GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CAPTAFOL
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER 116
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D. C. 20460
September 28, 1984
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279S1
TABLE OF CONTENTS
Introduction
I. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 35a
III. Requirement for Submission of Product-Specific data 59
IV. Submission of Revised Labeling and Packaging Information . . 64
A. Label Contents 64
1. Product Name 64
2. Company Name and Address 64
3. Net Contents 64
4. Product Registration Number 65
5. Producing Establishment
Registration Number 65
6A Ingredient Statement 65
6B Pounds Per Gallon Statement 65
7. Front Panel Precautionary Statements 65
7A Child Hazard Warning Statements 66
7B Signal Word 66
7C Skull and Crossbones and Word Poison 66
7D Statement of Practical Treatment 66
7E Referral Statement 66
8. Side/Back Panel Precautionary Labeling 66
8A Hazard to Humans and Domestic Animals 67
8B Environmental Hazard 67
8C Physical or Chemical Hazard 67
9 Misuse Statement 68
10A Storage and Disposal Block 68
10B Directions for Use 68
B. Collateral Information 68
V. Instructions for Submission 69
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APPENDICES
Page
II-l Bibliography (Including Guide for Use 70
II-2 FIFPA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 85
II-3 Certification of Attempt to Enter Into an Agreement with
Other Registrants for Development of Data, EPA Form 8580-6 . . 86
III-l Product Specific Data Report 87
IV-1 Labeling Requirements and Use Classification (40 CFR $162.10
and 40 CFR §162.11) 88
IV-2 Table of Labeling Requirements and Sample Labels 97
17-3 Physical/Chemical Hazards Labeling Statement 101
IV-4 Storage and Disposal Instructions 102
11
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA
Section 3(g)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, EPA has established the
Registration Standards program which will review all pesticide 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 avail-
able 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 necesssary to protect the public.
EPA has the authority under FIFRA §3(c)(2)(B) to require that
certain registrants submit 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 within 90 days of receipt of
this Guidance Document. The chart on the followina 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 reauest the Aaency 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 reaistered
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 Union Carbide Agricultural Products Co., Inc
v. Ruckelshaus, EPA was recently enjoined from implementing in
any way the "mandatory data licensing" aspects of section
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 the Guidance Document which do not
relate to compliance with the section 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 a Notice of intent to cancel the affected product
registration(s).
Registrants are reminded that S6(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 unreasonable 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 Forraulator'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 wills.not be _.-----
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as descritfj^ 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
recuirements in I-A and B.
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I. REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory position of the
Environmental Protection Agency (EPA) on cis-N-[1,1,2,2-tetrachloroethyl)thio] -
4-cyclohexene-l,2-dicarboximide (captafol), based on an evaluation of the
single registered manufacturing-use product (MOP), and certain end-use
products (EOPs) containing captafol as the sole ingredient. Labeling requirements,!
tolerances, special local needs registrations authorized by Section 24c of the
FIFRA, as well as registrations under Section 3 of FIFRA were considered in
this analysis. The Agency sets forth the data requirements that must be
met to register or reregister products, covered by this Standard.
This Standard addresses registration reouirements for current and future
MOPs and labeling requirements for EUPs. Captafol MOPs that differ appreciably
from the one described here may require amendments to this Standard. Also,
use-patterns that differ from those described here may also require amendments
to this Standard.
B. DESCRIPTION OF CHEMICAL
Captafol is the acceptable common name for cis-N-[(1,1,2,2-tetrachloro-
ethyl) thio]-4-cyclohexene-l,2-dicarboximide and is recognized by
the American National Standards Institute. Trade names for captafol are
Difolatan and Poleid. Other names include Haipen, Merpafol Ortho 5865,
Sanspor and Sulfemmide.
There is only one (1) EPA registered captafol MOP that may be used in
the manufacturing of end-use pesticide products. The Office of Pesticide
Programs Internal Control Number (EPA Shaughnessy Number) for captafol is
081701, and its CAS Number is 2425-06-1.
Captafol has the following identifying characteristics:
Empirical Formula:
Molecular Weioht: 349.1
Structural Formula:
a®
I i
NSC-C-H
a ci
Color: White
Physical state: Crystalline solid
Odor: Slightly characeristic fumigant odor.
Melting Point: 159-161°C (162°C, pure comDound)
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Solubility: Insoluble in water, very low solubility in aliphatic hydrocarbon
solvents. At 77°C, soluble at 2.5 g/LOO ml in isopropanol; at
24°C, soluble at 42.8 g/100 ml in toluene.
Stability: Stable under environmental conditions. Decomposes slowly at
melting point. Very slight hydrolytic decomposition in acid or
neutral pH at ambient temperature. Strong sodium and potassium
hydroxide solutions may cause spontaneous ignition of concentrate
forms, m neutral or weakly basic solution, captafol slowly
decomposes, the rate depending upon pH and temperature, being
very slow below 7.0 and rapid above 9.0.
Captafol is a broad spectrum fungicide which is registered with the EPA
for use in the control of foliar diseases of fruits and vegetables. It is
also registered for application to foliage of peanuts, seeds of corn, cotton,
peanuts, rice, and sorghum, to pineapple planting stock as a preplant treatment
and to wood as a preservative. End-use products (EUPs) that have captafol
as an active ingredient may be applied as either a spray or as a dust. As a
wood preservative it is applied as an aqueous suspension under pressure.
Captafol may be applied in combination with other fungicides and insecticides
but not with oil sprays or alkaline products such as hydra ted lime.
Captafol fungicidal activity is resistant to ultraviolet radiation. In
tests with selected fungi, exposure to ultraviolet radiation for 18 hours did
not significantly effect its fungicidal activity (W. D. Thomas, Phytopathology:
Vol 56: 151-152). In field tests captafol had an average persistence on 12
plant species of 5.6 weeks (D. Neely, Phytophathology: Vol. 60: 1583-1586).
Laboratory studies have demonstrated that captafol may move across plant
cuticle (Z. Sobel and L. V. Edgington, Phytopathology: Vol. 63: 505-510).
Captafol is manufactured as a 97% technical solely by Chevron Chemical
Company. It is in 16 EPA registered products under Section 3 of FIFRA as
amended September 30, 1978, and in 19 products under 24 (c) of the Act.
These products range from 25 to 80 percent wettable powders, from 35 to 65
percent dusts, and as 27 or 39 percent flowable. There is also an 80.0 %
water dispersible granular formulation.
C. REGULATORY POSITION AND RATIONALE
Based on a review and evaluation of all available data and other relevant
information on captafol, the Agency has made the following determinations:
1. Captafol is placed under Special Review because it has oncogenic
potential and is very highly toxic to fish. A Notice announcing
the Agency's decision to initiate a Special Review will be published
in the Federal Register. The Agency will not consider for re-
registration any currently registered product containing captafol
as a sole active ingredient until the Special Review has been con-
cluded. However, currently registered products will remain registered
while the Special Review is in process.
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Rationale: Captafol has met the risk criterion for oncocrenicity
in S162.11 (a) of Title 40 (CFR). Toxicology studies have shown
that captafol has an oncogenic potential in rats and mice.
Dietary exposure to captafol has induced dose-related tumors in mice
and rats.
Captafol is "very highly toxic" to fish (96-hour LCso for rainbow
trout is 21 parts per billion (ppb)). Reports of fish kills
involving application to cranberries identified hazards to non-
target organisms (criteria are met or exceeded as specified in
5162.11 (3) (ii) (C) and §162.11 (3) (i) (3)). Under registered
use patterns, after direct application to a 6-inch layer of water,
the use of captafol may result in a maximum calculated concentration
of more that 1/2 the acute ££50 for aquatic organisms representative
of the organisms likely to be exposed (as measured on test animals
specified in the Registration Guidelines). Application rates could
result in 2,200 ppb to 9,190 ppb in 1/2 acre foot of water, thus the
criteria may be exceeded. Hence, Special Review is necessary to
fully evaluate and determine the extent of the risk involved.
Captafol is hereby classified as a "Restricted Use" pesticide;
therefore, it is only for sale to and use by Certified Applicators
or persons under the direct supervision of a Certified Applicator.
Rationale: Based on surrogate data, risk estimates indicate that
an unreasonable risk may exist for farm workers exposed to captafol
while mixinq and/or loading and applyina captafol. Dietary risk
may exist for the general population via consumption of agricultural
commodities treated with captafol. To reduce the risk while the
Special Review is in process, the Agency is imposing certain interim
measures by restricting captafol use and reouiring label amendments.
The Agency is requiring that certain data be submitted on an ex-
pedited basis. These data include the following:
a. Residue Chemistry data as specified in the data tables under
5158.125.
b. Environmental Chemistry as specified in the data tables under
5158.130.
c. Toxicology as specified in the data tables under S158.135.
d. Toxicology exposure data as specified in the data tables under
5158.130.
Rationale: The Agency is concerned about captafol's oncogenic
potential and needs the data mentioned above to complete the Special
Review. In addition, in reference to residue chemistry data, a
review of these data indicate that the data are inadequate to
support registration of seed, seed-piece and other plant propagule
uses as non-food and non-feed uses. Data requirements to support
these uses are listed in Table A and B.
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The available environmental fate data are insufficient to fully
assess the potential for exposure of humans and non-target
organisms to captafol. When the required studies under §158.130
are submitted, a complete environmental exposure assessment can
be made.
4. An interim 24-hour reentry interval has been imposed for the
the agricultural uses of captafol until adequate data have
been submitted as specified in Table A, Section 158.130,
Subpart K, Re-entry.
Rationale: Captafol meets the criteria of 40 CFR, Section 158.140.
Yet, there are no data to estimate reentrv exposure to workers
entering areas treated with captafol. Given that captafol has
oncogenic potential, the Agency has set an interim time interval of
24 hours to caution any worker from reenterina the treated areas
without protective clothing. The data gap requires the submission
of captafol reentry data in accordance with 40 CFR Parts 158..140
(Reentry Protection Data Requirements). When data are submitted, the
Agency will reevaluate this restriction.
5. The Agency is requiring the following studies:
a. Environmental Chemistry data as specified in the data tables
under $158.130.
b. Product Chemistry data as specified in the data tables under
S158.120.
Rationale: There are inadequate data to conclude that captafol is
not a ground water problem. Metabolites and degradates in soil have
not been adequately studied. Mobility and the fate of the metabolites
and degradates are required on an expedited basis. The Agency
is concerned about surface water and the possible ground water
contamination by captafol. In order to characterize the potential
for captafol to enter ground water, the Agency needs the studies
mentioned above. For example, the available product chemistry
data are insufficient to fullv assess the chemical at this time.
When the required chemistry tests under S158.20 are submitted,
a complete product chemistry evaluation can be made.
%
6. Acute toxicity studies on estuarine and marine organisms are required
under this Standard. Data from fish early life stage studies,
aquatic invertebrate life cycle studies, aquatic oraanisms accumulation
and simulated or actual field testina with aquatic organisms may be
required for Special Review pending results from environmental
fate studies. Both the needed environmental fate data and the above
mentioned data are to be submitted on a expedited basis.
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Rationale: The Agency is concerned about the fish toxicity and
toxic effects to estuarine and marine organisms, because captafol
is very highly toxic to fish. The available environmental fate data
are insufficient to fully assess the potential for exposure of
humans and non-target organisms to captafol. When the required studies
under 40 CFR 5158.130 are submitted, a complete environmental exposure
assessment can be made.
There are insufficient data to characterize the acute and chronic
toxic effects of captafol on aquatic invertebrates. Toxicity data
are needed for assessing the hazards to aquatic invertebrates.
7. Product labeling must be revised to include a statement concerning
tumors, a requirement to use protective clothing and a restricted
use statement. In addition, all end-use products intended for
crop use, except seed uses and plant propaqule treatments, must
bear labeling restrictions for crop rotation and for reentering
treated areas. (Refer to Section F, Required Labeling.)
Rationale: To reduce risk from captafol's oncogenic potential and
its toxicity to fish, and to maintain existing registrations,
registrants must take certain interim measures by revising product
labeling as specified in Section F.
8. Manufacturing-use pesticide products containing captafol as a sole
active ingredient may be registered for sale, distribution, reform-
ulation, and use, subject to the terms and conditions specified in
this Standard. Registrants must provide or agree to develop
additional data, as specified in the tables, in order to maintain
existing registrations or to permit new captafol reaistrations.
Rationale: Wider FIFRA, the Agency cannot cancel or withhold
registration simply because data are missing or inadequate (see
Section 3(c)(2)(b) and 3(c)(7) of FIFRA). Rather, issuance
of this Standard provides a mechanism for identifying data needs
and sets a timetable for generation of needed data. These data
will be reviewed and evaluated when they are received and the
Agency will determine at that time if they will affect the
registration of captafol products.
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D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
All products that contain captafol as the sole active ingredient are
subject to this standard and must bear required labeling and either comply
with the acute toxicity limits, product composition, and use patterns
requirements listed in Section E of this document, or submit data and
a justification to amend the standard to encompass such products.
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 97.0 percent captafol
as the sole active ingredient. Each manufacturing-use product must
be fully described with an approoriate certification of limits. In
addition, the active ingredient found in the manufacturing-use captafol
products must be substantially similar to that in the currently
registered technical product. Any manufacturing-use product not
meeting these requirements will be considered a new product and will
require an amendment to the standard.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade and
manufacturing-use products containing captafol for acute toxicity
category I, provided that the labeling of those products bear
appropriate precautionary statements.
3. Use Patterns
To be registered under this standard, manufacturing-use products
containing captafol may be labeled for formulation only into end-use
products for use as a funqicide for foliar applications to fruits,
vegetables and peanuts, to seeds of corn, cotton, peanuts, rice,
sorqhum, to pineapple planting stock as a oreplant treatment, and to
wood as a preservative.
4. Labelinq of Existing Stocks
All captafol product labeling must reflect the required labelinq
as specified under Section F (which follows) within six months
after the date of this Standard.
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LABELING
All technical grade and manufacturing-use products and end-use product
(EDP's) must bear appropriate labeling as specified below and in 40
CFR §162.10. Other portions of this guidance package contain specific
information regarding labeling requirements. Required labeling must
be submitted within QQ days from the date of receipt of this Standard.
1. Precautionary statements to be used on labeling of all end-use captafol
products:
a. All end-use product labels must reflect the following statements:
RESTRICTED USE PESTICIDE. For retail sale to, and use only by
Certified Applicators or persons under their direct supervision
and only for those uses covered by the Certified Applicator's
certification. "This product is classified as a "Restricted Use
Pesticide because it contains captafol which has been determined
to cause tumors in laboratory animals."
Exposure to captafol during mixing, loading, and application may
be hazardous to your health.
This product contains captafol which has been determined to
cause tumors in laboratory animalsT
b. All end-use products must have the labeling claim under "Direction
for Use": "Wear impervious gloves, full body clothing during handling
and application.
c. All end-use products intended for crop use, except seed, seed
piece, and plant propagule treatments must bear the following
use restrictions:
i Do not rotate treated crop with crops other than those
with registered captafol uses.
ii Do not allow persons to enter treated areas within 24 hours
following application unless protective clothinq is worn.
Conspicuously post reentry information at site of application.
iii Do not use captafol-treated rice seed in fields subsequently
to be used for agricultural crops other than those with
with registerd captafol uses.
iiii Water from cranberry bogs, wetland taro fields (foliarly
treated with captafol) and rice fields planted with
captafol-treated rice seed must not be used for irrigation
of crops other than those with registered captafol uses.
2. For end use products that bear labeling for use in greenhouses:
a. Only the applicator is permitted to be in the greenhouse during appli-
cation of captafol to soil. Open vents to greenhouse during
application and at least 1 hour after application.
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b. Workers plantinq in captafol treated soil in greenhouse must
wear impervious gloves and full body clothing.
3. All products, manufacturing-use and end-use must bear the labeling
precautionary statements:
DANGER
Causes irreversible eye damage. Harmful if swallowed or inhaled.
May cause allergic skin reactions. Do not get in eyes. Wear goggles
or face shield when handling. Avoid contact with skin and clothing.
Remove and separately launder clothing before reuse.
This product contains captafol which has been determined to cause
tumors in laboratory animals.
In addition, the following specific environmental hazard labeling requirements
apply to either technical, manufacturing-use and end-use product as indicated.
a. All technical and MUP's must bear the following precautionary
statements:
This pesticide is extremely toxic to fish. DO not
discharge into lakes, streams, ponds, or public waters
unless in accordance with NPDES permit. For guidance contact
your Regional Office of the Environmental Protection Agency.
Do not discharge effluent containing cptafol into sewage systems
without obtaining permission from the sewage treatment authority.
b. All EUP's that allow foliar applications except foliar applications
to cranberries must bear the hazard precaution:
This pesticide is extremely toxic to fish. Do not apply
directly to water. Drift and runoff from treated areas may be
hazardous to aquatic organisms in neighboring areas. Do not
contaminate water by cleaning of equipment or disposal of wastes.
c. All EUP's that allow foliar application to cranberries must bear the
following environmental hazard precautions:
This pesticide is extremely toxic to fish. Fish may
be killed at recommendated application rates. Drift and
runoff from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate water
by cleaning of equipment or disposal of wastes.
d. All EUP's that allow seed treatment must bear the following
environmental hazard precaution:
This pesticide is extremely toxic to fish. Do not
contaminate water by cleaning of equipment or disposal
of wastes.
4. Both MUP's and EUP's may need special labeling to protect endangered
species. This will be determined after the required environmental
chemistry data are reviewed, and in coniunction with EPA's evaluation
of the potential risk of hazards to endangered species.
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G. Tolerance Reassessment
1. Non-Seed Applications
The established tolerances for captafol are presently expressed as the
fungicide captafol cis-N- [Cl, 1,2,2-tetrachloroethyl) thio] -4-cyclohexene-l, 2-
dicarboximide without specifying the metabolites. The following metabolites
have been identified in plants:
delta4-tetrahdyrophthalimide (II), phthalimide (III), 4,5-epoxyhexahydro-
phthalimide (3V), 4,5-dihydroxyhexahydrophthalimide (V), 3,hydroxy-delta4
tetrahydrophthalimide (VI), 5-hydroxy-delta3-tetrahydrophthalimide (VII), delta4
tetrahydrophthalamic acid (VIII), delta4-tetrahydrophthalic acid (IX), and
dichloroacetic acid (XIII).
The following table lists the present status for tolerances in parts per
million for residues of captafol.
Raw Agricultural Commodity
Parts Per Million in Captafol Residues
D.S. Canada Mexico Codex
Apples
Apricots
Blueberries
Cherries, sour
Cherries, sweet
Citrus fruits
Corn, Fresh (sweet K+CWHR)
Cranberries
Cucumbers
Madadamia nuts
Melons
Nectarines
Peanuts, hulls
Peanuts, meats (hulls removed)
Onions
Peaches
Pineapples
Plums (fresh prunes)
Potatoes
Taro (corn)
Tomatoes
Carrots
0.25
30.0
35.0
50.0
2.0
0.5
O.l(N)
8.0
2.0
O.l(N)
5.0
2.0
2.0
0.05
O.l(N)
30.0
O.l(N)
2.0
0.5
0.02
15.0
O.l(N) —
0.5
— —
10.0
2.0 —
— —
— —
— —
2.0 —
— —
2.0 —
— —
— —
— —
O.l(N) —
15.0
— —
0.2 —
O.l(N) —
— —
5.0 —
5.0
15.0
—
10.0
2.0
—
—
8.0
2.0
O.l(N)
2.0
—
— *
0.05
0.5
15.0
10.0
10.0
0.5
—
5.0
0.5
*Codex MRL for whole peanuts is 0.5 ppm.
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2. Seed Applications:
No tolerances have been established for captafol residues in or on any
crop for which captafol is registered solely for seed treatment, because
heretofore seed treatment uses have been considered to be nonfood uses. These
crops include: corn (field)/ cotton, peanuts, rice, sorghum (grain and forage).
3. Plant Metabolism:
Available plant metabolism data are not adequate to support the established
tolerances. Quantification and identification of captafol and its metabolites
were performed in only two studies, in each case only 7 days after last
treatment. One of the studies was with immature tomato plants. As indicated
in Table A, additional data must be submitted to qualify and identify residues
of captafol and its metabolites in three representative mature crops for
which use of captafol is registered.
Future tolerances and existing tolerances must be amended to include delta^-
tetrahydrophthalimide (THPI). Results of the required plant metabolism
studies may identify other metabolites of concern.
4. Animal Metabolism:
The metabolism of captafol in ruminants is adequately understood. The
available data on metabolism of captafol in poultry is inadequate, and therefore
residues in poultry eggs, fat, meat and meat by-products can not be assessed.
As in Table A, additional data must be submitted.
5. Analytical Methods for Residues:
Adequate gas chromatography methods are available for studies on residues
of captafol in or on raw agricultural commodities or processed food or feed
commodities on which tolerances are established. Method trials as indicated
in Table A must be conducted to evaluate methods to determine THPI, 3-OH
THPI, and 5-OH THPI in animal products, and THPI in plant commodities.
