v>EPA
UnlttdStatM
Environmental Protection
Ag*ncy
OfflMOf
Pwticidw and Toxic SubctanoM
WMhingtonDC 20460
March 1987
PwticidM
Guidance for the
Reregistration of
Pesticide Products
Containing Dichlobenil
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
CONTAINING
DICHLOBENIL
AS THE ACTIVE INGREDIENT
OPP NUMBER 027^01
CAS NUMBER 1191-65-6
MAR 2 31987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Covered by this Standard
A. Description of Chemical
B. Use Profile
C. Chemical Structures.
III. Agency Assessment 7
A. Summary
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 17
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard 25
VI. . Requirement for Submission of Generic Data 27
A. What are generic data?
B. Who roust submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 32
VIII. Requirement for Submission of Revised Labeling 33
IX. Instructions for Submission 34
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
Glossary of Terms and Abbreviations iii
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APPENDICES
I. DATA APPENDICES
Guide to Tables
Table A
Table B
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE INDEX APPENDIX
IV. BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
V. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of- Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI: Acceptable Daily Intake
a.i.: Active ingredient
CAS: Chemical Abstract Society (number)
o
Core Classifications: A general guide to the acceptability
of data for the purpose of supporting
registration (invalid, supplementary,
minimum, or guideline).
CSF: Confidential Statement of Formula
DNA: deoxyribonucleic acid
EPA: The Environmental Protection Agency, also "the Agency"
FT, F2: Refers to the generations in a multi-generation study
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act
LC5o: (median lethal concentration) a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals, expressed as weight
or volume of test substance per volume of air or
water or per weight of feed (e.g., rag/1 or ppm).
LD50: (median lethal dose) a statistically derived single
dose that can be expected to cause death in 50% of animals
when administered by the route indicated, expressed as
weight of substance per unit weight of test animal
(e.g., rag/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Indentification (number) - EPA's system
of tracking studies used in support of registrations.
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs
OES: Office of Endangered Species, U.S. Fish and Wildlife Service
PADI: Provisional Acceptable Daily Intake
iii
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PAI: Pure active ingredient
RACs: Raw Agricultural Commodities
Technical: Active ingredient as manufactured
TMRC: Theoretical Maximum Residue Contribution
iv
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I. INTRODUCTION
The Registration Standards Program
EPA has established the Registration Standards Program
to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with PIPRA. The standards
are applicable to rereglstration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active Ingredient
subject to this standard who wishes to continue to sell or
distribute that product must bring his product and labeling
Into compliance with PIPRA, as instructed by this standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to: (1) pesticides In clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards Program Involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of PIPRA. In Its review EPA Identifies
1. Studies that are acceptable to 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
necdeU cu replace studies that are now considered Inadequate.
3. Labeling revisions needed to ensure that the product
Is not mlsbranded 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 request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data In Its files pertaining to the pesticide's
AThe 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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active Ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA'a reassessment, results in the development of a
regulatory position, contained in thi's 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 PIPRA. 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.
i*. Restriction of the use of the p'estlcide to certified'
applicators or .other specially trained Individuals.
5. Modification of uses or formulation types.
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 CPR Part 151*
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
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EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical,
toxlcological, and environmental characteristics and fate of
a pesticide. This Registration Standard lists the data EPA
believes are necessary to resolve our concerns about this
pesticide. These data are listed in the Tables A, B, and C
in Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in issuance
by EPA of a Notice of Intent to Suspend the affected product
registrations.
Registrants are reminded- that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible
unreasonable adverse effects of a pesticide at any time that
they become aware of such information. Registrants should
notify the Agency of any Information, including Interim or
preliminary results of studies, if those results suggest
possible adverse effects on man or the environment. This
requirement continues as long as the products are registered
by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICAL
The following chemical is covered by this Registration
Standard:
Common name: Dichlobenll
Chemical name: 2,6-dichlorobenzonltrile
CAS number: 1194-65-6
Office of Pesticide Program Shaughnessy number: 027401
Empirical formula:
Trade names: Casoron*, H-133, Decabane*, 2,6-DBN,
Code 133*
Year of Initial Registration: 1964
Chemical Family: Benzonitrlle
Description of physical characteristics of chemical:
White crystalline solid with a melting point of 145 to
146 °C. At 20 °C this chemical is soluble at 25 ppm
in water, 10 g/100 g in methylene chloride and 4 g/100 g
in Toluene.
B. USE PROFILE
Type of Pesticide: Herbicide
Pests Controlled: Broadleaf weeds and grasses (annual and
perennial), and aquatic weeds.
Registered Uses: Terrestrial food and nonfood crop, aquatic
nonfood, forestry, and commercial and Industrial uses.
Predominant Use(s): Alfalfa and ladlno clover crops,
berry crops, grapes, pome fruits, stone fruits, citrus
fruits, nuts, ornamental trees and shrubs, rlghts-of-way ,
industrial sites, and aquatic sites.
Mode of Activity: Dichlobenll stimulates oxygen utilization
•while inhibiting esterlf ication of phosphorous,
which results in reduced merlstematlc cell growth and
inhibition of germination.
Formulation Types Registered: 99.5-96% Technical grade
4
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active Ingredient (ai), 85.5%-85% formulation intermediate
(PI), 2%, H%, and 10% active Ingredient (ai) granule
(G); 5055 ai wettable. powder (WP); 1.73%, 1.7756, 2.1%,
and 3.12% ai soluble concentrate/liquid (SC/L); and
6.75% ai liquid ready to use (RTU).
Method(s) of Application: Ground or aerial application.
Application Rates: Alfalfa and ladino clover 1.1 to
2.0 Ib ai/A; 4 to 6 Ib ai/A in cranberry bogs,
granular mix 3.1* to 6.75 Ib ai/A and up to 10 Ib
ai/A on very weedy bogs; 1 to 6 Ib al/A for
control of annual weeds in bearing, nonbearing,
nursery stock, noncltrus, nut crops; A to 7
Ib ai/A in citrus nurseries; terrestrial nonfood crops
10 to.20 Ib ai/A; aquatic weed control 7 to 15
Ib. ai/A.
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C. Chemical Structures
STUCTURE
CHEMICAL NAME
COMMON NAME OR
ABBREVIATION
I/
21
3/
2,6-dlchlorobenzonltrile
2,6-dichlorobenzoic acid
2,6-dlchlorobenzamlde
dichlobenil
2,6-DCBA
BAM
£/ Chemical structure for the herbicide Dichlobenil. :
2/ Chemical structure for the metabolite 2,6-dlchlorobenzoic
acid (2,6-DCBA).'
3/ Chemical structure for the metabolite 2,6-dichlorobenzamlde
(BAM). [BAM Is a primary metabolite of Dichlobenil
produced by soil microbes (95%)]*
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III. AGENCY ASSESSMENT
A. SUMMARY
Dlchlobenil has a low acute oral toxlcity (Category
III) and a moderate acute dermal toxicity (Category II).
Acute Inhalation, dermal sensitlzatlon, primary eye Irritat-
ion, primary dermal irritation, reproduction studies, and a
teratology study in a second species are required. Sufficient
data have been submitted to satisfy the data requirement for a
teratology study in rats. The oncogenic potential of dichlo-
benll could not be adequately determined from the study
submitted. Oncogenicity studies are required in mice and
rats. An animal metabolism study is also required. Dichlo-
benil is negative in a battery of mutagenicity tests for
gene mutation, chromosomal aberration, deoxyrlbonucleic acid
(DNA) repair, and transformation. No additional mutagenicity
tests are required.
Available data are insufficient to fully assess the
environmental fate and transformation of dlchlobenil.
Hydrolysis, photodegradatlon, metabolism, mobility, dissipation,
and. accumulation studies must be submitted.
The current data base suggests one major ecological
problem, the aquatic use of dlchlobenil. The guideline
requirements for acute testing of dichlobenil are only
partially satisfied.
The Agency is concerned about the potential for ground water
contamination by dlchlobenil. The Agency has determined that
additional data are needed to characterize the potential for
dichlobenil to enter ground water.
Data are available regarding residues of dlchlobenil and
its metabolite, 2,6-dichlorobenzoic acid (2,6-DCBA) In or on some
plant commodities. Data are still required for the parent and
2,6-DCBA in or on several addltonal commodities. Additional data
are also required reflecting residues of the metabolite,
2,6-dlchlorobenzamide (BAM) on all commodities.
B. PRELIMINARY RISK ASSESSMENT
Toxicology Characteristics
Acute Toxicity and Irritation Studies
Acute oral toxicity data place technical dlchlobenil in
Toxicity Category III (CAUTION). The acute dermal toxicity study
Indicates that technical dlchlobenil Is acutely lethal by the
dermal route, placing It In Toxicity Category II (WARNING). Acute
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Inhalation, primary eye Irritation, primary dermal Irritation
and dermal sensltlzatlon studies have not been submitted and
are required.
Subchronlc Toxlclty Studies
Sufficient data have been submitted to satisfy the data
requirements for subchronic oral toxiclty studies In a rodent
species. Rats (12/sex/dose) were treated with dichlobenil
In the diet for 13 weeks at dos-es of 0, 100, 1000, 3000, and
10,000 ppm (six males only). Compound-related effects Included
Increased absolute and relative liver and kidney weights at
1000 ppm and above, hepatic degeneration and an absolute
neutropenla and leukopenia at 3000 ppm and above, and mortality
(five out of six) and hepatic necrosis at 10,000 ppm. The
No-Observed-Effect-Level (NOEL) was 100 ppm (50 mg/kg/day)
and the Lowest Effect Level (LED was 1000 ppm (500 mg/kg/day)
based on Increased absolute and relative liver and kidney
weights.
The data requirements for a subchronic oral toxiclty
study in a nonrodent species have been satisfied by the
chronic (2-year) dog feeding study.
Chronic Toxlclty and Oncogenlclty Studies
Data requirements for a chronic dog feeding study have
been satisfied. Beagle dogs (H/sex/dose) were treated with
dichlobenil in the diet for 21 months at doses of 0, 20, 50,
and 350 ppm. The NOEL was 50 ppm (1.25 mg/kg/day) and the
LEL was 350 ppm (8.75 mg/kg/day) based on 1) increased absolute
and relative liver and thyroid weight In both sexes, 2) leuko-
cytic infiltration and flbrinoid degeneration around the
central hepatic veins In both sexes, 3) Increases In serum
alanlne aminotransferase (SGPT) (females) and serum alkaline
phosphatase (SAP) (males and females), and 1) Increase In liver
enzyme glucose-6-phosphatase (G6Pase) and glucose-6-phosphatase
dehydrogenaae (G6PD) activity (males and females).
In a core-supplementary two-year feedlng/oncogenlclty
study, 50 male and 50 female Fisher 311 rats were treated
with 0, 50, 100, or 3200 ppm of dichlobenil in the diet. A
tentative NOEL has been set at 50 ppm (avg. 3.17 mg/kg/day)
and a tentative LEL set at 100 ppm (avg. 27.8 mg/kg/day)
based on the following lesions: suppression of body weight
increase, depressed food consumption and liver and kidney
effects characterized by elevated relative organ weights,
clinical chemistry changes and non-neoplastic hlstopathologlc
changes. This 2-year rat feedlng/oncogeniclty study must be
resubmltted and reevaluated, because of deficiencies in
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reporting the results, namely lack of adequate summary tables
of survival, histopathologlcal examinations and in-life
observations.
The requirement for a new rat feeding/oncogeniclty study
will be reserved pending reevaluation of this study. A
lifetime feeding study is required in the mouse in order to
evaluate the oncogenic potential in mice.
Teratology
The data requirement for a teratology study in rats has
been satisfied. Groups of 25 Wistar rats were treated by
gavage on days 6 through 15 of gestation with 0, 20, 60, or
180 mg/kg/day of dichlobenil. The maternally toxic NOEL is 20
mg/kg/day and the LEL, based on decreased maternal weight
gain, feed consumption, and feed efficiency is 60 mg/kg/
day. The developmental NOEL is 60 mg/kg/day and the LEL is
180 mg/kg/day based on a slight increase in supernumary
thoracic ribs.
A teratology study in a second species (non-rodent)
is required.
Reproduction
The available ra't reproduction study does not adequately
evaluate the reproductive potential of dichlobenil because
fewer than 10 litters were obtained per group per mating,
only kidneys and livers were examined in the P2 generations,
and the data were presented only in summary form. Wistar
rats were treated with 0, 20, 50, or 100 ppm of dichlobenil
in the diet. The systemic NOEL observed in the study was 20
ppm (1 mg/kg/day) and the LEL, based on body weight depression,
was 50 ppm (2.5 mg/kg/day). The reproductive NOEL was 50 ppm and
the LEL, based on decreased viability of Fla pups and decreased
fertility for P2a and P2b parents, was 100 ppm. A new
reproductive study is required.
Mutagenlcity
Acceptable studies have been submitted to satisfy the
data requirements for gene mutation, chromosomal aberration,
and direct DNA damage. Dichlobenil showed no apparent mutagenic
potential in bacteria with or without activation when tested
^n vitro in mouse lymphoma. Dichlobenil was negative for
chromosomal aberration when tested in the metaphase analysis
assay using human lymphocytes. No direct (DNA) damage was
apparent with dichlobenil in human HeLa epithelioid cells
for DNA repair. There was no apparent transforming potential
with activation in the BALB/3T3 transformation assay. No
additional data are required.
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Metabolism
There are currently no acceptable metabolism studies with
dlchlobenll. Several metabolism studies are required (plant,
animal, soil and aquatic).
The manufacturing impurity (BAM) is the primary metabolite
of dichlobenil produced microbiologically in the soil accounting
for as much as 95/5 of all metabolites. Although BAM does
not appear to be more acutely toxic than dlchlobenll, there is a
potential toxiclty concern. Subchronic ingestion of BAM
produces a neuromuscular effect in rats, not observed with
the parent compound.
The metabolic pathways in plants for the degradation of
dichlobenil and the nature of the residue of dlchlobenll in
ruminants and poultry have not been adequately elucidated,
therefore, additional data are required. Although rat and
rabbit studies of dichlobenil metabolism revealed no
detectable residues of BAM or its hydroxy derivatives, plant
and soil metabolism studies have provided evidence that a
substantial portion of the terminal dichlobenil residues to
which livestock may be exposed in feed commodities from
treated crops may consist of BAM. On receipt of the data
requested, the need for and nature of tolerances for residues
In animal products will be determined. If residue studies
reveal detectable levels of BAM in feed commodities or other
metabolites of concern identified in the requested plant and
animal metabolism studies, then livestock feeding studies
using dichlobenil plus BAM (and other metabolites of concern)
may be required.
Miscellaneous Subchronic toxicity for the metabolite BAM
A core-minimum subchronic oral rat study was submitted.
Rats (10/sex/dose) were treated with BAM in the diet for 13
weeks at doses of 0, 50, 180, 600, and 2300 ppm. The NOEL :
(180 ppm [14 mg/kg/day]) and the LEL (600 ppm [49 mg/kg/day])
were based on decreased body weight gain and food efficiency,
Increased blood urea nitrogen (BUN), and reduced coagulation
times. There was also a possible reduction In muscle tone.
C. OTHER SCIENCE FINDINGS
Environmental Characteristics
Available data are insufficient to fully assess the
environmental fate and transformation of dichlobenil.
Hydrolysis, photodegradation, metabolism, mobility, dissipa-
tion, and accumulation studies must be submitted.
Reentry data are not required because dlchlobenll does
not meet the toxiclty or exposure criteria of 40 CPR 158.140.
Dichlobenil does not meet the toxiclty criteria of 40 CPR
10
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158.140 since 1) the acute dermal toxicity of the technical
grade of active ingredient is greater than 200 mg/kg (body
weight); 2) the acute oral toxicity of the technical grade
of active ingredient is greater than 50 mg/kg (body weight);
and 3) no other adverse effects have been observed.
The exposure criteria are based on the pesticide's use
patterns. The criteria for requirement of a proposed reentry
interval and the supporting data are listed in 40 CFR §158.140
and are discussed in §130-3 of Subdivision K. These use
patterns are characterized by a high likelihood of dermal or
inhalation exposure to persons who reenter treated sites
included in these classes which is not the case for dichlobenil.
The Agency is concerned about pesticide residues reaching
ground water. Dichlobenil has the potential to reach ground
water resources based on its chemical structure, water solubility
and use patterns. The Agency has determined that additional
data are needed to fully characterize the potential .for
dichlobenil to reach ground water.
Ecological Characteristics
Based on the available data, the aquatic use of dichlobenil
presents the only major ecological concern. Dichlobenil is
slightly toxic to game birds and moderately toxic to fish.
