r/EPA
Unrtad Statat
Environmental Protection
Agency
Officaof
P*cticidM and Toxic Subctancat
Washington DC 20460
•ne * "*6
PwticidM
Guidance for the
Reregistration of
Pesticide Products
Containing
Diquat Dibromide
as the Active Ingredient
-------
GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING AS THE ACTIVE INGREDIENT
DIQUAT DIBROMIDE
(032201)
CASE NUMBER 0288
CAS 85-00-7
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
JUNE 1986
-------
TABLE OF CONTENTS
I. Introduction
II. Chetnical(s) Covered by this Standard .......... 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment ................... 5
IV. Regulatory Position and Rationale ............ 17
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard ........... 28
VI. Requirement for Submission of Generic Data ..... . . 29
A. . What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted? .
• D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation .
VII. Requirement for Submission of Product-Specific Data . . 34
VIII. Requirement for Submission of Revised Labeling ..... 35
IX. Instructions for Submission ............... 36
A. Manufacturing use products (sole active)
B. End use products
C. Intrastate products
D. Addresses
-------
APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV.. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580- Formulator's Exemption Statement
ii
-------
I. INTRODUCTION
The Registration Standards Program
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 PIPRA. 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 PIPRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
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 dn health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of PIPRA. In its review EPA identifies
1. Studies that are acceptable to suppor.t 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 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-Stand-a-rd- to end use-products" if 'ne'C'essary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure -to comply with 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 proposed
cancellation of uses of the pesticide which have been determined
to cause unreasonable adverse effects on the environment.
-------
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide.
This Registration Standard: lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in Section VI - Requirement for Submission
of Generic Data, and Section VII - Requirement for Submission
of Product-Specific data. 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 unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. You should notify the
Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as your products are registered by the Agency.
-------
II. CHEMICAL COVERED BY THIS STANDARD
A. Description of chemical
The following chemical is covered by this Registration
Standard:
Common name: Diquat Dibromide
Chemical name: 6,7-Dihydrodipyrido(1,2-a:2',1'-c)
pyrazinediium dibromide
Chemical Family: Bipyridylium, dipyridylium
CAS Number: 85-00-7
OPP (Shaughnessy) Number: 032201
Empirical Formula: C12H12N2(ion) > C^H^B^^dibromide)
Trade names: deiquat, region, Aquaclde, Dextrone, FB/2,
Ortho Diquat, Reglone, Reglox, Weedtrine-D
Physical Characteristics: Yellow (solid); Red-brown (liquid)
M.W. : l84.0(ion); 344.0(dibromide)
Melting point (solid): 300°C
Boiling point (liquid): 100°C
Specific gravity: 1.22-1.27 «20.°C
Very soluble in water; slightly
soluble in alcohol and hydroxylic
solvents; insoluble in non-polar
organic, solvents
Non-volatile
B. Use Profile
Diquat is a non-selective contact herbicide, desiccant and
plant growth regulator registered for use as a general
herbicide for control of broadleaf and grassy weeds in
terrestrial non-crop and aquatic areas; as a desiccant in
seed crops and potatoes; and for tassel control and spot
weed control in sugarcane. Diquat may be foliarly applied
broadcast by ground equipment or aircraft, or directed spray
by ground equipment; or it may be injected below the water
•surface (for submerged weeds). Based on data compiled in 1983,
of the total amount of diquat dibromide applied in the U.S.,
approximately 2756 was used on rights-of-way; 22% on
industrial/manufacturing sites; 21% on golf courses/
ornamental plantings; and 18% for aquatic weed control.
The remaining 12$ included sites such as agricultural crops,
domestic dwellings, and parks.
Piquat was first registered for use in 1961 and is produced
by Chevron Chemical Company of Richmond, California, from
active ingredient manufactured outside the U.S. Diquat is
available as a 37.^5% active ingredient (A.I.) formulation
intermediate, a 35.3% A.I. manufacturing concentrate and
end-use formulations with concentrations ranging from
0.09% to 35.3% A.I.
-------
III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed data submitted to support the regis-
tration of diquat dibromide. Numerous data gaps exist for
diquat dibroraide and few definitive conclusions can be made.
However, based on the available data, the Agency has reached
the following interim conclusions. A detailed discussion of
the points summarized below appears in Section B.
1. Cataract formation is the most significant chronic toxicity
response to diquat dibromide currently recognized. Diquat
dibromide is not considered, at this time, to cause onco-
genic, teratogenic or reproductive effects. Additional
chronic data are required and further evaluation will be
conducted.
2. Ethylene dibromide (EDB), a known carcinogen, is a process
impurity in diquat dibromide formulations. Based on a risk
assessment discussed in Section B, the Agency has concluded
that the presence of EDB as a result of approved uses of
diquat dibromide will not pose a significant risk to
human health..
3. Diquat dibromide appears to be acutely toxic through
dermal exposure. The potential for toxicity is increased
with repeated exposure. This exposure can be reduced
through the imposition of protective measures (restricted
use classification, protective clothing requirement's,
precautionary labeling).
As a result of this review, the Agency has identified missing
data necessary to evaluate the environmental and human risks
associated with the use of diquat dibromide. These data must
be developed in order to maintain registrations of products
or register new products containing diquat dibromide. A
summary of these data gaps appears in Figure 1. Please note
that this.is only a summary and complete details can be
obtained by referring to the tables in Appendix I.
The Agency has also determined that certain label restrictions
or revisions are necessary. These include:
Restricted Use Classification Dermal Exposure Precaution
Protective Clothing Requirements Reentry Intervals
Crop Rotation Restriction Signal Word Revision
The Regulatory Position and Rationale section discusses the
Agency's position on each of these restrictions and the
Required Labeling section contains the specific wording
required for each of the labeling revisions.
-------
DIQUAT PIBROMIDE - - DATA GAPS
(Please refer to the tables in Appendix I for detailed
information regarding these requirements)
Toxicology
Acute Oral Toxicity - Rats
Acute Dermal Toxicity - Rabbits, Rats
Acute Inhalation Toxicity - Rats
Primary Eye Irritation - Rabbits
Primary Dermal Irritation - Rabbits
21-day Dermal Toxicity - Rabbits, Rats
21-day Inhalation Toxicity - Rats
1-year Chronic Feeding Study - Dogs
Mutagenicity Studies
Oncogenicity Studies (additional information
needed for existing rat and mouse studies)
Ecological Effects
Avian Dietary Toxicity
Freshwater Fish Toxicity
Aquatic Toxicity (Invertebrates and Marine Species)
Phytotoxicity
Nontarget Insect
Environmental Fate/Exposure
Degradation Studies (except hydrolysis)
Metabolism Studies
Mobility Studies
Dissipation Studies
Accumulation Studies
Reentry Studies
Spray Drift Studies
Other Exposure Data
Product'Chemistry/Residue Chemistry
Product Chemistry
Selected Residue Studies
Plant and Poultry Metabolism
Residue Analytical Method
FIGURE 1
-------
B. PRELIMINARY RISK ASSESSMENT
Numerous data gaps exist for diquat dibromide and few definitive
eonclus-icnrs cran be' matfe" pen'ding 're'c'eip'tr of "the ""required data.
The following assessment is based on the limited data avail-
able, and, therefore, is subject to change.
1. Acute and Subacute Toxicity. Adequate data are not
available to conclusively determine the acute toxicity
of diquat dibromide and additional studies are required.
However, based on the available acute dermal toxicity
data, diquat dibromide is tentatively classified as a
Toxicity Category I chemical.
Available acute data define the approximate LD^QS for
both oral and dermal exposure routes. These studies do
not, however, adequately describe the onset and duration
of the symptoms, the cause of death, or the resultant
internal changes. Data indicate that the oral acute
toxicity had an LDcQ of 400-440 mg/kg (rats) and the
acute, dermal LD5o nad a. range of 50-100 mg/kg (rats).
Data from subacute toxicity studies indicate that the
multi-dose dermal LD^o was in the range of 6-40 mg/kg
(rabbits).. Available data also indicate that diquat
dibromide causes ulceration and other signs of irrita-
tion of the gastric mucosa following oral and/or dermal
exposure.
Based on acute and subchronic animal studies, diquat
dibromide was found to cause serious toxic effects and
mortality at very low doses. Although human absorption
of diquat dibromide has been shown to be low (0.3%), the
demonstrated toxicity of this compound in animals is
sufficient to raise serious human health concerns follow-
ing dermal exposure.
Data show that diquat dibromide is not a skin sensitizer.
Therefore, no additional dermal sensitization data are
needed.
Additional LDcQ studies with rabbits and rats as well as
acute dermal irritation and subchronic dermal toxicity
studies are required to fully assess the acute and sub-
acute toxicity of diquat dibromide.
In order to evaluate reports of ulceration and other
irritations of the gastric mucosa, the minimum levels at
which diquat dibromide can cause lesions in the gastric
-------
mucosa and intestines resulting from both oral and dermal
exposure must be determined. In addition, the causes of
death in these studies must be determined and reported.
Because of the nature of the effects observed in the
available data, additional acute oral and derraal studies
are required to determine NOELs.
Available acute inhalation studies indicate that diquat
dibromide causes lung abnormalities. However, due to
deficiencies in these studies, additional data are required
to fully assess these effects. Therefore, both acute
and subchronic inhalation toxicity studies are required.
A reliable eye irritation study is not available and
is required.
2. Chronic Feeding/Oncogenicity Data. Diquat dibromide
administration has resulted in cataract formation in
both rats and dogs. The NOELs for these species are
0.22 mg/kg/day (5 ppm) and 1.7 mg/kg/day respectively,
based on available information. No compound related
increases in cataract formation were evident in the
mouse. Cataract formation is the most significant
specific chronic toxicity response to diquat dibromide
currently recognized. However, formation of cataracts
required several weeks exposure at the highest dose
levels tested and at the lower dose levels, consider-
ably longer periods were required for this condition
to -develop. Further evaluation will be conducted when
additional chronic data are received.
A rat chronic feeding/oncogenicity study tentatively
indicates that diquat dibromide is not oncogenic up to
375 ppm (highest dose tested [HOT]). Observed effects
are lens opacity and cataracts and possible nephropathy
in males. Other effects, at 375 ppm, were paracortical
cell hyperplasia in lymph nodes in males. Additional
historical control data and statistical analyses must be
submitted before this study will satisfy data requirements.
An 80-week oncogenicity study in the mouse is currently
awaiting additional histopathological data. The tentative
conclusion is that diquat dibromide is not oncogenic in
the mouse at up to 300 ppm (HOT).
Other chronic feeding studies (one in the dog and two in
the rat) reported cataract formation at the mid- and high-
dose levels. However, two of these studies are deficient
and provide only supplementary information and the third
is invalid.
8
-------
Mutagenicity Data. Mutagenicity information available
showed indications of both positive and negative responses.
In some cases, however, only summaries could be obtained
for Agency review. In order to assess mutagenicity of
diquat di bromide-,- subais-s-ion- o-f- all-existing studies is"
required. Based on the results of the review of these
studies, additional mutagenicity studies may be required.
At this time, there are no acceptable chromosome point
mutation assays (Ames type test) or chromosome aberration
studies. To clarify the potential of diquat dibromide
to cause point mutations or chromosome aberrations, new
tests for these study types are required.
Reproduction and Teratology Data. Diquat dibromide is
considered to be adequately tested for teratogenic and
reproductive effects. It is not considered to be either
teratogenic in rats, mice or rabbits or to cause adverse
reproductive effects in rats, as discussed below.
In one teratology study, Sprague Dawley rats were dosed
at 0, 125 and 500 ppm of diquat ion which was incorporated
in their diets. The maternal and fetotoxic NOELs are both
125 ppm; the teratogenic NOEL is greater than 500 ppm. No
rats died and all were reported to be in good condition;
no abortions were reported. Body weight gain was depressed
only in the group receiving 500 ppm and this group gained
31 percent less weight than the controls and 125 ppm dose
group. No other effects were reported.
In another study, diquat dibromide was .not teratogenic to
Specific Pathogen-Free (SPF) mice at the 1.0 mg/kg level,
expressed as diquat ion. However, this level was fetotoxic
because it retarded ossification. This level also caused
maternal toxicity by decreasing body weight gain and increas-
ing the incidence of toxic symptoms. The teratogenic NOEL
is 4.0 mg/kg/day.
In a rabbit teratology study, diquat fed to pregnant Dutch
rabbits for 28 consecutive days at doses of 0, 1.25, 2.5
and 5 mg of diquat ion/kg of body weight was not teratogenic
at any of the levels. There was maternal weight loss at
5 mg/kg/day.
In the three-generation reproduction study, rats were fed
levels of the test material of 0, 125 and 500 ppm. No
specific adverse effects on reproduction are indicated by
the study at doses up to and including 500 ppm. The only
abnormalities found were cataracts in animals fed 500 ppm
(the parental generation) and a unilateral cataract found
in one female treated at 500 ppm in the third generation.
-------
5. Other Effects
Ethylene Dibromlde (EPS) Contamination. The pesticide
EDB is a" carcittb'geh in laboratory animals. It has
been the subject of suspension and cancellation actions
(48FR46228, 48FR46234, October 11, 1983), and virtually
all authorized uses of the pesticide have been discon-
tinued.
EDB is an essential starting materia-1 in the production
of diquat dibromide and remains as a process impurity
in diquat dibromide formulations. However, 10 ppm is
certified maximum EDB level in the formulating use
products, and actual levels of EDB are lower than this
maximum.
Because EDB residues remain in these formulations,
there is the possibility for exposure to EDB through
diquat dibromide use. For this reason, the Agency
has assessed potential risks from EDB exposure result-
ing from the, use of diquat dibromide, as follows:'
Drinking Water. The maximum application rate for
aquatic uses is 2 Ibs. cation/surface acre-foot
(4 Ibs. diquat dibromide/surface acre-foot).
Assuming the maximum rate is applied 6 times a year,
0.015 parts per billion (ppb) EDB would concentrate in
the water.
At these application and frequency rates, treatment
of a one-acre pond 1 foot deep, with no volatilization
(contamination at maximum level for one week then
dropping to zero), results in .0017 ppb average
residue level in potable water (6/52 x 0.015 ppb).
Based on this residue level, the lifetime risk for a
60 kg person drinking 2 liters of water a day from a
source treated with the maximum amount of diquat
dibromide is 3 x 10~6.
This risk is calculated based on an extreme worst
case scenario, and mitigating factors imply that the
risk of 3 x 10~6 for EDB exposure will never occur from
the use of diquat dibromide. These factors include:
o EDB is highly volatile and levels will drop off
rapidly after treatment.
o Actual average levels of EDB are lower than
the 10 ppm maximum accepted in diquat dibromide
formulating-use products.
10
-------
o Most treatment is to moving bodies of water and
rapid dilution after treatment is likely.
o Most bodies of water are not treated 6 times a
year. ......
o The entire body of water would not be treated
each time.
o Most lakes are considerably deeper than 1 foot.
Dietary Risk. A preliminary dietary risk assess-
ment for EDB in diquat dibroraide has been conducted by
assuming that EDB residues in crops are proportional
to EDB levels in diquat dibromide. The theoretical
maximum residue concentration (TMRC) for diquat
dibromide is 0.06 mg/person/day or 8.6 x 10"^ mg/kg/day,
Assuming the maximum concentration of 10 ppra of EDB
in diquat dibromide, the dietary exposure to EDB
is 8.6 x 10"' mg/kg/day. The cancer potency (Q^*)
for EDB is 41 mg/kg/day. Therefore, the upper, bound
dietary risk is 4 x 10" .
However, in calculating this risk, several factors
are not considered which would imply that, like EDB
residues in drinking water, this level of risk from
the use of diquat dibromide will not be reached.'
This calculation does not consider the effect of
processing of commodities which contain EDB. Because
EDB is highly volatile, processing would dissipate
EDB which would lower residues further reducing.
exposure and risk. The calculation does not consider
the fact that average levels of EDB are lower than
the 10 ppm maximum concentration level in diquat
dibromide. And, finally, the calculation is based
on the TMRC for diquat dibromide which represents
an upper bound of expected residues.
Mixer/Loader and Applicator Exposure. Mixer/loader
and applicator exposures from both terrestrial and
aquatic applications were examined using field data
collected and reported by Wojeckl along with data
on paraquat, a chemical which behaves similarly to,
and has similar uses as, diquat dibroraide. The
aquatic studies evaluated two application techniques,
handgun application to water hyacinths and direct
injection for hydrilla control. Water hyacinths
were sprayed with a handgun using an airboat manned
G. A. Wojeck, J. F. Price, H. N. Nigg, and J. H. Stamper,
Worker Exposure to Paraquat and Diquat. Arch. Environ.
Coratam. Toxicol. 12, 65-70 (1983).
11
-------
by an applicator and a driver using a 1.76% a.i.
solution of diquat dibromide. The maximum total
body exposure was measured as 2.5 and .3 mg/hr for
the applicator and driver, respectively. .. Hydrilla
was controlled by direct injection into the water
using a concentrate of 2 gallon formulated diquat
dibromide/acre or 4.4£ a.i. solution. The applicator
and mixers/loaders received exposures of 0.2 and 0.6
mg/hr, respectively.
Because a hyacinths applicator could also be a
mixer/loader, combining the exposures of the hyacinths
applicator and the hydrilla mixers/loaders is assumed
to be a worst-case situation. These combined exposures
- mixer/loader for hydrilla control and applicator for
hyacinths control (2.5 + .6 mg/hr) - result in an
exposure of 3.1 mg/hr worked. The upper limit on the
maximum risk associated with EDB contamination can
then be calculated as 1 x 10~°. This assumes:
6 applications/year; 10 ppra maximum EDB contamination;
70 kg worker; 40 years of work related exposure; and
100% dermal absorption of EDB.
Terrestrial exposure does not pose a greater risk.
Using the terrestrial exposure data for paraquat,
and adjusting the maximum'application rate of 1/2
Ib. a.i./A to diquat dibromide's rate of 1 Ib.
a.i./A and assuming a similar acreage treated,
the highest exposure rates for a combined average
mixer/loader and applicator, rate is .82 mg/kg/day.
This, figure.is for the ground boom application
technique which, on a dally basis, is expected to
produce the greatest exposure of the customarily
used techniques. The range of exposure was reported
as 1.5 - 9.4 mg/kg/day.
Using 9.4 mg'/kg/day exposure to EDB, the upper bound
of the risk associated' with EDB exposure is 6 x 10~°.
Again, the assumptions behind this number are: 1
application/year (dessication); 10 ppm maximum con-
centration of EDB; 40 years of work exposure; and
100% dermal absorption.
Based on the worst-case assessments discussed above,
EPA has concluded that the presence of EDB as a
result of approved uses of diquat dibromide in aquatic
and terrestrial sites does not pose a significant
risk to human health, either to the public or the
applicator.
