£EPA
United States
Environmental Protection
Agency
Off ice of
Pesticides and Toxic Substa
Washington DC 20460
Pesticides
April 1987
Guidance for the
Reregistration of
Pesticide Products
Containing NABAM
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
NABAM
t.
AS THE ACTIVE INGREDIENT
GS-0641
CHEMICAL ABSTRACTS SERVICE (CAS) NUMBER: 142-59-6
EPA SHAUGHNESSY CODE: 014503
APRIL 1987
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C.
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TABLE OF CONTENTS Page
GLOSSARY OP TERMS AND ABBREVIATIONS
I. Introduction ,
II. Chemical(s) Covered by this Standard 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment ........ 10
A. Summary
B. Toxicology Characteristics
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale. . 27
A.. Regulatory Positions
B., Criteria for Registration
C. Acceptable Ranges and Limits
D.. Required Labeling'
I V., Products Subject to this Standard ... .. ... ......... . 35
VI. Requirement for Submission of Generic Data 37
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
i
i VII. Requirement for Submission of Product-Specific Data . .. 43
i
VIII.. Requirement for Submission of Revised Labeling 44
IX.. Instructions for Submission. . . .. .. ., . .......... 44
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 48
Guide to Tables
Table A
Table B
II. LABELING APPENDICES .. 76
Summary of label requirements and table
40 CPR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide' Disposal Instructions
Container" Disposal Instructions
III. USE INDEX APPENDIX 94
IV. BIBLIOGRAPHY APPENDICES ...139
Guide to Bibliography
Bibliography
W FORMS APPENDICES .. . 146
EPA Form 8580-1. PIFRA §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
11
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GLOSSARY OP 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).,
ai: 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-
i line requirements and thus do not
! support registration of a product..
in
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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"
PIPRA: 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.
LC5Q: (median lethal concentration): a statistically derived
concentration of a substance that can be expected to
cause death in 50 percent of test animals, expressed
as weight or volume of test substance per volume of
air o.r water or per weight of feed (e.g., mg/L or
ppm)... • •
(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.
MP-I: 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)
ppra: 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
daily 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.
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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-1-, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from civailable data in its files pertaining to the pesticide
1The 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 OF CHEMICAL
Common Name: Nabam
Chemical Name: Disodium ethylene bisdithiocarbamate
Chemical Abstracts
Service (CAS) Number: 142-59-6
EPA Shaughnessy Number: 014503
Empirical Formula:
Trade Names: Chem Bam; Dithane D-14; Dithane A-40; DSE;
Nabasan; Parzate; Spring-Bak.
B. USE PROFILE
Type of Pesticide: Broad spectrum fungicide.
Pests Controlled: Bacteria, fungi, algae, protozoa
Registered. Uses: Industrial sites (cooling towers, evaporative
condensers, air washer systems, secondary oil
recovery water and drilling fluids, pulp and
paper mills, cane sugar mills, beet sugar mills).
All registered food (except for use in sugar mill
flume water) and ornamental uses of
nabam, a total of 35, are currently suspended.
Technical nabam products may not be formulated
into end-use products for field or food crop uses.
Predominant Uses: Water cooling towers.
Mode of Activity: Enzyme activity inhibition.
Formulation Types Registered: Formulation Intermediates -
22.5, 25, and 30% nabam.
Ready-to-Use - 3.75 to 22% nabam.
Soluble Concentrate - 22% or 93% nabam.
Methods of Application: In industrial uses, nabam is added
directly to water either by a single
dose or continuous feed.
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Major Uses: Domestic usage of nabam as a pesticide (Typical
current year basis (1983-1985)):
Sector Ibs. x 1,000 Percent
Cooling Water 475 40
Sugar " 425 37
Paper 275 23
Totals 1175 100
C. BACKGROUND
Nabam 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, to protect
harvested products from deterioration, or as industrial biocides.
The chemical structure of nabam and the other EBDC's (amobam,
maneb,. metiram, mancozeb, 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, nabam is completely soluble
in water. 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 whi-te crystalline solid that is
soluble in water but insoluble in common organic solvents.
EBDC residues, in or on foods, are known to convert readily to
ETU during commercial processing or home cooking.
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. This process is 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
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.
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Figure 1
ETHYLENE THIOUREA (ETU)
H S
CH-, - N - C
I
CH2 - N - C'
I II
H S
C = S
NABAM
H S
1 II
CH2 -N-C-S-Na
CH2-N-C-S-Na
I II
H S
AMOBAM
H S
I II
CH2 - N - C - S - NH4
I
CH2-N-C-S-NH4
\ II
H S
MftNEB
H S ~
I II
- N - C - S -
CH2 -
f2
CH2
ZINEB
H S
1 II
- N - C -
- N - C -
\ 11
H S
S -
S - Zn
MANCOZEB
METIRAM
H S
1 11
CH2-N-C-S-
CH->-N-C-S-Mn
I 11
H S
Zry
X
H S
1 11
CH2 - N - C"- S -
CH2 - N - C - S - Zn(NH3) —
1 11
H S
H S
1 11
CH2-N-C-S-
1
CH2-N-C-S-
1 II
J3 H S
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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 on all EBDC's reporting on the results of
the evaluation. This evaluation resulted in the following
conclusions.
1. The potential risk o'f 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. Addit-ional 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 needs identified at that time included:
a. Metabolism studies designed to define the in_ 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.
d. Mammalian cell transformation assays on each of 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.
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Since issuance of the Decision Document, the Agency has issued
five data call-in notices for nabam as follows:
1. January 17, 1983: This notice required the submission of
the metabolism, dermal penetration and mutagenicity data
identified in the 19m82 Decision Document.
2. July 25, 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 nabam, 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
for the agricultural uses only.
3. October 19, 1984: This notice required dietary exposure,
product chemistry and toxicological (subchronic feeding and
inhalation) data considered necessary to reassess the
registration status of nabam.
4. March 20, 1985: This notice required registrants of
pesticide products containing nabam to submit all outstanding
data requirements as outlined under 40 CFR 158 regulations
for disciplines including product chemistry, toxicology,
wildlife and aquatic organisms, and envirnomental fate.
5. 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 - ETU) and residue data for ETU as well as
nabam.
The data required by these call-in notices to support the
continued registration of nabam products have been received
and considered by the Agency in its evaluation of nabam, as
presented in the assessment section of this Standard. Nabam
technical product registrations were amended in 1985 to
include a restriction which prohibited the use of such products
for formulation into pesticide products to be used on field
or food crops. Moreover, all registered end-use nabam products
with agricultural field or food crop uses have been suspended
because the registrants of the products did not commit to
submit (and failed to provide evidence that they were taking
steps to submit) the data required to support continued
registration of the agricultural field or food crops uses of
nabam, following the decision by the basic nabam produ.'eer not
to support those uses. Due to the prohibition on the use of
technical products, as noted above, and the suspension of., the
end-use products with agricultural field or food crop uses,
there are no remaining agricultural food or field crop uses
of nabam pesticide products. Some suspended end-use nabam .
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pesticide products are also labeled for terrestrial non-food
uses; no other nabam pesticide products are labeled for
terrestrial non-food uses. Therefore, as in the case of
agricultural field or food crop use, all terrestrial non-food
use of nabam pesticide products are currently suspended.
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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 nabam
is the hazard to the human thyroid from presence of
ethylenethiourea (ETU), a contaminant, degradation product,
and metabolite present in nabam and other EBDC products.
Additional chronic studies on nabam are required for
further evaluation.
2. ETU has caused developmentally toxic/teratogenic
effects in rats and hamsters. There are no adequate
teratology studies on nabam. Teratology studies
with nabam are required before its teratogenicity can be
fully assessed.
3. ETU has been classified as a Group B2 carcinogen in accordance
with the Agency's Guidelines for Carcinogen Risk Assessment
(September 26, 1986, 51 CFR 33992), based on studies which
show that it induced an increased incidence of thyroid
adenomas and adenocarcinomas in rats and hepatomas in mice.
4. Because of the presence of ETU in nabam, the Agency is
considering whether further regulatory actions are
warranted.
As a result of this review, the Agency has identified missing
data needed to further evaluate the environmental and human
risks associated with the use of nabam. These data must be
submitted in order to maintain registrations of products or
register new products containing nabam. 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.
The Agency has also determined that certain label restrictions
or revisions are necessary in order for nabam products to
remain in compliance with FIFRA, 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.
10
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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 nabam.
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Table 1.
Summary of Data Gaps for Nabam*
Nabam
Product Chemistry - All
Residue Chemistry - Plant and animal metabolism
Residue studies
Toxicology - Acute dermal and inhalation toxicity
Primary eye and dermal irritation
21-Day subchronic dermal toxicity
Chronic toxicity (rodent and nonrodent) (food uses)
Oncogenicity (rat and mouse)(food uses)
Teratology (rabbit and rat)
Reproduction (rat)(food uses)
Mutagenicity (gene mutation, cell transformation,
unscheduled DNA sysnthesis)
Ecological Effects - Avian oral toxicity
Avian dietary toxicity
Freshwater fish toxicity
Freshwater invertebrate toxicity
Estuarine and marine organism toxicity
Aquatic, organism accumulation
Simulated or actual field testing-aquatic
organisms
Nontarget area phytotoxicity-aquatic plant
growth
Environmental Fate - Hydrolysis
Photodegradation (water, soil)
Aerobic and anaerobic soil metabolism
Aerobic and anaerobic aquatic metabolism
Leaching and adsorption/desorption
Volatility (laboratory)
Field dissipation (terrestrial/aquatic)
Rotational crops (confined)
Fish accumulation
Reentry protection studies
Ethylenethiourea (ETU)
Toxicology - Chronic (rodent and non-rodent)
Reproduction
Dermal (percutaneous) absorption
Mutagenicity (promotion)
Environmental Fate - Hydrolysis
Photodegradation (soil and water)
Aerobic and anaerobic soil metabolism
Leaching and adsorption/desorption
Degradation (soil)
*Refer to Appendix A, Data Tables, for detailed information
12
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B. PRELIMINARY RISK ASSESSMENT
Toxicoloqical Studies - Nabam. In its review of nabam,
the Agency has considered the available data as summarized
below:
1. Acute Toxicity and Irritation Studies. Adequate data
are available to define the acute oral toxicity of
technical nabam products (LD5o=395 mg/kg/bw) as moderately
toxic (Toxicity Category II). There are no valid data to
characterize the acute dermal and inhalation toxicity or
eye and skin irritation of technical nabam. These studies
are required to support the continued registration of
nabam products.
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 potent, skin sensitizers. A study in the
open literature reported that a sensitization reaction in
humans was noticed following exposure to a 19% nabam
solution. This study adequately demonstrates that nabam
is a skin sensitizer and no further dermal sensitization
data are required at this time.
2. Subchronic Testing
Oral (Rodent, Nonrodent) Studies. There is no valid subchronic
90-day feeding study for either rodents or nonrodents available
on nabam. These studies are not required to support the
continued registrations of nabam for non-agricultural, industrial
uses. Continued registrations of nabam products for
terrestrial food uses where tolerances need to be established
require chronic feeding studies in both rodent and non-rodent
species. If chronic studies are conducted to support the
food uses of nabam, the 90-day feeding study for agricultural
and domestic non-food uses would not be necessary.
Dermal Studies. No adequate subchronic dermal studies
T21-day or 90-day) are available for review. Because
of the potential for accidental or incidental human
exposure during the application of nabam, a subchronic
dermal study (21-day) is required to support the continued
registration of all uses of nabam.
Inhalation Studies. There is no adequate subchronic
inhalation toxicity study for nabam. This study is normally
required to support the continued registration .of products
which consist of, or whose uses result in an inhalable
material such as a gas, volatile substance, or aerosol. The
Agency is reserving this requirement for nabam products
applied as sprays, or having the potential for. inhalation
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exposure, pending the result of an acute inhalation study
to determine if repeated exposure is at a concentration
likely to be toxic.
3 . Chronic Testing
Chronic Toxicity Studies. There are no adequate studies
defining long-term effects of nabam adminis'tration.
These studies are not required to support the registration
of products for non-food uses. For those nabam products
registered for use on food crops, use directions generally
specify application as part of an aqueous solution which
includes zinc sulfate. The zinc displaces the sodium in
nabam to form zinc ethylene bisdithiocarbamate (zineb).
Therefore, it is not evident what material or mixtures of
materials should be tested. An additional consideration
is that one of the major metabolites of nabam and the other
EBDC pesticides, ETU, has been demonstrated to have toxic
effects (including oncogenicity) to the thyroid. It is
not certain what effects the presence of zinc would have
with respect to the formation of ETU or the rate at which
ETU could be absorbed in the digestive tract. The requirement
for long-term feeding studies to support the registration
of products for food use would require preliminary studies
to determine what material should be tested.
Oncogenicity Studies. No studies assessing the oncogenicity
of nabam in rodents are available. Oncogenicity testing
is required to support each manufacturing-use product if the
active ingredient or any of its metabolites is structurally
related to a recognized carcinogen, causes mutagenic effects
or produces in subchronic studies a morphological effect
in any organ that may lead to a neoplastic change.
At this time, the Agency believes that the potential of
human exposure to nabam or its major metabolite, ETU,
is negligible from the use of nabam in most industrial
settings. The chemical is sold as ready-to-use formulations
in bulk containers and applied by trained and experienced
applicators. The labeling requires protective clothing
when handling nabam including gloves, face shields,
coveralls, and boots. For the most part, application is
made using automatic metering systems. In those situations
where nabam is applied by hand (such as with a cup or
small container) protective clothing serves to eliminate
significant exposure.
SPA lacks data on exposure to nabam from the metalworking
fluid and tanning uses. The Agency is requiring additional
chronic data and information on exposure to nabam for
these, and other industrial uses.
To support registrations of products for use on food and
agricultural and domestic non-food uses, oncogenicity
studies on nabam (or a mixture of nabam and zinc sulfate)
are required.
14
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Teratology Studies. There are no adequate teratogenicity
studies on nabam. Because of indications that ETU is
teratogenic, studies are required on two mammalian species
(preferably the rat and rabbit) to support all registered
nabam uses.
Reproduction Studies. There are no adequate reproduction
studies on nabam. Based on the limited and primarily
dermal human exposure potential, a two-generation reproductive
study is not required for industrial uses. This study is,
however, required to support the continued registration
of nabam products registered for use on food crops and
agricultural and domestic non-food uses.
Mutaqenicity Studies. A number of mutagenicity studies
with nabam have been recently submitted and reviewed by
the Agency. An Ames reverse mutation assay on-Salmonella
was conducted and no mutagenic response was observed in
the absence of S9 activation. However, unacceptably high
spontaneous background mutation frequencies occurred in
two of five tested strains with rat and mouse S9 activation.
The assay results were, therefore, considered questionable
and the study must be repeated.
Male mice innoculated with S_. typhimurium strain TA1530
were orally dosed with a solution containing 30% nabam.
Under the conditions of the assay, a mutagenic response
was not induced in the target bacterial cells. This study
is acceptable.
In a Chinese hamster ovary (CHO) cell forward mutation assay,
the test material did not induce a mutagenic response
with or without mouse S9 activation. However, with rat S9
activation there was a significant increase in the mutation
frequency at the highest dose tested. Since the effect
occurred at a moderately cytotoxic level, higher doses
should have been assayed to determine whether the response
was valid or artifactual. This study is inconclusive and
must be repeated.
In. a sister chromatid exchange (SCE) assay in CHO cells,
nabam did not induce a genotoxic response at four activated,
cytotoxic doses. In the presence of rat and mouse S9
activation, significant increases in sister chromatid
exchanges were observed at higher dose levels and nabam
is presumed to be positive for genotoxicity. However,
this study is inconclusive because moderate to marked
mitotic delays, as indicated by a considerable number of
first division metaphases, were observed at most of the
dose levels of nabam under both activated and nonactivated
conditions. This study must be repeated using lower dose
levels and longer cell exposure times than in the previously
submitted study.
15
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An in vivo bone marrow cytogenetic assay was conducted.
Under the conditions of the assay, the acute or subacute oral
exposure of male rats to nabam did not cause a clastogenic
response. In the acute part of the study, a Maximum Tolerated
Dose (MTD) was not demonstrated. Therefore, the acute
study is unacceptable and must be repeated at a sufficiently
high dose of nabam to elicit a toxic or cytotoxic effect.
The subacute study is acceptable and does not need to
be repeated.
In a transformation assay, nabam with S9 activation, did
not induce neoplastic transformation in C3H-10T 1/2 cells;
a cytotoxic effect was achieved at the highest dose.
In the presence of rat S9 activation there was no
increase in the number of transformed foci; however,
the highest dose of nabam tested was not cytotoxic.
Therefore, the nonactivated study is acceptable and the
rat S9 activated study is determined to be unacceptable.
Nabam did not exhibit promoter activity at the single
dose evaluated in the cell transformation assay for
promotion. Since it is possible that nabam was not assayed
at an effective level, the study is unacceptable and
should be repeated in a more appropriate cell line.
In an unscheduled DNA synthesis (UDS) assay, a significant •
increase in mean net nuclear grain counts was seen in
primary rat hepatocytes exposed to the highest non-cytotoxic
dose (5.0 ug/ml) of nabam. Increased UDS activity
occurred at levels below 5.0 ug/ml as well as at 10
ug/ml. At doses above 10 ug/ml, there was no cell
survival. Nabam is presumed to induce UDS, but the
study is classified as inconclusive and must be repeated.
Since the results of most of these assays are inconclusive
and must be repeated, a decision on the mutagenic potential
of nabam cannot be made at this time.
Metabolism Studies. The Agency has conditionally accepted,
pending the submission of further information on the study,
a rat metabolism study demonstrating that both by oral
and intravenous administration more than 90% of the total
l^c was excreted in urine and feces over the next 168
hours (7 days), with most of this excretion occurring
in the initial 24 hours.
A high proportion of the radioactivity excreted both in
urine and feces was tentatively identified as ethylene
thiourea (ETU). In the feces, the ETU fraction was
highest (>40% total 14C) in rats dosed with 100 mg/kg
nabam.
