United StatM
Environnwntal Protection
OfflMOf
Ptsticidw and Toxte Sutettncw
WMhington OC 20460
April 1987
Petficbtes
&EPA
Guidance for the
Reregistration of
Pesticide Products
Containing Mancozeb
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
MANCOZEB
(014504)
CAS No. 8018-01-7
AS THE ACTIVE INGREDIENT
APRIL 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
GLOSSARY OP TERMS AND ABBREVIATIONS
I. Introduction ................... ... 1
II. Chemical(s) Covered by this Standard
A. Description of Chemical
B. Use Profile
III. Agency Assessment ................... 9
A. Summary
B. Toxicology Characteristics
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale ............ 39
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard
VI. Requirement for Submission of Generic Data ....... 50
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
P. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . .56
VIII. Requirement for Submission of Revised Labeling ..... 57
IX. Instructions for Submission. .... .......... 57
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. Intrastate products
E. Addresses
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APPENDICES
PAGE
I. DATA APPENDICES 61
Guide to Tables •
Table A • •
Table B
II. LABELING APPENDICES 113
Summary of label requirements and table
40 CPR 16-2.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
III. USE. INDEX APPENDIX 138
IV. BIBLIOGRAPHY APPENDICES 242
Guide to Bibliography
Bibliography
V. FORMS APPENDICES 260
EPA Form 8580-1 PIPRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-6 Certification of Attempt to Enter Into an
Agreement with Other Registrants for Development
of Data
EPA Form 8580-4 Product Specific Data Report
EPA Form 8570-27 Generic Data Exemption Statement
ii
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GLOSSARY OF TERMS AND ABBREVIATIONS
The following terms are used throughout this Registration
Standard and are defined here for the convenience of the
reader.
ADI: (Acceptable Daily Intake) An acceptable daily intake
of pesticide residue based on a complete data base.
A/D Ratio: This ratio determines a level of concern
regarding whether effects observed in embryos
and fetuses from treated females are "primary"
(due to direct compound-related effects) or
"secondary" (to maternal toxicity). Thus, the
NOEL for maternal effects ("A" numerator)
divided by the embryo/fetal NOEL ("D" for
"developmental"), including frank terata (gross
congenital defects), defines this concern. If
A/D is less than "1", developmental toxicity of
a substance may be ascribed to secondary effects
of maternal toxicity; if greater than 2, the
substance is considered a direct (primary)
developmental toxicant. Scientific interpreta-
tion is required In the range, 1 to 2 (LEL's
may be used; or effects from other types of
studies, e.g., reproduction).
al: Active ingredient
CAS: Chemical Abstract Society (number)
Core Classification: A general guide to the acceptability
of data for the purpose of supporting
registration (invalid, supplementary,
minimum, or guideline)
Core Guideline: Studies which satisfy Agency data require-
ments .
Core Minimum: Studies which are acceptable to support
registration of pesticide products but were
not necessarily done according to Agency
guidelines.
Core Supplementary: Studies in this category are scienti-
fically sound, thus the information
may be useful. However, the studies
were performed under conditions that
deviated substantially from recommended
protocols. Studies do not meet guide-
line requirements and thus do not
support registration of a product.
111
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EEC: (Estimated Environmental Concentration) Estimated
pesticide concentration in the environment (terrestrial
or aquatic ecosystem).
EP: End-use Product
EPA: The Environmental' Protection Agency, also "the Agency"
PIFRA: The Federal Insecticide, Fungicide, and Rodenticide
Act
HDT: Highest dose tested
Invalid: Studies which are deficient in some vital parameter
or those studies which have been Judged not to be
scientifically sound or those studies whose
reliability is seriously questioned.
(median lethal concentration): a statistically derived
concentration of a substance that can be expected to
cause death in 5.0 percent of test animals, expressed
as weight or volume of test substance per volume of
air or water or per weight of feed (e.g., mg/L or
ppm).
LD5Q: (median lethal dose): a statistically derived single
dose that can be expected to cause death in 50
percent of animals when administered by the route
indicated, expressed as weight of substance per unit
weight of test animal (e.g., mg/kg).
MOS: Margin of Safety - The calculation of a margin of
safety Involves division of an appropriate NOEL by a
worker's estimated exposure. The result is a unitless
figure which gives an indication of how close a
worker's internal dose is in relation to the NOEL for
laboratory animals.
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number)—EPA's system
of tracking studies used in support of registrations.
MP: Manufacturing-use product
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level—the maximum dose used In
a test which produces no observed adverse effects.
OPP: The Office of Pesticide Programs (EPA)
IV
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OES: Office of Endangered Species, U.S. Pish and Wildlife
Service
OM: Organic matter (used to describe soils)
ppm: Parts per million
PADI: (Provisional Acceptable Daily Intake) An acceptable
daily Intake of pesticide residue based on a limited
data base.
PAI: Pure active ingredient
Technical: Active ingredient as manufactured
TMRC: (Theoretical Maximum Residue Contribution) An estimate
of dietary exposure obtained by multiplying residue
tolerance levels for a given pesticide by the average
dally per capita food consumption figure, then adding
the exposure figures for each crop. TMRC is usually
expressed in terms of mg ai/day, assuming a 60 kg
person.
v
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I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
Pesticides have been grouped into use clusters and will be
reviewed on the basis of a ranking scheme giving higher
priority to (1) pesticides in clusters used on food and feed
crops; and (2) pesticides produced in large volumes.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA identifies
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request^, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
•'•The scientific reviews may be obtained from the Information
Services Section, Program Management and Support Division
(TS-757C), EPA, 401 M St., SW, Washington, D.C. 20460.
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active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained-individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency
may propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
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EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxicological,
and environmental characteristics and fate of a pesticide. •
This Registration Standard"lists the data EPA believes are
necessary to resolve our concerns about this pesticide.
These data are listed in the Tables A, B, and C in Appendix I.
Failure to comply with the DCI requirements enumerated in
this Registration Standard may result in issuance by EPA of a
Notice of Intent to Suspend the affected product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants should notify
the Agency of any information, including interim or preliminary
results of studies, if those results suggest possible adverse
effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.
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II. CHEMICAL COVERED BY THIS STANDARD
A. DESCRIPTION OP CHEMICAL
Common Name: Mancozeb
Chemical Name: Manganese zinc ethylenebisdithiocarbamate [a
coordination product of zinc ion and maneb (manganous
ethylene-bisdithiocarbamate) containing 20 percent
manganese, 2.5 percent zinc, and 77.5 percent ethylene-
bisdithiocarbamate]
Chemical Abstracts Service (CAS) Number: 8018-01-7
EPA Shaughnessy Number: 014504
Empirical Formula: (C/jH6MnN2Sij)x(Zn)y
Trade Names: Dithane® M-45; Manzate®200; Fore®
B. USE PROFILE
Type of Pesticide: Fungicide (with minor insecticide use).
Pests Controlled: Fungi causing anthracnose, leaf blights,
downy mildew, rusts, seed decay, seedling blights, turf
diseases, and other fungal diseases; pear psylla nymphs
(Pacific Northwest only).
Registered Uses: Terrestrial food and nonfood crops; Aquatic
(food); Greenhouse (nonfood); Forestry; Outdoor Domestic.
Predominant Uses: The major use sites are apples, potatoes,.
and tomatoes. In addition, mancozeb is used on approxi-
mately 80 percent of the onion acreage in the United
States.
Mode of Activity: Enzyme activity inhibition.
Formulation Types Registered:
Formulating intermediate - 80 percent active ingredient
End-use products - dust, wettable powder, flowable
concentrate, granular
Methods of Application: Folia-r applications by aerial or
ground equipment. For ground equipment, mancozeb
suspensions typically are made from a wettable powder or
flowable concentrate that is applied by means of air
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blast sprayers or tractor-mounted boom sprayers. Dust
formulations are typically applied by means of truck- or
tractor-drawn duster or aerial equipment.
Treatment of the seeds may be accomplished by commercial
seed treatment equipment by seed companies or by addition
to the planter box at the farm site. Mancozeb may be used
as a spray furrow treatment of soil at planting of onion
sets. For treatment of surfaces of potato cut seed pieces
or whole tuber seed pieces, mancozeb is applied by means
of dip tanks or dusting equipment mounted over the seed
pieces on a conveyor belt.
C. BACKGROUND
Mancozeb is .one of six chemicals classified as ethylene bisdi-
thiocarbamate (EBDC) fungicides. These broad spectrum fungi-
cides are used to prevent crop damage by fungi and to protect
harvested products from deterioration. The chemical structure
of mancozeb and the other EBDC's (amobam, maneb, metiram, nabam,
and zineb) and their metabolite, ethylenethiourea (ETU) are
depicted in Figure 1.
The chemistry of the EBDC's is complicated by their instability
and their propensity to form polymers. While the solubilities
of several of the EBDC's in water and other solvents vary from
insoluble to completely soluble, the solubility of mancozeb is
unknown. The EBDC's are generally unstable in the presence of
moisture and oxygen, as well as in biological systems. A common
contaminant, degradation product, and metabolite of all EBDC's
is ETU, an odorless white crystalline solid that is soluble in
water but insoluble in common organic solvents. EBDC residues
are known to convert readily to ETU during the commercial
processing or home cooking of various EBDC-treated foods.
In 1977, the Agency initiated a special review (formerly
referred to as Rebuttable Presumption Against Registration
[RPAR]) of the EBDC's. The special review process is designed
to help the Agency determine whether to initiate procedures to
cancel, deny or reclassify registration of a pesticide product
because uses of that product may cause unreasonable adverse
effects on the environment, in accordance with sections 3(c)(6>)
and 6 of FIFRA. Regulations governing this process are set
forth in 40 CFR 154, which describes various risk criteria
and provides that a special review may arise if the Agency
determines that any of these criteria have been met.
The EBDC special review was based on the presumption that the
EBDC's and the metabolite, ETU, posed three kinds of risk to
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human health or the environment: oncogenicity, teratogenicity,
and acute toxicity to aquatic organisms. Three additional
areas of concern were also identified: thyroid toxicity,
mutagenicity, and skin sensitization. Skin sensitization was
subsequently determined not to meet a special review criterion.
The Agency evaluated these potential risks in depth, taking
into account uncertainties associated with the risk estimates,
considering the significant benefits of the EBDC's and weighing
various regulatory options. In 1982, the Agency-issued its
Decision Document reporting on the results of the evaluation.
This evaluation resulted in the following conclusions.
1. The potential risk of acute toxicity to aquatic organisms
resulting from use of mancozeb on commercially grown wild
rice would be mitigated through present cultivating
practices and the addition of a statement to the label
warning users of a hazard to fish.
2. Potential risks of teratogenicity and thyroid toxicity to
commercial and agricultural applicators would be adequately
reduced by requiring protective clothing.
3. Potential dietary exposure resulting from consumption of
home grown produce could be reduced- by highlighting
preharvest intervals on labels of noncommercial (home
use) products used by home gardeners.
4. The issues of whether EBDC's or ETU pose a potential risk
of oncogenicity, mutagenicity, teratogenicity, and thyroid
effects to man were subject to many uncertainties. Avail-
able data on oncogenicity and mutagenicity were not adequate
to resolve key scientific issues such as the mechanism of
action of EBDC's and ETU. Additional data on the EBDC's
and ETU were needed for the Agency to determine their muta-
genic potential and to assess human exposure and oncogenic
risk. Some data would be required at termination of the
special review while further data needs, with particular
emphasis on chronic studies, dietary residues and exposure,
would be identified during a later reregistration review.
Data determined to be needed at that time were:
a. Metabolism studies designed to define the j^n vivo
conversion of the various EBDC's to ETU and other
metabolites.
b. Dermal absorption studies designed to demonstrate the
dermal penetration of each of the EBDC's and ETU.
c. Five mutagenicity studies on each of the six registered
EBDC's.
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d. Mammalian cell transformation assays on each o.f the
six EBDC's and ETU.
With the issuance of the Decision Document, the Agency concluded
the special, review and returned the EBDC's to the registration
process on the condition that registrants comply with the label
changes and data requirements specified in the Decision Document.
Since issuance of the De'cision Document, the Agency has issued
four data call-in notices for mancozeb as follows:
1. January 17, 1983: This notice required the submission of
the metabolism, dermal penetration and mutagenicity data
identified in the 1982 Decision Document.
2. July 20, 1984: This notice advised registrants of the
Agency's concern about the existence of pesticides in
ground water and the designation of a number of chemicals,
including mancozeb, which may have the potential to con-
taminate ground water. The chemicals were designated
based on such factors as chemical structure, solubility,
and use patterns. The notice required submission of
certain environmental fate and product chemistry data.
3. October 19, 1984: This notice required dietary exposure,
product chemistry and toxicological (subchronic feeding and
and inhalation) data considered necessary to reassess the
registration status of raancozeb.
4. April 30, 1985: This notice required additional data,
not identified In the October 1984 call-in notice, but
considered necessary to the reassessment of the chemicals.
These data were additional toxicological (subchronic
feeding and inhalation) and residue data for ETU as well
as mancozeb.
The data required by these call-in notices have been received
and considered by the Agency in Its evaluation of mancozeb,
as presented in the assessment section of this Standard.
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GURE1
•CHEMICAL STRUCTURE OP EBDC'S AND ETU
S^ THIOURE«i (ETO)
H S
CH, - N - C
1
CH, - N - C
I II
H S
CH-
NABAM
H S
I II
- N - C - S - "a
CH2 - N - C - S - Sa
i n
H S
AMOBAM
H S
I II
dl2 - N - C - S - NH4
I
1
H
ZZNEB
H S
I II
CH2-N-C-S-
CH2-N-C-S-Mn
I II
H S
H S
I II
CH2 - N - C - S -
Ob-N-C-S-Zn
I H
H S
MANCDZBB
METIRAM
H S
I II
CH2 - N - C - S -
CH2-N-C-S-Mn
2 I «
H S
ZHy
H S
I II
CH2 - N - C - S -
I
CH2-N-C-S- Zn(NH3)—
I H
H S
H S
I II
CH2 - N - C - S
CH2 - N - C - S
I t
H S
8
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III. AGENCY ASSESSMENT
A. SUMMARY
Based on the review of available data, the Agency has reached
the conclusions set forth in this Standard. A summary of
those conclusions follow. A more detailed discussion is
contained in the remainder of this Chapter.
1. A major toxicological concern from exposure to mancozeb
is the hazard to the*human thyroid from presence of
ethylenethiourea (ETU), a contaminant, degradation product
and metabolite present in mancozeb and other EBDC products.
In addition to the thyroid effects, systemic effects have
been observed in both the kidney and prostate gland.
Additional chronic studies of mancozeb are required for
further evaluation.
2. ETU has caused developmentally toxic/teratogenic effects
in rats and hamsters. However, available data indicate
that mancozeb is not a primary developmental toxicant or
teratogen. An additional teratology study with mancozeb
is required before its teratogenicity can be fully assessed.
3. ETU has been classified as a Group 89 carcinogen in
accordance with the Agency's Guidelines for Carcinogen
Risk Assessment (September 26, 1986, 51 PR 33992), based
on studies which show that it Induced an increased Incidence
of thyroid adenomas and adenocarcinomas In rats and
hepatomas in mice.
*». The Agency has assessed both worker and dietary risk
associated with exposure to mancozeb and to ETU through
the use of mancozeb. Based on the results of these
assessments, the Agency believes additional evaluation of
the potential human health risks and additional regulatory
action, if applicable, is warranted.
As a result of this review, the Agency has Identified missing
data to further evaluate the environmental and human risks
associated with the use of mancozeb. These data must be
submitted in order to maintain registrations of products or
register new products containing mancozeb. A summary of
these data gaps appears in Table 1. Note that this is only a
summary and complete details can be obtained by referring to
the tables in Appendix I.
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The Agency has also determined that certain label restrictions
or revisions are necessary, in order for mancozeb products to
remain in compliance with FIPRA, as indicated below. Chapter IV,
Section D, Labeling, contains 'the specific wording for each of
the labeling statements and identifies the products to which
each labeling statement applies.
o Protective clothing requirements
o Environmental hazard precautions
o Reentry interval
o Worker safety rules
o Preharvest interval emphasis
The Regulatory Position and Rationale section discusses the
Agency's position regarding mancozeb.
10
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TABLE 1
SUMMARY OF DATA GAPS FOR MANCOZEB
(Refer to Appendix A, Data Tables, for
detailed Information and due dates.)
- Mancozeb -
Product Chemistry - All
Residue Chemistry - Plant and animal metabolism
Residue studies
Toxicology - Dermal sensltlzatlon
Subchronlc dermal
Chronic toxlclty (rodent and nonrodent)
Oncogenlclty (rat and mouse)
Teratology (rabbit)
Reproduction (rat)
Mutagenlclty (DNA damage/repair and promotion)
Dermal (percutaneous) absorption
Ecological Effects - Avian dietary toxicity
Avian reproduction
Estuarine and marine organism toxicity
Pish early life stage
Aquatic invertebrate life-cycle
Environmental Pate - Hydrolysis
Photodegradation (water, soil, air)
Aerobic and anaerobic soil metabolism
Aerobic and anaerobic aquatic metabolism
Leaching and adsorption/desorptlon
Volatility (laboratory and field)
Degradation (soil and aquatic)
Rotational crops (confined and field)
Irrigated crops
Pish accumulation
Reentry - Dissipation (foliar and soil)
- Ethylenethiourea (ETU) -
Toxicology - Chronic (rodent and nonrodent)
Reproduction
Dermal (percutaneous) absorption
Mutagenicity (promotion)
Environmental Pate -
Hydrolysis
Photodegradation (soil and water)
Aerobic and anaerobic soil metabolism
Leaching and adsorptlon/desorption
Degradation (soil)
11
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B. PRELIMINARY RISK ASSESSMENT
Toxicological Studies - Mancozeb. In Its review of mancozeb,
the Agency has considered the available data as summarized
below:
1. Acute Toxicity and Irritation Studies. Except for dermal
sensitization, adequate studies exist to define the acute
toxicity of mancozeb products, indicating that mancozeb
presents little or no acute hazard potential (Toxicity
Category III or IV); only one manufacturing-use formulation
presented results which could be considered moderately
t-oxic (Toxicity Category II) for acute inhalation and eye
irritation. [See Appendix II for a discussion of toxicity
categories.]
Skin sensitization was identified as an area of concern
during the special review of the EBDC's. At that time,
the Agency reviewed skin sensitization data submitted on
other EBDC's and concluded that the EBDC's are potential,
however, not very potent skin sensitizers. However,
because the EBDC's are potential skin sensitizers, testing
for dermal sensitization for mancozeb is required to
fully assess this potential.
No further studies are required at this time for acute
oral, acute dermal, acute inhalation, primary eye
irritation, and primary skin irritation.
2. Subchronic Testing
Oral (Rodent, Nonrodent) Studies. Studies submitted in
response to the Data Call-in Notice of October 19, 1984,
satisfy data requirements for subchronic testing in the
rat and dog by the dietary route, as discussed below.
In a 90-day feeding study, mancozeb was fed to Sprague-
Dawley rats at levels of 0, 30, 60, 125, 250 and 1000
parts per million (ppm). No gross clinical effects or
hlstological changes in the thyroid were reported at
levels of 250'ppm or below. At the 1000 ppm level,
depressed body weight and changes in hormone levels
accompanied by diffused hyperplasia of thyroid folllcular
epithelium were recorded in both males and females. How-
ever, slight but significant depression of Tij (tetraiodo-
thyronine) levels also occurred in females fed 250 ppm;
hence, the no observed effects level (NOEL) for thyroid
effects is 125 ppm.
12
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Residue analysis revealed dose-related increases of mancozeb •
in urine (from 0.3 ppm at the 30 ppm dose level to 10 ppm at
the 1000 ppm dose level, i.e., a 1% conversion), and in the
thyroid (< 4 ppm at 30 ppm mancozeb to 25 ppm at 1000 ppm
nancozeb, i.e., at least a 2.5 percent conversion). Deposits
of yellow-brown pigment were present in the lumen of renal
cortical tubules at all doses above 60 ppm (both sexes),
accompanied by an increased incidence of kidney degeneration
in 125 .ppm mancozeb males. The significance of the kidney
effects is not known at this time; however, the Agency is
requiring a chronic feeding study in rats that will further
address these effects. Based upon these histopathological
changes in kidneys at levels of 125 ppm and above, the systemic
NOEL for mancozeb is set at 60 ppm, equivalent to calculated
1 intakes of 3.5 mg/kg/day in males and 4.4 mg/kg/day in females.
A comparable subchronic study was performed in beagle dogs
> fed diets for 13 weeks containing 0, 10, 100, 1000, and
, 5000 ppm mancozeb. Toxic effects, namely, dose-related
anorexia and dehydration, decreased .food consumption, and
body weight loss (especially in females), were noted only
, at the two highest dose levels. Additional systemic effects
Including prostatic hypogenesis, were noted at the highest
dose level only. The overall systemic NOEL is determined
to be 100 ppm, equivalent to calculated intakes of approxi-
mately 3.0 mg/kg/day for males and 3.4 mg/kg/day for
females. Based upon thyroid effects only at the 5000 ppm
level, a NOEL for this organ may be set at 1000 ppm (29
mg/kg/day for both sexes).
1 In a 90-day dietary study, CD-I mice were fed mancozeb at
levels of 0, 10, 100, 1000, and 10,000 ppm. Increased
incidences of thyroid follicular cell hyperplasia/hyper-
trophy and decreased hepatic [enzyme] activity were
reported at 1000 ppm and higher, thus providing a NOEL
1 of 100 ppm, equivalent to a calculated intake of approxi-
mately 18 mg/kg/day for males and 22 mg/kg/day for females.
No further subchronic oral studies are required at this time.
Dermal Studies. No adequate subchronic dermal studies were
available for review. A 1965 subacute study involved the
daily application of 5000 mg/kg of an uncharacterized tech-
nical (undiluted "Zimaneb," stated to contain 80/5 active
ingredient) for 5 days to the clipped abdomen of four male
, and four female rabbits (half of which were abraded), with-
out clinical effects. However, adequate 21-day dermal data
are required to determine both cutaneous and systemic
effects of longer applications of technical mancozeb..
13
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Inhalation Studies. A series of adequate studies involv-
ing repeat schedules of rats exposed to mancozeb technical
report the following results. Sprague-Dawley rats of both
sexes (38/sex/group) were exposed "nose-only" to target
(nominal) aerosol concentrations of 0, 20, 80, and 320
mg/m3, respectively, for 6 hours/day, 5 days/week for 13
weeks. After *J weeks of exposure, significant reductions
in body weight were noted for high-dose males; additionally,
after 13 weeks treatment, reduction in Tij levels in high-
dose females were recorded, accompanied by hyperplasia of
follicular epithelium. Tissue residue analysis at 13 weeks
(blood, urine, thyroid) revealed increasing (mancozeb
dose-related) concentrations of ETU in urine and thyroid,
especially in females. The presence of yellow-brown
granular pigment in kidney tubules of both high-dose and
mid-dose males and females was noted. Based upon these
kidney inclusions, the systemic NOEL is determined to
be nominally 20 mg/m3 (= 8 mg/m3 respirable), while the
thyroid NOEL is 80 mg/m3 nominal (= 36 mg/m3 respirable).
No further inhalation studies are required at this time.
3. Chronic Testing
Ohronic Toxlcity Studies. There are no adequate studies
defining long-term effects of mancozeb administration. A
number of older studies, however, have supplied some useful
information. These data do not fulfill guideline require-
ments and, therefore, have been Judged supplementary.
In a 1965 study, weanling Wistar albino rats (25/sex/group)
were fed Dithane M-45 technical (86% al) at levels of 0,
25, 50, 100, and 1000 ppm in what was projected to be a
2-year study. The study was terminated at 90 weeks (21
months) because of excessive mortality in all groups.
The only significant finding reported was thyroid hyper- .
plasia in high-dose (1000 ppm) animals of both sexes,
as well as in a few males at each of the lower doses.
In a 2-year study, beagle dogs (Vsex/group) were fed a
Mazola/cod liver oil mixture of mancozeb at levels of 0,
25, 100, and 1000 ppm. No clinical toxicity was reported
at any dose. Body weight gains and food consumption were
unaffected by treatment, and all hematological and clinical
chemistry values were normal, except for consistently lower
l!31 uptakes recorded in high-dose animals. Only summary
histopathological data were available which indicate focal
hyperplasia in the thyroid of one mid-dose (100 ppm) male,
and Grade-1 hyperplasia in two high-dose (1000 ppm) animals,
both of which had lower than control 1*31 values. No
Individual animal data were included in the final report of
14
-------
this study (in addition to other deficiencies) resulting
in a classification of the study as supplementary.
Based upon these thyroid effects at 1000 ppm, a provisional
NOEL of 100 ppm mancozeb can be substantiated (equivalent
to an actual intake of 2.5 mg/kg/day), consistent with the
systemic NOEL of 3 mg/kg/day demonstrated in the fully
.adequate 90-day dog study discussed above.
Chronic studies in both rats and dogs are required.
Oncogenicity Studies. No studies assessing oncogenicity
of mancozeb in rodeVits are available. Oncogenicity studies
in both rats and mice are required.
Teratology Studies. An adequate rat teratology study
establishes a NOEL for maternal toxicity at 32 mg/kg/day
and a lowest effect level (LEL) at 128 mg/kg/day (decreased
.body weight). The NOEL and LEL for fetal toxicity is 128
mg/kg/day and 512 mg/kg/day (increased resorptlons),
respectively. A NOEL for teratogenic effects is set at
128 mg/kg/day and the LEL at 512 mg/kg/day (dilated
ventricles, spinal cord hemorrhage, delayed/incomplete
ossification of skull and ribs). Based on this study,
the A/D Ratio is 32/128 = 0.25 (see Glossary for explanation
of A/D Ratio).
1 In a 1968 study, three groups of New Zealand white female
•rabbits were orally intubated at 0, 25, and 250 mg/kg/day
(10 rabbits each). There was a slight decrease in maternal
,weight at the highest dose tested; no maternal or feto-
;toxicity and no gross or histological developmental abnor-
malities were reported. The teratology phase, however,
;had an insufficient number of animals per dose group and
has been classified as supplementary.
A rabbit teratology study with mancozeb is required.
Reproduction Studies. An adequate study assessing repro-
ductive effects of mancozeb over at least two generations
is not available. However, in the chronic feeding study,
four of the five groups of young Wistar rats (0, 25, 100,
and 1000 ppm) were mated twice to provide the F^a and F2b
.litters for a projected three-generation reproduction study
'(2 litters/generation, 20 matings each). No apparent
clinical or reproductive effects were reported at any level,
except for reduction of fertility at the highest dose tested,
'No fetal values were reported affected, and no histopatho-
' logical lesions were attributed to treatment. Provisional
reproductive toxicity parameters may be set as follows:
For parental clinical toxicity, the NOEL Is > 1000 ppm
15
-------
(= 50 mg/kg/day); for reproductive effects, the NOEL is
100 ppm (= 5 mg/kg/day) and the LEL is 1000 ppm (decreased
fertility); and for fetal effects, the NOEL is > 1000 ppm.
In addition, thyroid effects were examined in 15 males and
15 females from the ?2a generation after 3 months on diets
containing 100 and 1000 ppm mancozeb, and in an additional
intermediate dose group treated at 300 ppm mancozeb for 3
months. As positive controls, a group of 10 F2a weanlings
of each sex were fed the known goitrogen, propylthiourea
(PTU), for the same period of time, and additional Fpa
weanlings originally on control diets were placed on PTU
for the last 5 weeks of the same 3-month period. Only PTU-
treated animals and, to a much lesser extent, those on 1000
ppm mancozeb manifested thyroid dysfunction, as evidenced
by increased relative organ weight, lower protein-based
iodine (PBI), and hyperplasia. No. thyroid effects were
observed in the mancozeb animals. Further, only PTU-treated
rats showed markedly lower 1^31 uptakes but, despite the
presence of severe thyroid hyperplasia, they showed no
changes in PBI values.
A reproduction study is required.
Mutagenicity Studies. Mancozeb was negative for gene
mutation in a variety of bacterial and mammalian cell
In vitro assays except for Chinese hamster ovary (CHO)
cells.
An assay for unscheduled DNA synthesis in primary rat
hepatocyte cultures was inconclusive and must be repeated.
The negative studies submitted for iri vitro mammalian cell
transformation/promotion for mancozeb were Judged unaccept-
able because the assays were conducted at only one dose,
which may have been insufficient to -conclude the test
materials were not in vitro promoters. Promotion assays
Iri vitro must be submitted. A conclusion about the
mutagenicity of mancozeb cannot be made until the above
mentioned assays have been adequately performed and
evaluated by the Agency.
Metabolism Studies. In an adequate metabolism study in
rats, groups of 3 to 5 young adult Sprague-Dawley rats of
both sexes were given single oral doses of either 1.5 or
100 mg/kg l^C-mancozeb. Total radioactivity and excretion
of metabolites as well as residues of both the EBDC and
its metabolite, ETU, were measured. Selected tissues were
determined at specified time periods up to 96 hours.
16
-------
o Mancozeb is absorbed through the gastrointestinal
tract (approximately 50 percent) and is extensively
metabolized and/or degraded by the rat. ETU was the
major degradate/metabolite found in feces, urine, bile
and tissue. Of the total radioactive dose, approximately
18.76 percent and 5.2 percent was identified as ETU in
the urine and bile, respectively. The percentage of
ETU in the tissue was considered negligible. Therefore,
the total percentage of the dose that is bioavailable
as ETU is considered to be 23.96 percent.
o ETU residues derived from mancozeb treatment were
detected in the thyroid in the high-dose group only.
These residues averaged 1 ppm during the 24-hour period
following mancozeb administration but were below the
level of detection thereafter. Liver ETU residues
averaged 0.5 ppm in the low dose 6 hours after adminis-
tration and 0.66 ppm in the high dose group during the 2*4
hours- following mancozeb administration; residues of
ETU were undetectable thereafter.
Special Studies
Mancozeb Dermal (Percutaneous) Absorption/Penetration
Studies. In a dermal penetration study, 10 mg of Dithane
M-45 (8.3% ai, containing O.QH% ETU) was applied to
female Sprague-Dawley rats, and secured in place for 6
hours. Based on residues in urine and feces, a general
value of 1% absorption for mancozeb can be inferred. A
study using technical mancozeb, however, must be submitted
to satisfy regulatory requirements.
Human Studies. Two reports are available monitoring
potential effects of human mancozeb exposure.
In one report of a survey, 5^ workers of a mancozeb
manufacturing plant were subjected to physical exami-
nations, blood study, and urinalysis over a period of
8 months, and were reported to have been in good physical
health during this period. No exposure levels accompanied
this report.
In the second report, ETU, but not mancozeb, was detected
In the urine of aerial applicators (pilots) at a level of
0.2 ppm. The urine of mixer-loaders was negative. These.
results suggest that agricultural use of mancozeb results
in at least some applicator exposure to mancozeb and ETU.
17
-------
lexicological Studies - ETU. Since ETU, a contaminant,
degradation product, and metabolite of mancozeb and other EBDC
products, presents toxicological concerns, available data on
ETU were considered in the overall evaluation of mancozeb.
These data are summarized, as follows:
1. Subchronic Studies. During a 90-day rat feeding study
with mancozeb, discussed in the preceding section, an
additional group of animals received 250 ppm ETU.
Compound-related effects in this group were generally
comparable to those observed at 1000 ppm mancozeb.
Residue analysis for ETU in mancozeb-treated animals
revealed none in blood.
±n a rat study conducted to examine the subchronic effects
of ETU on the thyroid, levels of 50, 100, 500 and 750 ppm
were fed for 30, 60, 90 and 120 days. A NOEL was not deter-
mined in this study due to effects of ETU seen on thyroid
weights at all dosage levels at 120 days. In a second rat
study, levels of 0, 1, 5, 25, 125, and 625 ppm were fed for
30, 6Q, and 90 days. Thyroid hyperplasia, decreased uptake
of 1^5j by the thyroid, and decreased serum TO (trliodo-
thyronlne) and Tij (tetralodothyronlne) were seen. The
LEL was 25 ppm for these effects with 5 ppm (0.25 mg/kg)
considered the NOEL.
In a 90-day mouse study, ETU fed at levels of 0, 1, 10, 100,
and 1000 ppm resulted in Increased thyroid weights in females
and an increased incidence of follicular cell hyperplasia in
both sexes at levels of 100 ppm and higher. Liver toxicity
was only observed at the highest level, 1000 ppm.
In a 21-week study in Rhesus monkeys, at dosage levels of
0, 2, 10, 50 and 250 ppm, serum thyroid hormone concen-
trations were measured as well as iodine uptake in the
thyroid. Mild to moderate pituitary hypertrophy was seen:
at 50 and 250 ppm, as well as thyroid follicular lining cell
hypertrophy and hyperplasia (mild at 50 ppm; moderate to
severe at 250 ppm). Serum levels of Tjj were significantly
decreased in the 250 ppm group. Free serum Tij levels were
also signflcantly decreased in both the 50 and 250 ppm group;
iodine uptake was significantly Increased at these levels and
thyroid stimulating hormone (TSH) levels were significantly
increased at 250 ppm.
In a 6-month Rhesus monkey study, at dosage levels of 0,
50, 150, and 450 ppm, pituitary as well as thyroid hormone
levels were measured. A NOEL was not demonstrated.
18
-------
2. Oncogenlclty Studies. Three oncogenicity studies have
been reviewed, as discussed below:
In a mouse study (Innes), two hybrid strains of mice were
used [(C57BL/6 x C3H/Anf)F]. (Strain X) and (C57BL/6 x
(Strain Y)]. Eighteen mice per sex per group were used in
the treatment group. Only one dose was tested which was
stated to be the maximum tolerated dose. When the mice
were 7 days old, 21,5 mg/kg ETU was given by stomach daily.
At 28 days of age, the mice were given diets containing
646 ppm of ETU. The mice were sacrificed after a total of
83 weeks of treatment. Histopathology consisted of exami-
nation of all major organs and of all grossly visible lesions,
Thyroid glands were not examined. The incidence of liver
tumors, which were not classified as adenomas or carcinomas
but only as hepatomas, Is outlined in the following table:
Male Female
Control Treated Control Treated
Strain X 3/14 11/16 0/18 18/18
Strain Y 1/18 18/18 0/18 9/16
Totals: Controls - 4/68. Treated - 59/68
In a study with Charles River CD rats, 175 or 350 ppm ETU
was administered in the diet for 18 months. At that time,
5 rats/sex were sacrificed and the remaining rats were
placed on control diets until termination of the study at
24 months. The control group consisted of 32 male and 32
female rats. No thyroid lesions were seen in the control
group. The incidence of thyroid lesions in the ETU-treated
rats is presented below. The number of animals examined
was not given.
350 ppm 175 ppm
Lesion Males* Females Males Females
Thyroid carcinoma** 17 8 33
(follicular)
Thyroid solid cell 01 02
ademona
Hyperplastic goiter 17 13 96
Simple goiter 24 42
* All five male rats in the high dose group sacrificed
at 18 months had hyperplastic goiter; 3 had follicular
thyroid cancer.
** Two with lung metastases.
19
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In a two-year study, Charles River .rats were placed on
diets containing 0, 5, 25, 125, 250 or 500 ppm ETU. Body
weight gain was adversely affected at the highest dose
tested .at 18 and 24 months for both males and females.
131i uptake was statistically increased in male rats at
18 months in the 25 and 125 ppm groups and decreased at
500 ppm. At 24 months in the male rats, 131j; uptake was
significantly increased in the 5 ppm group and decreased
in the 500 ppm group. Because of large variability in
the values obtained, there were not statistically signi-
ficant differences in 131j uptake in female rats.
Histopathology incidence data were combined for males
and females. An increase in the number of rats with
cataracts/keratitis and with thyroid follicular adeno-
carcinoma/carcinoma was observed in the groups fed 250
ppm and 500 ppm ETU; with thyroid adenomas in the 250
ppm group; and with thyroid hyperplasia - in the 5, 25,
125 and 250 ppm groups. The LEL is 5 ppm (0.25 mg/kg/day)
for the effects of ETU on the thyroid in this study.
Relevant data are summarized as follows:
Tumor incidence data for rats,
including 18-month interim
sacrifice, fed ETU in the diet
Dose levels in ppm
0 5 25 125 250 500
Pathological lesions
Cataracts/keratitis
Thyroid carcinoma/
adenocarcinoTtia
(follicular)
Thyroid adenomas
Thyroid hyperplasia
Parathyroid hyperplasia
2
2
2
4
6
1
2
-
20
11
0
1
5
41
8
2
2
1
44
2
6
16
21
27
3
12
62
3
3
0
Number of rats per group 72 75 73 73 69 70
Statistics were not reported on the histopathological data.
Historical control data were not available. More detailed
information on this study is not available.
Teratology Studies. ETU has been shown to be a teratogen
in studies with rats and hamsters. In rats, it produces
a wide variety of anomalies in the central nervous,
urogenital and skeletal systems as well as other organs at
dosages that do not produce maternal or fetotoxicity.
The NOEL for these effects is 5 mg/kg. Administration of
T3/T4 with ETU to pregnant rats appears to reduce the
incidence of some of these effects.
20
-------
Mutageniclty Studies. Results of short-term assays
Indicate that ETU is weakly genotoxic; ETU has been
shown to give mixed results for gene mutation in both
bacterial and mammalian cell lines, but positive results
for DNA repair in human cells, yeast and bacteria.
Although reportedly positive in one mammalian cell
transformation assay using hamster cells, an adequate
assay in mouse cells was negative.
The negative studies submitted for iri vitro mammalian
cell transformation/promotion for both mancozeb and ETU
were Judged unacceptable because the assays were con-
ducted at only one *dose, which may have been insufficient
to conclude the test materials were not in vitro promoters
An i.r) vitro mammalian cell transformation/promotion assay
to address whether ETU has promoter (non-genotoxic)
activity is required.
Metabolism Studies. In a study with Rhesus monkeys, 50
percent o,f an administered dose of l^C-ETU was excreted
in the urine within 24 hours and 90 percent wi.thin 72
hours. Only 0-0.68 percent of the label was eliminated
in the feces at 24 hours and no radioac-tivity was found
at the 48 and 72 hour sampling periods.
In another study with Wistar rats, C ETU was predom-
inately excreted in the urine. The ratio of urine to
fecal excretion varies with dose, i.e., for 0.1 ppm ETU,
the ratio was 55/25, and at 10 ppm ETU, the ratio was
70/10. Minimal radioactivity was recovered as -^CC^
(X0.5 percent). The level of radioactivity plateaued in
the thyroid gland after 8 days of dosing and declined
rapidly once dosing was terminated.
6. Structure Activity Information. ETU is structurally
related to thiourea, methimazole, propylthiouracil, and
thiouracil, all thryoid inhibitors. Chronic studies on
thiourea in rats have shown that it Induces hepatpmas and
thyroid enlargement. Methimazole, propylthiouracil and
thiouracil all induce thyroid tumors in rats. Propyl-
thiouracil also Induces thyroid tumors in hamsters and
Guinea pigs and pituitary adenomas in mice. Thiouracil
induces hepatomas and thyroid tumors in mice.
Risk Assessment. The Agency does not have any oncogenicity
data on mancozeb. However, based on the data available on
ETU, as discussed in the preceding section, the Agency has
classified ETU, in accordance with the Agency's Guidelines
for Carcinogen Risk Assessment (September 26, 1986, 51 PR
33992), as a Group B2 oncogen, Probable Human Carcinogen.