12
-------
c. Immunotoxic and Neurotoxic Effects. Available data
do not indicate that diquat dibromide has either
specific immunotoxic or neurotoxic effects. No
additional data are required.
d. Metabolism. Available data indicate that diquat
dibromide is poorly absorbed within the gastro-
intestinal tract and, once absorbed, is rapidly
excreted in the urine. With the exception of
poultry data, no additional data are required.
e. Antidote. No specific antidote exists for diquat
dibromide poisoning. Since severe gastrointestinal
irritation may result from oral exposure, a specific
practical treatment for swallowing of diquat dibromide
must be developed.
C. OTHER SCIENCE FINDINGS
Environmental Fate. Environmental fate data are very limited.
All available data, with the exception of a hydrolysis study,
provide only supplementary information. Data are required.
The hydrolysis study shows that diquat dibromide Is stable
to hydrolysis in sterile, aqueous solutions buffered at pH 5
and 7 when incubated in the dark at 25°C for 30 days. At pH
9, diquat dibromide degraded by 10% over the 30-day incubation
period.
Ecological Effects. Available data suggest that the acute
hazard to non-target organisms is slight. This determination,
however, is preliminary and subject to change when additional
data .become available. Data are insufficient to evaluate the
chronic hazard to non-target organisms.
Data for birds and freshwater aquatic invertebrates indicate
that diquat dibromide ranges from moderately toxic to
practically nontoxic. Data for fish indicate that the toxicity
to freshwater fish ranges from slightly to practically non-toxic,
Because diquat dibromide is a non-selective herbicide and
since diquat dibromide has non-crop use patterns that overlap
endangered plant habitats, a danger to non-target plants
(including endangered species) may be present. Additional
data are required to more fully assess the impact of diquat
dibromide on non-target plants and endangered species.
13
-------
D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of diquat
dibrotnide in raw agricultural commodities, milk, eggs, meat,
fat
and meat byproducts-(40 CFR 180v226)v as follows:
Commodity
Cattle, fat
Cattle, meat byproducts
Cattle, meat
Eggs
Goats, fat
Goats, meat byproducts
Goats, meat
Hogs, fat
Hogs, meat byproducts
Hogs, meat
Horses, fat
Horses, meat byproducts
Horses, meat
Milk
Potatoes
Poultry, fat
Poultry, meat byproducts
Poultry, meat
Sheep, fat
Sheep, meat byproducts
Sheep, meat
Sugarcane
Parts Per Million (ppm)
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.02
0.1
0.02
0.02
0.02
0.02
0.02
0.02
0.05
Tolerances have also been established for residues of diquat
dibromide on irrigated crops, derived from the application
of the dibromide salt to aquatic sites, in or on the following
raw agricultural commodities (40 CFR 180.226). Where tolerances
are established at higher levels from other uses of the pesticide,
the higher tolerance also applies to residues of the aquatic uses.
Commodity
Avocados
Cottonseed
Cucurbits
Fish
Fruits
Fruits
Fruits
citrus
pome
small
Fruits, stone
Grain, crops
Grasses, forage
Hops
Parts Per Million (ppm)
0.02
0.02
0.02
0.1
0.02
0.02
0.02
0.02
0.02
0.1
0.02
14
-------
Commodity Parts Per Million (ppm)
Legume, forage 0.1
Nuts 0.02
Shellfish 0.1
Sugarcane 0.02
Vegetables, fruiting 0.02
Vegetables, leafy 0.02
Vegetables, root crop 0.02
Vegetables, seed and pod 0.02
A tolerance of 0.01 ppm has also been established for residues
of diquat dibromide in potable water. A food additive regula-
tion of 0.5 ppm has been established for processed potatoes,
including potato chips (21 CPR 193.160). A feed additive
regulation of 1.0 ppm has been established far dried potato
waste (21 CPR 561.215) .
EPA has evaluated the residue and toxicology data supporting
these tolerances, and reviewed all uses of diquat dibromide.
Based on the available data, the following conclusions have
been.made regarding residues of diquat dibromide:
o The metabolism of diquat dibromide in plants is not ade-
quately understood. The metabolism data for animals
(except poultry) are adequate.
o Tolerances of 0.02 ppm have been established for residues
of diquat dibromide in fat, meat, and meat byproducts of .
cattle, goats, hogs, horses and sheep. Available data
indicate that a more appropriate tolerance would be 0.05
ppm.
o Tolerances of 0.02 ppm have been established for residues
of diquat dibromide in poultry fat, meat, meat byproducts
and eggs. Available data indicate that the tolerance for
eggs should be raised to 0.05 ppm. The adequacy of the
remaining poultry tolerances will be assessed when addi-
tional metabolism data have been evaluated.
o Presently, potatoes are the only member of the root and
tuber vegetable group with a registered food use. There-
fore, a crop group tolerance for this group is not appro-
priate. Data support the 0.1 ppm tolerance for residues
in/or potatoes and the feed additive regulation of 1.0 ppm
for residue in potato wastes. Data indicate that the
current 0.5 ppm food additive regulation for residues in
or on processed potatoes should be increased to 1.0 ppm.
o Additional data are required to support the tolerance of
0.05 ppm for sugarcane. Residue studies are also required
for processed sugarcane products (molasses, bagasse, refined
15
-------
sugar) and, if residues are found to concentrate,
food/feed additive regulations must be proposed.
o In the past, tolerances were not required for commodities
grown for seed production. Because certain-seed, crops are
not under control of the grower and could be consumed by
humans or animals, the Agency is now requiring that toler-
ances be established for soybeans, sorghum (grain), alfalfa,
clover and vetch grown for seed if residues are found.
Carrots, radishes, turnips and cucurbits grown for seed are
not likely to be consumed by humans or animals; therefore,
no tolerance or exemption from tolerances for these crops,
which are presently special local need uses, is required.
o Tolerances of 0.02 ppm have been established in or on
numerous crops for residues of dlquat dibromide resulting
from irrigation with water containing residues of 0.01
ppm dlquat dibromide. These residues result from appli-
cation of diquat dibromide in or around aquatic sites.
The current data do not support these tolerances in certain
crops and crop groupings. Tolerances must be increased
or additional data must be submitted. For grain crops,
residue data are required for rice grain and straw. The
crop groupings may need to be revised in accordance with
updated groupings as established , in ^0 CPR Part 180.
These will be considered when tolerances for irrigated
crops are reassessed.
o The tolerance of 0.1 ppm in fish and shellfish is not
supported with data. Residue studies- are required.
o A tolerance of 0.01 ppra exists for residues of diquat
cation in potable water. Available data demonstrate that
the nature and magnitude of residues of diquat dibromide
in water are highly variable. Since the Agency no longer
establishes tolerances for residues of pesticides in
potable water (47FR25746, June 15, 1982), the tolerance
for dlquat- dibromide will be replaced with a designated
"acceptable residue level," if appropriate.
The acceptable daily intake (ADI) for diquat dibromide is
based on a rat chronic feeding study (ICI, 1985) with a
NOEL of 5 ppm. Using the NOEL of 5 ppm (0.22 mg/kg/day) and
a safety factor of 100, the ADI is 0.0022 mg/kg/day and the
maximum permissible intake (MPI) is 0.132 rag/day for a 60 kg
person. The established tolerances result in a total
theoretical maximum residue concentration (TMRC) of 0.0599
mg/day (1.5 kg diet) which corresponds to 45.35£ of the MPI
for a 60 kg person.
16
-------
IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data on diquat
dibromide, the Agency has made the determinations below. Refer to
Section- I-Y.D. for---specific -language for label' revisions:" Revisions
in tolerance levels supporting approved uses of diquat dibromide
will be accomplished when the Agency evaluates additional data and
completes tolerance reassessment for this pesticide.
1. The presence of the contaminant EDB, a potent animal carcin-
ogen, in diquat dibromide products is not expected to pose
a significant risk to human health with present uses.
Rationale: Based on the risk assessment for applicators,
food crop uses and drinking water discussed fully in .
Section III.B., exposure to EDB resulting from diquat use
is not expected to be significant. The Agency will carefully
evaluate new uses for diquat dibromide from the standpoint
of EDB exposure.
2. The Agency will not establish significant new food uses
until additional residue chemistry and chronic toxicology
data are available to assess existing uses.
Rationale: It is Agency policy not to establish significant
new uses where major data gaps exist. When additional
data are evaluated, the Agency will determine whether
significant new food uses may be established.
3. The Agency is requiring diquat dibromide products containing
25% active ingredient or greater to be labeled with the'
• signal word "DANGER"(Toxicity Category I). Products
containing from 2.5% up to 25% active ingredient must bear
the signal word "WARNING" (To.xicity Category II).
Rationale: Although additional dermal toxicity testing is
required, sufficient data have been generated to establish
that a Category I hazard exists for diquat dibromide
products, 25% active ingredient or greater. By extrapolating
from these data, products containing from 2.5% up to 25%
active ingredient would be considered Category II, based on
dermal toxicity.
M. The Agency i.s requiring all end-use products with 25% active
ingredient or greater and all end-use products with 2.5%
active ingredient or greater with domestic uses to be
classified for "Restricted Use."
Rationale; Based on acute and subacute dermal toxicity data,
diquat dibromide has the. potential to pose a significant
risk to users. Restricted use criteria are met for these
products for dermal toxicity hazards, defined in 40 CPR
Section 162.11. The Agency believes classification of
diquat dibromide as a restricted use pesticide is necessary
to protect users from the effects of dermal toxicity.
17
-------
Only certified applicators who have received instructions
on the safe handling of pesticides,.or those under the
direct supervision of certified applicators will be
permitted to handle these diquat dibroraide products.
5. Vhe Agency is requiring .additional precautionary .language .
for dermal exposure concerning the hazard of repeated contact
with skin, particularly when open cuts or sores exist, for
all diquat dibromide products.
Rationale: Preliminary findings in acute and subacute
toxicological data indicate high dermal toxicity potential,
particularly with repeated contact. Inclusion of this
precautionary text will emphasize the need for users to
exercise caution in handling diquat dibromide products,
in order to limit risks from dermal contact.
6. The Agency is imposing additional precautionary labeling
(including protective clothing requirements) for diquat
dibromide products classified in Toxicity Categories I
and II. Specific protective clothing is not required
for other products.
Rationale: These precautionary labeling statements provide
specific guidance for persons handling the most hazardous
of these products to increase the safety of.their usage.
This language describes protective clothing and equipment
as well as procedures for minimizing exposure to pesticidal
materials. Protective clothing will significantly reduce
mixer/loader/applicator contact with concentrates and sprays.
7. An interim 24-hr, reentry interval for crop sites, golf
courses and rights-of-way is being imposed for all diquat
dibromide products with these uses.
Rationale; Due to potential dermal toxicity hazards and
possible exposure to soil and foliar residues, this
interval is needed to protect, farmworkers and maintenance
personnel reenterlng treated sites. Unprotected persons
(i.e, workers not wearing protective clothing) will be
prohibited from entering treated sites for a 24-hr.
period. A 24-hour reentry interval is imposed as an
interim measure for sites where toxicity and exposure
criteria trigger data requirements under 40 CPR Section
158.140 and data have not been submitted. Once reentry
data are received and evaluated, the reentry interval
will be reassessed.
8. An interim 14-day swimming reentry interval for aquatic
sites Is being imposed for diquat dibromide products with
aquatic uses.
Rationale: Due to potential dermal toxicity hazards and
possible exposure to residues from aquatic application, an
18
-------
interim 14-day swimming reentry interval is being imposed
to protect individuals reentering treated sites. Although
data are not available to determine an appropriate reentry
period, a 14-day interval has historically been included
on labeling for these products. Therefore, a 14-day rentry
Interval will -be "imposed "'pending 'evaluation" of "aquatic
dissipation data.
9. The Agency is requiring the following studies to support all
existing tolerances In agricultural commodities: Plant and
poultry metabolism, storage stability, and analytical method.
Rationale : Metabolism of diquat dibromide in plants and
poultry has not been adequately defined. Plant metabolites
have not been quantified. Residues have not been character-
ized in poultry tissues. No storage stability data are
available for crops. An analytical method appropriate for
enforcement purposes must be developed for diquat dibroraide.
Present methodology does not permit adequate monitoring
of diquat dibromide residues.
10. The Agency is requiring additional residue data for sugarcane,
Residue studies are required for processed sugarcane products
(molasses, bagasse, refined sugar).
Rationale: Adequate data are not available to assess the
tolerance for sugarcane or describe residues of diquat in
processed sugarcane products.
11. The Agency is requiring residue data together with a
petition for establishing tolerances, if residues are
found, for soybeans, sorghum (grain), alfalfa, clover, and
vetch, grown for seed production.
Rationale: Review of these uses indicates that the present
non-food use classification for these commodities is
inappropriate. Since seed from these crops is not under
control of the grower, these crops could be directed to human
and/or animal consumption, and must be considered food uses.
12. The Agency will require increased tolerances of 0.05
for fruiting and leafy vegetables, and 0.1 ppm for avocados,
cottonseed, hops and sugarcane, or submission of additional
residue studies to support existing tolerances. Residue
data for rice grain and straw must also be submitted for the
grain crop grouping.
Rationale: Available data for irrigated crops do not
support existing tolerances for these individual commodities
or crop groupings.
13. The Agency will require an increased tolerance to 0.05 ppm
for residues in eggs and fat, meat, and meat by-products
of cattle, goats, hogs, horses and sheep. Residue data
are required for fish and shellfish.
19
-------
Rationale: Based on reevaluation of available feeding and
metabolism studies, 0.05 ppni more accurately reflects resi-
dues which are likely to occur In these animal products.
Adequate data are not available to determine whether the
established tolerances for fish and shellfish are acceptable,
14. The Agency will require an increase In the food additive
tolerance for processed potatoes to 1.0 ppm.
Rationale: Data for weathered residues in dried potatoes
indicate that 1.0 ppm is a more appropriate tolerance
level than 0.5 ppm.
15- The Agency is requiring a prohibition on planting of crops
for which dlquat dlbromlde is not registered, in fields
previously treated with diquat dlbromlde products. End-
use products with crop uses must Include a crop rotation
restriction on labeling.
Rationale: It Is Agency policy to Impose restrictions on
planting of rotational crops when data are insufficient to
assess the impact of planting subsequent crops. This
protects the public from possible residues in food and
feed resulting from previous pesticldal treatment.
16. The Agency is requiring additional data for acute/subacu'te
and chronic toxiclty, environmental fate, and exposure
to non-target organisms (Including plants).
Rationale: Available data are Insufficient to fully assess the
hazards from use of diquat dibromlde, or describe the behavior
of diquat dlbromlde in aquatic and terrestrial environments.
Preliminary findings from available data are discussed
in Section III.C.
17. The Agency is requiring reentry, glove permeability and
spray drift data.
Rationale: Since diquat dibromide is highly toxic via
the dermal route of exposure, these data are needed to
assess the hazards to persons handling the pesticide and
reentering treated areas, and to evaluate exposure resulting
from deposition of pesticldal materials downwind from
treated sites.
18. The Agency will not revise aquatic use restrictions related
to holding of water and measurement of residues, nor modify
the potable water food additive regulation for diquat dibromide
at this time.
Rationale: There is presently a 14-day restriction against
domestic and Irrigation use of water when treated by private
applicators. Appropriate chemical analysis to determine
20
-------
that residue levels are less than 0.01 ppra can be performed
in lieu of restricting use for 14 days when application is
under Federal or State programs. The practicality of
"holding" procedures for bodies of water, and the scientific
bases for establishing residue levels and measuring residues
in aquatic sites treated with diquat dibromide' are hot
firmly established. In addition, adequate data are not
available describing the fate of diquat dlbromide in aquatic
environments. Until additional data are evaluated to
determine more practical and appropriate restrictions and
tolerances, the existing restrictions and tolerance levels
will remain in effect.
19. The Agency is requiring a maximum application rate of 2 Ibs.
diquat cation per surface acre-foot for aquatic sites.
Rationale: Tolerances for irrigated crops and potable water
for diquat dlbromide have been established based on a
maximum application rate of 2 Ibs. diquat cation/surface
acre-foot. Application rates above this may exceed
established tolerance levels.
20. The Agency is requiring development and submission of specific
guidelines for treatment of poisoning from accidental'
ingestion of diquat dibromide,
Rationale: Since ho specific antidote exists for diquat
dibromide poisoning, and severe gastrointestinal Irritation
may result from oral exposure, it is essential to develop
specific practical treatment for swallowing of diquat dibromide
materials.
21. The Agency will not require endangered species labeling at
this time.
•
Rationale: The Agency is unable to assess hazards to endan-
gered species due to the the lack of critical information
concerning the behavior of diquat dibromide in the environment.
When required data are available for review, an Office of
Endangered Species opinion will be requested. Preliminary
endangered species labeling may be required prior to receipt
of additional data, however, when the Agency completes
generic labeling for aquatic and non-crop pesticides.
22. None of the risk criteria listed in 4-0 CFR 15^.7
initiating a special review have been met. Therefore,
diquat dibromide is not being placed in Special Review at
this time.
Rationale: After considering available toxicological data,
the Agency has determined that no reason exists for place-
ment of diquat dibromide into Special Review status.
Additional toxicological data (except dog feeding study)
will be available by mid-1987.
21
-------
23. While data gaps are being filled, currently registered
manufacturing-use and end-use products containing diquat
dibroraide as the sole active ingredient may be sold,
distributed, formulated, and used in the United States.
Registrants must provide or agree to. develop additional
data, as specified in Tables A and B of the Data Appendix,
The Agency will issue registrations for substantially
similar products and will consider new uses (except those
involving significant new food uses) on a case-by-case basis.
Rationale: Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the Agency may choose not to cancel
or withhold registration if data are missing or are inadequate
[see FIFRA Sections 3(c)(2)(B) and 3(c)(7)].
issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated and the
Agency will determine if the data will affect the registration
of diquat dibromide.
22
-------
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain diquat dibromide as the sole active
ingredient, bear required labeling, and conform to the
product composition, acute toxicity limits, and use pattern
requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MP's) must contain diquat
dibromide as the sole active, ingredient. Each MP formula-
tion 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 impuri-
ties found at greater than 0.1%. ,
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing diquat dibromide
provided that the prod.uct labeling bears appropriate precau-
tionary 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
for the uses listed below. The Use Index lists all registered
uses, as well as approved application rates and frequencies.
-Terrestrial, non-domestic, food uses: Alfalfa,*
clover,* potatoes, sorghum,* soybeans,*
sugarcane, vetch*
-Terrestrial, non-domestic, non-food uses: Golf
courses; manufacturing/industrial/commercial
sites; ornamental gardens, shade trees and woody
shrubs; parks; and rights-of-way
*Tolerances have not been established for these seed
crop uses
23
-------
-Domestic outdoor uses: Domestic dwellings, patios, and
walkways
-Greenhouse non-food uses: Beneath greenhouse benches
-Aquatic food, non-food uses: Canals, drainage ditches,
lakes, marshes, ponds, rivers, streams, and waterways
D. REQUIRED LABELING
All products must bear appropriate labeling as specified in
40 CPR 162.10 and PR Notices 83-2, 83-3. Appendix II contains
information on label requirements. All labeling changes must
appear on all products released for shipment after July 1988.
