3
O\
Ox
-------
Table A
Generic Data Requirements for Difenzoquat (cont'd)
-U158.590 - Nontarget Insects Footnotes
I/ Data is not required since applications to currently registered uses do not represent a significant exposure to
nontarget insects.
2/This requirement is reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRCDUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CONTAINING [NAME OF CHEMICAL]
Test Use Does EPA
Data Requirement Substance Patterns Have Data?
Part 158.190. Subpart C. Product Chemistrv
Product
61-2 -
61-3 -
Analvsi
Product
62-1 -
Physica
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
Identity and Composition
Description of Beginning
Materials and Manufac-
turing Process TGAI All
Discussion of Formation
of Impurities TGAI All
s and Certification of
Ingredients
Preliminary Analysis
of Product Samples TGAI All
1 and Chemical Characteristics
Color TGAI All
Physical State TGAI All
Odor TGAI All .
Melting Point TGAI All
Boiling Point TGAI All
I/
V
V
I/
V
V
V
V
Bibliographic Timeframe
Citation Must Additional for
(MRID) Data Be Submitted? Snlmi.q.qinn
I/
V
V
V
V
V
i/
i/
Yes2/ 6 Months
Yes3/ 6 Months
Yes4/ 12 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUF7OURING USE PRODUCTS CONTAINING [NAME OF CHEMICAL]
Data Requirement
Part 158.190. Suboart C. Product Chemi
Physical and Chemical
Characteristics (cont'd)
63-7 - Density, Bulk Density, or
Specific Gravity
63-8' - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
Test
Substance
stry (cont'd)
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
Use
Patterns
All
All
All
All
All
All
All
Bibliographic
Does EPA Citation
Have Data? (MRID)
V V
V i/
V V
V V
V V
V i/
V i/
Must Additional
Data Be Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
64-1 - Submittal of Samples
N/A
N/A
N/A
N/A
No
o\
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING USE PRODUCTS CCNTAINING [NAME OF CHEMICAL]
Part 158.190. Subpart C. Product Chemistry - Footnotes
I/ Although product chemistry may have been submitted -in the past, the Agency has determined that these data must be
resubmitted for each pesticide. New data requirements have been introduced and previously submitted data must be
updated. Therefore, bibliographic citations for the old data are not applicable.
o
V Complete information must be provided 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 must be provided, along with information regarding
the properties of each beginning material used to manufacture each product.
3/ 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.
V Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which
a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each analytical
method used.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing Difenzoquat
Does EPA Have Data Must Additional
To Satisfy Require- Data Be Submitted Time Frame
Test Use ments? (Yes, No, Bibliographic Under FIFRA Section for
Data Requirement Siubstance Pattern or Partially) Citation 3fcH2HB^ qnhmiQQi™
§158.135 Toxicology
ACUTE TESTING
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
Acute Oral - Rat MP
Acute Dermal MP
Acute Inhalation - Rat MP
Primary Eye Irritation -
Rabbit MP
Primary Dermal Irritation -
Rabbit MP
Dermal Sensitization -
Guinea Pig MP
Partially
Partially
Partially
Yes
Yes
No
00041883 Yes1/
00041883 Yes2/
00045641 Yes3/
00041883 No
00041883 No
Yes
9 Months
9 Months
9 Months
9 Months
I/The existing study is inadequate because only male rats, were tested. A study with female rats is required.
2/The existing study is inadequate because only male rabbits were tested. A study with female rabbits is required.
_3/The existing study is inadequate because only male rats were tested, the concentration of the test inaterial in
the inhalation chamber, and the size of particles were not determined. A full study is required.
-------
II. LABELING APPENDICES
72
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 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., "1 pound 10 ounces" rather than "26
ounces." In addition to English units, net contents may be
expressed in metric units. [40 CFR 156.10(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 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final
establishment 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 I56.10(f)]
73
-------
SUMMARY-2
Item 6A. INGREDIENTS STATEMENT - An ingredients statement is
required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR
I56.10(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 156.10(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 156.10(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 156.10(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 156.10(h)(1)(iii)]
74
-------
SUMMARY-3
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 156.10(h)(1)(iii)].
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on
the label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that
these statements be surrounded by a block outline. Each of the
three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 156.10(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 156.10(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 156.10(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.
75
-------
SUMMARY-4
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed
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 156.10(h)(1Miv).
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.
76
-------
SUMMARY-5
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
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.
77
-------
SUMMARY-6
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 156.10]
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.