6. Storage Stability:
The storage stability of captafol residues in or on animal and plant
samples is not adequately understood. Data are needed on the stability of
captafol and its tetrahydrophthalmide metabolite in representative crops,
such as apples, cherries, citrus, potatoes, tomatoes and sweet corn, and in
or on animal products (meat, milk, eggs) stored at subfreezing temperatures
for intervals approximating the storage intervals of treated samples, in
order to determine the magnitude of the residues.
7. Tolerances Needed to Allow Continued Registration of Uses:
a. Use in Propagation of Strawberry Plants
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There are no available data to support a nonfood use classification for the
use of captafol formulations on strawberries, i.e., it has not been demonstrated
that no dectectable residues will be found in or on strawberries harvested
from daughter plants which were produced from treated mother plants. Residues
of the captafol metabolite THPI are readily absorbed by plants (refer to
Nature of the Residue in Plants section). The metabolism of captafol in
plants is not adequately understood. As a result, the captafol tolerance
expression must be reevaluated upon receipt of the required plant metabolism
data. If residues other than intact captafol and THPI are determined to be
of concern, additional residue data for such metabolites in or on strawberries
may be required.
The following data are required at the present time: Residues of captafol
per se and its THPI metabolite in or on strawberries produced on daughter
plants originating from propagating plants which were treated (in the propagation
beds) at 7-day intervals beginning May 1 with the 4 Ib/gal FIG formulation
at 3 Ib ai/A.
Upon receipt of the above data, a decision will be made as to the appro-
priateness of the nonfood classification of this use, and whether a tolerance is
required. Alternatively, the registrant may cancel this 24(c) registration.
b. Use on Pear Trees as a Delayed Dormant to Green Tip Stages
An intrastate label has been issued by the state of New York (NY Reg.
No. 038655-10453) for use of the 4 Ib/gal F1C at 5 Ib ai/LOO gal during the
delayed dormant to green tip stages.
Data are not available for the use of captafol formulations on pear
trees nor has a tolerance been established for captafol residues in or on
pears. A tolerance must be proposed and the necessary data submitted, or
the intrastate label cancelled.
If the registrant wishes to maintain the active status of the intrastate
label, then the following data must be submitted, as well as a tolerance
proposal:
Residue of captafol per se and THPI in or ripe pears (or at the stage
harvested for storage) following application of the 4 Ib/gal F1C at 5 Ib
ai/100 gal during the green tip stage. The number of gallons applied per
acre must be specified and must be conducted in New York. Alternatively,
the label may be cancelled.
c. Use on Sugarcane Propagules.
A Florida state [24(c)l label for the 4 Ib/gal F1C formulation (FL760012)
is registered for seed-piece treatment at 500 ppm ai in water as a 20 minute
dip or at 12,500 ppm ai in water as a spray.
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Conclusions;
Seed treatments with captafol have been considered non-food uses. However,
available plant metabolism data indicate that residues of captafol may be
taken up into mature plants from treated seed. Therefore seed-piece treatments
are uses for which residue data and tolerance proposals must be submitted.
Captafol and its metabolite THPI are the residues of concern in plants;
however, the nature of the residue in plants is not adequately understood.
Should the required plant metabolism data indicate additional metabolites of
concern, then additional data and tolerance proposals for these metabolites
will be required. The following data are required:
Data reflecting residues of captafol and THPI in or on cane and forage
grown from seed pieces sprayed with a 12,500 ppm ai water suspension of the
4 Ib/gal F1C formulation. Forage must be collected at intervals throughout
the growing season or until residues are no longer dectectable. This is
necessary to determine appropriate pregrazing or prefceding intervals. If
detectable residues occur in mature cane, then processing studies must be
completed to determine whether residues concentrate in molasses, refined
sugar and bagasse. Tolerances must be proposed for cane and forage. Also,
if residues concentrate in processed products, appropriate food/feed additive
tolerances must be proposed. Tests must be conducted in sugarcane production
areas of Florida.
Processing studies, if needed, should utilize cane bearing measurable
weathered residues. The registrant may wish to propose label feeding and/or
grazing restrictions in lieu of submitting residue data for forage.
d. Use as a Seed Treatment for Cotton, Field Corn, Rice and Sorghums
A 4 Ib/gal EC formulation is registered for seed treatments to acid
delinted cottonseed at 0.094 Ib ai/100 Ib of seed, machine delinted cottonseed
at 0.141 Ib ai/100 Ib of seed, and to rice at 0.125-0.188 Ib ai/100 Ib of
seed. A 70% WP formulation is registered for seed treatments to field corn
at 0.47 oz ai/bushel or 0.875 Oz ai/100 Ib of seed, and to sorghum at 2.1 ozs.
ai/100 Ib of seed.
Heretofore, seed treatments with captafol have been considered non-food
uses. However, available plant metabolism data (refer to Nature of the
Residue in Plants section) indicate that residues of captafol may be taken up
into mature plants from treated seed. Therefore seed treatments are uses
for which residue data and tolerance proposals must be submitted. The nature
of the residue in plants is not adequately understood. If the required plant
metabolism data indicate additional metabolites of concern, additional residue
data and tolerance proposals for these metabolites will be required.
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The following data are required: Data reflecting residues of captafol and
THPI in or on cottonseed and forage grown from machine delinted seed treated
with the 4 Ib/gal F1C formulation at 0.141 Ib ai/100 Ib of seed, and from
acid delinted seed treated at 0.094 Ib ai/100 Ib of seed.
Forage samples must be collected at intervals throughout the growing
season or until residues are no longer detectable. This is necessary to
determine appropriate pregrazing or prefeeding intervals. If detectable
residues occur in seed, then processing studies must be completed to determine
whether residues concentrate in meal, hulls, soapstock and crude and refined
oil. Tolerances must be proposed for cottonseed and forage. Also, if residues
concentrate in processed products, appropriate food/feed additive tolerances
must be proposed. Test sites should include California and Texas which produced
22% and 38%, respectively, of the U.S. cottonseed crop in 1981 (preliminary
figures; Agricultural Statistics, 1982, p. 114).
Data are required reflecting residues of captafol and THPI in or on
field corn grain, forage, silage, and fodder grown fron seed treated with
the 70% WP formulation at 0.875 oz ai/100 Ib of seed. Forage and silage
samples must be collected at intervals throughout the growing season or
until residues are no longer detectable. If detectable residues occur in
grain, then processing studies must be completed to determine whether residues
concentrate in milled products and crude and refined oil. Tolerances must
be proposed for corn grain, forage, silage and fodder. Also, if residues
concentrate in processed products, appropriate food additive tolerances must
be proposed. Tests should be conducted in Illinois or Iowa which produced
13% or 17%, respectively, of the 1981 field corn crop (preliminary figures;
Agricultural Statistics, 1982, p. 32).
Data are needed reflecting residues of captafol and THPI in or on rice
grain and straw grown from seed treated with the 4 Ib/gal EC formulation at
0.188 Ib ai/100 Ib of seed. If detectable residues occur in grain, then
processing studies must be completed to determine whether residues concentrate
in polished rice, hulls, or milled products. Tolerances must be proposed
for rice grain and straw. Also, if residues concentrate in processed products,
appropriate food/feed additive tolerances must be proposed. Tests should be
conducted in Arizona and California which produced 37% and 23%, respectively,
of the O.S. rice crop in 1981 (preliminary figures; Agricultural Statistics,
1982, p. 21).
Data are required reflecting residues of captafol and THPI in or on
sorghum grain, forage, fodder, silage, and hay grown from seed treated with
the 70% WP formulation at 2.1 oz ai/100 Ib of seed. Forage, silage, and hay
samples must be taken at intervals throughout the growing season or until
residues are no longer detectable. If detectable residues occur in or on
grain, then processing studies must be completed to determine whether residues
concentrate in flour or milled products. Tolerances must be proposed for
sorghum grain, forage, fodder, silage, and hay. Also, if residues concentrate
in processed products, appropriate food additive tolerances must be proposed.
Tests should be conducted in Kansas and Texas which produced 27% and 31%,
respectively, of the D.S. sorghum corp in 1981 (preliminary figures; Agricultural
Statistics, 1982, p. 52).
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All processing studies should utilize raw agricultural commodities
bearing measurable weathered residues. The registrant may wish to propose
label feeding and/or grazing restrictions in lieu of submitting residue data
for forage, fodder, silage, hay or straw.
e. Tolerance for Residues of Captafol in Meat, Milk, Poultry or Eggs.
The maximum expected dietary intake of residues of captafol by beef
cattle would be 7.1 ppm if the diet consisted of 20% wet citrus pulp, 5% peanut
hulls, 30% potato culls, 20% wet tomato pomace, and 25% dry tomato pomace
should the pending tolerances (PP#7F1962/FAP#7H5166) for soybean hulls (3
ppm), hay (45 ppm) and forage (15 ppm) be established, the maximum expected
intake would be 15 ppm based on a diet consisting of 5% peanut hulls, 20% wet
tomato pomace, 25% dry tomato pomace, 20% soybean hulls, 10% soybean hay and
20% soybean forage. The maximum expected dietary intake of residues of
captafol by dairy cattle would be 5.6 ppm if the diet consisted of 25% dehydrated
citrus pulp, 10% wet citrus pulp, 30% cull potatoes, 10% wet tomato pomace,
and 25% dry tomato pomace: should the pending tolerances for soybean hav and
forage be established, the maximum intake would be 27 cpn based on a diet
consisting of 20% dry tomato pomace, 40% soybean hay, and 40% soybean forage.
The maximum expected dietary intake of residues of captafol by turkeys and
broilers would be 0.5 ppm if the diet included 5% dehydrated apple pomace,
10% peanut meal, 5% peanut soapstock, 7% potato culls, and 3% wet tomato
pomace. Should (after Special Review has been completed) the pending
tolerance for soybeans (1 ppm) be established, the maxium expected
intake would be 1.1 ppm based on a diet which includes 20% soybean seed,
30% soybean meal and 5% soybean soapstock in addition to
the feed items listed above. The maximum expected dietary intake of residues
of captafol by laying hens would be 0.4 ppm if the diet included 10% peanut
meal, 5% peanut soapstock, 5% pineapple bran, 20% potato culls and 2% wet
tomato pomace? should the pending tolerance for soybeans be established, the
maximum expected intake would be 1.2 ppm based on a diet consisting of 3%
pineapple bran, 20% potato culls, 2% wet tomato pomace, 50% soybean seed, 20%
soybean meal, and 5% soybean soapstock. The maximum expected dietary intake
of residues of captafol by swine is 1.8 ppm based on a diet consisting of 1%
dyhydrated citrus pulp, 10% wet citrus pulp, 9% peanut meal, 20% pineapple
bran, 50% potato culls and 10% wet tomato pomace; should the pending tolerances
for soybeans and soybean hulls be established, the maximum expected intake
would be 2.4 ppm if the diet consisted of 35% cull potatoes, 10% wet tomato
pomace, 20% soybean seed, 20% soybean meal, 10% soybean hulls and 5% soybean
soapstock.
The metabolism of captafol in ruminants (including milk) is adequately
understood. The metabolism of captafol in poultry is not adequately understood
due to the inadequacy of the available metabolism study. The established and
pending tolerances for captafol per se must be changed to reflect combined
residues of captafol and its metabolite THPI. It is likelv that such actions
will result in increases in the magnitude of established tolerances for feed
items. Such tolerance level increases would result in corresponding increases
in the maximum expected dietary intake of residues of concern (captafol and
THPI) by cattle, poultry and swine.
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The following data requirements are based on presently established tolerances
for residues of captafol in feed items: however, the petitioner should note
that if the feed item tolerances are altered in the future to include residues
of the metabolite THPI, then feeding studies reflecting the transfer of THPI
at maximum expected dietary levels to meat, milk, poultry and eggs will be
required. In addition, establishment of the soybean tolerances would significantly
increase required feeding levels. Since the metabolites of concern in poultry,
eggs, meat, and milk have not been delineated at the present time, data are
required reflecting residues of the parent and the metabolites THPI, PI,
3-CH THPI, and 5-OH THPI. The following data are required:
Cattle (> three cows/dosing level) must be dosed with 7, 21, and 70 ppm of
captafol in the total diet until residues plateau in milk, or for 4 weeks if
no residues are detected in milk. Milk must be sampled twice daily. Animals
must be slaughtered within 24 hours of the final dose and residues (see
above) determined in muscle, liver, kidney and fat as well as milk.
Poultry (>10 hens/dosing level) must be dosed with D.5, 1.5, and 5 ppm
of captafol in the total diet until residues plateau in eogs, or for 4 weeks
if no residues are detected in eaas. Egg samples should be taken twice
daily. Animals must be sacrificed within 24 hours of the final dose and
residues (see above) determined in muscle, liver, fat, skin, and gizzard
as well as eggs.
As the available metabolism studies (refer to Nature of the Residues in
Animals) have shown that there is a reasonable expectation of residues in
meat, fat, and meat by-products of cattle, goats, hogs, horses, and sheep, in
milk of cattle and goats, and in meat, meat by-products and fat of poultry,
category 3 of 40 CFR 180.6(a) does not apply. Thus tolerances must be
proposed, based on the above-required data, for these animal products. In
addition, should the required metabolism and/or residue data indicate a
reasonable expectation of residues in eggs, then a tolerance proposal for
eggs will also be required.
f. Regulatory Concern for Residues of Captafo]3/:
Residues of captafol have been detected in or on samples of domestic
fish. This commodity does not currently have established tolerances for
captafol residues. It is not known whether the residues of captafol
in or on this commodity are due to illegal use of captafol products
or contamination. Additional residue monitoring is required to determine
the cause of these illegal residues.
•»
8. Tolerance Reassessment Summary:
Sufficient data are available to determine that the currently established
tolerances for residues of captafol in or on the following commodities are
adequate: apricots, blueberries, cranberries, macadamia nuts, nectarines,
a/ The Agency is concerned about illegal residues in imported beans and
~~ imported strawberries and will consult with the PDA on this issue.
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peaches, peanut hulls, and taro conns (40 CFR 180.267). However, additional
data concerning residues of metabolite THPI must be submitted for the these
commodities since the residues of concern in or on plants have recently been
modified to include THPI. In addition to THPI data, other residue data are
required to support the tolerances for captafol in or on the following
commodities: apples, citrus fruits, corn (sweet), cucumbers, melons, onions,
peanuts, pineapples, plums (prunes), potatoes, and tomatoes. THPI data and
tolerance changes must be submitted for sweet and sour cherries. Residue
data and tolerance proposals must be submitted for the following commodities:
crops receiving only seed treatments (cotton, field corn, rice, and sorghum),
pears (state label use only), strawberries [propagating bed use: Section
24(c)l, sugarcane (seed piece use), and taro foliage. Tolerances for the
following commodities are pending: carrots, coffee beans, pecans, soybeans,
and soybean forage and hay. Plant metabolism of captafol is not adequately
understood, therefore residues other than captafol and THPI may need to be
sought if deemed to be of concern. The metabolites of concern in animal
products are the parent compound, THPI, 3-OH THPI, and -OH THPI. Additional
data are required for poultry metabolism. Also, feeding studies are required
for ruminants and poultry. Additional storage stability data are necessary
to validate the residue data. No crop group tolerances may be established
based on the available data.
The TT1RC is 1.4579 mg/day based on a 1.5-kg diet. The chancres in the
residue definition, the requested tolerance proposals and the pending tolerances
noted above will all affect a chancre in the TMPC level. The data requirements
to support established tolerances as listed in 40 CFR 180.267 are given in
Table A.
The Maximum Permissible Intake (MPI) for a 60 kg person is 1.68 mg/day
based on an Acceptable Daily Intake (ADI) of 0.028 mg/kg- The present
TMRC represents 86.8% of the MPI. The inclusion of the major metabolite
(THPI) in the tolerance expression may result in an increase in the TMRC
and a greater percentage of the MPI utilized.
The ADI for captafol is based on a chronic toxicity study in rats. A
NOEL was established at 56 ppm for non-oncogenic effects. In that study
the next highest dose level caused cholangiectasis in liver, increase
in hyperplasia of tubule epithelium, megaiocytic cells and
transtional cell hyperplasia in kidney, increased erosion/ulceration
hyperkertosis/acanthosis, ground substance in glandular mucosa, and dilated
pits in stomach. The reported dosage level was corrected from 75 ppm to
56 ppm based on the instability of captafol in the diet. In rat 56 pan
is approximately equivalent to 2.8 mgAa« Using a safety factor of 100
and a NOEL of 2.8 ma/kg/day, the ADI would be 0.028 mg/kcr for man.
The only registrant of technical captafol, Chevron Chemical Company, has
been requested to complete the histopathology examination of the low
and mid-dose liver and mammary aland tissues; therefore, the NOEL
may change. The NOEL of 56 ppm is for systemic effects excluding
the issue of oncogenicity for which a risk assessment will be performed.
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Use Pattern Statement
Captafol may only be used for formation into products intended for those
uses listed in F.3 above. For more detailed use-pattern information on all
registered uses of captafol (both single active and multiple active ingredient
products) refer to the EPA Compendium of Registered Pesticides, Volume II:
Fungicides and Nematicides, pp. C-09-95.01 to C-09-95.08 (Issue, Oct, 1974) and/or
DSE& Compilation of Registered Uses of Fungicides and Nematicides, pp. C-09-95.01
to C-09-95.11, (Issued Feb. 1, 1983), and /or EPA Index to Pesticide Chemicals
for captafol (Issued: Sept. 24, 1981).
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H. PRELIMINARY ANALYSIS OF CURRENT BENEFITS AND RISKS
1. Current Benefits Review
a. Introduction
The Agency has completed a preliminary review of benefits for
the major use sites for captafol. The following information
will be expanded during the Special Review.
b. Use Sites
Captafol is used as a non-systemic protectant fungicide that
has a broad spectrum of activity. It has a high level of
persistance on foliage and is apparently redistributed on
leaf surfaces by rain. This persistence allows the growers
of certain crops to choose between applications of captafol
at minimum rates using frequent intervals or higher rates
using less frequent intervals. It may be combined with
commonly used fungicides and insecticides, with the exception
of strongly alkaline materials and oil sprays.
Captafol is federally registered to control foliar diseases
of certain fruits and vegetables. The major sites are
citrus, potatoes, tomatoes, sweet corn, plums, watermelon,
apples, and cherries; nearly half of the usage is for the
last two crops. It is also federally registered for use on the
seed of corn, cotton, peanut, rice, and sorghum; peanut foliage;
cranberries; taro; pineapple planting stock; and in wood
preserving.
Approximately 4.5 to 5 million pounds are used per year.
Captafol is manufactured as a 97 percent technical by
Chevron Chemical Company. Osmose Wood Preserving Company,
Incorporated and the University of Hawaii, Cooperative Extension
Service also hold federal registrations. Currently, 16 products
are federally registered. There are 19 FIFRA section 24(c)
registrations. Formulations include 25 to 80 percent wettable
powders, 35 to 65 percent dusts, 27 or 39 percent flowable,
and 80 percent water dispensible granules. The 39 percent
flowable is the most widely used formulation for ground and
aerial applications and is used for wood preservation and
seed treatment.
c. Benefits on Apples
Captafol may only be applied to apples in the mid-western and
eastern states. It is applied by ground equipment to
control scab disease during the primary infection period.
The primary infection period is from the dormant to the
one-fourth green leaf stage of the apple tree. It is used as
a single application spray in place of multiple applications of
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alternative fungicides. Captafol generally is applied by an
airblast sprayer mounted on a truck or trailer. The spray volume
will vary according to the size of the trees. Plant protection
lasts until the blossom pink stage at the 12 pounds active
ingredient (Ib. ai.) rate dosage per acre or through blossom
petal fall of the 20 Ib. ai. per acre dosage. Infections
during the secondary infection period must be controlled by
other fungicides because of captafol's potential phytotoxicity
to fruit and leaves.
Captafol is used primarily in Michigan, New York, and
Pennsylvania. Use information indicate no captafol usage
in the western United States because labeling limits is use
to eastern and midwestern apples. Several fungicides are
used more extensively on apples than captafol in the Midwest
and Northeast in terms of base acres treated and pounds
active ingredient applied. A number of these other fungicides
are applied to control various diseases which may or may not
include apple scab.
Many registered alternatives are available. The most viable
include dichlone, captan, metiram, folpet, glyodin, thiram,
maneb, triforine, mancozeb, zineb, diammonium EBDC, and a
combination of thiophanate-methyl or benomyl with another
fungicide to which resistance has been not demonstrated. Up to
five applications of any one of the alternatives must be
made to control the primary stage infections accomplished by
one application of captafol. Even though captafol is much
more expensive per application than any of the other fungicides
used on apples, the difference in cost is much lower when the
number of applications required with the alternatives is
taken into account. Since up to five applications may be
needed, it may be more expensive than using captafol.
d. Benefits on Cherries
Usage for cherries is limited to those which are mechanically
harvested because captafol may cause an allergic reaction in
some individual hand harvesters. In addition, captafol may
only be applied to sour cherries, with the exception of
California and Oregon. It is most frequently applied in the
northcentral and eastern regions of the United States and is
registered for control of Coccomyces leaf spot, brown rot
blossom blight, and fruit brown rot. For sour cherries it
is applied using 3 to 9 Ib. ai. per acre, depending on disease
severity. For cherries in California and Oregon a rate of
2.4 to 4.8 Ib. ai. per acre is used. Application is generally
made using airblast sprayers.