In addition to the above, the following information must appear
on labeling:
1. Ingredients Statement
The ingredient statement must list the active ingredi-
ent as diquat dibromide.
2. Use Pattern Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for accept-
able use- patterns. Labeling must specify sites which are
listed in Use Patterns, Section C.3. However, no use may
be included on the label where the registrant fails to
agree to comply with data requirements in TABLE A for that
use pattern.
24
-------
3. Precautionary Statements
All Products
Under Hazards to Humans and Domestic Animals, add the
"Repeated contact with skin or contact with open cuts
or sores may increase the hazard associated with
this product."
Manufacturing-Use Products
a. Hazards to Humans . "Wear a protective suit of one or
two pieces that covers all parts of the body except
the head, hands, and feet. Wear chemical resistant
gloves, and chemical resistant shoes, shoe coverings
or boots. Wear goggles or a face shield."
b. Environmental Hazards. "This pesticide is toxic to
wildlife. Do not discharge effluent .containing
this product into lakes, streams, ponds, estuaries,
oceans, or public waters unless this product is
specifically identified and addressed in a NPDES
permit. Do not discharge effluent containing this
product to sewer systems without previously notify-
ing the sewage treatment plant authority. For
guidance, contact your State Water Board or Regional
Office of the EPA."
End-Use Products
a. Use Classification for Category I products and
Category II products for domestic us"e
"RESTRICTED USE PESTICIDE: Because diquat dibromide
may be highly toxic if absorbed through the skin, this
product is only for retail sale to and use by certified
applicators or persons under their direct supervision
and only for those uses covered by the certified
applicator's certification."
b. WORKER SAFETY RULES for Category I and II products
"Keep all unprotected persons, children, livestock, and
pets away from" treated area or where there is danger
of drift. Da not rub eyes or mouth with hands. If
you feel sick In any way, STOP work and get help
right away (see Practical Treatment section).
-------
HANDLE THE CONCENTRATE ONLY WHEN WEARING THE
FOLLOWING PROTECTIVE CLOTHING AND EQUIPMENT:
Wear a protective suit of one or two pieces that
covers 'all 'parts of'the'body except the head,
hands, and feet. Wear chemical resistant gloves,
chemical resistant apron, and chemical resistant
shoes, shoe coverings or boots. Wear goggles or
a face shield. If handling the concentrate with
a closed system - long sleeved shirt and long
legged pants may be substituted for the protective
suit.
WEAR THE FOLLOWING PROTECTIVE CLOTHING DURING
APPLICATION, EQUIPMENT REPAIR, EQUIPMENT CLEANING,
DISPOSAL OF SPRAY SOLUTIONS AND DURING EARLY
REENTRY TO TREATED AREAS:
Wear a protective suit of one or two pieces that
covers all parts of the body except the head,
hands, and feet. Wear chemical resistant gloves
and chemical resistant boots, shoes, or shoe
coverings. During application .only from a tractor
with a completely enclosed cab or aerially with
an enclosed cockpit - long sleeved shirt and
long legged pants may be worn in place of the
above protective clothing. Chemical resistant
gloves must be available in the cab or cockpit and
must be worn while exiting. This alternative
clothing is inadequate to protect you during
equipment repair, cleaning, or reentry.
IMPORTANT! Before removing gloves, wash them with
soap and water. Always wash hands, face, and arms
with soap and water before smoking, eating,
drinking, or toileting. After work, take off all
clothes and shoes. Shower using soap and water.
Wear only clean clothes. Do not use contaminated
clothing. Wash protective clothing and protective
equipment with soap and water after each use.
Personal clothing worn during use must be laundered
separately from household articles. Clothing and
protective equipment heavily contaminated or
drenched with diquat dibromide must be disposed of
according to state and local regulations. HEAVILY
CONTAMINATED OR DRENCHED CLOTHING CANNOT BE
ADEQUATELY DECONTAMINATED.
DURING AERIAL APPLICATION, HUMAN FLAGGERS ARE
PROHIBITED UNLESS IN TOTALLY ENCLOSED VEHICLES."
26
-------
c. Environmental Hazards for AQUATIC USES.
"This pesticide is toxic to wildlife. Do not apply
directly to water except as specified on this label.
Do not contaminate water by cleaning of. eqaipment
or disposal of wastes. Do not use treated water
for animal consumption, spraying or irrigation
within 14 days after treatment. Treatment of dense
weed areas can result in oxygen loss from decomposi-
tion of dead weeds. This loss can cause fish
suffocation. Therefore, treat only 1/3 to 1/2 of
the dense weed areas at a time and wait 14 days
between treatments. Consult your State Pish arid
Game agencies before applying this product to
public waters."
d. Environmental Hazards for NON-AQUATIC USES.
"This pesticide is toxic to wildlife. Do not apply
directly to water or wetlands (swamps, bogs,
marshes, and potholes). Do not contaminate water
by cleaning of equipment or disposal of wastes."
e. Crop Rotation Statement.
"Crops other than those on which diquat dibromide
may be applied may not be planted in diquat dibromide-
treated soil."
f. Reentry Statements.
All products with crop uses:
"Do not enter or allow entry into treated areas
within 24 hours after treatment unless protective
clothing is worn."
All products with golf course or rights-of-way uses:
!'Do not allow entry of maintenance personnel into
treated areas within 24 hours after treatment unless
protective clothing is worn."
All products with aquatic uses;
"Do not allow swimming in treated areas within
14 days after treatment."
27
-------
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing the pesticide identified in
Section II.A. are subject to certain ceaui.remen.ts. for data
submission or changes in composition, labeling or packaging
of the product. The applicable requirements depend on whether
the product is a manufacturing or end-use product.
Products are subject to this Registration Standard as
follows:
A. Manufacturing-use products containing this pesticide are
subject to: 1) The restrictions upon use, composition, or
packaging listed in Section IV; 2) The data requirements
listed in Tables A and B; 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.2
B. End-use products containing this pesticide are subject to:
1) The labeling requirements specified for end-use products
in Section IV; 2) If not eligible for. the formulator's
exemption, the data requirements listed in Table A.J
2 Data requirements are listed in the Tables in Appendix I
of this Registration Standard. The Guide to'Tables in that
Appendix explains how to read the Tables. Table A lists
generic data requirements applicable to all products containing
the pesticide subject to this Registration Standard. Table B
lists product-specific data applicable to manufacturing-use
products. The data in Tables A and B need not be submitted by
a producer who is eligible' for the formulator's exemption.
3 if you purchase from another producer and use as the source
of your active ingredient, only EPA-registered products, you
are eligible for the formulator's exemption for generic data
concerning that active ingredient (Table A) and product-
specific data for the manufacturing-use product you purchase
(Table B). Two circumstances nullify this exemption: 1) It
you change sources of active ingredient to an unregistered
product, formulate your own active ingreident, or acquire your
acitve ingredient from a firm With ownership in common with
yours, you individually lose the exemption and become subject
to the data requirements in Table A; 2) If no producer subject
to the generic data requirements in Table A agrees to submit
the required data, all end-use producers lose the exemption, and
become subject to those data requirements.
28
-------
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion o£ the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers Lo 'thre -data ~i is ted "in Table A, 'which are 'required to
be submitted by registrants to maintain in effect the regis-
tration 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 not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. If you choose to change sources of
supply, the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite- generic
data relevant to the uses of your product if, at? the time
4 Registrations granted after issuance of this Standard
will be conditioned upon submission or citation of the data
listed in this Registration Standard.
29
-------
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 su-brciscio« 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 PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data, and either—
(a) Submit the existing data that you believe will
satisfy the data requirements, or
(b) State that you will secure the data or have made
a contract to have any necessary studies completed
within the applicable time period.
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 submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
30
-------
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-comp.lian.ce. .wi.th. .the. D_CJL.. , JE.PA. 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 Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be -bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this'commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit 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.
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 require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not automatically
extend the timeframes for developing required data, and if
your waiver request is denied, your registration may be
suspended if you fail to submit the data.
-------
5. You request that EPA amend your registration by deletinc
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. bfou request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either 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
and await EPA approval, because.the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not automatically extend
the timeframe for submission of the data, nor will extensions
generally be given to conduct studies due to submittal of
inappropriate protocols.
F. 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. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring.
EPA will view failure to request an extension before
the 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. Time extensions
may be considered when joint data development is planned,
32
-------
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not automatically extend
the Limeframe for s~uorni'ss ion of the data. If EPA denies your
request for a time extension and you do not submit the data
as requested, EPA may begin proceedings to suspend the regis-
trations of your products.
G. Existing stocks provision upon suspension or cancellation.
EPA will permit continued sale and distribution of existing
stocks of a pesticide product which has been suspended or
cancelled if doing so would be consistent with the purposes
of the Act. However, the Agency has determined that if a
registration is suspended for failure to respond to a DCI
request under FIFRA sec. 3(c)(2)(B), an existing stocks
provision is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will
be suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act. The following information must be included in any
request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
33
-------
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
oroduct-snecific 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. As noted earlier, the Agency has decided
that it will not routinely require product-specific data for
end use products at this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section VI.D, E, f, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options VI.D.I." (submit data)
or VI.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
34
-------
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient ins tractions" and" precautions r re fleeting"
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In
addition, labeling requirements specific to products containing
this pesticide are specified in Section IV.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may issue a Notice of Intent to Cancel
the registration of your product under FIFRA sec. 6(b)(l).
35
-------
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Products (MUPs) containing Dlquat Dibromide
as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "PIPRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Pormulator's Exemption Statement (EPA Form ).
d. Product Specific Data Report (EPA Form 8580-4).
e. 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 to the Product Manager:
a. Two copies of any required product-specific data
(See Table B).
b. Three copies of draft labeling, Including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the Intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
c. "Notification of your decision regarding whether you
will conduct appropriate residue studies or increase
tolerances for particular irrigated crops for which tolerances
are not supported.
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated In response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
-------
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the forraulator's exemption. If for any
reason any test is delayed or aborted so that the agreed
schedule cannot fo'e" met,' immediately notify the Product Manager
and the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. End Use Products containing Diquat Dibromide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8b70-4)
c. Formulator's Exemption Statement (EPA Form ),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft 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. End-use product labeling
must comply specifically with the instructions in Section
IV (Regulatory Position and Rationale).
37
-------
C. Intrastate Products containing Diquat Dibromide as
sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
D. Addresses
The required information must be submitted to the following
address:
Richard F. Mountfort, PM-23
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
38
-------
APPENDIX I
DATA APPENDICES
39
-------
TGUIDfi-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
foll'owing format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port 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
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, fopd
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
40
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has-data in "its- fries Lftdt coiapTe tely~'sat rsfy "
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 infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
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 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration 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 DIQUAT DIBROMIDE
Data Requirement Test
Substance
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-2 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
Physical and Chemical
Characteristics
Use Does EPA Bibliographic Must Additional 2/Time Frame
Patterns Have Data?!/ Citationl/ Data be for
Submitted? Submission
All N/A N/A Yes 6 Months
All N/A N/A Yes 6 Months
All N/A N/A Yes 12 Months
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - .Boiling Point
TGAI
TGAI
TGAI
TGAI
TGAI
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data Requirement
Test Use Does EPA Bibliographic Must Additional ^/Time Prarne
Substance Patterns Have Data?_l/Citation£/ Data be for
Submitted? Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or TGAI All N/A
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:
64- 1 - Subroittal of samples TGAI, PAI All N/A
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A.
Yes
Yes
No _3/
Yes
NoV
Yes
Yes
No
6 Months
6 Months
6 Months
6 Months
15 Months
I/ Not applicable. Although product chemistry data may been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been Introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document:
6-mo. Date 12/31/86; 12-mo. Date 6/30/87; 15-mo. Date 9/30/87.
3/ Not required because the melting point of the pure form of the active ingredient is >30°C.
¥/ Not required because the pure form of the active Ingredient is polar.
43
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Does EPA Bibliographic Must Additional
Data Requirement Test Substance Have Data? Citation Data be
Submitted?
§158.125 Residue Chemistry
171-4 - Nature of Residue
(Metabolism)
- Plants PAIRA Partially 00055086
00056905
00065600
00065602
00065604
00067156
00067157
- Livestock PAIRA and Plant Partially 00065594
Metabolites 00065595
00065596
00065597
171-4 - Residue Analytical Method
- Plant residues TGAI and Partially 00071325
Metabolites 00115546
00115547
- Animal residues TGAI and Partially 00071325
Metabolites 00114449
171-4 - Storage Stability PAI No
00067162 Yes2/
00068221
00115563
00115583
00116728
00121305
00121307
00065599 Yes3/
00068229
00071328
00114410
00122705
00115559 Yes4/
00116728.
00116736
GS0288-002
00116739 Yes5/
- Yes6/
I/Time Frarne
for
Submission
18 Months
13 Months
12 months
12 months
24 months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DI'QUAT DIBROMIDE
Does EPA Bibliographic Must Additional ^/Tiine Frame
Data Requirement Test Substance Have Data? Citation Data be for
. Submitted? Submission
§158.125 Residue Chemistry - Continued
-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group #1 - Root and
Tuber Vegetables Group?/
°Crop 1 - Potatoes
—Crop Field Trials TEP Yes 00116/28 No
001*10590
- Crop Group #2 - Legume
Vegetables Group
°Crop 1 - Soybeans
— Crop Field Trials TEP Partially 00115575 Yes^a/ 18 Months
— Processed Food/Feed EP No Yes^/ 24 Months
- Crop Group #3 - Cereal
Grains Group
°Crop 1 - Sorghum
— Crop Field Trials TEP Partially 00115575 Yes9a/ i8 Months
— Processed Food/Feed EP No Yes^B/ 24 Months
45
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data Requirement
Test Substance
•Does EPA Bibliographic Must Additional 1/Tl-ne Frame
Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry - Continued
-4 - Magnitude of the Residue -
Residue Studies (Continued)
- Crop Group #4 - Non-Grass
Animal Feeds Group
°Crop 1 - Alfalfa
—Crop Field Trials TEP
°Crop 2 - Clover
—Crop Field Trials TEP
°Crop 3 - Vetch
—Crop Field Trials TEP
- Miscellaneous Commodities
"Sugarcane
—Crop Field Trials TEP
—Processed Foo,d/.Feed EP
No
No
No
Partially 00100410
00140586
Partially 00140586
YeslO/
Yesj^/
Yes 127
18 Months
18 Months
18 Months
18 Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Does EPA
Data Requirement Test Substance Have Data?
§158.125
171-4 -
-
*—
171-4 -
-
-
-
Residue Chemistry - Continued
Magnitude of the Residue in
Meat, Milk, Poultry and Eggs
Milk
Meat, Pat, Meat Byproducts of
Cattle, Goats, Hogs, Horses
and Sheep
Poultry and Eggs
Magnitude of the Residue -
Residue Studies
Potable Water
Pish
Shellfish
Irrigated Crops
TGAI or Plant Yes
Metabolites
TGAI or Plant Yes
Metabolites
TGAI or Plant Yes^/
Metabolites
EP Yes
EP Partially
EP Partially
EP Partially
Bibliographic
Citation
00031841
00140590
00031841
00140582
00116739
00068228
00068229
00115547
00116739
00135717
00068228
Q0135717
00031836
Must Additional
Data be
Submitted?
Nol4a/
N0l4a,b/
Nol4a,b/
No16/
Yesl7/
YesW
Yesl9/
207 21/
1/Time Frame
for
Submission
15 Months
15 Months
18 Months
47
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
§158.125 Realdue Chemistry - Continued
NOTE: All residue data requested in this Standard must be accompanied by information on the duration and conditions
of sample storage prior to residue analysis, and by data depicting the stability of diquat residues under uie
conditions and for the time intervals specified. Since the data required for individual cornmodi.les are
dependent on metabolism and stability studies, these data should be obtained and submitted prior to any
required residue data. It should also be noted that seed crop uses for soybeans, grain sorghum, ,aii an a,
clover and vetch, are now considered food uses, and are subject to the data requirements discussed aoove.
\/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document:
" 6-mo. Date 12/31/86; 15-mo. Date 9/30/8?; 18-mo. Date 12/31/87; 2U-mo. Date 6/30/88. For Nature of the Residue
in Plants and Magnitude of the Residue In Crops, the timeframes for submitting data are 18 or 24 months, as
appropriate, commencing the first planting season following issuance of the Standard. These timeframes -will oegin
with the Spring 198? planting season and data are due no later than October 1988. f
I/ Data must be submitted depicting the distribution and metabolism of ring-labeled (l^C) diquat in potato , tubers
" following foliar desiccation; in the grain and forage of a cereal grain crop such as corn, oats, or wheat
following foliar desiccation; and in soybeans (mature beans and forage) following foliar desiccation, xi tne
metabolism of diquat differs significantly in these three crops, metabolism data will be required for a,
representative commodity from each crop group for which there are registered tolerances.
\/ A ooultrv metabolism study is required. The chickens must be dosed for three days (at least) with rlng-r labeled
this method.
4/ Method RM-5X-1 (RM-8X-1) (MRID 00116728) must be tested on a variety of crops fortified with diquat at Q. 02-0.1 ppm
" when all the metabolism questions for diquat are resolved.
-•>/ Method RM-5-B (MRID 00116739) must be tested on a variety of animal tissues fortified with diquat at 0.02-0.1 ppm
" when all '-.he metabolism questions for diquat are resolved.
3/ Data must be submitted depicting decline over time in levels of diquat residues during storage of treated coranodi-
- Set, mder conditions used in residue tests submitted in support of established tolerances on these conFnodities.
A. a
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
§158.123 Residue Chemistry - Continued
7/ Presently, potatoes are the only member of this crop group with a registered food use. If food uses are sought
on remaining members of this crop group, then residue data will be required for carrot, radish, and sugar beet.
The 0.5 ppm food additive tolerance for residues of'dlquat on processed potatoes should be increased to 1.0 ppm.
8/ a) Data must be submitted depicting residues of concern in or on soybean seeds treated with the 2 Ib A.I,/gal
SC/L (soluble concentrate/liquid) formulation at 0.5 Ib cation/A (acre). Samples must be harvested one week
after treatment. Tests must be conducted in AR, IN, IA, MN, MS, MO, and OH. b) If detectable residues are
, found, an appropriate tolerance must be proposed and processing studies will be required.
9/ a) Data must be submitted depicting residues of concern in or on the seed of grain sorghum treated witn the 2 Ib
A.I./gal SC/L at 0.5 Ib cation/A. Samples must be harvested one week after treatment. Tests must be conducted
in KS, MB, and TX. b) If detectable residues are found, an appropriate tolerance must be proposed and
processing studies will be required.
4
ID/ Data must be submitted depicting residues of concern in or on seed from alfalfa treated with the 2 Ib A.I./gal SC/L
at 0.5 Ib cation/A. Samples must be harvested 3 days after treatment. Tests must be conducted jn CA, ID, and
WA. '.