-------
Seven days after administration, less than 0.01% of total
14c activity was associated with the thyroid in any of
the dose groups. In terms of the mass of the thyroid organ,
there were fairly high concentrations of ^C, with the
highest mean of 20 ppm equivalents in the thyroid of
males receiving a 100 mg/kg oral dose of nabam.
Further information on the rat metabolism study discussed
above must be submitted.
5. Special Studies
Domestic Animal Safety Studies.
The registered uses of nabam are such that under normal
circumstances and correct handling no significant exposure
involving domestic animals is anticipated. No data on
domestic animal safety are required.
Nabam Dermal (Percutaneous) Absorption/Penetration
Studies.
Mixtures of 14c-labeled and unlabeled nabam were applied at
0.1, 1 and 10 ug/rat in constant dosage volumes of 50 ul
to approximately 4.9 cm2 of rat skin. The rats were sacri-
ficed at 0.5, 1, 2, 4 and 10 hours, and measurements of
14C activity were made for blood, urine, feces, skin
and water from washing of skin. The results of this
study indicate that at least 0.3% of a 0.1 mg application
is absorbed in the 10 hours following application.
There is considerable uncertainty as to the upper limit,
and the mean amount of i4C not accounted for was 11%.
Because the industrial use patterns will result in only
negligible exposure, additional data are not required
now. However, if new uses would result in significant
dermal exposure or agricultural food uses are reinstated,
then further work would be required to determine whether
and at what rate the nabam bound to the skin continues
to be absorbed after 10 hours and whether bioaccumulation
occurs.
Human Studies.
There are no human data on the potential effects of
nabam.
Toxicological Studies - ETU. Since ETU, a contaminant, de-
gradation product, and metabolite of nabam and other EBDC
products, presents toxicological concerns, available data on
ETU were considered in the overall evaluation of nabam.
These data are summarized, as follows:
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1. Subchronic Studies. During a 90-day rat feeding study
with mancozeb, 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 (depressed body weight and changes in hormone
levels accompanied by diffused hyperplasia of thyroid
follicular epithelium). Residue analysis for ETU in
mancozeb-treated animals revealed none in blood.
In 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, 60, and 90 days. Thyroid hyperplasia, decreased
uptake of 125i by the thyroid, and decreased serum T^
(triiodothyronine) and 1^ (tetraiodothyronine) were seen.
The LE.L was 25 ppm for the 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 ETU, serum thyroid hormone con-
centrations 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 T4 (tetraiodothyronine)
were significantly decreased in the 250 ppm group. Free
serum 14 levels were also significantly 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 ETU, pituitary as well as thyroid
hormone levels were measured.. A NOEL was not demonstrated.
2. Oncogenicity 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)Fi [Strain X] and (C57BL/6 x
AKR)F]_ [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, 215 mg/kg ETU was given by
18
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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 examination 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
Control Treated
Female
Control Treated
Strain X
Strain Y
3/14
1/18
14/16
18/18
0/18
0/18
18/18
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
Lesion
Thyroid carcinoma**
(follicular)
Thyroid solid cell
ademona
Hyperplastic goiter
Simple goiter
Males*
17
0
17
2
Female
8
1
13
4
175 ppm
lales
3
0
9
4
Female;
3
2
6
2
* 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.
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.
1-5IT 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, 131I 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 131i uptake in female rats.
9
-------
Histopathology incidence data were combined for males and
females. An increase in the number of rats with
cataracts/keratitis and with thyroid follicular adenocarcinoma/
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/
adenocarcinoma
(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 72 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.
3. 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 system 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.
4. Mutaqenicity 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 in 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 iri vitro promoters.
An in vitro mammalian cell transformation/promotion assay
20
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to address whether ETU has promoter (non-genotoxic)
activity is required.
5. Metabolism Studies. In a study with Rhesus monkeys, 50
percent of an administered dose of l^C-ETU was excreted
in the urine within 24 hours and 90 percent within 72
hours. Only 0-0.68 percent of the label was eliminated
in the feces at 24 hours and no radioactivity was found
in the feces at the 48 and 72 hour sampling periods.
In another study with Wistar rats, 14C 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, at 10 ppm ETU, the ratio was 70/10.
Minimal radioactivity was recovered as C02 (<0.5
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 of which are thyroid inhibitors. Chronic
studies on thiourea in rats have shown that it induces
hepatomas and thyroid enlargement. Methimazole, propy-
lthiouracil and thiouracil all induce thyroid tumors in
rats. Propylthiouracil 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 nabam. 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 CFR
33992) as a Group B2 oncogen, Probable Human Carcinogen.
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, a Group B2 categorization
is appropriate if there is "sufficient evidence" of a 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.
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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
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 and Dietary Exposure and Risk. At this.time, the
Agency believes the potential of human exposure to nabam or
its major metabolite, ETU, is negligible from the use of
nabam in most industrial settings. The Agency is requiring
additional data and information on exposure to nabam in
industrial use settings. The Agency will rs-examine its
position regarding human exposure from industrial use of
nabam following receipt and review of the data and information
requested.
All field or food crop uses of nabam pesticide products are
currently suspended and the registered nabam technical products
are prohibited from being formulated into pesticides for use
on field or food crops. There should be no dietary exposure
to nabam from commodities currently processed from these
field or food crops. If nabam agricultural uses are reinstated,
the result may be an increased dietary exposure to ETU, which
because of exposure attributable to use of another EBDC
pesticide, mancozeb, already presents concern. The use of
nabam in sugar beet flume water is considered a food use and
possible source of dietary exposure to nabam. There are no
data available to assess the potential dietary exposure and
resulting risk from this use. However, any exposure to ETU
from such use would compound exposure levels. Additional
chronic toxicology and residue data are required to support
the registrations of nabam products for use on all food
2
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C. OTHER SCIENCE FINDINGS
Environmental Fate. Available data are insufficient to fully
assess the environmental fate of nabam. Data as set forth
in Table A are either required or reserved pending further
evaluation. The supplementary information discussed below
is provided from studies that did not fulfill the data require-
ments for registration and must be repeated:
Groundwater. Studies submitted in response to the 1984 Data
Call-in Notice gave only inconclusive results. However, these
studies do indicate that the major degradate, 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. Additional data are required
to fully assess the potential of nabam and ETU to contaminate
groundwater.
Ecological Effects. Available data are insufficient to com-
pletely evaluate the ecological effects of nabam. 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. Toxicity to Birds. Available avian dietary studies were
sufficient -to assess the subacute toxicity of nabam to birds.
The studies showed LC$Q values, for the mallard duck and
bobwhite quail of greater than 5000 ppm active ingredient
indicating that nabam is practically non-toxic to birds
from dietary exposure.
2. Toxicity to Fish, Aquatic Invertebrates, and Estuarine/
Marine Organisms. Data on representative products containing
a mixture of 15% nabam and 15% sodium dimethyl dithiocarbamate
indicate moderate toxicity to freshwater fish such as
rainbow trout and moderate to high toxicity to estuarine
organisms such as sheepshead minnow, American oysters, and
grass shrimp.
3. Risks to Nontarqet Organisms (Including Endangered Species).
The Agency has assessed the risks, based on available data,
from the uses of nabam. A discussion of this assessment
follows.
a. Terrestrial Organisms. Exposure of terrestrial vertebrates
to nabam may occur when these organisms seek refuge
or consume prey or water from aquatic sites adjacent
to facilities utilizing nabam. These aquatic sites may
be holding ponds or streams, rivers, estuaries, and lakes
receiving discharge directly from the installation or
holding pond. Available toxicity data for avian and
mammalian species do not indicate a hazard.
-------
Terrestrial vertebrates as well as invertebrates may be
exposed to nabam when used as a fungicide on ornamentals.
Residues that animals would be exposed to are expected to
be significantly below the levels indicated in studies
where toxicity would occur. Therefore, no hazard is
associated with this use for terrestrial organisms.
b. Aquatic Organisms. Freshwater and marine organisms
may be exposed to nabam from the aquatic non-food uses
(process waters from pulp mills, cooling towers).
Environmental levels of nabam are expected to di-
minish downstream of treatment plant discharges.
However, the amount will vary with the treatment process
and the ratio of the receiving body to the volume
of the discharge. Although a 200 fold dilution
generally occurs, thus eliminating the acute hazard
to the most sensitive species, the potential for an
extended acute (greater than 96 hours) or chronic
effect may occur. Secondly, the acute and chronic
toxicity of ETU has not been determined.
Additional use information is required including
the location of facilities using nabam as well as
aquatic residue monitoring at representative sites.
A final hazard assessment will be done upon receipt and
review of these data.
c. Endangered Species. There is inadequate information to
consider if the continued use of nabam poses a threat
to endangered species. Based on the avian toxicity
data available on technical nabam and the current use
rates, no ecological effects concerns have been identified
at this time including concerns for endangered species.
Additional use and monitoring data described above
will be used to determine if the use of nabam is a
threat to any endangered species.
Reentry Considerations. Toxicity and exposure criteria are set
forth in 40 CFR 158. If a chemical meets the specified criteria,
reentry data are required.
Nabam 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. Therefore, the chronic
toxicity criteria have been met. Nabam also meets the
exposure criteria in that it is registered (although currently
suspended) for use on crops which may involve substantial
exposure to residues.of the pesticide. Reentry data are
required.
-------
D. TOLERANCE REASSESSMENT
There are no established tolerances for residues of nabam
per se on any food or feed items. All food crop uses of
nabam are currently suspended. When used on food crops nabam
is tank mixed with zinc sulfate leading to the formation of
zineb. Nabam is not mixed with zinc sulfate when used on
onions to control smut. Therefore, for this use registrants
are required to submit residue -data on nabam. For the other
food crop uses, application actually consists of a solution of
zineb instead of nabam. Therefore, residues in agricultural
commodities treated with nabam are expected to be zineb.
The use of nabam as an industrial biocide to treat flume
water in sugar beet mills is considered to be a treatment of
a raw agricultural commodity. Regulations have been
established by the Food and Drug Administration under 21 CFR
173.320(b)(3) for nabam residues following application to sugar
mill grinding, crusher and/or diffuser systems. The treatment
of flume water, transporting and washing systems are under
EPA's jurisdiction. Residue data are required in this Standard
to determine if the residues concentrate in any of the
processed sugar commodities.
Residue Data. Residue data for nabam, ETU, and any other
residues of concern in sugar beets following a water treatment
in the flume water transporting and washing system are required.
A registered formulation of nabam should be applied at the
maximum use rate for the system. Also, a processing study
employing sugar beets containing measureable residues of
nabam with subsequent analysis of dehydrated pulp, molasses,
and refined sugar for nabam, ETU and any other residues of
concern is required.
Toxicology Data: The toxicology data for nabam are insufficient
to determine an Acceptable Daily Intake (ADI) and do not allow
a decision as to whether the toxicity observed in the studies
is due to nabam or ETU.
There are no data available to determine either a Provisional
Acceptable Daily Intake (PADI) or Acceptable Daily Intake (ADI)
for nabam.
26
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Product Chemistry. The Agency has evaluated the available
data which identify the ingredients, materials, and manu-
facturing process and discuss the physical and chemical
properties of nabam. All product chemistry data must be submitted
for each technical nabam product. Some additional product
chemistry data are required and some data previously submitted
needs to be updated. These requirements are presented in Data
Tables A and B.
25
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Product Chemistry. The Agency has evaluated the available
data which identify the ingredients, materials, and manu-
facturing process and discuss the physical and chemical
properties of nabam. All product chemistry data must be submitted
for each technical nabam product. Some additional product
chemistry data are required and some data previously submitted
needs to be updated. These requirements are presented in Data
Tables A end B.
-------
D. TOLERANCE REASSESSMENT
There are no established tolerances for residues of nabam
per se on any food or feed items. All food crop uses of
nabam are currently suspended. When used on food crops nabam
is tank mixed with zinc sulfate leading to the formation of
zineb. Nabam is not mixed with zinc sulfate when used on
onions to control smut. Therefore, for this use registrants
are required to submit residue data on nabam. For the other
food crop uses, application actually consists of a solution of
zineb instead of nabam. Therefore, residues in agricultural
commodities treated with nabam are expected to be zineb.
The use of nabam as an industrial biocide to treat flume
water in sugar beet mills is considered to be a treatment of
a raw agricultural commodity. Regulations have been
established by the Food and Drug Administration under 21 CFR
173.320(b)(3) for nabam residues following application to sugar
mill grinding, crusher and/or diffuser systems. The treatment
of flume water, transporting and washing systems are under
EPA's jurisdiction. Residue data are required in this Standard
to determine if the residues concentrate in any of the
processed sugar commodities.
Residue Data. Residue data for nabam, ETU, and any other
residues of concern in sugar beets following a water treatment
in the flume water transporting and washing system are required.
•A registered formulation of nabam should be applied at the
maximum use rate for the system. Also, a processing study
employing sugar beets containing measureable residues of
nabam with subsequent analysis of dehydrated pulp, molasses,
and refined sugar for nabam, ETU and any other residues of
concern is required.
Toxicology Data: The toxicology data for nabam are insufficient
to determine an Acceptable Daily Intake (ADI) and do not allow
a decision as to whether the toxicity observed in the studies
is due to nabam or ETU.
There are no data available to determine either a Provisional
Acceptable Daily Intake (PAD!) or Acceptable Daily Intake (ADI)
for nabam.
26
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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
nabam, the Agency has made the following determinations.
Where it is the Agency position that label revisions are needed
in order for a product to remain in compliance with FIFRA,
specific language will be set forth in Section D of this
Cnapter.
1. EPA is currently evaluating the potential human health
risks resulting from the food, field and food crop and
terrestrial non-food uses of nabam to determine whether
additional regulatory action is warranted on nabam and
the other EBDC pesticides containing the 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 product, 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 classi-
fication of ETU.
Nabam is currently used for certain food uses in industrial
settings. While the Agency lacks information enabling it
to quantify dietary exposure to nabam or ETU from
such uses, any increase in ETU exposure would add to a
level already presenting concern to the Agency due to that
resulting from the use of mancozeb. The nabam products
registered for use on field or food crops and terrestial
non-food uses are currently suspended. However, if
these uses were reinstated the use would result in addi-
tional dietary and applicator exposure to nabam and ETU.
Any level of ETU residue would, in the case of dietary
risk, increase overall exposure to ETU above the levels
resulting from mancozeb, which themselves present concern
to the Agency.
-------
2. The Agency does not believs that further regulatory
action on nabarn products registered for most
industrial non-food uses is warranted at this time.
Rationale: ETU, a contaminant, degradation product and/or
a metabolite of all the EBDC's, is mutagenic, oncogsnic
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 classification of ETU.
After considering exposure to ETU from the industrial,
non-food uses of nabam as discussed in the preceding Agency
Assessment section, the Agency believes that the risks
from exposure to ETU from most industrial uses of nabam
are not a concern at this time because applicator exposure,
based on available information, appears negligible.
Additional information is being required to assess
exposure to nabam from the metalworking and tanning uses.
3. The Agency will not consider any new food use tolerances
for nabarn.
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 nabam or ETU. No
new food uses will be considered until these issues are
resolved.
4. 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 nabam is
insufficient to determine whether observed toxicity is
due to nabam, ETU, or additional metabolites.
5. The Agency will not establish any food/feed additive
regulations pursuant to Section 409 of the Federal Food,
Drug and Cosmetic 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 this 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.
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6. The Agency is specifying precautionary labeling pertaining
to fish which must be added to the labels of all nabam products,
in order to remain in compliance with FIFRA.
Rationale: Based on available data, nabam has been
demonstrated to be moderately toxic to fish. Because of
its toxicity to fish, extending the warning language to
cover all nabam products will serve to alert users about
exposure to these organisms.
7. The Agency's position is that protective clothing
labeling for nabam 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 exposure
to nabam at this time is the hazard to the human thyroid
from the degradation product, ETU, an acknowledged goitrogen,
teratogen, and oncogen. Additional data are required to
determine whether nabam also poses a teratogenic risk.
Risks of teratogenicity and thyroid toxicity to commercial
applicators can be adequately reduced by maintaining
the requirement that protective clothing be worn while
mixing, loading and applying the chemical; the same would
appear true for agricultural mixers, loaders, and appli-
cators, should agricultural uses resume.
3. The Agency has determined that all 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.
9. While data gaps are being filled, currently registered
manufacturing-use products (MP's) and end-use products
(EP's) containing nabam 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 and provide
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
nabam and ETU as explained herein.
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10. The Agency will continue to require that, in order to
remain in compliance with FIFRA, the importance of
observing the preharvest intervals be highlighted on
labels of residential (homeowner) products. Language is
specified herein.
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 nabam cannot be fully
assessed at this time, the Agency believes continuation
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.
11. The Agency is requiring reentry data for nabam. In
order to remain in compliance with FIFRA, an interim
24-hour reentry interval requirement must be placed on
the labels of all nabam end-use products registered for
agricultural uses, until the required data are submitted
and evaluated and any change in this reentry interval
is announced.
Rationale. Nabam 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, should
agricultural uses of nabam be reinstated.
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard, products
must contain nabam 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 nabam 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.
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Acute Toxicity Limits - The Agency will consider registration
of technical grade and manufacturing-use products containing
nabam 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 may be labeled for formulation into
end-use products only for registered uses as listed in the Use
Index, Appendix III.
D. LABELING
All nabam products must bear appropriate labeling as specified
in 40 CFR 162.10. Appendix II contains information on label
requirements.
In order to remain in compliance with FIFRA, no pesticide
product containing nabam may be released for shipment by the
registrant after May 1, 1988, unless the product bears an
amended label which complies with the specifications of this
Standard.
In order to remain in compliance with FIFRA, no pesticide
product containing nabam 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 of this Standard.
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:
Nabam (disodium ethylene bisdithiocarbamate) (%)
Inert Ingredients (%)
2. Use Pattern. Statements. All manufacturing-use products
must state that they are intended for formulation into
end-use products only for acceptable use patterns.
However, no use may be included on the label where the
registrant fails to agree to comply with the data requirements
in Table A for that use pattern.