Endangered species triggers have been exceeded based on
toxicity and estimated exposure data. Available data are
discussed as follows:
Toxicity to Fish and Aquatic Invertebrates
There are sufficient data to characterize the acute
toxicity of dichlobenil as being of moderate toxicity to
coldwater and warmwater fish.
A 50% Wettable Powder (WP) tested against five species of
aquatic invertebrates suggests that the 50% WP is moderately to
slightly toxic to aquatic invertebrates.
Two fish studies demonstrate the principle metabolite
(2,6-DCBA) to be practically non-toxic to fish.
Direct application of a pesticide to water can present a
potential risk to fish and aquatic invertebrates. Dichlobenil
as both a 4% and 10% granular is registered to control aquatic
weeds in lakes, ponds, and reservoirs. Present label directions
permit treating of a third of the weed area. If a 6-acre
feet pond was only treated (at a 15 Ib. ai/A rate) for a
third of its surface then the maximum estimated residues
would be 0.25 ppm. This value is below the restricted
use trigger; but still raises endangered species concerns
for aquatic invertebrates.
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Based upon the above calculations we are not restricting this
pesticide at this time. Because there are concerns about
persistence, accumulation, and groundwater contamination, we
are requiring registrants to submit environmental fate studies
including dissipation and accumulation studies in order to
adequately address these concerns.
Toxicity to Birds
There is only partial information on avian acute toxicity
However, with an LCso " 1500 ppra, dichlobenil is slightly
toxic to pheasants.
Endangered Species
There are sufficient data on avian and aquatic organisms
to evaluate the hazard to endangered avian and aquatic species.
Only the aquatic herbicide use may result in a potential
hazard to aquatic invertebrates.
Alfalfa and ladino clover use directions specify aerial
application. These uses compared to other terrestrial sites
present even less hazard to aquatic organisms because 1)
only granular products are registered for these crops thereby
reducing drift, 2) use is limited (crops grown for seed in
the Northwest), and 3) application rates are 1.4 to 2.0 Ib
ai/A.
Birds could be exposed to granules by consuming them as
grit. The lowest LD«j(j is 1189 rag/kg to pheasants. With the
LD5Q of dichlobenil being approximately 1200 mg/kg to pheasants
which is by an order of magnitude (10) greater than the level
normally causing concern for bird deaths (100 mg/kg or
less) , there should be no problems for nonendangered or
endangered bird species.
The Endangered Species Cluster Program is designed to
assess the individual risk to endangered species from each of
the chemicals registered for a given use pattern. The Agency
is currently developing the clusters for endangered species
(plant and animal) on aquatic and noncrop sites. The Office
of Endangered Species (OES) will be requested to provide an
opinion for dichlobenil along with other chemicals in those
clusters.
Product Chemistry
The Agency has evaluated the available data which identify
the composition, beginning materials, and manufacturing
process and discuss the physical and chemical properties of
dichlobenil. The Agency is concerned about the possibility
of dichlobenil becoming contaminated with halogenated dibenzo-
p-dioxins, dibenzofurans, and nitrosamines during manufacture.
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The Agency's concern about dichlobenil is based upon its
chemical structure (polyhalogenated cyclic compound).
Available information suggests that halogenated dibenzo-p-
dioxin and dibenzofuran contaminants may be formed during
manufacture under certain conditions of temperature, pressure
and alkalinity.
Registrants are required to analyze their products for
nitrosamine contamination. The Agency is requesting data
describing the maufacturing process for dichlobenil, with
particular emphasis on data relating to the formation of
dibenzo-p-dioxins or dibenzofurans. The manufacturing process
description must describe each step of the manufacturing
process, including specification of acceptable conditions of
temperature, pressure or alkalinity. The Agency is particu-
larly interested in the presence of elevated temperature,
pressure or alkalinity at any stage of manufacture. If the
active ingredient is manufactured at more than one facility,
a description of the process used in each facility must be
submitted. The discussion of the formation of impurities
must pay particular attention to the possible formation of
nitrosamines or halogenated dibenzo-p-dioxins or dibenzofurans.
D. TOLERANCE REASSESSMENT
Tolerances have been established for residues of
dichlobenil in a variety of raw agricultural commodities
(RACs), meat, fat, and meat byproducts (40 CFR 180.231).
EPA has evaluated the residue and toxicology data supporting
tolerances and has made the following regulatory determinations
o Whether the current tolerances and food additive regu-
lations are sufficient to cover the actual residues
resulting from use (including uses registered under
FIFRA section 24(c) and intrastate uses).
o Whether group tolerances can be established in accor-
dance with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions
on use, grazing, or feeding of treated commodities
are necessary.
o Whether the tolerances are expressed accurately and
in current terminology.
The regulatory results of the Agency's review are set out
in Section IV.A., Regulatory Positions and Rationales.
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1. Residue Data.
The residue data reviewed In support of these tolerances
Include the following:
a. Data on the nature of the residues In both plants
and animals, Including Identification of major metabolites
and degradates of dichlobenil. The established tolerances
are based on occurrence of dichlobenil and Its metabolite
2,6-DCBA. The manufacturing Impurity BAM also occurs as a
soil mlcrobial metabolite of dichlobenil and may be
present at significant levels In the soil following
treatment. BAM will be added to the tolerance expression
which already includes dichlobenil and the metabolite
2,6-DCBA.
b. Radlolabeled studies on the uptake, translocatlon,
and metabolism of dichlobenil In plants which show that
2,6-DCBA is absorbed by roots and translocated In the
plant. The available data do not adequately elucidate
the nature of the residue In plants following soil appll-
• cation of dichlobenil. Additional data are required.
c. Radlolabeled studies on the metabolism and movement
of dichlobenil In rats, rabbits, and cows have identified
several metabolites that can occur in animal systems.
Several dichlobenil metabolites have been identified in
rat and rabbit urine and feces. If residue or animal
and plant metabolism studies Indicate detectable levels
of BAM or other metabolites of concern, then livestock
feeding studies using dichlobenil plus BAM may be required.
d. Analytical methodology for determining the levels of
residues of dichlobenil and Its metabolites (2,6-DCBA and
BAM) In plants and animals. An adequate gas chromato-
graphic (electron capture) method is available for
tolerance enforcement and collection of data pertaining
to residues of dichlobenil and 2,6-DCBA in or on plant
commodities, fish, and potable water. The method used
to collect BAM data must be fully described and validated.
Addltonal data are required on dichlobenil, 2,6-DCBA and BAM
If the requested data reveals additional metabolites of
.toxlcological concern other than BAM, additional analytical
methods for data collection and enforcement may be
required.
e. Storage stability data demonstrating residues of
dichlobenil. No storage stability data were submitted
to ascertain whether residues of dichlobenil are stable
in or on plant commodities when stored. Therefore, none
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of the available data on the magnitude of residues in plants
are considered adequate to support existing tolerances.
If the requested metabolism data indicate the presence of
addltonal residues of toxlcological concern in plant or animal
commodities, data depicting the stability of such residues in
storage will be required.
f. Data on the magnitude and levels of residues of
dichlobenil and its metabolites (2,6-DCBA and BAM) in individual
Raw Agricultural Commodities (RACs), animal products, and
processed food and feed items. Conclusions cannot be
reached regarding the magnitude of residues of dichlobenil
in animal products, because the magnitude of the residue
in feed items, metabolism in plants, and metabolism in
animals are not adequately defined. Additional data are
required.
2. Toxicology Data.
The toxicology data considered in support of the tolerances
Include a core-minimum subchronlc oral toxlc'lty study in rats
with a NOEL of 100 ppm (50 rag/kg/day), a chronic feeding
study In dogs with a NOEL of 50 ppm (1.25 mg/ kg/day), a rat
teratology study with a maternal toxic NOEL of 20 mg/kg/day
and a developmental NOEL of 60 rag/kg/day, and several mutagenicity
studies (all negative). Refer to the toxicology section
(section III B) for detailed information on available data
and additional requirements.
Due to toxlclty data gaps a Provisional Acceptable Daily
Intake (PADI) rather than an Allowable Daily Intake (ADI) was
established. The PADI Is based on the 2-year dog feeding
study NOEL of 50 ppm (1.25 mg/kg/day). Utilizing a safety
factor of 1000 because of the data gaps, the PADI is 0.00125
mg/kg/day. This is eqlvalent to a Maximum Permissible Intake
(MPI) of 0.0750 ing/day for a 60 kg individual. The Theoretical
Maximal Residue Contribution (TMRC) is 0.0195 mg/day based on
a dally food Intake of 1.5 kg (0.000325 mg/kg/day), which
utilizes 26 percent of the PADI.
When data gaps have been satisfied, an ADI will be
determined using the most sensitive study and the appropriate
safety factor. The data gaps existing for an ADI are
chronic/oncogenlcity study, teratolgy study, and reproduction
study.
3. Tolerances Issued.
Tolerances are established for dichlobenil and Its
metabolite 2,6-DCBA In or on the raw agricultural commodities:
Almond hulls, apples, avocados, blackberries, blueberries,
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citrus, cranberries, figs, grapes, mangoes, nuts, pears,
raspberries, and stone fruits.
Canadian tolerances have been established for residues
of dichlobenll in or on apples, peaches, blackberries, cran-
berries, grapes, blueberries, and raspberries.
No Mexican tolerances or Codex Maximum Residue Limits
(MRLs) have been established for dichlobenil.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
1. No referral to Special Review is being made at this time.
Rationale; None of the risk criteria listed in 40 CFR 154.7
have been met for dichlobenil. Therefore, no referral to Special
Review is being made at this time.
2. The Agency*will not classify dichlobenil as a restricted
use pesticide.
Rationale; Present aquatic label directions permit
treating a third of the weed area only. When a third of the
weed area is treated, the maximum estimated residue
(0.25 ppm) is below the restricted use trigger.
3. The Agency will assess the potential of ground water
contamination after environmental fate data are received.
Rationale; Available data indicate there is a concern
about dichlobenil1s potential for persistence in soil and
ground water contamination. These concerns cannot be adequately
addressed until sufficient data on the technical are received.
4. The Agency is not requesting additional reentry data.
Rationale: Dichlobenil does not meet the toxicity
criteria of 40 CFR 158.140 in that; 1) the acute dermal toxicity
of the technical grade of active ingredient is greater than
200 rag/kg (body weight); 2) the acute oral toxicity of the
technical grade of active ingredient is greater than 50 mg/kg
(body weight); and 3) no other adverse effects have been evidenced
5. The Agency will not at this time, require labeling to
protect endangered species.
Rationale; Labeling is being deferred until clusters
for endangered species (plant and animal) on aquatic and
terrestrial noncrop sites have been developed. Until receipt
of this information no labeling will be required. (See Other
Science Findings, Section III C).
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6. The Agency will not approve any significant »new food
uses of dlchlobenil until additional residue chemistry data
are available to assess existing uses.
Rationale; It is Agency policy not to establish
significant new uses where major data gaps exist. When
additional data are evaluated, the Agency will determine
whether significant new food use may be established.
7. The Agency has decided to add the metabolite BAM to
the tolerance expression which already Includes dlchlobenil
and the metabolite 2,6-DCBA.
Rationale; BAM is a potentially significant residue in
plant and animal products and BAM has been implicated in
adverse toxicological effects not attributable to dichlobenll
per se. The contribution of BAM to the total residue will be
determined upon receipt of the requested field studies.
8. The Agency is requiring residue data tp establish
tolerances for forage and hay of alfalfa and clover.
. Rationale; Review of these uses indicates that the
present non-food use classification for these commodities is
Inappropriate. Forage and hay may be diverted for livestock
feed prior to or after seed harvest. Therefore, tolerances
should be proposed and supporting data submitted.
9. The Agency is requiring data reflecting residues of
the metabolite BAM on citrus, apples, stone fruits, cranberries,
grapes, raspberries, nuts, almond hulls, avocados, figs and mangoes
•Significant new use is defined in H4 PR 27931*, May 11, 1979.
In the case of a new food or feed use, the Agency will consider
as significant an increase in Theoretical Maximum Residue
Contribution of greater than 1 percent.
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Rationale; BAM is a major microbial metabolite of
dichlobenil and is very stable in soil. This metabolite is
readily absorbed and translocated by plants. Because BAM has
tentatively been implicated in adverse toxicological effects not
attributable to dichlobenil per se, we are requiring
additional residue data depicting residues of BAM.
10. The Agency is requiring that the registrant make
appropriate label amendments to permit use on avocados and
figs or the established tolerances for residues in or on
avocados and figs will be revoked.
.Rationale; The available data are insufficient to assess
the adequacy of the established tolerances for the combined
residues of dichlobenil and its metabolite 2,6-DCBA in or on
avocados and figs, because no registered uses exist. It is
required that the registrant propose use directions and
submit appropriate supporting data reflecting residues of
dichlobenil, 2,6-DCBA, BAM and other residues of concern.
Alternatively, the tolerance for residues in or on avocados
and figs should be deleted from the 40 CFR.
11. The Agency is adopting the following positions
regarding dichlobenil, 2,6-DCBA, and BAM residues and tolerances:
(a) The Agency is requiring considerable data related to
dichlobenil, 2,6-DCBA, and BAM food tolerances, (b) The Agency
will revoke within one year of issuance of this Standard, the
avocado and fig tolerances if no uses for a pesticide product
on avocados and figs are proposed, (c) The Agency will delete
the non-food classification of seed crops after the registrant
submits tolerance proposals and supporting data demonstrating
no residue levels in forage and hay of seed crops.
Rationale; Support for these positions are as follows:
(a) The Agency lacks sufficient data to fully reassess
dichlobenil tolerances, (b) The Agency seeks to avoid :
confusion in the user community that may arise from maintaining
a crop tolerance for which there are no registered products.
(c) The nature of the residue in animals is not adequately
understood. On receipt of the data requested, the need for
and nature of tolerances for residues in animal products will
be determined. This requested residue data may increase the
livestock dietary exposure concentrations.
12. The Agency is requiring that the negligible residue
designation be deleted from the 40 CFR 180.231 tolerance entries.
Rationale; Under current Agency policy, negligible
residues which were used to describe levels below or at the
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limits of detection are no longer established.
13. The Agency is requiring that the registrant(s)
analyze their products for nitrosaraines.
Rationale; There is a potential for formation of these
contaminants during the manufacturing process and/or storage
of their products.
14. The Agency is requiring that the registrant(s)
submit data describing the manufacturing process, with particular
emphasis on data relating to the formation of dibenzo-p-dioxins
and dibenzofurans contaminants in their products.
Rationale; The potential exists for dibenzo-p-dioxin
and dibenzofuran contamination of dichlobenil products based
on chemical structure. We are requiring that the manufacturing
process be described in a detailed enough manner to allow a
determination of the likelihood of formation of these contam-
inants.
15. The Agency has identified certain data that will receive
immediate review when submitted.
Rationale; Certain data are essential to the Agency's
assessment of this pesticide and its uses and/or may trigger
the need for further studies which should be initiated as soon
as possible. The following studies have been identified to
recieve priority review as soon as they are received by the Agency
§158.120 Product Chemistry
61-1 Preliminary analysis
61-2 Description of beginning materials and
manufacturing process
61-3 Discussion of formation of impurities
. (dioxin and nitrosamine data)
S158.125 Residue Chemistry
171-4 Plant metabolism
171-4 Animal metabolism
171-4 Methodology
171-4 Storage stability
171-4 Magnitude of the residue (BAM data)
S158.130 Environmental Fate
161-1 Hydrolysis
161-2 Photodegradation in water
161-3 Photodegradation in soil
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162-1 Aerobic soil metabolism
162-2 Anaerobic soil metabolism
162-3 Anaerobic aquatic metabolism
164-1 Field soil dissipation
164-2 Field dissipation studies for aquatic uses
164-3 Field dissipation (forestry)
§158.135 Toxicology
81-3 Acute inhalation toxlcity - rat
81-4 Primary eye irritation
81-5 Primary dermal sensitization
81-6 Dermal sensitization
83-2 Oncogenicity - rat and mouse
85-1 General metabolism
§158.145 Ecological Effects
72-2 Acute ECcQ freshwater invertebrates
72-4 Fish early life stage and aquatic invertebrate
life cycle
16. While data gaps are being filled, currently registered
manufacturing use products (MPs) and end use products (EPs)
containing dichlobenil as the sole active ingredient may be
sold, distributed, formulated, and used, subject to the terms .
and conditions specified in this Standard. Registrants must
provide or agree to develop additional data as specified in
the Data Appendices in order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration simply because data are missing or
are inadequate (see FIFRA section 3(e)(2)(B) and 3(c)(7)). :
Issuance of this Standard provides a mechanism for identifying
data needs. These data will be reviewed and evaluated, after
which the Agency will determine if additional regulatory
changes are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain dichlobenil as the sole active ingre-
dient, bear required labeling, and conform to the product
composition, acute toxicity limits, and use pattern requirements
listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
MPs must contain dichlobenil as the sole active ingredient.