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For control of Coccomyces leaf spot disease, growers may choose
a "seasonal program" or a "reduced application program." For
the seasonal program, captafol may be applied at 0.5 to 1.0 Ib.
ai. in 100 gallons of water at 10 day intervals for three to
four treatments beginning at petal fall. The application
may be the same as those used for fruit brown rot. For the
reduced application program captafol is applied once at
petal fall using 3.0 Ib. ai. in 100 gallons of water. This
treatment may overlap one or more brown fruit rot treatments.
For brown rot blossom blight, captafol is applied using
three to six applications at two to four day intervals starting
at blossom development and continuing through petal fall.
It may be applied at 1.0 Ib. ai. in 100 gallons of water. In
major sour cherry producing states such as Michigan and Oregon,
generally 300 gallons and 400 gallons per acre, respectively,
are used.
For fruit brown rot, captafol is applied at 0.5 to 1.0 Ib. ai.
in 100 gallons of water and is applied when conditions are
favorable for disease development, such as extended periods
of rain. The history of disease in an orchard is also considered
Four applications may be made at ten day intervals from
petal fall and one application may be made after harvest.
With the exception of benomyl, captafol is the most expensive
fungicide per acre of application. Despite its cost, it is
still one of the most extensively used fungicides on cherries
in the northcentral and eastern parts of the U.S. The
most viable alternatives for these three diseases are dichlone,
dodine, ziram, and benomyl used in combination with a fungicide
against which resistance has not been demonstrated. Other
viable alternatives are also available, depending on the
disease. For brown rot blossom blight and fruit brown rot
additional alternatives include captan, sulfur, and triforine.
For leaf spot control glyodine, folpet, and zineb are available.
e. Benefits on Tomatoes
Captafol is limited for use on tomatoes which are
mechanically harvested. Generally these tomatoes are destined
for processing rather than fresh market. Captafol is registered
for control of anthracnose, early blight, late blight, gray
leaf spot, nailhead spot, Septoria leaf spot, and fruit rot.
In California it is also registered for control of black
mold. A rate of 1.2 to 16 Ib. ai. per acre may be used.
Row crop boom and airblast equipment, and airplane and
helicopter airblast equipment may be used.
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To control anthracnose captafol is generally applied using
two applications 20 days apart. To control black mold captafol
is mixed with 30 to 200 gallons of water per acre for ground
application and 10 gallons per acre for aerial application.
Application begins when fruits are well formed and continue
at seven to ten day intervals for up to six applications.
For control of the other diseases 30 to 150 gallons of water
per acre are used for ground applications and 5 to 10 gallons
per acres for aerial application. In Michigan the flowable
formulation may be applied by center pivot or solid set
irrigation equipment.
Despite captafol's high per acre application cost, it is
still one of the most extensively used fungicides on tomatoes.
In California and the north/northeastern United States, where
most of the processed tomatoes are produced, captafol holds the
second largest market share of base acres treated. Preliminary
data indicate that captafol usage on tomatoes has declined
slightly in the last two to three years.
Twenty-six alternative fungicides are registered for control
of one or more of the diseases for which captafol is registered.
The major ones include metiram, anilazine, captan, chlorothalonil,
diammonium EBDC, folpet, maneb, nabam, metalaxyl combined
with manozeb, and zineb. For the major diseases early blight,
late blight, and anthracnose, metiram, anilazine, captan,
chlorothalonil, diammonium EBDC, and maneb are the most
viable.
2. Preliminary Risk Analysis for Oncogenicity
a. Oncogenicity Studies
A two year mouse study (Chevron Chemical Company, 1981,
MRID 00088817) showed both compound and dose-related oncogenic
lesions at the middle and high dose groups. These lesions
included lymphosarcomas, myeloproliferative disease, harderian
gland hyperplasia, benign harderian gland adenomas, and
hemangiosarcomas. This compound also produced dose-related
non-oncogenic lesions at all dose levels. The control group
results were combined with those from a concurrently
run study on another chemical. As a result the Agency classified
this study as supplemental and is requiring that results for
separate controls be submitted. However, the information
was adequate to calculate a preliminary risk assessment
assuming no neoplasms in the controls, which represents the
worst case. There was a significant increase in mortality in
the middle and high dose mice, frequently accompanied by
neoplastic lesions. This preliminary assessment does not
take these early deaths-with-tumors into account. When the
Agency receives the additional control data, a time-to-tumor
assessment will be conducted.
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A two year rat feeding study (Hazelton Laboratories, 1983,
GS0122044) was also conducted and showed a dose-related
increased incidence of fibroadenomas of the mammary gland and
an increased incidence of neoplastic nodules in the liver of
females. Not all the animals at the middle and low doses
were subjected to histopathological examination so that the
numbers may not be representative.
A histopathological examination of the previously unexamined
female liver and mammary gland tissues at the middle and low
doses is required. The information will be included in the
risk assessment conducted during the Special Review. This
preliminary assessment is based on the results for the high
dose and controls only.
Captafol has oncogenic potential. The Agency has determined
that captafol meets or exceeds the risk criterion for
oncogenicity in 40 CFR § 162.11(a).
The Agency's Interim Cancer Assessment Guidelines
(41 PR 21402) state that when the Agency judges a chemical to
be a potential human carcinogen, the Agency must estimate its
possible impact on public health at current and anticipated
levels of exposure. The Agency recognizes that the available
techniques for assessing the magnitude of cancer risk to
human populations based on animal data are crude. Uncertainties
in the extrapolation of dose response data to very low dose
levels occur. Also, animals and humans have varying levels of
susceptibility. Thus, these estimates should be viewed as a
health hazard index that reflects the degree of oncogenic
activity and human exposure to captafol.
b. Exposure Analysis and Risk Estimates
»
1) Non-dietary
The Agency based the applicator exposure analysis on surrogate
data for pesticides with similiar use patterns, label directions,
and use patterns. Applicator exposure for fruit, citrus,
vegetable, pineapple planting stock, seed treatment, and
wood preservation application were calculated. An exposure
study on captafol was recently submitted. If valid, the
information will be used to revise the risk assessment.
For vegetables, fruit, and citrus, the use rates for captafol
are quite variable, depending on the desired number of
applications and the particular requirements for controlling
fungal diseases. The Agency used 2 Ib. ai. per acre for
ground application. Captafol is applied to citrus and fruit
using airblast equipment and to vegetables using ground boom
and aerial equipment. For aerial application, more concentrated
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suspensions are applied. Generally eight applications are
made per season with the exception of the use pattern for
sweet corn, which is treated with 16 applications per season.
For pineapple planting stock, the planting stock is tank
dipped in a 1.5 percent suspension at planting and then
planted by hand. Captafol is used to coat seeds using a
commercial seed treating apparatus. It is undiluted and in
dry form and applied usually at a rate of 2 ounces ai. per
100 pounds of seed.
The emulsifiable liquid concentrate formulation is registered
as a wood preservative for use with chromated copper arsenate.
A 0.02 to 0.04 percent ai. solution is used.
The dermal airblast, inhalation airblast, and ground boom
application were based on surrogate data from many pesticides
(J. C. Reinert and D. J. Severn, (?), GS0122055; J. Davis,
1978, GS0122054; and Versar, Inc., 1984, GS0122057,
respectively). Aerial, dip, and seed application were based
on captan (J. Jensen, 1982, GS0122056) and wood preservative
estimates on Position Document 2/3 on Wood Preservatives
(US EPA, 1980, GS01220058).
The Agency used the following assumptions to calculate exposure
to captafol:
i) The mixer/loader or applicator weighs 60 kg.
ii) Neither the mixer/loader nor applicator wears
protective clothing during application.
According to label directions before this
Guidance Document was issued, no protective
clothing was required except for one formulation.
iii) The Agency assumes 100 percent dermal penetration
A dermal penetration study was recently submitted
and is being reviewed. If valid, the information
will be used to revise the risk assessment.
iv) The Agency assumes a breathing rate of 1.2 cubic
meters per hour for applicators.
v) Application to pineapples assumes no inhalation
or dermal exposure because captafol is applied
mechanically as a dip and no such exposure
results.
vi) Application to pineapples assumes dermal
contact twice a day with 6 ml of treatment
suspension while planting seed pieces over 120
planting days per year. No inhalation exposure
results because planting is done outdoors.
26
-------
vii) Application to sweet corn assumes no inhalation
because no inhalation exposure results to the
applicator with aerial application.
viii) Aerial application did not consider exposure
for flagmen because they are rarely used.
Mechanical flagging is the prevalent practice.
ix) The seed treatment use combines mixing/loading and
applying because they are done at the same
time.
x) The wood preservative use assumes no inhalation
exposure. The captafol formulation does not
require mixing, and its application is usually
metered in with a remote pumping system. Its use
is in conjunction with chromated copper arsentate
(CCA) wood preservative solutions at ambient
temperatures. This use is also under presssure
in an enclosed treatment cylinder. If added by
hand, the mixer/loader (applicator) has minimal
opportunity for inhalation exposure. Also,
the excess treatment solution is usually
pumped back into a storage tank minimizing
any significant captafol exposure except for
the wood surface. Although captafol may have
a vapor pressure, as opposed to CCA salt
solutions with no vapor pressure, most treatment
facilities and the subsequent stacking and
drying is done outside, not in enclosed spaces.
xi) The wood preservative use assumes the mixer/loader
(applicator) accidentally comes in contact
with 6 ml of 30 percent concentrate each day.
The following Table 1 summarizes the exposure for a mixer/loader
and applicator in various use situations:
27
-------
Table 1 — ESTIMATION OF EXPOSURE FOR CAPTAFOL USAGE
DURING MIXING/LOADING AND APPLICATION
Use
Airblast
Inhalation
Dermal
Ground Boom
Inhalation
Dermal
Pineapple Dip
Inhalation
Dermal
Aerial —
Sweet Corn
Inhalation
Dermal
Seed
Treatment
Inhalation
Dermal
Wood
Preservative
Inhalation
Dermal
Airblast
Inhalation
Dermal
Ground Boom
Inhalation
Dermal
Pineapple Dip
Inhalation
Dermal
Aerial —
Sweet Corn
mg/hr
5.9
181
7.8
282
0.82
7.68
2
500
0.82
7.68
-
2340
0.06
26
1
18.6
—
180
hr/day hr/yr mg/kg/day
MIXING LOADING
0.5 4
0.5 4
0.5 4
0.5 4
0.5 60
0.5 60
0.5 8
0.5 8
0.25 0.75
0.25 0.75
— —
0.5 50
APPLICATION
4 32
4 32
4 32
4 32
— —
7.5 9.0
0.05
1.5
0.06
2.4
0.007
0.06
0.02
4
0.003
0.03
-
39
0.004
2
0.07
1.2 *
—
3
mg/kg/yr
0.4
12
0.5
20
0.84
7
0.3
64
0.01
0.1
3900
0.03
13
0.6
10
-
360
Inhalation
Dermal
2.3
16
0.4
0.6
28
-------
The preliminary risk estimates representing the worst case
is based on the incidence of neoplastic liver lesions
in rats and lymphosarcomas in mice. The extrapolation
linearized multi-stage model was used, and estimates were
based on 40 working years over a life span of 70 years. The
estimates which resulted for mixer/loader and applicator
combined ranged from 3 x 10~2 to 2 x 10~6, with 5 x 10~4 for
the major use sites.
2) Dietary
The estimates of dietary exposure to pesticide residues in
the diet are a function of several factors. These factors
include (1) the residues remaining in or on the commodity;
(2) the percentage of the commodity in the daily diet of
1.5 kilograms; and (3) 60 kilogram body weight. The residues
are measured in parts per million, and human exposure to
pesticide residues in a commodity is measured in terms of
milligrams of pesticide per kilogram of body weight per day.
The Agency's dietary estimates assume a uniform distribution
of treated crops among the U.S. population and an average
daily consumption of those crops by individuals. Although an
individual's exposure could vary considerably depending on
eating habits and geographic location, the values are considered
representative for the total U.S. population over a lifetime.
The Agency calculated worst case dietary exposure based on
the same multi-stage model and incidence of tumors. This
exposure was based on the TMRC, which assumes residues are at
100 percent of the tolerance levels. The actual dietary
exposure may be lower. The TMRC of 1.46 mg/day is equivalent
to 0.02 mg/kg/day for a 60 kg person. This results in a
preliminary oncogenicity risk estimate of 2 x 10~4.
3. Preliminary Risk Assessment for Ecological Effects
a. Ecological Effects Studies
The Agency reviewed several valid ecological effects studies,
which characterize captafol as very highly toxic to fish.
The results of these studies are summarized in Table 2.
29
-------
The preliminary risk estimates representing the worst case
is based on the incidence of neoplastic liver lesions
in rats and lymphosarcomas in mice. The extrapolation
linearized multi-stage model was used, and estimates were
based on 40 working years over a life span of 70 years. The
estimates which resulted for mixer/loader and applicator
combined ranged from 3 x 10~2 to 2 x 10~6, with 5 x 10~4 for
the major use sites.
2) Dietary
The estimates of dietary exposure to pesticide residues in
the diet are a function of several factors. These factors
include (1) the residues remaining in or on the commodity;
(2) the percentage of the commodity in the daily diet of
1.5 kilograms; and (3) 60 kilogram body weight. The residues
are measured in parts per million, and human exposure to
pesticide residues in a commodity is measured in terms of
milligrams of pesticide per kilogram of body weight per day.
The Agency's dietary estimates assume a uniform distribution
of 'treated crops among the U.S. population and an average
daily consumption of those crops by individuals. Although an
individual's exposure could vary considerably depending on
eating habits and geographic location, the values are considered
representative for the total U.S. population over a lifetime.
The Agency calculated dietary exposure based on the same
multi-stage model and incidence of tumors. This exposure was
based on the TMRC, which assumes residues are at 100 percent
of the tolerance levels. The actual dietary exposure may be
lower. The TMRC of 1.46 mg/day is equivalent to 0.02 mg/kg/day
for a 60 kg person. This results in a preliminary oncogenicity
risk estimate of 2 x 10~4-
3. Preliminary Risk Assessment for Ecological Effects
a. Ecological Effects Studies
The Agency reviewed several valid ecological effects studies,
which characterize captafol as very highly toxic to fish.
The results of these studies are summarized in Table 2.
30
-------
Table 2—ACUTE TOXICITY STUDIES FOR FISH
Species
Results for 96-hour
in parts per billion
Citation
(MRID)
USING TECHNICAL FORMULATIONS
Lepomis macrochius
(Bluegill sunfish)
Lepomis macrochius
(Bluegill sunfish)
Lepomis macrochius
(Bluegill sunfish)
Lepomis macrochius
spomis
Jlueqi
(Bluegill sunfish)
Salmo gairdneri
(Rainbow trout)
Salmo gairdneri
(Rainbow trout)
Carassius auratus
(Goldlife)
Ictalurus punctatus
Channel catfish
Lepomis macrochius
(Bluegill sunfish)
Salmo gairdneri
Rainbow trout)
158
(137 - 180.9)
45
(35.78 - 56.60)
212
(150 - 600)
230
(180 - 320)
27
(23.81 - 40.48)
190
(161.4 - 223.8)
USING FORMULATED PRODUCT
178
(146 - 217)
28
59
21
U.S. EPA, 1980,
GS0122036
U.S. EPA, 1976,
GS0122037
U.S. EPA, 1980,
GS0122038
Thompson et al.,
1980, 00069607
U.S. EPA, 1976,
GS0122034
U.S. EPA, 1980,
GS0122033
Johnson and Finley,
1980, 00003503
same
same
same
31
-------
b. Risk Assessment
The Agency is concerned about the effect of captafol on fish
as a result of drift and/or run-off during application to
cranberries, orchards, and tomatoes. The Agency is also looking
into captafol's effect on endangered species.
Biological monitoring studies (R. W. Felthousen, 1977,
GS0122059 and GS0122060) in New Jersey resulted in fish kills
after the application of captafol at 5 Ib. ai. per acre.
There is a possibility that the entire fish population was
eliminated in one bog. it cannot be directly proven that the
fish kill resulted from the captafol application because
residue studies were not done. However, captafol is very
highly toxic to fish, and the fish kill occurred shortly
after application. The Agency is also aware that cranberry
bogs may be irrigated by sprinkler systems or by flooding,
which would increase the possibility of a future fish kills.
Because many bogs border viable waters, aerial applications
would also increase the chance of fish exposure to captafol
from drift.
The Agency is concerned about the use of captafol in orchards
based on the two incidents in cranberries and based on current
use practices. In Florida the recommended application rate
to citrus is 16 to 20 Ib. ai. per acre. The label states
that captafol be used only in orchards with overhead irrigation,
which assures that the fungicide is distributed to the new
leaves and fruit. This may result in runoff and is of concern
because many groves are located near or on estuaries.
The Agency has estimated possible aquatic environmental
concentrations. Generally citrus is sprayed using airblast
equipment to achieve proper penetration and coverage. From
100 to 2,000 gallons of water per acre are used. Multiple
applications are not recommended at the higher dosage
rates.
The following spray drift model assesses the spray drift
impact on a graduated basis. (This diagram is not to scale).
This model assumes normal wind under average conditions.
32
-------
wind direction —>
17%
50%
83%
0.5 acre
30' 20C
3%) (33?
0.5 acre
)' 1C
i) (6<
0.5 acre
)0' C
5%) (1C
1 acre pond
208.7'
i
)0%)
208.7
This model assumes that captafol is sprayed over an area
0 to 300 feet from a one acre pond. This area is divided
into 100 foot intervals consisting of 0.5 acres. The wind
is blowing from the application site towards the pond.
Under normal circumstances approximately 40 percent of the
spray will not hit the target. One-half of this off-target
spray can be expected to volatize, which results in 20 percent
of the material remaining. This material will drift towards
the one acre pond. The model assumes that the amount of
material drifting will decrease 33 percent with each 100
foot interval. The percentages from each 100 foot interval
were averaged to determine the percentage of pesticide available
for drift, which are 83%, 50%, and 17%. Following is a
sample calculation of the amount of drift entering the pond,
assuming 20 Ib. ai . are applied.
20 Ib. ai. x 20% x 0.5 acres x 83% = 1.66 Ib.
20 Ib. ai. x 20% x 0.5 acres x 50% = 1.0 Ib.
20 Ib. ai. x 20% x 0.5 acres x 17% = 0.34 Ib.
1.66 + 1.0 + 0.34 = 2.90 Ib.
The amount entering the pond spreads throughout the pond,
which is six feet deep. The expected residues in the
pond are 180 parts per billion (ppb) and exceeds the
An estuary is represented using one-half acre foot of water.
The expected residues using the same procedure and application
rate results in 2,200 ppb, which also exceeds the LC5Q.
33
-------
The Agency also estimated the impact of runoff. The runoff
model assumes the a six -acre-feet pond (one acre large and
six feet deep) and has a drainage of ten acres with one
percent of the application rate entering the water. At the
20 Ib. ai. application rate, the expected residues would be
two pounds or 122 ppb. The fish LC$Q values are approached
or exceeded.
The results of these estimates meet or exceed the Special
Review criterion specified in 40 CFR §§ 162.11(3) (ii) (C) and
The Agency also is concerned about the use of captafol on
tomatoes. In certain areas, growers use a plastic cover to
keep weeds down, hasten maturity through heat retention,
retain soil fumigants, and to shed rain. Too much rain causes
the fruit to split or develop soft spots, which detracts from
the overall quality of the product. When plastic is used, it
covers two feet on each side of the center, or four out of every
six feet are covered with plastic. Irrigation is used on all
tomatoes in California, as well as in other areas. The result
of using plastic and irrigation may create a hazard to fish
because of run-off from the plastic into the irrigation system
and into associated waters.
With regard to the protection of endangered species from the
use of captafol, the Agency has prepared a request for a
formal consultation with the Office of Endangered Species,
U.S. Fish and Wildlife Service, U.S. Department of the
Interior on September 26, 1984 (as required by Section 7 of
the Endangered Species Act of 1973, as amended).
This assessment is preliminary in nature and will be
refined during the Special Review process, when additional
environmental fate and ecological effects data can be included.
34
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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 I/ 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 and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2/, 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
I/ 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/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
35a
-------
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
11-2] 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)f/
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.)
*/ FIFRA Section 3(c)(2)(B) authorizes joint development of
data b~y 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)
35b
-------
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 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)(ill)]; 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.
