GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
2,6-DICHLORO-4-NITROANILINE
(DCNA)
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
DECEMBER 1983
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data 38
III. Requirement for Submission of Product-Specific
Data 65
IV. Submission of Revised Labeling and Packaging
Information 66
A. Label Contents 66
1. Product Name 66
2. Company Name and Address 66
3. Net Contents 66
4. EPA Registration Number 67
5. EPA Establishment Number 67
6A Ingredient Statement 67
6B Pounds Per Gallon Statement. . . 67
7. Front Label Precautionary Statements 68
7A Child Hazard Warning Statements 68
7B Signal Word 68
7C Skull and Crossbones and Word Poison 68
7D Statement of Practical Treatment 68
7E Referral Statement 68
8. Side/Back Panel Precautionary Labeling 68
8A Hazard to Humans and Domestic Animals 68
8B Environmental Hazard 69
8C Physical or Chemical Hazard 69
9 Misuse Statement 70
IDA Storage and Disposal Block 70
10B Directions for Use 70
B. Collateral Information 70
V. Instructions for Submission 71
NOTE: Attached to this document are copies of the letters used
to transmit the document to registrants and notify them
of required studies.
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APPENDICES
II-l Bibliography 72
II-2 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 81
II-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6 82
III-l Product Specific Data Report (End-Use Products) ... 83
IV-2 Table of Labeling Requirements 85
IV-3 Physical/Chemical Hazards Labeling Statement 88
IV-5 Storage and'Disposal Instructions 89
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product "must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1,
1977. These pesticides will be reviewed in use clusters
which are prioritized on the basis of a ranking scheme giving
preference to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active
ingredient. If we find serious concerns, we will bring
formulated products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that certain registrants submit generic data that will answer
our questions regarding the hazard that may result from the
intended use of the pesticide under review. Further, §3(c)
(2)(B) provides that these data are to be submitted by
those registrants who do not qualify for the formulator's
exemption [FIFRA § 3(c)(2)(D)] . Normally, this means that
the registrants who are responsible for filling the data
gaps are the manufacturing-use product producers (basic
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suppliers of the active ingredient). However, end-use producers
will not qualify for the formulator's exemption if the source
of their active ingredient: (1) is not registered with EPA,
and/or (2) is produced by the registrant's firm, or a firm
which has ownership in common with the registrant's firm.
These end-use producers can qualify for the formulator's
exemption if they change their source of supply to a registered
source, "provided the source does not share ownership in
common with the registrant's firm. If the end-use product
registrant decides to switch sources, a new Confidential
Statement of Formula, EPA Form 8570-4, must be submitted to
the appropriate Product Manager with-in 90 days of receipt of
this Guidance Document. The chart on the following page
shows what is generally required of those who do and do not
qualify for the formulator's exemption in the Registration
Standards program.
If you decide to request the Agency to discontinue the
registration of any of your products subject to the reregistra-
tion requirements of this Guidance Document, please notify
the Product Manager named in the cover letter, within 90
days from the receipt of this document, that you wish to
voluntarily cancel the registration(s). If you decide to
maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined. EPA will issue a notice of intent to cancel
or suspend the registration of any currently registered
product if you fail to comply with the requirements set
forth in this Guidance Document.
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved, EPA
has decided to proceed with the requirements in this Guidance
Document which do not relate to compliance with the §3(c)(l)(D)
provisions and to supplement the Document with additional
guidance when circumstances permit. Failure to comply with
the provisions of the subsequent guidance will also result
in issuance by EPA of an intent to cancel the affected product-
registration ( s ) .
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B. ____^
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I. REGULATORY POSITION
A. Introduction
This Registration Standard presents the regulatory position
of the Environmental Protection Agency (the Agency) on registra-
• «_ -
tion of manufacturing-use products (MPs) containing the fungicide
2,6-dichloro-4-nitroaniline (DCNA). The Agency's position is
based on a consideration of available data for all currently
registered uses and registered MPs with DCNA as the sole
active ingredient.
The Standard considers labeling requirements, tolerances,
Special Local Need registrations authorized by FIFRA Section
24(c), as well as Federal Registrations granted or pending
under FIFRA Section 3. Finally, the Agency sets forth the
data requirements that must be met to register and reregister
products covered by this document.
This Standard addresses registration requirements for current
or substantially similar future MPs and their intermediaries.
DCNA MPs that differ appreciably from these described here
may require amendments to the Standard. Additionally, use
patterns which differ from those described here may also require
amendments to the Standard.
B. Description of the Chemical
The approved common name for 2 ,6-dichloro-4-nitroaniline
is dicloran by the British Standards Institution (BSD.
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More commonly used names are DCNA and botran. Other names
include: ditranil, allisan, and resisan. The Chemical
Abstracts Service (CAS) Registry Number is 99-30-9. The
Office of Pesticides Programs (OPP) Internal Control Number
(EPA Shaughnessy Number) is 031301 and the Caswell Number
'is 311.
The structural formula is: via
DCNA is a yellow, crystalline powder. The empirical formula is
(^6H4o2N2^-'-2 • Tne molecular weight is 207.0. The solubility
of DCNA in ethanol is 0.2% at 20°C and its melting point is
192-194°C.
C. USE PROFILE
There are currently two (2) registered MPs consisting of the
technical grade of DCNA (95% and 90%) and twentyone (21)
registered end-use products containing DCNA as the sole
active ingredient. There are also twenty-two (22) products
containing DCNA in combination with other pesticides. In
addition, there are twenty-one (21) FIFRA Section 24(c) "Special
Local Need" registrations and thirty-five (35) intrastate
registrations.
Upjohn Company is the only registrant of technical DCNA. DCNA
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has been registered by U.S.E.P.A. and is a protectant fungicide
to control a variety of pre-harvest and post-harvest diseases on
a number of fruit and vegetable crops. It is also registered for
use on cotton, a number of ornamentals, a seed-piece dip for sweet
potatoes, a peanut seed treatment, and in greenhouses on cucum-
• bers, lettuce, rhubarb, and tomatoes. Current major use sites in-
clude celery, peaches, grapes, and lettuce (Approximately 80% of
the total active ingredient is used on lettuce). DCNA is a non-
systemic, protectant fungicide that is particularly effective
against fungi in the genera Botrytis, Rhizopus, Sclerotinia,
Sclerotium, and Monilinia.
DCNA may be formulated with other pesticides such as captan,
benomyl, and parathion. It is not compatible with some oil-
based pesticides. The formulated products are marketed as
4, 5, 6, 8, 10, 12, 15, 20, 30, 35, or 50% dusts, a 48.8 or
75% wettable powder, a 9 or 30% flowable concentrate, as a
0.5% or 3% ready-to-use liquid, a 3% formulation in fruit wax
and as 0.2% impregnated fruit wrap.
DCNA may be applied in the field using aircraft or ground
equipment. It can be applied as a post-harvest treatment to
some fruits and vegetables as a dip, spray, or dust, and to
ornamental crops prior to storage or shipping.
D. Regulatory Position
Based on a review and evaluation of all available data and other
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relevant information on DCNA, the Agency has made the following
determinations:
1. MPs containing DCNA as the sole active ingredient may be
registered for sale, distribution, and reformulation into
.end-use products, and for use, subject to the terms and
conditions specified in this Standard.
2. Registrants must provide or agree to develop additional
data, as specified in Table A and Table B of this Standard, in
order to maintain existing registrations or to obtain new
product registrations.
3. Sufficient data are available to show that technical DCNA
has a low acute oral toxicity (toxicity category IV), low acute
dermal toxicity (toxicity category IV). It does not induce
skin or eye irritation to mammals. It falls in toxicity
category III for dermal irritation and inhalation. DCNA is
a skin sensitizer.
4. Insufficient data are available to evaluate the subchronic
dermal or the subchronic inhalation hazard of DCNA. The
intended use of the product is expected to result in subchronic
dermal and respiratory contact to the user or applicator.
5. Since DCNA is an aniline compound, it must be tested for
photosensitization reactions.
6. Due to preliminary evidence, the Agency suspects that DCNA
induces a systemic effect as ocular toxicity or opacity of the
7
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cornea. Oculotoxicity and cataractogenicity tests are required.
7. Available data are insufficient to fully assess the en-
vironmental fate and the exposure to humans and non-target
organisms from the currently registered uses of DCNA.
8. DCNA is structurally similar to a known carcinogen.
However, a study on rats fed DCNA at dose levels of 20, 100,
and 3000 ppm, showed no oncogenic effects. A second oncogenic
study is required to corroborate the findings of the rat study.
9. Tolerance regulations are presently expressed in terms
of the parent compound. DCNA metabolites in plants and animals
have not been adequately identified or quantified. Existing
tolerances may need to be reassessed to include any possible
major metabolites.
10. The presence or absence of dioxins must be ascertained.
Depending on the pH and the amount of nitrophenol (contaminant)
in the manufacturing process, formation of dioxins are possible.
Therefore manufacturing and product chemistry data are required.
11. DCNA is considered a general use pesticide.
12. Based on an unacceptable study (glucose study), DCNA is
metabolized rapidly with a half-life of 2 days in glucose
treated aerobic soil. This study does not meet the aerobic
soil metabolism requirements.
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E. Regulatory Rationale
The Agency has determined that it will continue to allow the
registration of products containing DCNA,7j after considera-
tion of the following:
1. It is not the Agency's policy to cancel or withhold registra-
tion merely because data are missing or inadequate (see FIFRA
Sections 3(c)(2)(B) and 3(c)(7)). Rather, publication of this
Standard provides a mechanism for identifying; 1) data needs,
2) registration requirements under the Standard; and 3) allows
for the upgrading of labels during the period in which the
required data are being developed. These data will be reviewed
and evaluated when they are received, and the Agency will
determine, at that time, if the new data will affect the regis-
tration(s) of DCNA.
2. ; Based on the limited data available, there is no indication
that there are any chronic, oncogenic, teratogenic, or
mutagenic properties of DCNA. '•
3. j The Agency has no information, to. date, that indicates
continued use will result in any unreasonable adverse effects
to man or his environment during the time data are being
developed.|
4. Currently, no federal or state reentry intervals have
been established. Exposure during reentry operations
should be minimal when DCNA is soil incorporated. The
main route of exposure is dermal from the handling of DCNA
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treated crops. Reentry intervals will be considered after
evaluation of the required toxicological data.
5. No human toxicological hazards of concern to this Agency,
have been identified in studies reviewed for this Standard.
"There are" questions concerning oculotoxicity and photo-
sensitization that must be addressed. When the required
studies are submitted, the Agency will be able to assess
these potential problem areas.
6. The acceptable daily intake (ADI) for DCNA was set using
a two year rat feeding study with a no observed effect level
(NOEL) of 100 ppm (5 mg/kg). A hundred-fold safety factor was
used and the ADI calculated was 0.05 mg/kg/day with a maximum
permissible intake (MPI) of 3.0 mg/day (60 kg person). The
latest (current) theoretical maximum residue contribution
(TMRC) for DCNA based on established tolerances is 1.7622
/
mg/day for a 1.5 kg diet; the percent ADI utilized is 58.74.
F. Criteria for Registration under This Standard
To be covered by this Standard, products must contain DCNA
as the sole active ingredient, bear required labeling,
and conform to the product composition, acute toxicity limits,
and use-pattern requirements listed in Section F of this document.
The applicant for registration or reregistration of products
subject to this Standard must'Comply with all terms and conditions
described herein. These include making a commitment to fill
data gaps on a schedule specified by the Agency. Applicants for
10
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registration under this Standard must follow the instructions
contained in this guidance package and complete and submit the
appropriate forms within the time specified.
G. Acceptable Ranges and Limits
1. Product Composition Standard
To be covered under this Standard, MPs must contain DCNA as
the sole active ingredient. Each MP formulation proposed
*
for registration must be fully described and include an
appropriate certification of limits for all contaminants and
impurities, and carry-over starting materials and/or inter-
mediates above the level of 0.1% in the technical products.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade products
and'MPs containing DCNA for any acute toxicity category,
provided that the labeling of those products bears appropriate
precautionary statements.
3. Use Patterns
To be registered under this Standard manufacturing-use products
containing DCNA may be labeled for formulation only into
end-use products for:
"Terrestrial, food use on: apricots, blackberries, boysen-
berries, carrots, celery, cherries (sweet), cotton seed, garlic,
grapes, kiwi, lettuce, nectarines, onions, peaches, peanut seed,
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plums, prunes, potatoes, raspberries, snap beans, and sweet
potatoes.
"Terrestrial, non-food use on: ornamentals
"Greenhouse, food use on: lettuce, cucumber, rhubarb, and
tomatoes.
"Greenhouse, non-food use on: ornamentals
H. REQUIRED LABELING
All MPs containing DCNA must bear appropriate labeling as
specified in 40 CFR 162.10. Other portions of the guidance
package contain specified information regarding label requirements,
1. Ingredient Statements
The ingredient statement for MPs must list the active ingredient
as:
2 ,6 dichloro-4-nitroaniline %
2. Use Pattern Statements
All MPs must state that they are intended only for formulation
into end-use products for the use patterns listed above.
