UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
CERTIFIED MAIL
Subject; initiation of Reregistration Process for Manufacturing-
Use Products and Formulation-Use Products Containing
Thiram as the Single Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, EPA's Office of
Pesticide Programs has begun the reregistration process for
pesticide products containing the subject active ingredient.
Significant changes to the statute were made in 1972, 1975,
and 1978; thus, current requirements may be substantially
different from those in effect at the time your product(s)
were registered. The first phase of reregistration requires
that you (1) make a commitment to the Agency regarding data
development, and (2) subsequently submit revised product
labeling and associated information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s) (Attachment A), and a separate list of registrants
with products subject to this manufacturing-use standard and
which contain this active ingredient (Attachment B). The
latter list is for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its registered uses, and its rationale for the regulatory
actions being taken at this time. Additionally, the Guidance
Document contains instructions describing certain of the
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steps you must take to maintain registration for your
product(s). Products not brought into compliance with the
Guidance Document as supplemented by subsequent information
from EPA about compliance with certain data support requirements
will be subject to suspension and/or cancellation.
Specifically, the enclosed Guidance Document does the
following:
1. Introduces the purpose of this document.
2. Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data that
must be submitted to complete the Agency's evaluation
of each product. In addition, a bibliography identifying
the data which are considered part of the data base
supporting the registration standard is included.
3. Sets out time-frames for submission of required
data.
4. Explains how to revise labeling for manufacturing-
use products. (As the Guidance Document explains,
labeling is not required at this time.)
5. Provides submission instructions.
Because of the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific
requirements and procedures in order that you may respond in
correct and timely manner. Since a part of these requirements
is under Section 3(c)(2)(B) of FIFRA, your first response may
be required within 90 days from receipt of this letter.
Please note that if you do not respond or do not comply fully
with the requirements, your application may be rejected or
your product registration cancelled or suspended.
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please
contact the Product Manager listed below who will assist you
in every reasonable way. If you wish to discuss the data
requirements or request that certain data be waived, you must
write to the Agency and indicate those data requirements with
which you take issue and your rationale for doing so. After
the Agency has had a chance to review your submission, the
Product Manager will contact you to set up a meeting for the
purpose of resolving all issues relative to data requirements.
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Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v.
Administrator, EPA was enjoined by the District Court for
the Eastern District of Missouri from implementing in any way
the "mandatory data licensing" aspects of §3(c)(l)(D) of
FIFRA. EPA has appealled this decision to the U.S. Supreme Court.
Because of this unresolved situation, EPA has decided to proceed
with the requirements in this guidance package which do not
relate to the "data licensing" issue and to supplement the package
with additional guidance when circumstances permit.
If you have any question concerning this Guidance Document,
you may contact the Product Manager listed below:
Henry M. Jacoby
Product Manager (21)
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, DC 20460
Phone: (703) 557-1900
^Sincerely,
(Ju^^—^
uglas D. Campt, Director
fegistration Division
Enclosure
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ATTACHMENT A
PRODUCTS AFFECTED BY THIS
REREGISTRATION PROCESS
Following is a list of your products affected by this rereg-
istration process. If this list is incomplete or inaccurate
in any way, please notify the Product Manager (PM) identified
in the letter.
Name of Products
Dupont Thiram Technical
Thiram Technical
Vancide TM
Thiram 75
Thiram 100 Fungicide
Thiram 65
Thiram 80% Wettable Powder
Thiram Technical
Thiram Technical Wettable Powder
Thiram Technical
Tetramethylthiuram Disulfide
React-Rite® TMTD
EPA Registration Number
352-114
1117-131
1965-43
2749-10
2749-11
2749-12
2749-79
4581-258
8236-2
45728-1
46588-1
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ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT, THIRAM
T"he information attached will allow registrants with pesticide
products containing the above ingredient to contact one
another regarding joint data development or sharing the cost
of data development under section 3(c)(2)(B) of FIFRA. This
information includes the following: EPA Reg. No., company
name, company address, active ingredient, percentage of active
ingredient and type of formulation, such as Manufacturing-Use
Product (MUP), Technical Product (TP), Wettable Powder (WP),
and Formulation-Use Product (FUP),
Active Formulation
EPA Reg. No^ Co. Name & Address Ingredient Type
352-114 E.I. du Pont de Nemours Thiram 99% MUP and TP
and Company
Legal Department D7045
Wilmington, DE 19898
1117-131 Virginia Chemicals Inc. Thiram 98.5% MUP and TP
3340 West Norfolk Road
Portsmouth, VA 23703
1965-43 R. T. Vanderbilt Company, Thiram 97.0% MUP and TP
Inc.
230 Park Avenue
New York, NY 10017
2749-10 Aceto Chemical Company, Thiram 75.0% FUP and WP
Inc.
126-02 Northern Boulevard
Flushing, NY 11368
2749-11 Aceto Chemical Company, Thiram 99.45% MUP and TP
Inc.
126-02 Northern Boulevard
Flushing, NY 11368
2749-12 Aceto Chemical Company, Thiram 65.0% FUP and WP
Inc.
126-02 Northern Boulevard
Flushing, NY 11368
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2749-79
4581-258
8236-2
45728-1
46588-1
Aceto Chemical Company,
Inc.
Agricultural Chemicals Division
126-02 Northern Boulevard
Flushing, NY 11368
Pennwalt Corporation
Pennwalt Building
Three Parkway
Philadelphia, PA 19102
Prochemie International, Inc.
488 Madison Avenue
New York, NY 10022
UCB Chemicals Corp.
3340 West Norfolk Road
Portsmouth, VA 23703
Reactor Products, Inc.
P. O. Box 128
Old Summerville Road
Armuchee, GA 30105
Thiram 75.0% FUP and WP
99.0% MUP and TP
97.0% MUP and TP
98.5% MUP and TP
98.0% MUP
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CHEMICAL INFORMATION FACT SHEET FOR THIRAM,
BIS-(DIMETHYLTHIOCARBAMOYL) DISULFIDE
FACT SHEET NUMBER: EPA Case Number 22, Reregistration Standard - THIRAM
DATE ISSUED: June 1, 1984
1. Description of Chemical
Generic Name: Bis-(dimethylthiccarbarnyl) disulfide
Cannon Name: Thiram
Trade Names: Trade names and other names for thiram are AAtak, Arasan,
Delsan, Mercuram, Nonersan, Polyram-Alltra, Pomarsol,
Spatrete, Tersan, Thimer, Thiramad, Thirasan, Thiuramin,
Trametan, Triampa, Tripomol, Tuads, Vancide, Tetramethylthiuram
disulfide, TM-95, TMTD, and TMTDS.
EPA Shaughnessy Code: 079801-7
Chemical Abstract Service (CAS) Number: 137-26-8
Year of Intitial Registration: August 5, 1948, DuPont's Tetramethyl
Thiuramdisulfide, EPA Reg. No. 352-114
Pesticide Type: Fungicide and Rodenticide
Chemical Family: Organo-sulfur
U.S. and Foreign Producers:
1. E.I. du Pont de Nemours and Company
2. UCB Societe Anonyme, Belgium, for Virginia Chemical Inc., Prochimie
International, Inc., and UCB Chemical Corp.
3. R.T. Vanderbilt Company, Inc.
4. Aagrunol Chemicals, B.V., for Aceto Chemical Co., Inc.
2. Use Patterns and Formulations
Application Sites: Fruit, vegetable and ornamental plants (including
turf grasses), vegetable and field crop seeds, bananas, prcpagules of
sweet potatoes, tree seedlings, bulbs and cuttings of ornamental bulbs,
soil, textiles, polyurethane, wood pulp; and sites around homes, air-
ports, seedling nurseries.
Types of Formulations: Dusts, Wettable Powders and Flowable Suspensions.
Types and Methods of Application: Dusting, Spraying and Dipping.
Application Rates: See Use Patterns in EPA Compendium of Registered
Pesticides, Vol. II, Fungicides and Nematicides, Part I, Pages T-30-
00-01 through T-30-00-09.
Usual Carriers: Marl, Talc, Clays, Petroleum Oil, Graphite, Vermiculite,
Mineral Oil, Charcoal and Water.
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3. Scientific Findings
Chemical Characteristics:
Physical State: Powder (Micronilled)
Color: Cream to White
Odor:
Boiling Point: Not Applicable
Melting Point: Range 155-156°C
Flash Point: > 300° F
Toxicity Characteristics;
All toxicological data reviewed by the Agency were found to be lacking
in information for evaluation, such as identification of compound tested,
dose response information, individual animal information, pathology reports,
etc.
Physiological and Biochemical Behavioral Characteristics:
Foliar Absorption: The available data do not provide direct evidence
that thiram is or is not absorbed by roots or aerial portions of
plants.
Translocation: There is inadequate data to conclude that thiram is
translocated in plant tissue, but indirect evidence exists to
indicate thiram or a degradate of thiram may enter plant tissue.
Mechanism of Pesticidal Action: Not understood as a fungicide. As a
repellant to rodents.
Metabolism and Persistence in Plants and Animals: The metabolism of
thiram in plants and animals is not adequately understood.
Environmental Characteristics;
Adsorption and Leaching in Basic Soil Types: Inadequate data.
Microbial Breakdown: Inadequate data.
Loss from Photodecomposition and/or Volatilization: No data.
Bioaccumulation: No data.
Resultant Average Persistence: No data.
Ecological Characteristics;
Hazards to fish and wildlife
Rainbow trout 96-hr LC5o = 0.130
Bluegill sunfish 96-hr 1X50 = 0.044
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(Characterized as "very highly toxic" to both cold water and warm
water fish.)
Thiram is "noderately toxic" to birds. There is insufficient information
to fully characterize the toxicity of thiram to mammals. Generally, the
subcutaneous toxicity is "high," the acute oral toxicity is slight to
"moderate," and in some species (mouse) "practically non-toxic." Thiram
is characterized as "relatively non-toxic" to honeybees and predaceous
ladybird beetles.
Potential problems Related to Endangered Species:
Additional data (estimated environmental concentrations, persistence,
avian reproduction studies, accumulation) are required to complete
the endangered species assessment for thiram.
Efficacy Review Results:
No efficacy reviews were made.
Tolerance Assessments:
1. List of Crops and Tolerances:
The following table lists the present status for tolerances in parts per
million for residues of thiram:
Raw Agricultural Commodity
Apples
Bananas
Celery
Onions (dry bulb)
Peaches
Strawberries
Tomatoes
U.S.
7
7a
7
0.5
7
7
7
Canada
0.1
1.0
-
—
7
7
7
Mexico
7
7
0.5
7
7
7
Codex
lc
5b
~
3b
ob
ob
a. 7 parts per million in or on bananas (from preharvest and postharvest
application) of which not more than 1 part per million shall be in the
pulp after peel is removed and discarded.
b. A temporary Codex MRL for the residues of dithiocarbamates (of which
thiram is a member) expressed n terms of mg CS2Ag/ has been established.
c. Temporary Codex MRLs of 1 and 0.1 ppm have been established for total
dithiocarbamates residues (including thiram expressed as ppm CS2) in or
on whole bananas and banana pulp, respectively.
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2. Seed Applications:
No tolerances have been established for thiram residues in or on any crop
for which thiram is registered solely for seed treatment, because heretofore
seed treatment uses have been considered to be nonfood uses. These crops
include: barley, beans (dry and succulent), lima beans, beets, broccoli,
brussels sprouts, cabbage, cantaloupe, carrots, castor bean, cauliflower,
collards, corn (sweet and field), cotton, cowpeas, cucumber, eggplant, endive,
flax, forage-fodder grasses, kale, kohlrabi, lentils, lettuce, millet,
muskmelons, mustard, oats, okra, onion, peanuts, peppers, pumpkins, radish,
rice, rye, safflower, sesame, small-seeded legumes, sorghum, soybeans, spinach,
sugar beets, sunflower, swiss chard, tomato, turnips, watermelon, and wheat.
Results of Tolerance Assessment:
Insufficient data are available to assess the adequacy of the tolerance
for thiram in or on all thiram-treated commodities having such tolerances:
apples, bananas, celery, onions (dry bulb), peaches, strawberries, and tomatoes
(40 CFR 180.132). Note that either green onions must be deleted from thiram
labels or residue data and a tolerance proposal must be submitted. Also note
that the in-furrow treatment for cotton must either be removed from thiram
labels or residue data and tolerance proposals must be submitted for forage,
seed, and processed products. In addition, many seed treatment uses are
registered for thiram on crops not having tolerances for thiram; the continued
"nonfood" classification of these uses is contingent upon the receipt of
plant metabolism studies demonstrating that thiram residues of concern are
not translocated into food/feed crops grown from thiram-treated seed. If
residues of concern are translocated, then residue data and tolerance proposals
must be submitted for all of these crops (or at least all of the representative
commodity members of each involved crop group). Finally, tolerances for
thiram animal products have not been established; if the requested animal
metabolism studies reveal that thiram residues of concern are transferred to
animals, then animal residue data (feeding studies) and appropriate tolerance
proposals will be required for ruminants and poultry. It is imperative that
the metabolism of thiram in plants and animals be elucidated, since many of
the above-noted data gaps are dependent upon the outcome of the metabolism
studies. Refer to the appropriate preceding sections for details of data
gaps. The data are insufficient to allow the establishment of any crop group
tolerances.