78
-------
SUMMARY-7
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
TARFT. FT.FMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precaut ionary
statements
Keep Oat of Reach
of Children
(Child hazard
warninq)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
-
All products
All products
All products
All products
Liquid products
where dosage is
given as IDS.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel
immediately
before or
following
Rea. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
•hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . ,"
"Distributed by . . . ." etc.
May be in metric units in addition to
U.S. units.
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SUMMARY-8
LABELING REQUIREMENTS OF THE FIFRA. AS AMENDED (cont'd)
ITEM
7C
7D
7E
Q
8A
8B
I ABET, ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF RFJOUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicitv
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front Danel
All products
All products
in Categories
I, II, and III
All products
PLACEMENT
REOUIPEP
Front panel •
Category I;
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
ON LABEL
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 headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
SUMMARY-9
LABELING REQUIREMENTS OF THE FIFRA. AS AMENDED (COnt'd)
ITEM
8C
9A
9B
10A
10B
IOC
LABFT, FT.FMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
ISO^F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Aaency
All products
All products
PLACEMENT
REDUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
CM LABEL
PREFERRED
. Same as above
Preferably
blocked
"
>
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
CCMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
sional 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 other directions
for use.
Refer to Appendix II guides STQR,
CCMT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
CO
-------
PHYSICAL-CHEMICAL HAZARDS
Criteria Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 -inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposui
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.
-------
STOR-1
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.
83
-------
PEST/DIS-1
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 pesticid
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."
-------
CONT/DIS-L
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
(bottles, cans, iars)
Non-aerosol products
(baas )
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thorouahlv before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
[Triple rinse (or equivalent). Then offer
! for recycling or reconditioning, or puncture
i 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
land dispose of in a sanitary landfill, or
i incineration, or, if allowed by state and
i local authorities, by burning. If burned,
Istav 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
i particles. Empty residue into application
[equipment. Then dispose of liner in a
[sanitary landfill or by incineration if
[allowed by state and local authorities.
[if drum is contaminated and cannot be
[reused^/, dispose of in the same manner.
[Completely empty bag into application
[equipment. Then dispose of empty bag in
[a sanitary landfill or by incineration,
[or, if allowed by State and local
[authorities, by burning. If burned, stay
!out of smoke.
[Return empty cylinder for reuse (or
[similar wording).
V Manufacturer
and how fiber
may replace this phrase with one indicating whether
drum may be reused.
85
-------
III. BIBLIOGRAPHY APPENDICES
86
-------
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contain;
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 ir
support of past regulatory decisions. Selections from othei
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 tc
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.
87
-------
b. Document Date. When the date appears as fou:
digits with no question marks, the Agency took ii
directly from the document. When a four-digii
date is followed by a question mark, th<
bibliographer deduced the date from evidence ii
the document. When the date appears as (19??)
the Agency was unable to determine or estimate th«
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 tc
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 elemem ,
immediately following the word "under,"
the registration number, experimental us.o
permit number, petition number or othe^r
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.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00004610 Feeny, R.W.; Higham, J.W.; Snyder, E.H.; Colbert, D.R.; Agamalian,
H. (1975) Avenge: (CL 84,777): Determination of CL 84,777
(1,2-Dimethyl pyrazolium methyl sulfate) and Bromoxynil (3,5-
Dibromo-4-hydroxylbenzonitrile) Residues in Barley Straw and
Grain Following Ground Application (California): Report No. C-
592. (Unpublished study received Jan 8, 1975 under 241-EX-64;
prepared in cooperation with Lake Ontario Environmental Labor-
atory, submitted by American Cyanamid Co., Princeton, N.J.; CDL:
224170-R)