They must specify specific sites listed in Use Patterns in
Section G.3 of the Standard. A limiting factor will be the
data that supports these use patterns. No use may be included
on the label, or labeling, where the registrant fails to agree
II
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to comply with the data requirements in either TABLE A for
that use pattern, or TABLE B.
3. Precautionary Statements
Labels for all MPs containing DCNA must bear statements
Deflecting the acute human toxi-city of the compound. DCNA
is tentatively placed in Toxicity Category IV for dermal
toxicity effects, and Category IV for acute oral and acute
inhalation toxicity effects. The required precautionary
statements associated with all Toxicity Categories are
specified in 40 CFR §162.10.
a. Required Statements
Environmental Hazards: Do not discharege into lakes, streams
ponds or public waters unless in accordance with NPDES
permit. For guidance contact your regional Office of EPA.
I. Tolerance Reassessment Summary
The tolerances for DCNA residues, as cited in 40 CFR 180.200,
in or on the following commodities are adequate: carrots,
celery, cucumbers, endive, garlic, lettuce, rhubarb, snap
beans, and tomatoes (greenhouse grown only). In addition,
we conclude that finite residues of DCNA will be incurred
in milk, eggs, and the fat, meat, and meat by-products of
cattle, goats, hogs, horses, poultry, and sheep. Tolerances
for finite residues of DCNA and its metabolites in milk,
eggs, and the fat, meat, and meat by-products of cattle, goats,
l3
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hogs, horses, poultry, and sheep are presently under Agency
review. The adequacy of the tolerances for DCNA residues in
or on the following crops cannot be assessed at this time due
to the presence of data gaps: apricots, blackberries, boysen-
berries, cherries (sweet), cottonseed (data needed for processed
products only), grapes, kiwi fruit (only method recovery data
required), nectarines, onions, peaches, plums, potatoes,
raspberries, and sweet potatoes.
The ADI for DCNA is 0.05 mg/kg/day and the TMRC is 1.7622
ing/day. The MPI is 3 mg/day based on a 60 kg body weight.
Currently, the human diet potentially accounts for 58.74%
of the ADI. Since the TMRC is based on the established
tolerances published in 40 CFR 180.200 and because the
adequacy of some of these tolerances presently cannot be
assessed, a future change in the TMRC is anticipated.
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EPA,.Index to Pesticide Chemicals
Site and Pest
AGRICULTURAL CROPS
5001AA Apricot (preharvest)
ADMCB Brown rot blossom
and twig blight
(Monilinia)
ALMCB Brown rot of fruit
(Monilinia)
.BFRAQ Rhizopus fruit rot
2.6-DICHLORO-4-NITRCANILINE
Dosages and Tolerance, Use, Limitations
Formulat i on(s)
20 pptn preharvest
1 day preharvest interval through
5.0 pounds per acre as a spray or
3.0 pounds per acre as a dust.
3.0 Ib/A
(4-152 D)
2.5-3.0 Ib/A
(4-152 D)
or
1.0 lb/
100 gal
(752 WP/D)
•5001EA Apricot (postharvest)
_MCB Brown rot of fruit
(Monilinia)
:BFRAQ Rhizopus fruit rot
0.805 lb/110
gal water
(48.82 WP)
3.22 lb/110
gal dilute
wax
(48.82 WP)
0.75 lb/100
gal water
(752 WP/D)
Delayed dormant.and foliar applica-
tion. Apply at red bud, early
bloom, and bloom.
Foliar application. Apply at 18
days, 10 days and 1 day prior to
harvest.
May be formulated with captan.
10 ppm postharvest
Do not exceed the recommendations
stated for each use pattern below.
Postharvest treatment to nonstored
apricots. Apply as a dip or spray
over a suitable brush bed. Apply 1
gallon of dilute suspension to coat
2,000 to 2,500 pounds of fruit. Do
not dip more than 2 minutes.
Formulated with thiophanate-methyl.
Postharvest treatment to nonstored
apricots. Apply in a flow through
spray system. Use mechanical agita-
tion of wax mixture. Apply 1 gallon
of dilute wax mixture to coat 2,000
to 2,500 pounds of fruit.
Formulated with thiophanate-methyl.
Postharvest treatment to nonstored
apricots. Tank mix with benomyl.
Add fruit wax. Apply the mixture
during packing line operations at
the rate of 35 to 45 gallons per
hour using flat-fan or flood jet
nozzles. Use mechanical agitation
of wax mixture. Collect spray run-
off and discard. Do not treat fruit
packed in containers which do not
allow adequate drainage.
Issued: 9-24-81
II-031301-2
15
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EPA Index to Pesticide Chemicals
2,6-DICELORO-4-NITROANILINE
Site and Pest
Dosages and Tolerance, Use, Limitations
Formulation(s)
15003AA
Beans (succulent) (snap)
HANSAQ
White mold
(Sclerotinia)
01002AA
01003AA
01018AA
"'SAW
Blackberry
Boysenberry
Red Raspberry
Botrytis fruit rot
14003EA
ICZSAQ
Boysenberry
Carrot
Postharvest decay
(Sclerotinia)
2.24-2.4 Ib/A
(bush varie-
ties)
or
3.0 Ib/A
(pole varie-
ties)
(4-15% D)
(755 WP/D)
3.0 Ib/A
(4-15% D)
or
1.0 lb/
100 gal
[250 gal/A]
(75% WP/D)
20 ppm
2 day preharvest interval through
3.0 pounds per acre for pole varie-
ties, or 2.4 pounds per acre for
bush varieties.
Foliar application. Apply wettable
powder in 100 gallons per acre for
pole varieties.,, and in 75 gallons
per acre for bush varieties. Apply
when disease is anticipated. Repeat
at 7 day intervals as needed.
May be formulated with sulfur; or
copper oxychloride sulfate and
sulfur.
15 ppm on each crop
1 day preharvest interval through
2.5 pounds per acre as a spray or
3.0 pounds per acre as a dust.
Do not make more than 4 applications
per season.
Use limited to Pacific Northwest.
Delayed dormant and foliar applica-
tion. Apply just prior to bloom.
Repeat at 7 day intervals for dust,
or at 10 day intervals for wettable
powder.
May be formulated with sulfur; or
copper oxychloride sulfate and
sulfur.
See Blackberry cluster.
10 ppm postharvest
Postharvest treatment (10 second
dip) through 0.75 pound per 100
gallons.
0.75 lb/ Postharvest treatment to nonstored
100 gal carrots. Dip carrots for 10 seconds
(75% WP/D) in a well-agitated suspension. Add
0.38 pound per 100 gallons of dip
suspension after 500 bushels are
treated. Drain and flush tank after
each 1,000 bushels treated and re-
fill with fresh dip suspension.
Issued: 9-24-81
II-031301-3
/fc
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EPA Index to Pesticide Chemicals
Site and Pest
'13002AA
•IBTSAQ
Pink rot
(Sclerotinia)
-2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance, Use, Limitations
Formulation(s)
15 ppm
7 day preharvest interval through
1.5 pounds per acre.
4 week preharvest interval for a
single application through 4.0
pounds per acre.
1.5-4.0 lb/ Foliar and soil application. Use a
100 gal/A sprayer with drop nozzle boom to di-
(75% WP/D) rect spray to the base of plant and
adjacent soil. Apply 1.5 pounds per
acre when disease is anticipated or
approximately 10 weeks prior to har-
vest. Repeat at 7 day intervals in
summer or at 14 day intervals in
fall and winter. If early disease
is not likely, apply 4.0 pounds per
acre in a single application 4 to 8
weeks before harvest.
05002AA
rfCB
TALMCB
TBFRAQ
Cherry (sweet) (preharvest)
Brown -rot blossom
and twig blight
(Monilinia)
Brown rot of fruit
(Monilinia)
Rhizopus fruit rot
2.5-3.0 Ib/A
(4-15% D)
or
0.75-1.0 lb/
100 gal
(75% WP/D)
05002EA
'IALMCB
'IBFRAQ
Cherry (sweet) (postharvest)
20 ppm preharvest
1 day preharvest interval through
10.0 pounds per acre as a spray or
3-.0 pounds per acre as a dust.
Delayed dormant and foliar applica-
tion. We'ttable powder may be tank
mixed with captan. Apply at pop-
corn, bloom, full bloom, and petal
fall for blossom and twig blight.
For fruit rots, apply 10 days and 1
day before harvest.
May be formulated with sulfur; cap-
tan; or copper oxychloride sulfate
and sulfur.
20 ppm preharvest
Do not exceed the recommendations
stated for each use pattern below.
Brown rot of fruit
(Monilinia)
Rhizopus fruit rot
1.61 lb/110 Postharvest treatment to nonstored
gal water sweet cherries. Apply as a dip or
(48.82 WP) spray over a suitable brush bed.
Apply 1 gallon of dilute suspension
to coat 2,000 to 2,500 pounds of
fruit. Do not dip more than 2 min-
utes.
Formulated with thiophanate-methyl.
Issued: 9-24-81
II-031301-4
11
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Site and Pest
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance, Use, Limitations
Formulation(s)
Cherry (sweet) (postharvest) (continued)
28007AA
Cotton
IAKRAQ
Rhizopus boll rot
10010CA
ICHSAQ
Cucumber (greenhouse)
Sclerotinia stem
rot
1.0 lb/100 Postharvest treatment to nonstored
gal water sweet cherries. Apply as a spray
(752 WP/D) while sorting. Do not recirculate
or used spray.
1 gal 9% F1C/
75 gal water
or
1,200 ppm
a.i.
(92 F1C)
0.1 ppm cottonseed
Do not apply later than 14 days
after first bolls open through 2.0
pounds per acre.
Do not feed treated gin trash to
livestock.
2.0 Ib/A Foliar application. Apply wettable
(62 D) powder in sufficient water for thor-
or ough coverage. Apply prior to or as
1.5-1.75 Ib/A first bolls begin to open. Repeat
(752 WP/D) 14 days later.
5 ppm
No preharvest interval through 1.0
pound per_^100 gallons water.
1.0 lb/ Foliar application to greenhouse
100 gal grown plants. Apply to diseased
(752 WP/D) areas of plants. Additional appli-
cations may be required after 14
days.
Issued: 9-24-81
II-031301-5
-------
EPA Index to Pesticide Chemicals
L4007AA
L4011AA
Site and Pest
Garlic
Onion
[CRSAS
White rot
(Sclerotium)
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance,'Use,'Limitations
Formulation(s)
5 ppra
At-planting soil application through
30.0 pounds per acre (or 43,560 lin-
ear feet of furrow) as a spray, or
24.0 pounds per acre (or 43,560 lin-
ear feet of furrow) as a dust.
Do not plant spinach as a follow-up
crop on treated soil. When lettuce
is to be planted as a follow-up
crop, plow soil to 8 inches and disc
the treated area prior to seeding.
14.8-24.0
lb-/A
(4-15% D)
(50% D)
or
0.75-1.2 oz/
50 ft of row
(6% D)
or
24.0-30.0 lb/
100 gal/A
(75% WP/D)
or
in North Cen-
tral States
4.5-8.0 Ib/A
(4-15% D)
or
4.5-7.5 lb/
100 gal/A
(75% WP/D)
Soil application. For direct seed-
ing, broadcast dust or spray and mix
into top 1.5 inches of soil 1 to 2
weeks before onions are seeded. For
planting sets or buds, broadcast
dust or spray and mix into 1.5
inches of soil, or apply specified
rates per 43,560 linear feet of fur-
row to soil around sets or buds.
Rate per acre will vary in local
areas. For wettable powder, use low
pressure (30 to 40 pounds per square
inch) spray equipment and 50-mesh or
coarser screens. Center the front
nozzle on the furrow so that spray
strikes the soil around the sets or
buds and rear nozzle sprays the cov-
ering soil as it fills the furrow.
May be formulated with sulfur.
Issued: 9-24-81
II-031301-6
If
-------
EPA Index to Pesticide Chemicals
Site'and'Pest
'01014AA
'1ARBAW
TCJQBB
Bunch rot
(Botrytis)
Storage rot
0601SEA
TBFAAX
'IBFBAW
Kiwi'Fruit
Alternaria fruit
rot
Botrytis fruit rot
'13028AA
Lettuce,"Head
••GATBAW
TIAZSAQ
Botrytis wilt
of lettuce
Sclerotinia drop
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance,'Use,'Limitations
Formulation(s)
10 ppra
1 day preharvest interval through
2.0 pounds per acre.
Apply dusts using ground equipment.
1.8 Ib/A
(4-15% D)
or
0.09 oz/
50 ft of row
(6% D)
or
1.0 lb/
100 gal
[200 gal/A]
(75% WP/D)
1 gal 2% EC/
9 gal soft
water
(2% EC)
1.8-2.0 Ib/A
(4-15% D)
Foliar application. Apply wettable
powder soon after shatter. When
tank mixing wettable powder with
gibberellins, iLse with last gibber-
ellins application only. Follow
with dust application after cluster
tightening. Repeat at 2 week inter-
vals. Or, if dust is used alone,
apply while clusters are loose and
repeat at 2 week intervals.