No ADI has been established for thiram. The TMRC is 0.7380 mg/day based
on a 1.5 kg diet and the relevant tolerances (40 CFR 180.132) and food factors.
Problems that are Known to Have Occurred with Use of the Chemical.
Two workers exposure effects have been identified:
1. Illness in pine seedling planters and handlers resulting from handling
thiram-treated pine seedlings without protective clothing (the illness
resulted from the ingestion of alcohol after such an exposure).
Note: Thiram is the methyl analog of Antabuse, bis-(diethylthiocarbomyl
sulfide), a drug used in rehabilitating alcoholics.
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2. Skin rashes of the hands and head resulting frcm exposure to thiram in
handling thiram-treated pine seedlings.
These health effects have been reduced by restrictions that require workers
to wear gloves and protective clothing when handling thiram products.
4. Summary of Regulatory Position and Rationale
Based on historical use experience (human health effects reports) and the
benefits from the pesticidal uses, the Agency has determined to allow the
registration of thiram opducts to continue for existing use-patterns until
the hazards are better^defined by the data requirements under the Thiram
Registration Standard.
5. Summary of Major Data Gaps
All toxicology data, both acute and chronic studies.
Product chemistry data
Residue chemistry studies
Environmental fate
Hydrolysis studies
Photodegradation studies
Metabolism studies
Mobility studies
Dissipation studies
Accumulation studies
Re-entry
Foliar dissipation studies
Soil dissipation studies
Dermal exposure studies
Inhalation exposure studies
Avian reproduction studies
Field studies with mammals and birds
Aquatic organism studies
Non-target insect studies
6. Contact Person
Eugene M. Wilson
EPA
Office of Pesticide Programs
Registration Division (TS-767-C)
Crystal Mall #2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
Telephone (703) 557-1900
DISCLAIMER: The information presented in this Chemical Information
Fact Sheet is for informational purposes only and may not be used to
fulfill data requirements for pesticide registration and reregistration.
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27S92
GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
THIRAM
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER 22
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D. C. 20460
JUNE 29, 1984
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position and Rationale 4
II. Requirement for Submission of. Generic Data 20
III. Requirement for Submission of Product-Specific
Data 46
IV. Submission of Revised Labeling and Packaging
Information . 50
A. Label Contents 50
1. Product Name 50
2. Company Name and Address 50
3. Net Contents 50
4. Product Registration Number 51
5. Producing Establishment
Registration Number 51
6A Ingredient Statement 51
6B Pounds Per Gallon Statement 51
7. Front Panel Precautionary Statements 51
7A Child Hazard Warning Statements 52
7B Signal Word 52
7C Skull and Crossbones and Word Poison 52
7D Statement of Practical Treatment 52
7E Referral Statement 52
8. Side/Back Panel Precautionary Labeling 52
8A Hazard to Humans and Domestic Animals 53
8B Environmental Hazard 53
8C Physical or Chemical Hazard 53
9 Misuse Statement 54
10A Storage and Disposal Block 54
10B Directions for Use 54
54
B. Collateral Information 54
V. Instructions for Submission 55
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APPENDICES
Pag
II-l Bibliography (Including Guide for Use) 56
II-2 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 67
.11-3 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-6 68
III-l Product Specific Data Report 69
IV-1 Labeling Requirements and Use Classificataion
(40 CFR §162.10 and 40 CFR S162.ll) 70
IV-2 Table of Labeling Requirements and Sample Labels 75
IV-3 Physical/Chemical Hazards Labeling Statement 79
IV-4 Storage and Disposal Instructions 80
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 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 use. The regulatory position may
require the registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide to certified
applicators, provide reentry intervals, modify uses or formulation types,
specify certain packaging limitations, or other requirements to assure that
proper use of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein but is available
upon request, concentrates on the technical grade of the active inredient
and identifies missing generic data. However, during the review of these
data we are also looking for potential hazards that may be associated with
the formulated (end-use) products that contain the active ingredient. If we
find serious concerns, we will bring formulated products under the provisions
of the Registration Standards program to the extent necessary to protect
the public.
EPA has the authority under FIFRA §3(c)(2)(B) to require that certain
registrants submit 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)(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 cannon with the registrant's firm, or their
source does not take necessary steps to ccmply with the data production
requirements. These end-use producers can qualify for the formulator's
exemption if they change their source of supply to a registered source,
in compliance with the data production requirements, provided the source
does not share ownership in cannon 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
following page shows what is generally required of those who do and do not
qualify for the formulator's exemption in the Registration Standards program.
If you decide to request the Agency to discontinue the registration of
any of your products subject to the reregistration requirements of this
Guidance Document please notify the Product Manager named in the cover
letter, within 90 days frcm 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 registrations of any currently registered
product if you fail to ccmply with the requirements set forth in this Guidance
Document.
This Guidance Document will be supplemented by EPA with additional
information about compliance with data support requirements. In Monsanto
v. Adminstrator, EPA was enjoined from implementing in any way the "mandatory
data licensing" aspects of §3(c)(l)(D) of FIFRA. EPA has appealed this
decision to the U.S. Supreme Court. Because this situation is currently
unresolved, EPA has decided to proceed with the requirements in this Guidance
Document which do not relate to compliance with the §3(c)(l)(D) provisions
and to supplement the Document with additional guidance when circumstances
permit. Failure to ccmply with the provisions of the subsequent guidance
will also result in issuance by EPA of an intent to cancel the affected
product registration(s).
Registrants are reminded that §6(a) (2) of FIFRA requires you at any
time to submit factual information raising concerns of possible adverse
effects of a pesticide. You should notify the Agency of interim results of
studies in progress if those results show possible adverse effects
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Pormulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
'I
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 I
registrant fulfills the requirements specified in the Guidance I
Document for manufacturing-use product(s). Such end-use products I
will be subject to the labeling changes required.for products in "II*. I
above. If there are no manufacturing-use products registered by any !
company end-use products will be required to be reregistered. i
NOTE: If all registrants in "I" above fail to meet the requirements in
I-A and B above, then the registrants in "11" lose their right to
Iqualify for the formulator's exemption and become subject to the
[requirements 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
bis(dimethylthiocarbamoyl)disulfide (thiram), based on an
evaluation of all registered manufacturing-use products
(MUP's), formulation-use products (FUP's), and certain end-use
products containing thiram 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 requirements for
current and future MPs. Thiram MPs that differ appreciably
from those 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. USE PROFILE
Thiram is the acceptable common name for bis
(dimethylthiocarbamoyl)disulfide and is recognized by the
American National Standards Institute. Trade names and other
names for thiram are AAtak, Arasan, Delsan, Mercuram, Nomersan,
Polyram-Alltra, Pomarsol, Spatrete, Tersan, Thimer, Thiramad,
Thirasan, Thiuramin, Trametan, Triampa, Tripomol, Tuads, Vancide,
Tetramithylthiuram disulfide, TM-95, TMTD, and TMTDS.
There are ten (10) "manufacturing-use" and/or "for-
mulation use" thiram products that may be used in the manufac-
ture of another end-use pesticide product which bears labeling
that identifies thiram as one of the active ingredients. The
percent thiram in these products range from 65 to 99.45.
The Office of Pesticide Programs Internal Control Number
(EPA Shaughnessy Number) for thiram is 079801-7, and its CAS
Number is 137-26-8.
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Thiram has the following identifying characteristics:
Empirical Formula: CeH12N2s4
Molecular Weight: 240.4
Structural Formula: S S
I I
(CH3)2-N-C-S-S-C-N-(CH3)2
Thiram is a broad spectrum fungicide that has registered
uses for control of diseases of fruits, vegetables, and
ornamentals (including turf) for seed rot and seedling diseases
of vegetables and field crops (as a seed treatment), for post-
harvest diseases of bananas (as a fruit dip or spray), for
diseases of sweet potatoes, tree seedlings, plant cuttings
and ornamental bulbs (as a seedling or propagule treatment),
to control diseases of onions (as a soil treatment), for
mold and mildew control in textiles and polyurethane (as a
spray or additive), for slime control in the manufacture of
paper, and for repelling animals from various application
sites.
Thiram is formulated into dusts, granules, liquid
concentrates, pastes, wettable powders and flowable suspen-
pesnsions. Thiram is also formulated in combination with
a variety of insecticides.
The major use of thiram is in rubber processing as an
accelerator and vulcanizer. It has also been used as a
bacteriostat in soap.
C. REGULATORY POSITION
Based on a review and evaluation of all available data
and other relevant information on thiram, the Agency has made
the following determinations:
1. Manufacturing-use pesticide products containing
thiram as a sole active ingredient may be registered
for sale, distribution, formulation and use in the
United States, subject to the terms and conditions
specified in this standard. Applicants having
products not conforming to this standard must apply
to amend the document so those products containing
thiram may be registered and reregistered. Mixtures
and end-use products containing thiram may not be
registered or reregistered under this standard.
However, the use patterns of the end-use products were
considered for purposes of determining generic data
requirements for thiram.
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2. Available data do not show that any of the risk
criteria listed in Section 162.11(a) of Title 40 of
the U.S. Code of Federal Regulations have been met
or exceeded for the uses of thiram specified in this
standard.
3. Registrants must provide or agree to develop additional
data, as specified in the tables attached to this
standard, in order to maintain existing registrations
or to permit new thiram registrations.
4. Under this standard precautionary labeling of all products
must be revised as stated under Required Labeling. In addition
all end-use products intended for crop use, except seed,
seed piece and plant propagule treatments must bear labeling
restrictions for crop rotation and for reentering treated areas,
5. Limited data are available to identify the movement and fate
of thiram in soils. Because this data indicate a potential
for ground water contamination, the Agency is requiring data
needed to assess this potential (see Table A, Environmental
Chemistry Data).
D. REGULATORY RATIONALE
1. Based on historical use experience (human health effects
reports) and the benefits from the pesticidal uses, the Agency
has determined that it should allow the registration of thiram
products to continue for existing use-patterns until the risk
of hazards are better defined by the data requirements
specified in Table A and B of this document. Regulatory
action may be needed when the risk of hazards has been identified.
2. Two worker exposure effects have been identified:
a. Illness in pine-seedling planters and handlers
resulting from handling thiram-treated pine seedlings
without protective clothing (the illness results
from the ingestion of alcohol after such an exposure).
Note: Thiram is the methyl analog of Antabuse, bis-
(diethylthiocarbomyl sulfide), a drug used in rehabili-
tating alcoholics.
b. Skin rashes of the hands and head resulting from
exposure to thiram in handling thiram-treated pine
seedlings.
These health effects have been reduced by label precautions
and will be reduced further by label precautions under this
Standard that require workers to wear gloves and protective
clothing when handling thiram treated products.
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3. As all of the required toxicology data to support the
uses of thiram MUP and FUP products have never been submitted
or were submitted and are presently considered to be inadequate
to support established registrations and tolerances,
regulatory actions regarding the tolerances must await the
receipt of these data. Section 180.132 of the Code of Federal
Regulations, Title 40, Parts 150 to 189 lists the tolerances
for thiram.
4. The registered seed treatment uses of thiram have been
considered non-food or non-feed uses. A review of the residue
chemistry data available indicated that the data were inadequate
to support the seed, seed-piece and other plant propagule
treatment uses as non-food or non-feed uses. Data requirements
to support these uses are listed in Table A and B.
5. The Agency has a concern for ground water contamination
because preliminary data indicate that thiram is very mobile in
silty clay loam soil and has a half-life of 4 to 5 weeks in
neutral soil. Under this Standard, data are required on an
accelerated basis to determine this potential risk of hazard.
6. Thiram meets the criteria of 40 CFR, Section 158.140.
Therefore an interim 24-hour reentry interval has been applied
until the receipt and evaluation of reentry data specified in
Table A, Section 158.130, Subpart K, Re-entry.
7. It is not the Agency's policy to cancel or to withhold
registration merely because data are missing or inadequate
(See Sections 3(c)(2)(B) and 3(c)(7) of FIFRA). Rather,
publication of this standard provides a mechanism for identify-
ing data needs and registration under the standard allows for
the upgrading of labels during the period in which the required
data are being developed. These data will be reviewed and evaluated
when they are received and the Agency will determine at that
time whether they will affect the registration(s) of thiram products.
E. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
All products that contain thiram as the sole active
ingredient are subject to this standard and must either comply
with the acute toxicity limits, product composition, and use
patterns requirements listed in Section F of this document
or submit data and a justification to amend the standard to
encompass such products.