21
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The Agency's classification of ETU was made in accordance
with its guidelines for carcinogen risk assessment. These
guidelines categorize the evidence on carcinogenicity of
chemicals in terms of how likely it is that the chemical is
a human carcinogen. Under this scheme, Group B2 categoriza-
tion is appropriate if there is "sufficient evidence" of the
chemical's carcinogenicity from animal studies. "Sufficient
evidence" is defined as an increased incidence of malignant
tumors (or combined malignant and benign tumors) in multiple
species or strains, in multiple experiments, or to an unusual
degree with regard to incidence, site or type of tumor, or
age at onset.
ETU induced an increased incidence of thyroid adenomas and
adenocarcinomas in two separate studies with rats and of
hepatomas in two strains of mice. Furthermore, ETU induced
the thyroid tumors in rats after one year or less of treatment
and induced both the thyroid tumors in rats and the hepatomas
in mice to an unusual degree in a single experiment.
The classification as a Group B2 oncogen is also supported
by positive structure-activity data since several other
thyroid inhibitors (i.e., thiouracil and thiourea) have been
found to induce hepatomas and/or thyroid tumors in rodents.
EPA acknowledges that the studies considered in arriving at
its classification of ETU were not carried out in accordance
with EPA guidelines for oncogenicity studies. EPA, however,
does consider the studies adequate to conclude that ETU is
oncogenic to rats and mice due to the magnitude of the response
seen. The Agency's conclusions regarding the classification
of ETU will be reconsidered when results of additional studies
on ETU are available.
Worker Exposure and Risks. The Agency has assessed the risks
associated with systemic effects of mancozeb and the terato-
genic, thyroid, and oncogenic effects attributable to ETU.
Information available to the Agency about use practices
indicates that aerial loading and application are performed
by different people. For other application methods (ground
boom, airblast, sprinkler and seed treatment), loading and
application are performed by the same person. Dermal and
inhalation exposure to mancozeb is given in Table 2. Mixer/
loaders and applicators are also exposed to ETU in the tank
mix. Data for technical mancozeb and field measurements
after mixing indicate that direct exposure to ETU corresponds
to 0.5 percent of that for mancozeb for mixer/loaders and 0.6
percent for applicators. The values for direct exposure of
workers to ETU are given in Table 3.
22
-------
Mancozeb - in the subchronic dog study, the NOEL for systemic
effects is 100 ppm or 3 mg/kg/day (see discussion in preceding .
section). Using the exposure estimates as presented in Table 2,
and a 1 percent rate for dermal absorption of raancozeb, the
Agency has calculated margins of safety for mixer/loaders and
applicators. These margin's of safety are given in Table 4.
ETU - ETU has been shown to be a teratogen in studies with
rats and hamsters. In rats, it produces a wide variety of
anomalies in the central nervous, urogenital and skeletal
systems. The NOEL for these effects is 5 mg/kg.
In asessing teratogenic margins of safety, the Agency
-------
First, dietary exposure to ETU from use of mancozeb and
potential risks for adverse effects from this exposure were
assessed. Average field trial residues of ETU, obtained from
studies submitted in support of mancozeb tolerances, were
used for this dietary exposure analysis. The ETU residues
for processed products were calculated by using the appropriate
conversion factors, calculated from the available data, for
each of the processed commodities since some mancozeb converts
to ETU during the processing of the raw agricultural commod-
ities. These residues were then reduced by the percent of
crop treated with mancozeb obtained from actual usage data.
The results of this analysis indicate that the average
consumer in the U.S. population receives a direct dietary
exposure to ETU from mancozeb use of 0.000036 mg/kg/day.
The PADI for ETU was derived from the 2-year chronic feeding
study in Charles River rats with an LEL of 0.25 mg/kg/day.
An uncertainty factor of 10,000 was applied because the
thyroid effect at the LEL was guite pronounced and because
the lack of other data (e.g., reproduction and chronic studies)
prevents determination of the most sensitive toxicological
end point. This resulted in a PADI of 0.00003 mg/kg/day.
The effect on which the PADI is based was hyperplasia of the
thyroid; a NOEL for this effect was not established for this
study.
The dietary exposure to ETU of 0.000036 mg/kg/day occupies 120
percent of the PADI.
Secondly, dietary exposure to mancozeb and potential risks
for adverse effects were assessed. The residues used in the
analysis were the average field trial residues of mancozeb,
obtained from data submitted in support of established toler-
ances, reduced by the percent of crop treated. Based on
these average residues, the average consumption estimate for
the U.S. population is calculated as 0.00097 mg/kg/day mancozeb.
The PADI for mancozeb was derived from a 90-day feeding study
in dogs with a NOEL of 3 mg/kg/day and a safety factor of
1000 for a PADI of 0.003 mg/kg/day.- The effects noted included
decreased body weight gain and hypogenesis of the prostate in
males.
The dietary exposure to mancozeb of 0.00097 mg/kg/day occupies
32.2 percent of the PADI.
Thirdly, a risk assessment was conducted to determine potential
oncogenic risks from dietary exposure to ETU from use of
mancozeb. For this assessment, actual residues for both ETU
and mancozeb from field trials were used.
24
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The Agency's Carcinogen Assessment Group derived risk models
based on various bioassays on ETU. The most sensitive sex-
species end point was found to be male mouse liver tumors in
the Innes study. The potency, or QI*, was calculated to be
0.14 (mg/kg/day)-1.
The dietary exposure analysis indicates that the average
,consumer in the U.S. population receives a dietary exposure
of 0.000036 mg/kg/day ETU from conversion of mancozeb on
crops. This analysis was based on average field residues for
ETU reduced by the percent crop treated with mancozeb. The
potential dietary risk is calculated by multiplying exposure
by the QI*:
Dietary Risk = Exposure x QI*
= 0.000036 x 0.14
= 5 x 10~6
In addition, there is dietary exposure from, conversion of
mancozeb to ETU in vivo after eating food containing mancozeb
residues. Metabolism studies in rats show that 50 percent of
the ingested mancozeb residues are absorbed through the
gastrointestinal tract and that 24 percent are metabolically
converted to ETU. In order to determine the dietary exposure
to ETU from conversion of mancozeb residues in this way, the
mancozeb dietary exposure of 0.00097 mg/kg/day is multiplied
|by 12 percent (50 percent x 24 percent) to yield an exposure
of 0.00012 mg/kg/day ETU. Multiplying this by the QI* of
,0.14 (ing/kg/day)"1 yields a risk of 1.7 x 10
The total potential dietary risk from exposure to ETU from
'use of mancozeb on food crops is obtained by adding 5 x 10
(which is equal to .5 x 10"^) and 1.7 x 10"*:
1 Total Dietary Oncogenic Risk = 2.2 x 10"5
;Lastly, because ETU has been shown to be a teratogen in
studies with rats and hamsters, an exposure and risk assess-
ment was conducted for this effect. In rats, ETU produces a
wide variety of anomalies in the central nervous, urogenital,
and skeletal systems as well as other organs at dosages that
ido not produce maternal or fetotoxicity. The NOEL for these
.effects is 5 mg/kg/day.
The mancozeb and ETU crop residues were derived from studies
submitted by the registrant. The dietary exposure from use
of mancozeb on certain crops is presented in Table 8. The
crops were chosen because they are th.e most widely consumed
and have the highest residues. The ETU residues included
those resulting from mancozeb conversion on the crops or
during processing as well as those resulting from in vivo
25
-------
conversion of mancozeb. For apples, grapes, and melons, it
was assumed that 100 percent of the crop was treated since it
is important to calculate what ETU residues a pregnant women
could maximally consume on a given day. The mancozeb and ETU
residues given in the table are those representing the upper
95 percent confidence limits for residues.
For apple juice, the exposure was adjusted for percent of
crop treated (32 percent) since juice could be made from a
mixture of treated and untreated apples.
The dose for one day in mg/kg and margins of safety for apples,
grapes, and melons was based on the total ETU dietary exposure
in ppm shown above, taking into account the amount of these
foods eaten in a single day by pregnant women.
Commodity
All apple products
Grapes
Melons
Dose for
one day
(mg/kg)
0.009
0.01"
0.015
MOS
556
333
333
In conclusion, the margins of safety are all above 100 for
teratogenic effects for the U.S. population of pregnant women
from exposure to ETU from use of mancozeb on food crops.
26
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TARLF 2
Crop/Method
Apples
Aerial
Airhlast
Onions
Aerial
Gr.Room
Potatoes
Aerial
Gr.Boom
Sprinkler4/
Seed4/
Tomatoes
Aerial
Gr.Room
Home Use
Dermal and Inhalation Exposure to Mancozeb in mq/kq 2/
Mixer/Loader^/
AnnlicationV
Application I-/
Dermal
Inhalation
Dermal
Inhalation
Dermal
Daily Yearly Daily Yearly Daily Yearly
0.099 n.?96 Neql. Neql
0.221 3.091 Neql. Neql
0.210 3.7R5 Neql. Neql
0.276 1.932 Neql. Neql.
Daily Yearly Daily Yearly
Inhalation
Daily Yearly
0.032
6.210
0.10R
2.069
0.061
1.5R9
0.097
49. 6R
1.512
16.54R
1.103
19. OR
0
0
0
0
0
0
.001
.013
.003
.015
.002
.010
0
0
0
0
0
0
.003
.101
.041
.125
.030
.120
0
3
0
1
0
1
5
0
.OQ6
.7R3
.022
.274
.012
.151
.429
.550
0.019
30.26
0.302
10.19
0.221
13.R2
5.429
0.550
O
0
0
0
0
0
0
0
.001
.013
.003
.013
.002
.010
.002
.003
0.003
0.101
0.041
0.125
0.030
0.120
0.002
0.003
0.096 0.670
1.534 1R.40
0.126 0.503
0.003 0.01R
0.017 0.210
Neql. Neql.
0.019 0.134
O.R50 10.20
0.025 0.101
0.003 O.Olfl
0.017 0.210
Neql. Neql.
_!/ With the protective clothinq specified in this standard.
2/ In cases where the mixer/loader is the same person as the applicator, the exposure From
mixinq/loadinq is included in the exposure estimates For applicators.
3/ Applicators without protective clothinq.
4/ In the case of sprinkler and seed use oF potatoes, exposure estimates were with protective clothinq only.
-------
TARLE 3
CO
Crop/Method
Apples
aerial
airh.last
Onions
aerial
ground
Potatoes
aerial
ground
sprinkler
seed
Tomatoes
aerial
qround
Home Use
nermal Exposure to Ethylene Thiourea (FTTH) in
Tjoadinq Application
Mancozeb
Trading Rxnosure
Daily Yearly
0.099 0.296
0.221 3.091
0.210 3.785
FTTH exposure
based on
Daily Yearly
n.noos 0.0015
n.onn o.ni-ss
0.0011 0.0189
Mancozeh
Application Ex.
Daily Yearly
0.006
3.783
0.022
1.274
0.012
151
429
0.27* 1.932
0.0014 0.0097
0.550
0.019
0.850
0.025
0.019
30.26
0.302
10.19
0.221
13.82
5.429
0.550
0.134
10.20
0.101
ETU exnosure
based on 0.6%V
Daily Yearly
Negl.
0.0227
0.0001
0.0076
0.0001
0.0069
0.0276
0.0028
0.0001
0.0051
0.0002
0.0001
0.1816
0.0018
0.0611
0.0013
0.0829
0.0276
0.0028
0.0008
0.0612
0.0006
_!/ With the protective clothinq specified in this standard.
2/ Based on maximum level of ETU found in mancozeb.
3/ Rased on levels of ETU found in Manzate 200 technical and solution. FTTT was measured in
the container, a^ter mixing (3 min.), at 2 hours, and A hours. Assuming an initial 0.5%
ETn level, the 4 hour level was about 10% higher (4500 ppm vs initial 4000 ppm); therefore,
the applicator exposure to ETM has been increased to (4500/4000 x 0.5% = about 0.6% FTTU) .
With potato sprinkler and seed use, the 0.5% conversion factor was used because solution
is applied immediately after mixinq in one operation.
4/ In cases where the mixer/loader is the same person as the anplicator, the exnosure from
~ mixing/loading is included in the exnosure estimates for applicators.
-------
TABLE 4
Margins of Safety (MOS) for
Systemic Effects From Exposure to Mancozeb-*-/
NOEL = 3 mg/kg/day (dog)
Loading
Application
Mancozeb
Exposure MOS
(mg/kg/day)
Apples
aerial 0.099 3,030
airblast
Onions
aerial 0.221 1,357
, ground boom
Potatoes
' aerial 0.210 1,429
ground boom
sprinkler
seed
Tomatoes
1 aerial 0.276 1,087 .
ground boom
.Home Use
Mancozeb
Exposure
(mg/kg/day)
0.007
3.796
0.025
1.287
0.014
1.161
5.431
0.553
0.022
0.867
0.025
MOS
42,857
79
12,000
233
21,429
258
55
542
13,636
346
15,000
!_/ With the protective clothing for loaders and applicators specific
in this standard and using a 1% dermal absorption rate for
mancozeb. In cases where the mixer/loader is the same person
as the applicator, the exposure from mixing/loading is included
in the exposure estimates for applicators.
29
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TA^LE 5
Margins of Safety (MOR) For
Teratoqenicity Due to Exposure to E
NOEL = 5 mq/kq/dav (rat)
Loading Application
y
ETU Exposure
(mq/kq/dav) . MOS
Apples
aerial O.nn07 7,143
'
airblast
Onions
aerial 0.0016 3,125
qround boom
Potatoes
aerial 0.0016 3,125
qround boon
sprinkler
seed
Tomatoes
aerial 0.0021 2,381
qround boom
Home rise.
ETU Exposure
(mq/kq/dav)
0.0002
0.0575
0.0009,
'
0.0143
0.0012
0.0121
0.0406
.
0.0048
0.0008
0.0112
0.0002
MOS
2,5,0 no
87
5,556
350
4,167
413
124
1,042
6,250
446
25,000
_!/ With the protective clothinq for loaders and applicators specified
in this standard. In cases where the mixer/loader is the same person
as the applicator, the exposure from mixinq/loadinq is included in
the exposure estimate for applicators.'
2/ Exposure estimates include ijn vivo conversion of mancozeb to
ETO (see Aqency Assessment).
30
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TABLE 6
Margins of Safety (MOS) for Systemic
(Thyroid) Effects Due to Exposure to ET
Subchronic NOEL = 0.25 mqAq/dav (rat)
Chronic LEL = 0.25 mq/kq/dav (rat)
Loading
Application
pm Exposure MOS
(mqAq/dav)
(daily)
Apnles
aerial 0.0005 500
airblast
Onions
aerial 0.0011 221
qround boom
Potatoes
aerial 0.0011 227
around boom
snrinkler
seed
Tomatoes
aerial 0.0014 179
qround boom
Home Use
ETTJ Exnosure
(mqAq/dav)
(daily)
Neql.
0.0227
0.0001
0.0076
0.0001
0.0069
0.0276
0.0028
0.0001
0.0051
0.0002
MO^
>?,500
11
2,500
33
2,500
36
9
89
2,500
48
1,250
I/ With the protective clothinq for loaders and applicators specified
in this standard. In cases where the mixer/loader is the same
person as the applicator, the exposure from mixinq/loadinq is
included in the exnosure estimate for applicators.
31
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TABLE 7
Cancer Risk (lifetime) from
Oj* = n.14 (mq/kq/dav)"1
Loadinq
Application
Rased on Daily Exposure Only^/
ETU Exposure Risk
(mq/kq/day)
Apoles
aerial fi. 0x10-6 4.8x10-7
airblast
Onions
aerial 6.3x10-5 5.0x10-6
q round boom
Potatoes
aerial 6.7x10-5 5.4x10-6
q round boom
sprinkler
seed
Tomatoes
aerial 3.9x10-5 3.1x10-6
q round boom
Home Use
ETU Exposure
(mq/kq/day)
2.2x10-6
7.6x10-4
"
2.5x10-5
4.0x10-4
l.lxlO-4
1.3x10-5
1.5x10-5
3.7xlO-4
2.2x10-6
Risk
1.8x10-7
6.1x10-5
2.7x10-6
2.6x10-5
2.0x10-6
3.2x10-5
8.8x10-6
1.0x10-6
1.2x10-6
3.0x10-5
1.8x10-7
I/ With the protective clothinq for loaders and applicators specified
in this standard. In cases where the mixer/loder is the same
person as the applicator, the exposure from mixinq/loadinq is
included in the exposure estimates for applicators.
2/ Annualized daily exposures.
32
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TABLE 8
Dietary Exposure to ETU
for Apples, Grapes and Melons
Apples
(Fresh and dried)
Apple Juice
Grapes
Melons
Mancozeb*
(ppm)
11.10
0.13
11. MO
3.50
ETUl
(ppm)
0.08
0.01
0.01
0.05
Mancozeb2
Remaining
(ppm)
11.32
0.12
11.39
TotalB
ETU
in vivo
~Tppm)
0.02
1.38
0.46
I/ Based on data submitted by the registrant.
2/ Obtained by subtracting the ETU residues from the mancozeb
residues.
3/ Total ETU residues in vivo were calculated by adding the
ETU residues on the commodity to the ETU generated by the
conversion of mancozeb residues in vivo. For example,
for apples, the ETU residues on THe commodity (0.08 ppm)
were added to the ETU residues generated in vivo (1.36
ppm). The latter was obtained by multiplying the mancozeb
residues remaining on the commodity (11.32 ppm) by 1255
(5055 gastrointestinal absorption of mancozeb times the
24/5 conversion in vivo from mancozeb to ETU).
33
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C. OTHER SCIENCE FINDINGS
Environmental Fate. Available data are insufficient to fully
assess the environmental fate of mancozeb. The supplementary
information discussed below is provided from studies that did
not fulfill the data requirements for registration and must be
repeated:
1. Hydrolysis. A radiolabeled hydrolysis study demonstrates
that mancozeb degrades with a half-life of approximately
1 to 2 days at pH 5, 7, and 9. The major degradation
products were ethyleneurea (EU) (38 to 47 percent) and
ethylenethlourea (ETU) in combination with dlformylethylene-
diamine (DF-EDA) (29 percent). Other Identified degradates
included ethylenethiuron disulflde, ethylenebisisothio-
cyanate sulfide, l-(2-imidiazolinyl)-2-imidazoline thione,
hydantoin, 2-imidazoline, and ethylenedlamine. Individual
levels of ETU were not determined in this case. Data avail-
able on other EBDC's indicate that ETU is stable to hydrolysis
at pH 5 and 7. At pH 9> ETU is very slowly hydrolyzed.
2. Anaerobic Aquatic Metabolism. Mancozeb and ETU declined
with half-lives of approximately 92 days and 29 to 35 days,
respectively.
3. Mobility. The runoff water from silt loam,soil beds treated
with radiolabeled mancozeb contained 1.16 percent of the
applied radioactivity, following application of water over a
7-day period. No radioactivity was detected in the sediments.
4. Groundwater. Studies submitted in response to the 1984
Data Call-In Notice gave only Inconclusive results.
However, these studies do Indicate that the major degra-
date, ETU, has the potential to leach. Due to lack of an
analytical method specific for ETU, no data are available
that confirm ETU actually Is in groundwater.
Ecological Effects. Available data are Insufficient to com-
pletely evaluate the ecological effects of mancozeb. Data, as
set forth In Table A, are either required or reserved pending
further evaluation. The following conclusions can be made
based on available data:
1. Toxlclty to Birds. Avian multiple-dose oral toxicity
studies are sufficient to suggest a tentative assessment
of the toxicity of mancozeb to birds. The studies sub-
mitted showed acute toxicity to the House Sparrow and
Mallard duck of approximately 1500 rag/kg and > 6400 mg/kg,
respectively. Based on these results, mancozeb is no more
than slightly toxic to avian wildlife on an acute basis.
34
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Toxiclty to Fish, Aquatic Invertebrates, and Estuarlne/Marlne
Organisms. Ninety-six hour LCKQ studies on rainbow trout
(0.46 pprn) and bluegill sunfish (1.54 ppm) indicate mancozeb
is moderately tqxic to warmwater fish but highly toxic to cold-
water fish. A 4.8-hour ECcQ to- daphnia yielded a value of 0.58
ppm; therefore, mancozeb is highly toxic to aquatic inverte-
brates. There are no acute studies for estuarine organisms.
Risks to Nontarget Organisms (Including Endangered Species).
The Agency has assessed the risks, based on ,the available
data, from the aquatic, terrestrial and seed treatment uses
of mancozeb. Based on these assessments, there does not
appear to be any concern for acute effects to birds for
any uses of mancozeb. Additional data are required to
complete a chronic risk assessment for these organisms as
v:ell as acute effects to and estuarine organisms.
a. Terrestrial Organisms. Mancozeb's highest registered
use rate is for turf (19.06 Ib. ai/A). Immediately
after application, foraging animals such as rabbits
and ducks could be exposed to maximum estimated
residues on grass of 4,080 ppm. This level is well
below the acute LCcQ level for avian species and below
the equivalent tox!.city levels for rats. Exposure
levels resulting from lower application rates to all
other sites., where mancozeb is applied to foliage,
present even less acute risk to terrestrial organisms.
Mancozeb's use as a seed protectant may well result in
. exposure to seed eating birds. Based on the House
Sparrow acute oral LD^g of approximately 1500 mg/kg, a
small bird would need, to -consume more than 150 times its
daily normal intake to obtain a toxic dose of mancozeb.
Though there is'little acute risk to terrestrial organ-
isms, until the receipt of avi'an reproduction studies:,
no risk assessment for chronic effects can be conducted.
b. .Aquatic Organisms. Aquatic food uses including wild
rice, taro and- cranberries could result in exposure to
aquatic organisms' from drift, runoff, or overflow. Only
mancozeb's use on taro in Hawaii and on wild rice in
Minnesota may result in some acute concern to freshwater
fish. The lowest known aquatic LC^g is a 96-hour
to rainbow trout (0.46 ppm). The wild rice (1.5 Ib.
al/A) and taro (1.2-1.5 Ib. ai/A) uses 'are direct
applications to water. A maximum estimated exposure
level for these uses is 0.330 ppm in water where the
crop is grown. If an overflow were to occur into an
adjacent one acre pond or marsh 2 feet deep 'the
35
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residues could be approximately 0.. 049 ppm. For cran-
berries, at an application rate' of 2.4 - 4.8 Ibs.
ai/A, the level may be 0.066 ppm in a 6-foot pond out-
side the treatment area. An estimated environmental
concentration (EEC) for the taro, wild rice and cran-
berry uses Indicates the possibility of endangered
species (fish and aquatic invertebrates) concerns.
Preliminary acute risk assessments have been conducted
for the major use patterns such as apples (8 Ibs. al/A),
potatoes (1.68 Ibs. ai/A), sweet corn (1.24 Ibs. al/A),
and grapes (3.23 Ibs. al/A). Using models for runoff
and assuming 5 percent drift, residue levels in 6-foot
ponds would range from 0.012 ppm for sweet corn to 0.083
ppm for apples. Based on these estimates, there appears
to be concern for acute effects to fish and aquatic
invertebrates only from the use of mancozeb on apples.
In the absence of sufficient environmental fate and
chronic fish and aquatic invertebrate data, a complete
risk assessment cannot be performed.
The Agency is consulting with the U.S. Pish and Wildlife
Service regarding these endangered species concerns.
Should a Jeopardy opinion be issued, endangered species
labeling may be necessary.
Reentry Considerations. Toxlcity and exposure criteria are set
forth in 40 CPR 158.If a chemical meets the specified criteria,
reentry data are required. •
Mancozeb does not meet the acute toxicity criteria, and there
is no epidemiological evidence that residues of this pesticide
cause adverse effects on persons entering treated sites. How-
ever, ETU has demonstrated evidence of oncogenicity, mutagenicity,
teratogenicity and thyroid effects and mancozeb has caused
thyroid effects. Therefore, the chronic toxicity criteria have
been met. Mancozeb also meets the exposure criteria in that
it is registered for use on crops which may involve substantial
exposure to residues of the pesticide. Reentry data are required.
Product Chemistry. The Agency has evaluated the available data
which identify the ingredients, materials, and manufacturing
process and discuss the physical and chemical properties of
mancozeb. In particular, the Agency has noted the possibility
of the formation of nitrosamines. Analysis to identify and
quantify nitrosamines is being required along with additional
product chemistry data requirements identified in the data
tables.
36
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D. TOLERANCE REASSESSMENT
Tolerances, expressed as zinc ethylene bisdithiocarbamate,
have been established for residues of mancozeb in a variety
of raw agricultural commodities, and meat byproducts (40
CPR 180.176 and 40 CFR 180.319), and In processed food (21
CPR 193.460) and feed (21 CPR 561.410). EPA has evaluated
the residue and toxicology data supporting tolerances. The
following were considered during this evaluation:
0 Whether the current tolerances and food additive regula-
tions are sufficient to cover the actual residues resulting
1 from use (including PIPRA section 24(c) and intrastate
uses).
0 Whether group tolerances can be established in accordance
with 40 CPR I80.34(f).
0 Whether, in the absence of tolerances, restrictions on use,
grazing, or feeding of treated commodities are necessary.
0 Whether the tolerances are expressed accurately and in
current terminology.
The regulatory results of the Agency's review are set out in
'Section IV.A., Regulatory Positions and Rationales.
.Residue Data. The residue data reviewed in support of these
tolerances include the following:
1. Data on the nature of the residues in both plants and
animals, including identification of major metabolites
and degradates of mancozeb. The metabolism is not
completely understood. Metabolites identified thus far
1 include ethylenethiourea (ETU), ethylenediamine, ethylene-
urea, 2-imidazollne, ethylenethiuram monosulfide,
3-(2-lmldazolin-2-yl)-2-imidazolidinethlone, glycine,
hydantoin, allantoin, and N-formyl-ethylenediamine.
i
2. Radlolabeled studies on the uptake, translocation and
1 metabolism of mancozeb in plants. These studies do not
i provide sufficient information regarding residues in
plants.
3. Radiolabeled studies on the metabolism and translocation
of mancozeb in poultry and ruminants. Ruminant metab-
olism is adequately understood. The poultry studies are
not adequate to permit conclusions regarding the adequacy
of existing or pending tolerances.
37
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4. Analytical methodology for deteririning the levels of
residues of mancozeb in plants and animals. Available
methods are adequate for collection of data pertaining
to residues of mancozeb. However, none of the methods
are specific for mancozeb and are, therefore, inadequate
for enforcement purposes.
5. Storage stability data. These data demonstrate that
residues of mancozeb per s_£ in crop samples are stable
over long periods (_>_ 1 year) of frozen storage and,
pending validation of the analytical method used, that
ETU in stored frozen crops is stable for £ 6 months.
6. Data on the magnitude and levels of residues of mancozeb
in individual raw agricultural commodities, animal products,
and processed food and. feed items. Data are inadequate
to support tolerances. Data show that ETU concentrates
on processing.
Toxicology Data. The toxicology data for mancozeb are insuf-
ficient to determine an Acceptable Daily Intake (ADI) or whether
the toxicity observed in the studies is due to mancozeb or ETU.
There are no acceptable chronic studies on which to calculate
an ADI, therefore, a subchronic study has been used to calcu-
late a Provisional ADI (PADI). Because a subchronic study was
used, an uncertainty factor of 1000 (rather than 100 used with
chronic studies) was employed. The PADI for mancozeb is 0.003
mg/kg/day based on the 90-day dog feeding study with a NOEL of
3 mg/kg/day.
The theoretical maximum residue contribution (TMRC), based oh
the assumption that 100 percent of each crop is treated and
contains residues at the tolerance level, is 0.028 mg/kg/day
or approximately 900 percent of the PADI. Based on a more
realistic dietary assessment, using average field trial residues
and estimated percent of crop treated, the estimated average
consumption for the U.S. population is 0.00097 mg/kg/day or
32.2 percent of the PADI.
Tolerances Issued. Currently, tolerances for mancozeb are
expressed as zinc ethylenebisdithiocarbamate equivalents, as
are the tolerances for other pesticides of the dithiocarbamate
class. These tolerances are set forth in 40 CFR 180.176 and
180.319 and in 21 CFR 193.460 and 561.410. There are several
Canadian tolerance established for residues of EBDC's, includ-
ing mancozeb, as well as several Codex Alimentarius tolerances.
There are no Mexican tolerances.
38
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS AND RATIONALES
|Based on the review and evaluation of all available data on
,mancozeb, the Agency has made the following determinations.
Where it is the Agency's position that label revisions are
.needed in order for a product to remain in compliance with
FIFRA, specific language is set forth in Section D of this
;Chapter.
1. EPA is currently Evaluating the potential human health
risks resulting from the use of mancozeb to determine
whether additional regulatory action is warranted on
mancozeb and the other EBDC pesticides containing t;he
common contaminant, degradation product, and metabolite,
ETU.
Rationale; The EBDC's were placed in special review in
1977 based on the presumption that the EBDC's and ETU
posed potential risks to human health or the environment.
The special review was concluded in 1982 and the EBDC's
were returned to the registration process. The special
review issues and the Agency's decisions are discussed in
the Background section of this document.
ETU, a contaminant, degradation oroduct and metabolite
of all the EBDC's, is mutagenic, oncogenic and teratogenic,
and the Agency has classified it as a Group B2 oncogen
(Probable Human Carcinogen). See the Agency Assessment
section of this Standard for a discussion of the classifi-
cation of ETU.
The Agency has assessed both worker and dietary risk
associated with exposure to mancozeb and to ETU through
the use of mancozeb, as discussed in the preceding Agency
Assessment section. Based on the results of these assess-
ments, the Agency believes additional evaluation of the
potential human health risks and additional regulatory
action, if applicable, is warranted.
2. The Agency will not consider establishment of new food use
tolerances for mancozeb.
Rationale; The current residue chemistry and toxicology
data are not sufficient to assess existing and pending
tolerances. The toxicology data base is insufficient to
determine an ADI and also does not allow a decision as to
whether observed toxicity is due to mancozeb or ETU. No
new uses will be considered until these issues are resolved,
39
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3. The Agency will consider the need for establishment of
tolerances for ETU and any Intermediate metabolites when
data are sufficient to permit such decisions.
Rationale; The toxicology data base for mancozeb is
insufficient to determine whether observed toxicity is
due to mancozeb, ETU, or additional metabolites.
4. The Agency will not establish any new food/feed additive
regulations pursuant to Section 409 of the Federal Food,
Drug and Comestic Act (FFDCA) and is deferring action on
previously established food/feed additive regulations.
Rationale: The Delaney Clause in Section 409 of the FFDCA
bars the establishment of food additive regulations for
substances which induce cancer in man or test animals, with
certain exceptions. The Agency is. currently developing a
position relative to the Delaney Clause and FIFRA. Once
vhis policy has been established, the Agency will determine
what action is required in relation to pesticides which
have produced positive oncogenic responses in chronic
animal studies.
5. Mancozeb is currently registered for use on barley, oat,
rye, wheat, peanuts and corn. The Agency is requiring
tolerances and supporting data or feeding restrictions
for forage and hay of barley, oat, rye and wheat, and for
hay and vines of peanuts, and tolerances/supporting data
for corn silage and peanut hulls.
Rationale; Tolerances have not been proposed or estab-
lished for these commodities in which residues of mancozeb
could occur. The registrant(s) must propose tolerances
and provide appropriate supporting data. In the case of
forage and hay of barley, oat, rye and wheat, and hay and
vines of peanuts, the registrant may- establish feeding
restrictions, in lieu of proposing tolerances. The regis-
trant(s) must inform the Agency within 90 days which option
is selected. A feeding restriction for corn s.1.lage would
be impracticable and unenforceable; because peanut hulls
do not remain under grower control, a feeding restriction
is not practical. Therefore, a feeding restictlon is not
an option for these commodities.
6. Mancozeb is currently registered for treatment of seed and
planting stock for flax, pineapple, rice, safflower, and
sorghum. The Agency is requiring tolerances/supporting
data for these treatments. -Tolerances will be required
either at the maximum residue level, or, if residues are
nondetectable, at the limit of detection.
40
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Rationale; In the past, seed and planting stock treat-
ments were automatically considered to be nonfood uses.
The Agency now requires tolerances to ensure that unaccept-
able residues do not occur in the commodities grown from
treated seed or stock. For those crops for which seed or
planting stock treatment is the only registered use and
which have no tolerances for mancozeb, tolerances must
be established to either reflect the maximum expected
residue, or, if no measurable residues are detected, the
limit of detection of the analytical method.
7. The Agency is requiring data to assess the human exposure
to mancozeb residue in tobacco products and pyrolysis
products of mancozeb in tobacco smoke.
Rationale; No residue data have been submitted for
residues of mancozeb in or on tobacco and the Agency is,
therefore, unable to assess the effects of this use of
mancozeb.
8. The Agency is requiring reentry data for mancozeb. In
order to remain in compliance with FIFRA, an interim
24-hour reentry interval requirement for agricultural
uses of mancozeb must be placed on the labels of all
mancozeb end-use products, until the required data are
submitted and evaluated and any change in this reentry
interval is announced.
Rationale: Mancozeb meets both the chronic toxicity and
exposure criteria specified in 40 CFR 158.140 for reentry
data. Until these data are received and evaluated, an
interim 24-hour reentry interval will serve to reduce
exposure of field workers to this chemical.
9. In order to.remain in compliance with FIFRA, it is the
Agency's position that mancozeb products should continue to
contain precautionary labeling pertaining to fish.
Rationale; Based on available data, mancozeb has been
demonstrated to be moderately toxic to warmwater fish and
highly toxic to coldwater fish and aquatic invertebrates.
Commercially grown wild rice was the only aquatic use
considered in the 1982 Decision Document. At that time,
it was believed that cultivating practices prevented most
nontarget organism exposure. In the Decision Document,
the Agency concluded that the risks of acute toxicity to
aquatic organisms were not unreasonable as long as an
appropriate warning was added to the label. Pending
receipt and evaluation of additional data, the Agency is
maintaining its position regarding-a label warning.
41
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10. The Agency is not specifying endangered species labeling
at this time.
Rationale: The Agency's risk assessments indicate that
certain endangered fish could be at risk from an acute
exposure to mancozeb resulting for some of its registered
uses. The Agency is consulting with the U.S. Fish and
Wildlife Service. Endangered species labeling may be
necessary in the future based on the results of this
consultation.
11. The Agency will evaluate the potential of mancozeb to
contaminate groundwater after it has received and evaluated
additional reguired environmental fate data.
Rationale; Mancozeb was identified as a chemical with
the potential to contaminate groundwater and a data
call-in notice was issued. Results of studies received
as a result of that notice were inconclusive, however,
they demonstrate .that ETU has the potential to leach.
Additional data are required to fully assess the potential
of mancozeb and ETU from the use of mancozeb to contaminate
groundwater.
12. It is the Agency's position that, in order to remain in
compliance with FIFRA, the importance of observing the
preharvest intervals be highlighted on labels of residential
(homeowner) products. Specific language is identified.
Rationale. In the 1982 Decision Document, the Agency
determined that, as a risk reduction measure to reduce
human dietary exposure, preharvest intervals must be
highlighted on residential labels so that home garden
users will be encouraged to comply with them. Although
the risks from dietary exposure to mancozeb cannot be
fully assessed at this time, the Agency believes contin-
uation of this emphasis as a risk reduction measure is
warranted. Specific language has been chosen to emphasize
to users the importance of adherence to .the preharvest
intervals.
13. The Agency's position is that protective clothing labeling
for mancozeb products, as stipulated in the 1982 Decision
Document, should be updated as noted herein in order to
remain in compliance with FIFRA.
Rationale; A major toxicological concern from worker
exposure to mancozeb at this time is the hazard to the
human thyroid from the degradation product, ETU, an
acknowledged goitrogen, teratogen, and oncogen. Addi-
tional data are required to determine whether mancozeb
42
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poses a teratogenic risk and to clarify the kidney
effects observed in the 90-day feeding study in rats. '
The Agency estimates that risks to commercial and agri-
cultural mixers, loaders and applicators from exposure
can be reduced five fold by complying with current
requirements that protective clothing be worn while
mixing, loading and applying the chemical.
14. The Agency is requiring analysis of mancozeb to determine
whether nitrosamines may be formed.
Rationale; There is a possibility for the formation of
nitrosamines during the manufacture of mancozeb; however,
the Agency does not have adequate data to determine
whether nitrosamines actually are formed.
15. The Agency has determined that all required data will
be immediately reviewed as they are submitted.
Rationale; Because of the general concerns over ETU
and the EBDC's, the Agency believes it is essential
that all data be reviewed, as they are received.
16. While data gaps are being filled, currently registered
manufacturing-use products (MP's) and end-use products
(EP's) containing mancozeb as the sole active ingredient
may be sold, distributed, formulated, and used, subject
to the terms and conditions specified in this Standard.
However, significant new uses will not be registered.
Registrants must provide or agree to develop additional
data, as specified in the Data Appendices, in order to
maintain existing registrations.
Rationale; Under FIFRA, the Agency may elect not to
cancel or withhold registration even though data are
missing or are inadequate (see FIFRA section 3(c)(2)(B)
and 3(c)(7)). Issuance of this Standard provides a
mechanism for identifying data needs. These data will
be reviewed and evaluated, after which the Agency will
determine if additional regulatory changes are necessary.
The Agency has elected not to consider registration of
any significant new uses while data gaps are being filled
and data evaluated, based on its concerns for mancozeb
and ETU as explained herein.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain mancozeb as the sole active ingredient, bear
required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed
In this section.
C. ACCEPTABLE RANGES AND LIMITS
Product Composition Standard - To be registered or reregis-
tered under this Standard, manufacturing-use products (MP's)
must contain mancozeb as,the sole active Ingredient. Each
MP formulation proposed for registration must be fully des-
cribed with an appropriate certification of limits, stating
maximum and minimum amounts of the active ingredient and
inert ingredients which are present in products, as well as
impurities found at greater than 0.1% and any N-nitroso
compounds at greater than 1 ppm.
Acute Toxicity Limits - The Agency will consider registration
of technical grade and manufacturing-use products containing
mancozeb provided that the product labeling bears appropriate
precautionary statements for the acute toxicity category In
which each product is placed.
Use Patterns - To be registered under this Standard, manu-
facturing-use products must be labeled for formulation Into
end-use products for registered uses, as listed in the Use
Index, Appendix III.
D. LABELING
All mancozeb products must bear appropriate labeling as
specified in 40 CPR 162.10. Appendix II contains information
on label requirements.
In order to remain In compliance with PIPRA, no pesticide
product containing mancozeb may be released for shipment by
the registrant after May 1, 1988, unless the product bears an
amended label which complies with the specifications in this
Standard.
In order to remain In compliance with PIPRA, no pesticide
product containing mancozeb may be distributed, sold, offered
for sale, held for sale, shipped, delivered for shipment, or
received and (having been so received) delivered or offered
to be delivered by any person after May 1, 1989, unless the
product bears an amended label which complies with the
specifications in this Standard.
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In addition to the above, in order to remain in compliance with
FIFRA, the following information must appear on the labeling:
1. Ingredient Statement. The Ingredient statement for MP's
must list the active ingredient as:
A coordination product of zinc ion and manganese
ethylene blsdithiocarbamate ..................... (% ai)
In which the Ingredients are:
Manganese"1"*" .................................... (%)
Zinc++ ......................................... (%)
Ethylene bisdithiocarbamate ion (CijHg^Sjj) ..... (%)
2. Use Pattern Statements. All manufacturing-use products
must state that they are intended for formulation into
end-use products for acceptable use patterns. However,
no use may be Included on the label where the registrant
falls to agree to comply with the data requirements In
Table A for that use pattern.