May be formulated with sulfur; cop-
per oxychloride sulfate and sulfur;
copper as cuprous and cupric oxide
and sulfur; naled and sulfur; sulfur
and captan.
20 ppm postharvest
Postharvest treatment through 1 gal-
lon 2 percent emulsifiafale concen-
trate per 9 gallons soft-water.
Postharvest treatment to nonstored
kiwi fruit. Apply by spraying over
a suitable brush bed. Apply 1 gal-
lon of wax mixture to 5,000 pounds
of freshly cleaned fruit. Once
opened, use entire contents of con-
tainer with formulation (5 gallons)
within 120 days.
Formulated with orthophenylphenol.
10 ppm
14 day preharvest interval through
2.0 pounds per acre.
Single application immediately after
thinning through 4.0 pounds per
acre.
Foliar application. Apply at thin-
ning. Repeat in 7 to 10 days.
May be formulated with sulfur; cop-
per oxychloride sulfate and sulfur;
or copper as cuprous and cupric ox-
ide and sulfur.
Issued: 9-24-81
II-031301-7
20
-------
Site and'Pest
EPA Index to Pesticide Chemicals
~2,6-DICHLORO-4-NITROANILINE
Dosages and Tdlerance,'Use;'Limitations
Fbrmulati6n(s)
Lettuce;' Head (continued)
2.0-4.0 lb/ Foliar and soil application. Apply
100 gal/A low rate at thinning. Repeat in 7
(75% WP/D) days. Or, apply high rate, once,
immediately after thinning. Use a
drop nozzle boom to direct spray to
lower portion of plants and sur-
rounding soil. Some temporary leaf
bronzing may be noted soon after
wettable powder application.
13031CA
Lettuce, Leaf (greenhouse)
BAABAW
Botrytis blight and 1.8 Ib/A
rot (4-15% D)
or
2.0 lb/
100 gal/A
(75% WP/D)
05003AA
05004AA
BADMCB
IALMCB
IBFRAQ
Nectarine (preharvest)
Peach (preharvest)
10 ppm
14 day preharvest interval through
2.0 pounds per acre.
Do not apply to wilted plants or
seedlings.
Foliar application to greenhouse
grown plants. Apply 7 days after
transplanting. Repeat when plants
are half mature. Some temporary
leaf bronzing may be noted soon
after wettable powder application.
May be formulated with sulfur; cop-
per oxychloride sulfate and sulfur;
or copper as cuprous and cupric ox-
ide and sulfur.
20 ppm preharvest
1 day preharvest interval through
5.0 pounds per acre as a spray or
3.6 pounds per acre as a dust.
Brown rot blossom
and twig blight
(Monilinia)
Brown rot of fruit
(Monilinia)
Rhizopus fruit rot
3.6 Ib/A Delayed dormant and foliar applica-
(4-15% D) tion. Wettable powder may be tank
or mixed with captan. Apply at pink
2."5-3.25 Ib/A bud and full bloom for blossom and
(5-6% D) twig blight. For fruit rots, apply
or at 18 days, 10 days and 1 day prior
0.75-1.0 lb/ to harvest.
100 gal May be formulated with sulfur; cap-
(75% WP/D) tan; copper oxychloride sulfate and
sulfur; copper as cuprous and cupric
oxide and sulfur; or sulfur and
captan.
Also refer to Peach (preharvest) for additional
use information.
Issued: 9-24-81
II-031301-8
21
-------
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Site and Pest
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
05003EA
TALMCB
IBFRAQ
Nectarine (postharvest)
Brown rot of fruit
(Monilinia)
Rhizopus fruit rot
1BFRAQ
Rhizopus fruit rot
20 ppm postharvest
Do not exceed the recommendations
stated for each use pattern below.
Onion
1.61 lb/110 Postharvest treatment to nonstored
gal water nectarines. Apply as a dip or spray
(48.82 WP) over a suitable brush bed. Apply 1
gallon of dilute suspension to coat
2,000 to 2,500 pounds of fruit. Do
not dip more than 2 minutes.
Formulated with thiophanate-methyl.
4.83 lb/110 Postharvest treatment to nonstored
gal dilute nectarines. Apply as a spray on
wax roller beds. Use mechanical agita-
(48.82 WP) tion of wax mixture. Apply 1 gallon
of dilute wax mixture to coat 2,500
pounds of fruit.
Formulated with thiophanate-methyl.
2.0 lb/100 Postharvest treatment to nonstored
gal water nectarines. Apply only with fruit
(75% WP/D) wax. Use mechanical agitation of
wax mixture. Apply the mixture dur-
ing packing line operations at the
rate of 30 to 35 gallons per hour at
18 to 30 pounds per square inch.
Use flat-fan or flood jet nozzles.
Collect and discard spray run-off.
1 gal 32 RTU/ Postharvest treatment to nonstored
12,500 Ib nectarines. Apply using a spray-
fruit brush applicator to washed and par-
(3% RTU) tially dried fruit.
1 gal 9% F1C/ Postharvest treatment to nonstored
2 gal ready- nectarines. Apply 1 gallon of mix-
to-use wax ture using a spray-brush applicator
emulsion to 12,500 pounds of washed and par-
or tially dried fruit.
32 a.i.
mixture
(92 F1C)
See Garlic cluster.
Issued: 9-24-81
II-031301-9
£2-
-------
Site and Pest
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance,'Use,"Limitations
Formulation(s)
05004AA
IALMCB
IBFRAQ "
Peach (preharvest)
Brown^rot^of fruit 1.5-2.4.Ib/A Foliar application. Apply 18 days,
(Monilinia) or 10 days, and 1 day prior to harvest.
Rhizopus fruit rot 0.24-0.36 oz/ May be formulated with sulfur; or
tree captan.
(6% D)
05004EA
IBFBAW
IBFRAQ
Peach (postharvest)
Botrytis fruit rot
Rhizopus fruit rot
Refer to Nectarine (preharvest) cluster for addi-
tional information.
20 ppm postharvest
Do not exceed the recommendations'
stated for each use pattern below.
0.75 lb/ Postharvest treatment to nonstored
100 gal peaches. Immediately after picking,
water dip or spray fruit with suspension.
(75Z WP/D) Do not recirculate used spray sus-
pension. Or, apply in the proces-
sing line- operations during or after
the defuzz.ing process. Apply by
brushes, spray, or in the hydrocool-
er. Brushes: Apply to the brush
with traversing feeder nozzle ca-
pable of metering approximately 10
gallons of suspension per hour with
the valve completely open. Agitate
suspension. Unused suspension
should be caught and discarded.
Spray: Direct a mist spray down
upon the rotating peaches. Apply
approximately 45 gallons of suspen-
sion per hour at 20 to 25 pounds per
square inch. TJ80 nozzles are re-
commended. Hydrocooler: As volume
decreases, make up to original vol-
ume by adding 0.75 pound per 100
gallons of water. Drain and flush
daily. Do not treat peaches packed
in containers which do not allow
adequate drainage.
Issued: 9-24-81
11-031301-10
-------
Site-atid'Pest
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance,'Use;'Limitations
F6rrmilation(s)
(postharvest) (continued)
2.0 lb/
100 gal
water
(75% WP/D)
FIALMCB
FTBFRAQ
Brown rot of fruit
(Monilinia)
Rhizopus fruit rot
0.805 lb/110
gal water
(48.8% WP)
Postharvest treatment to nonstored
peaches. For use on freezing and
canning peaches only. Do not use
for fresh fruit market. -Apply as a
dip immediately after picking. Agi-
tate suspension. As volume de-
creases, make up to original volume
by adding 2.0 pounds per 100 gallons
of water. Drain and flush system
daily.
Postharvest treatment to nonstored
peaches. Apply as a dip or spray
over a suitable brush bed. Apply 1
gallon of dilute suspension to coat
2', 000 to 2,500 pounds of fruit. Do
not dip more than 2 minutes.
Formulated with thiophanate-methyl.
Postharvest treatment to nonstored
peaches. Apply in a flow through
spray system. Apply 1 gallon of
dilute wax mixture to coat 2,000 to
2,500 pounds of fruit.
Formulated with thiophanate-methyl.
Postharvest treatment to nonstored
peaches. For use on freezing and
canning peaches only. Do not use
for fresh fruit market. Apply as a
dip immediately after picking. Agi-
tate suspension. As volume de-
creases, make up to original volume
by adding 2.0 pounds per 100 gallons
of water. Drain and flush system
daily.
1 gal 3% RTU/ Postharvest treatment to nonstored
12,500 lb peaches. Apply using a spray-brush
fruit applicator to washed and partially
(3% RTU) dried fruit.
2 gal 9% F1C/ Postharvest treatment to nonstored
75 gal water peaches. For use on freezing and
or canning peaches only. Do not use
2,400 ppm for fresh fruit market. Apply by
a.i. dip or drench. Agitate mixture.
(9% F1C)
3.22 lb/110
gal dilute
wax
(48.8% WP)
2.6 lb/100
gal water
(75% WP/D)
Issued: 9-24-81
11-031301-11
-------
Site and Pest
EPA. Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance, Use, Limitations
Formulation(s)
(postharvest) (continued)
ICZQBB
IBFRAQ
Postharvest rot
decay
Rhizopus fruit rot
1 gal 0.5%
RTU/10,000
Ib fruit
(0.5% RTTJ)
Postharvest treatment to nonstored
peaches. Apply to fresh peaches
using manufacturer's applicator.
1 gal 9% FlC/ Postharvest treatment to nonstorea
2 gal ready- peaches. Apply 1 gallon of wax mix-
to-use wax ture using a spray-brush applicator
emulsion to 12,500 pounds of washed and par-
.or tially dried fruit.
32 a.i.
mixture
(9% FlC)
1 gal 9% FlC/ Postharvest treatment to nonstored
100 gal
water
or
900 ppm
a.i.
(9% FlC)
peaches. For fresh fruit market.
Apply as a spray or dip.
./U15AA Peanuts
KAAQBB Damping-off
KAAACG Damping-off
(Aspergillus)
KAARAQ Damping-off
(Rhizopus)
KABQBB Seed rot
KABACG Seed rot
(Aspergillus)
KABRAQ Seed rot
(Rhizopus)
0.6 oz/100
Ib seed
(20% D)
or
1.2-1.8 oz/
100 Ib seed
(30% D)
or
1.75 oz/100
Ib seed
(35% D)
1.06 oz/100
Ib seed
(2.82 Ib/gal
or 30% FlC)
N.F.
Do not use treated seed for food,
feed, or oil purposes..
Seed treatment. Apply with standard
commercial dust seed treater to uni-
formly cover the seed.
Formulated with captan; or captafol.
Seed treatment. Tank mix with thi-
ram. Add a peanut seed binder- Ap-
ply as a slurry through an SS-AMP
treater designed to treat peanut
seed. Use only the thiram formula-
tion and seed binder specified on
the labeling. Do not dilute with
water.
Issued: 9-24-81
11-031301-12
-------
EPA Index to Pesticide Chemicals
Site and Pest
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance, Use, Limitations
Formulation(s)
5005AA
5006AA
ADMCB
5005EA
5006EA
ALMCB
BFRAQ
Plum (preharvest)
Prune (fresh) (preharvest)
Brown rot blossom
and twig blight
(Monilinia)
1.0 lb/
100 gal
[250 gal/A]
(75% WP/D)
Plum (postharvest)
Prune (fresh) (postharvest)
Brown rot of fruit
(Monilinia)
Rhizopus fruit rot
1.61 lb/110
gal water
(48.8% WP)
3.22 lb/110
gal dilute
wax
(48.8% WP)
15 ppm preharvest
Last application at full bloom
through 2.5 pounds per acre.
Delayed dormant and foliar applica-
tion. Apply at popcorn and full
bloom.
15 ppm postharvest
Do not exceed the recommendations
stated for each use pattern below.
Postharvest treatment to nonstored
plums and fresh prunes. Apply as a
dip or spray over a suitable brush
bed. Apply 1 gallon of dilute sus-
pension to coat 2,000 to 2,500
pounds of fruit. Do not dip more
than 2 minutes. Do not apply to
early plums which may not be suscep-
tible to decay.
Formulated with thiophanate-methyl.
Postharvest treatment to nonstored
plums and fresh prunes. Apply in a
flow through system. Apply 1 gallon
of dilute wax mixture to coat 2,000
to 2,500 pounds of fruit. Do not
apply to early plums which may not
be susceptible to decay.
Formulated with thiophanate-methyl.
Issued: 9-24-81
11-031301-13
-------
Index to Pesticide Chemicals
Site and Pest
2,6-DICHLORO-4-NITROANILINZ
Dosages and Tolerance, Use, Limitations
Formulation(s)
55005EA
LALMCB
[BFRAQ
(postharvest) cluster (continued)
(Plum (postharvest))
Brown rot of fruit
(Motrilinia)
Rhizopus fruit rot
AQ
Rhi-zopus fruit rot
L4013AA
Potato
5AABAW
1ANSAQ
Botrytis blight
White mold
(Sclerotinia)
2.0 lb/100 Postharvest treatment to nonstored
gal water plums. Apply only with fruit wax.
or Apply during packing line operations
7.5-9.0 lb/ using flat-fan or flood jet nozzles.
