&EPA
United StatM
Environmental Protection
Agency
Off ice of
Pesticides and Toxic Substance*
Washington OC 20460
June 1987
Pesticides
Guidance for the
Reregistration of
Pesticide Products
Containing
PARAQUAT DICHLORIDE
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
PARAQUAT DICHLORIDE
AS THE ACTIVE INGREDIENT
GS0262
CAS NUMBER 1910-42-5
JUNE 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Glossary of Terms and Abbreviations iii
I. Introduction 1
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
C. History
III. Agency Assessment 7
A. Summary
B. Tolerance Reassessment
C. Toxicological Assessments
D. Other Science Findings
IV. Regulatory Position and Rationale 27
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Labeling
V. Products Subject to this Standard 36
VI. Requirement for Submission of Generic Data 38
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. Testing Protocols, Standards for Conducting
Acceptable Tests, Guidance on Evaluating and
Reporting Data
F. Procedures for requesting a change in testing
protocol
G. Procedures for requesting extensions of time
H. PR Notice 86-5 and Any Other Requirements
Referenced or Included Within this Notice
I. Existing stocks provision upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 45
VIII. Requirement for Submission of Revised Labeling 46
IX. Instructions for Submission 47
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES 50
Guide to Tables
Table A
Table B
II. LABELING APPENDICES 98
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 123
IV. BIBLIOGRAPHY 163
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 190
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 8580-4 - Product Specific Data Report
EPA Form 8570-27 - Generic (Formulator's) Exemption
Statement
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
The following terms are used throughout this Registration
Standard and are defined here for the convenience of the reader.
ADI: (Acceptable Daily Intake) An acceptable daily intake of
pesticide residue based on a complete data base.
A/D Ratio: This ratio determines a level of concern regarding
whether effects observed in embryos and fetuses from
treated females are "primary" (due to direct compound-
related effects) or "secondary" (to maternal toxicity).
Thus, the NOEL for maternal effects ("A" numerator) divided
by the embryo/ fetal NOEL ("D" for "developmental"),
including frank terata (gross congenital defects) , defines
this concern. If A/D is less than "1", developmental
toxicity of a substance may be ascribed to secondary
effects of maternal toxicity; if greater than 2, ther
substance is considered a direct (primary) developmental
toxicant. Scientific interpretation is required in the
range, 1 to 2 (LEL's may be used; or effects from other
types of studies, e.g., reproduction).
ai: Active ingredient
CAS: Chemical Abstract Society (number)
Core Classification: A general guide to the acceptability of
data for the purpose of supporting registration (invalid,
supplementary, minimum, or guideline).
Core Guideline: Studies which satisfy Agency data requirements.
Core Minimum: Studies which are acceptable to support regis-
tration of pesticide products but were not necessarily
done according to Agency guidelines.
Core Supplementary: Studies in this category are scientifically
sound, thus the information may be useful. However, the
studies were performed under conditions that deviated
substantially from recommended protocols. Studies do not
meet guideline requirements and thus do not support
registration of a product.
EEC: (Estimated Environmental Concentration) Estimated pesticide
concentration in the environment (terrestrial or aquatic
ecosystem).
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EP: End-use Product
EPA: The Environmental Protection Agency, also "the Agency"
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
Guidelines for Carcinogen Risk Assessment: The Agency's
guidelines for classifying a chemical based on evidence
of its carcinogenicity (September 26, 1986, 51 FR 33992).
The guidelines categorize the evidence in terms of how
likely it is that the chemical is a human carcinogen:
Group A - Human Carcinogen: This category is reserved
for those chemicals for which there is sufficient
evidence of carcinogenicity from human epidemiological
studies.
Group B - Probable Human Carcinogen: This group is
divided into subgroups 1 and 2. Group Bl requires
some human epidemiological evidence. Group B2 is
appropriate if there is "sufficient evidence" of
the chemical's carcinogenicity from animal studies.
"Sufficient evidence" is defined as an increased
incidence of malignant (or combined malignant and
benign) tumors (1) in multiple species or strains,
(2) in multiple experiments, or (3) to an unusual
degree with regard to incidence, site or type of
tumor, or age at onset.
Group C - Possible Human Carcinogen: This group is
appropriate if there is "limited evidence" of
carcinogenicity in animals in the absence of human
data. "Limited evidence" means that the data suggest a
carcinogenic effect but are limited because (1) the
studies involve a single species, strain, or experiment;
or (2) the experiments are restricted by inadequate
design or reporting; or (3) an increase [is seen] in the
incidence of benign tumors only. Among the types of
evidence which may be seen are definite malignant tumor
response in a single well-conducted experiment or marginal
response in a tissue known to have a high and variable
background rate.
Group D - Not Classified.
Group E - This group is reserved for chemicals determined
to be non-carcinogenic in animal and/or human studies.
HDT: Highest dose tested
IV
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Invalid: Studies which are deficient in some vital parameter
or those studies which have been judged not to be
scientifically sound or those studies whose reliability
is seriously questioned.
LC5Q: (median lethal concentration): a statistically derived
concentration of a substance that can be expected to cause
death in 50 percent of test animals, expressed as weight
or volume of test substance per volume of air or water
or per weight of feed (e.g., mg/L or ppm).
LD5Q: (median lethal dose): a statistically derived single dose
that can be expected to cause death in 50 percent of animals
when administered by the route indicated, expressed as
weight of substance per unit weight of test animal (e.g.,
mg/kg).
MOS: Margin of Safety - The calculation of a margin of safety
involves division of an appropriate NOEL by a worker's
estimated exposure. The result is a unitless figure which
gives an indication of how close a worker's internal dose
is in relation to the NOEL for laboratory animals.
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number)--EPA's system of
tracking studies used in support of registrations
MP: Manufacturing-use product
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level—the maximum dose used in a test
which produces no observed adverse effects.
OPP: The Office of Pesticide Programs (EPA)
OES: Office of Endangered Species, U.S. Fish and Wildlife
Service
OM: Organic matter (used to describe soils)
ppm: Parts per million
PADI: (Provisional Acceptable Daily Intake) An acceptable daily
intake of pesticide residue based on a limited data base.
PAI: Pure active ingredient
Technical: Active ingredient as manufactured
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TMRC: (Theoretical Maximum Residue Contribution) An estimate of
dietary exposure obtained by multiplying residue tolerance
levels for-a given pesticide by the average daily per
capita food consumption figure, then adding the exposure
figures for each crop. TMRC is usually expressed in
terms of mg ai/day, assuming a 60 kg person.
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C) , EPA-, 401 M St., SW, Washington, D.C. 20460.
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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 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 the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
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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 the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
Common Name
Chemical Name
Empirical Formula
Trade Name
OPP/Shaugnessy No.
Chemical Abstract
Service (CAS)
Registry No.
Paraquat dichloride
1 ,1 ' -dimethyl-4,4' -bipyridinium ion
4C12N2 (dichloride)
Cekuquat, Crisquat, Herboxone, Gramuron,
Dextrone , Dexuron , Esgram, Gramaxone,
Gramanol, Herbaxon, Goldquat 276, Pillaquat,
Paracol, Paraquat Cl , Pillarxene, Sweep,
Actor, PP148 (dichloride) and Dextrone X.
061601 (dichloride)
1910-42-5 (dichloride)
Type of Pesticide
Pest Controlled
Registered Uses
Predominant Use
Method of
Application
Mode of Activity
Formulation -
Manufacturing-
Use Product
End-Use Product
B. USE PROFILE
Contact herbicide, desiccant, defoliant,
or plant growth regulator
Weeds or other vegetation
Cropland, noncropland, forestry ornamentals,
and turf
Field crops (corn and soybeans)
Broadcast, band, or directed spray by ground
equipment, or aircraft
Lipid peroxidation resulting in disruption
of cell membrane
29.1% and 43.5% active ingredient
Soluble concentrates, pressurized liquids
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C. HISTORY
Paraquat was discovered in 1882 and has been used as an oxidation-
reduction indicator under the name of methyl virologen since 1932.
The first commercial paraquat formulation for agricultural use was
produced by Imperial Chemical Industries, Ltd. in England and was
registered there in 1962. It was registered in the United States
in 1964.
Paraquat was accepted as a candidate for the Rebuttable Presumption
Against Registration (RPAR) process in 1978 and an intense scien-
tific review of the paraquat data base was initiated. The Agency
identified the following areas where paraquat was believed to
exceed the risk criteria under 40 CFR 162.11: teratogenicity,
lack of emergency treatment, chronic effects, reproductive effects,
oncogenicity (data gap), mutagenicity (data gap), and acute
effects. Other areas of concern include mammalian toxicity and
avian reproductive effects.
A Paraquat Decision Document was issued in October 1982 (43 FR
30613) in which the Agency concluded that available data did not
support an RPAR in relation to the criteria identified in 1978.
To date, all other areas of concern have been evaluated and none
of the risk criteria have been exceeded. (Note: Under the
current Special Review criteria, the risk criterion for acute
inhalation has not been exceeded. Paraquat has the potential to
cause adverse effects but the Agency believes it does not because
the generated droplets are not respirable.)
After the RPAR review, the Agency believed that the acute effects
level was very close to estimated applicator exposures. However,
the significance of this could not be interpreted without addi-
tional dermal and inhalation data and more precise information
relating to applicator exposure. These data have since been called
in and have been evaluated for this document.
The following lists the data that have been required under FIFRA
section 3(c)(2)(B) since the 1982 Decision Document:
Groundwater Data Call In (PCI)
Degradation studies - Lab Field dissipation study -
hydrolysis soil
photodegradation (water, soil) forestry areas
Soil metabolism study - Lab Water solubility
aerobic soil
anaerobic soil Vapor pressure
Mobility studies - Octanol water partition
leaching coefficient
adsorption
desorption
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PCI from Decision Document
Nondietary exposure Mutagenicity studies
Worker/applicator exposure New study or additional
Face-mask filtration capacity information for an earlier
study -
Spray particle size for
field application techniques Chronic feeding study (rats)
Oncogenicity study (rats)
Acute inhalation Reproduction study
21-Day subchronic dermal study
The regulatory conclusions regarding these data and the relation-
ship to the concerns of 1982 Decision Document are discussed in
the Agency Assessments section.
One significant result of the Decision Document was that the
registrant voluntarily cancelled certain noncrop uses including
rights of way. These use patterns had the potential to cause
problems with birds and mammals. Currently, the only anticipated
wildlife problems are with endangered species and the Agency
believes that label statements will be adequate to protect
endangered plants and animals.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all data, submitted to support the regis-
tration of paraquat, available through June 1, 1985. Several
toxicological studies received after this date have been reviewed
and, therefore, included in this Standard. Based on the review
of these data, the Agency has reached the following conclusions.
A discussion of this review follows this summary section.
Tolerance Reassessment. The ADI (acceptable daily intake) has
been set using a recent more sensitive study. The ADI is based
on a 1-year dog feeding study (MRID 00132474) with a NOEL (no-
observed-effect level) of 0.45 mg/kg/day. Applying a safety
factor of 100 results in an ADI of 0.0045 mg/kg/day and a maximum
permissible intake (MPI) of 0.27 mg/kg/day (for a 60 kg person).
The theoretical maximum residue contribution (TMRC), the total
of all published tolerances, is 0.1134 mg/day- The TMRC con-
stitutes 42 percent of the MPI.
Toxicological Assessment. With the exception of an inhalation
study, the toxicology data base is complete. Paraquat is extremely
toxic to mammals (Category I) by all routes of exposure; however,
it is noted that inhalation toxicity is dependent on particle size.
Based on positive findings in the rat, the Agency has classified
paraquat as a Group C oncogen (Possible Human Carcinogen), in
accordance with Agency Guidelines for Carcinogen Risk Assessment
(September 26, 1986, 51 FR 33992).
Worker Exposure Analysis. Quantitative exposures to workers
(mixers, loaders, and applicators) were estimated using data
called in after the Decision Document.
Worker Safety Calculations. The margins of safety (NOEL/exposure)
appear adequate for all workers.
Hazard Assessment for Terrestrial and Aquatic Organisms and
Endangered Species.Based on available information,the Agency
does not anticipate that wildlife populations, excluding endan-
gered species, will be adversely affected when paraquat is used
according to label directions. As a result of consultations
with the Office of Endangered Species (OES), only one bird,
the Attwater's greater prairie chicken, and several plants were
determined to be in potential jeopardy for certain uses.
As a result of this determination, labeling to protect endangered
species is required for all end-use products used for treatment
of crops, rangeland and pastures. This labeling is addressed in
Pesticide Registration (PR) Notices 87-4 and 87-5, issued May 1,
1987.
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Environmental Fate Assessment. Environmental fate data were
evaluated for compliance with current data requirements. The
available data indicate that paraquat will not leach in agri-
cultural soils. The major degradate (QINA) has a potential
for leaching. Data deficiencies, were identified and additional
data are required to fill the data gaps.
Review of Product Chemistry Data. Product chemistry data
were evaluated for compliance with current data requirements.
Data deficiencies were identified and additional data required
to fill the data gaps.
Analysis of Paraquat*s Restricted-Use Classification. All
agricultural products will retain the restricted-use classi-
fication. One homeowner end-use product containing 0.276
percent paraquat cation available to the public on a unres-
tricted basis will continue to be unrestricted.
Analysis of Current Label Statements. The warning statements
that currently appear on paraquat labels were evaluated to
determine if they were appropriate and adequately protected
workers and the environment. In addition to label statements
required by Part 162.10, statements in the following areas
have been added.
o Restricted use classification
o Worker safety statements
o Grazing and feeding restrictions
As a result of this review, the Agency has identified missing
data which are necessary to evaluate risks associated with
the use of paraquat. These data must be developed in order
to maintain registrations of products or register new products
containing paraquat. The following table summarizes the data
gaps. Please note that this is only a summary, and more
details can be obtained by referring to the data tables.
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SUMMARY OF DATA GAPS - PARAQUAT
Environmental Fate:
Toxicology
Residue Chemistry
Photodegradation (water)
Aerobic and anaerobic soil metabolism
Leaching and adsorption/desorption
Terrestrial and conditional long-term
field dissipation studies
Rotational crops
Aquatic nontarget organism
90-Day inhalation
Storage stability of paraquat in
animal tissues
Support data for various commodities
New enforcement analytical methodology
Product Chemistry
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B. TOLERANCE REASSESSMENT
Tolerances have been established for residues of paraquat on a
wide variety of raw agricultural commodities, in meat, fat, and
meat byproducts of animals (40 CFR 180.205), in processed food
(21 CFR 193.331), and in feed (21 CFR 561.289) derived from raw
agricultural commodities.
1. Residue Data. The residue data reviewed in support of these
tolerances include:
a. Data on the nature of the residues in both plants and
animals, including identification of major metabolites
and degradates of paraquat. The terminal residue of
concern is paraquat per se. Tolerances are set on the
parent compound only.
b. Radiolabeled studies on the uptake, translocation, and
metabolism of paraquat in plants show that paraquat is
not measurably metabolized by plants.
c. Radiolabeled studies on the metabolism and translocation
of paraquat in pigs, goats, cattle, poultry, and rats.
d. Analytical methodology for determining the levels of
residues of paraquat in plants and animals. Such methods
have been determined to be suitable for residue determina-
tions but not for enforcement purposes.
e. Storage stability data demonstrating that residues of
paraquat are stable in plant samples for up to 5 months.
Similar data on animal products to support the results
of animal feeding studies have not been submitted.
f. Data on the magnitude and levels of residues in indivi-
dual raw agricultural commodities, animal products, and
processed food and feed items.
At the same time that the Agency evaluated the data supporting
tolerances, EPA also determined whether:
0 All use patterns (including those registered under FIFRA
section 24(c) and intrastate uses) and methods of appli-
cation are supported by existing tolerances;
0 The existing uses of paraquat require the establishment
of tolerances in animal products because of residues
that may transfer to animals from feed items derived
from raw agricultural commodities;
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0 Food additive tolerances are necessary because residues
in the raw agricultural commodities concentrate in pro-
cessing;
0 Crop group tolerances could be established in accordance
with 40 CFR 180.34(f);
0 In the absence of certain tolerances, restrictions on
use, grazing or feeding are necessary; and
0 The tolerances are expressed accurately and in current
terminology.
2. Dietary Assessment. The toxicity data considered to estab-
lish an ADI include:
a. A 1-year feeding study in dogs, with a NOEL of 0.45
mg/kg/day. This study was selected as the basis for
the ADI. A safety factor of 100 results in an ADI of
0.0045 mg/kg/day and a MPI of 0.27 mg/day (for a 60 kg
individual).
b. A chronic feeding/oncogenicity study in rats, with a
NOEL of slightly below 25 ppm or 1.25 mg/kg/day. This
study was rejected as the basis for the ADI for two
reasons.
(1) The NOEL of the dog study is slightly lower.
(2) The lowest dose (25 ppm) approximates the
systemic NOEL. Twenty-five ppm is an approxi-
mate NOEL because som.e minor lenticular changes
at or near the end of the study were observed at
that level. If this study were used for the ADI
calculation, a higher safety factor would have
to be used to compensate for these effects. If
a safety factor as high as 300 were to be used
with this rat study, it would approximate the
ADI resulting from the dog study. Thus, the dog
study yields a more conservative ADI.
The TMRC for paraquat, based on published tolerances, is 0.1134
mg/day. The TMRC constitutes 42 percent of the MPI. Daily
dietary exposure to paraquat, therefore, is less than the cal-
culated acceptable daily intake for humans.
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C. TOXICOLOGICAL ASSESSMENTS
Acute Oral and Dermal Toxicity. Acute toxicity studies show
that via the oral and dermal routes, paraquat is extremely toxic
(Category I) (Toxicity categories are discussed in 40 CFR 162.10.)
Symptoms of toxicity associated with oral and dermal acute exposure
include lethargy, weakness, diarrhea, wheezing, bloody nose,
anorexia, adipsia, anoxia, hyperpnea, tachycardia, cyanosis, and
pulmonary changes.
Acute Inhalation Toxicity. In the 1982 Decision Document, the
Agency determined that the acute inhalation toxicity data avail-
able at that time were inadequate and insufficient to provide a
definitive conclusion with respect to acute inhalation toxicity.
Additional data were required.
In 1985, two new acute inhalation toxicity studies on rats were
received. One was performed using aerosolized paraquat with more
than 90 percent of. the particle diameters below 0.3 urn. The LCso
for this study was a range of 0.6-1.4 ug/L (Toxicity Category I).
The second study was performed using aerosolized paraquat particles
with a median diameter of 21.5 to 23 urn, with about 0.2 percent
less than 2.5 urn. The LC5Q for this study was approximately 3.5
ug/L (Toxicity Category I). The difference in LC^Q values between
these two studies can be explained by the difference in particle
sizes reaching the alveolar region of the lung.
In the first study, virtually all the particles were small enough
to reach the lung alveoli and be absorbed. In the second study,
only a small percentage of the total particles were small enough
to reach the alveoli. The inverse relationship between inhalation
toxicity and particle size, within limits, is a well-known toxi-
cological phenomenon. (The topic of pulmonary disposition is
discussed in Toxicology, the Basic Science of Poisons, edited by
L. Casarett and J. Doull, published by McMillan Publishing Company,
Inc., New York, 1975.)
Also in 1985, the Agency received some laboratory information on
the particle size of paraquat droplets that might be formed during
aerial application and knapsack spraying. Virtually no droplets
smaller than 15 urn were formed for either method of application.
The Agency does not expect that the field application droplet
spectrum will significantly differ from the droplet spectrum found
in the laboratory studies. Therefore, EPA believes that the two
acute inhalation studies described above overestimate the potential
acute inhalation hazard to workers.
Irritation and Sensitization (Eye and Dermal). Paraquat causes
severe eye irritation (Category I)in male rabbits. Symptoms
reported after exposure to 0.1 ml of test material included com-
plete opacity in 3 of 6 rabbits tested: purulent discharge ran
from the eyes into the mouth, causing severe burning of the
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mucosa and inability to eat. A severe burning of the nasal mucosa
was also seen in most rabbits. Other studies show paraquat to be
a moderate dermal irritant (Category III). Signs of toxicity
included: slight to severe erythema and very slight to slight
edema in most rabbits; hemorrhaging edematous lungs, discolored
grainy livers, soft vascularized kidneys and decreased body fat in
some rabbits. A dermal sensitization study in guinea pigs shows
paraquat not to be a skin sensitizer.
Subchronic Toxicity. In the 1982 Decision Document, margins of
safety for workers repeatedly exposed to paraquat were calculated
based upon the results of two subchronic inhalation studies,
each with a NOEL of 0.01 ug/L. The particle size of aerosolized
paraquat in one of the studies was 2 um. Although not specific-
ally stated, it is assumed that the particle size in the other
study was also about 2 um. The 1982 Decision Document also
noted, however, that such small particle sizes were an unlikely
occurrence in the field and that realistic margins of safety
would probably be greater. Data available at that time did not
allow establishment of margins of safety consistent with actual
use. Furthermore, margins of safety relating to repeated dermal
exposure of workers were not presented in the 1982 Decision Docu-
ment because the available subchronic dermal data were inadequate
and dermal absorption rate studies were not available.
Additional inhalation and dermal data on worker exposures were
required to be submitted to the Agency. Determinations of par-
ticle sizes of paraquat droplets formed during application were
also required to be submitted. In addition, subchronic dermal
data and dermal absorption rate data were also required.
All the required information has now been submitted to and eval-
uated by the Agency.
The available subchronic toxicity data for paraquat include a
90-day feeding study with dogs, a 21-day dermal study with
rabbits, and two 3-week inhalation studies with rats. Dermal
absorption data on humans are also available.
The 90-day dog feeding study is adequate. The NOEL in that
study is 20 ppm (0.5 mg paraquat cation/kg bwt) and the LEL
(lowest effect level) is 60 ppm (1.5 mg of paraquat cation/kg
bwt). The toxic signs at the 60 ppm level were alveolitis,
increased lung weight, and alveolar collapse.
The 21-day dermal study with rabbits demonstrated a NOEL of 1.15
mg paraquat cation/kg bwt with respect to localized skin effects
at the sites of application (inflammation; ulceration, scabbing
and acanthosis). No evidence of systemic toxicity was observed
in this study at dosage levels up to and including 6.0 mg para-
quat cation/kg bwt, the highest dosage level tested.
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The two 3-week inhalation studies, previously used in the 1982
Decision Document to calculate margins of safety for workers
used aerosolized paraquat particles of about 2 urn. The Agency
now has information generated in the laboratory indicating
that during aerial application or knapsack spraying virtually no
paraquat particles _< 1 5 urn are formed. Since particles > 15 urn
are not inhalable, the Agency has now decided that it would be
inappropriate to use these studies to calculate margins of
safety for workers. The results of recently submitted acute
inhalation studies with paraquat, in which toxicity was observed
to be inversely related to particle size, also support the
decision.
The two old 3-week inhalation studies were also deficient in
that attention was focused primarily on effects on the respira-
tory organs/tissues and inadequate evaluation of systemic toxi-
city in other organs/tissues was performed. To more fully assess
the potential inhalation hazard to workers repeatedly exposed to
paraquat, the Agency is requiring submission of a 90-day inhala-
tion study which will assess not only respiratory but also other
systemic toxicities in test animals exposed to paraquat aerosols.
The final protocol for this study is to be determined in consul-
tation with the Agency when the results of particle size studies
under field conditions are available. A 90-day study, rather
than a 3-week study, is required in order to fully evaluate the
potential long-term toxicity of paraquat exposure to workers
repeatedly exposed to paraquat over extended periods of time.
The Agency now has acceptable dermal absorption data derived, in
part, from studies on humans. These data indicate that about 0.5
percent of paraquat is absorbed through the skin over a 24-hour
exposure period. Inasmuch as dermal data from humans are prefer-
able to dermal data from other species, the Agency has used the
dermal absorption rate of 0.5 percent together with recently
submitted dermal exposure data to determine dermal absorption
of paraquat by workers regularly exposed to paraquat by the dermal
route of exposure. Inhalation exposure was also determined for
these same groups of workers based on recently submitted inhala-
tion exposure data and an assumed inhalation absorption rate of
100 percent. Finally, absorption for combined dermal and inhala-
tion exposures was also determined. Margins of safety for
workers regularly exposed to paraquat were then calculated by
relating dermal absorption and inhalation absorption separately
and then combined to the NOEL of 0.5 rag paraquat cation/kg
bwt/day derived from the 90-day dog feeding study described
previously. The results are presented in Table 1.
In all cases except two, the combined dermal and inhalation
margins of safety are greater than 100 and are considered by the
Agency as adequate for protection of workers. In two instances,
margins of safety for combined dermal and inhalation exposures
14
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Table 1. Margins of Safety for Subchronic Hazard to Workers
(Combined Dermal and Inhalation Exposure)
Use/Worker
Directed sprays in Orchards,
Vineyards, Windbreaks^
Shade and Ornamental Trees
Ground .Boom
Low Acreage*
High Acreage*
Hand-Held Spray Gun
Low Acreage*
High Acreage*
Ground Boom Application to
Field Crops (Corn, Soybeans,
Sorghum, Wheat)
Individual Farmers*
Commercial Contractors
Mixer/Loader (only)
Applicator (only)
Aerial Application to
Field Crops (Corn, Soybeans
Sorghum, Wheat)
Mixer /Loader (only)
Pilot (only)
Flagger - with resp. prot.
Flagger - no resp. prot.
Aerial application to
Cotton (Defoliant Use)
Mixer/Loader (only)
Pilot (only)
Flagger-with resp. prot.
Flagger-no resp. prot.
Work Exposure During
Noncrop Uses
Large Sites*
Small Sites*
Daily Dermal
From Lunchick
EAB (11/22/85)
(ug/kg/day)
63
290
57
260
820
750
69
79
29
160
160
20
7
38
38
290
280
Exposure
Adjusted for
dermal absorp.
(ug/kg/day)
0.32
1.45
0.29
1.30
4.10
3.75
0.35
0.40
0.15
0.80
0.80
0.10
0.04
0.19
0.19
1.45
1.40
Margin
of
Safetyt
1600
340
1700
380
120
130
1400
1300
3300
630
630
5000
3000
2600
2600
340
360
Daily Inhalation
Exposure (from
Lunchick
ug/kg/day)
0.69
3.10
0.04
0.16
2.50
0.30
2.20
0.26
0.77
0.77
7.70
0.05
0.18
0.18
1.80
3.10
0.14
Margin
of
Safetyt
720
160
13000
3100
200
1700
230
1900
650
650
65
10000
2800
2800
280
160
3600
Daily Dermal
Plus Inhal.
Exposure
(ug/kg/day)
1.01
4.55
0.33
1.46
6.60
4.05
2.55
0.66
0.92
1.57
8.50
0.15
0.22
0.37
1.99
4.55
1.54
Margin
of
Safetyt
500
110
1500
340
80
120
200
760
540
320
60
3300
2300
1400
250
110
330
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Table 1. Margins of Safety for Subchronic Hazard to Workers
Dermal and Inhalation Exposure (cont'd).
Use/Worker
Ground Boom Application to
Cotton (Defoliant Use)tt
Mixer /Loader (early season)
Mixer/Loader (late season)
Applicator Nearly season)
Applicator (late season)
Ground Boom Application to
Cotton (Dessication Use)tt
Mixer/Loader (Minimum)
Mixer/ Loader (Maximum
Applicator (Minimum)
Applicator (Maximum)
Worker Exposure During
Use on Range, Pasture
and Forage Crops
Worker Exposure During
Resin Soaking
Worker Exposure During
Tree Injection
Daily Dermal Exposure
From Lunch ick
EAB (11/22/85)
(ug/kg/day)
34
250
9
35
270
810
46
74
Adjusted for
dermal absorp.
(ug/kg/day)
0.17
1.25
0.05
0.18
1.35
4.05
0.23
0.37
Margin
of
Safety^
2900
400
10000
2800
370
120
220
140
Daily Inhal.
Exposure
(fr.Lunchick
ug/kg/day)
0.01
0.07
0.30
1.10
0.08
0.13
1.50
2.40
Margin
of
Safetyt
50000
7100
1700
450
6300
3800
330
210
Not Greater than Use on Field Crops
Not Greater than "Backpack" use in Orchards, etc.
Daily Dermal
Plus Inhal.
Exposure
(ug/kg/day)
0.18
1.32
0.35
1.28
1.43
4.18
1.73
2.77
0.06**
Margin of
Safetyt
2800
380
1400
390
350
120
290
180
8300
*Mixer/Loader plus applicator.
tCalculated by dividing NOEL of 500 ug/kg/day (from a 90-day feeding study in dogs) by the daily combined
dermal and inhalation exposures of workers.
**Fron Lunchick, EAB (February 10, 1986).
ttFrom Lunchick, EAB (January 28, 1986).
-------
were below 100. For individual farmers who mix and load and
apply paraquat by ground boom to field crops, the margin of
safety was 80. These margins of safety were calculated assum-
ing that workers wore protective gloves only during mixing or
loading. Workers who wear the protective clothing required by
the label will have margins of safety exceeding those presented
in this document. Current labeling requires that mixer/loaders
wear face shield, rubber gloves, apron and waterproof footwear
when handling or mixing paraquat concentrate. Data available
to the the Agency demonstrate that these protective clothing
will reduce exposure to mixer/loader/applicators. Therefore,
the Agency believes that the MOS of 80 is a conservative esti-
mate, and that the actual MOS is higher.