The applicant for registration of reregistration of
products subject to this standard must comply with all terms
and conditions described in it, including committing to fill
data gaps on schedule. Applicants for registration under
this standard must followthe instructions contained in this
guidance package and complete and submit the appropriate
forms within the time specified.
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F. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
Technical grade products must contain at least 97.0 percent
thiram as the sole active ingredient. Each manufacturing-
use product must be fully described with an appropriate
certification of limits. In addition, the active ingredient
found in the manufacturing-use thiram products must be sub-
stantially similar to that in currently registered technical
products. 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 thiram for acute
toxicity category II, provided that the labeling of those
products bear appropriate precautionary statements.
3. Use Patterns
To be registered under this standard, manufacturing-use
products containing thiram may be labeled for formulation only
into end-use products for use as a fungicide for foliar
applications to fruits, vegetables and ornamentals (including
turf), and as a seed treatment for vegetable and field crops;
as a post-harvest treatment of bananas; as a pre-planting
dip for sweet potatoes, tree seedlings, cuttings, and orna-
mental bulbs; as a soil treatment for onions; as a treatment
in manufacture of paper, textiles, and polyurethane; and as
an animal repellent.
G. REQUIRED LABELING
All technical grade and manufacturing-use products containing
thiram 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.
Precautionary statements to be used on labeling of thiram products;
1. All end-use products with labeling for use on tree seedlings
(conifer and deciduous species), plant propagules and any
other use site (commodity) that may be directly handled, such
that human skin is exposed to the treated commodity, must bear
use precautions under the Directions for Use heading
that instructs:
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"(Name of use site(s), e.g. pine seedlings) that are
treated with this product must bear distinct labeling
that instructs:
CAUTION: Treated with thiram. Wear rubber gloves
and protective clothing when handling products
treated with thiram. Direct exposure to skin may
result in severe dermatitis."
2. All end-use products that bear labeling for seed treatment
must include the following precautionary statements:
Causes eye and skin irritation. Harmful if swallowed,
inhaled or absorbed through skin. Do not get in eyes,
on skin, or on clothing. Wear goggles or face shield
and rubber gloves when handling. Avoid inhaling of
spray mist or dust. Do not use or store near food
or feed.
During commerical exposure in seed treatment and loading
operations, wear goggles, clean rubber gloves, protective
clothing, and a pesticide respirator jointly approved by
the Mine Safety and Health Administration (form-
erly the U. S. Bureau of Mines) and by the National
Institute of Occupational Safety and Health under
provisions of 30 CFR, Part 11. Wash hands, arms and
face thoroughly with soap and water after handling and
before eating or smoking. Routinely shower or bathe after
work, wash all clothing with soap and hot water before
reusing.
3. All products, manufacturing-use and end use, must bear the
labeling precautionary statement:
Consumption of alcoholic beverages increases the toxic
effects of thiram.
In addition, the following specific environmental hazard
labeling requirements apply to technical and manufacturing-
use products:
1. All MUPs must bear the following precautionary
statements:
This pesticide is toxic to fish. Do not discharge
into lakes, streams, ponds, or public waters unless
in accordance with an NPDES permit. For guidance,
contact your Regional Office or the Environmental
Protection Agency.
2. All end-use products (EUPs) intended for outdoor use,
including seed treatments, must bear the following
precautionary statements:
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This pesticide product is toxic to fish. Do not contamin-
ate water by cleaning of equipment or disposal of material.
Drift or ranoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not apply
directly to water or wetlands.
3. Both MUPs and EUPs may need special labeling to protect
endangered species. This will be determined after the
required environmental chemistry data are reviewed, and
in conjunction with EPA's evaluation of the potential risk
of hazards to endangered species.
All end-use products intended for crop use, except seed, seed piece
and plant propagule treatments must bear the use restriction:
Do not rotate treated crop with crops other than
those with registered thiram uses.
Do not reenter treated areas within 24-hours following
application unless protective clothing is worn.
H. Tolerance Reassessment
1. Non-Seed Applications
The established tolerances for thiram are presently expressed
as the fungicide thiram (tetramethyl thiuram disulfide) without
specifying any metabolites. The metabolism of thiram in plants and
animals is not adequately understood. Available data do not provide
direct evidence that thirara is or is not absorbed by root or shoot
portions of plants. Therefore, it is not known whether or not thiram
is systemic.
Thiram per se_ has not been identified as a residue in root-
treated plants, however it has not been adequately sought. The
following metabolites of thiram have been tentatively identified
in plant sap using a fungal bioassay on paper chromatographs:
DDC-beta-glucoside (DDC= dimethyldithiocarbamate), DDC-L-alanine,
thiazolidine-2-thione-4-carboxylic acid, and an unidentified
fungitoxic compound. The residues of concern cannot be determined
at this time due to the inadequacy of the available data. Also,
the nonfood use category for thiram seed treatments cannot be
upheld or denied until the receipt of the requested plant
metabolism data.
Reassessment of the established thiram tolerances must await
receipt and evaluation of the toxicological studies as requested
on the accompanying Tables A and B. The available toxicological
data are unacceptable for use in establishing tolerances. Con-
sequently, a "No Observable Effect Level" (NOEL) cannot be establish-
ed at this time, hence a maximum permissible intake (MPI) cannot
be calculated.
10
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The following table lists the present status for tolerances
in parts per million for residues of thiram:
Raw Agricultural Commodity U.S. Canada Mexico Codex
Apples
Bananas
Celery
Onions (dry bulb)
Peaches
Strawberries
Tomatoes
7
?a
7
0.5
7
7
7
0.1
1.0
-
-
7
7
7
7
—
7
0.5
7
7
7
3b
lc
5b
l_
3b
3b
»
3b
2. Seed Applications:
No tolerances have been established for thiram residues
in or on any crop for which thiram is registered solely for
seed treatment, because heretofore seed treatment uses have
been considered to be nonfood uses. These crops include:
barley, beans (dry and succulent), lima beans, beets, broccoli,
brussels sprouts, cabbage, cantaloupe, carrots, castor bean,
cauliflower, collards, corn (sweet and field), cotton, cowpeas,
cucumber, eggplant, endive, flax, forage-fodder grasses,
kale, kohlrabi, lentils, lettuce, millet, muskmelons, mustard,
oats, okra, onion, peanuts, peppers, pumpkins, radish, rice,
rye, safflower, sesame, small-seeded legumes, sorghum,
soybeans, spinach, sugar beets, sunflower, swiss chard,
tomato, turnips, watermelon, and wheat.
fl—7 parts per million in or on bananas (from preharvest and
postharvest application) of which not more than 1 part
per million shall be in the pulp after peel is removed
and discarded.
b. A temporary Codex MRL for the residues of dithiocarbamates
(of which thiram is a member) expressed in terms of mg
CS2/kg, has been established.
c. Temporary Codex MRLs of 1 and 0.1 ppm have been established
for total dithiocarbamates residues (including thiram
expressed as ppm CS2) in or on whole bananas and banana
pulp, respectively.
11
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Use directions and limitations:
The use directions and limitations for seed-treated
crops are outlined in the table below.
Crop
Formulations
Treatment rate3
Comments
Barley
Beans
(dry and
succulent
types)
Beans,
lima
50-75% D
50% WP/D
2.9-4 Ib/gal F1C
43-70% WP
3.75-70/5 WP/D
1.67 Ib/gal (17%) RTU
25-75% D
65-75% WP
50% WP/D
2.9-4 Ib/gal F1C
1.22 Ib/gal (12.71%) RTU
75% D
43-70% WP
70% WP/D
25-75% D
65-75% WP
50% WP/D
2.9-4 Ib/gal F1C
75% D
43-70% WP
70% WP/D
2.05(d)
0.063-1.935 (mai,s)
0.975-1.05 (d,s)
0.93-1.075 (mai,s)
1.5-1.65(d)
1.4-1.575(5)
Beets
Broccoli
Brussels
Sprouts
Cabbage
50-75% D
75% WP
50% WP/D
3-4 Ib/gal F1C
75% D
43-70% WP
70% WP/D
50-75% D
75% WP
50% WP/D
4.0(d)
2.48-4.2(s)
4.3(mai,d)
3.73-4.0(mai,s)
4.0(d)
2.48-4.2(s)
12
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Carrots
Cauliflower
Collards
Endive
Kale
Kohlrabi
Lettuce
Mustard
Peppers
Radish
Spinach
Swiss Chard
Turnips
Cantaloupe
Cucumber
Pumpkin
Squash
Watermelons
Castor Bean
Corn, field
Corn, Sweet
3-4 Ib/gal FlC
75% D
70% WP
70% WP/D
(as above)
3.73-4.0(mai,s)
50-75% D
75% WP
50% WP/D
2.9-4 Ib/gal FlC
75% D
43-70% WP
70% WP/D
50-75% D
75% WP
50% WP/D
3 Ib/gal FlC
75% D
70% WP
70% WP/D
50-75% D
75% WP
50% WP/D
3-4 Ib/gal FlC
2.9-3.8 Ib/gal FIC
18.5-75% D
42-70% WP
70% WP/D
50-75% D
75% WP
50% WP/D
4 Ib/gal FlC
50% WP/D
2.9-3.8 Ib/gal FlC
2.25(d)
1.28-2.36(s)
2.1-2.635(d)
2.25(d)
2.25-2.36(s)
2.1-2.25(mai,s)
1.28-1.575(s)
0.75-0.95 Unspecified method
of treatment
1.12(ma i,s)
1.5-2.67(d)
2.5-3.98(s)
1.47-1.52(3)
13
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Cotton
Cowpeas
Eggplant
Okra
Flax
Forage-
Fodder
Grasses
75% D
42-43% WP
37.5-70% WP
18.5% D
50-75% D
75% WP
50% WP/D
3-4 Ib/gal F1C
75% D
43-70% WP
37.5-70% WP
2.9-3.8 Ib/gal PIC
50-75% D
75% WP
50% WP/D
3-4 Ib/gal F1C
1.22 Ib/gal (12.71%)
1.24 Ib/gal (13.85%)
75% D
43-70% WP
70% WP/D
50-75% D
75% WP
50% WP/D
3-4 Ib/gal F1C
75% D
70% WP
70% WP/D
50-75% WP
50% WP/D
2.9 Ib/gal PIC
70% WP
70% WP/D
1.5-3.76(mai,s)
0.74 oz/bu(mai,s)
2.25(d) Treatment is
1.39-2.36(s) different for
acid, delinted,
reginned or fuzzy
seed (see
labels for details)
2.1-3.0(mai,s)
0.86-12
l.O-l.OS(d)
0.975-1.05(3)
Unspecified method
of treatment.
RTU
RTU
0.93-1.075(mai,s)
3.0(d)
1.86-3.15(s)
2.8-4.0(mai,s)
2.65(d)
1.41-2.775(5)
1.4 oz/bu(mai,s)
50-75%
4.0(d)
14
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75% WP
50% WP/D
3-4 Ib/gal FlC
75% D
70% WP
70% WP/D
3 Ib/gal FlC
Lentils 3 Ib/gal EC
Millet 50-75% D
75% WP
50% WP/D
3-4 Ib/gal FlC
75% D
43% WP
70% WP
70% WP/D
Muskmelons
Oats
Onion
43% WP
37.5% WP/D
1.67 Ib/gal (17%)
50-75% D
75% WP/D
3-4 Ib/gal FlC
75% D
3 Ib/gal FlC
50-75% D
75% WP
Peanuts 25-75% D
75% WP
50%
3-4 Ib/gal FlC
75% D
43-70% WP
37.5-70% WP/D
4.0-4.2(s)
3.73-4.0(mai,s)
2.48
1.54
1.2-3.0(d)
1.95-2.0(s)
Unspecified method
of application.
Unspecified method
of application.
2.15-3.0(mai,s)
0.93 oz/bu(mai,s)
1.505(d)
0.75(d,s,sp)
RTU 0.63-0.835(3)
3.0(d)
3.0-3.15(s)
3.0(ma i,s)
1.86
Unspecified method
of application.
8 oz/10 Ib seed (sets)(d)
or 8 oz/lb pelleted seed(d)
2.25-2.275(d)
2.252.36(s)
1.5-2.25(mai,s)
15
-------
Peas
Rice
Rye
43% WP
4 Ib/gal F1C
1.72(d)
Tank mix with 2,6-
dichloro-4-nitro-
aniline; or 2,6-
dinitro-4-nitro-
aniline and
carboxin.
25-75% D
75% WP
50% WP/D
2.9-4 Ib/gal F1C
75% D
43-70% VIP
70% WP/D
50-75% D
75% WP
50% WP/D
75% D
70% WP
70% WP/D
1.67 Ib/gal (17%) RTU
2.9-3.8 Ib/gal F1C
75% WP
3-4 Ib/gal F1C
50-75% D
75% WP
50% WP/D
2.9-4 Ib/gal F1C
70% WP
70 WP/D
1.5-1.65(d)
1.5-1.575(3)
2.15-2.25(d)
1.25-3.29(5)
0.63-0.835(mai,s)
0.75
6.0(s)
Unspecified method
of application
Use is limited to
CA; apply as a
slurry to water-
seeded rice.