3. Disposal Statements. Because mancozeb has not been
designated as an acute or toxic hazardous waste under
the Resource Conservation and Recovery Act (RCRA), the
following is the appropriate pesticide disposal statement
for mancozeb products :
"Wastes resulting from the use of this product
may be disposed of on site or at an approved
waste disposal facility."
The labels of all products must bear the appropriate
container disposal statement (See Appendix II).
4. Precautionary Statements
Manufacturing-Use Products
"This pesticide is toxic to fish. Do not discharge
effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or public water unless this
product Is specifically identified and addressed in
an NPDES permit. Do not discharge effluent containing
this product to sewer systems without previously
notifying the sewage treatment plant authority. For
guidance, contact your State Water Board or Regional
Office of the EPA."
End-Use Products
Outdoor Use Products (other than aquatic food and
seed treatment)
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"This pesticide is toxic to fish. Drift and runoff
from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not apply directly
to water or wetlands (swamps, bogs, marshes, and
potholes). Do not contaminate water by cleaning of
equipment or disposal of wastes."
Seed Treatment Products
"This pesticide is toxic to fish. Cover or incorporate
spilled treated seed. Do not contaminate water by
cleaning of equipment or disposal of wastes."
Aquatic Food Use Products (cranberry, wild rice, taro)
"This pesticide Is toxic to fish. Drift and runoff
from treated areas may be hazardous to aquatic
organisms in neighboring areas. Do not contaminate
water by cleaning of equipment or disposal of wastes."
All Home Use Products
"PROTECTIVE MEASURES: Always spray with your back to
the wind. Wear long-sleeve shirt, long pants, and
rubber gloves. Wash gloves thoroughly with soap and
water before removing. Change your clothes immediately
after using this product and launder separately from
other laundry Items before reuse. Shower immediately
after use."
Home Use Products with Pood Uses
"Preharvest intervals on this label are specified so
that pesticide residues will be at an acceptable
level when the crop is. harvested.."
All Agricultural Products
"After (sprays have dried/dusts have settled/vapors
have dispersed, as applicable) do not enter or allow
entry into treated areas until the 24-hour reentry
interval has expired unless wearing the personal
protective equipment listed on the label.
"WORKER SAFETY RULES
"Keep all unprotected persons, children, livestock, and
pets away from treated area or where there is danger of
drift.
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"Do not rub eyes or mouth with hands. See First Aid
(Practical Treatment Section).
"PERSONAL PROTECTIVE EQUIPMENT - For Mixers, Loaders,
Applicators and Early Reentry Workers.
"HANDLE THIS PRODUCT ONLY WHEN WEARING THE FOLLOWING
PROTECTIVE CLOTHING AND EQUIPMENT: a long-sleeve
shirt and long pants or a coverall that covers all
parts of the body except the head, hands, and feet;
chemical resistant gloves; shoes, socks, and goggles
or a face shield. During mixing and loading, a
chemical resistant apron must also be worn.
"During application from a tractor with a completely
enclosed cab with positive pressure filtration, or
aerially with an enclosed cockpit, a long-sleeve
shirt and long pants may be worn in place of the
above protective clothing. Chemical resistant gloves
must be available in the cab or cockpit and worn
while exiting.
"IMPORTANT! Before removing gloves, wash them with
soap and water. Always wash hands, face, and arms
with soap and water before eating, smoking or drinking,
Always wash hands and arms with soap and water before
using the toilet.
"After work take off all clothes and shoes. Shower
using soap and water. Wear only clean clothes. Do
not use contaminated clothing. Wash protective
clothing and protective equipment with soap and water
after each use. Personal clothing worn during use
must be laundered separately from household articles.
Clothing and protective equipment heavily contaminated
or drenched with mancozeb must be destroyed according
to state and local regulations.
"HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE
ADEQUATELY DECONTAMINATED.
"During aerial application, human flaggers are
prohibited unless in totally enclosed vehicles."
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V. PRODUCTS RTTR.TFCT TO THIS STANDARD
AT .1 nroducts containinq one or more of the pesticides
identified in Section II.A. are subject to certain requirements
for data submission or chanqes in composition, labeling or
packaging of the product. The apolicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if anv) upon use, composition, or
packaging listed in Section iv, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B^
3. The labeling requirements specified for manufacturing
use products in Section iv.
4. Administrative requirements (application forms, Confiden-
tial statement of Formula, data compensation provisions)
associated with reregistration.
2 Data reguirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registra-
tion Standard. Table B lists product-specif.ic data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Tab.le C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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B. Manufacturing use products containing this pesticide
as one of multiple active ingredients are subject to:
The data requirements Listed in Table A.
C. End use products containing this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section TV if they pertain to the
end use product.
2. If eligible for the formulator's exemption^, the
data reguirements listed in Table C.
3. If not eligible for the formulator's exemption, the
data reguirements listed in Table A and the data reguire-
ments listed in Table C.
4. The labeling reguirements specified for 'end use
products in Section IV.
D. End use products containing this .pesticide as one of
multiple active ingredients are subject to:
a. If not eligible for the formulator's exemption,
the date reguirements listed in Tables A and C.
b. If eligible for the formulator's exemntion, the
data requirements listed in Table C.
3 if you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemntion for generic
data concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table R).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acguire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data reguirements in Table A.
2) If no producer subject to .the generic data reguirements
in Table A agrees to submit the reguired data, all end use
producers lose the exemption, and become subject to those
data reguirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of ^IFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
he submitted by registrants to maintain in effect the regis-
tration of products containing this active ingredient.4
A. What are generic data?
Generic data nertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often reguired
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data reauest under FIFRA sec.
3(c)(2)(B) (r>CI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 5 152.R5) to submit
generic data in response to a nci notice if the registrant
who supplies the active ingredient in his product is complying
with the data reguest.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
reguired data. Tf the registrants who have committed to
generate and submit the reguired data fail to take appropriate
steps to meet the reguirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both
your product(s) and their product(s) unless you commit to submit
and submit the reguired data in the specified timeframe. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
4 Registrations granted after issuance of this Standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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If you are not now eliqibJ.e for a formulator's exemption,
you may qualify for one if you change your source of suoplv
to a reqistered source that .does not share ownership in
common with your firm. Tf you choose to chanqe sources of
supply, the Confidential Statement of: Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
this active ingredient after the issuance of this Registration
Standard, you will be required to submit or cite generic
'data relevant to the uses of your product if, at the time
the application is submitted, the data have been submitted
to the Agency by current registrants. If the reguired data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar nroducts are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. Me)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
,active ingredient, the uses for which such data are reguired,
and the dates by which the data must be submitted to the
Agency.
i
D. How to comply with PCI reguirements.
Within 90 days of vour receipt of this Registration
Standard, you must submit to FPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(R) Summary Sheet" (EPA Form
85RO-1, enclosed) for each of vour products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
i '
1. You will submit the :data yourself.
! 2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows-you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by. the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adeauate assurance that the
person whom vou state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting reguested data as a task force or consortium, a
representative of the group should reguest a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The reauest must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom -EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing
the data reguirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general nolicy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing nrogram, but the other registrants developing the
data have refused to accept its of^er. [If your offer is
accepted, you may gualify for Option 2 above by entering
into an agreement to supply the data.]
In order to gualify for this method, you must:
1. File with EPA a completed "Certification of Attemnt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 858H-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its eguivalent:
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[Your company name] offers to share in the burden of
producing the data reguired pursuant to FIFRA sec.
3(c)(2)(R) in the fname of active ingredient! Registration
Standard upon terms to be agreed or railing agreement
to be bound by binding arbitration as provided by PIFRA
section 3(c)(2)(B)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data reguired under the DCI, then you
may gualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill ,its
commitment to develop and submit the data as reguired bv this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the reguired
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data.
4. You reguest a waiver of the data reguirement. If
you believe that a data reguirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a reguirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data reguire-
ment applies, EPA does not anticipate that many waivers will
be granted. A reguest for waiver does not extend the time-
frames for developing reguired data, and if your waiver
reguest is denied, your registration may be suspended if you
fail to submit the data.
, 5. You reguest that EPA amend your registration by deleting
:the uses for which the data are needed. You are not required
to submit data for uses which are no longer on your label.
6. You reguest voluntary cancellation of the registration
'of your product(s) for which the data are needed.
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E.
Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if
the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.C.
20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
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extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once
dates have been committed to and EPA has accepted these
commitments, any subsequent requests for a time extension
must be submitted in writing to the Office of Compliance
Monitoring at the address ^given in Section IX.E.
EPA will view failure to request an extension before
the data submission response deadline as a waiver of any
future claim that there was insufficient time to submit the
data. While EPA considers your request, you must strive to
meet the deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
: A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
' Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
55
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such permission would be consistent with- the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the Quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DOT authoritv, p.PA has determined that certain
product-specific data are required to maintain your registrations
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table R. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely reguire product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data require-
ments, vou must follow the same procedures as for generic data.
See Section vi.D, E, F, and G. You should note, however, that
product chemistry data are reguired for every product, and the
only acceptable responses are options VI.D.I. (submit data)
or VI.D.fi.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to he labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supportinq the product
and its uses. General labelinq reauirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). In.
addition, labelinq requirements specific to products containing
this pesticide are specified in Section IV.n of this Reqistra-
tion Standard. Applications submitted in response to this
notice must include draft labelinq for Agency review.
If you fail to submit revised labelinq as. required,
which complies with 40 CFR 162.10 and the specific instructions
in Section iv.n., EPA may seek to cancel or suspend the
reqistration of your product under FIFRA sec. 6.
IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Reqistration Division
for each product subject to this Reqistration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemotion Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
5 if on the Summary Sheet, you commit to develop the data,
nresent arquments that a data reauirement is not applicable
or should be waived, or submit protocols or modified protocols'
for Aqency review, you must submit a copy of the Summary
Sheet (and any supportinq information) to the Office of
Compliance Monitoring, which will be monitorinq the data
qenerated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitorinq at the
address qiven at the end of this section. (Actual studies
are not to be submitted to the Office of- Comoliance Monitorinq.)
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2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Aonlication for Pesticide Registration (EPA
Form 8570-1) .
b. Two copies of any required product-specific data
(See Table B) .
c. Three conies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific nata Report (E*>A Form 8580-4).
3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject pesticide
in combination with other active ingredients.
1. within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-2.7),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notifv the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
58
-------
C. End Use Products containing the subject pesticide as sole
active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(R) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two conies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form a580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 3-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended type sizes of the text. End use oroduct labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing the subject pesticide either
as sole active ingredient or in combination with other
active ingredients.
These products are being called in for full Federal regis-
tration. Producers of these products are being sent a letter
instructing them how to submit an application for registration.
59
-------
E. Addresses
The required information must be submitted to the following
address:
Lois A'. Rossi, Product Manager (Team 21)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agencv
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
60
-------
APPENDIX I
Data Tables
61
-------
TGUIDE-1
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CER Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the table.
62
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
63
-------
TABLE A V
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Composition
Must Additional Time Frame
Does EPA Bibliographic Data be for
Have Data?2/ Citation?/ be Submitted? Submission
§158.120 Product Chemistry
Product Identity and Composition;
61-1 - Product Identity and Disclosure TGAI N/A
of Ingredients
61-2 - Description of Beginning TGAI N/A
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI N/A
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis of Product
Samples TGAI N/A
62-2 - Certification of Ingredient
Limits TGAI N/A
62-3 - Analytical Methods to Verify
Certified Limits TGAI N/A
Physical and Chemical Characteristics
63-2 - Color TGAI N/A
63-3 - Physical State TGAI N/A
Yes
Yes
YesV
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
6 Months
6 Months
-------
TABLE A V
GENERIC DATA REQUIREMENTS FOR MANCOZEB1
cn
Data Requirement
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/faater Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements:
Composition
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
Does EPA Bibliographic
Have Data?2/ Citation2/
N/A
N/A!/
N/A5/
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data be
be Submitted?
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Time Frame
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
64-1 - Submittal of samples
N/A
N/A
No
-------
TABLE A
I/
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.120 Product Chemistry (continued)
_!/ The unregistered dry solid technical serves as a manufacturing-use product.
2/ Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been Introduced and previously
submitted data must be updated. Therefore, bibliographic citations for old data are not applicable.
3/ All nltrosamines must be identified and quantified In six samples; two samples of each must be analyzed
shortly after production, 3 months after production and 6 months after production. A method sensitive
to 1 ppm of N-nitroso contaminants must be used.
V Not applicable since the product decomposes when heated.
5/ Not applicable since the product Is a solid at room temperature.
ON
ON
-------
TABLE A
DATA RFQniREMRNTS FOR
Data Requirement
Test
Substance
noes F.PA
Have nata?
Riblioqranhic
Citation
Must Additional
nata he
Submitted?
Time Frame
for
Submission
S158.125 Residue Chemistry
171-4 - Nature of Residue
(Metabolism)
- Plants
PAIRA
Partially
- Livestock
PAIRA
Partially
00064927
00064932
00088826
00088829
00088833
00088894
00088921
00088923
00064930
00064931
00064Q32
00088831
00088834
00088835
00088924
00088924
00097110
00097112
00152696
00156715
00160703
00164509
00164510
00097148
00160780
00160781
00164879
00164880
40065801.
I/
2/
Yes
18 Months
3/
Yes
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCO7ER
Data Requirement
Test
Substance
Does EPA
Have Data?
ioqraphic
Citation
Must Additional.
Data be
Submitted?
Time Frame
for
Submission
S15B.125 Residue Chemistry (continued)
171-4 - Residue Analytical
Method
TGAI &
Metabolite;?
TGAI &
Metabolites
Partially
-4 - Storage Stability
TEP or PAI, &
metabolites
Partially
5a/
171-4 - Magnitude of the Residue-
Residue Studies for Each
Pood Use
- Crop Group ftl - Root and Tuber Vegetables
o Crop 1 - Carrots
— Crop field trials TEP
Partially
00040149
norvini si
00088892
00089871
0009013?
00097112
00097861
00098667
00129291
00147940
00160709
00162913
00164640
00164641
40065802
4006580!
40065804
40121001
00164640 40019501
00164641
00160707
4/
Yes
15 Months
5b/
Yes
Approved
protocol:
3 months
Studv:
18 months
7/
Yes
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
vO
o Crop 2 - Potatoes
— Crop field trials
TEP
— Processed Food/Feed EP
o Crop 3 - Sugar Beet Roots
— Crop field trials TEP
— Processed Food/Feed EP
Partially
Partially
Partially
Partially
00071616
00097024
00097110
00097113
00097123
00097151
00097183
00160708
40121002
40121003
00159480
00089875
00091501
00097137
.00160726
00159477
8/
Yes
9/
Yes
10/
Yes
ll/
Yes
18 Months
2/
24 Months
18 Months
2/
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test
Substance
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
o Crop 4 - Turnip Roots
— Crop Field Trials
12/
TEP Yes
14/
- Crop Group #2 - Leaves of Root and Tuber Vegetables
o Crop 1 - Sugar Beet Tops
— Crop field trials TEP
— Processed Food/Feed EP
o Crop 2 - Turnip Tops
— Crop field trials TEP
- Crop Group #3 - Bulb Vegetables
o Crop 1 - Onions
— Crop field trials TEP
Partially
Yes
16/
Yes
17/
Partially
00089875
00091501
00160726
00159477
00097023
00160723
13/
No
15/
Yes
No
Reserved
18/
Yes
18 Months
18 Months
2/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test
Substance
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group #4 - Leafy Vegetables
o Crop 1 - Celery
— Crop field trials TEP
19/
Partially
o Crop 2 - Fennel
— Crop field trials
TEP
No
Crop Group #5 - Brassica Leafy Vegetables
23/
Crop Group #6 - Legume Vegetables
24/
o Crop 1 - Beans (succulent and dried)
25/
o Crop 2 - Soybeans
22/
00097109
00160718
40122801
40122802
20/
Yes
2V
Yes
18 Months
2/
18 Months
2/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Test Does EPA
Data Requirement Substance Have Data?
§158.125 Residue Chemistry (continued)
- Crop Group #7 - Fruiting Vegetables (Except Cucurbits ).?JL/
o Crop 1 - Tomatoes
— Crop field trials TEP Partially
— Processed Food/Feed EP Yes
0 28/
- Crop Group #8 - Cucurbit Vegetables
o Crop 1 - Cucumbers
— Crop field trials TEP Partially
o Crop 2 - Melons
— Crop field trials TEP Partially
Bibliographic Must Additional
Citation Data be
Submitted?
27/
00088926 Yes
00089874
00097105
00097119
00097231
00160709
40121001
00159481 No
29/
00097109 Yes
00160710
40121001
30/
00097109 Yes
00160711
40121001
Time Frame
for
Submission
2/
18 Months
24 Months
2/
18 Months
2/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each Food Use
31/
o Crop 3 - Pumpkins
o Crop 4 - Summer Squash
— Crop field trials TEP
33/
- Crop Group #9 - Pome Fruits
g o Crop 1 - Apples
•g
— Crop field trials TEP
— Processed Food/Feed EP
o Crop 2 - Crabapples
— Crop field trials TEP
o Crop 3 - Pears
— Crop field trials TEP
Partially
Partially
Partially
No
Partially
00097109
00160712
00160713
40121001
00097109
00159472
40128802
00159472
00159478
40128802
00091500
40128801
32/
Yes
34/
Yes
35/
Yes
36/
No
37/
Yes
18 Months
2/
18 Months
24 Months
2/
18 Months
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test
Substance
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
o Crop 4 - Quinces
— Crop field trials
TEP
- Crop Group #10 - Stone Fruits
40/
o Crop 1 - Apricots
40/
o Crop 2 - Nectarines
40/
o Crop 3 - Peaches
39/
- Crop Group #11 - Small Fruits and Berries
o Crop 1 - Cranberries
— Crop field trials TEP
41/
o Crop 2 - Grapes
— Crop field trials
TEP
— Processed Food/Feed EP
No
Partially
Partially
Partially
00093258
00160721
00089873
00093258
00160722
00159475
0015947Q
38/
No
42/
Yes
43/
Yes
44/
Yes
18 Months
2/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOP. MANCOZEB
Data Requirement
Test
Substance
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
- Crop Group #12 - Tree Nuts"
46/ .
o Crop 1 - Almonds
cn
45/
47/
- Crop Group #13 - Cereal Grains
o Crop 1 - Barley
— Crop field trials TEP
— Processed Food/Feed EP
o Crop 2 - Corn (sweet, field, and popcorn)
— Crop field trials TEP
— Processed Food/Feed EP
o Crop 3 - Oats
— Crop field trials TEP
— Processed Food/Feed EP
Partially
Partially
Partially
Partially
Partially
Partially
00091503
00093261
00160717
00159473
00097109
00131898
00160719
00160720
00159474
00091503
00091503
48/
No
48/
No
49/
Yes
50/
Yes
No
51/
>
5V
18 Months
24 Months
2/
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test -
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time -Frame
for
Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
o Crop 4 - Rye
— Crop field trials TEP
— Processed Food/Feed EP
o Crop 5 - Wheat
— Crop field trials TEP
CN
Processed Food/Feed EP
No
No
Partially
Yes
- Crop Group f 14 - Forage, Fodder, and Straw of the Cereal Grains
o Crop 1 - Barley forage, hay, and straw
— Crop field trials TEP Partially
00091503
00160714
00091503
00160714
54/
o Crop 2 - Corn forage, fodder, and silage
— Crop field trials TEP
Partially
00093261
00159473
00160717
00093263
00097109
00131898
00160719
No
52/
)
52/
No
53/
Yes
No
55/
No
56/
Yes
2/
18 Months
2/
18 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Test
Substance
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
o Crop 3 - Oat forage, hay, and straw
— Crop field trials TEP No
o Crop 4 - Rye forage and straw
— Crop field trials TEP No
•^j o Crop 5 - Wheat forage, hay, and straw
— Crop field trials TEP Partially
- Crop Group #15 - Miscellaneous Commodities
o Crop 1 - Asparagus
— Crop field trials TEP Partially
o Crop 2 - Bananas
— Crop field trials TEP Partially
00091503
0.0160714
00097021
00160715
00090132
00160716
57/
NO
58/
No
59/
Yes
60/
Yes
61/
Yes
18 Months'"
2/
18 Months
2/
18 Months
2/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Test
Data Requirement Substance
§158.
171-4
*^J
CO
125 Residue Chemistry (continued)
- Magnitude of the Residue-
Residue Studies for Each
Food Use
o Crop 3 - Cottonseed
— Crop field trials TEP
— Processed Food/Feed EP
o Crop 4 - Papayas
— Crop field trials TEP
o Crop 5 - Peanuts
— Crop field trials TEP
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?
62/
Partially 00093259 Yes
00160727
63/
No — Yes
64/
Partially 00089879 Yes
00090776
00160724
65/
Partially 00093260 Yes
00097167
00160725
Time E'rame
for
Submission
2/
18 Months
24 Months
2/
18 Months
2/
18 Months
— Processed Food/Feed EP
o Crop 6 - Tobacco
— Crop field trials TEP
Partially
No
00159476
Yes
66/
67/
24 Months
2/
Yes
1.8 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Test Does EPA Bibliographic Must Additional Time Frame
Data Requirement Substance Have Data? Citation Data be for
Submitted? Submission
§158.125 Residue Chemistry (continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
68/
o Crop 7 - Seed, Seed Piece, Planting Stock, and Propagation Stock Treatments
69/ 2/
— Crop field trials TEP Partially 00097142 Yes 18 Months
*70/
— Processed Food/Feed EP No — Yes 24 Months
71/
- Meat/Milk TGAI or Plant Yes 00089871 Reserved
(Liver and Kidney) Metabolites 00097862
00155843
N° - Poultry/Eggs Yes 00089871 72/
00129291 Reserved
00155843
I/ Data depicting the uptake, distribution, and metabolism of mancozeb in pome fruit and fruiting vegetable crops
following foliar applications must be submitted. Sampling intervals through at least 21 days must be included.
The identities and quantities of residues in or on mature plant parts must be determined in order to elucidate
the terminal residues. Residue identities must be confirmed by a method such as GC, HPLC and/or mass spectros-
copy. Data reflecting solvent extraction efficiency of mancozeb residues must also be represented. Represen-
tative samples from these tests must also be analyzed by enforcement methods to ascertain that these methods are
capable of determining all metabolites of concern.
2/ Registrants are provided 18 months to submit data commencing with the first planting season after issuance of
the Standard, consistent with PR Notice 85-5. Data are due no later than December 31, 1988.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCO7EB
S15R.125 Residue Chemistry - Continued
V Metabolism studies utilizing noultrv are required. Animals must he dosed for three days with fl^Clmancozeb at a
level sufficient to make residue identification and quantification possible. Eqqs must be collected twice daily
durinq the dosinq period. Animals must be sacrificed within 24 hours of the final dose. The distribution and
characterization of residues must be determined in eqqs, liver, kidney, muscle, and fat. Precautions must be
taken to minimize FBDC deqradation durinq analysis steps due to the presence of water, methanol, and atmospheric
oxyqen. Samples from the studies requested above should also be analyzed usinq current enforcement methods to
ascertain the validity of these methods. Upon receipt of the requested data, the need for, and nature of,
tolerances for residues in animal nroducts will be determined.
£/ Residues of ethylenethiourea (FTTH) and mancozeb per se in/on crop samples must be subiected to analysis bv the
•' multiresidue methods published as an addendum to Subdivision O. Protocols for methods I, II, III, and IV are
available from NTIS under Order No. PB86 203734/AS. Tf the requested data reqardinq the nature of the residue in
plants and animals reveal additional metabolites of toxicoloqical concern, additional analytical methods for data
collection and enforcement may be required.
^a/ Available storaqe stability data are adequate to demonstrate that mancozeb is stable in/on frozen plant samples
^ for up to 12 months and ETU is stable for up to 6 months in frozen plant samples.
5b/ TO support crop residue data, storaqe stability studies must be conducted on both weathered samples (mancozeb) and
fortified frozen samples (mancozeb, metabolites and FTTI) of one representative crop from each crop qroupinq /4f) CER
180.34) on which reqistered uses of mancozeb exist. Analyses of each crop must be conducted over a time period that
includes the time interval that the raw aqricultural comnnoditv is held in-frozen storaqe prior to the crop residue
analysis. To support residue data on processed commodities, fortified storaqe stability data are required for all
processinq studies submitted to the Aqency. Analyses must be conducted over a time period that includes the frozen
storaqe of the raw aqricultural commodity prior to processinq and each processed commodity prior to the residue
analysis. Protocols for these studies must be submitted to and approved by the Aqency prior to initiatinq the
studies. [Continued on next paqe.l
-------
(a) Storage stability data using weathered samples. Data are required on the parent compound, mancozeh, in which
crop samples field treated with a typical end use product are frozen immediately upon harvesting. The inteqrity
of the samples must he maintained by freezinq. The samples must he analyzed for mancozeb on the day thev arrive
at the analytical laboratory, and then stored frozen and analyzed periodically for mancozeb durinq the time
intervals specified in the Aqency approved protocol.
(h) Storage stability data using fortified samples, nata are required on mancozeb, FTTH, and metabolites in
which a qroup of untreated samples of raw aqricultural commodities and processed crops are fortified (spiked)
with only mancozeh^pure active inqredienti, another aroup of samples is fortified with only ETU, and other qroups
are fortified individually with each additional metabolite. Immediately after fortification, the samples fortified
with mancozeb must he analyzed for mancozeb and FTU; samples fortified with RTU must he analvzed for only FTTH;
and samples fortified with other metabolites must be analyzed for only the metabolite with which the sample was
fortified. Sample inteqrity must be maintained by freezinq, and analyses for mancozeb, RTTJ, and metabolites
must be conducted periodically durinq the time intervals specified in the Anency awproved protocol.
(c) Storage stability data for livestock/poultry feeding studies. If cattle and poultry feedinq studies are
required (see footnote 71 and 71), fortified storaqe stability studies will he required on all animal commodities
(i.e., tissues, milk and eqqs) for which residue data are submitted to the Aqencv. Analyses must he conducted
over a time period that includes the time interval that each commoditv is held in frozen storaqe prior to
residue analyses.
OO
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
6/ A crop group tolerance is inappropriate at the present time because additional data are required to support
tolerances for residues of mancozeb in or on potatoes, carrots, and sugar beets (refer to the appropriate corp
sections for details of data requirements), and proposed use directions must be submitted along with appropriate
supporting residue data for radishes.
7_/ Data depicting mancozeb, ETU, and other residues of concern in or on carrots resulting from multiple foliar
applications of a WP formulation at 1.7 Ib ai/A and, in separate tests, a D formulation at 1.7 Ib ai/A, must be
submitted. Foliar applications must begin at the stage when disease first threatens and must be repeated at
7-day intervals. Tests must be conducted in CA(51%), MI(7%), and TX(14%), since these states collectively represent
72% of the U.S. carrot production (Agricultural Statistics, 1984, p. 153). The registrant must propose a maximum
number of applications per season or a maximum seasonal rate. The submitted data must reflect this proposed
maximum rate. Data depicting mancozeb, ETU, and other residues of concern in or on carrots harvested 7 days
following the last of several foliar applications of the 5.6% D formulation at 2.24 Ib ai/A must be submitted.
8/ Data depicting mancozeb, ETU, and other residues of concern in or on potatoes harvested on the last day of
multiple foliar applications of a WP and D formulation (in separate tests, applied 7 days apart) at 1.7 Ib ai/A
must be submitted. Separate tests must be done using ground (including irrigation applications) and aerial
CD equipment. The registrant must propose a maximum seasonal use rate or a maximum number of applications per
IV) season; required tests must reflect this proposed maximum rate. In addition, a PHI must be proposed. Tests
should be conducted in CA(6%), ID(25%), or WA(16%), ME(6%), ND(5%), and WI(6%) which collectively produce 63%
of the total U.S. potato crop (Agricultural Statistics, 1985, p. 104). Data depicting mancozeb, ETU, and other
residues of concern in or on potatoes harvested on the day of the last of several foliar applications of the
5.6% D formulation at 2.4 Ib ai/A must be submitted. Data depicting mancozeb, ETU, and other residues of concern
in or on potatoes harvested on the day of the last of several foliar applications of the 4.8% D formulation at
1.92 Ib ai/A must be submitted.
9/ Data depicting mancozeb, ETU, and other residues of concern in or on potato chips, granules, and flakes processed
fron potatoes treated in the field with mancozeb and bearing measurable weathered residues must be submitted.
Exaggerated rates may be needed to achieve these residues. If the residues concentrate in any of these processed
comnodities, food/feed additive regulations would be required; final disposition of any food/feed additive
regulations would be dependent upon the Agency's position regarding Delaney Clause issues.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
10/ Data depicting mancozeb, ETU, and other metabolites of concern in or on sugar beet roots harvested 14 days following
multiple foliar applications, made 1 days apart, of a D and WP formulation (in separate tests) at 1.7 Ib ai/A
must be submitted. Separate tests must be performed using ground and aerial equipment for each formulation. The
registrant must propose a maximum seasonal use rate or a maximum number of applications per season; required
tests must reflect this proposed maximum rate. Tests must be performed in CA(23%), ID(15%), MN(20%), and ND(11%)
which collectively produce ca. 69% of the total U.S. sugar beet crop (Agricultural Statistics, 1985, p. 164).
Data depicting mancozeb, ETU, and other residues of concern in or on sugar beet roots 14 days following the first
of multiple foliar applications of the 4.8% D formulation at 1.92 Ib ai/A must be provided.
ll/ Data depicting mancozeb, ETU, and other residues of concern in or on sugar beet pulp processed from sugar beet
roots bearing measurable weathered residues must be submitted. Exaggerated rates may be needed to achieve these
residues. If concentration is found to occur, a feed additive regulation would be required; final disposition
of food/feed additive regulations would be dependent upon the Agency's position regarding Delaney Clause issues.
12/ Data in support of the proposed tolerance for mancozeb residues in or on turnips are currently under review.
^ 13/ No additional data are required; data submitted for sugar beets may be translated to turnips.
14/ A crop group tolerance is not appropriate at the present time because additional data are required to support the
established tolerance for residues of mancozeb in or on sugar beet tops (see appropriate section for details of
data requirements), and residue data for turnip tops are presently under review for a proposed tolerance.
15/ Data reflecting mancozeb, ETU, and other residues of concern in or on sugar beet tops harvested 14 days following
the last of multiple foliar applications, 7 days apart, with the 80% WP (or a F1C) by aerial equipment, and with
the 4.8% D formulation by both ground and aerial equipment (in separate tests) at 1.7 Ib ai/A/application must be
submitted. A maximum seasonal use rate or a maximum number of applications per season must be proposed; required
tests must reflect the proposed maximum rate. Tests must be conducted in CA(23%), ID(15%), MN(20%) and ND(11%)
which collectively produced ca. 69% of the 1984 U.S. sugar beet crop (Agricultural Statistics, 1985, p. 76).
Data depicting mancozeb, ETU and other residues of concern in or on sugar beet tops 14 days following the last of
multiple foliar applications of the 4.8% D formulation at 1.92 Ib ai/A must be submitted. Tests must be conducted
in CA.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
16/ No conclusions may be made at the present time because available data on support of the proposed tolerance for
mancozeb residues in or on turnip tops are currently under review.
17/ A crop group tolerance is not appropriate at the present time because additional residue data are required to
support the established tolerance for residues of mancozeb in or on dry bulb onions (refer to onions section for
details), and use directions must be proposed, and appropriate supporting residue data submitted, for green onions
and one additional commodity (garlic, leeks, or shallots).
18/ Data depicting mancozeb, ETU, and other residues of concern in or on dry bulb onions harvested 7 days after the
last of several foliar applications of, in separate tests, the 80% WP formulation at 2.4 Ib ai/A and a D formulation
at 1.96 Ib ai/A must be submitted. Aerial and ground equipment must be represented in separate tests. Tests
must be conducted in CA(23%), CO(8%), NY(12%) or PA(9%), and TX(19%), which collectively represent 71% of the
U.S. commercial dry bulb onion acreage (1982 Census of Agriculture, Vol. 1, Part 51, pp. 346-347). Data
depicting mancozeb, ETU, and other residues of concern in or on dry onions harvested 7 days following the last of
multiple foliar applications of the 5.6% D formulation at 2.8 Ib ai/A. Tests must be conducted in TX.
The registrants must propose label restrictions limiting the maximum number of applications per season and maximum
seasonal use rate. The required data must reflect these restrictions. ,
19/ A crop group tolerance of 10 ppm has been proposed for residues of mancozeb, based on the representative crops
celery, lettuce and spinach. Conclusions cannot be made at the present time because available data in support of
the pending crop group tolerance (based on celery, lettuce, and spinach)-are currently under review.
20/ Data depicting mancozeb, ETU, and other residues of concern in or on celery harvested 14 days following the last
of multiple foliar applications of the 3.2% D formulation at 1.6 Ib ai/A and, in separate tests the-80% WP
formulation at 1.7 Ib ai/A, must be submitted. Applications must begin at emergence and be repeated at 3-day
intervals in the plant bed and at 7-day intervals in the field. Tests must reflect use of aerial equipment (for
the 80% WP formulation) or aerial and ground equipment (for the 3.2% D formulation). The registrant must propose
a maximum seasonal application rate or maximum number of applications per season. Required studies must be
conducted in CA(70%), FL(19%), and MI(8%), which collectively account for 97% of U.S. celery production (Agricultural
Statistics, 1984, p. 156). Data depicting mancozeb, ETU, and other residues of concern in or on celery harvested
14 days following the last of several foliar applications at 1.92 Ib ai/A (aerial and ground equipment must be
represented in separate tests) must be submitted. Tests must be conducted in CA.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
21/ Fennel is to be treated with the 80% WP or the 32% or 37% F1C at 1.7 Ib ai/A beginning at emergence and repeated
at 3-day intervals in the seed bed and at 7-day intervals in the field. Aerial and ground treatments must be
made in geographically representative locations. Fennel is to be harvested at the 7-day PHI. Residues of
mancozeb, ETU, and any others of concern should be determined before and after stripping, trimming, and washing.
A maximum seasonal application rate or number of treatments per season must be proposed. The 4.8% D must be
applied by air and ground repeatedly at 1.92 Ib ai/A to fennel grown in CA. Fennel is to be harvested at the 14-
day PHI according to Intrastate label 6023-3043.
22/ Data in support of the proposed crop group tolerance of 10 ppm for mancozeb residues in or on members of the
Brassica Leafy Vegetables Group are currently under review.
2_3/ A crop group tolerance is not appropriate at the present time because proposed use directions and appropriate
supporting residue data would have to be submitted for peas (Pisum spp.; one succulent variety and one dried
variety); and available data in support of the pending tolerances for mancozeb residues in or on beans and
soybeans are currently under review.
CQ>4/ Data in support of the proposed tolerance for mancozeb residues in or on beans are currently under review.
25/ Data in support of the proposed tolerances for residues of mancozeb in or on soybeans, soybean meal, and soybean
oil are currently under review.
26/ Data in support of the proposed crop group tolerance for residues of mancozeb in or on .members of the Fruiting
Vegetables (Except Cucurbits) Group (except tomatoes) are currently under review.
27/ Data depicting mancozeb, ETU, and other residues of concern in or on tomatoes harvested 5 days following the last
of multiple foliar applications of a D formulation at 2.4 Ib ai/A and, in separate tests, of WP or F1C at 2.5 Ib
ai/A must be submitted. Use of ground and aerial equipment must be represented (in separate tests). Studies
must be conducted in CA(27%) and FL(50%), which collectively produce 77% of U.S. tomatoes (Agricultural Statistics,
1985, p. 172). Data depicting mancozeb, ETU, and other residues of concern in or on tomatoes harvested 5 days
following the last of multiple foliar applications of the 5.6% D formulation at 2.8 Ib ai/A by aerial and ground
equipment (in separate tests) must be submitted. Tests must be conducted in TX. The registrant must propose a
maximum seasonal application rate or maximum number of applications per season. Required studies must reflect
this proposed maximum rate.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
28/ A crop group tolerance is not appropriate at the present time because additional data are required to support the
established tolerances for residues of mancozeb in or on cucumbers, melons, and summer squash.
29/ Data reflecting mancozeb, ETU, and other residues of concern in or on cucumbers following the last of multiple
foliar applications of a WP formulation at 2.5 Ib ai/A and, in a separate test, a D formulation at 2.4 Ib ai/A
must be submitted. Foliar applications must begin at the 2-leaf stage and be repeated at 5-day intervals.
Samples must be collected 5 days following the final application. Use of aerial and ground equipment must be
represented in separate tests. The registrant must propose a maximum number of applications per season or a
maximum seasonal rate. The submitted data must reflect this proposed maximum rate. Tests must be conducted in
CA(6%), FL(12%), MI(15%), TX(11%), and NC(14%) since these states collectively represent 73% of the U.S. cucumber
acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 343). Data from tests conducted in TX depicting mancozeb,
ETU and other residues of concern in or on cucumbers collected 5 days following the last of multiple foliar
applications of the 5.6% D formulation at 2.8 Ib ai/A must be submitted.
30/ Data reflecting mancozeb, ETU, and other residues of concern in or on melons harvested 5 days following the last
of multiple foliar applications (by aerial equipment) of a WP formulation at 2.5 Ib ai/A and, in a separate test,
a D formulation at 2.4 Ib ai/A (using both ground and aerial equipment) must be submitted. Foliar applications
must begin at the 2-leaf stage and be repeated at 5-day intervals. , The registrant must propose a maximum number
of applications per season or a maximum seasonal rate. The submitted data must reflect this proposed maximum
rate. Tests must be conducted in CA(53%), and TX(20%), since these states collectively represent 73% of the U.S.
^ cantaloupe acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 339). Data from tests conducted in TX depict-
ing mancozeb, ETU and other residues of concern in or on melons collected 5 days following the last of multiple
foliar applications of the 5.6% D formulation at 2.8 Ib ai/A must be submitted.
31/ Data in support of the proposed tolerance for mancozeb residues in or on pumpkins are currently under review.
32/ Data reflecting mancozeb, ETU, and other residues of concern in or on summer squash following multiple foliar
applications, using aerial equipment, of a WP formulation at 2.5 Ib ai/A and, in a separate test, a D formulation
at 2.4 Ib ai/A must be submitted. Foliar applications must begin at the 2-leaf stage and be repeated at 5-day
intervals. Samples must be collected 5 days following the final application. The registrant must propose a
maximum number of applications per season or a maximum seasonal rate. The submitted data must reflect this
proposed maximum rate. Tests must be conducted in CA(15%), FL(21%), and NJ(6%), since these states collectively
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
represent the major U.S. summer squash growing regions (1982 Census of Agriculture, Vol. 1, Part 51, p. 353).
Data from tests conducted in TX depicting mancozeb, ETU and other residues of concern in or on summer squash
collected 5 days following the last of multiple foliar applications of the 5.6% D formulation at 2.8 Ib ai/A
must be submitted.
33/ A crop group tolerance is not appropriate at this tine because additional data are required to support the
established tolerances for residues of mancozeb in or on apples and pears (refer to the individual crop sections
for details of data requirements).