\
ll/ Data must be submitted depicting residues of concern in or'on seed from clover treated with the 2 Ib A.I./gal SC/L
at 0.5 Ib cation/A. Samples must be harvested 3 days after treatment. Tests must be conducted in CA, MI, MN,
NY, OH, OR, and WA.
12/ Data must be submitted depicting residues of concern in or on seed from vetch treated with the 2 Ib A.I./gal SC/L
at 0.25 Ib cation/A. Samples must be harvested 3 days after treatment. Tests must be conducted in MS, OR, and
PA.
13/ a) Residue data must be submitted from sugarcane and sugarcane forage harvested 3 months after application in PL
or PR, and 5 months after application in HI, of the 2 Ib A.I./gal SC/L formulation (as a plant growth regulator)
at 0.25 Ib cation/A in 3~10 gal of water per acre using aerial equipment, b) Residue data must be submitted from
sugarcane forage harvested after spot application of the same formulation (as a herbicide) at 1 Ib cation/A by
ground spray equipnent, in 50-100 gal of water per acre. This test must be conducted in HI on sugarcane also
subjected to diquat application as a plant growth regulator. Studies should reflect the maximum number of
applications permitted per season when diquat is used as a herbicide. This number must be proposed as'a label
amendment when these data are submitted, c) Residue data must be submitted from the processed products of sugarcane:
molasses, bagasse, and refined sugar. Should residues be found to concentrate upon processing, then appropriate
food/feed additive tolerances must be proposed. Application of exaggerated rates of diquat may be necessary to
determine concentration of residues in the processed products of sugarcane.
49
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
§158.125 Residue Chemistry - Continued
IV a) Additional data may be required for milk, meat, or eggs if the required metabolism testing reveals metabolites of
toxicological concern, b) The egg and meat, fat and meat by-products tolerances should be raised to 0.05 ppm.
JL5/ On receipt and evaluation of the required poultry metabolism data, the adequacy of these residue data will be
assessed.
_16/ If the required aquatic metabolism studies indicate the presence of additional degradates of toxicological concern
in natural waters following treatment with diquat, additional residue data depicting the levels of such degradates
in natural water following registered use will be required.
IT/ Additional residue studies on fish employing diquat in water at levels which would be expected at the time of
application are required. ' • -
18/ Additional residue studies on shellfish utilizing diquat in water at levels which would be expected at the time
of application are required. "
19/ Data must be submitted reflecting irrigation of tomatoes and mustard greens with natural water which has been
treated with diquat to control severe aquatic weed infestations. Such data should reflect residues resulting from
both surface and overhead sprinkler irrigation in accordance with standard agricultural practices (i.e., multiple
irrigation) using water containing 0.01 ppm diquat residues or water under grower control treated 1^ days previ-
ously and the crops must be harvested immediately after the final irrigation. Alternatively, a higher tolerance
level of 0.05 ppm for these two groups could be proposed. Crop groupings may need to be revised in accordance
with updated groupings established in 40 CPR Part 180. These revisions will be considered when tolerances for
irrigated crops are reassessed.
20/ Data must be submitted reflecting residues of diquat cation in or on rice grain and straw following production
using standard agricultural practices. Such data should reflect the maintenance of flooded fields using diquat
treated water.
21/ Data must be submitted reflecting diquat cation residues in or on avocados, cottonseed, hops and sugarcane result-
ing from irrigation with diquat treated water. Samples should reflect residues likely to result from following
standard agricultural practices. Alternatively, a higher tolerance level of 0.1 ppm on these crops could be
proposed.
-------
TABLE'A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBRQMIDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional I/Time Frame
Data be for
Submitted? Suomission
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-1 - In Air
METABOLISM STUDIES-LAB:
TGAI or PAIRA A,B,D,P,H
TGAI or PAIRA A,B,D,F,H
TGAI or PAIRA A
TGAI or PAIRA A
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic TGAI or PAIRA
162-1 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
TGAI or PAIRA A,B,F,H
TGAI or PAIRA A
D
D
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
TGAI or PAIRA A,B,D,F,H
A,F
A,F
Yes
No
No
No
No
No
No
No
No
No
No
0015^100
00151101
No
Yes
Yes
No!/
Yes
Yes!/
Yes
Yes
Yes
Yes
Reserved^/
9 Months
9 Months
2? Months
27 Months
27 Months
27 Months
12 Months
12 Months
51
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data Requirement Test Use
Substance Patterns
§158.130 Environmental Pate - Continued
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP A,B,P,H
164-2 - Aquatic (Sediment) TEP D
164-3 - Forestry TEP
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term TEP A
ACCUMULATION STUDIES:
165-1 - Rotational Crops PAIRA A
(Confined)
165-2 - Rotational Crops TEP A
(Fiold)
165-3 - Irrigated Crops TEP D
165-4 - In Fish TGAI or PAIRA A,B,D
lfic_c _ in Adnatic Non-Taraet TEP D
Does EPA Bibliographic
Have Data? Citation
No
No
N/A
N/A
No
No
No
No
No
No
Must Additional
Data be
Submitted?
Yes
Yes
Reserved^"/
Yes
Reserved^/
Yes
Yes
Yes
I/Time Frame
for
Submission
27 Months
27 Months
39 Months
r
159 Months
12 Months
12 Months
Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
§158.130 Environmental Fate - Continued
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document:
9-mo. Date 3/31/87; 12-mo. Date 6/30/8?; 15-mo. Date 9/30/87; 27-mo. Date 9/30/88; 39-mo. Date 9/30/89.
2/ Not required due to the apparent low volatility of diquat dibromide.
3/ An acceptable anaerobic aquatic metabolism study will, satisfy the requirement for an anaerobic soil study.
V Data will be required based on results of the lab study.
5/ Data will be required if the dissipation rate determined In the field dissipation study indicates that pesti-
cide residues do not readily"dissipate In soil.
6/ Data will be required If significant residues of concern are found in the confined study.
53
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data
§158.
Requirement
135 Toxicology
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted
1/Vime Frame
for
Submission
i
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Rat
- Acute Inhalation Toxicity
- Rat
- Primary Eye Irritation
- Rabbit
- Primary Dermal Irritation
- Rabbit
- Dermal Sensitization
TGAI
TGAI
TGAI
MP
MP
TGAI
All
All
All
All
All
All
Partially
. Partially
Partially
No
No
Yes
00140572
00091316
00061634
00061633
00155475
Yesl/
Yesl/
Yes!/
Yes
Yes
No
•9 Months
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
82-2
- 90-Day Feeding:
- Rodent, and
- Non- rodent (Dog)
- 21-Day Dermal
- Rabbit
TGAI
TGAI
TGAI
A,C,E
A,C,E
All
No
No
Partially
00140576
00140577
No!/
Yes5_/
Yesi/
18 Months
12 Months
- Rat
82-4 - 21-Day Inhalation:
TGAI
All
No
Yea!/
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data Requirement Test
Substance
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity - TGAI
- Rodent, and
- Non-rodent (Dog)
83-2 - Oncogenicity - TGAI
- Rat (preferred), and
- Mouse (preferred)
83-3 - Teratogeniclty - TGAI
- Rat
- Rabbit
83-4 - Reproduction - Rat TGAI
2-generation
MOTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal TGAI
Aberration
Use Does EPA Bibliographic Must Additional I/Time Frame
Patterns Have Data? Citation Data be for
Submitted? Submission
A,C,E
Partially 00079829
00080982
00081508
00140579
00145855
Partially 00140578
A,C,E
• Partially 00079829
00080982
00081508
00140579
Partially 00079830
All
Yes .00145855
Yes 00061635
A,C,E Yes 00140589
All Partially 00148843
00148845
All Partially 00061638
55
Yes8/ 9P Days
Yesl/ 50 Months
Yes8/ 90 Days
Yes!P_/ 90 Days
No
No
No
Yes 9 Months
Yes 12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data
§158
Requirement
.135 Toxicology - Continued
8U-4 - Other Genotoxic Effects
SPECIAL TESTING
85-1
85-2
- General Metabolism
- Dermal Penetration
Test
Substance
TGAI
PAI or PAIRA
Choice
Use
Pattern
All
A.C.E
A,C,E
Does EPA
Have Data?
Yes
Yes
Yes
Bibliographic
Citation
00061636
0501^905
00055107
00031050
Must Additional
Data be
Submitted?
Yes!!/
No
No
I/Time Frame
Submission
OTHER
- Practical Treatment
for Oral Ingest ion
Choice
All
No
Yes
12 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
§158.135 Toxicology - Continued
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document:
90-day Date 9/30/86; 9-mo. Date 3/31/87; 12-mo. Date 6/30/87; 18-mo. Date 12/31/87; 50-mo. Date 8/31/90.
2_/ NOEL's must be shown for effects on the gastric system in addition to results of the usual investigational
parameters. The causes of death must be accounted for as completely as possible.
3/ The spray mist generated must be of respireable size to assure that dlquat will be inhaled and absorbed
~ by the lung. Both vapor and aerosol studies must be conducted and information on the particle size
provided.
V Although there is no 90-day feeding study with rodents, there is available a 2-year chronic feeding study with rats.
Thus, the 2-year study fills this data gap.
5/ If a chronic feeding study in dogs is conducted, this requirement will be deleted.
6/ Available studies do not adequately assess the hematology, clinical chemistry, ur'inalysis, or histopathological
parameters.
II A 21-day inhalation study is required rather than a 90-day study. The spray mist generated must be of
~ respireable size to assure that diquat will be inhaled and absorbed by the lung.
8/ Additional historical control data for target tissues and statistical analyses of both neoplastic and non-
neoplastic lesions must be submitted.
9/ The available study does not adequately assess the hematology, clinical chemistry, urinalysis or histopathology
parameters.
1Q/ Additional information regarding the existing study must be submitted as follows: a) microscopic readings to include
all available tissues not yet examined for all mice in the study; b) individual animal pathology sheets showing the
gross necropsy and microscopic findings on the same sheet; c) tables summarizing the pathological findings that
clearly show for each tissue the actual number of animals examined and the number of animals with each lesion type;
d) explanation for the missing mice.
ll/ In order to clarify the issue of potential mutagenicity of diquat, a summary table of all known mutagenicity
studies with diquat Is required, together with the results and exact references. Copies of these studies should
also be submitted. Other mutagenicity study types may be required pending review of this mutagenicity summary
table and accompanying studies.
57
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDB
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.142 Spray Drift
201-1 - Droplet Size Spectrum
202-1 - Drift Field Evaluation
§158.75 Other Exposure Data
Test
Substance
TEP
TEP
TEP
TEP
TEP
TEP
Use
Pattern
D,H
A
A
A
A
A
Does EPA
Have Data?
No
No
No
No
No
No
Bibliographic Must Additional
Citation Data be
Submitted?
Yes^/
Yes3/
Reserved^/
Reserved5/
Yes6/
Yes6/
1/Tii.ie Frarne
~ for
Submission
27 Months
21 Months
6 Months
6 Months
- Permeability of Pro-
tective Clothing
TEP
A,D,F,H
No
Yes7/
6 Months
58
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
158.140 Reentry Protection , §158.142 Spray Drift, §138.75 Other Exposure Data - Continued
Data must be submitted within the Indicated time frame, based on the date of the Guidance Document:
27-mo. Date 9/30/88.
For each end-use, the registrant Is required to propose an acceptable reentry Interval. The reentry Interval
may be based on one of the following criteria: (a) data on dissipation of residues (decline curve), on human
exposure to those residues, and on toxiclty of the residues; or (b) determination of that time beyond which
there are no detectable dlslodgeable or inhalable residues remaining in the worker/occupant environment. If
the registrant has reason to believe that an end-use will not cause exposure bo residues, a request for waiver from
this data requirement should be submitted within 6 months of issuance of the Standard.
Soil Dissipation data are required only for uses where workers will be exposed directly to substantial quantities
of soil during their work, i.e. for use on potatoes where hand harvesting would be performed.
Human exposure monitoring data may be submitted at the registrant's option.
If the registrant opts to submit human exposure monitoring data, both Dermal Exposure and Inhalation Exposure
must be submitted in order to allow for complete interpretation.
The spray drift droplet spectrum and field evaluation may be done together in order to evaluate the droplet
spectrums that are associated with actual field use patterns.
•
Quantitative data must be submitted regarding the permeability of chemical resistant gloves to both diquat dibrcmide
and contaminant EDB. If these data are not available, they must be generated using methods described in,American
Society of Testing and Materials (ASTM) 739-81 - Standard Test Method for Resistance of Protective Materials to
Permeation by Hazardous Liquid Chemicals or an equivalent method.
59
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data Requirement
Test Use Does EPA Bibliographic Must Additional I/Time Frarne
Substance Pattern Have Data? Citation Data be for
. Submitted? Submission
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI
A,B,D,H
Yes
00106559i/ No
GS9999-OOL3/
71-2 - Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Manmal Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
- Actual Field Testing TEP
- Mammals, and
- Birds
A,B.D,(E, Partially 00116565!/
F)I/>H 00034769!/
A,B,D,H Partially 00034769!/
N/A
A,B,D Partially 001199881/
N/A
N/A
Yes
Yes
Yes
9 Months
9 Months
?.l\ Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data
§158
Requirement
.145 Wildlife and
Test Use Does EPA
Substance Pattern Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
I/Time Frame
for
Submission
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING
72-1
72-2
- Freshwater Pish Toxicity
- Coldwater Pish Species
- Warmwater Pish Species
- Acute Toxicity to
Freshwater Invertebrates
TGAI A,B,D,(E,F)1/,H No
TEP D Yes
TGAI A.B.D.H No
TEP D Yes
TGAI A,B,D,(E,F)V,H Yes
TEP D Partially
001389631/
00115858!/
0013896L2/
000280021/
001389631/
001389621/
001155721/
00027203!/
001155761/
001389631/
050014653/
001158621/
Yes
No
Yes
No
No
Yes
9 Months
9 Months
9 Months
72-3 - Acute Toxicity to
Estuarine and Marine
Organisms
- Pish
- Mollusk
- Shrimp
TGAI
A,B,D
Partially 00062l88l/
Yes.6/
12 Months
61
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data
§158
72-4
72-5
72-6
Requirement
.1^5 Wildlife and
Test
Substance
Aquatic Organisms - Continued
- Pish Early Life Stage, TGAI
and Aquatic Invertebrate
Life-Cycle
- Pish - Life Cycle TGAI
- Aquatic Organism TGAI, PAI or.
Use
Pattern
A,B,D
A,B,D
A,B,D
Does EPA Bibliographic
Have Data? Citation
No
No
No
Must Additional
Data be
Submitted?
Yes!/
Reserved^/
Yesl/
1/TLme Frame
for
Submission
t
15 Months
12 Months
72-7
Accumulation
- Crustacean
- Pish
- Insect Nymph
- Mollusk
• Simulated Field Testing
- Aquatic Organisms
- Actual Field Testing
-Aquatic Organisms
Degradation
Product
TEP
A,B,D
No
Reserved^./
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
§158.1*15 Wildlife and Aquatic Organisms - Continued
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document:
9-mo. Date 3/31/87; 12-mo. Date 6/30/87; 15-mo. Date 9/30/87.
2/ Study on Its own fulfills Guidelines requirements.
_3/ Study must be combined with other studies to fulfill Guidelines requirements.
V Required to support manufacturing-use product.
5/ Reserved pending receipt and review of fate data.
6/ Required to support the following uses associated with coastal counties: sugarcane, aquatic weed control, and
rights-of-way.
7/ Required to support aquatic weed control use and may be required to support sugarcane and rights-of-way use pending
results of fate data.
8/ Reserved pending results of partial chronic fish/invertebrate life cycle and fate data.
9/ Refer to Environmental Pate table, study 165-4.
63
-------
TABIE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDK
Data Requirement Test Use
Substance Pattern
§158.150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/
Seedling Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
123-1 - Seed Germination/
Seedling Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER III
124-1 - Terrestrial Field
124-2 - Aquatic Field
I/ Data must be submitted within
TEP B,D
TGAI B,D
TGAI B,D
TGAI B,D
TGAI B,D
TGAI B,D
TGAI B,D
TEP B
TEP D
the indicated time
Does EPA Bibliographic Must Additional JL/TLne Frame
Have Data? Citation Data be for
Submitted? Su omission
No
No
No
No
No
No
No
No
No
frame, based on date of
Ncii/
Yes 9 Months
Yes 9 Months
Yes 9 Months
Reserved!/
Reserved!/
Reserved!/
Reserved!/
Reserved!/
the Guidance Document: 9-mo. Date 3/31/8?.
2/ Data are required only for Special Review and certain public health situations.
3/ Reserved pending results of Tier I.
V Reserved pending results of Tier II.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DIQUAT DIBROMIDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
'Must Additional VTlme Frame
Data be for
Submitted? Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute TGAI A,B
contact toxicity
Honey bee - toxicity TEP A,B
of residues on
foliage
Honey bee subacute (Reserved)
feeding study
141-5 - Field testing for TEP A,B,
pollinators
No
No
Yes
Reserved^/
9 Months.
No
Reserved^/
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document:
9-mo. Date 3/31/87.
2/ Data from this study are not required at this time. Requirement will depend on results of the acute contact study.
65
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DIQUAT DLBHOMTDE
Data Requirement
Test Use " Does EPA Bibliographic Must Additional ^/Tiine Frame
Substance Pattern Have Data?J/Citation_j/ Data be for
~ Submitted? Submission
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP All N/A N/A Yea 6 Months
Disclosure of
Ingredients
61-2 - Description of Beginning MP All N/A N/A Yes 6 Months
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP All N/A N/A Yes 6 Months
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP All N/A N/A Yes 12 Months
62-2 - Certification of Limits MP All N/A N/A Yes 12 Months
62-3 - Analytical Methods to Verify MP All N/A N/A Yes 12 Months
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP All N/A N/A Yea 6 Months
63-3 - Physical State MP All N/A N/A Yes 6 Months
63-4 - Odor MP All ' N/A N/A Yes 6 Months
66
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DIQUAT DIBROMIDE
Data Requirement Test
Substance
Use
Pattern
Does EPA Bibliographic
Have Data?!/ Citation!/
Must Additional I/Time Frame
Data be for
Submitted? Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 -
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
64- 1
Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammablllty
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements :
- Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
All
All
All
All
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A .
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
6
6
6
6
6
15
6
6
15
Months
Months
Months
Months
Months
Months
Months
Months
Months
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency lias determined that
these data must be resubmitted for each manufacturing use product. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are riot applicable.
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document:
6-mo. Date 12/31/86; ; 12-mo. Date 6/30/87; 15-mo. Date 9/30/87.
67
-------
APPENDIX II
LABELING APPENDICES
68
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
69
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL' 'PRECAUTIONARY 'STATEMENTS -"Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 1C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on .
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(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 162.10(h)(2)].
70
-------
SUMMARY-3
Item 3A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route!s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product-
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified-
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) re-served any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
• for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
71
-------
SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. 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.
72
-------
SUMMARY-5
Item IDA. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. 'When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
73
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDKD
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
• Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . ,"
"Distributed by. . .," etc.