Each MP formulation proposed for registration must be fully
described with an appropriate certification of limits, stating
maximum and minimum amounts of the ai and each inert ingredient
which are present in products, as well as impurities found at
greater than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and" MPs containing dichlobenil provided that the product
labeling bears appropriate precautionary statements for the
acute toxicity category in which each product is placed.
3. Use Patterns
To be registered under this Standard, technical grade or
MPs containing dichlobenil may be labeled for formulation
into EPs registered only for the uses listed in Appendix III,
EPA Index to Pesticide Chemicals--Dichlobenil. This Index
lists all registered uses as well as approved maximum
application rates and frequencies. .
D. REQUIRED LABELING
All products roust bear appropriate labeling as specified
in 40 CFR 162.10. Appendix II contains information on label
requirements.
No pesticide product containing dichlobenil may
be released for shipment by the registrant after April,
1988 unless the product bears an amended label which complies
with the requirements of this Standard.
No pesticide product containing dichlobenil may be
distributed, sold, offered for sale, held for sale, shipped,
22
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delivered for shipment, or received and (having so received)
delivered or offered to be delivered by any person after
April, 1989 unless the product bears an amended label
which complies with the requirements of this Standard.
In addition to the above, the following information must
appear on the labeling:
1. Ingredients Statement
The ingredient statement for MPs must list the active
'ingredient as:
2,6-dichlorobenzonitrile
2. Use Pattern Statements
All manufacturing-use products must state that they
are intended for formulation into end-use products for
acceptable use patterns. Labeling must specify sites,
which are listed in Use Patterns, Section C.3. 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.
3. Precautionary Statements
Statements for Manufacturing-Use Products
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 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 the EPA.
Statements for End-Use Products
End-Use Products with Aquatic Weed Control (Nonfood) Use
Do not contaminate untreated water by cleaning of
equipment or disposal of wastes. Treatment of weed areas can
result in oxygen loss from decomposition of dead weeds. This
loss can cause fish suffocation. Therefore, treat only 1/3
of the weed areas at a time and wait 14 days between treatments.
Consult your State Environmental Regulatory Agency concerning
the need for a permit before applying this product to public
waters.
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End-Use Products with Aquatic Food (Cranberry) Uses
Do not contaminate water by cleaning of equipment or
disposal of wastes.
End-Use Products with Nonaquatic Uses (non-granular products)
Do not apply directly to wat^er or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate water by
cleaning of equipment or disposal of wastes.
End-Use Products with Nonaquatic Uses (granular products)
Cover, collect, or incorporate granules spilled on the
soil surface. 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.
Worker Safety Rules
IMPORTANT! Always wash hands, face, and arms with soap
and water before smoking, eating, drinking, or toileting. [For
nongranular formulations: Before removing gloves, wash them
with soap and water].
Keep all unprotected persons, children, livestock, and
pets away from treated area or where there is a danger of drift,
Do not rub eyes or mouth with hands. If you feel sick
in any way, STOP work and get help right away. See Statement
of Practical Treatment.
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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 B2
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 reregistratlon.
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 Tabled.
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 1-ngredlents 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.
o
2. If eligible for the formulator's exeraption3, the
data requirements listed In Table C.
3. If not eligible for the forraulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
b. 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 forraulator'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-reglstered products,
you are eligible for the forraulator's exemption for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active Ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
In Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of PIPRA 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.1*
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active Ingredient. Such data are relevant to an
evaluation of all products containing that active Ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
»
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data In response to a DCI notice if the registrant
who supplies the active Ingredient in his product is complying
with the data request.
If you are not now eligible for a forraulator'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 Fonrula must Identify
the new source(a) and you must submit a Pcrmulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active Ingredient after the Issuance of this Registration
Standard, you will be required to submit or cite generic
data relevant to the uses of your product If, at the time
** 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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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 PIPRA 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 (PIPRA 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 "PIPRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to Jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to Join In
•an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data Is taking appropriate
steps to secure It. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
Include the following Information:
_2b
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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. Pile with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, 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 mall receipt). Your offer must, •
at a minimum, contain the following language or Its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to PIPRA sec.
3(c)(2)(B) in the Dlchlobenll Registration Standard upon
terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FIPRA section
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 yo'ur 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.
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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
fall to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Procedures for requesting a change in testing protocol.
. If you will generate the required data and plan to use
test procedures which deviate from (or are not specified in)
either EPA's Pesticide Assessment Guidelines or the Reports
of Expert Groups to the Chemicals Group, Organization for
Economic Cooperation arid Development (OECD) Chemicals Testing
Programme, you must submit for EPA approval the protocols
you propose to use.
You should submit your protocols before beginning testing
and await EPA approval, because the Agency will not ordinarily
accept as sufficient studies using unapproved protocols.
A request for protocol approval will not extend the tiraeframe
for submission of the data, nor will extensions generally be
given to conduct studies due to submlttal of inappropriate
protocols.
P. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than Is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which Is made as an Initial response to a section
3(c)(2)(B) request notice must be submitted In writing to
the Product Manager listed at the end of this section and
must be made before the deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
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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 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 ad-equaoy of funding, since the Agency believes
that with proper planning these can be overcome. Time extensions
may be considered when Joint data development Is planned,
or when the Agency must approve a new or modified protocol
before the study can be begun.
A request for an extension does not extend the tiraeframe
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.
G. Existing stocks provision upon suspension or cancellation.
The Agency has determined that If a registration Is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you:
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
Information must be Included In any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, Including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIPRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under Its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
.this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed In Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
Is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, P, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.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.
32
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
PIPRA 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
•UO CPR 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 CPR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under PIPRA sec. 6.
-------
IX. INSTRUCTIONS FOR. SUBMISSION
A. Manufacturing Use Products (MUPs) containing Dlchlobenil
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)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. 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 raockup of the labeling suitable for
storage In 8-1/2 x 11 files. The draft label must Indicate
the Intended colors of the final label, clear Indication'
of the front panel of the label, and the Intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement Is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting Information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated In response to this notice. This submission Is In
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring
-------
3. Within the times set forth in Table A. you must
submit to the Registration Division all generic data, unless
you are eligible for the forraulator's exemption. If for any
reason any test is delayed or aborted so that the 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 Dichlobenil
in combination with other active ingredients.
1. Within 90 days from receipt of. this document, you
must submit to the Product Manager in the Registration Division:
•• *
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1). •
b. Confidential Statement of Formula (EPA Form 8570-10
c. Forraulator'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 forraulator'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 Dichlobenil as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Pormulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
35
-------
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 Dichlobenil 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
Registration Division (TS-767C)
' Office of Pesticide Programs
Environmental Protection Agency
HOI 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-3^2)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
36
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TGUIDE-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticide covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
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
B
C
D
E
F
G
H
Terrestrial, food
Terrestrial, non-food
Aquatic, food
Aquatic, non-food
Greenhouse, food
Greenhouse, non-food
Forestry
Domestic outdoor
I » Indoor
Any other designations will be defined in a footnote to the table,
37
-------
TGUIDE-2
4. Does EPA have data? (Column 1). 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 term may also Indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to-be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be-submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
Its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained In a footnote to the table.
•
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previ.ous 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.
38
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TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL 99-5% and 96% TECHNICALS
Data Requlranent
Test
Substance
Does EPA Have Data
To Satisfy this Bibliographic
Requlrenent? (Yes, Cltatlorfc/
No. Partially)
Must Additional Time frame
Data be for
Submitted? Submission^/
§158.120 Product Chemistry
61-1 - Product Identity and TGAI
Disclosure of Ingredients
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
No
No
No
Yes
Yes3/
YesV
6 Months
6 Months
6 Months
Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of
Ingredient Limits
62-3 - Analytical Methods to
Verify Certified Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
TGAI
TGAI
TGAI
TGAI
TGAI
No
NO
No
No
No
YesV
YesV
Yes
Yes
12 Months
12 Months
12 Months
6 Months
6 Months
vO
-------
TABLB A
GENERIC DVTA REQUIREMENTS FOR DICHLOBENIL 99-5% and 96% TECHNICALS
Data Requirement
§158.120 Product Chemistry (cont*
Physical and Chemical
Characteristics
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density,
or Specific Gravity
Test
Substance
d)
TGAI
TGAI
TGAI
TGAI
63-8 - Solubility TOAI or PAI
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 -Stability
PAI
PAI
PAI
TGAI
TCAI
Does EPA Have Data
To Satisfy This Bibliographic
Requirement? (Yes, Citation^/
No, Partially)
No
No
N/A^/
No
No
No
No
No
No
No
Must Additional
Data be
Submitted?
Yes
Yes
No
Yes
Yes9/
Yes
Yes
Yes
Yes
YeslO/
Time frame
for
Submission]/
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
Other Requirements;
64-1 - Submlttal of Samples
4*.
O
TGAI
No
Yes
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DICHLOBENIL 99.5% and 96% TECHNICALS
§158.120 Product Chemistry Footnotes
jy Data roust be submitted within the indicated timeframes, which begin on the date of the Guidance Document (see front
cover for this date).
_£/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
3j The following additional data are required for each product:
o 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, and purifi-
cation procedures and quality control measures.
o The name and address of the manufacturer, producer, or supplier of each beginning material used to manufacture
the product. Also, a copy of all available technical specifications, data sheets and other documents in vdiich
the manufacturer, producer, or supplier of the beginning material describes its composition and properties must
be submitted.
0 Registrants must analyze their products for formation of nitrosamines, and sufficient detail must be provided on the
manufacturing process to determine the likelihood of formation of dibenozo-p-dioxin and dibenzofuran contamination.
V The following information is required:
o A discussion of each impurity believed to be present at ^> 0.1% based on knowledge of the beginning materials, all
possible chemical reactions, and any contamination.
J>/ In order to satisfy this data requirement, five or more representative samples must be analyzed for the amount of
~~ active ingredient and each impurity for which a certified limit is required, using valid analytical methods.
J>/ Since certified limits were not provided, the following information is required:
o Upper and lower limits must be provided, validated, and certified for dichlobenil in each product.
o Upper limits must be provided, validated, and certified for each impurity present at > 0.1% (w/w) , and for each
"toxicologically significant" impurity present at < 0.1% (w/w) in each product listedT
o All nitrosamines must be identified and quantified in six samples of each product; two samples of each must be
analyzed shortly after production, 3 months after production and 6 months after production, respectively. A method
sensitive 1 ppm of N-nitroso contaminants must be used. An upper limit must be provided (and certified) for each
nitrosamine found.
o Certifications should be submitted on EPA Form 8570 (Rev. 2-85).
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DICHLOBENIL 99.5% AND 96% TECHNICALS
§158.120 Product Chemistry Footnotes (cont'd)
7/ The following additional Information la required:
o Quantitative methods to determine all Impurities for which certified limits are required In each product,
o Each method must be accompanied by validation studies of the precision and accuracy of the method.
"/ Not applicable since the product Is a solid at roan temperature.
Determinations must be made at 20 or 25 °C, and must be reported In ppn or g/100 ml solvent.
Information regarding the effects of metal, metal Ions, and elevated temperatures la required.
ro
-------
TABLE A
GENERIC DATA REQUIRHMENTS FOR DICHLOBENIL
Does EPA Have
Data To Satisfy Must Additional
Test This Require- Bibliographic Data Be
Data Requirement Substance ment? (Yes, No Citation Submitted?
or Partially)
§158.
171-2
171-3
171-4
171-4
125 Residue Chemistry
- Chemical Identity2/ No
- Directions for Use3/ Yes
- Nature of Residue
(Metabolism)
- Plants PAIRA Partially
- Livestock PAIRA 4 Plant Partially
Metabolites
- Residue Analytical
Method
- Plant Residues PAI 4 Partially
Metabolites
- Animal Residues PAI 4 Partially
Metabolites
Yes
product labels No
00113758 Yes"/
00137791
00067651
00111219 Yes5/
00113741
00147021
00036252 00113759 00113721
00036253 00113767 00113738
00036254 00113768 GS0147-001 Yes6/
00036255 00113774 GS0117-002
00109109 00113739
00147021 00113720
00113757
00042489 Reserved?/
00042490 ~
00042491
00067652
00042488
Time frame
for
Submission^/
6 Months
18 Months
18 Mon
15 Months
15 Months
-------
TABLE A
GENERIC CATA RBQUDiQMENTS FOR DICHLOBENIL
Test
Data Requirement Substance
§158.125 Residue Chemistry (cont'd)
171-1 - Storage stability PAI
171-1 - Magnitude of the Residue -
Residue Studies for
Each Food UseV
- Citrus Fruits Group(RAC) TEP
Processed Food/Feed TEP
- Pome Fruits GroupH/
k o Apples (RAC) TEP
^
Processed Food/Feed TEP
o Pears TEP
- Stone Fruits Group(RAC) TEP
Processed Food/Feed TEP
- Small Fruits and Berries
Group1 7/
o Blackberries TEP
o Blueberries TEP
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
No
Partially
Partially
Partially
No
Yes
Partially
No
Partially
Partially
Bibliographic
Citation
00113757
00113767
00113757
00109109
00113790
00109109
00109109
00113771
00113772
00113773
00113768
00109109
Must Additional Time frame
Data Be for
Submitted? Submission]/ '
Yes ft/ 15 Months
Yes™/ 18 Months
Yes]^/ 21 Months
Yes}2 18 Months
Yes £3/ 21 Months
NoW 18 Months
YeaJS/ 18 Months
Yea^y 21 Months
Yes^/ 18 Months
Yes^9/ 18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLODENIL
Test
Data Requirement Substance
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Tlmeframe
Data Be for
Submitted? Submission^/
§158.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residue -
1 Residue Studies for
Each Pood Use (cont'd)
pa*
•^ o Cranberries
o Grapes (RAC)
Processed Pood/Peed
o RasiJberrles
- Tree Nuts Group
o Almond Hulls
- Miscellaneous
Commodities
o Avocados
o Pigs (RAC)
Processed Pood/Peed
o Mangoes
EP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partially
Partially
No
Partially
Partially
No
Partially
Partially
No
Partially
00109109
00113778
00113782
00113790
00113799
00113768
00113790
00113768
00113739
00113740
00109109
GS01 47-001
GS01 47-002
00109109
*#w
Yes22*
Yes£3/
YeslS/
Yes2!!/
Yes2?/
Yes^6/
Yes27,28/
Yes28/
Yes2?/
18 Months
18 Months
24 Months
18 Months
18 Months
18 Months
18 Months
18 Months
24 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Data Requirement
Test
Substance
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Mist Additional
Data Be
Submitted?
Time frame
for
Submission1/
§138.125 Residue Chemistry (cont'd)
171-4 - Magnitude of the Residue -
Residue Studies
- Crops Grown Solely
for Seed
o Alfalfa
EP
o Clover EP
- Meat/milk/poultry/ TEP
eggs
- Potable water/fish TEP
Partially
Partially
No
No
00036253
00036258
00113790
00036255
00036258
Yes30/
Yes31/
Reserved^2/
Reserved33/
18 Months
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
§158.125 Residue Chemistry Footnotes
I/ Data must be submitted within the Indicated tlmefranes, which begin on the date of the Guidance Document (see front
cover for this date).
2_/ Refer to Product Chemistry Data Requirement Tables.
3/ See Index. Except avocados and figs.
V Grapes and one additional orchard crop (apple, cherry, pear, or plum) are to receive soil applications of benzene-
labeled [iqC]dlchlobenll at or above 6 Ib al/A 30 days prior to harvest, under conditions comparable to those
specified In the label. Exaggerated application rates may be necessary. Analyses should Include hydrolysis and
reextractlon steps to determine conjugated ^C-resldues of dlchlobenll. Samples from requested metabolism studies
must also be analyzed using accepted enforcement methods.
5/ Ruminants and poultry must be dosed for at least 3 days with benzene-labeled [llJC]dlchlobenll at concentrations In
the total diet that will result In sufficient residues In tissues, milk, and eggs for characterization. Animals
must be sacrificed within 24 hours of the final dosing. Milk and eggs must be collected twice dally. ^C-Resldues
In muscle, fat, kidney, liver, milk, and eggs must be characterized. Samples from requested metabolism studies must
also be analyzed using accepted enforcement methods. If these studies do not reveal the presence of metabolites
obviously passing through BAM as an Intermediate, then separate studies Involving the feeding of [l^CjBAM may be
required.