34/ Data reflecting mancozeb, ETU, and other residues of concern in or on apples harvested 21 (PA and VA or WV) or
30 days (CA, MI, NY and WA) after the last of several foliar treatments (at 7-day intervals) with, in separate
tests: (i) the 80% WP, 32% F1C, or 37% F1C at 1.7 ai/100 gal; and (ii) the 3.2% D formulation at 10.0 Ib ai/A
must be submitted. Tests must be conducted in CA(6%), MI(9%), NY(12%), PA(7%) and WA(36%), v/hich represent ca.
70% of the U.S. apple production (Agricultural Statistics, 1985, p. 186). The registrant(s) must propose label
restrictions that: (i) limit the number of applications per season; (ii) limit the maximum seasonal use rate;
and (iii) standardize the maximum single application use rate among the various formulations. These label
restrictions must be reflected in the data supplied in response to the above requirements. ETU residue data
O for all apple samples stored _> 6 months must be submitted to replace existing studies since it has been shown
i that ETU is not stable in apples for longer than 6 months..
35/ A feed additive regulation for mancozeb residues in dry apple pomace based on a 13x concentration factor
(compared with washed fruit) is indicated, however, final disposition of this feed additive regulation is
dependent upon the Agency's position regarding Delaney Clause issues.
36/ No data are required because the data requested for apples will be translated to crabapples.
37/ Data, reflecting mancozeb, ETU, and other residues of concern in or on pears harvested 15 days after the last
of several foliar applications at 7-day intervals of, in separate tests, the (i) 80% WP, 72% WP, 32% F1C or
37% F1C and (ii) the 3.2% D formulations at 8.4 Ib ai/A (applied by both aerial and ground equipment) must be
submitted. Tests must be conducted in CA(44%), OR(21%) or WA(29%), since these states collectively represent
94% of the U.S. commercial pear production (Agricultural Statistics, 1985, p. 214). The registrants must also
propose label restrictions limiting the number of applications per season and the maximum seasonal use rate,
and standardizing the maximum single use rate across labels and formulations. The data requested above must
reflect these proposed label restrictions.
38/ No data are required because the data requested for pears will be translated to support this tolerance.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
39/ A crop group tolerance is not appropriate at the present time because available data in support of the proposed
tolerance for residues of mancozeb in or on peaches are currently under review; and proposed use directions and
appropriate supporting residue data must be submitted for cherries (sour or sweet) and plums or fresh prunes.
40/ Data in support of the proposed tolerance for mancozeb residues in or on these crops are currently under review.
4I/ A crop group tolerance is not appropriate at the present time because additional data are required to support the
existing tolerances for residues of mancozeb in or on cranberries and grapes (refer to the sections on cranberries
and grapes for details of data requirements); and proposed tolerances and use directions must be submitted, along
with appropriate supporting residue data, for residues in or on a Rubus species and strawberries.
42/ Data depicting mancozeb, ETU, and other residues of concern in or on cranberries resulting from multiple foliar
applications of the 80% WP formulation or an F1C at 5 Ib ai/A and, in separate tests, the 3.2% D formulation at
3.2 Ib ai/A must be submitted. Ground and aerial equipment must be used in separate tests. The PHI must be
30 days. Tests must be conducted in MA(50%), WI(36%), and WA(4%), which collectively produce 90% of U.S. cran-
berries (Agricultural Statistics, 1985, p. 204). The registrants must proposed a maximum seasonal application
rate or a maximum number of uses per season. Required tests must reflect this rate.
OO
OOP/ Data depicting mancozeb, ETU, and -other residues of concern in or on grapes and raisins resulting from multiple
foliar applications of the 80% WP formulation and, in separate tests, a D formulation at 3.4 Ib ai/A are required.
Ground and aerial equipment must be made in separate tests. Tests must be conducted in CA(90%) and NY(4%), which
collectively produce 94% of U.S. grapes (Agricultural Statistics, 1985, p. 206). The registrant must propose a
maximum seasonal application rate and a posttreatment interval for mancozeb use in CA. Required data must
reflect these proposals.
44/ Food/feed additive regulations for mancozeb residues in grape pomace (wet and dry), grape juice, and raisin waste,
since mancozeb concentrates and ETU levels increase in these commodities during processing, are indicated. However,
final disposition of these food/feed additive regulations is dependent upon the Agency's position regarding
Delaney Clause issues.
45/ A crop tolerance is not appropriate at the present time because available data in support of the proposed tolerance
for residues of mancozeb in or on almonds are currently under review; and proposed use directions must be submitted
along with appropriate supporting residue data for two additional group members (pecan and English walnut) if a
crop group tolerance is desired.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCO5EB
§158.125 Residue Chemistry - Continued
46/ Data in support of the proposed tolerance for residues of mancozeb in or on almonds are currently under review.
47/ A crop tolerance is not appropriate at the present time because additional data are required to support the
established tolerance for residues of mancozeb in or on corn (fresh sweet and dried field) and wheat [refer to
individual crop sections for details] and proposed use directions and appropriate supporting residue data must
be submitted for rice and sorghum.
48/ Since the registered use on wheat is identical to that on barley, the requested data for wheat will be translated
to barley. The barley and wheat processing studies fulfill the requirements for residue data in barley milled
products.
49/ Data depicting mancozeb, ETU, and other residues of concern in or on kernels plus cobs of sweet corn and field
corn following multiple foliar applications of the 80% WP formulation (or an F1C) at 1.3 Ib ai/A and, in a
separate test, the D formulation at 0.04 Ib ai/1000 sq ft (applications must be made at 1.3 Ib ai/A) are required.
Applications must be made using ground and aerial equipment in separate tests. Applications must begin at the
normal time of disease onset and be repeated at 4-day intervals. Corn must be harvested at 7 days following the
last application for sweet corn and popcorn and at 40 days following the last application for field corn. Tests
must be conducted in OR(12%) or WA(12%) in the case of sweet corn and at a single site in a major growing area
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
53/ Data depicting mancozeb, ETO, and other residues of concern in or on the grain of wheat treated with the 80% WP,
and 3.2% D formulation (in separate tests) at 1.7 Ib ai/A must be provided. Three foliar applications must be
made at 7-day intervals using ground and aerial equipment (in separate tests). Grain must be harvested at 26 days
following the last application. Tests must be conducted in either ID(3%), WA(6%), OR(3%) or MT(14%); KS(17%) or
MO(3%); MN(5%), Np(ll%) or SD(5%); and OK(7%) or TX(6%) which represent ca. 80% of U.S. commercial wheat production
(Agricultural Statistics, 1985, p. 5). Data depicting mancozeb, ETU, and other residues of concern in or on wheat
treated in CA with multiple foliar applications of the 4.8% D formulation at 1.92 ai/A must also be provided.
54/ A crop tolerance is not appropriate at the present time because additional data are required to support the
established tolerance for residues of corn (fresh sweet and dried field) and wheat and one other cereal grain
(refer to individual crop sections for details of data requirements).
55/ Since the registered use on wheat is identical to that on barley, the requested data for wheat straw will be
translated to barley straw. Since forage and hay are raw agricultural comnodities of barley, the registrant must
either propose tolerances and provide appropriate supporting residue data or establish feeding restrictions. The
established 25 ppm tolerance for residues of mancozeb in or on the straw of barley may be inadequate based on the
available data.
r-£6/ Data depicting mancozeb, ETU, and other residues of concern in or on field corn forage and fodder treated with
multiple foliar applications of the 80% WP, and 3.2% D formulation (in separate tests) at 1.3 Ib ai/A and the
80% WP at 1.2 tbsp actual/gal/435 sq ft (in separate tests) must be provided. Applications must be made using
ground and aerial equipment in separate tests and repeated at 4-day intervals. Samples must be collected at the
40-day PHI. Tests must be conducted in either IA(7%), MN(8%), NE(6%), NY(8%) and WI(11%) which produce ca. 40%
of U.S. corn silage (Agricultural Statistics, 1984, p. 33). In addition, the registrant must specify a maximum
seasonal use rate or number of applications which must reflect the data.
57/ Since the registered use on wheat is identical to that on oats, the requested data for wheat straw will be
translated to oat straw. Since forage and hay are raw agricultural commodities of oats, the registrant must
either propose tolerances and provide appropriate supporting residue data or establish feeding restrictions.
58/ Since the registered use on wheat is identical to that on rye, the requested data for wheat straw will be
translated to rye straw. Since forage and hay are raw agricultural commodities of rye, the registrant must
either propose tolerances and provide appropriate supporting residue data or establish a feeding restriction.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
59/ Data depicting mancozeb, ETU, and other residues of concern in or on straw from wheat treated with the 3.2% D and
the 80% WP or the 32 and 37% F1C formulations (in separate tests) in three applications at 1.7 Ib ai/A using
ground and aerial equipment at 7-day intervals must be submitted. Samples must be harvested at the 26-day
PHI. Trials must be conducted in ID(3%)/MT(3%)/OR(3%)A/A(6%), KS(17%)/MO(3%), MN(5%), ND(11%)/SD(5%), OK(7%) and
TX(6%) representative of ca. 70% of U.S. commercial wheat production (Agricultural Statistics, 1985, p. 5). Data
depicting mancozeb, ETU, and other residues of concern in or on straw from wheat treated in CA with 4.8% D formu-
lation at 1.92 Ib ai/A must also be submitted. Alternatively, the registrant may elect to cancel this state use
permitted under EPA Reg. No. 6023-3043. Since forage and hay are raw agricultural commodities of wheat, the
registrant must either propose tolerances and provide appropriate supporting residue data or establish feeding
restrictions.
60/ Data depicting mancozeb, ETU, and other residues of concern in or on asparagus harvested from plants treated with
multiple postharvest foliar applications using a D formulation at 1.7 Ib ai/A/application applied with both
ground and aerial equipment (in separate tests) must be submitted. The registrant must propose a maximum seasonal
application rate or maximum number of applications per season and submit data reflecting residues resulting from
such application. Tests must be conducted in CA(36%), MI(20%) and WA(31%) which collectively account for 87% of
the U.S. commercial asparagus acreage (1982 Census of Agriculture, Vol. 1, Part 51, p. 335).
\O
*61/ Data depicting mancozeb, ETU, and other metabolites of concern in or on bananas harvested on the day
of the last of several foliar applications of the 80% WP or 37% F1C formulation at 3.4 Ib ai/A are required.
Aerial and ground equipment must be used in separate tests. Tests must be conducted in HI which represents 100%
of domestic U.S. banana production (Agricultural Statistics, 1985, p. 193) as well as in Honduras or Costa Rica,
which represent 25% and 24%, respectively, of all U.S. banana imports (U.S. Imports of Fruits and Vegetables
under Plant Quarantine Regulations, Fiscal Year 1971; U.S.D.A.; February 1982). The registrant must also propose
label revisions establishing a maximum number of applications per season or maximum seasonal use rate. Required
studies must reflect the proposed maximum rate.
62/ Data depicting mancozeb, ETU, and other residues of concern in or on cottonseed following multiple foliar
applications (using both ground and aerial equipment in separate tests) of a D formulation at 1.6 Ib ai/A/
application and, in a separate test, the 80% WP (or a F1C) formulation at 1.7 Ib ai/A. The registrant must
propose a maximum seasonal use or list the number of applications per season. Also, a PHI must be proposed.
Submitted data must reflect this proposed PHI and maximum rate. Required tests must be conducted in AZ(9%),
MS(12%), and TX(30%) which collectively produce 75% of the U.S. cottonseed (Agricultural Statistics, 1985,
p. 108). Data depicting mancozeb, ETU, and other residues of concern in or on cottonseed grown in CA, resulting
from multiple foliar applications of the 4.8% D formulation at 1.92 Ib ai/A must be submitted.
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TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
63/ Data are required depicting concentration of mancozeb, ETU, and other residues of concern during processing of
cottonseed hulls, meal, crude oil, refined oil, and soapstock derived from cottonseed bearing measurable weathered
residues. If concentration occurs during processing, food/feed additive regulations would be indicated; however,
final disposition of these food/feed additive regulations would be dependent upon the Agency's position regarding
Delaney Clause issues.
64/ Data depicting mancozeb, ETU, and other metabolites of concern in or on whole fruit and pulp samples of papayas
harvested on the day of the last of several foliar applications of, in separate tests, a WP or a F1C formulation
at 2.1 Ib ai/A, and the 3.2% D formulation at 1.92 Ib ai/A are required. Applications with ground and aerial
equipment must be included in separate tests. The registrant must also propose label revisions establishing
a maximum seasonal use rate or maximum number of applications per season. The required data must reflect the
proposed maximum rate. The tests must be conducted in HI, represents 99% of commercial papaya production in
the U.S. (1982 Census of Agriculture, Vol. 1, Part 51, p. 363).
65/ Data depicting mancozeb, ETU, and other metabolites of concern in or on nutmeats from peanuts harvested 0 days
after the last of several foliar applications at 7-day intervals in separate tests: (i) the 80% WP, 32% F1C, or
37% F1C at 1.7 Ib ai/A; (ii) the 3.2% D, 4% D, or 4.8% D formulation at 1.7 Ib ai/A are required. Applications by
aerial and ground equipment must be represented in separate tests. The tests must be conducted in AL(15%) or
GA(49%), NC(10%) or VA(6%), and TX(8%), since these states represent 88% of commercial U.S. peanut production
(Agricultural Statistics, 1985, p. 121). Data depicting mancozeb, ETU, and other residues of concern in or on
peanut vine hay harvested' 14 days after the last of of several foliar applications at 7-day intervals of, in
separate tests: (i) the 80% WP, 32% F1C, or 37% F1C at 1.2 Ib ai/A; (ii) the 3.2% D, 4% D, 4.8% D formulation at
1.2 Ib ai/A are required. Applications by aerial and ground equipment must be represented in separate tests.
The tests must be conducted in AL(15%) or GA(49%), NC(10%) or VA(6%), and TX(8%), since these states represent
88% of commercial U.S. peanut production (Agricultural Statistics, 1985, p. 121). The registrant must propose
tolerances or impose feeding restrictions for treated peanut hay and vines following treatment at 1.7 Ib ai/A.
66/ Data depicting residues in meal, crude oil, refined oil, and soapstock processed from peanuts bearing measurable,
weathered residues are required. If residues concentrate in any of these processed commodities, food/feed additive
regulations would be required; however, final disposition of these food/feed additive regulations would be dependent
upon the Agency's position regarding Delaney Clause issues.
67/ Data depicting mancozeb, ETU, and other residues of concern in or on green, freshly harvested tobacco receiving
the following full-season treatment schedule: (i) multiple foliar plant bed treatments of the 37% F1C formulation
at 0.02 Ib ai/100 sq yards; and (ii) multiple foliar applications (to plants set in field) by air and, in separate
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.125 Residue Chemistry - Continued
tests, by ground equipment, of the 37% F1C formulation at 1.3 Ib ai/100 gal must be submitted. The registrant
must propose a maximum seasonal application rate or a maximum number of applications per season. Required studies
must reflect these rates. Data depicting mancozeb, ETU, and other residues of concern in or on green, freshly
harvested tobacco receiving multiple foliar applications of the 80% WP formulation in the plant bed, and in the
field, at 1.6 Ib ai/A must be submitted. Tests must be conducted in CT, GA, KY, MD, MO, NC, OH, PA, SC, TN, and
VA. If residues in freshly harvested green tobacco exceed 0.1 ppm, data depicting residues in or on dried or
cured tobacco will be required. If residues in or on dried or cured tobacco exceed 0.1 ppm, pyrolysis products
derived from the active ingredient must be characterized and the level of residue in smoke must be quantified.
([14c]Mancozeb must be used for identification of pyrolysis products.)
68/ The following crops having tolerances for residues of mancozeb may be seed treated with mancozeb prior to planting:
barley, corn (field), cotton, oats, peanuts, potato, rye, tomato, and wheat. Crops for which seed or planting/
propagation stock treatment is the only registered use and which have no tolerances for mancozeb include:
caprifigs, flax, pineapple, rice, safflower, and sorghum.
69/ The following data are required: Data depicting mancozeb, ETU and other residues of concern in or on flax,
pineapple, rice, safflower, and sorghum resulting from seed treated with mancozeb according to the label directions
of the product having the maximum permissible use rate. [In some cases the maximum rate is present on a multiple
active ingredient formulation label.] Samples of all raw agricultural commodities for each crop must be collected
at the shortest interval after planting in which they could be used for food or feed purposes. Tolerances must
be proposed that reflect either the maximum expected residue levels or, if no measurable residues are detected,
the limit of detection of the analytical method.
TO/ All required processing studies (refer to Footnote 69) must utilize raw agricultural commodities bearing measurable
weathered residues. Given the long intervals between planting treated asparagus stock or caprifigs and harvesting
the raw agricultural commodities, no residue data are required for asparagus and caprifigs.
71/ Upon receipt of the data requested in the section "Storage Stability Data", the established tolerances for liver
and kidney will be reassessed, and the adequacy of the available data regarding the magnitude of residues will be
determined with consideration for any additional metabolites of toxicological concern.
72/ Upon receipt of the data requested, in this registration standard, the available data for poultry and eggs will be
evaluated, with consideration for any additional metabolites of toxicological concern.
-------
TABLE A
GENERIC DATA RETIREMENTS FOR MANCOZEB
Data Requirement
Composition
Does EPA Have Data
Use to Satisfy This Bibliographic Must Additional Time Frame
Patterns Requirement? (Yes, Citation Data be for
No or Partially?) Submitted? Submission
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1
- Hydrolysis
Photodegradat ion
161-2
161-3
161-4
- In water
- On soil
- In Air
PAIRA
ETU
PAIRA
ETU
PAIRA
ETU
PAIRA
A,B,C,E,F
A,B,C,E,F
A,B,C
A,B,C
A
A
A
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
ReservedV
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
METABOLISM STUDIES-LAB:
162-1
162-2
162-3
162-4
- Aerobic Soil
- Anaerobic Soil
- Anaerobic Aquatic
- Aerobic Aquatic
PAIRA
ETU
PAIRA
ETU
PAIRA
PAIRA
A,B,E,F
A,B,E,F
A
A
C
C
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
27 Months
27 Months
27 Months
27 Months
27 Months
27 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement Composition
Does EPA Have Data
Use to Satisfy This Bibliographic Must Additional Time Frame
Patterns Requirement? (Yes, Citation Data be for
No or Partially?) Submitted? Submission
§158.130 Environmental Fate (continued)
MOBILITY STUDIES:
163-1 - Leaching and
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DEGRADATION STUDIES-FIELD:
164-1 - Soil
\O
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
PAIRA
ETU
TEP
TEP
TEP
ETU
TEP
TEP
TEP
A,B,C,E,F No
A,B,C,E,F No
A,E,F No
A,E,F No
A,B No
A,B No
C No
No
A,B No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
12 Months
12 Months
12 Months
15 Months
27 Months
27 Months
27 Months
50 Months
165-1 - Rotational Crops PAIRA
(Confined)
165-2 - Rotational Crops TEP
(Field)
165-3 - Irrigated Crops TEP
A,C
A,C
A,C
No
No
No
Yes
Reserved^/
39 Months
Yes
39 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Composition
Does EPA Have Data
Use to Satisfy This
Patterns Requirement? (Yes,
No or Partially?)
Bibliographic Must Additional Time Frame
Citation Data be for
Submitted? Submission
§158.130 Environmental Fate (continued)
ACCUMULATION STUDIES (continued)
165-4 - In Fish PAIRA
165-5 - In Aquatic Nontarget TEP
Organisms
A,B,C
Yes
12 Months
I/ This study is reserved pending results of volatility studies.
Reserved pending results of confined rotational crop study.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data
§158
Requirement Composition
.135 Toxicology
Does EPA Have Data
to Satisfy This
Use Requirement? (Yes,
Patterns No or Partially?)
Must Additional
Bibliographic Data be
Citation Submitted?
Time Frame
for
Submission
ACUTE TESTING:
81-1
81-2
81-3
81-4
vO
81-5
- Acute Oral Toxicity TGAI
- Rat
- Acute Dermal TGAI
- Acute Inhalation TGAI
- Rat
- Eye Irritation TGAI
- Rabbit
- Dermal Irritation TGAI
- Rabbit
All Yes
All Yes
All Yes
All Yes
All Yes
00047146 No
00093926
00142522
00047146 No
00093927
00142522
00047146 No
00093928
00145996
00142522 No
00047146 No
00093927
00142522
81-6 - Dermal Sensitization TGAI
- Guinea Pig
81-7 - Delayed TGAI
Neurotoxicity - Hen
All
All
No
No
Yes
No
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data
§158.
Requirement
135 Toxicology -
Composition
Continued
Use
Patterns
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially?)
Must Additional
Bibliographic Data be
Citation Submitted?
Time Frame
for
Submission
SUBCHRQNIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding
- Rodent, and
- Non-rodent
- 21-Day Dermal
- Rabbit
- 90-Day Dermal
- Rabbit
•
TGAI
(Dog) TGAI
TGAI
TGAI
- 90-Day Inhalation: TGAI
- Rat
All
All
All
All
All
Yes
Yes
No
No
Yes
00160704 No
00160705 No
Yes
Reserved^/
00160706 No
00160782
12 Months
^O
°°CHRONIC TESTING;
83-1 - Chronic Toxicity:
- Rodent
- Nbnrodent
TGAI
ETO
TGAI
ETU
All
All
All
All
No
No
No
No
YesW
50 Months
50 Months
50 Months
50 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Does EPA Have Data
to Satisfy This Must Additional Time Frame
Use Requirement? (Yes, Bibliographic Data be for
Data Requirement Composition Patterns No or Partially?) Citation Submitted? Submission
§158.135 Toxicology - Continued
83-2 - Oncogenicity:
- Rat TGAI . All
- Mouse TGAI All
83-3 - Teratogenicity:
- Rat TGAI All
- Rabbit TGAI All
83-4 - Reproduction TGAI All
ETU All
_ MUTAGENICITY TESTING
V° 84-2 - Gone Mutation TGAI All
84-2 - Chromosomal Aberration TGAI All
No
No
YesV
YesV
50 Months
50 Months
Yes 00093929 No
No
No
No
Yes 00148231
00148232
00148233
00148234
00148235
Yes 00148231
00148232
00148233
00148234
00148235
Yes
Yes3/
YesV
00148236 No
00148237
00148238
00148239
00149193
00148236 No
00148237
00148238
00148239
00149193
15 Months
39 Months
39 Months
-------
TABLE A
GENERIC DATA REQUIREMEOTS FOR MANCOZEB
Data Requirement
Composition
Use
Patterns
Does EPA Have Data
to Satisfy This
Requirement? (Yes,
No or Partially?)
Bibl iographi c
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.135 Toxicology - Continued
84-4 - Other Mechanisms of TGAI
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA
85-2 - Dermal (Percutaneous) PAIRA
Absorption - Rat ETU
All
All
All
Partially 00148231 00148236 Yes£/V 12 Months
00148232 00148237
00148233 00148238
00148234 00148239
00148235 00149193
•h
Yes 00159611 Mb
00159612
Partially 00127950 Yes8/ 12 Months
I/ Not required (mancozeb is not an organophosphate).
2/ The requirement for a 90-day dermal study depends upon the outcome of the 21-day dermal study and upon
—•* application rates.
O 3/ The studies are required individually for mancozeb and ETU.
c*4/ There must be emphasis on the reporting of possible neurologic effects (both from in-life observations
and histologic examination) in the'chronic feeding studies. In the rodent study, additional animals
must be utilized that would allow performance of jji situ neurological examinations.
5/ Registrants who conduct chronic feeding and/or oncogenicity studies should inform the Agency in writing
~~ of the dosage levels planned and their reasons for believing that the highest dose approaches or equals
the Maximum Tolerated Dose observed in subchronic or range finding studies, and must also consult with
the Agency to determine that the appropriate dosage levels are being used in the chronic feeding and/or
oncogenicity studies. If EPA subsequently determines that the study was conducted using a dosage rate
that was too low to assess long-term effects, the study may be deemed not to satisfy the data requirement.
6/ The UDS assay in primary rat hepatocytes must be repeated. Additionally, adequate promotion assays in vitro
~~ must be submitted.
7/ A mammalian cell transformation assay on mancozeb and ETU, with or without metabolic activation, in one of the
~~ following viral cell cultures capable of detecting enhancement of transformation by chemicals (promotion):
Syrian hamster embryo cells infected with simian adenovirus, or Fischer rat embryo cells infected with
Rauscher leukemia virus, or mouse embryo cells infected with AKR (mouse) leukemia virus.
8/ A study or studies must be carried out that clearly establishes a maximum absorption rate for mancozeb and for
~~ ETU. Registrant must discuss protocol with Agency prior to commencement of the study.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes, Bibliographic
Pattern No or Partially) Citation
Must Additional Data
Be Submitted Under
FIFRA §3(c) (2) (B)?
Time Frames for Data
Submission
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
TEP
TEP
TEP
TEP
A,B,C,E,F
A,B,C,E,F
A,B,C,E,F
A,B,C,E,F
No
No
No
No
Yegl/ _ 27 Months
Yes2/ - 27 Months
NcP/
_!/ For each end-use, the registrant is required to propose an acceptable reentry interval based either upon data:
(a) on dissipation of residues (decline curve), on human exposure to those residues, and on toxicity of the residues;
or (b) on determination of that time beyond which there are no detectable dislodgeable or irihalable residues remaining
in the worker environment. If the registrant has reason to believe that an end-use will not cause exposure to resi-
dues, a request for waiver from this data requirement should be submitted.
2/ Soil dissipation data are required only for uses where workers will be exposed directly to substantial quantities of
soil during their work, e.g., where hand harvesting will be performed.
3_/ Human-exposure monitoring data may be submitted, if the registrant wishes to use the "allowable exposure method" of
determining reentry intervals. The data submitted are limited to foliar .and soil dissipation studies, human
exposure (and reentry intervals) would be estimated from dislodgeable residues as explained in Subdivision K of the
Guidelines. If exposure studies are submitted, both dermal exposure and inhalation exposure nust be submitted.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement Composition
§158.145 Wildlife and Aquatic
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LDcn
~J\J
71-2 - Avian Dietary LC5o
71-3 - Wild Mammal Toxicity
^j. 71-4 - Avian Reproduction
O
IV)
71-5 - Simulated and Actual
Field Testing
- Mammals, and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LCso
Organisms
TGAI
TGAI
ETU
TGAI
TGAI
ETU
TEP
TGAI
TEP
(3.8 lb FC)
Does EPA Have Data
to Satisfy This
Use Requ i remen t ? ( Yes ,
Patterns No or Partially?)
I/
A,B,C,H,[F] Yes
I/ 2/
A,B,C,H,[F] No
A,B,C,H No
A,B No
A,B,C No
A,B,C No
A,B,C No
L/
A,B,C,H,[F] Yes
C No
Bibliographic
Citation
00080717^/
000360943/
000807163/
00097173
40118501
40118502
Must Additional
Data be
Submitted?
No
I/
Yes
v
Reserved
No
6/
Yes
I/
Reserved
z/
Reserved
No
8/
Yes
Time Frame
for
Submission
9 Months
18 Months
9 Months
9/
ETU
A,B,C
No
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data Requirement Composition
§158.145 Wildlife and Aquatic
72-2 - Acute LC5o
Freshwater
Invertebrates
72-3 - Acute LCso Estuarine
and Marine Organisms
- Fish
_^
CD
Oj - Shrimp
- Oyster
Organisms -
TGAI
TEP
(3.8 Ib FC)
ETU
TGAI
TEP
(3.8 Ib FC)
ETU
TGAI
TEP
(3.8 Ib FC)
ETU
TGAI
TEP
(3.8 Ib FC)
Use
Patterns
Continued
A,B,C,H,
C
A,C
C
C
C
C
C
C
C
C
Does EPA Have Data
to Satisfy This
Requirement? ( Yes ,
No or Partially?)
V
[F] Yes
No
No
No
No
No
No
No
No
No
No
Must Additional
Bibliographic Data be
Citation Submitted?
40118503 No
8/
Yes
I/ !!/
Reserved
Yes
Yes
l/io/
Reserved
Yes
Yes
9/ 10/
Reserved
Yes
Yes
Time Frame
for
Submission
9 Months
12 Months
12 Months
12 Months
12 Months
12 Months
12 Months
9/
EIU
No
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data
Requirement
Composition
§158.145 Wildlife and Aquatic Organisms
72-4
- Fish Early Life Stage
and
Does EPA Have Data
to Satisfy This Must Additional
Use Requirement? (Yes, Bibliographic Data be
Patterns No or Partially?) Citation Submitted?
- Continued
Invertebrate Life-Cycle
72-5
72-6
Fish
Invertebrate
(Freshwater and
Estuarine)
- Fish - Life-Cycle
Estuarine
Freshwater
- Aquatic Organism
TGAI
ETU
TGAI
ETU
TGAI
TGAI
TGAI
A,B,C
A,B,C
A,B,C
A,B,C
C
C
A,C
No
No
No
No
No
No
No
12/
Yes
w
Reserved
ll/
Yes
13/
Reserved
14/
Reserved
li/
Reserved
Yes
Time Frame
for
Submission
15 Months
15 Months
15 Months
Accumulation (Fish).
72-7 - Simulated or Actual
Field Testing
Aquatic Organisms
TEP
A,B,C
No
10/
Reserved
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
§158.145 Wildlife and Aquatic Organisms - Continued
V Required to support the manufacturing use product for reformulation into these end-use products.
2/ Only one species is required.
3/ The study must be cited in conjunction with the other similar studies in order to fulfill the requirement.
_4/ Only one species is required due to likelihood of repellancy.
5/ Pending the results of photolysis and hydrolysis studies there may be requirements for waterfowl and upland game
bird studies.
6/ All outdoor uses permit multiple applications before or during breeding season for birds.
T/ Pending results of avian reproduction studies on technical mancozeb and environmental fate data such as hydrolysis
and photolysis the study could be required to support such uses as apples, corn, cranberries, grapes and turf.
8/ Required to support the cranberry use.
9/ ETU is the primary degradate of mancozeb. The material is water soluble and is persistent in water beyond 4 days.
10/ Reserved pending results of environmental fate data such as hydrolysis, photolysis, aquatic field dissipation and
studies on technical mancozeb.
ll/ The daphnia EC^Q for mancozeb is 0.58 ppm and the estimated environmental concentrations for such sites as apples,
cranberries, potatoes, and grapes exceed l/100th of an invertebrate EC5Q.
12/ The rainbow trout LC5Q for mancozeb is 0.46 ppm and the estimated environmental concentrations for such sites as
apples, cranberries, potatoes, and grapes exceed l/100th of a fish LX^o-
13/ Reserved pending results of environmental fate data such as hydrolysis and photolysis and chronic invertebrate
life-cycle study.
jl_4/ May be required to support the cranberry and taro uses.
15/ May be required to support the cranberry and wildrice uses pending the results of partial chronic studies on
technical mancozeb.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Data
§158.
121-1
Requirement Composition
150 Plant Protection
- TARGET AREA PHYTOTOXICITY TEP
Does EPA Have Data
to Satisfy This
Use Requirement? (Yes,
Patterns No or Partially?)
C No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
V
No
NONTARGET AREA PHOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
TIER I
- Seed Germination/
Seedling Emergence TGAI
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER II
- Seed Germination/
Seedling Emergence TGAI
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER III
C No
C No
C No
C No
C No
C No
2/
No
2/
No
Yes
No~
2/
No
v
Reserved
124-1 - Terrestrial Field
124-2 - Aquatic Field
TEP
TEP
C
C
No
No
2/
No
Reserved
I/
_!/ Whether data are required is determined on a case-by-case basis, where phytotoxicity
issues may be involved.
2/ Use in aquatic sites does not require submission of terrestrial phytotoxicity data.
3/ Reserved pending results of Tier I.
4/ Reserved pending results of Tier II.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOP. MANCOZEB
Data Requirement
Compos it ion
Does EPA Have Data
to Satisfy This
Use Requirement? (Yes,
Patterns No or Partially?)
Must Additional Time Frame
Bibliographic Data be for
Citation Submitted? Submission
I/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honeybee acute
contact LD5Q TGAI
141-2 - Honey bee - toxicity
of residues on
foliage TEP
141-3 - Honey bee subacute
feeding study [Reserved]
^ 141-4 - Field testing for
^ pollinators TEP
"^ NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to [Reserved]
aquatic insects
142-2 - Aquatic insect
life cycle study [Reserved]
142-3 - Simulated or actual
field testing for 3/
aquatic insects [Reserved]
A,B,G,H
A,B,G,H
Yes
Yes
00018842
00001949
No
No
A,B,G,H
2/
No
No
v
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR MANCOZEB
Does EPA Have Data
to Satisfy This Must Additional Time Frame
Use Requirement? (Yes, Bibliographic Data be for
Data Requirement Composition Patterns No or Partially?) Citation Submitted? Submission
§158.155 Nontarget Insect
143-1 - NONTARGET INSECT TESTING -
thru PREDATORS AND PARASITES 3/
143-3 [Reserved]
I/ Reserved pending development of test methodology.
2/ As data from acute contact and residual studies indicate low toxicity to honeybees, no further testing is required.
3/ Reserved pending Agency decision as to whether the data requirement should be established.
O
CO
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANCOZEB (80% FORMULATION INTERMEDIATE)
Data Requirement
Composition
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of MP
Beginning Materials
and Manufacturing
Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to MP
Verify Certified Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
Does EPA Have Data
to Satisfy This Must Additional Time Frame
Requirement? (Yes, Bibliographic Data be for
No or Partially?)!/ Citation!/ Submitted? Submission
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
2/
Yes
3/
Yes
Yes
c
Yes~
(
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANCOZEB (80% FORMULATION INTERMEDIATE)
Does EPA Have Data
to Satisfy This Must Additional Time Frame
Requirement? (Yes, Bibliographic Data be for
Data Requirement Composition No or Partially?)!/ Citation!/ Submitted? Submission
§158.120 Product Chemistry
Physical and Chemical Characteristics
(Continued)
63-4
63-5
63-6
63-7
_ . 63-8
0 63-9
63-10
63-11
63-12
63-13
Other
- Odor
- Melting Point
- Boiling Point
- Density, Bulk Density, or
Specific Gravity
- Solubility
- Vapor Pressure
- Dissociation Constant
- Octanol/V/ater Partition
Coefficient
- pH
- Stability
Requirements:
TGAI
TGAI
TGAI
TGAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
PAI
TGAI
TGAI
N/A
N/Al/
N/A!/
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 6 Months
Yes 15 Months
64-1 - Submittal of samples
N/A
N/A
No
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANCOZEB (80% FORMULATION INTERMEDIATE)
§158.120 Product Chemistry (Continued)
V Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmltted for each pesticide. New requirements have been Introduced and previously submitted data
must be updated. Therefore, bibliographic citations for old data are not applicable.
_2/ Details of the manufacturing process, Including the relative amounts of beginning materials, a description of the
equipment used to produce the product, reaction conditions, the duration of each step of the process, and purifi-
cation procedures and quality control measures must be submitted.
3/ A discussion of each Impurity believed to be present at >^ 0.1% based on knowledge of the beginning materials, all
possible chemical reactions, and any contamination, must be submitted.
_V Five representative batches of the 80% FI must be reanalyzed for mancozeb per se_ using the specific method required
under 62-3 because Interfering (CS2~llberatlng) Impurities may be present.
5/ Based on the analyses of mancozeb per se using a specific method (see 62-1), new upper and lower limits for mancozeb
per £3e must be provided and certified, If different from those already provided. All nltrosamlnes must be identified
and quantified in six samples of each product; two samples of each must be analyzed shortly after production, 3
months after production and 6 months after production. A method sensitive to 1 ppm of N-nltroso contaminants must
be used. An upper limit must be provided (and certified) for all nitrosamines found. Certifications should be
submitted on EPA Form 8570 Rev. 2-85.
&/ A specific method must be submitted to differentiate between mancozeb per jje and interfering (CS2-liberating)
_» impurities which may be present.
7/ Not applicable since the product decomposes when heated.
F/ Not applicable since the product Is a solid at room temperature.
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING MANCOZEB
Does EPA Have Data
To Satisfy This
Use Requirement? (Yes, Bibliographic
Data Requirement Composition Patterns No or Partially) Citation
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral - Rat MP All Yes
81-2 - Acute Dermal MP All Yes
81-3 - Acute Inhalation - Rat MP All Yes
— .
IM 81-4 - Primary Eye MP All Yes
Irritation - Rabbit
81-5 - Primary Dermal MP All Yes
Irritation - Rabbit
00097182
00126511
00097182
00126511
00148229
00097182
00126511
00148229
00148230
00097182
00126511
00097182
00126511
00148229
Must Additional Time Frame
Date Be for.
Submitted? Submission
No
No
No
No
No
81-6 - Dermal Sensitization
Guinea Pig
MP
All
No
Yes
9 Months
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APPENDIX II
Labeling
113
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SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)J
Item 5. EPA ESTABLISHMENT NUMBER --The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
114
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SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations/ the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 ,to 30 14 point 10 point
over 30 18 point . 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i ) ]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and ill. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a.block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
115
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SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h)(2 ) (i ) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii ) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
116
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.1,0 (h) (l)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, ond
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will-be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
117
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SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review. "
116
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
vO 6A
6B
7
7A
7B
LABEL ELEMENT
Product narte
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds /gal Ion
statement
Front panel
precautionary
statements
Keep Out of Readi
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Bottom front
panel: or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or ,
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child.
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . . , "
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the .panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
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SUMMARY-7
ITEM
7C
7D
i
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others:
Grouped with
side panel
precaut ionary
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.
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
ro IOB
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling. "
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Chapter 1—Eavironmental Protection Agency
$162.10 Labeling requirements.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) Warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling. -
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
12?
-------
pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. If the immediate
container is enclosed within a wrapper or outside container
through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
123
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(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except'as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally,accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces." ;
124
-------
(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. .The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
125
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(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one, followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
126
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Hazard Indicators
Oral LD5Q
Inhalation LC
50
Derma! \JDfn
50
Eye effects
Skin effects
1
Up to and
Including
50 rog/kg
Up to and
Including
.2 mg/Mter
Up to and
Including
200 mg/kg
Corrosive;
cornea! opacity
not reversible
within 7 days
Corrosive
Toxic Ity (
II
From 50 thru
500 Big/kg
From .2 thru
2 mg/l Iter
From 200
thru 2000
Cornea! opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor1es
III
From 500 thru
5000 mg/kg
From 2 thru
20 mg/Mter
From 2,000 thru
20,000
No cornea! opacity;
Irritation
reversible
within 7 days
..Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 n»g/ liter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I* All
pesticide products meeting the criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
(B) Toxicity Category II.
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
All pesticide products meeting the
II shall bear on the front panel1'
All pesticide products meeting the
III shall bear on the front panel
All pesticide products meeting the
IV shall bear on the front panel
127
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(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out. of reach of
children." Only in cases where the'likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Above 5 to 10
Above 10 to 15
Above 15 to 30
Over 30
Points
Required
signal word,
all capitals
6
10
12
14
18
"Keep out
of reach of
Children"
6
6
8
10
12
128
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(2) Other required warnings and precautionary statements. The
warnings and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans.
and Domestic Animals," "Environmental Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxlclty
category
Precautionary statements by toxicIty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
IV . .
Fatal (poisonous) If swallowed (Inhaled or
absorbed through skin). Do not breathe
vapor Idust) or spray mist). Do not get
In eyes, on skin, or on clothing (Front
panel statement of practical treatment
required. I.