. 35c
-------
TABLF A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Does EPA Have Data
To Satisfy This
V Use 2/ Requirement? (Yes,
Composition Patterns No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
S158.135 Toxicology
ACUTE TESTING;
R.1.-1 - Acute Oral Toxicity - Rat
81-2 - Acute Dermal Toxicity
81-3 - Acute Inhalation Toxicity
-Rat
81-7 - Acute Delayed
Neurotoxicity - Hen 9
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding -
Rodent, Non-rodent
82-2 - 21-Day Dermal 9
82-3 - 90-Day Dermal 9
82-4 - 90-Day Inhalation -
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal 9
TGAI
TGAI
TGAI
TGAI
A,B
A,B
A,B
_
Yes
Yes
No
_
GS 0122046
GS 0122046
-
_
TGAI
TGAI
TGAI
TGAI
TGAI
A,B
A,B
Partially
No
00093672 (Rodent)
No
No
Yes (6 months)
Yes (Non-rodent)
(18 months)
Yes (18 months)
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAPOL
Data Requirement
I/ Use
apposition Pattern
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/
§158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity - TGAI
2 species: Rodent
and Non-rodent
83-2 - Oncogenicity Study - TGAI
2 species: Rat and
Mouse preferred
83-3 - Teratogenicity - TGAI
2 species
83-4 - Reproduction, TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI
4
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Partially
Partially
Partially
Yes
Partially
Yes
Yes
GS 0122044 (rodent)
GS 0122044 (rat)4
00088817 (mouse)4
05001994 5
GS 0122042 (rat)
GS 0122045 (rabbit)7
GS 0122048 (rabbit)7
GS 0122043
GS 0122040
00046435
GS 0122040 / 0122047
GS 0122046/ 00027544
GS 0122041
Yes (non-rodent)
(36 months)
(rodent)10
Yes 1° 11
Yes6 (12 months)
No
Yes8 (12 months)
No
No
36
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAPOL
Data Requirement
V Use 2/
Composition Pattern
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)?V
§158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism
PAI or PAIRA
85-2 - Domestic Animal Safety 9 Choice
j
85-3 - Dermal Absorption TGAI
A,B
A,B
Yes
No
00061996
00096902
No
Yes (6 months)3
a/ A dermal absorption study was received by EPA (July 17f 1984); at the time of the issuance of this
Standard the study was under Aqency review.
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
$158.135 Toxicology
(continued)
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 Crop; B=tferrestrial, Nbn-Foodr C=Aqauticf Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Nbn-Food; G=Forestry; H=Domestic Cutdoor; I=Indoor.
V Data must be submitted no later than indicated in Table A.
4/ These studies have been classified as supplementary and need additional information from the registrant in order
to determine if they may be used to satisfy the data requirement.
V This study has been classified as supplementary and a study is needed to clarify the equivocal results.
6/ A study in hamsters using two test groups, one dosed on day 7, and the other dosed on day fi of gestation, is needed.
7/ This recently submitted study is currently under review.
8/ A gene mutation test in mammalian cells in culture with and without metabolic activation or utilizing cells with
metabolically competent cells.
V This test is not required.
10/ Additional histopathology is needed for G3 0122044, chronic rat study.
ll/ Additional information is needed for 00088817t mouse oncogenicity study.
38
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GENERIC DATA REQUIREMENTS FOR CAFTAFOL
Data Requirement
Compositionb
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Older FIFRA Section
3(c)(2)(B)?c
EPA REG. NO. 239-2230 (97%T)a
§158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Diclosure
of Ingredients TGAI
61-2 - Description of Beginning
Materials and Manufacturing
Process TGAI
61-3 - Discussion of Formation of
Impurities TGAI
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of
Product Samples TGAI
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 N/Ad
63-7 - Density, Bulk Density, or TGAI
Specific Gravity
Yes
Partially
No
GS0122030
GS0122032
No
Yes
Yes
Partially
Yes
Yes'
Yes
Yes
N/A
No
GS0122028, GS0122030
GS0122029
GS0122029
GS0122029
GS0122029
Yes
No
No
No
No
No
No
a The 97% technical (T) also serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient: PAI = pure active ingredient.
c Data must be submitted no later than 6 months from the date of this Standard.
d Not required because the <*7% technical is a solid at room temperature.
39
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Composition13
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)?c
EPA REG. NO. 239-2230 (97%T)a
S158.12Q Product Chemistry (continued)
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/ Water Partition
Coefficient
63-12 - pH
63-13 - Stability
other Requirement;
64-1 - Submittal of Samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
Partially
No
No
Nb
No
Yes '
N/A
GS0122051
GS0122050
Yes
Yes
Yes
Yes
Yes
No
No
a The 97% technical (T) also serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient: PAI = pure active ingredient.
c Data must be submitted no later than 6 months from the date of this Standard.
40
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Composition1/
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/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA
Partially
See Footnote A
Yes3
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
Presently there are
no established tolerances
171-4 - Storage Stability Data
PAIRA and plant
metabolites
Pure Analytical
Standards and
metabolites
Pure Analytical
Standard and
metabolites
PAI
Partially
See Footnote B
Yes4
Partially
Partially
Partially
See Footnote C
See Footnote C
00091274
Yes6
Yes?
A. Bibliographic Citations: 00025129, 00025130, 0009619, 00096916, 00072884, 0081808 and 05003661.
B. Bibliographic Citations: 00096829, 00096830, 00025952, 00025119, 00025120, 00025124, 00025127, 00061996,
00053240 and 00096902.
C. Bibliographic Citations: 00096847, 00096848, 00096843, 00091215, 00091214, 0052318, 0031709, 00025123,
00096911, 00025123 and 00025133
GS0122001, GS0122002, GS0122003, GS0122004, GS0122005, GS0122006, GS0122052
GS0122053
41
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TABLE A
DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Composition1/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue-
Residues Studies for Each
Food Use
Citrus Fruit Group?
Citrus Fruits EP
Pome Fruits Grouph
Apples EP
Pears EP
Stone Fruits Group*
Apricots EP
Cherries^ Sour and Sweet EP
Nectarines EP
Peaches EP
Plums (Fresh Prunes) EP
Small Fruit and Berries GroupJ
Blueberries EP
Cranberries EP
Strawberries EP
Partially
Partially
None
Partially
Partially
Partially
Partially
Partially
Partially
Partially
None
GS0122012
GS0122007
GS0122008
GS0122009
GS0122010
00096828 and GS0122011
Same as for Apricots
Same as for Apricots
GS0122021
00096889 and GS0122014
Yes12
Yes8
Yes
Yes11
Yes18
Yes21
Yes23
Yes1*
Yes
42
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAPOL
Data Requirement
Composition1/
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/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue-
Residues Studies for Each
Food Use
Tree Nuts Group^
Macadamia Nuts EP
Pecan Nutmeats (Shells removed)
(Pending)
Cereal Grains Group1
Corn, fresh (including
sweet, kernels plus cobs
with husks removed) EP
Other Raw Agricultural Conmodities
Coffee beans (green) (Pending)
Peanuts, meats (hulls removed) EP
Peanuts, hulls EP
Pineapples EP
Sugarcane EP
Taro (corm) EP
Partially
Partially
Partially
Partially
Partially
None
Partially
GS0122015
Yes16
GS0122013
Yes13
GS0122017
GS0122018
Same as for Peanuts Meats
GS0122020
GS0122025
Yes1*
Yes1?
Yes22
Yes
43
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPPAPOL
Data Requirement
Composition!/
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue-
Residues Studies for Each
Food Use
Root and Tuber Vegetable Group3
Carrots (Pending)
Potatoes EP
Bulb Vegetable Groupb
Onions EP
Legume Vegetable
(Succulent or Dried) Group0
Soybeans (Pending)
Foliage of Legume Vegetable
Grcupd
Soybean Forage and Hay (Pending
Fruiting Vegetables (Except
Cucurbits Group6
Tomatoes EP
Cucurbit Vegetable Groupf
Cucumbers EP
Melons EP
Partially
Partially
GS0122022
GS0122023
GS0122050
GS0122019
Partially
Partially
Partially
GS0122025
GS0122026
GS0122027
00096817
GS0122016
Yes24
Yes20
yes
26
Yesi?
44
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TABLE A
GENERIC DRTA REQUIREMENTS FOR CAPTAPOL
§158.125 Residue Chemistry (continued)
a. Residue data are required for two additional members of eht group (radish and sugar beet). Note that
data in support of a proposed tolerance for captafol residues in or on carrots are currently under review.
b. Residue data are required for one additional member of this crop group (garlic, leek or shallot).
c. Residue data are required for the three representative commodities of this group: beans (one succulent
and one dried variety); peas (one succulent and one dried variety) and soybeans; captafol formulations
are currently not registered for use on any member of this crop group (use on soybeans has been
proposed.
d. Same as c above.
e. Residue data are required for one additional member of this group (peppers). IR4, Rutgers University
PP No. OE2365 (099439) submitted data pertaining to residues of captafol per se in or on peppers; however
the data will not satisfy group tolerance requirements because no data pertaining to residues of THPI
were submitted.
f. Residue data are needed for an additional representative member of this crop group (summer squash).
Currently, captafol formulations are registered for use only on cucumbers and melons.
g. A tolerance of 0.5 ppm has been established for the residues of captafol in or on citrus fruits.
Additional data are required to fully support this group tolerance.
45
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAPOL
§158.125 Residue Chemistry (continued)
h. A crop group tolerance is not appropriate, as additional data are required for the representative
commodities apples and pears. A tolerance has been established for apples but not for pears.
i. A crop group tolerance is not appropriate because the tolerances established for members of this crop
group differ by more than a factor of five (2-50 ppm). Data are required in support of established
tolerances for representative crops.
j. Crop group tolerance is not appropriate because residue data on captafol per se and its THPI metabolite
are required for a Rubus spp., grape, strawberries, blueberries and cranberries. Also, the established
PHI for blueberries (21 days) differ significantly from that of cranberries (50 days).
k. A crop group tolerance is not appropriate because residue data for three representative connodities
(almond, pecan and English walnut) are required. Residue data have been submitted for almond, but no
data on the THPI metabolite were submitted. A petition to establish a tolerance for residues of
captafol per se in or on pecans (PP No. 6F1795) is currently under review.
1. A crop group tolerance is not appropriate because: 1. Additional data are required to support the
established tolerance for fresh corn, 2. Registered uses on field corn, sorghum and rice (seed
treatment only) differ significantly from uses on sweet corn (seed treatment in ID and PL and
multiple foliar applications in FL; 3. Residue data and tolerance proposals are required for
rice, sorghum, and field corn; 4. Residue data are required for one additional member of this
crop group (wheat).
46
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPPAPOL
S15R.125 Residue Chemistry (continued)
I/ Composition: TGAI = Technical grade of the active ingredient? PAIRA = Pure active ingredient, radiolabeled;
TEP = Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than 12 months from the date of receipt of this Standard.
3/ The metabolism of captafol in plants is not adequately understood due to the lack of sufficient data on this
topic. The following additional data are required:
The uptake, distribution, and metabolism of carbonyl-labeled [^c]captafol in representative crops,
preferably a tree fruit, potatoes, tomatoes and corn following foliar and soil applications. Sampling
intervals through at least 21 days post-treatmeent must be included. The identities and quantities of
residues in or on mature plant parts must be determined in order to elucidate the terminal residues.
Residue identities must be confirmed by a method such as GC, HPLC, and/or mass spectrometry.
4/ Presently, the metabolism of captafol [cis-N-[(l,2,2-tetrachloroethyl)thio]-4-cyclohexene-l,2-dicarboxijnide(I)]
in ruminants is adequately understood. However, the available data for poultry metabolism of captafol are
inadequate; thus the residues of concern in poultry and eggs cannot be ascertained. The following additional
data are required:
Poultry (laying hens) must be dosed with carbonyl-labeled [14C]captafol daily for at least 3 days. Resi-
dues must be characterized in tissues (including muscle, liver, kidney, fat, heart, gizzard, and skin) and
eggs. Animals must be sacrificed within 24 hours of the last 14c-
-------
Data demonstrating the stability of captafol and its tertrahydropthalamide (THPI) metabolites in or on
representative crops (such as apples, cherries, citrus, potatoes, tomatoes, and sweet corn) and animal
products (meat, milk, and eggs) stored at subfreezing temperatures for intervals approximating the
storage intervals of treated samples used to determine the magnitude of the residue.
8/ Apples. Residue data involving levels of captafol per se and its THPI metabolite in or on apples following
delayed or dormant spray application using either the 4 Ib/gal FIG or 80% WDG formulation at 20 Ib ai/A from
tests conducted in midwestern states.
9/ Apricots. Residue data from apricots treated with twice with dormant applications of the 80% WP at 6.4 ai/A,
once in the fall and again in early spring at bud swell. Captafol and THPI residues should be determined
separately for fruit samples taken at their normal time of harvest. The studies should be conducted in CA,
OT, and WA. Note that other metabolites may need to be sought if the requested plant metabolism studies reveal
the presence of other residues of concern.
10/ Blueberries. Residues of captafol and its THPI metobolites in or on mature blueberries following multiple
treatment with the 4 Ib/gal F1C or 80% WDG at 4 Ib ai/A. Applications should begin at the early green tip
stage and continue at 1-week intervals throughout petal fall after which application should continue at 10-day
intervals until 21 days prior to harvest. Tests should be conducted in ME, MI, and NJ.
Residue data for captafol and THPI (analyzed and reported separately) from sour cherries harvested at their
normal time of maturity after being subjected to the following treatment regime: (i) four foliar treatments
during the blooming period (treatments spaced 2 days apart, ending at petal fall) with the 4 Ib/gal F1C
sprayed to runoff at 1 Ib ai/100 gal until normal fruit maturity. The studies should take place in
MI (65.4%), NY (6.2%) and OR (3.7%); percentages of U.S. sour cherry production contributed by states shown
parenthetically.
ll/ Residue data for captafol and THPI (analyzed and reported separately) from sweet cherries harvested at normal
maturity after four foliar treatments during the blooming period (treatments spaced 4-7 days apart, ending at
petal fall) with the 80% WP or the 4 Ib/gal F1C sprayed to runoff at 1.6 Ib ai/100 gal (400 gal spray/A). The
studies should take place in CA or OR.
%
In addition, since the metabolism of captafol in plants is not adequately understood (see Nature of the Residue
in Plants section), data for additional metabolites of captafol may be required if the requested studies
discover residues of concern other than captafol and THPI.
12/ Residue data from orange products (dried pulb, peel, oilr molasses, juice) processed from whole oranges bearing
measurable, weathered residues. Exaggerated rates of applications only may be required to obtain such initial
residues. Captafol and THPI should be quantified separately.
48
-------
Residue data concerning oranges (in FL) treated from late dormant to tight bloom with the 4 Ib/gal or 80% WDG
at 20 Ib ai/A followed by treatments from tight bloom to petal fall at 10 Ib ai/A. Whole mature fruit should
be harvested and analyzed for oaptafol per se and THPI separately. Other metabolites may need to be determined
if the required plant metbolism data indicate such a necessity.
13/ Data reflecting residues of captafol and THPI in or on sweet corn (kernels plus cob with husks removed) grown
from seed treated with the 4 Ib/gal F1C formulation at 4 oz ai/100 b of seed and treated with 15 aerially-
applied foliar applications (made 4 days apart) of the 4 Ib/gal F1C or 80% WDG formulation at 1 Ib ai/A.
Samples must be harvestd 5 days after the last foliar applications. Tests must be conducted in Fl.
Since seed treatement is no longer considered a non-food use for captafol, label restrictions prohibiting
feeding or grazing of treated crops and limiting use to corn grown for fresh market should be added to both
24(c) labels (ID80005000 and FL8006400); alternatively, data reflecting residues in or on sweet corn forage
and cannery waste following seed treatments, and appropriate tolerance proposals must be submitted.
14_/ Residues of captafol and its THPI metabolite in or on cranberries 50 days after the last of three foliar
applications made at 10-day intervals with the 4 Ib/gal EC or the 80% WDG formulation at 5 Ib ai/A,
Tests should be conduceted in MS and WI.
15/ Residue data involving captafol residues (captafol per se and its THPI metabolite ) in or on cucumbers as a
result of a foliar spray when first true leaves appear and at weekly intervals thereafter using either the
80% WP, 80% WDG, or 4 Ib/gal F1C formulation at 1.6 ai/A from tests conducted in CA and/or TX.
Residue data involving captafol residues (captafol per se and its THPI metabolite) in or on cucumbers following
a single spray application of the 4 Ib/gal F1C or 80~%~WDG at 3.25 Ib ai/A directed to the bed soil after
the last cultivation or when vines begin to run from tests conducted in southeastern states.
16_/ Residue data for captafol and THPI (analyzed and reported separately) in or on macadamia nutmeats after 16
foliar treatments made twice weekly during the 8-week period in February and March. The studies should be
done in Hawaii.
IT/ Residue data involving residues of captafol (captafol per se and its THPI metabolite) in or on any melon
variety other than watermelon as the result of a spray application of the 80% WP, 4 Ib/gal F1C, or 80% WDG
formulation at 2.5 Ib ai/A (using 100-150 gal spray/A) beginning when first true leaves appear and repeated
at weekly intervals thereafter from tests conducted in CA and TX.
Residue data involving residues of captafol (captafol per se and its THPI metabolite) in or on watermelons
from aerial applications of the 80% WDG at 2.5 Ib ai/A (using 5 gal spray/A) beginning when plants start
to vine and repeated at 5- to 10-day intervals from tests conducted in any southeastern (FL, GA, or SC) and
western (CA and TX) location.
49
-------
Residue Data involving residues of captafol (captafol per se and its THPI metabolite) in or on watermelons
fron aerial applications of the 4 Ib/gal F1C at 2.5 Ib ai/A (using 5 gal spray/A) beginning when plants
start to vine and at 5- to 10-day intervals thereafter from tests conducted in TX. Alternatively, this state
label could be cancelled.
Residue data involving levels of other captafol metabolites may also be required if the requested plant meta-
bolism data show other residues of concern to be present in significant amounts in mature plants.
18/ Same as with Apricots.
19/ Data reflecting residues of captafol and THPI in or on peanut nutmeats and hulls 14 days after the last of
12 foliar applications (made 10 days apart) of the 80% WDG formulation at 1.6 Ib ai/A. Both aerial and ground
applications must be represented. Plants must be grown from seed treated with one of the registered D form-
ulations at 0.2 Ib ai/100 Ib of seed. Tests must be conducted in peanut production regions in FL (4%),
GA (42%) TX (10%), and VA (8%); percentage of 1981 peanut crop production is given in parentheses (preliminary
figures; Agricultural Statistics, 1982, p. 126). If GA can represent both AL (15%) and NC (14%), then 93%
of the peanut production area will be represented.
Data reflecting residues of captafol and THPI in meal, crude oil, refined oil, and soapstock processed from
nutmeats having measurable weathered residues. If residues are found to concentrate in any of these processed
products, appropriate food/feed additive tolerances must be proposed.
20/ Residues of captafol and its tetrahydrophthalimide (THPI) metabolite in or on onions (dry bulb) on the day
of the last of 12 weekly applications of the 4 Ib/gal F1C or the 80% WDG formulation at 1.25 Ib ai/A. Tests
should be conducted in CD (10%), ID (8%), or OR (14%), MI (8%), and NY (13%); percent contribution to annual
U.S. dry bulb onion production is given in parenthesis.
Residues of captafol and THPI in or on green onions on the day of the last of 8-10 foliar applications of the
4 Ib/gal FLC or 80% WDG applied weekly at 1.25 Ib ai/A. Tests should be conducted in CA (40%) and TX (50%);
percent contribution to annual U.S. green onion production is given parenthetically. Alternatively the labels
and commidity|definition could be changed from "onions" to "onions (dry bulb)."
Note that other metabolites of captafol may need to be sought in the above requested studies if the plant meta-
bolism studies reveal additional residues of concern.
21/ Sams as with Apricots.
22/ Residues of captafol and its THPI metabolite in or on whole pineapple fruits and forage grown from slips
treated with a single dip application at 0.125 Ib ai/gal (31.25 Ib ai/A) followed by eight foliar spray treat-
ments at 8 Ib ai/A with either the 80% WP, 80% WDG, or the 4 Ib/gal F1C formulation. Tests should be conducted
in HI.
50
-------
Determination of residues (captafol and its THPI metabolit) in juice and bran processed form captafol-treated
pineapple bearing detectable, weathered residues of captafol.
23/ Residue data for captafol and THPI (analyzed and reported separately) from dried prunes processed from plums
(fresh prunes) bearing measurable weathered residues. Exaggerated rates may be required to obtain such residue
levels.
A tolerance for dried plums should be proposed based on this data, if necessary.
24/ Combined residues of captafol and THPI in or on whole potatoes harvested on the day of the last of 16 weekly
applications of either a F1C, WDG or WP formulation at 1.6 Ib ai/A. Tests must be conducted in CA, ID, ME, and
WI.
Residues of captafol per se and its THPI metabolite in dried potatoes, potato chips, and granules processed
from potatoes containing tolerance-level or above (>0.5 ppm ) weathered residues of captafol.
25/ Data reflecting residues of captafol and THPI in or on taro root (corn) and foliage 11 weeks after the last
of 23 foliar sprays (applied 7 days apart) with the 80% WDG formulation at 1.6 Ib ai/A. Tests should be con-
ducted in HI.
26/ Residue of captafol per se and its THPI metabolite in or on mature tomatoes harvested on the day of the last
of 10 foliar applications (using ground and aerial equipment) with either the 4 Ib/gal F1C, the 80% WP or the
80% WDG formulation at 2.5 Ib ai/A; treatments are to begin when fruit is well formed and continued at 7-day
intervals. Tests should be conducted in CA and FL using both aerial and ground equipment.