00004611 Higham, J.W.; Feeny, R.W.; Snyder, E.H; Kushnak, G. ; O'Hare, T.R.
(1975) Avenge: (CL 84,777): Determination of CL 84,777 (1,
2-Dimethyl-3,5-diphenyl pyrazolium methyl sulfate), Bromoxynil
(3,5-Dibromo-4-hydroxylbenzonitrile) and MCPA (2-Methyl-4-
chlorophenoxyacetic acid) Residues in Barley Grain and Straw
Following Ground Application of Avenge Alone and in Combination
with MCPA, Bromoxynil, 2,4-D and Bromoxynil plus MCPA: Montana:
Report No. C-593. (Unpublished study received Jan 8, 1975 under
241-EX-64; prepared in cooperation with Montana State Univ. ane
Lake Ontario Environmental Laboratory, submitted by American
Cyanami'd Co., Princeton, N.J. ; CDL: 224170-S)
00004612 Higttam, J.W.; Feeny, R.W.; Poeppel, M.O.; O'Hare, T.R. (1975)
Avenge: (CL 84,777): Determination of CL 84,777 (1,2-Di-
methyl-3,5-diphenyl pyrazolium methyl sulfate) and Bromoxynil
(3,5-Dibromo-4-hydroxybenzonitrile) Residues in Barley Straw and
Grain Following Ground Application (North Dakota): Report
No. C-595. (Unpublished study received Jan 8, 1975 under
241-EX-64; prepared in cooperation with Lake Ontario Environ-
mental Laboratory, submitted by American Cyanamid Co., Prince-
ton, N.J; CDL:224170-U)
00004613 Higham, J.W.; Feeny, R.W.; Cheston, K.G.; Snyder, E.H.;
Nowatski, R.; O'Hare, T.R. (1975) Avenge (R) (CL 84,777):
Determination of CL 84,777 (1,2-dimethyl-3,5-diphenyl pyrazolium
methyl sulfate), Bromoxynil, (3,5-Dibromo-4-hydroxylbenzonitrile
and MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Barle:
Grain and Straw Following Ground application of Avenge alone and
in combination with MCPA. Bromoxynil or 2,4-D (North Dakota):
Report No. C-596. (Unpublished study received Jan 8. 1975 under
241-EX-64; prepared in cooperation with Lake Ontario Environment;
Laboratory, submitted by American Cyanamide Co. Princeton, N.J.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquate Methyl Sulfate Standard
MRID Citation
00004614 Higham, J.W.; Steller, W.A. (1974) Avenge (CL 84,777): The Gas
Chromatographic Determination of (1,2-Dimethy1-3,5-diphenyl py-
razolium methyl sulfate) in Fortified Barley Foliage, Grain and
Straw: Report No. C-519. Includes method M-411 dated Apr 26,
1973. (Unpublished study received Jan 8, 1975 under 241-EX-64;
submitted by American Cyanamid Co., Princeton, N.J.; CDL:
224170-W)
00004630 Higham, J.W.; Manuel, A.J.; Snyder, E.H. (1974) Avenge:
(CL 84,777): The Gas Chromatographic Determination of
(1,2-Dimethyl-3,5-diphenyl pyrazolium methyl sulfate) in
Fortified Wheat Foliage, Grain, and Straw: Report No. C-537.
Includes method M-411 dated Apr 26, 1973. (Unpublished study
received Nov 14, 1975 under 6F1703; submitted by American
Cyanamid Co., Princeton, N.J.; CDL:094738-B)
00004637 Elenewski , C.A.; Wang, T.-. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethyl-3,3,5-diphenyl-lH-pyrazo-'
lium methyl sulfate) Residues in Wheat Grain and Straw Follow:
jGround Application (California, 1975): Report No. C-842. (Un-
published study received Nov 14, 1975 under 6F1703; submitted b
American Cyanamid Co., Princeton, N.J.; CDL:094738-K)
00004641 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (l,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate) Residues in Wheat Grain and Straw Following
Ground Application (Oklahoma, 1975): Report No. C-794. (Unpub-
lished study received Nov 14, 1975 under 6F1703; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094738-0)
00004647 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethy1-3,5-diphenyl-lH-pyrazolium
methyl sulfate) Residues in Wheat Grain and Straw Following
Ground Application (Texas, 1975): R4eport No. C-840. (Unpub-
lished study received Nov 14, 1975 under 6F1703; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094738-U)
00004648 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate) Residues in Wheat Grain and Straw Following
Ground Application (Texas, 1975): Report No. C-841. (Unpub-
lished study received Nov 14, 1975 under 6F1703; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094738-V)
90
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00004652 Elenewski, c.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84-777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate) and Bromoxynil (3,5-Dibromo-4-hydroxylbenzoni-
trile) -Residues in Wheat Grain and Straw Following Aerial Ap-
plication of Avenge Alone and in Combination with Bromoxynil,
(Arizona): Report No. C-808. (Unpublished study received Nov
14, 1975 under 6F1703; prepared in cooperation with Biodynamics
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094738-AA)
00004653 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate) and Bromoxynil (3,5-Dibromo-4-hydroxylbenzoni-
trile) Residues in Wheat Grain and Straw Following Ground Appli
cation of Avenge Alone and in Combination with Bromoxynil,
(California): Report No. C-807. (Unpublished study received
Nov 14, 1975 under 6F1703; prepared in cooperation with Biody-
namics, Inc., submitted by American Cyanamid Co., Princeton,
N.J.; CDL:094738-AB)
9
00004654 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate) and Bromoxynil (3 ,5-Dibromo-4-hydroxylbenzoni-
trile) Residues in Wheat Grain and Straw Following Aerial Ap-
plication of Avenge Alone and in Combination with Bromoxynil,
(California): Report No. C-814. (Unpublished study received
Nov 14, 1975 under 6F1703; prepared in cooperation with
Biodynamics, Inc., submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:094738-AC)
00004655 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate), Bromoxynil (3,5-Dibromo-4-hydroxylbenzonitrile
and MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Duru.