6/ Complete description of the analytical methodology, Including validation data, for the detection and quantltatlon
of BAM In oranges, apples, peaches, blackberries, blueberries, cranberries, grapes, almonds, and alfalfa. If the
requested data regarding the nature of the residue In plants and animals reveal additional metabolites of
toxlcologlcal concern other than BAM, additional analytical methods for data collection and enforcement may be
required. Residues of the metabolites 2,6-DCBA and BAM In or on crop samples must be subjected to analysis by
S"1^?^^^?1;00018 *• IIf HI* and IV avallable from National Technical Information Service (NTIS) under Order
i w ,?? 203PVAS- If tne requested data regarding the nature of the residue In plants reveal additional
metabolites of toxlcologlcal concern, additional analytical methods for data collection and enforcement may be
FGUIP
7/ Data are not required at the present time because there are no tolerances for residues of dlchlobenll In animal
commodities. Tne need for such tolerances will be evaluated on receipt of data required under Nature of the
Residue In Livestock (refer to footnote 5/).
-------
TABU? A
GENERIC DATA REQUIREMENTS FDR DICHLOBENJL
§158.125 Residue Chemistry Footnotes (cont'd)
8_/ Details of storage intervals and conditions of samples used to support all established tolerances for residues of
dlchlobenll must be submitted. These data must be accompanied by data depleting the percent decline in residues
at the time and under the conditions specified. It should be noted that all residue data requested in this
Standard must be accompanied by data regarding storage Intervals and conditions of sample storage, and data
depleting the stability of dichlobenil residues of concern in appropriate sample substrates under the conditions
and for the time intervals specified.
£/ BAM is a major mlcrobial degradation product of dlchlobenll and Is very stable in soil. The metabolite is readily
absorbed and translocated by plants. Because BAM has tentatively been Implicated in adverse toxlcologlcal symptoms
not attributable to dlchlobenil per se (Toxicology Chapter of the Registration Standard for Dlchlobenll dated
August 28, 1986), we are requiring additional residue data depleting residues of BAM in or on certain representative
group members. Complete description of the analytical methodology, Including validation data, for the detection and
quantltation of BAM in oranges, apples, peaches, blackberries, blueberries, cranberries, grapes, almonds, and
alfalfa are required If the requested plant metabolism studies reveal the presence of additional metabolites
00 of concern, then data will be required depleting residues of these metabolites.In or on treated foods or feeds.
Ip/ Data must be submitted In support of this crop group tolerance depleting residues of BAM and any residues of concern
other than dichlobenil and 2,6-DCBA in or on oranges (harvested at maturity) .following a single spring application
of a G formulation and the 50* WP formulation (each In separate tests) at 6 Ib al/A. The registrant must propose a
PHI .and submit appropriate data in support of this proposal. Tests must be conducted in Florida and California.
Ulchlobenll, 2,6-DCBA, BAM, and any other residues of concern must be determined in dried citrus pulp, wet pulp
molasses, and oil processed from fruit bearing measurable weathered residues. Exaggerated rates may be necessary.
ll/ If a crop group tolerance is desired, additional supporting residue data must be submitted for pears.
12/ Data must be submitted depleting residues of BAM and any residues of concern other than dlchlobenil and 2 6-DCBA in
Q*^IL?V8* (?arVS!tfi a! m?turlty) following ground application with the 50% WP and a 0 formulation (each In
separate tests). Tests should be conducted In Washington, New. York, Pennsylvania, California, and Virginia
~ SEJ"!^ S6 SUbmltted dePlctlng residues of dichlobenil, 2,6-DCBA, BAM, and any other residues of concern in apple
iSS t^
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
§158.125 Residue Chemistry Footnotes (cont'd)
IV Data required for apples will be translated to satisfy data requirements for pears.
15/ To meet the requirements for a crop group tolerance, data must be submitted depleting residues of dlchlobenll, 2,6-
DCBA, BAM, and other residues of concern In or on peaches (In California and South Carolina) and pi urns/ fresh prunes
(In Idaho, Michigan, and Washington) 30 days after one soil treatment with a 0 formulation (peach and plum) and a WP
formulation (plum only) at 6 Ib al/A.
16/ Data must be submitted which depict the potential for concentration of dlchlobenll, 2,6-DCBA, BAM, and other residue
of concern In dried prunes processed from plums (fresh prunes) bearing measurable weathered residues. If
concentration occurs, a food additive tolerance must be proposed.
177 Should the reglstrant(s) seek a crop group tolerance, proposed use directions and supporting residue data must be
submitted for strawberries, and additional data will be required to support the existing tolerances for dlchlobenll
In or on blueberries, cranberries, and grapes.
18/ Data must be submitted depleting residues of BAM In or on blackberries harvested at regular Intervals following a
son application with a 0 and 50% WP formulation (In separate tests) at 5 Ib al/A. A decline study Is necessary to
ascertain the need for a FHI.
19/ Data must be submitted depleting residues of BAM In or on blueberries harvested at regular Intervals following a
soil application with a G and a WP formulation (In separate tests) at 6 Ib al/A. A decline study Is necessary to .
ascertain the need for a FHI.
20/ Data must be submitted depleting dlchlobenll, 2,6-DCBA, BAM, and other residues of concern In or on cranberries
harvested after soil application of the 6.75% Multiple Active Ingredient (MAI) G formulation. Separate tests must
be conducted reflecting a single spring application at 10 Ib al/A, and two or more applications at rates totaling
10 Ib ai/A/season. Tests must be conducted In Washington and Oregon. Alternatively, the registrant may elect to
cancel this use permitted under SLN's OR-830066 and WA-8300^5.
21/ Data must be submitted depleting residues of BAM In or on cranberries harvested after the last of two prebloom
applications (separated by 3 weeks) with a G formulation at H Ib al/A (total). The registrant must propose a PHI
and submit data accordingly. Tests must be conducted In Massachusetts and Wisconsin.
vO
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TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
§158.125 Residue Chemistry Footnotes (cont'd)
22/ Data must be submitted depicting residues of dlchlobenll, 2,6-DCBA, BAM, and any other residues of concern In or on
grapes following two soil applications (one In early to middle February, and one no later than May 1) with a G and
a WP formulation (In separate tests) at 6 Ib al/A. The registrant must propose a PHI and submit data In support
of the proposal. Tests must be conducted In California and New York. • •• -
23/ Data must be submitted depleting dlchlobenll, 2,6-DCBA, BAM, and any other residues of concern In raisins, raisin
waste, Juice, and dry pomace derived from grapes bearing measurable weathered residues. If the data Indicate that
residues concentrate In any of these proposed commodities, appropriate food/feed additive tolerances must be
proposed.
2V To adequately support the established crop group tolerance, data must be submitted depleting residues of dlchlobenll,
2,6-DCBA, BAM, and other residues of concern In or on almonds and pecans 30 days after a single soil application of
... a G formulation and, In separate tests, the 50% WP formulation, at 6 Ib al/A.' Tests must be conducted using ground
equipment. Tests on almonds must be conducted In California; those on pecans must be conducted In Georgia, and
^ New Mexico or Oklahoma. Although additional data are also required for English walnuts and filberts, data requested
o for almonds and pecans will be substituted to fulfill data requirements for these crops.
25/ Data must be submitted reflecting residues of dlchlobenll, 2,6-DCBA, BAM. and other residues of concern In or on
almond hulls 30 days following a single soil application of the 50* WP and, In separate teats, a G formulation,
at b Ib al/A. Tests must be conducted using ground equipment, and must be performed In California.
26/ Available data are Insufficient to assess the adequacy of the established tolerance for dlchlobenll and It's
metabolite 2,6-DCBA In or on avocados because no registered uses have been proposed. We recommend that the
IS m *?* Propose use directions and submit appropriate supporting data. Tests must be conducted In California
and Florida. Alternatively, the tolerance will be revoked.
— SSSa5j! ^ aPr lr- •T1°1';'!t to asses3 the adequacy of the established tolerance and proposed use directions
a^Si ?ie ~2S" tXES? %* fo™?atl°?S.d0 ** I«ently Include this corrxxttty. The registrant must either
label use SlSrMrJS ? ^*8' °r US6 exlstlr« France "HI be revoked. If the registrant elects to anend the
'51~! SSiS a^la^^^^ ^
—on ^^^
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TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
§158.125 Residue Chemistry Footnotes (cont'd)
297 Data roust be submitted depleting residues of dlchlobenll, 2,6-DCBA, BAM, and any other residues of concern In or
on mangoes (harvested at maturity) following a full season application schedule (Including one soil application In
early-to-middle February and a second application no later than May 1) using a 0 formulation at 6 Ib al/A. Appli-
cations must be conducted using ground equipment and tests must be conducted In Florida. A maximum seasonal use
rate and number of applications should be proposed.
30/ The nonfood use classification of alfalfa grown for seed Is Inappropriate, and the registrant must (1) propose'
appropriate tolerances for residues of dlchlobenll, 2,6-DCBA, BAM, and other residues of concern In or on alfalfa
forage and hay following two applications of the 4% 0 formulation at 2 Ib al/A; and (11) submit residue data In
support of such tolerances. Tests should be conducted In the northwest region of the U.S. Residues must be determl
In hay and the forage from which hay was prepared. Alternatively, the registrant may elect to cancel this
use. Separate aerial and ground treatments must be represented.
3J7 The nonfood classification of clover grown for seed Is Inappropriate, and the reglstrant(s) must:
(1) propose appropriate tolerances for residues of dlchlobenll, 2,6-DCBA, BAM, and other residues of concern In or
on clover forage and hay following a single application of the ^% G formulation at 2 Ib al/A; and (11) submit
residue data In support of such tolerances. Tests must be conducted In California. Residues should be determined
In hay and In the forage crop from which hay was prepared. Alternatively, the registrant may elect to cancel this
use. Aerial and ground treatments must be represented.
32/ No conclusions can be reached at this time regarding the magnitude of residues of dlchlobenll In animal products
because the magnitude of the residue In feed Items (Including water), metabolism In plants, and metabolism In
animals are not adequately defined. Upon receipt of these data, the necessity for and nature of tolerances
for residues In animal products will be determined.
33/ No conclusions can be reached at this time regarding the magnitude of residues of dlchlobenll In potable water and
fish, because the metabolism In plants and animals Is not adequately defined and because a temporary fish tolerance
reflecting 0.05 ppn dlchlobenll residues In water Is currently pending (PP#6G3351/PAP#6H5ll89). Upon receipt of
beevalSated ^P™***1^6"683 of the tolerance for residues In fish and an acceptable level In potable water will
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR DICHLOBENIL
Data Requirement
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes,
Substance Patterns No or Partially)
Bibliographic
Citation
Mist Additional
Data be
Submitted?
Tlmeframe
for
Submission1/
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxlclty - TOAI
Rat
81-2 - Acute Dermal Toxlcity - TGAI
Rabbit
81-3 - Acute Inhalation TCAI
Toxlcity - Rat
81-1 - Primary Eye Irritation TCAI
*8l-5 - Primary Dermal TOAI
Irritation
81-6 - Dermal Sensltizatlon TCAI
81-7 - Delayed TCAI
Neurotoxlcity - Hen
SUBCHRONIC TESTING;
82-1 - 90- Day Fteedlng:
- Rodent, and TCAI
- Nonrodent (Dog) TGAI
Yes
Yes
No
No
No
No
No
00112500 No
00113796 No
Yes.
v Yes
Yes
Yes
No2/
9 Months
9 Months
9 Months
9 Months
Yes
No
00107106 No
No3/
LH
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TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes
Data Requirement Substance Patterns No or Partially)
S158,
82-2
82-3
82-4
82-5
Must Additional
. Bibliographic Data be
Citation Submitted?
Timeframe
for
Submission J[/
,135 Toxicology (continued)
- 21 -Day - Rabbit
- 90-Day Dermal - Rabbit
- 90-Day Inhalation -
Rat
- 90-Day Neurotoxicity -
Hen/Mammal
TGAI
TGAI
TGAI
TGAI
No
No
No
No
Reserved^/
NoV
No""
. 6/
No
CHRONIC TESTING:
83-1
83-2
83-3
83-4
- Chronic Toxicity
- Rodent, and
- Nonrodent (Dog)
- Oncogenicity
- Rat (preferred) ,
and
- Mouse (preferred)
- Teratogenicity
- Rat
- Second Species
- Reproduction - Rat
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
No
Yes
No
No
Yes
No
No
7/
Yes~
00067649 No
7/
Yes"
Yes
00147437 No
Yes
Yes
48 Months
48 Months
48 Months
12 Months
30 Months
2-generation
cn
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TABLE A
GENERIC DATA REQUIREMENTS FDR DICHLOBENIL
Data Requirement
Test
Subs tance
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Patterns No or Partially)
Bibliographic
Citation
Hist Additional
Data be
Submitted?
Timeframe
for
Submission1/
§158.135 Toxicology (continued)
MUTAGENICITY TESTING:
84-2 - Gene Mutation TGAI
(Ames Test)
84-2 - Structural Chromosomal TGAI
Aberration
84-2 - Other Mechanisms of TGAI
Mutagenicity
SPECIAL TESTING;
85-1 - General Metabolism PAI or PAIRA
Yes
Yes
Yes
No
00153579
00153576
00153586
00153577
00153578
00153580
00153581
No
No
No
Yes
24 Months
Jy Data must be submitted within the indicated time frames, which begin on the date of the Guidance Document (see front
cover for this date).
2/ Dichlobenil is not an organophosphate; therefore, this study is not required.
"3/ The subchronic dog st 'y requirement is satisfied by the chronic dog study.
5/ The requirement for tula study is reserved until environmental fate data gaps have been satisfied and it can be
determined whether the aquatic uses result in human dermal exposure (i.e., washing and swimming in ponds, lakes,
and reservoirs).
5/ This study is not required because of limited opportunity by this route of exposure.
*>/ This is not required because an acute delayed neurotoxicity study (81-7) is not required.
1J A study submitted (Accession No. 258695;MRID No. 00147438) needs to be resubmitted and reevaluated before it can
be determined if it satisfies the requirement for a rat feed ing/oncogen icity study (timeframe for submission is
Cn6 months). The requirement for a new rat feeding/oncogenicity study will be reserved pending the final
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
SI58.135 Toxicology footnotes
classification of this study.
LH
Ln
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Data Requirement
Does EPA Have Data
To Satisfy This
Test Use Requirement? (Yes, Bibliographic
Substance Patterns No or Partially) Citation
Must Additional Tlmeframe
Data be for
Submitted? Submission*/
§158.130 Environmental Pate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In Water
161-3 - On Son
161-1 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
C/l 162-3 - Anaerobic Aquatic
CN
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
A _» . . t * «•*. . .
TGAI
TOAI
TGAI
TGAI
TQAI
TGAI
TGAI
TGAI
TGAI
or PAIHA AtB,C,D,G,H
or PAIRA A,B,C,D,G
or PAIRA A,G
or PAIRA
or PAIRA A,B,G,H
or PAIRA A
or PAIRA C,D,G
or PAIRA C,D
or PAIRA A,B,C,D,G,H
No
No
No
No
No
No
No
No
Partially 00151561
Yes
Yes
Yes
2/
No
Yes
Yes3/
Yes
Yes
V
Yes
9 Months
9 Months
9 Months
27 Montlis
27 Months
27 Months
27 Months
12 Months
Adsorption/Desorptlon
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Data Requirement
§158.130 Environmental Pate
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD:
161-1 - Soil
161-2 - Aquatic (Sediment)
161-3 - Forestry
161-1 - Combination and
Tank Mixes
161-5 - Soil, Long-Term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
Test Use
Substance Patterns
(continued)
TEP
TEP
TEP A,B,H
TEP C,D
TEP G
TEP
TEP A,C
PAIRA A,C
TEP A,C
TEP C,D
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
No
No
No
No
No
No
No
No
No
No
Mist Additional
Bibliographic Data be
Citation Submitted?
No£/
No£/
' ' Yes
Yes
Yes
No£/
Reserved 5/
Yes6/
Yes?/
Yesfy
Tlmeframe
for
Submission^/
27 Months
27 Months
27 Months
—
50 Monttis
39 Months
50 Months
39 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy This Mast Additional
Use Requirement? (Yes, Bibliographic Data be
Patterns No or Partially) Citation Submitted?
Tlmeframe
for
Submission1/
§158.130 Environmental Fate (continued)
165-4 - In Pish TCAI or PAIRA A,B,C»D,Q
165-5 - In Aquatic Nontarget TEP D,Q
Organisms
No
No
Yes
Yes
12 Months
12 Months
V Data must be submitted within the Indicated tlmeframes, which begin on the date of the Guidance Document (see front
cover for this date).
2/ Data are not required to support current registered uses or are otherwise not applicable for this Standard.
3/ An acceptable anaerobic aquatic metabolism study will satisfy this requirement.