3.. Disposal Statements. Because nabam 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 nabam products:
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"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).
3• 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, con-
tact your State Water Board or Regional Office of the EPA."
End-Use Products
a. Agricultural Use Products
"This pesticide is toxic to fish. Drift and runoff
from treated areas may be hazardous to aquatic organ-
isms 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."
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 Food 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
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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.
"Do not rub eyes or mouth with hands. See First Aid
(Practical Treatment Section)."
"PERSONAL PROTECTIVE EQUIPMENT
HANDLERS (MIXERS, LOADERS, AND APPLICATORS) AND
EARLY REENTRY WORKERS MUST WEAR 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 nabam must be destroyed according
to state and local regulations.
HEAVILY CONTAMINATED OR DRENCHED CLOTHING CANNOT BE-
ADEQUATELY DECONTAMINATED.
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During aerial application, human flaggers are prohibited
unless in totally enclosed vehicles."
b. Industrial Use Products
"This pesticide is toxic to fish. Spills, sprays, and
runoff from use site may be hazardous to aquatic organ-
isms 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."
"HANDLE (INCLUDING MIXING, LOADING, OR APPLYING) 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; and
goggles or a face shield. During mixing and loading, a
chemical resistant apron must also be worn."
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V. PRODUCTS Srm.TFCT TO THIS STANDARD
All products containinq one or more of the nesticides
identified in Section T.I. A. are subject to certain reou i r^Tients
for data submission or channel in composition, la'n^linn or
packaging of the product. The applicable requirements depend
on whether the product is a manuFacturing or end use product
and whether the pesticide is the sole active inqredient or
one of multiple active inqredients.
Products are subject to this Reqistration Standard as
follows:
A. Manufacturing use products containinq this pesticide as
the sole active inqredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and 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 rereqistration.
2 Data requirements are listed in the three Tables in
Appendix I of this Reqistration 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-specific data applicable
to manufacturing use products. The data in Tables A and B
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
Table C lists product-specific data applicable to end use
products. The Agency has decided that, in most cases, it
will not require the submission of product-specific data for
end use products at this time. Therefore most Registration
Standards do not contain a Table C.
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R. Manufacturing use products containinq this pesticide
as one of multiple active inqred ients arre subject to:
The data requ i rements listed in Table A.
C. End use products containino this pesticide as the
sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaqing listed in Section iv if they pertain to the
end use product.
2. If eliqible for the formulator's exemption^, the
data recjuirements listed in Table C.
3. If. not eligible for the formulator's exemption, the
data requirements listed in Table A and the data require-
ments listed in Table C.
4. The labelinq requirements specified for end use
products in Section IV.
D. End use products containinq this pesticide as one of
multiple active inqredients are subject to:
a. If not eliqible for the formulator's exemption,
the date requirements listed in Tables A and C.
b. If eliqible for the formulator's exemption, the
data reauirements listed in Table C.
3 if you purchase from another producer and use as the
source of your active inqredient only EPA-reqistered products,
you are eliqible for the formulator's exemption for qenericf
data concerninq that active inqredient (Table A) and product-
specific data for the reqistered manufacturinq use product
you purchase (Table R).
Two circumstances nullify this exemption:
1) If you chanqe sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active inqredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data requirements
in Table A agrees to submit the required data, all end use
producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC HATA
This portion of the Reqistration Standard is a notice
issued under the authority of ^TFRA sec. 1(c)(2)(R). Tt
refers to the data listed in Table A, which are required to
he submitted by registrants to maintain in effect the renis-
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 inqredient. Such data are relevant to an
evaluation of all products containinq 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 "tvnical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFR& sec.
3(c)(2)(B) (HCI Notice). FPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 5 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data reguest.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
recfuired data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements 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 required data in the specified timeframe. In
such cases, the Aqency 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 eligible For a formal a tor' s exemption,
you may qualify for one if vou chanqe vour source of supplv
to a reqistered source that does not share ownershin in
common with your f i rm. T f- you choose to change sources of
supply, the Confidential. Statement of "ormula must identify
the new source(;s) and you must submit a ^ormulator's F.xemnt ion
Statement form.
Tf you annly for a new reqistration for products containing
this active inqredient after the issuance of this Reqistration
Standard, you will he required to submit or cite qeneric
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 required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which
current registrants of similar products are required to provide
such data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail
to comply with the condition of that registration to provide
data, the reqistration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current- uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Reqistration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580-1., enclosed) for each of your products. On that form
vou must state which of the followinq six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adequate assurance that the
person whom you state will provide the data is takinq appropriate
steps to secure it. The agreement to produce the data need
not sneoify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants tooiether are generating or
submitting requested data as a task force or consortium, a
representative of the qroun should request a Joint nata
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 requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an aqreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering
into an agreement to supply the data.]
In order to qualify for -this method, you must:
1. File with EPA a completed "Certification of Attemnt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
.registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
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[Your company name! offers to share in the burden of
producing the data required nursuant to FIFR<\ sec.
"Uc)(2)(R) in the Tname of active ingredient] Registration
Standard upon terms to 'ie aqreed or failinq aqreement
to he bound bv binding arbitration as provided bv PIPRA
section ?(c)(2)(R)(iii).
The remainder of your offer may not in any way attempt to
limit this commitment. If the other reqistrant to whom your
offer is made does not accept your offer, and if: the other
reqistrant informs us on a OCI Summary Sheet that he will
devel.on and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other reqistrant must fulfill its
commitment to develop and submit the data as required by 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 required
data in the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the data,
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apoly to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by deleting
the uses for which the data are needed. You are not reguired
to submit data for uses which are no longer on your label.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
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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
As r.essmen i; Guidelines, unless other protocol or s ta.-i.1a rds .•*;••:
approved for use by the Aqency in writing.
As rioted 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 fof 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
42'
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such permission would be consistent with the Act. The following
Information must be included in any request for an existinq
stocks provision:
1. Fxnlanation of why an existing stocks orovision is
necessarv, including a statement of the auantitv of
existing stocks and vour estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions o^ F
VTI. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its OCI authority, EPA has determined that certain
Droduct-specific data are required to maintain your registrations
in eiffect. 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 Pvegistration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely reguire product-specffic
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 reguired to submit the data at
this time.
In order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section 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. <5. (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.
-------
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA cequires each product to be labeled with Accurate,
complete and sufficient instructions and precautions, reflecting
the Aqency's assessment oF the data supporting the product
arvl its uses. General labelinq requirements are set out in
40 OFR 1*2.10 (see Appendix TI - LABELING and .SUMMARY). Tn
addition, labelinq requirements specific to products containing
this pesticide are specified in Section IV.n of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labelinq for Agency review.
If you fail to submit revised labeling 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
registration 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 Registration Division
for each product subject to this-Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator1s Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
reguirements 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,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
44
-------
2. Within 9 months from receipt of this document you
must-, submit to the Product Manager:
a. Application for Pesticide Registration (PPA
Form 8570-1) .
h. Two conies of any required nroduct-specifie data
(See Table R).
c. Three conies 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 label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (E^A Form 858D-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.
3. 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 8570-27),
if applicable.
2. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the 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.
45
-------
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. FIFP.A Section .1(c)(2)(^) Summary Sheet, with
appropriate attachments^ (EPA Form 8580-1).
h. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-?.?),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Two copies of any product-specific data, if required
by Table C.
b. Product Specific Data Report (EPA Form 8580-4),
if Table C lists required product-specific data.
c. Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling should
be either typewritten text on 8-1/2 x 11 inch paper or a mockup
of the labeling suitable for storage in 8-1/2 x 11 files. The
draft labeling must indicate the intended colors of the final
label, clear indication of the front panel of the label, and
the intended tyne sizes of the text. End use product labeling
must comply specifically with the instructions in Section IV
(Regulatory Position and Rationale).
D. Intrastate Products containing 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.
46
-------
E. Addresses
The reauired information must he submitted to the following
address:
Lois A,. Rossi, Product Manager (Team 71)
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.
47
-------
I. DATA APPENDICES
48
-------
TGUIDE-1
GUIDE TO TABLES
Tables A and B 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.
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 i:o which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = 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.
-------
TGUIDE-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YjjS - 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.
»^." •
r° — - A
i£ n
-------
TARLR A
GRNERIC DATA RROUIRRMRNTS FOR NARAM
Data Requirement
SI 58. 120 Product Chemistry
Product Identity
61-1 - Product Identity and
Disclosure of Ingredients
61-? - Description of Reqinninq
Materials and Manufacturing
Process
61-3 - Discussion of formation of
Impurities
Analysis and Certification of
Product Ingredients
Test
SuhstanceV
TGAI
TGAI
TGAI
62-1 - Preliminary Analysis TGAI
62-2 - Certification of Ingredient TGAI
Limits
62-3 - Analytical Methods to Verify TTQAI
Certified Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
6 3- A - rvior
TGAI
TGAI
TGAI
Use noes RPA Riblioqraphic
Patterns Have Data? Citation
All No
All. No
All No
All No
All No
All No
All Yes
All Yes
All No
Must Additional.
Data be
Submitted?2/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
51
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TABLE A
GFNRRIC OA'PA RROFIIRRMRNTS POP NARAM
Data Requirement
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-5 - Melting Point
63-6 - Boilinq Point
63-7 - Density/ Bulk Density, or
Specific Gravity
63-R - Solubility
63-Q - Vapor Pressure
63-in - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-1? - pH
63-13 - Storaqe Stability
Other Requirements:
64- 1 - Submittal of samples
Test Use Does FPA
SuhstanceV Patterns Have Data?
PAT All No
TGAI All No
TGAI All No
TGAI or PAT All No
PAT All No
PAI All . No
PAI All No
TGAI All. NA
TGAI All No
TGAI, PAI NA No
Bibliographic Must Additional
Citation Data be
Submitted?2/
YesV
Yes
Yes
Yes
Yes
ves
Yes
No
Yes
NA
Timeframe
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
V Composition: TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient.
_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 reguirements have been introduced and previously submitted data must be
updated. Therefore bibliographic citations for the old data are not applicable.
3/ The melting point of the solid material remaining after the removal of water is required.
52
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TABLE A
GRMERIC DATA REQUIREMENTS FOR NARAM
Data Requirement
§158.125 Residue Chemistry
171 -2 - Chemical. Identity
171-3 - Directions for Use
Test
SubstanceV
THAI
Does EPA Rihliocjraphic
Have Data? Citation
No
No
Must Additional
Data be
Submitted?2/
YesV
Yes
Tirnef.rame
for
Submission
6 Months
6 Months
171-4 - Nature of ResidueV
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal residues
171-4 - Storage Stability Data
PATRA
Partially
PAIRA & Plant Partially
Metabolites
TGAI & Yes
Metabolites
TGAI &
Metabolites
No
or PAI, No
& Metabolites
00088825,00088826,
00088833,00088831,
00097231,00088921
00088834,00088835
00088826
00041704
00097051
00088826
00041704
40118601
40065802
,00097051,
,40065801,
,00088891,
,00159693,
,00159693,
,40065803,
53
Yes1'/
Yes6/
Yes7/
ves7/
Yes*/
18 Months
18 Months
15 Months
15 Months
Annroved
protocol:
3 months
Study:
18 months
-------
TARLE A
GENERIC DATA RROniREMF.NTS FOR NARAM
Data Requirement
Test
SubstanceV
Does EPA
Have nata?
Riblioqraphic
Citation
Must Additional
nata be
Submitted?7/
Timeframe
for
Submission
S15R.125 Residue Chemistry - Continued
171-4 - Magnitude of the Pesidue-
Residue Studies for Each
Pood UseV
171-4 - Maqnitude of the Residue -
Residue Studies
o Crop 2, Suqar Reet -
Flume Water
— Crop Field Trials TEP
— Processed Food/Feed EP
— Meat/Milk/
Poultrv/Eqqs
THAI or Plant
Metabolites
No
No
Partially
YesV
Reserved^ I/
1R Months
24 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
FOOTNOTES
§158.125 Residue Chemistry - Continued
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient; radiolabeled;
TEP = Typical end-use product.
2/ Data must be submitted for individual tests no later than specified in Column 7(Timeframe for Submission).
3/ Refer to Product Chemistry Data Tables.
4_/ Residue data are required to reinstate registration of any food crop use that is presently suspended.
Currently suspended uses include: asparagus, beansdima and snap), beets, swiss chard, broccoli, cabbage, cauli-
flower, cantaloupe, cucumber, squash, watermelon, carrots, celery, cherries(sour), citrus, corn(sweet), grapes,
hops, kale and mustard greens, lettuce, onions, peppers, spinach, strawberries, tomatoes, turnips and wheat.
Additional data are required reflecting residues of nabam in or on onions. The registrant must propose a
tolerance for onions and submit data reflecting nabam, ETU, and other residues of concern resulting from appli-
cation following the established use directions. Applications must be made using nabam alone without zinc sulfate.
Tests must be conducted in OR(12%), NY(11%), C0(8%), TX(8%), CA(7%), ID(6%), and MI(6%) (state production figures
follow abbreviations parenthetically) which represent states producing approximately 58% of the U.S. onion crop
(Agricultural Statistics, 1983, p. 164). Use directions must be proposed and appropriate supporting data
submitted for two additional group members (garlic and leeks or shallots).
5_/ Studies are required indicating the uptake, distribution, and metabolism of nabam in food crops following soil
application at planting. Sampling intervals through at least 21 days must be included. The identities and quanti-
ties of residues in or on mature plant parts must be determined in order to elucidate the terminal residues.
Residue identities must be confirmed by a method such as GC, HPLC and/or mass spectrometry. Data reflecting
solvent extract efficiency of nabam residues must also be represented.
6/ Metabolism studies are required utilizing ruminants and poultry. Animals must be dosed for 3 days with [-^Clnabam
at a level sufficient to make residue identification and quantification possible. Milk and eggs must be collected
twice daily during the dosing period. Animals must be sacrificed within 24 hours of the final dose. The distri-
bution and characterization of residues must be determined in milk, eggs, liver, kidney, muscle, and fat.
55
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7/ If the requested data reqacdinq the Nature of the Residue in Plants and Animals reveal additional metabolites
of toxicoloqical concern, additional analytical methods for data collection and enforcement may he required.
8/ To support crop residue data, storage stability studies must be conducted on both weathered samples (nabam) and
fortified frozen samples (naham, metabolites and FTTH) of one representative crop from each crop qroupinq (40 CFR
180.34) on which reqistered uses of nabam exist. Analyses of each crop must he conducted over a time period that
includes the time interval that the raw aqricultural commodity 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.
(a) Storaqe stability data using weathered samples. Data are required on the parent compound, nabam, in which
crop samples field treated with a typical end use product are frozen immediately upon harvestinq. The inteqritv
of the samples must be maintained by freezinq. The samples must be analyzed for nabam on the dav they arrive at
the analytical laboratory, and then stored frozen and analyzed periodically for nabam durinq the time intervals
specified in the Aqencv approved protocol.
(h) Storage stability data using fortified samples. Pata are required on nabam, ETU, and metabolites in which
a qroup of untreated samples of raw aqricultural commodities and processed crops are fortified (spiked) with
only nabam (pure active inqredient), another qroup of samples is fortified with onlv ETO, and other qroups are
fortified individually with each additional metabolite. Immediately after fortification, the samples fortified
with nabam must he analyzed for nabam and ETU; samples fortified with ETU must be analvzed for only KIT I; and
samples fortified with other metabolites must be analyzed for onlv the metabolite with which the sample was
fortified. Sample inteqritv must he maintained by freezinq, and analyses for nabam, ETU, and metabolites
must be conducted periodically durinq the time intervals specified in the Aqency approved protocol.
(c) Storaqe stability data for livestock/poultry feeding studies. If cattle and poultry feedinq studies are
required (see footnote 11), fortified storaqe stability studies will be required on all animal commodities
(i.e., tissues, milk and eqqs) for which residue data are submitted to the Aqencv. Analyses must be conducted
over a time period that includes the time interval that each commodity is held in frozen storaqe prior to
residue analyses.
9/ Residue data must be submitted depictinq nabam, ETIJ and any other residues of concern in sugar beets following a
water treatment in the flume water transporting and washinq system. A reqistered formulation of nabam should be
applied at the maximum use rate for the system. Rased on this data an appropriate pesticide tolerance level should
be proposed under 40 CFR 180.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
§158.125 Residue Chemistry - Continued
10/ A processinq study is required emplovinq suqar beets containinq measurable residues of nabam with subsequent
analysis of dehydrated pulp, molasses and refined suqar for nabam, ETU and any other residue of concern. If
residues are found to concentrate in any of the processed commodities, the Aqency will assess the need for
appropriate food/feed additive tolerances. However, final disposition of these food/feed additive tolerances would
be dependent upon the Aqency's position reqardinq nelaney Clause issues.
ll/ Presently, the nature of the residue in animals is not adequately understood. On receipt of the data requested
in the section entitled "Nature of the Residue in Animals," the appropriate nature of tolerances for residues in
animal products will be determined and, with consideration for any newly found metabolites of toxicoloqical concern,
the need for feedinq studies depictinq the maqnitude of residues in animal products will be determined.
57
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodeqr adat ion
161-2 - In Water
161-3 - On Soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
163-1 - Leaching and
Adsorption/Desorption
Test
SubstanceV
TGAI or PAIRA
ETU
TGAI Or PAIRA
ETU
TGAI or PAIRA
ETU
TGAI or PAIRA
TGAI or PAIRA
ETU
TGAI or PAIRA
ETU
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
ETU
Use
PatternsV
A,B,D,H
A,B,D,H
A,BfD,H
A,B,D,H
A
A
—
A,B,H
A,B,H
A
A
D
D
A,B,D,H
A,B,D,H
Does EPA
Have Data?