Wheat Grain and Straw Following Aerial Application of Avenge
Alone and in Combination with MCPA or Bromoxynil, (Minnesota):
Report No. C-823. (Unpublished study received Nov 14, 1975 un-
der 6F1703; prepared in cooperation with Biodynamics, Inc., sub
mitted by American Cyanamid Co., Princeton, N.J.; CDL:094738-AD
91
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID
00004656
Citation
Elenewski,
nation
methyl
trile)
plication
(Montana)
C.A. ; Wang, T. (1975) Avenge: (CL 84,777): Determi-
of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
sulfate) and Bromoxynil (3,5-Dibromo-4-hydroxylbenzoni-
Residues in Wheat Grain and Straw Following Ground Ap-
of Avenge Alone and in Combination with Bromoxynil,
Report No. C-812. (Unpublished study received Nov
14, 1975 under 6F1703; prepared in cooperation with Biodynamics
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094738-AE)
00004657
Elenewski
nation
methyl
trile)
C.A. ; Wang, T. (1975) Avenge: (CL 84,777): Determi-
of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
sulfate) and Bromo.xynil (3 ,5-Dibromo-4-hydroxylbenzoni-
Residues in Wheat Grain and Straw Following Aerial App
cations of Avenge Alone and in Combination with Bromoxynil,
(Montana): Report No. C-813. (Unpublished study received
Nov 14, 1975 under 6F1703; prepared in cooperation with Bio-
dynamics, Inc., submitted by American Cyanamid Co., Princeton
N.J.; CDL:094738-AF)
00004658 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-nimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate) and Bromoxynil (3,5-Dibromo-4-hydroxylbenzoni-
trile) Residues in Wheat Grain and Straw Following Ground Ap-
plication of Avenge Alone and in Combination with Bromoxynil,
(Oregon): Report No. C-806. (Unpublished study received Nov 1^
1975 under 6F1703; prepared in cooperation with Biodynamics,
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094738-AG)
00004659 Elenewski, C.A.; Wang, T. (1975) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1,2-Dimethyl-3,5-diphenyl-lH-pyrazolium
methyl sulfate), Bromoxynil (3,5-Dibromo-4-hydroxylbenzonitri1(
and MCPA (2-Methyl-4-chlorophenoxyacetic acid) Residues in Whej
Grain and Straw Following Ground Application of Avenge Alone ar
in combination with MCPA or Bromoxynil, (Oregon): Report No. C-
820. (Unpublished study received Nov 14, 1975 under 6F1703;
prepared in cooperation with Biodynamics, Inc., submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094738-AH)
92
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00004660 Feeny, R.W.; Poeppel, M.O. (1974) Avenge: (CL 84,777): Determi-
nation of CL 84,777 (1 ,-2-Dimethyl-3 ,5-diphenyl-lH-pyrazolium
methyl sulfate) Residues in Wheat Grain and Straw Following
Ground Application, (Washington): Report No. C-780. (Unpub-
lished study received Nov 14, 1975 under 6F1703; submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094738-AI)
00005567 Higham, J.W.; Feeny, R.W.; Cheston, K.G.; Snyder, E.H.; Wingfield,
C.B. (1975) Avenge: (AC 84,777): Determination of CL 84,
777 (1,2-Dimethyl-3,5-diphenyl pyrazolium methyl sulfate), Bro-
moxynil (3,5-Dibromo-4-hydroxylbenzonitrile) and MCPA (2-Methyl-
4-chlorophenoxyacetic acid) Residues in Barley Grain and Strav
Following Ground Application (Colorado): Report No. C-594. (U;
published study received Jan 8, 1975 under 241-EX-64; prepared
in cooperation with Lake Ontario Environmental Laboratory, sub-
mitted by American Cyanamid Co., Princeton, N.J.; .CDL:224170-T,
3
00030577 Bailey, D.E.; Morgareidge, K. (1974) Dominant Lethal Study in Rats
with AC 84777: Laboratory No. 2088. (Unpublished study received
on unknown date under 4G1453; prepared by Food and Drug Research
Laboratories, Inc., submitted by American Cyanamid Co., Prince-
ton, N.J.; CDL:094933-E)
00036710 Bailey, D.E.; Gallo, M.A.; Cox, G.E. (1975) Final Report: Chronic
Oral Toxicity Study in Rats with AC 84,777: Laboratory No. 1626.