Residues of captafol per se and its THPI metabolite in or on mature tomatoes which received a single foliar
application (at fruit formation) with the 4 Ib/gal F1C or the 80% WDG formulation at 16 Ib ai/A and (in a
separate test with either the F1C or the WDG) two foliar applications, separated by 20 days, at 8 Ib/A. Tests
should be conducted in CA and FL using either ground or aerial equipment for application.
Residue data from greenhouse tests in which a single soil drench treatment with the 4 bl/gal F1C formulation
is made at 24 Ib ai/A 14 days prior to planting. Residues of captafol per se and THPI must be determined.
51
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
Composition!/
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
163-1 - Leaching and>% TGAI or PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
1fi-a_-J _ \7r>la4-i1 ii-xr SPiol/n TRD
Use 2/
Pattern
A,C,E
A,C
A,
A
A,E
A
C
C
A,E
A,E
a_R
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
No
No
No
No
Partially4/ 00096916
Partially5/
Partially6/ 00026453
No
Partially7/ 00096917
00096972
Mr> _—
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes (24 months)
No
Yes (24 months)
Yes (24 months)
Yes7 (6 monts)
Yes (6 months)
Veio If. T¥v\nH-»c \
52
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TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Data Requirement
Composition^/
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/
158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD;
164-1 - Soil
164-2 - Aquatic (Sediment)
Water
TEP
TEP
TEP
C
C
No
No
No
Yes (24 months)
Yes (24 months)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES;
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
TEP
No
165-5 - In Aquatic Non-Target
Organisms
Reentry Studies
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
C
A,C
NO
partially^/
No
No
No
00096919
Yea?/ (36 months)
Yes (24 months
Yes (24 months)
Yes (24 months)
Yes (24 months)
(24
I/ Composition; TGAI = Technical grade of the active ingredient; PAIRA - Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
4/ Study 00096919 partially fulfills data requirements by providing information on the rate of carbonyl-labeled [14C]
captafol degradation a loamy sand soil and on the identification, formation and decline of [l^C] captafol degradate
in aerobic soil. The study did not provide information on the 4 cyclohexene ring opening (degradation) in aerobic
soil. An additional aerboic soil metabolism study is required utilizing 4 cyclohexene ring labeled captafol as the
test substance. The study must be conducted as the same soil type and at the same concentration, temperature and
moisture as the study in which carbonyl-labeled captafol was used as the test substance.
5/ Data fron an anaerobic soil metabolism study need not be submitted if data from the anaerobic aquatic metabolism study
study described in §162.3 of this subdivision have been submitted. An anaerobic aquatic metabolism study has been
submitted which partially fulfills data requirements.
6/ One study has reviewed, 00026453, and it is scientifically valid. This study partially fulfills data requirements by
providing information on the rate of anaerobic aquatic degradation of carbonyl-labeled [^C] captafol in a loamy
sand soil, and on the identification, formation and decline of [l^C]! captafol degradates in water plus loamy sand.
The study did not provide information on the 4-cyclohexene ring opening (degradation) in anaerobic water plus loamy
sand. An additional anaerobic aquatic metabolism study is required utilizing 4-cyclohexene ring-labeled captafol as
the test substance. The study must be conducted using water plus sediment obtained from and representative of that
found at the intended aquatic use site. This study must be submitted in order to waive the anaerobic soil data
requirements.
7/ Two studies partially fulfill data requirements by providing data on the mobility of captafol residues aged in sandy
loam soil 20-30 days, however the aged captafol residue were not characterized (00096917), and on the mobility of
[14c]captafol in silty clay loam, sandy loam, clay, and clay loam soils (00096972). Additional data are needed on
the mobility of aged captafol residues (captafol) and its degradates in soil. For the study of pesticide degradates
mobility, captafol must be aged for 30 days or one half-life using appropriate laboratory conditions, soil sampling
protocols, and analyses. The degradates must be identified. This will fulfill data requirements for terrestrial,
food crop use patterns. To fulfill the data requirements for greenhouse food crop use patterns, batch equilibrium
(adsorption/desorption) studies are required on a minimum of four soils. The soils selected must be soils such as
sand (agricultural), sandy loam, silt loam, clay or clay-loam, each having a pH within a range of 4-8. Batch equili-
brium (adsorption/desorption) studies on one aquatic sediment obtained from or representative of the of the proposed
aquatic use area required to fulfill the aquatic food, crop use patterns.
'%
Based on leaching and aerobic soil metabolism studies data requirements, captafol is immobile in soil varying in
texture from clay to sandy loam. The immobility of captafol in soil and its degradation in soil are expected to
result in a low potential for ground water contamination by captafol. However, aged [l^c] captafol residues are
mobile in sandy loam, but as was true for the parent compound, the degradation of captafol degradates is expected to
reduce the potential for groundwater contamination by captafol degradates.
The Agency is concerned about the contamination of ground water by captafol and its metabolites. Data required for
the evaluation of the potential for contamination of ground water are being required on an accelerated basis.
54
-------
TABLE A
GENERIC DATA REQUIREMENTS -FOR CAETAFOL
8/ The data requirements for Long Term Soil Dissipation Studies will be based on the results of Aerobic Soil Metabolism
and Terrestrial Field Dissipation Studies.
9/ Study 0009691 partially fulfills data requirements by providing data on the uptake of aged [14C]captafol residues
by rotated carrots (roots and tops) grown under confined conditions. Additional studies are needed providing infor-
mation on the identity of [-^C] captafol residues ages in a sandy loam soi by 2 rotated small grain and rotated
leafy vegetable. The results of this study (00096919) indicate that field accumulation studies on rotational crops
are required to establish rotation restriction intervals or to determine if tolerance are needed for rotational
crops.
10/ The Agency is imposing a 24-hour reentry interval pending receipt and evaluation of reentry data.
55
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAFOL
Use V
Data Requirement Composition*/ Pattern
$158.145 Wildlife and
Aquatic Organisms
Avian and Mammal Testing
71-1 Acute Avian Oral Toxicity TGAI A,C
71-2 Acute Avian Dietary Toxicity THAI ArC
a. Waterfowl
b. Upland game
71-3 Wild Mammal Toxicity
71-4 Avian Reproduction TGAI A,C
71-5 Simulated and Actual TEP A
Field Testing on Mammals
and birds
Aquatic Organisms Testing
72-1 Acute Freshwater F|sh ToxicityTGAI A,C
a. Warmwater
TEP A,C
c. Coldwater TGAI A,C
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Bibliographic
Citation
00096964*
GS0122039*
00096965*
00030479*
00041447*
GS0122036*
GS0122037*
GS0122038*
00003503*
GS0122034*
GS0122033*
GS0122035*
00069607*
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)23/
No
NO
NO
No
Reserved^
No
No
No
56
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CAPTAPOL
Data Requirement
Composition!/
Does EPA Have Data
TO Satisfy This
Use ?/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIPRA Section
72-2 Acute Toxicity, Freshwater
Invertebrates
72-3 Acute Toxicity, Estuarine
and Marine Organisms
Oyster
Shrimp
Marine fish
72-4 Fish Early Life Stage
and Aquatic Invertebrate
Life Cycle
72-6 Aquatic Organisms
Accumulation
72-7 Simulated or Actual Field
Testing-Aquatic Organisms
TGAI
TEP
TGAI
TEP
TGAI,PAI
TGAI,PAI
TEP
A,C
A,C
A,C
A,C
AfC
A,C
A,C
Yes
Yes
No
No
No
No
00062907*
00003503*
00097842**
No
Reserved**
Reserved?
Reserved?
Reserved7
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 non-food crop: C = Aquatic food crop? D = aquatic non-food
~~ crop? E = greenhouse food crop; P = greenhouse non food crop: G = Forestry: H = domestic outdoor: I = indoor.
3/ Data must be submitted no later than 6 months after the publication of this standard.
57
-------
TABLE A
f GENERIC DATA RT^TIRKMEKTS FDR CAPTAFOL
Footnotes (continued)
4/ Pending results of environmental fate data.
5/ Uses such as citrus (with acreage in excess of 300,000 acres in coastal counties).
6/ Data may be required to support such uses as citrus pendinq the results of environmental fate data.
7/ Data may be required pending the result of environmental fate data.
* Study fulfills requirements on its own.
** Study in conjunction with another study fulfills requirements.
58
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III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This Section 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 S3(c)(2)(B)."
^J Product specific data pertains to data that support the
formulation which is marketed; it usually includes product chemistry
data and acute toxicology data.
59
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
Data Requirement
Composition^
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)?c
EPA REG. NO. 239-2230 (97%T)a
$158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Diclosure
of Ingredients TGAI
61-2 - Description of Beginning
Materials and Manufacturing
Process TGAI
61-3 - Discussion of Formation of
Impurities TGAI
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of
Product Samples TGAI
Physical and Chemical Characteristics
Yes
Partially
No
GS0122030
GS0122032
Partially
GS0122028, GS0122030
a The 97% technical (T) also serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient: PAI = pure active ingredient.
c Data must be submitted no later than 6 months from the date of this Standard.
No
Yes
Yes
Yes
63-2
63-3
63-4
63-5
63-6
63-7
- Color ,„
- Physical State
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
N/A^
TGAI
Yes
Yes
Yes
Yes
N/A
No
/
GS012202Q
GS0122029
GS0122029
GS0122029
No
No
No
No
No
No
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
Data Requirement
Composition*3
Does EPA Have Data
To Satisfy This
Requirement? (Yesf
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
EPA REG. NO. 239-2230 (97%T)a
$158.120 Product Chemistry (continued)
63-R - Solubility
63-Q _ vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/ Water Partition
Coefficient
63-12 - pH
63-13 - Stability
other Requirement;
64-1 - Submittal of Samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
Partially
No
No
No
No
Yes
N/A
GSni22051
GS0122050
Yes
Yes
Yes
Yes
Yes
No
No
a The 97% technical (T) also serves as a manufacturing-use product.
b Composition: TGAI = technical grade of the active ingredient; PAI = pure active ingredient.
c Data must be submitted no later than 6 months from the date of this Standard.
61
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MAMFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
Data Requirement
Composition"
V
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)?V
§158.135 Toxicology
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation Toxicity
-Rat
- Primary Eye
Irritation - Rabbit
- Primary Dermal
Irritation
- Dermal Sensitization
MP
MP
MP
MP
MP
MP
Yes
Yes
No
Yes
Yes
Yes
GS 0122046
GS 0122046
-
GS 0122049
00087538
00014690
No
No
Yes (6 months)
No
No
No
62
-------
TABLE B
PRODUCT SPECIFIC DATA RETIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CAPTAFOL
$158.135 Toxicology
(continued)
I/ Composition: MP = Manufacturing-use product.
2!/ Data must be submitted no later than 6 months from the date of receipt of this Standard.
63
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IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
- Note: This section applies to end-use products only to the
extent described under Section II of this document. Otherwise,
the following information pertains exclusively to manufacturing-
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 S162.11(c)], pack-""
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
IV-1 and IV-2], as indicated by the following paragraphs of this
chapter of the guidance document.
If owners of currently registered products fail to submit
revised labeling and packaging information complying with this
Section and/or Section II, EPA may issue a notice of intent to.
cancel the registration under FIFRA $6(b)(l).
A. Label Contents
40 CFR S162.10 (Appendix IV-1) requires that certain spe-
cific 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 the table
entitled: "Labeling Requirements of FIFRA, As Amended".
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. See Appendix
IV-1. [40 CFR Sl62.10(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.
See Appendix IV-1. [40 CFR Sl62.10(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
64
-------
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. See Appendix IV-1. [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. See Appendix IV-1.
[40 CFR Sl62.10(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. See Appendix IV-1. [40 CFR S162.10(£)]
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. See Appendix IV-1. [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.
65
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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.
See Appendix IV-1. [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. See Appendix IV-1.
[40 CFR S162.10 (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. See Appendix IV-1. [40 CFR
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. See Appendix IV-1. [40 CFR 5162.10
-------
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. 'See Appendix IV-1. [40 CFR §162.10
Item SB. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CFR
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 incnes, 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).
67
-------
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
S163.61-10(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."
See Appendix IV-1. [40 CFR 5162.10(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 usa
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-4 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR OSE - 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. See
Appendix IV-1. [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.
68
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be'addressed as follows:
Henry M. Jacoby, Product Manager 21
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Phone No. (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 (Aopendix
III-l).
c. Two copies of any required product-specific data.
^ <
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms
to the requirements of this guidance document and the
results of the short-term data, the registrant may
submit such labeling. (End-use product labeling
needs to comply specifically with the instruction in
Section II of this guidance document.) The labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for
stortage in 8-1/2 x 11 inch files. The draft label
must indicate the intended colors of the final label,
clear indication of the front panel label, and the
intended type sizes of the text.
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.
After the Supreme Court has ruled on the Monsanto Decision,
you will be informed as to when you must submit your Application
for Amended Pesticide Registration (EPA Form 8570-1) and the
associated data support information.
: 69
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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
70
-------
Appendix II-l
(continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
71
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Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
MRID No.
00025129 Cheng, H.M. 1976. Metabolism of carbonyl-14C-difolatan in young
tomato and corn plants. Chevron Chemical Co. File No. 721.14.
Dated December 2 and submitted by Chevron Chemical Co. under
PP#7F1962(099190).
00025130 Cheng, H.M. 1976. Absorption, translocation, and metabolism of
[carbonyl-l^JTHPI in young tomato plants. Chevron Chemical Co.
File No. 721.14. Dated August 16 and submitted by Chevron Chemical
Co. under PPI7F1962(099190).
00096919 Pack, D.E. 1973. 14C-difolatan uptake from soil by carrots - EPA
protocol. Chevron Chemical Co. File No. 773.21/Difolatan. Dated
October 12. Submitted by Chevron Chemical Co. as Reference No. 4
in "Difolatan fungicide - Supplementary Environmental Data"
(120308).
00096916 Pack, D.E. 1973. The soil metabolism of carbonyl-14C-difolatan.
Chevron Chemical Co. File No. 773.21. Dated November 287.
Submitted By Chevron Chemical Co., as Reference No. 1 in "Difolatan
fungicide - Supplementary Environmental Data" (120308).
00072884 Pack, D.E. 1980. Analysis of soybeans grown from seeds treated
with 14C-captafol - greenhouse study. Chevron Chemical Co. File
No. 721.14. Dated July 21. Submitted by Chevron Chemical Co. to
RGB.
0081808 Potter, J.L. 1965. Preliminary studies on the j.n vitro degradation
of difolatan by crop macerates and filtrates. Dated May 5,
prepared by the California Chemical Co., and submitted by
Chevron Chemical Co. under PP#5G0453(114475) and PP#6F0492(1114612).
05003661 Solel, Z. and L.V. Edgington,. 1973. Transcuticular movement of
fungicides. Phytopathology, Vol. 63, April, pp. 505-510. (Not
registrant submitted.)
00096829 California Chemical Co. 1965. Technical Report Nos. 5K7926 and
5K7945. Submitted under PP#5G0453(114475). ^
00096830 California Chemical Co. 1965. Technical Report Nos. 5K7926 and
5K7945. Submitted under PP#5G0453(114475).
72
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Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
MRID No.
00025952 Cheng, H.M. of Chevron Chemical Co. 1977. Metabolism of difolatan
in chickens. Report dated November 3, 1975. Submitted under
PP#7F1962(096160).
00025119 Cheng, H.M. of Chevron Chemical Co. 1977. Metabolism of 14C-
carbonyl captofol in rats-characterization and quantification of
*4C in tissues. Report dated February 26, 1979. Submitted under
PP#7F1962(099190).
00025120 Cheng, H. M. of Chevron Chemical Co. Metabolism of [carbonyl-14C]
THPI and [carbonyl-l4C]THPI-epoxide by rats. Report dated June 15,
1979. Submitted under PP#7F1962(099190).
00025124 Cheng, H. M. of Chevron Chemical Co. Metabolism of carbonyl 14C
captafol in a lactating goat. Report dated July 9, 1979. Submitted
under PP#7F1962(099190).
00025127 Crossley, J. of Chevron Chemical Co. The stability of difolatan
in human blood. Report dated October 4, 1967. Submitted under
PP#7F19692(099190).
00061996 Crossley, J. of Chevron Chemical Co. Difolatan: fate in animals.
Report dated October 29, 1968. Submitted under PP#9F0797(115899).
00053240 Crossley, J. of Chevron Chemical Co. The fate of difolatan in a
lactating ruminant (goat). Report dated June 10, 1970. Submitted
under PP#9F0797(115899).
00096902 Lee, H. of Chevron Chemical Co. Metabolism of difolatan in rats:
identification of urinary metabolites. Report dated February 28,
1972. Submitted under PP#7F1962(096160).
00096847 California Chemical Co. 1964. Difolatan residue analysis-thin
layer chromatographic method (Method RM-6). Submitted under
PP#5G0453(114470).
00096848 California Chemical Co. 1964. Difolatan metabolism - the analysis
of residues of dichloroacetic acid using microcoulometric gas
chrcmatogrpahy (method RM-6C) Submitted under PP#5G0453(114470).
73
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
MRID No.
00096843
00091215
00091214
00052318
0031709
00025123
00096911
00025123
00025133
00091274
00096889
California Chemical Co. 1965. The analysis of residues of difolatan
and three tetrahydrophthalic acid derivatives (Method RM-6-D). Sub-
mitted under PP#5G0453(114473).
Chevron Chemical Co. 1965. Difolatan residue analysis by electron
capture gas chronatography (Method RM-6B). Submitted under
PP#6F0492(114607).
Chevron Chemical Co. 1965. Difolatan residue methods - a comparison
of RM-6 and RM-6B for several crops. By P. Berteau. Submitted
under PP#6F0492(114607).
Chevron Chemical Co. 1966. Difolatan residue analysis - thin layer
chromatographic method (Method RM-6, revised). Submitted under
PP#6F0492(114607).
Chevron Chemical Co. 1973. Addendum to RM-6B for determination of
residues of difolatan in sweet corn, tomatoes, and peanuts. Submitted
under PP#3F1412(118300).
Chevron Chemical Co. 1975. Determination of captafol residues by
gas chromatography method RM-6E-1. Submitted under PP#6E1775.
Chevron Chemical Co. 1976. Determination of residues of captan
and its metabolites in animal tissues (Method RM-1G-1). Submitted
under PP#7F1962(096160).
Chevron Chemical Co. 1978. Determination of captafol residues by
gas chronatography method RM-6E-2. Submitted under PP#7F1962(099190).
Chevron Chemical Co. 1979. Determination of captafol, captan,
THPI, and 3-OH THPI in tissues and eggs and determination of captan
THPI, 3-OH THPI, and 5-OH THPI in milk and cream. Submitted under
PP#7F1962(099190).
Chevron Chemical Co. 1979. Determination of residues of THPI in
crops - Residue Method RM 6J-1 and RM 1J-1. By E.J. Elliott, J.C.
Lai and F.J. Schwab. Submitted under PP#8F2047(070837).
Chevron Chemical Co. 1966. Storage stability of difolatan
residue samples. File: 741.10/Difolatan. Test Nos. 712-716,
776, 831, and 871. Submitted under PP#6F0492(114611).
IR-4. Rutgers University. 1976. Test Nos. 3210, 3209, 3241,
3011, and 3202-3205 in Section D of PP#6E1175 (undesignated
accession number).
74
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
MRID No.
00096828
00096817
00096858
00097842
00069607
00062907
00030479
00096964
Chevron Chemical Co. 1966. Residue data sheets for experiment
T-714. Section D. PP#6F0492(114607).
Chevron chemical Co. 1967. Test Nos. 710, 716, 717, 869, and
870. Residue data sheets in Section D of PP#6F0492(114607).
Chevron Chemical Company. 1966. Section A of PP#6F0492(114510).
Sanders, H.O. (1969) Toxicity of Pesticide to the Crustacean
Gammarus iacustris. By U.S. Fish and Wildlife Service, Fish-Pesticide
Research Laboratory. Washington, D.C.: USFWS, (Technical papers
of the Bureau of Sport Fisheries and Wildlife 25; Stauffer T-2214;
published study; CDL:246020-K)
Thompson, C.M.; Griffen, J.; Boudreau, P.; et al. (1980) Acute
Toxicity of Difolatan Technical (Sx-945) to Bluegill Sunfish
("Lepomis macrochirus11): ABC Report #26575/#26576. (Unpublished
study received Feb 2, 1981 under 239-2369; prepared by Analytical
Bio Chemistry Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif., CDL:244371-8)
Forbis, A.D.; Boudreau, P.; Cranor, W.; et al. (1980) Static Acute
Toxicity of Difolatan Technical (SX-945) to "Daphnia magna" (S-
1798): ABC Report # 25857. (Unpublished study received Nov 19,
1980 under 239-2211; prepared by Analytical Bio Chemistry
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:243833-A)
Beavers, J.B.; Fink, R. (1979) Final Report: One-Generation
Reproduction Study—Mallard Duck: Project No. 162-109. (Unpublished
study including addendum and letters dated Dec. 1, 1978; Mar 1,
1979; Apr 2, 1979 and Nov 14, 1978 from J.B. Beavers to Francis X,
Kamienski, received Feb 21, 1980 under 239-2211; prepared by
Wildlife International, Ltd., submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:099267-A)
Fink, R.; Beavers, J.B.; Grimes, J.: et al. (178) Final Report:
Acute Oral 11)59—Bobwhite Quail: Difolatan Technical: Project No.