NO
No
No
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
Bibliographic Must Additional
Citation Data be
Submitted?3/
Yes
Yes
Yes
Yes
Yes
Yes
Reserved^/
Yes
Yes
Yes5/
— Yes
Yes
— Yes
Yes
Yes
Timeframe
for
Submission
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
27 Months
27 Months
27 Months
27 Months
27 Months
27 Months
12 Months
12 Months
58
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data Requirement
§158.130 Environmental Fate -
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4. - In Fish
,165-5 '- In Aquatic Non-Target
Test Use
SubstanceV Patterns^/
Continued
TEP A
TEP A
TEP A,B
ETU A,B,
TEP D
TEP
TEP A
PAIRA A
TEP A
TEP
TGAI or PAIRA A,B,D
TEP A,B,D
Does EPA Bibliographic
Have Data? Citation
No
No
NO
No
NO
NA
No
No
NO
NA
No
NO
Must Additional
Data, be
Submitted?3/
Yes
Reserved^/
Yes
Yes
Yes
No
Reserved^/
Yes
Reserved^/
No
Yes
Reserved^/
Timeframe
for
Submission
12 Months
27 Months
27 Months
27 Months
39 Months
12 Months
, .Organisms
59
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
§158.130 Environmental Fate - Continued
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient; radiolabeled;
TEP = Typical end-use product; ETU = ethylene thiourea.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
V Data must be submitted no later than indicated for individual tests (requirements).
4/ Data are reserved depending on results of volatility test.
5/ An anaerobic aquatic metabolism study may replace the anaerobic soil metabolism study.
6/ Deferred, pending the receipt of terrestrial field dissipation studies, Section 164-1.
7/ Deferred, pending the receipt of data from confined rotational crop studies Section 165-1.
8/ Deferred, pending the receipt of fish accumulation data, Section 165-4.
60
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Date
§158.
Requirement
135 Toxicoloqy
Test
SubstanceV
Use Does EPA
Patterns^/ Have Data?
Bibliographic Must Additional
Citation Data be
Submitted?
Timef ranie
for
Submission
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Rabbit
- Acute Inhalation Toxicity
- Rat
- Eye Irritation - Rabbit
- Dermal Irritation - Rabbit
- Dermal Sensitization -
Human
- Delayed
Neurotoxicity - Hen
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI,
TGAI
A,B,D,H Yes
A,B,D,H No
A,B,D,H NO
A,B,D,H No
A,B,D,H NO
A,B,D,H Yes
AfB,D,H NO
00121050 No
Yes
Yes
Yes
Yes
00121050 No
No9/
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
82-2
82-3
- 90-Day Feeding:
- Rodent, and
- Nonrodent (Dog)
- 21-Day Dermal - Rabbit
- 90 -Day Dermal - Rabbit
TGAI
TGAI
TGAI
A,B,D,H NO
A,B,D,H NO
A,B,H NO
Yes
Yes
ReservedV
15 Months
12 Months
61
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data
§158.
82-4
82-5
Requirement
135 Toxicology - Continued
- 90 -Day Inhalation:
- Rat
- 90-Day Neurotoxicity:
- Hen
-Mammal
Test Use
SubstanceV PatternsV
TGAI A,B,H
TGAI A,B,D,H
Does EPA
Have Data?
NO
NA
Bibliographic Must Additional
Citation Data be
Submitted?
Reserved^/
NAV
Timeframe
for
Submission
CHRONIC TESTING:
83-1
83-2
83-3
- Chronic Toxicity -
2 species:
- Rodent, and
- Nonrodent (Dog)
- Oncogenicity -
2 species:
- Rat (preferred), and
- Mouse (preferred)
- Teratogenicity -
2 species:
- Rat
- Rabbit
TGAI A,B,H
ETU
TGAI A,B,H
ETU
TGAI A,B,H
TGAI A,B,H
TGAI A,B,D,H
TGAI A,B,D,H
NO
. No
NO
NO
NO
NO
NO
No
Yes3/5/
Yes3/5/8/
Yes3/5/
Yes3/5/
Yes3/5/
YesVl/
Yes
Yes
50 Months
50 Months
50 Months
50 Months
50 Months
50 Months
15 Months
15 Months
62
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TABLE A
GENERIC- DATA REQUIREMENTS FOR NABAM
Data Requirement
§158.135 Toxicology - Continued
83-4 - Reproduction - Rat
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test)
84-2 - Structural Chromosomal
Aberration
84-4 - Other Mechanisms
of Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism PAI
Rat
85-2 - Domestic Animal
Safety
85-3 - Percutaneous Absorption -
(rat)
- Human Exposure Studies As
Test Use
Substancel/ Patterns2/
TGAI A,B,H
ETU
TGAI A,B,D,H
TGAI A,B,D,H
TGAI A,B,D,H
ETU A,B,D,H
or PAIRA A,B,D,H
Choice
PAIRA A,B,D,H
Appropriate IP
Does EPA
Have Data?
No
.No
Partially
Partially
Partially
No
Yes
No
Partially
No
Bibliographic Must Additional Tlmeframe
Citation Data be for
Submitted? Submission
Yes3/
Yes3/
00153559,00152701, Yesll/
00152702
00152700,00152699 Yes£2y
00151955,00151954 YesW
YesW
00160825 No
No
00156613 YesT/
Yesl3/
39 Months
39 Months
9 Months
12 Months
12 Months
12 Months
6 Months
6 Months
17Composition:PAI = Pure active ingredient; ETU = Ethylene thiourea; PAIRA = Pure active ingredient radiolabeled;
Choice = Choice of several test substances determiner] on a case-by-case basis; TGAI = Technical grade of the active
ingredient.
2/ The use patterns are coded as follows: A = Terrestrial, Foal Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I =
Indoor; IP= Industrial preservative (including metal cutting fluid and tanning uses).
... " 63
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
§158.135 Toxicology - Continued
3/ Study or studies are required to support registrations of nabam-containing products involving use on food, field or
food crops and terrestrial non-food uses. Preliminary studies to determine the material to be tested (i.e., nabam
or nabam mixed with an aqueous solution including zinc sulfate in which zinc replaces the sodium in nabam to form
zineb) are required.
4/ The requirement for a 90 day dental study depends upon the outcome of the 2.1 day dermal study and upon application
rates.
j>/ 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/ Required if use may result in repeated inhalation at a concentration likely to be toxic.
11 Although the study is acceptable, additional information is required to give more precise measurement of the amount
on nabam absorbed and bound to the skin. For field and food uses and terrestrial non-food uses, a
study determining the maximum rate of absorption of ETU is required. Registrants must discuss the protocol
with the Agency prior to the commencement of the study.
&/ In the chronic studies, there must be emphasis on reporting of possible neurologic effects (both from in-life
~ observation and histologic examination). In the chronic rodent study, additional animals trust be utilized that
would allow performance of in situ neurological examinations.
9/ Not required. (Nabam is not an organophosphate).
10/ A mammalian cell transformation assay on nabam 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 nouse embryo cells infected with AKR (mouse) leukemia virus.
ll/ The following data are required: Ames reverse mutation in Salmonella with rat and mouse S9 activation; and
Chinese Hamster Ovary (CHO) cell forward nutation assay with rat S9 activation.
12/ The following data are required: sister chromatid exchange (SCE) assay in CHO cells using lower dose levels and
longer cell exposure times than in the previously submitted study.
13/ For each registered use (testing material and design of study will depend on particular use), testing protocols are
to be submitted no later than 90 days from the date of the registrant's receipt of this Standard. The data must be
submitted no later than 6 months after the protocol review has been completed.
^64
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data Requirement
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
Test
Substance
TEP
TEP
TEP
TEP
Use
Pattern
A,B,H
A,B,H
A,B,H
A,B,H
Does EPA
Have Data?
No
NO
No
No
Bibliographic Must Additional
Citation Data be
Submitted?
YesVV
YesV
NoV
NoV
Timeframe
for
Submission
27 Months
27 Months
27 Months
27 Months
I/ Dislodgeable residue studies must be conducted on one field grown variety of cut flowers and a glass house grown
variety. These studies must be capable of identifying both the parent compound and its breakdown product, ethylene
thiourea (ETU), at least at the established NOEL levels.
2/ Dislodgeable residue studies must be conducted on one field grown food crop should the registrants request that
any of the currently suspended food crop uses be restored. These residue studies must be capable of identifying
both the parent compound and the ethylene thiourea at levels safely below the established NOEL levels.
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 must
be submitted. Exposure data and information are being required for the industrial uses of nabam under a
separate Data Call-in Notice.
65
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data
§158.
Requirement
Test Use
SubstanceV PatternsV
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?3/
Timeframe
for
Submission
,145 Wildlife and Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Acute Avian Oral Toxicity
- Avian Dietary
Toxicity
- Wild Mammal Toxicity
- Avian Reproduction
- Simulated and Actual
Field Testing -
Mammals and Birds
TGAI
TGAI
ETU
TGAI
TGAI
ETU
TEP
A,
A,
A,
A,
A,
A,
A,
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
B,D,H
NO
Yes 00022923
NO
No
NO
No
NO
Yes
No
Reserved11/
No
Reserved^/
No
9 Months
9 Months
18 Months
AQUATIC ORGANISM TESTING
72-1
72-2
72-3
- Freshwater Fish LCso
- Acute LCcjQ Freshwater
Invertebrate
- Acute LC5o Estuarine
and Marine Organisms
- Fish
TGAI
TEP4/
ETU
TGAI
TEP4/
ETU
TGAI
TEP4/
ETU
A,
D
D
A,
D
D
D
D
D
B,D,H
B,D,H
NO
NO
NO
NO
NO
NO
NO
Yes 107906
NO
Yes
Yes
Reserved8/13/
Yes5/
Yes
Reserved^3/
Yes5/
NO
Reserved8/13/
9 Months
9 Months
9 Months
9 Months
12 Months
66
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data
§158.
Requirement
Test
SubstanceV
Use
Patterns^/
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data be
Submitted?3/
Timeframe
for
Submission
145 Wildlife and Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING - cont'd
72-4 -
72-5 -
72-6 -
72-7 -
- Shrimp
- Oyster
Fish Early Life Stage and
Invertebrate Life
Cycle
- Freshwater
- Estuarine
Fish Life - Cycle
Aquatic Organism
Accumulation
Simulated or. Actual Field
TGAI
TEP
ETU
TGAI
TEP
ETU
TGAI
ETU
TGAI
ETU
TGAI
TGAI
TEP
D
D
D
D
D
D
D
D
D
D
D
D
D
No 00107905
Yes 00097064
No
No
No
No
No
No
No
No
No
No
No
Yes5/
NO
Rese r ved^/13/
Yes5/
YespV
Reserved^/13/
Reserved6/
Reserved^/V}£/
Reserved6/
ReservedV£AV
Reserved^/
Yes
Yes7/
12 Months
12 Months
12 Months
15 Months
24 Months
Testing - Aquatic
Organisms
67
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
FOOTNOTES
§158.145 Wildlife and Aquatic Organisms - Continued
I/ TGAI = Technical grade of active ingredient; ETU = ethylene thiourea; TEP = Typical end-use product.
2/ A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop; D = Aquatic, Nonfood; E = Greenhouse,
Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I = Indoor.
V Not required for industrial or ornamental uses.
4/ Typical end-use product is the mixture of 15% nabam and 15% sodium dimethyl dithiocarbamate.
5_/ Required to support uses such as cooling towers, pulp mills, sugar refineries, and oil recovery processes where
discharges into aquatic systems are likely to occur.
6/ Both fish and invertebrate life cycle data may be required to support such uses as cooling towers, pulp mills,
sugar refineries, and oil recovery processes where discharges into aquatic systems are likely to occur. This
requirement is dependent upon the results of the monitoring study.
7/ Monitoring of nabam in industrial effluents and receiving waters is be required where the pesticide is used as a
biocide in cooling towers, pulp and paper mills, oil operations, as well as sugar refineries. Based on use infor-
mation (i.e., geographic sites, amount used, etc.), the registrant is required to develop acceptable protocols
(within 3 months) to sample a representative number of the above facilities. These studies are required to assess
the release of nabam into the environment due to concern for endangered aquatic species and chronic effects to
aquatic organisms. Any protocol developed for monitoring this chemical must meet the following requirements:
(i) use of standard analytical methods, i.e., HPLC or MSGC, to measure nabam and the degradate ethylene thiourea,
(ii) sites selected for sampling must be where nabam is currently being used and be representative of small and
large facilities and/or volumes, (iii) sites selected must also be representative of (1) a range in volume of the
receiving water bodies or rivers and (2) freshwater and estuarine ecosystems, (iv) samples taken for analysis must
be taken before treatment, after treatment, and from receiving waters, (v) sampling should be done at regular
intervals for a long enough period of time to account for such things as seasonal and use variations.
8/ ETU is the primary degradate of nabam. The material is water soluble and is persistent in soil and water beyond
4 days.
9/ Reserved pending the results of monitoring and data from fish early life stage and chronic invertebrate studies.
10/ Most agricultural uses call for multiple applications; therefore resulting in repeated exposure to birds.
ll/ Pending the results of photolysis and hydrolysis studies there may be requirements for waterfowl and upland
game bird studies.
12/ Pending results of avian reproduction studies on technical nabam and environmental fate data such as hydrolysis
and photolysis.
13/ Reserved pending results of environmental fate data such as hydrolysis, photolysis, aquatic field dissipation
studies on technical nabam.
68
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TABLE.A
GENERIC DATA REQUIREMENTS FOR NABAM
Data Requirement Test __ Use ^ Does EPA
SubstanceV Patterns^/ Have Data?
§158.
121-1
150 Plant Protection
- Target Area TEP
Phytotoxicity
D No
Bibliographic Must Additional Timeframe
Citation Data be for
Submitted? Submission
NoV
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER II
- Seed Germination/ TGAI
Seedling Emergence
- Vegetative Vigor TGAI
- Aquatic Plant Growth TGAI
TIER III
- Terrestrial Field TEP
- Aquatic Field TEP
D NO
D No
D No
D NO
D NO
D NO
D No
D NO
NoV
NoV
Yes 9 Months
NoV
NoV
ReservedV
NoV
Reserved^/
69
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
FOOTNOTES
§158.150 - Plant Protection - (Cont'd)
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient; TEP = Typical end-use
product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food
Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop, F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor;
I = Indoor.
3/ Whether data are required is determined on a case-by-case basis, where phytotoxicity issues may be involved.
4/ Use in cooling towers does not require submission of terrestrial phytotoxicity data.
5_/ Reserved pending results of Tier I.
6/ Reserved pending results of Tier II.
70
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
Data Requirement
Test use Does EPA Bibliographic Must Additional Timeframe
SubstanceV Patterns^/ Have Data? Citation Data be for
Submitted? Submission
§158.155 Nontarqet Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey Bee Acute
Contact Toxicity TGAI A,B,H Yes 00036935 No
141-2 - Honey Bee - Toxicity TEP A,B,H No No3_/
of Residues on
Foliage
141-4 - Honey Bee Subacute Reserved4_/
Feeding Study
141-5 - Field Testing for TEP A,B,H No NoV
Pollinators
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute Toxicity to ReservedS/
Aquatic Insects
142-2 - Aquatic Insect ReservedS/
Life Cycle Study
142-3 - Simulated or Actual ReservedS/
Field Testing for
Aquatic Insects
143-1 - NONTARGET INSECT ReservedS/
thru TESTING - PREDATORS
143-3 AND PARASITES
71
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TABLE A
GENERIC DATA REQUIREMENTS FOR NABAM
FOOTNOTES
§158.155 Nontarqet Insect - (Cont'd)
I/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic,
Food Crop; D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic
Outdoor; I = Indoor.
V As data from the acute contact study show low toxicity to honey bees, no further testing is required.
4/ Reserved pending development of test methodology.
5/ Reserved pending Agency decision as to whether the data requirement should be established.
72
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NABAM
Data Requirement
Test Use
Substance1/ Patterns
Does EPA Bibliographic Must Additional Timeframe
Have Data? Citation Data be for
Submitted?2/ Submission
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and MP
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
Physical and Chemical Characteristics
63-2 - Color MP
63-3 - Physical State MP
63-4 - Odor MP
All
All
All
Yes
Yes
Yes
All
All
All
Yes
Yes
Yes
All
All
All
Yes
Yes
Yes
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
6 Months
6 Months
73
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NABAM
Data Requirement Test
SubstanceV
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements:
64- 1 - Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
NA
Use
Patterns
All
All
All
All
All
All
All
All
All
NA
Does EPA Bibliographic Must Additional
Have Data? Citation Data be
Submitted?2/
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Timeframe
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
6 Months
15 Months
I/ Composition: MP = Manufacturing-use product,
2/ Although product chemistry data may have been submitted in the past,
be resubmitted for each manufacturing-use product. New requirements
data must be updated. Therefore bibliographic citations for the old
the Agency has determined that these data must
have been introduced and previously submitted
data are not applicable.
74
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NABAM
Data
§158.
Requirement Test Use Does
SubstanceV PatternsV Have
.135 Toxicology
EPA Bibliographic Must Additional Timeframe
Data? Citation Data be for
Submitted? Submission
ACUTE TESTING
81-1
81-2
81-3
81-4
81-5
81-6
- Acute Oral Toxicity - Rat MP A/B,D
- Acute Dermal Toxicity MP A,B,D
- Rabbit
-Acute Inhalation Toxicity MP A,B,D
- Rat
- Primary Eye Irritation MP • A,B,D
- Rabbit
- Primary Dermal Irritation MP A,B,D
- Rabbit
- Dermal Sensitization MP A,B,D
- Guinea Pig
Yes 9 Months
- Yes 9 Months
Yes 9 Month
Yes 9 Months
Yes 9 Months
Yes 9 Months
I/ Composition: MP = Manufacturing-use product.
2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Nonfood; C = Aquatic, Food Crop;
D = Aquatic, Nonfood; E = Greenhouse, Food Crop; F = Greenhouse, Nonfood; G = Forestry; H = Domestic Outdoor; I =
Indoor.
75
-------
II. LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storage Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
-------
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)]
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)]
77
-------
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 III. [40 CFR 162.10(h) (1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(1)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements 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 CER 162.10(h)(2) ]. .
78
-------
-UMMARY-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.
79
-------
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 162.10(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, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
80
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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.
81
-------
SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
. REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
82
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SUMMARY-7
ITEM
7C
7D
7E
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
precautionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
*
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution _where_applicable.