100 gal Use mechanical agitation of wax mix-
water ture. With conventional applicators
(75% WP/D) (30 to 50 gallons per hour), apply
100 gallons of mixture at 2.0 pound
rate to approximately 50,000 pounds
of fruit. With low volume applica-
tors (5 to 8 gallons per hour), ap-
ply 100 gallons of mixture at 7.5 to
9.0 pound rate to approximately
500,000 pounds of fruit.
1 gal 3Z RTD/ Postharvest treatment to nonstored
12,500 lb plums. Apply using a spray-brush
fruit applicator to washed and partially
RTU) dried fruit.
1 gal 9% F1C/ Postharvest treatment to nonstored
75 gal plums. Apply 1 gallon of mixture
ready-to— use using a spray-brush applicator to
wax emulsion 12,500 pounds of washed and partial-
or ly dried fruit.
3% a.i.
mixture
(9Z F1C)
0.25 ppm
14 day preharvest interval through
1.5 pounds per acre.
Do not feed treated potatoes to
livestock.
1.5 lb/100
gal/A
(75% WP/D)
Prune (fresh) (preharvest)
•Prune (fresh) (postharvest)
Use limited to North Central States.
Foliar application. Apply beginning
at layby. Repeat at 10 to 14 day
intervals.
See Plum (preharvest) cluster.
See Plum (postharvest) cluster.
Issued: 9-24-81
11-031301-14
27
-------
EPA Index to Pesticide Chemicals
130234CA
IBKBAW
14018DA
3AQMCC
BBCSAS
Site and Pest
Red Raspberry
Rhubarb (greenhouse)
Botrytis leaf
blight
2,6-DICHLORO-4-NITROANTLINE
Dosages and Tolerance, Use, Limitations
Formulation(s)
See Blackberry cluster.
10 ppm
3 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/ Foliar application to greenhouse
100 gal grown plants. Apply when first buds
(75% WP/D) emerge from crowns'. Repeat at 7 day
intervals.
Sweet Potato (plant beds)
Scurf
(Monilochaetes)
Southern blight
(Sclerotium)
0.75 lb/7.5
gal water
(dip)
or
2.25-2.81 lb/
14 gal water
(bed spray)
(75% WP/D)
1401 SEA
HCERAQ
Sweet Potato (postharvest)
N.F.
Do not plant tomatoes as a follow-up
crop in beds.
Dip treatment to seed-pieces for
plant beds. Dip seed sweet potatoes
10 to 15 seconds in well-agitated
suspension. Drain and bed promptly.
Prepare fresh suspension daily.
OR
Seed-piece treatment in plant beds.
Apply to 1,000 square feet of plant
beds. Spray or sprinkle over bedded
sweet potatoes before covering soil.
10 ppm postharvest
Postharvest treatment through 900
ppm in water or wax.
Do not rinse after treatment.
Rhizopus soft rot
0.75 lb/100 Postharvest treatment to nonstored
gal water sweet potatoes. Dip treatment: Dip
(75% WP/D) roots for 10 to 15 seconds in well-
agitated suspension. Add 0.38 pound
per 100 gallons of dip suspension
after 500 bushels are treated.
Drain and flush tank after each
1,000 bushels treated and refill
with fresh dip suspension. Spray
application: Apply using an 8001
fan-shaped nozzle at 50 to 75 pounds
per square inch immediately after
washing while the sweet potatoes are
conveyed on chain rollers or belts.
In recirculating systems, as volume
decreases, make up to original vol-
ume. Where black rot is a problem,
do not recirculate used spray.
Issued: 9-24-81
11-031301-15
23
-------
Site'and'Pest
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance,'Use, Limitations
Formulation(s)
Sweet'Potato (postharvest) (continued)
Tomato (greenhouse)
'BAW
Botrytis stem rot
1 gal 9% F1C/ Postharvest treatment to nonstored
100 gal sweet potatoes. Spray or dip for 10
water seconds immediately after washing.
or Do not reclaim used spray.
900 ppm a.i.
(92 F1C)
1 gal 9% F1C/ Postharvest treatment to nonstored
100 gal sweet potatoes. Apply by spray or
ready-to-use flood to washed and drained sweet
wax emulsion potatoes at a rate not more than 1
gallon of dilution per 750 pounds
of sweet potatoes.
or
900 ppm a.i
(9% F1C)
1.8 Ib/A
(4-15Z D)
or
0.09 oz/50
ft of row
(6% D)
or
0.75 lb/
100 gal
(752 WP/D)
5 ppm
No preharvest interval through 1.8
pounds per acre.
Seedlings or newly set transplants
may be injured by drenching.
Foliar application to greenhouse
grown plants. Apply to stem of
plant from ground level up to a
height of 18 to 24 inches.
May be formulated with sulfur; or
copper as cuprous and cupric oxide
and sulfur.
Issued: 9-24-81
11-031301-16
-------
Site"and'Pest
EPA" Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages'and Tolerance, Use,'Limitations
Formulation(s)
L065DA
1108DA
412 ODA
&ABAH
ORNAMENTALS
(Ornamental'Plants (herbaceous'plants and bulbs; woody shrubs,'trees and
vines))"
Chrysanthemum (nursery stock)
Geranium (nursery stock)
Rose (nursery stock)
Botrytis blight
1111AA
APSEA
Gladiolus
Dry rot
(Stromatinia)
1.8 Ib/A
(4-15Z D)
or
1.5 Ib/A
(52 D)
or
0.09 oz/50
ft of row
(6Z D)
or
0.38-0.56 lb/
100 gal
(752 WP/D)
Refer to Rose (nursery stock) in Hydrangea (nurs-
ery stock) cluster for additional information.
Foliar application to stock cut-
tings. Apply when disease is antic-
ipated or first appears. Apply to
foliage and flowers at 7 to 14 day
intervals. During prolonged damp,
cool periods apply at 5 to 7 day
intervals.
May be formulated with sulfur; or
captan.
14.8-15.9
Ib/A
(4-15% D)
(75% WP/D)
or
12.5 Ib/A
(5% D)
.or
0.75 oz/50
ft of row
(6% D)
Soil application. Apply per 14,520
linear feet of row using a 12 inch
band centerd on furrow. Apply at
planting so that treated soil sur-
rounds conns. Apply wettable powder
as a spray or dust.
May be formulated with sulfur; or
captan.
Issued: 9-24-81
11-031301-17
30
-------
Site and"Pest
EPA Index to Pesticide Chemicals
2,6-DICKLORO-4-NITROANILINE
Dosages and Tolerance,'Use, Limitations
Formulation(s)
31111FA
3AABAW
Gladiolus (cut flowers)
Botrytis blight
1.8 Ib/A of
cut flowers
(4-152 D)
or
1.5 Ib/A of
cut flowers
(52 D)
or
0.09 oz/50
row ft of
cut flowers
(62 D)
or
0.56 lb/
100 gal
(752 .WP/D)
34073DA
34073JD
34120DA
34120JD
SAW
Hydrangea (nursery stock)
Rose (nursery stock)
Botrytis blight
1.8 Ib/A
(4-152 D)
or
1.5 Ib/A
(52 D)
or
0.09 oz/50
ft of row
(62 D)
or
1.0 lb/
100 gal
(752 WP/D)
(4-152 D)
or
1.0 lb/
100 gal
(752 WP/D)
Cut flower treatment. Apply thor-
oughly and force fungicide between
spikes. Apply to bunched cut flower
spikes after harvest and before
shipment or storage.
May be formulated with sulfur; or
captan.
Foliar application to nursery stock.
Apply prior to lifting for shipment
or storage. Apply before disease
appears.
May be formulated with sulfur; or
captan.
Application to stored plants and
storage area. Thoroughly dust or
spray storage area. Dust, spray, or
dip all canes and dead foliage. Re-
peat during long storage periods.
May be formulated with sulfur; or
captan.
Refer to Rose (nursery stock) in Chrysanthemum
(nursery stock) cluster for additional informa-
tion.
Issued: 9-24-81
11-031301-18
31
-------
Site'and'Pest
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance,'Use, Limitations
Formulation(s)
31065CA
51108CA
54120CA
5AABAW
Rose (nursery stock) See Chrysanthemum (nursery stock) cluster and
Hydrangea (nursery stock) cluster.
(Ornamental (and forest) Greenhouse Plants)
Chrysanthemum
Geranium
Rose
Botrytis blight
1.8 Ib/A
(4-152 D)
or
1.5 Ib/A
(5% D)
or
0.09 oz/50
ft of row
(6% D) •
or
0.38-0.56 lb/
100 gal
(75% WP/D)
Foliar application to greenhouse
grown plants. Apply when disease is
anticipated or first appears. Apply
to foliage and flowers at 7 to 14
day intervals. During prolonged
damp, cool periods apply at 5 to 7
day intervals.
May be formulated with sulfur; or
captan.
Issued: 9-24-81
11-031301-19
-------
001500
AAAAAA
'900300
AAAAAA
Site and Pest
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Dosages and Tolerance, Use, Limitations
Formulation(s)
AERIAL AND TANK MIX APPLICATIONS
Aerial Application
Refer to
AGRICULTURAL CROPS
ORNAMENTALS
All sites
All sites
Tank Mix
Refer to
AGRICULTURAL CROPS
Apricot, Cherry (sweet). Grapes,
Nectarine, Peach, Peanuts
Issued: 9-24-81
11-031301-20
33>
-------
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
Listing of Registered Pesticide Products by Formulation
95%'technical chemical
2,6-dichloro-4-nitroaniline (031301)
001023-00057
90%'formulation intermediate
2,6-dichloro-4-nitroaniline (031301)
001023-00043
4%"dust
2,6-dichloro-4-nitroaniline (031301)
001023-00042
5%"dust
2,6-dichloro-4-nitroaniline (031301) plus captan (081301)
000239-02307 000239-02309
61'dust
2,6-dichloro-4-nitroaniline (031301)
000279-02386 000550-00042 000635-00485 000769-00355
001023-00035 001202-00273 001526-00442 002935-00402
011169-00001
2,6-dichloro-4-nitroaniline (031301) plus sulfur (077501)
000148-00722 000148-00863 000279-02424 000279-02498
000279-02518 000279-02613 000769-00356 002935-00403
011169-00002
2,6-dichloro-4-nitroaniline (031301), copper oxychloride sulfate
(023503) plus sulfur (077501)
000279-02611
2,6-dichloro-4-nitroaniline (031301), naled (034401) plus sulfur
(077501)
000279-02351
2,6-dichloro-4-nitroaniline (031301), copper as cuprous and cupric oxide
(042403) plus sulfur (077501)
000148-00849
2,6-dichloro-4-nitroaniline (031301), sulfur (077501) plus captan
(081301)
000279-02963 00769-00358
8%'dust
2,6-dichloro-4-nitroaniline (031301)
001023-00019
103"dust
2,6-dichloro-4-nitroaniline (031301)
001023-00041
Issued: 9-24-81 11-031301-21
-------
EPA Index to Pesticide Chemicals
2,6-DICKLORO-4-NITROANILINE
Listing of Registered Pesticide Products by Formulation (continued)
122 dust
2,6-dichloro-4-nitroaniline (031301)
001023-00039
15% dust
2,6-dichloro-4-nitroaniline (031301)
001023-00040
201 dust
2,6-dichloro-4-nitroaniline (031301) plus captan (081301)
000239-02408
2,6-dichloro-4-nitroaniline (031301) plus captafol (081701)
000239-02407
30% dust
2,6-dichloro-4-nitroaniline (031301) plus captan (081301)
001023-00049
35% dust
2,6-dichloro-4-nitroaniline (031301) plus captan (081301)
000239-02274
2,6-dichloro-4-nitroaniline (031301) plus captafol (081701)
000239-02273
50Z dust
2,6-dichloro-4-nitroaniline (031301)
000550-00086
48.8% wettable powder
2,6-dichloro-4-nitroaniline (031301) plus thiophanate-methyl (102001)
004581-00341
75Z wettable powder/dust
2,6-dichloro-4-nitroaniline (031301)
000769-00395 001023-00036 002749-00186
2% emulsifiable concentrate
2,6-dichloro-4-nitroaniline (031301) plus orthophenylphenol (064103)
004581-00343
9Z flowable concentrate
2,6-dichloro-4-nitroaniline (031301)
008764-00014
30% (2.82 Ib/gal) flowable concentrate
2,6-dichloro-4-nitroaniline (031301)
007501-00028
Issued: 9-24-81 11-031301-22
-------
EPA Index to Pesticide Chemicals
2.6-DICHLORO-4-NITROANILINE
Listing of Registered Pesticide Products by Formulation (continued)
0.5% liquid-ready to use
2,6-dichloro-4-nitroaniline (031301)
008764-00007
3Z liquid-ready to use
2,6-dichloro-4-nitroaniline (031301)
008764-00015
Issued: 9-24-81 11-031301-23
-------
EPA Index to Pesticide Chemicals
2,6-DICHLORO-4-NITROANILINE
999999 State Label Registrations
A2 Reg. No.