V Data are required using the batch equilibrium method on four soils and an aquatic sediment. An aged leaching study
(for degradation products) on one soil Is also required.
5/ Data may be required depending on the results of field dissipation studies on terrestrial and aquatic food crops
and aerobic soil metabolism studies.
£/ No restriction on the planting of rotational crops In treated areas Is being Imposed since there are no data
available at this time to foroi the basis of a specific restrictive Interval. However, after the required data are
received and evaluated a label restriction may be Imposed If It Is needed.
7/ Data may be required If significant residues of concern are found In the confined rotational crop study.
Jy No restriction on the use of irrigation water used on dichlobenll-treated crops Is being Imposed since relevant data
are not available at this time. After such data are received and evaluated a label restriction may be required.
CO
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Data Requirement
Test
Substance
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes,
Patterns No or Partially)
Bibliographic
Citation
Must Additional
Data be
Submitted?
§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 TEP
Evaluation
§158.75 Other Exposure Data TEP
A,B
A,B
A,B
A,B
No
No
No
No
No
No
No"
I/
>
I/
>
V
No
A,B,C,D,Q No
A,B,C,D,Q No
2/
No
2/
No~
No2/
V Data are not required. Under 40 CFR 158.140, reentry data are not required for dlchlobenll If the pesticide and
Its use patterns meet certain criteria. Those criteria Include both toxlclty and exposure. The "When Required"
paragraphs of Subdivision K of the Pesticide Assessment Guidelines discuss the circumstances under which §158.140
requires reentry data.
£/ Data are not required to support current registered uses or are otherwise not applicable for this Standard.
-------
TABLR A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Test
Data Requirement Substance
§158.1H5 Wlldife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral TGAI
Toxicity
71-2 - Avian Dietary LC5o
- Upland Game Bird, and TGAI
- Waterfowl TGAI
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
71-5 - Simulated Field
Testing
- Mammals, and TEP
- Birds TEP
Does EPA Have Data
To Satisfy Requlre-
Use ment? (Yes, No or
Pattern Partially)
A,B,C,D,H No
A,B,C,D,H Yes
A,B,C,D,H No
A,B,C,D,H No
A,B No
A,B No
A,B No
Must Additional Tlroeframe
Bibliographic Data Be for
Citation Submitted? Submission^/
••
Yes 9 Months
00022923 No
Yes 9 Months
No
No
No
No
Ox
O
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TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
§158
Data Requirement
.115 Wlldife and
Test
Substance
Does EPA Have Data
To Satisfy Require-
Use ment? (Yes, No or
Pattern Partially)
Must Additional Timeframe
Bibliographic Data Be for
Citation Submitted? Submission^/
Aquatic Organisms (cont'd)
AQUATIC ORGANISM TESTING
72-1
ON
72-2
72-3
- Freshwater Fish Toxlclty
- Coldwater Fish TGAI
Species
- Warmwater Fish TGAI
Species
- Warmwater Fish TEP
Species
- Coldwater Fish TEP
Species
- Coldwater Fish Metabolite
Species
- Warmwater Fish Metabolite
Species
- Acute Toxiclty'to TGAI
Freshwater
Invertebrates TEP
- Mcute Toxic ity to TGAI
A.B.C.D.H Yes
A,B,C,D,H Yes
C,D No
C,D No
D Yes
. D Yes
A,B,C,D,H No
C,D No
C,D No
10091602 No
10091602 No
No2/
No2/
10091602 Noy
10091602 Noj3/
Yes 9 Months
No2/
NoV
Estuarlne and
Marine Organisms
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Does EPA Have Data
To Satisfy Require- Mist Additional Tlmeframe
Test Use ment? (Yes, No or Bibliographic Data Be for
Data Requirement Substance Pattern Partially) Citation Submitted? Submission^/
§158.115 Wlldlfe and
Aquatic Organisms (cont'd)
AQUATIC ORGANISM TESTING (cont'd)
72-4 - Pish Early Life TGAI C,D No
Stage, and
- Aquatic Invertebrate TGAI C,D No
Life Cycle
72-5 - Pish Life Cycle TGAI C,D No
72-6 - Aquatic Organism TGAI A.B.C.D No
YesV 15 Months
Yes^/ 15 Months
Reserved£/
Yesy/ 12 Months
Accumulation
72-7 - Simulated or Actual
Field Testing Aquatic
Organisms
TEP
D
Partial^/
113752
Reserved^/
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TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Wildlfe and Aquatic Organisms Footnotes
V Data must be submitted within the Indicated time frames, which begin on the date of the Guidance Document (see front
cover for this date).
2/ The Inerts of the granular formulation are not likely to cause the product to be more toxic than technical.
3/ Reserved pending receipt and review of fate data such as photolysis, hydrolysis and aquatic field dissipation.
V Exposure levels as compared freshwater toxlclty do not present a concern.
•V Direct application to water exceeds 0.01, the fish LCcq of technical dlchlobenll, and the aquatic Invertebrate
£€50 for* a formulated product of dlchlobenll. Reserved for cranberry use pending receipt of photolysis,
hydrolysis and aquatic field dissipation.
£/ Reserved pending the results of the partial fish life cycle and aquatic field dissipation study.
•jj See data requirements for §158.130.
g/ Incomplete reporting of residue analysis mortality and growth data. Only the study on the 4% granular product
could be used In partial fulfillment of this requirement.
Reserved pending results of aquatic field dissipation studies and remaining acute and chronic aquatic toxlclty
studies.
-------
TABLE A
GENERIC EATA REQUIREMENTS FOR DICHLOBENIL
Does EPA Have Data
To Satisfy Require- Wast Additional Tlmeframe
Test Use ment? (Yes, No or Bibliographic Data Be for
Data Requirement Substance Pattern Partially) Citation Submitted? Submission^/ .
§158.150 Plant Protection
121-1
- TARGET AREA TEP A.B,C,D No
PHYTOTOXICITY
No
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI A,B,C,D No
Seedling Emergence
- Vegetative Vigor TGAI A,B,C,D No
- Aquatic Plant Growth TGAI A,B,C,D No
TIER II
- Seed Germination/ TGAI A,B,C,D No
Seedling Emergence
- Vegetative Vigor TGAI A,B,C,D No
- Aquatic Plant Growth TGAI A.B.C.D No
TIER III
- Terrestrial Field TEP A,B No
- Aquatic Field TEP D No
Yes 6 Months .
6 Months
Yes
Yes • 6 Months
Reserved2/
Reserved2/
Reserved2/
Reserved3/
Reserved3/
O\
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DICHLOBENIL
§158.150 Plant Protection Footnotes
V Data must be submitted within the Indicated tlmefranes, which begin on the date or the Guidance Document (see front
cover for this date).
£/ Reserved pending results of Tier II.
3/ Reserved pending results of Tier II.
O\
U1
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Test
Data Requirement Substance
Use
Patterns
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
ttjst Additional
Data be
Submitted?
Tlmeframe
for
Submission]/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
- Honeybee Acute
Contact Toxicity
- Honeybee - Toxicity
of Residues on
Foliage
111-4 - Honeybee Subacute
Feeding Study
141-5 - Field Testing For
Pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute Toxicity to
Aquatic Insects
142-1 - Aquatic Insect
Life Cycle Study
142-3 - Simulated or Actual
Field Testing for
ON Aquatic Insects
ON
TGAI
TEP
A.B,0,H
A,B,G,H
Yes
No
00018842
TEP
A,B,G,H
No
No
No2/
Reserved^/
Reservedjj/
Reserved^/-
Reserved^/
-------
TABLE A
(ENERIC DATA REQUIREMENTS FOR DICHLOBENIL
Does EPA Have Data
To Satisfy This Mist Additional . Tlmeframe
Test Use Requirement? (Yes, Bibliographic Data be for
Data Requirement Substance Patterns No or Partially) Citation Submitted? Submission
§158«155 Nontarget Insect (continued)
NOMTARGET INSECT TESTING - Reserved^/
PREDATORS AND PARASITES
143-1 -
thru
1^3-3 -
j/ Data must be submitted within the indicated tlmeframes, which begin on th edate of the Guidance Document (see front
cover for this date).
2/ As data from the acute contact study show low toxiclty, no further testing is required.
3/ Reserved pending development of test methodology.
4/ Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DICHLOBENIL
Data Requiranent
Test
Substance
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No. Partially)
Bibliographic
Citation2/
Mist Additional
Data be
Submitted?
Time Frame
for
Submission^/
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-U - Odor MP
No
No
No
No
No
No
No
No
No
Yes
Yes3/
YesV
Yes5/
Yes£/
Yes?/
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
O\
CO
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DICHLOBENIL
Does EPA Have
Data Requirement Test Data To Satisfy Bibliographic. Must Additional Time Frame
Substance This Requirement? (Yes, Citation2/ Data be for
No, Partially Submitted? Submission1
§158.
120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12
63-11
63-15
63-16
63-17
63-18
63-19
63-20
- pH
- Oxidizing or Reducing
Action
- Flammablllty
- Explodablllty
- Storage Stability
- Viscosity
- Mlsclblllty
- Corrosion Characteristics
MP
MP
MP
MP
MP
MP
MP
MP
MP
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
6 Months
Other Requirements;
64- 1 - Submittal of samples
MP
No
Yes
6 Months
Os
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DICHLOBENIL
§158.120 Product Chemistry Footnotes~
V Data must be submitted within the indicated timeframes, vhich begin on the date of the Guidance Document
(see front cover for this date).
fj Not applicable. Although product chemistry data may have been- submitted in the past, the Agency has determined that
these data must be resubmitted for each manufacturing-use product. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
2/ The following additional data are required for each product:
o 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, and purifi-
cation procedures and quality control measures.
o The name and address of the manufacturer, producer, or supplier of each beginning material used to manufacture
the product. Also, a copy of all available technical specifications, data sheets and other documents in vfrich
the manufacturer, producer, or supplier of the beginning material describes its composition and properties must
be submitted.
0 Registrants must analyze their products for formation of nitrosanines and sufficient detail must be provided on
the manufacturing process to determine the likelihood of formation of dibenzo-p-dioxin and dibenzofuran
contamination.
V The following information is required:
o A discussion of each impurity believed to be present at ^> 0.1% based on knowledge of the beginning materials, all
possible chemical reactions, and any contamination.
jV In order to satisfy this data requirement, five or more representative samples must be analyzed for the amount of
active ingredient and each impurity for which a certified limit is required, using valid analytical methods.
j>/ Since certified limits were not provided, the following information is required:
o Upper and lower limits must be provided, validated, and certified for dichlobenil in each product.
o Upper and lower limits must be provided, validated, and certified for each intentionally added inert.
o Upper limits must be provided, validated, and certified for each impurity present at ^ 0.1% (w/w), and
for each "toxicologically significant" impurity present at < 0.1% (w/w) in each product:
0 All nitrosamines must be identified and quantified in six samples of each product; two samples of each must be
analyzed shortly after product, 3 months after production and 6 months after production, respectively. A method
sensitive to 1 ppm of N-nitroso contaminants must be used. An upper limit must be provided (and certified) for
each nitrosamine found.
0 Certifications should be submitted on EPA Form 8570 Rev. 2-85.
2j The following additional information is required:
0 Quantitative methods to determine all impurities for which certified limits are required in each product.
0 Quantitative methods to determine all intentionally added inerts in all products.
0 Each method must be accompanied by validation studies of the precision and accuracy of the method.
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SUMMARY-1
LABEL CONTENTS
40 CPR 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 CPR I62.10(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 CPR I62.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CPR I62.10(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 CPR I62.10(g)]
71
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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 I62.10(h)(l)(11)]
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)(!)(!)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxlcity Category I on the basis of oral, dermal,
or inhalation toxlcity, 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 I62.10(h)(1)(1)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxlcity Categories I,
II, and III. [40 CFR I62.10(h) (1) (Hi)]
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 I62.10(h)(l)(iil)]
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 I62.10(h)(2)].
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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 I62.10(h)(2)(1)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CPR I62.10(h)(2)(11)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - PLAMMABILITY
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 - PIPRA sec.. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) Indicated
certain formulations/uses are to be restricted (Section 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.reregistratlon. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated In accordance with
the provisions of 40 CPR I62.11(c). You will be notified of
the Agency's classification decision.
73
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CPR I62.10(h)(l)(lv)
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.
74
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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 CPR 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.
75
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SUMMARY-6
LABELING REQUIREMENTS OF THE PIPRA, AS AMENDED
ITEM
1
2
3
1
,5
>J
7s
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Eat. 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.
al/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.
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SUWIARY-7
ITEM
7C
7D
->J
xj
7E
8
8A
8B
LABEL ELEMENT
Scull & cross-
bones and word
POISON (In red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
pr ecaut lonary
statements
Hazards to
hunans and
domestic
animals
Environnental
hazards
APPLICABILITY
OP REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or Inhala-
tion toxlcity
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
FHKh'KHHKJI
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings In
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environnental hazards include bee
caution where applicable.
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SUMMARY-8
ITEM
8c
9A
9B
10A
10B
IOC
T.ARRT, ET.EMKNT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
. disposal block
Directions
.for use
APPLICABILITY
OP REQUIREMENT
All pressurized
products, others
with flash
rpolnts under
150°P
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 fron 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
CO
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Chapter 1—Eavirormental 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
79
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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;
80
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II
(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)(n) 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
onco 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 liquid 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."
-------
(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.
82
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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 psrcentages 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:
83
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Hazard Indicators
Oral LO^
Inhalation 1C..
50
Dermal LD.ft
50
Eye effects
Skin effects
1
Up to and
Including
50 »gAg
Up to and
Including
.2 ing/liter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive
Toxicity <
II
From 50 thru
500 «g/Kg
.
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea 1 opacity
reversible
•Ithln 7 days;
Irritation
persisting for
7 days
Seve-e Irritation
at 72 hours
:ategortes
III
From 500 thru
5000 mg/Kg
From 2 thru
20 mg/Mter
From 2,000 thru
20,000
No cornea 1 opacity;
Irritation
reversible
within 7 days
Mode-ate Irritation
at 72 hou-s
IV
Greater than
5000 mg/kg
Greater than
20 «g/l Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hou^s
(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
the basis of its oral/ inhalation or
from skin and eye local effects) the
in red on a background of distinctly
skull and crossbones shall appear in
word "poison."
(B) Toxicity Category II.
to Toxicity Category I on
dermal toxicity (as distinct
word "Poison" shall appear
contrasting color and the
immediate proximity to the
criteria of Toxicity Category
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
II shall bear
All pesticide
III shall bear
All pesticide
IV shall bear
products meeting the
on the front panel*
products meeting the
on the front panel
products meeting the
on the front panel
84
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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) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 10 to 15
Poir
Required
signal word,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
85
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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.
Toxicltr
category
Precautionary statements by toxlclty category
Oral, Inhalation, or dermal toxic1t>
Skin and eye local effects
I .
II .
Ill .
IV .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin). Do not breathe
vapor Idustl or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
May be fatal If swallowed (Inhaled or
abso'bed through the skin). Do not breathe)
va?D-s (dust or spray nlst). Do not get In)
eyes, on skin, or on clothing. (Appropriate)
fl-st aid statements required.].
Harmful If swallowed I Inhaled or absorbed
through the skin). Avoid breathing vapors
(dust or spray mist). Avoid contact with
sk'n (eyes or clothing]. (Appropriate
first aid statement required.!.
(No precautionary statements required.].
Corrosive, causes eye and skin damage lor
skin Irritation). Do not get In eyes, on
skin, or on cloth'ng. Mear goggles or'face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
(Appropriate first aid statement required.)
Causes eye land skin) Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. (Appropriate first
aid statement required.].
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin w'th 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
86
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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 LDc,Q 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 LC^Q 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$Q of 100 mg/kg or less, or
a subacute dietary LC$Q 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 belov 20*F; If there Is a
flashback at any yalvt opening.
Flash point above 20*F and not over 80*F or If
the flam* extension Is nor* than 18 In. long
at a distance of 6 In. from the flam*.
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 a«ay
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposui e 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) NONPRESSURIZEO CONTAINERS
Extremely flammable. Keep a«ay from fire,
sparks, and heated surfaces.
Flammable. Keep a«ay from heat and open flame.
Do not use or store near heat or open flame.
87
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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;
(2) 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
(2) 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:
(_!) 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;
88
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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;
(,3) 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.
89
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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. I, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978]
90
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°P; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 Inches
long at a distance of
6 Inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. -Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. 'Do not
puncture or 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.
91
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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.
U. 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 violation of Federal
Law. If these wastes cannot be disposed of by use according to
label Instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or Inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in ^0 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
I*. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products Intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard In trash."