83
-------
I— lnvironm«nfol Protection Agency
§ 162.10
cant obtained the dau from another
firm (identify): applicant copied dau
from a publication: applicant obtained
a copy at the data from EPA).
(d) The applicant shall submit with
his application a statement that EPA.
in its evaluation of the properties, effi-
cacy. and safety of the formulated
end-use product, may not consider any
data as supporting the application.
except the following data:
d) The data the applicant has sub-
mitted to EPA under paragraph (b) of
chis section:
(2) Other dau pertaining to the
safety of the product's active ingredi-
ents. rather than to the safety of the
end-use product; and
(3) Existing tolerances, food additive
regulations, exemptions, and other
clearances issued under the Federal
Food. Drug, and Cosmetic Act.
(e) If the applicant knows that any
item of data he submitted under this
section was generated by (or at the ex-
pense of) another person who original-
ly submitted the data to EPA (or its
predecessor. USDA) on or after Janu-
ary 1. 1970. to support an application
for registration, experimental use
permit, or amendment adding a new
use to an existing registration, or for
reregistration (unless the applicant
and the original data submitter have
reached written agreement on the
amount and the terms of payment of
any compensation that may be pay-
able under FIPRA section
3(cxlXOxil) with regard to approval
of the application), the applicant shall
submit to EPA a statement that he
has furnished to each such identified
original data submitter. -
(DA notification of the applicant's
intent to apply for registration, includ-
ing the proposed product name:
(2) An offer to pay the person com-
pensation. with regard to the approval
of the application, to the extent re-
quired by PIPRA sections 3(c)(l)(D)
and 3(cX2XD):
(3) An identification of the item(s)
of dau to which the offer applies:
(4) An offer to commence negotia-
tions to ascertain the amount and
terms of compensation to be paid: and
(5) The applicant's name, address,
and telephone number.
(f) If the applicant's product con-
tains any active ingredient other than
those that are present solely because
of the Incorporation into the product.
during formulation, of one or more
other registered pesticide products
purchased from another producer.
then the applicant shall also comply
with f 162.9-5 as to such active ingre-
dient, and the application shall con-
tain an acknowledgment that for pur-
poses of PIFRA section 3(CX1XD) the
application relies on (and any result-
ing registration should be regarded as
If it were based on the Administrator's
consideration of) the following data: •
(1) All dau submitted or specifically
cited by the applicant in support of
the registration: and
(2) Each other item of dau In the
Agency's files which:
(1) Concerns the properties or effects
of any such active ingredient; and
(11) Is one of the types of dau that
EPA would require to be submitted for
scientific review by EPA if the appli-
cant sought the initial registration
under FIPRA Section 3
(44 PR 37984, May 11.19T9J
I ltt.10 Ubcilag rtqiUnaenu.
(a) Central—U) Contents of the
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Part. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed in paragraph (b) of this
section:
(ii) The name and address of the
producer, registrant, or person for
whom produced as prescribed in para-
graph (c) of. this section:
(ill) The net contents as prescribed
in paragraph (d) of this section:
84
-------
§162.10
TIM* 40—ProtKtion of Environment
(Iv) The product registration
number as prescribed In paragraph (e)
of this section:
(v) The producing establishment
number as prescribed In paragraph
-------
Chapter I—environmental Protection Agency
§ 16X10
my agency or the Federal Govern-
menu
(vi) The name of a pesticide which
contains two or more principal active
ingredients if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser
(viil) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act aad these regula-
tions;
(lx) Claims as to the safety of the
pesticide or its ingredients. Including
statements such as "safe." "nonpoison-
ous." "noninjurious." "harmless" or
"nontoxte to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
<* ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units. Le^ "1 pound 10 ounces" rather
than "26 ounces."
(5) In «*M1fl*'i to the required units
speclflsd. net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable In good
manufacturing practice. Variation
below a stated minimum, is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
other print on that pan of the label
on which it appears and shall run par-
86
-------
§ 16X10
Title 40—Protection of
ailel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or Imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
padcage If the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—"•«
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or propri-
etary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25
-------
Chapter I—environmental Protection Agency
§ 162.10
inert Ingredients > to b« listed in the
ingredient statement if he determines
that such ingredient(s) may poae a
hazard to man or the environment.
-------
I—environmental Protection
stances under which they are required
follow:
(A) IX a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LD« of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" la required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC- of 1 ppm or leas.
the statement "This Pesticide is Toxic
to Pish" Is required,
(C) If a pestidde intended for out-
door use contains an active ingredient
with an avian acute oral LDi. of 100
mg/kg or less, or a subacute dietary
LC- of 500 ppm or less, the statement
••This Pesticide is Toxic to Wildlife" Is
required.
(O) If either acddent history or field
studies demonstrate that use of the
§162.10
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) Por uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(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 dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
Ity or explosive characteristics of the
pestidde are required as follows:
I a or I
Oa net puvmor norwMc
* i3P f off CUM
UM or WE* n«r MM
jtervlse the use or the pesticide. When
followed, direction* must be adequate
to protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
fii) Placement of directions for use.
Directions may appear on any portion
of (he label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter Is securely
attached to each package of the pesti-
cide, or placed withm the outside
wrapper or bag:
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular" and
(C) The Administrator determines
that it is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for we—
-------
§ 162.10
TiH« 40—Protection of Environment
placement of the statement of practi-
cal treatment is some reference .such
33 "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
cB) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXlXliiXA) of
this section. The applicant may. how*
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (hX2) of this
section If they do not appear on the
front panel.
(IV Placement and prominence All
the require front panel warning state-
menu shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ment! for the front panel warning
statements on various sizes of labels:
Sin o< i
von*
<««0 out
5 md
J n 10
10 10 15..
U to 30..
OMT X
« i
to I
t
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(1) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
rooty
i ay tenon
Om.
* *mo**t (MiMd or woorMd \ COTMM. OMOM *r« «nd «n oamogo (or
ovougn tatl Oo not oroomo vtoor (dutt Of «roy I ntfaon). Oo not gtt «
of
d]
Uov bo IOM 4 wwtoiMd CinniMrt or MorMd | Cmm tyo (•« Mnl mmon. Oo not ON m
nougn Wo ««1. Oo not oraodo ««eoni toua or I on IMA, or an donna. KarmM * u»o ..... «i. IAO-
mil. Oo not ad M *rM. on •«. or on i grognon Dm M ii»Mniii« nauraa.]
(IrMHoa or Mnir*rrii Mougn ino I A«ad eonaa ««•» non. ty«« or oomrg. in cu« at
(Ou« or tony ™«1. I eamoet i niiimiiin HMD •»«• or nun «tn ottmy ot
(•yea or aonngj. (Aooro- 1 MMT. O«
J. I
) ---------- CNo oraeaiM
(U) Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the circum-
89
-------
§ 16X10
Title 40—Protection of Environment
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
U) The label clearly shows that the
product Is intended (or use only in
manufacturing processes and specifies
the typei« areas, or
objects to be treated.
dv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vl) The method of application. In-
cluding instructions for dilution, if re-
quired, and type of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
results without causing unreasonable
advene effects on the environment.
(vtli) Specific limitations on reentry
to areas where the pestidde has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(Ix) Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirement! of 40 CFR Pan 185. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set In type of the same minimum sizes
as required for the child hazard warn-
ing (See Table in i 1811.)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such ac
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops. *n(r"«L«, objects, or
in or adjacent to certain areas.
(D) (Reserved]
9V
-------
Oiopter I—fnvir«nm«n»aJ Proft. both of these uses may appear
on a product labeled for restricted use.
Such products shall be subject to the
provisions of f 162.KXJX2).
(1) General Use Classification. Pesti-
cide products bearing directions for
use(s) classified general shall be la-
beled with the exact words "General
Classification" 'mmediately below the
beading "Dim '.Ions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of misbrscding.
(2) Restricted Use Classification.
Pesticide products bearing direction
for useis) classified, restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(I) Front panel statement of restrict-
ed UM classification. (A) At the top of
the front panel of the label, set In type
§ 1o2.11
of the same minimum sizes as required
for human hazard signal words (see
cable Ln 5 162.10(hKl)(lv)). and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use, the state-
ment "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 per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified 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]
C40 PR. 28288. July 3, 1973: 40 PR 32329.
Aug. L 1975: 40 PR 3MT1. Aug. 31. 1979. u
amended u 43 PR 3784, Feb.». 1978]
11C2.11 Criteria for dcUnninftdom of un-
reaMBabte advtrM dTeeta,
(a) Criteria for Issuance of Notice of
Intent to Deny Registration, Cancel
Registration, or to Hold a Hearing—
(1) Presumption, (i) A rebuttable pre-
sumption shall arise that a notice of.
intent to deny registration pursuant to
section 3(cx6) of the Act. a notice of
Intent to cancel registration pursuant
to section ftbXl) of the Act. or a
notice of intent to hold a hearing to
determine whether the registration
should be cancelled or denied, as ap-
propriate, shall be issued, upon a de-
termination by the Administrator that
the pesticide meets or exceeds any of
the criteria for risk set forth in para-
graph (ax3) of this section. Upon such
determination, the Administrator
shall issue notice by certified mail to
the applicant or registrant, as the case
may be. stating that the applicant or
registrant has the opportunity to
submit evidence in rebuttal of such
presumption in accordance with para-
graph (aX4) of this section. The appli-
cant or registrant shall have forty-five
92
-------
9142.11
TM« 40 -Eroteclk
(46) days from the date such notice is
sent to submit evidence in rebuttal of
the presumption: provided, however.
that for good cauae shown the Admin-
istrator may grant an additional sixty
(80) days in which such evidence may
be submitted.
(11) At any time an applicant or reg-
tstrant may petition the Administrator
to withdraw his application or termi-
nate his registration. The Administra-
tor may. in his discretion, deny any pe-
tition for withdrawal or for termina-
tion and proceed in accordance with
these regulations.
(2) Rebuttal of Presumption. The
party seeking new or continued regis-
tration may rebut the presumption
arising under paragraph (aXl) of this
tuctlon by nit lining the affirmative
harden or proof set forth In paragraph
(aX4) of this section. After review of
the evidence submitted in rebuttal of
ti\f presumption, the Administrator
shall determine in accordance with
paragraph (4) of this I 162.11 Results in a mMi™™* calculated
concentration following direct applica-
tion to a 9-inch layer of water more
than V% the acute LC*. for aquatic or*
ganisms representative of the organ-
isms likely to be exposed as measured
on test «*H*»*I« specified in the Regis-
tration Guidelines,
(11) Chronic Taxicitv. (A) Induces on-
cogenic effects in experimental mam-
malian species or in fn»« as a result of
oral. Inhalation or dermal exposure: or
induces mutagenic effects, as deter-
mined by multitest evidence.
(B) Produces any other chronic or
delayed toxic effect in test anlmnJn at
any dosage up to a level, as deter-
mined by the Administrator, which is
p«biffan*1*llT higher »**y« that to
which humans can reasonably be an-
ticipated to be exposed, taking into ac-
count *"*pi" margins of safety: or
(C) Can reasonably be anticipated to
result in significant local, regional, or
national population reductions in non-
target organisms, or fatality to mem-
bers of endangered species.
(ill) Lack of Emtrvmet Treatments.
Has no known antidotal, palliative, or
first aid treatments for amelioration
of toxic effects in man resulting from
a single exposure.
(4) Burden of Proof. Upon finding in
arffT"1an*>* with paragraph (1) of this
{ 18X11(4) that notice pursuant to sec-
tions 3(0(6) or 8(bXl) of the Act. or
notice of Intent to hold a hearing to
determine whether the registration
should be cancelled or denied, as ao-
93
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PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Isabel Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
94
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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.
95
-------
PEST/DIS-1
PESTICIDE^DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food, or
feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
that are Acute Hazardous Wastes or are assigned to Toxicity
Category I on the basis of oral or dermal toxicity, or Toxicity
Category I or II on the basis of acute inhalation toxicity
must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal
of excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients that are
Toxic Hazardous Wastes or meet any of the criteria in 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
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original container
in several layers of newspaper and discard in trash."
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles^ cansj J_ars)
Non-aerosol products
(baqs)
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 others _products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
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.
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.
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.
.Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder for reuse (or
similar wording)
]J Manufacturer- may replace this phrase with one indicating
whether and how fiber drum may be reused.
97
-------
III. USE INDEX
98
-------
EPA Index to Pesticide Chemicals
cO 14503 NABAM* V
TYPE PESTICIDE: Fungicide, Algaecide, Antimicrobial, Antifoulant
FORMULATIONS; "'
FI (13.5%, 1.47 Ib/gal or 15%, 17.1%, 2.14-2.21 Ib/gal or 22.5%, 2.4-
2.5 Ib/gal or 25%, 2.88-3.0 Ib/gal or 30%)
SC/S (93%)
SC/L (2.0 Ib/gal or 22%, 22%)
RTU (0.33 Ib/gal or 3.75%, 0.39 Ib/gal 4.5%, 0.51 Ib/gal or 5.58%, 0.6
Ib/gal or 7.5%, 0.9 Ib/gal or 9.75%, 1.1 Ib/gal or 12%, 1.19 Ib/gal
or 12.5%, 14%, 1.47 Ib/gal or 15%, 1.425 Ib/gal or 15%, 18%, 2.1 lb/
gal or 22%)
GENERAL WARNINGS AND LIMITATIONS: Protective clothing consisting of long
pants, long sleeved shirt, gloves, hat and boots must be worn during mix-
ing and loading for agricultural crop and ornamental plant uses. Wear
goggles or face shield, rubber gloves and protective clothing (hats, long
sleeve shirt, long pants and boots) when handling for aquatic sites and
commercial and industrial uses.
For uses on agricultural crops and ornamentals(with an onion use as the
exception), nabam is mixed with zinc sulfate to form zineb. For each 1.0
pound active ingredient or nabam, add 0.75 to 1.0 pound zinc sulfate (36
percent metallic zinc) or 1.0 to 1.25 pounds zinc sulfate (22.8 to 25.5
percent metallic zinc) per 100 gallons of water. Dosages and limits are
given in pounds active ingredient nabam. For vegetables, field crops, and
ornamentals, unless otherwise specified apply on a regular 7 to 10 day
schedule or more frequently under severe disease conditions. Begin when
disease first appears and continue as long as disease conditions prevail.
Consult a State Agricultural Cooperative Extension Service regarding spe-
cific recommendations for these applications; and for fruit spray sched-
ules. Apply with standard high volume, concentrate, or aircraft equip-
ment. A suitable spreader-sticker may be added for certain hard-to-wet
crops. Nabam is compatible with most insecticides, fungicides, and nutri-
tional spray mixtures. Do not combine with emulsive or soluble type spray
oils as sprayer screens and nozzles may become clogged.
For aquatic sites and commercial and industrial uses, dosages are given
in active ingredient nabam.
Definition of Terms:
a.i,, - active ingredient
MAI - multiple active ingredient(s)
ppm - parts per million
*disodiura ethylene bisdithiocarbamate
Issued: 10-30-84 II-014503-1
-------
Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/16002AA
FJAAPEJ
/28001AA
FAAACDP
FFABPCN
FJAAUAH
/28002AA
/13011AA
/13021AA
/L3025AA
/28022AA
FFABPAU
FMBCCBM
TERRESTRIAL FOOD CROP
(Agricultural Crops)
Asparagus . .
Rust (Puccinia)
Beans (lima and snap)
Anthracnose
(Colletotrichum)
Downy mildew
(Phytophthora)
Rust (Uromyces)
Beets
Downy mildew
(Peronospora)
Leaf spot
(Cercospora)
1.0 lb/100
gal
or
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
1.0 lb/100
gal
or
1.0-1.5 Ib/A
[100-125
gal/A]
(2.0 Ib/gal
or 22% SC/L)
N.F.
Foliar application. Apply to new
fern growth after harvest or to new
plantings at first sign of disease.
Repeat at 10 day intervals until
fern growth is completed.
7 ppm as zineb
7 day preharvest interval through
1.0 pound per 100 gallons.
Foliar application. Apply after
first blossoms appear.
1.0 lb/100
gal
or
1.0-1.5 Ib/A.
(2.0 Ib/gal
or 22% SC/L)
7 ppm as zineb, beet (garden) roots
only
25 ppm as zineb., beet tops
7 day preharvest interval for beet
tops for food or feed through 1.0
pound per 100 gallons.
Foliar application.
Issued: 10-30-84
••>.v II-014503-2
-------
/13005AA
/L3007AA
/13008AA
"FFABPAU
FMBCAAX
/10002AA
/L0010AA
/10012AA
/10008AA
FAAACDP
FFA3PEA
FBAQMCO
FBATAAX
/28073AA
FBASAAX
FBAMCBM
Site and Pest
Broccoli
Cabbage
Cauliflower
Downy mildew
(Peronospora)
Leaf spot
(Alternaria)
EPA Index to Pesticide Chemicals
NAB AM
Dosages and Tolerance, Use, Limitations
Formulation(s)
7 ppm as zineb
7 day preharvest interval through
1.0 pound per 100 gallons.
Off.
Cabbage
Cantaloupe
Cucumber
Squash
Watermelons
Anthracnose
(Colletotrichum)
Downy mildew
(Pseucjoperoho-
spora)
Gummy stem blight
(Mycosphaerella)
Leaf blight
(Alternaria)
Carrots
Alternaria blight
(late blight)
Cercospora blight
(early blight)
Cauliflower
Foliar application. Apply in plant
bed and field. For downy mildew,
apply at weekly intervals as long
as disease is present.
1.0 lb/100
gal
or
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
(22% SC/L)
See Broccoli cluster.
4 ppm as zineb for cucumbers, mel-
ons, and squash
5 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/100 Foliar application. Apply when
gal vines are 4 to 6 inches long. Re-
or peat at weekly intervals. Direct
1.0-1.5 Ib/A sprays especially to underside of
(2.0 Ib/gal leaves.
or 22% SC/L)
(22% SC/L)
7 ppm as zineb
7 day preharvest interval if tops
are to be used as food or feed
through 1.0 pound per 100 gallons.