1.875-2.0(s) Use is limited to
CA; apply as a
slurry prior to
preplant soaking.
1.85(d)
0.98-1.95(s)
0.93 oz/bu(mai,s)
16
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Safflower
Sesame
50-75% D
50% WP/D
3-4 Ib/gal FlC
43% WP
70% WP
70 WP/D
3 Ib/gal FlC
50-75% D
75% WP
50% WP/D
3-4 Ib/gal FlC
75% D
43-70% WP
70% WP/D
Small Seeded 30-75% D
Legumes
Sorghum
75% WP
50% WP/D
3-4 Ib/gal FlC
75% D
70% WP
70% WP/D
1.22 Ib/gal
(12.71) RTU
1.24 Ib/gal
(13.85%) RTU
50-75% D
75% WP
50% WP/D
2.9-4 Ib/gal FlC
75% D
43% NP
70% WP
70 WP/D
Soybeans
2.0(d)
2.0-2.1(s)
1.935(mai,s)
0.93 oz/bu(mai,s)
1.01
1.5-1.575(s)
Unspecifed method
of application.
1.4-1.61(mai,s)
4.0(d)
2.48-4.2(s)
3.75-4.0(mai,s)
1.83-1.86
1.2-1.35(d)
1.27-1.95(3)
l.SKmai, s)
2.15(ma i,s)
0.93 oz/bu(mai,s)
Unspecified method
of application.
25-75% D
65-75% WP
50% WP/D
2.9-4 Ib/gal FlC
0.98 lg/gal (12.41%) RTU
1.15 lg/gal (14.66%) RTU
0.975-1.65(d)
0.73-1.05(s)
17
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Sugar Beets
Sunflower
Tomato
1.2 Ig/gal (16.01%) RTU
1.22 Ig/gal (12.71%) RTU
1.24 Ig/gal (13.85%) RTU
75% D
43-70% WP
0.53 Ib/gal (5.7%) RTU
1.67 Ib/gal (17%) RTU
50-75% D
50% WP
3-4 Ib/gal F1C
75% D
3 Ib/gal F1C
3 Ib/gal F1C
50-75% D
75% WP
50% WP/D
3-4 Ib/gal F1C
75% D
70% WP
70% WP/D
43% WP
0.8-1.075(mai,s)
4.0(d)
4.0-4.2(s)
4.0(ma i,s)
2.48
1.03(s)
3.0(d)
3.0-3.15(s)
4.0(mai,s)
2. 8 (ma i , s)
0.8 6(ma i, s)
Unspecified method
of application.
Wheat
3 Ib/gal
50-75% D
50% WP/D
3-4 Ib/gal FlC
43-70% WP
37.5-70% WP/D
1.67 Ib/gal (17%) RTU
1.86
1.65(d)
1.65-1.725(5)
Unspecified method
of application.
0.63-1.72(mai,s)
2.9-3.8 Ib/gal FlC 0.92-0.95
Unspecified method
of application.
a Rate given as oz ai/100 Ib seed unless otherwise specified;
d = dry treatment, s = slurry treatment, sp = spray treatment,
mai = multiple active ingredient formulation.
18
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Use Pattern Statement
Thiram may only be used for formulation into products
intended for those uses listed in F.3 above. For more
detailed use-pattern information on all registered uses
of Thiram (both single active and multiple active ingredient
products) refer to the EPA Compendium of Registered Pesticides,
Volume II: Fungicides and Nematicides, pp. T-30-01 to T-30-09
(Issued: 1975); and/or USDA Compilation of Registered Uses
of Fungicides and Nematicides, pp. T-30-01 to T-30-09 (issued
1978); and/or EPA Index to Pesticide Chemicals for Thiram
(Issued: 09-07-82, 45 pp.).
19
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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 ^/ 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.
20
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type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note; The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-2] for each of your products. On that form you must
state which of the following methods you will use to comply
with the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you nave entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix II-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data Ey 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)
21
-------
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)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
22
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement Composition
§158.135 Toxicology
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
\/ Pattern No or Partially) Citation 3(c)(2)(B)?3/
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Oral LD5Q - Rat
- Dermal 11)50
- Inhalation 1X50 - Rat
- Acute Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
A,B,C,D,E,F,G,H No
A,B,C,D,E,F,G,H No
A,B,C,D,E,F,G,H No
A,B,C,D,E,F,G,H No
Yes
Yes
Yes
No
(6 months)
(6 months)
(6 months)
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
Rodent, Non-Rodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
A,C,E No
No
No
No
Yes
No
No
No
18 months
Rat
82-5 - 90-Day Neurotoxicity-
Hen/Mammal
TGAI
No
No
23
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Use 2/
Composition 1/ Pattern
Does EPA Have Data
to Satisfy This
Requi rement ? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity - TGAI
2 species: Rodent
and Non-rodent
83-2 - Oncogen!city 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
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
A,C,E
A,C,E
A,C,E,
A,C,E
No
No
No
NO
A,C,E
A,C,E
A,C,E
No
No
No
Yes (36 months)
Yes (36 months)
Yes (36 months)
Yes (24 months)
Yes (12 months)
Yes (12 months)
Yes (12 months)
24
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition 1/ Pattern No or Partially) Citation 3(c)(2)(B)T3/
§158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A,C,E No - Yes (18 months)
85-2 - Domestic Animal Safety Choice - No - No
1/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient/ radiolabelledj 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 = Terrestrial, Non-Food; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within the time Indicated under this column from the time of receipt of this Standard.
25
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TABLE A
GENERIC DATA REQUIREMENTS TOR THIRAM
Data Requirement
Compositionb
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIt'RA Section
3(c)(2)(B)?c
158.120 Product Chemistry [I. EPA Reg. Nos. 352-114
Product Identify and Composition;
61-1 - Product Identity and Disclosure
of Ingredients TGAI
61-2 - Description of Beginning Mate-
rials 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/A^
63-7 - Density, Bulk Density, or
Specific Gravity TGAI
(98.5%T) and 4581-258 (99%T)a]
Yes
Partially6
No
No
Yes
Yes
Yesf
Yes
N/A
Yes
GS0122006, GS0122007
GS0122008
GS0122010
GS0122009
GS0122011, GS0122013
GS0122009, GS0122010
GS0122009, GS0122010
GS0122010
GS0122009, GS0122010
GS0122009, GS0122010
No
Yes
Yes
Yes
No
No
Yes
No
No
No
a The technical (T) products also serve as manufacturing-use products.
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 98.5% technical is a solid at room temperature.
e Not satisfied for EPA Reg. No. 4581-258 (99% T).
f Not satisfied for EPA Reg. No. 352-114 (98.5% T).
26
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TABLE A
GENERIC DATA REQUIREMENTS FDR THIRAM
Data Requirement
Composition13
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry [I. EPA Reg. Nos. 352-114 (98.5%T) and 4581-258 (99%)a (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 Requirements;
64-1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
Yesd
No
No
No
No
Partially6
N/A
GS0122011
GS0122011
No
Yes
Yes
Yes
Yes
Yes
No
a The technical (T) products also serve as manufacturing-use products.
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 Partially satisfied for EPA Reg. No. 4581-258 (99% T.).
e Not satisfied for EPA Reg. No. 352-114 (98.5% T).
27
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Composition
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry [II. EPA Reg,
Product Identify and Composition;
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis of Product
Samples
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
Nos. 1187-131 (98.5%T) and 8236-2 (99%T)]a
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
N/Af
TGAI
Yes
No®
No
Yes
Yes
No
No
N/A
Yes
GS0122016, GS0122017
GS0122014, GS0122018
GS0122019
GS0122020, GS0122017
GS0122015
GS0122020 GS0122021
GS0122014, GS0122015
GS0122020, GS0122021
GS0122014, GS0122020
No
Yes
Yes
Yes
No
No
Yes
Yes
No
No
a The technical (T) products also serve as manufacturing-use products.
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 Partially satisfied for EPA Reg. No. 1187-131 (98.5% T).
e Fully satisfied for EPA Reg. No. 1187-131 (98.5% T).
f Not required because the 98.5% technicals are solid at room termperature.
28
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Composition
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry [II. EPA Reg. Nos. 1187-131 (98.5%T) and 8236-2 (99%T)a (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 Requirements;
64-1 - Submittal of samples
TGAI or PAI
PAI
PAI
PAI
TGAI
TGAI
N/A
No
No
No
No
Yes
Nod
N/A
GS0122014, GS0122020
GS0122020
Yes
Yes
Yes
Yes
No
Yes
No
a The technical (T) products also serve as manufacturing-use products.
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 Partially satisfied for EPA Reg. No. 1187-131 (99.5% T.).
29
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Compositionb
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry [III. EPA Reg. Nos. 1965-43 (97%T) and 45728-1 (98.5%T)a]
Product Identify and Composition;
61-1 - Product Identity and Disclosure
of Ingredients TGAI Yes GS0122016,
GS0122012
61-2 - Description of Beginning Mate-
rials 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 - ColorTGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point N/Ae
63-7 - Density, Bulk Density, or
Specific Gravity TGAI
No
No
No
No
No
No
N/A
No
No
Yes
GS0122015, GS0122014 Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
a The technical (T) products also serve as manufacturing-use products.
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 Fully satisfied for EPA Reg. No. 45728-1 (98.5% T).
e Not required because the technicals are solids at room temperature.
30
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Compositionb
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
158.120 Product Chemistry [III. EPA Reg. Nos. 1965-43 (97%T) and 45728-1 (98.5%T)a] (Continued)
63-8 - Solubility TGAI or PAI No Yes
63-9 - Vapor Pressure PAI No Yes
63-10 - Dissociation Constant PAI No Yes
63-11 - Octanol/Water Partition
Coefficient PAI No Yes
63-12 - pH TGAI No Yes
63-13 - Stability TGAI No Yes
Other Requirements;
64-1 - Submittal of samples N/A N/A . , No
a The technical (T) products also serve as manufacturing-use products.
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.
31
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Composition I/
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants PAIRA
Partially
GS0122036, 05003661 Yes3
GS0122024,
- 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 Analtyical
Standard and
metabolites
Pure Analytical
Standard and
metabolites
PAI
No
GS0122037
Partially
N/A
No
Footnote A
GS0122037
Yes4
Yes5
A. Bibliographic citations: GS0122022, 00002931, 00098135, GS0122023, 00098644, GS0122024, GS0122025, GS0122026,
GS0122027, GS0122028, GS0122029, GS012230, GS0122031, 00085531, GS0122032, GS0122033, 00045166, 00090174,
GS0122034, GS0122035, 00098137, GS0122039
32
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
§158.125 Residue Chemistry
Composition I/
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c)(2)(B)?2/
(continued)
171-4 - Magnitude of the Residue-
Residues Studies for Each
Food Use
o Onions (dry bulb)
o Celery
o Tomatoes
o Apples
o Peaches
o Strawberries
o Bananas
o Cotton
o All seed uses
o Meat/milk/poultry/eggs
EP
EP
EP
EP
EP
EP
EP
EP
EP
TGAI or
Partially
Partially
Partially
Partially
Partially
Partially
Partially
No
No
GS0122038, 00041997
00098190, 00090158
00090157
00098190
00089610, 00098190
00098132, 00089409
00075880
00097049, 00098142
00098143, 00047581
00098137
Yes?
Yes8
Yes*
YeslO
Yesn
Yes12
Yes i3
Yesi4
Yes15
Yes 16
Plant Metabolites
33
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
S158.125 Residue Chemistry (continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA - Pure active iingredient, radiolabelled; TEP =
Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than 24 months from the date of receipt of this Standard.
3/ Studies concerning the uptake, metabolism and translocation of [c] thiram by a small grain crop, a root crop,
and a leafy vegetable. (*Note the thiocarbamate carbon should be labeled.) Plants must be planted in treated soil and
the same plants must subsequently be treated foliarly. Radioactive residues must be characterized and quantified in
grain, roots, and foliage. A method such as GC or HPLC msut be used followed by verification by MS.
Studies concerning the uptake and translocation of [14C] thiram into a small grain, cotton, and soybeans following
planting of seed treated with [14C] thiram at the respective maximum registered rates. Total radioactivity must be
quantified in all plant parts at various stages of growth, including the forage stage and at harvest of the raw
agricultural commodity. This study is necessary to determine whether thiram seed treatments may continue to be
considerd nonfood uses or whether tolerances (and the requisite residue data) are required for the commodities derived
from these crops. [Refer to the section concerning seed treatments.]
4/ Metabolism studies utilizing lactating ruminant dosed with [14C] thiram at 7 ppm (or more, if necessary, to obtain
sufficient metabolite levels for identification) in the diet for 3 days. (*Note the thiocarbamate should be labeled.)
Animals must be sacrificed within 24 hours of the final dose and residues must be characterized and quantified in milk,
muscle, fat, kidney, and liver. Milk must be sampled twice daily throughout the dosing period.