(Unpublished study received Nov 14, 1975 under 6F1703; prepared
by Food and Drug Research Laboratories, Inc., submitted by Amer-
ican Cyanamid Co., Princeton, N.J.; CDL:094731-A)
00036788 Ku, C.; Srinivasan, V.; Jenny, K. (1974) CL 84,777: Avenge:
Wild Oat Herbicide: Metabolic Studies of 14C-Labeled CL 84,777
in Hydrolytic and Photolylic Environments: PD-M 11. Summary of
studies 094733-M and 094740-G. (Unpublished study received Nov
14, 1975 under 6F1703; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094740-L)
93
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00037922 Co.x, G.E.; Bailey, D.E.; Morgareidge, K.; et al. (1973) Report: 90-
Day Feeding Study in Dogs with AC 84777: Laboratory No. 1680.
(Unpublished study received Nov 14, 1975 under 6F1703; prepared
by Food and Drug Research Laboratories, Inc. and Consultants in
Ophthalmology, submitted by American Cyanamid Co., Princeton,
N.J.; CDL:094732-A)
00037923 Tegeris, A.S.; Underwood, P.C. (1975) Eighteen Month Carcinogenici-
ty Study on AC 84777. (Unpublished study received Nov-14, 1975
under 6F1703; prepared by Pharmacopathics Research Laboratories
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094732-B)
00037924 Reno, F.E. (1974) Final Report: Three-Generation Reproduction Stu
in Rats: Project No. 362-147. (Unpublished study received Nov
14, 1975 under 6F1703; prepared by Hazleton Laboratories, Inc.
submitted by American Cyanamid Co., Princeton, N.J.; CDL:
.094732-C)
00037925 Reno, F.E. (1974) Final Report: Teratology Study in Rats: Project
No. 362-150. (Unpublished study received Nov. 14, 1975 under
6F1703; prepared by Hazleton Laboratories, Inc., submitted by
American Cyanamid Co., Princeton, NJ.; CDL:094732-D) .
00037926 Sleight, B.H., III. (1973) Acute Toxicity of AC-84777 to Bluegill
(Lepomis macrochirus) and Rainbow Trout (Salmo gairdneri).
(Unpublished study received Nov 14, 1975 under 6F1703; prepared
Bionomics, Inc., submitted by American Cyanamid Co., Princeton
N.J.; CDL:094732-F)
00037927 Bentley, R.E. (1974) Acute Toxicity of Prowl: 3E, Prowl)
4E, and Avenge 2A-S to Bluegill (Lepomis macrochirus) and
Rainbow Trout (Salmo gairdneri). (Unpublished study re-
ceived Nov 14, 1975 under 6F1703; prepared by Bionomics, EG&G,
Inc., submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094732-H)
00037928 Fink, R. (1973) Final Report: Eight-Day Dietary LC50:—Mallard
Ducks: Project No. 362-142. (Unpublished study received Nov 14
1975 under 6F1703; prepared by Environmental Sciences Corp.,
submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094732-1)
94
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00037957 Cox, G.; Gatterdam, P.; Miller, P.; et al; (1973) Avenge Wild Oat
Herbicide: Persistence and Metabolism of CL-84,777 [1,2-Dimeth-
yl-3,5-diphenyl pyrazolium methyl sulfate] in Barley and Wheat:
PD-M 10. Final rept. (Unpublished study received Nov 14, 1975
under 6F1703; submitted by American Cyanamid Co., Princeton,
N.J.; CDL:094733-Q)
00037958 Gatterdam, P.; Jenney, K.; Patterson, M. (1975) Avenge: Difen-
zoquat: Fate on Barley under Field Conditions (Fort Collins,
Colorado): PD-M 10. (Unpublished study received Nov 14, 1975
under 6F1703; submitted by American Cyanamid Co., Princeton,
N.J. ; CDL:094733-R)
.00037959 Be'rger, H. ; .Colavita, J.H.; Kim-, O.K.; -et al. (1974) Plant
Industry Toxicology: Egg and Tissue Residue Study in Chickens
»Treated with Avenge Herbicide: FD 22. Includes method M-504
dated Apr 10, 1974. Unpublished study including report no.