162-101. (Unpublsihed study received Dec 13, 1978 under 239-2211;
prepared by Wildlife Internatioanl Ltd, and Washington College,
submitted by Chevron Chemical Col, Richmond, Calif.; CDL:236618-A)
75
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
MRID No.
00096965 Fink, R.; Beavers, J.B.; Grimes, J.; et al. (1979) Final Report:
Eight-day Dietary ICso—Bobwhite Quail: Difolatan Technical (SX-
945): Project No. 162-114. (Unpublished study received Mar 13,
1979 under 239-2211; prepared by Wildlife International Ltd. and
Washington College, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:237803-8)
00041447 Beavers, J.B.; Fink, R.; Grimes, J.; et al. (1979) Final Report;
One-Generation Reproduction Study—Bobwhite Quail: Project No. 162-
108. (Unpublished study including addendum and letters dated
Dec. 11, 1978; Mar 1, 1979; Apr 2, 1979; Apr 25, 1979 and Nov 14,
1978 from J.B. Beavers to Francis X, Kamienski, received Feb 21, 1980
under 239-2211; submitted by Chevron Chemical Co., Richmond,
Calif., CDL:099267-B)
00003503 Johnson, W. and M. Finley 1980. Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates. USDI Publication
137, Washington, D.C.
00014690 Cavalli, R.D. (1970) Skin Sensitization Potential
of RE 12,420 (75% SS):SOCO 156/111:85. (Unpublish-
ed study received Jun 21, 1972 under 239-EX-61;
submitted by Chevron Chemical Co., Richmond, Calif.
CDL:223505-U).
00046435 Shirasu, Y., M. Moriya, K. Kato, A. Furuhashi,
and T. Kada; (1976) Mutagenicity Screening of
Pesticides in the Microbial System. Mut.
Research 40, 19-30.
00061996 Crossley, J. (1968) Difolatan: Fate in Animals:
File No. 721.14. (Unpublished study received Apr
15, 1969 under 9F0797; submitted by Chevron Chem-
ical Co., Richmond, Calif.; CDL:091370-E)
00087538 Cerkanowicz, D.A. (1981) The Skin Irritation Pot-
ential of Difolatan 80 WDG: Socal 1837 (S-1977). *
(Unpublished study received Dec 1, 1981 under
239-2495; submitted by Chevron Chemical Co., Rich-
mond, Calif.; CDL:246325-E)
00027544 Bradfield, L. G. (1980) Dominant Lethal Study of Difolatan
Technical: Socal 1354. (Unpublished study received Feb.
11, 1980 under EPA Registration File 239-2211; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:099266-A).
76
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
MRID No.
00088817 Chevron Chemical Company (1981) Difolatan Tech-
nical (SX-947) Lifetime Mouse Oncogenicity Feed-
ing Study: Socal 1330 (S-1391). (Unpublished
study received Jul 30, 1981 under 239-2211; CDL:
246380-A)
00093672 Reno, F.E., J.L. Barlow, G.A. Burdock, et. al.
(1981) Subchronic Toxicity Study in Rats: Difolatan
Project No 2107-102. Final Rept. (Unpublished
study received Dec 15, 1981 under 239-2230?
prepared by Hazleton Laboratories America, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:246577-A)
00096902 Lee, H. (1972) Metabolism of Difolatan in Rats:
Identification of Urinary Metabolites: File No.
721.14. (Unpublished study received Jun 9, 1977
under 239-2211; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:096157-D)
05001994 Robens, J.F. (1970) Teratogenic Activity of Sev-
eral Phthalimide Derivitives in the Golden Hamster.
Toxicology and Applied Pharm. 16, 24-34.
77
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
GS No.
GS0122001 Buttler, B. and W. D. Hermann. 1981. High-pressure liquid
chromatographic determination of captan, captafol, and folpet
residues in plant material. J. Agric. Food Chem. Vol. 29(2);257-
260.
GS0122002 Chevron Chemical Co. 1973. Revision of difolatan residue analysis
by electron capture gas chromatography method RM-6B. Submitted
under PP#4E1480(093931).
GS0122003 Chevron Chemical Co. 1980. Determination of captafol and THPI
residues in crops (Method RM-6K-1). Submitted under PP#8F2047
(070837).
GS0122004 Chevron Chemical Co. 1980. Determination of captafol and THPI
residues in crops (Method RM-6K-2). Submitted under PP#8F2047(070837)
GS0122005 Chevron Chemical Co. 1981. Determination of captafol and THPI
residues in coffee beans. (Method RM-6L). Submitted under
PP#8F2047(070837).
GS0122006 Ngoran, N., C.D. Ercegovich, K.D. Hickey and R.O. Mumma. 1979.
An improved analytical procedure for captafol residues in apple
wood, leaves, and fruit. J. Agric. Food Chem. Vol. 27 (6):1167-
1170.
GS0122007 Chevron Chemical Co. 1970. Test Nos. 1171, 1250, 1251, 1356,
1357 (Sample Nos. 1, 2, 4, and 5), 1430, 1501, 1543, 1715, and
1802 in Section D of PP#OF0895(116328).
GS0122008 Chevron Chemical Co. 1966. Residue data sheets for experiments T-
708, T-718, T-785, T-862. Section D. PP#6F0492(114607).
GS0122009 Chevron Chemical Co. 1966. Residue data sheets for experiments
T-1176, 1175. Section D. PP#6F0492(114605).
GS0122010 Chevron Chemical Co. 1966. Residue data sheets for experiments
T-1181, T-1182. Section D. PP#6F0492(14611).
GS0122011 Chevron Chemical Co. 1968. Residue data sheets for experiments
"T"-2647-2650, 3229-3231, 3245-3248, 2660-2663, 3249, 3250, 3252,
3253, 3424, 3580-3582, 3825, 3826, 4031, 4032, 4991, 5027, 5028.
Section D. PP#8E2062 (096918 and 099965).
78
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
GS No.
GS0122012 Chevron Chemical Co. 1971. Residue data sheets for tests
T-1608, T-1641, T-1642, T-1643, T-1644, T-1769, T-1770, T-1771, T-
1773, T-1774. Submitted in Section D. PP#1F1020(116849).
GS0122013 Chevron Chemical Co. 1973. Test nos. 977, and 2420-2424 in Section
D of PPf3F1412(118300).
GS0122014 Chevron Chemical Co. 1971. Test nos. 963, 964, 965, 1808, and
1809 in Section D of PP#1F1020(116849).
GS0122015 Chevron Chemical Co. 1970. Residue data sheets for experiments
T-1636, T-1637, T-1638, T-1872, T-1752, T-1870, T-1871. Section
D. PPfOF0895(116328).
GS0122016 Chevron Chemical Co. 1981. Test No. T-5401 in a captafol amendment
entitled Difolatan 80 Water Dispersible Granules EPA Reg. No. 239-
NEW, 12-03. Residue Chemistry Data submitted by Chevron Chemical
Co. on November 18, 1981 to RGB (under 239-2495; in Accession No.
246324).
GS0122017 Chevron Chemical Co. 1976. Test nos. 2636, 2637, 2638, 2793,
2860, 2861, 3038, 3185, 3186, 3187, 3359, and 3360 in Section D of
PPI6F1676 (no accession number available).
GS0122018 Chevron Chemical Co. 1974. Test Nos. 2628, 2629, 2630, and 2631
in Section D of PP#4G1420(118327).
GS0122019 Chevron Chemical Co. 1971. Test Nos. 966-968 and 1003 in Section
D. Submitted under PP#1F1020 (116849).
GS0122020 Chevron Chemical Co. 1970. Test Nos. 1518, 982, 1448, and 1429
in Section D of PP#OF0895(116328).
GS0122021 Chevron Chemical Co. 1966. Residue data sheets for experiment
T-1183, T-1184, T-1190. Section D. PP#6F0492(114611).
GS0122022 Chevron Chemical Co. 1970. Test Nos. 778-780, 826, 1138-1141,
1342-1349, and 1716-1718 in Section D of PP#OF0895(116328).
GS0122023 Chevron Chemical Co. 1983. 12.03. Residue chemistry data to
support an amendment to the difoloatan 4 flowable (EPA Reg. No.
239-2211-AA) label for potatoes to add sprinkler irrigation
applications. Submitted February 16, 1983 (249527).
79
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
GS No.
GS0122024 IR-4. Rutgers University. 1974. Section D of PP#4E1480(093931).
GS0122025 Chevron Chemical Co. 1966. Test Nos. 711, 890, and 891 in Section
D of PP#6F0492(1146505).
GS0122026 Chevron Chemical Co. 1966. Test Nos. 1177^and 1178. Submitted
under PP#6F0492(114605).
GS0122027 Chevron Chemical Co. 1981. Test Nos. 5400 and 5404. 12-03.
Residue chemistry data to support a new label registration for
difolatan 80 water dispersible granules. EPA Reg. No. 239-NEW.
Submitted November 18, 1981 (246324).
GS0122028 Chevron Chemical Company, Ortho Division. 1965. Ortho method of
analysis D-VIII, Difolatan by Gas Chromotography data 2/8/65,
PP#6F0492(114612).
GS0122029 Chevron Chemical Company. 1966. Data sheets for EPA Reg. No. 239-
2230 in PP#6F0492(114612).
GS0122030 Chevron Chemical Company, Ortho Divison. 1967. Data from
correspondence sent to EPA on EPA Reg. No. 239-2230 data 5/25/67,
and located in the registration jacket.
GS0122031 EPA. 1975. Captafol. EPA-1 (tentative), In Manual of Chemical
Methods for Pesticides and Devices. EPA, OTS.
GS0122032 Sittig, Marshall (ed.). 1977. Pesticides Process Encyclopedia.
Corp. Park Ridge, NJ. p.82.
GS0122033 U.S. EPA. 1980. Report on Toxicity of Difolatan Technical to
Rainbow Trout. (U.S. EPA, Chemical and Biological Investigations
Branch, Beltsville, MD. Flow Through, Test No. 2466, unpublished
report.)
GS0122034 U.S. EPA. 1976. Report on Toxicity of Captafol technical 97% to
Rainbow Trout. (U.S. EPA Chemical and Biological Investigations
Branch, Beltsville, MD. Static Jar, Test No. 7A4/76, unpublished
report.)
80
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Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
GS No.
GS0122035
GS0122036
GS0122037
GS0122038
GS0122039
GS0122040
GS0122041
GS0122042
U.S. EPA. 1980. Report on the Toxicity of Difolatan Technical to
Daphnia magna. (U.S. EPA, Chemical and Biological Investigations
Branch, Beltsville MD, Static Jar, Test No. 2458, 10/24/80,
unpublished report.)
U.S. EPA 1980. Report on Toxicity of Difolatan Technical to
Bluegill Sunfish in a Static Test. (U.S. EPA, Chemical and Biological
Investigations Branch, Beltsville, MD. Static Jar, Test No. 2465,
11/19/80, unpublished report.)
U.S. EPA. 1976. Report on Toxicity of Captafol Technical 97% on
Bluegill Sunfish. (U.S. EPA, Chemical and Bological Investigations
Branch, Beltsville, MD. Static Jar. Test No. 994, 7/14/76,
unpublished report.)
U.S. EPA. 1980. Report on the Toxicity of Technical Difolotan to
Bluegill Sunfish in a Flow-through Test. (U.S. EPA, Chemical and
Biological Investigations Branch, Beltsville, MD. Flow Through,
Test No. 2465, 11/19/80, unpublished report.)
Beavers, J.B., and R. Fink. 1979 Final Report: Eight-day
Dietary LCsQ-Mallard Duck: Difolatan Techincal (SX-945): Project
No. 162. (Unpublished study received under 239-2211; prepared by
Wildlife International ltd. and Washington College, Submitted by
Chevron Chemical Co., Richmond, Calif.; CDL:237803-B.)
Moriya, M., K. Kato, and Y. Shirasu. (1978) Effects
of Cysteine and a Liver Metabolic Activation System
on the Activities of Mutagenic Pesticides., Mut. Res.
57, 259-263
Tezuka, H., N. Ando, R. Suzuki, M. Terahata, M.
Moriya, and Y. Shirasu. (1980) Sister-Chromatid
Exchanges and Chromosomal Aberrations in Cultured
Chinese Hamster Cells Treated with Pesticides Pos-
itive in Microbial Reversion Assays. Mut. Res.
78, 177-191.
Bio/Dynamics, Inc. (1983) Teratology Study in
Rats of Difolatan Technical. Project #83-2716.
Oct. 14, 1983. (Unpublished study received under
239-2230; submitted by Chevron Chemical Co, Richmond,
Calif.; EPA Ace. No. 251812.)
81
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Appendix II-l
GS No.
GS0122043
GS0122044
GS0122045
GS0122046
GS0122047
GS0122048
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
Bio/Dynamics, Inc. (1983) Two-Generation Reproduc-
tion Study in SpragueHDawley Rats. Project #80-2530.
Oct. 10, 1983. (Unpublished study received under
239-2230; submitted by Chevron Chemical Co, Richmond,
Calif.; EPA Ace. No. 251972-251977.)
Hazleton Laboratories. (1983) 2 Year Chronic Toxicity
Study in Rats of Difolatan Technical (SX-945).
#2107-103. June 15, 1983. (Unpublished study received
under 239-2230; submitted by Chevron Chemical Co.,
Richmond, Calif.; EPA Ace. No. 250921-250924.)
Bioresearch Laboratories Ltd. (1983) Teratology
Study in the Rabbit with Captafol Technical.
#81154. Dec. 6, 1983. (Unpublished study received
under 239-2230; submitted by Chevron Chemical Co.,
Richmond, Calif.; EPA Ace. No. 253055-253056.)
Chevron Chemical Co. (1984) Toxicology Data. March
1, 1984. S-2153, 2154, 1967, and 1858. (Unpublished
studies received March 2, 1984 under 239-2230;
submitted by Chevron Chemical Co., Richmond, Calif.;
EPA Ace. No. 252599.
EG&G/Mason Research Institute. (1983) In Vivo
Cytogenetics Study in Rats with Chevron Difolatan
Technical (SX-945). Oct. 7, 1983. MRI-224-CCC-83-31
(Unpublished study received under 239-2230; submitted
by Chevron Chemical Co., Richmond, Calif.; EPA Ace.
No. 252331-252332.
Bio/Dynamics Inc. (1984) Teratology Study in Rabbits
with Captafol Technical. Feb. 22, 1984. Proj. NQ.
83-2734. (Unpublished study received under 239-2230;
submitted by Chevron Chemical Co., Richmond, Calif.;
EPA Ace. No. 248965.
82
-------
GS No
GS0122049
GS0122050
GS0122051
GS0122052
GS0122053
GS0122054
GS0122055
GS0122056
GS0122057
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
Chevron Chemical Co. (1981) Primary Eye Irritation
in Rabbits. Sept. 11, 1981. Socal 1838. (Unpublish-
ed study received under 239-EUOL; submitted by
Chevron Chemical Co., Richmond, Calif.; EPA Ace. No.
246326.
Chevron Chemical Co. 1981. 12.03. Residue chemistry data to
support a new label registration for difolatan 80 water dispersible
granules. Submitted November 18, 1981 (246324).
California Chemical Company, Ortho Division, 1963. Report
entitled "Difolatan- A Preliminary Report on It's Hydrolysis
and Related Reactions" dated 7/30/63. File No. 740.10. By
P. E. Berteau. Located in PP No. 6F0492 (114610).
Chevron Chemical Co. 1965. Difolatan residue methods - a
comparison of RM-6 and RM-6B for several crops. By P. Berteau.
Submitted under PP No. 6F0492 (114607).
Chevron Chemical Co. 1973. Revision of difolatan residue
analysis by electron capture gas chromatography method
RM-6B. Submitted under PP No. 4E1480 (093931).
Davis, J. 1978. An analysis of Exposure Data Obtained During
the Airblast Spraying of Orchards with Selected Pesticides.
Unpublished EPA Laboratory Report.
Reinert, J. C., and D. J. Severn. (?) Dermal Exposure
to Pesticides: EPA's Viewpoint. ACS Symposium Series (in print).
Jensen, J. K. 1982. Applicator Exposure Analysis, Captan Position
Document 2/3. Final Report, Environmental Fate Branch, Hazard
Evaluation Division, US EPA.
Versar, Incorporated 1984. Applicator and Mixer/Loader Exposure to
Pesticides During Ground Boon Spraying Operation, Final Report.
EPA Contract No. 68-01-6271, Task No. 48.
GS-122058 US EPA 1980. Position Document 2/3 on Wood Preseratives.
83
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Appendix II-!
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Captafol Standard
GS No
GS0122059
GS0122060
Felthausen, R. W. 1977. Data Review of Interim Report for
Experimental Use Permit for Aerial Application on Cranberries
(239-EUP-62). Data review dated January 31, 1977:
Environmental Safety, Efficacy and Ecological Effects
Branch, US EPA.
Felthausen, R. W. 1977. Data Review of Interim Report for
Experimental Use Permit for Aerial Application on Cranberries
(239-EUP-62). Data review dated May 7, 1977: Environmental Safety,
Effficacy and Ecological Effects, US EPA.
-------
Appendix .TI-2
OMB Approval No. 20004468
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
IODUCT NAME
iptlCANTS 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
D1. 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 Tatting Programme, I enclose the protocols that I will use:
D 2. 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
G 3. 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 product]):
D 5. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
EGISTRANTS AUTHORIZED REPRESENTATIVE
\
SIGNATURE
DATE
A Form 8S80-1 (10-82)
85
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Appendix "II-3
OMB Aooroval No 2OOOJM6B
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
.
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary
into an agreement with one or more other registrants to develop jointly, or to share in th
items or data:
i. However, my firm would prefer to ente
e cost of developing, the following require
1 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 b
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was mad
to the following firmfe) on the following date(s) :
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) abof
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. 1 understand EPA will promptly infon
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statemei
does not apply to applicants for new products.) 1 give EPA permission to disclose this statement upon request.
TYPED NAME SIGNATURE DATE
EPA Form 88804 (10-32) 86
-------
APPENDIX HI-1
fUJUIC? SP
SEA
NO.
SIC CKTA SEEOK?
DOCUHBC fff
-
•^^^•J^^^^K^J ^^K
•^VTXV^XXGiv^U
Qyiftal *M ^o.
S158.2)
3SOB3O
uUHUTKV
61-i
6i-Z
61-3
tt-1
&2~2
6i-3
&3-Z
s: -3
63-4
fij-3
63-o
63-7
63-3
63-9
63— ifl
o3-U
&:-i2
&-U
63-14
63-15
63-. .6
6J-.7-
6J-. .8
63-19
64-20
53-21
sisa.-us
ai-i
ai-i
ai-3
81-4
81-3
81-9
}"ffT r^ T«^t
IdKicity oc
inopBilenta
fSSS^
rn»i-t»« •].-»< gjt
^«^M^i^4^«l ««rfl
J^-^^^^^J J ^^^^
Tn^^^^i i ^^1^3
Exvliznoicv
anmlvsia
C^m.f tctiaTi 06
Idadta
Afi^LyQAftl BBtSSOOS
liiBttt
r«ii-^
PttvaiczU. stata
Odor
KBltsia ooint
Bolllna ooinr
catoicy, tulit-
dsnmity, or
Sn^tmilicy
OC9DBiAM6V
pvtitim
ffmrfflrtmtt
ca
StaBlliCT1
Ozjdu: ng/rfoucsng
?lamm«s^liC7
PiiBl^iaaHiey
Stccape arum I ipy
ViacsBirv
Mi«?'^:ti>ti1ir7
oiajocnac ISMK-
dcnn voitao*
Aetroi oral LD-50,
rat
ACUCB j i^pynji i
LD-50
Aoite mruilaiacn,
IC-50 rar
anaaey «jw
irritadcn. rabbit
izd'Cadon
tLai
Test not
*»iyi k* nu
fa: ny
product
Ustad
fc»ij3*)
1^ .H-MiB-if iri
a '.! IIIMyU
dsta reeaize
f*|Mnq |Q>fBk
—
PM tj4^«
09 <*li&B
IMTTf^ b?
SUQ&t»^
ting
Data
cu-
|HM!»«^i)
_
(Fee sat OM Only)
^jm^.qnad
87
-------
Appendix IV-1
Chapter I—Environmental Protection Agency
§11
obtained the data, from anothe
(identify): applicant copied da/
a publication: applicant obt
a coby of the data from EPA).
(dAThe applicant shall submit
his application a statement that
in its {valuation of the properties/effi-
cacy. Vnd safety of the formulated
end-use product, may not consider any
supporting the application.
following data:
data the applicant lias sub-
?A under paragraph (b) of
(1
data
except
(1)
mitted to
this sect!
(2) Oth
safety of
ents, rathi
end-use
(3) Exist
regulations.
data pertaining to the
te product's actwe ingredi-
than to the safety of the
ct; and
tolerances, food additive
xemptions/ and other
clearances issued undezf the Federal
Food. Drug, ana Cosmera Act.