Poultry metabolism studies in which laying hens are dosed with [14C] thiram at 0.6 ppm (or more, if necessary, to
obtain sufficient metabolite levels for identification) in the diet for 3 days. Animals must be sacrificed within 24
hours of the final dose and residues must be characterized and quantified in eggs, muscle, fat, gizzard, heart, liver,
and skin. Eggs must be sampled twice daily throughout the dosing period.
jj/ A validated method (preferably GC) which can be used to enforce the established tolerances for residues of thiram
per se_ in or on apples, celery, peaches, strawberries, tomatoes, bananas, snd onions.
A validated confirmatory method (preferably MS).
(It should be noted that the available plant metabolism data are sufficient. Should the required metabolism data
reveal additional metabolites of concern adequate regulatory methods may be required. Also, the available plant
metabolism data, though insufficient, indicate that residues will not be restricted to the surfaces of treated crops.
Surface stripping extraction procedures will be unacceptable. )
34
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
6/ Data demonstrating the stability of thiram residues in or on representative plant and animal samples stored at freezing
~ temperatures for intervals up to 1 year or for a period approximately that used for the residues studies which follow
or those requested.
7/ Residue data involving thiram residues in or on dry bulb onions following the in-furrow application at-planting of
~ either a 65-75% WP or 5-7.5% G formulation at 2.06 Ib ai/A (36-inch row spacing) from tests conducted in western
states. See discussion below concerning green onions.
The requirement for data involving thiram studies in or on onions as the result of seed treatments will be dependent
upon results of the requested plant metabolism data (see plant metabolism section), which would qualify such seed
treatments as either non-food uses or food uses. Additionally, unless removal of green onions from the existing 5% G
formulation labels is considered appropriate, we recommend the proposal of a green onion tolerance and the requirement
of residue data reflecting use of this formulation for green onions as an in-furrow treatment at-planting at 2.06 Ib
ai/A from geographically representative test locations. The Mexican tolerances for residues of thiram per se in or
on onions has been established at 0.5 ppm. No Canadian tolerance or Codex MRL exists for thiram residues in or on
onions. Use of the 5% G formulations on green onions (this would qualify as a food use) is not supported by any
submitted data; nor has a tolerances been established for thiram residues in or on green onions. Unless the registrant
opts for removal of green onions from the existing labels, submission of data pertaining to the use of thiram
formulations on greeen onions and the level of residues contained therein as well as the subsequent establishment of a
green onion tolerance will be necessary.
8/ Residue data from trimmed and washed mature celery from plants which were treated before transplanting with the
4 Ib/gal FlC and, in a separate test, a representative WP formulation at 0.25 Ib ai/1,2000 square feet (9.08 Ib ai/A),
at least four times at 3-day intervals. The studies should take place in CA, which produces 69% of the U.S. celery
crop (Agricultural Statistics, 1982, p. 158).
Residue data from trimmed and washed mature celery raised from transplants foliarly-treated four times at 0.25
Ib ai/1,2000 square feet (9.08 Ib ai/A), and, after transplanting, treated at least 20 times at 2.1 Ib ai/A with a
representative WP formulation at 3-7 day intervals. These tests should take place in FL (since the latter treatment
is registered in FL only).
9_/ Data reflecting residues on the day of the last of 20 foliar applications (3-5 day intervals) with one of the WP
formulations and at 1.125 Ib ai/100 gal and the 3.3% D formualtion at 1 Ib ai/A. FlC and WP data should represent the
maximum expected dosage rate (ai/A) based on typical commercial row spacings and volume of spray/A. Tests should be
conducted in CA(29%) and FL(42%); the contribution to U.S. fresh market tomato production, as designated in Agri-
cultural Statistics, 1982, p. 176, is given parenthetically.
Data pertaining to thiram residues in or the processed products of tomatoes (pomace, puree, catsup, and juice)
processed from field-treated tomatoes which contain measurable weathered residues.
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
10/ Residue data fron apples treated at least 10 times at 2.6 Ib ai/A with a representative D formulation and the 65% WP
(prepared as a D formulation) both aerially and ground-applied (separate tests), sampled on the day of the last
treatment. The studies should take place in NY and WA.
Residue data from apples treated at least 10 times at 1.3 Ib ai/100 gal with 65% WP, sampled on the same day as the
last treatment. The studies should take place in NY and WA.
Residue data fron apples harvested on the same day of the last of at least 10 treatments with the 4 Ib/gal F1C at 1.3
Ib ai/100 gal (sprayed to runoff). The studies should take place in NY and WA.
Residue data from apples and appropriate processed apple products (wet pomace, dry ponace and juice) produced upon
processing of apples having weathered residues at or above the tolerance. This may require that the apples be treated
at exaggerated rates.
ll/ Residue data at 7 days posttreatment reflecting 5 applications of 3-day intervals during blossom development and
12 applications at 10-day intervals beginning at petal fall. The following formulations must be applied: 65-95%
WP and 4 Ib/gal FlC (at 1.3 Ib ai/100 gal); 3.41 Ib ai/A of a representative D formulation. Tests should involve both
aerial and ground applications and must be conducted in CA, PA, and SC. The number of gallons of spray material
applied (FlC and WP per acre must be specified and must reflect good agricultural practices.
A temporary Codex MRL of 3 ppm has been established for dithiocarbamate residues (including thiram) in or on peaches
expressed as ppm CS2. The Canadian and Mexican tolerances are identical to the U.S. tolerance. Compatibility between
the U.S. tolerances and Codex MRL will not be assessed until receipt of the requested data.
12/ Data reflecting residues at daily intervals from 0-7 day following the last of five foliar applications at 10-day
intervals with the 7.5% D and 4 Ib/gal FlC formulations at 3 and 3.25 Ib ai/application, respectively. Tests must be
conducted in CA and FL, which respectively produce 7.3% and 9% of the U.S. strawberry crop (Agricultural Statistics,
1982, p. 229). If necessary, PHIs must be proposed.
13/ Residue data involving thiram residues in or on whole bananas and the pulp from the use of the 65% WP. Three pre-
harvest applications must be made at weekly intervals beginning at flower emergence at 0.65 Ib ai/5 gal. Tests must
be conducted in two or more of the following countries: Guatemala, Nicaragua, Costa Rica, Panama, Columbia, or
Ecuador.
Residue data involving thiram residues in or on whole bananas and the pulp from the use of the 0.1% RTU formulation
applied postharvest as a 0.1% ai paste brushed on crown areas (formulated with ziram, sodium O-phenylphenate, and
sulfur.
36
-------
TABI£ A
GENERIC DATA REQUIRENENTS FOR THIRAM
14/ Because no tolerance exists for thiram residues in or on cotton, no conclusions can be made at this time. However,
unless in-furrow treatment (considered a food use) are removed from the existing labels, the proposal of such a
tolerance will be necessary as will the submission of data involving thiram residues in or on cotton (and, perhaps,
cottonseed products), as a result of in-furrow treatments. Seed treatment data may also be required pending results
of requested plant metabolism studies (uptake of residues into plants grown from thiram-treated seed).
IS/ As no residue data were submitted that reflect seed treatment and knowledge of the plant metabolism of thiram is
incomplete, we cannot determine the necessity for tolerances for thiram residues in or on crops treated in this
manner. When the data requirements outlined in the Nature of the Residue section are completed we will be able to
assess the need for these tolerances and accordingly, for each crop let stand their non-food status, or required
appropriate residue data and tolerance proposals.
16/ The following feeding studies will be required, but only if the requested animal metabolism studies reveal that
thiram residues of concern transfer to animal products;
Lactating ruminants must receive thiram in the diet at 2.5, 10.5 and 35 ppm for 4 weeks or until residue plateau in
milk. All residues of concern must be quantified in milk (collected twice daily), liver, and fat. If the requested
plant metabolism studies reveal that one or more residues of concern other than thiram per se occur in or on feed
items, then these metabolites must also be fed to the same animals receiving thiram per se at levels proportionate to
their occurrence in or on feed items.
Laying hens must receive thiram in the diet at 0.6, 1.8, and 6.0 ppm for 4 weeks or until residues plateau in eggs.
All residues of concern must be quantified in eggs (collected twice daily), fat, gizzard, liver, muscle, and skin.
As noted above for ruminants, other residues of concern found in or plants if they exist, must be fed.
I?/ If the animal metabolism studies reveal that thiram residues of concern transfer to animal derived raw agricultural
commodities and if feeding studies indicate that animal tolerances are needed then validated enforcement methods
for identification and quantification of the residue will be required.
37
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TABLE A
GENERIC DATA REQUIREMENTS FDR THIRAM
Data Requirement
§15ft. 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:
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Composition I/ Pattern No or Partially) Citation 3(c) (2) (B)?3/
TGAI or PAIRA A,B,C,
TGAI or PAIRA A,B,C,
TGAI or PAIRA A,B,C,
TGAI or PAIRA A,B,C,
TGAI or PAIRA C
TGAI or PAIRA C
163-1 - Leaching and TGAI or PAIRA A,B,C,E,F,H
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab) TEP A,B,C,E,F
163-3 - Volatility (Field) TEP A,B,C,E,F
No
No
NO
No
No
No
No
No
No
No
No
Yes (6 months)
Yes (6 months)
Yes (6 months)
Yes4 (6 months)
Yes (2 years)
Yes8 (2 years)
Yes (2 years)
Yes (2 years)
Yes (6 months)
Yes4 (6 months)
Yes4 (6 months)
38
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Use 2/
Data Requirement Composition I/ Pattern
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:
164-1 - Soil TEP A,B,C,H
164-2 - Aquatic (Sediment) TEP C
164-3 - Forestry TEP None
164-4 - Combination and
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially)
No
No
No
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?3/
Yes (2 years)
Yes (2 years)
yes^
No5
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
PAIRA
TEP
TEP
TGAI or PAIRA
A,B,C,E,F,H
No
A,B,C
A,B,C
C
A,B,C
No
No
No
No
165-5 - In Aquatic Non-Target
Organisms TEP
No
Yes (4 years)
Yes (4 years)
Yes (4 years)
Yes (4 years)
Yes (4 years)
No7
39
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TABLE A
GENERIC DATA REQUIREMENTS FDR THIRAM
Data Requirement
Use 2/
Composition I/ 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
§158.130 Environmental Fate
(continued)
Subpart K Re-entry
132-1 Foliar Dissipation
132-1 Soil Dissipation
133-3 Dermal Exposure
133-4 Inhalation Exposure
TEP
TEP
TEP
TEP
A,B,C
A,B,C
A,B,C
A,B,C
No
No
No
No
Yes (2 years)
Yes (2 years)
Yes (2 years)
Yes (2 years)
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 = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within time indicated under column from date of receipt of this Standard.
4/ Not required because thiram has no forestry use.
5/ Not required because this Standard only deals with single active ingredient products.
6/ May be required, depending on results from 164-1, 164-2 and 162-1. If required, must be submitted within 4 years
after notified of the need.
7/ May be required, depending on results from 165-4.
40
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TABLE A
GENERIC DATA REQUIREMENTS FDR THIRAM
Data Requirement
§158.145 Wildlife and
Aquatic Organisms
Avian and Mammalian Testing
71-1 Avian Oral LE^g
71-2 Avian Dietary 0:50
a. waterfowl
b. upland game
71-3 Wild Mammal Toxicity
71-4 Avian Reproduction
71-5 Simulated and
Actual Field Testing
for Mammals and Birds
Aquatic Organism Testing
72-1 Freshwater Fish LC5o
a. warmwater
b. coldwater
72-2 Acute LC50 - Freshwater
Invertebrates
Composition
TGAI
TGAI
TGAI
TGAI
TEP
TGAI
TEP
TGAI
TEP
TGAI
use y
I/ Pattern
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B,H
A,B
N/A 6/
A,B
N/A 6/
A,B
Does EPA Have Data
to Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Yes
Yes
Yes
No
Partially
No
Yes
Yes
Yes
Yes
No
00073683
GS0122040
00034769
00034769
GS0122041
00103373
GS0122042
00090294
GS0122043
00090293
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?V
No
No
No
Yes 4/
(12 months)
Reserved V
No
No
No
No
Yes
(6 months)
41
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TABLE A (Con't)
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Use 2/
Composition 1/ Pattern
Does EPA Have Data
to Satisfy This
Requi rement ? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
72-3 Acute LC5Q - Estuarine TGAI
and Marine Organisms
72-4 Fish Early Life
Stage and Aquatic
Invertebrate Life-cycle TGAI
72-5 Fish Life-cycle TGAI
A,B
72-6 Aquatic Organism
Accumulation
A,B
A,B
A,B
TGAI
PAI or
Degradation Product
72-7 Simulated or Actual TEP
Field Testing -
Aquatic Organisms
A,B
No
No
No
No
No
Reserved /
Reserved 5/
Reserved ^/
Reserved •*/
Reserved •*/
^/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows; A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted within time indicated under column from date of receipt of this Standard.