May be fatal If swallowed (Inhaled or
absorbed through the skin]. Do not breathe
vapors [dust or spray mist). Do not get In
eyes, on skin, or on clothing. (Appropriate
first aid statements required.).
Harmful If swallowed (Inhaled or absorbed
through the skin). Avoid breathing vapors
(dust or spray mist). Avoid contact with
skin (eyes or clothing!. [Appropriate
first aid statement required.!.
(No precautionary statements required.).
Corrosive, causes eye and skin damage lor
skin Irritation). Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful or fatal If swallowed.
[Appropriate first aid statement required.)
Causes eye [and skin) Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. [Appropriate first
aid statement required.!.
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or. skin with plenty of water. • Get
medical attention If Irritation persists.
(No precautionary statements required.).
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
129
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damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC$Q of 1 ppm or less, the statement
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, or
a subacute dietary LCsg of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams.
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on the
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve opening.
Flash point above 20*F and not over 80*F or If
the flame extension Is more than 18 In. long
at a distance of 6 In. from the flame.
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
130*F may cause bursting.
Flammable. Contents under pressure. Keep away
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to
temperatures above 130*F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame* Do not puncturfe or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURI ZED CONTAINERS
Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
130
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(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "Se^ directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(l_) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(_3) The product will not come into the hands of the general
public except after incorporation into finished products; and
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(JU The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(\) There is information readily available" to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes;
131
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(2^) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
(2.) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(4_) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use":
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crop's,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved]
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
132
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(F) Other pertinent information which the.Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j)(2).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General Classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s)classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in § 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the .front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other;
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as .amended at' 43 FR 5786, Feb. 9, 1978]
133
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture .or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
134
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged' in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
135
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or Toxicity
Category I or II on the basis of acute inhalation toxicity must
bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a vio-
lation of Federal Law. If these wastes cannot be disposed
of by use according to label instructions, contact your
State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional
Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 40 CFR
261, Subpart C for a hazardous waste must bear the following
pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office for
guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal state-
ment:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility." :
5. Products intended for domestic use only must bear the follow-
ing disposal statement; "Securely wrap original container in
several layers of newspaper and discard in trash."
136
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CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
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.
Triple rinse (or equivalent).Then dispose
of in a sanitary landfill or by other
approved state and local procedures
Glass containers
Fiber drums
with liners
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
reused1, dispose of in the same manner.
Paper and
plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.'
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
137
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APPENDIX III
Use Index
138
-------
REVISED ATTACHMENT
' To .
REREGISTRATION STANDARD
FOR
, MANCOZEB
APPENDIX III
EPA Compendium of Acceptable Uses
(Use Index)
6 October 198?
NOTE: Remove pages 139 through. 241 from the Rer-egistration
Standard for- MANCOZEB and insert the attached pages
- 138 -
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO*,
A COORD I NOTION PRODUCT OF MANGANESE IS'/., ZINC £%,
ETHYLENE BISDITHIOCARBAMATE &£%
TABLE OF CONTENTS
Site Name Page
TERRESTRIAL FOOD CROP .. ' . £
(Agricultural Crops) £
(Agr ic.ul'tural Seed Treatment) 17
TERRESTRIAL NONFOOD CROP 22
(Agricultural Crops) • ££
(Ornamental 'Plants and Forest Trees) £3
GREENHOUSE NONFOOD CROP 56
(Ornamental Plants and Forest Trees) 56
AQUATIC FOOD CROP 57
(Agricultural Crops) 57
African Violets £3
Anthuriurn £3
Apple ••-••..•• •••-.- .--.•• • . • 3
• Arborvitae •••:.. £3
Arizona Cypress £4
Asparagus . . 5
Asparagus (planting stock) . 5
.Aster £4
.Azalea ' '.''.-•' £4
Banana 5
Barley - 6
Barley (seed) 17
Begonia £5
Buckeye £5
. Buffaloberry ' •' '•'•'. -.-''. • . -£6-
........ Camel.]..! a.., ...;. ..-.-._..;. ./..••..;..:• ..„•-.•.::•.'...,.••:•.. .,•• ._••-•.-. ..v,-: ..•^.'•: : '• •• *.- .•;:-§^"-
;_":.r..""..'.CaipVif i'g'- \:. • "\ '.. '/ '.:.-''"";.. .V.'.'' •'-,'"' 'Vv'"''.'••••' .:.'.:';.;'".'''..;""..-. ."; •.''-•' . '•'• -5.".
Carnation £6
Carrot 5
Celery 7
Chrysanthemum £7
Cordyline £7
Corn (field)(seed) 17
Corn (hybrid seed production) 8
Corn, Field and/or Forage 8
Corn, Pop 8
Corn, Sweet 8
Cotton .9
Cotton (seed) 1.8
Crabapple 3
Cranberry 57
Cucumber 9
Dahlia £8
Dieffenbachia £8
Douglas-Fir £9
Dracaena £9
Eastern Redcedar £9
Issued: 1O-30-84 11-014504-i
139
-------
EPfl Compendium of ftcceptable Uses
ZINC ION ftND MftNGftNESE ETHYLENE BISDITHIOCftRBflMflTE 80%,
ft COORD I NOTION PRODUCT OF MONGftNESE 16%, ZINC £%,
.ETHYLENE BISDITHIOCflRBftMftTE 62%
TflBLE OF CONTENTS
Site Name _ Page
Elm 30
Epcot Display Crops 30
..Euonymus • 30
Fennel 10
Ficus . ... . 31
Firethorn 31
Flax (seed) 18
Flowering Crabapple 31
Flowering Dogwood 3£
Fuchsia 3£
Geranium 33
Gladiolus . 33
Grapes 10
Hawthorn .34
'•• Holly ••••••'-.••••• "';••'•' - 34
Hollyhock 35
Honeysuckle 35
Horsechestnut £5
Hydrangea • . 36
Iris • ' . 36
Japanese Aralia . 37
Japanese fiucuba .37
Juniper • 37
Ligustrurn . 38
Lilies ' 38
• Magnolia •.'••'-- •...'.' ' ... • • 39 •
.
--'- ....'••'"..•.,;-. "C \:'.-.;/. -v-.'';-,. . ...- '.-'. ', ;':. •;.'•:••• •:-•• ' • '• ''•••: :.•••"•.''.-•.• ' ••'-. -39 '.
Melons " ' ' 9
Mountainash 40
Mountain— laurel 40
Narcissus 40
Oak 41
Oats 6
Oats (seed) 19
Onion (directed seeded) 11
Onion (dry bulb) 11
Orchids (Dendrobiurn spp. ) 41
Ornamental Conifers (including Christmas trees) 4£
Ornamental Ferns 4£
Ornamental Flowering Plants 43
Ornamental Herbaceous Plants 43
Ornamental and/or Shade Trees 43
Ornamental Turf 43
Ornamental Woody Shrubs and Vines 43
Pachysandra 48
Pansies 49
Papaya IE-
Issued: 10-30-84 I I -01 4504- ii
140
-------
EPfi Compendium of ftcceptable Uses
ZINC ION flND MfiNGftNESE ETHYLENE BISDITHIOCflRBflMflTE 80'/4,
.ft COORDINATION PRODUCT OF MfiNGflNESE IS'/-, ZINC £'/.,
TflBLE OF CONTENTS
Site Name ' • Page
Peanuts 13
Peanuts (seed) 19
Pear . 6
Peonies 49
Peperqmia . . 50
' Phiiodendron . ' . 50
Photinia 50
Pineapple (propagation stock) 13
Poinsettia 51
Potato • • .14
Potato (seed pieces) 15
Quince . 3
Rhododendron Hybrids/Cultivars . £4
Rice (seed) ' • • ........ 20
•Rose •'••• •'• ' "'•••• •••••.-.. • 51
Rye . 6
Rye (seed) £0
Safflower (seed) • . £0
..Schefflera . 5£
. Skunkbush Sumac . • ' . •. 5£
Snapdragon . . 53
Sorghum (seed) £1
Squash (summer) . 9
Statice 53
Sugar Beet 15
Syngonium . .. • • • • . • " ' •- • • 53
...... . .. .. ..
fo'irna'tci' .•;'.?. '/.•'"• ;. • .-•/''.?''.'';''.'.. '•"••'.'.'''' ':''".' ''.:'•' '•'•. '/'•.-''••' .-.''/". .'• .''••'' '1.6'
Tomato '(seed) ' ' ' £1
Tulips 54
Venus Fly Trap 54
Viburnum 55
Walnut 55
Wheat 6
Wheat (seed) ££
White fish 55
Zinnia 56
Issued: 10-30-84 II-014504-iii
141
-------
EPA Compendium of Acceptable Uses
cO14504 ZINC ION AND MANGANESE ETHYLENE BI3DITHIOCARBAMATE SO*,
A COORDINATION PRODUCT OF MANGANESE 16X, ZINC £#,
ETHYLENE BISDITHIOCARBAMATE 6£'/.*
TYPE PESTICIDE; Fungicide, Insecticide
FORMULATIONS!
FI (SO'/.)
D (3. £'/., 3. £5'/., 3. 9'/., 4'/-, 4. 8'/., 5'/., 5. 6'/., 6'/., 6. 4'/., 7'/-,
G (3.9-/O
WP (IS'/., 405C, 48*, 60'/., 70*, 7£*, 74. 44'/., 75*, 80S)
WP/D (80*)
F1C .,.(.£. 85 Ib/gal.. or 30%, 3..48 Ib/gal. or. 32*, 4 Ib/gal or 37*)
GENERAL WARNINGS AND LIMITATIONS; Mancozeb is compatible with most
commonly used agricultural fungicides, insecticides, and growth
regulators. Consult spray compatibility charts or consult a State
Agricultural Extension Service prior to preparing tank mixes.
Precaut ionary Statement: Protective measures for home products:
Always spray with your back to the wind. Wear long-^sleeve shirt,
long pants and rubber gloves. Wash gloves thoroughly with soap and
water before removing. Change your clothes immediately after this
product'and launder separately from other laundry items before re-
use. Shower immediately after use.
For all agricultural products: After sprays have dried or dust
have settled or vapors have dispersed, as applicable, do not enter
or allow, entry i.nto treated areas until the £4—hour reentry inter—.
val has expired unless wearing the personal protective equipment
listed on the'label. Personal protective equipment for mixers,
loaders, applicators, and early reentry workers. Handle this pro-
duct only when wearing the following protective clothing and equip-"
rnent : a long—sleeve shirt and long pants or a coverall .that covers
all parts.of the body except the the head, hands, and feet; chemi-
cal, resistant gloves; shoes, socks,: and goggles or a face shield.
•.',-;.;.-:„>...:.•'•}':'..'. •Pur?-*.ri9: ^.i--**:n9:.. ^fld/v^01*^ *:n.S» •• .^•.
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE IS'/., ZINC £'/.,
ETHYLENE BISDITHIOCARBAMATE 62* ,
GENERAL WARNINGS AND LIMITATIONS;
-------
EPfl Compendium of flcceptable Uses
ZINC ION AND MONGftNESE ETHYLENE BISDITHIOCftRBflMftTE 80%,
ft COORDINATION PRODUCT OF MftNGftNESE IS'/., ZINC £•/.,
ETHYLENE BISDITHIOCftRBftMftTE 6£%
Site and Pest
Dosages and Tolerance, Use, Limitations
Formui at i on(s)
/040010ft
/0400£ftfl
/04003ftft
/04004flft
ftpple
Crabapple
Pear
Quince
7 ppm (apple)
10 pprn (crabapple, pear, .and
q u i nee)
ftpple - £1 day preharvest inter—
;yal in ftL, ftR, DE, Gft, IL, IN,
KS, KY, MD, MO, NJ, NC, OH, Pft,
SC, TN, Vfl, and Wv through 8.4
pounds per acre.
- 30 day preharvest intei—
val in states not listed above
through 8.4 pounds per acre.
Crabapple, pear, quince - 15 day
preharvest interval through 8.4
pounds per acre.
Pear - Postharvest application .
through 17.0 pounds per acre.
Do not graze livestock in or on
treated areas.
FIftDGftP
FIBFPCH
FIftLMCB
Bitter rot •
(Glornerel la)
Black rot
( Physalospora)
Brown rot of
fruit
(Monilinia)
0.7-1.7 lb/
100 gal
(70%, 75%,
80% WP)
F1C)
or
FJftFGBI
FEftJVflG
FCAFGflL
': zoth.yr i urn) . . ".
Gall rusts
(Gymnosporan-
g i urn )
Scab (Venturia)
Sooty blotch
(Gloeodes)
or
0.8-1.6 tbls
act ual*/gal
(80% WP)
or
CMftI]
1. 08-1.44
Ib/lOO gal
(7£'/. WP)
or
0.7 tbls
actual*/ gal
(70-/. WP)
Delayed dormant and foliar appli—
'cation. For scab, apply at green
tip or delayed dormant and repeat
at 7 to 14 day intervals. For
rusts, apply at blossom time and
repeat at 7 to 14 day intervals.
For other'diseases, apply at
, f-i r;st.. co.v.er... and ...repeat. .at, .7; .to , 1.4.
'day inter..val's..' For..'apples,. may .
be tank mixed with dinocap, thio-
phanate-methy 1, or triad irnefon.
For pears, may be tank mixed with"
dinocap or triadirnefon.
May be formulated with dinocap.
Issued: 10-30-84
11-014504-3
144
-------
EPft Cornpendi urn of Acceptable Uses
ZINC ION ftND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
A COORD I NOTION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 6£%
Site and Pest
.Dosages and Tolerance, -Use, Limitations
Formal at ion(s)
Apple cluster
(cont inued)
0. 6-0. 6£5
lb/100 gal
"(80% WP)
(3£%, 27%
F1C)
/0400300
IRAXALH
(pear)
Pear psy1 la
nymphs
1. 125-1.3 lb/
100 gal
(70%, 75%,
S0%: WP)
(3£%, 37%
F1C)
IMAI:
1.OS Ib/lOO
gal
WP)
't800-1,000
gal/AH
(70%, 75-/.
BO'/. WP)
(3£%, 37%
F1C)
CMAI3
1. 08-1.44 .
lb/100 gal
(7£% WP)
Delayed dormant and foliar appli-
cation. For apple only. Tank
mix with benornyl. flpply by
ground equipment at one—half inch
green tip. Repeat at 7 to 14 day
intervals, or as needed through
cover sprays. May be used with
spray oil.
Foliar application. Apply at
petal fall and repeat at 7 to 10
day intervals. [Registration.
Numbers 00035£-00341 and
0003S£-00398 have 14 to £8 day
intervals.] Effective control of
young nymphs can be obtained by
using £ to 3 consecutive sprays.
New growth should be protected.
Timing should coincide with the
initial appearance of pear psy1 la
nymphs. Consult a .State Agricul-
tural Extension Service for recorri-
mendat ions.
May be formulated with dinocap.
...;. pos,.tharyes..t f,O;l iar ...appl i.cat.ion.. •...
Cansul.t. a..,5tat.e. Agricurtural '. .'-.. ;
Extension Service for specific
timing recommendations.
May be formulated with dinocap.
Issued: 10-30-84
II-014504-4
145
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORD I NOT I ON PRODUCT OF MANGANESE 16'/., ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 6£'/.
Site and .Pest
Dosages and
For mil 1 at i on (;
Tolerance, Use, Limitations
/1600£AA
Asparagus
0.1 pprn (negligible residue)
Apply only on ferns after spears
have been harvested through 1.7
pounds per acre.
FJAAPEJ
Ru.st. (Puccinia) . 1. 5-1. 7 .lb/A Postharvest. foliar application.
(70/4, 75J4, • Apply when rust appears. Apply
8054 WP)
(32/4, 37'/4
F1C)
(3.£/4, 4. &'/•
D)
or
1.6 tbls
actual*/ gal
as long as disease persists - usu-
ally 4 applications at 10 day in-
tervals.
May be formulated with carbaryl.
(BO/. WP)
/16002DA
FIAXPAO.:..
1. 44-1.68
. lb/A
(4. 8'/. D)
Asparagus (planting stock)
. £r.own. . r,ot , ..... ;..
;;(Per>ici 1.1
0.1 pprn (negligible residue)
Dip treatment through 0.8'pound
per 10O. gallons.
:. 0. 7~9
-------
EPft Compendium of ftcceptable Uses
ZINC ION fiND MflNGftNESE ETHYLENE BISDITHIOCftRBftMftTE 80%,
ft COORD I NOTION PRODUCT OF MftNGflNESE 16%, ZINC £%,
ETHYLENE BISDITHIOCftRBftMftTE 6£*
Site and Pest
Dosages and
Forrm.ilat ion (s)
'olerance. Use, Lirnitat ions
/£806£ftfl
/£8064ftft
/£S065ftfl
Barley
Oats
Rye
Wheat
fract ions)
1 pprn (flours)
5 pprn (grain (s) )
£0 ppm (milled feed
£0 ppm (bran(s))
£5 pprn (straw (s))
£6 day preharvest interval
through £.6 pounds per acre.
Do not make more than 3 applica-
tions per season.
Do not graze livestock in treated
areas within £6 days after appli—
cat ion.
FCftlSBL
FCflGHftM
FCfiDSBL
FJflGPEJ
FMBSPEQ
/06019DO
:FI.BFFftj<>;.
FIBFDBB .
/ .14003flfl
Glume botch
(Septoria)
Helrninthospori-
urn spot blotch
Septoria leaf
blotch
Leaf rust
(Puccinia)
Tan spot
(Pyrenophora)
Caprifi q
1.5-1.7 Ib/P
(70/4, 75/4,
80% WP) '' '
(3£%, 37%
F1C)
(3. £'/. D)
1.. 0-£. 0 Ib/ft
(37% F1C)
Foliar application. fipply at on-
set of disease or when plants are
in ti1lering—to-joint ing stage.
Repeat at 7 to 10 day intervals.
For barley and wheat, may be tank
mixed with t r i ad i rne f on.
Foliar application. Tank mix.with
benomyl. fipply when disease ap-
pears or at flag leaf emergence.
Repeat at 14 day intervals.
N. F.
.. .;.... Erid.Qs.epsi s , .
-------
EPft Compendium of Acceptable Uses
ZINC ION ftND MftNGflNESE ETHYLENE BISDITHIOCftRBflMftTE SO'/.,
A COORDINATION PRODUCT OF MflNGflNESE 16%, ZINC £%,
ETHYLENE BISDITHIOCftRBAMftTE 6£%
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnu i at i on (s)
Carrot (continued)
0. 96-1.6
Ib/fl
(3. £% D)
... or
i.£-1.6'tbls
act ual*/gal
C435 sq.ft]
(60-/. WP)
CMfllD
1. £-1.68
(4. 8% D)
Ib/ft
Celery ;
FBflMCBM
FBftSSBL
Early blight
(Cercospora)
Late blight
(Septoria)
1.5-1,7 Ib/.fl
(70-/4, 75S,
80% WP)
(3£-/., 37%
, F1C)
or
5 ppm
14 day preharvest interval
through 1.7 pounds per acre.
Remove excess residues by strip-
ping, trimming, and washing.
Foliar application. Apply at
emergence. Repeat, at 3 to 5 day
intervals in the plant bed, and
at 7 day intervals in the field.
May be tank mixed at 1. 1£5 to 1.6
pounds per acre with benomyl,
.tjhiophan.at'e^methy.lj. ,or.,.rfix.e.d, ., .:.
'coppers..' '•.;...•'":' '• . '• •'•;• ' .'.. '• . '' '
or
1. 6 tbls
act ual*/gal
C435 sq. ft:
(80% WP)
Issued: 10-30-84
II-014504-7
148
-------
EPft Cornpendiurn of Acceptable Uses
ZINC ION FIND MftNGftNESE ETHYLENE BISDITHIOCftRBflMftTE SO'/,
ft COORD I NOT I ON PRODUCT OF MflNGftNESE 16%, ZINC £%,
ETHYLENE BISDITHIOCRRBRMOTE 62%
Site and Pest
Dosages and Tolerance, Use,
Formu1 at i on(s)
Limitations
/S8005BO Corn (hybrid seed production)
/28006Aft Corn, Field and/or Forage
/• 150040ft Corn, Pop
/ISOOSftft Corn, Sweet
0. 1 pprn (corn grain (except pop-
corn grain))
0. 5 pprn (popcorn grain; and fresh
corn including sweet corn
(kernels plus cob with
. husk removed))
5.6 ppm (corn fodder and forage)
Field corn, popcorn, and hybrid
seed production corn - 40 day pre-
harvest interval through 1.3
pounds per acre.
Popcorn and sweet corn - 7 day
preharvest interval through 1.3
pounds per acre; and, do not
graze or feed forage or fodder to
1ivestock.
FBftTHftM
FJflfiPEJ
/15005ftft
FBftHTftM
Northern and
southern corn
leaf bli ghts
(Helrnintho-
sporiurn spp. )
Common corn
rust
(Puccini a)
1. 125-1.3
Ib/fl
(7O%, 75%,
80% WP)
(32%, 37%
F1C)
or
1. 2 tbls
act ual*/gal
."' C435 sq.ft:
. (SO.%.. WP).... ':.' ..
(corn, sweet)
Northern and
southern corn
leaf blights
(Helmintho-
spor i urn . spp. )
Foliar application. fipply when
disease appears. Repeat at 4 to'
7 day intervals for sweet corn
and popcorn, and at 4 to 14 day
intervals for field corn and hy-
brid seed production corn dependr
ing upon the severity of infec-
t ion.
CMOI3 Foliar application. flpply when
0.02-0.04 lb/ disease appears. Repeat at 4 to
1,000 sq.ft 7 day intervals.
(4% D) Formulated with carbaryl.
or
(4.8% D)
Corn. Field and/or Forage
See Corn (hybrid seed production)
cluster.
Corn, Pop
See Corn (hybrid seed production)
cluster.
Issued: 10-30-84
II-014504-8
149
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCftRBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE 1654, ZINC 2/4,
ETHYLENE BISDITHIOCARBAMATE 6254
/28007AA
Site and Pest
Cotton
Dosages and Tolerance, Use, Limitations
Formu1at i on(s) • . '
0.5 ppm (cottonseed)
Do not apply after bolls are open
through 1.7 pounds per acre.
Do not graze livestock in treated
areas or feed gin trash to liver
stock.
FJAGPEJ
Rust (Puccini a)
/10010AA
/10001Aft
/I0013Aft
FBATAAX
FAAACDP
FFABPEA..
:.; . . •*• •- •. :
FBftQMCO
FMBCCBM
FEAJCCV
Crabapple
•Cucumber
Melons
Squash (summer)
Alternarie leaf
blight
Anthracnose
(Col letotri-
ohurn)
0.87-1.7 Ib/A
(7054, 7554,
80% WP)
(32/4, 37%
F1C)
or
1.44-1.6 Ib/A
(.3. £56 D)
.. •'. .CPseucfp.per.isn.O'-.
spora)
Gurnrny stern
blight (Myco-
sphaerel la)
Leaf spot
( Cer cospora )
Scab
(Cladosporium)
1. 5-2. 5 Ib/A
(70*, 7554,
QO% WP)
(3£%, 37/4
•FIG) . . • -•
... .or •..-,...... .,
Use Limited to the southwestern
states.
Foliar application. Apply when
rust appears. Repeat at 10 to 14
day intervals.
(3.254, 4. 8*
5. 654, B% D)
or
1.2-2. 4 tbls
actual*/gal
C435 sq.ft]
(8054 WP)
CMAI3
0.72-1.8 Ib/ft
(4854, 7254 WP)
or
0.96-2.4 Ib/A
(3.2/4, 4.854,
6* D)
or
See Apple cluster.
4 ppm
5 day preharvest interval through
2. 5. pounds per acre.
Foliar application. Apply at'
2-leaf stage. Repeat at 5 to 7
day intervals. Apply to both
upper and lower leaf surfaces.
May be tank mixed with:dinocap,
. -c.ap.t-af ol,... or: .beppm..y 1.....' •.. . . ; , • ...
,.May .'be. .fqrmul.aited. with dinocap;.:
carbaryl; rnalathion; rnetalaxyl;
or dicofol, carbaryl, and sulfur
Issued: 10-30-84
II-014504-9
150
-------
EPA Compendi urn of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 6£%
Site and Pest
Dosages and Tolerance, Use, Limitations
Formu1at i on < s)
Cucumber cluster (continued)
0. 1£8 oz/100
ft of row
(3. £7C D)
..... ... . or .
" ' 6. 7 tbls
act ua I*/ gal
(70% WP)
/£8OO8AA
Fennel
FBAMCBM
FBASAAX
Early blight
(Cercospora)
Late blight
(Alternaria)
1.5-1.7 Ib/A
(7054, 75'/.,
SO'/. WP)
(32%, 37%
F1C)
1O ppm
7 day preharvest interval through
1.7 pounds per acre.
Remove excess residues by strip-
ping, trimming, and washing.
Foliar application. ftpply at
emergence. Repeat at 3 to 5 day
intervals in the plant bed, and
at 7 day intervals in the .field.
/01014AA
Grapes
FJBFGBG
FIARQBB
FRAMCEY
FFABPCV
Black rot
(Guignardia)
Bunch rot
Dead arm
(Crypt osporel-
la)
Downy miIdew
(Plasrnopara)
1.0-3.4 Ib/ft
(70%, 75%,
80% WP)
(3£%, 37%
F1C)
(3. £%, 4.8%,
8% D)
or
l.£-3.£ tbls
actuaI*/gal
(80% WP)
or
7 ppm
£8 ppm (in raisins)
In CA, do not apply after fruit
set through 3. 4 pounds per acre.
In areas other than CA - 66 'day
preharvest interval . through.. ,3. 4 .
' 'r- .Acre. . .; ,. • . .-.•.•••,:.-.- ',--,x- -'..,• :•
Delayed dormant and foliar appli-
cation. Apply when shoots are
0.5 to 1.5 inches long, 3 to 5
inches long, and 8 to 1O inches
long. Continue at 10 to 14 day
intervals. May be tank mixed
with dinocap, benomyl, or triadi-
rnefon.
May be formulated with dinocap.
Issued: 10-30-84
11-014504-10
151
-------
EPft Compendium of ftcceptable Uses
ZINC ION ftND MP-NGftNESE ETHYLENE BISDITHIOCftRBAMATE BO'/.,
fl COORD I NOTION PRODUCT OF MftNGflNESE 16'/., ZINC £•/.,
ETHYLENE BISDITHIOCftRBftMftTE 6£'/.
Site and Pest
Dosages and Tolerance, Use, Limitat ions
Formulation(s)
Grapes (continued)
FLftNUflG
FFfiBPflU
FIBQBfiW
FCfiEflftX
CMftID
1. 08-2.88
Ib/ft
<.7£*. WP) . ,
or
0.7 tbls
act ual*/gal
(70-/. WP)
Melons
Oats
Oniorr (direct seeded)
Onion smut
. (Urocystis)
.Orison.-, .(.d-'r-y .'.•buTb).
Botrytis leaf
blight (blast)
Downy mildew
(Peronospora)
Neck rot
(Botrytis)
Purple blotch
(filternaria)
£. 33-£. 4
lb/100
gal/ft
(70*, 75'/.,
SO'/. WP)
(3£'/., 37%
• FIG) ^
1.57-£. 44
Ib/fl
(70%, 75%,
SO'/. WP)
(3£'/., 37%
F1C)
or
1. 68-1.96
Ib/A
(4.8-/., 5. 6
D)
or
See Cucumber cluster.
See Barley cluster.
0. 5 ppm
fit-piant ing furrow drench through
£.4 pounds per acre (£9,000
linear feet of row).
Soil application. ftpply as a fur-
row drench at planting.
7 day preharvest interval through
£.44 pounds per acre.
Do not allow spray or dust to con-
tact bulbs after lifting from
soil. Do not. apply to exposed
bulbs.
Foliar application. ftpply on a
protective schedule beginning
when diseases are reported in
area. Repeat at 7 day intervals
throughout the season.
May be formulated with rnetalaxyl.
Issued: 10-30-84
11-014504-11
152
-------
EPft Compendium of flcceptafale Uses
ZINC ION ftND MftNGftNESE ETHYLENE BISDITHIOCftRBflMflTE SO'/..
A COORDINATION PRODUCT OF MftNGftNESE 16'/., ZINC 2%,
ETHYLENE BISDITHIOCftRBftMOTE 62*
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnulat ion (s)
Onion (dry bulb) (continued)
1. 6-2. 4 tbls
actuaI*/gal
C435 sq.ft]
....... . (80-/..WP)
CMflID
0. 72-0. 96
Ib/fi
-/. WP)
Papaya
FIBFPCN
ftnthracnose
(G1 orner e 11 a)'
Phytophthora
fruit rot
I'. 5-2. 1 Ib/ft
BO'/. WP)
(32'/., 37'/.
F1C)
or
1.6-1.92 Ib/fi
10 pprn whole fruit, with no
residue present in the edible
pulp after the peel is removed
and discarded. •
No preharvest interval through
2.1 pounds per acre.
Foliar application. ftpply at
flowering. Repeat at 7 to 14 day
intervals. ftpply to crown, blos-
som area, central column, and
developing fruit. Odd a suitable
spreader—st icker.
or
act ual*/gal
(8054 WP)
Issued: 10-30-84
11-014504-12
153
-------
EPA Cornpendi urn of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
ft COORD I NOT I ON PRODUCT OF MANGANESE 16%, ZINC 2%,
. ETHYLENE BISDITHIOCARBAMATE 62%
Site and Pest
Dosages arid Tolerance, Use, Limitations
Forrnuiat ion (s)
/SBC150ft
Peanuts
0.5 ppm
65.0 ppm (vine hay)
14 day preharvest interval
through 1.2 pounds per acre.
No preharvest interval through
1.7.pounds .per acre, and do not
feed treated vines to livestock.
Tank mix — Do not graze or feed
treated vines, hay or hulls to
1 i vestock.
FMBCCBM
FJftGPEJ.
Leaf spot
(Cercospora)
Rust (Puccinia)
0.7-1.7 Ib/A
(70%, 75%,
BO'/. WP)
(32%, 3754
F1C)
<3.£%, 4%,
4. 8% D)
CMAI]
0. 96-1.5 Ib/A
(4. 8%, 5% D)
Foliar application. Apply when
disease first appears, or is
first reported in the area. Re-
peat at 10 to 14 day intervals,
or 7 day intervals during humid
weather. May be tank mixed with
thiophanate-niethyl.
May-be formulated with carbaryl.
FMBCCBM
FJAGPEJ
FCAJACC
Leaf spot
(Cercospora) (70%, 75%,
Rust (Puccinia) 8O% WP)
Web blotch (32%, 37%'
... Xflsc.oc.hyta.).. .. ,.. 'F.1C>- . ,. .
Pear
0.7-1.3 Ib/A Foliar application. Tank mix
with benomyl. Apply 35 to 4O
days after planting, or when dis-
ease first appears. • Repeat at 10
to, 14 ..day. ..'intervals .for Cerco-
.;. • spora.... .7 £ o . 10 d ay.... i n't e.r.ya.l"s for
rust, and at 7 to 14 day intei—
vals for web blotch. Spray oil
may be added.
See Apple cluster.
/06013DO
FIBIPCN
Pineapple (propagation stock) N. F.
Phytophthora £.52-2.7 lb/
heart rot of 1O gal
sterns and buds (70%, 75/. WP)
(32%, 37%
F1C)
Preplant dip. Stir suspension
frequently. Up to 10O gallons of
suspension should be used for the
treatment of planting material
for 1 acre depending upon the
size and cleanliness of plant
stock. Replace suspension when
two—thirds of the volume has be-
come discolored by soil.
Issued: 10-30-84
11-014504-13
154
-------
EPA Compendium of Acceptable Uses
\
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80*,
A COORD I NOTION PRODUCT OF MANGANESE 16*, ZINC £*,
ETHYLENE BISDITHIQCARBAMATE 6£*
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrm.il at ion (s)
/140130ft
FBAMAAX
FBASPCN
Potato
Early blight
(Alternaria)
'Late' blight' ' '"'
(Phytophthora)
0.7-1.7 Ib/A
(70*,. .75*,.
80* WP)
(32*, 37*
F1C)
(3. £*, 4. 8*,
5.6*, 8* D>
or
0.8-1.6 tbls
actual*/gal
C435 sq.ft]
(80* WP)'
or
0.78-1.68
Ib/ft
(3. £*., 3. 9*,
'4*,' 4.8*,
6* D)
(40* WP)
or
0. 128 oz/100
ft of row
<3. £* D) ' .
'#1..'/•••••'•:'
v; '(Phytophthora) 0. 7£-0. 96
•Ib/ft
; (48* WP)
1.0 pprn (interim)
No preharvest interval through
1.7 pounds per acre.
Foliar application. ftpply when
plants are 4 to 6 inches high.
Repeat at 7 to 10 day intervals.
Begin at low rate
plants grow. May
with triphenyltin
May be formulated
chlor; carbaryl;
and increase as
be tank mixed
hydroxide.
with rnethoxy-
rna lathi on ; sul-
fur; or
sulfur.
dicofol, carbaryl, and
.'Foliar appl.icat ion.'. •• May.-be . .tank
mixed with rnancozeb or rnaneb
(0.64 pound a. i. per acre) for
supplemental control of early
blight.
Formulated with rnetalaxyl.
Issued: 10-30-84
11-014504-14
155
-------
EPA Compendium'of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE 16'/., ZINC £'/.,
.ETHYLENE BISDITHIOCARBAMATE 6£*
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnu 1 at i on ( s)
/14013AA
Pot at o (seed pieces)
FKABFAK
FEAJSDY
Fusarium seed
piece decay
Scab
(St rept orny ces)
0..93-1. 05
50 gal
(70-/-, 75'/.,
SO'/. HP)
(SO'/- WP/D)
F1C)
or'' v '•' "
0.04-0.084
lb/100 lb
seed pieces
(4.8-/., 5. 6/.,
6*, 6. 4'/., '
7'/., 8'/. D)
1.0 ppm (interim)
Dip treatment through 1.05 pound
per 50 gallons; or dust treatment
thr.ough 0.084 pound per 100
pounds seed pieces.
Do.not use treated seed pieces
for food or feed purposes.
lb/ Seed piece treatment. Dip or
thoroughly dust whole or cut seed
pieces. Plant as soon as possi-
ble after treatment. If dipped
seed pieces are to be held before
planting, spread out to dry in a
cool place. Seed treatment with
"dusts may be held for a week or
longer at cool temperatures and
high relative humidity to aid
suberi zat ion. • .
Quince
/£566£AA '
Squash (s.ummer)
Sugar 'Beet
FMBCCBM
Leaf spot
(Cercospora)
1.1S5-S.44
Ib/A
(SO-/. WP>
(3£'/., 37-/.
F1C)
(4.8-/. D)
See Apple cluster.
See Barley cluster.
See.. Cuc.urnber cluster. ,. .. . . .
£ pprn
65 pprn (tops)
14 day preharvest interval
through £.44 pounds per acre.
Do not feed treated tops to
livestock.
Foliar application. Apply when
disease first threatens. Repeat
at 7 to 1O day intervals as need-
ed. May be tank mixed with thia-
bendazole, triphenyltin hydrox-
ide, benornyl, or thiophanate-meth-
Issued: 10-30-84
11-014504-15
156
-------
EPA Cornpendiurn of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
A COORDINATION PRODUCT OF MflNGflNESE !&•/., ZINC £'/.,
ETHYLENE BISDITHIOCARBAMATE 6£'/.
Sits and Pest
Dosages and Tolerance, Use, Limitations
Forrnu i at i on (s)
/1 100500
FBAMAAX
FMAXSDG
FHACBAW
FBASPCN
FMAAXA.A.
FBASPCN
Tomato
Anthracnose
(Glornerel la)
Early b'l i'gh't
(Alternaria)
Gray leaf spot
(Sternphy 1 i urn)
Gray mold
(Botrytis)
Late blight
(Phytophthora)
0. 96-£.5 Ib/A
.(SO* WP)
(3£54,' 37* '••"•
F1C)
or
0. 96-£. 4 Ib/A
(ti• c!%7 cj• o%
D)
. or
1. £-£'. 4 tbls
actuaI*/gal
C435 sq.ftD-
(30% WP)
CMAI3
1.!£-£.4 Ib/O
(3. £%,' 4%,
4. 8%, 654 D)
or
0. 1£8 oz/100
ft of row
(3. £'/-D) .
4 ppm
5 day preharvest interval through
£.5 pounds per acre.
Foliar application. Apply when
seedlings emerge or when trans-
plants are set in the field. Re-
peat at 7 day intervals. May be
tank mixed with anilazine or beno-
rny 1.
May be formulated with carbaryl;
rnalathion; or dicofol, carbaryl
and sulfur.
.. Baqt.eria.l spot, . 1.125-1.3 lb/ Fol.iar. appl icat.i.on. .Tank mix ..
•:'..'\ Ix^arii.hprnonas^) '-'! .^"iOO "ga'iy.A;;?.. wi:t.h. basi.c' CQpper..s.al.f a.te -or. . '.
." ' / (70*. 75'/. other 'fixed coobers. Aoolv whe>
WP)
(3£*, 37'/4
F1C)
Late blight CMAID
(Phytophthora) 0.7£-0.96
Ib/A
<4S* WP)
Wheat
other 'fixed coppers. Apply when
seedlings emerge. Repeat at 3 to
4 day; intervaIs.
Foliar application. May be tank
mixed at low rate with mancozeb
or maneb (1.6 pounds a. i. per
acre).
Formulated with rnetalaxyl.
See Barley cluster.
Issued: 1O-30-S4
11-014504-16
157
-------
EPO Compendium of Acceptable Uses
ZINC ION flND MftNGftNESE ETHYLENE BISDITHIOCftRBftMftTE 80%,
ft COORDINftTION PRODUCT OF MftNGftNESE 16%, ZINC 2%,
ETHYLENE BISDITHIOCftRBftMftTE 62%
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnulat ion (s)
(agricultural Seed Treatment)
General Warnings and Limitations; Do not use treated seed for
food, feed or oil purposes. The Federal Seed ftct requires that
seed treated with a pesticide must contain a dye which imparts an
unnatural color to the seed if the seed is intended to be moved
in interstate commerce. Seeds to be treated should be cleaned
and well cured prior to treatment. ftpply to dry seed with conven-
tional dry, slurry, or rnist seed treating equipment or as a
planter-box application. Dust or wet table powder formulations
may -be applied dry or as a slurry except as noted.
/280630ft
FLOEUflL
FKflftQBB
FLftWUftL
FKflLQBB
Barley (seed)
Covered smut
(Ust ilago)
Darnping-of f
False loose
srnut
(Ustilago)
Seedling •
blights and
seed decay
l.O-l. 61
oz/bu
(8% D)
(70%, 75%,
80% WP)
(80% WP/D)
'"'-'•/ F1C)
or
2. 1-3. 375
oz/100 Ib
(70%, 75%,
80% WP)
or
1.,85-3.,35.
37%
32%,
F1C)
N. F.
Seed treatment,
/28006P,ft
FKftfiQBB
FKftBQBB
FKftFDBB
Corn (field) (seed)
Damping—off
Seed rots
Seedling
blights
Issued: 10-30-84
1. 15-2.4
oz/bu
(8% D)
(70%, 75%,
80% WP)
(80% WP/D)
(37% F1C)
or
2. 1-4. 35
oz/100 Ib
(70%, 75%,
80% WP)
or
1.85-4. 3 oz/
100 Ib
(30%, 32%,
37% F1C)
11-014504-17
N. F.
Seed treatment.