1.0 lb/100
gal
or
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
Foliar application.
See Broccoli cluster.
Issued: 10-30-84
II-OL4503-3
101
-------
Site and Pest
/28003AA
FBAMCBM
FBASSBL
/05002AA
Early blight
(Cercospora)
Late blight
(Septoria)
Cherry (sour)
FMBCCDJ
Cherry leaf spot
(Coccomyces)
/15005AA
Corn
FBATHAM
FJAAPEJ
Helminthosporium
leaf spots
Rust (Puccinia)
Cucumber
EPA Index Co Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
5 pptn as zineb
14 day preharvest interval through
1.0 pound per 100 gallons.
Remove residues by stripping, trim-
ming, and washing.
Foliar application. Apply in plant
bed and field at weekly intervals.
1.0 lb/100
gal
or
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
(22% SC/L)
7 ppm as zineb
7 day preharvest interval through
0.5 pound per 100 gallons.
Mix with 6.0 ounces zinc sulfate (36
percent metallic zinc).
0.5 lb/100 Delayed dormant, preharvest and
gal postharvest foliar application.
(2.0 Ib/gal
or 22% SC/L)
5 ppm as zineb, sweet corn (kernels
plus CWHR)
No preharvest interval through 1.0
pound per 100 gallons.
Do not feed treated forage to dairy
animals or animals being finished
for slaughter.
1.0 lb/100
gal
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
Foliar application.
See Cantaloupe cluster.
Issued: 10-30-84
II-014503-4
102
-------
Site and Pest
/01014AA
FIBFGBG
FFABPCV
FICAGAP
/08020AA
FFABPEA
/13011AA
/13020AA
FFABBBA
/13021AA
Black rot
(Guignardia)
Downy mildew
(Plasmopara)
Ripe rot
(Glomerella)
Downy mildew
(Pseudoperono-
spora)
Kale
Lettuce
Downy mildew
(Bremia)
Mustard Greens
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulaeion(s)
7 ppm as zineb
7 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/100 Delayed dormant and foliar applica-
gal tion.
(2.0 Ib/gal
or 22% SC/L)
60 ppm as zineb
14 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/100 Delayed dormant and foliar applica-
gal .tion. Apply drenching spray on
(2.0 Ib/gal crowns when new growth starts. Be-
or 22% SC/L) gin vine sprays at training.
10 ppm as zineb
10 day preharvest interval through
1.0 pound per 100 gallons.
Refer to Beets for pest and use information.
10 ppm as zineb
10 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/100
gal
or
1.0-1.5 lb/A
(2.0 Ib/gal
Soil and foliar application. Apply
as a drenching spray in plant bed
when seed is planted. Repeat at
weekly intervals until transplant-
ing. In field, apply when disease
or 22% SC/L) appears. Repeat at weekly intervals
(22% SC/L) or more often under severe disease
conditions.
10 ppm as zineb
10 day preharvest interval through
1.0 pound per 100 gallons.
Refer to Beets for pest and use information.
Issued: 10-30-84
II-014503-5
103
-------
/1401LAA
/16004AA
FKAABAW
FFABPAU
FCAEAAX
/14011DA
FLANUAG
/28017AA
FAAAQBB
FMAVCBM
/13024AA
FFABPAU
FGARAAV
Site and Pest
Onion
Onions (green)
Botrytis blight
(blast)
Downy mildew
(Peronospora)
Purple blotch
(Alternaria)
Onion
Onion smut
(Urocystis)
Pet
Anthracnose
Cercospora leaf
spot
Spinach
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Fonnulation(s)
7 ppm as zineb
7 day preharvest interval for green
onions and no preharvest interval
for bulb or dry onions through 1.0
pound per 100 gallons.
1.0 lb/100 Foliar application.
gal
or
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
(22% SC/L)
N.F.
Apply without zinc sulfate.
1.0 Ib/A At-planting soil application. Apply
(2.0 Ib/gal in sufficient water as a furrow
or 22% SC/L) drench at seeding.
7 ppm as zineb
No preharvest interval through 1.0
. pound per 100 gallons.
1.0 lb/100
gal
(22% SC/L)
Downy mildew 1.0 lb/100
(blue mold) gal
(Peronospora) or
Whice rust (Albugo) 1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
(22% SC/L)
Squash
Foliar application.
10 ppm as zineb
10 day preharvest interval through
1.0 pound per acre.
Foliar application.
See Cantaloupe cluster.
Issued: 10-30-84
II-014503-6
104
-------
/01016AA
"FGAKDBS
FMBCMCO
/13025AA
/11005AA
FAAAGAP
FHAGCCV
FBAMAAX
FBASPCN
FMBCSBL
FMBCSDG
/28022AA
Site and Pest
Strawberry
Leaf scorch
(Diplocarpon)
Leaf spot
(Mycosphaerella)
Swiss Chard
Tomato
Anthracnose
(Glomerella)
Cladosporium leaf
mold
Early blight
(Alternaria)
Late blight
(Phytophthora)
Leaf spot
(Septoria)
Leaf spot
(Stemphylium)
Turnips
4ft
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
7 ppm as zineb
7 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/100
gal
(2.0 Ib/gal
or 22% SC/L)
Delayed dormant and foliar applica-
tion.
25 ppm as zineb
7 day preharvest interval through
1.0 pound per 100 gallons.
Refer to Beets for pest and use information.
4 ppm as zineb
5 day preharvest interval through
1.0 pound per 100 gallons.
1.0 lb/100
gal
or
1.0-1.5 Ib/A
(2.0 Ib/gal
or 22% SC/L)
(22% SC/L)
Foliar application. Begin when
first fruits are set, at first signs
of disease, or when plants are set
in the field where, blights are nor-
mally severe.
Watermelons
7 ppm as zineb, with or without
tops, or turnip greens
7 day preharvest interval for turnip
tops for food or feed through 1.0
pound per 100 gallons.
Refer to Beets for pest and use information.
See Cantaloupe cluster.
Issued: 10-30-84
•'11-014503-7
105
-------
Site and Pest
EPA Index Co Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/34022AA
/34036AA
FBADOAV
FBADSAQ
/31057AA
/31065AA
/3LL84AA
FAAACDP
FMBCQBB
FJAAQBB
/31111AA
FMCDBAW
FMCDCFH
FMCESDB
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
Azalea
Camellia
Petal blight
(Ovulinia)
(on azalea)
Petal blight
(Sclerotinia)
(on camellia)
Carnation
Chrysanthemum
Snapdragon
Anthracnose
(Colletotrichum)
Leaf spots
Rusts
Gladiolus
Leaf and flower
spot (Botrytis)
Leaf and flower
spot (Curvularia)
Leaf and flower
spot (red spot)
(Stemphylium)
0.5 lb/100 Foliar and soil application. Mix
gal with 6.0 ounces zinc sulfate (36
(2.0 Ib/gal. percent metallic zinc). Apply 2 to
or 22% SC/L) 3 times per week while flowers are
opening. Spray flowers, soil, and
litter under the plants.
1.0 lb/100
gal
(22% SC/L)
Foliar and soil application. Apply
when flower buds swell in spring.
Apply to open flowers, soil, and
litter under the plants. Repeat at
3 to 5 day intervals until end of
blossoming season.
1.0 lb/100
gal
(2.0 Ib/gal
or 22% SC/L)
1.0 lb/100
gal
or
(2.0 Ib/gal,
or 22% SC/L)
1.0 lb/100
gal
[60 gal/Al
(22% SC/L)
Foliar application.
Foliar application.
Foliar application. Apply when dis-
ease first appears. Repeat at 3 to
5 day intervals until end of blos-
soming season.
Issued: 10-30-84
II-014503-8
106
-------
/65018MA
Site and Pest
AQUATIC NON-FOOD
(Aquatic Sites)
Air Washer Water Systems
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
DBABAAA
FYAFQBB
Slime-forming
bacteria
Slime-forming fungi
In treating air washer systems pre-
clean by introducing a suitable de-
tergent solution into the system and
allow air washer to run with fan off
for 2 hours. Flush. Check all noz-
zles, and manually clean those that
are plugged.
May be fed directly from drum or
diluted with water and fed by any
suitable system. Apply directly to
the sump or basin or at any point
in the system where formulation will
be uniformly mixed.
0.4-2.4 oz/ Water treatment (3.0 to 18 ppm ac-
1,000 gal tive ingredient). Initial dose:
system water Apply 2.4 ounces (18 ppm) 1 to 3
times per week or as needed to con-.
trol growth. Subsequent dose: When
control is evident, apply 0.4 to 0.8
ounce (3.0 to 6.0 ppm) every 3 days
or as needed.
Formulated with sodium dimethyldi-
thiocarbamate.
(0.39 Ib/gal
or 4.5% RTU)
(1.47 Ib/gal
or 15% RTU)
(18% RTU)
0.4-4.0 oz/ Water treatment (3.0 to 30 ppm
1,000 gal a.i.). Initial dose: Apply 2.4 to
system water 4.0 ounces (18 to 30 ppm) 1 to 3
times per week or as needed to
control growth. Subsequent dose:
When control is evident, apply 0.4
to 0.8 ounce (3.0 to 6.0 ppm) every
3 days or as needed.
Formulated with sodium dimethyldi-
thiocarbamate.
(1.47 Ib/gal
or 15% RTU)
Issued: 10-30-84
II-014503-9
107
-------
Site and Pest
EPA Index Co Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/65005MA
DBABAAA
Brewery Pasteurizers
Slime-forming
bacteria
0.24-4.8 oz/ Water treatment (1.8 to 36 ppm ac-
1,000 gal tive ingredient). Slug or intermit-
system water tent method. Initial dose: When
(1.47 Ib/gal system is noticeably fouled, apply
or 15% RTU) 0.36 to 4.8 ounces (2.7 to 36 ppm).
Repeat until control is achieved.
Subsequent dose: When control is
evident, apply 0.36 to 2.4 ounces
(2.7 to 18 ppra) every 3 days or as
needed to maintain control. Contin-
Initial dose:
uous method.
When
/65019MA
Commercial and Industrial Water
Cooling Towers
DBABAAA
FYAFQBB
Slime-forming
bacteria
Slime-forming fungi
0.4-2.4 oz/
1,000 gal
system water
(0.33 Lb/gal
or 3.75%
RTU)
(0.39 Ib/gal
or 4.5% RTU)
(0,9 Ib/gal
or 9.75%
RTU)
(1.47 Ib/gal
or 15% RTU)
(18% RTU)
system is noticeably fouled, apply
0.36 to 3.12 ounces (2.7 to 23 ppm)
Subsequent dose: Use continuous
feed at 0.24 to 1.2 ounces (1.8 to
9.0 ppm).
Formulated with sodium dimethyldi-
thiocarbamate.
Dosage will depend on the condition
of the system prior to .treatment.
Systems which are heavily contami-
nated should be cleaned first. Ap-
ply to the cleaned system or when
growth is first noticed. May be fed
directly from drum or diluted with
water and fed by any suitable sys-
tem. Apply directly to the sump or
basin or at any point in the system
where formulation will be uniformly
mixed.
Water treatment (3.0 to 18 ppm ac-
tive ingredient). Initial dose:
Apply 2.4 ounces (18 ppm) 1 to 3
times per week or as needed to con-
trol growth. Subsequent dose: When
control .is evident, apply 0.4 to 0.8
ounce (3.0 to 6.0 ppm) every 3 days
or as needed.
Formulated with sodium dimethyldi-
thiocarbamate.
Issued: 10-30-84
II-014503.-10
-------
Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Commercial and Industrial Water Cooling Towers (continued)
0.4-8.0 oz/ Water treatment (3.0 to 60 ppm ac-
1,000 gal tive ingredient). Initial dose:
system water Apply 2.4 to 8.0 ounces (18 to 60
(1.47 Ib/gal ppm) 1 to 3 times per week or as
or 15% RTU) needed to control growth. Subse-
quent dose: When control is evi-
dent, apply 0.4 to 0.8 ounces (3.0
to 6.0 ppm) every 3 days or as need-
ed.
Formulated with sodium dimethyldi-
thiocarbamate.
1.22 oz/1,000 Water treatment (9.2 ppm active in-
gal system gredient). Apply on a continuous
basis to system and to make-up
water. As a preventive, apply week-
ly.
Formulated with sodium dimethyldi-
thiocarbamate, isopropanol, and
2,4,5-trichlorophenol , potassium
salt.
water
(0.51 Ib/gal
or 5.58%
RTU)
PKAAAAA
DBABAAA
FYAFQBB
Algae
Slime-forming
bacteria
Slime-forming fungi
52.5-210 lb/ Water treatment. Initial dose: In
1,000,000 a large, clean system, apply 105
gal system pounds per 1,000,000 gallons (13 ppra
water active ingredient). When system is
or noticeably fouled, apply 210 pounds
19.08 oz/ (25 ppm). In smaller systems, apply
1,000 gal 19.08 ounces (31 ppm), and repeat
system water if needed. Subsequent dose: When
(2.1 Ib/gal control is evident, apply 52.5 to
or 22% RTU) 105 pounds per 1,000,000 gallons
(6.3 to 13 ppm) once per week. In
smaller systems, apply 19.08 ounces
(3L ppm) once per week, and repeat
as needed.
Issued: 10-30-84
11-014503-11
109
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Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Commercial and Industrial Water Cooling Towers (continued)
/65019MA (evaporative condensers,.heat
exchanger water systems, com-
mercial and industrial cooling
towers, influent systems such
as flow through filters and
lagoons, and industrial water
scrubbing systems)
PKAAAAA Algae 0.24 to 4.8
DBABAAA Slime-forming oz/1,000 gal
bacteria water system
FYAFQBB Slime-forming fungi (1.47 Ib/gal
or 15% RTU)
/65025MA Oil Recovery Water
FYAFQBB Fungal slime
1.53-2.85
lb/100 bbl
water
or
0.15-0.22
lb/100 bbl
water
(0.39 Ib/gal
or 4.5% RTU)
(1.19 Ib/gal
or 12.5%
RTU)
(1.47 Ib/gal
or 15% RTU)
(18% RTU)
Water treatment (1.8 to 36 ppm
a.i.). Slug or intermittent method.
Initial dose: When system is no-
ticeably fouled, apply 0.36 to 4.8
ounces (2.7 to 36 ppm). Repeat un-
til control is achieved. Subsequent
dose: When control is evident, ap-
ply 0.36 to 2.4 ounces (2.7 to 18
ppm) every 3 days (daily, for algae)
or as needed to maintain control.
Continuous method. Initial dose:
When system is noticeably fouled,
apply 0.36 to 3.12 ounces (2.7 to
23 ppm). For algae, repeat until
control is achieved. Subsequent
dose: Use continuous feed at 0.24
to 1.2 ounces (1.8 to 9.0 ppm).
Formulated with sodium dimethyldi-
thiocarbamate.
Do not apply in marine and/or estu-
arine oil fields.
Water treatment (3.2 to 62 ppm ac-
tive ingredient). Apply in secon-
dary and tertiary petroleum water-
flood systems. For control of fungi
and bacteria, and growth inhibition
of Bacillus cerus and Desulfovibrio
desulfuricans, apply 0.15 to 0.22
pound (3.2 to 4.8 ppm). For growth
inhibition of heterotrophic bacteria
including Pseudomonas spp. , apply
1.53 to 2.85 pounds (33 to 62 ppm).
Inject directly into and mix thor-
oughly with the produced water,
fresh or salt water or commingled
water.
Formulated with sodium dimethyldi-
thiocarbamate.
Issued: 10-30-84
11-014503-12
1 10
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Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Oil Recovery Water (continued)
1.2-75 ppm
a.i.
(1.1 Ib/gal
or 12% RTU)
(1.47 Ib/gal
or 15% RTU)
Water treatment. Apply to under-
'ground flood water.
Formulated with sodium dimethyldi-
thiocarbamate; or ethylenediamine
and sodium dime thy Idithiocarbamate.
DBABAAA
Slime-forming
bacteria
0.25-1.22 lb/ Water treatment (30 to 146 ppm
1,000 gal a.i.). Slug or intermittent method.
total volume Initial dose: Apply 1.22 pounds
(1.47 Ib/gal (146 ppm). Subsequent dose: Apply
or 15% RTU) 0.25 pound (30 ppm) weekly to main-
tain control.
Formulated with sodium dimethyldi-
thiocarbamate.
/65008MA
Pulp and Paper Mill Systems
DBABAAA
FYAFQBB
Slime-forming
Apply depending upon the type of
stock, complexity of the system,
quality of raw water, and type and
degree of contamination. May be
drip fed continuously from the drum
or fed by suitable chemical pumps
such as adjustable proportioning
types; variable speed, positive dis-
placement type; or by the recipro-
cating type. The formulation should
be fed as early as possible in the
system at such points including the
hydropulper, machine chest or broke
system.
May be used as a slimicide in the
manufacture of paper and paperboard
that contact food in accordance with
prescribed conditions-(CFR 21, In-
direct Food Additives, Section
176.300).
0.015-0.3 lb/ Water treatment. Continuous treat-
bacteria ST finished
Slime-forming fungi paper
(0.39 Ib/gal
raent is recommended, but slug or in-
termittent is also suggested on cer-
tain labeling.
or 4.5% RTU) Formulated with sodium dimethyldi-
(1.47 Ib/gal thiocarbamate.
or 15% RTU)
(18% RTU)
Issued: 10-30-84
11-014503-13
1 1 1
-------
Sice and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Pulp and Paper Mill Systems (continued)
0.088-0.44
Ib/ST pulp
or paper
produced
(dry basis)
(2.1 Ib/gal
or 22% RTU)
0.068-0.34
Ib/ST of
pulp or
paper
(dry basis)
(1.47 Ib/gal
or 15% RTU)
0.023-0.38
Ib/ST pulp
or paper
produced
(1.47 Ib/gal
or 15% RTU)
Water treatment. For slime control
in white water apply using either
continous feed or semi-slug addi-
tion. Average starting dose is 0.11
pound.