4/ Protocols for avian reproduction studies must be submitted to EEB for approval prior to conducting the tests.
5/ Requirement is reserved pending a review of outstanding ecological effects and environmental fate data.
6/ Not applicable at this time.
* Study on its own fulfills guideline requirements.
** Study must be combined with other studies to fulfill guideline requirements.
42
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Data Requirement
Composition 1/
Does EPA Have Data
to Satisfy This
Use "I/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
158.155 Nontarget Insect
NONTARGET INSECT TESTING
POLLINATORS ;
141-1 - Honey bee acute
contact
141-2 - Honey bee -
toxicity of
residues on
foliage
141-4 - Honey bee sub-
acute feeding
study
141-5- Field testing
for pollinators
TGAI
A,B,G,H
TEP
A,B,G,H
[Reserved]^/
TEP
A,B,G,H
Yes
00036935
No
No
No4
No"
43
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TABLE A
GENERIC DATA REQUIREMENTS FOR THIRAM
Does EPA Have Data Must Additional
to Satisfy This Data Be Submitted
Use Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c) (2)(B)?3/
158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects A,B,G,H No - 6/
142-2 - Aquatic insect
life-cycle study A,B,G,H No - 6/
142-3 - Simulated or actual
field testing for A,B,G,H No - 6/
aquatic insects
143-1 - NONTARGET INSECT
thru TESTING - A,B,G,H No - 6/
143-3 PREDATORS AND
PARASITES
\/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows; A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic,
Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry;
H = Domestic Outdoor; I = Indoor.
3/ Data must be submitted no later than [date to be established if data are required in the future].
4/ As acute contact LD5Q test showed thiram to be non-toxic to honey bees, no further testing is required.
5/ Reserved pending development of test methodology.
6/ Reserved pending Agency decision as to whether the data requirement should be established.
44
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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 §3(c)(2)(B)."
V Product specific data pertains to data that support the
formulation which is marketed; it usually includes product chemistry
data and acute toxicology data.
45
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING THIRAM
Data Requirement
Composition*3
Does EPA
Have Data to
Satisfy This
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
GS0122001 thru GS0122004
GS0122004
EPA Reg. Nos 2749-12 (65% FI), 2749-10 (72% FI), 2749-79 (80% FI), and 2749-11 (99.45% FI)a
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Indentity and Disclosure
of Ingredients MP Yes
61-2 - Description of Beginning Mate-
rials and Manufacturing Process MP Nc^
61-3 - Discussion of Formation of
Impurities MP No
Analysis and Certification of Product
Ingredients;
62-1 - Preliminary Analysis of Product
Samples MP No
62-2 - Certification of Ingredient
Limits MP Partially
62-3 - Analytical Methods to Verify
Certified Limits MP Partially
Other Requirements;
64-1 - Submittal of Samples N/A N/A
GS0122005
GS0122022
No
Yes
Yes
Yes
Yes
Yes
No
a/ FI = formulation intermediate.
b/ Composition; MP = Manufacturing-use product.
c/ Data must be submitted no later than 6 months from the date of this Standard.
d/ Partially satisfied for EPA Reg. No. 2749-11 (99.45% FI).
46
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING THIRAM
Data Requirement
Composition13
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c) (2) (B) ?c
EPA Reg. Nos. 1965-43 (97% T), 8236-2 (97% T), 4581-258 (99% T), 2749-12 (65% FI), 2749-10 (75% FI),
2749-70 (80% FI), and 2749-11 (99.45% FI)»
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Mate-
rials and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients;
62-1 - Preliminary Analysis of Product
Samples
62-2 - Certification of Ingredient
Limits
62-3 - Analytical Methods to Verify
Certified Limits
Other Requirements;
64-1 - Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
GS0122001 thru GS0122004
GS0122010 and GS0122012
GS0122055 and GS0122007
Yes
Nod
No
No
Partially GA0122005 and GS0122009
Partially GA0122022
N/A
No
Yes
Yes
Yes
Yes
Yes
No
a/ The technical products (T) also serve as manufacturing-use products; FI = formulation intermediate.
b/ Composition; MP = Manufacturing-use product.
c/ Data must be submitted no later that 6 months frcm the date of this Standard.
d/ Partially satisfied for EPA Reg. No 2749-11.
47
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TABLE B
PRODUCT SPECIFIC DATA REQUIRAEMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING THIRAM
Data Requirement
Composition13
Does EPA
Have Data to
Satisfy This
Requirement?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?c
EPA Reg. NOs. 352-114, 1187-131, and 45728-1 (98.5%
158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure
of Ingredients MP
61-2 - Description of Beginning Mate-
rials and Manufacturing Process MP
61-3 - Discussion of Formation of
Impurities MP
Analysis and Certification of Product
Ingredients;
62-1 - Preliminary Analysis of Product
Samples MP
62-2 - Certification of ingredient Limits MP
62-3 - Analytical Methods to Verify
Certified Limits MP
Other Requirements;
64-1 - Submittal of Samples N/A
Yes
Partially
Yesd
No
Partially
Partially
N/A
GS0122008, GS0122010,
GS0122016
GS0122009, GS0122017
GS0122011, GS0122017
GS0122009, GS0122017
GS0122022
No
Yes
Yes
Yes
Yes
No
a/ The 98.5 % technicals (T) also serve as manfacturing-use products.
b/ Composition; MP = Manufacturing-use product.
c/ Data must be submitted no later than 6 months from the date of this Standard.
d/ Not satisfied for EPA Reg. No. 352-114.
48
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING THIRAM
Data Requirement
Composition V
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Irritation - Rabbit
81-5- Primary Dermal MP
Irritation
81-6 - Dermal Sensitization MP
No
No
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)?2/
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD
81-2 - Dermal
50 ~Rat MP
LD50 MP
81-3 - Inhalation LC50 - Rat MP
81-4 - Primary
Eye MP
No
No
No
No
Yes ( 6
Yes ( 6
Yes ( 6
Yes ( 6
months )
months )
months )
months )
Yes ( 6 months)
Yes ( 6 months)
_1/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted within the time indicated under this column from date of receipt of this Standard.
-------
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 §162.11(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 §162.10 (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 §162.10(b)]
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
See Appendix IV-1. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
50
-------
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rattier 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 §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix IV-1. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is immediately below the product name. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. 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.
51
-------
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 §162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" shall appear on
the label in red on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
proximity to the word poison. 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 §162.10 (h) (1 )( iii) ]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV-1. [40 CFR §162.10(h) ( 1 ) (iii ) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. See Appendix IV-1. [40 CFR §162.10
(h)(2)J
52
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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
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CFR
§162.10(h)(2)(ii)3
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix IV-3. The requirement is based on the results
of the flashpoint determinations and flame extension
tests required to be submitted for all products.
These statements are to be located in the side/back
panel precautionary statements section, preceded by
the heading "Physical/Chemical Hazards." Note that
no signal word is used in conjunction with the flam-
mability statements.
2. Criteria for declaration of non-flammability. The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163.61-8(c)(13)
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163.61-8(c)(13)(ii);
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13)(i).
53
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3. Declaration of non-flammability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix IV-1. [40 CFR §162.10(1)(2)(ii) ]
Item 10A. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. Make certain that the statement you use
pertains specifically to your product. These instructions
must be grouped and appear under the heading "Storage and
Disposal" in the directions for use. This heading must be
set in the same type sizes as required for the child hazard
warning. Refer to Appendix IV-4 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. 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.
54
-------
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
Pnone 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 (Appendix
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.
55
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Appendix II-l
Guide to Use of This Bibliography
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.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject) , can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
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
56
-------
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.
57
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Thiram Standard
00002931 Keppel, G.E. (1971) Collaborative study of the determination of
Dithiocarbamate residues by a modified Carbon disulfide
evolution method. Journal of the AOAC Association of Official
Analytical Chemists 54(3):528-531. (Also in unpublished
submission received on unknown date under OF0939; submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:094582-G)
00034769 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds. By U.S. Fish
and Wildlife Service, Patuxent Wildlife Research Center. Wash-
ington, D.C.: U.S. FWS. (Special Scientific Report—Wildlife
No. 191; report no. 33423a; also in unpublished submission re-
ceived Mar 28, 1979 under 3125-236; submitted by Mobay Chemical
Corp., Kansas City, Mo.; CDL:237905-B)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00041997 Ryker, T.C. (1970) Letter sent to C.C. Compton dated Jun 26, 1970:
Thiram residues in onions. (Unpublished study received Nov
1, 1970 under 1E1123; prepared by E.I. du Pont de Nemours & Co.,
submitted by Interregional Research Project No. 4, New Bruns-
wick, N.J.; CDL:090898-A)
00045166 Pease, H.L. (1953?) Determination of Dithiocarbanate Fungicide Res-
sidues. Undated method. (Unpublished study received Aug 20,
1957 under PP0144; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, Del.; CDL:092424-G)
00047581 E.I. du Pont de Nemours & Company, Incorporated (1968) Residue Data
Thiram—Bananas. (Unpublished study received Sep 10, 1968 under
9F0758; CDL:093070-B)
00073683 Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal,
pharmaceutical and other chemicals to wild birds. Toxicology
and Applied Pharmacology 21:315,316,319. (Incomplete; also in
unpublished submission received Mar 21, 1977 under 352-338; sub-
mitted by E.I. du Pont de Nemours & Co., Wilmington, Del.; CDL:
228727-AI)
00075880 E. I. du Pont de Nemours & Company (1955) Results of tests on the
Amount of Residue Remaining on Apples: [Thiram]. (Unpublished
study received on unknown date under PP0052; CDL:090050-B)
58
-------
Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Thiram Standard
00085531
00089409
00089610
00090157
00090158
00090174
00090293
00090294
Lacy, M.L. (1970) Letter sent to C.C. Ccmpton dated Nov 30, 1970
[Determination of Thiram residues in onions]. Unpublished
study received Nov 1, 1970 under 1E1123; prepared by Michigan
State Univ., Dept. of Botany and Plant Pathology, submitted by
Interregional Research Project No. 4, New Brunswich, N. J.;
CDL:090898-B)
E.I. du Pont de Nemours & Company (1958) Additional Data in Support
of Petition: Summary: Thiram. (Compilation; unpublished
study, including published data, received Dec 15, 1958 under
PP0204; CDL:090232-B)
E.I. du Pont de Nemours & Company, Incorporated (1955) Results
of Tests on the Amount of Residue Remaining on Apples: Thiram.
Includes method dated Dec 9, 1954. (Unpublished study received
Feb 25, 1955 under PP0009; CDL:090009-D)
E.I. du Pont de Nemours & Company, Incorporated (1960) Results of
Tests on the Amount of Residue Remaining on Celery: [Thiramj,
(Unpublished study received Oct 20, 1960 under PP0278; CDL:
090300-A)
E.I. du Pont de Nemours & Company, Incorporated (1960) Control of
Certain Diseases of Celery with Thylate Thiram Fungicide and
Combinations of Thylate with Manzate Maneb Fungicide or Parzate
C^iieb Fungicide. (Compilation; unpublished study received
Oct 20, 1960 under PP0278; CDL:090300-B)
Pease, H.L. (1957) Determination of dithiocarbamate fungicide res-
Sues Journal of the Association of Official Agricultural
Chemists40(4)-.1113-1118. (Also in unpublished submission re-
2^?Sct 20 I960 under PP0278; submitted by E I. du Pont de
Nemours & Co.! Inc., Wilmington, Del.; CDL:090300-C)
McCann, J.A. (1972) Tersan 75: Rainbow Trout (Salmo gairdneri):
Test No 463. (U.S. Agricultural Research Service,
SStiSdes Regulation Div., Animal Biology Laboratory, Fish
Toxicity Laboratory; unpublished study; CDL:130512-A)
McCann, J.A. (1972) Tersan 75: Bluegill (Leponis macrochirus):
Test No. 446. (U.S. Agricultural Research Serv-
IS! Pesticides Regulation Div., Aniinal Biology Laboratory,
Fish Toxicity Laboratory; unpublished study; CDL:130513-A)
59
-------
Appendix Il-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Thiram Standard
00097049 E.I. du Pont de Nemours & Company, Incorporated (1957) Summary
of Thiram and Dithiocarbamate Residue Data on Strawberries.
(Unpublished study received Jan 8, 1957 under unknown admin.
no.; CDL:124402-D)
00098132 E.I. du Pont de Nemours & Company, Incorporated (1956) Results of
Tests on the Amount of Residue Remaining on Peaches: Thiram.
(Unpublished study received Sep 1, 1956 under PP0091; CDL:
090121-A)
00098135 Breault, E.A. (1960) Letter sent to H.W. Gerritz dated Dec 13,
1960: Thiram (tetramethyl thiuram disulfide) on celery. (U.S.