158
-------
/asoo7AA
FKAAQBB
FKAFQBB
/£8009AA
FKAAQBB
FKALQBB
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE BO'/.,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 6£%
Site and Pest
Cot t on (seed)
Damping—off
Seed 1 ing
blights
Flax (seed)
Darnping-of f
Seed 1 ing
blights and
seed decay
Dosages and ; o 1 erancg. Use, '., i rn i t at i ons
Formal at ion(s)
N. F,
2. 1-2.55 oz/ Seed treatment. Apply £. 1 to
100 Ib
or
4.£-4.8 oz/
; 100 Ib
(8% D>
(70%, 75'/.,
BO'/. WP)
(SO'/. WP/D)
(30%, 3£%,
37% F1C)
1. 575-3. ££
oz/bu
(B% D)
(70%, 75%,
80% WP)
(80% WP/D)
(37% F1C)
or
£. 85-5. 76
oz/100 Ib
(70%, 75%,
ap%.WP).
£. 53-5. 65'oz/ -
100 Ib
(30%, 3£%,
37% F1C)
£.55 ounces of acid delinted
seed. Apply 4. £ to 4.8 ounces to
reginned seed.
N. F.
Seed treatment. When the dust is
used as a slurry, apply 3.£ ounc-
es per bushel.
Issued: 10-30-84
11-014504-18
159
-------
EPfl Compendium of ftcceptabie Uses
ZINC ION flND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
ft COORDINATION PRODUCT OF MANGANESE 16'/-, ZINC £•/.,
ETHYLENE BISDITHIOCARBAMATE .££%
Site and Pest
Dosages and iolerance. Use, •'._::.rni tat ions
F o r rn u 1 a t i o n ( s)
/£806200
FLflEUftL
FKflftQBB
FLflWUftL
FKftLQBB
Oats (seed)
Covered smut
(Ustilago)
Darnping-of f
Loose smut
(Ustilago)
Seed 1 ing
bli ghts and
seed decay
1.0-1. 61
'oz/bu
(&'/. D)
(70%, 75%,
'80% WP)
(80% WP/D)
(37% F1C)
or
3. £-5. 04 o
100 Ib
(70'/., 75/-,
80 J4 WP)
or
N.F.
Seed treatment.
100 Ib
/£8015ftft
FKftfiQBB
FKfiFQBB
FKftBQBB
Peanuts (seed)
Damping—off
Seedling
bl i ghts
Seedling rots
1. 575-3. 2£5-
os/bu.
D)
BO'/. WP)
(SO'/. WP/D)
or
6.37-12.81
os/100 Ib
N.F. • •
Seed treatment. Apply to shelled
peanuts.
SO'/. WP)
or
1.45-1.85
oz/bu
or
4. 65-12. 8 os'/
100 Ib
(3£'/-, 37'/..
F1C)
Issued: 10-30-84
11-014504-19
160
-------
EPA Cornpendiurn of Acceptable Uses
/2807£AA
FKAFADD
/£S064RA
FLATTAQ '
FLAEUAL
FKALQBB
/£8076AA
FJAAPEJ
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/-,
A COORDINATION PRODUCT OF MANGANESE IS'/., ZINC £%,
ETHYLENE BISDITHIOCARBAMATE G£%
Site and Pest
R i ce (seed)
Seedling
blight/rot
(Achlya)
Use, L 1 rn i t at i cms
Dosages and I o I-erance,
Forrnu 1 at i on ( s )
N.F.
1.39-3.35 Seed treatment. Apply before,
oz/100 Ib during, or after soaking in
or water.
£.0-4.£ Ib/ST
(8% D)
(70%, 75'/.,
SO'/. WP)
(SO'/. WP/D)
(30'/., 3£'/,
37'/. F1C)
Rye (seed)
Bunt (Til-let ia) : I. 0-1.:61
N.F.
Seed 'treatment.
Covered srnut
(Ust ilago)
Seed 1 ing
blights and
seed decay
Safflower (seed)
Rust (Puccinia
earthami)
oz/bu
80% WP)
"(80% WP/D)
(37% FlC)
or
1.82-2. B8
oz/100 Ib
(70%, 75%,
8O% WP)
. or
3. £". ozV-bu.
'
or
1. 67-£. 85 oz/
100 Ib
(30%, 3£%,
37% FlC)
1.43-1.7 oz/
100 Ib
(70%, 75%,
80% WP)
(8O% WP/D)
(30%, 3£%,
37% FlC)
N.F.
Seed treatment.
Issued: 10-30-84
11-014504-20
161
-------
/280.19AA
FLAMSCC
FKAAQBB
FKAFQBB
/11005AA
FKAAQBB
FKABQAB
EPACompendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORD I NOT I ON PRODUCT OF MANGANESE IS'/:, ZINC £•/.,
ETHYLENE BISDITHIQCARBAMATE 62*
Site and Pest
Sorghum (seed)
Dosages and Tolerance, Use, Limitations
Forrnu 1 at i on ( s) .
N. F.
Covered kernel 1.15-2.4
smut (Sphace- oz/bu
lotheca)
Damping-off
Seed 1 i rig
bl ights
. D)
(70%,
BO'/. WP)
(80% WP/D)
(3£'/., 37'/.
F1C)
or
2. 16-4. 0 oz/
100 Ib
SO'/. WP)
or • ' ' ' "
£. 1-3. 6 oz/
100 Ib
Tomato (seed)
Darnping-of f
Seed rot
37-/-
5. 63-6. 75
os/I00 Ib
FKftFQBB
(bacteria and/ (&% D)
or fungi)- (70/4, 75'/.,
..? .-,. .v .Seed.^ ing . ;...... . ...SO* . WP). :• .-..,
Seed treatment.
N.F.
Seed treatment. Apply only as a
siurry.
37'/. F1C)
Issued: 1O-30-84
11-014504-21
162
-------
EPfl Compendium of Occeptable Uses
ZINC ION OND MONGONESE ETHYLENE BISDITHIOCORBftMOTE 80%,
ft COORDINOTION PRODUCT OF MONGONESE 16%, ZINC 2%,
ETHYLENE BISDITHIOCORBOMOTE 62%
/280650ft
FLOTTflQ
FKOLQBB
Site and Pest
Wheat (seed)
Common bunt
(Tilletia)
Seedling
bli ghts and.
seed decay
Dosages and iolerance. Use,
Formalat ion(s)
ion?
1. 0-1. 61
oz/bu
(8% D)
(70%, 7554,
80% WP)
(80% WP/D)
(37'/. F1C)
or
1. 7£5-£. 66
02 / 100 Ib
BO'/. WP)
or
l;;'53^£::'e»: "' "
oz/100 Ib
(30%, 3£/4,
37/4 F1C)
N.F.
Seed treatment.
/260030ft
TERRESTRIAL NONFOOD CROP
(flqricultural Crops)
Tobacco
FFABPftU
N.F.
flnthracnose.. . . p. .4, .lb/10.0 .ho.l iar. application .-in., plant, bed..
chum)
B1ue mold
(downy mildew)
(Peronospora)
or size of a dirrie or when blue' mold
0.012-0.02 appears. Repeat at 3 to 14 day
lb/100 sq.yd intervals through transplanting.
plant bed
C3-5 galD .
(70%, 75% WP)
(37% F1C)
Blue mold 0.8—1.3 Ib/ Foliar application. Opply in
(downy mildew) 100 gal . field when b 1 ue rno 1 d is reported
(Peronospora) (70%, 75% WP) in the. area. Repeat at 3 to 7
(37% F1C) day intervals.
Issued: 10-30-84
11-014504-22
163
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE BO'/.,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £'/.,
ETHYLENE BISDITHIOCARBAMATE &£"/.
Site and Pest
Dosages and Tolerance, Use, Limit at-ions
Forrnulat ion (s)
(Ornamental Plants and Forest Trees)
General Warnings and Limitations; Unless specified otherwise, ap-
ply when plants are well leafed out or at first sign of disease
in a full coverage spray at 7 to 10 day intervals throughout sea-
son; or, consult a State Agricultural Cooperative Extension Ser-
vice for recommendations. A suitable spreader-sticker may be add-
ed. Do not apply when air temperatures are expected to reach or
exceed 30 F (3£.£ C).
/3101£AA African Violets
FBAPBAW Botrytis blight 1.1£5-1.££5
lb/100 gal
(70-/-, 75V-,
• • • • ••- ••-. .-••-. ••••'••••"••• -• •;:•••'-•* aov. WP) •"
(37/. F1C)
CMAI]
1. 08 .lb/100
. ' '•' 'gal''
(72% WP)
Foliar application.
May be formulated with dinocap.
/310£1AA
FAAACDP
Anthur i urn
/350£1AA
FBAECBM
Spadix rot
(Anthracnose)
,.. ,. ._. (Col letQtri-... . (70>, JS;^ .
j'J;/:' J'ch'Oinr). .?•'."•''•"• =;/'.''";'•••'• • 80%'-W'P).''.!'.v/;
CMAI3
1.08 lb/100
gal
(7£'/. WP)
Arborvitae
Cercospora
blight
1.1£5—1.££5 Foliar application
lb/100"gal May be formulated with dinocap..
1.1£5-1.££5
lb/100 gal
SO'/. WP)
(37* F1C)
CMAID
1.08 lb/100
gal
<7£'/. WP)
Foliar application.
May be formulated with dinocap.
Issued: 10-30-84
11-014504-23
164
-------
tPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
ft COORDINATION PRODUCT OF MANGANESE 16%, ZINC £#,
ETHYLENE BISDITHIOCARBAMATE 6£%
/35£64AA
PBAECBM
FDAAMCD
Site and Pest
Arizona Cypress
Dosages and Tolerance, Use, Limitations
Forrnuiat ion (s)
Cercospora twig 1.1£5—1.££5
blight
Monochaet ia
canker
1 b7100 gal
(70%, 75%,
80% WP)
\37% F1C)
CMAI]
1.08 lb/100
gal
(?£•/• WP)
Foliar application.
May be formulated with dinocap.
/310£6AA
FJAAPEJ
Aster
:Rust ('Puccinia) 1. IS'S-^i. 2£5
lb/100 gal
(70%, 75%,
SO'/. WP)
(37% F1C)
CMftn
1.08 lb/100
gal
"'• Foliar 'application; '
May be formulated with dinocap.
/340££AA
/ 34036 A A
flzalea
Came Ilia . . r, ... ......
' RhododeWdp'ori '.M'ybrids/Cu'1% i;v'ars.
FIftftCFO
FMBCCBM
FMBCDCB
PBftDOAV
FBftDSAQ
FDACPCN
Cy1indrocladium
rot (azalea)
Leaf spot
(Cercospora)
(rhododendron)
Leaf spot
(Discosia)
(rhododendron)
Petal blight
(Ovulinia)
(azalea and
rhododendron)
Petal blight
(Sclerotinia)
(cameIlia)
Phytophthora
d ieback
(azalea)
1. 125-1. ££5
lb/100 gal
or
1. £ tbls
actual*/gal
(70-/., 75%,
BO% WP)
(37% F1C)
CMftID
0.6-1.£ lb/
100 gal
(40%, 60%,
72% WP)
or
1.4 Ib/A
D)
or
Foliar and soil application. Ap-
ply £ to 3 times per week while
flowers are opening. Apply to
flowers and ground under bushes
thoroughly.
May be formulated with dinocap;
carbaryl; or th iophanate-rnethy 1.
Issued: 1O-3O-84
II-014504-£4
165
-------
/31034AA
FBAPBAW
EPft Corn bend i urn of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE G£%
Site and Pest
/35429AA
/35017AA
FCADGBG
Dosages and Tolerance, Use, Limitations
Forrnu iat ion ( s)
Azalea cluster (continued)
0. 47-O. 7 oz/
5 gal
(70% WP)
Begonia
Botrytis blight. 1. 125—1. ££5 hollar application.
lb/100 gai
(70%, 75%,
80% WP)
(37% F1C)
CMftH
b.g ib/ioo
gal
(60% WP)
or
1.08 lb/100
gal
(72% WP)
May be formulated with dinocap;
or th iophanate-rnethy 1.
Buckeye
Horsechestnut
Leaf blotch 1.1'25-1.££5 Foliar application.
. ,.....• .(Gui.gnard.ia).. .gal , ,. ... May. be. forrn.ula:ted .with..dinocap.
(Alternaria) 80% WP) ' " ' ' ' '.•••'
(37% F1C)
1.08 lb/100
gal
(7£% WP)
Issued: 10-30-84
II-014504-£5
166
-------
EPfl Compendium of ficceptable Uses
ZINC IQN'OND MflNGflNESE ETHYLENE BisoiTHiocftRBfiMftTE so-/.,
fl COORDINATION PRODUCT CDF MftNGftNESE 16*, ZINC 2*,
ETHYLENE BISDITHIOCORBfiMftTE 62*
Site and Pest
Dosages and Tolerance, Lisa, Limi-t at ions
Formai at ion(s)
/34033ftA
FMBCCFP
Buffaloberry
Leaf spot
(Cy 1 indro-r
spor'ium)
Do not use fruit for food or feed
purposes.
1.125-1.225 Foliar application.
lb/100 gal May be formulated with dinocap.
(70%, 75*,
8054 WP)
(37% F1C)
/3105700
FMBCSBL
FJftftUftH
Carnat ionr " :
Leaf spot
..;
' ' '• ' (40*, 60*, " '
72*, WP) .
or
0. 47-0. 7 oz /
5 gal
(70* WP)
or
(4* D)
or
1. 12-1.49
tbls
actual*/ gal
(74. 44* WP)
Issued: 10-30-84
11-014504-26
167
-------
EPO Compendium of Acceptable Uses
ZINC ION OND MONGONESE ETHYLENE BlSDITHIOCORBOMOTE SO'/.,
ft COORDINATION PRODUCT OF MONGONESE 16%, ZINC £%,
ETHYLENE BISDITHIOCORBOMOTE 62%
/3106500
FBODOCC
FBODBOW
FJOOPEj
Site and Pest
Chrysanthemum
Dosages and lolerance. Use, Limitations
Forrnul at ion (s)
flscpchyta ray
blight
Bot r y t i s pet a 1
spot
•0.8—1.6 lb/ holiar application. Opply twice
100 gal weekly during the whole blooming
or season.
1.3-1.6 tbls May be formulated with dinocap;
Rust (Puccinia) actual*/gal carbaryl ; or thiophanate-methyl .
(70%, 75'/.,
SO'/. WP)
(37-/. F1C)
[MOID
0.9-1.2 lb/
1OO gal
60*,
•• ••
FMBCCBM-"
Cordyline
;Leaf spot
(Cercospora)
or
0. 8-1. 6 lb/0
(8-/. D)
.or
0. 47-0. -7 02 /•
5 gal
(70-/4 WP)
or
1.12-1.49
tbls
actual*/ gal
1. 125-1. S£5
lb/100 gal
<70'/., 75%,
80% WP)
F1C)
CMOI]
1.08 lb/100
gal
(72-/. WP)
Foliar application.
May be formulated with dinocap.
Issuedi
10-30-84
11-014504-27
168
-------
EPA Cornpendiurn of Acceptable Uses
ZINC ION ftND MflNGftNESE ETHYLENE BISDITHIOCflRBftMftTE 8056,
fl COORDINATION PRODUCT OF MANGANESE IS'/., ZINC £"/.,
ETHYLENE BISDITHIOCARBAMATE G2%
/31084AA
FBAPBAW
Site and Pest
Dah1ias
Dosages and Tolerance, Use, Limitations
For mil 1 at i on (s)
Botrytis blight 1.1£5— 1.225 Foliar application.
: Ib/lOO gal May be formulated with dinocap;
or carbaryl ; th iophanate— methyl ; or
1.2-1.6 tbls dinocap, carbaryl, and rnalathion.
'•• • actual*/ gal
(70/4, 75%,
BO'/. WP)
(37% F1C)
CMAi:
0.3-1.2 lb/
100 gal
or
0. 47-0. 7 oz/
5 gal
WP) .
or .
/31089AA
FMBCLAA
Dieffenbach ia
Brown leaf
spot (Lepto-
sphaeria)
(4y. D)
or
1. 12-1. 49
tbls
actual*/gal
1. 125-1. 225
lb/100 gal
80-X WP)
(37% F1C)
Foliar application.
May be formulated with dinocap.
1. 08 lb/100
gal
(72% WP)
Issued: 10-30-84
11-014504-28
169
-------
EPA Compendium of Acceptable Uses
\
ZINC ION ftND MftNGONESE ETHYLENE BISDITHIOCftRBftMftTE 80%,
ft COORDINOTION PRODUCT OF MftNGONESE 16%, ZINC £%,
ETHYLENE BISDITHIOCORBOMOTE G£%
/350440ft
FBOVPBD
Site and Pest
Douglas-Fir
Swiss needle
cast (Phae—
cryptopus)
/3109£0ft
FMBGFflK
Dracaena
Leaf spot
(Fusari urn)
Dosages and Tolerance, Use,-Limitations
Form u1a tion(s)
1.125-1.££5
lb/100 gal
(70%, 75%,
ao% UP>
(37% F1C)
CMfll]
1.08.lb/100
gal
<7£% WP)
''1. i£5-'i.' ££5
Ib/lOO gal
(70%, 75%,
80% WP)
(37% .F1C).
CMOI]
0.9 lb/100
gal
(60% WP)
or
1. OS lb/100
Foliar application.
May be formulated with dinocap.
Foliar' appl icat ion.
May be formulated with dinocap;
or th iophanate— methyl .
/350470ft
FBOTCBM
FBOOPBU
Eastern Redcedar
Cercospora
blight
Phornopsis
blight
1. 125-1. ££5
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
CMOI:
1.08 lb/100
gal
<7£% WP)
Foliar application.
May be formulated with dinocap.
Issued: 10-30-84
II-014504-£9
170
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
. A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIQCARBAMATE 6£%
Site and Pest
Dosages and Tolerance,
Forrnu 1 at i on (s)
Li nil tat ions
/35049AA
FMACGAT
Elm
Black leaf spot 1.125-1.£25
(Gnomonia) lb/100 gal
(70%, 75%,
SO* WP)
(37% F1C)
Foliar application.
May be formulated with dinocap.
[MAID
1.08 lb/100
gal
<7£% WP)
/£8083AA
FKAGAAX
FAAAQBB
FBAABAW
FKAGCAM
.FFABQBB
FMAXQBB.
FBAQMCO
FBASQBB
FHAGQBB
/34053AA.
FAAACDP'
Epcot Display Crops
• •'r'' A11©r'nar'ia "spp.''•' CSLND'' ' '" ' '•
Anthracnose 1.6—2.4 lb/
Botrytis blight 100 gal/A
Cercospora (80% WP)
Downy mildew
Gray leaf spot •• • •
Gurnrny .stern
blight (Mycos-
phaerella)
Late blight
Leaf mold
Euonymus . •....•
Anthracnose
(Colletotri-
ch urn)
1. 125-1. ££5
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
CMAI]
1.08 lb/100
gal
(7£% WP)
SLN':-' Use' limited to The Land,'
FL.
Foliar application.
Foliar application.
May be formulated with dinocap.
Issued: 10-30-84
11-014504-30
171
-------
EPft Compendium of ftcceptable Uses
ZINC ION ftND MftNGP-NESE ETHYLENE BISDITHIOCftRBftMftTE SO'/.,
ft COORD I NOTION PRODUCT OF MflNGftNESE 16%, ZINC £%,
ETHYLENE BISDITHIOCflRBflMftTE &£%
/34058flft
FMBCCBM
Site and Pest
Ficus
Leaf spot
(Cercospora)
Dosages and lolerance. Use, Limitations
Forrnu 1 at ion (s)
1. 125-1. ££5
lb/100 gal
(70%, 75%,
80% .WP)
(37% F1C)
Foliar application.
May be formulated with dinocap.
CMP.I:
1.08 lb/100
gal
(?£•/ WP)
Firethorn
FEftJFflM'"•••
/350560ft
FJftFGBI
FEflJVftG
FMBCSCM
(Fusiclad i urn)
l.'125-i. 225
lb/100 gal
(70*, 75'/.,
SO'/. WP)
<37'/. F1C)
CMftlD
0.9 lb/100
gal
(60'/. WP)
or
i.08 lb/100
Foliar application.
May be formulated with dinocap;
or thiophanate—methyl.
Flowering Crabapple
Cedar-apple 1.125-1.££5
rust (Gyrnno- lb/100 gal
sporangium) or
Scab (Venturia) 1.2 tbls
Leaf spot actual*/gal
XSphaeropsis) (70%, 75%,
8054 WP)
(37% F1C)
CMflH
1.2 lb/100
gal
(40% WP)
or
1.08 lb/100
gal
(72% WP)
Foliar application.
May be formulated with dinocap;
or carbaryl.
172
Issued: 10-30-84-
11-014504-31
-------
EPfl Compendium of Acceptable Uses
ZINC ION ftND MftNGONESE ETHYLENE BISDITHIQCORBOMOTE 80%,
A COORD I NOT I ON PRODUCT OF MANGONESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 6£%
Site and Pest
Dosages and Tolerance, Use, Limitations
For mil 1 at i on (s)
Flowering Crabapple (continued)
CMftID
1.2 lb/100
gal
(60* WP)
/350570ft
FAABEAH
FMBCSBL
Flowering Dogwood
Anthracnose
(spot anthrac-
nose) (Elinoe)
Leaf spot
: (Septoria) :' '"•'
/311040A
FBftPBOW
FJOOPEK
1. 125-1. ££5
lb/100 gal
or
l.S tbls
"actual*"/ gal'
(70%, 75'/.,
80'/. WP)
F1C)
Fuchsia
Botrytis blight
Rust (Puccinia-
strurn)
CMftID • ' .
O.9 lb/100
gal
(60% WP)
or
1.08 lb/100
gal
(72% WP). ,.,..
1. 125-1. ££5
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
CMfill
1.08 lb/100
gal
(72% WP)
Delayed dormant and foliar
application. ftpply at delayed
dormant. Repeat at £ week
intervals during cover periods.
Formulated with thibphanate—
-methyl.
Foliar application. Apply when
buds begin to open, when bracts
have fallen, 4 weeks later, and
again in late summer after flower
buds for' next season are formed.
May be formulated with dino.cap;
or thiophanate—methyl.
Foliar application.
May be formulated with dinocap.
Issued: 10-30-84
11-014504-32
173
-------
EPfl Cornperidi urn of Acceptable Uses
ZINC ION fiND MftNGONESE ETHYLENE BISDITHIOCflRBFlMftTE BO'/.,
ft COORDINATION PRODUCT OF MflNGANESE 16*, ZINC £"/.,
ETHYLENE BISDITHIOCflRBftMflTE &£'/.
/3110Sftfl
FJflAPEJ
Site and Pest
Geranium
Dosages and tolerance, Use, Limitations
Formu 1 at i on ( s)
Rust (Puccinia) 1.1£5-1.££5 Foliar application.
lb/100 gal May be formulated with dinocap.
(7054, 75/4,
80% WP)
•/. F1C)
/Sllllftfl
FMCDBflW •'•'••'
FMCDCFH
Glad iolus
• -: Le'af and f 1 bt^er
spot
(Botrytis)
Leaf and flower
spot
(Curvula'r ia)
1. 08 lb/100
gal
<7£'/. WP)
0. 6-i. £ Ib7
100 gal
or
0.6-1.6 tbls
actual*/gal
C£-3 gal/
1,000 sq. ft]
(7054, 7554,
8O.5C WP)
(37-/. F1C)
Foliar application. flpply 1. £4
pounds in 100 to 150 gallons per
acre. On flower spikes, reduce
to 0.6 pound in 100 gallons per
acre. flpply weekly before dis-
ease appears and £ or 3 times per
week during periods of heavy dis—
eas.e activity and during rainy
weather.
May be formulated with dinocap;
or carbaryli
or*
(3.£5-/. D)
or
1. 1£-1.49
tbls
act ual*/gal
(74. 44-/.
or
0. 54-1. 08
Ib/gal
(7£% WP)
Issued: 10-30-84
11-014504-33
174
-------
EPfl Compendium of Acceptable Uses
ZINC ION ftND MftNGftNESE ETHYLENE BISDITHIOCflRBftMftTE SO'/,
A COORDINATION PRODUCT OF MftNGftNESE 16*, ZINC £*,
ETHYLENE BISDITHIOCftRBftMftTE 62*
Site and Pest
Dosages and iclerance. Use, Limitations
Forrnulat ion (s)
RJflFGBI
FBflTFftP,
FMflVPCH
FJOFGBI
FEftJVflG
/340700ft
PPflftflftD
Hawthorn
Cedar-apple
rust (Gyrnno-
sporangi urn
juniperi- .
virginianae)
Fabraea leaf
spot
Frogeye leaf
spot
1. 125-1. 225
Ib/iOO gal
8054 WP)
(37% F1C)
CMftID
0.9 lb/100
gal
(Physalospora) <60'/. WP)
Hawthorn rust or
(Gyrnnosporan- 1.08 lb/100
giurn globosum) gal
"Scab (Vehturia) ••'»'-*=»* >'>"*'< ••"•
Ho11y .
Purple blotch
of hplly
1. 125--1. £25
lb/100 gal'
or
1.2-1.6 tbls
actuaI*/gal
(70%, 75'/.,
SO'/. WP)
(37-/. F1C)
•iMO 1-3••';"":*. '/;•::';":
1.2 lb/100
gal
(40% WP)
or
0. 47-0. 7 02 /
5 gal
(70-/. WP)
or
1. 12-1.49
tbls
actuaI*/gal
(74. 44'/. WP)
or
, 1.OS lb/100
gal
WP)
i-oliar application.
May be formulated with dinocap;
or thiophanateTiiethyl.
Foliar application.
May be formulated with dinocap;
or carbaryl..
Issued: 10-30-84
11-014504-34
175
-------
EPfl Compendium of Acceptable Uses
\
ZINC ION ftND MflNGftNESE ETHYLENE BISDITHIOCftRBflMftTE SO'/,
A COORDINATION PRODUCT OF MANGANESE IS'/., ZINC £%,
ETHYLENE BISDITHIOCARBAMATE &£%
/311£.1AA
FAAACDP
FMBCCBM
FJAAPEJ
Site and Pest
Hoilyhock
Anthracnose
••; y> '
FBAfHAS.
Dosages and Tolerance, Use, Limitations
Formalat ion(s)
1.125—1.££5 Foliar application.
lb/100 gal May be formulated with dinocap;
or carbaryl; dicofol, carbaryl, and
1.3 tbls sulfur; or dinocap, carbaryl, and
(Cercospora) actual*/gal rnalathion.
Rust (Puccinia) (70%, 75%,
80% WP)
(37% F1C)
CMOI:
1.2 lb/100
gal
. (40% WP) .
-. •• • .•; ... . .-,.-. . •-, ^^
O. 47-0. 7 oz/
5 gal
(70% WP)
or
(4%, 6% D)
or
1.08 lb/100
gal
(7£% WP)
.HoneysMck 1 e ... .;.
.••.'..., Leaf blight
(Herpobasi—
di urn) ; s
1. 125-1. ££5
lb/100 gal
or
1.2 tbls.
actual*/gal
(70%, 75%,
80% WP)
(37% F1C)
CMftID
1.2 lb/100
gal
(40% WP)
or
0. 47-0.7 os/
5 gal
(70% WP)
or
Foliar application.
May be formulated with dinocap;
or carbaryl.
Issued: 10-30-84
11-014504-35
176
-------
EPft Compendium of ftcceptable Uses
ZINC ION flND MflNGfiNESE ETHYLENE BISDITHIOCfiRBfiMfiTE SO'/.,
ft COORD I NOT I ON PRODUCT OF MflNGPlNESE 16'/., ZINC £"/.,
ETHYLENE BISDITHIOCflRBftMftTE 6254
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnu i at i on (s)
Honeysuckle (continued)
1.08 lb/100
gal
<7£% WP)
/34073flft
FBftPBfiW
FMBCCBM
Hydrangea
Botrytis blight
Leaf spot
(Cercospora)
1.125
Ib/lOO gal
(70"/., 75'/.,
SO'/. WP)
(37% F1C)
t-oliar application.
May be formulated with dinocap.
1.08 lb/100
gal
(7£'/. WP)
/311£6ftfi
FMBCDBD
FIftPMCY
iris-
Leaf spot 0.125-1.2£5
(Didymellina) lb/100 gal
Ink spot of or
bulbs and leaf 1.2-1.6 tbls
blight actual*/gal
. . (My.stro. .' . :;.. . <70%,. 75.*,... .... ; =-/: ,,. v ,•'•..,.• •,.::-.
Foliar application.
May be formulated with dinocap;
carbaryl; or dinocap, carbaryl,
and malath ion. ;
(37V. F1C)"'
CMOI:
1.2 lb/100
gal
(40% WP)
.or
0. 47-0. 7 oz/
5 gal
(70-/. WP)
or
Issued: 10-30-84
D)
or
1. 12-1. 49
tbls
actual*/gal
(74.44-/. WP)
or
11-014504-36
.177
-------
EPft Compendium of ftcceptable Uses
\
ZINC ION ftND MftNGflNESE ETHYLENE BISDITHIOCftRBftMOTE 80%,
ft COORDINflTION PRODUCT OF MftNGflNESE 16'/., ZINC £'/-,
ETHYLENE BISDITHIOCftRBftMftTE 62%
Site and Pest
Dosages and Tolerance, Use, Limitations
Forniulat ion (s)
Iris (continued)
/34329flft
FftflflCBP
FMCBfiftX
/35073PP
FBftEPBU
Japanese flralia
flnthracnose
-------
EPfl Compendium of Acceptable Uses
ZINC ION ftND MflNGftNESE ETHYLENE BISDITHIOCfiRBOMflTE 80%,
ft COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE &£%
Site and Pest
Dosages and Tolerance, Use, Limitations
Formalat ion(s)
/34088AA
FMBCCBM
Li gustrum
Leaf spot
(Cercospora)
1. 125-1. ££5
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
CMAID
1.08 lb/100
gal
(7£% WP)
Foliar application.
May be formulated with dinocap.
Li 1ies
FBfiOBfiW '
Botryt' is blight i: 1£5-1. ££'5 ' Fdl iar application^
lb/100 gal
or
1.2-1.6 tbls
actuaI*/gal
(70%, 75%,
8O% WP)
(37% F1C)
May be formulated with dinocap;
carbaryl; or dinocap, carbaryl,
and ma lath ion.
CMAI:
1.2 lb/100
gal
-------
EPfl Compendium of Acceptable Uses
ZINC ION flND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80'/.,
A COORDINATION PRODUCT OF MANGANESE 16'/., ZINC £'/.,
ETHYLENE BISDITHIOCARBAMATE &£'/.
Site and Pest
Dosages and Tolerance, Use, Limitations
Formu1 at i on(s)
/3508£AA
FMBCGAN
/35083RA
FMBCAAX
FMBCPCE
/31137AA
FBADBAW
Maqnolia
Leaf spot 1.125-1.££5
(Gloeosporium) lb/100 gal
(70-/., 7554,
SO'/. WP)
(3754 F1C)
CMftlj
1.08 lb/100
gal
(?£•/. WP)
Maple
Leaf spot
(ftlternaria)
Leaf spot ' "
(Phyllosticta)
1. 1£5-1.££5
lb/100 gal
(70S, 75%,
80% WP)
(•37% F1C).
EMOI3
1.08 Ib/lOO
gal
Marigold
Botrytis bios- 1.1£5-1.££5
som bli ght
lb/100 gal
80-/. WP)
F1C)
CMfilD
1.08 lb/100
gal
<7£'/. WP)
Foliar application.
May be formulated with dinocap.
Do not use on sugar maples intend-
ed "for the production of maple
syrup.
Foliar application.
May be formulated with dinocap.
Foliar application.
May be formulated with dinocap..
Issued: 10-3O-84
11-014504-39
180
-------
EPft Compendium of Acceptable Uses
ZINC ION ftND MflNGftNESE ETHYLENE BISDITHIOCftRBftMftTE BO'/.,
ft COORDINATION PRODUCT OF MftNGftNESE 16'/., ZINC £'/.,
ETHYLENE BISDITHIOCftRBftMfiTE &£'/.
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnu 1 ai: i on (s)
/35085ftft
FCftDGBG
FMBCEftW
Mountainash
Leaf blotch
(Guignard ia)
Leaf spot
(Ent omospor i —
urn)
1.1£5-1.££5 Foliar application.
lb/100 gal May be formulated with dinocap.
(70*, 7554,
80% WP)
(37% F1C)
1.08 lb/100
gal
WP)
/34097ftft
FBftDOftV' :
FMBCCBM
Mount a i n—1aure1
bl i ght
(Ovulinia)
Leaf spot
(Cercospora)
"l.'125-i: 2£5
lb/100 gal
(70-/., 75%,
SO'/. WP)
F1C)
1.08 lb/100
gal
'/. WP)
Foliar'arid 'scii 1 'application. ftp-
ply £ to 3 times per week while
flowers are opening. flpply to
flowers and ground under bushes
thoroughly.
May be formulated with dinocap.
Narcissus
FIBQSfiQ
";'/.':'.'.?'$.re.iTBo.tryti's. '..-.I'.'i£S.-i. 2£5
blight) " Ib/lOO gal
(Sclerotinia) (70%, 75%,
Smoulder (neck 80% WP)
rot) (37% F1C)
(Sclerotinia)
CMftID
1.08 lb/100
gal
(7£% WP)
l'iatf .appl rc^t ion. ' - . ..-. — .'..v:''
May be formulated with.dinocap.
Issued: 10-30-84
11-014504-40
181
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80*,
A COORDINATION PRODUCT OF MANGANESE IS'/-, ZINC £'/.,
ETHYLENE BISDITHIOCARBAMATE 6S*
Site and Pest
Dosages and i.olerance. Use, Limitations
Formu i at i on (s)
/35093AA
FEflFTflB
FMBCflftN
Oak
Leaf blister
(Taphriha)
Leaf spot
(fict inopelte)
1. 125-1.225
lb/100 gal
(70*, 75'/.,
80^ WP)
(37% F1C)
CMAID
1.08 lb/100
gal
WP)
Foliar application.
May be formulated with dinocap.
/31147AA
FBADBfiW
Orchids (Dendrobium spp. )
'Bot'rytis bios- 1. 125-1.225 ' Foliar application.
sorn bl i ght
lb/100 gal
(70'/i, 75%,
80% WP)
F10
May be formulated with dinocap.
CMAI3
i:08 lb/100
gal
<72'/. WP)
Issued: 10-3O-84
11-014504-41
182
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80*,
A COORDINATION PRODUCT OF MANGANESE IS*, ZINC. £•/.,
ETHYLENE BISDITHIOCARBAMATE 62*
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnu 1 at i on ( s)
/35007DA Ornamental Conifers (including
Christmas trees)
FBAVLBK
FBfiVLBK
FJftFCEQ
FMfiJSftJ
Lbphoderm i urn
needle cast
Lophoderrniurn
needle cast
Pine gall rust
(Cronart ium)
Scirrhia brown
spot
3. 15-3.3 lb/
100 gal
(70*, 75*,
80* WP)
(37* F1C)
(3£*, 37*
F1C)
[MAID
1.08 lb/100
gal
(7£* WP)
1. 125-1. ££5
lb/100 gal
SO'/. WP)
F10
CMfllD
1.08 lb/100
gal
(7£% WP)
Foliar application to nursery
plantings and newly transplanted
stock. flpply at 3 week intervals
during sprinkler irrigation, and
at monthly intervals the rest of
the year when the beds are not
covered with snow. ftdd a suita-
ble spreader-sticker.
May be formulated with dinocap.
Foliar application. Apply in
spring or early summer before in-
fection occurs. Repeat after
heavy rains and at £ week inter-
vals as long as needed.'
May be formulated with dinocap.
Ornamental Ferns . . .
,••-•-. ••'• .-•;•• >:.::v;,----v' v-.;'' •>-''"•;' >•'•:••••*.'V-'-y'S' •'
Rhizoctonia i. 125'-1. ££5
blight lb/100 gal
(70*, 75*,
80* WP)
F1C)
Foliar application.
May be formulated with dinocap.
CMftID
1.08 lb/100
gal
<7£'/. WP)
Issued: 10-30-84
183
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EPft Compendium of Acceptable Uses
ZINC ION ftND MftNGftNESE ETHYLENE BISDITHIOCflRBftMftTE 80%,
ft COORDINflTION PRODUCT OF MftNGflNESE 16*, ZINC £"/.,
ETHYLENE BISDITHIOCflRBftMOTE 6£%
Site and Pest
Dosages and Tolerance, Use,' Limitations
Forrnu 1 at ion (<=>)
/31003ftft
/31000ftft
/35000ftft
/34000ftfl
/341£0ft«
FMBCQBB
FZZZQBB
Ornamental Flowering Plants
Ornamental Herbaceous Plants
Ornamental and/or Shade Trees
Ornamental Woody Shrubs and
Vines
Rose
Leaf spots
Plant pathogens
1.1£5-1.2£5
lb/100 gal
(70-/., 75)4 WP)
0. 8-1.6
lb/100 gal
or
0. 4-0. 8 tbls
'actual*/gal
(SO'/. WP)
Foliar application. Tank mix
with dinocap, benornyl, or
thiophanate—methyl.
Registration Number 00035E-00341
includes a long list of ornamen-
tal sites (for field, nursery$
and greenhouse) and another of
diseases or pathogens but does
not specify which diseases will
be controlled on each site. In
addition to most of the other
ornamentals listed in this
report,' the label includes more
than 50 other sites.
Ornamental Turf
fllgae
Do not graze treated area or feed
clippings.to livestock. ftpply in
4 to 15 gallons per-1,000 square
.... .feet,, by .hose-end- or. .pressure..;.. ,..._
:.". ''..; Sprayer.'s.<'.',", . '.''. •':.' ;... ':. .-.-..':•':'.-. \ ] •
4. 8-5. 0 oz/
1 , OOO sq . ft
Issued: 10-30-84
8O-X WP)
(37% F1C)
CMOI3
4. 8 oz/1, 000
sq. ft
(40'/. WP)
or
£.88 oz/1, 000
sq. ft
(7£'/. WP)
or
0. 7 tbls
act ual*/gal/
£5-50 sq. ft
(70% WP)
11-014504-43
Foliar application. fipply when
algae begins to appear. Repeat
at 7 day intervals until threat
is past.
May be formulated with dinocap;
or carbaryl.
184
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EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
ft COORDINftTION PRODUCT OF MftNBftNESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 6£%
Site and Pest
Dosages and Tolerance,
Formu1at i on(s)
Use, Limitations
Ornamental Turf (continued)
F.BAHRAM
FMBCHftM
FBftTHRM
FJAftPEJ
Brown patch
(Rhizoctonia)
Leaf spots
(Helmintho-
sporium)
Melting out
(Helrnintho-
spor iurn)
Rust (Puccinia)
£. 4-3. £ oz/
1,000 sq. ft
(70%, 75%,
80% WP)
(3754 F1C)
£. 4-7. 0 oz/
1, GOO sq. ft
(80% WP)
(37* F1C)
CMAID
£. 5-3. 74 oz/
1, 000 sq.ft
(3.9% G)
or •• .... ...
sq. ft
(4O% WP)
or
£. 4-3. 6 oz/
1,000 sq.ft
(60% WP)
or
0. 7 tbls
actual*/gal/
£5-50 sq.ft
(70% WP)
or
£.88 oz/1,000
sq. ft
(7£% WP)
or
3. £-4. 8 oz/
1, 000 sq.ft
<74.44*
Foliar application. Apply when
grass greens up in the spring,
and repeat at 7 to 14 day inter-
vals for Helrninthospori urn diseas-
es and at 7 day intervals for
brown patch.