Water treatment. Intermittent meth-
od. Apply 0.2 to 0.34 pound for 2
hours every 8 hours. Continuous
method. Apply 0.068 to 0.23 pound
on a continuous basis.
Formulated with sodium dimethyldi-
thiocarbamate.
Water treatment. Slug method. Ini-
tial dose: When the system is no-
ticeably fouled, apply 0.023 to 0.38
pound. Repeat until control is
achieved. Subsequent dose: When
control is evident, apply 0.023 to
0.3 pound. Treat as needed to main-
tain control. Continuous method.
Initial dose: Apply as in slug
method. Subsequent dose: Maintain
control by continuous feeding at the
levels in slug method.
Formulated with sodium dimethyldi-
thiocarbamate.
0.11-0.33 lb/ Water treatment. Apply by slug
ST dry pulp method to troubled areas. Intermit-
(2.1.1b/gal tent or continuous feeding to the
or 22% RTU) white water, the beaters, hydropulp-
ers, etc., can also be used.
0.028-0.28 Water treatment. Apply directly to
Ib/ST pulp mill system.
or paper Formulated with sodium dimethyldi-
produced thiocarbamate and sodium penta-
(14% RTU) chlorophenate.
Issued: 10-30-84
U-014503-14
112
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Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Pulp and Paper Mill Systems (continued)
0.06-0.24 lb/ Water treatment.
ST dry paper Formulated with ethylenediamine and
or paper- sodium dimethyldithiocarbamate.
board
products
(1.1 Ib/gal
or 12% RTU)
0.038 Ib/ST Water treatment. Apply at beater,
finished fan pump, head box, or wire tray by
paper continuous or slug feed, depending
(0.6 Ib/gal on system.
or 7.5% RTU) Formulated with alkenyl (90% CIS,
10% C16) dimethyl ethyl ammonium
bromide.
/65028MA
Seawater Heat Exchangers
(shipboard)
IIDAAAC
DBABAAA
FYAFQBB
Barnacle larvae
Slime-forming
bacteria
Slime-forming fungi
1.5 ppra a.i.
(1.47 Ib/gal
or 15% RTU)
Apply to clean systems. Feed di-
rectly from the drum. The preferred
feed point is immediately after the
strainer. Do not feed, to a .system
while the cooling water is used as
either a brine source or a heat sup-
ply for fresh water evaporators.
Water treatment. Apply 1.5 ppm ac-
tive ingredient for 100 minutes eve-
ry 3 to 4 days. This is accomplish-
ed by feeding 1.5 liters formulation
over a 100 minute period for every
100 tons per hour of flow rate.
Formulated with sodium dimethyldi-
thiocarbamate.
Issued: 10-30-84
11-014503-15
1 13
-------
Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(a)
/65005MA
Sugar Beet Processing Water
DBABAAA
FYAFQBB
Slime-forming
bacteria
Slime-forming fungi
1.5-3.0 ppm
a.i. by
weight of
beets sliced
per day
(1.47 Ib/gal
or 15% RTU)
The formulation should be fed di-
rectly into the process. The point
or points of addition will depend
on mill design. Frequently, the
dosage will be split between the
fresh water entering the diffuser,
into the pressed pulp water return
line to the diffuser or fed direct-
ly into a certain point in the dif-
fuser depending on diffuser type.
Feed through a chemical feed pump
such as the adjustable proportion-
ing type; the variable feed, posi-
tive displacement type; or the reci-
procating type. May be used to con-
trol microorganisms in sugar beet
mills in accordance with prescribed
conditions at a level of 3.0 ppra ac-
tive ingredient by weight of raw
beets (CFR 21, Secondary Direct Food
Additives, Section 173.320). There-
fore, do not exceed a feed rate of
5.88 pounds active ingredient per
1,000 short tons of beets sliced per
24 hours.
Processing water treatment. Feed
continuously. In general, 1.5 ppm
will provide adequate control, how-
ever, the rate may be increased to
3.0 ppm when slicing beets deterio-
rated by freezing or lengthy stor-
age. The 1.5 to 3.0 ppm levels can
be achieved by adding 0.034 to 0.069
ounce active ingredient per minute
per 1,000 short tons of beets sliced
per day. Refer to labeling for
chart on dosages for varying amounts
of beets sliced per day.
Formulated with sodium dimethyldi-
thiocarbamate.
Issued: 10-30-84
11-014503-16
-------
EPA Index to Pesticide Chemicals
Site and Pesc
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/65005MA
-DBABAAA
FZZZQBB
Sugar Beet Flume Water Transporting
and Washing Systems
Bacteria
Fungi
0.3-0.77 ppm
a.i.
or
2.57-6.48 lb/
1,000,000
gal in sys-
tem
(0.39 Ib/gal
or 4.5% RTU)
(1.47 Ib/gal
or 15% RTU)
(18% RTU)
/650050A
Sugarcane Processing
Water treatment. Apply initially
at high rate on a continuous or once
per shift basis. Thereafter, add
at low rate to the system per 8 hour
shift. The concentration may be in-
creased to high rate per shift if a
decrease in pH or increase in odor
is detected.
Formulated with sodium dimethyldi-
thiocarbaraate.
The formulation should be fed di-
rectly into the cane juice so that
the treated juice circulates to all
parts of the mill tandem. The point
or points of addition will depend
on mill design. Frequently, the
dosage will be split between the
crusher juice' and juice from the
last mill. The best addition is to
the juice which is circulated back
to the crusher or first mill. Do
not add to maceration water. Feed
through a chemical feed pump such
as the adjustable proportioning
type; the variable feed, positive
displacement type; or the recipro-
cating type. May be used to control
microorganisms in sugarcane mills
in accordance with prescribed condi-
tions at a level of 3.0 ppm active
ingredient by weight of raw cane
(CFR 21, Secondary Direct Food Addi-
tives, Section 173.320). Therefore,
do not exceed a feed rate of 5.88
pounds active ingredient per 1,000
short tons of cane ground per 24
hours.
Issued: 10-30-84
11-014503-17
1 15
-------
Sice and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Sugarcane Processing (continued)
FZZZQBB
Fungi
1.5-3.0 ppm
a.i. by
weight of
cane ground
per day
(0.33 Ib/gal
or 3.75%
RTU)
(0.39 Ib/gal
or 4.5% RTU)
(1.47 Ib/gal
or 15% RTU)
(18% RTU)
Sugarcane juice treatment. The
standard dose is 1.5 ppm. Condi-
tions warranting some increase would
be grinding of cane damaged through
freezing, poor weather, or delays
between cutting and grinding. The
1.5 to 3.0 ppm levels can be achiev-
ed by adding 0.034 to 0.069 ounce
active ingredient per minute per
1,000 short tons of cane ground per
day. Refer to labeling for chart
on dosages for varying amounts of
cane ground per day.
Formulated with sodium dimethyldi-
thiocarbamate.
/810040A
FYAAQAA
FYAAQBB
INDOOR
(Industrial Preservatives and Additives)
Fuel Oil (No. 2 oil, intermediate
fuel oil, and No. 6 oil), Lubri-
cating Oil, and Hydraulic Fluids
(storage)
Bacteria
Fungi
0.78 Ib/ST
contaminated
fluid
or
45 ppm a.i.
by weight
(1.47 Ib/gal
or 15% RTU)
Additive incorporation. Apply ini-
tially at specified rate. Subse-
quent dosages may be decreased once
the contaminants have been brought
under control.
Formulated with sodium dimethyldi-
thiocarbamate.
Issued: 10-30-84
11-014503-18
1 16
-------
Site, and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/810050A
FYADQBB
FYADQBB
Leather
(brining and curing hides)
Bacteria 0.46-0.064 Preservative incorporation. Aids
Fungi lb/100 hides in the preservation of stored hides
when added to the raceway.
Formulated with sodium dimethyldi-
thiocarbamate.
processed
(1.47 Ib/gal
or 15% RTU)
'YABQBB
(fat liquoring stock)
Mold 0.075-0.15
lb/1,000 Ib
wet weight
(1.47 Ib/gal
or 15% RTU)
Preservative incorporation. Pro-
tects stock from mold damage due to
the presence of extracts, fillers,
and oils.
Formulated with sodium dimethyldi-
thiocarbamate.
'YABQBB
(tanning)
Mold
0.09-0.15 Preservative incorporation. Rate
lb/1,000 Ib depends upon the climate and length
white weight of holding time. Add prior to the
(1.47 Ib/gal last bicarbonate addition.
or 15% RTU) Formulated with sodium dimethyldi-
thiocarbaraate.
810060A
YABQBB
Leather Processing Liquors
(pickling liquor)
Mold
0.075-0.15%
a.i.
(1.47 Ib/gal
or 15% RTU)
Preservative incorporation. Pre-
vents mold damage of pickled stock
for 3 weeks. Add prior to the addi-
tion of sulfuric acid.
Formulated with sodium dimethyldi-
thiocarbamate.
'ADQBB
(soaking liquors)
Fungi
0.09-0.15 Ib/ Preservative incorporation. To pre-
ST solution vent loss of hide substance due to
fungal action in soaking liquors,
apply at low rate. If hides are to
be held longer than 2 weeks, apply
the high rate.
Formulated with sodium dimethyldi-
thiocarbamate.
(1.47 Ib/gal
or 15% RTU)
Issued: 10-30-84
11-014503-19
117
-------
Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/8L0070A
-FYAIQBB
Metalworking Cutting Fluids
Fungi
0.012-0.075%
a.i.
(1.1 Ib/gal
or 12% RTU)
(1.47 Ib/gal
or 15% RTU)
0.41-0.1 lb/
100 gal
coolant
(2.1 Ib/gal
or 22% RTU)
'810080A
)BADAAA
•YADQBB
3BABAAA
Oil Recovery Drilling Fluids
Deterioration/
spoilage bacteria
Fungi
Slime-forming
bacteria
1.425-7.35
lb/100 bbl
mud
(0.39 Ib/gal
or 4.5% RTU)
(1.19 Ib/gal
or 12.5%
RTU)
(1.47 Ib/gal
or 15% RTU)
(18% RTU)
8.58 lb/100
bbl
(1.47 Ib/gal
or 15% RTU)
Preservative incorporation. For use
in cutting fluids and other metal-
working fluids.
Formulated with sodium dimethyldi-
thiocarbamate; or ethylenediamine
and sodium dimethyldithiocarbamate.
Preservative incorporation (49 to
123 ppm active ingredient). For use
in water-dispersible metalworking
coolants. Dosage depends upon the
severity of the problem. For indi-
vidual machines, add directly to the
sump; for central systems, add to
the discharge side of the reservoir.
Repeat weekly. When dosage level
exceeds 74 ppm, it is recommended
that multiple additions of 25 ppm
each be made at hourly intervals.
Do not apply in marine and/or estu-
arine oil fields.
Additive incorporation. Use in
water-based drilling muds such as
those containing starches, xanthan-
ate gums, and wood sugars. May be
put through the mud hopper or added
to the sump suction.
Formulated with sodium dimethyldi-
thiocarbamate.
Additive incorporation.
Formulated with sodium dimethyldi-
thiocarbamate.
Issued: 10-30-84
11-014503-20
1 18
-------
Site and Pest
DBADAAA
FYADQBB
DBABAAA
DBADAAA
DBABAAA
/810010A
/810140A
/810120A
/810160A
/810090A
/810020A
EPA Index Co Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
Pill Recovery Drilling Fluids (continued)
0.0006-0.15%
a.i. by
weight/bbl
mud or
packer fluid
(1.1 Ib/gal
or 12% RTU)
(1.47 Ib/gal
or 15% RTU)
Additive incorporation. Use in
drilling muds, gypsum muds, and
packer fluids.
Formulated with sodium dimethyldi-
thiocarbamate; or ethylenediamine
and sodium dimethyIdithiocarbamate.
(workover and completion
fluids)
Deterioration/
spoilage bacteria
Fungi
Slime-forming
bacteria
Deterioration/
spoilage bacteria
Slime-forming
bacteria
0.37-1.47 lb/ Additive incorporation. Apply to
1,000 gal water based workover or completion
fluids fluids.
Formulated with sodium diraethyldi-
thiocarbamate.
(1.47 Ib/gal
or 15% RTU)
8.58 lb/100
bbl
(1.47 Ib/gal
or 15% RTU)
Preservation of Adhesives and Ani-
mal Glues, Inks, Latex, Mineral
Slurries, Paints and Coatings and
Paper Coatings
Additive incorporation.
Formulated with sodium dimethyldi-
thiocarbamate.
FYADQBB
?YABQBB
Fungi
0.006-0,15% Preservative incorporation.
a.i. Formulated with sodium dimethyldi-
(1.1 Ib/gal thiocarbamate; or ethylenediamine
or 12% RTU) and sodium dimethyldithiocarbamate.
(1.47 Ib/gal
or 15% RTU)
Preservation of Applied Films
(paints and other coatings, ad-
hesives and animal glues)
Mildew .
0.012-0.15%
a.i.
(1.1 Ib/gal
or 12% RTU)
(1.47 Ib/gal
or 15% RTU)
Preservative incorporation.
Formulated with sodium dimethyldi-
thiocarbamate; or ethylenediamine
and sodium dimethyldithiocarbamate.
Issued: 10-30-84
11-014503-21
119
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Site and Pest
EPA Index to Pesticide Chemicals
NABAM
Dosages and Tolerance, Use, Limitations
Formulation(s)
/810160A
FYADQBB
Preservation in Pulp and Paper
Mills .
Fungi
30-150 ppm
a.i.
(1.47 Ib/gal
or 15% RTU)
Preservative incorporation. Add
directly to the material to be pre-
served prior to manufacturing into
the finished product, i.e., pulp,
broke, polymers, defoamers, alum,
emulsions, adhesives, paper mill
coatings, pigment slurries, etc.
The dosage rate will depend upon the
material to be preserved and the
storage time. The usual addition
should be 30 to 45 ppm. Under ex-
treme conditions of spoilage, the
dosage rate should be increased to
38 to 120 ppm. The above recommen-
dations are based on a maximum stor-
age time of 2 weeks. For storage
greater than 2 weeks, the maximum
concentration should be increased
to 150 ppm.
Formulated with sodium dimethyldi-
thiocarbamate.
Pulp preservation.
0.088-0.44
Ib/ST pulp
(dry basis)
(2.1 Ib/gal
or 22% RTU)
0.03-0.38 lb/ Additives system treatment (3.6 to
1,000 gal
(1.47 Ib/gal
or 15% RTU)
45 ppm active ingredient). Slug
method. Initial dose: Applications
should be made directly at the rate
of 0.03 to 0.38 pound per 1,000 gal-
lons (3.6 to 45 ppm). Repeat until
control is achieved. Subsequent
dose: Apply 0.03 to 0.3 pound per
1,000 gallons (3.6 to 36 ppm). Con-
tinuous method. Initial dose: Ap-
ply as in slug method. Subsequent
dose: Apply by continuous feeding
at the levels in the slug method.
Issued: 10-30-84
120
11-014503-22
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EPA Index Co Pesticide Chemicals
NABAM
Site and Pest Dosages and Tolerance, Use, Limitations
Fonnulation(s)
AE'RIAL AND TANK MIX APPLICATIONS
01500 Aerial Application
&AAAA
Refer to
TERRESTRIAL FOOD CROPS
All sites
TERRESTRIAL NON-FOOD CROPS
All sites
121
Issued: 10-30-84 11-014503-23
-------
EPA Index to Pesticide Chemicals
NAB AM
Listing of Registered Pesticide Products by Formulation
13.5002 13.52 formulation intermediate
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
000400-00121 031910-00010
15.0002 152 (1.47 Ib/gal) formulation intermediate
nabara (014503) plus sodium dimethyldithiocarbamate (034804)
000400-00119 031910-00001
17.1002 17.1% formulation intermediate
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
000400-00123
!2.5002 22.5% (2.14-2.21 Ib/gal) formulation intermediate
nabam (014503)
031910-00008
'.5.0002 25% (2.4-2.5 Ib/gal) formulation intermediate
nabam (014503)
031910-00009
.0.0002 30% (2.88-3.0 Ib/gal) formulation intermediate
nabam (014503)
000400-00122 031910-00007*
*jacket currently unavailable for review
3.0015 93% soluble concentrate/solid
nabam (014503)
000707-00070*
*suspended 3-84
2.0015 22% (2.0 Ib/gal) soluble concencraCe/liquid
nabam (014503)
000707-00003
2.0015 22% soluble concentrate/liquid
nabam (014503)
000279-00827
3.7516 3.75% (0.33 Ib/gal) liquid-ready to use .
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
033576-00037
4.5016 4.5% (0.39 Ib/gal) liquid-ready to use
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
009386-00023 031910-00011
.5.5816 5.58% (0.51 Ib/gal) liquid-ready to use
nabam (014503), sodium dimethyldithiocarbaraate (034804), isopropanol
(047501) plus 2,4,5-trichlorophenol, potassium salt (064204)
003635-00110
Issued: 10-30-84
11-014503-24
122
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EPA Index to Pesticide Chemicals
NABAM
Listing of Registered Pesticide Products by Formulation (continued)
&007.5016 7.5% (0.6 Ib/gal) liquid-ready to use
nabam (014503) plus alkenyl (90% CIS, 10% C16) dimethyl ethyl ammonium
bromide (069102)
008103-00002
&009.7516 9.75% (0.9 Ib/gal) liquid-ready to use
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
010485-00016
&012.0016 12% (1.1 Ib/gal) liquid-ready to use
nabam (014503), ethylenediamine (004205) plus sodium dimethyldithiocar-
bamate (034804)
001757-00061
&012.5016 12.5% (1.19 Ib/gal) liquid-ready to use
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
031910-00016 031910-00018
SO 14.0016 14% liquid-ready to use
nabam (014503), sodium dimethyldithiocarbamate (034804) plus sodium
pentachlorophenate (063003)
003876-00060
&015.0016 15% (1.47 Ib/gal) liquid-ready to use
&015.0016
&018.0016
&022.0016
naibam (014503)
000337-00058
001757-00059
005009-00022
009386-00007
010349-00030
033561-00001
034571-00003
plus sodium dimethyldithiocarbamate (034804)
001706-00164 001757-00048 001757-00051
003876-00062
008540-00017
009640-00031
022555-00008
033576-00036
045017-00014
001757-00069
005009-00023
009386-00011
011576-00013
033576-00031
035909-00001
004643-00028
008591-00028
010349-00029
031910-00002
033772-00001
15% (1.425 Ib/gal) liquid-ready to use
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
. 031910-00019
18% liquid-ready to use
nabam (014503) plus sodium dimethyldithiocarbamate (034804)
031910-00012
22% (2.1 Ib/gal) liquid-ready to use
nabam (014503)
001677-00032 007779-00009 007779-00018
010329-00001
007779-00019
Issued: 10-30-84
11-014503-25
123
-------
EPA Index to Pesticide Chemicals
NABAM
Listing of Registered Pesticide Products by Formulation (continued)
9999999 State Label Registration
CA Reg. No.