004581-04385
CA Reg. No.
00014-8-05206
000239-04233
002935-06626
006973-03594
007001-07676
011369-08787
035296-05817
GA Reg. No.
004581-04401
MD Reg. No.
004581-04400
NC Reg. No.
004581-04399
NJ Reg. No.
004581-04396
PA Reg. No.
004581-04398
SC Reg. No.
004581-04397
VA Reg. No.
004581-04402
WA Reg. No.
004581-04393
000148-05206
000239-04252
004581-04391
006973-03595
008764-07255
011369-08804
000148-05209
001202-05087
005967-05182
006973-03600
010972-06248
011656-05770
000239-04232
001202-05088
005967-05183
007001-07674
011369-08783
011656-05771
010873-05407 010873-07141
005131-06784
Issued: 9-24-81
11-031301-24
37
-------
II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix II-l) is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in -this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registration(s)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data V Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted 2/. Any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines, or data collected under the approved
protocols of the Organization for Economic Cooperation
and Development (OECD). If you wish not to develop data
which are necessary to support the registration or
reregistration of certain uses appearing in your labeling,
you may delete those uses at the time you submit your
revised labeling.
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
V Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless^of any such
product's unique composition or use- Product-specific data relate
only to the properties or effects of a product with a particular
composition (or" a group of products with closely similar composition)
2/ USEPA, 1982. Pesticide Registration; Proposed Data
Requirements Part 158. FEDERAL REGISTER of November 24,
1982 (47 FR 53192)
38
-------
type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note: The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-2] for each of your products. On that form you must
state which of the following methods you will use to comply
with the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix II-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued at bottom of next page)
39
-------
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This
option is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from bottom of previous page)
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend^the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in^
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop_and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B){iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
•not.required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
40
-------
GENERIC DATA REQUIREMENTS FOR DOSJA
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
Oonposition No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/7/
§158.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients
61-2 - Statement of Composition
TGAI
TGAI
Yes
Partially4 GS0113054
Yes
Yes
-t:
61-3 .- Discussion of Formation of TGAI
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Limits TGAI
62-3 - Analytical Methods for TGAI
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point
63-7 - Density, Bulk Density, or TGAI
Specific Gravity
No
Yes
PartiallyS
PartialIy6
PartiallyS
Yes
Yes
No
Yes
N/A
No
GS0113052
GS0113052,GS0113053
GS0113055
GS0113057
GS0113054
GS0113054,GS0113052
GS0113054
Yes
Yes
Yes
No
No
Yes
No
Yes
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/7/
§158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
(continued)
- Solubility
- Vapor Pressure
- Dissociation constant
- Octanol/water partition
TGAI OR PAI
PAI
PAI
PAI
Partially3 GS0113054
No —
No
No
Yes
Yes
Yes
Yes
coefficient
63-12
63-13
-t-
VJ Other
64- 1
- PH
- Stability
Requirements:
- Submittal of samples
TGAI
TGAI
N/A
Yes GS0113055
Yes GS0113054
N/A
No
No
No
_!/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient.
_2/ Data must be submitted no later than 6 months from the date of this Standard.
3/ A quantitative value for water only is requested.
4/ The purity of starting materials and quality control measures are lacking; names and addresses of producers
of materials are required.
5/ 5 or more recent samples must be analyzed.
_6/ Identities and upper limits of unintentional ingredients; upper and lower limits for DCNA and inerts;
analysis for nitrosamines.
7/ All 158.120 data must be submitted for each MP registered.
"8/ Quantitative methods to determine manufacturing impurities are needed.
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirements
Does EPA Have Data
To Satisfy This
_!/ Requirement? (Yes,
Composition No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- plants
- Livestock
171-4' - Residue Analytical Method
- Plant residues
- Animal residues
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue-
^ Residue Studies for Each
Food Use
- Crop Group - Root and Tuber
Vegetable
o Carrots
— Crop field trials
— Processed Food/Feed
0 Potatoes
— Crop field trials
— Processed Food/Feed
PAIRA
PAIRA and plant
metabolites
TGAI and metabolites
TGAI and metabolites
PAI
TEP
EP
TEP
EP
Partially15 GS0113050 Yes
Partially3 GS0113060 & GS0113061 Yes
Yes
No16
Partially4
Yes
Yes
GS0113062 & GS0113063
GS0113064
No
Yes
Yes
GS0113065 & GS0113066
GS0113067
Partially7 GS0113068
No
No
No
Yes
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirements
Does EPA Have Data
To Satisfy This
_!/ Requirement? (Yes,
Composition No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
continued
171-4 - Magnitude of the Residue
continued
0 Sweet Potatoes
— Crop field trials TEP
— Processed Food/Feed EP
- Crop Group - Bulb Vegetables
0 Garlic
~~^ — Crop field trials
— Processed Food/Feed
0 Onions
— Crop field trials
— Processed Food/Feed
- Crop Group - Leafy Vegetables
(except Brassica Vegetables)
0 Celery
— Crop field trials TEP
— Processed Food/Feed EP
Partially17
N/A
TEP
EP
TEP
EP
Yes
N/A
Partially8
N/A
Yes
N/A
GS0113069, GS0113070,
GS0113071 & GS0113072
Yes
GS0113073
No
GS0113074, GS0113075 &
GS0113076
Yes
GS0113077 8, GS0113078
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
Ccmposition No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
o Endive
— Crop field trials TEP
— Processed Food/Feed EP
0 Lettuce.
— Crop field trials TEP
u\
— Processed Food/Feed EP
0 Rhubarb
— Crop field trials TEP
— Processed Food/Feed EP
- Crop Group - Legume Vegetables
0 Snap Beans
— Crop field trials TEP
— Processed Food/Feed EP
Yes
N/A
Yes
N/A
Yes
N/A
Yes
N/A
GS0113079 S, GS0113080
GS0113079 & GS0113080
GS0113081 & GS0113082
GS0113083 & GS0113084
No
No
No
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
Composition No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
Crop Group - Fruiting Vegetables
(except cucurbits)
o Tomatoes (Greenhouse grown only)
— Crop field trials TEP
— Processed Food/Feed EP
fe
^ - Crop Group - Fruiting Vegetables
(cucurbits)
° Cucumbers
— Crop field trials TEP
— Processed Food/Feed EP
- Crop Group - Stone Fruits
0 Apricots
— Crop field trials TEP
— Processed Food/Feed EP
Yes
Yes
N/A
Partially10
N/A
GS0113085, GS0113086,
GS0113087 & GS0113088
No
Yes
GS0113089
No
GS0113090, GS0113091,
GS0113092, GS0113093,
S, GS0113094
Yes
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR DCNA
Data Requirement
Does EPA Have Data
To Satisfy This
_!/ Requirement? (Yes,
Composition No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
o Cherries (sweet)
— Crop field trials
— Processed Food/Feed
0 Nectarines
~t
^ — Crop field trials
— Processed Food/Feed
0 Peaches
— Crop field trials
— Processed Food/Feed
0 Plums
— Crop field trials
— Processed Food/Feed
TEP
EP
TEP
EP
TEP
EP
TEP
EP
Partiallyll
N/A
Partiallyll
N/A
Partiallyll
N/A
Partiallyll
N/A
GS0113085, GS0113086,
GS0113087 & GS0113098
GS0113099, GS0113100,
GS0113101 & GS0113102
GS0113103, GS0113104,
GS0113105, GS0113106,
GS0113107 & GS0113108
GS0113109, GS0113110,
GS0113111, GS0113098,
& GS0113087
Yes
Yes
Yes
Yes
-------
TABLE
GENERIC DftTA REQUIREMENTS TOR DCNA
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group - Small Fruits and Berries
o Blackberries
— Crop field trials
— Processed Food/Feed
0 Boysenberries
— Crop field trials
— Processed Food/Feed
0 Grapes
— Crop field trials
— Processed Food/Feed
0 Raspberries
— Crop field trials
— Processed Food/Feed
TEP
EP
TEP
EP
Partiallyl2
N/A
Partiallyl2
N/A
TEP
EP
TEP
EP
Yes
Partially*2
N/A
GS0113109
Yes
GSOH3109
Yes
GS0113086, GS0113087,
GS0113109 & GS0113114
GS0113114
GS0113109
No
Yes
Yes
-------
TABLE
GENERIC DATA REQUIREMENTS FOR DCNA
Data Requirement
Does EPA Have Data
To Satisfy This
_!/ Requirement? (Yes,
Composition No or Partially)
Bibliographic
•Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Crop Group - Miscellaneous commodities
o Cottonseed
— Crop field trials TEP
— Processed Food/Feed EP
0 Kiwi fruit
jjj — Crop field trials TEP
— Processed Food/Feed EP
0 Peanut hay, hulls, and seed
(pending tolerances)
— Crop field trials TEP
— Processed Food/Feed EP
Yes
GS0113086, GS0113087,
GS0113109 & GS0113115
Partially^
N/A
In Agency review
In Agency review
GS0113116, GS0113117,
GS0113118 & GS0113119
No
Yes
Yes
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition No or Partially) Citation 3(c) (2) (B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- potable Water
- Fish
- irrigated Crops
— Field trials
— Processed Food/Feed
- Food Handling
- Meat/milk/poultry/eggs
(pending tolerances)
EP
EP
EP
EP
EP
EP
TGAI or plant
metabolites
N/A
N/A
N/A
N/A
N/A
N/A
In Agency review —
—
—
—
—
—
—
—
_!/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP =
\f. Typical end-use product; EP = End-use product.
^> _2/ Data must be submitted no later than 48 months from issuance of the standard.
3/ Identification of the metabolites in the muscle and liver of a ruminant after oral administration of l^C ring
labeled DCNA. In addition a 14c DCNA poultry and swine study is required characterizing the residues in eggs
and tissues respectively.
4/ Storage stability data involving meat, milk and eggs required.
3/ Recovery data required to validate the method used in the collection of the residue data.
6/ A processing study for dried potatoes, potato granules and chips are required.
I/ Additional residue data resulting from the use of irrigation equipment and aerial application are required or
submission of recovery data from a benzene extraction and use of an EC-GC detector.
8/ Additional data on onion grown in Texas and California for dryland production.
9/ Residue data for field trials and processing fractions required for field grown tomatoes if that use were to be
registered.
10/ Data on post harvest dip treatments with 48.8% WP formulation is needed that reflect total use pattern.
TF/ Additional data reflecting total use pattern.
~12/ Residue data involving 4 applications of the 75% WP/D and any 4 to 15% D formulations at 2.5 and 3 Ib/A respectively
T3/ Additional data on raisin waste, wet and dry ponace and on grape juice reflecting total registered uses.
T4/ Residue data on cottenseed hulls, meat, oil, and soapstock processed from field treated cottonseed containing
residue of DCNA at or near the tolerance level.
15/ Data is needed to clearly identify and quantify DCNA metabolites.
T6/ Methodology for the analysis of residues in meat, milk, poultry, and eggs are needed.
T?/ Postharvest spray dip, or flood application to washed and unwashed with 9% flowable concentrate at 900 ppm
active ingredient. Treatments should include a ready-to-use wax emulsion.
-------
TABLE
GENERIC DATA REQUIREMENTS FOR DCNA
Data Requirement
V Use 2/
Ocmposition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
,Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodeg rada t ion
161-2 - In water
161-3 - On soil
161-4 - in Air
METABOLISM STUDIES-LAB:
h 162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES;
163-1 - Leaching and
Adsorp t ion/Desorp t ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA A,B,E,F
TCAI or PAIRA
TCAI or PAIRA
TCAI or PAIRA
TCAI or PAIRA
TCAI or PAIRA
TGAI or PAIRA
TEP
TEP
A,B,E,F
E,F
No8
A,B,E,F
A
N/A4
A,B,E,F
A
N/A
N/A
No8
No8
No
Partiallyl3
No8
—
—
Noll
No
00086942
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use _2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
.Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
A,B Nol2
N/A
N/A5
N/A6
Yes
—
—
— —
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
-"
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Organisms
TEP
PAIRA or TGAI A
NO
No°
TEP
TGAI or PAIRA
A
N/A
A,B
N/A
Yes'
Yes
Yes
No
Yes
10
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DONA
§158.130 Environmental Fate
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product; N/A = not applicable t
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; E>=Greenhouse, Food Crop
F=Greenhouse, Non-Food
V Data must be submitted no later than 48 months after the issuance of the standard.
_4/ Data not required due to tentative vapor pressure (1.2x10"^), low water solubility, and
high soil adsorption.
j>/ No forest use of DCNA
6/ Data requirement not being implemented for this standard.
_7/ Data requiremtent depends on results of th aerobic soil metabolism and terrestrial dissipation studies.
8/ No data submitted, all data required.
9/ No data submitted, however, all data may be required based on results of the confined study.
1Q/ Required if significant concentrations are likely to be found in aquatic environments.
ll/ Bioassay did not provide reliable data; both leaching and adsorption/desorption data are required.
12/ Controls contaminated, pattern of decline not established; all data required.