May be in inatric 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-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement^ oj:
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
hunans and
domestic
animals
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as a!x>ve
Same as above
COMMENTS
•
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
LH
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted.
block
Misuse
statanent
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash.
points under
150 °F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for . use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediate ly
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
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
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent wi^ih its labeling."
Must be set apart aud cle.itrly distin-
guishable from f ran other directions
for use.
Refer to Appendix I I guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
f
May be in metric as, well as U.S. units
-------
Chapter 1—Environmental Protection Agency
§162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section; .
(iii) The net contents as prescribed in paragraph (d) ot tnis
ssction *
(iv) 'The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para
graph (f) of this section; ,
(vi) An ingredient statement as prescribed in paragraph (g) ot
this section; .
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section; .
(viii) The directions for use as prescribed in paragraph (i)
of this section; and .
(ix) The use classification(s) as prescribed in paragraph (})
of this section. .,._,.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be piacea
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All-required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded. • .
3 Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-lanauaqe versions of the labeling.
(4) Placement of Label-(i) General. The label shall appear
be securely attached to the immediate container of the
on or
77
-------
pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B)- Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for -purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices; "
(v) Any statement directly or indirectly .implying that the
pesticide or device is recommended or endorsed by any agency of
•the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
78
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative .state meats on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is. not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the netCcontent statement
shall be in terms of liquid measure at 68°F .(20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liqu,id and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content sha_ll be stated in terms of the
largest suitable units, i.e., " 1 pound 10 ounces" rather than
"26 ounces."
79
-------
(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variatioa below a
stated minimum is not permitted. in no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) producing establishments registration number. The^producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) ingredient statement--(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement. ~
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text" "of the ingredient statement must run parallel
with other text on the panel en which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
80
-------
(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient (s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table
81
-------
Hazard Indicators
Oral LD
50
Inhalation LC
50
Oenmal LD
50
Eye effects
Skin effects
1 .
Up to and
Includ Ing
50 mg/kg
Up to and
Includ Ing
.2 mg/( fter
Up to and
Includ Ing
200 rog/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive
Tox 1 c 1 ty c
1 !
From 50 thru
500 mg/kg
From .2 thru
2 mg/ liter
From 200
thru 2000
Corneal opacity
reversible
' within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor!es
! ! !
From 500 thru
5000 mg/kg
From 2 thru
20 mg/! Iter
From 2,000 thru
20,000
No cornea! opac'ty;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
!V
Greater than
5000 mg/kg
Greater than
20 mg/I Her j
Greater than
20,000
No Irritation
1
!
Mild or si Ight |
Irritation at
72 hours J
1
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word *Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red .on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
All pesticide products meeting the
front panel*
(B) Toxicity Category II
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Cautioj)*."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
II shall bear on the
All pesticide products meeting the
III shall bear on the front panel
All pesticide products meeting the
IV shall bear on the front panel
82
-------
(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal-word- appe-ar on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature.of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph ( h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely, to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Over 30
Poir
Required
signal .word ,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
83
-------
(2) Other required warnings and precautionary statements. The
warnincs and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) 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. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Precautionary statements by toxicIty category
Toxic It,
category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
II
III
IV
Fatal (poisonous) If swallowed I Inhaled or
absorbed through sklnl. Do not breathe
vapor Idust] or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
required.).
May be fatal If swallowed (Inhaled or
absorbed through the skin]. Do not breathe
vapors (dust or spray mist]. Do not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.].
Harmful If swallowed (Inhaled or absorbed
through the skin). Avoid breathing vapors
Idust or spray mist]. .Avoid contact with
skin teyes or clothing]. (Appropriate
first aid statement required.].
I No precautionary statements required.].
Corrosive, causes eye and skin damage (or
skin Irritation], Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.]
Causes eye land skin] Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate fIrst
aid statement required.].
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
[No precautionary statements required.),
(ii) Environmental hazards. 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 potentj:a^_accidervtj_ injury or
84
-------
damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
i tig i eu iefi t v-ith- a fish" acute LC^Q" of -1- ppm or tess-, 'th-e- statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD5Q of 100 mg/kg or less, or
a subacute dietary LC5Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash pofnt at or below 20*F; If there fs a
flashback at any valve opening.
Flash point above 20*F and not over 80*F or If
the flame extension Is more than 18 In. long
at a distance of 6 In, from the flame.
Extremely flammable. Contents undsr 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 open flame. Do not
puncture or Incinerate container. Exposure to
temperatures above 130*r may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame. Do not puncturfe or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURI2ED CONTAINERS
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 or open flame.
85
-------
(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect- the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(i i i) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(1) The label clearly shows that the product is intended for
use~only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
O) The product will not come into the hands of the general
pubTic except after incorporation into finished products; and
(_4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(1) The label clearly states that the prcjduct is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and .
(_3) The product is also a drug and regulated under the provisions
of ttie Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators
on "the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
86
-------
(_2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(_3) The product,, as - finally manufactured / formulated-,' mixed, or
repackaged is registered; and
(_£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use":
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv). The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied,.meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162 .10(h}(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
87
-------
(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
env ironment.
(j) Statement of Use Classification. By October 22, 1976, all
nest-ioi de products r?.us-b- bear- on -their--labels' a: statement, of" use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2) .
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978]
88
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
A.
'Coiners
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
Keep away from
pressure
f ire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
89
-------
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.
90
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, irust 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 (see list in this Appendix) or are assigned to Toxicity Category
I on the basis of oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute 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
(see list in this Appendix) or meet any of the criteria in 40 CFR 261,
Subpart C for a hazardous waste must bear the following pesticide disposal
statement: '
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
91
-------
PEST/DIS-2
POOS
P070
P004
POOS
P006
POOS
P010
P011
P012
P021
PQ22
P024
P030
P031
P037
P039
P040
107-13-1
116-06-3
309-00-2
107-18-6
1302-45-0
504-24-5
7778-39-4
1303-28-2
1327-53-3
592-01-8
75-15-0
106-47-8
506-77-4
60-57-1
298-04-4
297-97-2
PESTICIDE ACTIVE INGREDIENTS THAT ARE ACUTE HAZARDOUS WASTES
I. PESTICIDES ON THE "E" LIST (with RCRA # and CAS *
[40 CFR 261.33(e)]
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine (Avitrol)
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroan i1ine
Cyanides (soluble cyanide salts
not otherwise specified)
Cyanogen chloride
Dieldrin
O,O-Diethyl S-[2-ethylthio)ethyl]
phospnorodithioate (disulfoton)
O,O-Diethyl O-pyrazinyl
phosphorothioate (Z inophos®)
Dimethoate
0,O-Dimethyl O-p-nitrophenyl
phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
Dinoseb
Endosulfan
Endothall .
Endrin
Famphur
Fluoroacetamide
Heptachlor .
Hexachlorohexahyd ro-e xo, exo-
d ime thanonaphthalene (Isodri n)
Hydrocyanic acid
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Oc tame thylpyr ophosphorami de
(CMPA, schradan)
Parathion
Phenylmercuric acetate (IMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
P044
P071
P047
P034
P02U
P050
P088
P051
P097
P057
P059
P069
P063
P066
P072
P075
P085
P089
P092
P094
P098
P102
P105
P106
P058
60-51-5
298-00-0
534-52-1
131-89-5
88-85-7
115-29-7
129-67-9
72-20-8
52-85-7
640-19-7
76-48-8
465-73-6
74-90-8
16752-77-5
86-88-41
54-11-5
152-16-9
56-38-2
62-38-4
298-02-2
151-50-8
107-19-7
26628-22-8
143-33-9
62-74-8
92
-------
PEST/DIS-3
Strychnine and salts P108 57-24-9
50-41-3
0,0,0,0-Tetraethyl P109 3689-24-5
dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate Pill 107-49-3
Thallium sulfate P115 7446-18-6
Thiofanox P045 39196-13-4
Toxaphene P123 8001-35-2
Warfarin (>0.3%) P001 81-81-2
Zinc phosphide (>10%) P122 1314-84-7
50 ACTIVES
II. PESTICIDES DERIVED FROM TRI-, TETRA-, AND PENTACHLOROPHENOLS
[40 CFR 261.31]
2-Chloroethyl 2-(2,4,6-trichloro-
phenoxy) ethyl ether
Dehydroabietylammonium
pentachlorophenoxide
Erbon
O-ethyl 0-(2,4,5-trichlorophenyl)
e thylp hosphonoth ioate
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(Hexachlorcphene)
—Potassium salt of
—Sodium salt of
—Disodium salt of
Pentachlorophenol
—Potassium salt of
—Sodium salt of
—Zinc salt of
—Zinc salt of N-alkyl
(cl6~Cl8)-1'3-propanediamine
—Pentachlorophenyl laurate
Potassium trichlorophenate (2,4,6)
Potassium trichlorophenate (2,4,5)
Silvex
—2-Butoxyethyl ester
—Butoxypolypropoxypropyl ester
—Butoxypropyl ester
—Diethanolamine salt
—Diisopropanolamine salt
—Dimethyl ami ne salt
—Dipropylene glycol isobutyl
ether ester
—Ethanolamine salt
—2-Ethylhexyl ester
—Isooctyl ester
F027 5324-22-1
F027 35109-57-0
F027 136-25-4
F027 327-98-0
F027 70-30-4
F027 67923-62-0
F027 3247-34-5
F027 5736-15-2
F027 87-86-5
F027 7778-73-6
F027 131-52-2
F027 2917-32-0
F027
F027 3772-94-9
F027 2591-21-1
F027 35471-43-3
F027 93-72-1
F027 19398-13-1
F027 53404-07-2
F027 25537-26-2
F027 51170-59-3
F027 53404-09-4
F027 55617-85-1
F027 53535-26-5
F027 7374-47-2
F027 53404-76-5
F027 53404-14-1
93
-------
PEST/DIS-4
—Isopropanolamine salt
—Monohydroxylaluminum salt
—Polypropoxyprcpyl ester
—Potassium salt
—Propylene glycol isobutyl
ether ester
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—Triisopropanolamine salt
—Tripropylene glycol isobutyl
ether ester
Sodium 2-(2,4,5-trichlorophenoxy)
ethyl sulfate
Tetrachlorophenols
—Alkylamine*amine salt (as in
fatty acids of coconut oil)
—Potassium salt
--Sodium salt
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenol salt of
2,6-bis [ (dimethylanino)methyl]
cyclohexanone
2,4,5-Trichlorophenol, sodium salt
2,4,6-Trichlorophenol, sodium salt
2,4,5-Trichlorophenoxyacetic acid
—Alkyl C-12 amine salt
—Alkyl C-13 amine salt
—Alkyl C-14 amine salt
—N,N-diethylethanolamine salt
—Dimethyl amine salt
—N,N-dimethyllinoleylamine salt
—N,N-dimethyloleyl amine salt
—N-oleyl-1,3-propylene
diamine salt
—Sodium salt
—Triethanolamine salt
—Triethylamine salt
—AlXyl (C3H7 - C7H9) ester
—Arnyl ester
—Butoxyethoxypropyl ester
—2-Butoxyethyl ester
—Butoxypropyl ester
—Butyl ester
—Dipropylene glycol isobutyl
ether ester
—2-Ethylhexyl ester
—Isobutyl ester
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
F027
53404-13-0
69622-82-8
83562-66-7
2818-16-8
53466-84-5
37913-89-6
17369-89-0
53404-74-3
53404-75-4
53535-30-1
3570-61-4
25167-83-3
53535-27-6
25567-55-9
95-95-4
88-06-2
53404-83-4
136-32-3
3784-03-0
93-79-8
53404-84-5
53404-85-6
53535-37-8
53404-86-7
6369-97-7
53404-88-9
53404-89-0
53404-87-8
13560-99-1
3813-14-7
2008-46-0
120-39-8
1928-58-1
2545-59-7
1928-48-9
93-79-8
53535-31-2
1928-47-8
4938-72-1
-------
PEST/DIS-5
--Isopropyl ester F027 93-78-7
—Propylene glycol isobutyl FU27 53466-86-7
ether ester
—Tripropylene glycol isobutyl F027 53535-32-3
ether ester
4-(2,4,5-Trichlorophenoxy)butyric F027 93-80-1
acid [2,4,5-T3]
2-(2,4,5-Trichlorophenoxy)ethyl F027 69633-U4-1
hydrogen sulfate [2,4,5-TES]
l,4',5'-Trichloro-2'-(2,4,5- F027 69462-14-2
trichlorophenoxy)
methanesulfonanilide [Edolan U]
95
-------
PEST/DIS-6
PESTICIDES THAT ARE TOXIC HAZARDOUS WASTES
PESTICIDES ON THE "F" LIST (with
[40 CFR 261.33(f)]
Acetone
Ac ry Ion i t r i 1 e*
Ami trole
Benzene*
Bis( 2-ethylhexyl ) phthalate
Cacodylic acid
Carbon tetrachloride*
Chloral (hydrate)
( chloroacetaldehyde )
Chlordane, technical*
Chlorobenzene*
4 -Chloro-m-cresol
Chloroform*
o-Chlorophenol
Creosote
Cresylic acid (cresols)*
Cyclohexane
Cyc lohexanone
Decachlorcoctahydro-1 , 3 , 4-metheno-
2H-cyc lobu ta [ c , d ] -pentalen-2-one
(Kepone, chlordecone)
l,2-Dibromo-3-chloroprooane (DBCP)
Di butyl phthalate
S-2 , 3-( Dichloroallyl diisopropyl-
thiocarbamate) (diallate,Avadex)
o-Di chlorobenze ne*
p-Dichlorobenzene*
Di chlorod i f luororae thane
(Freon 12®)
3 , 5-Dichloro-N- ( 1 , 1-dime thyl-2-
propynyl) benzamide
(pronamide, Kerb®)
Dichloro diphenyl dichloroethane
(ODD)
Dichloro diphenyl trichloroethane
(DDT)
Dichloroethyl ether
2 , 4-Dichlorophenoxyacet i c ,
salts and esters (2,4-D)*
1 , 2-Dichloropropane
1 , 3-Dichloropropene (Telone)
Dimethyl phthalate
Epichlorohydrin
( l-chloro-2 , 3-epoxypropane )
Ethyl acetate
Ethyl 4f4'-dichlorobenzilate
(chlorobenzilate)
RCRA #,
U002
U009
U011
U019
U028
U136
U211
U034
U036
U037
U039
U044
U048
U051
U052
U056
U057
U14Z
U066
U069
U062
U070
U072
U075
U192
U060
U061
U025
U240
U083
U084
U102
U041
U112
U038
and CAS #
67-64-1
107-13-1
51-82-5
71-43-2
117-81-7
75-60-5
56-23-5
302-17-0
57-74-9
108-90-7
59-50-7
67-66-3
95-57-8
8021-39-4
1319-77-3
110-82-7
108-94-1
143-50-0
96-12-8
84-74-2
2303-16-4
95-50-1
106-46-7
75-71-8
23950-58-5
72-54-8
50-29-3
1191-17-9
94-75-7
8003-19-8
542-75-6
131-11-3
106-89-8
141-78-6
510-15-6
*Proposed for deletion by TCLP proposal
96
-------
PEST/DIS-7
Ethylene dibromide (EDB)
Ethylene dichloride*
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene*
Hexachlorocyclopentadiene
Hexachloroethane*
Hydrofluoric acid
Isobutyl alcohol*
Lead acetate
Lindane*
Maleic hydrazide
Mercury
Methoxychlor*
Methyl alcohol (methanol)
Methyl bromide
Methyl chloride
2,2'-Methylenebis
(3,4,6-trichlorophenol)
(hexachlorophene)
[acute waste per 261.31]
Methylene chloride*
Methyl ethyl ketone*
4-Me thyl-2-pentanone
(nethyl isobutyl ketone)
Naphthalene
Nitrobenzene*
p-N i trophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentachlorophenol*
[acute waste per 261.31]
Phenol*
Pyridine*
Resorcinol
Safrole
Selenium di'sulfide
Silvex [acute waste per 261.31]
1,1,2,2-Tetrachloroethane*
Tetrachloroethylene*
2,3,4,6-Tetrachlorophenol*
[acute waste per 261.31]
Thiram
Toluene*
1,1,1-Trichloroethane*
(methyl chloroform)
Tr i chloroethylene*
Tr i chloromonofluorone thane
(Freon 11®)
2,4,5-Trichlorophenol*
[acute waste per 261.31]
2,4,6-Trichlorophenol*
[acute waste per 261.31]
U067
U077
U115
U122
U125
U127
U130
U131
U134
U140
U144
U129
U148
U151
U247
U154
U029
U045
U132
106-93-4
107-06-2
75-21-8
50-00-0
98-01-1
118-74-1
77-47-4
67-72-1
7664-39-3
78-83-1
301-04-2
58-89-9
123-33-1
7439-97-6
72-43-5
67-56-1
74-83-9
74-87-3
70-30-4
(JO 80
U159
U161
U165
U169
U170
U184
U185
U242
U188
U196
U201
U203
U205
U233
U209
U210
U212
U244
U220
U226
U228
U121
U230
U231
75-09-2
78-93-3
108-10-1
91-20-3
98-95-3
100-02-7
76-01-7
82-68-8
87-86-5
108-95-2
110-86-1
108-46-3
94-59-7
7488-56-4
93-72-1
79-34-5
127-18-4
137-26-8
108-88-3
71-55-6
79-01-6
75-69-4
95-95-4
88-06-2
97
-------
PEST/DIS-3
2,4,5-Trichlorophenoxyacetic acid U232 93-76-5
(2,4,5-T)*
[acute waste per 261.31]
Warfarin «0.3%) U248 B1-31-2
Xylene U239 1330-20-7
Zinc phosphide «10%) Q249 1314-84-7
83 ACTIVES
98
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must Dear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear
container disposal statements:
one of the following
"oni-ainer Tvpe Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(baqs)
Aerosol products
Do not 'reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must
based on container type, listed
Container Type
bear container disposal
below:
Statement
instructions,
Metal
containers
(non-aerosol)
Triple rinse (or e'quivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures
'**"""_ _™ . ~\ « " ___ l_ -_ L, _ 1 _ * _» /-, —.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manners
Paper and
plastic bags
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.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording) .
V Manufacturer may
~~ whether and how
replace this phrase with one indicating
fiber drum may be reused.
99
-------
APPENDIX III
USE INDEX APPENDIX
100
-------
EPA Index to Pesticide Chemicals
J221H DIQUAT DIBROMIDE*
TYPE PESTICIDE: Herbicide, Desiccant, Plant Regulator
FORMULATIONS:
7l(35.3%)
SC/L (0.021 lb/gal.
0.08 lb/gal, 0.083 lb/gal, 0.1 lb/gal, 0.105 lb/gal,
RTU
0.106 lb/gal, 0.2 lb/gal, 0.4 lb/gal, 0.5 lb/gal, 2 lb/gal, 0.19*,
0.38Z, 1.852, 2.36X)
(0.0942, 0.23Z)
GENERAL WARNINGS AND LIMITATIONS; A nonselective contact herbicide for
nonerop weed control, aquatic weed control, and a plant regulator and
desiccant for agricultural seed crops. Avoid spray contact with food
crops or ornamental plants. Chemical becomes inactivated upon contact
with soil. The dosages for this chemical were calculated using the ca-
tion by weight.