For flaggers with no respiratory protection working in field
crops being aerially sprayed, the margin of safety is 60.
However, current labels require that workers not reenter
treated fields without protective clothing until sprays have
dried. Moreover, if working in an area where spray mist
exposure is possible, workers are required to wear goggles and
face mask for protection. The MOS for workers wearing such
protective clothing is 320.
Teratology and Reproduction. The available teratology studies
on paraquat include a mouse and a rat study. A three-generation
reproduction study in rats is also available.
The 1982 Decision Document determined that the available tera-
tology data were adequate and that paraquat was not teratogenic.
This determination is based on the two studies discussed below.
No additional data were required.
Paraquat was not teratogenic to the Alderley Park strain of mice
under the conditions of this study. The levels of paraquat
cation administered were 0, 1, 5, and 10 mg/kg of body weight.
Reductions in maternal body weight gain occurred at the 5 and 10
mg/kg levels. Fetotoxicity (partially ossified sternebrae) was
also observed at the 10 mg/kg level. The maternal NOEL was 1
mg/kg and the fetotoxic NOEL was 5 mg/kg.
Paraquat was not teratogenic to the Alderley Park strain of
rats under the conditions of this study. The levels of
paraquat cation fed were 1, 5, and 10 mg/kg of body weight.
Maternal toxicity (piloerection, hunched appearance, weight
loss, and respiratory distress in some rats) and fetotoxicity
(slight reduction in weight and slight retardation in ossifi-
cation) were observed at the 5 mg/kg level. The maternal and
fetotoxic NOEL was 1 mg/kg.
17
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In its 1982 Decision Document, the Agency determined that the
available reproductive data were inadequate. A two-generation
reproduction study was required. An adequate study has now been
submitted. Technical paraquat dichloride had no effect on repro-
duction in the Wistar-derived Alderley Park strain of rats in a
three-generation study. The levels of paraquat cation fed were
25, 75, and 150 ppm. An increased incidence of alveolar histio-
cytosis in the lungs of male and female parents was noted at the
75 ppm level resulting in a systemic NOEL of 25 ppm. Since the
NOEL for this study is higher than that from the dog study used
to calculate the ADI an adequate margin of safety (> 100) exists
with respect to human exposure.
Chronic Toxicity. In the 1982 Decision Document, the Agency
determined that the available chronic toxicity data were inade-
quate. Chronic toxicity studies consisting of two oral feeding
studies (dog and rat) were requested and subsequently submitted
to the Agency. The new data, which are adequate, are summarized
below.
In the 1-year dog study, Alderley Park beagle dogs were fed 0,
15, 30, and 50 ppm paraquat cation. The systemic NOEL is 15 ppm
(0.45 rag of paraquat cation/kg bwt). The systemic LEL is 30 ppm
(moderately increased severity and extent of chronic pneumonitis).
The NOEL from this study was used to calculate the ADI for human
dietary exposure to paraquat.
In a combined toxicity and carcinogenicity study in rats (113
to 126 weeks), 25, 75 and 150 ppm paraquat cation were fed to
Fischer 344 strain of rats. Although very slight effects (mostly
lenticular changes) were observed at the 25 ppm level in both
sexes, they occurred mostly after 104 weeks of treatment. Until
that time, or through most of the life span of the animals, a
NOEL was in fact 25 ppm. Toxic symptoms observed at the 75 ppm
level included an increased incidence of opacities, cataracts,
and nonneoplastic lung lesions (alveolar raacrophages and
epithelialization, and slight peribronchilar lymphoid hyperplasia)
The Agency considers the NOEL for this study to be slightly below
25 ppm (1.25 mg paraquat cation/kg bwt). Although very slight
toxicity was observed in this study at the lowest dosage level
tested, the effect was not considered by the Agency to be serious
enough to warrant requiring a new study, particularly since the
dog study described has a NOEL of about one-half that observed in
the rat study.
Oncogenicity. In the 1982 Decision Document, the Agency deter-
mined that the available oncogenicity data were inadequate.
Two oncogenic studies (rat and mouse) were requested and subse-
quently submitted to the Agency. These studies are summarized
below:
18
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In the mouse oncogenic study, paraquat was not oncogenic to male
or female Alderley Park strain mice under the conditions of this
study. The levels of paraquat cation fed for 97 to 99 weeks
were 12.5, 37.5, and 100/125 ppm of paraquat cation. (Initially,
the highest level fed was 100 ppm, but it was changed to 125 ppm
in the 36th week of testing because no toxic signs appeared at
that level.) The systemic NOEL for non-oncogenic effects was
12.5 ppm (1.87 mg paraquat cation/kg bwt). This study is adequate.
In the combined toxicity and carcinogenicity study in Fischer
344 strain of rats discussed above under "Chronic Toxicity," the
interpretation of the lung lesions was difficult. The Agency
received three interpretations of the histopathology of the lungs
in the rat study. Review of the submitted data by one pathologist
indicated an increase in the incidence of pulmonary neoplasms
(adenomas and carcinomas, but especially adenomas) in lungs of
male and female rats. However, a histopathology report by a
second pathologist, who reexamined the same lung slides, did not
indicate an oncogenic effect attributable to the administration
of paraquat. The third pathologist found that the incidence of
pulmonary adenomas and carcinomas did not show a relationship to
treatment with paraquat.
Other dose-unrelated tumor types observed included pituitary,
thyroid and adrenal glands, all within the range reported for
historical controls.
There was an increase of incidences of pancreatic islet cell
adenomas (mid-dose), mammary gland benign fibroepithelial and
testis interstitial cell tumors (high dose) over concurrent con-
trols in male rats. Malignant lymphomas were also increased in
males; however, based on the Agency's review, it was a relatively
small elevation, dose-unrelated and could not be attributed to
the compound. At the high dose in male rats, there was an increase
over concurrent controls in the incidence of lipomas of the skin
and subcutis. None of these increases in incidences of tumors
were statistically significant.
Squamous cell carcinoma was a predominant tumor in the head
region of the male and female rats. This uncommon tumor occurred
in 51.6 percent of all rats having tumors of the skin and subcutis
in the head region. In high dose males, the incidence of this
tumor was significantly increased over concurrent controls. How-
ever, since the rats were group-housed, exposure other than oral
due to scratching and/or fighting cannot be excluded.
The Agency has, based on this rat study and other data discussed
in this section, classified paraquat as a Group C oncogen (Possible
Human Carcinogen) in accordance with the Agency's Guidelines for
Carcinogen Risk Assessment. These guidelines categorize the
evidence of carcinogenicity of chemicals in terms of how likely
19
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it is that the chemical is a human carcinogen. Under this scheme,
Group C categorization is appropriate if there is "limited evidence"
of the chemical's carcinogenicity from animal studies. "Limited
evidence" is defined as studies that:
o involve a single species, strain, or experiment and do not
meet the criteria for "sufficient evidence" (...to an unusual
degree in a single experiment with respect to high incidence,
unusual site or type of tumor, or early age of onset);
o are restricted by inadequate dosage levels, inadequate
duration of exposure to agent, inadequate period of follow
up, poor survival, two few animals, or inadequate reporting;
or
o show an increase in the incidence of benign tumors only.
The Agency has concluded that the data presently available for
paraquat provides Limited evidence of oncogenicity in animals,
in that there is only one study with one species (rat) and one
strain (Fischer 344) with positive findings (skin tumors in
high-dose males only). Although the type of tumor was considered
to be uncommon, it was not of unusually high incidence nor did it
appear early. A quantitative estimation of the oncogenic potential
is not justified by the weight-of-evidence: there is limited evidence
of oncogenicity in a single sex, strain, and species in one study
with an adequate negative study in a second species (mice).
Mutagenicity. In its 1982 Decision Document, EPA determined the
available mutagenicity data were inadequate. Additional data
were required and have been submitted to the Agency. The evalua-
tion of mutagenic properties of paraquat is based on 21 studies
as follows:
a. Nine gene mutation assays: J5. typhimurium TA 92, 98, 10,
1535, 1537, 1538 and G 46 his-strains; A. nidulans strains
35 and ?3 ; and L5178Y mouse lymphoma ceTls in culture.
b. Five structural chromosome aberration assays: dominant
lethal (Charles River GDI mice and Swiss-Webster mice);
cytogenic (human lymphocytes and bone marrow of Wistar
rats); and micronucleus test in mice.
c. Seven DNA damage/repair assays: J5. typhimurium TA 1978
and 1538 strains; Sacch. cerevisiae D4, JDI and "other"
strains; human embryo epithelial cells; rat hepatocytes
in culture; and sister chromatid exchange in Chinese
hamster lung fibroblasts.
Based on review of these data, the Agency has concluded that
paraquat was negative in eight studies (mostly in gene mutation
and chromosomal aberration assays); weakly positive in four
20
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studies (two gene mutation, one chromosomal aberration and one
DNA damage/repair assays); and positive in four studies (all
DNA damage/repair assays). Five studies (three gene mutation,
one chromosomal aberration and one DNA damage/repair) were not
acceptable.
Based on these studies, paraquat is considered weakly genotoxic.
Additional mutagenicity studies are not required.
Metabolism. Paraquat dichloride or paraquat dimethyl sulfate
(radiochemical purity: 99.3-99.8 percent), labeled with 1 ^C,
in either methyl groups or in the ring, was poorly absorbed from
the gastrointestinal tract of mammals and was excreted in feces
mostly as unchanged paraquat. However, after an oral dose,
there was microbial degradation of paraquat in the gut. (In one
study with rats, 30 percent of a dose of paraquat appeared in
feces in a degraded form.) A portion of these microbial degra-
dation products can be absorbed and be excreted in urine, whereas
the remainder is excreted in feces.
In studies with cows and rats, about 96 percent and 70 to 96
percent, respectively, of the administered radioactivity (single
oral doses) was excreted in feces within 2 to 3 days as unchanged
paraquat. In studies with a goat and pigs, in which I^C-labeled
paraquat was administered orally for 7 consecutive days, 50
percent and 70 percent, respectively, of the total radioactivity
was recovered in feces, also as unchanged paraquat. In a study
with a goat, 33 percent of the radioactive dose was also present
in the contents of the digestive tract, but these determinations
were not made for pigs after the animals were killed.
However, in studies in which ^C-methyl labeled paraquat was admin-
istered subcutaneously to rats or was injected intramuscularly into
monkeys, 70 to 80 percent and 59 percent, respectively, of the
radioactivity was recovered in urine as unchanged paraquat. Most
of this radioactivity was eliminated in 24 hours after dosing.
The distribution of radioactivity was studied in the heart,
brain, liver, kidneys, muscle (forequarter and hindquarter),
blood, fat (peritioneal and subcutaneous), and lungs of goats
and pigs. Expressed as ug (micrograms) of paraquat ion/g of
tissue, most of the radioactivity was found in lungs, kidneys
and liver. With the exception of liver and peritoneal fat, the
radioactivity in all tissues studied was associated with unchanged
paraquat. In the liver, about 3 percent of the radioactivity
was associated with 4-(1,2-dihydro-l-methyl-2-oxo-4-pyridyl)-l-
methylpyridinium ion (compound I or monopyridone) and about 3
to 4 percent of the radioactivity was associated with 1-methyl-4-
(4-pyridyl) pyridinium ion (compound II or raonoquat). Peritoneal
fat contained about 6.5 percent of the radioactivity in that
tissue as monoquat. Similar findings were observed in studies
21
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with rats. Paraquat accumulated in the lungs of goats and rats,
but not pigs. Additional metabolism studies are not required.
Miscellaneous Studies. Three studies contribute significantly
to an overall assessment of paraquat toxicity. These are: 1)
acute dermal absorption study with humans; 2) urinary excretion
study in monkeys; and 3) oral corrosion potential study with
rabbits.
In the first study, single doses of 1^C-methyl-labeled paraquat
(99.8 percent pure) were applied on the forearms, hands and legs
of six adult male volunteers (age 30 to 74), and absorption was
measured by determining total 1^C in urine. Absorption was very
slow from all application sites (average values of 0.23 to 0.29
percent of the dose during 5 days after dosing).
In the second study, monkeys injected intramuscularly with
paraquat eliminated 58.6 percent of the dose in the urine within
7 days.
The figures for average human absorption (0.23 to 0.29) in the
table below are corrected for the recovery of 58.6 percent of the
administered dose in the monkeys. However, taking into account
the great variations in the human urinary excretion of ^C-paraquat
(see range in table below showing up to 0.702 percent dermal
absorption) and the fact that only urinary excretion of 14-C was
measured, a 0.5% dermal absorption rate is considered to be a
reasonable figure to use in estimating dermal exposure in the
margin of safety calculations.
Site of Dermal
Human Urinary Excretion of
(% of the applied dose)
Applications
Forearm
Back of Hand
Lower Leg
Average Standard Deviation Range
0.293
0.230
0.285
0.117
0.078
0.232
0.205-0.519
0.123-0.341
0.052-0.702
In the third study, 1 ml aliquots of paraquat dichloride (28.6
percent a.i.) and its aqueous dilutions ranging from 1:2 to
1:200 were applied to the tongue of New Zealand strain rabbits.
Dilutions as small as 1:100 were corrosive to the tongue. Other
affected tissues were larynx, lungs, liver, and kidneys. In the
case of lungs, necrotizing pneumonia, congestion/edema, and
pulmonary hemorrhage were reported. Laryngeal- lesions were
also observed at the 1:200 dilutions.
22
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Lack of Emergency Treatment. The Agency indicated, in its 1982
Decision Document, that both the oral administration and skin
absorption of paraquat have been responsible for poisoning inci-
dents. Case histories from accidental poisonings indicated that
varying amounts of paraquat are lethal (a sip to several mouth-
fuls); death is generally caused by pulmonary insufficiency; and
accidents are frequently the result of storage in unmarked bottles
Case histories from accidental dermal exposure demonstrated that
paraquat can be percutaneously absorbed in amounts sufficient to
cause death.
The Agency believed at that time that the therapeutic approach
to treatment of acute oral exposure is only partially effective.
The 81 percent survival rate occurring in case histories avail-
able to the Agency in combination with rapid availability of
treatment information (provided by placement of a 24-hour emer-
gency treatment telephone number on all labeling) suggests an
adequate emergency treatment for accidental oral ingestion. On
April 14, 1982, the Agency established an exemption from the
requirement of tolerance for an emetic which is incorporated
into paraquat formulations. The emetic is intended to induce
rapid vomiting thereby reducing the absorption of paraquat. The
Agency is continuing to require the emetic to be incorporated
into all formulations of paraquat.
In the 1982 Decision Document, the Agency noted that relatively
few dermal exposure cases have resulted in fatalities from para-
quat products. With the exception of a homeowner use product
containing a very low concentration of active ingredient, all
products bear Restricted Use Classification. Applicators of
such products are required to undergo training in the safe handl-
ing of pesticides and receive instruction in product labeling
and labeling interpretation. Current paraquat product labeling
bears instructions for mixers and applicators in exposure reduc-
tion techniques. Mixers are instructed to "wear a full face
shield, rubber gloves and apron" while applicators facing a risk
of exposure are instructed to "wear goggles and approved face mask
capable of filtering spray droplets." They are also instructed to
"wear waterproof footwear and clothing when spraying or when con-
tacting vegetation wet with spray." The Agency believes that the
precautionary measures dictated by current labeling are adequate
for prevention of dermal acute toxicity.
Worker Exposure Analysis. An assessment of worker exposure to
paraquat which estimated worker exposure during different appli-
cation techniques was conducted. The exposure estimates were
derived from surrogate data, corrected for paraquat's use rates,
and additional data submitted by the registrant(s). Three
different application techniques were initially evaluated: aerial,
ground boom, and hand spraying. A fourth technique, tree injec-
tion, was subsequently evaluated. The application techniques
23
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and usage scenarios have large ranges in exposure rates or hours
of exposure, which is normal for a herbicide with numerous use
patterns. Therefore, many of the exposure estimates are presented
a.s a mean with its corresponding range. All of the exposure
estimates were unadjusted for dermal or respiratory absorption
rates, however, this adjustment was made during the process of
estimating margins of safety.
Specific exposure information and a discussion of the studies
used are available in the science support document, Exposure
Estimates for Registered Uses of Paraquat, and its addendum.
Margins of Safety. Margins of safety (MOS) were calculated for
workers using paraquat. The calculation involves division of an
appropriate NOEL by a worker's estimated exposure. The result
is a unitless figure which gives an indication of how close a
worker's internal dose is in relation to the NOEL for laboratory
animals.
Daily dermal exposures were adjusted for a dermal absorption rate
of 0.5 percent by dividing the exposure by 200. Daily inhalation
exposures were not adjusted, i.e., a 100 percent absorption rate
was assumed. Margins of safety were calculated for dermal and
inhalation exposure separately and then for combined dermal and
inhalation exposures by relating these values to a NOEL of 0.5
mg/kg/day (500 ug/kg/day) derived from a 90-day subchronic feeding
study in dogs. The LEL in this study was 1.5 mg/kg/day at which
dosage level toxic effects in the lung were observed.
All MOS's are considered adequate. Only two worker groups have
an MOS < 100. Individual farmers who mix/load and apply paraquat
by ground boom application to field crops have an MOS of 80.
Flaggers with no respiratory protection working in field crops
being aerially sprayed with paraquat have an MOS of 60. All
other workers have an MOS > 100. More detailed information is
available in the preceding discussion of subchronic toxicity.
24
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D. OTHER SCIENCE FINDINGS
Hazard Assessment for Aquatic Organisms. Paraquat would not
normally be expected to present a hazard to fish or aquatic
invertebrates at expected rates up to 1.0 Ib ai/A. Available
acute toxicity data indicate that paraquat is slightly toxic to
certain species of fish and moderately toxic to daphnid. This
is based on a 96-hour LC5Q of 13 ppm for bluegill and a 48-hour
LC5Q values for daphnia ranging from 1.2 ppm to 8.0 ppm. Initial
exposure of aquatic organisms to paraquat, based on direct appli-
cation to water 6 inches deep at rates ranging from 0.25 to 1.0
Ib ai/A would be expected to range from 0.184 to 0.734 ppra. This
results in at least at twofold margin of safety for fish (based
on 1/10 the LC5g) and approximates the LC5Q for aquatic inverte-
brates. Paraquat, however, is not applied directly to water.
Terrestrial use of paraquat would result in less contamination of
water and a greater margin of safety. Paraquat appears to tightly
bind to most soils and is not expected to runoff.
Hazard Assessment for Terrestrial Organisms. There is no evi-
dence to suggest that the use of paraquat has either resulted in
kills or has affected mammalian or avian populations. Data suggest
that mammals, especially lagoraorphs, feeding on freshly sprayed
vegetation and eggs of ground-nesting birds sprayed with paraquat
would be affected most. The Agency does not expect either of
these to occur with high frequency. Mammals are unlikely to feed
on a site immediately after spraying. With respect to the potential
for paraquat to have toxic effects on bird's eggs, some embryo
mortality could result when paraquat replaces cultivation and
ground-nesting birds are allowed to continue to brood and eggs
receive a direct hit. However, most, if not all, uses of paraquat
are either not applied during avian egg laying season; are applied
under conditions not conducive to laying eggs on the ground; or
would not allow ground-nesting birds to continue their brooding.
Endangered Species Hazard Assessment. The Agency has consulted
with the Office of Endangered Species (OES) regarding endangered
species concerns. As a result of this consultation, only one
bird and several plants were determined to be in potential jeopardy.
Because of species use patterns and relative moderate toxicity, no
mammals were determined to be in jeopardy. The only avian species
for which it was determined there may be a "may affect" situation
is the Attwater's greater prairie chicken. There may be situations
when this ground-nesting bird's eggs would be sprayed with paraquat
when it is applied to existing ground cover in corn. Paraquat use
on corn creates a potential for affecting up to 41 percent of the
total prairie chicken population. In addition, since paraquat is
a nonselective herbicide, plants which are associated with grass-
land habitats or any other habitat to which paraquat can be
applied could potentially be exposed to paraquat.
25
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As a reasonable and prudent alternative, if paraquat is not
used in the range of the Attwater's greater prairie chicken,
or within or adjacent to the habitat of numerous plants identi-
fied by OES, jeopardy will be avoided. Therefore, labeling to
protect endangered species is required for all end-use products
used for treatment of crops, rangeland, and pastures. This
labeling is addressed in PR Notices 87-4 and 87-5, dated May 1,
1987.
Environmental Fate. A review of the data indicates that only
the hydrolysis and photodegradation in soil requirements are
fulfilled. Paraquat dichloride was stable to hydrolysis at
25°C and 40°C at pH 5, 7, and 9 for up to 30 days. Other data
indicate that paraquat has a half life of > 2 weeks in water
plus soil, is immobile in silt loam and silty clay loam and
slightly mobile in sandy loam soils. Adsorption of paraquat is
positively correlated with soil cation exchange capacity and is
not readily desorbed from soil organic matter and clay. Paraquat
does not leach except in sand and does not volatilize. Based on
the information available paraquat should not reach groundwater.
The paraquat degradate (QINA) is very loosely absorbed on the
organic matter/clay complex and, therefore, has a potential for
groundwater contamination. The additional data required are set
forth in Table A, Appendix I. Once these data are received, the
potential for groundwater contamination will be reevaluated.
In response to the groundwater data call in, the Agency was
referred to a number of existing studies, and additional studies
were received and reviewed by the Agency. The additional data,
however, resulted in the filling of only one additional data
requirement--photodegradation on soil.
Product Chemistry. The available data have been evaluated which
identify the ingredients, identify the materials and manufacturing
process and discuss the physical and chemical properties of the
technical grade of the active ingredient and the manufacturing-use
product. Specific data requirements have been identified and are
listed in the data table.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
Based on review and evaluation of all available data and other
relevant information on paraquat, the Agency has made the follow-
ing determinations. Where label revisions are specified, specific
language is set forth in Section D of this Chapter.
1. None of the risk criteria listed in 40 CFR 154.7 for initiat-
ing a special review have been met. Therefore, paraquat is
not being placed in special review at this time.
Rationale; After considering data submitted concerning acute
inhalation, subchronic toxicity, and chronic toxicity, the
Agency has determined that no reason exists for placement of
paraquat into special review status.
Although paraquat has been found to be an oncogen, as
discussed in the Agency Assessment section, the Agency does
not believe, at this time, that it meets the criteria requir-
ing a special review. The regulations provide that the
Administrator may conduct a special review if a pesticide
use "may pose a risk of inducing in humans an oncogenic . . .
effect, which is of concern in terms of either the degree of
risk to individual humans or the number of humans at some
risk."
After considering applicator exposure to paraquat, also
discussed in the Agency Assessment section, the Agency has
concluded that the risks posed by paraquat are not of con-
cern in terms of the magnitude of risk to the individual
applicators.
2. The Agency is continuing to require that an emetic cleared
under 40 CFR 180.1001(b) and (c) be incorporated into all
manufacturing use and end use products containing paraquat.
Rationale; Based on the history of poisoning by accidental
ingestion of paraquat and partial effectiveness of therapeutic
treatment after exposure, the Agency determined that an emetic
is needed in the formulations to induce rapid vomiting thereby
reducing absorption of paraquat.
3. The Agency is requiring that those products or formulations
already classified as "Restricted Use" and labeled with
worker safety rules maintain these label statements and
"Restricted Use" classification.
Rationale; The available acute oral, dermal, inhalation,
and ocular data indicate that the Toxicity Category for
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these formulations is I. Based on the high acute toxicity
to animals and people from intentional or inadvertent exposure,
those formulations were classified as "Restricted Use." The
Agency believes that the "Restricted Use" classification and
current precautionary labeling are necessary to continue to
protect mixer/loaders and applicators from effects of dermal
and inhalation toxicity.
4. The Agency has determined that the 0.276 percent paraquat
formulation available to the public on an unrestricted basis
will continue to be unrestricted.
Rationale: This formulation is Toxicity Category IV in
acute studies with rats and Toxicity Category III in acute
dermal and inhalation studies with rabbits. When used accord-
ing to the label directions, the formulation is not likely
to present a significant health hazard to humans.
5. The Agency will not require additional residue data on the
following raw agricultural commodities: carrots, potatoes,
turnips, onions, broccoli, cabbage, cauliflower, apricots,
peaches, strawberries, acerola, bananas, guava, mint hay,
safflower, oats, Chinese cabbage, collards, lettuce, rhubarb,
guar, lima beans, snap beans, cherries, plums, wheat, aspara-
gus, coffee beans, hops, papayas, sorghum grain, bean forage,
pea forage, apples, pears, nectarines, small fruits, almond
hulls, avocados, cottonseed, kiwifruit, passion fruit, sugar-
cane, sorghum forage, pistachios, and sunflower; the follow-
ing animal products: meat and fat of cattle, meat, fat and
meat by products of other livestock and milk; and the follow-
ing crop groupings: fruiting vegetables (except cucurbits,)
citrus fruits, and tree nut.
Rationale; The Agency has determined that the available
residue data adequately support the established tolerances
for these raw agricultural commodities and animal products.
6. The Agency is requiring additional residue data on the follow-
ing raw agricultural commodities: sugar beets, bean hay,
sweet corn, alfalfa, pineapple, range grass, rye, sugar beet
tops, pea hay, field corn, clover, figs, pasture grass,
turnip tops, cucurbit vegetables, corn forage and fodder,
trefoil, soybean forage, hay, and straw, sorghum silage and
hay, wheat hay and straw; meat byproducts of poultry, and
eggs; and on processed foods derived from the following raw
agricultural commodities: potatoes, sugar beets, tomatoes,
wheat, coffee beans, plums, figs, alfalfa, spent hops, olives,
pineapples, and sugarcane. Refer to Table A for details on
type of data required.
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Rationale; A review of the available data indicates that the
Agency does not have sufficient residue data to support the
established tolerances for paraquat on the above commodities.
7. The Agency requires residue data together with a petition
for establishing tolerances, if necessary, for cotton forage
and sugarcane forage. Alternatively, a statement may be
placed on the label restricting the grazing or feeding of
treated commodities. Each registrant will have 6 months to
notify the Agency which alternative it chooses. Refer to
Table A for details of residue data required.
Rationale: Review of the available data indicate that the
residue data are required to cover the possible transfer of
residue to animals from the feed items.
8. The Agency will require an increased tolerance of 0.1 ppm
for olives. Alternatively, a statement may be placed on the
label prohibiting application when olives on the ground are
to be harvested. Each registrant will have 6 months to
notify the Agency as to which alternative it has selected.
Rationale; The available residue data indicate that the 0.05
ppm tolerance level is too low because higher residues occur
in fruit which come in contact with the ground after treatment,
Increasing the tolerance for olives from 0.05 to 0.1 ppm
would increase the TMRC by only 0.04 percent which represents
a negligible increase in risk due to dietary exposure.
9. The Agency will not establish any new food/feed addition regu-
lations pursuant to Section 409 of the Federal Food, Drug and
Cosmetic Act (FFDCA) and is deferring action on previously
established food/feed additive regulations.
Rationale; The Delaney Clause in Section 409 of the FFDCA
bars the establishment of food/feed additive regulations for
substances which induce cancer in man or test animals, with
certain exceptions. The Agency is currently developing a
position relative to the Delaney Clause and FIFRA. Once
this policy has been established, the Agency will determine
what action is required in relation to pesticides which have
produced oncogenic responses in chronic animal studies.
10.
The Agency will propose the following technical changes in
the listing of paraquat tolerance.
a. The listings for "pea forage" and "bean forage" will be
changed to "pea hay" and "bean hay".
b. The listing for "small fruits" will be changed to read
"small fruits (excluding strawberries and cranberries)."
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c. The listing for "hop vines" will be deleted.
Rationale; The above changes are required because:
a. The terras "bean hay" and "pea hay" are currently used
instead of "bean forage" and "pea forage."
b. The existing tolerance for strawberries is 5 times that
for other small fruits and will be listed separately.
The use directions for cranberries vary significantly
from the use directions for the remaining small fruits.
c. The listing for "hop vines" is unnecessary because the
Agency has determined that hop vines are neither a raw
agricultural commodity nor an animal feed item.
11. The Agency will establish the following group tolerances if
requested by the registrants: Brassica leafy vegetables,
pome fruits,- and stone fruits.
Rationale: Available residue data on existing members of
the groups are adequate to support such group tolerances,
and the uses and tolerances are substantially similar as
required by 40 CFR 180.34(f).
12. The Agency has determined that the following group tolerances
cannot be set: root and tuber group, leaves of root and
tuber group, bulb vegetables, leafy vegetables (except
Brassica), legume vegetables, foliage of legume vegetables,
cereal grains, forage, fodder, hay and straw of cereal
grains and nongrass animal feeds.
Rationale; The reasons why group tolerances are not appro-
priate are described for each group in Table A, but include
the following: residue data are not available for designated
representative crops, use patterns are not sufficiently
similar, or maximum residues vary by a factor of more than 5.
13. The Agency is requiring that uses for paraquat on ground
cherry and garlic be deleted from the labeling of all end-use
products.
Rationale; The uses on ground cherry and garlic are not
supported by tolerances.
14. The Agency will require a label restriction for figs prohibit-
ing application when figs on the ground are to be harvested.