Government; unpublished study; CDL:092556-A)
00098137 Rosen, D.E. (1962) Letter sent to William Stokes dated May 22,
1962 Thiram fungicide residues in bananas. (Unpublished study
received on unknown date under PP0359; submitted by E.I. du Pont
de Nemours & Co., Inc., Wilmington, Del.; CDL:092643-A)
00098142 E.I. du Pont de Nemours & Company, Incorporated (1959) Thiram:
Residues in Peaches and Strawberries. (Compilation; unpub-
lished study received on unknown date under PP0204; CDL:
098740-A)
00098143 E.I. du Pont de Nemours & Company, Incorporated (19??) Residue
(ppm): Thiram: Whole Fruit. (Unpublished study received on
unknown date under PP0359; CDL:098907-A)
00098190 E.I. du Pont de Nemours & Company, Incorporated (1957) Results of
Tests on Amount of Residue Remaining on Food Crops: Thiram.
Includes undated method entitled: Determination of dithio-
carbamate fungicide residues. (Compilation; unpublished study
received Aug 4, 1957 under PP0144; CDL:090172-C)
00098644 Cullen, T.E. (1964) Spectrophotcmetric determination of dithio-
carbamate residues on food crops. Analytical Chemistry 36(1):
221-224. (Also in unpublished submission received Nov 16, 1965
under unknown admin, no.; submitted by FMC Corp., Philadelphia,
Pa.; CDL:120299-A)
60
-------
Appendix, il-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Thiram Standard
00103373 Midwest Research Institute (1977) Initial Scientific Review of
Thiram: MRI Project No. 4307-L; RvR Project No. 78. (Unpub-
lished study received Jun 15, 1982 under unknown admin, no.;
prepared in cooperation with RvR Consultants, submitted by
Bonide Chemical Co., Inc., Yorksville, NY; CDL:247670-A)
05003661 Solel, Z.; Edgington, L.V. (1973) Transcuticular movement of
fungicides. Phytopathology 63(4):505-510.
61
-------
Appendix II-l
BIBLIOGRAPHY
THIRAM REGISTRATION STANDARD
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS0122001
GS0122002
GS0122003
GS0122004
GS0122005
GS0122006
GS0122007
GS0122008
GS0122009
GS0122010
U.S. EPA (undated) Registration
Jacket for Thiram 65, EPA Registration
No. 2749-12, Statement of
ingredients received 2/20/67.
U.S. EPA (undated) Registration
Jacket for Thiram 75, EPA Registration
No. 2749-12, Statement of
ingredients received 2/20/67.
U.S. EPA (undated) Registration
Jacket for Thiram 80% Wettable Powder,
EPA Registration No. 2749-79, Statement of
ingredients received 11/20/70.
U.S. EPA (undated) Registration
Jacket for Thiram 100 Fungicide,
EPA Registration No. 2749-11, Statement of
ingredients received 3/17/75.
U.S. EPA (undated) Registration
Jacket for Thiram 100 Fungicide,
EPA Registration No. 2749-11, Data in
correspondence received 5/20/75.
U.S. EPA (undated) Registration Jacket
for Pennwalt Thiram Technical,
EPA Registration No. 4581-258, Memorandum from
Richard Loranger to Henry Jacoby dated 10/6/81.
U.S. EPA (undated) Registration Jacket
for DuPont Thiram Technical,
EPA Registration No. 352-114, Composition of
DuPont Thiram Technical dated 11/8/68.
Ibid., Confidential Statement of
Formula received 2/7/77.
Ibid., General Chemistry Data on
DuPont Thiram Technical dated 2/4/77.
U.S. EPA (undated) Registration
Jacket for Pennwalt Thiram Technical,
EPA Registration No. 4581-258, Confidential
Statement of Formula dated 5/4/73.
62
-------
Appendix II-l
BIBLIOGRAPHY
THIRAM REGISTRATION STANDARD
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS0122011
GS0122012
GS0122013
GS0122014
GS0122015
GS0122016
GS0122017
GS0122018
GS0122019
GS0122020
GS0122021
Ibid., Product Data Bulletin #9a,
Thiram Technical received 8/20/73.
U.S. EPA (undated) Registration
Jacket for Vancide TM,
EPA Registration No. 1965-43, Ingredient
Statement dated 10/5/65.
Sittig, Marshall (ed). 1977. Pesticide
Process Encyclopedia. Noyes Data Corp.
Park Ridge, NJ. p. 464.
U.S. EPA (undated) Registration
Jacket for Thiram Technical,
EPA Registration No. 8236-2, Formula
Sheet received 10/29/69.
Data
U.S. EPA (undated) Registration Jacket 9
for Tetramethylthiuram disulfide React-Rite
TMTD, EPA Registration No. 45728-1, Material
Safety Data Sheet received 11/24/81.
Ibid., Confidential Statement
Formula dated 5/24/82.
of
U.S. EPA (undated) Registration Jacket
for Thiram Technical,
EPA Registration No. 8236-2, Data from a
Confidential Statement of Formula dated 11/8/68
Ibid., Data Sheets for a 97% Thiram Product
received 8/27/69 and 10/29/69.
U.S. EPA (undated) Registration
Jacket for Thiram Technical,
EPA Registration No. 1187-131, Confidential
Statement of Formula dated 5/27/82.
Ibid., Information from Product Chemistry
Data received 5/27/82.
Ibid., Data from Bulletin Thiram-01
received 2/26/84.
63
-------
Appendix II-l
BIBLIOGRAPHY
THIRAM REGISTRATION STANDARD
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS0122022 Association of Official Analytical
Chemists. 1980. Official Methods of
Analysis. 13th Edition. Sections
29.165 - 29.171.
GS0122023 Clarke, D. G., H. Baum, E. L. Stanley, and
W. F. Hester. 1951. Determination of
dithiocarbamates. Anal. Chem. 23(12):1842-
1846.
GS0122024 U.S. EPA 1954. Correspondence File for
Pesticide Petition No. 0052 (EPA
Accession No. 113119). Method of Analysis
for Thiram Residues in Crops.
GS0122025 U.S. EPA 1956. Correspondence File for
Pesticide Petition No. 0091 (EPA
Accession No. 113251). Determination of
Dithiocarbamate Residues on Crops.
GS0122026 Heurmann, R. F. 1957. Determination of residue
quantities of dialkydithiocarbamates by amine
evolution. J.A.O.A.C. 40(1):264-270.
GS0122027 Keppel, G. E. 1957. Report on tetramethylthiram
disulfide (thiram). J.A.O.A.C. 40(1):270-273.
GS0122023 Keppel, G. E. 1959. Report on the determination of
tetramethylthiram disulfide (thiram) on corn
and apples. J.A.O.A.C. 42(3):545-548.
GS0122029 U.S. EPA 1970. Correspondence File for Pesticide
Petition No. 0278 (EPA Accession No. 113804).
Memorandum to Chief Chemist, Cincinnati District,
pertaining to a method tryout on celery
dated 11/29/70.
GS0122030 Keppel, G. E. 1962. Thiram residues in
tomatoes, strawberries, and celeries. J.A.O.A.C.
45(2):410-414.
GS0122031 Keppel, G. E. 1969. Modification of the
carbon disulfide evolution method for
dithiocarbamate residues. J.O.A.C. 52(1):162-167,
64
-------
Appendix II-l
BIBLIOGRAPHY
THIRAM REGISTRATION STANDARD
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS0122032
GS0122033
GS0122034
GS0122035
GS0122036
GS0122037
GS0122038
GS0122039
GS0122040
Lowen, W. K. 1951. Determination of
dithiocarbamate residues on food crops.
Anal. Chem. 43(3):717-720.
McKinley, W. P. and S. A. Magarvey. 1960.
Paper chromatography of ferbam, maneb,
nabam, thiram, zineb, and ziram.
J.A.O.A.C. 43(3):717-720.
Pesticide Analytical Manual (PAM), Vol. II.
Dithiocarbamates.
Pesticide Analytical Manual (PAM), Vol. II.
Pesticide Regulatory Section 180.132.
Dekhuijzen, H. M. 1964. The systemic
action of dimethyldithiocarbamates on cucumber
scab caused by Cladosporium cucumerinum
and the conversion of these compounds
by plants. Neth., J. Plant Path.
70(Suppl. 1): 75 pp. [Not registrant-
submitted. ]
Robbins, R. C., and J. Kasteclic. 1961.
Fate of tetramethylthiuram disulfide in the
digestive tract of the ruminant animal.
J. Agric. Food Chem. 9(4):256-260.
[This was not registrant-submitted.
Labeled thiram was not used, tissues and
milk were not analyzed, data were variable,
95% of the dose was not recovered.]
U.S. EPA 1970. Correspondence File for
Pesticide Petition No. 1E1123 (EPA
Accession No. 117227). Correspondence to
C.C. Compton submitted by IR-4 under
Section D dated 11/30/70.
Association of Official Analytical Chemists.
1980. Official Methods of Analysis 13th
Edition. Sections 29.165-29.171.
Tucker, R. K. and D. G. Crabtree. (1970).
Handbook of toxicity of pesticides to wildlife.
Resource Pub: 84, U.S.D.I., Fish and Wildlife
Service, Denver Wildlife Research Center.
Washington, DC 131 p. (Fiche ID IBAOTHI03).
65
-------
Appendix II-l
BIBLIOGRAPHY
THIRAM REGISTRATION STANDARD
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS0122041 Enviro. Control Inc., 1981. Hazard Information
review: Bis (dimethylthiocarbamyl) Disulfide.
IR-220 Prepared under EPA Contract No.
68-01-5789 (TSCA Interagency testing
Committee). (Fiche ID No. BAOTHI04).
GS0122042 McCann, J. A. 1976. Bluegill sunfish (Leponis
macrochirus). Test No. 996 (U.S. EPA, Chemical
and Biological Investigations Branch, Animal
Biology Laboratory). (Fiche ID No. BAOTHI01).
GS0122043 McCann, J. A. 1976. Rainbow Trout (Salmo
gairdneri). Test No. 1001 (U.S. EPA, Chemical
and Biological Investigations Branch, Animal
Biology Laboratory). (Fiche ID No. BAOTHI02).
66
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Appendix II-2
OMB Approval No. 2000-0468
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANTS 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, I am responding in the following manner:
D1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures 1 will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will 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
D3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
D 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
D 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
8* Form 8680-1 (10-82)
67
-------
Appendix II-3
OMB Approval No. 2000-0468
To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
. I am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
This firm or group of firms 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. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
firm(s) accepted my offer.
nmtUVjar, llOnC \3I LIIUM? llllli\J/ qyi«c^t.cvi^jjJE_vj_Lw»_^.^_^_^^^^_^^^^^,,^MM^^^^^».^^^^^^^^^^M»»«'»»-^^^^"-™^™i^^^^^^^^^"^'^»> i —
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraphj3) above
have agree?to submit the data listed in paragraph (2) above in accordance with the Not.ce I understand EPA wm P™*^°"J
me whether my firm must submit data to avoid suspension of its registrat.on(s) under FIFRA SectIOn 3(c)(2)(B). (Th.s statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
»* Form 8580* (10-82)
SIGNATURE
68
-------
APPENDIX III-l
SEA Registration No.
PVOLUCT SfrsCiSTC DMA SHORT
Guidance Docunenc fcr_
Oats
Begis ttaticn
Guideline Mo.
$158.20
61-1
61-2
51-3
62-1
62-2
62-3
63-2
53-3
63-4
63-5
53—6
63-7
63-3
63-9
63-10
63-11
63-12
63-13
63-14
— 53^3"
Kane of Test
Identity cc
Statement at
f craaticn o£
Preliminary
analysis
Cartiricaticn oc
Test not
required
fee ay
product
listed
above
(ehecfc
belcw)
I am complying with
data reouireoents bv
Citing MHlDti
1
Analytical netncos)
limits f
Colcr
Physical state
Odor
Melting ooinc I
Boiling coint
Density, buUe-
density, or
soedfic cravity
Soiueilirv
Vaocc oressure
ocnatant
Octanol/water
partition
coefficient
ca
Staoilitv
—
Oxidizing/reduciiigi
reaction
pi ajiiMM^-j i i tv i
63-. .6 j SxDlcdaoi_Utv
63-17 1 Storage staoilitv
63-13 Visccsitv
53-19 MisdbiliW
Sucnit—
ting
Data
(At-
tached)
(For -PA Ose Only)
Accession tAaaBers
Assigned
1
1
Garrosicn
characteristics
63-21
SlSd.135
31-1
41-J
Dielectric creajc-
Acute oral LD-^Q,
Acute cftrrail I
LI>50 1
a 1-3 i Acute uinalaticn,
1
ai-4
al-3
al-a
X-50 rat
~3*'~^[tO*fJ-\7 ^nf£
^* j"|rcaj^.y i ,i _••. .ica ^
irritation
CenTHL sensitiza-
69
-------
Appendix IV-1
Chapter I—Environmental Protection Agency
§ 162./0
cabt obtained the data from anothe
fir» (identify); applicant copied dal
Iron a publication; applicant obtained
a copy of the data from EPA).