93
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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, canSj iars)
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)
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.
Plastic containers
Triple rinse (or equivalent).Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent).Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen cl-lnglng
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
reused1, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by Incineration,
or, if allowed by State and local
authorities, by burning.
out of smoke.
If burned, stay
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
94
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EPA Index to Pesticide Chemicals
DICHLOBENIL
TABLE OF CONTENTS
Site Name
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa (seed crop)
Almond
Apple
Blackberry
Blueberry
Cherry
Cranberry Bogs
English Walnut
Filbert
Grape
Grapefruit
Ladino Clover (seed crop)
Lemon
Lime
Mango
Nectarine
Oranges
Peach '
Pear
Pecan
Plum
Prune
Raspberry
Tangerine
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
Amur Corktree
Arborvitae
Aah
Azalea
Azalea (Kuruae hybrids)
Azalea (Mollis hybrids)
Barberry
Beauty Bush
Birch
Boxelder
Boxwood
Camellia
Caragana
Cleyera Japohica
Cotoneaster
Cottonvood 95
Crabapple (ornamental)
Deutzia
~'i!/ It i Hi
Page
5
5
5
6
5
5
7
5
5
5
8
8
8
8
5
5
8
5
5
5
5
6
6
8
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
Issued: 2-19-86 I-027401-i
-------
EPA Index to Pesticide Chemicals
DICHLOBENIL
TABLE OF CONTENTS
Site Name Page
Dogwood 10
Eastern Redcedar 10
Elm 10
Ellwood False Cypress . 10
English Ivy • 10
English Walnut 10
Euonymus 10
Filbert (ornamental) 10
Fir 10
Flowering Almond 10
Flowering Quince 10
Forsythia 10
Gardenia 10
Goldenraintree 10
Hackberry 10
Heather 10
Holly (excluding Ilex crenata, I. rotunda, I. vomitoria) 10
Honeylocust 10
Honeysuckle 10
Juniper 10
Kinnikinnick • 10
Laurel 10
Leucothoe • 11
Lilac 11
Linden 11
Locust 11
Magnolia 11
Maple 11
Mock Orange 11
Nandina 11
Oak 11
Ostnanthus • 11
Paxistima 11
Pecan (ornamental) 11
Photinia 11
Pine 11
Pittosporum 11
Podocarpus 11
Poplar 11
Privet 11
Pyracantha 11
Rhododendron 11
Rockrose 11
Rose 11
Russian Olive 11
Spirea 11
Spruce 96 11
Squawcarpet .11
. Viburnum 11
^^-..j. t.iQ.p* Ii-027401-ii
-------
EPA Index to Pesticide Chemicals
DICHLOBENIL
TABLE OF CONTENTS
Site Name
Weigela 11
Yew 11
(General Soil Treatment and Composting) 11
Soil Application 11
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments) 12
Noncrop Areas 12
Pre-paving/lining 12
AQUATIC NON-FOOD 13
(Aquatic Sites) 13
Lakes, Ponds, and Reservoirs 13
Sewage Lines 13
FORESTRY 14
(Ornamental Plants and Forest Trees) 14
Arborvitae14
Ash 14
Birch 14
Boxelder 14
Cottonwood 14
Eastern Redcedar 14
Elm . 14
English Walnut 14
Fir 14
Holly 14
Honeylocust 14
Juniper - 14
Lilac 14
Linden 14
Locust 14
Magnolia 14
Maple 14
hountainash 14
Oak 14
Pecan 14
Pine 14
Poplar 14
Privet 14
Rose 14
Russian Olive 14
Spruce 14
Squawcarpet 15
Yew 15
'.' 97
•« • -. •• .— <
—' - * y—i jj J
Page
Issued: 2-19-86
I-027401-iii
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EPA Index Co Pesticide Chemicals •• "
DICHLOBENIL
TABLE OF CONTENTS
Site Name Page
INDOOR 15 •
(Commercial and Industrial Uses) . 15
Adhesives „ 15
98
Issued: 2-19-86 I-027401-iv
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EPA Index to Pesticide Chemicals
DICHLOBENIL*
TYPE PESTICIDE; Herbicide
FORMULATIONS ;
DRAFT
Tech (99.
FI (85Z)
G (2Z, 4Z, 10Z)
WP (502)
SC/L (1.73Z, 1.77Z, 2.1Z, 3.12Z)
RTU (6.75Z)
GENERAL WARNINGS AND LIMITATIONS; A terrestrial and aquatic herbicide
used to control broadleaf weeds, grasses, and aquatic vegetation in orna-
mental woody plants, nut and fruit crops, lakes, and noncrop areas. Also
controls root growth in sewer joint grout gels and in sewer lines. To
control perennial weeds use either soil surface treatments in late fall
(November 15 to February 15) or soil incorporated treatment immediately
after application in late fall or early spring before May 1. To control
annual weeds apply either in the early spring or after cultivation has
removed established weeds. If treatments are followed with 0.5 to 1 inch
of water by overhead irrigation, use the lower dosages. Shallow incorpo-
ration is recommended in southern areas when temperatures are high. When
applying granules, a uniform application can be obtained by applying half
the granules over the entire area and then repeating with the remaining
granules. If application ia made to dry soil, lightly sprinkle with water
to moisten soil to a depth of 0.25 to 0.5 inch. Do not use on sloping
areas as run-off may injure desirable plants in adjacent areas. Do not
use on plants any part of which is used for human or animal consumption.
Do not use' on extremely light soil or in greenhouses. Do not apply to
transplants, cutting beds, or newly set transplants. Do not apply if air
temperatures are expected to rise above 70 F (21.1 C) within the following
week. Do not disturb soil in treated areas as long as the weed control
program is being maintained. Do not store product with propagative mate-
rials such as seeds, bulbs, or tubers.
Agricultural Crop Tolerances (other than those listed in the text):
Avocados 0.15 (N) ppm
Figs 0.15 (N) ppm
TIME REQUIRED FOR CONTROL; Not located.
PHYTOTOXICITY TO TARGET WEEDS; Leaves may absciss and exhibit a black or
brown discoloration. .
PHYTOTOXICITY TO CROPS; Not located.
MODE OF ACTION; Stimulates oxygen utilization and. inhibits esterification
of phosphorus, resulting in reduced meristematic cell growth and inhibi-
tion of germination.
' 99
*2,6-dichlorobenzonitrile
Issued: 2-19-86 ' 1-027401-1
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EPA Index to Pesticide Chemicals
DICHLOBENIL
BROADLEAF WEEDS CONTROLLED;
iAAGBV Arrowleafed tearthumb
3FAKAA Aster
3KAOAA Beggarsticks
3FCRBA Bristly oxtongue thistle
DXABBC Buckhorn plantain
BFAWBG Bull thistle
3FBWBB Canphorveed
BFAWBB Canada thistle
\DABBA Carpetweed
\ZAAAC Chickweed
BLAGBA Citronmelon
3YABBA Common bogbean
3FBUBA Common sunflower
3MAJAA Cottongrass
3FBPAA Cudweed
•AAHBE Curly dock
3FDHBB Dandelion
3GADAA Dodder
BFBIBB Dogfennel
3NAFAA Eveningprimrose
BFCHBA Fall hawkbit
BFCUAA Falsedandelion
ELMAEBB Florida pus ley
VDADAA Gisekia
BDAEAA Gooaefoot
2AAHBA Green sorrel
3FCXAA Groundsel
3FBXAA Hawkweed
3DAEBD Jerusalemoak goosefoot
lAAGAC Knotweed
EAAGBP Ladysthumb
BDAEAB Laobsquarter
BVAGBE Leafy spurge
ZAAABA Little hairgrass
LAAGBK Marshpepper «martweed
DSABBB Maypop passionflower
•:OACBA Miner* lettuce
3FAJBN Mugvort
^AACE Muskrat grass
3MADAA Nutsedge
iAAGBO Pennsylvania smartweed
3KAWAA Pepperweed
\AAABI Pigweed
3FCKBB Pineappleweed
)XABAA Plantain
3FCEBF Prickly lettuce
VAAABP Purslane
3FAEAA Ragweed
\FACBI Redroot pigweed
•AAHBB Red sorrel
BFARBI Russian knapweed
(a)
(a)
(a)
(d)
(d)
(d)
(a)
(a)
(a)
(a)
(d)
(a)
(a)
(a)
(a)
U)
(d)
(a)
(d)
100
Issued: 2-19-86
1-027401-2
-------
1DAKBA
JKAHBA
:AAAAZ
:AAGAD
IFDCAA
iFAOBA
JFCABB
JVAGAA
>MAHBA
.AAGBG
1AAADE
iLAKBC
1AAGBB
-AAABM
1AAABB
•FAflBA
IKBKBB
iKBABA
•MAGBE
IFAJAA
iKADBB
>PABBG
EPA Index to Pesticide Chemicals
DICHLOBENIL
BROADLEAF WEEDS CONTROLLED (continued)
' •».
Russian thistle
Shepherdspurse
Short viregrass
Smar tweed
Sowthistle
Spanishneedles
Spotted catsear
Spurge
Stranglevine
Swamp smart weed
Tide land clover
Virginia strawberry
Water smartweed
Western lilaeopsis
Wideleaf grass
Wild carrot
Wild mustard
Wild radish
Wool grass bulrush
Wormwood
Yellow rocket
Yellow wood sorrel
(d)
(a)
(a)
(d)
(a)
(a)
(a)
(a)
(a)
(a)
(a)
(a) in cranberry bogs.
(b) in alfalfa (seed crop) and ladino clover (seed crop).
(c) in noncrop areas.
(d) in soil application (mineral soils).
(e) in pre-paving/ lining (vinyl pool liners).
GRASSES AND OTHER MONOCOTS CONTROLLED:
:ACKBA Annual bluegrass
3AADAA Bentgrass (a)
ACKAA Bluegrass
AAVBA Bluejoint reedgrass (a)
QATBA Coffeeweed
ABRBA Common velvetgrass (a)
ABFAA Crabgrass (a)
OASBC Florida betony
ACUAA Foxtail
ACUBF Green foxtail (b)
ABSBD Hare barley
OAFBA Henbit
ABZBA Italian ryegrass (b)
YAEAA Loose t rife U)
QBDBA Marsh peavine (a)
BABBD Marsh St. Johnswort U)
ACNBA Natalgrass
ADAAA Needlegrass U) | Q |
ADGBA Oniongrass (a)
Issued: 2-19-86
1-027401-3
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EPA Index to Pesticide Chemicals
DICHLOBENIL
GRASSES AND OTHER MONOCOTS CONTROLLED (continued)
Orchardgrass
Percatory bean
Purple deadnettle
Quackgrass
Rattlesnakegrass
Rice cutgrass
Rough bentgrass
Rush
Seashore saltgrass
Smooth brome
Stargrass
Tall fescue
Texas pan i cum
Timothy
Witchgrass
if
(a)
(a)
(a)
(a)
(a)
(a) in cranberry bogs.
(b) in alfalfa (seed crop) and ladino clover (seed crop).
WOODY PLANTS CONTROLLED;
Dogwood
Roots
(a)
(f)
(a) in cranberry bogs.
(f) in adhesives (grout gel) and sewage lines.
AQUATIC WEEDS CONTROLLED;
Chara
Coontail
Elodea
Naiads
Northern watermilfoil
Pondweed
NONFLOWERING PLANTS CONTROLLED;
Brackenfern
Fiddleneck
Field horsetail
Haircap moss
Horsetail
Royal fern
Sensitive fern
Water horsetail
(a.) in cranberry bogs.
Issued: 2-19-86
(a)
(a)
U)
(a)
(a)
102
1-027401-4
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EPA Index to Pesticide Chemicals
13001BA
)3001AA
)3001DA
3400IAA
)4001DA
H009AA
)1009DA
)S002AA
)5002DA
03009AA
03009DA
03005AA
0300SDA
) 102IAA
1102IDA
)6007AA
J6007DA
)S003AA
•5003DA
)5004AA
•5004DA
)4003AA
(4003DA
)3008AA
>3008DA
)5005AA
)5005DA
Site, Dosage
and Formulation
(Ib a.i./A;
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa (seed crop) N.F.
DICHLOBENIL
Tolerance, Use, Limitations
1.4-2.0
(42 G)
000400-00168
Do not graze or use forage from treated areas.
Do not use seed for food or feed purposes.
General Information; Apply only to established
stands.
Use limited to the northwestern United States.
Postemergence. Soil treatment. Apply by ground
or by air. Make a second application 4 to 6 weeks
after the first application but before irrigating,
using 2 pounds active ingredient per acre without
soil incorporation.
Almond
Almond (nursery
stock)
Apple
Apple (nursery stock) fruit
Blueberry
Blueberry (nursery
stock)
Cherry
Cherry (nursery
•tock)
English Walnut
English Walnut
(nursery stock)
Filbert
Filbert (nursery
•tock)
Crape
Crape (nursery stock)
Mango
Mango (nursery stock)
Nectarine
Nectarine (nursery
•tock)
Peach
Peach (nursery stock)
Pear
Pear (nursery stock)
Pecan
Pecan (nursery stock)
Plum
Plum (nursery stock)
0.15 (N) ppm (almond, almond hulls, apples, blue-
berries, grapes, mangos, nuts, pears,
stone fruit)
30 day preharvest interval for nuts and stone
103
Issued: 2-19-86
1-027401-5
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Site, Dosage
and Formulation
Ub a.i./A)
Almond cluster (continued)
Prune
Prune (nursery stock)
EPA Index to Pesticide Chemicals
DICHLOBENIL
Tolerance, Use, Limitations
4-6
(22, 42 G)
000769-00536
(502 WP)
037100-00001
Almond (nursery
stock)
Apple
Broadcast or directed spray. Soil treatment. Ap-
ply in early spring before weed germination or
after cultivation has removed established weeds.
Use the higher rate for hard-to-control weeds.
Do not apply within 4 weeks after transplanting
(6 months on pecan transplants).
See Almond cluster.
See Almond cluster.
Apple (nursery stock) See Almond cluster.
Blackberry
Raspberry
4-5
(22, 42 G)
000769-00536
(502 WP)
037100-00001
Blueberry
Blueberry (nursery
•tock)
Cherry (nursery
stock)
0.15 (N) ppm
General Information: Apply only to established
plantings. Do not apply during new shoot emer-
gence.
Broadcast or directed spray. Soil treatment.
See Almond cluster.
See Almond cluster.
See Almond cluster.
See Almond cluster.
104
Issued: 2-19-86
1-027401-6
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.010AA
Site. Dosage
and Formulation
(Ib a.i./A)
Cranberry Bogs
4.
(42 C)
, 000400-00168
4-6
(42 G)
[SLN]
3.4-6.8
(6.752 RTU)
English Walnut
English Walnut
(nursery stock)
Filbert
Filbert (nursery
•tock)
Grape
EPA Index to Pesticide Chemicals
DICHLOBENIL
Tolerance, Use, Limitations
0.15 (N) ppo (cranberries)
General Information; Temporary reddening of cran-
berry plants may occur, especially with late
•pring applications or when applied to sandy bogs.
Do not apply after cranberry plants start to
bloom. Do not apply to young beds, newly sanded
beds, or on bogs prior to or immediately after
mowing for vines.
Prebloom application. Two equal applications
•hould be made with 3 to 6 weeks between treat-
ments. Do not make a spring application if a
treatment was made the previous fall.
Postharvest application. Use the higher dosage
on weedy bogs. Do not apply if a treatment was
made the previous spring.
SLN - Use limited to OR and WA.
Soil treatment. Apply in March.
Formulated with dalapon.
See Almond cluster.
See Almond cluster.
See Almond cluster.
See Almond cluster.
See Almond cluster.
Crape (nursery stock) See Almond cluster*
105
Issued: 2-19-86
1-027401-7
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EPA Index to Pesticide Chemicals
002AA
002 DA
»
004AA
004DA
005AA
005DA
006AA
:006DA
:008AA
I008DA
'008AA
!004AA
I011AA
:OIOAA
3016BA
Sice. Dosage
and Formulation
(Ib a.i./A)
Grapefruit
Grapefruit (non-
bearing)
Lemon
Lemon (non-bearing)
Lime
Lime (non-bearing)
Oranges
Oranges (non-bearing)
Tangerine
Tangerine (non-
bearing)
3-6
(22, 42 G)
000802-00536
(502 WP)
037100-00001
DICHLOBENIL
Tolerance, Use, Limitations
. \
0.15 (N) ppm (citrus fruit)
Do not allow livestock to graze in treated areas.
General Information: Do not apply during 6 months
following possible freeze damage.
Broadcast or directed spray. Soil treatment. Ap-
ply in the spring before weeds emerge or after re-
moving established weeds. Incorporate immediately
into the soil to a depth of 1 to 2 inches using a
power driven rotary hoe.