Rationale; The available data do not support the established
tolerance level of 0.05 ppm on figs because higher residues
were found in figs harvested from the ground.
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15. The following crops require label statements restricting
grazing or feeding of the treated crop or cover crop: barley
hay and straw, oat hay and straw, citrus crop grouping (cover
crop), tree nuts group (cover crop), avocado (cover crop),
figs (cover crop), guava (cover crop), and pistachios (cover
crop).
Rationale; A review of Agency files indicates that no data
exist to support tolerances necessary for grazing of listed
crops and cover crops.
16. The Agency is requiring that grazing restrictions be deleted
from product labels for the use patterns of range grass,
pasture grass, alfalfa, birdsfoot trefoil, clover, and
field corn.
Rationale: The Agency has determined that a grazing restric-
tion for these treated commodities is not practicable. This
change will not result in a significant increase in the
existing TMRC and thus will not appreciably increase the
risk to humans due to dietary exposure.
17. The Agency is not requiring a reentry interval for currently
registered uses of paraquat. The current reentry label state-
ments will continue to be required on all end-use fornmlations,
Rationale; The Agency has reviewed the available information
on the registered uses of paraquat and the cropping practices
in those crops. The potential for fieldworker exposure to
paraquat residues appears to be very low. That is, for the
current registered uses, agricultural practices in those
crops do not involve fieldworkers in prolonged, substantial
contact with pesticide treated surfaces. Therefore, the
Agency does not require submission of reentry data as detailed
in 40 CFR 158.140. The Agency reserves the right to require
such data in the future if a change in registration or
agricultural practices would cause substantial exposure for
field workers. The Agency has also determined that current
precautionary labeling and worker safety rules are adequate
to protect the mixer/loader/applicator from exposure.
18. The Agency is not requiring a groundwater advisory statement
for products containing paraquat.
Rationale: Available data indicate that paraquat is immobile
in silt loam and silty clay loam and slightly mobile in sandy
loam soils. Paraquat is not readily desorbed from soil and
does not leach in agricultural soils. There is a potential
for the QINA degradate to leach in soils because it is
loosely absorbed to organic matter and clay. Additional
data are required to further determine this potential.
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19. The Agency is requiring labeling to protect endangered
species for all end-use products used for treatment of
crops, rangeland, and pasture. This labeling is addressed
in PR Notices 87-4 and 87-5.
Rationale: Although available data and information on
habits of various species of animals indicate that paraquat
will not cause problems with stable wildlife populations,
its acute and subchronic toxicity may be hazardous to
unstable or endangered populations. Consultation with the
Office of Endangered Species (OES) indicated that these
populations may be in jeopardy in areas treated with paraquat,
20. While the data gaps are being filled, currently registered
manufacturing-use products and end-use products containing
paraquat as the sole active ingredient may be sold, distri-
buted, formulated, and used in the United States, subject
to the terms and conditions specified in this Standard.
Registrants must provide or agree to develop additional
data, as specified in the Data Tables, in order to maintain
existing registrations.
The Agency will issue registrations for substantially
similar products. New uses will be considered on a case-
by-case basis.
Rationale; Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the Agency does not normally cancel
or withhold registration simply because 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 identify-
ing data needs. These data will be reviewed and evaluated
and the Agency will determine if the data will affect the
registration of paraquat.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain paraquat 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
Product Composition Standard. To be registered or reregistered
under this Standard, manufacturing-use products (HP's) must
contain paraquat as the sole active ingredient. Each MP formula-
tion proposed for registration must be fully described with
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appropriate certification of limits, stating maximum and minimum
amounts of the active ingredient and inert ingredients which are
present in products, as well as impurities found at greater than
0.1 percent.
Acute Toxicity Limits. The Agency will consider registration of
technical grade and manufacturing-use products containing paraquat
provided that the product labeling bears appropriate precautionary
statements for the acute toxicity category in which product is
placed.
Use Patterns. To be registered under this Standard, manufacturing-
use products must must be labeled for formulation into end-use
products for registered uses, as listed in the Use Index, Appendix
III.
D. LABELING
All products must bear appropriate labeling as specified in 40
CFR 162.10. The labels of all products must also bear the appro-
priate disposal statements. See Appendix II for specific infor-
mation regarding label requirements.
In order to remain in compliance with FIFRA, no pesticide product
containing paraquat may be released for shipment by the registrant
after July 1, 1988, unless the product bears an amended label
which complies with the requirements of this Standard.
In order to remain in compliance with FIFRA, no pesticide product
containing paraquat may be distributed, sold, offered for sale,
held for sale, shipped, delivered for shipment, or received and
(having been so received) delivered or offered to be delivered
by any person after July 1, 1989, unless the product bears an
amended label which complies with the requirements of this
Standard.
In addition to the above, in order to remain in compliance with
FIFRA, the following information must appear on the labeling:
1. Ingredient Statement. The ingredient statement for HP's
must list the active ingredient as:
Paraquat dichloride, 1,1'-dimethyl-4,4*-
bipyridinium ion (% ai)
2. Use Pattern Statements. All manufacturing-use products
must state that they are intended for formulation into
end-use products for acceptable use patterns. However,
no use may be included on the label where the registrant
fails to agree to comply with the data requirements in
Table A for that use pattern.
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3. Precautionary Statements
Manufacturing-Use Products. Labels of all HP's must bear
the statement:
"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 an
National Pollutant Discharge Elimination System (NPDES)
permit. Do not discharge effluent containing this product
to sewer systems without previously notifying the sewage
treatment plant authority. For guidance contact your
State Water Board or Regional Office of EPA.
End-Use Products
a. All formulated EP's must bear the following statement:
"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."
b. Labels of all products classified for restricted use:
must bear the following statement:
"RESTRICTED USE PESTICIDE. 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 certi-
fication."
c. Labels of all products registered for use on oats and
barley must bear the following statement:
"Do not graze treated oats and barley to livestock.
Do not feed treated oats and barley to livestock."
d. Labels for all products registered for use on citrus,
tree nuts, avocados, guava, and pistachios must bear
the following statement:
"Do not graze treated areas. Do not feed cover
crops grown in treated areas to livestock."
e. Labels for all products registered for use on figs
must bear the following statements:
"Do not graze treated areas or feed cover crops
grown in treated areas to livestock."
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"Do not apply paraquat when figs to be harvested
are on the ground."
f. The use for ground-cherry and garlic, and the grazing
and feeding restriction for the use patterns of range
grass, pasture grass, alfalfa, birdsfoot trefoil, clover,
and field corn must be deleted from product labels.
g. All end-use products labeled for use on agricultural
crops must bear the following statements:
"Worker Safety Rules/Reentry Statements
"USE STRICTLY IN ACCORDANCE WITH DANGER STATEMENTS
AND DIRECTIONS, AND WITH APPLICABLE STATE AND FEDERAL
REGULATIONS.
"DO NOT get on skin, eyes or clothing. DO NOT inhale
spray mist. WASH SPLASHES from skin and eyes immed-
iately. REMOVE and wash contaminated clothing.
WASH before eating, smoking and drinking. WEAR full
face shield, rubber gloves, apron and waterproof
footwear when handling or mixing concentrate. WEAR
waterproof footwear and clothing when spraying or
when contacting vegetation wet with spray.
"DO NOT enter treated areas without protective clothing
until sprays have dried. AVOID working in spray
mist. If there is risk of exposure wear goggles and
approved face mask capable of filtering spray
droplets.
"KEEP all unprotected persons out of operating areas
or vicinity where there may be danger of drift.
Certain states may require more restrictive reentry
intervals; consult your State Department of Agriculture
for further information. Written or oral warnings
regarding use of protective clothing and accidental
exposure must be given to workers who are expected
to be in treated areas or in areas about to be treated.
"IMPORTANT: The effect of swallowing paraquat is
more severe than the effect from skin contact or
from inhaling spray mist. This product should not
cause injury if used according to label instructions.
Follow the label as if your life depends on it."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and fi2.
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confiden-
tial Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data requirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eligible for the formulator's exemption, the
data requirements listed in Table C.
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 registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, fornmlate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.^
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timefrarae. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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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 Formulator1s Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
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 yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost oT
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.
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The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI.EPA has determined that,
as a general policy,it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for 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:
40
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[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data,
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed.You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed"!
41
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E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for 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
42
-------
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to. requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
43
-------
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.
44
-------
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data 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.
45
-------
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 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 seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
46
-------
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(1)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. 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
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.)
47
-------
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combinationwith other active ingredients.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
48
-------
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. 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).
D. Intrastate Products containing the subject pesticide either
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.
E. Addresses
The required information must be submitted to the following
address:
Robert J. Taylor (PM 25)
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.
49
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APPENDIX I
DATA TABLES
50
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 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
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table,
51
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The terra 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.
52
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE TECHNICAL
Guideline Citation and Name of Test
Test
Substance1/
Guidelines
Status1/
Are Data
Required
Yes No
Footnote
Number
Data Must Be
Submitted Within
Timeframe
Listed Below^/
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI
TGAI
TGAI
TGAI
R
CR
M EX]
m O
[X] [~]
[X]
[ J
TGAI
TGAI
TGAI
TGAI
TGAI
R
R
R
R
R
[X]
[XI
[X]
[X]
[X]
u
[J
o
o
[~]
3, 4
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT BICHLORIDE TECHNICAL
Guideline Citation and Name of Test
Test
Substance1 /
Guidelines
Status1/
Data Must Be
Are Data Footnote Submitted Within
Required Number Timeframe
Yes No Listed Below^/
§158.120 Product Chemistry (cont'd)
Physical and Chemical Characteristics (cont'd)
63-7
63-8
63-9
63-10
63-11
n
>•
63-12
63-13
Other
64-1
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/Water Partition
Coefficient
-pH
- Stability
Requirements
- Submittal of Samples
TGAI
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
TGAI, PAI
R
R
R
R
R
R
R
CR
©
©
o
o
o
©
©
o
o
o
|_ A.J
r XT'!
[_ A.J
©
O
o
©
6 Months
6 Months
6 Months
6 Months
_!_/ TGAI = Technical Grade of the Active Ingredient (the Agency considers the TGAI to be the dried technical salt).
PAI = Pure Active Ingredient; R = Required; CR = Conditionally Required.
2J Data must be submitted within the indicated tiraeframe based on the date of the Guidance Document.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE TECHNICAL
§158.120 Product Chemistry (cont'd)
3/ Details of the manufacturing process including the relative amounts of beginning materials; a description of the equipment
used to produce the product reaction conditions; the duration of each step of the process; purification procedures; and
quality control measures are needed.
bj The name and address of the manufacturer, producer, and supplier of each beginning material used to manufacture technical
are needed.. Also, a copy of all available technical specifications, data sheets, and other documents in which the
manufacturer, producer, or supplier of the beginning material describes its composition and properties must be submitted.
j>/ A discussion of each impurity believed to be present at >_ 0.1%, based on knowledge of beginning materials, possible
chemical reactions, and any contamination present, is required.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity present at
> 0.1% (w/w) using valid analytical methods.
Ln
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT BICHLORIDE
Data Requirements
Compositi
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Hist Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission^/
§158.125 Residue Chemistry
171-2 - Chemical Identity
171-3 - Directions for Use
171-4 - Nature of Residue (Metabolism)
- Plants
TGAI
PAIRA
Yes
Yes
Yes
Ln
- Livestock
PAIRA and Plant
Metabolites
Yes
171-4 - Residue Analytical Method
- Plant residues
TGAI and Metabolites
Partially
- Animal residues
TGAI and Metabolites
Partially
00113684 00113715
Registered Label
00065602 00091378
00065604 00114411
00091365 00114414
00091366
00028596 00089748
00028597 00114414
00028598 00114422
00028599 00117783
00025269
00030476
00032141
00032240
00037058
00090400
00112663
00114411
00114421
00114446
00114453
00114465
00114466
00138258
00162742
00162743
00036306 00114421
00037058 00114422
00112663
No
No
No
No3/
Yes4/ 24 Months
Yes5/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission2/
en
-j
§158.125 Residue Chemistry (cont'd)
171-4 - Storage Stability Data PAI
171-4 - Magnitude of Residue—Residue
Studies for Each Food Use
- Root and Tuber Vegetables
Group?/
- Carrots TEP
- Potatoes TEP
f
- Potato chips EP
- Potato granules EP
- Potato (dried) EP
- Sugar beet roots TEP
- Processed sugar beets EP
(dehydrated pulp, molasses,
and sugar)
- Turnip roots TEP
- Leaves of Root and Tuber
Vegetables Group11/
Partially
Yes
Yes
No
No
No
Partially
No
Yes
00037057 00113702 Yes6/ 15 Months
00030476
00033612
00091376
00105060
00113709
00030476
No
No
Yes8/ 24 Months
Yes8/ 24 Months
Yes8/ 24 Months
Yes9/ 24 Months
Yes10/ 24 Months
No
- Sugar beet tops
TEP
Partially
00113709
Yes12/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data
§158.
00
Requirements
125 Residue Chemistry (cont'd)
- Turnip tops
- Bulb Vegetables Group1 V
- Onions
- Leafy Vegetables (except
Brassica vegetables) Group1
- Lettuce
- Rhubarb
- Brassica Leafy Vegetables
Group16/
- Broccoli
- Cabbage
- Cauliflower
- Chinese Cabbage
- Col lards
- Legume Vegetables Group 1^/
- Beans (succulent, lima,
and snap)
Composition1/
TEP
TEP
V
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Partially
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Bibliographic
Citation
00030476
00113680
00136330
00114474
00139741
00031863
00103245
00030476
00030476
00030476
00030476
00030476
00033223
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission^/
Yes13/ 24 Months
No
No
No
No
No
No
No
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission2/
§158.125 Residue Chemistry (cont'd)
- Guar TEP Yes 00114420
- Peas (succulent) TEP Yes 00030476
- Soybeans TEP Yes 00015768
00015769
00015770
00015771
00015772
£ 00015773
00015774
00015775
- Soybean hulls EP Yes 00015768
00015769
00015770
00015771
00015772
00015773
00015774
00015775
t
00025268
- Foliage of Legume Vegetable
Group20/
- Bean vines and hay TEP Partially 00030476
00033223
No
No
00025268 No18/
00030676
00031742
00032427
00033530
00034112
00098579
00109728
00114446
00030676 No19/
00031742
00032427
00033530
00034112
00098579
00109728
00114446
Yes21/ 24 Months
- Pea vines and hay
TEP
Partially
00030476
Yes22/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
CompositionV
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)7
Timeframe for Data
Submission2/
§158.125 Residue Chemistry (cont'd)
- Soybean forage and hay
Fruiting Vegetables (except
cucurbits) Group2V
- Processed tomatoes (wet and
dry pomace, puree, catsup,
and juice)
- Cucurbit Vegetables Group
- Citrus Fruits Group
- Pome Fruits Group28/
- Apples
TEP
Partially
TEP
EP
TEP
TEP
Yes
No
Partially
Yes
TEP
Yes
00015768 00025268 Yes23/ 24 Months
00015769 00030676
00015770 00032427
00033530
00034112
00098579
00109728
00015771
00015772
00015773
00015774
00015775
00030476
00033223
00059596
00027988
00030476
00033223
No
Yes25/ 24 Months
Yes26/ 24 Months
00023329 00070779 No27/
00027298 00070780
00033695 00113821
00035665
00033695
00035664
00070779
00113821
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No/ or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission2/
§158.125 Residue Chemistry (cont'd)
- Pears
- Stone Fruits Group29/
- Apricots
o>
- Cherries
- Nectarines
- Peaches
TEP
Yes
TEP
TEP
TEP
TEP
Yes
Yes
Yes
Yes
- Plums
- Dried prunes
Small Fruits and Berries
Group31/
TEP
EP
TEP
Yes
No
Yes
00033695
00035664
00113821
00035663
00113821
00023329 00033695
00027965 00113821
00035663
00113821
00023329
00023883
00027695
00033035
00033694
00033695
00035663
00070780
00070784
00113709
00113821
00023329 00035663
00033035 00113709
00033695 00114436
00023329 00113709
00023883 00113821
00027968 00114411
00033695 00138258
00070780
No
No
No
No
No
No
Yes30/ 24 Months
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PARAQUAT BICHLORIDE
Data Requirements
Composition^/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission^/
§1
58.125 Residue Chemistry (cont'd)
- Tree Nuts Group32/ TEP
Yes 00023329
00023883
00027971
00030929
00033695
00035666 No
00070780
00113821
GS0262-004
N5
Cereal Grains Group33/
- Barley grain
- Corn, field and fresh
(including sweet kernels,
plus cob with husks removed)
TEP
TEP
Yes
Partially
00114411
No
00015751 00023512 Yes34/ 24 Months
00015752 00030647
00015955 00030683
00016441 00031744
00016442 00033223
00016444 00093182
00016445 00114426
00023131
- Corn milled products
EP
Partially
Oat Grain
- Oat milled products
TEP
EP
Yes
No
00015751
00015752
00015955
00016441
00016442
00016444
00016445
00023131
00114411
00023512
00030647
00030683
00031744
00033223
00093182
00114426
Yes35/ 24 Months
No
No36/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B>?
Timeframe for Data
Submission2/
§158.125 Residue Chemistry (cont'd)
- Rice Grain37/
- Rye Grain
- Sorghum Grain
OJ
TEP
TEP
- Sorghum milling fractions
(except flour)
- Wheat Grain
EP
TEP
- Wheat milled fractions EP
- Forage, Fodder, Hay, and Straw
of Ceral Grains Group41/
- Barley hay and straw TEP
- Corn forage, silage, and fodder TEP
No
Yes
Partially
Yes
No
Partially
Partially
00023131 00070872
00026963 00113709
00027178 00114421
00033223
00114421
00027311
00113693
00114411
00140828
Yes38/ 24 Months
No
Yes39/ 24 Months
No
Yes40/ 24 Months
00114411
00015751
00015752
00015955
00016441
00016442
00016444
00016445
00023131
00023512
00027972
00027973
00030647
00030683
00031519
00031744
00033208
00033223
00093182
No42/
Yes43/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PARAQUAT BICHLORIDE
Data Requirements
Compositionl/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission^/
§158.125 Residue Chemistry (cont'd)
- Oat hay and straw
- Rice strawA5/
- Sorghum forage, fodder,
silage, and hay
- Wheat hay, and straw
Grass Forage, Fodder, and
Hay Group
TEP
TEP
TEP
TEP
Nongrass Animal Feeds (Forage,
Fodder, Straw, and Hay) Group49/
- Alfalfa
TEP
- Alfalfa meal
Birdsfoot Trefoil
Clover
EP
TEP
TEP
Partially
Partially
Partially
Partially
Partially
No
Partially
Partially
00114411
00026963
00027178
00070872
00027311
00114411
YesW 24 Months
Yes47/ 24 Months
00033223 00114466 Yes*8/ 24 Months
00058773 00117783
00114424
00032140 00114464 YesSO/ 24 Months
00058774 00114465
00105061 00114467
00114405 00126671
00114421 00128624
00114424
00114424
00114424
00117783
Yes51/ 24 Months
Yes52/ 24 Months
Yes53/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements Composition1/
§158.125 Residue Chemistry (cont'd)
- Crown Vetch54/
- Miscellaneous Commodities
- Acerola TEP
- Asparagus TEP
m - Avocados TEP
- Bananas TEP
- Coffee beans TEP
- Processed products (roasted EP
beans and instant coffee)
- Cottonseed TEP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Yes
Yes
Yes
Yes
Yes
No
Yes
Bibliographic
Citation
00128221
00033532
00113675
GS 0262-006
00113709
00139733
00139734
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Time frame for Data
Submission^/
No
No
No55/
No
No
Yes56/ 24 Months
00031739
00033612
00091372
No
- Cotton forage
- Figs
- Dried figs
- Guava
TEP
TEP
EP
TEP
No
Partially
No
Yes
00139735
00114419
Yes57/ .24 Months
Yes58/ 24 Months
Yes59/ 24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
§158.125 Residue Chemistry (cont'd)
- Hops
- Hop Vines
- Spent Hops
- Hops (dried)
- Kiwifruit
ON
ON
- Mint hay
- Spent Mint Hay
- Olives
- Olive Oil
- Papaya
- Passion Fruit
- Pineapple
- Pineapple Forage
- Pineapple Juice
- Pineapple Bran
Compos iti on V
TEP
TEP
EP
EP
TEP
TEP
EP
TEP
EP
TEP
TEP
TEP
TEP
EP
EP
Does EPA Have Data
To Satisfy This
Requirement? (Yes/
No, or Partially)
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
No
No
Bibliographic
Citation
00113686
00113686
-
00113686
00088195
00137859
00137859
00139737
-
00033695
00037056
00114411
00114411
-
_
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission2/
No
No61/
Yes62/ 24 Months
No63/
No
No
No
No6*/
Yes65/ 24 Months
No
No
No66/
No6?/
Yes68/
Yes68/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Does EPA Have Data Must Additional Data
To Satisfy This Be Submitted Under
Requirement? (Yes, Bibliographic FIFRA §3(c)(2)(B)?
Data Requirements Compos it ion V No, or Partially) Citation Timeframe for Data
Submission^/
§158.125 Residue Chemistry (cont'd)
- Pistachios
- Saf flower Seed
- Sugarcane
- Sugarcane Forage
- Sugarcane bagasse
- Sugarcane juice
- Sugarcane molasses refined sugar
- Sunflower Seed
- Sunflower meal
- Sunflower seed hulls
171-4 _ Magnitude of Residues
in Meat, Milk, Poultry, and Eggs
- Milk
TEP
TEP
TEP
TEP
EP
EP
EP
TEP
EP
EP
TGAI or Plant
Metabolites
Yes
Yes
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
00027550 No69/
00113699
00114411 No
00114411 No
00114469
Yes70/ 24 Months
00114411 No7V
00114469
00114411 No7V
00114469
Yes72/ 24 Months
00106570 No
00114422
00106570 No73/
001 06570 No7V
00090978 No
00114414
00114422
00117783
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission2/
§158.125 Residue Chemistry (cont'd)
- Meat, Fat, and Meat Byproducts
of Pigs
- Meat and Fat of Cattle
oo
- Meat Byproducts of Cattle
- Meat, Fat, and Meat Byproducts
of Poultry
- Eggs
TGAI or Plant
Metabolites
TGAI or Plant
Metabolites
TGAI or Plant
Metabolites
TGAI or Plant
Metabolites
Yes
Yes
No
No
Partially
00036305
00114414
00114422
00117783
00090978
00114414
00114422
00117783
00038503
No
No
Yes75/ 18 Months
Yes76/ 18 Months
Yes76/ 18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT BICHLORIDE
§158.125 Residue Chemistry - (cont'd)
\J Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TEP =
Typical end-use product; EP = End-use product.
2J Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
3/ If the toxicology review concludes that any of the metabolites, occurring in animals along with paraquat, are of
concern, additional methodology as well as revision of the tolerance regulation for meat, milk, poultry, and eggs
will be required.
4/ Current methodology is acceptable for obtaining residue data but is only minimally adequate for enforcement/monitoring
purposes due to the fact that it is too long and cumbersome. The length of procedure is caused by long digestion times,
use of ion-exchange columns, and the fact that the determination step is colorimetric. New methodology is required
which allows faster determination of paraquat in raw agricultural commodities and food.
5/ If review of the toxicology information conclude that metabolites occurring in animals are of toxicological significance
additional methodology including validation data and sample chromatograms, as well as completion of a successful method
trial for the metabolites of concern, will be needed.
6/ No data are available concerning the storage stability of paraquat residues in animal commodities. The following data
are required:
o Data reflecting the stability of paraquat residues of concern in animal tissues stored at freezing temperatures for
time intervals approximately those of the samples of animal tissues and products from treated animals used in
animal feeding studies to determine the magnitude of the residue.
o All residue data requested in this Standard must be accompanied by data regarding storage length and conditions
of storage of samples analyzed. These data must be accompanied by data depicting the stability of residues under the
conditions and for the time intervals specified.
TJ A crop grpup tolerance is not appropriate at the present time for the following reasons:
o No data were submitted for radishes, a representative commodity of this group.
o The established tolerances for commodities of this group differ by a factor of more than 5X, the tolerances
on carrots and turnip roots are 0.05 ppm, and the tolerances on sugar beet roots and potato tubers are 0.5 ppm.
o The registered uses for the representative commodities differ significantly, preharvest desiccation applications
are permitted on potatoes but not in carrots or sugar beets or turnips; the maximum rate of treatment for the
preplant/preemergence application on potatoes is 0.5 cat ion/A while on carrots and sugar beets it is 1 Ib cation/A.
8/ Data are required depicting residues in granules, chips, and dried potatoes processed from tubers bearing measurable
weathered residues. If residues are found to concentrate upon processing, appropriate food/feed additive regulations
would be required; final disposition of food/feed additive regulations would be dependent upon the Agency's position
regarding Delaney Clause issues.
VO
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.125 Residue Chemistry - (cont'd)
9/ Data are required depicting residues in or on sugar beet roots resulting frcm a preemergence application at
1 Ib cation/A. Tests must be conducted in CA, ID, MM, ND.
10/ Data are required depicting residues in the processed products of sugar beets (dehydrated pulp, molasses, and sugar) from
beets bearing measurable weathered residues. An exaggerated rate of application may be necessary to obtain measurable
residues in the raw agricultural commodity. If residues are found to concentrate in the processed products, appropriate
food/feed additive regulations would be required; final disposition of food/feed additive regulations would be dependent
upon the Agency's position regarding Delaney Clause issues.
11 / A crop group tolerance is inappropriate at the present time for the following reasons:
o The established tolerances for the representative commodities of this group differ by more than a factor of 5, the
tolerance for sugar beet tops is 0.5 ppm, and the tolerance for turnip tops is 0.05 ppm.
o Additional data are required to support existing tolerances for paraquat residues in or on sugar beet tops.
12/ Data are required depicting residues in or on sugar beet tops resulting from a" preeaiergence application a 1 Ib cation/A.
Tests must be conducted in MM, CA, ID, and ND.
13/ Data are required depicting residues in or on turnip tops resulting from a preeaiergence application of the
2 Ib/gal soluble concentrate (SC/L) formulation at 1 Ib cation/A. Test must be conducted in AL or GA, AZ or CA,
FL, TN, and TX.
14/ A group tolerance is not appropriate at the present time because data on representative commodities other than onions
are not available.
15/ A group tolerance is not appropriate at the present time because data on representative commodities other than lettuce
are not available.
16/ Adequate data are available for the representative commodities broccoli and cabbage. Adequate data are also available
for collards, a commodity considered a suitable substitute for the representative commodity mustard greens. Since
the registered usage on these crops is identical, a crop group tolerance of 0.05 ppm would be acceptable.
17/ A crop group tolerance is not appropriate at the present time for the following reasons:
o There are no established tolerances for dry beans and peas, a tolerance is pending for dry beans.
o The use directions differ significantly among commodities: preplant/preemergence applications are not permitted on
greens, postemergence directed spray applications are permitted only on guar and soybeans, but the registered rate
on guar is 2X the registered rate on soybeans.
o Data in support of a proposed tolerance on pigeon peas are currently under review.
1_8/ The available data do not support the established 0.05 ppm tolerance for paraquat residues in or on soybeans following
registered preharvest desiccation use of the paraquat formulations. Based on the submitted data it is recommended
that the tolerance for paraquat residues be increased to 0.25 ppm.
1_9/ The available data demonstrate that residues may concentrate in the processed commodity hulls by a factor 11.2X,
therefore, based on a recommended tolerance of 0.25 ppm, a food/feed additive regulation of 3.0 ppm is indicated
for residues in hulls. Final disposition of this food/feed additive regulation is dependent upon the Agency's
position regarding Delaney Clause issues.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
1158*125 Residue Chemistry - (cont'd)
20/ A crop group tolerance is inappropriate at the present time for the following reasons:
o Additional data are required to support existing tolerances for paraquat residues in or on bean hay, pea hay, and
soybean forage.
o Use directions differ significantly among commodities; posteraergence directed spray and harvested aid applications
are permitted only on soybeans.
21 / Data are sufficient to ascertain the adequacy of the estabished tolerance of residues of paraquat cation in or on bean
forage, but not the established tolerances for residues in or on bean hay because no data were submitted concerning
bean hay. The 40 CFR entry "bean forage" must be amended to "bean vines." The following data on bean hay are required.
o Data depicting residues of paraquat cation in or on bean hay resulting from a single preemergence ground application
of the 2 Ib/gal SC/L formulation at 1 Ib cation/A. Tests must be conducted in WI, NY, OR, and FL.
2_2/ The available data are adequate to support the established tolerance for residues of paraquat in or on pea forage.
The 40 CFR entry of "pea forage" should be amended to the appropriate commmodity definition "pea vines." No data
were submitted concerning residues in or on pea hay. Thus, data must be submitted depicting residues in or on pea
hay resulting from a single preemergence application of the 2 Ib/gal SC/L formulations at 1 Ib cation/A. Test must be
conducted in WI, WA, and MN.