C-447, received Nov 14, 1975 under 6F1703; submitted by Ameri>
Cyanamid Co., Princeton, N.J.; CDL:094733-S).
00038488 Steller, W.A.; Snyder, E.H. (1973) Avenge: GLC Determination of
Avenge (CL 84,777) Residues in Cattle Tissues (Kidney, Liver,
Muscle and Fat): Report No. C-388. Includes method M-457 datec
Sep 24, 1973. (Unpublished study received Nov 14, 1975 under
6F1703; submitted by American Cyanamid Co-. , Princeton, N.J. ;
CDL:094733-N)
00041883 American Cyanamid Company (1973) Toxicity Data: Avenge Herbicide,
Technical: Report A-73-38. (Unpublished study received Nov 25,
1974 under 5G1576; CDL:094325-B)
00041893 Goldhamer. R.E. (1973) Repeated Application Dermal Toxicity Study
in Rabbits: Experiment Reference No. A-883. (Unpublished stud^
received Nov 25, 1974 under 5G1576; prepared by Biometric Test-
ing, Inc., submitted by American Cyananr.id Co., Princeton, N.J. •
CDL:094325-M)
95
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OFFICE OF PESTICIDE PROGRAMS *
REGISTRATION STANDARD BIBLIOGRAPHY '
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00042220 Wellman, W.W. (197H Letter sent to M. Vega dated Nov 23, 1971
[Eye irritation studies testing mint oil]. (Unpublished
received May 17, 1972 under 11628-4; prepared by K.O. Scot In-
terplanetary, Inc., submitted by Turner Laboratories, Inc.,
Carolina, Puerto Rico; CDL:100507-A)
00043775'Hui , T. (1974) Avenge Wild Oat Herbicide: Soil-Leaching Studies c
CL 84,777 [1,2-Dimethyl-3,5-diphenyl-pyrazolium methyl sul-
fate]: Project No. 2-488. (Unpublished study received Nov 14
1975 under 6F1703; prepared in cooperation with Rutgers, The '
State Univ. of New Jersey, Agricultural Experiment Station,
Cooperative Extension Service, Soils and Crops Dept., Soil Te.^
ing Laboratory, submitted by American Cyanamid Co., Princeton,
N.J. ; CDL:094734-F)
00045626 Kim, O.K.; Wang, T.; Higham, J. ; et al. (1975) Avenge: De-
' termination of CL 84,777 (1, 2-Dimethyl-3,5-Diphenyl-lH-pyra-
zolium methyl sulfate) Residues in Soil: California: Report
No. C-838. (Unpublished study received Nov 14, 1975 under
6F1703; submitted by American Cyanamid Co., 'Princeton, N.J.;
CDL:094739-C)
00045627 Kim, O.K.; Weis, M.E.; Van Scoik, W.S. (1974) Avenge: The
Gas Chromatograph Determination of (1,2-Dimethyl-3,5-diphenyl
pyrazolium methyl sulfate) Residues in Soil (Undisturbed Soil
Plot—Minnesota): Report No. C-560. (Unpublished study receiv<
Nov 14, 1975 under 6F1703; prepared in cooperation with Univ. <
Minnesota, Agronomy Dept., Northwest Experiment Station, sub-
mitted by American Cyanamid Co., Princeton, N.J.; CDL:094739-D
00045628 Kim, O.K.; Feeny, R.W.; Weis, M.E.; et al. (1974) Avenge:
Determination of CL 84,777 (1,2-Dimethyl-3 ,5-diphenyl pyrazoln
methyl sulfate) Residues in Soil: (Minnesota): Report No. C-56.
(Unpublished study received Nov 14, 1975 under 6F1703; prepait.
in cooperation with Univ. of Minnesota, Agronomy Dept. , North-
west Experiment Station, submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094739-E)
00045629 Kim, O.K.; O'Hare, T.R.; Van Scoik, W.S. (1974) Avenge: De-
termination of CL 84,777 (1,2-Dimethyl-3 ,5-diphenyl pyrazolium
methyl sulfate) Residues in Soil (Montana): Report No.. C-558.