(Cleopatra mandarin, rough lemon, sour orange, sweet orange)
4-6
(42 G)
(502 WP)
Grapefruit (non-
bearing)
Ladino Clover (seed
crop)
1.4-2.0
(42 C)
000400-00168
Lemon
Lemon (non-bearing)
Line
Lime (non-bearing)
Issued: 2-19-86
Broadcast or directed spray. Soil treatment. Ap-
ply the first application in the early spring af-
ter removal of banks and the second in early sum-
mer, not less than 30 days after the first.
See Grapefruit cluster.
N.P. :
Do not graze or use forage from treated areas.
Do not use seed for food or feed purposes.
General Information; Apply only to established
•tands.
Use limited to the Pacific Coastal States. Dor-
mant application. Soil treatment. Apply by
ground or by air. Make application when adequate
rainfall or supplemental irrigation is assured.
See Grapefruit cluster.
See Grapefruit cluster.
See Grapefruit cluster.
See Grapefruit cluster.
1-027401-8] Q£
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EPA Index to Pesticide Chemicals
DICHLOBENIL
Site, Dosage Tolerance, Use, Limitations
and Formulation
(Ib a.i./A)
Mango See Almond cluster.
Mango (nursery stock) See Almond cluster.
Nectarine See Almond cluster.
Nectarine (nursery See Almond cluster.
stock)>
Oranges , See Grapefruit cluster.
Oranges (non-bearing) See Grapefruit cluster.
Peach See Almond cluster.
Peach (nursery stock) See Almond cluster.
Pear , See Almond cluster.
Pear (nursery stock) See Almond cluster.
Pecan See Almond cluster.
Pecan (nursery stock) See Almond cluster.
Plum See Almond cluster.
Plum (nursery stock) See Almond cluster.
Prune See Almond cluster.
Prune (nursery stock) See Almond cluster.
Raspberry See Blackberry cluster.
Tangerine See Grapefruit cluster.
Tangerine (non- See Grapefruit cluster.
bearing)
107
iMued: 2-19-86 1-027401-9
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EPA Index to Pesticide Chemicals
DICHLOBENIL
Tolerance, Use, Limitations
Site, Dosage
and Formulation
(Ib a.i./A)
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
Amur Corktree
Arborvitae
Ash
Azalea
Azalea (Kurume
hybrids)
Azalea (Mollis
hybrids)
Barberry
Beauty Bush
Birch
Boxelder
Boxwood
Camellia
Caragana
Cleyera Japonica
Cotoneaster
Cottonwood
Crabapple
(ornamental)
Deutzia
Dogwood
Eastern Redcedar
Elm
Ellwood False Cypress
English Ivy
English Walnut
Euonymua
Filbert (ornamental)
Fir
Flowering Almond
Flowering Quince
Forsythia
Gardenia
Coldenraintree
Hackberry
Heather
Holly (excluding Ilex
crenata, I. rotunda,
I. vomitoria)
Honeylocust
Honeysuckle
Juniper
Kinnikinnick
Laurel
N.F.
Do not apply for 4 weeks after transplanting.
General Information: Do not apply to fruit stock
within 3 months prior to or following grafting,
budding of root stocks, or planting of new grafts.
Do not use on St. Lucie fine sand or Azrell fine
sand. For circular areas around shrubs or trees,
apply 0.33 to 4.25 ounces of product to a diameter
of 2 to 6 feet, respectively. Do not apply more
than 6 pounds active ingredient per acre on aza-
leas, boxwoods, euonymus, forsythia, heather,
holly, ivy, and lilac.
108
Issued: 2-19-86
1-027401-10
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EPA Index Co Pesticide Chemicals
Site. Dosage
and Formulation
(Ib a.i./AJ
DICHLOBENIL
Tolerance, Use, Limitations
Amur Corktree cluster (continued)
4081DA Leucothoe
4089DA Lilac
5075DA Linden
5077DA Locust
5082DA Magnolia
5083DA Maple
4094DA Mock Orange
4100DA Nandina
5093DA Oak
4199DA Osmanthus
4200DA Paxistima
5353DA Pecan (ornamental)
4110DA Photinia
5098DA Pine
4113DA Pittosporum
5099DA Podocarpufl
5101DA Poplar
4088DA Privet
4058DA Pyracantha
4118DA Rhododendron
4119DA Rockrose
4120DA Rose
5109DA Russian Olive
4130DA Spirea
5116DA Spruce
4256DA Squawcarpet
•4137DA Viburnum
•5128DA Weigela
•5130DA Yew
4-8
(21, 4Z G)
000400-00170
(50Z WP)
037100-00001
Broadcast or directed spray. Soil treatment. Ap-
ply in the late fall or in the early spring and
incorporate immediately into the toil. Use the
lower dosage to control annual weeds and the high-
er dosage to control perennial weeds.
(General Soil Treatment and Composting)
»0008DA Soil Application
10-20
(4Z G)
000400-00168
General Information; Do not transplant into
treated aoils.
Soil treatment to control nutsedge in mineral
•oils. Incorporate immediately to a depth of 4
to 6 inches.
Issued: 2-19-86
1-027401-11
109
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-70000A
670110A
EPA Index to Pesticide Chemicals
DICHLOBENIL
Site, Dosage Tolerance. Use, Limitations
and Formulation
(Ib a.i./A)
(Noncrop, Wide Area, and General Indoor/Outdoor Treatments)
Noncrop Areas
0.23-0.45 Ib a.i./
1,000 sq.ft
(4Z, 102 G)
000400-00168
Pre-paving/lining
0.23-0.28 Ib a.i./
1,000 sq.fc
(41, 10Z G)
000400-00168
3.8-4.5 Ib a.i./
1,000 aq.ft
(50Z WP)
037100-00001
(3.122 SC/L)
001769-00305
Do not seed or transplant into treated areas for
24 months.
General Information; This site includes areas
around buildings, roadways, fences, window wells,
bicycle paths, cemetery memorials, golf cart
paths, railroad, utility, and highway rights-of-
vay, electrical substations, lumber yards, petro-
leum installations, farm fuel storage tanks, stor-
age areas, above ground tanks and pipes.
Soil treatment. Apply November 1 to March 1 in
most areas and until April 1 in the northern
United States. Use the higher dosage for hard-to-
control weeds and in dry soil areas.
General Information: This site includes roadways,
parking lots, recreational areas, sidewalks, and
vinyl pool liners before paying/lining.
Soil treatment before paving with asphalt or be-
fore placement of vinyl pool liners. Distribute
granules, incorporating into the soil to a depth
of 2 to 4 inches, with a rake or tiller immediate-
ly after the final grade.
Soil .treatment before paving with asphalt. Mix 1
gallon of product with 1.5 to 3 gallons of water
for each 1,000 square feet. Do not mix with as-
phalt primer or asphalt. Apply solution just
prior to laying the asphalt. Seal with a suita-
ble oil base primer after application.
no
Issued: 2-19-86
1-027401-12
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EPA Index to Pesticide Chemicals
>5031MB
S50260A
Site, Dosage
and formulation
(Ib a.i./AJ
AQUATIC NON-FOOD
(Aquatic Sites)
Lakes, Ponds, and
Reservoirs
7-10
(42, 10Z G)
000400-00171
10-15
(4Z, 10Z G)
Sewage Lines
(2.1Z SC/L)
001769-00255
[MAI]
DICHLOBENIL
Tolerance, Use, Limitations
General Information; Do not use in commercial
fish or shellfish waters. Do not apply to water
which will be used for crop irrigation, livestock
watering, or human consumption. Do not use fish
from treated waters for food or feed foj 90 days •
after treatment.
Soil or water surface treatment to exposed bottoms
or shorelines. Apply during early spring to ex-
posed bottoms or to the water surface. Use the
lower dosage if the soil is wet at the time of ap-
plication, or if water is less than 1 foot deep.
Water surface treatment. Use the lower dosage if
shallow water is less than 2 feet deep, and the
higher dosage in deep water (over 5 to 6 feet).
Apply when wave action is at a minimum.
General Information; Do not treat roots in storm
sewers or other drains where waste water will not
be treated or controlled. Do not use in storm
drains. Start treatment at the first manhole in
the upstream section of the line and plug the
downstream end while treating.
Solution treatment. Use a solution of 300 gallons
of water and 1.5 gallons of product to treat a
200-foot, 6-inch sewer line. Allow 30 to 60 min-
utes of treatment per section.
Foam treatment. Use 700 gallons of foam solution
— to fill a 400-foot, 6-inch sewer line. To obtain
(1.732, 1.77Z SC/L) this rate, mix 1.75 gallons of product with 35
gallons of water.
Formulated with vapam.
in
Isaued: 2-19-86
1-027401-13
-------
0019DA
0020DA
•0023DA
>0029DA
I0037DA
»004IDA
.0042DA
I0114DA
J0043DA
10115DA
J0048DA
10050DA
10116DA
)0052DA
30053DA
30054DA
30055DA
30117DA
30057DA
30Q58DA
30059DA
30060DA
30118DA
30119 DA
30121DA
30064DA
Site, Dosage
and Fonnulacion
(Ib a.i./A)"
EPA Index to Pesticide Chemicals
DICHLOBENIL
Tolerance, Use, Limitations
FORESTRY
(Ornamental Plants and Forest Trees)
Arborvitae (forest/ N.F.
•helterbelt)
Ash (forest/shelter-
belt)
Birch (forest)
Boxelder (forest/
shelcerbelt)
Cottonvood (forest/
•helterbelt)
Eastern Redcedar
(forest/shelterbelt)
Elm (forest/shelter-
belt)
English Walnut
(forest/shelterbeIt)
Fir (forest/shelter-
~be"lt)
Holly (shelterbelt)
Honeylocust (forest/
shelterbelt)
Juniper (forest/
•helterbelt)
Lilac (shelterbelt)
Linden (forest/
•helterbelt)
Locust (forest/
•helterbelt)
Magnolia (forest)
Maple (forest)
Mountainash (forest/
•helterbelt)
Oak (forest/shelter-
belt)
Pecan (forest/
•helterbelt)
Pine (forest/shelter-
belt)
Poplar (forest/
•helterbelt)
Privet (shelterbelt)
Rose (shelterbelt)
Russian Olive
(•helterbelt)
Spruce (forest)
112
Issued: 2-19-86
1-027401-14
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EPA Index to Pesticide Chemicals
DICHLOBENIL
Site, Dosage Tolerance, Use, Limitations
ano Formulation
(Ib a.i./A)
Arborvitae (forest/shelterbelt) cluster (continued)
120DA Squawcarpet (shelter-
belt)
073DA Yew (forest/shelter-
belt)
Refer to TERRESTRIAL NON-FOOD CROP, (Agricultural
Crops), Amur Corktree cluster for pest, dose, and
use information.
INDOOR
(Commercial and Industrial Uses)
.0010A Adhesives
100-200 ppm For root control in grouts of sewer joints. Pre-
(50Z WP) manufacture incorporation. Incorporate product
037100-00001 into the mixture of acrylamide nonomers used to
produce the grout gel.
AERIAL AND TANK MIX APPLICATIONS
)1500 Aerial Application
tAAAA
~ Refer to
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Alfalfa (seed crop), Ladino Clover (seed crop)
Issued: 2-19-86 1-027401-15
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EPA Index to Pesticide Chemicals
DICHLOBENIL
Listing of Registered Pesticide Products by Formulation
99.52 technical chemical
dichlobenil (027401)
000400-00172 000400-00175
852 formulation intermediate
dichlobenil (027401)
000400-00176 002217-00677
002217-00680 037100-00004
037100-00005
granular
dichlobenil (027401)
000400-00170 000769-00536
005584-00023 007401-00395
42 granular
dichlobenil (027401)
000400-00168 000400-00171
002217-00675 002217-00682
102 granular
dichlobenil (027401)
000400-00178 002217-00679
502 vettable powder
dichlobenil (027401) '
000400-00169 002217-00676
002217-00678
042057-00086
000769-00535
044215-00056
000802-00536
037100-00003
000400-00177
037100-00002
037100-00006
037100-00001 047901-00001
1.732 soluble concentrate/liquid
dichlobenil (027401) plus •odium methyldithiocarbamate (039003)
009993-00002
1*772 soluble concentrate/liquid
dichlobenil (027401) plus sodium methyldithiocarbamate (039003)
009993-00003
2.12 soluble concentrate/liquid
dichlobenil (027401)
001769-00255
3.122 soluble concentrate/liquid
dichlobenil (027401)
001769-00305
State Label Registrations
AZ Reg. No.
010583-09396
114
Issued: 2-19-86
1-027401-16
-------
EPA Index to Pesticide Chemicals _
/JlD *
DICHLOBENIL W«VX' *
• a
Listing of Registered Pesticide Products by Formulation (continued).
CA Reg. No.
011364-09868
NM Reg. No.
010583-03257
NY Reg. No.
038655-10448
TX Reg. No.
010583-08649
Special Local Need Registrations (24(c))
6.752 liquid-ready to use
OR830066 WA830045
115
Issued: 2-19-86 1-027401-17
-------
EPA Index to Pesticide Chemicals
DICHLOBENIL
Appendix A-l
Listing of Active Ingredient(s) Found in Combination With the Report Chemical
Chemical Common Name EPA Acceptable
Code (source) Common/Chemical Name
028901 dalapon (ANSI) 2,2-dichloroproprionic acid
039003 vapam (ISO) sodium methyldithiocarbamate
— Use EPA Acceptable Common/Chemical Name
116
iKued: 2-19-86 1-027401-18
-------
EPA Index to Pesticide Chemicals
DICHLOBENIL
Auxiliary Documentation
Registration Number Cancellation Date
002749-00237 02-01-84
002749-00255 02-01-84
013360-00001 12-05-84
117
Issued: 2-19-86 I-027401-a
-------
BIBGUIDE-1
GUIDE TO USE OP 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 OP ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to Identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone -for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OP 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)CO 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 whenevej; specific reference Is needed.
.»
4. FORM OP ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
118
-------
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 123^5.6, the
first study would be 123^56-A; the second, 123^56-
B; the 26th, 123^56-Z; and the 27th, 123^56-AA.
119
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dichlobenil Standard
MRID CITATION
00018842 Atkins, F..L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research.Report CF-
7501. (Unpublished study received May 8, 1971 under 1F1174;
prepared by Univ. of California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-B)
000??923 Hill, E.; Heath, R.; Spann, J. et al. (1975) -Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special
Scientific Report—Wildlife No. 191. (U.S. Dept. of the
Interior, Fish and Wildlife Service, Patuxent Wildlife
Research Center.
00036252 Thompson-Hayward Chemical Company (1965) Analytical Method for the
Determination of 2,6-D1chlorobenzoic acid Residues in Alfalfa.
Method no. A-49 dated Dec 1, 1965. (Unpublished study received
Nov 23, 1969 under OF0951; CDL:091620-B)
00036253 Phipps, F.E. (1966) Analytical Method for the Detertnination of
Dichlobenil Residues 1n Alfalfa. Includes method no. A-48 dated
Dec 1, 1965. (Unpublished study including data found in
091620-H, received Nov 23, 1969 under OF0951; submitted by
Thompson-Hayward Chemical Co., Kansas City, Kans.; CDL:091620-C)
00036254 Thompson-Hayward Chemical Company (1966) Analytical Method for
the Determination of 2,6-Dichlorobenzoic acid Residues in
Clover. Method no. A-92 dated Jul 25, 1966. (Unpublished
study received Nov 23, 1969 under OF0951; CDL:091620-D)
00036255 Rouppet, J. (1966) Analytical Method for the Determination of
Dichlobenil Residues in Clover. Includes method no. A-91 dated
Jul 25. 1966. (Unpublished study received Nov 23, 1969 under
OF0951; submitted by Thompson-Hayward Chemical Co., Kansas City,
Kans.; CDL:091620-E)
00036258 Perry, B.; Palmer, D.; H111, B.; et al. (1969) Analytical Method
for the Determination of Dichlobenil Residues 1n Alfalfa Hay.