23/ The following data are required:
o Data depicting residue in or on soybean forage and hay treated preemergence with the 2 Ib/gal SC/L formulation
at 1 Ib cat ion/A. Tests must reflect both ground and aerial applications. Forage and hay must contain ^-75%
and 20% moisture, respectively, at the time of analysis. Tests must be conducted in IL, IA, IN, MO, MN,
OH, and MS.
o Data depicting residues of concern in or on soybean forage (harvested from both indeterminate and determinate
varieties) collected on the day of and 5, 10, and 15 days following a preharvest desiccation with the 2 Ib/gal
SC/L formulation at 2 Ib cation/A using ground and aerial equipment. Determinate varieties must be treated when
soybeans are fully developed and indeterminate varieties must be treated when seed moisture is < 30%. Tests must
be conducted in the major soybean production areas identified above.
o Appropriate tolerances for paraquat residues in or on soybean hay and straw must be proposed and the existing
tolerances for residues in or on soybean forage must be revised based on the above-requested data.
24/ The data are sufficient to support the established tolerance for residues in or on the members of the fruiting
vegetables (except cucurbits) group.
25/ Data are required depicting residues in the commodities wet and dry pomace, puree, catsup, and juice processed from
tomatoes bearing measurable weathered residues. If residues are found to concentrate in any of the processed
commodities, appropriate food/feed additive regulation would be required. However, final disposition of food/feed
additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
-------
TABLE A
GENERIC MTA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158*125 Residue Chemistry - (cont'd)
26 / Data are required depicting residues in or on the representative commodities of the cucurbit vegetables group; cucumbers
melons (cantaloupe or rauskmelon), and summer squash treated with 2 Ib/gal SL/C formulation preplant at 1 Ib cation/A;
preanergence at 1 Ib cation/A; and with multiple postemergence directed spray applications at 0.5 Ib cat ion/A up
to a day prior to harvest. Samples must be harvested 24 hours after the last postemergence directed spray application.
Tests must be conducted in CA. Alternatively, the registrant may request cancellation of the SLN registration
held by CA (CA-830054).
27/ The data are adequate to support the established tolerances for residues of paraquat in or on citrus fruits group.
No additional data are required. However, the grazing restrictions must be expanded to prohibit the feeding
of cover crops grown in treated areas to livestock.
287 The data for apples and pears are adequate to support the established 0.05 ppm tolerances for residues of paraquat
cation in or on these commodities. Since the registered uses for paraquat formulations on apples and pears are
identical, the crop group tolerance of 0.05 ppm would be acceptable for all members of the pome fruits group
provided that the grazing restriction for all pone fruits is expanded to prohibit the feeding of cover crops grown
in treated areas to livestock. ,
29/ The data are adequate to support the established tolerances for paraquat on the representative commodities peaches,
cherries, and plums. Since registered usage on these crops is identical, a crop group tolerance of 0.05 ppm would
be acceptable provided the grazing restriction for all stone fruits is expanded to prohibit the feeding of cover
crops grown in treated areas to livestock.
30/ Residue data must be submitted for dried prunes processed from fresh plums bearing measurable weathered residues.
If residues are found to concentrate in dried prunes, an appropriate food additive regulation would be required.
However, final disposition of food/feed additive regulations is dependent upon the Agency's position regarding
Delaney Clause issues.
31/ The 40 CFR 180.205 entry "small fruit" is to be amended to read "small fruit (except strawberries and cranberries)."
The specific use directions and limitations for cranberries should be established or cranberries should be specifically
excluded from the tolerance (for residues in or on small fruit) and use directions. In the original petition, the
use directions were different than for other berries.
32/ The grazing restriction for nuts must be expanded to prohibit the feeding to livestock of cover crops grown in
treated areas.
33/ A group tolerance is not appropriate at the present time because additional data are required to support existing
tolerances for paraquat residues in or on field corn and sweet corn (kernels plus cob with husks removed).
NJ
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.125 Residue Chemistry - (cont'd)
34/ The following data are required to support the tolerances on field corn and sweet corn:
o Residue data for field corn grain harvested at normal maturity (~70-89% dry matter) following two
postemergence, directed spray applications, the first in early July, and the second in August, with the
2 Ib/gal SC/L formulation at 0.5 Ib cation/A application. These data will satisfy requirements for postemergence
use of paraquat for witchweed eradication and the postmergence use for control of annual broadleaf weeds and
grasses. Tests must be conducted in IA, IL, NE, and OH.
o Residue data for sweet corn (kernels plus -cob with husks removed) harvested 60 to 80 days after a single
preemergence broadcast spray application with the 2 Ib/gal SC/L formulation at 1 Ib cation/A and, in separate tests,
after a single postemergence, directed spray application with the SC/L at 0.5 Ib cation/A. Tests must be conducted
in CA (11%), FL (34%), NY, MN, WI, and OR or WA.
35/ An additional processing study is required in which field corn grain bearing detectable weathered residues of
paraquat is processed into oil (crude and refined) and milled products. Exaggerated rates may be necessary to
obtain detectable residues in or on grain. If residues are found to concentrate, a food/feed additive regulation
would be required. However, final disposition of food/feed additive regulations is dependent upon the Agency's
position regarding Delaney Clause issues.
36/ No data depicting residues in processed products were submitted, however, data requested for wheat milled
products will be translated to oats.
37/ The available data for rice grain are currently under review, therefore, the adequacy of the proposed tolerance
cannot be made at the present time.
38/ There are no data to assess the adequacy of the tolerance for paraquat residues in or on rye grains. A use for
paraquat on rye and supporting data must be submitted. Alternatively, the tolerance for paraquat residues in
or on rye grain will be deleted from the 40 CFR.
39y An additional processing study is required in which grain sorghum bearing detectable, weathered residues resulting
from presently registered uses of paraquat is processed into milled products and flour. Exaggerated rates may be
necessary to obtain detectable residues in or on grain. If residues are found to concentrate, a food/feed additive
regulation would be required. However, final disposition of food/feed additive regulations is dependent upon the
Agency's position regarding Delaney Clause issues.
The following data on wheat processed products are required:
o Wheat grain bearing measurable weathered residues of paraquat must be processed into milled products. Exaggerated
rates may be necessary to obtain residues in or on grain. If residues are found to concentrate, a food/feed
additive regulation would be required. However, final disposition of food/feed additive regulations is dependent
upon the Agency's position regarding Delaney Clause issues.
u>
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.125 Residue Chemistry - (cont'd)
41 / A crop group tolerance is not appropriate at the present time for the following reasons:
o Additional residue data are required to support currently established tolerances for corn forage and fodder.
o Data and tolerance proposals must be submitted for residues in or on barley hay and straw, corn silage, and
hay and straw, sorghum silage and hay, and wheat hay and straw.
42/ No additional data are needed for barley hay and straw because the requested data for wheat hay and straw (when
received) will be translated to barley.
43/ The following data are required:
o Residue data for field corn forage, fodder, and silage treated preplant/preemergence with the 2 Ib/gal SC/L
formulation at 1 Ib cation/A and postemergence by directed spray (once in July and once in August) with the same
formulation at 0.5 Ib cation/A/application. Samples must be collected on the day of final treatment and at regular
intervals thereafter to determine the necessity of the PHI following postemergence directed spray treatments.
Tests must be conducted in IA, MI, MN, NE, NY, or PA and WI. An approximate tolerance for paraquat residues in
or on corn silage must be proposed and the existing tolerance on fodder and forage revised.
o Residue data for sweet corn forage treated preplant/preemergence with the 2 Ib/gal SC/L formulation at 1 Ib cation/A.
Tests must be conducted in CA, FL, and NE, MN, WI, and OR or WA.
o The label directions for postemergence directed spray treatment of field corn must be modified by deleting the
currently posted feeding and grazing restrictions.
44/ No additional data are needed for oat hay and straw because the requested data on wheat hay and straw (when received)
will be translated to oats.
45/ A conclusion regarding the adequacy of the proposed tolerance cannot be made at the present time: the available data
are currently under review.
46/ Data supporting the proposed preharvest aid use and tolerance for paraquat residues on sorghum fodder are currently
under review and will not be assessed at this time. A tolerance of 0.05 ppm exists for paraquat residues in or on
sorghum fodder. Tolerances for residues in or on silage and hay must be proposed based on the following required
data:
o Data reflecting residues in or on sorghum silage and hay harvested at normal maturity after a single preplant or
preemergence application with the 2 Ib/gal SC/L formulation at 1 Ib cation/A and a postemergence directed spray
treatment with the same formulation at 0.5 Ib cation/A. Tests must be conducted in GA, KS, SD and NM, or TX.
47/ The following additional data are required:
o Residues in or on wheat hay and straw harvested at normal maturity following a single preemergence broadcast spray
application with the 2 Ib/gal SC/L formulation at 1 Ib cation/A. Tests must be conducted in KS, ND, and OK.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
$158.125 Residue Chemistry - (cont'd)
48/ The following additional data are required:
o Data depicting residues in or on forage and hay from pastures treated broadcast with the 2 Ib/gal SC/L formulation
at 0.5 Ib cation/A. In areas east of the Rocky Mountains, tests conducted in TX, KY, NY, TN, AL and SD, and samples
must be harvested 30 days posttreatment. In areas west of Cascade and Sierra Nevada Mountains, tests must be
conducted in CA and OR or WA, and samples must be taken when growth has reached 3-6" height. A tolerance must be
proposed for hay based on the results of the requested data, or a label restriction against the cutting treated grass
must be proposed. (Note: The pending 60 ppm tolerance level may be acceptable.)
o Data depicting residues in or on forage and hay from rangeland treated broadcast with 2 Ib/gal SC/L formulation at
0.5 Ib.cation/A. Samples must be harvested the day of application. Tests must be conducted in the States cited
above for areas west of the Rocky Mountains and areas west of the Sierra Nevada and Cascade Mountains. Tolerances
must be proposed for grass forage and hay based on the requested studies.
49/ A crop group tolerance is inappropriate at the present time for the following reasons:
o Additional data are needed for alfalfa and clover, the representative commodities of this group.
50/ The following additional data are needed:
o Residues in or on alfalfa forage, seed and hay from pasture and rangeland treated broadcast with the 2 Ib/gal SC/L
formulation at 0.5 Ib cation/A. Samples must be harvested the day of application. Tests must be conducted in the
major alfalfa growing regions of the country, including WI, CA, NE, PA and NC.
Tolerances must be proposed for alfalfa forage, seed and hay, based on the results of the requested studies.
(Note: The pending 60 ppm tolerance level may be acceptable.)
51/ The following data are needed for alfalfa meal:
o Residue^data with meal processed from alfalfa bearing measurable weathered residues. If residues are found to
concentrate in meal, an appropriate food/feed additive regulation would be required. However, final disposition
of food/feed additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
52/ The following data are required:
o Data depicting residues in or on birdsfoot trefoil from pasture and rangeland treated with the 2 Ib/gal SC/L
formulation at 0.5 Ib cation/A. Samples must be harvested the day of application. Tests must be conducted in MI
and WI. Tolerances must be proposed for forage and hay based on the results of the requested studies. (Note: The
pending 60 ppm tolerance level may be acceptable.)
53/ The following data are required:
o Data depicting residues in or on clover from rangeland treated with the 2 Ib/gal SC/L formulation at 0.5 Ib
cation/A. Samples must be harvested the day of application. Tests must be conducted in TX (13%), MO (11%),
KY, NY, and OR.
Tolerances must be proposed for residues in or on clover forage and hay based on the required data. (Note:
The pending 60 ppm tolerance level may be acceptable.)
54/ Since the tolerance for crown vetch is pending, no conclusions will be made at this time.
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TABLE A
GENERIC DATA REQUIREMENTS FDR PARAQUAT DICHLORIDE
§158.125 Residue Chemistry - (cont'd)
55/ No further data are needed for avocados provided that the grazing restriction is expanded to prohibit the
feeding of cover crops grown in treated areas to livestock.
56/ The following data are needed for processed coffee products:
o Residues of concern must be determined in roasted beans and instant coffee fron beans bearing measurable weathered
residues. If residues concentrate in either of these processed products, an appropriate food additive regulation
would be required. However, final disposition of food/feed additive regulations is dependent upon the Agency's
position regarding Delaney Clause issues.
57/ Data are required depicting residues in or on cotton forage harvested 15 days after preharvest desiccation application
of 2 Ib/gal SC/L formulation at 0.5 Ib cat ion/A. Tests must be conducted in AZ, CA, MS, and TX. Alternatively, a
label restriction may be proposed against the foraging of livestock in treated areas.
58/ Based on available data a tolerance of 0.3 ppm must be proposed for figs or the following data are required:
o Data reflecting paraquat residues on figs caught in ground nets or picked from trees after the last of several
directed spray applications with the 2 Ib/gal formulation at 1 Ib cation/A application. Also, the label restriction
against application when figs to be harvested are on the ground is required. The grazing restriction must be
expanded to prohibit the feeding of cover crops grown in treated areas to livestock.
59/ The following data are needed on processed figs:
o Data from processing studies reflecting residues of concern in or on dried figs must be submitted. Fresh
figs used for drying must exhibit measurable weathered residues. If residues are found to concentrate following
processing, an appropriate food additive regulation would be required. However, final disposition of food/feed
additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
60/ The grazing restriction must be expanded to prohibit the feeding of cover crops grown in treated areas to livestock.
61_/ The tolerance on hop vines will be revoked because hop vines are not a raw agricultural commodity of hops nor are
they a feed item.
62/ The following data are needed on spent hops:
o Residues of concern in or on spent hops harvested after the last of three directed spray applications with the
2 Ib/gal SC/L formulation at 0.5 Ib cation/A/application. If residues are found to concentrate upon processing,
an appropriate food/feed additive regulation would be required. However, final disposition of food/feed
additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
63/ The data indicate that residues in dried hops processed from green hops may concentrate up to 5.3X. Therefore,
the food additive regulation on dried hops should be increased from 0.2 ppm to 0.5 ppm. However, final disposition
of food/feed additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
64/ An increased tolerance of 0.1 ppm must be proposed for olives. Alternatively, a label restriction prohibiting
application when olives to be harvested are on the ground must be proposed.
65/ Residue data are needed for olive oil processed from olives bearing measurable residues (exaggerated rates may be
necessary) demonstrating whether residues concentrate in olive oil. If residues are found to concentrate, an
appropriate food additive regulation for olive oil would be required. However, final disposition of food/feed
additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
SI58.125 Residue Chemistry - (cont'd)
66/ The available data will be adequate to support the established tolerance on pineapple provided a label restriction
is added limiting the number of applications to three a season.
67/ A feed additive regulation for residues of paraquat cation in or on pineapple forage is indicated. Review of
available data suggest that a tolerance of 0.05 ppra may be appropriate. However, final disposition of food/feed
regulations is dependent upon the Agency's position regarding Delaney Clause issues.
68/ Residues must be determined in pineapple juice and bran processed from pineapple bearing measurable residues. If
residues are found to concentrate in either.of the processed products, an appropriate food/feed additive regulation
would be required. However, final disposition of food/feed regulations is dependent upon the Agency's position
regarding Delaney Clause issues.
69/ No further data will be required provided that the grazing restriction is expanded to prohibit the feeding of cover
crops grown in treated areas to livestock.
TO/ The following additional data are needed:
o Data depicting paraquat residues in and on sugarcane forage frcm tests reflecting the following treatment schedule:
1) Two early season applications of the 2 Ib/gal SC/L at rates of a least 0.5 ai/A, applied in 100 to 200 gallons
of water per acre; 2) A single preharvest desiccation treatment of the 2 Ib/gal SC/L at 0.25 ai/A applied by air in
no more than 10 gal of water per acre. Cane and forage must be harvested no more than 3 days after desiccant
application, and no more than 30 days following the final postemergence weed-control treatment. An adequate
residue analytical method must be used in these studies. The test must be performed in FL and HI. Alternatively, a
label restriction prohibiting the feeding or grazing of livestock on treated forage may be proposed rather than
submitting forage residue data.
71 / Food additive regulations of 2.5 ppm in bagasse and 4 ppm in sugarcane juice are indicated. These levels are based on
the results of processing studies submitted under the currently registered weed control and desiccant use of paraquat
on sugarcane. However, final disposition of food/feed regulations is dependent upon the Agency's position regarding
Delaney Clause issues.
72/ Residues must be determined in molasses and refined sugar processed from sugarcane bearing measurable residues. If
residues are found to concentrate in either of these processed products, appropriate feed addit regulations would
be required. However, final disposition of food/feed regulations is dependent upon the Agency's position regarding
Delaney Clause issues.
73/ A food/feed additive tolerance of 10 ppm is indicated for residues in sunflower meal. However, final disposition of
food/feed additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
74/ The established tolerances of 6 ppm in sunflower hulls should be increased to 15 ppm. However, final disposition of
food/feed additive regulations is dependent upon the Agency's position regarding Delaney Clause issues.
75/ The following data are needed:
o A validated analytical method capable of detecting residues in cattle liver at or below the established 0.01 ppm
tolerance. EPA recommends that the registrant test the method used for pig liver, which has the required sensitivity.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.125 Residue Chemistry - (cont'd)
o A feeding study depicting residues in liver of cattle fed paraquat cation at no less than 11.2 ppm in the diet over
a 28-day period and killed within 24 hours after the feeding period. Residues must be determined by the validated
method requested above.
o As an alternative to the above, a proposed higher tolerance level in liver and kidney may be acceptable.
76/ A feeding study is required depicting residues in the fat, meat, and meat byproducts of poultry fed paraquat cation at
no less than 1.4 ppm in the diet for 28 days and killed within 24 hours after the feeding period. Eggs must be
collected and analyzed for residues of paraquat at intervals throughout the feeding period. A validated analytical
method capable of detecting residues of paraquat cation at 0.01 ppm must be used.
oo
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT BICHLORIDE
Data Requirements Composition^/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis TGAI or PAIRA
Photodegradat ion
1 61 -2 - In Water TGAI or PAIRA
> 161-3 - On Soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA
1 62-4 - Aerobic Aquatic TGAI or PAIRA
MOBILITY STUDIES:
163-1 - Leaching and TGAI or PAIRA
Adsorption/ Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Use This Require- Bibliographic FIFRA §3(c) (2)(B)?
Pattern2/ ment? (Yes, No Citation Timeframe for Data
or Partially) Submission-^/
A,B,G,H
A,B,G
A,G
A
A,B,G,H
A
G
N/AV
A,B,G,H
A
*
A
Yes
No
Yes
No
No
No
No
N/AV
No
No
No
00148506 No
Yes
00146806 No
001 46807
No
Yes
Yes
NoV
No
Yes
No
No
9 Months
27 Months
27 Months
1 2 Months
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TABLE A
DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
§158.130 Environmental Fate -
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Compos it ion^/
(cont'd)
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
: TEP
Use
Pattern2/
A,B,H
None
G
N/AV
A
A
A
N/A?/
A,B,G
G
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
No
N/A?/
No
N/A5/
No
No
No
N/A5/
No
No
Must Additional Data
Be Submitted Under
Bibliographic FIFRA §3(c)(2)(B)?
Citation Timeframe for Data
Submission^/
Yes 27 Months
No
NoV
No
Conditional6/
50 Months
Yes 39 Months
Conditional7/
50 Months
No
No
Yes 12 Months
Organisms
00
o
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.130 Enyiroimental Fate - (cont'd)
V (Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product.
2J The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
5/ This study is not currently required based on preliminary data which indicate that paraquat leaching out of treated
areas into soil would be almost totally absorbed and less than 1% desorption would subsequently occur, and provided
there is no substantial increase in total poundage used or no major change in use pattern.
5/ N/A = Not applicable for the purposes of this'Standard.
6/ Conditionally required; depends upon dissipation rate in the field dissipation study.
2J Conditionally required—if significant residues of concern are found in the confined study. Consult with Agency
upon completion of confined study.
oo
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements Composition1/
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP
132-1 - Soil Dissipation TEP
133-3 - Dermal Exposure TEP
133-4 - Inhalation Exposure TEP
§158.142 Spray Drift
201-1 - Droplet Size Spectrum TEP
201-1 - Drift Field Evaluation TEP
Does EPA Have
Data To Satisfy
Use This Require-
Pattern2/ ment? (Yes, No
or Partially)
N/A4/
N/A4/
N/A4/
N/A4/
A,B Yes
A,B Yes
Must Additional Data
Be Submitted Under
Bibliographic FIFRA §3(c)(2)(B)?
Citation Timeframe for Data
Submission3/
No
No
No
No
00153437 No
00153438
00153437 No
00153438
_iy Composition: TEP = Typical end-use product.
2J The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
4/ N/A = Not applicable for the purpose of this Standard.
oo
to
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR PARAQUAT BICHLORIDE
Use
Data Requirements CompositionV Pattern2/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Must Additional Data
Be Submitted Under
Bibliographic FIFRA §3(c)(2)(B)?
Citation Timeframe for Data
Submission^/
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-7
- Acute Oral Toxicity - Rat TGAI A,B,H
- Acute Dermal Toxicity TGAI A,B,H
- Rabbit
- Delayed TGAI A,B,H
Neurotoxicity - Hen
Yes
Yes
No
00054573 00162748
00081825 00162870
00054574
00162748
No
No
No4/
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding: TGAI A
- Rodent, and
- Nonrodent (Dog) A
- 21 -Day Dermal - Rabbit TGAI A,B,H
- 90-Day Dermal - Rabbit TGAI A,B,H
- 90-Day Inhalation: TGAI A,B,H
- Rat
No
Yes
Yes
No
Partially
0007241 6
00156313
00030788
00113718
No5/
No
No
No6/
Yes?/ 15 Months
82-5 - 90-Day Neurotoxicity:
- Hen
— Mammal
TGAI
A,B,H
A,B,H
No
No
oo
CO
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Does EPA Have
Data To Satisfy
Use This Require- Bibliographic
Data Requirements Composition1/ Pattern2/ ment? (Yes, No Citation
or Partially)
§158.135
Toxicology - (cont'd)
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission^/
CHRONIC TESTING:
83-1 -
83-2 -
83-3 -
83-4 -
Chronic Toxicity - TGAI A,B Yes
2 species:
- Rodent, and
- Nonrodent (Dog) A,B Yes
Oncogenicity - TGAI
2 species:
- Rat (preferred) , and A,B Yes
- Mouse (preferred) A,B Yes
Teratogenicity - TGAI
2 species:
- Rat A,B,H Yes
- Mouse A,B,H Yes
Reproduction - Rat TGAI A,B,H Yes
00138637
001 32474
001 38637
40183501
00087924
00113714
00096338
00126783
No
No
No
No
No
No
No
2-generation
00
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT BICHLORIDE
Use
Data Requirements Composition1/ Pattern2/
§158.135 Toxicology - (cont'd)
MUTAGENICITY TESTING:
84-2 - Gene Mutation TGAI A,B,H
84-2 - Structural Chromosomal TGAI A,B,H
Aberration
84-4 - Other Genotoxic Effects TGAI A,B,H
SPECIAL TESTING:
85-1 - General Metabolism PAI or PAIRA A,B,H
85-2 - Dermal Penetration Choice A,B,H
86-1 - Domestic Animal Choice A,B,H
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
This Require- Bibliographic PIPRA §3(c)(2)(B)?
ment? (Yes, No Citation Timeframe for Data
or Partially) Submissions/
Yes 00152690
00152691
Yes 00073487
00152692
Yes 00152693
00152695
Yes 00028597 00036297
00028598 00055107
00028599 00126096
Yes 00126096
00126097
00126098
00126099
No
No
No
No
No
No
No
Safety
00
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.135 Toxicology - (cont'd)
I/ Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabeled; Choice - Choice of several
test substances determined on a case-by-case basis.
j2/ The use patterns are coded as follows: A - Terrestrial, Pood Crop; B = Terrestrial, Nonfood; C = Aquatic, Pood Crop;
D = Aquatic, Nonfood; E = Greenhouse, Pood Crop; P = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
]•[/ This study is not required because paraquat is not a carbamate or an organophosphate and is not chemically related to
these compounds.
5/ The acceptable 2-year rat study fulfills this requirement.
F/ The registered use of the product does not involve purposeful application to human skin and its pesticidal use does not
result in comparable human exposure.
7/ The submitted studies were classified as supplemental data because several important parameters were either not tested
or were inadequately tested. Because of very low LCtjo values and very low NOEL,. a 90-day study with coarse particles
(and with complete histopathology, organ weights, hematology, and clinical chemistry) should be performed.
00
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TABLE A
GENERIC DATA. REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements Composition! /
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and
- Waterfowl
71 -3 - Wild Mammal 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
00
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Use This Require- Bibliographic FIFRA §3(c)(2)(B)?
Pattern2/ ment? (Yes, No, Citation Timeframe for Data
or Partially) Submission^/
A,B,G,H Yes
A,B,G,H
Yes
Yes
A,B,G,H Yes
A Yes
A Yes
A Yes
A Yes
A Yes
A Yes
00102038
05008363
00029001
00088881
00088881
00162745
00110453 00110455
00110454 00162746
00110453 00110455
00110454 00162746
00162741
00162747
00162741
00162747
00162741
00162747
00162741
00162747
No
No
No
No
No
No
No
No
No
No
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition^/
Use
Pattern^/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No,
or Partially)
Bibliographic
Citation
Mist Additional Data
Be Submitted Under
FIFRA S3(c)(2)(B)?
Timeframe for Data
Submission^/
§158.145 Wildlife and
Aquatic Organisms - (cont'd)
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish Toxicity TGAI
- Cold-water Fish Species,
and
- Warmwater Fish Species
72-2 - Acute Toxicity to TGAI
Freshwater Invertebrates
72-3 - Acute Toxicity to TGAI
Estuarine and Marine
Organisms
72-4 - Fish Early Life Stage, TGAI
and
- Aquatic Invertebrates
Life Cycle
A,B,G,H
A,B,G,H
A.B.G.H
A
Yes
Yes
Yes
No
A
A
No
No
00116622 00162737
00162736 00162738
00116622 00162738
00162737 GS0262-028
00114473
00116622
GS0262-028
No
No
No
No5/
00
00
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Use This Require- Bibliographic F-IFRA §3(c)(2)(B)?
Data Requirements Composition1/ Pattern2/ ment? (Yes, No, Citation Timeframe for Data
or Partially) Submission3/
§158.145
Aquatic
72-5 -
72-6 -
Wildlife and
Organisms - (cont'd)
Fish - Life Cycle TGAI A No
Aquatic Organism TGAI, PAI or A
Accumulation Degradation
Product
- Crustacean No
- Fish No
- Insect Nymph No
- Mollusk No
No5/
No
No
No
No
72-7 - Simulated Field Testing
- Aquatic Organisms
- Actual Field Testing
- Aquatic Organisms
TEP
No
No
No6/
No6/
00
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
§158.145 Widllfe and Aquatic Organisms - (cont'd)
V Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood Crop; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the indicated timeframe, based on the date of the Guidance Document.
5/ These studies are not required because paraquat binds tightly to sediment and is biologically unavailable,
is only moderately toxic to aquatic organisms and has a low estimated environmental concentration.
5/ These studies are required for pesticides that may have continuous or recurrent exposure to fish. There are no
aquatic uses for paraquat and paraquat is not likely to transport to water in significant quantities from
runoff.
J3/ These studies are required for pesticides intended for application to water or for pesticides that may translocate- to
aquatic habitat and will occur at potentially toxic levels; neither of these situations is likely to occur.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1/
Use
Pattern2/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No,
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission
§158.150 Plant Protection
121-1 - TARGET AREA EP
PHYTOTOXICITY
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/ TGAI
Seedling Emergence
^ 1 22-1 - Vegetative Vigor TGAI
«t
122-2 - Aquatic Plant Growth TGAI
TIER II
123-1 - Seed Germination/ TGAI
Seedling Emergence
123-1 - Vegetative Vigor TGAI
123-2 - Aquatic Plant Growth TGAI
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
3/
3/
3/
3/
3/
3/
3/
3/
jy Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; EP = End-use product.
2J The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood Crop; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
_3/ These data are not required in accordance with §158.150.
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Data Requirements
Composition1/
Use
Pattern2/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No,
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honeybee acute
contact toxicity TGAI
141-2 - Honeybee - toxicity TEP
of residues on
foliage
141-4 - Honeybee subacute
feeding study
141-5 - Field testing for TEP
pollinators
A,B
A,B
(Reserved)4/
A,B
Yes
No
00028772
05001991
No
No3/
No
No3/
VO
NO
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TABLE A
GENERIC DATA REQUIREMENTS FOR PARAQUAT DICHLORIDE
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
Use This Require- Bibliographic FIFRA §3(c)(2)(B)?
Data Requirements Composition1/ Pattern2/ ment? (Yes, No, Citation Timeframe for Data
or Partially) Submission
§158.155 Nontarget Insect - (cont'd)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to (Reserved)5/
aquatic insects
142-1 - Aquatic insect (Reserved)5/
life-cycle study
142-3 - Simulated or actual (Reserved)5/
field testing for
aquatic insects
143-1 - NONTARGET INSECT (Reserved)5/
TESTING - PREDATORS
thru AND PARASITES
143-3
\J Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I = Indoorc
3/ As data from the acute study indicate low toxicity to honeybee, no further testing is required.
4/ Reserved, pending development of test methodology.