(Unpublished study received Nov 14, 1975 under 6F1703; prepared
in cooperation with Montana State Univ., Experiment Station,
submitted by American Cyanajnid Co., Princeton, N.J.; CDL:
094739-F)
96
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
MRID Citation
00045631 Kim, O.K.; Amen, C.R.; Jensen, A.O.; et al. (1974) Avenge:
Determination of CL 84,777 (1,2-Dimethyl-3,5-diphenyl pyrazoliu
methyl sulfate) Residues in Soil: Oregon: Report No. C-557.
(Unpublished study received Nov 14, 1975 under 6F1703; prepared
in cooperation with Oregon State Univ., Crop Science Dept.,
submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094739-H)
00045632 Kim, O.K.; O'Hare, T.R.; Van Scoik, W.S.; et al. (1974)
Avenge: Determination of CL 84,777 (1,2-Dimethyl-3,5-
diphenyl pyrazolium methyl sulfate): Residues in Soil: (South
Dakota): Report No. C-559. (Unpublished study received Nov 14,
1975 under 6F1703; prepared in cooperation with South Dakota
State Univ., submitted by American Cyanamid Co., Princeton,
N.J.; CDL:0947397I)
00045641 DeProspo, J. (1973) Acute Inhalation Study of Avenge 95-S in Rats:
'contract No. 120-2059-83. Final rept. (Unpublished study re-
ceived Nov 14, 1975 under 6F1703; prepared by Affiliated Medica
Research, Inc., submitted by American Cyanamid Co., Princeton,
N.J.; CDL:094730-D)
00052458 Fink, R. (1973) Final Report: Eight-Day Dietary LC:50—Bobwhite
Quail: Project No. 362-141. (Unpublished study received Nov 14
1975 under 6F1703; prepared by Environmental Sciences Corp.,
submitted by American Cyanamid Co., Princeton, N.J.; CDL:
094732-J)
00052478 Poeppel, M.O.; Wang, T.; O'Hare, T.R.; et al. (1975) [Residues of
Various Chemicals in Barley Grain and Straw]: Report No. C-722.
(Unpublished study including report nos. C-783, C-784, C-839...
received Nov 14, 1975 under 6F1703; prepared in cooperation wit
Lake Ontario Environmental Laboratory and others, submitted by
American Cyanamid Co., Princeton, N.J.; CDL:094737-A)
97
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Difenzoquat Methyl Sulfate Standard
Citation
00052480 Kim, ?; Steller, ? (1974) GLC Determination of CL 84,777 Residues
in Chicken Tissues (Kidney, Liver, Muscle, Skin and Eggs).
Method M-504 dated Apr 10, 1974. (Unpublished study received
Nov 14, 1975 under 6F1703; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:094737-C)
00052481 Kim, D.; Cheston,.K. (1975) Avenge: Wild Oat Herbicide: Resi-
dues in Cattle Tissues (Muscle, Liver, Kidney and Fat): Report
No. C-777. (Unpublished study received Nov 14, 1975 under
6F1703; submitted by American Cyanamid Co., Princeton, N.J.;
CDL:094737-D)
00057909 LeBlanc, G.A. (1976) Acute Toxicity of Avenge to Daphnia magna.
•(Unpublished study received Jun 29, 1976 under 241-250; prepare
by EG&G, Bionomics, submitted by American Cyanamid Co., Prince
ton, N.J.; CDL:224778-B)
00058830 Fink, R. (1976) Final Report: Acute Oral LD50—Mallard Duck: Proj-
ect No. 130-111. (Unpublished study received Jun 29, 1976 unde]
241-250; prepared by Truslow Farms, Inc., submitted by American
Cyanamid Co., Princeton, N.J.; CDL:224778-C)
00060111 American Cyanamid Company (1977) General Summary: [Avenge in Wheat:
Grain and Straw]. (Compilation; unpublished study received Apr .
1977 under 241-250; CDL:229617-A)
00060117 American Cyanamid Company (1975) General Summary: [Studies to De-
termine Avenge and 2,4-D Residues in Barley Grain and Straw].