Agricultural Crop Tolerances (other than those listed in the text):
Avocados
Cottonseed
Cucurbits
Fish
Fruits, citrus
Fruits, pome
Fruits, small
Fruits, stone
Grasses, forage
Hops
Legumes, forage
Nuts
Shellfish
Vegetables, fruiting
Vegetables, leafy
Vegetables, seed and pod
0.02
0.02
0.02
0.1
0.02
0.02
0.02
0.02
0.1
0.02
0.1
0.02
.1
.02
.02
.02
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
Livestock Tolerances:
Cattle, fat
Cattle, mbyp
Cattle, meat
Eggs
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk
Poultry, fat
Poultry, mbyp
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm.
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
*6,7-dihydrodipyrido(1,2-a:2',1'-c)pyrazinediinium dibromide
Issued: 6-17-85
1-032201-1
101
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
GENERAL WARNINGS AND LIMITATIONS (continued)
0.02 ppm
0.02 ppm
0.02 ppm
0.02 ppm
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
Definition of Terms:
fl.oz - fluid ounce(s)
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS: Wilting, necrosis.
PHYTOTOXICITY TO CROPS: Not located.
MODE OF ACTION: ' Causes the formation of free radicals during photosyn-
thesis which acts to disrupt membrane permeability.
BROADLEAF WEEDS CONTROLLED:
PAAAAAE Annual weeds
PAAAAAC Broadleaf weeds
PAZAAAC Chickweed
PAAAAAF Perennial weeds
PBMABAA Sedge
PAAAAAA Weeds
PCAAZ5A
PCAAAAA
GRASSES AND OTHER MONOCOTS CONTROLLED
Bemtudagrass
Grasses
AQUATIC WEEDS CONTROLLED:
PCSABAA Bladderwort
PFDABAA Cattail
PBBABBA Coontail
PCRAAAB Duckweed
PCHACAA Elodea
PDJABAA Naiad
PIIACAA Pithophora
PAAAABN Pondweed
PEPACBA Salvinia rotundifolia
PIXACAA Spirogyra
PECABBA Waterhyacinth
PAKAEBA Waterlettuce
PCDABAA Watermilfoil
(a) Top kill only.
Issued: 6-17-85
(a)
1-032201-2
102
-------
jZZB
gZZA
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
PLANT REGULATOR CLAIMS:
Desiccant
Plant regulator (prevent tasseling)
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
TERRESTRIAL FOOD CROP
(Agricultural Crops)
General Warnings and Limitations: Do not graze treated areas or feed
treated forage to livestock. Do not use seed from treated plants for
food, feed or oil purposes.
JE1BA Alfalfa (seed crop)
JQ3BA Clover (seed crop)
0.38-0.50
(2 Ib/gal SC/L)
J13AA Potato
0.25
(2 Ib/gal SC/L)
Sorghum (Grain)
(seed crop)
0.38-0.50
(2 Ib/gal SC/L)
N.F.
Broadcast. Postharvest desiccation. Apply in 15
to 30 gallons of water. For aerial application
apply in 5 to 10 gallons of water. Desiccation
is complete in 3 to 10 days.
0.02 ppm (vegetable, root crop)
Application should be made at least 7 days before
harvest.
General Information: Do not apply to drought
stressed potatoes. Apply a non-ionic surfactant.
Broadcast. Preharvest desiccation. Apply in 50
to 100 gallons of water for ground application or
5 to 10 gallons of water for aerial application.
Allow a minimum of 5 days between applications.
N.F.
Broadcast. Preharvest desiccation. Apply in 15
to 30 gallons of water per acre by ground and 5
to 10 gallons by air. Apply within 1 to 2 weeks
of harvest and when seeds have not more than 30
percent moisture.
Issued: 6-17-85
1-032201-3
103
-------
EPA Index to Pesticide Chemicals
/15010BA
/25003AA
/23024BA
Site, Dosage
and Formulation
(Ib cation/A)
Soybean (seed crop)
0.33-0.30
(2 Ib/gal SC/L)
Sugarcane
0.25
(2 Ib/gal SC/L)
0.50-1.00
(2 Ib/gal SC/L)
Vetch (seed crop)
0.25
(2 Ib/gal SC/L)
DIQUAT DIBROMIDE
Tolerance, Use, Limitations
N.F.
Broadcast. Preharvest desiccation. Apply in 15
to 30 gallons of water per acre by ground and 5
to 10 gallons by air. Apply 1 week before har-
vest.
0.05 ppm
Do not apply within 5 months of harvest.
General Information: Add a non-ionic surfactant.
Use limited to FL, HI, and PR. Broadcast. Plant
regulator. Apply during flower initiation period
(first 3 weeks in September) to prevent flowering
(tasseling) of cane. Apply by aircraft in 3 to
10 gallons of water per acre.
Use limited to HI. Spot treatment. For control
of annual weeds and sedge. Apply in 50 to 100
gallons of water per acre. Use power sprayer with
boom, or hand sprayer with wand to thoroughly wet
weeds.
N.F.
Broadcast. Preharvest desiccation. Apply in 15
to 30 gallons of water per acre by ground and 5
to 10 gallons by air. Desiccation is complete in
3 to 10 days.
/330070A
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
General Warnings and Limitations: Apply a non-ionic surfactant.
full coverage to the point of run-off.
Golf Course
Apply
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
5-20 parts water applications as needed. Do not water treated
(0.021 Ib/gal, 0.08 areas for 24 to 36 hours after application.
Ib/gal, 0.083 Ib/
gal, 0.1 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal SC/L)
(1.852 SC/L)
Issued: 6-17-85
1-032201-4
104
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
Golf Course (continued)
1 part product/32 Directed spray. Apply full coverage to thoroughly
parts water wet weeds.
(0.4 Ib/gal SC/L)
1 part product/10
parts water
(2.36% SC/L)
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
20-40 parts water application as needed.
(0.2 Ib/gal SC/L)
1 part product/50 Directed spray. Thoroughly"wet weeds. Repeat
parts water application as needed.
(0.4 Ib/gal SC/L)
1 part product/50- Directed spray. Use higher dosage for mature
100 parts water weeds. Repeat application as needed.
(0.5 Ib/gal SC/L)
1 part product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
(fairways)
5.4-10.89 Directed spray. Use on dormant Bermudagrass,
(0.08 Ib/gal SC/L) Centipedegrass, St. Augustinegrass, and Zoysia
grass fairways. Thoroughly wet weeds.
!J030A Ornamental Gardens
1 part, product/ Directed spray. Thoroughly wet weeds. Repea't
5-20 parts water applications as needed. Do not water treated
(0.021 Ib/gal, 0.08 areas for 24 to 36 hours after application.
Ib/gal, 0.083 Ib/
gal, 0.1 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal SC/L)
(1.85% SC/L)
1 part product/32 Directed spray. Apply full coverage to thoroughly
Iparts water wet weeds.
(0.4 Ib/gal SC/L)
or
Issued: 6-17-85 1-032201-5
105
-------
Site, Dosage
and Formulation
(Ib cation/A)
EPA Index to Pesticide unemicais
DIQUAT DIBROMIDE
Tolerance, Use, Limitations
Ornamental Gardens (continued)
i part produet/'-H>-
parts water
(2.362 SC/L)
1 part product/
20-40 parts water
(0.2 Ib/gal SC/L)
1 part product/
50 parts water
(0.4 Ib/gal, 0.5
Ib/gal SC/L)
Directed spray. Thoroughly wet weeds
application as needed.
Directed spray. Thoroughly wet weeds.
application as needed.
Repeat
Repeat
1 part, product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
/350000A Ornamental Shade
Trees
1 part product/
100 parts water
(0.5 Ib/gal SC/L)
/340040A Ornamental Woody
Shrubs
1 part product/
100 parts water
(0.5 Ib/gal SC/L)
Directed spray. Treat when weeds are 1 to 6 inch*
es high. Thoroughly wet weeds. Repeat applica-
tion as needed.
Directed spray. Use a shield to protect desired
foliage. Treat when weeds are 1 to 6 inches high.
Thoroughly wet weeds. Repeat application as need-
ed.
Issued: 6-17-85
1-032201-6
106
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
TERRESTRIAL NON-FOOD CROP
(Noacrop, Wide Area,' and" General Indoor/Outdoor Treatments)
General Warnings and Limitations: Apply a non-ionic surfactant. Apply
full coverage to the point of run-off.
I110A Driveways
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
5-20 parts water applications as needed. Do not water treated
(0.021 Ib/gal, 0.08 areas for 24 to 36 hours after application,
Ib/gal, 0.083 Ib/
gal, 0.1 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal SC/L)
1 part product/ Directed spray. Apply full coverage to thoroughly
32 parts water wet weeds.
(0.4 Ib/gal SC/L)
1 part product/
10 parts water
(2.362 SC/L)
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
20-40 parts water application as needed.
(0.2 Ib/gal SC/L)
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
50 parts water application as needed.
(0.4 Ib/gal, 0.5
Ib/gal SC/L)
1 part"product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
3150A Fencerows
1 part product/ Directed spray. Thoroughly wet weeds. ' Repeat
5-20 parts water applications as needed. Do not water treated
(0.021 Ib/gal, 0.08 areas for 24 to 36 hours after application.
Ib/gal, 0.083 Ib/
gal, 0.1 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal SC/L)
or
Issued: 6-17-85 1-032201-7
107
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
Fencerows (continued)
I pare product/' ' Directed spray." Apply full""coverage to thoroughly
32 parts water wet weeds.
(0.4 Ib/gal SC/L)
1 part product/
10 parts water
(2.362 SC/L)
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
20-40 parts water application as needed.
(0.2 Ib/gal SC/L)
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
50 parts water application as needed.
(0.4 Ib/gal, 0.5
Ib/gal SC/L)
1 part product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
/670090A Industrial Sites
50-200 gal product/ Directed spray. Application may be made any time
A during the growing season. Spray until weeds are
(0.192, 0.38% SC/L) thoroughly wet. Repeat applications should be
(0.0942 RTU) made to control perennials and late germinating
annual weeds.
1 part product/50- Directed spray. Use the higher dosage for mature
100 parts water weeds. Repeat application as needed.
(0.5 Ib/gal SC/L)
1 part product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
Issued: 6-17-85 1-032201-8
108
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
DOOQA Noncrop Areas
General Informat^jonj Noncrop Areas jlnclude
rights-of-way, substations, areas around electric
utilities, commercial buildings, manufacturing
plants, storage yards, rail yards, and non-flood-
ed portions of ponds, lakes, and ditches.
1 part product/ Directed spray. Thoroughly wet weeds. Repeat
5-20 parts water applications as needed. Do not water treated
(0.021 Ib/gal, 0.08 areas for 24 to 36 hours after application.
Ib/gal, 0.083 Ib/
gal, 0.1 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal SC/L)
1 part product/
32 parts water
(0.4 Ib/gal SC/L)
1 part product/
10 parts water
(2.362 SC/L)
1 part product/
20-40 parts water
(0.2 Ib/gal SC/L)
1 part product/
50 parts water
(0.4 Ib/gal SC/L)
1 part product/50-
100 parts water
(0.5 Ib/gal SC/L)
Directed spray. Apply full coverage to thoroughly
wet weeds.
Directed spray. Thoroughly wet weeds. Repeat
application as needed.
Directed spray. Thoroughly wet weeds. Repeat
application as needed.
Directed spray. Use the higher dosage for mature
weeds. Repeat application as needed.
1 part product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
Issued: 6-17-85
1-032201-9
105
-------
/630030A
/670120A
Site, Dosage
and Formulation
(Ib cation/A;
DOMESTIC OUTDOOR
(Household)
EFA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Tolerance, Use, Limitations
Domestic Dwellings,
Outdoor
(0.232 RTU)
Patios. Walkways
1 part product/
5-20 parts water
(0.021 Ib/gal, 0.08
Ib/gal, 0.083 Ib/
gal, 0.1 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal SC/L)
1 part product/
32 parts water
(0.4 Ib/gal SC/L)
1 part product/
10 parts water
(2.36Z SC/L)
1 part product/
20-40 parts water
(0.2 Ib/gal SC/L)
1 part product/
. 50 parts water
(0.4 Ib/gal SC/L)
Spot treatment. Spray weeds thoroughly. Spray
weeds in early growing stages when moisture and
temperatures promote growth.
General Information: Apply a non-ionic surfac-
tant. Apply full coverage to the point of run-
off.
Directed spray. Thoroughly wet weeds. Repeat
applications as needed. Do not water treated
areas for 24 to 36 hours after application.
Directed spray. Apply full coverage to thoroughly
wet weeds.
Directed spray. Thoroughly wet weeds. Repeat
application as needed.
Directed spray. Thoroughly wet weeds. Repeat
application as needed.
1 part product/50- Directed spray. Apply to young weeds.
100 parts water
(2 Ib/gal SC/L)
Issued: 6-17-85
1-032201-10
1 1C
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
AQUATIC NON-FOOD
(Aquatic Sites)
General Warnings and Limitations: Do not use the treated areas for
animal consumption, swimming, spraying, irrigation or domestic purposes
for 14 days after treatment. Do not apply to aquatic sites in Florida.
Do not apply to muddy water. Apply a surfactant. A copper sulfate pre-
treatment may be advised when algae and submerged weeds are present.
Local conditions may affect the use of this chemical. Consult Agricul-
tural Extension Services for specific recommendations as to dosage and
time of application, and for control of other weeds.
J21MA Drainage Ditches
821MB
E13MA Lakes , Ponds
JI3MB
1.6-4.2 Water treatment. For control of submerged weeds.
(0.08 Ib/gal, Dilute and inject below the water surface, or pour
0.083 Ib/gal, directly into the water while moving slowly over
0.1 Ib/gal, the area in a boat. Apply early in the season be-
0.105 Ib/ fore weed growth has reached the surface.
gal, 0.106 Ib/gal,
0.2 Ib/gal, 0.4
Ib/gal, 0.5 Ib/
gal, 2 Ib/gal
SC/L)
20-40 gal product/A
(1.852, 2.362 SC/L)
2.24-8.40 Water treatment. For control of Pithophora spp.
(0.08 Ib/gal, 0.083 and Spirogyra spp. Repeat application may be ne-
Ib/gal, 0.1 cessary for heavy infestations or where reinfesta-
lb/gal[ 0.105 Ib/ tions may occur from seed, fragmentation or es-
gal, 0.106 Ib/ cape.
gal, 0.2 Ib/gal,
0.41b/gal, 0.5 Ib/
gal, 2 Ib/gal
SC/L)
28-84 gal prod-
uct/A
(1.852, 2.362 SC.L)
Issued: 6-17-85 1-032201-11
11 1
-------
Site, Dosage
and Formulation
(Ib cation/A)
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Tolerance, Use, Limitations
Drainage Ditches cluster (continued)
4-15
(0.08 Ib/gal,
0.083 Ib/gal,
0.1 Ib/gal,
0.105 Ib/gal,
0.106 Ib/gal,
0.2 Ib/gal, 0.4
Ib/gal, 0.5 Ib/
gal, 2 Ib/gal
SC/L)
40 gal product/A
(2.362 SC/L)
12-18 gal product/
1,000 sq.ft
(0.08 Ib/gal SC/L)
treatment",
For coacrol~ of- co'cntail and Elo-
dea.
Foliar treatment. For control of floating weeds.
Apply in sufficient water (150 to 200 gallons) to
thoroughly wet weeds. Use the higher dosage for
late season applications. For aerial application
of waterlettuce use 7.5 gallons of water per
0.80-2.0
(0.08 Ib/gal, 0.083 surface acre.
Ib/gal, O..I Ib/
gal, 0.105 Ib/gal,
0.106 Ib/gal, 0.2
Ib/gal, 0.4 Ib/
gal, 0.5 Ib/gal,
2 Ib/gal SC/L)
8-12 fl.oz/1,000
sq.ft
(0.4 Ib/gal SC/L)
10-15 gal product/A
2.36% SC/L)
1.66-2.0 Foliar treatment. For control of cattail and
(0.08 Ib/gal, 0.083 duckweed. Apply in 30 to 150 gallons of water.
Ib/gal, 0.1 Ib/ Apply before flowering of weeds or as a late sea-
gal, 0.106 Ib/gal, son treatment. Repeat application as needed.
0.2 Ib/gal, 0.4
Ib/gal, 0.5 Ib/
gal, 2 Ib/gal
SC/L)
1 part product/
5 parts water
(0.1 Ib/gal SC/L)
Issued: 6-17-85
1-032201-12
112
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib cation/A)
Drainage Ditches cluster (continued)
16 fl.o*/ 1,000-
sq.ft
(0.4 Ib/gal SC/L)
20 gal product/ A
(2.36Z SC/L)
D33MA Marshes
|33MB Streams, Rivers,
$32MA Waterways, and
132MB Canals
1.66-3.22 Water treatment. For control of submerged weeds.
(0.083 Ib/gal SC/L) Dilute and inject below the water surface, or pour
directly into the water while moving slowly over
2.00-4.00 the area in a beat. Apply early in the season be-
(0.2 Ib/gal SC/L) fore weed growth has reached the surface.
20-40 gal product/A
(1.85Z SC/L)
2.3-8.4 Water treatment. For control of Pithophora spp.
(0.083 Ib/gal, 0.2 and Spirogyra spp. Repeat application may be ne-
Ib/gal SC/L) cessary for heavy infestations or where reinfesta-
t ions may occur from seed, fragmentation or es-
28-84 gal product/ cape.
A
(1.852 SC/L)
5.9-11.6 Water treatment. For control of coontail and Elo-
(0.083 Ib/gal SC/L) dea.
4.00
(0.2 Ib/gal SC/L)
84-140 gal prod-
uct/A
(1.85% SC/L)
0.83-1.24 Foliar treatment. For control of floating weeds.
(0.083 Ib/gal SC/L) Apply in sufficient water (150 to 200 gallons) to
thoroughly wet foliage. Use the higher dosage for
1.00-1.50 late season applications.
(0.2 Ib/gal SC/L)
10-15 gal product/A
(1.85Z SC/L)
Issued: 6-17-85 1-032201-13
113
-------
Site, Dosage
and Formulation
(Ib cation/A)
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Tolerance, Use, Limitations
Marshes cluster (continued)
2.00
(0.2 Ib/gal SC/L)
Foliar treatment. For control of cattail and
duckweed. Apply in 100 gallons of water and thor-
oughly wet foliage. Repeat application as needed.