5/ Reserved, pending Agency discussion as to whether the data requirement should be established.
vo
CO
-------
PRODUCT-SPECIFIC DATA
TABLE B
FOR MANUFACTURING-USE PRODUCTS CONTAINING PARAQUAT DICHLORIDE
Guideline Citation and Name of Test
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
Test
Substance^ /
MP
MP
MP
MP
MP
MP
MP
MP
MP
Guidelines Are Data
Status1/ Required
Yes No
R O
R ©
R [X]
CR [X]
R [X]
R [X]
R [X]
R IX]
R [X]
[X]
O
o
O
O
o
o
o
O
Data Must Be
Footnote Submitted Within
Number Timeframe Listed
Below2/
No
3,4 Yes 6 Months
5 Yes 6 Months
6 Yes 1 2 Months
7 Yes 1 2 Months
8 Yes 12 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
-------
TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PARAQUAT DICHLORIDE
Guideline Citation and Name of Test
§158.120
Physical
(cont'd)
63-7 -
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
Product Chemistry (cont'd)
and Chemical Characteristics
Density, Bulk, Density, or
Specific Gravity
- pH
- Oxidizing or Reducing
Action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion Characteristics
Requirements
64-1 - Submit tal of samples
\J MP = Manufacturing-use Product; R
2J Data must be submitted within the
VO
Ln
Data Must Be
Test Guidelines Are Data Footnote Submitted Within
Substance V Status Required Number Timeframe Listed
Yes No Below2/
MP R
MP CR
MP CR
MP CR
MP R
MP R
MP CR
MP CR
MP R
MP CR
= Required; CR = Conditionally
indicated timeframe, based on
[X]
[x]
[X]
IX}
[X]
[5c]
[X]
[X]
[X]
o
Required
the date of
[_]
G
G
G
G
G
G
G
G
[X]
the Guidance Document.
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
-------
TABLE B
PRODUCT-SPECIF1C DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PARAQUAT DICHLORIDE
§158.120 Product Chemistry - (cont'd)
3/ Details of the manufacturing process including the relative amounts of beginning material; a description of the
equipment used to produce the product, reaction conditions, the duration of the process; purification procedures,
and quality control measures are required.
j4/ The name and address of the manufacturer, producer, and supplier of each beginning material used to manufacture the
product are needed. Also, a copy of all available technical specifications, data sheets, and other documents
in which the manufacturer, producer, or supplier of the beginning materials describes its composition and properties
must be submitted.
5/ The following data are required for the MUP's:
o A discussion of each impurity believed to be present at _>. 0.1% based on the knowledge of beginning materials,
possible chemical reactions,.and any contamination present.
6/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity present at
2. 0.1% (w/w) using valid analytical methods.
2/ The following additional data are required:
o Upper and lower limits must be provided, validated, and certified for each intentionally added inert in the MUP.
o Upper limits must be provided, validated, and certified for each impurity present at _>. 0.1% (w/w).
o Upper and lower limits must be provided, validated, and certified for paraquat dichloride in the MUP.
J3/ None of the methods for quantification of paraquat dichloride and manufacturing impurities in paraquat dichloride
have been validated. Therefore, the following additional information is required:
o Qiantitiative methods are required to determine paraquat and all impurities and intentionally added inerts for which a
certified limit is required. Each method must be accompanied by validation studies of the precision and accuracy of
this method.
\o
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TABLE B
PRODUCT-SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING PARAQUAT DICHLORIDE
Data Requirements Composition
§158.135
Toxicology
Does EPA Have Data
To Satisfy This
Requirement? (Yes , Bibliographic
No, or Partially) Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c)(2)(B)?
Timeframe for Data
Submission
ACUTE TESTING
81-1 -
81-2 -
81-3 -
81-4 -
81-5 -
81-6 -
Acute Oral Toxicity - Rat MP
Acute Dermal Toxicity MP
- Rabbit
Acute Inhalation Toxicity MP
- Rat
Primary Eye MP
Irritation - Rabbit
Primary Dermal MP
Irritation - Rabbit
Dermal Sens itizat ion MP
Guinea Pig
Yes 00054573
00081825
00162748
00162870
Yes 00054574
00162748
Yes 00046105
001 53733
Yes 00054575
Yes 00054576
Yes 001 55289
00162744
No
No
No
No
No
No
-------
APPENDIX II
LABELING
98
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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)]
99
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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)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the 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)].
100
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2)(i)]
Item 8B. ENyiRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the 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.
101
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SUMMARY-4
Classificati-on 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.
102
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to 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.
103
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/ gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
. be qualified by "Packed for . . . ,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
SIM1ARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statanent of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Hist be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
o
Ln
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
IABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150 °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
Immediately
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 with its labeling."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
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) of this
section;
(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) of
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 (j)
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 placed
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-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
107
-------
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(g)(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;
108
-------
(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 statements 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 net content 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 shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
109
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(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. Variation 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 on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
t10
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(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 below:
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Hazard Indicators
Oral LD
50
Inhalation LC
Derma 1 LD
Eye effects
Skin effects
1
Up to and
Including
50 mg/kg
Up to and
1 nc 1 ud 1 ng
.2 mg/l Iter
Up to and
Including
200 mg/kg
Corrosive;
cornea! opacity
not reversible
within 7 days
Corros 1 ve
Toxic Ity <
II
From 50 thru
500 mg/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor1es
III
From 500 thru
5000 mg/kg
From 2 thru
20 mg/l Iter
From 2,000 thru
20,000
No corneal opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/l Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(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 backgrpund of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
(B) Toxicity Category II. All pesticide products meeting the
criteria of Toxicity Category II shall bear on the front panel*
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
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(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 appear 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) PIacement 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
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
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(2) Other required warnings and precautionary statements. The
warnings 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.
Toxlclty
category
Precautionary statements by toxlclty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
II
III
IV
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin]. Do not breathe
vapor Idust] or spray mlstl. Do not get
In eyes, on skin, or on clothing I Front
panel statement of practical treatment
required.).
May be fatal If swallowed I Inhaled or
absorbed through the skin]. Do not breathe
vapors Idust 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 (eyes or clothing]. (Appropriate
first aid statement required.).
(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 (and 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 potential accident, injury or
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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
ingredient with a fish acute LC50 of 1 ppm or less, the 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 LD^Q of 100 mg/kg or less, or
a subacute dietary LCso 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 point at or below 20*F; If there Is 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 under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
I30*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*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 tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZED 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.
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(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:
(_!) 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;
(_3) The product will not come into the hands of the general
public 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:
(_!') The label clearly states that the product is for use only
by physicians or veterinarians;
(2^) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3^) The product is' also a drug and regulated under the provisions
of The Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(I) 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;
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(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;
(J3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(_4) 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.
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(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must 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]
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or 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.
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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.
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or Toxicity
Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a viola-
tion of Federal Law. If these wastes cannot be disposed
of by use according to label instructions, contact your
State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR
261, Subpart C for a hazardous waste must bear the following
pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according
to label instructions, contact your State Pesticide or Environ-
mental 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 state-
ment :
"Wastes resulting from the use of this product may be dis-
posed of on site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the follow-
ing disposal statement:
"Securely wrap original container in several layers of
newspaper and discard in trash."
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar) .
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type,listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent).Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke. _____
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording) _____
J_/ Manufacturer may replace this phrase with one indicating
~~ whether and how fiber drum may be reused.
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APPENDIX III
USE INDEX
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EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP 5
(Agricultural Crops) 5
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments) £8
TERRESTRIAL NONFOOD CROP £9
(Ornamental Plants and Forest Trees) £9
(Noncrop, Wide Area, and General Indoor/Outdoor
Treatments) 3O
FORESTRY 31
Acerola 5
Alfalfa 6
Almond 7
Apple 7
Apple (ornamental) £9
Apricot 5
Arborvitae £9
Arbovitae (shelterbelt) 31
Ash £9
Asparagus 8
Avocado 5
Bahiagrass (pasture, rangeland) 8
Banana 5
Barley 9
Beans (lima) 9
Bermudagrass (pasture, rangeland) 9
Blackberry 1O
Blueberry 1O
Boysenberry 1O
Broccoli 9
Cabbage 9
Cantaloupe 9
Carrots 9
Cauliflower 9
Cherry 5
Chinese Cabbage 9
Citrus (ornamental) £9
Citrus Fruits 5
Clover 11
Coffee 5
Collards 9
Corn 11
Corn, Field 1£
Cotton 1£
Cucumber 9
Eggplant 9
Elm £9
Elm (shelterbelt) 31
Fallowland £8
Fig 5
Issued: 4-11-85 I-O616,Ol-i
Provisional Update: 6-15-87
124
-------
EPft Compendium of Acceptable Uses
PftROOUflT DICHLORIDE
TflBLE OF CONTENTS
Site Name Page
Filbert 5
Filbert (ornamental) £9
Fir £9
Fir (shelterbelt) 31
Flowering Olmond £9
Flowering Ppricot £9
Flowering Cherry £9
Flowering Peach £9
Flowering Pear £9
Flowering Plum £9
Grapes 14
Grasses
-------
EPft Compendium of Acceptable Uses
PftRftQUftT DICHLORIDE
TftBLE OF CONTENTS
Site Name Page
Pumpkin 9
Rangeland £1
Raspberry 10
Rhubarb ££
Rights-of-Way 30
Safflower ££
Sorghum ££
Sorghum (grain crop) ££
Soybeans S3
Spearmint 19
Squash 9
Strawberries £5
Sugar Beets £5
Sugarcane • £6
Sunflower (oil crop) £6
Tomato £7
Turnips 9
Uncultivated Non-figricultural Preas 3O
Walks, Driveways and Posts 3O
Walnut £8
Watermelon 9
Wheat £8
Issued: 4-11-85 I-O616Ol-iii
126
-------
EPft Compendium of Acceptable Uses
:c061601 PflRRQUfiT DICHLORIDE*
TYPE PESTICIDE; Herbicide, Defoliant, Desiccant, Plant Regulator
FORMULATIONS;
FI (£9.IX, 43.5X)
SC/L (£ Ib/gal, £O.4#)
PrL (0.276'X)
GENERflL WARNINGS QND LIMITflTIONS; RESTRICTED USE PESTICIDE. ft
nonselective herbicide and desiccant with fast acting contact ac-
tion. Chemical is inactivated upon contact with soil. This chemi-
cal is toxic to fish. Do not apply directly to water or wetlands
(swamps, bogs, marshes, and potholes) or contaminate water by
cleaning of equipment or disposal of wastes. Do not inhale spray
mist. Remove and wash contaminated clothing. Wear full face
shield, rubber gloves, apron and waterproof footwear when handling
or mixing concentrate. Wear waterproof footwear and clothing when
spraying or when contacting vegetation wet with spray. Do not en-
ter treated areas without protective clothing until sprays have
dried, ftvoid working in spray mist. If there is risk of exposure
wear goggles and approved face mask capable of filtering spray
droplets. Keep all unprotected persons out of operating areas or
vicinity where there may be danger of drift. Certain states may
require more restrictive reentry intervals; consult your State
Department of Agriculture. Written or oral warnings regarding use
of protective clothing and accidental exposure must be given to
workers who are expected to be in treated areas or in areas about
to be treated. Apply when weeds are succulent and new growth is 1
to & inches high. Thoroughly cover weed foliage. Weeds emerging
after application will not be controlled. Do not combine with sus-
pension type fertilizers. For band treatments, reduce dosage pro-
portionately.
Dosages for this chemical were calculated using the cation by
weight.
Agricultural Crop Tolerances (other than those listed in text):
Beans, forage O. 1 ppm
Beans, hay 0.4 ppm
Oat, grain O. OS ppm
Rye grain O. O5 ppm
Livestock Tolerances;
Cattle (fat) O. Ol ppm (N)
Cattle (meat) O. Ol ppm (N)
Cattle (mbyp) O. Ol ppm (N)
Eggs O.01 ppm (N)
Goats (fat) O. Ol ppm (N)
Goats (meat) O. Ol ppm (N)
Goats (mbyp) O.Ol ppm (N)
Hogs (fat) O. Ol ppm (N)
Hogs (meat) O. Ol ppm (N)
Hogs (mbyp) O. Ol ppm (N)
*1,1*-dimethyl-4,4'-bipyridinium dichloride
Issued: 4-11-85 I-O616O1-1
Provisional Update: 6-15-87^07
-------
EPft Compendium of Acceptable Uses
PftRftQUflT DICHLORIDE
GENERAL WARNINGS fiND LIMITATIONS (continued)
Milk
Poultry (fat)
Poultry (meat)
Poultry (mbyp)
Sheep (fat)
Sheep (meat)
Sheep (mbyp)
0.01 ppm (N)
0.01 ppm (N)
0.01 ppm (N)
O.O1 ppm (N)
0.01 ppm (N)
0.01 ppm (N)
0.01 ppm (N)
TIME REQUIRED FOR CONTROL: ftcts within a few hours of application.
PHYTOTOXICITY TO TflRGET UEEDS; Causes wilting and rapid desicca-
tion of foliage.
PHYTQTQXICITY TO CROPS;
will be killed.
Plants emerged at the time of application
MODE OF flCTION; Causes the formation of free radicals during photo-
synthesis which acts to disrupt membrane permeability.
BROQDLEQF WEEDS CONTROLLED;
PftftftftftB Rnnual broad leaf weeds
PCQBIftO Burclover
PBFftEftC Bursage
PEHflGRft Buttercup
PBZfiCBO Carolina geranium
PfiZftftftC Chickweed
PCQfifiOB Clover
PBFDDftft Cocklebur
PBFftEBfi Common ragweed
PEWOHBL Cut leaf groundcherry
PBFDHBB Dande1i on
PEDftBBft Desert rockpurslane
PEftfiHftft Dock
PBFBIBB Dogfennel
PftRftBftfl Fiddleneck
PBZfiBftO Filaree
PEMfiEBB Florida pursley
PBFCXfift Groundsel
PCOOFBfi Henbit
PBDfiEftB Lambsquarter
PBGfiftftB Morningglory
PFBPEftfi Nettle
PftftfififlF Perennial weeds
PftORftBI Pigweed
PDXABftfi Plantain
PBFCEBF Prickly lettuce
PFMOFBB Puncturevine
PPPflPBP Purslane
PBFOEftfi Ragweed
(a)
(b)
(c)
(c)
(b)
Issued: 4—11—85
I-0616O1-S
128
-------
EPP Compendium of Pcceptable Uses
PPRPQUPT DICHLORIDE
BRDPDLEPF WEEDS CONTROLLED (continued)
pCQBYBH Red clover
pBKPHBP Shepherdspurse (c)
PCQPMBF Sicklepod
PZPPPCS SmartMeed
PBFDUPP Spikeweed (b)
PBVRGRO Spurge
PBKPNBB Tansy mustard
pflAPPPX Thistle
PBKBDBP Tumble mustard
PDftOBBB Velvet leaf
PBKflFBE Wild mustard
PBKBPBP Wild radish
PEUftNBP Witchweed
PDPfiBPP Woodsorrel
(a) Use the higher dosages.
(b) Treat when weeds are small.
(c) Top kill and suppression only.
PCflCKBft
PCftftftOB
PCRBSPft
PCftBHBB
PCAftZBPl
PCflCKPft
PCflflRBD
PCftfiTPfi
PCftCFBL
PCflRTBK
PCABRBP
PCflBFPP
PCAflTBM
PCACEBD
PCflOFPP
PCRCUBP
PCftBIBP
PC&BZBP
PCftCWBC
PCftCWBG
PCABSBF
PCRCBBD
PCABBBP
PCACCBP
PCABZPP
GROSSES RND OTHER MONDCQT5 CONTROLLED;
Pnnual bluegrass
Pnnual grasses
Barley (volunteer)
Barnyard grass
Berrnudagrass (c)
Bluegrass
Broad leaf signal grass
Brome (a)
Bull paspalum
Cheat
Common velvet grass
Crabgrass (b)
Downy brome
Fall pan i cum
Foxtail
Giant foxtail
Goosegrass
Grasses
Italian ryegrass
Johnsongrass (c)
Johnsongrass (seedling)
Little barley (d)
Nirnblewill
Nut sedge
Orchard grass
Perennial grasses (c)
Rice
Ryegrass
Signal grass
Smooth brorne (c)
Issued: 4-11-85
I-061&G1-3
129
-------
PCRBMBE
PCOCEBL
PCftCIBfl
PCftftOBB
EPft Compendium of Pcceptable Uses
PORfiQURT DICHLORIDE
GROSSES flND OTHER MONDCDTS CONTROLLED (continued)
Tall fescue
Texas panicum
Timothy
Mild oats
(c)
(a) Use the higher dosages.
-------
EPft Compendium of Occeptable Uses
PftRftQUOT DICHLORIDE
Site. Dosage
and Formulation
(Ib cation/0)
Tolerance. Use. Limitations
TERRESTRIOL FOOD CROP
(ftgricultural Crops)
General Warnings and Limitations: Do not use around home gar-
dens, schools, recreational parks or playgrounds. To prevent
injury to germinating crop seedlings, do not apply preplant or
preernergence to soils lacking clay minerals, i.e., peat, mulch,
pure sand or artificial planting media. For band or spot treat-
ment, reduce dosage in proportion to area actually treated. Op-
ply a surfactant.
W602000 ftcerola
'050010ft Opricot
'£800000 ftvocado
'0600200 Banana
'050020ft Cherry
'£000100 Citrus Fruits
010020ft Coffee
060050ft Fin
'0300500 Filbert
'030070O Macadam ia Nut
r050030ft Nectarine
'£801400 Olive
0601000 Papaya
'0500500 Plum (fresh prunes)
'0500600 Prune
O. 50-1.OO
(£ Ib/gal SC/L)
O.O5 (N) ppm (acerola, apricot, avocado,
banana, cherry, citrus
fruits, coffee beans, fig,
nectarine, nuts, olive,
papaya, plums (fresh prunes))
Do not graze treated areas. Do not feed
cover crops grown in treated areas to live-
stock.
General Information; Do not apply when
nuts or figs to be harvested are on the
ground.
Directed spray. Opply in 3O to 15O gal-
lons of water per acre. Do not allow
spray to contact green sterns, fruit or fo-
liage. Use a shield when spraying around
young trees. Retreatment or spot treat-
ment may be necessary for hard-to-kill
weeds.
Issued: 4-11-85
I-O61601-5
131
-------
EPfi Compendium of Rcceptable Uses
PftRftQUfiT DICHLORIDE
Site. Dosage
and Formulation
-------
EPft Compendium of ftcceptable Uses
PftRftQUftT DICHLORIDE
Site, Dosage
and Formulation
-------
EPft Compendium of Acceptable Uses
PfiRfiQUftT DICHLORIDE
Site. Dosage
and Formulation
-------
EPO Compendium of Occeptable Uses
PflRflQUOT DICHLORIDE
Site. Dosage
and Formulation
(Ib cation/ft)
/2806300 Barley
O.£5-1.00
<£ Ib/gal SC/L)
Tolerance. Use. Limitations
0.05 (N) pprn (grain)
Do not graze treated
grain to livestock.
areas 01* feed treated
Prep 1 ant or preernergence. Broadcast or
band. Opply in SO to 60 gallons of water
per acre by ground or in 5 to 10 gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
Meed emergence. Seeding should be done
with a minimum of soil disturbance.
/1500£00
/1300500
/130070O
/10020ft
/140030ft
/13008OO
/13010ftft
/13009flfi
/10010OO
/llOOlflft
/100600
/15009flft
aooiioo
/1001£ftft
/1302600
/loooaoo
^£01700
Beans (lima)
Broccoli
Cabbage
Cantaloupe
Carrots
Cauli flower
Chinese Cabbage
Col lards
Cucumber
Eggplant
Muskmelon
Peas
Pumpkin
Squash
Turnips
Wat errne 1 on
O.5O-1.OO
(£ Ib/gal SC/L)
Bermudagrass (pas-
ture, rangeland)
O. £5
(£ Ib/gal
SC/L)
Issued: 4-11-85
0.05 ppm (beans (lima, succulent),
broccoli, cantaloupe, cabbage,
carrots, cauliflower, Chinese
cabbage, col lards, cucumber,
muskmelon, peas (succulent),
pumpkin, squash, watermelon)
0.£ ppm (peas, forage)
0.8 ppm (peas, hay)
0.05 pprn (turnips, roots, tips)
General Information; Seeding should be
done with a minimum of soil disturbance.
Crop plants emerged at time of application
will be killed. Odd a non-ionic surfac-
tant.
Prep1ant or preemergence. Broadcast or
band. Use sufficient water to give thor-
ough coverage. Seedbeds should be formed
as far ahead of planting and treatment as
possible to permit maximum weed emergence.
5 ppm
Do not graze treated areas or mow for hay
within 40 days after treatment.
Use limited to the South and Southeast.
Broadcast or band. Use band treatment
over the drill row when recovery of sod is
desired. Opply in £O to 3O gallons of wa-
ter per acre in late summer or early fall,
prior to or at the time of seeding winter
annuals. Opply broadcast when existing
grass species are undesirable and total
suppression is required. Sod must not ex-
ceed 3 inches in height.
I-O61601-9
135
-------
/01009ftfl
/01003ftP>
/01006QA
EPft Compendium of ftcceptable Uses
PfiRfiQUftT DICHLORIDE
Site. Dosage
and Formulation
-------
Site. Dosage
and Formulation
(Ib cation/ft)
Clover
EPO Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Tolerance. Use, Limitations
O.50-O.75
(£ Ib/gal SC/L)
/2B005AA
O.5O-1.00
(£ Ib/gal SC/L)
0.£5-O.50
(£ Ib/gal SC/L)
O.£5-0.5O
<£ Ib/gal SC/L)
5 ppm
4£ day preharvest interval.
General Information; Do not apply if re-
growth, following the last fall cutting,
is more than £ inches tall. Do not apply
more than once per season.
Use limited to CO (counties of Del Norte,
Siskiyou, Modoc, Shasta, Lassen, Plurnas,
Sierra and Nevada), CO, ID, MT, NV, OR,
UT, WA, and WY. Dormant application.
Broadcast. Apply in £0 to 100 gallons of
water per acre by ground or in 5 to 10 gal
Ions of water per acre by air.
See Acerola cluster.
See Beans (lima) cluster.
O.O5 (N) ppm (fresh (including sweet
(K+CWHR))
O.05 (N) ppm (sweet, grain, forage, and
fodder)
Do not graze treated areas.
Prep1ant or preemergence. Broadcast or
band. Apply in £O to 60 gallons of water
per acre by ground or in 5 to 10 gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
Prep1ant or preemergence. For use where
corn will be planted directly into cover
crop, established sod, or in previous crop
residues. Tank mix with atrasine;
atrazine plus simazine; bladex; or
alachlor plus atrazine. fipply in £0 to 60
gallons of water per acre. Tank mix of
paraquat dichloride and atrazine may be ap-
plied in liquid nitrogen fertilizer and/or
complete liquid fertilizer solutions in
combination with a non—ionic surfactant.
Preplant or preemergence. Broadcast.
Tank mix with metolachlor and atrazine.
Issued: 4-11-85
1-061601-11
137
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Site. Dosage
and Formulation
(Ib cation/ft)
Corn (continued)
0.50
(£ Ib/gal SC/L)
O.£5-0.5O
(2 Ib/gal SC/L)
0.50
(£ Ib/gal SC/L)
/£8OO6AA
Corn. Field
O. 25
(£ Ib/gal SC/L)
'28OO7AA
Cot t on
O.12-O.£5
(2 Ib/gal SC/L)
Tolerance. Use. Limitations
Prep1ant or preemergence. Broadcast.
Tank mix with metolachlor and cyanazine.
Preplant or preemergence. Broadcast.
Tank mix with metolachlor and metribuzin
or linuron.
Postemergence. Directed spray. For use
in United States Department of Agriculture
Witchweed Eradication Program. Apply in
10 to 2O gallons of water per acre. Ini-
tiate treatment in early July and repeat
in early August if regrowth of grass weeds
occurs.
0.05 (N) ppm (grain, fodder, and forage)
Postemergence. Directed spray. Apply in
£O to 40 gallons of water per acre. For
control of weeds and grasses less than 4
inches tall. Apply when corn plants are
at least 1O inches tall. Direct spray no
higher than the lower 3 inches of
corn stalks. Do not mix with liquid fer-
tilizer. May be tank mixed with atrazine.
0.5 ppm (cottonseed)
3 day preharvest interval. Seven day pre-
harvest interval when used with phosphate
or chlorate defoliants.
Do not graze lactating dairy animals. Do
not graze livestock in treated fields un-
til 15 days after treatment. Remove live-
stock from treated area 30 days before
slaughter. Do not feed gin trash to live-
stock.
General Information; May be applied as a
split application. Repeat application if
necessary. Do not make more than £ appli"
cations or exceed a total of £ pints per
acre.
Use limited to CA. For control of emerged
volunteer barley. Preplant. Broadcast.
Apply in 5 to 10 gallons of water per acre
by air. Apply to preformed seedbeds.
Issued: 4-11-85
I-O616O1-1£
138
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Site, Dosage
and Formulation
(Ib cation/A)
Cotjbon (continued)
O. 50-1.OO
(£ Ib/gal SC/L)
Tolerance. Use. Limitations
O. 1£
(£ Ib/gal SC/L)
O.£5-O.5O
(2 Ib/gal SC/L)
O. 12
(£ Ib/gal SC/L)
Cucumber
Eggplant
Fill
Filbert
Prep1ant. Broadcast. Apply in £O to 6O
gallons of water per acre. Beds should be
preformed to permit maximum weed emergence
prior to treatment. Seeding should be
done with a minimum amount of soil distur-
bance.
Preharvest desiccation. Broadcast. Tank
mix with phosphate or chlorate defoli-
ants. Apply in 10 to 30 gallons of water
per acre by ground or 3 to 10 gallons by
air. Apply when 80 percent or more of the
bolls are open and the remaining bolls are
mature.
Preharvest desiccation of stripper cot-
ton. Broadcast. Apply in 1O to 30 gal-
lons of water per acre by ground or 3 to
1O gallons by air when 85 percent or more
of the bolls are open and the remaining
bolls are mature. When foliage is dense,
use 2 applications of the lower dosage if
necessary.
Use limited to AZ and CA. Preharvest defo-
liation. Broadcast. Tank mix with phos-
phate or chlorate defoliants. Apply in 1O
to 30 gallons of water per acre by ground
or 3 to 1O gallons by air when 6O percent
or more of the bolls are open and the re-
maining bolls are mature.
See Beans (lima) cluster.
See Beans (lima) cluster.
See Acerola cluster.
See Acerola cluster.
Issued: 4-11-85
I-O616O1-13
139
-------
EPA Compendium of ftcceptable Uses
PftRftQUPT DICHLORIDE
/01014fift
Site. Dosage
and Formulation
(Ib cation/ft)
Grapes
O. SO-1.00
<£ Ib/gal BC/L)
/£B066Bft
Grasses (grown for
seed)
O. 50
<£ Ib/gal SC/L)
Guar
O. 50
(£ Ib/gal SC/L)
/O6OO6OO
/06O14ftft
Guava
l.OO
(£ Ib/gal SC/L)
Tolerance. Use. Limitations
Do not graze treated areas. Do not use in
vineyards established less than 3 years.
Use limited to CO. Directed spray.
Postemergence. Opply in 50 to 150 gallons
of Mater per acre. Do not allow spray to
contact green stems, fruit or foliage.
Use a shield when spraying around vines.
Retreatment or spot treatment may be neces-
sary for hard-to-kill weeds.
5.0 ppm grass, pasture, rangeland
Do not graze treated areas. Do not use
seed from treated areas for animal feed.
Do not use straw from treated areas for
animal bedding or feed.
Prep1ant. Broadcast. ftpply in £O to 40
gallons of water per acre to seedbed when
weeds are at the 3 to 5 leaf stage. Treat-
ment can be repeated prior to or on the
day of seeding. Odd a non—ionic surfac-
tant to the finished spray.
O.5 ppm (guar beans)
4 day preharvest interval. Do not graze
treated areas or feed treated forage to
livestock.
Preharvest desiccation. Broadcast. ftpply
in £O to 3O gallons of water per acre af-
ter pods are mature.
O.OS (N) ppm
Do not graze treated areas. Do not feed
cover crops grown in treated areas to live-
stock.
Preemergence. Directed spray. ftpply in
5O to 15O gallons of water per acre. Do
not allow spray to contact green stems,
fruit or foliage, as injury may result.
Use a shield when applying around young
trees. Retreatment or spot treatment may
be necessary for hard-to-kill weeds.
Issued: 4-11-85
I-O616O1-14
140
-------
/080£Oftfi
Site. Dosage
and Formulation
(Ib cation/ft)
Hops
EPft Compendium of ftcceptable Uses
PRRftQUftT DICHLORIDE
Tolerance. Use. Limitations
O. 5O
(£ Ib/gal SC/L)
0.1 ppm (fresh hops)
0.5 ppm (hop vines)
14 day preharvest interval. Do not allow
animals to graze in treated hopyards. Hop
vine refuse and silage may be fed to live-
stock.
General Information; Do not apply more
than 3 times per season. Do not allow
spray to contact green sterns, foliage,
flowers, or cones, as injury may result.
Use limited to ID, OR, and WP. Directed
spray. Postemergence. fipply in £0 to 100
gallons of water per acre. Spray in inter-
spaces and around the base of hop plant-
ings. Do not apply around hop vines less
than 10 feet tall. Retreatment or spot
treatment may be necessary.