13/ Additional data required, i.e., 1/2 life in unamended soil and decline of degradates.
-------
TABLE
GENERIC DATA REQUIREMENTS poR DCNA
Does EPA Have Data 'Must Additional
To Satisfy This Data Be Submitted
I/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Patterns No or Partially) Citation 3(c) (2) (B)?3/
§158.135
Toxicology
ACUTE TESTING:
81-1 -
81-2 -
81-3 --
81-7 -
Oral LD5Q - Rat
Dermal LDgg
Inhalation 1X59 - Rat
Acute Delayed
Neurotoxicity - Hen
TGAI A,B,E,F
TGAI A,B,E,F
TGAI A,B,E,F
TGAI
Yes 00096966,00086879
Yes 00086894
Yes 00086879
Not required —
No
No
No
—
SUBCHRONIC TESTING:
82-1 -
82-2 -
82-3 -
82-4 -
90-Day Feeding -
Rodent, Non-rodent
21-Day Dermal
90-Day Dermal
90-Day Inhalation -
TGAI A,F
TGAI A,B,E,F
TGAI A,B,E,F
TGAI A,B,E,F
Not required5?
No
Not applicable^
Not required 5
—
Yes
—
—
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal
TGAI
A,B,E,F
Not required
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TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
V Use 2/
Oonposition Pattern
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
Rat
Dog
TGAI
A,B,E,F
Yes
83-2'-
83-3 -
83-4 -
Oncogenicity Study -
Rat and
Mouse
Teratogenicity -
Rabbit
Reproduct ion ,
2-generation
TGAI
TGAI
TGAI
A,B,E,F
A,B,E,F
A,B,E,F
Partially6
PartiallylO
Yes
MUTAGENICITY TESTING
84-2 -
84-2 -
84-2 -
Gene Mutation
Chromosomal Aberration
Other Mechanisms of
TGAI
TGAI
TGAI
A,B,E,F
A,B,E,F
A,B,E,F
No?
No?
No?
00082717,00082719
00085718,00026810
0008271 ,00082719
00080869
00082269
No
Yes
Yes
No
Yes
Yes
Yes
Mutagenicity
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TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
_!/ Use 2/
Composition Pattern
Dqes EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
'Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A,B,E,F
85-2 - Domestic Animal Safety Choice A
Oculotoxicity TGAI A,B,E,F
Cataractogenicity TGAI A,B,E,F
Partially?
Yes8
No
No
00096066,00082672 Yes
00087015 Yes
Yesll
Yesll
I/ Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several
test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, food use; B = Terrestrial, non-food; E = Greenhouse, food
use; F = Greenhouse, non-food.
_3/ Data must be submitted no later than 48 months from the issuance of the standard
4/ Due to the mode of use, a 90 day dermal study is not required, a 21 day dermal study will suffice.
]!>/ The inhalation toxicity of DCNA is very low in the acute study, therefore subchronic inhalation study will not be
required.
6/ Requires a mouse oncogenicity study.
T/ The submitted studies were graded unacceptable or supplementary data.
8/ Photosensitization data, information regarding eye pathology in 2 year chronic studies, and another study with
emphasis on the eye as target organ are warranted.
9/ Subchronic oral effects are evaluated in conjunction with the 2 chronic feeding studies.
10/ Requires an additional teratology study.
lT/ Required as DCNA is suspected to induce a systemic effect as ocular toxicity or opacity of the cornea.
-------
TABLE
GENERIC DATA REQUIREMENTS FOR DCNA
Does EPA Have Data ,Must Additional
To Satisfy This Data Be Submitted
I/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement
§158.140
132-1 -
132-1 -
133-3 -
133-4 -
Reentry Protection
Foliar Dissipation
Soil Dissipation
Dermal Exposure
Inhalation Exposure
Composition Pattern
TEP
TEP
TEP
TEP
No or Partially) Citation 3(c)(2) (B)?3/
(
No - -
No - -
No -
. NO
_!/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ These data requirements are being held in reserve, pending evaluation of required toxicological data.
-------
TABLE ,
GENERIC DKTA REQUIREMENTS FDR DOSIA
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LD^Q
71-2 - Avian Dietary LC^Q
71-3 •- Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
\
^ 72-1 - Freshwater Fish LC5Q
72-2 - Acute LCcn Freshwater
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes, Bibliographic
Oonposition Pattern No or Partially) Citation
TGAI A,B,E,F No
TGAI A,B,E,F Partially6 00087027
TGAI A Not applicable —
TGAI A,B No
TEP A,B No
TGAI A,B Yes 00096064,00087028
00096058
TGAI A,B NO
Must Additional
'Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Yes
Yes
—
Reserved 4
No
No
Yes
Invertebrates
72-3 - Acute LC5Q Estuarine
and Marine Organisms
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
TGAI
TGAI
A,B
A,B
Not required
No
Reserved^
-------
TABLE
GENERIC DATA REQUIREMENTS FDR DCNA
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requi rernsnt? (Yes,
No or Partially)
Bibliographic
Citation
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
Degradation
Product
TEP
A,B
No
Must Additional
Data Be Submitted
Under F1FRA Section
3(c)(2)(B)?3/
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-5 - Fish - Life-Cycle TGAI A,B No
72-6 - Aquatic Organism TGAI, PAI OR A,B No5
Reserved^
No
Reserved^
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; E=Greenhouse,
Food crop; F=Greenhouse, Non-Food.
3/ Data must be submitted no later than 48 months for the issuance of the standard
4/ Reserved pending Environmental Fate data.
I)/ Not normally required
6/ Technical material must be used in the study.
-------
TABLE
GENERIC DATA REQUIRBHtWTS FOR DCNA
Data Requirements
Composition
I/
Does EPA Have Data
To Satisfy This
Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.150 Plant Protection
121-1 - TARGET AREA EP
PHYTOTQXICITY
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/ TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
TIER II
*T-
0 123-1 - Seed Germination/ TGAI
Seedling Emergence
123-1 - Vegetative Vigor TGAI
123-2 - Aquatic Plant Growth TGAI
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
No
No
No
No
No
No
No
No
No
No 4/
No _4/
No 4/
No 4/
No 4/
No 4/
No 4/
No V
No 4/
"17Composition:TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
~~ EP = End-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; OAquatic, Food Crop;
~~ D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted no later than 48 months for the issuance of the standard
4/ These requirements are generally waived unless it is believed there is a phototoxicity problem.
-------
TABLE
GENERIC DATA REQUIREMENTS FOR DCNA
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
'Must Additional
Data Be Submitted
Under FTFRA Section
3(c)(2)(B)?3/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact LD5Q TGAI
141-2' - Honey bee - toxicity TEP
of residues on
foliage
141-3 - Wild bees important in TEP
alfalfa pollination -
toxicity of residues
-------
TABLE
GENERIC LWTA REQUIREMENTS FOR DCNA
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_!/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)? 3/
§158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to (Reserved)5
aquatic insects
142-2 - Aquatic insect (Reserved)5
life-cycle study
142-3 - Simulated or actual (Reserved)^
field testing for
aquatic insects
- 143-1 - NONTARGET INSECT (Reserved)5
^ TESTING - PREDATORS
thru AND PARASITES
143-3
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop:
D=Aqautic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted no later than 6 months from the issuance of the standard
4/ Reserved pending development of test methodology
5/ Reserved pending decision as to whether the data requirement should be established
-------
TABLE
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DCNA
Data Requirement
Composition
V
Does EPA Have Data
To Satisfy This
Requi rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/6/
§158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Ingredients
Analysis and Certification
of Product Ingredients;
62-1 - Preliminary Analysis
62-2 - Certification of Limits
^ 62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
specific gravity
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Yes
Partially^
No
No
Partially4
Partially^
Yes
Yes
No
No
GS0113054
GS0113052, GS0113053
& GS0113055
GS0113057
GS0113054
GS0113054 & GS0113052
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
-------
TABLE
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING DCNA
Data Requirement
Ocmposition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD5Q - Rat
81-2 - Dermal LEt^n
81-3 - Inhalation LC5° - Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
MP
MP
MP
MP
MP
MP
Yes
Yes
Yes
Yes
Yes
Yes
00096966 & 00086879 No
00086894 No
00029057 No
00086892' No
00086892 No
00082721 No
_!/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than 48 months fron the issuance of the Standard
-------
Ill. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA. of. product-specific data* listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix III-l)
to fill "gaps" identified by EPA concerning your product. 'Under
the authority of FIFRA Section 3(c)(2)(B), EPA has determined
that you must submit these data to EPA in order to register or
reregister your product(s). All of these data must be submitted
not later than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
V Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
65
-------
IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not end-use products.
The.-Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10], as indicated
by the following paragraphs of this chapter of the guidance
document.
You will be informed later when you must submit the revised
labeling set forth in this guidance package.
A. Label Contents
40 CFR §162.10 requires that certain specific labeling
statements must appear at certain locations on the label.
This is referred to as format labeling. Specific label
items listed below are keyed to Tables D, E, and F (Appendix
IV-2).
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. [40 CFR
§162.10(b)]
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.
[40 CFR §162.10(c}]
Item 3. NET CONTENTS - A net content statement is required
on all labels. 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
stated in terms of weight, expressed as avoirdupois pounds
66
-------
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. [40 CFR §162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-:
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and 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 ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
67
-------
Size of Label Signal Word as Re- "Keep Out of Reach
on Front Panel quired Minimum Type of Children"
in Square Inches Size All Capitals as Required
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 - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
[40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. [40 CFR §162.10 (h)(l)(i).]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. [40 CFR §162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR §162 .10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR §162.10(h) (1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR §162.10 (h)(2)]
68
-------
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 taken to avoid
accident, injury or damage. [40 CFR §162.10 (h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-t-arget organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR §162.10(h ) (2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix IV-3. 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 flam-
mability statements.
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163 . 61-8(c)(13)
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163 . 61-8(c)(13)(ii);
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
69
-------
3. Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the'notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
[40 CFR §162.10(1)(2)(ii)]
Item 10A. 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. Make certain that the statement you use
pertains specifically to your product. 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 IV-5 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other 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.
70
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Mr. Henry M. Jacoby (PM-21)
.Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
,Washington, D.C. 20460
Telephone: 703/557-1900
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA
Form 8580-1. Refer to Appendix II-2 with appropriate
attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III-l).
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
Note; If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed,
notify the Product Manager listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1)
and the revised labeling set forth in this guidance package.
71
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Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite 'basic
documents and commentaries upon them, treating them as a
single study-
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
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
72
-------
Appendix II-l
(continued)
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
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
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 umber 123456, the
first study would be 123456-A; the second, 123456-B;
the 26th, 123456-Z; and the 27th, 123456-AA.
73
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Appendix II-1
Registration Standard Bibliography for DCNA. Citations are
considered to be part of the data base supporting registration
under the standard.
00026810
00029057
00036935
00080869
00082269
00082672
00082717
Kakuk, T.J.; Weddon, T.W.; Thomas, R.W., et al.
(1979) Reevaluation of Potential Hepatic Effects
of Botran in Beagle Dogs—Supplemental Report:
Technical Report No. 001-9610-79-005. (Unpub-
lished study received Dec 19, 1979 under 1023-51;
prepared in cooperation with Woodward Research
Corp., submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:241511-A)
Horn, H.J. (1961) U-2069: Acute Inhalation Toxicity.
(Unpublished study including letters dated Aug.
8, 1961 from E.S. Feenstra to W. Klomparens
and Aug 3, 1961 from H.J. Horn to E.S. Feenstra,
received Jun 1, 1963 under PP0375; prepared by
Woodard Research Corp., submitted by Upjohn
Co., Kalamazoo, Mich.; CDL:090404-AA)
Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975)
Toxicity of Pesticides and Other Agricultural
Chemicals to Honey Bees: Laboratory Studies.
By University of California, Dept. of Entomology.
UC, Cooperative Extension. (Leaflet 2287; published
study.)
Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Somers
Test in the Albino Rabbit: 100-037. (Unpublished
study received Mar 31, 1966 under 6F0474;
prepared by International Research and Devel-
opment Corp., submitted by Upjohn Co., Kalamazoo,
Mich.; CDL: 090529-H)
Lobdell, B.J.; Johnston, C.D.; Cronin, M.T.I. (1965)
U-2069: Effect on Reproductive Capacity through
Three Generations in the Rat. Final rept.