AERIAL AND TANK MIX APPLICATIONS
9001500
AAAAAAA
Aerial Application
Refer to
TERRESTRIAL FOOD CROPS
(Agricultural Crops)
Alfalfa (seed crop), Clover (seed crop), Potato,
Sorghum (Grain) (seed crop), Soybean (seed crop),
Sugarcane, Vetch (seed crop)
AQUATIC NON-FOOD
(Aquatic SitesT
Drainage Ditches, Lakes, Ponds
Issued: 6-17-85
1-032201-14
114
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Listing of Registered Pesticide Products by Formulation
|.3002 35.32 formulation intermediate
diquat dibromide (032201)
000239-02276
1.0215 0.021 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
008123-00066
(.0815 0,08 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
001769-00174 010827-00035
|.0815 0.083 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
008123-00037 008123-00048 010088-00013 010088-00035
011515-00029 011547-00007 011547-00031 011694-00040
045128-00016
1.1015 0.1 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
002155-00043 002155-00063 002155-00064 003837-00023
004000-00062 005197-00037 009313-00014 012310-00014
1.1015 0.105 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
000334-00255
8.1115 0.106 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)~
004828-00064
1.2015 0.2 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
000239-02279 000491-00201 006762-00023 008123-00102
010292-00013 010827-00078
4.4015 0.4 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
005080-00004 008959-00009
6,5015 0.5 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
011214-00018
1.0015 2 Ib/gal soluble concentrate/liquid
diquat dibromide (032201)
000239-01663
1.1915 0.192 soluble concentrate/liquid
diquat dibromide (0322011
010383-00003
Issued: 6-17-85 1-032201-15
115
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Listing of Registered Pesticide Products by Formulation (continued)
&200.3815 0.382 soluble concentrate/liquid
diquat dibromide (.032201)
010383-00004
i201.8515 1.852 soluble concentrate/liquid
diquat dibromide (032201)
009205-00010
&202.3615 2.36Z soluble concentrate/liquid
diquat dibromide (032201)
001685-00064
&200.0916 0.094Z liquid-ready to use
diquat dibromide (032201)
010088-00017 010383-00002
&200.2316 0.232 liquid-ready to use
diquat dibromide (.032201)
010583-00010
9999999 State Label Registrations
010583-09354
AZ Reg. No.
010583-09353
FL Reg. No.
000239-05850
023335-04068
037347-03124
NM Reg. No.
010583-03260
OU Reg. No.
007587-09122
TX Reg. No.
010583-08653
006020-03371
023335-04069
037347-05455
037830-08362 037830-08363
006020-03376
033356-03494
013437-08873
037347-03123
Issued: 6-17-85
1-032201-16
116
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number
BROADLEAF WEEDS CONTROLLED:
DAE Annual weeds
UAC Broadleaf weeds
jlAC Chickweed
ItAF Perennial weeds
-------
'23003BA
?ZZZZZB
/14013AA
PZZZZZB
/24006BA
PZZZZZB
/15010BA
PZZZZZB
/2S003AA
PAAAAAE
PZZZZZA
PBMABAA
/23024BA
PZZZZZB
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fommlation/Registration Number (continued)
Clover (seed crop)
Desiccant
(2 Ib/gal SC/L)
000239-01663
Potato
Desiccant
(2 Ib/gal SC/L)
000239-01663
Sorghum (Grain) (seed crop)
Desiccant
(2 Ib/gal SC/L)
000239-01663
Soybean (seed crop)
Desiccant
(2 Ib/gal SC/L)
000239-01663
Sugarcane
Annual weeds
Plant regulator (prevent tasseling)
Sedge
(2 Ib/gal SC/L)
000239-01663
Vetch (seed crop)
Desiccant
(2 Ib/gal SC/L)
000239-01663
/330070A
PAZAAAC
PCAAAAA
PAAAAAA
TERRESTRIAL. NON-FOOD CROP
(Ornamental Plants and Forest Trees)
Golf Course
Chickwfeed
Grasses
Weeds
(0.021 Ib/gal SC/L)
008123-00066
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
Issued: 6-17-85
811
1-032201-18
-------
6030A
IMA
MAA
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
.isting by Site/Pest and Site/Foraulation/Registration Number (continued)
Golf Course (continued)
(0.083 Ib/gal SC/L>-
008123-00037 010088-00013
011547-00007 011547-00031
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
(0.106 Ib/gal SC/L)
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201
010292-00013 010-827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.85% SC/L)
009205-00010
(2.36* SC/L)
001685-00064
Ornamental Gardens
Grasses
Weeds
(0.021 Ib/gal SC/L)
008123-00066
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
(0.083 Ib/gal SC/L)
008123-00037 008123-00048
011515-00029 011547-00007
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
010088-00035
011694-00040
002155-00064
009313-00014
011515-00029
045128-00016
003837-00023
012310-00014
006762-00023 008123-00102
010088-00013
011694-00040
002155-00064
009313-00014
010088-00035
045128-00016
003837-00023
012310-00014
Issued: 6-17-85
1-032201-19
119
-------
/350000A
.PAAAAAC
PCAAAAA
/340040A
PAAAAAC
PCAAAAA
ETTH inueA vo resLJLtiue
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued)
Ornamental Gardens (continued)
(0,106 Ib./gsl .SC/LX
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201 006762-00023 008123-00102
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.85% SC/L)
009205-00010
(2.36% SC/L)
001685-00064
Ornamental Shade Trees
Broadleaf weeds
Grasses
(0.5 Ib/gal SC/L)
011214-00018
Ornamental Woody Shrubs
Broadleaf weeds
Grasses
(0.5 Ib/gal SC/L)
011214-00018
/670110A
PCAAAAA
PAAAAAA
TERRESTRIAL NON-FOOD CROP
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
Driveways
Grasses
Weeds
(0.021 Ib/gal SC/L)
008123-00066
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
Issued: 6-17-85
1-032201-20
120
-------
1150A
44AA
44AA
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued)
Driveways (continued)
(0.083 Ib/gal SC/L)
008123-00037 008123-00048
011515-00029 011547-00007
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
(0.106 Ib/gal SC/L)
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
.011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.85% SC/L)
009205-00010
(2.362 SC/L)
001685-00064
Fencerows
Grasses
Weeds
(0.021 Ib/gal SC/L)
008123-00066
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
(0.083 Ib/gal SC/L)
008123-00037 008123-00048
011515-00029 011547-00007
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
010088-00013
011694-00040
002155-00064
009313-00014
010088-00035
045128-00016
003837-00023
012310-00014
006762-00023 008123-00102
010088-00013
011694-00040
002155-00064
009313-00014
010088-00035
045128-00016
003837-00023
012310-00014
Issued: 6-17-85
1-032201-21
121
-------
/670090A
PAAAAAC
PCAAAAA
/670000A
PCAAAAA
PAAAAAA
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued)
Fencerows (continued)
(0.106 Ib/gar SC/D*
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201 006762-00023 008123-00102
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.85Z SC/L)
009205-00010
(2.36* SC/L)
001685-00064
Industrial Sites
Broadleaf weeds
Grasses
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(0.19% SC/L)
010383-00003
(0.38% SC/L)
010383-00004
(0.0942 RTU)
010088-00017
010383-00002
Noncrop Areas
Grasses
Weeds
(0.021 Ib/gal SC/L)
008123-00066
Issued: 6-17-85
1-032201-22
122
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Noncrop Areas (continued)
(0.08 Ib/gai SC/Lf
001769-00174 010827-00035
(0.083 Ib/gal SC/L)
008123-00037 008123-00048
011515-00029 011547-00007
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
(0.106 Ib/gal SC/L)
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.852 SC/L)
009205-00010
(2.362 SC/L)
001685-00064
010088-00013
011694-00040
002155-00064
009313-00014
010088-00035
045128-00016
003837-00023
012310-00014
006762-00023 008123-00102
U030A
%2BA
JlAAC
DOMESTIC OUTDOOR
(Household)
Domestic Dwellings, Outdoor
Bennudagrass
Broadleaf weeds
Grasses
Perennial weeds
(0.232 RTU)
010583-00010
Issued: 6-17-85
1-032201-23
123
-------
/670120A
PCAAAAA
PAAAAAA
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued)
Patios, Walkways
Grasses
Weeds
(0.021 Ib/gal SC/L)
008123-00066
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
(0.083 Ib/gal SC/L)
008123-00037 008123-00048
011515-00029 011547-00007
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
(0.106 Ib/gal SC/L)
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004' 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.852 SC/L)
009205-00010
(2.36Z SC/L)
001685-00064
010088-00013
011694-00040
002155-00064
009313-00014
010088-00035
045128-00016
003837-00023
012310-00014
006762-00023 008123-00102
/6502IMA
/65021MB
AQUATIC NON-FOOD
(Aquatic Sites)
Drainage Ditches
Pest (see lists above)
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
Issued: 6-17-85
1-032201-24
124
-------
I1JMA
113MB
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued;
Drainage Ditches (continued)
(0.083 Ib/gaF SC/L)
008123-00037 010088-00013
011694-00040 045128-00016
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
(0.105 Ib/gal SC/L)
000334-00255
(0.106 Ib/gal SC/L)
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.852 SC/L)
009205-00010
(2.36% SC/L)
001685-00064
Lakes, Ponds
Pest.' (see lists.above)
(0.08 Ib/gal SC/L)
001769-00174 010827-00035
(0.083 Ib/gal SC/L)
008123-00037 010088-00013
011694-00040 045128-00016
(0.1 Ib/gal SC/L)
002155-00043 002155-00063
004000-00062 005197-00037
011515-00029 011547-00031
002155-00064
009313-00014
003837-00023
012310-00014
006762-00023 008123-00102
011515-00029 011547-00031
002155-00064
009313-00014
003837-00023
012310-00014
Issued: 6-17-85
1-032201-25
125
-------
/65033MA
/65033MB
/65032MA
/65032MB
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Lakes, Ponds (continued)
(0.105 Ib/gal SC/L)
000334-00255
(0.106 Ib/gal SC/L)
004828-00064
(0.2 Ib/gal SC/L)
000239-02279 000491-00201 006762-00023 008123-00102
010292-00013 010827-00078
(0.4 Ib/gal SC/L)
005080-00004 008959-00009
(0.5 Ib/gal SC/L)
011214-00018
(2 Ib/gal SC/L)
000239-01663
(1.852 SC/L)
009205-00010
(2.362 SC/L)
001685-00064
Marshes
Pest (see lists above)
(0.083 Ib/gal SC/L)
045128-00016
(0.2 Ib/gal SC/L)
010292-00013 010827-00078
(1.852 SC/L)
009205-00010
Streams, Rivers, Waterways, and Canals
Pest (see lists above)
(0.083 Ib/gal SC/L)
045128-00016
(0.2 Ib/gal SC/L)
010292-00013 010827-00078
Issued: 6-17-85
1-032201-26
126
-------
EPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued)
Streams, Rivers, Waterways, and Canals (continued)
(1.852 SC/L)
009205-00010
Issued: 6-17-85 1-032201-27
12?
-------
SPA Index to Pesticide Chemicals
DIQUAT DIBROMIDE
Auxiliary Documentation
Cancelled Reg. No. Cancellation Date
5=515 3/05/85
239-2247 3/14/85
739-2395 3/14/85
10120-16 1/29/85
11524-4 3/28/85
The following Reg. Nos. could not be located and have been left out of
this report.
478-114
9205-16
10663-11
The aquatic site dosages were calculated using a 1 acre and a water depth
of 2 feet area.
Issued: 6-17-85 I-032201-a
128
-------
APPENDIX IV
BIBLIOGRAPHY APPENDICES
129
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography .contains
citations of all studies considered relevant by SPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography-
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a .conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by-"Master Record Identifier," or
MRID, number. This number is unique to the citation, .and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
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.
130
-------
BIBGUIUE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to shew a personal aatnor.
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 Eirst submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
•
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next eleinent,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accesston 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.
131
-------
OFFICE UF PESTICIDE PROGRAMS
REGISTRATION STANCARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00027203 Swabey, Y.H.; Schenk, C.F. (1963) Algicides and Aquatic Herbicides:
Taste and Odour in Water; Laboratory Studies on Fish Toxicity;
Field Toxicity Studies. By Ontario Water Resources Commission,
Laboratory Div., Biology Branch. ?: CWRC. (Atrazine/T38; also
in unpublished submission received Oct 12, 1976 under 10065-8;
submitted by Fisons Corp., Agricultural Chemicals Div., Bedford
Mass.; CDL:226310-F)
00028002 Wellfiorn, T.L.; Jr. (1969) The toxicity of nine therapeutic and
herbicidal compounds to striped bass. Progessive Fish-Cultur-
Lst 31(? ):27-32. (Also in unpublished submission received Aug
20, 1976 under 39445-1; submitted by American Carbonyl, Inc.,
Tenafly, N.J.; CDL:228232-C)
00031050 Feldmann, R.J.; Maibach, H.I. (1974) Percutaneous penetration of
sane pesticides and herbicides in man. Toxicology and Applied
Pharmacology 28(? ):126-132. (Also in unpublished submission
received Apr 23, 1980 under 10279-7; submitted by Purdue Freder-
ick Co., Norwalk, Conn.; CDL:242321-R)
00031336 Tucker, 3.V.; Pratt, R.D. (1972) Overhead Irrigation with Water -
Containing Diquat—Crop Residue Data.' (Unpublished study re-
ceived Sep 15, 1972 under 1F1101; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:090862-G)
00031841 Calderbank, A.; McKenna, R.H.; Walley, J.K. (1966) Bipyridylium
Herbicides: Feeding Clover Hay and Barley Dessicated with Di-
quat, to Cattle. (Unpublished study received Sep 15, 1972 under
1F1101; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:090862-N)
00034769 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds. By U.S. Fish
and Wildlife Service, Patuxent Wildlife Research Center. Wash-
ington, D.C.: U.S. FWS. (Special Scientific Report—Wildlife
No. 191; report no. 33423a; also in unpublished submission re-
ceived Mar 28, 1979 under 3125-236; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:237905-B)
132
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00055086 Coats,G.E.; Funderburk, H.H.,Jr.; Lawrence, J.M.: ec al (1966)
Factors Affecting Persistence and Inactivation of Diquat and
Paraquat, weed Research 6(l):58-66. (Also in unpublished
submission received Apr 7, 1971 under unknown admin, no.; sub-
mitted by Chevron Chemical Co., Richmond, Calif.; CDL:180000-B)
00055107 Daniel, J.W.; Gage, J.C. (1966) Absorption and excretion of Diquat
and Paraquat in rats. British Journal of Industrial Medicine
23:133-136. (Also in unpublished submission received Apr 7,
1971 under unknown admin, new; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:180000-Z)
00056905 Funderburk, H.H., Jr. (1969) Diquat and paraquat. Pages 285-291
only, in Degradation of Herbicides. Edited by P.C. "Kearney and
D.D. Kaufman. ?: Marcel Dekker, Inc. (Also in unpublished
submission received Jun 6, 1970 under 1F1103; submitted by
PPG Industries, Inc., Barberton, Ohio; CDL:090868-K)
00061633 Carney, I.F.; Riley, R.A.; Glaister, J.W. (1976) Diquat dibromide:
Acute Inhalation Study: Report No. CTL/P/222. (Unpublished
study received Jan 27, 1981 under 239-1663; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:244244-A)
00061634 Parkinson, G.R. (1974) Diquat dichloride and Diquat dibromide: Com-
parison of Dermal Toxicity and Local Irritancy: Report No. HO/
IH/P/116. (Unpublished study received Jan 27, 1981 under 239-
1663; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
244244-B)
00061635 Palmer, S.; Pratt, I.S. (1974) Diquat dibromide: Teratogenic Stud-
ies in the Rabbit: Report No. HO/CTL/P/114B. (Unpublished study
received Jan 27, 1981 under 239-1663; submitted by Chevron Chem-
ical Co., Richmond, Calif.; CDL:244244-C)
00061636 McGregor, D.B. (1974) Dominant Lethal Study in Mice of Diquat:
401567: Report No. 148. (Unpublished study received Jan 27,
1981 under 239-1663; prepared by Inveresk Research Internation-
al, submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
244244-D)
00061638 Anderson, D.; Richardson, C.R.; Howard, C.A.; et al. (1978) Diquat:
Cytogenetic Study in the Rat: Report No. CTL/P/366. (Unpub-
lished study received Jan 27, 1981 under 239-1663; prepared by
Imperial Chemical Industries, Ltd., submitted by Chevron Chemi-
cal Co. , Richmond, Calif.; CDL:244244-F)
13
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
OOG52133 Cutl3r> P.A. (19b5) Commercial fishery investigations. Payes 55-
77, in Effects of Pesticides on Fish and Wildlife. Washington,
D.C.: U.S. Fish and Wildlife Service. (Circular 226; available
from: Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402; 1966 O--797-999; published
study; CDL;092011-R)
00065594 Griggs, R.E.; Davis, J.A. (1975) Diquat: Excretion and Metabolism
in a Goat: AJR 2585 A. (Unpublished study received Aug 22, 1977
under 239-1663; prepared by Plant Protection Ltd., submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:231429-C)
00065595 Leahey, J.P.; Gatehouse, D.M.; Carpenter, P.K.; et al. (1976)
Diquat: Metabolism and Residues in a Cow: AR 2698 A. (Unpub-
lished study received Aug 22, 1977 under 239-1653; prepared by
Imperial Chemical Industries Ltd., England, submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:231429-D)
00065596 Leahey, J.P.; Hemingway, R.J. (1973) Diquat: A Study of the Metabo-
lism and Residues in Hens and Their Eggs: AR 2438 B. (Unpub-
lished study received Aug 22, 1977 under 239-1663; prepared by
Plant Protection Ltd., submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:231429-E)
00065597 Leahey, J.P. (1974) Diquat: Residues in the Tissues of Rats and a
Goat Dosed with Diquat and Its Photoproducts: AR 2503 A. (Un-
published study received Aug 22, 1977 under 239-1663; prepared
by Plant Protection Ltd., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:231429-F)
00065599 Hemingway, R.J.; Leahey, J.P.; Davis, J.A.; et al. (1973) Diquat:
Metabolism of Diquat and Its Photoproducts in Goats: AR 2448 B.
(Unpublished study received Aug 22, 1977 under 239-1663; pre-
pared by Plant Protection Ltd., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:231429-H)
00065600 Hemingway, R.J.; Leahey, J.P.; Davis, J.A.; et al. (1974) Diquat:
Metabolism of Diquat and Its Photoproducts in a Cow: AR 2530B
(R). (Unpublished study received Aug 22, 1977 under 239-1663;
prepared by Plant Protection Ltd., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:231429-I)
00065602 Calderbank, A. (1968) The bipyridylium herbicides. Pages 127-235,
In Advances in Pest Control Research: Vol. 8. Edited by R.L.
Metcalf. ?: John Wiley & Sons, Inc. (Also in unpublished sub-
mission received Aug 22, 1977 under 239-1663; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:231430-B)
134
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00065604 Calderbank",' A.; Slade, P. (1976) Diquat and' paraquat. In Herbi-
cides: Chemistry, Degradation and Mode of Action: volume 2.