(Cascade, Yakima Cluster and Bullion varieties)
O. 50
(£ Ib/gal SC/L)
Kiwi Fruit
/OSOllflft
O.50-1.0O
(£ Ib/gal SC/L)
Postemergence. Directed spray. flpply in
£O to 1OO gallons of water per acre. For
suckering and stripping, spray only basal
£ feet of vines. Do not apply to hop
vines less than 1O feet tall. Repeat as
necessary.
0.OS ppm
Do not treat more than 3 times per year.
14 day preharvest interval.
GeneraIInformat i on 8 Do not allow spray
to contact green stems, fruit or foliage.
Use a shield when spraying young trees.
Directed spray. ftpply in 3O to ISO gal-
lons of water per acre. Retreatment or
spot treatment may be necessary for
hard—to-kill weeds.
Issued: 4-11-85
1-061601-15
141
-------
/130£0ftft
Site, Dosage
and Formulation
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Site. Dosage
and Formulation
(Ib cation/ft)
/14011AA Onions
O. 50-1.OO
(£ Ib/gal SC/L)
Tolerance. Use. Limitations
O.O5 ppm (dry, bulb, green onions)
£OO day preharvest interval in CA.
60 day preharvest interval elsewhere.
Preplant or preemergence. Broadcast to
seeded onions. Apply in £O to 1OO gallons
of Mater per acre. Allow maximum weed
emergence prior to treatment. Use the
higher dosage for heavy weed infestation
and for control of wild oats. Seeding
should be done with a minimum of soil dis-
turbance.
/060140ft
Papaya
Passion Fruit
/28035ftft
Pastures
O. £5-O.5O
(£ Ib/gal SC/L)
O.£5-O.5O
(£ Ib/gal SC/L)
See Acerola cluster.
O. £ ppm
Do not graze treated areas.
General Information; If bark is still
green, wrap vine prior to application to
prevent injury. If applied during har-
vest, apply only after picking fruit off
the ground.
Refer to Guava for dose and use patterns.
5 ppm (grass, pasture, rangeland)
Genera1 Informat i on; Use band treatment
when recovery of sprayed sod is desired.
Broadcast when existing grass species are
undesirable and total suppression is need-
ed.
Broadcast or band. Apply in sufficient wa-
ter to make 17 to 75 gallons of dilute
spray per acre. Use as a broadcast treat-
ment when existing grass should be sup-
pressed and as a band treatment when recov-
ery of existing grass is desired.
Use limited to east of Rocky Mountains.
Broadcast or band. Apply prior to or at
time of seeding grasses or forage legumes
such as alfalfa, clover and birdsfoot tre-
foil. Use the higher rate to suppress vig-
orous and coarse sod species such as
brome. Apply only to pastures which are
not more than £ to 3 inches in height.
Issued: 4-11-85
I-O616O1-17
143
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Site, Dosage
and Formulation
(Ib cation/ft)
Pastures (continued)
O.£5-0.5O
(£ Ib/gal SC/L)
Tolerance. Use. Limitations
/05O04AA
Peach
0.50-1.00
(£ Ib/gal SC/L)
O. 5O-1.00
<£ Ib/gal SC/L)
Use limited to west of Cascade and Sierra
Nevada Mountains. Broadcast or band. fip-
ply prior to or at time of seeding grasses
such as hardinggrass and Palestine orchard-
grass. Apply in October through December
after first fall rains and after weeds
have emerged. Apply on moderate to heavi-
ly grazed areas. Do not use in areas with
heavy sod and weed growth.
O.OS (N) ppm
Do not graze treated areas. Do not treat
trees established less than 3 years. Do
not replant in treated soil.
General Information; Do not allow spray
to contact green sterns, fruit or foliage.
Use a shield when spraying around young
trees. Make only 1 application per year.
Apply only in orchards where trees have
been established 1 year or more.
Use limited to CA. Postemergence. Direct-
ed spray. Apply in 3O to 150 gallons of
water per acre. Do not allow spray to con-
tact green stems, fruit or foliage. Use a
shield when spraying around young trees.
Retreatrnent or spot treatment may be neces-
sary for hard-to-kill weeds.
Use limited to OR, LA, MO, OK, TX, and
states East of the Mississippi River- Di-
rected spray. Postemergence. Tank mix
with simazine. Apply in 50 to £OO gallons
of water per acre. Use the lower dosage
on coarse textured or low organic matter
soils, and the higher dosage on fine tex-
tured or high organic matter soils.
See Apple cluster.
See Beans (lima) cluster.
Issued: 4-11-85
I-O61601-18
144
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
/03008AA
Site, Dosage
and Formulation
-------
/06013ftft
/030110ft
Site. Dosage
and Formulation
(Ib cation/ft)
Pineapple
O.50-1.OO
(£ Ib/gal SC/L)
Pistachio
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Tolerance. Use, Limitations
/14O13AA
Plum (fresh prunes)
Potato
O.1£-O.£5
<£ Ib/gal SC/L)
O.25-O.SO
(£ Ib/gal SC/L)
O. OS (N) ppm
2O day preharvest interval.
Directed spray. Posternergence. Apply in
1OO to £00 gallons of Mater per acre. Re-
treatment may be necessary on more mature
Meeds.
O.05 ppm
O. OS (N) ppm (nuts)
Do not exceed £ applications after shell
split.
7 day preharvest interval.
Do not graze treated areas or feed cover
crops grown in treated areas to livestock.
Refer to Kiwi Fruit for dose and use infor-
mation.
See Acerola cluster.
O. 5 ppm
3 day preharvest interval. Do not graze
livestock in treated potato fields.
Genera1 Inforrnat ion; To avoid injury to
subsequent crops, do not use on mulch or
peat soils. Do not use for desiccating po-
tato vines when potatoes are to be stored
or used for seed. Odd a non—ionic surfac-
tant to the finished spray.
Use limited to CO. For control of emerged
volunteer barley. Prep1ant. Broadcast.
Apply in 5 to 1O gallons of water per acre
by air to preformed seedbeds.
Preplant or preemergence. Broadcast. fip~
ply in 30 to 1OO gallons of water per acre
by ground or in 5 to 1O gallons of water
per acre by air. Delay application to pro-
vide maximum weed emergence but not later
than ground cracking.
Issued: 4-11-65
I-O616O1-2O
146
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Site. Dosage
and Formulation
(Ib cation/ft)
Potato
-------
EPft Compendium of ftcceptable Uses
PftRftQUftT DICHLORIDE
/130S3flft
Site, Dosage
and Forrnulat ion
(Ib cation/fi)
Rhubarb
/£7008ftft
/£8O19ftft
/S4OO6ftfi
O. 5O-1.OO
(£ Ib/gal SC/L)
Safflower
O. 1£-O.£5
(£ Ib/gal SC/L)
0.5O-1.OO
(£ Ib/gal SC/L)
Sorghum
0.5O-1.0O
(£ Ib/gal SC/L)
Tolerance. Use, Limitations
O. OS (N) ppm
Do not graze treated areas.
General Information; Do not apply more
than £ applications per season.
Dormant application. fipply before crown
buds begin to grow. ftpply 5O to 150 gal-
lons of spray mix per acre.
O.05 (N) ppm (seed)
Use limited to Cft. For control of emerged
volunteer barley. Prep1ant. Broadcast.
Apply by air in 5 to 1O gallons of water
per acre. fipply to preformed seedbeds.
Prep1ant or preemergence. Broadcast or
band. fipply in £O to 60 gallons of water
per acre by ground or in 5 to 10 gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
O.OS (N) ppm (forage, grain)
Preplant or preemergence. Broadcast or
band. fipply in £0 to 60 gallons of water
per acre by ground or in 5 to 10 gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit minimum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
Sorghum (grain crop) O.O5 ppm (forage, grain)
0. £5-O.SO
(£ Ib/gal SC/L)
O.£5-O.SO
(£ Ib/gal SC/L)
Preemergence. Broadcast. Tank mix with
atrazine.
Preplant or preemergence. For control of
barnyardgrass, crabgrass. and fall pani-
cum. Tank mix with atrazine and terbu-
tryn. fipply in £O to 6O gallons of water
per acre. Use where sorghum will be plant-
ed directly into previous crop residues.
Issued: A-11-85
I-O616Ol-2£
148
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EPfi Compendium of ftcceptable Uses
PPROQUfiT DICHLORIDE
Tolerance. Use. Limitations
Site. Dosage
and Formulation
(Ib cation/ft)
Sorghum (grain crop) (continued)
O. £5-O.5O
(£ Ib/gal
SC/L)
/280230ft
Soybeans
O.£5-1.00
(£ Ib/gal SC/L)
O.£5-0.50
(£ Ib/gal SC/L)
0. £5
<£ Ib/gal SC/L)
Postemergence. Directed spray or band
treatment between the crop rows. For con-
trol of crabgrass and pigweed 3 inches or
less in height. Treat when crop is at
least 1£ inches tall. Use the lower rate
for weeds less than £ inches tall and the
higher rate for weeds £ to 3 inches tall.
ftpply in 2O to 40 gallons of water per
acre. Apply so that only the lower 3 inch-
es or less of sorghum stalk is sprayed.
O.05 (N) ppm (soybeans and forage)
Postemergence directed spray: Do not
graze treated areas or feed treated forage
to livestock. Preharvest broadcast: Do
not pasture livestock within 15 days after
treatment. Remove livestock from treated
fields at least 3O days before slaughter.
Do not use treated vines for feed or for-
age.
Genera1 Information; fipply in £0 to 6O
gallons of water per acre by ground or £
to 10 gallons by air. Seeding should be
done with a minimum of soil disturbances.
Prep1ant or preemergence. Broadcast or
band. Use the lower rate when spring
weeds are less than 4 inches high or when
a directed spray or cultivation will be
used within 3 weeks after planting. Seed-
beds should be formed as far ahead of
planting and treatment as possible to pei—
mit maximum weed emergence.
Prep 1 ant or preernergence. Broadcast. For
use in minimum tillage systems. Tank mix
with alachlor and linuron.
Preemergence. Broadcast or band. Tank
mix with linuron. For use where soybeans
will be planted directly into preformed
bed, cover crop, or in previous crop resi-
dues.
OR
Issued: 4-11-85
I-0£lG01-£3
149
-------
Site. Dosage
and Formulation
(Ib cation/8)
Soybeans (continued)
0. 25-O.50
(2 Ib/gal SC/L)
EPft Compendium of Acceptable Uses
PflRRQUflT DICHLORIDE
Tolerance, Use, Limitations
0.£5-O.50
<2 Ib/gal SC/L)
0. 25-1.0O
(2 Ib/gal SC/L)
O.25-0.50
(2 Ib/gal SC/L)
0.O63-0.125
(2 Ib/gal SC/L)
0.1S-O.25
(2 Ib/gal SC/L)
Preernergence. Broadcast. Tank mix with
rnetribuzin. For preernergence control of
smartweed, pigweed, and cocklebur. Use
the higher dosage if weeds are 4 to 6 inch-
es tall.
OR
Preemergence. Broadcast. Tank mix with
alachlor and metribuzin. For preernergence
control of smartweed, piqweed. cockleburt
foxtai1T and crabgrass. Use the higher
dosage if weeds are 4 to 6 inches tall.
Preernergence. Broadcast. Tank mix with
pendirnethalin and metribuzin or linuron
and metribuzin. Use the higher dosage for
dry conditions or when weeds are 3 to 6
inches tall.
Preemergence. Broadcast.
oryzalin and metribuzin.
Tank mix with
Postemergence. Directed spray or directed
band application between crop rows. Use
the lower rate for control of seedling
/iohnsongrassT crabgrass. goose grass, bra-
chiaria. Texas millet and pigweed less
than 2 inches tall. Use the higher rate
for weeds 2 to 4 inches tall. Do not
treat if crop is less than 8 inches tall.
Retreat after 7 to 14 days if needed. Do
not treat more than twice.
Preharvest. Broadcast. flpply when soy-
bean plants are mature. Use the higher
rate for control of cocklebur.
Issued: 4-11-85
I-OS1601-24
150
-------
EPfl Compendium of Acceptable Uses
PRRAQUAT DICHLORIDE
Site. Dosage
a r. w For m u 1 a t i o n
(Ib cat ion/A)
Tolerance, Use. Limitations
Soybeans (centinued)
CSLND
0. 1£
(£ Ib/gal BC/L)
/OlOl&flfl
Squash
Strawberries
/£500£Rfi
0. 5
(£ Ib/gal SC/L)
Sugar Beets
O.1£-O.£5
(£ Ib/gal SC/L)
0. 5O-1.OO
<£ Ib/gal SC/L)
SLN - Use limited to RR.
Postemergence. Directed spray or band
treatment. For control of annual broad—
leaf weeds £ to 3 inches tall and grasses
£ to 4 inches tall. flpply the first spray
when soybeans are 8 inches tall and a sec-
ond spray 7 to 14 days later. Rpply £O
gallons of finished spray per acre to the
lower 3 inches of the soybean plant. R
non-ionic surfactant may be applied to the
finished spray. Do not apply more than £
applications per year.
See Beans (lima) cluster.
0.£5 ppm
Do not graze livestock in treated areas.
£1 day preharvest interval.
Do not apply more than 3 times per season.
Postemergence. Directed spray. flpply in
£0 to GO gallons of water per acre. Use
ground equipment directing spray between
the rows.
0.5 ppm (sugar beets and tops)
Use limited to Cfl. For control of emerged
volunteer barley. Prep1ant. Broadcast.
Rpply by air in 5 to 10 gallons of water
per acre. flpply to preformed seedbeds.
Preplant or preernergence. Broadcast or
band. flpply in £0 to &0 gallons of water
per acre by ground or in 5 to 10 gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
Issued: 4-11-85
I-O61601-£5
151
-------
EPfl Compendium of ficceptable Uses
PftRfiQUftT DICHLORIDE
/25003AO
Site, Dosage
arid Formal at ion
(Ib cation/ft)
Sugarcane
O. £5-0.50
(£ Ib/gal SC/L)
0.50
(2 Ib/gal SC/L)
0.50
<£ Ib/gal SC/L)
O.12-0.25
(2 Ib/gal SC/L)
To 1 er-ance. Use. Limitations
O.5 (N) ppm
Postemergence directed spray in Lfi: 30
day preharvest interval.
General Information; When using directed
sprays, apply when weeds are 2 to 6 inches
high. ftvoid contact with cane foliage.
Make a second and final application, if
necessary, when new growth is 2 to & inch-
es high.
Use limited to Lft. Postemergence. Direct-
ed spray. fipply in £O to £00 gallons of
water per acre. For tiller control, apply
when tillers are less than 18 inches
high. Use the higher rate with heavier
weed growth or tiller growth.
Use limited to FL. Posternergence. Direct-
ed spray. fipply in 5O to 10O gallons of
water per acre. fipply early in the season
(March to fipril). Do not apply after June
1st, as cane growth may be stunted and
yield reduced.
Use limited to HI. Posternergence. Direct-
ed spray. fipply in 20 to 2OO gallons of
water per acre. Do not apply after cane
rows have closed in.
Use limited to FL and TX. Preharvest des-
iccation. Broadcast. fipply by air in 4 to
1O gallons of water per acre. fipply to ma-
ture plant or stubble cane. Use the high-
er rate under cool, cloudy conditions. ftp-
ply 3 to 14 days before burning and hai—
vest. For best results, apply when the
weather is clear and warm.
/£701100
Sunflower (oil crop) £ ppm (seeds)
O.50-1.00
(£ Ib/gal SC/L)
e ppm (seeds;
Do not graze treated areas or feed treated
forage to livestock.
Preplant or preernergence. Broadcast or
band. ftpply in £0 to 60 gallons of water
per acre by ground or in 5 to 1O gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
Issued: 4—11-85
I-061601-£6
152
-------
EPfl Compendium of ficceptable Uses
PfiRftQUftT DICHLORIDE
Site. Dosage
ar.i! Formulation
(Ib cation/Pi)
Tolerance. Use. Limitations
Sunflower (oil crop) (continued)
O.£5-0.5O
(£• Ib/gal SC/L)
/11005P.fi Tomato
0.1£-0.£5
(£ Ib/gal SC/L)
O.50-1.00
(£ Ib/gal SC/L)
0. 50
(£ Ib/gal SC/L)
Turni PS
Preharvest desiccation. Broadcast. fipply
when sunflower seeds reach physiological
maturity and harvest 7 to £1 days after ap-
plication, fipply in £O to 40 gallons of
water per acre by ground or 5 gallons by
air. Use the higher rate when crop stands
or weed infestations are heavy.
0.05 pprn (vegetables, fruiting)
Use limited to Cfi. For control of
emerged volunteer barley. Preplant.
Broadcast. fipply by air in 5 to 10 gal-
lons of water per acre. fipply to pre-
formed seedbeds.
Preplant or preemergence. Broadcast or
band. ftpply in £O to 6O gallons of water
per acre by ground or in 5 to 1O gallons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
Use limited to Middle fttlantic, Southeast,
South Central regions and Southwest to the
Western boundary of TX. Postemergence.
Directed spray. Band application between
the rows. fipply in £O to 1OO gallons of
water per acre. Use shields to protect
crop plants. Can be used between plastic
mulch covered rows. Do not make more than
3 applications per crop season.
See Beans (lima) cluster.
Issued: 4-11-85
I-O&1601-£7
153
-------
EPA Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
/O3O09AA
Site. Dosage
and Formulation
(Ib cation/ft)
Walnut
O. 5-1.OO
(£ Ib/gal SC/L)
O. 5-1.00
(£ Ib/gal SC/L)
/£8065AA
Tolerance, Use. Limitations
O.05 (N) ppm (nuts)
Make only 1 application per year. Apply
only in orchards where trees have been es-
tablished 1 year or more.
General Information; Do not allow spray
to contact green stems, fruit or foliage.
Use a shield when spraying around young
trees.
Directed spray. Apply in 3O to 150 gal-
lons of water per acre.
Use limited to CA. Directed spray. Tank
mix with simazine. Apply in 5O to £00 gal-
lons of water per acre. Use the lower dos-
age on coarse textured or low organic mat-
ter soils, and the higher dosage on fine
textured or higher organic matter soils.
Do not apply to sandy soil.
See Beans (lima) cluster.
0.05 (N) pprn (grain)
Do not graze treated areas.
Broadcast or band. Prep 1 ant or preerner-
gence. Apply in £0 to 60 gallons of water
per acre by ground or in 5 to 1O ga.llons
of water per acre by air. Seedbeds should
be formed as far ahead of planting and
treatment as possible to permit maximum
weed emergence. Seeding should be done
with a minimum of soil disturbance.
(Noncrop. Wide Area, and General Indoor/Outdoor Treatrnents)
Watermelon
Wheat
O.£5-1.00
(£ Ib/gal SC/L)
/66OO£AA
Fallowland
O. £5-O.5
(£ Ib/gal SC/L)
Broadcast. Apply to postharvest wheat
stubble. Use £O to 60 gallons of water by
ground or in 5 to 10 gallons of water per
acre by air. Odd a non-ionic surfactant.
May be tank mixed with £,4-D or banvil.
Issued: 4-11-85
I-O616Ol-£8
154
-------
EPft Compendium of ftcceptable Uses
PftRftQUOT DICHLORIDE
Site. Dosage
and Formulation
(Ib cat ion/ft)
Tolerance. Use. Limitations
TERRESTRIftL NONFOOD CROP
(Ornamental Plants and Forest Trees)
General Warnings and Limitations; Do not use around home gar-
dens, schools, recreational parks or playgrounds.
/35094-ftft ftpple (ornamental)
/35021fift ftrborvitae
/3502Eftft fish
/35095ftft Citrus (ornamental)
/3B049ftft Elm
/35352ftft F i1bert (ornamental)
/35051ftfl Fir
/35052ftft Flowering ftlmond
/350530ft Flowering ftpricot
/35055flft Flowering Cherry
/35058ftft Flowering Peach
/35059ftfl Flowering Pear
/35060ftft Flowering Plum
/35093ftft Oak
/35367RO Olive (ornamental)
/35098RO Pine
O.5O-1.OO
(2 Ib/gal SC/L)
/330100ft Ornamental Lawns
/SSOOOOft Ornamental Plants
(flower beds and
foundation plant-
ings)
/SSOOOOft Ornamental Trees
/34004Qft Ornamental Woody
/670110ft Shrubs
CMRI3
(0.276% prL)
General Informations Do not allow spray
to contact green stems, fruit or foliage.
Use a shield when spraying around young
trees.
Directed spray. ftpply in 3O to 15O gal-
lons of water per acre. Retreatrnent or
spot treatment may be necessary for
hard-to-kill weeds.
General Informations Treated areas may
reseeded £4 hours after application.
be
Edging and spot treatment. Directed
spray. Spray weeds thoroughly. Repeat
plication when necessary.
Formulated with petroleum distillates.
ap-
Issueds 4-11-85
I-OS1601-29
155
-------
/35353flfl
EPft Compendium of Pcceptable Uses
PftRftQUfiT DICHLORIDE
Site. Dosage- Tolerance. Use. Limitations
and Formu1at ion
-------
EPfl Cornpendi urn of Occeptable Uses
PftRftQUftT DICHLORIDE
Site. Dosage Tolerance. Use. Limitations
and Formulation
(Ib cation/ft)
FORESTRY
General Warnings and Limitations; Do not use around home gardens,
schools, recreational parks or playgrounds. Do not allow animals
to graze on treated areas.
/30019flfl ftrborvitae (shelter-
belt) General Information; Do not allow spray
/3004£ftft Elm (shelterbelt) to contact green stems, fruit or foliage.
/30043ftft Fir (shelterbelt) Use a shield when spraying around young
/300578ft Oak (shelterbelt) trees.
/30058ftft Pecan (shelterbelt)
/300590ft Pine (shelterbelt)
0.5O-1.OO Directed spray. ftpply with a non—ionic
(£ Ib/gal SC/L surfactant in 50 to £OO gallons of water
per acre. Do not allow spray to contact
green stems, fruit or foliage. Use a
shield when spraying around young trees.
Retreatment or spot treatment may be neces-
sary for hard—to—kill weeds.
Issued; 4-11-85 I-O616O1-31
157
-------
EPfl Compendium of acceptable Uses
PfiRfiQUfiT DICHLORIDE
Site. Dosage
and Form u 1 at i on
(Ib cation/ft)
'3509Bfifi Pine (Loblolly, Long-
leaf, Pitch, Pond,
Short leaf, Slash,
Spruce, Virginia)
0.30-5.00% cation
(wt/wt)
(£ Ib/gal SC/L)
1.00%-A.00% cation
(wt/wt)
(£ Ib/gal SC/L)
Tolerance, Use, Limitations
General Information; Select trees from
sites not subject to periods of extreme
drought and from vigorous, non—stagnated
stands either natural or planted. In stag-
nated stands or commercial timber stands,
do not treat sooner than 3 years after com-
mercial thinning. Resin soaking can occur
from treatments made any time of the year,
however, cool season treatments under non-
drought conditions are recommended. The
interval between application and tree har-
vest should be at least 6 months, prefera-
bly 1£ to £4 months. Treatment may encour-
age beetle attack or cause premature death
of tree. Desiccation of xylem tissue,
rather than resin soaking, is more likely
at higher dosages. Treatment can result
in reduced stem growth.
Bore—hole application. Plant regulator
(resin soaking). Bore O.38 to O.6£ inch
holes £ to G inches deep, depending on
tree diameter, sloping slightly downward
rather than directly towards center of
tree. Lower concentrations are usually ap-
plied at higher volumes of 15 to 35 milli-
liters per tree, resulting in application
of 45 to 1OO milligrams per tree. Using £
to 4 percent solutions and applying 5 mil-
liliters per single hole per tree results
in application of 1OO or £OO milligrams
per tree. Forty—five to 1OO milligrams
per tree have resulted in effective
oleo-resin induction.
Tree injection. Plant regulator (resin
soaking). Injections should be made be-
neath bark and just beneath cambium lay-
er. Make injections 1 to £ inches apart
around one-third of tree circumference, or
no closer than 3 inches apart all around
tree. fipply O.£ to O.4 milliliters per in-
jection. Using £ to 4 percent solution re-
sults in 36 to 144 milligrams chemical ap-
plied per 9 inch diameter tree, for holes
spaced 1 inch apart around one-third of
tree or 3 inches apart all around tree.
Issued: 4-11-85
I-O61601-3£
158
-------
EPfl Compendium of Occeptable Uses
PGRftQUfiT DICHLORIDE
Site. Dosage
and Formalat ion
(Ib cat ion/A)
Pine (continued)
1. 00'/--5. CO'/, cat ion
(wt/wt)
<£ Ib/gal SC/L)
Tolerance. Use. Limitations
Bark cut treatment. Plant regulator
(resin soaking). Remove a 1 inch wide
streak of bark about 1 to 2 feet from
ground level. Total length should not ex-
ceed one-third of tree circumference. ftp-
ply spray to exposed xylem to run-off.
For a 9 inch diameter tree, 3 milliliters
of spray will cover the streak. Using 3
rnilliliters of £ to A percent solution
will result in applications of BO to 120
milligrams of chemical per streak.
90015OO
QERIflL ftND TflNK MIX flPPLICflTIONS
fierial Application
— Refer to
99003OO
Tank Mix
TERRESTRIQL FOOD CROP
(agricultural Crops)
fllfalfa, Barley, Clover, Corn, Cotton,
Lettuce, Melons, Peppers, Potato,
Safflower, Sorghum, Soybeans, Sugar Beet,
Sugarcane, Sunflower (oil crop), Tomato,
Wheat
Refer to
TERRESTRIAL FOOD CROP
(ftoricultural Crops)
fllfalfa, Asparagus, ftpple, Corn, Corn
(Field), Cotton, Peach, Pear, Peppermint
(Spearmint), Sorghum (grain crop). Soy-
beans, Walnuts
(Noncrop. Hide ftrea. and General
Indoor/Outdoor Treatments)
Fallowland
Issued: 4-11-85
I-0616O1-33
159
-------
EPfl Compendium of acceptable Uses
PfiRftQUftT DICHLORIDE
Listing of Registered Pesticide Products by Formulation
&-029. 1002 £9. IS formulation intermediate
paraquat dichloride (O616O1)
010182-00113
&043.5002 A3.5% formulation intermediate
paraquat dichloride (O616O1)
010182-00115
&102.0015 2 Ib/gal soluble concentrate/1iguid
paraquat dichloride (O61&O1)
Ol0182-00074 O101BS-OO111 O1O1B2-OO11S 051O36-OOO77
<01O182-O0111> PL86O002 OR7900O8
&220.4015 £O.4% soluble concentrate/1iguid
paraquat dichloride (O61601)
010182-OO103*
•a-jacket currently unavailable for review.
&200.2819 0.27&% pressurized liquid
paraquat dichloride (O616O1) plus petroleum distillates (O63503)
010182-00114
9999999 State Label Registrations
Cft Reg. No.
OOO239-O4224
HI Reg. No.
O37843-O8551
Issued: 4-11-85 I-O616O1-34
160
-------
EPfl Compendium of flcceptable Uses
PPRftQUfiT BICHLORIDE
ftppendix ft-1
Listing of ftctive Ingredient(s) Found in Combination with the
Report Chemical
Chemical Common Name EPft ftcceptable
Code (source) Common/Chemical Name
O63503 petroleum distillate —
— Use Common Name
Issued: 4-11-85 I-O616O1-35
161
-------
EPfi Compendium of Acceptable Uses
PARAQUAT DICHLORIDE
Appendix A-£
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chemical
Code
1001O1
030OO1
O£98O1
1011O1
Common Name
(source)
cyanazine (ISO)
£, 4-D
dicamba
metribuzin
EPft Acceptable
Common/Chemical Name
£-CC4-chloro-6-
(ethylamino)—S—triazi
n-£-y13-am i noD-£-
methyl propionitrile
£,4-dichlorophenoxy-
acetic acid
A—amino—6—(1,1—di-
methylethy1)—3-
(methylthio)-l,£, 4-
triazin-5(4H)-one
— Use Common Name
Issued: 4-11-85
I-O616O1-36
162
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APPENDIX IV
BIBLIOGRAPHY
163
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been 'considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM 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.
164
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??) , the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
165
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00015751 Rose, W.; Worsham, D.; Slagowski, J.L. (1978) Metolachlor
(Dual(R) 8E); Atrazine (AAtrex(R) 80W); Paraquat (Paraquat
CL): AG-A No. 4959 1,11. (Unpublished study received Mar 16,
1979 under 100-583; prepared in cooperation with EN-CAS Labora-
tories and Chevron Chemical Co., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237819-F)
00015752 Kern, C.L.; Staniforth, D.; Slagowski, J.L. (1978) Metolachlor
(Dual(R) 8E); Atrazine (AAtrex(R) SOW or 4L); Paraquat
(Paraquat CL): AG-A No. 5000 1,11 (Unpublished study received
Mar 16, 1979 under 100-583; prepared in cooperation with Iowa
State Univ., EN-CAS Laboratories and Chevron Chemical Co., sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237819-H)
00015768 Kincaid, L.; Slagowski, J.L. (1978) Metolachlor + Linuron + Para-
quat; Dual 8E + Lorox 50W + Paraquat 2CL: AG-A No. 4762 1,11.
(Unpublished study including letter dated May 23, 1978 from J.D.