Foliar application. Apply when
disease appears. For Helmintho —
sporiurn diseases and brown patch,
apply £.4 to 3.5 ounces at 7 to
10 day intervals for tees and
greens, at 7 to 14 day intervals
for fairways, and at 14 to £1 day
intervals for home lawns. Under
favorable disease conditions, ap-
ply 5.0 to 7.0 ounces at 3 to 5
day intervals. . For .rust';, apply
£.'4; to 3.5 ounces at 7 to lO'day
intervals.
Foliar application. Apply lower
rates as a preventive, and higher
rates under disease conditions at
schedule given above.
...Formulated, wi.th dinocap; ca.rbar-
y.l V'aniiazine; or .tKiophanate-
methyl.
Issued: 10-30-84
11-014504-44
185
-------
EPfl Compendium of Acceptable Uses
ZINC ION ftND MftNGflNESE ETHYLENE BISDITHIOCftRBftMflTE 80*,
fl COORDINATION PRODUCT OF MftNGflNESE 16*, ZINC £'/.,
ETHYLENE BISDITHIOCARBftMftTE 62'/.
Site and Pest
Dosages and
Forrnulat ion ((.
Tolerance, Use, Limitations
Ornamental Turf (cont inued)
FMflPGflK
FBfiXCEX
FHftlQBB
Copper spot
(Gloeocerco-
spora)
Fusarium blight
(F. rose urn)
Red•thread
(pink thread)
(Cort iciurn)
SI irne molds
3. 0-7. 0 oz /
1,000 sq. ft
SO'/. WP)
F1C)
£. 5-3. 74 os/
1, 000 sq. ft
t3'. 9* G)" ;; ""••••
or
4. 8 os/1, 000
sq. ft
<4.oy. WP)
' ' 'or-' :
2.4-3.6 os/
1, 000 sq. ft
(60'/. WP)
or . .
0. 7 tbl.s
actual*/gal/
25-5Q .sq. ft. . .
''' ^
Foliar application. fls a preven-
tive, apply 3.0 to 4.8 ounces
when grass greens up in the
spring and repeat at 7 to 14 day
intervals throughout the season.
When conditions are favorable for
disease development, apply 4.8 to
7.0 ounces and repeat at 7 day in-
tervals until threat is past.
Foliar application. ftpply lower
rates as a preventive, and higher
rates under disease conditions at
schedule given in previous use
pattern.
Formulated with dinocap; carbar—
yl; anilasine; or thiophanate-
rnethyl. . ...
or
£. 88-5. 76 os/
1, 000 sq. ft
(7£"/. WP)
or
3. £-4. 8 os/
1, 000 sq. ft
(74.44-/.
Issued: 10-30-84
11-014504-45
186
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80S,
ft COORDINATION PRODUCT OF MANGANESE 16'/., ZINC £'/C,
" ETHYLENE BISDITHIOCARBAMATE 6SS
Sita and Pest
Dosages and Tolerance?, Use, Limitations
Formu1 at ion(s)
Ornamental Turf (continued)
FtfAQSAQ
Dollar spot 4.75-7.0 oz/
.. (Sclerotinia) . 1,000 sq. ft
(70S, 75S,
aos WP)
(37S F1C)
Foliar application. As a preven-
tive, apply 4.75 to 7.0 ounces
when grass greens up in the
spring and repeat at 7 to 14 day
intervals. When conditions are
favorable for disease develop-
ment, apply at high rate and re-
peat at 7 day intervals until dis-
ease threat is past. May be tank
mixed with a cadmium fungicide
under severe disease conditions.
£.5^3.74 "oz/'
1, 000 sq. ft
(3. 9'/. G)
or
4. 8 oz/1., OOO
• sq.'f t; : ' ' • '
(40-/. WP>
or
1.8 os/1, 000
sq. ft
(GO'/. WP)
or
.4. 3£-5.. 7£> -QS
(7£-/- WP)
or
3. 2-4. 8 oz/
1 , 000 sq. ft
(74.
Foliar application. Apply lower
rates as a "preventive, and higher
rates under disease conditions at
schedule given in previous use
pattern.
Formulated .with dinocap;. carbai—.
yl; ariilazi'he; or' thiophahate—
methyl.
Issued: 10-30-84
11-014504-46
187
-------
EPA Compendium of Acceptable Uses
ZINC ION.AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE 16'/., ZINC £/.,
ETHYLENE BISDITHIOCARBAMATE ££'/.
Dosages and lolerance, Use;, Limitations
FormuI at i on (s)
Ornamental Turf (continued)
FBAAPE5 Pythiurn blight 6.3-7.0 oz/ Foliar application. Apply at
. . . 1,000 sq.ft first sign of disease and repeat
(70%, 75%, at 5 day intervals or more fre-
80% WP) quently if conditions are favora—
(37% F1C) ble for disease development. Con-
tinue until disease threat is
oast.
FHAJFAK
Snow mold
(Fusar i urn
nivale)
[MAID
6. 4 oz/1, 000
sq. ft
<40'/. WP)
.or
-Si 76 ;:6zYi', 000
sq. ft
<7£* WP)
or
3. £-4. 3 oz/
". l,'000-'sq-:.ft "
(74. 44-/. WP)
4.8-7.0 oz/
1 , OOO sq. ft
Foliar application. Apply as in
previous use pattern.
Formulated with dinocap; or car-
bary1.
SO'/. WP)
CMAI:
3.74 oz/1,000
sq. ft
(3.9% G)
or
4.8 oz/1,000
sq. ft
(40% WP)
or
£. 4-3. 6 oz/
1, 000 sq.ft
(60% WP)
or
Foliar application. Apply during
the winter at. a £ to & week inter-
val.
Foliar application. Apply as in
previous use pattern.
Formulated with dinocap; carbar-
yl; anilazine; or thiophanate-
rnethyl.
Issued: 10-30-84
11-014504-47
-------
EnA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE 16'/-, ZINC £'/.,
ETHYLENE BISDITHIOCARBAMATE 6£*
Site and Pest
Dosages and Tolerance, Use, Limitations
Formu1 at ion(s)
Ornamental Turf (continued)
4. 3£-5. 76 oz/
. 1, 000 sq. ft
(7 a-/. WP>
or
3.2-4. 8 oz/
1, 000 sq. ft
/341O6AA
Pachysandra
FBATVAL
FDAQVAL
Volutella leaf
bi ight and
stern canker
1.5-1.6 lb/50 Foliar application. Apply at
gal/5,000 first sign of. disease. Repeat at
sq.ft 10 to 14 day intervals for a mini-
••'or '•'•'•'• "'"'• rnurn of 5 applications.
3.£ tbls May be formulated with dinocap;
actual*/gal/ carbaryl; or th iophanate-rnethyl.
50 sq.ft
• 80'/. W
(37X. F1C)
CMAID
1.44-1.6 lb/
5O gal
/5,000 sq.ft
(An-/. TZ'L
or
0.45 lb/50
gal/5, OOO
sq. ft
(60-/. WP)
Issued: 10-30-84
11-014504-48
189
-------
EPR Compendium of Acceptable Uses
ZINC I DIM fiND MflNGftNESE ETHYLENE BISDITHIOCftRBftMftTE BO'/.,
ft CDORDINflTION PRODUCT OF MftNGftNESE 16%, ZINC £%,
ETHYLENE BISDITHIOCftRBftMftTE 62%
73114900
FQftflCDP
i t e ?. r: d M e? s T
Pansies
flnthracnose
(Colletotri
ch urn)
Dosages and lolerancg. Use, Limitations
Foriv.u 1 at i on ( s)
1. 125-1. £25
lb/100 gal
or
1.2 tbls
actual*/gal
(70-/., 75%,
BO-/. UP)
(371/. F1C)
Foliar application.
May be formulated with dinocap;
thiophanate—methyl; ; or dinocap,
carbaryl, .and malathion.
0.3 lb/100
gal
(60* WP)
"or"'' '' '•"•'•
0.47-0.7 os/
5 gal
(70* WP)
.-. 1.1-51-fift,
FBBJBflW
FBBGPCN
D).
or
1.08 lb/100
gal
<72'/. WP)
:Peon.i.gs ;.; .-r.-.•:••'.^:.- * v: .;.•
Botrytis leaf,
stern and bud
blight
Phytophthora
tip blight
1.125-1.£25
lb/100 gal
or
1.2 tbls
actual*/gal
(70%, 75%,
30% WP)
(37% F1C)
CMPII:
1.2 lb/100
gal
(40% WP)
or
i. 08 lb/100
gal
(72% WP)
Foliar and soil application. ftp-
ply in early spring and early _.
fall, drenching soil around
plants as well as the foliage.
Destroy all infected parts proropt-
ly.
May be formulated with dinocap;
or carbaryl.
Issued: 10-30-84
11-014504-49
190
-------
EPfl Compendium of Acceptable Uses
ZINC ION 'PND MftNGflNESE ETHYLENE BISDITHIOCPRBflMATE 80%,
fl COORDINATION PRODUCT OF MANGANESE 16*,' ZINC 2%,
ETHYLENE BISDITHIOCARBAMATE £2%
b i'" e r.rid
Dosages and Tolerance, Use, Limitations
Formulat ion ( s )
/3_1152 A A
FMBCCBM
Peperomia
Leaf spot
(Cercospora)
1.125-1.225 Foliar application.
lb/100 gal May be formulated with dinocap.
(70%, 75%,
80% WP)
7% F1C)
CMfll]
•1.08 lb/100
gal
(72'/. WP)
/31155flft
FMBCDflB
PBfiflPCN
Ph ilodendron
Leaf spot
(Dactylaria)
Phytophthora
blight
1. 125-1^225
lb/100 gal
(70%, 75'/.,
SO'/. WP)
(37% F1C)
CMAID :
1.08 lb/100
gal
(72% WP)
Foliar application.
May be formulated with dinocap.
41
FMBCFftft
Phot inia
-;:. •..:.'. .':.•;,•: .' : "•:••••-.•• ?..•.'•.-
'• ; Lea-f V.spot'.". . .
(Fabraea)
Mi. 125-1. 225.
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
F61 iar .ajap-l icat-ion. \. • '.-. . .'.
May be formulated with dinocap;
or thiophanate—methyl.
0.9 lb/100
gal
(60% WP)
or
1.08 lb/100
gal
(72% WP)
Issued: 10-30-84
11-014504-50
191
-------
EPfl Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 62%
/31159AA
r£AJSCB
bite and Pest
Poinsett ia
Scab/spot
anthracnose
(Sphaceloma)
/34120AA
-MAEDBS
-MBCCBM.
-JAGPBW
Rose
Blaqk spot
'(D i p-1 ocar pon)
Leaf spot
(Cercospora-)
Rust
< Phragmid i urn)
Dosages and Tolerance, Use, Limitations
Forrnu i at i on (s)
1.. 125-1. 225
lb/100 gal
Foliar application.
May be formulated with dinocap;
or thibphanate-methy1.
BO'/. WP)
(37% F1C)
CMftID
O. 9 lb/100
gal
<6O% WP)
or
1.08 lb/100
gal
C7S-/. WP>
•1.125—1.225. Foliar application.
• Ib/iOO gal May be- forrniala'ted with dinocap;
or . carbaryl ; thiophanate—methy 1 ;
1.2-1.6 tbls dicofol, carbaryl, and sulfur-; or
actual*/gal dinocap, carbaryl, and malathion.
(70%, 75%,
8O% WP)
(37% F1C)
(8% D)
0.9-1.2 lb/
1OO gal
(40%, 60% WP)
or
1.4 Ib/ft
(4% D)
or
0.47-0.7 os/
5 gal
(70% WP)
or
(4%, 6% D)
or
Issued: 10-30-84
M-014504-51
' 192
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/,
A COORDINATION PRODUCT OF MANGANESE IS'/., ZINC 2%,
ETHYLENE BISDITHIOCARBAMATE 62%
'Site and Pest
Dosages and Tolerance, Use, Limitations
Forma I at i on(s)
Rose (continued)
1.12-1.49
tbls
actual*/gal
(74.44% WP)
or
1.08 lb/100
gal
(?£•/. WP)
Also refer to Ornamental Flowering Plants
cl uster.
/31175AA
FMBCAAX
Schefflera
Leaf spot
(37% FlC)
Foliar application.
May be formulated with dinocap;
or thiophanate-niethy 1.
CMAI3
0.9 Ib/lOO
gal
or
:!,... pav;:l.hx/10O:
\g-ai' ' •'•• :- •'••• '•''•'
(72% WP)
/34126AA
FWBCCFP
Skunkbush Sumac
Leaf spot
(Cylindro-
sporiurn)
1. 125-1. 225
lb/100 gal
(70*/., 75'/.,
80-/4 WP)
(37% FlC)
CMAID
1.08 lb/100
gal
(72% WP)
Foliar application.
May be formulated with dinocap.
Issued: 10-30-84
11-014504-52
193
-------
EPft Compendium of Acceptable Uses
ZINC ION ftND MflNGftNESE ETHYLENE BISDITHIOCftRBftMftTE SO'/.,
9 COORD I NOTION PRODUCT OF MftNGONESE 16'/., ZINC 2*,
ETHYLENE BISDITHIOCftRBftMflTE 62*
Site and Pest
Dosages and Tolerance, Use, Limitations
Forrnu 1 at ion (s)
/31184P.P,
FJftGPEJ
Snapdragon
Rust (Puccinia) 1.125-1. 225.
lb/1'00 gal
or
• 1. 2 tbls
act ual*/gal
/3141 4P.fi
FMBCCBM
Sta'tice • '' •• •" "•''
Leaf spot
(Cercospora)
B0% WP)
(37% FIC)
CMP.I3
0.9-1.2. lb/
100 gal
60S,
or
<4'/. D)
1. 125-1.225
lb/100 gal
B0% WP)
(37% FIC)
1 . 08 1 b/ 1 00
gal
(72-/. WP)
hollar application.
May be formulated with carbaryl;
thiophanate—methyl; or dinocap,
carbaryl, and malath ion.
Foliar application.
May be formulated with dinocap.
FMBCCBF
Synqoni urn
Leaf spot
(Cephalo
sporiurn)
1. 125-1. 225
lb/100 gal
80-/C WP)
(37'/. FIC)
CMAI3
1. 08 lb/100
gal
<72'/. WP)
Foliar application.
May be formulated with dinocap.
Issued: 10-3O-84
11-014504-53
194
-------
tPfi Compendium of ftcceptable Uses
ZINC ION AND MftNGONESE ETHYLENE BISDITHIOCftRBftMfiTE 8Q-/.,
0 COORDINflTION PRODUCT OF MONGONESE 16%, ZINC 2%,
ETHYLENE BISDITHIOCftRBftMRTE 62%
Site arid Pest
Dosages arid Tolerance, Use, Limitations
Forrnulat ion (s>
/3120500
FBOOBOW
lulips
Botrytis blight 1.1£5-1.££5
(fire)
/.3135ipO._
'• -• .'' *'
FOOOQBB"
Venus Fly. Trap
ft'nthracnose'
lb/100 gal
or
l.£ tbls
actual*/gal
(70%, 75%,
BO'/- WP)
(37% F1C)
CMOI:
l.£ lb/100
gal
(40% WP)
- -'or"' ' •'' '•' •' ""•'
0. 47-0. 7 02 /
5 gal
(70% WP)
; or ...
(4% D)
or
1.08 Ib/lOO
gal
(72% WP)
'l.'125-ll £25
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
[MAID
1.08 lb/100
gal
(72% WP)
Foliar application.
May be formulated with dinocap;
carbaryl; or dinocap, carbaryl,
and rnalath ion.
Foliar application.'
May be formulated with dinocap.
Issued: 10-30-84
11-014504-54
195
-------
e.PA' Compendium of Acceptable Uses
\
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC £%,
ETHYLENE BISDITHIOCARBAMATE 62%
Site and Pest
Dosages and
Form a 1 at i on ( s )
iolerance. Use, Limitations
/34137AA Viburnum
,-FABPCV Downy mildew
(Plasmopara)
.-MBCRAD Leaf spot
(Ramularia)
/35122AA Walnut
Anthracnose
(Gnornonia)
1. 125-1. ££5
lb/100 gal
(70%, 75%,
80% WP)
(37% F1C)
CMAIH
1.08 lb/100
gal
(72% WP)
1. 125-1. £25
lb/100 gal
(70%, 75%,
80% .WP)
Foliar application.
May be formulated with dinocap.
Do not use treated walnuts for
feed.or feed purposes.
Foliar application.
May be formulated with dinocap;
or thiophanate—rnethy 1.
35227AA
'AAAGAN
MBCCFP
White Ash
CMOI3.
0.9 lb/100
gal
(60X. WP)
or
1. 08 lb/100
"•''""• "(72%':WP) '•"" "
Anthracnose 1.125-1.225
(Gioeosporiuni) lb/100 gal
Leaf spot
(Cy1indro-
sporium)
(70%, 75%,
80% WP)
(37% F1C)
CMAI:
0.9 lb/100
gal
(60% WP)
or
1.08 lb/100
gal
(72% WP)
Foliar application.
May be formulated with dinocap;
or thiophanate-rnethy 1.
Issued: 10-30-84
11-014504-55
196
-------
/J1213AA
FBATAAX
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,.
A COORDINATION PRODUCT OF MANGANESE 16'/., ZINC 2%,
ETHYLENE BISDITHIOCARBAMATE 62'/.
•'•: e ano Pest
Z i nn i a
Leaf blight
(Alternaria)
Dosages and
iolerance, Use, Limitations
F o rrnu lat ion ( s)
1. 125-1. 225
lb/100 gal
or
1.2 tbls
actual*/gal
SO'/. WP)
(37% F1C)
CMAID
0.9-1.2 l.b/
100 gai
(40%, SO'/.,
72"/. WP) : • •
or
0. A7-0. 7 oz/
5 gal.
(70-/. WP)
••..;• or ' ' • • ': '' ''\
.(4* D)
or
1. 12-1. 49
tbls
actual*/gal
WP).,
Foliar application.
May be formulated with dinocap:
carbaryl; thiophanate-methyl; or
dinocap, carbaryl and malathion.
GREENHOUSE NONFOOD CROP
(Ornamental Plants and Forest Trees)
General Warnings and Limitations;
may be added.
A suitable spreader—sticker
Refer to TERRESTRIAL NON-FOOD CROPS, (Ornamental Plants and
Forest Trees), the 70, 75, 80 percent wettable powder, and 37
percent flowable concentrate single active ingredient formula-
tions; and, the 60 percent wettable powder formulated with
thiophanate—methyl for Greenhouse Uses.
Issued: 10-30-84
11-014504-56
197
-------
EPfl Compendium of Acceptable Uses
ZINC ION ftND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORD I NOT I ON PRODUCT OF MANGANESE IS'/., ZINC. £'/., .
ETHYLENE BISDITHIOCARBAMATE G£'/.
Site and Pe?st Dosages arid Tolerance, Use, i-irnitat ions
Form u 1 at i on ( s )
AQUATIC FOOD CROP
(Agricultural Food Crops)
/01010AA Cranberry 7 ppm
30 day preharvest interval
through 5. 0 pounds per acre.
"IBFQBB Fruit rot £.33-5.0 Ib/A Foliar application. Apply at rnid-
(70%, 75'/., bloorn. Repeat at 7 to 10 day •
80'/. WP) intervals as needed.
<3£'/., 37%
F1C)
or .
. ' 1. 92-3. 2 Ib/ft
-.-... •.-.-.•.-. (3..2%.. D) .
flERIflL QND TQNK MIX flPPLICflTIQNS
•g00136'0 '-' . •' Aerial fl p p. l:i cat! oh •:.''.• .'•. ; •••:••''•"_','•'.••'•••• ;-;:-- '••.'. '.'••..-."•;''.• .'••/ • ..•'.'.
- ' "•
— • • Refer to •• ' '. •
TERRESTRIflL FOOD CROP
(flqri cultural Crops)
fill sites except Capri fig, Onions
(direct seeded), Pineapple, Pota-
.. ....... . . . to ..(seed pieces)
'V-.)'':;0:!.".!.":{ :.:"""•' i :' "...~.'!. "_'•?': " "flQUftT.IC'''FQOD CROP i:..,".--; ,•,/'- ..-•"', ".;.". '-.:' '• '.' !• ;..:. '•.'..'.' .' ;. .."'"'.
(flq'r icultural Food Crops)
Cranberry
99003'00 Tank Mix
Refer to
TERRESTRIflL FOOD CROP
(flqri cultural Crops)
flpple. Barley, Celery, Cucumber,
Grapes, Melons, Peanuts, Pear,
Potato, Squash (summer), Sugar
Beet, Tomato, Wheat
TERRESTRIflL NONFOOD CROP
(Ornamental Plants and Forest Trees)
Ornamental Flowering Plants,
Ornamental Herbaceous Plants,
Ornamental and/or Shade Trees.,
Ornamental Turf, Ornamental Woody
Shrubs and Vines, Rose
Issued: 10-30-84 11-014504-57
198
-------
EPft Compendium of Occeptable Uses
ZINC ION AND MfiNGfiNEBE ETHYLENE BISDITHIOCftRBAMflTE 80*,
A COORD INOTION PRODUCT OF MflNGflNESE 16*, ZINC £*,
ETHYLENE BISDITHIOCfiRBftMRTE 6£*
—isting of Registered Pesticide Products by Formulation.
i.OSO. 0002 80* .formulation intermediate
zinc ion and manganese ethylene bisdithiocarbarnate 80*, a coordi-
nation product of manganese 15*, zinc 2*, ethylene bisdithiocar-
bamate 62* (014504)
000707-00102 .
4003. 2003 3. £* dust
zinc ion and manganese ethylene bisdithiocarbamate 80*, a coordi-
nation product of manganese 16*, zinc £*, ethylene bisdithiocar-
bamate 6£* (014504)
001202-00131
zinc ion and manganese ethylene bisdithiocarbamate SO*, a coordi-
nation product of manganese 16*, zinc £*, ethylene bisdithiocar-
bamate 62* (0145O4) plus rna lath ion (057701)
O37686-OOOSS 037686-00061
&003.£503 3.£5* dust
zinc ion and manganese ethylene bisdithiocarbarnate 80*, a coordi-
nation product of manganese 16*, zinc £*, ethylene bisdithiocar-
,.•„•.- .^ . •• •-. .barnate 6£.* (Q.I4504) t rna.lathion (057701) .plus folpet (0816O1).
' ' • •' ''•'•' •' ' '"• 0£3486-'-00070# '"•• ". . '•'.'• ' "• '•''•'.'' '• •'• ' ' :- ' •• •".'•'• • .'".
^suspended .:
&003.3003 3.9* dust ' '
sine ion and manganese ethylene bisdithiocarbamate SO*, a coordi-
nation product of manganese 16*, zinc £*, et.hyiene bi sd it h iocar-
bamate 62* (014504) plus rnethoxychlor, technical (034001)
&-0-O4. 003 4* dust
zinc ion and manganese ethylene bisdithiocarbamate 80*, a coordi-
nation product of manganese 16*, zinc £*, ethylene bisdithiocar-
bamate 6£* (0145O4)
004185-00386
zinc ion and manganese ethylene bisdithiocarbarnate 80*, a coordi-
nation product of manganese 16*, zinc £*, ethylene bisdithiocar-
bamate 62* (014504) plus carbaryl (056801)
002393-00244 . 004185-00497
zinc ion and manganese ethylene bisdithiocarbamate 80*, a coordi-
nation product of manganese 16*, zinc 2*, ethylene bisdithiocar-
bafnate 62* (0145O4) ; £, 4-dinitro-6-octyl*phenyl crotonate 2,6—
dinitro-4-octyl*phenyl crotonate nitrobctyIphenols (principally
dinitro) *a mixture of 1—rnethyIhepty1, 1—ethylhexyl and 1 —pro—
pylpentyl (036001); carbaryl (056801) plus rnalathion (057701)
000602-OO231
Issued: 10-3O-84 11-014504-58
199
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBfiFlATE 80%,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC 2%,
ETHYLENE BISDITHIOCARBAMATE 62%
Listing of Reg-istered Pesticide Products by Formulation (continued)
&004.8003 4. 8% dust
sine ion and manganese ethylene bisd ith iocarbarnate 30%, a coordi-
nation product of manganese 16%, zinc £%, ethylene bisdithiocar-
baniate 62% (014504)
000554-00086 000769-00388 004185-00512 006735-00185
009779-00102 037686-00046 042057-00079
zinc.ion.and manganese ethylene bisd ithiocarbarnate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
barnate 62% (014504) plus carbaryl (056801)
. 000404-00326 000769-00385 009779-00114 037686-00048
s-005. 0003 5% dust
zinc ion and manganese ethylene bisd itniocaroarnate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar—.
barnate 62%. (014504) plus carbaryl (056801)
. 0.04185-00384. . .- -..'•. .
&005.6003 5. 6% dust
zinc ion and manganese ethylene bisdithiocarbamate 80%, a coordi-
nation product of manganese 16%, zinc 2%,. ethylene bisdithiocar-
.•••;'.'•..•.•'• •' -"'•'.: r^barriavbe-62%.^ •'= ' •••'.-•• '"• -'•/V:-'''-1.: •'• :•'• ..-•'.•• v ..- • •'•: .••..-••: :: ' • ','•;•'•.
006735-00202 " ' - " '.
&'006. 0003 6% dust
zinc ion and manganese ethylene bisdithiocarbamate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar—
barnate 62% (014504)
... . 000400-00336 . QOOS02-00437 OO2935-O0354 OO7OO1-00333
' '.'.-,'^-\/•:•.. '!'•'•' -\^?:>659p^o636;i'.V:;Vo^i682:-tio>i^^ 042463-00043'. ':;'.'..
zinc ion and manganese ethylene bisdithiocarbamate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
bamate 62% (014504) plus carbaryl (056801)
023486-00069
sine ion and manganese ethylene bisdithiocarbarnate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
barnate 62% (014504), 1,1-bis(chloropheny1)-2,2,2-trichloroethan-
ol. (010501), carbaryl (056801) plus sulfur or sulphur (077501)
009404-00019
&006.4003 6. 4% dust
zinc ion and manganese ethylene bisdithiocarbarnate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
barnate 62% (0145O4)
002393-00197 010107-00092 010107-00100
Issued: 10-30-84 11-014504-59 200
-------
EPA Compendium of flcceotable Uses
ZINC I ON AND MflNGftNESE ETHYLENE BlSDITHIOCORBfiMftTE SO'/..
fl COORDINATION PRODUCT OF MftNGftNESE 16'/., ZINC £'/.,
ETHYLENE BISDITHIOCftRBfiMftTE 6£'/.
Listinq of Registered Pesticide Products by Formu iat i on (continued)
S-007. 0003 7% dust
zinc ion and manganese ethyl ene bisd ithiocarparnate SO'/., a coordi-
nation product of manganese 16'/«, zinc 2/£, ethylene bisd ith iocar—
barnate 62'/. (014504)
000904-00292 011656-00006
&OOS. 0003 8'/. dust
zinc ion and manganese ethylene bisd ithiocarbarnate SO'/., a coordi-
nation product of manganese 16'/-,. zinc £'/•, ethylene bisd ith iocar—
barnate 62% (014504)
000072-00544 000477-00263 000477-00230 000535-00237
000779-00105 000802-00428 001202-00256 001202-00257
001345-00010 001526-00502 002124-00601 008590-00132
008590-00289 009592-00003 009782-00034 014782-00007
034704-00029 034704-00188 042057-00060
&050...0003 50% dust .. . . .....:. .
zinc ion and manganese ethylene bisd ith iocarbarnate 80%, a coordi-
nation product of manganese IB'/-, zinc 2%, ethyiene bisd ith iocar—
barnate 62% (O14504)
042056-00006* ...
.:'• •:• •.••:•' ,; , '•-..';"• *current'l y.. .uriava i 1 able . for- review. .••.'.-: '. '• .• ' '.. ' .-. . . ... ',
&003. 9004 3. 9'/. granular . .
zinc ion and manganese ethylene bisd ithiocarbarnate 80%, a coordi-
nation product of" manganese 16'/-, zinc 2*/-., ethylene bisd ith iocar—
barnate 62"/. (014504) plus 2, 4-dich loro-6- (o-cnloroani 1 ino) -s-
triazine (080811)
&0.18. 0006 18'/. wet table powder
zinc ion and manganese ethylene bisd ithiocarbarnate SO'/., a coordi
nation product of manganese IS'/., zinc 2'/-, ethylene bisd ith iocar
barnate 62% (014504); lindane (garnrna isorner of benzene hexachlo-
ride) (009001); .2, 4-d initro-6-octy l*phenyl crotonate £, 6-d ini-
tro— 4— octy l*pheny 1 crotonate nitrooctyl phenols (principally
dinitro) *a mixture of 1-methy Iheptyl, 1-ethylhexyl and 1-pro-
pylpentyl (036001) plus carbaryl (056801)
000602-00 155#
ttsuspended
&040. 0006 40'/. wet table powder .
zinc ion and manganese ethylene bisd ithiocarbarnate SO'/., a coordi
nation product of manganese !&•/•, zinc 2%, ethylene bisdithiocar
barnate 62* (014504) plus carbaryl (056801)
001769-00190
Issued: 10-30-84 II-014504-6O
-------
EPfi Compendium of acceptable Uses .
ZINC ION AND MftNGflNESE ETHYLENE BISDITHIOCfiRBftMftTE SO'/.,
ft COORDINATION PRODUCT OF MANGANESE 1654, ZINC £?4,
ETHYLENE BISDITHIOCARBAMfiTE 62*
Listing of Registered Pest icice 'Products by Formulation (continued)
40'/. yget table powder (cont i nued )
zinc ion and manganese ethylene bisd ithiocarbarnate 30'/., a coordi-
nation product of manganese 16'/., sine 2%, ethylene bisdithiocar—
barnate 62'/. (014504) plus sulfur or sulphur (077501)
007001-00098
&048. 0006 48'/. wet table powder
sine ion and manganese ethylene bisd ithiocarbarnate 60''-, a coordi-
nation product of manganese IS'/-, sine £'/•, ethylene bisdithiocar-
barnate 62% (014504) plus N- (2, 6-d iniethy 1 pheny 1 ) -N- (rne't hoxyace-
tyl)alanine, methyl ester (113501)
000100-005£9
&060. 0006 SO'/, wet table powder
zinc ion and manganese ethylene bi sd ithiocarbarnate 80%, a .coordi-
nation product of manganese 16'/., zinc £%, ethylene bisdithiocai—
barnate 6£'/. (014504) plus th iophar.ate-rnethy 1 (10£001)
000372-00048
&070.. 0006 7O'/.. wet table powder . . .
" '•• ••• ; '••: ; zinc, ion and- manganese :'ethy-lene 'bi'sd ithiocarbarnate 80^, a' coordi-
nation product of manganese 16/*, zinc £'/-, ethylene bisd ith iocar-
barnate 6£'/. (014504) • . .
000707-00179
zinc ion and manganese ethylene bi sd i tn iocarbamate 80/4, a coordi-
nation, product of manganese 16'/-, zinc S/4, ethyiene bisd ith iocar—
... . bania,be. 6£/.. (0.14504). ..pi. us.. £,.4-dini tro-6-octy l*oneny 1 crotonate
y.;......... '. ..'-.': ';£V6^d'in.i.tr.o-4-.crct.y,l*pheny 1 crotonat'.e-. nt'troocty Iphenols- (princi-
pally dinitro) *a mixture of 1-rnethyIhepty 1, 1-ethylhexyl and
1-propylpentyl (036001)
008222-000037.
&073. 0006 7SV- wet table powder
zinc ion and manganese ethylene bisdithiocarbarnate 80%, a coordi-
nation product of manganese 16/4, zinc 2%, ethylene bisd ith iocar—
barnate 6£% (0145O4) plus 2,4-dinitro-6-octyl*pheny1 crotonate
2,6-d initro-4-octyl*pheny1 crotonate nitrooctyIphenols (princi-
pally dinitro) *a mixture of 1—rnethyIhepty 1, 1—ethylhexyl and
1-propylpentyl (036001)
000707-00093
Issued: 10-30-84 11-014504-61
202
-------
EPft Compendium of ftcceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
ft COORDINflTION PRODUCT OF MANGANESE 16%, ZINC £•/.,
ETHYLENE BI3DITHIOCARBAMATE Si'/.
List inn
Registered Pesticide Products by horrnulation (continued)
£074. 4406 74.44?. wettajle
sine ion ana manganese ethylene Disd itniocarbamate SO"/-, a coordi-
nation product of manganese 16'/-, zinc £'/•, ethylene bisd i th iocar-
barnate 62"/4 (014504) plus 2, 4-d i ni tro— 6— octy i*pheny 1 crotonate
2, 6-d initro-4-octy i*phenyl crotonate nitroocty Iphenois (princi-
pally dinitro) *a mixture of 1-rnethy Ihepty 1, 1-ethylh-exy 1 and
i-propylpentyl (036001)
002217-00514
&075. 0006 75'/. wet table -powder
zinc ion and manganese ethylene bi sd ithiocarbarnare SO'/, a coordi-
nation product of manganese 16/4, zinc £'/•, ethyiene bisd i th iocar-
barnate 6£'/- (O145O4)
000707-00180
&080. 0006 8O'/. wet tab ID powder
sine ion and manganese ethylene bisd ithiocarbarnate SO'/-, a coord i-
• •' nation product of manganese 16/4, zi?nc £#, ethylene bisd ith iocar-
barnate 6£'/. (014504)
OOO352-00341
000707-00087
.00£125-000.43. -.
004581-00358
009404-00013
(000707-00078
000352-O0341)
000539-00235
0008297-00224
.0022:17-00426
005887-OO052'
.042057-00091
000557-01938
000869-00084
003314-OOO69
007001-00273'
043981-OOOO9
000707-00078
001685-00065
OO4581-00357
008590-00555.
AL820024
CT800002
FL820056
6P80.001.3,
:.'i.-D.a00046''
KY800017
MI 800004
M08 10022
NC 800029
OK770011
OR800081
OR820009
PflS 10005
TN800013
TX 780041
VH760014
V0800017
Wfl 790062
WflS 10085
ft RS 10028
CT 8000 06
FL820O67
,.HI.790.020
, .-ibai-oossi :
MDS00007
MI 300005
M0820010
ND780009
OK810017
OR800082
Pft.770007
SC800006
TN810019
TX 790026
V0790008
VT770007
Wft800056
C0790124
FL770008
FL840O20
. HI 830006
•'KS78O005
MDSOO017
MI 80000 6
NC800004
NY770007
OR770059
OR800092
PP800013
SC 800009
TX 770007
TXS20017
Vft790023
Wft770048
Wfi800057
Ufl800107
FL6 10046
GftSOOOOa
... I.D790030.
• KY800O13
MD800021
MI810O16
NC800009
OH810010
OR790020
ORB 10089
PP800029
TN80O010
TX 77 00 12
UT80O009
VfiSOOOlS
WA780067
W0800090
Issued: 10-30-84
11-014504-62
203
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE 80%,
A COORDINATION PRODUCT OF MANGANESE 16%, ZINC 2%,
ETHYLENE BISDITHIOCARBAMATE 62%
Listing of Registered Pesticide Products by Formulation (continued)
&OS0.0007 60'/. wettable powder/dust
zinc ion and manganese ethylene bisd ithiocarbamate 80/4, a coordir
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
barnate 62% (014504)
000707-00097
$£30.0014 30% (£.85 Ib/qal) flowatale concentrate
zinc ion and manganese ethylene bisdithiocarbamate 80%, a coordi-
nation, product of manganese 16%, zinc 2%, ethylene bisdithiocai—
barnate 62% (014504)
043789-00049 043789-00050
S-232.0014 32% (3.48 Ib/qal) flowable concentrate
zinc ion and manganese ethylene bisd ithiocarbamate SO'/., a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
bamate 62% (014504)
. . ,, 000707-00162.. '.. ,-,. .... ... ... .
&237.0014 37% (4 Ib/oal) flowable concentrate
zinc ion and manganese ethylene bisdithiocarbamate 80%, a coordi-
nation product of manganese 16%, zinc 2%, ethylene bisdithiocar-
:. /..-'.'•' . .,-b'amat-e 62%.. C.0145.04 )•., v •.;•,,..•.•,:./•'•. .':..,•• •-..•••-. ,-• .--.';••' ..-. •..-.•..•.-.• ••'••
. : 060352-00398 000707-00156 0022935-00430*
*jacket currently avai-lable
(000352-00398
000707-00156)
OR820008 WA800036 WA850O04
S999999 State Label Registrations
AZ Reg. No.
011656-057S1
CA Reg. No.
001202-05046
011149-04665
006O23-03043
011169-04601
008278-10167 010972-07149
.011369-08782 011369-08813
.FL Reg. No.
007478-07993
009859-08983
021275-05539
007478-08020
009859-10166
009404-03476 009782-03651
014775-08733 014775-08734
Gft Reg. No.
000707-07617
Issued: 10-30-84
11-014504-63
204
-------
Compendium of ftcceptable Uses
ZINC ION AND MflNGflNESE ETHYLENE BISDITHIOCfiRBSMflTE SO'/-,
ft COORDINATION PRODUCT OF MANGANESE 16'/.. ZINC £•/..
ETHYLEiME BI SDITHIOCARBAMATE 6£"/.
Listing of Registered Pesticide- Products by Formulation (continued)
HI Reg. No.
000707-07621
MI Reg. No.
000635-OQ180
Pft Reg. No. .
000707-07612 .
TX Reg. No.
031143-04466
UT Reg. No.
042057-05784
Wfl Reg. No. . ' .
. 007404-06535 .. ,... . .;, ........ ........
Issued: 10-30-84 11-014504-64
205
-------
EPft Compendium of ftcceptable Uses
ZINC ION flND MftNGflNESE ETHYLENE BISDITHIOCPlRBftMflTE SO'/.,
«^COORDINftTION PRODUCT OF MfiNGPNESE 16'/., ZINC £'/-,
ETHYLENE BISDITHIOCflRBftMflTE be."/
flooendix fi-1
Listing of ftctive Ingredient (s) •
Report Chemical
Chemical Common Name
Code (source)
oaoaii
036001
081601 •
•qo-goor -..•;.
057701
113501
034001
anilazine (ISO)
056801 carbaryl
010501 dicofol
dinocap (ISO)
folpet
.I'indane.-.- '.
rnalat h ion
rnetalaxyl
rnethoxychlor
077501 sulfur
•
102001 thiophanate-rnethyl
—— Use Common Name
.'-ound in Combination with the
EPft flcceptable
Common/Chemical Name
£,4-dichloro-6-(o-
ch 1 oroan i 1 i no.) -s-
triazine
1,1-bis(chloropnen-
y1>-£,£,£-trichloro-
ethanol
£,4—dinitro—6—oc—
tyl*phenyi crotonate
£,6-d initro-4-octy1*-
phenyl crotonate
nitrooctyi phenols
(principally d.i.ni-
tro) *a mixture of
1-rnethylhepty 1,
1-ethylhexyl and
1-propy1penty1
lindane (gamma
isorner of benzene
hexachloride)
N-(£, 6-dirnethy 1- -
pheny 1) -N- (rnethoxy-
acetyl)alanine,
methyl ester
rnethoxychlor, techni'
cal ' •
sulfur or sulphur
Issued: 10-30-84
11-014504-65
206
-------
EPA Compendium of Acceptable Uses
ZINC ION AND MANGANESE ETHYLENE BISDITHIOCARBAMATE SO'/.,
A COORDINATION PRODUCT OF MANGANESE 16*, ZINC 2*,
ETHYLENE BISDITHIOCAR3AMATE 62*
Appendix A-£
Listing of Active Ingredient(s) Which May Be Included in Tank Mixes
Chemical
Code
080811,
008001.