(Compilation; unpublished study received Apr 26, 1977 under 241-
250; CDL:229616-A)
00060118 American Cyanamid Company (1975) Avenge: Residue—Barley.
(Unpublished study received Apr 26, 1977 under 241-250; CDL:
229616-B)
98
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V. FORMS APPENDICES
99
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EPA Form 8580-1
OMB Approval No. 2070-0057
Expires 11/30/89
FIFHA SECTION 3ICH2HB1 SUMMARY SHEET
NO
NAME
DATE GuiO*NCŁ DOCUMENT ISSUED
With mo«ct to lt<« rtqu*«mtfit to nbmit "j«n«f«" dmimpOMd by th« FIFHA
Giudtnct Documtnt. I im rapondinf m rn» following m««incr:
](C)(2HBI notic« conum«d m (f>« r«(<<«octd
LJ I. I wtll uomit dltl m I timtiy mtnntr to «ltf*T (ni ( allowing rtquirrtifnti. II rh« t*n proc«0urn I will ud dtvictt Irom (or K« not
u«ci(Md ml rh« Ht^irtmion Guid«lmti or rnt Protocali canturxd m oil Hiporti a) Expert Crouai td tnt Crtimcjii Grouo. OECO
aRinf rVo«r«mm«. t «nclOH (tM pratocolt tnn I mlt u«:
Attach separate page with a list of the data requirements your
company agrees to satisfy.
D 2, I luv« ttmrrd utto *n tfrMmmt with on* ;3h:inti lor n«w orocucal
LJ S. I rtqutrt volonttfY cinctllition of tht njinntion of tnu product. (Thu option a not miltOli to ippl«:*nu for n«w producu.)
SIGNATURE
DATE
100
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EPA Form 8580-6
OMB Approval No. 2070-0057
Expires 11/30/89
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To QutiifY. ctrrify ALL fovr «*mti POR DEVELOPMENT OF DATA
1. 1 *m duly lutfvxired to represent the following firm(t) who ire subject to (he require-
ment! of • Notice under FIFHA Section 3(cl(2H81 contained in « Guxitnat Document
to totxTVt dJt» concerning the *cte d«j lined in per*jr»ori (2) ibove in »
-------
CMB Approva
207(
Expires ll/
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Subpart C
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
Meltina roint
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 complyinc
data requirenx
Citing MRID
Number or
EPA Accession
Number
? with
ants by
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assioned
—
~
-
EPA Form 8580-4
102
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PRODUCT SPECIFIC DATA REPORT (cont'd)
OB Approve
20'
Expires ll/
EPA Reg. No..
Date
Guidance Document for_
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20,
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stability
Oxidizing/reducing
reaction
Flammabi litv
Explodabilitv
Storacre stability
Viscosity
Miscibility
Corrosion
character i st ics
Dielectric break-
down voltaae
Acute oral
toxicity. rat
Acute dermal
toxicitv , rabbit
Acute inhalation,
toxicitv. rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicitv, hen
Test not
required
for my
product
listed
above
(check
below)
.
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assioned
EPA Form 8580-4 (cont'd)
-------
OB Approval No. 207(
Expiration Date ll/3<
GENERIC DATA EXEMPTTCN STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified abc
certify that:
(1) I have read and am familiar with the terms of the Notice -from EPA dated
concerning a requirement for submission of "generic" data on the a
ingredient named urder FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product, de
our lack of intent to submit the generic data in question, on the grounds that the pr
contains the active ingredient solely as the result of the incorporation into the pr
of another product which contains that active ingredient, which is registered under
Section 3, and which is purchased by us from another producer.
(3) An accurate Confidental Statement of Formula (CSF) for the above-idem:
product is attached to this statement. That formula statement indicates, by company i
registration number, and product name, the source of the subject active ingredient "
firm's product, or
The CSF dated on file with EPA is complete, current and accura
contains the information requested on the current CSF Form 8570-4. The regi
source(s) of the above named active ingredient in my product(s) is/are
and their'registration number (s) is/are .
My firm will apply for an amendment to the registration prior to changing the sc
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portic
this Statement is no longer true, or if my firm fails to comply with the undertaJcings
in this Statement, my firm's product's registration may be suspended under FIFRA Sec
3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for
product, my firm relies on the efforts of other persons to provide the Agency with
required generic data. If the registrant (s) who have connitted to generate and submit
required data fail to take appropriate steps to meet requirements or are no longe
compliance with this Notice's data requirements, the Agency will consider that both
and my firm are not in compliance and will normally initiate proceedings to suspend
registrations of my firm's product(s) and their product(s), unless my firm commits
submit and submits the required data in the specified time frame. I understand that
such cases, the Agency generally will not grant a time extension for submitting the dat
Registrant's authorized representative:
(Signature
Dated:
(Typed)
EPA Form 8570-27
104
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