Edited by P.C. Kearney and D.D. Kaufraann. New York, N.Y.:
Marcel Dekker, Inc. (Reprint; also in unpublished submission
received Aug 22, 1977 under 239-1663; submitted by Chevron Chem-
ical Co., Richmond, Calif.; CDL:231430-D)
00067156 Leahey, J.P.; Carpenter, P.K. (1975) Diquat: Uptake of Diquat and
Its Photoproducts from Soil by Rotational Crops: AR 2621 A.
(Unpublished study received Aug 22, 1977 under 239-1663; pre-
pared by Plant Protection Ltd., England, submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:231432-G)
00067157 Cavell, B.D. (1976) Diquat: A Review of Its Photodegradation: Re-
port Series TMJ 1433B. (Unpublished study received Auy 22, 1977
under 239-1663; prepared by Imperial Chemical Industries,
Ltd., England, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:231432-H)
00067162 Leahey, J.P.; Griggs, R.E.; Allard, G.B. (1973) Diquat: Residues
of Diquat and Its Photoproducts on Barley and Oats after Desic-
cation with 14C-Diquat: AR 2478B. (Unpublished study received
Aug 22, 1977 under 239-1663; prepared by Plant Protection Ltd.,
England, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:231432-M)
00068221 Hill, I.R. (1975) Diquat: Degradation of Diquat and Its Photoprod-
ucts in Soil: AR 2573A. (Unpublished study received Aug 22,
1977 under 239-1663; prepared by Plant Protection Ltd., submit-
ted by Chevron Chemical Co., Richmond, Calif.; CDL:231431-B)
00068228 Haven, D.S. (1969) Levels of the herbicide diquat in two estuarine
molluscs and in the water and mud. Virginia Journal of Science
20:51-53. (Also in unpublished submission received Aug 22, 1977
under 239-1663; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:231431-N)
00068229 Hiltibran, R.C.; Underwood, D.L.; Fickle, J.S. (1972) Fate of Di-
quat in the Aquatic Environment: WRC Research Report No. 52.
Final rept. (Unpublished study received Aug 22, 1977 under
239-1663; prepared by Univ. of Illinois, Dept. of Agronomy,
Water Resources Center, submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL-.231431-0)
00071325 Plant Protection Limited (1972) Determination of Residues of Diquat
in Crops and Animal Tissues: Spectrophotometric Method. Method
PPRAM-5 dated Dec 6, 1972. (Unpublished study received Jan 27,
1981 under 239-1663; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:244243^)
135
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00071328 riughes, H.E.; Leahey, J.P. (1979) Diquat: Residues Resulting in the
Eggs and Tissues of Hens Dosed with 14C-Diquat Desiccated
Barley Grain: AR 2581 B. (Unpublished study received Jan 27,
1981 under 239-1663; prepared by Plant Protection Limited,
England, submitted by Chevron Chemical Co./ Richmond, Calif.;
CDL:244243-E)
00079829 Rogerson, A.; Broad, R.D.; Rutty, D.A. (1976) Diquat Dibromide; 2
Year Feeding Study in Rats: Report No. CTL/P/253. (Unpublished
study received Aug 22, 1977 under 239-1663; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:23143.4-A)
00079830 Ben-Dyke, R.; Strachan, E.; Newman, A.J. (1975) Diquat Dibromide
Monohydrate: Evaluation of Potential Carcinogenicity in Dietary
Administration to Mice for 80 Days: LSR Report No. 76/ILYI/144.
Includes undated method TBM/4. (Unpublished study, including
letters dated Jun 3, 1977 from P.B. Banhan to R.N.D. Birtley and
M.H. Litchfield; Jul 26, 1977 from H.G. Franke to L.R. Stelzer,
received Aug 22, 1977 under 239-1663; prepared by Life Science
Research, England, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:231434-B)
00080982 Rogerson, A.; Broad, R.D.; Rutty, D.A. (1978) Diquat Dibromide: 2-
Year Feeding Study in Rats—(Amended Report): Report No. CTL/P/
253(A). (Unpublished study received Jun 28, 1979 under 239-
1663; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
238760-A)
00081508 Rogerson, A.; Broad, R.D.; Rutty, D.A. (1978) Diquat Dibromide: 2-
Year Feeding Study in Rats—(Amended Report): Report No. CTL/P/
253 (A). (Unpublished study received Sep 14, 1979 under 239-
2247; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
098973-E)
00091316 Swan, A.A.B. (1960) Toxicological Report: ...(Diquat): Supplement
to Report No. TR/35. (Unpublished study received May 1, 1965
under unknown admin, no.; prepared by Plant Protection, Ltd.,
England, submitted by Chevron Chemical Co., Richmond, Calif;
CDL:109787-A)
00100410 Chevron Chemical Co. (1971) Residue Data Sheet: Sugar Cane.
(Conpilation; unpublished study received Jul 11, 1972 under un-
known admin, no.; CDL:120274-A)
136
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
GOI06559 rink, R.; Beavers, J.; Joiner, G.; et al. (1982) Final Report: A-
cute Oral LD50—Mallard Duck: Diquat Technical (SX-1260):
Project No. 162-131. Rev. (Unpublished study received May 13,
1982 under 239-1663; prepared by Wildlife International Ltd. and
Washington College, submitted by Chevron Chemical Co., Richmond,
CA; CDL:247503-A)
00114410 Chevron Chemical Co. (1971) Residues in Milk from Cows Receiving
Paraquat. (Compilation; unpublished study received on unknown
date under OF0986; CDL:091699-A)
00114449 Chevron Chemical Co. (1961) Determination of Residues of Diquat
and Paraquat in Various Crops. (Compilation; unpublished study
received May 13, 1963 under unknown admin, no.; CDL-.124104-A)
00115546 Chevron Chemical Co. (1961) Analyses for Residues of Diquat in
Plant Tissues. (Compilation; unpublished study received Aug
11, 1961 under 239-1663; CDL:001351-B)
00115547 Chevron Chemical Co. (1970) Diquat: The Results of Tests on the
Amount of Residue Remaining, Including a Description of the
Analytical Methods Used. (Compilation; unpublished study re-
ceived Dec 12, 1970 under 1F1101; CDL:090861-A)
00115559 Chevron Chemical Co. (1961) Diquat Residues in Potatoes and Var-
ious Crops. (Compilation; unpublished study received Apr 5,
1962 under unknown admin, no.; CDL:120122-A)
00115563 Homer, R.; Morgan, C.; Stubbs, J.; et al. (1959) DipyridyliuTi
Quarternary Salts: Residues in Potato Tubers after Foliar Appli-
cation of 14-C Labelled ... K8483: Experimental Report No. PP/
E/ll. (Unpublished study received Jun 20, 1963 under unknown
admin, no.; prepared by Imperial Chemical Industries, Ltd.,
' submitted by Chevron Chemical Co., Richmond, CA; CDL:120267-E)
00115572 McCann, J. (1967) Diquat/Dibromide: Bluegill (Lepomis macro-
chirus): Test No. 54. (U.S. Agricultural Research Service,
Pesticides Regulation Div., Animal Biology Laboratory; unpub-
lished study; CDL:132049-A)
00115575 Chevron Chanical Co. (1961) Analyses for Residues of Diquat in
Castor Beans, Sorghum and Soybeans. (Compilation; unpublished
study received Jun 15, 1961 under 239-2247; CDL:224725-B)
137
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00115576 Wheeler, R. (1978) 48 Hour Acute Static Toxicity of Diquat Di-
bromide (SX958) to 1st Stage Nyrrph Water Fleas (Daphnia magna
Straus). (Unpublished study received Sep 15, 1978 under 239-
1663; submitted by Chevron Chemical Co., Richmond, CA; CDL:
235179-A)
00115583 Slade, P.; Calderbank, A. (1966) Bipyridylium Herbicides: The Deg-
radation of Diquat after Its Application to Plants: Central File
No. A126,360. (Unpublished study received Aug 22, 1977 under
239-1663; prepared by Imperial Chemical Industries, Ltd., sub-
mitted by Chevron Chemical Co., Richmond, CA; CDL:23142'8-P)
00115858 Simonin, H.; Skea, J. (1977) Toxicity of diquat and cutrine to
fingerling brown trout. New York Fish and Game Journal 24(1):
37-45. (Also in unpublished submission received Sep 14, 1979
under 239-2247; submitted by Chevron Chemical Co., Richmond,
CA; CDL:098974-C)
00115862 Nicholson, S.; Clerman, R. (1974) Toxicity of diquat to the crus-
tacean amphipod hyalella from Chautauqua Lake. Environmental
Letters 7(3):215-227. (Also in unpublished submission received
Sep 14, 1979 under 239-2247; submitted by Chevron Chemical Co.,
Richmond, CA; CDL:098974-N)
00116565 Fink, R.; Beavers, J.; Joiner, G.; et al. (1981) Subacute Feeding-
Reproduction Screening Bioassay—Bobwhite Quail: Diquat Tech-
nical (SX-1306): Project No. 162-137; S-1984. Final rept.
(Unpublished study received Sep 3, 1982 under 239-1663; pre-
pared by Wildlife International Ltd., submitted by Chevron
Chemical Co., Richmond, CA; CDL:248290-B)
00116728 Chevron Chemical Co. (1978) Diquat 2 Spray—Potatoes. (Compila-
• tion; unpublished study received Sep 14, 1979 under 239-2247;
CDL:098975-A; 098970)
00116736 Great Lakes Chemical Corp. (1970) Analyses for Residues of Bromine
and Other Chemicals in Various Products. (Compilation; unpub-
lished study received on unknown date under unknown admin, no.;
CDL:127345-A)
00116739 Chevron Chemical Co. (1977) Residue Chemistry Data and Data Refer-
ence List To Support Label Amendment for Diquat Water Weed Kill-
er. (Compilation; unpublished study received Aug 22, 1977 under
239-1663; CDL:231427-A)
138
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00119988 r'inK, R.; Beavers, J.; Joiner, G.; et al. (1982) One-generation
Reproduction—Bobwhite Quail: Diquat Technical (SX-1306):
Project No. 162-142; S-2070. Final rept. (Unpublished study
received Sep 3, 1982 under 239-1663; prepared by Wildlife In-
ternational Ltd., submitted by Chevron Chemical Co., Richmond,
CA; CDL:248290-C)
00121305 Akhavein, A.; Linscott, D. (1968) The dipyridylium herbicides, par-
aquat and diquat. Residue Reviews 23:98-145. (Also in unpub-
lished submission received Dec 21, 1982 under 239-2247; submit-
ted by Chevron Chemical Co., Richmond, CA; CDL:249102-C)
00121307 Simsiman, G.; Daniel, T.; Chesters, G. (1976) Diquat and endothall:
Their fates in the environment. Residue Reviews 62:131-174.
(Also in unpublished submission received Dec 21, 1982 under 239-
2247; submitted by Chevron Chemical Co., Richmond, CA; CDL:
249102-E)
00122705 Hemingway, R.; Oliver, C. (1972) Diquat: Metabolism in Fish:
AR 2356'A. (Unpublished study received Dec 21, 1982 under 239-
2247; prepared by Imperial Chemical Industries Ltd., Eng., sub-
mitted by Chevron Chemical Co., Richmond, CA; CDL:249104-V)
00135717 Chevron Chemical Co. (1970) Diquat: Residue Tolerance Petition: The
Results of Tests on the Amount of Residue Remaining, Including a
Description of the Analytical Methods Used: Water, Aquatic Life
and Soil. (Compilation; unpublished study received Dec 12,
1970 under 1F1101; CDL:090861-A)
00138961 Thompson, C.; Griffen, J.; Forbis, A. (1980) Acute Toxicity of
Diquat 2 Spray (SX-1261) to Rainbow Trout ...: ABC Report
#26194; S-1834. (Unpublished study received Feb 6, 1984 under
239-2424; prepared by Analytical Bio-Chemistry Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, CA; CDL:
252355-A)
00138962 Thonpson, C.; Griffen, J.; McKee, M. (1980) Acute Toxicity of Di-
quat 2 Spray (SX-1261) to Bluegill Sunfish ...: ABC Report
#26193; S-1835. (Unpublished study received Feb 6, 1984 under
239-2424; prepared by Analytical Bio-Chemistry Laboratories,
Inc. , submitted by Chevron Chemical Co., Richmond, CA? CDL:
252355-B)
00138963 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. U.S. Fish and
Wildlife Service, Washington, D.C. (Resource publication 137;
also in unpublished submission received Feb 6, 1984 under
239-2424; submitted by Chevron Chemical Co., Richmond, CA;
CDL:252355-C)
139
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibroau.de Standard
MRID CITATION
00140572 Swan, A. (1962) R.17,191 1,1-Ethylene 2,2-Dipyridilium Dichloride:
Report No. TR/375. Interim toxicological rept. (Unpublished
study received 1^62 under 7FOb94; prepared by Imperial Chemical
Industries, Ltd., submitted by Chevron Chemical Co., Richmond,
CA; CDL:092832-B)
00140576 Cookson, J.; McElligott, T. (1966) The Dermal Toxicity of Diquat:
Report No. IHR/200. (Unpublished study received 1966 under
7F0594; prepared by Imperial Chemical Industries, Ltd., Eng.,
submitted by Chevron Chemical Co., Richmond, CA; CDL:092882-G)
00140577 Swan, A. (1963) The Dermal Toxicity of Diquat Dichloride
(R.17,191): Report No. TR/540. (Unpublished study received
1963 under 7F0594; prepared by Imperial Chemical Industries,
Ltd., submitted by Chevron Chemical Co., Richmond, CA; CDL:
092882-H)
00140578 Hurst, E. (1966) A Long-term Toxicity Test with Diquat Dichloride
Monohydrate in Dogs: Report No. IHR/195. (Unpublished study
received 1966 under 7F0594; prepared by Imperial Chemical In-
dustries, Ltd., submitted by Chevron Chemical Co., Richmond,
CA; CDL:092882-1)
00140579 Kohn, F. (1965) Report to Imperial Chemical Industries Limited:
Two-year Chronic Oral Toxicity of Diquat—Albino Rats (Feeding
Levels of 1000, 500 and 250 PPM). (Unpublished study received
1965'under 7F0594; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, CA; CDL:
092882-^1)
00140582 Black, W.; Calderbank, A.; Douglas, G.; et al. (1966?) Silage
Feeding Experiments following the Use of Diquat as a Desiccant.
(Unpublished study received on unknown date under 7F0594; sub-
mitted by Chevron Chemical Co., Richmond, CA; CDL:092882-O)
00140586 Chevron Chemical Co. (1967) Diquat: The Results of Tests on the
Amount of Residue Remaining, Including a Description of the
Analytical Method Used. (Compilation; unpublished study re-
ceived 1967 under 7F0594; CDL:092882-S)
00140589 Griffiths, K.; Kinch, D. (1972) Diquat Dibrcmide: Three-generation
Reproduction Study in Rats: Report No. HO/1H/R/331A. (Unpub-
lished study received Feb 15, 1974 under 4G1470; prepared by
00140590 Chevron Chemical Co. (1974) Diquat: The Results of Tests on the
Amount of Residue Remaining, Including a Description of the
Analytical Methods Used. (Compilation; unpublished study
received Feb 15, 1974 under 4G1470; CDL-.093914-D)
140
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Diquat Dibromide Standard
MRID CITATION
00145355'CoIIey, -J.-;" Warren,' S.; Heywood, R. (1965) Diquat Dibromide Evalua-
tion of Potential Carcinogenicity and Chronic Toxicity by Pro-
longed Dietary Administration to Rats: Final Report: HRC Report
No. ICI 406-83763. Unpublished study prepared by Huntingdon Re-
search Centre. 2660 p.
00148843 Levin, D.; Hollstein, M.; Christman, M.; et al (1982) A new Sal-
monella tester strain (TA102) with A.T base pairs at the site of
mutation detects oxidative mutagens. Proc. Natl. Acad. Sci. USA
79(DEC): 7445-7449.
00148844 Anderson, D.; McGregor, D.; Purchase, I.. (1976) Dominant lethal
studies with paraquat and diquat In male CD-I mice. Mutation
Research 40:349-358.
00148845 Bignami, M.; Crebelli, R. (1979) A simplified method for the induc-
tion of 8-azaguanine resistance in Salmonella typhimurium. Tox-
icology Letters 3:169-175.
00154100 Skidmore, M. (1985) Diquat Hydrolytie Stability In Aqueous Solu-
tion at PH 5, 7 and 9: Interim Report. Unpublished study pre-
pared by ICI Plant Protection DIv. 6 p.
00154101 Upton, B.; Hendley, P.; Skidmore, M. (1985) Diquat: Hydrolytie Sta-
bility in Water at PH5, 7 and 9: Report No. RJ0452B. Unpub-
lished study prepared by ICI Plant Protection Div. 24 p.
00155475 Thompson, J. (1985) Modified Buehler Test for the Skin Sensitiza-
tion Potential of Diquat Herbicide Concentrate (SX-1569): Study
No. Socal 2356. Unpublished study prepared by Chevron Environ-
mental Health Center. 32 p.
05001465 Crosby, D.G.; Tucker, R.K. (1966) Toxicity of Aquatic herbicides to
Daphnia Magna. Science 154(3746):289-291.
05014905 Siebert, D.; Lemperle, E. (1974) Genetic effects of herbicides:
induction of mitotlc gene conversion in Saccharomyces
cerevlsiae. Mutation Research 22:111-120.
GS0288-002 California Chemical Co. (I960) [Plant Protection Limited] Standard
Official Method No. 151 for the Determination of Residues of
Diquat (l:l'-ethylene-2:2'-Dipyridylium Dibromide, K8483,
GS9999-001 Hudson, R.H.; Tucker, R.K.; Haegele, M.A. (1984) Handbook of
Toxicity of Pesticides to Wildlife. USDI Publication 153,
Washington, D.C.
141
-------
APPENDIX V
FORMS APPENDICES
142
-------
OMB Approval No. 2000-O468
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
6PA REGISTRATION NO.
PRODUCT NAME
A.Tt_:CANT3 MA.-.SE '
DATE GOiOANCE DOCUMENT liSUtD"""
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained ir. the r°ftreni.ej
Guidance Document, 1 am responding in the following manner
D 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from lor are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Grouo, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I have entered into in agreement with on* or more other registrants under FIFRA section 3(C)(2l(B)(ii) to satisfy the following data
requirements. The tastt. and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
O 2. I enclose a completed "CsrtificaWon of Attempt to Enter Into-an Agreement with Other Registrants for Development of Oat?" witn
respect to the following data requirements:
LJ 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary eanc*llation of tha registration of this product (This option is not available to applicants for new products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 868O1 (10-32)
143
-------
OMB Approve/ No. 2000-0468 .
CERTIFICATION OF ATTEMPT TO ENTER ~~
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To W*Ujbmit data to avoid suspension of its registration(s) under FIFRA Section 3
-------
PORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. Product Name
Applicant's Name and Address
As an authorized representative of the applicant for registration of the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s):
(2) Each active ingredient listed in paraqraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is 'registered under FIFPA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (8) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Form No.- 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source: Product name and Reg. No.
Signature
nate Title
EPA Form (April 1985)
145
------- |