(d\The applicant shall submit
his application a statement that 5fPA.
in itsVvaluation of the properties/effi-
cacy, Vnd safety of the formulated
end-usa product, may not consid/r any
data aA supporting the application,
except tne following data:
(1) The. data the applicant flas sub-
mitted to1
thissectii
(2) Oth
5 A under paragraph (b) of
data pertaini
to the
safety of the product's acttfe ingredi-
ents, rathert than to the s^ety of the
end-use prooVict; and
(3) Existing tolerances, fcod additive
regulations, exemptions/ and other
clearances isstaed undey the Federal
Food, Drug, anti Cosmeyc Act.
(e) If the applicant mows that any
item of data he\subm*ted under this
section was generated
pense of) anothenpej;
ly submitted the
jy (or at the ex-
who original-
to EPA (or its
predecessor, USDAyon or after Janu-
ary 1, 1970, to supfort an application
experimental • use
\nt adding a new
stration, or for
the applicant
for registration,
permit, or amen<
use to an existin
reregistration (
and the origina/ data\ submitter have
reached written agreement on the
amount and the termsW payment of
any compensation that\ may be pay.-
able unde/ FIFAA section
3(cXlXDXii)/vith regard to approval
of the application), the applicant shall
submit to HP A a statement that he
has furnished to each sue* identified
original da/a submitter
(DA notification of the Applicant's
intent to /pply for registration, includ-
ing the proposed product
(2) An/offer to pay the person com-
pensation, with regard to the approval
of the/application, to the exnent re-
quired/by FIFRA sections 3(c\(lXD)
and 3/CX2XD);
(3)/An identification of the it\em(s)
, to which the offer applies:
An offer to commence neg^tia-
to ascertain the amount
of compensation to be paid;
(5) The applicant's name, addre
telephone number.
If the applicant's product ion-
tain any active ingredient other /nan
thos\ that are present solely because
of theVincorporation into the product,
duringXformulation, of one o/ more
other Vfigistered pesticide Products
purchase^ from another /roducer,
then theVpplicant shall aA/o comply
with J 162J9-5 as to such a/tive ingre-
dient, andYhe applicatioii shaU con-
tain an acknowledgment /hat for pur-
poses of FIFRA sectiony8(c)(l)(D) the
application relies on (afcd any result-
ing registratiorAshouldr be regarded as
if it were based MI th/Administrator's
consideration of)\he/following data;
Cted or specifically
it in support of
of data in the
(1) All datasubr
cited by the appl,
the registration;
(2) Each othe/itef!
Agency's files wXich:
(i) Concerns the properties or effects
of any such awive ingreoient; and
(ii) Is oneyBf the typesVjf data that
EPA wouldyequire to be submitted for
scientific ntview by EPA i\ the appli-
cant sought the initial registration
under EEFRA Section 3(c\5) of a
producywith composition anck intend-
ed uses/identical to those proposed for
the applicant's product, under~ the
data/requirements in effect oa the
date/ EPA approves the applic\nt's
present application.
-------
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 classifications) 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 part 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.
(11) All required label text must:
(A) Be set in 6-point or larger .type:
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary,
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label—
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency
§ 162.10
any agency of the Federal Govern-
ment;
(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;
(viii) 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, (i) Except
as provided in paragraph (a)(6)(ii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been 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:
(i) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to § 162.6(bX4).
(c) Name and address of producer,
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
producer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • * *," "Distribut-
ed by * • V or "Sold by • • *" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68' F (20'C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semiso-
lid, viscous or pressurized, or is a mix-
ture of liquid and solid, the net con-
tent statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, i.e., "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above tyiinimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label,
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
other print on that pan of the label
on which it appears and shall run par-
72
-------
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 regis-
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.
(g) Ingredient statement—<1) 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 in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides -which 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.
Title 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(c)(6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms ' of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-.
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(I) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
[date]." , ,_ ,
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
(7) Inert ingredients. The Adminis-
trator may require the name of any
73
-------
Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency
§ 162.10
inert ingredient(s) to be listed in the
ingredient statement il 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 require-
ments concerning content, placement,
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
Tojpoty cat«ooo«*
Hazard
n*ca
tors j
i
1 { II
III
IV
Oral ID.-
| Up to and nduding 50
mg/kg.
inhalation LC__.| Up to and including .2
mg/«a».
Up to and including 200
mg/kg.
\ From SO mm 500 mg/kg.. from 500 tfmj 5000 mg/
I *<9-
From .2 mru 2 mg/litar._: From 2. BK; X ms/CMr.
0«rm»! ID...
Greater ttian 5000 mg/
*9,
Sreater tnan 20 mg/Btar.
From 200 thru 2000....
! From 2.000 thru 20.000.- Graatar than 20.000.
Eye attacls
CorrotN*: com**)
opacity notrawrvtta
writwi 7 day*.
Com«»l opacity
reveratte within 7
days: mutton
persisting tor 7 days.
Savara irritation at 72
hours.
i No comaal opacity;
i ff Ration fawfrsiWa.
! within7days.
I Moderate mutton at 72
j hour*
No irritation.
MM or sfcgnt irritation «
72 nan.
(i) Human hazard signal word—(A)
Toxicity Category I. 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 IL All pesti-
cide products meeting the criteria of
Toxicity Category II shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicity Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. 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 permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(il) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
ing, storage or use is demonstrated by
the applicani.to be extremely remote,
or tf the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(ill) Statement of practical treat-
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 (hX2) 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
Points
Size of label front panel m square ;
inches '
capitals
5 and under
Above 5 to 10
Above 10 to 15
6
10
12
Above 15 to 30 1 14
Ov«»30
18
6
6
8
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(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Tow*
Precautionary statements by loncrty category
Oral, inhalation, or derma/ toncny
Stan and aye local effect*
Fatal (pononous) t swallowed [inflated or absorbed
through stun]. Do not bream* vapor [dust or spray
mat]. Do not get in eyes, on skirt, or on domng
(Front panel statement ot practical treatment re-
Corrosive, causes eye and ston damage [or-«kn
| irritation}. Do not get in eyes, an skm. or on
! doffing, wear goggles or face shield and rubber
gloves when handling. Harmful or fatal « swallowed.
1 [Appropriate first aid statement raquredj
Causes eye (and skin] rntaoon. Do not get in eyes.
on stan. or on dotting. Harmful if swallowed. [Ap.
propnaM first aid statement requreaj
Harmful if swallowed [inhaled or absorbed through the Avoid contact with skin, eye* or doming. In case of
skin]. Avoid breanng vapors [dust or soray mat]. contact immediately flush eyes or skm with plenty of
Avod contact with skm [eyes or doffing]. [Appro- water. Set medical mention if rnaoon
pnate first aid statement required.].
May be fatal * swallowed C'mnaled or absorbed
through me skin]. Do not breathe vapors (dust or
spray mot). Do not get in eyes, on start, or on
I (No precautionary statements required.].
[Nopr*
maty statement* recuredj
(ii) 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 circum-
74-A
-------
Appendix W-l (continued)
Chapter 1—Environmental Protection Agency
§ 162.10
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 LDv> of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlif e" 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 Pish" is required.
(C) If a pesticide intended for out-
door use contains an active ingredient
with an avian acute oral LDU of 100
ing/kg or less, or a subacute dietary
LC» of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(P) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(iii) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Flash port
Raquirad text
(A) PtttssumZEO CONTUNCMS
Flash pan* at or below JO" F; » mere is a flasfibac* at Extremely flammable Contents under pressure. Keep away from
any verve openng. j *•• sparks, and Mealed surfaces. Oo not puncture or incinerate
i container. Exposure to temperatures above 130* f may cause
i bursting.
Rasn point above 20* F and not over W F or if me , Flammable. Contents under pressure. Keep away from heat.
flame extensor* a more men 18 in tang at a distance ! sparks, and open flame. Oo not puncture or incinerate container
of C in tram the flame.
Alomerpi
Ezpotm to twnparaturM aoov* 130* F may eaua* bunting.
Conttna unoar prasaura. Oo not uaa or stora naar naat or span
llama. Oo not punctura or inowata contamr. Expoaura to
tamparaturaa abova 130* F may causa bursting.
IS) NoNmcssumzco CONTAMf M
Al or batow 20-F
Abowa 20* F and not ovar SO' F—
AbowW F and not ovar 1SCT f..
Extramaly nammabl*. Kaap away from rVa. (parks, and naatad
surfaeaa.
Flammable. Kaap away Irom haat and opan flama.
"... ..! Oo not usa or stora naar haat or opan flame.
(i) Directions for Use—(I) General
requirements—(i) Adequacy and clar-
ity of directions. Directions for use
must be stated in terms which can be
easily read and understood by the
average person likely to use or to su-
pervise the use of the pesticide. When
followed, directions must be adequate
to protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) U required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag:
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular." and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(iii) Exceptions to reguirement for
direction for use—(A) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
74-B-
-------
Appendix TV-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 of pesticide prod-
ucts involved;
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
Title 40—Protection of Environment
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(1) The statement of use classifica-
tion as prescribed in 162.10(j) immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(iii) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type(s) of application ap-
paratus or equipment required.
(vii) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
adverse effects on the environment.
(viii) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These .
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing (See Table in § lB2.10(hXl)(iv).)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
74-C
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Appendix IV-1 (continued)
Chapter I—Environmental Protection Agency
§162.11
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(P) 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
easonable adverse effects.
(a)Ncriteno JOT Issuance of Not
Intenr^to Deny Registration, Ca
Registration, or to Hold a Heajtng—
(1) Preswnption. (i) A rebuttab/e pre-
sumption SJiall arise that a notice of
intent to demy registration pursuant to
section 3(cX\of the Act,/notice of
intent to cancV registration pursuant
to section 6(bJU) of t/e Act, or "a
notice of intent V> holp a hearing to
determine whethV Jme registration
should be cancellea^Sr denied, as ap-
propriate, shall be/fliued, upon a de-
termination by th/AdVunistrator that
the pesticide meAs orVcceeds any of
the criteria for^isk set florth in para-
graph (aX3) o/this sectionV Upon such
determination. the Administrator
shall issue/otice by certifie\ mail to
the applic/tit or registrant, as\he case
may be,ystating that the applicant or
registrant has the opportuniV to
submtir evidence in rebuttal of auch
presumption in accordance with pa
(aX4) of this section. The app>
It or registrant shall have forty-fivl
74-D
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LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
APPENDIX IV-2
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . , "
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
75
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AEBENDIX IV-2 (Continued)
ITEM
1C
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
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
.
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
76
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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
choli nes 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
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
77
-------
APEE2JDEJ IV-2
PRODUCT
NAME
General Use ?«s-fc±
PRODUCT
NAME
Reatrlgted Fae ?ggtle±de
78
-------
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
79
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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 the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
.... 10 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.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
80
-------
Appendix iv-4
(continued)
4. Instructions on wnat to do if the container is damaged in
any way, or if tne pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs,
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
oresentlv meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
81
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Appendix iv-
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type
•r™""^i^—"-""™^?'"^^^™
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aeroso.
(bags)
products
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag.Discard bag in trasn.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
82
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Appendix iv-A"
(continued)
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
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
iManufacturer
and how fiber
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder tor reuse (or
similar wording).
may replace this phrase with one indicating whether
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.
83
-------
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):
Acrolein
Aldicarb
Aldrin
Allyl alconol
Aluminum phospnide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen cnloride
2-Cyclonexyl-4,6-dinitropnenol
Dieldrin
0,0-Dietnyl S-[2-ethylthio)ethyl] phosphoroditnioate
(disulfoton, Di-Syston)
0,0-Dietnyl 0-pyrazinyl phosphorothioate (Zinopnos)
0^0-Dimetnyl 0-p-nitrophenyl phosphorotnioate (methyl paratnion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclonexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endotnall
Endrin
Fampftur
Fluoroacetamide
Heptacnlor
Hexanethyl tetrapnosphate
Hydrocyanic acid
Hydrogen cyanide
Metnomyl
alpha-Naphtnyltniourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Paratnion
84
-------
Appendix IV--4
(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 dithiopyropnosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc pnosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
85
-------
Appendix IV-4 -
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetracnloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine nydrochloride
Creosote
Cresylic acid
Decachlorooctahydro-l,3f4-metheno-2H-cyclobuta[cfd]-pentalen-2-one
(keponer chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene 9
^££c«ori™S-«LS!-n2-Pro£ynyl, benza.iae ,prona.ide,Kerb,
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts U,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl 4?4^-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
86
-------
Appendix IT7-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alconol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Metnyl ethyl ketone
4-Methyl-2-pentanone (metnyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene &
Trichloromonofluoromethane (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
87
-------
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dicnlorodifluoromethane (Freon 12 )
Diethyl pnthalate
Dimethy1amine
Dimethyl pnthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11 )
Vinyl chloride
Xylene
88
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