(e) If the applicant mows that any
item of data he\submjfcted under this
section was generated Joy (or at the ex-
pense of) anothenpenon who original-
ly submitted the ttafa to EPA (or its
predecessor. USDAyon or after Janu-
ary 1. 1970, to support an application
lental • use
adding a new
an. or for
the applicant
' dataVsubmitter have
lent on the
termsXpf payment of
Ion that\may be pay-
section
1th regard to approval
;ion). the applicant shall
?A a statement that he
to each suck identified
, submitter
Ication of the Applicant's
includ-
for registration.
permit, or amenc
use to an existing
reregistration
and the orig
reached writ
amount and tt
any come
able unc
3(c) telephone number.
of- data
ies or ei
ijent: and
Vof data
If the applicant's produce
tairit any active ingredient other
those, that are present solely b
of theV incorporation into the p:
duringVformulation. of one
other registered pesticide «r
-------
Appendix IV-1 (continued)
§ 162.10
(iv) The product registration
number as prescribed in paragraph (e)
of this section: -
(v) The producing establishment
number as prescribed in paragraph (f)
of this section:
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this
section:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(viii) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification(s) as pre-
scribed in paragraph (j) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this pan must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger .type:
(B) Appear on a clear contrasting
background: and
< C) Not be obscured or crowded.
(3? La.nyva.ge to be •used. All required
label or labeling text shall appear-in
the English language. However, the
Asency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
Title 40—Protection of Environment
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer, if it is a pan of the package as
customarily distributed or sold.
(ii) Tank cars and other bulk con-
tainers—(A) Transportation. While 2
pesticide product is in transit, the ap-
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, marking and placarding of haz-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirements. In addition, when any
registered pesticide product is trans-
ported in a tank car, tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers,
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
ucts are stored in bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling, including
all appropriate directions for use, shall
be securely attached to the container
in the immediate vicinity of the dis-
charge control valve.
(5) False or misleading statements.
Pursuant to section 2(q)(l)
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency
§U
any agency of the Federal Govern-
mentt
(vi) The name of a pesticide which
contains two or 'more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling:
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(vul) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous," "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as* directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains- all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (1) Except
as provided in paragraph (a)(6Xli) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(II) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk'
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
labeL
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(21) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 152.S(b)(4).
(c) Name and address of prodi
registrant, or person for whom
duced. An unqualified name and
dress given on the label shall be
sidered as the name and address of
producer. If the registrant's name
pears on the label and the registry
not the producer, or if the name of
person for whom the pesticide
produced appears on the label, it &
be qualified by appropriate won
such as "Packed for • * '," "Distril
ed by • • •." or "Sold by • • •" to si
that the name is not that of the p
ducer.
(d) Net weight or measure of
tents. (1) The net weight or meas
of content shall be exclusive of wr
pers or other materials and shall
the average content unless explicit
stated as a minimum quantity. 1
(2) If the pesticide is * liquid, I
net content statement shall be
terms of liquid measure at 68* F (201
and shall be expressed in conventioi
American units of fluid ounces, pin
quarts, and gallons.
(3) If the pesticide is solid or semii
lid. viscous or pressurized, or is a m
ture of liquid and solid, the net eg
tent statement shall be in term
weight expressed as avoirdupt
pounds and ounces.
(4) In all cases, net content shall
stated in terms of the largest suits!
units, i.e.. "1 pound 10 ounces" rati
than "26 ounces."
(5) In addition to the required uu
specified, net content may be
pressed in metric units.
(6) Variation above
tent or around an average is p<
ble only to the extent that it
sents deviation unavoidable in go
manufacturing practice. Variatii
below a stated m<"
-------
Appendix IV-1 (continued)
§162.10
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments reyis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of. the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(gj Ingredient statement—(I) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents: and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert Ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be ic the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement.
(1) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
TItl« 40—Protection of Environment
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency
inert ingredfent(s) to be listed in the
ingredient statement if he determines
that such ingredient(s) may pose a
hazard to man or -the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific
ments concerning content, placem
type size, and prominence are
below.
(1) Required front panel statemt
With the exception of the c
hazard warning statement, the text
quired on the front panel of the 1
is determined by the Toxicity Cat*
ry of the pesticide. The category lj
signed on the basis of the hig;
hazard shown by any of the indicat
in the table below:
Hazard mdKatora
rM'OW
MflaMBon LC— _
"-"•••" "M
Tdflcfly caiagonas
'
Up co and Mdutng 50
mo/kg.
UD to and including 3.
mg/K«r.
Up to and 'mOuang 200
tng/ho,
Canaan*: comaal
ooacty not ra»ar«*la
M0in7daya.
II !
:
Prom 50 mm WO mg/kgj
From .2 mm 3 mg/ttar — !
From 200 mm 2000 — |
Cornaal oeaety !
ravarMla wrtrtn 7 |
days: mtabon j
parmng tor 7 day*. !
now*. ;
« 1
From 500 BWJ 5COO mg/ I
X* I
From 2. cws SS .na/Har-,
From 2.000 mm 20.000—i
NO comaa* ocaoty? j
Mthin 7 days.
Modaraia ontanen at 72 •
news. j
IV
Oraatar man 5000
"*
Sraatar man JOmj
Sraatar man 20.0M
No vntioon.
MiW of stiQftt vn&D
72 nous.
(1) Human hazard signal word—(A)
Toiicity Category L All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front -panel the signal word "Warn-
ing."
(C) Toxicity Category 111. All pesti-
cide products meeting the criteria of
Toxicity Category HI shall bear on
the front panel the signal word "Cau-
tion."
(D) Tosicity Category TV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permit
except when the Agency deternii
that such labeling is necessary to
vent unreasonable adverse effects
man or tne environment. In no c
shall more than one human haz
signal word appear on the front pa
of a labeL
(ii) Child hazard warning. Every
tlcide product label ahail bear oni
front panel the statement "keep out
reach of children." Only in a
where the likelihood of contact
children during distribution, mar
ing. storage or use is demonstrated
the applicant, to be extremely renu
or if the nature of the pesticide is si
that it is approved for use on i
or small children, may the Administ
tor waive this requirement.
(iii) Statement of practical tn
ment—
-------
Appendix IV-1 (continued;
§ 162.10
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXlXiiiXA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front paneL
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Title 40—Protection of Environment
Siza of laoai from canal n seuaf •
cncnas
„__. "Ka«o out
J3* „ i o* raacn of
££,2? ; 0**""
*(»-• • "f lfl
Aggy, 10 »J 1J
Aftov* IS to JO
OfOT
si
10 i
12 i
181
S
8
a
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals," "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans 'and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route
qurad.1.
May M fatal if mMomd fmnalad or aeaeroad
motion tti* stanj. Oo not braattw vaoon Ceust or
spray mat]. Oo not gal a *yo. an sun. or on
doming. CAopropnata1 first aid statsrnanta raouvad.].
Harmful a maiiowad Cinnatao or aeseroad motion ma
akin]. Av«J oraamng vapora tduw or »ray mat].
wMid contao wvot sjun C^wa or doiftn^j.
pnaM first ftd statarrMnt raouwo.1.
[No pracauaonaiy naiarnana raourad.]
I Corrnma. mnaa tva and nun oamaga Cor-i*u>:
I irmaaon]. Oo not gat n (yn. on slun. or on
I ctotnme. W«ar googMs or laca «Mid and njeoar
j gtovaa «rwn handling. Harmful or fatal 4 n»«ao»»d.
I CAppropnata first Jid statarnant raoutfvd.1
| Cnnai «ya (and Stan] rmanon. Oo not oat n cyaa.
on Hon. or on dotting. Harmful if iwtuomta. CAo-
propnata first aid statarnant raouvad.J
| Avoid ujinaci wim vun. cyaa or domng. in caaa of
; contact immaovtaiy ftusn «y«a or sun witn pianty of
• mnr. Gat nwolcai anannon >f mnanon
i CNo pracauoenary natanMnn raeuwva]
(U) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate, precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the circtun-
93
-------
Appendix J.V-JL
Chapter I—Environmental Protection Agency
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD» of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC» of 1 ppm or less,
the statement "This Pesticide is Toxic
to Fish" is required.
(O If a pesticide intended for out*
door use contains an active ingredient
with an avian acute oral LD» of 100
mg/kg or less, or a subacute dietary.
LCta of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
I
pesticide may result in fatalit
birds, fish or mammals, the state
"This pesticide is extremely to
wildlife (fish)" is required.
(E) For uses involving foliar ap
tion to agricultural crops, fores
shade trees, or for mosquito
ment treatments, pesticides toxi
pollinating insects must bear appi
ate label cautions.
(F) For all outdoor uses other
aquatic applications the label
bear the caution "Keep out of
ponds or streams. Do not cont
water by cleaning of equipment 01
posal of wastes."
(ill) Physical or chemical hau
Warning statements on the flama
ity or explosive characteristics of
pesticide are required as follows:
Fiaan
Raquradtaxt
(A)
Flaan pom « or Batow 3ST f-. t mare « a Raanoack it Enramaly flammaota. Contains unoar prasaura. Kacp m
any vafcw opaftng. \ *«. marks, ana h«MM wrfacaa. Do net punoura or n
i coraamar. Exposure to tampanuuras aeo»a 130* F
! BuMng.
Fits* port aMM 20* f and not o»ar 80* F or * ma \ Flammaow. Comants undar praaawa. Kaap away ten
ftama artamion a men man 1> in long at a Guinea • sparks, and opan flama. Oo not punoura or ffenarata a
el • in-lrom tna flama: j Exooawa to temparatt»ea too** 130* F may CBUM t
Comantt unoar praaaura. Oo noc uaa or wora mar naata
Kama. Oo not pgncajra or inonanta «oiua»iar. £901
tamparaajras aao«a 130* F may eauaa bmong.
(B) Nn>»aiiiii«mn COHTUM***
At or bao» 20*
I Euramaty nammarta. Kaao away from Ara. »aru. and
ABOW 20* F and not ovar 8
-------
Appendix IV-1 (continued)
§162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing' processes.
provided that:
U) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type
-------
Appendix IV-1 (continued)
Chapter 1—Environmental Protection Agency
Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (JX1) and (2) of this
section. Any pesticide product for
which some uses are classified for gen-
eral use and others for restricted use
shall be separately labeled according
to the labeling standards set forth in
this subsection, and shall be marketed
as separate products with different
registration numbers, one bearing di-
rections only for general use(s) and
the other bearing directions for re-
stricted use<5) except that, if a product
has both restricted use(s) and general
use(s). both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of i 162.KKJX2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified ceneral shall be la*
beled with the exact words "General
Classification" 'mmediately below the
heading "Oiret tions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbranding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use das-'
sification on the front panel as de-
scribed below:
(i) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set in type
of the same minimum sizes as requi
for human hazard signal words (
table in § 162.10(h)(lXiv)). and app«
ing with sufficient prominence relat
to other text and graphic material
the front panel to make it unlikely
be overlooked under customary con
tions of purchase and use, the su
ment "Restricted Use. Pesticide" si
appear. '
(B) Directly below this statement
the front panel, a summary statenn
of the terms of restriction imposed
a precondition to registration si
appear. If use is restricted to certifl
applicators, the following statement
required: "For retail sale to and
only by Certified Applicators or p
sons under their direct supervision a
only for those uses covered by the C
tified Applicator's certification,"
however, other regulatory restrict!!
are imposed, the Administrator i
define the appropriate wording fort
terms of restriction by regulation.
(k) Advertising. [Reserved]
.[40 PR 28268. July 3, 1975: 40 PR 33
AUK. 1. 1979: 40 FR 36571. Aug. 21. 197!,
amended at 43 FR 5786. Feb. 9.19781
Lll Criteria for determinations of
unable advene effects.
teria for Issuance of Not
(a)
Intent
Repist
(1)
sumption
intent to
section 3(c)(
intent to
to section
notice of intent
determine whet
should be cancel!
propriate, shall
termination by t
the pesticide m<
the criteria
graph (a)(3)
determinati
shall
the appli
may be,
regis'
su
P
Registration, Cq
• to Hold a Heat
', (i) A rebuttahfe pi
arise that a notice
registration
of the Act,/ notice
registration pursui
) of tlfe Act. or
ho]* a hearing
registratl!
denied, as
led. upon at
inistrator th
or*
be
set
:ceeds any
irth in pai
su
itrati
by certifie\ mail
,eca
that the applicant
the opportune
in rebuttal of
this sectlor
the
on in accordance with
(a)(4) of this section. The apt
or registrant shall have f orty-fi
96
-------
APPENDIX IV-2
LABELING REQUIREMENTS OP THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6D
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
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front -
panel or end
of label text
Bottom rront
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
t
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.
97
-------
AfiBENDIX IV-2 (Continued)
ITEM
7C
7D
7E
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
Envi ronmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
I
(
,
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.
98
-------
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
cholines terase
inhibitors
All products
All products
PLACEMENT ON LABEL
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
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
I
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
99
-------
S1MPT2
PRODUCT
NAME
i Vfi
USE.
pssncce
PRODUCT
NAME
Seatrl ctad 7ae r-s-tl
100
-------
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 tnan 13 incnes
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. Flasnpoint 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.
101
-------
Appendix iv-4
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 tne directions for use portion of
tne label under'the Heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include tne Heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under .........6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30. .12 point
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,
Eacn 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 handl'ing 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.
102
-------
Appendix iv-4
(continued)
4. Instructions on wnat 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 otner
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 tne
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:
103
-------
Appendix iv-4
(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 tne nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear tfte following pesticide disposal
statement:
"Wastes resulting from tne 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 tfte
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trasn."
C. Container Disposal Instructions
Tne label of eacft product must bear container disposal
instructions appropriate to tne type of container.
1. All products intended for domestic use must bear one
of tne following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trasft.
Do not reuse bag. Discard bag in trasn.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
104
-------
Appendix
(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)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
otner procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaJcing 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
reused1, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill oir 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.
105
-------
Appendix IV-4
(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);
Acroiein
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
Oieldrin
0,0-Diethyl S-[2-ethyIthio)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-cyclohexylpnenol
2,4 Dinitrophenol
Oinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
106
-------
Appendix
(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)
Tetraetnyl 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).
107
-------
Appendix IV-4-
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F* List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)ptnalate
Cacodylic acid
Carbon tetracbloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclonexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta[c,d]-pentalen-2-one
(Jcepone, cnlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12 )
3,5-Dichloro-N-(1rl-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
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 4f4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
108
-------
Appendix
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Isobutyl alconol
Lead acetate
Lindane
Maleic nydrazide
Mercury
Metnyl alcohol
Metnyl bromide
Metnyl cnloride
2,2'-Metnylenebis (3,4,6-tricnloropnenol) (nexacnlorophene)
Metnylene cnloride
Metnyl etnyl Ice tone
4-Metnyl-2-pentanone (metnyl isobutyl Icetone)
Napntnalene
Nitrobenzene
p-Nitrophenol
Pentacnloroetnane
Pentacnloronitrobenzene (PCNB)
Pentacloropnenol
Pnenol
Pnospnoroditnioic acid, 0,0-dietnyl, metnyl ester
Propylene dicnloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4 r5-Tfetracttlorobenzene
1e1f2,2-Tetracnloroetnane
Tetracnlorcetnylene
2,3,4,6-Tetracftloropnenol
Ttiiram
Toluene
1,1,i-Tricnloroetnane
Tricnloroetnylene
Tricnloromonofluorometnane (Freon 11 )
2,4,5-Tricnloropnenol
2,4,6-Tricnloropnenol
2,4,5-Tricnloropftenoxyacetic acid (2,4,5-T)
Xylene
109
-------
Appendix IV-4
(continued)
'Toxic" Commercial' Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Ace topne none
Acrylic acid
Aniline
Benzene
Chlorobenzene
Cnloroforra
Cyclonexane
Cyclonexanone
Dicnlorodifluororaetiiane (Freon 12 )
Dietnyl pntnalate
Dimetnylamine
Dimetnyl pntnalate
1,4-Dioxane
Etnylene oxide
Formaldenyde
Formic acid
Isooutyl alconol
Meleic anhydride
Metnyl alconol (metnanol)
Metftyl etnyl ketone
Metnyl metnacrylate
Napntnalene
Saccnarin and salts
Thiourea
Toluene
1,1,1-Tricnloroetnane
1,1,2-Tri cnloroe tnane
Tricnlorofluororaetnane (Freon
Vinyl cnloride
Xylene
110
-------
EPA Index to Pesticide Chemicals
CAPTAFOL*
TYPE PESTICIDE; Fungicide/Acaricide
FORMULATIONS; Tech (97%); D (35%, 60%, 65%); WP (25%, 70%, 80%);
EC (39%); F1C (27%, 4 Ib/gal)
GENERAL WARNINGS AND LIMITATIONS; Dosage rates are expressed in active
ingredient (exceptions are registration number 3008-27 which is used for
surface mold control and 239-2313 listing uses for peach and nectarine).
Agricultural Crop Tolerances; All are listed at individual crop sites.
Site and Pest
AGRICULTURAL CROPS
Apple
Apple scab
(venturia)
Dosages and Tolerance, Use, Limitations
Formulation(s)
0.25 ppm
No preharvest interval through
12.0 pounds per acre. Do not
prune following captafol
application. Do not apply oil
after captafol application as
phytotoxicity may occur. Captafol
applications later than 1/4 inch
green tip stage may produce foliage
injury and/or fruit russeting.
0.8 lb/100
gal
[use up to
600 gal/A]
(80% WP)
12.0-20.0 lb/
A [Use 100
to 400 gal]
(4.0 Ib/gal
F1C)
(80% WP -
granular
size)
Dormant or delayed dormant applica-
tion. Apply a single spray at up
to 1/4 inch green tip stage
of growth.
/04001AA
FEAJVAG
Use limited to Midwestern and
Eastern States. Dormant or delayed
dormant application. Make a single
application during dormant period
or up to 1/4 inch green tip stage.
Use the higher rates and gallonage
for larger trees. This application
gives scab protection through the pink
stage. For later scab protection, use
another suitable fungicide.
* (cis-N- ((1,1,2,2, -tetrachloroethyl) thio) -4 cyclohexene-1,2,-dicarboximide)
Issued; 09-24-81
Revised; 08-24-84
11-081701- 1
-------
EPA Index to Pesticide Chemicals
Site and Pest
Apple (continued)
Apricot
Scab (Cladosporium)
Brown rot blossom
blight
Blueberry
Fusicoccum canker
CAPTAFOL
Dosage and Tolerance, Use, Limitations
Formulation(s)
5.0 lb/100
gal
[use up to
400 gal/A]
(4.0 Ib/gal
F1C)
400 gal/A
(80% WP)
or
1.5 fl oz
(3 tbls)
27% FlC/gal
(27% F1C)
0.8-1.0 lb/
100 gal
(80% WP)
2-4 Ib/A
[use 20-250
gal/A]
(4.0 Ib/gal
F1C)
(80% WP -
granular
size)
Use limited to Midwestern and
Eastern States. Dormant or
delayed dormant application.
Make a single application during
dormant period or at up to 1/4 inch
green tip stage. Use the higher
gallonage for larger trees. This
application gives scab protection
up to petal fall. For later scab
protection, use another suitable
fungicide.
30 ppm /05001AA
No preharvest interval through
12.8 pounds per acre.
rates in fall before rains begin
and repeat in late winter prior to
bud swell or apply higher rates as
single treatment after leaves have
dropped or prior to fall rains.
Delayed dormant and foliar FEAJCCV
application. Use sufficient spray FBADMCB
per acre depending on size of tree
to provide full coverage. Apply
at prebloom, full bloom, petal fall
and shuck split and repeat at 10 to
14 day intervals though harvest. Do
not apply after shuck split in
California, Oregon, or Washington,
or if fruit is to be dried.
25 ppm /01009AA
21 day preharvest interval through
4.0 pounds per acre.
Delayed dormant and foliar applica- FDAAFAN
tion. Begin applications at bud
break and repeat at 4 to 6 week
intervals. Resume application immedi-
ately after harvest and continue
through leaf drop.
Issued: 09-24-81
Revised: 08-24-84
II-081701-2
-------
EPA Index to Pesticide Chemicals
Site and Pest
Blueberry (continued)
Mumnyberry
Phomopsis twig
blight
Anthracnose fruit
rot
Cherry (sweet)
Brown rot blossom
blight
Cherry (sour)
Cherry leaf spot
(cocccmyces)
CAPTAPOL
Dosages and Tolerance, Usef Limitations
Formulation(s)
2-4 Ib/A
[use 20-250
gal/A]
(4.0 Ib/gal
F1C)
(80% WP -
granular
size)
2-4 Ib/A
[use 20-250
gal/A]
(4.0 Ib/gal
F1C)
(80% WP -
granular
size)
0.8-1.6 lb/
100 gal
(80% WP)
0.4-1.0 lb/
100 gal
(80% WP)
(80% WP -
granular
size)
Delayed dormant and foliar
applications. Begin applications
at early green tip stage and repeat
at 1 to 2 week intervals throughout
petal fall.
FIBMMCB
FBAEPBU
Foliar application.
Begin applications at full bloom and
repeat at 10 to 20 day intervals.
FAAAGAN
2 ppm /05002AA
No preharvest interval through 1.6
pounds per 100 gallons.