039101
081701
036001
014505
06O101
102001
109901
Common Name
(source)
anilasine (ISO)
basic co.pper sulfate
benornyl
captafol
dinocao (ISO)
nianeb
thiabendazole
th iophanate-rnethy i
triad irnef on
EPA Acceptable
Common/Chem i ca 1 Name
.£, 4-dich loro-6- (o-
chloroani1ino)-s-
triasine
£:, A-dinitro-6-oc-
tyl*phenyi crotonate
i2, £-dini tro-4-octyl*-
phenyl crotonate
nit rooct y1ph eno1s
(principally dini-
. t r o): *a rn i x t ur e of •
1-rnethyihepty.l, '
1-ethylhexyl and
1-propy1penty1
£-(4-thiazoly1)ben-
z invi-da.sol.e .• • • '
1-(4-chlorophenoxy)—
3, 3-dirnethy 1-1- ( 1H-
1,2,4-triazoi-l-yl)-
2-butanone
083601
triphenyltin hydroxide
—- Use Common Name
Issued: 10-30-84
11-014504-66
207
-------
NOTE:
Pages 208 through 2^1
are left blank intentionally
- 241 -
-------
BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances, where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted.' The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
243
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BIBGUIDE-2
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
244
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00001949 Johansen, C.; Eves, J. (1969) Bee Research Investigations, 1969:
Small-scale Bee Poisoning Tests with Honey Bees (HB) and
Alfalfa Leafcutter Bees (LB). (Unpublished study received Sep
15, 1971 under 1F103Z; prepared by Washington State Univ., sub-
mitted by Hercules, Inc., Wilmington, Del.; CDL:091917-H)
00018842 Atkins, F..L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499; Research Report CF-
7501. (Unpublished study received May 8, 1971 under 1F1174;
prepared by Univ. of California—Riverside, Dept. of Entomology,
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090973-B)
00036094 Robinson, D.; Shillam, K.W.G. (1966) Toxicity of Dithane S.35, Di-
thane M.45 and Stam F.34 to Wild Birds: Report No. 1694/66/222.
(Unpublished study received Jun 11, 1970 under OF0932; prepared
by Huntingdon Research Centre, submitted by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:091587-U)
00040149 Gordon, ?; et al. (1967) Without title. Journal of the Associa-
tion of Official Analytical Chemists 50(5):1103-1108. (Incom-
plete article dealing with Ethylenebisdithiocarbamate residues;
also : In unpublished submission received Apr 3, 1972 under
2F1258; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
095544-C)
00040151 Rohm & Haas Company (1960) Determination of Micro Quantities of
Dithanes in Plants, Fruits, and Vegetables. Method 852-2 dated
Apr 25, 1960. (Unpublished study received Apr 3, 1972 under
2F1258; CDL:095544-E)
00040146 Schering, AG (1966) Method for Residue Determination of Promecarb
in Plant Material. Method no. 34 615/3 dated Jul 28, 1966.
(Translation; unpublished study received Apr 11, 1972 under
2G1262; submitted by Nor-Am Agricultural Products, Inc., Naper-
ville, 111.; CDL:095557-G)
00064927 Rohm and Haas Company (1970) Components of Residues from Dithane
M-45 in and on Leafy Plants: RAR Memorandum No. 571. (Unpub-
lished study received Aug 2, 1972 under 1F1050; CDL:091882-C)
00064930 Rohm and Haas Company (1970) The Fate of C14-Ethylene thiourea
Ingested by Dairy Cows: An Experiment to Determine the Occur-
rence of Residues and Metabolites in Milk, Tissues, and Excreta:
Research Report No. 23-22. (Unpublished study received Aug 2,
1972 under 1F1050; CDL:091882-F)
245
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID ' CITATION
00064931 Margolin, S. (1970) Feeding of C14 Labeled Ethylene thiourea to
Dairy Cattle to Obtain Samples of Milk, Tissues, and Excreta for
Residue Analysis: Contract No. 32-338-12-69. (Unpublished study
received Aug 2, 1972 under 1F1050; prepared by Affiliated Med-
ical Enterprises, Inc., submitted by Rohm & Haas Co., Philadel-
phia, Pa.; CDL:091882-G)
00064932 Rohm and Haas Company (1970) Isolation of C14 Activity in
Naturally Occurring Material from Substrates Treated with C14-
Dithane M-45: RAR Memorandum No. 576. (Unpublished study
received Aug 2, 1972 under 1F1050; CDL:091882-H)
00071616 Ciba-Geigy Corporation (1981) Study of Various Compounds for Res-
idue Tolerances in Potatoes: AG-A 4601. (Compilation; unpub-
lished study, including AG-A 4614, 4615, 4903..., received Apr
15, 1981 under 100-607; CDL:070020-A)
00080716 Harper, K.H.; Palmer, A.K. (1964) Toxicity of Dithane M 45 to the
Mallard Duck: 1000/64/215:2. (Unpublished study received Nov 9,
1965 under 6F0467; prepared by Huntingdon Research Centre, Eng-
land, submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
090519-B)
00080717 Harper, K.H.; Palmer, A.K. (1965) Toxicity of Dithane M-45 to the
Japanese Quail (Conturnix japonica): 1152/65/69. (Unpub-
lished study received Nov 9, 1965 under 6F0467; prepared by
Huntingdon Research Centre, England, submitted by Rohm & Haas
Co., Philadelphia, Pa.; CDL:090519-C)
00088826 Nash, R.G. (1976) Uptake of ethylenebis(dithiocarbamate) fungicides
and ethylenethiourea by soybeans. Journal of Agricultural and
Food Chemistry 24(3):596-601. (Also tn unpublished submission
received Dec 9, 1981 under 707-78; submitted by Rohm & Haas
Co., Philadelphia, Pa.; CDL:070528-H)
00088829 Hoagland, R.E.; Frear, D.S. (1976) Behavior and fate of ethyl-
enethiourea in plants. Journal of Agricultural and Food Chem-
istry 24(1):129-131. (Incomplete; also in unpublished submis-
sion' received Dec 9, 1981 under 707-78; submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL:070528-L)
00088931 Rohm and Haas Company (1969) A Study To Determine Residue Levels
in Milk and Tissues from a Cow Fed C14 Dithane M-45: Lab 23
Res. Rpt. No. 18. (Unpublished study received Dec 9, 1981
under 707-78; CDL:070528-N)
246
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00088833 Lyman, W.R.; Lacoste, R.J. (1975) New developments in the chemistry
and fate of ethylenebisdithiocarbamate fungicides. Pages 67-
74 In Environmental Quality and Safety: Supplement Volume III:
Pesticides: Lectures held at the IUPAC Third International
Congress of Pesticide Chemistry; Jul 3-9, 1974; Helsinki,
Finland. Edited by Frederick Coulston; et al. Stuttgart,
West Germany: Georg Thieme Publishers. (Also in unpublished
submission received Dec 9, 1981 under 707-78; submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:070528-P)
00088834 Saxton,' A.D. (1972) A C14-ethylene Thiourea Rat-feedi,ng Study:
An Experiment To Determine the Excretion Pattern and the Ac-
cumulation and Decline in Thyroid Tissues of C14 Residues:
Research Report No. 23-51. (Unpublished study received Dec
9, 1981 under 707-78; submitted by Rohm & Haas Co., Philadel-
phia, Pa.; CDL:070528-Q)
00088835 Saxton, A.D. (1972) A C14-Jaffe's Base Rat-feeding Study: An
Experiment To Determine the Excretion Pattern and the Accumu-
lation of C14 Residues in the Body Tissues: Research Report
No. 23-54. (Unpublished study received Dec 9, 1981 under
707-78; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
070528-R)
00088892 Rohm and Haas Company (1970) The Determination of Ethylene Thiourea
in Milk as the Diacetyl Derivative: RAR Memorandum No. 574.
Method dated Jul 2, 1970. (Unpublished study received Dec 9,
1981 under 707-78; CDL:070519-G)
00088894 Lyman, W.R. (1977) The Fate of Ethyl enebisdithiocarbamate Fungi-
cides in the Environment. (Unpublished study received Dec 9,
1981 under 707-78; submitted by Rohm & Haas Co., Philadelphia,
Pa.; CDL:070520-A)
00088921 Graham, W.H.; Bornak, W.E. (1972) Greenhouse Studies with C14-
Ethylene Thiourea on Potatoes and Tomatoes and Photodecomposi-
tion in Water: Laboratory 23 Research Report No. 23-52. (Unpub-
lished study received Dec 9, 1981 under 707-78; submitted by
Rohm & Haas Co., Philadelphia, Pa.; CDL:070525-G)
00088923 Rhodes, R.C. (1977) Studies with manganese 14C ethylenebis(di-
thiocarbamate) (14C maneb) fungicide and 14C ethylenethio-
urea (14C ETU) in plants, soil, and water. Journal of Agri-
cultural and Food Chemistry 25(3):528-533. (Also in unpublished
submission received Dec 9, 1981 under 707-78; submitted by Rohm
& Haas Co., Philadelphia, Pa.; CDL:070525-I)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00088924 Lyman, W.R. (1971) The metabolic fate of Dithane M-45. Pages 243-
256, In Pesticide Terminal Residues. London, England: Butter-
worths. (Also in unpublished submission received Dec 9, 1981
under 707-78; submitted by Rohm & Haas Co., Philadelphia, Pa.;
CDL:070525-J)
00088926 Rohm and Haas Company (1973) ETU Residues in Tomatoes Treated with
ETU and Potential ETU Precursors: TR 23-73-2. (Unpublished
study received Dec 9, 1981 under 707-78; CDL:070526-A)
00089871 Rohm & Haas Company (1962) Microdetermination of Dithanes in Milk,
Eggs and Animal Tissue. (Compilation; unpublished study re-
ceived Nov 15, 1962 under PP0382; CDL:090412-C)
00089873 Rohm & Haas Company (1962) Analytical Results and Residue Analysis
of Dithane M-45 on Grapes. (Compilation; unpublished study
received Nov 15, 1962 under PP0382; CDL:090412-E)
00089874 Rohm & Haas Company (1962) Dithane M-45 Residue Analysis: Toma-
toes. (Compilation; unpublished study received Nov 15, 1962
under PP0382; CDL:090412-F)
00089875 Rohm & Haas Company (1962) Dithane M-45 Residue Analysis: Sugar
Beets. (Compilation; unpublished study received Nov 15, 1962
under PP0382; CDL:090412-G)
00089879 Isenhour, L.L. (1962) Dithane M-45 Residue Analysis: Papaya.
(Unpublished study received Nov 15, 1962 under PP0382; submit-
ted by Rohm & Haas Co., Philadelphia, Pa.j CDL:090412-K)
00090132 Rohm & Haas Company (1962) Residues of Dithane M-45 on Bananas.
Includes method dated Apr 12, 1962 and method 852-2 dated Aug 2,
1955. (Compilation; unpublished study, including letter dated
May 8, 1961 from R.T Schuckert to Dr. Swisher, Mr. Kampmeier,
Dr. Levesque, et al., received Aug 1, 1962 under PP0374; CDL:
090403-C)
00090776 Rohm & Haas Company (1964) Residue Analysis and Analytical Method
(Additional Data). (Compilation; unpublished study received
Jan 2, 1964 under PP0422; CDL:090459-A)
00091500 Rohm & Haas Company (1966) Residue Summary: Dithane. (Compila-
tion; unpublished study received Feb 28, 1966 under 6F0467;
CDL:090518-A)
248
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00091501 Rohm & Haas Company (1964) Residue Summary: Dithane. (Compila-
tion; unpublished study received Feb 28, 1966 under 6F0467;
CDL:090518-E)
00091503 Rohm & Haas Company (1965) Residue Summary: Dithane. (Compila-
tion; unpublished study receivced Feb 28, 1966 under 6F0467;
CDL:090518-G)
00093258 Rohm & Haas Company (1965) Analytical Results of Dithane M-45
Residues. (Compilation; unpublished study received Nov 2, 1965
under 6F0476; CDL:090532-E)
00093259 Rohm & Haas Company (1964) Analytical Results of Dithane M-45
Residues: Cotton Seed. (Compilation; unpublished study re-
ceived Nov 2, 1965 under 6F0476; CDL:090532-F)
00093260 Rohm & Haas Company (1965) Analytical Results of Dithane Residues
in Peanuts, Peanut Hay and Grain Millings. (Compilation; un-
published study received on unknown date under 6F0476; CDL:
090532-G)
00093261 Rohm & Haas Company (1965) Analyses for Residues of Dithane in
Grain and Straw. (Compilation; unpublished study received on
unknown date under 6F0476; CDL:090532-H)
00093263 Rohm & Haas Company (1965) Analytical Results of Dithane M-45
Residues in Corn. (Compilation; unpublished study received Nov
2, 1965 under 6F0476; CDL:090532-J)
00093926 Rohm and Haas Company (1980) Acute Toxicity Report: Dithane M-45:
Report No. 79R-180. (Unpublished study received Jan 28, 1982
under 707-78; CDL:246662-B)
00093927 Rohm & Haas Company (1979) Toxicity of Dithane M-45 to Rabbits:
Report No. 79R-180. (Compilation; unpublished study received
Jan 28, 1982 under 707-78; CDL:246662-C)
00093928 Baldwin, R.C.; Hagan, J.V. (1982) Dithane M-45: Acute Inhalation
Toxicity Study in Rats: Report No. 81R-171. Final rept. (Un-
published study received Jan 28, 1982 under 707-78; submitted
by Rohm & Haas Co., Philadelphia, Pa.; CDL:246662-D)
00093929 Kam, C.; Stevens, K.R.; Gallo, M.A. (1980) Teratologic Evaluation
of Dithane M-45 in the Albino Rat: Volume I: Snell Project
# 10065-009. (Unpublished study, including letter dated Dec 4,
1979 from W,T. Lynch to Kent Stevens, received Jan 28, 1982
under 707-78; prepared by Booz, Allen & Hamilton, Inc., sub-
mitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:246663-A)
249
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00097021 Rohm & Haas Company (1966) Residue Summary: Dithane RH-539.
(Compilation; unpublished study received Nov 1, 1966 under
7F0625; submitted by ?; CDL:090817-I)
00097023 Rohm & Haas Company (1967) Residue Summary: Dithane M-45.
(Compilation; unpublished study received on unknown date under
7F0625; submitted by ?; CDL:090817-K)
00097024 Rohm & Haas Company (1967) Residue Summary: Dithane M-45.
(Compilation; unpublished study received on unknown date under
7F0625; submitted by ?; CDL:090817-L)
00097105 Wagner, F.E., Jr. (1966) Letter sent to C.F. Gordon dated Jul 18,
1966: Analytical results of pesticide residues. (Unpublished
study received Nov 7, 1966 under 707-78; submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL:024199-B)
00097109 Rohm & Haas Company (1969) Results of Tests on the Amount of
Residue Remaining in Crops Including a Description of the
Analytical Method: Dithane M-45. (Compilation; unpublished
study received Sep 24, 1972 under 2F1258; CDL:091789-B)
00097110 Rohm and Haas Company (1970) A Study To Determine Residue Levels
in Milk, Tissues and Excreta from Cows Fed Field-aged Residues
Due to Dithane M-45 on Alfalfa Hay: Research Report No. 23-21.
(Unpublished study received Aug 1, 1971 under 1F1050; CDL:
091880-B)
00097112 Rohm & Haas Company (1970) Results of Tests on the Amount of Res-
idue Remaining in Potatoes, Animal Tissues, Milk and Soil In-
cluding a Description of the Analytical Methods Used: Dithane
M-45. (Compilation; unpublished study received Aug 2, 1971
under 1F1050; CDL:091881-A)
00097113 Rohm & Haas Company (1971) =Dithane M-45 Residues in Potatoes).
(Compilation; unpublished study received Aug 3, 1972 under
1F1050; CDL:091883-A)
00097119 Rohm & Haas Company (1964) Residue Analysis and Analytical
Method. (Compilation; unpublished study received Nov 9, 1965
under 6F0467; CDL:092756-C)
00097123 Rohm & Haas Company (1968) Residue Studies of Dithane M-45 on
Potatoes. (Compilation; unpublished study, including RAR memo
no. 121, received Jan 23, 1969; Mar 26, 1968 under 8F0625;
CDL:092919-B)
250
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00097137 Rohm & Haas Company (1963) Residues of Dithane M-45 in Sugar
Beets. (Compilation; unpublished study received Apr 9, 1964
under 707-78; CDL:101461-A)
00097142 Rohm & Haas Company (1964) Residues of Dithane M-45 on Cotton
Seed. (Compilation; unpublished study received May 8, 1964
under 707-78; CDL:102562-A)
00097148 Rohm and Haas Company (19??) Status of Research on Dithane M-45
Residues. (Unpublished study received Oct 11, 1968 under 707-
78; CDL:119708-A)
00097151 Rohm & Haas Company (1962) Analytical Results on Dithane Residue:
Potatoes. (Unpublished study received-May 4, 1962 under un-
known admin, no.; CDL:119727-A)
00097167 E.I. du Pont de Nemours & Company, Incorporated (1971) Data Sup-
porting the Use of Benlate Benomyl Fungicide plus Manzate
200 Fungicide (Tank Mix) for Control of Certain Diseases
of Peanuts. (Unpublished study received on unknown date
under 352-341; CDL:126318-A)
00097173 McCann, J.A.; Pitcher, F. (1973) Dithane M-45: Bluegill (Lepo-
mis macrochirus): Test No. 544. (U.S. Environmental Pro-
tection Agency, Pesticides Regulation Div., Animal Biology Labo-
ratory; unpublished study; CDL:128295-A)
00097182 Parsons, R.D. (1979) Dithane M-45 Flowable Agricultural Fungicide:
Acute Toxicity Profile on the Formulated Product: Report
No. 79R-38. (Unpublished study received Jun 5, 1979 under 707-
156; submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:
238564-A) •
00097183 Rohm and Haas Company (1978) Analytical Report of Pesticide Res-
idues vi'a CS2 Method. (Unpublished study received Apr 23,
1979 under 707-78; CDL:238645-A)
00097231 Pease, H.L.; Holt, R.F.; Sutton, R. (1971) Ethylene Thiourea/Maneb
Residues on Field Sprayed Tomato Plants and Bean Plants. (Un-
published study received Mar 30, 1972 under 2F1256; submitted by
E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:
095150-B)
00097861 Rohm and Haas Company (1970) The Determination of Ethylene Thiourea
in Cow Tissues and Fat as the Diacetyl Derivative: RAR Memoran-
dum No. 590. Method dated Jul 23, .1970. (Unpublished study re-
ceived Dec 9, 1981 under 707-78; CDL-/ 319-H)
251
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00097862 Lyman, W.R. (1981) Residues in Milk and Meat from Cows Fed Alfalfa
Hay Having Residues from Dithane M-45: Technical Report No. 36F-
81-21. (Unpublished study received Dec 9, 1981 under 707-78;
submitted by Rohm and Haas Co., Philadelphia, Pa.; CDL:070519-J)
00098667 Interregional Research Project Number 4 (1973) Dithane M-45—Taro
Project. (Compilation; unpublished study received on unknown
date under 4E1508; CDL:094008-B; 094007)
00127950 Haines, L. (1980) Dithane M-45 Percutaneous Absorption in Rats:
. Technical Report No. 34F-80-9. (Unpublished study received
Apr 28, 1983 under 707-78; submitted by Rohm & Haas Co., Phila
delphia, PA; CDL:250063-D)
00126511 Krzywicki, K.; De Crescente, M. (1983) Toxicity Report: Dithane F-
45 Flowable Agricultural Fungicide: Report No. 83R 002A. Final
rept. (Unpublished study received Mar 7, 1983 under 707-156;
submitted by Rohm & Haas Co., Philadelphia, PA; CDL:249732-A)
00129291 Rohm & Haas Co. (1983) Residues: Dithane M-45. (Compilation;
unpublished study received May 13, 1983 under 707-78; CDL:
071599-A)
00131898 Rohm & Haas Co. (1982) Study: Dithane M-45 Residue on Corn.
(Compilation; unpublished study received Sep 6, 1983 under 707-
78; CDL:251204-A)
00142522 Kryzwicki, K.; Wargo, R. (1983) Toxicity Report: on Mithane M 45 DG
Fungicide: Final Report: 83R 086A. Unpublished study prepared
by Rohm and Haas Co. 9 p.
00145996 Hagan, J.; Baldwin, R. (1982) Dithane M-45: Acute Inhalation: Re-
port No. 81R-171. Unpublished study prepared by Rohm and Haas
Company. 9 p.
00147940 Rohm and Haas (1985) Product Chemistry Information—Dithane M-45.
Unpublished compilation. 476 p.
00148229 Watts, M. (1984) Acute Oral LD50 in B6C3F1 Mice with Dithane M-45
Fungicide: Report No. 83R 213A. Unpublished study prepared by
Rohm and Haas Co. 15 p.
00148230 Watts, M. (1984) Acute Oral LD50 in Fischer-344 Rats with Dithane
M-45 Fungicide: Report No. 83R 213B. Unpublished study prepared
by Rohm and Haas Co. 20 p.
252
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00148231 McGlynn-Kreft, A.; McCarthy, K. (1984) Ethylenethiourea Mammalian
Cell Transformation Test, Protocol 83P-58: Report No. 84R 0056.
Unpublished study prepared by Rohm and Haas Co. 27 p.
00148232 McLeod, P.; Doolittle, D. (1985) Dithane M-45 Mammalian Cell Trans-
formation Test for Promotion: Protocol No. 83P-057: Report No.
84R-297. Unpublished study prepared by Rohm and Haas Co. 33 p.
00148233 Chism, E. (1984) Dithane M-45; Microbial Mutagen Assay: [S-9 Pre-
pared from Aroclor 1254 Induced Fischer 344 Rats]: Report No.
84R-0059. Unpublished study prepared by Rohm & Haas Co. 10 p.
00148234 Chism, E. (1984) Dithane M-45; Microbial Mutagen Assay: [S-9 Pre-
pared from Aroclor 1254 Induced B6C3F1 Mice]: Report No. 84R-
0060. Unpublished study prepared by Rohm and Haas Co. 11 p.
00148235 McCarroll, N. (1984) Host Mediated Assay in Mice with Compound Di-
thane M-45: Final Report No. 84RC-025B (Definitive): Project No.
417-411. Unpublished study prepared by Hazleton Laboratories
America, Inc. 56 p.
00148236 McCarroll, N. (1985) Host Mediated Assay in Mice with Compound Di-
thane M-45: Final Report: Revised: Project No. 417-415. Unpub-
lished study prepared by Hazleton Laboratories America, Inc.
37 p.
00148237 Foxall, S.; Byers, M. (1985) Dithane M-45 CHO/HGPRT Gene Mutation
Assay: Report No. 84R-0207. Unpublished study prepared by Rohm
and Haas Co. 57 p.
00148238 Byers, M. (1985) Dithane M-45 in vitro Unscheduled DNA Synthesis
Assay: Report No. 84R-280. Unpublished study prepared by Rohm
and Haas Co. 32 p.
00148239 Sames, J.; McLeod, P.; Doolittle, D. (1984) Dithane M-45 in vivo
Cytogenetic Study in Fischer-344 Rats: Report No. 84R-246. Un-
published study prepared by Rohm and Haas Co. 47 p.
00149193 Ivett, J. (1985) Mutagenicity Evaluation of Dithane M-45 Fungicide
Lot No. 0842 (TD 83-224) Rohm and Haas Protocol No. 83P-54 in an
in vitro Sister Chromatid Exchange Assay 1n Chinese Hamster
Ovary (CHO) Cells: Final Report: Rohm and Haas Report No. 84RC-
60: LBI Project No. 20990. Unpublished study prepared by Litton
Bionetics, Inc. 38 p.
253
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00152696 Yen, S. (1985) Distribution of Radiolabeled Mancozeb Metabolites in
Soybeans: Technical Report No. 31L-85-18. Unpublished report
prepared by Rohm and Haas Co. 53 p.
00155843 Predmore, L.; Shaffer, S. (1986) Field Aged Mancozeb Residues on
Alfalfa Hay Feeding Study in Lactating Dairy Cows: Final Report:
ABC Study No. 33553. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 56 p.
00156715 Yen, S. (1986) Distribution of Radiolabeled Mancozeb Metabolites in
Sugar Beets: Report No. 31L-86-08. Unpublished study prepared
by Rohm and Haas Co. 361 p.
00159472 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Processed Apple Samples: Tech. Report No. 310-86-
12. Unpublished study prepared by Rohm and Haas Co. in coopera-
tion with Enviro-Bio-Tech, Ltd. 103 p.
00159473 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Processed Barley Samples: Tech. Report No. 310-86-
09. Unpublished study prepared by Rohm and Haas Co. in coopera-
tion with Enviro-Bio-Tech, Ltd. 41 p.
00159474 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Processed Corn Samples: Tech. Report No. 310-86-10.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech., Ltd. 58 p.
00159475 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Processed Grape Samples:. Tech. Report No. 310-86-
08. Unpublished study prepared by Rohm and Haas Co. in coopera-
tion with Env1ro-Bio-Tech., Ltd. 123 P.
00159476 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Processed Peanut Samples: Tech. Report No. 310-86-
07. Unpublished study prepared by Rohm and Haas Co. in coopera-
tion with Enviro-Bio-Tech., Ltd. 44 p.
00159477 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Processed Sugarbeet Samples: Tech. Report No. 310-
86-11. Unpublished study prepared by Rohm and Haas Co. 1n co-
operation with Enviro-Bio-Tech., Ltd. 43 p.
00159478 OTh'nger, J.; Lyman, W.; Larkin, R. (1986) Food Processing Studies
for Apples Treated with Mancozeb: Tech. Report No. 310-86-13.
Unpublished study prepared by Rohm and Haas Co. 1n cooperation
with National Food Laboratory. 90 p.
254
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00159479 01 linger, J.; Lyman, W.; Larkin, R. (1986) Food Processing Studies
for Grapes Treated with Mancozeb: Tech. Report No. 310-86-15.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with National Food Laboratory. 97 p.
00159480 Ollinger, J.; Lyman, W.; Larkin, R. (1986) Food Processing Studies
for Potatoes Treated with Mancozeb: Tech. Report No. 310-86-16.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with National Food Laboratory. 79 p.
00159481 Ollinger, J.; Lyman, W.; Larkin, R. (1986) Food Processing Studies
for Tomatoes Treated with Mancozeb: Tech. Report No. 310-86-14.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with National Food Laboratory. 108 p.
00159611 DiDonato, L.; Longacre, S.U986) Mancozeb Pharmacokinetic Study in
Rats: Report No.85R-123. Unpublished study prepared by Rohm &
Haas. 340 p.
00159612 Nelson, S. (1986) Metabolism of [Carbon 14] Mancozeb in Rat: [with
a Summary of ETU and EBDC Analyses in Plasma, Liver, and Thyroid
after Mancozeb Administration]: Technical Report No. 31H-86-02.
Unpublished study prepared by Rohm & Haas Co. 459 p.
00160703 Reibach, P. (1986) Distribution of Radiolabeled Mancozeb Metabo-
lites and Degradation Product in Wheat Plants: Technical Report
No. 31L-86-03. Unpublished study prepared by Rohm and Haas Co.
: 272 p.
00160704 Goldman, P.; Bernacki, H.; Quinn, D.; et al. (1986) Mancozeb:
Three-month Dietary Toxicity Study in Rats: Report No. 85R-167.
Unpublished study prepared by Rohm and Haas Co. 550 p.
00160705 Cox, R. (1986) Three-month Dietary Toxicity Study in Dogs [Using]
Mancozeb: Final Report: Project No. 417-416. Unpublished study
prepared by Hazleton Laboratories America, Inc. 517 p.
00160706 Hagan, J.; Fisher, J.; Baldwin, R. (1986) Mancozeb: Two-week Inha-
lation Toxicity Study in Rats: Final Report: Report No. 85R-190.
Unpublished study prepared by Rohm and Haas Co. 209 p.
00160707 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU for
Carrot Residue Samples: Analytical" Report No. 31A-86-06. Unpub-
lished study prepared by Rohm and Haas Co. in cooperation with
Enviro-Bio-Tech, Ltd. 133 p.
255
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00160708 Rohm and Haas Co. (1976) Residues of Mancozeb and ETU in Potato
Tubers. Unpublished compilation. 531 p.
00160709 Rohm and Haas Co. (1972) Residues of Mancozeb and ETU in Tomatoes.
Unpublished compilation. 433 p.
00160710 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU for
Cucumber Residue Samples: Analytical Report No. 31A-86-10.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 90 p.
00160711 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU for
Melons: Analytical Report No. 31A-86-09. Unpublished study pre-
pared by Rohm and Haas Co. in cooperation with Enviro-Bio-Tech,
Ltd. 83 p.
00160712 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU for
Summer Squash Residue Samples: Analytical Report No. 31A-86-13.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 150 p.
00160713 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU for
Winter Squash Residue Samples: Analytical Report No. 31A-86-14.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 95 p.
00160714 Rohm and Haas Co. (1981) Residues from Mancozeb Fungicide in Wheat
Grain, Wheat Milling Fractions, and Wheat.Straw. Unpublished
compilation. 289 p.
00160715 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU for
Asoaragus Residue Samples: Analytical Report No. 31A-86-07.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 63 p.
00160716 Rohm and Haas Co. (1972) Residues of Mancozeb and ETU in Bananas.
Unpublished compilation. 321 p.
00160717 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Barley Samples: Analytical Report No. 31A-86-18.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 112 p.
00160718 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU
Residues for Celery Samples: Analytical Report No. 31A-86-11.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 186 p.
256
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00160719 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Field Corn Samples: Analytical Report No.
31A-86-08. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Enviro-Bio-Tech, Ltd. 181 p.
00160720 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Sweet Corn Samples: Analytical Report No.
31A-86-15. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Enviro-Bio-Tech, Ltd. 167 p.
00160721 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU
Residues for Cranberry Samples: Analytical Report'No. 31A-86-16.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 128 p.
00160722 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Grape Samples: Analytical Report No. 31A-86-25.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 147 p.
00160723 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU
Residues for Onion Samples: Analytical Report No. 31A-86-17.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 186 p.
00160724 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Papaya Samples: Analytical Report No. 31A-86-22.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 105 p.
00160725 Satterthwaite, S. (1986) Analytical Reports of Mancozeb and ETU
Residues for Peanut Samples: Analytical Report No. 31A-86-26.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 125 p.
00160726 Satterthwaite, S. (1986) Analytical Reports of Dithane and ETU
Residues for Sugarbeet Samples: Analytical Report No. 31A-86-12.
Unpublished study prepared by Rohm and Haas Co. in cooperation
with Enviro-Bio-Tech, Ltd. 222 p.
00160727 Rohm and Haas Co. (1985) Determination of ETU [and Mancozeb in
Cotton]. Unpublished compilation prepared in cooperation with
Enviro-Bio-Tech and E.I. du Pont de Nemours and Co, Inc. 11 p.
257
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.E OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
00160780 Schweitzer, M. (1986) Distribution and Identification of Radiola-
beled Mancozeb Metabolites in Dairy Goats: Technical Report No.
31L-86-04. Unpublished study prepared by Rohm and Haas Co. in
cooperation with ABC Laboratories. 343 p.
00160781 Smith, S. (1986) Metabolism Study of [Carbon 14] Radiolabeled
Mancozeb in Laying Hens: Technical Report No. 31L-86-07. Unpub-
lished study prepared by Rohm and Haas Co. 338 p.
00160782 Hagan, J.; Fisher, J.; Baldwin, R. (1986) Mancozeb: Subchronic In-
halation Toxicity Study in Rats - Thirteen-week Interim Report:
Project No. 86R 003. Unpublished study prepared by Rohm and
Haas Co. 413 p.
00162913 Rohm and Haas Co. (1986) Residue Analytical Methods for Ethylene-
bisdithiocarbamate Fungicides. Unpublished study. 24 p.
00164509 Yeh, S. (1986) Additional Investigation of Radiolabeled Mancozeh
Metabolites in Soybeans: Addendum to Technical Report No. 31L-
85-18: Technical Report No. 310-86-55. Unpublished study pre-
pared by Rohm and Haas Co. 135 p.
00164510 Reibach, P. (1986) Distribution of Radiolabeled Mancozeb Metabo-
lites and Degradation Products in Wheat Plants: Addendum to
Technical Report No. 31L-86-03: Technical Report No. 310-86-54.
Unpublished compilation prepared by Rohm and Haas Co. 121 p.
00164640 Yeh, S. (1986) Mancozeb and ETU Storage Stability Study on Apple,
Tomato an'' '/heat: (Interim Study): Technical Report No. 310-
86-148: 310-86-43. Unpublished study prepared by Rohm & Haas,
Spring House Research Laboratories.. 132 p.
00164641 Yeh, S. (1986) Eighteen-month Mancozeb Storage Stability Study on
Grapes: Technical Report No. 310-86-53. Unpublished study pre-
pared by Rohm & Haas Co., Spring House Research Laboratories.
14 p.
00164879 Schweitzer, M. (1986) Isolation and Characterization of Radio-
labeled Mancozeb: Metabolism Tissues of Lactatfng Dairy Goats:
Technical Report No. 310-86-45. Unpublished study prepared by
Rohm and Haas Co. 152 p.
00164880 Smith, S. (1986) Addendum to Metabolism Study of [Carbon 14] Radio-
labeled Mancozeb in Layin'g Hens: Technical Report No. 310-86-52.
Unpublished study prepared by Rohm and Haas Co. 266 p.
258
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
40019501 Yeh, S. (1986) Mancozeb Residues on Crops—Time Intervals from Har-
. •: ' vest to Analysis for Mancozeb or Ethylenethiourea (ETU): Labora-
• tory Project Identification: 310-86-155. Unpublished study pre-
pared by Rohm and Haas Co. 27 p.
40065801 Bontoyan, W.; Looker, J.; Kaiser, T. et al (1972) Survey of
Ethylenethiorea in Commerical Ethylenebisdithiocarbamate
Formulations. Journal of the AOAC. 55(5): 923-925
40065802 Onley, J. (1977) Gas-Liquid Chromatographic Method.for Determining
Ethylenethiourea in Potatoes, Spinach, Applesauce, and Milk:
Collaborative Study. Journal of the AOAC. 60(5): 1111-1115.
40065803 Onley, J.; Giuffrida, L.; Ives, F. et al (1977) Gas-Liquid
Ghromatography and Liquid Chromatography of Ethyl enethiourea
in Fresh Vegetable Crops, Fruits, Milk, and Cooked Foods.
Journal of AOAC. 60(5) 1105-1110.
40065804 Onley, J.; Yip, G. (1971) Determination of Ethylene Thiourea
Residues in Foods, Using Thin Layer and Gas Chromatography.
Journal of AOAC. 54(1): 165-169.
40118501 U.S. EPA, (1980) Biological Report of Analysis of Dithane-45;
96-hour LC50 (Bluegill): Static Jar Test 2444. Prepared
by Terrestrial and Aquatic Biology Laboratory, Beltsville
MD. 5 p.
40118502 U.S. EPA, (1980) Biological Report of Analysis of Dithane-45;
96-hour LC50 (Rainbow Trout): Static Jar Test 2447. Pre-
pared by Terrestrial and'Aquatic Biology Laboratory, Belts-
ville MD. 5 p.
40118503 U.S. EPA, (1980) Biological Report of Analysis of Dithane-45;
48-hour EC50 (Daphnia magna): Static Jar Test 2460. Pre-
pared by Terrestrial and Aquatic Biology Laboratory, Belts-
vine MD. 3 p.
40121001 Pease, H.; Holt, R. (1972) Residue Studies on Crops Treated with
Ethylenebisdithiocarbamate Fungicides. Unpublished Status
Report dated 11/1/72. Prepared by E.I. du Pont de Nemours &
Company. 17 p.
40121002 Gerhold, N. (1972) Analytical Results for Ethylene Thiourea (ETU)
Residues: Potato. Sample Code Nos. 72-22, 72-23 and 72-26
Notebook Reference LDH 28409. Unpublished compilation prepared
by Rohm and Haas Company. 44 p.
259
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mancozeb Standard
MRID CITATION
40121003 Rohm and Haas Company (1972) Analytical Results for Ethylene
Thiorea (ETU) Residues: Potato. Sample Code No. 72-111; Notebook
Reference 28416. Unpublished study. 25 p. '
40122601 Cetas, R. (1971) Analytical Results for Ethylene Thiourea (ETU)
Residues: Potatoes. Sample Code, 2-71-275. Unpublished study
prepared by Rohm and.Haas Company. 26 p.
40122701 Skall, G. (1973) Analytical Results of Dithane/ETU Residue:
Potatoes. R.A.R. 2-72-128. Unpublished study prepared by
Rohm and Haas Company. 26 p.
40122801 Stelter, T. (1972) Analytical Results for Ethylene Thiourea (ETU)
Residues: Celery. Sample Code Nos. 2-72-045, 2-72-048, 2-72-
049 and 2-72-053; Notebook Reference LDH 28416. Unpublished
Compilation prepared by Rohm and Haas Company. 47 p.
40122802 Stelter, T. (1972) Analytical Results of Dithane M-45 Residues:
Celery. R.A.R. Nos. 2-72-045, 048, 049 and 053 dated October
23, 1972. Unpublished study prepared by Rohm and Haas Company.
7 p.
40128801 Rohm and Haas Company (1986) Submission of Crop Residue Data:
Pears, in response to Mancozeb Data Call-In dated
October 19, 1984.
40128802 Rohm and Haas Company (1986) Submission of Crop Residue Data:
Apples, in response to Mancozeb Data Call-In dated
October 19, 1984.
260
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APPENDIX V
Forms
261
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OMB Approval Ho. 2000-C46S
FIFHA SECTION 3(CI(2H6) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With rejpect 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:
1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I endow the protocols that I will UK:
[j 2. I have entered into in 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
D 3. I encloss a complated "Certification of Attempt to Enter Into an Agriement with Other Registrants for Oevalopmant of Data" with
respect to the following data requirements:
D 4. I request that you imand my rtgismtion by delating the following utes (this option is not available to applicants for new products):
D 5. I riqueit voluntary cancillation of thi registration of this product (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form S680-1 (10-82)
262
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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
1. I am duly authorized to represent the following firrn(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) rf final agreement on all termi could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
EPA Form 8580-8 (10-62)
SIGNATURE
DATE
263
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PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
§153.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
<
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity^
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
264
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage •
Acute oral
toxicity, rat .
Acute dermal
toxicity,' rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion .
Test not
required
for my .
product
listed
abov,e .
(check
below)
,
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
-
•
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
265
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OMB Approval No. 2070-0057
Expiration Date 11/30/89
"GENERIC" DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the
active ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient, solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are
My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
266
EPA Form 8570-27
*U. S. GOVERNMENT PRINTING OFFICE 1987: 716-002/60685
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