Riggleman to Robert A. Kahrs, received Mar 16, 1979 under 100-
583; prepared in cooperation with Chevron Chemical Co. and E.I.
du Pont de Nemours & Co., Inc., submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:237821-J)
00015769 Searcy, V.; Herman, D.; Slagowski, J.L. (1978) Metolachlor + Linu-
ron + Paraquat: Dual 8E + Lorox 50W + Paraquat 2CL: AG-A
No. 4892 1,11. (Unpublished study including letter dated
May 23, 1978 from J.D. Riggleman to Robert A. Kahrs, received
Mar 16, 1979 under 100-583; prepared in cooperation with Chevron
Chemical Co. and E.I. du Pont de Nemours & Co., Inc., submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-L)
i
00015770 Schnappinger, M.G.; Slagowski, J.L. (1978) Metolachlor + Linuron +
Paraquat (Dual 8E + Lorox 50W + Paraquat 2CL): AG-A No. 4915 I,
II. (Unpublished study including letter dated May 23, 1978 from
J.D. Riggleman to Robert A. Kahrs, received Mar 16, 1979 under
100-583; prepared in cooperation with Chevron Chemical Co. and
E.I. du Pont de Nemours & Co., Inc., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:237821-L)
00015771 Rose, W.; Worsham, D.; Slagowski, J.L. (1978) Metolachlor + Linuron
+ Paraquat: Dual(R) 8E + Lorox 50W + Paraquat 2CL: AG-A
No. 4955 I,II. (Unpublished study including letter dated May
23, 1978 from J.D. Riggleman to Robert A. Kahrs, received Mar
16, 1979 under 100-583; prepared in cooperation with Rocky Mount
Experiment Station, Chevron Chemical Co. and E.I. du Pont de
Nemours & Co., Inc., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:237821-M)
166
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00015772 Kincaid, L.; Slagowski, J.L. (1978) Metolachlor (Dual(R) 8E);
Metribuzin (Sencor 50W); Paraquat (2C1): AG-A No. 4764 1,11.
(Unpublished study including letter dated May 23, 1978 from
J.D. Riggleman to Robert A. Kahrs, received Mar 16, 1979 under
100-583; prepared in cooperation with E.I. du Pont de Nemours &
Co., Inc. and Chevron Chemical Co., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:237821-M)
00015773 Searcy, S.; Herman, D.; Slagowski, J.L. (1978) Metolachlor
(Dual(R) 8£); Metribuzin (Sencor 50W); Paraquat (2C1): AG-A
No. 4894 1,11. (Unpublished study including letter dated
May 23, 1978 from J.D. Riggleman to Robert A. Kahrs, received
Mar 16, 1979 under 100-583; prepared in cooperation with E.I. du
Pont de Nemours & Co., Inc. and Chevron Chemical Co., submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-0)
00015774 Schnappinger, M.G.; Slagowski, J.L. (1978) Metolachlor (Dual(R)
8E); Metribuzin (Sencor SOW); Paraquat (2 Cl): AG-A No. 4916 I,
II. (Unpublished study including letter dated May 23, 1978 from
J.D. Riggleman to Robert A. Kahrs, received Mar 16, 1979 under
100-583; prepared in cooperation with E.I. du Pont de Nemours &
Co., Inc. and Chevron Chemical Co., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:237821-P)
00015775 Rose, W.; Worsham, D.; Slagowski, J.L. (1978) Metolachlor (Du-
al (R) 8E); Metribuzin (Sencor 50W); Paraquat (Cl): AG-A No.
4957 1,11. (Unpublished study including letter dated May 23,
1978 from J.D. Riggleman to Robert A. Kahrs, received Mar 16,
1979 under 100-583; prepared in cooperation with E.I. du Pont
de Nemours & Co., Inc. and Chevron Chemical Co., submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:237821-Q)
00015955 Luke, J.E.; Slagowski, J.L. (1978) Metolachlor (Dual(R) 8E);
Atrazine (AAtrex(R) SOW); Paraquat (Paraquat CL): AG-A
No. 4964. (Unpublished study received Mar 16, 1979 under 100-
583; prepared in cooperation with EN-CAS Laboratories and Chev-
ron Chemical Co., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:237819-G)
00016441 Thomas, J.; Herman, D.; Slagowski, J.L. (1977) Residue Report:
Field Corn: AG-A No. 4167 II. (Unpublished study received Nov
10, 1977 under 100-EX-59; prepared in cooperation with Chevron
Chemical Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:232192-I)
167
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00016442 Coan, R.M.; Karusta, G.; Slagowski, J.L. (1977) Residue Report:
Field Corn: AG-A No. 4187 11,111. (Unpublished study received
Nov 10, 1977 under 100-EX-59; prepared in cooperation with
Chevron Chemical Co., submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL-.232192-J)
00016444 Westmoreland, W.G.; Slagowski, J.L. (1977) Residue Report: Field
Corn: AG-A No. 4247 11,111. (Unpublished study received Nov 10,
1977 under 100-EX-59; prepared in cooperation with Chevron Chem-
ical Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
232192-L)
00016445 Davidson, W.E.; Slagowski, J.L. (1977) Residue Report: Field Corn:
AG-A No. 4288 I,II. (Unpublished study received Nov 10, 1977
under 100-EX-59; prepared in cooperation with Chevron Chemical
Co., submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
232192-M)
00023131 Leary, J.B.; Slagowski, J.L.; Marxmiller, R.L. et al. (1979) Sum-
mary of Residue Data. (Unpublished study received Jan 10, 1980
under 201-279; prepared in cooperation with Chevron Chemical Co.
and others, submitted by Shell Chemical Co., Washington, D.C.;
CDL:241596-B)
00023329 Ross, J.A.; Tucker, B.V.; White, J.C.; et al. (1978) Residues in
Sour Cherries, Plums, Grapes, Pecans, Filberts, Lemons and
Oranges. Resulting from the Application of Simazine in Tank Mix-
ture with Paraquat: Report No. ABR-78042. (Unpublished study
received Aug 2, 1978 under 100-437; prepared in cooperation with
Chevron Chemical Co. and En-Cas Laboratories, submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:234570-A)
00023512 Houseworth, L.D.; Schnappinger, H.G.; Slagowski, J.L.; et al.
(1979) Tank Mixes of Metolachlor (6E, 8E) plus Simazine and/or
Atrazine plus Paraquat or Glyphosate—Corn: Summary of Residue
Data: Report No. ABR-79105. (Unpublished study received Dec 10,
1979 under 100-583; prepared in cooperation with Chevron Chem-
ical Co. and others, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:241647-A)
00023883 Thompson, R.; Jensen, ?; Elmore, C.; et al. (1974) Crop Residue
Studies Summary for Devrinol 50-WP (4 Lbs. A.I./A) Tank Mixed
with Simazine 80-WP (0.5-1 Lb.A.I./A) and/or Paraquat
(1 L.b.A.I./A) in California/Arizona. (Unpublished study re-
ceived Dec 17, 1974 under 476-2150; prepared in cooperation with
Kern County Land Company and others, submitted by Stauffer Chem-
ical Co., Richmond, Calif.; CDL:028423-J)
168
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00025268 Freeman, C.R.; Dewey, M.L.; Kensler, D.L., Jr.; et al. (1975) Sum-
mary: Residues in Soybeans after a Tank-Mix, No-Till Application
of Paraquat CL, Lasso, and Sencor. (Unpublished study received
Jul 2, 1975 under 239-2186; prepared in cooperation with Morse
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:119803-C)
00025269 Chevron Chemical Company (1974) Analysis of Paraquat Residues.
Method RM-8-6 dated Nov 5, 1974. (Unpublished study received
Jul 2, 1975 under 239-2186; CDL:119803-D)
00026963 Freeman, C.R.; Dewey, M.L.; Pinkerton, G.; et al. (1975) Summary:
Residues of Paraquat and Atrazine in Grain Sorghum after a Tank-
Mix, No-Till Application. (Unpublished study received Jun 24,
1975 under 239-2186; prepared in cooperation with Morse Labora-
tories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:110503-B)
00027178 Kalens, K.J.; Kirby, B.W.; Kincade, R.T.; et al. (1971) Summary
Residue Tests in Grain Sorghum Resulting from Postemergence Di-
rected Sprays of Paraquat Alone or a Tank-Mixture of Paraquat
and Atrazine. (Unpublished study received Jun 24, 1975 under
239-2186; prepared in cooperation with Pattison's Laboratories,
Inc. and others, submitted Chevron Chemical Co., Richmond,
Calif.; CDL:221809-B)
00027298 Thompson, J.P.; Rivers, J.B.; Reddy, K.P.; et al. (1968) Residue
Data Sheet: Test No. T-1466. (Unpublished study including test
nos. T-1467, T-1462, T-1463..., received Feb 8, 1968 under
7F0592; prepared in cooperation with U.S. Laboratories, Inc. and
Pattison's Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:090763-A)
00027311 Imperial Chemical Industries, Limited (1965) Residues of Gramoxone
in Wheat. (Unpublished study received Nov 11, 1970 under
1F1014; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:091758-B)
00027550 Yavssey, L.O. (1978) Devrinol(R) Selective Herbicide: Summary of
Crop Residue Data on Nuts. (Unpublished study received Feb 25,
1980 under 476-2108; prepared in cooperation with Fowler Farm
Management and Reedly College, submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL:099271-C)
169
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00027695 Bauermeister, F.H. (1968) Field Data Sheet for Tenoran™(R)t.
(Unpublished study received Nov 29, 1968 under 8192-4; submitted
by Ciba Agrochemical Co., Summit, N.J.; CDL:094766-BV)
00027965 Tucker, B.V.; Coan, R.M. (1973) Residue Report: Cherries: AG-A
No. 2605. (Unpublished study including test no. T-2390, re-
ceived Apr 19, 1974 under 100-437; prepared in cooperation with
Chevron Chemical Co. and Univ. of Michigan, submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:009436-P)
00027968 Tucker, B.V.; White, J.C. (1973) Residue Report: Grapes: AG-A
No. 2728 (Unpublished study received Apr 19, 1974 under 100-
437; prepared in cooperation with Chevron Chemical Co., sub-
mitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:009436-S)
00027971 Tucker, B.V. (1973) Residue Report: Walnuts: AG-A No. 2722. (Un-
published study received Apr 4, 1974 under 100-437; prepared in
cooperation with Chevron Chemical Co., submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:009436-V)
00027972 Hiddleson, L.; Tucker, B.V. (1973) Residue Report: Corn: AG-A
No. 2711. (Unpublished study received Apr 19, 1974 under 100-
437; prepared in cooperation with Chevron Chemical Co., submit-
ted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:009436-W)
00027973 Conner, B.J.; Tucker, B.V.; Thompson, L. (1973) Residue Report:
Corn: AG-A No. 2629 I-II. (Unpublished study received Apr 19,
1974 under 100-437; prepared in cooperation with Chevron Chemi-
cal Co. and Univ. of Kentucky, submitted by Ciba-Geigy Corp.,
Greensboro, N.C.; CDL:009436-X)
00027988 Hurst, H. (1975) 1975 Standardized Weed Control Tests: Test
No. 10883. (Unpublished study received Feb 18, 1977 under 100-
583; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
228112-X)
00028596 Hendley, P.; Leahey, J.P.; Spinks, C.A. (1976) Paraquat: Metabo-
lism and Residues in Hens: AR 2676A. (Unpublished study re-
ceived Mar 25, 1980 under 239-2186; prepared by ICI, submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:099330-B)
00028597 Hendley, P.; Leahey, J.P.; Spinks, C.A.; et al. (1976) Paraquat:
Metabplism and Residues in Goats: AR 2680A. (Unpublished study
received Mar 25, 1980 under 239-2186; prepared by ICI, submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:099330-C)
170
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00028598 Leahey, J.P.; Hendley, P.; Spinks, C.A. (1976) Paraquat: Metabolism
and Residues in Pigs Using 14C-Methyl Labelled Paraquat: AR-
2694A. (Unpublished study received Mar ?5, 1980 under 239-2186;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
099330-D)
00028599 Spinks, C.A.; Hendley, P.; Leahey, J.P.; et al. (1976) Paraquat:
Metabolism and Residues in Pigs Using 14C-Ring Labelled Para-
quat: AR 2692A. (Unpublished study received Mar 25, 1980 under
239-2186; prepared by ICI, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:099330-E)
00028772 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1973) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. Rev. By Univ. of California—Riverside, Dept.
of Entomology. Riverside, Calif.: UC, Agricultural Extension
Service. (Also in unpublished submission received Apr 2, 1980
under 454-556; submitted by Dow Chemical U.S.A., Midland, Mich.;
CDL:242149-Z)
00029001 Fink, R.; Beavers, J.B.; Grimes, J.; et alI. (1979) Acute Oral
LD50—Bobwhite Quail: Paraquat dichloride Technical Salt (SX-
1142): Project No. 162-121. Final Rept. (Unpublished study
received Feb 21, 1980 under 239-2422; prepared by Wildlife
International, Ltd., submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:241819-A)
00030476 Slagowski, J.L.; Hope, H.J.; Ogg, A., Jr.; et al. (1978) Residue
Chemistry Data: Paraquat CL—Vegetables: Residue Tolerance Peti-
tion. (Unpublished study received Apr 9, 1980 under OE2345;
prepared in cooperation with Louisiana State Univ., Horticulture
Dept. and others, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:099374-A)
00030647 Freeman, C.R.; Dewey, M.L.; Pate, D.A.; et al. (1973) Summary:
Residues of Paraquat and Aatrex (Atrazine) in Corn Resulting
from Post Emergence Directed Spray Applications of the Chemicals
in a Tank Mix. (Unpublished study received Jul 2, 1975 under
239-2186; prepared in cooperation with Morse Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
119806-C)
171
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
0003U676 Kincade, R.T.; Tucker, B.V.; Kalens, K.J.; et al. (1971) Residue
Data Sheet: Soybeans: Test No. T-1803. (Unpublished study in-
cluding test nos. T-1805, T-1806 and T-1994, received Jul 13,
1971 under 239-2186; prepared in cooperation with Pattison's
Laboratories, Inc. and others, submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:001476-B)
00030683 Kincade, T.; Dewey, M.L.; Johnson, R.R.; et al. (1970) Residue
Data: Summary: Paraquat. (Unpublished study received Jun 14,
1971 under 239-2186; prepared in cooperation with Monsanto Co.
and others, submitted by Chevron Chemical Co., Richmond, Calif.;
CLD:001473-B)
00030788 Grimshaw, P.; Hardy, C.J.; Cobb, L.M.; et al. (1979) Three Week In-
halation Study in Rats Exposed to an Aerosol of Paraquat (Repeat
Study). (Unpublished study received Feb 21, 1980 under 239-
2186; prepared by Huntingdon Research Centre, submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL-.241818-A)
00030929 Pack, D.E.; Baker, H.R.; Kurtz, G.W.; et al. (1972) Summary: Para-
quat: Residue Tolerance Petition—Nuts. (Unpublished study re-
ceived Feb 1, 1974 under 4F1481; prepared in cooperation with
Dal are Association, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:093933-B)
00031519 David, J.H.; Tyler, B.A.; Lewis, W.D.; et al. (1969) Summary—Res-
idue Data: Paraquat + Atrazine Registration Request: Corn—Pre-
plant, Pre-emergence Application. (Unpublished study received
Feb 3, 1969 under 239-1994; prepared in cooperation with Geigy
Chemical Corp. and others, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:001444-B)
00031739 Whipp, A.A.; Kalens, K.J. (1972) Summary of Residue Test Data for
the Tank-Mixture of Paraquat CL Spray and Cotoran SOW (Fluo-
meturon) on Cotton. (Unpublished study received Jul 30, 1973
under 239-2186; prepared in cooperation with Pattison's Labora-
tories, Inc. and others, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:026962-C)
00031742 Pate, D.A.; Dewey, M.L.; Kincade, R.T.; et al. (1973) Summary: Res-
idues of Paraquat and Lorox (Linuron) in Mature Soybeans Result-
ing from Post Emergence Directed Spray Applications of the Chem-
icals in a Tank Mix. (Unpublished study received Jul 30, 1973
under. 239-2186; prepared in,cooperation with Morse Laboratories,
Inc., submitted by Chevron Chemical Co.; Richmond, Calif.; CDL:
026962-H)
172
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard'
MRID CITATION
00031744 Baker, H.R.; Henning, R.C.; Dewey, M.L.; et al. (1971) Summary of
Residue Tests with a Tank-Mixture of Paraquat, Atrazine and
Simazine Applied as a Preplant, Preemergence Spray in Corn.
(Unpublished study received Jul 30, 1973 under 239-2186; pre-
pared in cooperation with Morse Laboratories, submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:026962-K)
00031863 Chu, Y.Y.; Miller, L.K.; Archer, T.E.; et al. (1979) Summary:
Paraquat. (Unpublished study received May 21, 1980 under 239-
2186; prepared in cooperation with Washington State Univ.,
Dept. of Horticulture and others, submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:099441-A)
00032140 Schinski, W.L.; Henning, R.C.; Agbakoba, C.S.O.; et al. (1977) Res-
idue Chemistry Data: Paraquat—Alfalfa. (Unpublished study re-
ceived Mar 27, 1980 under 239-2186; prepared in cooperation with
Morse Laboratories, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:242115-A)
00032141 Leary, J.B. (1978) Analysis of Paraquat Residues. Method RM-8-10
dated Apr 28, 1978. (Unpublished study received Mar 27, 1980
under 239-2186; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:242115-B)
00032240 Leary, J.B. (1978) Analysis of Paraquat Residues. Method RM-8-10
dated April 28, 1978. (Unpublished study received Apr 9, 1980
under OE2345; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:099374-B)
00032427 Henning, R.C.; Dewey, M.L.; Freen, C.R.; et al. (1974) Summary of
Residue Data Resulting from Application of the Tank Mixture of
Paraquat CL and Sencor 50 W.P. for Weed Control in Stubble-
Planted Soybeans. (Unpublished study received Jul 2, 1975 under
239-2186; prepared in cooperation with Morse Laboratories, Inc.
and Mobay Chemical Corp., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:119807-C)
00033035 Thompson, R.; Jensen, ?; Elmore, C.; et al. (1974) Crop Residue
Studies Summary for Devrinol 50-WP (4 Lbs. a.i./A) Tank Mixed
with Simazine 80-WP (0.5-1 Lb.a.i./A) and/or Paraquat (1
Lb.a.i./A) in California/Arizona. (Unpublished study received
Dec 17, 1974 under 476-2108; prepared in cooperation with Univ.
of California—Davis and others, submitted by Stauffer Chemical
Co., Richmond, Calif.; CDL:101111-C)
173
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00033208 Davis, D.L.; Pack, D.E.; Kohn, G.K.; et al. (1968) Paraquat—Corn
Registration Request: Post Emergence—Directed Applications,
USDA Witchweed Eradication Program: Residue Data. (Unpublished
study received Feb 28, 1969 under 239-2186; submitted by Chev-
ron Chemical Co., Richmond, Calif.; CDL:001464-B)
00033223 Nelson, C.R.; Parkins, M.; Watson, D.J.; et al. (1964) Summary-
Residue Data: Paraquat No-Residue Registration: Preplant and
Pre-emergence Treatment for Weed Control. (Unpublished study
received Sep 3, 1965 under 239-1994; prepared in cooperation
with Diablo Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:001428-A)
00033530 Whitehead, J.D.; Kalens, K.J.; Baker, H.R.; et al. (1972) Residues
of Paraquat Ion in Forage and Mature Soybeans following Direct-
ed, Post Emergence Spray Treatment. (Unpublished study received
Mar 10, 1972 under 239-2186; prepared in cooperation with Patti-
son's Laboratories, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:001477-B)
00033532 Fisher, H.C.; Tucker, B.V.; Baker, H.R. (1969) Summary of Residue
Test Data. (Unpublished study received Nov 24, 1969 under 239-
2186; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
001467-B)
00033612 Pack, D.E.; Nelson, C.R.; Reddy, K.P.; et al. (1967) Summary, Para-
quat Registration: Preplant and Preemergence Cotton and Potatoes
Residue Data. (Unpublished study received Mar 5, 1967 under
239-1994; prepared in cooperation with Dal are Associates and
others, submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:001439-A)
00033694 Nelson, C.R.; Parkins, M.; Watson, D.L.; et al. (1965) Residue Data
Sheet: Peach: Test No. T-647. (Unpublished study including test
nos. T-286, T-675, T-676..., received Oct 13, 1965 under 239-
1994; prepared in cooperation with Diablo Laboratories, Inc. and
Dal are Associates, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:001421-A)
00033695 Nelson, C.R.; Parks, D.E.; Davis, D.L.; et al. (1965) Summary-
Residue Data: Paraquat—No-Residue Registration; Weed Control
around Trees and Vines. (Unpublished study received Jun 7, 1965
under 239-1994; prepared in cooperation with Diablo Labora-
tories, Inc. and others, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:001421-B)
174
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00034112 Kirby, B.W.; Kalens, K.J.; Gladden, 0.; et alI. (1969) Paraquat:
Soybean—Preharvest Weed Desiccation: Residue Summary. (Unpub-
lished study received Jun 17, 1969 under 239-1994; prepared in
cooperation with Pattison's Laboratories, Inc., submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:001465-B)
00035660 Rolofson, G.L. (1978) Three Generation Reproduction Study in Rats
with Terbutryn Technical Individual Body Weight Data: IRDC Study
No. 382-011. (Addendum I; unpublished study received Jun 5,
1980 under 100-540; submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:e42573-A)
00035663 De Guzman, D.; Dorman, D.C.; LaRue, J.; et al. (1980) Devrinol(R)
Selective Herbicide: Summary of Crop Residue Data on Stone
Fruits. (Unpublished study received Jun 9, 1980 under 476-2199;
prepared in cooperation with Reedley College and others, submit-
ted by Stauffer Chemical Co., Richmond, Calif.; CDL:242620-E)
00035664 De Guzman, D.; Dorman, D.C. (1980) Devrinol(R) Selective Herbi-
cide: Summary of Crop Residue Data on Pome Fruits. (Unpublished
study received Jun 9, 1980 under 476-2199; prepared in coopera-
tion with Reedley College, submitted by Stauffer Chemical Co.,
Richmond, Calif.; CDL:242620-F)
00035665 De Guzman, D.; Dorman, D.C.; Rodgers, W.; et al. (1980) Devri-
nol(R) Selective Herbicide: Summary of Crop Residue Data on
Citrus. (Unpublished study received Jun 9, 1980 under 476-2199;
prepared in cooperation with Reedley College, submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:242620-G)
00035666 De Guzman, D.; Dorman, D.C.; Stiles, N.; et al. (1980) Devri-
nol(R) Selective Herbicide: Summary of Crop Residue Data on
Nuts. (Unpublished study received Jun 9, 1980 under 476-2199;
prepared in cooperation with Reedley College, submitted by
Stauffer Chemical Co., Richmond, Calif.; CDL:242620-H)
00036297 Leahey, J.P.; Hemingway, R.J.; Davis, J.A.; et al. (1972) Paraquat:
Metabolism in a Cow: Report No. AR 2374 A. (Unpublished study
received Feb 1, 1975 under 5F1598; prepared by Plant Protection,
Ltd. in cooperation with Veterinary Surgery, submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:095986-N)
00036305 Hemingway, R.J.; Edwards, M.J.; Jegatheeswaran, T.; et al. (1975)
Paraquat—Residue Transfer and Toxicology Trial on Young Growing
Pigs: Report No. AR 2572A. (Unpublished study received Feb 1,
1975 under 5F1598; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:095986-V)
175
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00036306 Chevron Chemical Company (1974?) The Determination of Paraquat Res-
idues in Fat. (Unpublished study received Feb 1, 1975 under
5F1598; CDL:095986-Y)
00037056 Bevenue, A. (1971) Summary: Paraquat: Residue-Tolerance Petition.
(Unpublished study received Nov 27, 1972 under 3G1336; prepared
in cooperation with Univ. of Hawaii, Agricultural Biochemistry
Dept., Pesticide Laboratory, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:093573-A)
00037057 University of Hawaii (1972) Summary of Freezer Storage Studies for
Guava and Passion Fruit (Shelf-Life of Paraquat Residues in the
Fruit). (Unpublished study received Nov 27, 1972 under 3G1336;
prepared by Agricultural and Biochemistry Dept., Pesticide Lab-
oratory, submitted by Chevron Chemical Co., Richmond, Calif.;
COL:093573-B)
00037058 University of Hawaii (1969) Passion Fruit: Revision of Paraquat
Residue Analysis Method RM-8 (Chevron Chemical Co.). Analysis
method dated Oun 1969. (Unpublished study received Nov 27,
1972 under 3G1336; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:093573-C)
00038503 Fletcher, K. (1967) Production and viability of eggs from hens
treated with Paraquat. Nature 215(?/Sep 23):1407-1408. (Also
in unpublished submission received May 18, 1973 under 3G1396;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
093732-D)
00046105 Gage, J.C. (1968) Toxicity of Paraquat and Diquat aerosols gener-
ated by a size-selective cyclone: Effect of particle size dis-
tribution. British Journal of Industrial Medicine 25(? ):304-
314. (Also in unpublished submission received Nov 18, 1969
under unknown admin, no.; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:103531-B)
00054573 Rittenhouse, J.R. (1977) S-1101: The Acute Oral Toxicity of Para-
quat 3 Lbs/Gal Concentrate: SOCAL 1058/31:44. (Unpublished
study received Aug 17, 1977 under 239-2460; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:231334-B)
00054574 Bullock, C.H. (1977) S-1102: The Acute Dermal Toxicity of Ortho
Paraquat 3Lb/Gal. Concentrate (Using the Standard Occluded Meth-
od): SOCAL 1059/29:40. (Unpublished study received Aug 17, 1977
under 239-2460; CDL:231334-C)
176
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OFFICE OF PF.STICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00054575 Bullock, C.H. (1977) S-1103: The Eye Irritation Potential of Ortho
Paraquat 3LB/Gal Concentrate: SOCAL 1060/30:70. (Unpublished
study received Aug 17, 1977 under 239-2460; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:231334-D)
00054576 Bullock, C.H. (1977) S-1104: The Skin Irritation Potential of Ortho
Paraquat 3Lb/Gal Concentrate: SOCAL 1061/30:71. (Unpublished
study received Aug 17, 1977 under 239-2460; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:231334-E)
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, no.; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:180000-Z)
00058773 Chevron Chemical Company (1976) Residue Chemistry Data to Support
Amendment for Ortho Paraquat CL (EPA Reg. No. 239-2186) for
Bermuda Pastures: Summary. (Compilation; unpublished study
received May 28, 1976 under 239-2186; CDL:224494-A)
00058774 Chevron Chemical Company (1975) Residue Chemistry Data: Paraquat.
(Compilation; unpublished study received Nov 17, 1975 under 239-
2186; CDL:224422-A)
00059596 Chevron Chemical Company (1975) Residue Chemistry Data To Support
Amendment of Ortho Paraquat CL...Label for Postemergence Direct-
ed Spray Application for Control of Weeds in Tomatoes and Pep-
pers. (Compilation; unpublished study received May 24, 1976 un-
der 239-2186; CDL:224466-A)
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)
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. Kaufmann. 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)
00070779 Stauffer Chemical Company (1980) Devrinol(R) 50-WP Selective Her-
bicide: Summary of Crop Residue Data on Apples, Peaches, and
Citrus. (Compilation; unpublished study received Dec 11, 1980
under 476-2108; CDL:243859-A)
177
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00070780 Stauffer Chemical Company (1980) Devrinol(R) 50-WP Selective Her-
bicide: Summary of Crop Residue Data on Apples, Pears, Citrus,
Peaches, Grapes and Walnuts. (Compilation; unpublished study
received Dec 11, 1980 under 476-2108; CDL:243860-A)
00070784 Stauffer Chemical Company (1980) Devrinol(R) 4-F Selective Herbi-
cide: Summary of Crop Residue Data on Apples, Peaches, and Cit-
rus. (Compilation; unpublished study received Dec 11, 1980 un-
der 476-2199; CDL:243860-A)
00070872 Chevron Chemical Company (1980?) Residue Chemistry Data: Paraquat,
Atrazine, Terbutryn--Grain Sorghum. (Compilation; unpublished
study received Mar 24, 1981 under 239-2186; CDL:244724-A)
00072416 Sheppard, D.B. (1981) Paraquat Thirteen Week (Dietary Administra-
tion) Toxicity Study in Beagles: Report No. 2481--72/111A;
I.C.I. Study No. PD 0394. (Unpublished study received Apr 14,
1981 under 239-2186; prepared by Hazleton Laboratories Europe,
Ltd., England, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:244873-A)
00073487 Anderson, D.; Richardson, C.R.; Howard, C.A.; et al. (1978) Para-
quat: A Cytogenetic Study in the Rat: Report No. CTL/P/367.