(Unpublished study received Mar 16, 1965 under
5F0434; prepared by Woodard Research Corp., submitted
by Upjohn Co., Kalamazoo, Mich.; CDL:098141-A)
Eberts, F.S.; Meeks, R.C.; Vliek, R.W. (1964) Letter
sent to A.A. Forist dated Aug 26, 1964: Excretion
of Botran-C14 (2,6dichloro-4-nitroaniline-U-C14)
by Man. (Unpublished study received Mar 29,
1965 under 5F0434; submitted by Upjohn Co.,
Kalamazoo, Mich.; CDL:090471-Y)
Upjohn, H.L. (1962) Botran Clinical Study. (Un-
published study received on unknown date
under 5F0434; submitted by Upjohn Co., Kalamazoo,
Mich.; CDL:097519-R)
-------
Appendix II-l (Continued)
00082719
00082721
00085718
00086879
00086892
00086894
00086942
Evans, J.S.; Mengel, G.D.; Bostwick, L. (1963)
Letter sent to W.M. Klomparens dated Dec 23,
1963: Botran (U-2069): Effect of oral administration
final report, four month's study. (Unpub-
lished study received 1964 under 5F0434; submit-
ted by Upjohn Co., Kalamazoo, Mich.; CDL:097520-B)
Johnston, R.L.; Schwikert, R.S. (1963) Letter
sent to E.S. Feenstra dated Feb 21, 1963:
U-2069: 2 ,6-dichloro-4-nitro aniline, or Botran:
Skin sensitization in guinea pigs: Ref. 5567-64-RLJ-
106B. (Unpublished study received 1964 under 5F0434;
submitted by Upjohn Co., Kalamazoo, Mich.;
CDL:097520-D)
' Sex Pheromone in Bobwhite Quail:
Laboratories Project No. 221-B.
Piccirillo, V.J.; Orlando, D.A. (1980) Single
Dose Oral Toxicity Study with Two Component ' Heliothis
virescens
Borriston
(Unpublished study received Aug 7, 1981 under
36638-10; prepared by Borriston Laboratories,
Inc., submitted by Conrel, an Albany International
Co., Needham Heights, Mass.; CDL:245801-N)
Wesley, M.M.; Weddon, T.E.; Kakuk, T.J. (1980)
Toxicologic Profile of Botran ( 2 ,6-Dichloro-4-nitro-
aniline) in Animals and Man: Technical Report
No. 218-9610-80-005. (Unpublished study re-
ceived Nov 17, 1981 under 1023-36; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL :070501-C)
Raczniak, T.J.;'Wood, D.R. (1980) Primary Eye
Irritation Evaluation in New Zealand White
Rabbits with Botran Technical (U-2069): Technical
Report No. 218-9610-80-001. (Unpublished study re-
ceived Nov 17, 1981 under 1023-36; submitted by
Upjohn Co., Kalamazoo, Mich.; CDL:070501-S)
Raczniak, T.J.; Wood, D.R. (1980) Acute Dermal
Toxicity Screen in New Zealand White Rabbits
with Botran Technical (U-2069) : Technical
Report No. 218-9610-80-003. (Unpublished study
received Nov 17, 1981 under 1023-36; submitted
by Upjohn Co., Kalamazoo, Mich.; CDL :070501-U)
Van Alfen, N.K.; Kosuge , T. (1976) Metabolism
of the Fungicde 2,, 6-dichloro-4-nitroaniline
in soil. Journal of Agricultural and Food
Chemistry 24:584-588. (Also1 In ' unpublished sub-
mission received Nov 17, 1981 under 1023-36;
submitted by Upjohn Co., Kalamazoo, Mich.;
CDL:070503-AW)
75
-------
Appendix II-l (Continued)
00087015
00087027
00087028
00096058
00096064
00096066
00096966
Imming, R.J.; Banerjee, B.N.; Woodard, M.W.; et
al. (1968) Botran: Tissue Residues and Safety
Evaluation in Calves Fed This Material in the
Diet for 28 to 30 Days. (Unpublished study
received Nov 17, 1981 under 1023-36; prepared
by Woodard Research Corp., submitted by Upjohn
Co., Kalamazoo, Mich.; CDL:070502-K)
Bellies, R.P.; Scott, W.; Knott, W.; et al. (1965)
Botran: Subacute Toxicity in Mallard Ducks.
(Unpublished study received Nov 17, 1981 under
1023-36; prepared by Woodard Research Corp., sub-
mitted by Upjohn Co.-, Kalamazoo, Mich.; CDL :070502-AD)
Bellies, R.P.; Scott, W.; Knott, W.; et al. (1965)
Botran: Acute Toxicity in Rainbow Trout.
(Unpublished study received Nov 17, 1981 under
1023-36; prepared by Woodard Research Corp., sub-
mitted by Upjohn Co., Kalamazoo, Mich.; CDL:070502-AE)
Pitcher, F.A.; McCann, J.A. (1974) Botran Technical:
Bluegill ( "L. macrochirus"): Test No. 742.
(U.S. Agricultual Research Service, Chemical
& Biological Investigations Branch, Technical
Services Div. , Animal Biology Laboratory; unpublished
study; CDL:127912-A)
Pitcher, F.G.; McCann, J.A. (1974) "Botran Technical:
Rainbow Trout . (U.S. Environmental Protection
Agency, Chemical & Biological Investigations
Branch, Technical Services Div., Animal Biology
Laboratory; unpublished study; CDL:165061-A)
Upjohn Company (1971) Botran: Safety and Toxico-
logical Studies. (Unpublished study received
Apr 14, 1971 under 1023-EX-296; CDL: 210038-B)
Chevron Chemical Company (1978) Captafol Environmental
Chemistry: Summary. Summary of studies 092742-D,
092742-E", 094494-1 through 094494-L, 095114-D,
095114-E, 095114-G through 095114-L, 120308-A
through 120308-E, 121275-A, 121275-B, 131100-A,
234046F through 234046-H, 234046-J, 234046-K,
234046-M, 234046-N, 234046-Q, 234046-R, 234046-U,
234046-V, 234046-AA through 234046-AC, 234046-AF,
234046-AH. (Unpublished study received May
30, 1978 under 239-2211; CDL:234046-A)
76
-------
Appendix II-l (Continued)
GS0113050 Groves, R. and R.S. Chough. 1970. J. Agric. Food
Chem. 18(6).
GS0113052 Upjohn Co. 1976. Confidential Statement of Formula
for EPA Reg. No. 1023-43.
GS0113053 Upjohn Co. 1973. Confidential Statement of Formula
for EPA Reg. No. 1023-57.
GS0113054 Upjohn Co. 1974. Section A of PP 4F1500.
GS0113055 Upjohn Co. 1962. PP T421.
GS0113056 Sittig, Marshall. 1977. Pesticides Process
Encyclopedia, p. 175.
GS0113057 Zweig, Gunter. 1964. Analytical Methods for Pesticides,
Plant Growth Regulators,, and Food Additives. Vol III, p. 63,
GS0113060 Jaglan, P.S., et.al. 1978. Metabolism of 14C Botran
in the Goat. Upjohn Co. Report No. 217-78-9760-001.
Submitted under PP 2F2607.
GS0113061 Eberts, F.S., R.C. Meeks, and R.W. Vlick. 1967. Me-
tabolism of Botran (2,6 dichloro-4-nitroaniline) by
the Rat. Upjohn Co. Submitted under PP 9F0558.
GS0113062 Upjohn Co. 1965. Microcoulometric analysis of 2,6 di-
choloro-4-nitroaniline. Submitted under PP 5F0434.
GS0113063 Upjohn Co. 1968. Modification of Botran determination
on waxed nectarines. Report No. 211-9760-13. Submitted
under PP 1G1161.
GS0113064 Upjohn Co. 1964. Stability of 2,6 dichloro-4-nitroaniline
in frozen macerated Tissues. Submitted under PP 5F0434.
GS0113065 Upjohn Co. 1964. Sample Nos. 1-4. Submitted under
PP 0421.
GS0113066 Upjohn Co. 1964. Sample Nos. 16-19. Submitted under
PP 0421.
GS0113067 Upjohn Co. 1964. Sample Nos. 79-94, 156-165, 96-104,
106,107. Submitted under PP 6F0474
GS0113068 Upjohn Co. 1966. Sample Nos. 915-917, 973-976. Submitted
under PP 2F2607.
GS0113069 Upjohn Co. 1963. Sample Nos. 243 A and B, 244 A and B
and 245 A and B. Submitted under PP T375.
77
-------
Appendix II-l (Continued)
GS0113070
GS0113071
GS0113072
-GS0113073--
GS0113074
GS0113075
GS0113076
GS0113077
GS0113078
GS0113079
GS0113080
GS0113081
GS0113082
GS0113083
GS0113084
Upjohn Co. -1964. Sample Nos. 6-10, 2028-2033, 2105,
2109, 2111, 2113, 2115, 2128-2131, 2134-2141, 2184-
2186, 2180, 2223-2227, 2269- 2272, 2293-2296, 2309-
2314. Submitted under PP T421.
Upjohn Co.
2117-2123,
PP 5F0434.
Upjohn Co. 1966
under PP 6F0474
1965. Sample Nos. 787
2198-2210, 2189, 2193.
1896, 2089-2099,
Submitted under
Sample Nos. 2164-2179. Submitted
Upjohn Co. 1964. Analysis of Garlic for 2,6 di-
chloro-4-nitroaniline. Submitted under PP 5F0434.
Upjohn Co. 1964. 2,6 dichloro-4-nitroaniline on
Washington onions. Submitted under PP T421.
Upjohn Co. 1964 Analysis on onion for 2,6 di-
chloro-4-nitroaniline residue. Submitted under
PP 5F0434.
Upjohn Co. 1964. Analysis on onion for 2,6 di-
chloro-4-nitroaniline residue. Submitted under
PP 6F0474.
Upjohn Co. 1965. Analysis of Celery for DCNA
residue. Submitted under PP 6F0474.
Upjohn Co. 1966. Residue determination for DCNA
in Celery. Submitted under PP 6F0474.
Boyack, G.A., and D.H. Boot. 1962. Residue of 2,6
dichloro-4-nitroaniline on lettuce dusted with
Botran. Submitted under PP T375.
Upjohn Co. 1964. Analysis of head lettuce for 2,6
dichloro-4-nitroaniline residue. Submitted under
PP 5F0434.
Boyack, G.A., and
4-nitroaniline on
under PP T375.
D.H. Boot. 1962.
treated rhubarb.
2,6 dichloro-
Submitted
Upjohn Co. 1965. Analysis of hothouse rhubarb
for DCNA residues. Submitted under PP 6F0747.
Upjohn Co. 1964. Analysis of Green Beans of
2,6 dichloro-4-nitroaniline residue. Submitted
under PP 5F0434.
Upjohn Co. 1965. Analysis of field dusted snap
beans for DCNA residues. Submitted under PP 6F0474
78
-------
Appendix II-l (Continued)
GS0113085 Upjohn Co. 1963. Section D in PP T375.
GS0113086 Upjohn Co. 1964. Section D in PP T421.
GS0113087 Upjohn Co. 1965. Section D in PP 5F0434.
GS0113088 Upjohn Co. 1982. Section D in PP 2G2610.
GS0113089 Upjohn Co. 1965. Analysis on cucumber for 2,6
dichloro-4-nitroaniline residue. Submitted under
PP 6F0474.
GS0113090 Boyack, G.A., and D.H. Boot. 1962. Residue of
2,6 dichloro-4-nitroaniline on apricots treated
wuth Botran. Submitted under PP T375.
GS0113091 Kilgore, W.W., K.W. Cheng, and J.M. Ogawa. Ex-
traction and determination of 2,6 dichloro-4-
nitroaniline in processed fruits. Submitted
under PP T375.
GS0113092 Upjohn Co. 1964. 2,6 dichloro-4-nitroaniline on
California apricot. Submitted under PP 5F0434.
GS0113093 Upjohn Co. 1964. Analysis of apricot for 2,6
dichloro-4-nitroaniline residue. Submitted
under PP 5F0434.
GS0113094 Upjohn Co. 1974. Section D of PP 4F1500.
GS011309-8 Upjohn Co. 1982. Section D of PP 2F2607.
GS0113099 Upjohn Co. 1964. 2,6 dichloro-4-nitroaniline
on California nectarines. Submitted under
PP T421.
GS0113100 Upjohn Co. 1965. Analysis of dipped nectarine
for DCNA residue. Submitted under PP 7G0602.
GS0113101 Upjohn Co. 1967. Report Nos 211-9760-14, -15, and
-16. Submitted under PP 7G0602.
GS0113102 Upjohn Co. 1970. Report Nos. 912-9760-29, -30, -31,
-52, -53, -54, -55, and -56. Submitted under
PP OF0973.
GS0113103 Upjohn Co. 1962. 2,6-Dichloronitroaniline on sprayed
Peach in California. Submitted under PP T375.
GS0113104 Boyack, G.A., and D.H. Boot. 1962. Analysis of
peaches and apricots dipped in suspensions of
2,6-Dichloronitroaniline (DCNA). Submitted by the
Upjohn Co. under PP T375.
79
-------
Appendix II-l (Continued)
GS0113085
GS0113086
GS0113087
GS0113088
GS0113089
GS0113090
GS0113091
GS0113092
GS0113093
GS0113094
GS0113098
GS0113099
GS0113100
GS0113101
GS0113102
GS0113103
GS0113104
Upjohn Co. 1963. Section D in PP T375.
Upjohn Co. 1964. Section D in PP T421.
Upjohn Co. 1965. Section D in PP 5F0434.
Upjohn Co. 1982. Section D in PP 2G2610.
Upjohn Co. 1965. Analysis on cucumber for 2,6
dichloro-4-nitroaniline residue. Submitted under
PP 6F0474.