Includes method no. A-246 dated Oct 23, 1969. (Unpublished
study Including data found in 091620-C, received Nov 23, 1969
under OF0951; submitted by Thompson-Hayward Chemical Co., Kansas
City, Kans.; CDL:091620-H)
00042488 Thompson-Hayward Chemical Company (1972) Analytical Method for the
Determination of Dichlobenil Residues in Fish. Method no. A-319
dated Nov 21, 1972. (Unpublished study received on unknown
date under 1F1074; CDL:091844-C)
120
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
. Registrations Under the Dichlobenil Standard
MRID CITATION
00042489 Thompson-Hayward Chemical Company (1972) Analytical Method for the
Determination of 2,6-Dichlorobenzamide Residue in Fish. Method
no. A-320 dated Nov 21, 1972. (Unpublished study received on
unknown date under 1F1074; CDL:091844-D)
00042490 Thompson-Hayward Chemical Company (19??) Clean-Up for the Residue
Determination of 2,6-Dichloro-3-hydroxybenzonitrile (3-OH-di-
chlobenil) in Fish Samples. Undated method no. A-321. (Unpub-
lished study received Jun 18, 1971 under 1F1074; CDL:091844-E)
00042491 Thompson-Hayward Chemical Company (19??) Gas Chromatographic Deter-
mination of 2,6-Dichloro-3-hydroxy benzonitrile (3-OH-dichlo-
benil) Residues in Pre-cleaned Samples. Undated method no.
A-322. (Unpublished study received Jun 18, 1971 under IF 1074;
CDL-.091844-F)
00067649 Til, H.P.; Feron, V.J.; Huismans, J.W.; et al. (1969) Chronic
(Two-year) Toxicity Study with Dichlobenin (H 133) in Beagle
Dogs: Report No. R 2813. (Unpublished study received Jun 16,
1971 under 1F1074; prepared by Central Instituut Voor Voeding-
sonderzoek, submitted by Thompson-Hayward Chemical Co., Kansas
City, Mo.; CDL:091847-C)
00067651 Wit, J.G.; Van Genderen, H. (1966) Metabolism of the herbicide
2,6-dichlorobenzonitrile in rabbits and rats. Biochemical
Journal 101:698-706. (Also in unpublished submission received
Jun 16, 1971 under 1F1074; submitted by Thompson-Hayward Chem-
ical Co., Kansas City, Kans.; CDL:091847-E)
00067652 Thompson-Hayward Chemical Company (1970) Analytical Method for
the Determination of 2,6-Dichlorobenzamide Residues in Fish;
Methoa no. A-267 dated Jul 10, 1970. (Unpublished study re-
ceived Jun 16, 1971 under 1F1074, CDL:091847-G)
00107106 Hodge, H.; Maynard, E.; Downs, W.; et al. (1961) Ninety Day Feed-
Ing Studies of Casoron in Rats. (Unpublished study received
Apr 26, 1965 under unknown admin, no.; prepared by Univ. of
Rochester School of Medicine and Dentistry, Dept. of Pharmacol-
ogy, submitted by Thompson-Hayward Chemical Co., Kansas City,
KS; CDL:108430-A)
00109109 Thompson-Hayward Chemical Co. (1966) Residues of Casoron in Cran-
berries. (Compilation; unpublished study received Jun 16, 1966
under 6F0500; CDL:090578-A; 090579; 090580; 090581; 090577)
121
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dichlobenil Standard
MRID CITATION
00111219 Amchem Products, Inc. (1970) Petition for Negligible Residue Tol-
erance for Bromoxynil ... in Wheat, Oats, Barley, Rye and Flax.
(Compilation; unpublished study received Nov 4, 1971 under
OF0994; CDL:091710-B) OFFICE OF PESTICIDE PROGRAMS
00112500, International Bio-Research, Inc. (1962) Acute Toxlcity Study on
Rats for Casoron. (Unpublished study received Oct 1, 1963
under 6F0500; submitted by Thompson-Hayward Chemical Co.,
Kansas -City, KS; CDL:090576-B)
00113720 Upton, E. (1965) Casoron and 2,6-Dichlorobenzoic Acid Residue:
Analysis of Cranberries from Plots Treated with Fall Application
of Casoron: Report No. R-580. (Unpublished study received May
17, 1965 under 148-614; submitted by Thompson-Hayward Chemical
Co., Kansas City, KS; CDL:000639-A)
00113721 Upton, E. (1968) Dichlobenil and 2,6-Dichlorobenzoic Acid: Residue
Analysis of Lemons: Report No. R-684. (Unpublished study re-
ceived May 6, 1968 under 148-615; submitted by Thompson-Hayward
Chemical Co., Kansas City, KS; CDL:000646-A)
00113738 Thompson-Hayward Chemical Co. (1969) Dichlobenil and 2,6-Dichloro-
benzoic Acid Residue Analysis of Apricots. (Compilation; unpub-
lished study received Oct 7, 1969 under 9F0837; CDL:091443-A)
00113739 Upton, E. (1969) Dichlobenil and 2,6-Dichlorobenzoic Acid Residue
Analysis of Filberts, Pecans, Walnuts, Almonds and Almond Hulls:
Report No. R-741. (Unpublished study received Oct 7, 1969 under
9F0837; submitted by Thompson-Hayward Chemical Co., Kansas City,
KS; CDL:091444-A)
00113740 Meulemans, K. (1970) Supplementary Dichlobenil and 2,6-Dichloro-
benzoic Acid Residue Analysis of Almond Nuts and Hulls: Report
No. R-779. (Unpublished study received Jan 16, 1970 under
9F0837; submitted by Thompson-Hayward Chemical Co., Kansas City,
KS; CDL:091445-A)
00113741 Houtman, A.; Bolhuis, L. (1967) C14 Contents of Milk and Some
Tissues of Dairy Cattle Given Drinking Water Containing Dichlo-
benil C14: Report No. 56646/11/67-56639/9/67. (Unpublished
study received Oct 8, 1969 under 9F0837; prepared by N.V.
Philips-Duphar, Neth., submitted by Thompson-Hayward Chemical
Co., Kansas City, KS; CDL:091445-B)
122
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dichlobenil Standard
MRID CITATION
00113752 Cope, 0.; McCraren, J.; Eller, L. (19??) Effects of dichlobenil on
two fishpond environments. Weed Science:158-165. (Also in un-
published submission received Aug 3, 1970 under OF0951; submit-
ted by Thompson-Hayward Chemical Co., Kansas City, KS; CDL:
091943-K)
00113757 Thompson-Hayward Chemical Co. (1967) Study: Dichlobenil Residue in
F1sh, Soil, Hater, and Crops. (Compilation; unpublished study
received Nov 14, 1966 under 6F0500; CDL:092786-A)
00113758 Pate, D.; Funderburk, H. (19??) Absorption, translocation, and
metabolism of 14C-labelled dichlobenil. Pages 17-26, In Iso-
topes in Weed Research. International Atomic Energy Agency:
Vienna, Austria. (SM-69/2; also in unpublished submission re-
ceived Nov 17, 1966 under 6F0500; submitted by Thompson-Hayward
Chemical Co., Kansas City, KS; CDL:092786-B)
00113759 Thompson-Hayward Chemical Co. (1967) Study: Dichlobenil Residue in
Fish, Soil, Water, and Crops. (Compilation; unpublished study
received Feb 23, 1967; Feb 24, 1967 under 6G0502; CDL:092788-A)
00113767 Thompson-Hayward Chemical Co. (1966) Dichlobenil and 2,6-Dichloro-
benzoic Acid: Residue Analysis of Citrus Fruit: Report No. R-
608. (Compilation; unpublished study received Feb 10, 1966
under 148-614; CDL:101181-A; 101167; 101169; 101168)
00113768 Thompson-Haywa'rd Chemical Co. (1966) Dichlobenil and 2,6-Dichloro-
benzoic Acid: Residue Analysis of Small Fruits: Report No. R-
613. (Compilation; unpublished study received Mar 17, 1966
under 148-614; CDL:101178-A; 101179)
00113771 Thompson-Hayward Chemical Co. (1964) Residues of Casoron in
Peaches. (Compilation; unpublished study received on unknown
date under 148-615; CDL:120091-A)
00113772 Thompson-Hayward Chemical Co. (1964) Residues of Casoron in
Prunes. (Compilation; unpublished study received on unknown
date under 148-615; CDL:120092-A)
00113773 Thompson-Hayward Chemical Co. (1964) Residues of Casoron in
Cherries. (Compilation; unpublished study received on unknown
date under 148-615; CDL:120093-A)
00113774 Thompson-Hayward Chemical Co. (1964) Residues of Casoron in
Pears. (Compilation; unpublished study received on unknown
date under 148-615; CDL:120094-A)
123
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Dichlobenil Standard
MRID CITATION
00113778 Thompson-Hayward Chemical Co. (1963) Data Supplementing Application
for Registration of Casoron for Use in Cranberries. (Compila-
tion; unpublished study received Jan 18, 1963 under unknown
admin, no.; CDL:120099-A)
00113782 Upton, E. (1963) The; Determination of 2,6-Dichlorobenzoic Acid
Residues as a Possible Metabolite of Casoron 1n Cranberries:
Report No. R-401. (Unpublished study received Nov 1, 1963 under
unknown admin, no-.; submitted* by Thompson-Hayward Chemical Co.,
Kansas City, KS; CDL:120103-A)
00113790 Thompson-Hayward Chemical Co. (1962) Determination of Casoron
Residues in Various Crops. (Compilation; unpublished study re-
ceived on unknown date under 148-EX-2; CDL:122636-A)
00113796 Kay, J. (1962) Acute Percutaneous Toxicity of Casoron. (Unpub-
lished study received Jun 16, 1967 under 148-EX-12; prepared by
Industrial Bio-Test Laboratories, Inc., submitted by Thompson-
Hayward Chemical Co., Kansas City, KS; CDL:122658-A)
00113799 Upton, E. (1963) The Determination of Casoron and 2,6-Dichloro-
benzoic Acid Residues in Cranberries: Report No. R-251. (Un-
published study received Jan 4, 1963 under unknown admin, no.;
submitted by Thompson-Hayward Chemical Co., Kansas City, KS;
CDL:223797-A)
00137791 Verloop, A. (1972) Fate of the herbicide dichlobenil in plants and
soil in relation to its biological activity. Pages 55-103, In
Residue Reviews:Vol. 43. By F. Gunther, ed. New York, NY:
Springer-Verlag. (Also in unpublished submission received Apr
3, 1984 under 47286-1; submitted by Valhar Chemical Corp., •
Greenwich, CT; CDL:252845-G)
00147021 Beynon, K.; Wright, A. (1972) The fates of the herbicides chlorthl-
amid and dichlobenil in relation to the residues in crops, soil,
and animals, p. 23-53 1n Residue Reviews v. 43, edited by F.
. Gunther. New York, NY: Springer-Verlag.
00147437 Koeter, H. (1984) Oral Embryotoxic1ty/Teratogenic1ty Study with
Dichlobenil 1n Rats: Final Report: Report No. V 84.026/231045.
Unpublished study prepared by Netherlands Organization for Ap-
plied Scientific Research. 109 p.
00151561 Will ems, A.; Groeneveld, A.; Joustra, K. (1985) The Mobility of
Dichlobenil In Four Soils: Report No. 56635/15/85. Unpublished
study prepared by Duphar B.V. 26 p.
124
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OFFIC€ OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supposing
Registrations Under the Dichlobenil Standard
MRID CITATION
00153576 Richold, M.; F.dgar, D.; Ransome, S.; et al (1984) The Mutagenic
Potential of Dichlobenil Technical in vitro Mouse Lymphoma
L5178Y Cell Mutation Test: Report No. PDR 381/831001: 56645/61/
83. Unpublished study prepared by Huntingdon Research Centre
pic. 30 p.
00153577 Allen, J.; Hales, 0.; Brooker, P; et al (1984) Test on Mutagenic
Potential of Dichlobenil 1n vitro Study of Metaphase Chromosomes
of Human Lymphocytes: Report No. PDR 380/83977: 56645/59/83.
Unpublished study prepared by Huntingdon Research Centre pic.
19 P.
00153578 Jens, D. (1983) Micronucleus Test on Dichlobenil: Int. Doc. No.
56645/57/83. Unpublished study prepared by Duphar B.V. 12 p.
00153579 Seket, J. (1983) Ames Test to Assess the Potential Mutagenic Effect
of Dichlobenil: Int. Doc. No. 56645/58/83. Unpublished study
prepared by Duphar B.V. 21 p.
00153580 Allen, J.; Proudlock, R. (1984) Autoradlographic Assessment of DNA
Repair in Mammalian Cells after Exposure to Dichlobenil Techni-
cal: Report No. PDR 382/831065: 56645/60/83. Unpublished study
prepared by Huntingdon Research Centre pic. 20 p.
00153581 Matthews, E. (1984) Evaluation of Dichlobenil Technical in the in
vitro Transformation of Balb/C-3T3 Cells with S9 Activation
Assay: Final Report: Project No. 20992. Unpublished study pre-
pared by Litton Bionetics. 16 p.
00153586 Morlya, M.; Ohta, T.; Shlrasu, Y. (1981) Report on the Results of
DNB with Bacteria: Duphar Report No. 56645/22/82: Translated by
Kal1-Dupha, K.K. Unpublished study prepared by the Institute
of Environmental Toxicology. 9 p.
40094602 Johnson, W.; Flnley, M. (19UO) Handbook of Acute Toxldty of
Chemicals to F1sh and Aquatic Invertebrates: Resource
Publication 137. USDI F1sh and Wildlife Service, Washington,
D.C. 98 p.
GS0147-001 Thompson-Hayward Chemical Co.(1969) Determination of Dichlorben.1l
(Casoron) and Its Metabolite, 2,6-D1chlorbenzo1c Acid 1n
Crops. 4 p.
6SO147-002 Donaldson, D. (1969) Dichlobenil and 2,6-Dichlorbenzoic Add
Residue analysis of F1gs. 8 p.
125
-------
FIFHA SECTION 3*atc item ioi tn AOI
ipeciticd in) ft* Rt^iTTniiofl Cuio>lm«i oc fhf Protocoli containtd in tnt Rtportl «f Eiptfl Ccoupt to ft* CAtmiuh Ciouo. OECO
Chffniull Toting Ptopimmi. I cndOM tht proiocoll t^t I will u»:
O 2. I rwvt tnttrvd into in •orwmtnt wrtti on* or mor* othn rtfinnnn und«r FIFRA action 3(C)(2)(8)(ii) to truly tht following dill
r»quinm«na Th« WU. «nd »ny rtquirtd prolocolt. will b« •ibmirttd to EPA by:
NAME OF OTHER REGISTRANT
O 2. I tnclOM I conplfttd "CirtHcJtwn ol Animpt to Enttr Into an Agr««mtnt with Otn«r Rtgimcntt lor Orrtlopmtni of Cm" Miiri
ritpKt to ttii following did raquirtmtfitt:
. I rtquvt tt\n you imtnd my ragiftnnion by d(l*img (tit following urn Ithit option • not cvaiUblt to •ppliunti lor «*•» productt):
O&
SIONATURC
OATC
VA Pom MW-1
126
-------
OMB Appro**/ No. 30CTXU&?
(To QutlHr. etrtifvALL fovrttimi)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly euthoriied to represent the following firm(i) who tit subject to the require-
ments of « Notice under FIFRA Section 3(cH2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
ACTIVC INCMCOUMT
NAME Of FIRM
Cf A COMPANY MUMflCM
(Thu firm or o/ooo ol firms it referred to below *i "my firm".)
2. My firm it willing to develoo and tubrnit ffte d«t« •» required by ttui Notice, if neonv*ry. However, my firm would prefer to
into «n agreement with on* or more otrter registrants to develoo fointly. or to th*re in the cott ol developing, the following reou"«3
hern» or
3. My firn hi* olltrrd in writing te tntfr into wcfi an agreement. Copxi ol thr ofltn arc anacttttf. TMI otltr wti irrr«oeibl« ind mcludtd an oHf to Dt
bound by an arbitration daeriion under FIFflA Section 3(cl(2)(B)(iii) if final agreement en all tcrmicou
-------
EPA Reg. No.
PRODUCT SPECIFIC DATA REPORT
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)
Accession Numbers
Assigned
-
*
128
-------
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
Oxidlzlng/reduc ing
reaction
Plarnnability
Explodabillty
Storage stability
Viscosity
Misclbility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute Inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tlon
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)
(Par EPA Use Only)
Accession Numbers
Assigned
129
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(MB Approval No. 2000-0468
Expiration Date 5/31/86
ATTACHMENT D
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Nunber:
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 frcra EPA
dated concerning a requirement for submission of generic data
on the active Ingredient named under PIPRA sec. 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 PIPRA sec. 3,
and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSP) 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 CSP dated ___^ on file with EPA is complete, current and
accurate and contains the Information requested on the current CSP Form
No. 8570-4. The registered source(s) of the above named active Ingredient
In my product(s) Is/are
and their registration nunber(s) Is/are
tty finn will apply for an amendment to the registration prior to
changing the source of the active Ingredient In our product.
CO I understand, and agree on behalf of my fira, 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 FIPRA sec. 3(c)(2)(B).
Registrant's authorized representative:
Signature
Dated: '
(Typed)
130
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