(Unpublished study received May 29, 1979 under 239-2186; pre-
pared by Imperial Chemical Industries, Ltd., England, submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:238662-A)
00081825 Clark, D.G. (1965) The Acute Toxicity of Paraquat: Report No. IHR/
170. (Unpublished study received Feb 23, 1965 under 5G0440;
prepared by Imperial. Chemical Industries, Ltd., England, submit-
ted by Chevron Chemical Co., Richmond, Calif.; CDL:090478-C)
00087924 Litchfield, M.H.; Sotheran, M.F.; Banham, P.B.; et al. (1981)
Paraquat: Lifetime Feeding Study in the Mouse: Report No. CTL/
P/556. (Unpublished study received Dec 22, 1981 under 239-
2186; prepared by Imperial Chemical Industries, Ltd., England,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
246504-A)
00088195 interregional Research Project Number 4 (1977) Summary of Residue
Chemistry Data: Paraquat. (Compilation; unpublished study re-
ceived Dec 4, 1981 under 2E2611; CDL:070510-A)
00088881 Hill, E.F..; Heath, R.G.; Spann J.U. (1975) Lethal Dietary Toxic-
ities of Environmental Pollutants to Birds. (U.S. Fish and
Wildlife Service, Patuxent Wildlife Research Center; Special
scientific report--wildlife no. 191; unpublished study; CDL:
246395-B)
178
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00089748 Stevens, M.A.; Walker, G.H.; Walley, J.K. (1964) The Excretion of
14C-Paraquat by the Cow: Report No. THR/164. (Uunpublished
study received Aug 30, 1965 under 239-1994; prepared by Imperial
Chemical Industries, Ltd., England, submitted by Chevron Chemi-
cal Co., Richmond, Calif.; CDL:050874-E)
00090400 California Chemical Company (1965) Analysis of Paraquat Residues:
Bio Assay (Lemna minor): File 740.10. Method RM-8b dated
Feb 9, 1965. (Unpublished study received Feb 25, 1965 under
5G0440; CDL:090479-G)
00090978 Imperial Chemical Industries Limited (1966) Bipyridylium Herbi-
cides: Paraquat Grazing Trial. (Unpublished study received May
6, 1966 under 6F0483; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:090542-AA)
00091365 Chevron Chemical Company (1964?) The Fate of Paraquat in Plants.
(Unpublished study received Mar 2, 1966 under 6F0483; CDL:
090543-B)
00091366 Plant Protection, Limited (1966) Bipyridylium Herbicides: Residues
in Potato Tubers following Haulm Desiccation with 14C-Para-
quat. (Unpublished study received Mar 2, 1966 under 6F0483;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
090543-C)
00091372 Chevron Chemical Company (1966) Summary: Paraquat. (Compilation;
unpublished study received Mar 2, 1966 under 6F0483; CDL:
090543-1)
00091376 Chevron Chemical Company (1965) Residue Data Sheet: Potatoes.
(Compilation; unpublished study, including test nos. T-301,
T-312, T-323A..., received Mar 2, 1966 under 6F0483; CDL:
090543-M)
00091378 Slade, P. (1965?) Bipyridylium Herbicides: The Behavior of the
Methyl sulphate Anion in Plants following Foliar Application of
Paraquat Dimethylsulfate. (Unpublished study received Mar 2,
1966 under 6F0483; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:090543-P)
00093182 Shell Chemical Company (1973) Supportive Residue Data for Bla-
dex(R) Herbicide Tank Mix Combination with Paraquat (Minimum
Till Corn). Includes methods MMS-R-202-3 dated Oct 1969 and
RM-8 dated Feb 20, 1970. (Compilation; unpublished study re-
ceived Jul 11, 1973 under 201-279; CDL:000987-A)
179
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00096338 Hodge, M.C.E.; Palmer, S.; Weight, T.M.; et al. (1977) Paraquat
Dichloride: Teratogenicity Study in the Mouse: Report No. CTL/
P/364. (Unpublished study received Mar 5, 1981 under 239-2186;
prepared by Imperial Chemical Industries Ltd., submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:244499-A)
00098579 Chevron Chemical Company (1980) Paraquat Soybeans. (Compilation;
unpublished study received Apr 20, 1982 under 2F2672; CDL:
070782-A)
00102038 Hudson, R.; Tucker, R.; Haegele, M. (1972) Effect of age on sensi-
tivity: Acute oral toxicity of 14 pesticides to mallard ducks
of several ages. Toxicology and Applied Pharmacology (22): 556-
561. (Also in unpublished submission received Oct 26, 1977
under 1016-69; submitted by Union Carbide Corp., Arlington,
VA; CDL:096397-E)
00103245 Slagowski, J. (1981) Residue Data Sheet: Paraquat. (Unpublished
study received Jun 4, 1982 under 239-2186; submitted by Chevron
Chemical Co., Richmond, CA; CDL:247643-A)
00105060 Chevron Chemical Co. (1980) Residue Chemistry Data to Support an
Amendment of the Paraquat CL Label for Potatoes to Include Pre-
plant-preemergence Treatment by Ground or Aerial Application.
(Unpublished study received Jun 16, 1982 under 239-2186; CDL:
247683-A)
00105061 Chevron Chemical Co. (1981) Residue Chemistry Data to Support an
Amendment of the Paraquat CL Label for Alfalfa to Add Aerial
Application. (Unpublished study received Jun 16, 1982 under
239-2186; CDL:247684-A)
00106570 Illinois (1982) Ortho Paraquat CL Special Local Need 24(C) Request:
No-till Sunflowers. (Compilation; unpublished study received
Jul 12, 1982 under IL 82/11; CDL:247838-A)
00109728 Chevron Chemical Co. (1974) Summary: Residues in Soybeans after a
Tank-mix, No-til Application of Paraquat CL, Lasso, and Lorox.
(Compilation; unpublished study received Jun 24, 1975 under 239-
2186; CDL:221806-C)
00110453 Fink, R.; Beavers, J.; Joiner, G.; et al. (1981) Subacute Feeding-
Reproduction Screening Bioassay (Bobwhite Quail): Paraquat
Technical (SX-1305): Project No. 162-138; S-1994. Final rept.
(Unpublished study received Aug 18, 1982 under 239-2186; pre-
pared by Wildlife International Ltd., submitted by Chevron
Chemical Co., Richmond, CA; CDL:248133-B)
180
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00110454 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) One-generation
Reproduction—Bobwhite Quail: Paraquat Technical (SX-1305):
Project No. 162-142. Final rept. (Unpublished study received
Aug 18, 1982 under 239-2186; prepared by Wildlife International
Ltd., submitted by Chevron Chemical Co., Richmond, CA; CDL:
248133-C)
00110455 Fink, R.; Beavers, J.; Joiner, G.; et al. (1982) One-generation
Reproduction—Mallard Duck: Paraquat Technical (SX-1305):
Project No. 162-145. Final rept. (Unpublished study received
Aug 18, 1982-under 239-2186; prepared by Wildlife International
Ltd., submitted by Chevron Chemical Co., Richmond, CA; CDL:
248133-D)
00112663 Chevron Chen^sl Co. (1966) Residue Determination of Paraquat
in Dust nit and Animal Tissues. (Compilation; unpublished
study received Jul 1, 1966 under 6F0483; CDL:092772-D)
00113675 Interregional Research Project No. 4 (1976) The Results of Tests on
the Amount of Paraquat Residues Remaining in or on Asparagus,
Including a Description of the Analytical Method Used. (Compi-
lation; unpublished study received Jul 3, 1976 under 6E1845;
CDL:095940-A)
00113680 Interregional Research Project No. 4 (1978) Paraquat: Onions:
Residue Chemistry Data. (Compilation; unpublished study re-
ceived Mar 1, 1978 under 7E1931; CDL:096957-A)
00113684 Chevron Chemical Co. (1967) Name, Chemical Identity and Composition
of the Pesticide Chemical: Paraquat. (Unpublished study re-
ceived Mar 19, 1974 under 4F1481; CDL:098107-A)
00113686 Chevron Chemical Co. (1975) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Methods Used: Paraquat. (Compilation; unpublished study re-
ceived Apr 10, 1975 under 5F1619; CDL:098184-B)
00113693 Chevron Chemical Co. (1978) Paraquat CL—Winter Wheat. (Compila-
tion; unpublished study received Jun 13, 1979 under 239-2186;
CDL:098333-A)
00113699 Interregional Research Project No. 4 (1978) The Results of Tests on
the Amount of Paraquat Residues Remaining in or on Pistachios
Including a Description of the Analytical Method Used. (Compi-
lation; unpublished study received Jul 6, 1979 under 9E2229;
CDL:098378-A)
181
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00113702 Interregional Research Project No. 4 (1979) Results of Tests and
Descriptions of Analytical Methods Used Regarding the Amount of
Paraquat Residue in or on Rhubarb. (Compilation; unpublished
study received May 21, 1980 under OE2364; CDL:099442-A)
00113709 Chevron Chemical Co. (1964) Paraquat Dresidue [sic] Data. (Com-
pilation; unpublished study received Oct 22, 1964 under 239-EX-
53; CDL:122824-A)
00113714 Hodge, M.; Palmer, S.; Weight, T.; et al. (1977) Paraquat Dichlo-
ride: Teratogenicity Study in the Rat: Report No. CTL/P/365.
(Unpublished study received Jan 15, 1979 under 239-2186; submit-
ted by Chevron Chemical Co., Richmond, CA; CDL:236763-A)
00113715 Chevron Chemical Co. (1979) Ortho Paraquat Concentrate-3: Product
Chemistry Data. (Compilation; .unpublished study received Jun
13, 1979 under 239-2460; CDL:238617-A)
00113718 Hardy, C.; Grimshaw, P.; Cobb, L.; et al. (1979) Three Week Inhala-
tion Study in Rats Exposed to an Aerosol of Paraquat: ICI/254/
7949. (Unpublished study received Oct 16, 1979 under 239-2186;
prepared by Huntingdon Research Centre, Eng., submitted by
Chevron Chemical Co., Richmond, CA; CDL:241188-A)
00113821 Stauffer Chemical Co. (1979) Residue Data: Summaries and Analytical
Data for Devrinol, Devrinol/Simazine and Devrinol/Paraquat on
Citrus. (Compilation; unpublished study received Nov 13, 1979
under 476-2108; CDL:241323-A)
00114405 Chevron Chemical Co. (1974) Ortho Paraquat CL Residue Data from
Dormant Application on Alfalfa and Clover. (Compilation; unpub-
lished study received Oct 25, 1974 under 239-2186; CDL:028529-B)
00114411 Chevron Chemical Co. (1970) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Methods Used: Paraquat. (Compilation; unpublished study re-
ceived Sep 24, 1970 under IF 1014; CDL:091759-A)
00114414 Chevron Chemical Co. (1967) Name, Chemical Identity and Composition
of the Pesticide Chemical: Paraquat. (Compilation; unpub-
lished study received Apr 3, 1967 under 7F0592; CDL:092880-A)
00114419 Chevron Chemical Co. (1972) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Methods Used: Paraquat. (Compilation; unpublished study re-
ceived Nov 27, 1972 under 3G1325; CDU093570-B)
182
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00114420 Interregional Research Project No. 4 (1974) Residues of Paraquat
CL in Guar. (Compilation; unpublished study received Sep 17,
1974 under 5E1549; CDL:094213-A)
00114421 Chevron Chemical Co. (1975) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method Used: Paraquat. (Compilation; unpublished study re-
ceived Feb 10, 1975 under 571591; CDL:094359-A)
00114422 Chevron Chemical Co. (1975) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Method Used: Paraquat. (Compilation; unpublished study re-
ceived Feb 24, 1975 under 5F1598; CDL:094363-B)
00114424 Chevron Chemical Co. (1975) Summary: Pasture Reseeding: Paraquat.
(Compilation; unpublished study received Jun 9, 1975 under
5F1639; CDL:094443-A)
00114426 Chevron Chemical Co. (1975) Summary of Residue Data for Field Corn
Treated with Paraquat as a Harvest-aid. (Compilation; unpub-
lished study received May 2, 1975 under 5F1625; CDL:094560-C)
00114436 Chevron Chemical Co. (1962) Study: Paraquat Residue on Almond &
Apple Orchards. (Compilation; unpublished study received May
8, 1963 under unknown admin, no.; CDL:119370-A)
00114446 Chevron Chemical Co. (1970) Residue Data: Paraquat. (Compila-
tion; unpublished study received Feb 3, 1971 under 239-EX-59;
CDL:122836-B)
00114453 Chevron Chemical Co. (1964) Residues of Paraquat in Sugar Cane
and Other Crops. (Compilation; unpublished study received
May 13, 1963 under unknown admin, no.; CDL:124215-A)
00114464 Chevron Chemical Co. (1977) Residue Chemistry Data To Support
Amendment to Ortho Paraquat CL ... Label for Suppression and
Control of Broad!eaved Weeds and Grasses in Alfalfa Seedlings.
(Compilation; unpublished study received Jul 6, 1977 under
239-2186; CDL:230954-A)
00114465 Chevron Chemical Co. (1977) Residue Chemistry Data To Support
Amendment to Ortho Paraquat CL ... Label To Add Princep as a
Tank Mix for Improved Control of Weeds and Grasses in Dormant
Alfalfa. (Compilation; unpublished study received Apr 18, 1977
under 239-2186; CDL:230970-A)
183
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00114466 Chevron Chemical Co. (1977) Residue Chemistry Data To Support
Amendment of Ortho Paraquat CL ... Label for Bermudagrass
Pastures To Add Air Applications. (Compilation; unpublished
study received Nov 28, 1977 under 239-2186; CDL:232339-A)
00114467 Chevron Chemical Co. (1977) Residue Chemistry Data To Support Label
Amendment for Ortho Paraquat CL—Ground Application for Control
or Suppression of Weeds and Grasses in Dormant Alfalfa—North
Central States, N.Y., N.J. and Pa. (Compilation; unpublished
study received Jan 3, 1978 under 239-2186; CDL:232602-A)
00114469 Chevron Chemical Co. (1977) Residue Chemistry Data To Support
Amendment to Ortho Paraquat CL ... Label To Add Louisiana and
Hawaii for Directed Spray Kill of Weeds and Grasses in Sugar-
cane. (Compilation; unpublished study received Jan 23, 1978
under 239-2186; CDL:232727-A)
00114473 Wheeler, R. (1978) 48 Hour Acute Static Toxicity of Paraquat
Dichloride Salt (SX957) to 1st Stage Nymph Water Fleas (Daphnia
magna Straus). (Unpublished study received Sep 15, 1978 under
239-2422; submitted by Chevron Chemical Co., Richmond, CA;
CDL:235419-A)
00114474 Florida, Dept. of Agriculture & Consumer Services (1978) Residue
Chemistry To Support the Use of Paraquat CL on Lettuce as a
Postemergence Directed Spray. (Compilation; unpublished study
receiv.ed Nov 7, 1978 under FL 78/44; CDL:236543-A)
00116622 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chem-
icals to Fish and Aquatic Invertebrates. By U.S. Fish and Wild-
life Service, Columbia National Fisheries Research Laboratory.
Washington, DC: USFWS. (Resource publication 137, pages 59,60
only; published study; CDL:248614-Q)
00117783 Chevron Chemical Co. (1970) The Results of Tests on the Amount of
Residue Remaining, Including a Description of the Analytical
Methods Used: Paraquat. (Compilation; unpublished study re-
ceived Jun 17, 1970 under OF0986; CDL:091698-B)
00126096 Chevron Chemical Co. (1982) Elimination of C-14 Labeled Paraquat
in Rhesus Monkeys following a Single Parenteral Dose. (Unpub-
lished study received Feb 8, 1983 under 239-2186; CDL:249511-A)
00126097 Chevron Chemical Co. (1982) Percutaneous Absorption of Paraquat.
(Unpublished study received Feb 8, 1983 under 239-2186; CDL:
249511-B)
184
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00126098 Chevron Chemical Co. (1982) Percutaneous Absorption of Paraquat.
(Unpublished study received Feb 8, 1983 under 239-2186; CDL:
249511-C)
00126099 Chevron Chemical Co. (1982) Percutaneous Absorption of Paraquat.
(Unpublished study received Feb 8, 1983 under 239-2186; CDL:
249511-D)
00126671 Chevron Chemical Co. (1983) Residue Chemistry Data to Support
a Registration Amendment of the Paraquat CL (EPA Reg. No. 239-
2186AA) Label for Alfalfa to Reduce the Interval between
Application and Harvest. (Compilation; unpublished study
received Apr 1, 1983 under 239-2186; CDL:249856-A)
00126783 Lindsay, S.; Banham, P.; Godley, M.; et al. (1982) Paraquat:
Multigeneration Reproduction Study in Rats—Three Generations:
Report No. CTL/P/719. (Unpublished study received Apr 5, 1983
under 239-2186; prepared by Imperial Chemical Industries PLC,
U.K., submitted by Chevron Chemical Co., Richmond, CA; CDL:
249911-A; 249912)
00128221 Zapat, R.; Gonzalez-Ibanez, J. (1982) The Results of Tests on the
Amount of Paraquat Residues Remaining in or on Acerola. (Un-
published study received Apr 25, 1983 under 239-2286; prepared
by Chevron Chemical Co. and Univ. of Puerto Rico, Agricultural
Experiment Station; submitted by Interregional Research Project
No. 4, New Brusnwick, NJ; CDL:071577-A)
00128624 Chevron Chemical Co. (1982) Paraquat Alfalfa—between Cuttings-
Residue Summary: Multiple Applications. (Compilation; unpub-
lished study received May 19, 1983 under 239-2186; CDL:250383-B)
00132474 Kalinowski, A.; Doe, J.; Chart, I.; et al. (1983) Paraquat: 1 Year
Feeding Study in Dogs: Report No. CTL/P/734. (Unpublished study
received Oct 24, 1983 under 239-2186; prepared by Imperial Chem-
ical Industries PLC, Eng., submitted by Chevron Chemical Co.,
Richmond, CA; CDL:251668-A; 251669)
00136330 Interregional Research Project No. 4 (1976) The Results of Tests on
the Amount of Paraquat Residues Remaining in or on Onions
Including a Description of the Analytical Methods Used. (Comp-
ilation; unpublished study received Feb 28, 1977 under 7E1931;
CDL:097509-A)
00137859 Interregional Research Project No. 4 (1977) The Results of Tests
on the Amount of Paraquat Residues Remaining in or on Mint
Including a Description of the Analytical Metod Used. (Compila-
tion; unpublished study received Feb 13, 1978 under 239-2186;
CDL:096810-A)
185
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00138258 Interregional Research Project No. 4 (1976) The Results of Tests on
the Amount of Paraquat Residues Remaining in or on Strawberries
Including a Description of the Analytical Methods Used. (Compi-
lation; unpublished study received Aug 20, 1976 under 6E1853;
CDL:072501-A)
00138637 Woolsgrove, B.; Ashby, R.; Hepworth, P.; et al. (1983) Paraquat:
Combined Toxicity and Carcinogenicity Study in Rats: LSR Report
No. 82/ILY217/328. (Unpublished study received Feb 9, 1984
under 239-2460; prepared by Life Science Research, Eng., submit-
ted by Chevron Chemical Co., Richmond, CA; CDL:252372-A; 252373;
252374; 252375; 252376; 252377; 252378; 252379; 252380; 252381;
252382; 252383)
00139733 Chevron Chemical Company (1966) Residue Study: Paraquat and Gram-
oxone on Bananas. (Reports by various sources; unpublished
study received Feb 21, 1967 under 7F0592; CDL:090762-A)
00139734 Chevron Chemical Company (1966) Residue Data Sheet: Coffee: Para-
quat and Diquati Test No. T-355. (Compilation; unpublished
study including test nos. T-357, T-606, T-1092..., received Feb
21, 1967 under 7F0592; CDL:090762-B)
00139735 Chevron Chemical Company (1966) Residue Data Sheet: Figs: Para-
quat: Test No. T-1028. (Compilation; unpublished study includ-
ing test nos. T-1029, T-1030 and T-1031, received Feb 21, 1967
under 7F0592; CDL:090762-C)
00139737 Chevron Chemical Company (1966) Residue Data Sheet: Olives: Para-
quat: Test No, T-1024. (Compilation; unpublished study includ-
ing test nos. T-1025, T-1026 and T-1027, received Feb 21, 1967
under 7F0592; CDL:090762-E)
00139741 Chevron Chemical Company (1966) Residue Data Sheet: Lettuce: Para-
quat: Test No. T-617. (Compilation; unpublished study includ-
ing test nos. T-1142 and T-1143, received Feb 21, 1967 under
7F0592; CDL:090762-I)
00140828 Chevron Chemical Company (1981) Residue Data Sheet: Wheat: Para-
quat (Compilation; unpublished study, including test nos. T-5409
and T-5411, received Nov 17, 1981 under 239-2186; CDL:070514-A)
00146806 Day, S.; Hemingway, R. (1981) [Carbon-14] Paraquat: Degradation
on a Sandy Soil Surface ifr Sunlight: Report Series RJ 0168B.
Unpublished study prepared by ICI Plant Protection Division.
40 p.
186
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MR ID CITATION
00146807 Pack, D. (1982) Long Term Exposure of [Carbon 14] Paraquat on a
Sandy Soil to California Sunlight. Unpublished study prepared
by Chevron Chemical Company. 16 p.
00148506 Upton, B.; Hendley, P.; Skidmore, M. (1985) Hydrolytic Stability
in Water at pH 5, 7 and 9: Paraquat: Report No. RJ0436B. Un-
published study prepared by ICI Plant Protection Division.
25 p.
00152690 Clay, P.; Thomas, M. (1985) Assessment of Mutagenic Potential Using
L5178Y Mouse' Lymphoma Cells: Paraquat Dichloride: Report No.
CTL/P/1398. Unpublished report prepared by Imperial Chemical
Industries Pic. 31 p.
00152691 Cross, M. (1985) Assessment of Mutagenic Potential Using L5178Y
Mouse Lymphoma Cells: Paraquat Dichloride: Report No.
CTL/P/1374. Unpublished report prepared by Imperial Chemical
Industries Pic. 30 p.
00152692 Sheldon, T.; Howard, C.; Wildgoose, J.; et al. (1985) A Cytogenetic
Study in Human Lymphocytes in vitro: Paraquat Dichloride: Report
No. CTL/P/1351. Unpublished report prepared by Imperial
Chemical Industries Pic. 25 p.
00152693 Trueman, R.; Ashby, J.; Burlison, B. (1985) Assessment for the
Induction of Unscheduled DNA Synthesis in Primary Rat Hepatocyte
Cultures: Paraquat Dichloride: Report No. CTL/P/1339. Unpu-
blished report prepared by Imperial Chemical Industries Pic.
43 p.
00152694 Sheldon, T.; Richardson, C.; Shaw, J.; et al. (1985) An Evaluation
of Paraquat Dichloride (Technical) in the Mouse Micronucleus
Test: Report No. CTL/P/1369. Unpublished report prepared by
Imperial Chemical Industries Pic. 24 p.
00152695 Howard, C.; Wildgoose, J.; Clay, P.; et al. (1985) An in vitro
Sister Chromatid Exchange Study in Chinese Hamster Lung Fibro-
blasts: Paraquat Dichloride: Report No. CTL/P/1392. Unpublished
report prepared by Imperial Chemical Industries Pic. 38 p.
00153437 Chester, G.; Ward, R. (1984) Occupational exposure and drift hazard
during aerial application of paraquat to cotton. Arch. Environ.
Contam. Toxicol. 13:551-563.
00153438 Hogarty, C. (1975) Exposure of Spray Operators to Paraquat. Unpub-
lished study prepared by Institute for Industrial Research and
Standards. 145 p.
187
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00153733 Head, L.; Marsh, J.; Millward, S. (1985) Paraquat: 4 Hour Acute
Inhalation Toxicity Study in the Rat: Report No. CTLP/1325.
Unpublished study prepared by Imperial Chemical Industries PLC.
113 p.
00155289 Thompson, J. (1985) Modified Buehler Test for the Skin Sensitiza-
tion Potential of Paraquat 3 Concentrate (SX-1465) [Using Guinea
Pigs]: Study # SOCAL 2355. Unpublished study prepared by
Chevron Environmental Health Center. 34 p.
00156313 Cox, R. (1986) Twenty-one Day Dermal Toxicity Study in Albino Rab-
bits with Paraquat Technical (SX-1465): Project No. S-2718:
2107: Final Report. Unpublished study prepared by Hazleton La-
boratories America, Inc. 271 p.
00162736 Palmateer, S. (1980) Biological Report of Analysis: [Toxicity
Test of Paraquat on Rainbow trout]. Unpublished study prepared
by U.S. Environmental Protection Agency, Terrestrial & Aquatic
Biology Laboratory. 1 p.
00162737 Palmateer, S. (1979) Biological Report of Analysis: [Toxicity Test
of Paraquat on Bluegills], Unpublished study prepared by U.S.
Environmental Protection Agency, Terrestrial & Aquatic Biology
Laboratory. 1 p.
00162738 McCann, J. (1977) Biological Report of Analysis: [Toxicity Test of
Ortho Paraquat CL Concentrate on Rainbow trout]. Unpublished
study prepared by U.S. Environmental Protection Agency, Animal
Biology Laboratory. 1 p.
00162741 De Lavaur, E.; Grolleau, G.; Siou, G. (1973) Experimental intoxica-
tion of rabbits by alfalfa treated with paraquat. Translated
from Annales de Zoologie Ecologie Animal e 5(4) :609-622.
00162742 Soderquist, C.; Crosby, D. (1972) The gas chromatographic determi-
nation of paraquat in water. Bullentin of Environmental Contam-
ination & Toxicology 8(6):363-368.
00162743 Pope, J.; Benner, J. (1974) Colorimetric determination of paraquat
residues in soil and water. J. Assoc.of Org. Chemists 57:292-
294.
00162744 Fodre, S.; Sipos, K.; Berencsi, G. (1978) The Irritant and Allerge-
zing- Effect of Gramoxone [Paraquat] Studied in Guinea Pigs: TR-
79-0932. Unpublished study prepared by Institute for Public
Health and Epidemiology, Szeged Medical University. 10 p.
188
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Paraquat Standard
MRID CITATION
00162745 McCann, J.; Teeters, W.; Urban, D.; et al. (1981) A short-term di-
etary toxicity test on small mammals. P. 132-142 of the Second
Conference of Avian and Mammalian Wildlife Toxicology; published
in American Society for Testing and Materials; 1981.
00162746 Hoffman, D.; Eastin, W. (1982) Effects of lindane, paraquat, toxa-
phene, and 2,4,5-trichlorophenoxyacetic acid on mallard embryo
development. Archives of Environmental Contamination and Tox-
icology 11:79-86.
00162747 Newman, J. (1971) Paraquat: Effect on Hares: TMJ 651 A. Unpub-
lished study prepared by Plant Protection Ltd., ICI Agricultural
Division. 16 p.
00162748 Kimbrough, R.; Gaines, T. (1970) Toxicity of paraquat to rats and
its effect on rat lungs. Toxicology and Applied Pharmacology
17:679-690.
00162870 Murray, R.; Gibson, J. (1972) A comparative study of paraquat in-
toxication in rats, guinea pigs and monkeys. Experimental and
Molecular Pathology 17:317-325.
05001991 Stevenson, J.H. (1978) The acute toxicity of unformulated
pesticides to worker honey bees (Apis mellifera). Plant
Pathology 27(1):38-40.
05008363 Hudson, R.H.; Haegele, M.A.; Tucker, R.K. (1979) Acute oral and
percutaneous toxicity of pesticides to mallards: correlations
with mammalian toxicity data. Toxicology and Applied
Pharmacology 47(3):451-460.
40183501 Busey, W. (1986) An Independent Pathology Review of the Lung
Slides from a Rat Chronic Toxicity/Carcinogenicity Study with
Paraquat. Chevron Protocol Number PQ-86-1. Prepared by
Experimental Pathology Laboratories, Inc. 144 p.
GS0262-004 Chevron Chemical Co. (1967) Residue Data Sheet: Almonds:
Paraquat. Unpublished compilation prepared by Diablo
Laboratories, Inc. 5 p.
GS0262-006 Chevron Chemical Co. (1966) Residue Data Sheet: Avocados:
Paraquat: Test No. T-1020. (Unpublished study prepared
by Diablo Laborities, Inc. 4 p.
GS0262-028 US EPA (1979) 48-Hour EC50: Paraquat dichloride 29.1%: Daphnia
Magna: Test 2431. Unpublished report prepared by Terrestrial
Aquatic Biology Laboratory. 1 p.
189
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APPENDIX V
FORMS
190
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OMB Aooroval AJo 200OCtS£
FIFHA SECTION 3(C)(2H6) SUMMARY SHEET
EPA REGISTRATION NO
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUME\T ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2MB) notice contained in the referenced
Guidance Document, I am responding in the following manner:
C 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECO
Chemicals listing Programme, I enclose the protocols that I will use:
I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
O 3. I inclose a completed "Certification of Attempt to Entir Into in Agreement with Othir Reentrants for Development of Data" with
respect to the following data requirements:
. I request that you amend my registration by dilating the following uses (this option is not availaole to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form IMO-1 (10-12)
191
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OMB Aooroval No. 20OO-0468
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent The following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms ii referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
My firm has offtrtd in writing to enter into such an agreement. Copies of tht offers an attached. That offer was irravocabla and includtd in offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's prodyct(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its regjstration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form
(10-82)
192
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor^pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
193
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Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/ reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corros ion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
Droduct
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
194
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
"GENERIC" DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address: ^
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated ^_ on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
EPA Form 8570-27 195
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