Boyack, G.A., and D.H. Boot. 1962. Residue of
2,6 dichloro-4-nitroaniline on apricots treated
wuth Botran. Submitted under PP T375.
Kilgore, W.W., K.W. Cheng, and J.M. Ogawa. Ex-
traction and determination of 2,6 dichloro-4-
nitroaniline in processed fruits. Submitted
under PP T375.
Upjohn Co. 1964. 2,6 dichloro-4-nitroaniline on
California apricot. Submitted under PP 5F0434.
Upjohn Co. 1964. Analysis of apricot for 2,6
dichloro-4-nitroaniline residue. Submitted
under PP 5F0434.
Upjohn Co. 1974. Section D of PP 4F1500.
Upjohn Co. 1982. Section D of PP 2F2607.
Upjohn Co. 1964. 2,6 dichloro-4-nitroaniline
on California nectarines. Submitted under
PP T421.
Upjohn Co. 1965. Analysis of dipped nectarine
for DCNA residue. Submitted under PP 7G0602.
Upjohn Co. 1967. Report Nos 211-9760-14, -15, and
-16. Submitted under PP 7G0602.
Upjohn Co. 1970. Report Nos. 912-9760-29, -30, -31,
-52, -53, -54, -55, and -56. Submitted under
PP OF0973.
Upjohn Co. 1962. 2,6-Dichloronitroaniline on sprayed
Peach in California. Submitted under PP T375.
Boyack, G.A., and D.H. Boot. 1962. Analysis of
peaches and apricots dipped in suspensions of
2,6-Dichloronitroaniline (DCNA). Submitted by the
Upjohn Co. under PP T375.
80
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APPEKDIX XI-2
OMB Approval No. 2000-0468 (Expires 12-31-831
FIFRA SECTION 3(C}(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
?L1CANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, 1 am responding in the following manner
D T: I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will USB:
D2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
U3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
-G1STRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
Form 8580-1 (10-82)
-------
APPENDIX II-3
OMB Aoorovat No, 2000-0468 /Expires: 12-31-83)
{To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
I am duly authorized to represent the following firm(s) who are subject to the require-
nents of a Notice under F1FRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my'firm".)
1 My-firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all tsrms could not be reached otnerwise. This offer was made
to the following firm(s) on the following daie(s):
NAME OF FIRM
DATE OF OFFER
:
rHoweverr none of those firm(s! accented mv offer.
r
t
. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. ! understand EPA will promptly inform
me whether my firm must submit data to avoid susoension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
j TYPED NAME
SIGNATURE
DATE
Form 8580-6 (10-82)
-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline No.
§158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
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
63-4 Odor
63-5 Melting point
63-6 Boiling point
63-7 Density, bulk-
density, or
specific gravity
63-8 Solubility
63-9
63-10
63-11
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
' 63-12 | pH
Test not
required
for my
product
listed
above
(check
below)
I
I am complying with |
data requirements by|
Citing MRID#
Submit- |
ting |
Data | (For EPA Use Only)
(At- I Access ion Numbers
tached) (Assigned
\
83
-------
Appendix IV-1 (continued)
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
Test not
1 required
If or my
1 product
1 listed
1 above
[(check
Name of Test | below)
Stability
Oxidizing/reducing
reaction
Flammability
Explod ability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
I am complying with
data requirements by
Citing MRIDt
Submit-
ting
Data
(At-
tached)
'
(For EPA Use Only)
Accession Numbers
Assigned
84
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APPENDIX IV-2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
t
6B
7
7A
7B
LABEL ELEMENT
Product: name
Company name
and address
Net: contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precau t ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Bottom front:
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immed iately
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.
-------
APPENDIX IV-2 (continued)
ITEM
7C
7D
7E
if
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
' statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
r
PLACEMENT
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precau t ionary
statements.
Front panel
None
None
None
ON LABEL
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preced ing
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
86
-------
APPENDIX IV-2 (continued)
ITEM
8C
9A
9C
10A
IOC
10D
U.S.
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
^
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
chol ines terase
inhibitors
All products
All products
PLACEMEN]
REQUIRED
None
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In the
directions
for use
In the
directions
for use
None
I1 ON LABEL
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
87
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
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 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.
88
-------
Appendix IV-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
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." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
I I Required type size I
jSize of label j for the heading I
jfront panel in I STORAGE AND DISPOSAL |
I square inches | (all capitals) I
I T
|10 and under 6 point I
I Above 10 to 15 8 point I
lAbove 15 to 30 10 point I
lOver 30 12 point I
i ; L
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. 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.
89
-------
Appendix IV-5 (continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
' pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. 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
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal 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."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
•that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
90
-------
Appendix IV-5 (continued)
"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."
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."
3. 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."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
iNon-aerosol products | Do not reuse container (bottle, can, jar).
[(bottles, cans, jars)I Rinse thoroughly before discarding in trash,
I Non-aerosol products I Do not reuse bag. Discard bag in trash.
I (bags) j
lAerosol products I Replace cap and discard containers in
I I trash. Do not incinerate or puncture.
91
-------
Appendix IV-5 (continued)
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers--
(non-aerosol)
Plastic containers
Glass containers
1 Triple rinse (or
1 for recycling or
1 and dispose of in
1 other procedures
1 authorities.
1 Triple rinse (or
1 for recycling or
1 and dispose of in
1 incineration, or,
1 local authorities
1 stay out of smoke
equivalent). Then offer
reconditioning, or puncture
a sanitary landfill, or by
approved by state and local
equivalent). Then offer
reconditioning, or puncture
a sanitary landfill, or
if allowed by state and
, by burning. If burned,
•
1 Triple rinse (or equivalent). Then dispose
1 of in a sanitary landfill or by other ;
I approved state and local procedures.
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^ , dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the first page of this Appendix.
92
-------
Appendix IV-5 (continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts);
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4 ,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
93
-------
Appendix IV-5 (continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued:
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0 ,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
94
-------
Appendix IV-5 (continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta [c,d]-pentalen-2-one
(kepone, chlordecone)
l,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
95
-------
Appendix IV-5 (continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11 )
2,4, 5-Trichlorophenol
2,4,6-Trichlorophenol
2 ,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
96
-------
Appendix IV- 5 (continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
97
-------
\sSa.t
\ ~*f
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
CERTIFIED MAIL
SUBJECT: Initiation of Reregistration Process for Pesticide
Products Containing 2,6-Dichloro-4-Nitroaniline
(DCNA) as the Single Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, EPA's Office of
Pesticide Programs has begun the reregistration process for
pesticide products containing the subject ingredient. Signifi-
cant changes to the statute were made in 1972, 1975, and
1978; thus, current requirements may be substantially different
from those in effect at the time your product(s) were registered.
The first phase of reregistration requires that you (1) make
a commitment to the Agency regarding data development and
(2) subsequently submit revised product labeling and associated
information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s) (Attachment A), and a separate list of registrants
with products subject to this standard and which contain
this active ingredient (Attachment B). The latter list is
for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its registered uses, and its rationale for the regulatory
actions being taken at this time. Additionally, the Guidance
Document contains instructions describing certain of the
98
-------
steps you must take to maintain registration for your product(s).
Products not brought into compliance with the Guidance Document
as supplemented by subsequent information from EPA about compliance
with certain data support requirements will be subject to suspension
and/or cancellation.
Specifically, the enclosed Guidance Document does the
following:
1. Introduces the purpose of this document.
2. Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data
that must be submitted to complete the Agency's
evaluation of each product. In addition, a
bibliography identifying the data which is considered
part of the data base supporting the registration
standard is included.
3. Sets out time-frames for submission of required
data.
4. Explains how to revise labeling for maufacturing use
products. (As the Guidance Document explains,
labeling is not required at this time.)
5, Provides submission instructions.
Because of the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific require-
ments and procedures in order that you may respond in a correct
and timely manner. Since a part of these requirements is under
Section 3(c)(2)(B) of FIFRA, your first response may be required
within 90 days from receipt of this letter. Please note that
if you do not respond or do not comply fully with the requirements,
your application may be rejected or your product registration
cancelled or suspended.
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please contact
the Product Manager listed below who will assist you in every
reasonable way. If you wish to discuss the data requirements
or request that certain data be waived, you must write to the
Agency and indicate those data requirements with which you take
issue and your rationale for doing so. After the Agency has
had a chance to review your submission, the Product Manager will
contact you to set up a meeting for the purpose of resolving all
issues relative to data requirements.
99
-------
Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v.
Administrator, EPA was recently enjoined by the District
Court for the Eastern District of Missouri from implementing
in any way the "mandatory data licensing" aspects of §3(c)(l)(D)
of FIFRA. EPA is assessing the implications of the injunction
for the reregistration process. Because of this unresolved
situation, EPA has decided to proceed with the requirements in
this guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
If you have any questions concerning this Guidance Document,
you may contact the Product Manager listed below:
Mr. Henry M.'Jacoby
Product Manager 21
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Telephone: (703) 557-1900
Sincerely,
Douglas D. Campt, Director
Registration Division (TS-767
Enclosure
100
-------
ATTACHMENT A
PRODUCTS AFFECTED BY THIS
REREGISTRATION PROCESS
Following is a list of your products affected by this rereg-
istration process. If this list is incomplete or inaccurate
in any way, please notify the Product Manager (PM) identified
in the letter.
101
-------
ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT 2,6-Dichloro-4-nitroaniline
The information attached will allow registrants with pesticide
products containing the above ingredient to contact one
another regarding joint data development or sharing the cost
of data development under section 3(c)(2)(B) of FIFRA. This
information includes the following: EPA Reg. No., company
name, company address, active ingredient, percentage of active
ingredient and type of formulation, such as Manufacturing-Use
Product (MP), Technical Product (TP), Wettable Powder (WP),
and Granular (G).
EPA Reg. No
239-2273
239-2274
239-2307
239-2309
239-2407
239-2408
279-2386
279-2424
279-2498
279-2518
279-2611
279-2613
279-2963
400-240
400-271
400-277
550-42
550-86
Co. Name and Address
Chevron Chemical Co.
Ortho Division
940 Hensley St.
Richmond, Ca. 94804
do
do
do
do
do
FMC Corp.
Agricultural Chemical Grp.
2000 Market St.
Philadelphia, Pa. 19103
do
do
do
do
do
do
% Active
Ingredient
35.0%
Uni royal
Division
74 Amity
Bethany,
Chemical
of Uni royal,
Road
Ct- 06525
Inc
do
do
Van Waters &
Ag. Dept-
2256 Junction
San Jose, Ca.
do
Rogers
Av.
95131
35.0%
5.0%
5.0%
20.0%
20.0%
6.0%
6
6
6
6
6
6
0%
0%
0%
0%
0%
0%
6.0%
6.0%
6.0%
6.0%
6.0%
Fo rmulat ion
Type
D
D
D
D
D
D
D
D
D
D
D
D
D
102
-------
EPA Reg. Np_
769-355
Co. Name and Address
% Active
Ingredient
1202-273
1526-442
2749-186
2792-42
2792-43
2935-402
2935-403
7501-28
Woolfolk Chem. Works, Inc
P.O. Box 938
Ft. Valley, Ga. 31030
A «
6.0%
Puregro Company
1276 Halyard Drive
W. Sacramento, Ca,
95691
Arizona Agrochemical Co
Chemical Distributors
P.O. Box 21537
Phoenix, Az 85036
Aceto Chemical Co.,
Agriculture Div-
126-02 Northern Blvd
Flushing, NY 11368
Inc.
Decco-Tilbelt
Pennwalt Corp
P.O. Box 120
Monrovia, Ca
do
Division
91016
Wilbur Ellis Co.
191 W. Shaw Ave. Suite
Fresno, Ca 93704
do
Gustafson, Inc..
P.O. Box 220065
Dallas, Tx 75222
6.0%
6.0%
75.0%
107
48.8%
2.0%
6.0%
6.0%
30.0%
Attachment B
(continued)
Formulat ion
Type
D
769-356
769-358
769-395
1023-19
1023-35
1023-36
1023-39
1023-40
1023-41
1023-42
1023-43
1023-49
1023-57
do
do
do
Up j ohn Co .
Tuco Division
7171 Portage Rd .
Kalamazoo, Mi 49001
do
do
do
do
do
do
do
do
do
6.0%
6.0%
75.0%
8.0%
6.0%
75.0%
12.0%
15.0%
10.0%
4.0%
90.0%
30.0%
95.0%
D
D
WP
D
D
WP
D
D
D
D
MP
D
TP
D
WP
WP
EC
D
D
FC
103
-------
Attachment B
(cont i nue d )
% Active Formulation
EPA Reg. No. Co. Name and Address Ingredient Type
8764-7 FMC Corp. 0.5% L
Citrus Machinery Div.
P.O. Box 4800
6446 Fremont Ave.
Riverside Ca. 92504
8764-14- do 9.0% EC
8764-15 do 3.0% L
11169-1 San Joaquin Sulphur Co. 6.0% D
P.O. Box 127 •
Lodi, Ca 95240
11169-2 do 6.0% D
34704-182 Platte Chemical Co. 6.0% D
150 South Main
Fremont, Ne 68025
104
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