Use limited to California and Oregon. FBADMCB
Delayed dormant and foliar appli-
cation. Use sufficient spray per acre
depending on tree size to provide
thorough coverage. Apply at prebloom,
bloom and petal fall.
50 ppm /05002AA
No preharvest interval through 9.0
pounds per acre.
Foliar application. Use sufficient FMBCCDJ
spray per acre depending on the tree
size, to provide thorough coverage.
Begin applications at petal fall and
repeat at 10 day intervals for 3 to
4 applications, then make a final
application to the foliage after
harvest.
Issued: 09-24-81
Revised: 08-24-84
II-081701-3
-------
Site and Pest
Cherry (sour)
(continued)
Brown rot blossom
blight
Brown rot fruit
rot
Cherry leaf spot
(Coccomyces)
EPA Index to Pesticide Chemicals
CAPTAPOL
Dosages and Tolerance/ Usef Limitation
Pormulation(s)
Use limited to Monmorency variety -
to be mechanically harvested.
1.0 lb/100 Foliar application. FBADMCB
gal Use sufficient spray per acre,
(4 Ib/gal depending on the tree size, to
FlC) provide thorough coverage. Begin
(80% WP - applications at popcorn stage of
granular blossom development. During periods
size) of wet weather repeat application at
2 to 4 day intervals through petal
fall.
1.0 lb/100 Foliar application. FIALMCB
gal Apply during wet weather or when
(4 Ib/gal conditions are favorable for disease
FLC) development. Begin at petal fall or
(80% WP - when leaves first unfold and repeat
granular at 10 day interval. Do not exceed
size) 4 applications.
•v.
0.5-1.0 lb/ (a) seasonal program and post harvest FMBCCDJ
100 gal control. Foliar application. Use
(4 Ib/gal FlC) sufficient spray per acre for thorough
coverage. Begin application at petal
fall or when leaves unfold and repeat
at approximately 10 day intervals for
3 to 4 applications. Make one applica-
tion after harvest. Use the higher
rate during periods of wet weather or
when conditions are favorable for
disease development.
3 lb/100 gal (b) Reduced application program.
[up to 300 Foliar application. Use maximum
gal/A] gallonage on mature trees. Make
(4 Ib/gal FlC) single application at petal fall or
when leaves unfold for control
through harvest.
Issued: 9-24-81
Revised: 08-24-84
II-081701-4
-------
EPA Index to Pesticide Chemicals
Site and Pest
Corn (field)
Damping off and
seed rot
Cotton
(Acid delinted seed)
Damping-off and
seed rot
(Machine delinted
seed)
Damping-off and
seed rot
Cranberry
Fruit Rot
Cucumber
CAPTAFOL
Dosage and Tolerance, Use, Limitations
Formulation(s)
N.F.
0.47 oz/bu Seed treatment. Apply as a water
or slurry.
0.875 oz/100
Ib
(70% WP)
/28006AA
FKAIQBB
N.F.
/28007AA
0.094 Ib/
100 Ib seed
(4 Ib/gal
F1C)
Seed treatment. For use in slurry
treaters. Do not allow to stand over-
night. Clean out equipment thoroughly
between treating operations. Shake,
roll or agitate container to improve
uniformity.
FKAIQBB
Ib seed
(4 Ib/gal
F1C)
0.141 lb/100 Seed treatment. For use in slurry FKAIQBB
treaters. Do not allow to stand over-
night. Clean out equipment thoroughly
between treating operations. Shake,
roll or agitate container to improve
uniformity.
8 ppm /01010AA
50 day preharvest interval through
5.0 pounds per acre.
Foliar applications. Vary the rate FIBFQBB
according to the plant size. Apply
at bloom and repeat at 10 to 14 day
intervals for a total of 3 appli-
cations each year.
3-5 lb/100-
300 gal/A
(4 Ib/gal
F1C)
(80% WP -
granular
size)
2 ppm /10010AA
No preharvest interval through 3.5
pounds per acre.
Issued: 09-24-81
Revised: 08-24-84
II-081701-5
-------
EPA Index to Pesticide Chemicals
Site and Pest
Cucumber (continued)
Alternaria leaf
blight
Anthracnose
Downy mildew
Gummy stem blight
blight
Scab
Fruit rot
(Belly rot)
CAPTAPOL
Dosage and Tolerance, Use, Limitations
Pormulation(s)
1.20-1.6 Ib
A
[Use 50-150
gal/A]
(4 Ib/gal
F1C)
(80% WP)
3.25 Ib/A
[use 30-50
gal/A]
(4 Ib/gal
F1C)
Foliar application. Apply when FBATAAX
first tree leaves appear and continue
at weekly intervals. Adjust rate of FAAACDP
water per acre used to obtain FFABPEA
thorough coverage. FBACMCO
FFAJCCV
Grapefruit
Lemon
Lime
Orange (including Murcott Honey
and Temple cultivars)
Tangerines
Melanose
Scab
Citrus rust mite*
Use limited to Southeastern United FIACRAM
States. Foliar and soil application.
Make at single application after last
cultivation or when vines begin to
run. Direct spray to the bed soil.
0.5 ppm /02002AA
Do not apply to any citrus when /02004M
mature fruits are on the tree. Do /02005AA
not concentrate more than 2 times /02006AA
when tank mixing with Boron
formulations. Do not tank mix /02008AA
with Boron or technical manganese
formulations for aerial application.
Nixing captafol and spray oils will
cause phytotoxicity.
Use limited to Florida on fruit FIBLDAP
for processing. Foliar application. FEAJEAH
Apply up to 2000 gallons per acre, ILAJBCA
depending on the size of tree or
or equivalent amount per acre as a
concentrate spray. Use the higher
rate on groves with a history of
severe scab.
Foliar applicaton by air. Use a
suitable spreader-sticker. Do not
concentrate more than 1:1 with water,
or use 10 gallons finished spray per
acre. Apply as a delayed dormant spray
after crop harvest and crop hedging or
pruning. Apply only in groves equipped
with overhead irrigation since rain-
fall or overhead irrigation during
dry seasons is required to redistribute
the captafol to newly developed leaf
and fruit growth.
*"rust mite" control is an acaricidal (insecticidal) claim, not fungicidal.
3.2-4.0 Ib/
100 gal
[use up to
2000 gal/A]
(4 Ib/gal
F1C)
12 lb/10
gal/A
(4 Ib/gal
F1C)
Issued: 09-24-81
Revised: 08-24-84
11-081701-6
-------
EPA Index to Pesticide Chemicals
Site and Pest
Grapefruit
Orange
Tangerine
Melanose
Scab
Macadamia Nuts
Raceme (Blossom
blight) (Botrytis)
CAPTAFOL
Dosage and Tolerance, Use, Limitations
Formulation(s)
0.5 ppm
Do not apply to any citrus when
mature fruits are on the trees.
Captafol can cause a rind spotting
when applied to young citrus fruit.
Do not concentrate sprays above
6 times the ground concentration
when tank mixing with Boron formu-
lations. Do not mix captafol
and spray oils. Do not tank mix
with Boron for aerial application.
/02002AA
/02006AA
/02008AA
0.8-1.0 lb/
100 gal
[use up to
2000 gal/A]
(4 Ib/gal
F1C)
5.0 lb/10
gal/A
(4 Ib/gal
F1C)
1.6 lb/100
gal [use 700
gal/A]
or
1.6 lb/10
gal [use 70
gal/A] for
mist blower
application
(80% WP)
or
11 lb/700
gal/A
or
Use limited to Florida to fruit
for processing. Foliar application.
Use maximum gallonage for larger
trees or equivalent amount per acre
as a concentrate spray. Use higher
rate on groves with a history of
severe melanose.
V.
Foliar application by air. Use on
orange or temple oranges for
processing and on temple oranges for
fresh market. Apply as a post-bloom
spray (from 2/3 petal fall to 3 weeks
after petal fall).
0.1 ppm
No preharvest interval through 11.2
pounds per acre.
Use limited to Hawaii. Delayed
dormant & foliar application.
Apply at weekly intervals during the
bloom period of February and March.
Apply twice weekly during periods
of severe infection. Follow small
gallonage recommendation for mist
applications.
FIBLDAP
FEAJEAH
/03007AA
FBADBAW
Issued: 09-24-81
Revised: 08-24-84
11-081701- 7
-------
Site and Pest
Macadcmia Nuts
(continued)
Melons (cantaloupe,
honey dew, musk-
melon & others)
Alternaria leaf
blight
Downy mildew
Anthracnose
Gummy stem blight
Nectarine
Coryneum blight
Peach leaf curl
Onion
Purple blotch
Downy mildew
Botrytis (blight)
EPA Index to Pesticide Chemicals
CAPTAPOL
Dosage and Tolerance, Use, Limitations
Formulations
11 lb/70
gal/A
for mist
blower appli-
cation
(4 Ib/gal flC)
5 ppm
No preharvest interval through 2.5
pounds per acre.
1.25-2.5 lb/ Foliar application. Apply gallonage
A [use 100 level as required to obtain through
coverage. Begin application when
first tree leaves appear and repeat
at weekly intervals.
/10001AA
to 150 gal/
A]
(80% WP)
(4 Ib/gal
FlC)
6.4-12.8 lb/
A
(80% WP)
or
1.5 fl. oz.
27% FlC/gal
(27% FlC)
1.25 lb/100
gal/A
(4 Ib/gal
2 ppm
Dormant application. Use up to 400
gallons water per acre or sufficient
water to cover. Apply lower rate in
the fall before rains begin and
repeat in late winter prior to bud
swell; or apply the higher rate as
a single treatment after leaves have
dropped prior to fall rains.
0.1 ppm
No preharvest interval through 1.25
pounds per acre.
Foliar application. Begin applica-
tions when disease first appears and
repeat at 7-10 day intervals.
FBATAAX
FFABPEA
FAAACDP
FBAQMCO
/05003AA
FBAZCEL
FEAGTAB
/14011AA
FCAEAAX
FFABPAU
FBAABAW
Issued: 09-24-81
Revised: 08-24-84
11-081701- 8
-------
Site and Pest
EPA Index to Pesticide Chemicals
CAPTAPOL
Dosage and Tolerance, Usey Limitations
Formulation(s)
Peach
Coryneum blight
Peach leaf curl
Peanut
Cercospora leafspot
6.4-12.8
Ib/A
(80% WP)
or
1.5 fl. oz.
27% FlC/gal
(27% FlC)
Damping off and seed
rot (Aspergillus)
Damping off and seed
rot (Rhizopus)
Damping off and seed
rot
Pineapple
1.5 Ib/A
[use 10-60
gal/A
ground
equip, or
5-10 gal/
A aerial]
(4 Ib/gal
FlC)
0.11-0.2 Ib
/100 Ib seed
(35% D)
(60% D)
(65% D)
30 ppm
Dormant application. Use up to
400 gallons water per acre or
sufficient water to cover. Apply
lower rate in the fall before rains
begin and repeat in late winter prior
to bud swell; or apply the higher
rate as a single treatment after
leaves have dropped prior to fall
rains.
2 ppm (in hulls)
0.05 ppm (hulls removed)
14 day preharvest interval through
1.5 pounds per acre. Do not graze
treated area or feed treated vines or
hay to livestock. Do not hog down
treated areas.
Foliar application. Apply when
disease first appears (25-45 days
post-plant). Repeat at 10-14 day
intervals to maintain control.
/05004AA
FBAZCEL
FEAGTAB
/28015AA
FMBCCBM
Seed treatment. Apply with
commerical treating machine for
uniform seed treatment coverage.
May be formulated with 2,6-
dichloro-4-nitroaniline.
0.1 ppm
No preharvest interval through
31.25 pounds per acre.
FKAIACG
FKAIRAQ
FKAIQBB
/06013AA
Issued: 09-24-81
Revised: 08-24-84
11-081701-9
-------
EPA Index to Pesticide Chemicals
Site and Pest
Pineapple (continued)
Pineapple heart rot
Plum
Prune
Brown rot blossom
blight
Potato
Early blight
Late blight
Rice
CAPTAFOL
Dosage and Tolerance, Use, Limitations
Formulation(s)
1.25 lb/10
gal mixture
(4 Ib/gal
F1C)
(80% WP)
8 lb/400
gal/A
(4 Ib/gal
F1C)
Dip treatment. Dip slips immediate-
ly before planting using 100 to 250
gallons dip per acre.
Soil application. Apply first
application immediately after plant-
ing; repeat at monthly intervals for
a maximum of 8 applications.
2 ppm
No preharvest interval through 1.6
pounds per 100 gallons.
Use limited to California and
Oregon. Delayed dormant and foliar
application. Use sufficient spray
per acre depending on tree size to
provide thorough coverage. Apply at
prebloom, bloom and petal fall.
0.5 ppm
No preharvest interval through 1.6
pounds per acre.
0.75-1.6 Ib/A Foliar application. Apply in
(4 Ib/gal FlC) sufficient water to cover. Begin
FIBIPCN
0.75-1.6 Ib
100 gal
(80 WP)
(80% WP)
(25% WP)
Seed rot and seedling 0.125-0.188
disease (Achlya) lb/100 Ib
Seed rot and seedling seed
disease (Pythium) (4 Ib/gal
Seed rot and FlC)
seedling disease
(HeLninthosporum)
when plants are 6 inches high and
continue at 5 to 10 day intervals.
Under severe disease condition use
higher listed dosage and shorter
spray intervals. May be formulated
with captan.
N.F.
Seed treatment. Treat seeds prior
to pre-soaking when planting in
flooded fields.
/05005AA
/05006AA
FBADMCB
/14013AA
FBAMAAX
FBASPCN
/28072AA
FKAFADD
FKAFPES
FKAFHAM
Issued: 09-24-84
Revised: 08-24-84
11-081701- 10
-------
Site and Pest
Sorghum (grain and
forage)
Damping-off and
seed rot
Sweet Corn
EPA Index to Pesticide Chemicals
CAPTAFOL
Dosage and Tolerance, Use, Limitations
Formulation(s?
2.1 oz/100
Ib
(70% WP)
Northern corn leaf
blight
Southern corn leaf
blight
0.38-1.0 Ib/
A
(4 Ib/gal
F1C)
Taro (wetland)
Phytophthora leaf
blight
0.75-1.5 Ib/
100 gal/A
(4 Ib/gal
F1C)
N.F.
Seed treatment.
slurry.
Apply as a water
0.1 ppm
5 day preharvest interval through
1.0 pound per acre. Use limited
to Florida. For fresh vegetable
use only. Do not feed treated
forage to livestock or allow
animals to graze treated area.
Foliar application by air. Use in
3 to 5 gallons as required for
thorough coverage. When disease
conditions are prevalent use 0.38
to 0.5 pounds per acre on a 2 day
schedule to protect new growth. As
a preventive or under light disease
conditions use 0.75 to 1.0 pound on
a 4 day schedule.
0.02 ppm
11 week preharvest interval through
1.5 pounds per acre. Use limited to
Hawaii. Do not apply more than 36
pounds captafol per acre per year.
Folair application. Begin when
infection is expected (normally 3
months after planting) and repeat
at 7 to 14 day intervals until danger
of infection is passed (normally 5
months after first application).
Under very wet conditions, use the
higher dosage or the shorter spray
interval. Under dry conditions,
treat at 14 to 21 day intervals.
/28019AA
FKAIQBB
/15005AA
FBATSBP
FBATCDM
/14006AA
FBATPCN
Issued: 09-24-81
Revised: 08-24-84
11-081701-11
-------
EPA Index to Pesticide Chemicals
Site and Pest
Totiato
Anthracnose
Early blight
Fruit rot
Gray leaf mold
(Stemphylium)
Late blight
Nailhead spot
Anthracnose fruit
rot
Black mold
(Alternaria
alternata)
CAPTAPOL
Dosage and Tolerance, Use, Limitations
Formulation(s)
15.0 ppm
No preharvest interval through
16 pounds per acre. Use limited
to mechanically harvested tomatoes.
Immature fruit may be spotted when
captafol is combined with insecti-
cides during periods of high
temperature or drought stress.
/11005AA
1.2-2.5 lb/
[use 30-150
gal/A for
ground
equipment
or 5-100
gal/A by
air]
(4 Ib/gal
F1C)
(80% WP)
8-16 Ib/A
(4 Ib/gal
F1C)
1-2 Ib/A
[use 30-200
gal/A by
ground or
10 gal/A
by air]
(4 Ib/gal
F1C)
Apply when first fruits are well
formed and repeat at 7 to 10 day
intervals. When weather conditions
favor disease development, use
higher rate and begin application
when plants are set in fields.
FAAACDP
FBAMAAX
FBASPCN
FMAXSDG
FMBFAAX
FIBFQAB
Foliar application. Apply as a
single spray when the first fruits
are formed; or use 4 to 8 pounds
actual in two applications. Apply
the first treatment when first fruits
are formed followed by a second
treatment 20 days later.
Use limited to California. Foliar
application. Apply when first fruits
are well formed and repeat at 7 to
10 day intervals.
FAAACDP
FIBFAAX
Issued: 09-24-81
Revised: 08-24-84
11-081701- 12
-------
EPA Index To Pesticide Chemicals
Site and Pest
Watermelon
Anthracnose
Downy mildew
Gummy stem blight
CAPTAFOL
Dosage and Tolerance, Usey Limitations
Formulat ion(s)
5.0 ppm
No preharvest interval through 2.5
pounds per acre.
1.2-2.5 lb/ Foliar application.
[use in 50-
150 gal/A]
(4 Ib/gal
F1C)
(80% WP)
Begin applications when plants start
to vine and repeat at 5-10 day
intervals as needed. Use lower
gallonage for initial application and
increase for thorough coverage depend-
ing upon plant size.
/10008AA
FAAACDP
FFABPEA
FBAQMCO
STRUCTURE, WOOD PRODUCTS AND WOOD COMMODITIES
Wood Protection treatment by pressure
/640100AA
Surface mold
1-2 pints 39% Wood protection treatment by pressure.
EC/300 gal
preservative
solution.
(39% EC)
AERIAL AND TANK MIX APPLICATIONS
Aerial Application
Add one pint of the formulation to 300
gallons ready to use wood preserving
solution for pressure treatment of
wood. (Wood preserving solutions of
0.5 to 6.0 percent concentration of
copper-chrome arsenate or fluoride-
chrcme arsenate-phenol preservative
in water are suitable for use. This
gives the recommended minimum of 200
ppm active ingredient concentration.)
Under extremely hot humid conditions,
the concentration may be doubled to get
the required control.
9001500
AAAAAAA
Refer to
AGRICULTURAL CROPS
Peanuts, sweet corn, tomato
Issued: 09-24-81
Revised: 08-24-84
11-081701- 13
-------
EPA Index to Pesticide Chemicals
CAPTAFOL
Listing of Registered Pesticide Products by Formulation
97% technical chemical
captafol (081701)
000239-02230
35% dust
captafol (082701) plus 2,6-dichloro-4-nitroaniline (031301)
000239-02273
60% dust
captafol (081701) plus 2,6-dichloro-4-nitroaniline (031301)
000239-02407
65% dust
captafol (081701)
000239-02198
25% wettable powder
captafol (081701) plus captan (081301)
000239-02195
70% wettable powder
captafol (081701) plus methoxychlor (034001)
000239-02409
80% wettable powder
captafol (081701)
000239-01716 000239-02217
80% wettable powder (granular size)
captafol (081701)
000239-02495
39% emulsifiable concentrate
captafol (081701)
003008-00027
27% flowable concentrate
captafol (081701)
000239-02313
4 Ib/gal flowable concentrate
captafol (081701)
000239-02211 000239-02369
Issued: 09-24-81 11-081701- 14
Revised: 08-24-84
-------
EPA Index to Pesticide Chemicals
CAPTAPOL
State Label Registration
CA Reg. No.
000239-04198
HI Reg. No.
000239-04168 037843-08576
NY Reg. No.
038655-10453
9999999
Issued: 09-24-81
Revised: 08-24-84
11-081701-15
-------
Auxiliary documentation: Summary
Site
Citrus (bark treatment)
Citrus (soil treatment)
Corn (seed treatment)
Peanuts (foliar treatment)
Pineapple (foliar treatment)
Pineapple (dip treatment)
Potato (water treatment)
EPA Index to Pesticide Chemicals
CAPTAFOL
of 24c registrations by Crop.
Pest
Foot rot (Phytophthora)
Strawberry (nursery stock)
Sugarcane (growth regulator)
Not Fungicidal
Tomato (soil treatment, green-
house)
Watermelon (foliar treatment)
Greasy spot
(Mycosphaerella)
Seed rot and seedling
blight (Pythium,
Rhizoctonia, Rhizopus)
Leaf spot (Cercospora)
Heart rot (Phytophthora)
Heart rot (Phytophthora)
Accession number
FL800038
FL820033
FL780064
ID800050
TX770010
HI770006
HI770006
Early blight (Alternaria) OR810083
WA780027
Early blight (Alternaria)
Late blight (Phytophthora) CO790018
MI800016
NE800016
Anthracnose (Colletotrichum)
AR790002
stimulation of germination FL760012
Fusarium crown and root OH760002
rot NC760003
Anthracnose (Colletotrichum)
Downy mildew (Pseudoperonospora)
Gummy stem blight TX780044
(Mycosphaerella)
Issued: 08-24-84
11-081701-16
------- |