001202-05100
Issued: 10-30-84 11-014503-26
124
-------
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number
TERRESTRIAL FOOD CROP
(Agricultural Crops)
/16002AA Asparagus
FJAAPEJ Rust (Puccinia)
(2.0 Ib/gal or 22% SC/L)
000707-00003
/28001AA Beans (lima and snap)
FAAACDP Anthracnose (Colletotrichum)
FFABPCN Downy mildew (Phytophthora)
FJAAUAH Rust (Urorayces)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/28002AA Beets
FFABPAU Downy mildew (Peronospora)
FMBCCBM Leaf spot (Cercospora)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/13005AA Broccoli
FFABPAU Downy mildew (Peronospora)
FMBCAAX Leaf spot (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/13007AA Cabbage
FFABPAU Downy mildew (Peronospora)
FMBCAAX Leaf spot (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
Issued: 10-30-84
11-014503-28
125
-------
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Cabbage (continued)
(22% SC/L)
000279-00827
/10002AA Cantaloupe
FAAACDP Anthracnose (Colletotrichum)
FFABPEA Downy mildew (Pseudoperonospora)
FBAQMCO Gummy stem blight (Mycosphaerella)
FBATAAX Leaf blight (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/28073AA Carrots
FBASAAX Alternaria blight (late blight)
FBAMCBM Cercospora blight (early blight)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/13008AA Cauliflower
FFABPAU* Downy mildew (Peronospora)
FMBCAAX Leaf spot (ALternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/28003AA Celery
FBAMCBM Early blight (Cercospora)
FBASSBL Late blight (Septoria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
Issued: 10-30-84
11-014503-29
126
-------
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Celery (continued)
(22% SC/L)
000279-00827
/05002AA Cherry (sour)
FMBCCDJ Cherry leaf spot (Cocco.myces)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
Citrus Fruits
Greasy spot (Mycosphaerella)
Rust mites
(93% SC/S)
000707-00070
Corn
Helrainthosporiura leaf spots
Rust (Puccinia)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
Cucumber
Anthracnose (Colletotrichum)
Downy mildew (Pseudoperonospora)
Gummy stem blight (Mycosphaerella)
Leaf blight (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003 . =• •'
(22% SC/L)
000279-00827
/01014AA Grapes
FIBFGBG. Black rot (Guignardia)
FFABPCV Downy mildew (Plasmopara)
FICAGAP Ripe rot (Glomerella)
(93% SC/S)
000707-00070
/02000AA
FMAYMCO
ILAAADA
/15005AA
FBATHAM
FJAAPEJ
/10010AA
FAAACDP
FFABPEA
FBAQMCO
FBATAAX-
Issued: 10-30-84
11-014503-30
127
-------
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Grapes (continued)
(2.0 Ib/gal or 22% SC/L)
000707-00003
/08020AA Hops
FFABPEA . Downy mildew (Pseudoperonospora)
(2.0 Ib/gal or 22% SC/L)
000707-00003
/13011AA Kale
FFABPAU Downy mildew (Peronospora)
FMBCCBM Leaf spot (Cercospora)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/13020AA Lettuce
FFABBBA Downy mildew (Bremia)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/13021AA Mustard Greens
FFABPAU Downy mildew (Peronospora)
FMBCCBM . Leaf spot (Cercospora)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
• . . 000707-00003
/14011AA Onion
FKAABAW Botrytis blight (blast)
FFABPAU Downy mildew (Peronospora)
FCAEAAX Purple blotch (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
Issued: 10-30-84
11-014503-31
-------
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Onion (continued)
(22% SC/L)
000279-00827
yi4011DA Onion
*FLANUAG Onion smut (Urocystis)
(2.0 Ib/gal or 22% SC/L)
000707-00003
/16004AA Onions (green)
FKAABAW Botrytis blight (blast)
FFABPAU Downy mildew (Peronospora)
.FCAEAAX Purple blotch (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827 . ' .
/28017AA Pepper ' .
FAAAQBB Anthracnose
FMAVCBM Cercospora leaf spot
(22% SC/L)
000279-00827
/13024AA Spinach
FFABPAU Downy mildew (blue mold) (Peronospora)
FGARAAV White rust (Albugo)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/10012AA Squash
FAAACDP Anthracnose (Colletotrichum)
FFABPEA Downy mildew (Pseudoperonospora)
F5AQMCO Gummy stem blight (Mycosphaerella)
FBATAAX Leaf blight (Alternaria)
(93% SC/S)
000707-00070
Issued: 10-30-84
11-014503-32
129
-------
EPA Index Co Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Squash (continued)
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/01016AA Strawberry
FGAKDBS Leaf scorch (Diplocarpon)
FMBCMCO Leaf spot (Mycosphaerella)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/13025AA Swiss Chard
FFABPAU Downy mildew (Peronospora)
FMBCCBM Leaf spot (Cercospora)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/11005AA Tomato
FAAAGAP Anthracnose (Glomerella)
FHAGCCV Cladosporium leaf mold
FBAMAAX Early blight (Alternaria)
FBASPCN Late blight (Phytophthora)
FMBCSBL Leaf spot (Septoria)
FMBCSDG Leaf spot (Stemphylium)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/28022AA Turnips
FFABPAU Downy mildew (Peronospora)
FMBCCBM Leaf spot (Cercospora)
(93% SC/S)
000707-00070
Issued: 10-30-84
11-014503-33
130
-------
yiOOOSAA
FAAACDP.
FFABPEA
FBAQMCO
FBATAAX
/28065AA
FJAGPEJ
FJAMPEJ
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Sita/Pest and Site/Formulation/Registration Number (continued)
Turnips (continued)
(2.0 Ib/gal or 22% SC/L)
000707-00003
Watermelons
Anthracnose (Colletotrichum)
Downy mildew (Pseudoperonospora)
Gummy stem blight (Mycosphaerella)
Leaf blight (Alternaria)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
Wheat
Leaf rust (Puccinia)
Stem rust (Puccinia)
(93% SC/S)
000707-00070
TERRESTRIAL NON-FOOD CROP
(Ornamental Plants and Forest Trees)
/34022AA Azalea
FBADOAV Petal blight (Ovulinia) (on azalea)
FBADSAQ Petal blight (Sclerotinia) (on camellia)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
734036AA Camellia
FBADOAV Petal blight (Ovulinia) (on azalea)
FBADSAQ Petal blight (Sclerotinia) (on camellia)
(93% SC/S)
000707-00070
Issued: 10-30-84
11-014503-34
1 .J
-------
EPA Index to Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Camellia (continued)
(2.0 Ib/gal or 22% SC/L)
000707-00003
(22% SC/L)
000279-00827
/31057AA Carnation
FAAACDP Anthracnose (Colletotrichum)
FMBCQBB Leaf spots
FJAAQBB Rusts
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/31065AA Chrysanthemum
FAAACDP Anthracnose (Colletotrichum)
FMBCQBB Leaf spots
FJAAQBB .Rusts
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003
/31111AA Gladiolus
FMCDBAW Leaf and flower spot (Botrytis)
FMCDCFH Leaf and flower spot (Curvularia)
FMCESDB Leaf and flower spot (red spot) (Stemphylium)
(93% SC/S)
000707-00070
(2.0 Ib/gal or 22% SC/L)
000707-00003.
(22% SC/L)
000279-00827
A31184AA Snapdragon
FAAACDP Anthracnose (Colletotrichum)
FMBCQBB Leaf spots
FJAAQBB Rusts
(93% SC/S)
000707-00070
Issued: 10-30-84
11-014503-35
132
-------
EPA Index to Pesticide Chemicals
NAB AM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Snapdragon (continued)
(2.0 Ib/gal or 22% SC/L)
000707-00003
AQUATIC NON-FOOD
(Aquatic Sites)
/65018MA Air Washer Water Systems
DBABAAA Slime-forming bacteria
FYAFQBB Slime-forming fungi
(0.39 Ib/gal or 4.5% RTU)
031910-00011
(1.47 Ib/gal or 15% RTU)
000337-00058 001757-00051 004643-00028 005009-00022
005009-00023 008591-00028 009386-00011 009640-00031
011576-00013 031910-00002 033576-00036 033772-00001
(18% RTU)
031910-00012
/65005MA Brewery Pasteurizers
DBABAAA Slime-forming bacteria
(1.47 Ib/gal or 15% RTU)
003876-00062 034571-00003
/65019MA Commercial and Industrial Water Cooling Towers
PKAAAAA Algae
DBABAAA Slime-forming bacteria
FYAFQBB Slime-forming fungi
(0.33 Ib/gal or 3.75% RTU)
033576-00037
(0.39 Ib/gal or 4.5% RTU)
009386-00023 031910-00011
(.0.51 Ib/gal or 5.58% RTU)
. 003635-00110
(0.9 Ib/gal or 9.75% RTU)
. 010485-00016
(1.47 Ib/gal or 15% RTU)
000337-00058 001757-00051
005009-00022 005009-00023
009386-00011 009640-00031
Issued: 10-30-84
003876-00062
008540-00017
011576-00013
11-014503-36
004643-00028
008591-00028
031910-00002
133
-------
'65019MA
'KAAAAA
IBABAAA
TAFQBB
65025MA
YAFQBB
BABAAA
EPA Index to Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Commercial and Industrial Water Cooling Towers (continued)
(1.47 Ib/gal or 15% RTU) (continued)
033561-00001 033576-00036 033772-00001 034571-00003
035909-00001
(18% RTU)
031910-00012
(evaporative condensers, heat exchanger water systems, commercial
and industrial cooling towers, influent systems such as flow
through filters and lagoons, and industrial water scrubbing sys-
tems)
Algae
Slime-forming bacteria
Slime-forming fungi
(1.47 Ib/gal or 15% RTU)
000337-00058 001757-00051 003876-00062
005009-00022 005009-00023 008540-00017
011576-00013
033772-00001
009386-00011
033561-00001
035909-00001
009640-00031
033576-00036
004643-00028
008591-00028
031910-00002
034571-00003
Oil Recovery Water
Fungal slime
Slime-forming bacteria
(0.39 Ib/gal or 4.5% RTU)
031910-00011
(1.1 Ib/gal or 12% RTU)
001757-00061
(1.19 Ib/gal or 12.5% RTU)
031910-00016 031910-00.018
(1.47 Ib/gal or 15% RTU)
001757-00059 009386-00007
031910-00002
(1.425 Ib/gal or 15% RTU)
031910-00019
(18% RTU)
031910-00012
010349-00029 022555-00008
Issued: 10-30-84
11-014503-37
134
-------
/65008MA
DBABAAA
FYAFQBB
/65028MA
IIDAAAC
DBABAAA
FYAFQBB
/65005MA
DBABAAA
FYAFQBB
/65005MA
DBABAAA
•FZZZQBB
EPA Index to Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Pulp and Paper Mill Systems
Slime-forming bacteria
Slime-forming fungi
(0.39 Ib/gal or 4.5% RTU)
031910-00011
(0.6 Ib/gal or 7.5% RTU)
008103-00002
(1.1 Ib/gal or 12% RTU)
001757-00061
(14% RTU)
003876-00060
005009-00022
009386-00011
045017-00014
(1.47 Ib/gal or 15% RTU)
001757-00059 004643-00028
008591-00028 009386-00007
033576-00031 033772-00001
(18% RTU)
031910-00012
(2.1 Ib/gal or 22% RTU)
001677-00032 007779-00009 010329-00001
Seawater Heat Exchangers (shipboard)
Barnacle larvae
Slime-forming bacteria
Slime-forming fungi
(1.47 Ib/gal or 15% RTU)
001757-00048
Sugar Beet Processing Water
Slime-forming bacteria
Slime-forming fungi
(1.47 Ib/gal or 15% RTU)
001706-00164 001757-00059
031910-00002
005009-00023
031910-00002
009386-00011 022555-00008
Sugar Beet Flume Water Transporting and Washing Systems
Bacteria
Fungi
(0.39 Ib/gal or 4.5% RTU)
031910-00011
(1.47 Ib/gal or 15% RTU)
001706-00164 031910-00002
Issued: 10-30-84
11-014503-38
135
-------
/650050A
FZZZQBB
EPA Index to Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Sugar Beet Flume Water Transporting and Washing Systems (continued)
(18% RTU)
031910-00012
Sugarcane Processing
Fungi
(0.33 Ib/gal or 4.5% RTU)
033576-00037
(0.39 Ib/gal or 4.5% RTU)
009386-00023 031910-00011
(1.47 Ib/gal or 15% RTU)
001706-00164 001757-00059
005009-00023 009386-00011
033576-00036 033772-00001
(18% RTU)
031910-00012
004643-00028
022555-00008
005009-00022
031910-00002
INDOOR . .
(Commercial and Industrial Uses)
/810040A Fuel Oil (No. 2 oil, intermediate fuel oil, and No. 6 oil), Lubricating
Oil, and Hydraulic Fluids (storage)
FYAAQAA Bacteria
FYAAQBB Fungi
(1.47 Ib/gal or 15% RTU)
031910-00002
/810050A Leather
(brining and curing hides)
FYADQBB Bacteria
FYADQBB Fungi
(1.47 Ib/gal or 15% RTU)
001757-00069
(fat liquoring stock)
FYABQBB Mold
(1.47 Ib/gal or 15% RTU)
001757-00069
Issued: 10-30-84
11-014503-39
136
-------
FYABQBB
/810060A
FYABQBB
FYADQBB
/810070A
FYAIQBB
/810080A
DBADAAA
FYADQBB
DBABAAA
EPA Index Co Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Formulation/Registration Number (continued)
Leather (continued)
(tanning)
Mold
(1.47 Ib/gal or 15% RTU)
001757-00069
Leather Processing Liquors
(pickling liquor)
Mold
(1.47 Ib/gal or 15% RTU)
001757-00069
(soaking liquors)
Fungi
(1.47 Ib/gal or 15% RTU)
001757-00069
Metalworking Cutting Fluids
Fungi
(1.1 Ib/gal or 12% RTU)
001757-00061
(1.47 Ib/gal or 15% RTU)
001757-00059
(2.1 Ib/gal or 22% RTU)
007779-00018
Oil Recovery Drilling Fluids
Deterioration/spoilage bacteria
Fungi
Slime-forming bacteria
(0.39 Ib/gal or 4.5% RTU)
009386-00023 031910-00011
(1.1 Ib/gal or 12% RTU)
001757-00061
(1.19 Ib/gal or 12.5% RTU)
031910-00016 031910-00018
(1.47 Ib/gal or 15% RTU)
001757-00059 009386-00007
022555-00008 031910-00002
(18% RTU)
031910-00019
010349-00029 010349-00030
Issued: 10-30-84
11-014503-40
137
-------
DBADAAA
FYADQBB
DBABAAA
/810010A
/810020A
/810090A
/810120A
/810140A
FYADQBB
/810190A
FYABQBB
/810160A
FYADQBB
EPA Index to Pesticide Chemicals
NABAM
Appendix B
Listing by Site/Pest and Site/Fonnulation/Registration Number (continued)
Oil Recovery Drilling Fluids (continued)
(workover and completion fluids)
Deterioration/spoilage bacteria
Fungi
Slime-forming bacteria
(1.47 Ib/gal or 15% RTU)
009386-00007 022555-00008
Preservation of Adhesives and Animal Glues, Inks, Latex, Mineral Slur-
ries, Paints and Coatings and Paper Coatings
Fungi
(1.1 Ib/gal or 12% RTU)
001757-00061
(1.47 Ib/gal or 15% RTU)
001757-00059 045017-00014
Preservation of Applied Films (paints and other coatings, adhesives and
animal glues)'^~
Mildew
(1.1 Ib/gal or 12% RTU)
001757-00061
(1.47 Ib/gal or 15% RTU)
001757-00059 045017-00014
Preservation in Pulp and Paper Mills
Fungi
(1.47 Ib/gal or 15% RTU)
045017-00014
(2.1 Ib/gal or 22% RTU)
007779-00009
L •'•
'^ ~.
r f
Issued: 10-30-84
11-014503-41
138
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IV. BIBLIOGRAPHY APPENDICES
13
-------
BIBGUIDE-1
GUIDE TO USE OP THIS BIBLIOGRAPHY
1. CONTENT OP BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in -
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies «in support of past regulatory
decisions. Selections from other-sources including the
published literature, in those instances where they have
been considered, will be Included.
2. UNITS OP ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
'ohls 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 Md)(U) 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 heeded.
U-. 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.
140
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BIBGUIDE-2
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.
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.
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.
*
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 wrth 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, 12345K-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
141
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nabam Standard
MRID CITATION
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00088825 Vonk, J.W. (1975) Chemical Decomposition of Bisdithiocarbamate
Fungicides and Their Metabolism by Plants and Microorganisms.
(Unpublished study received Dec 9, 1981 under 707-78; prepared
by Drukkerij Elinkwijk BV, The Netherlands, submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL:070528-G)
00088826 Nash, R.G. (1976) Uptake of ethylenebis(dithiocarbamate) fungicides
and ethylenetniourea by soybeans. Journal of Agricultural and
Food Chemistry 24(3):596-601. (Also in unpublished submission
received Dec 9, 1981 under 707-78; submitted by Rohm & Haas
Co., Philadelphia, Pa.; CDL:070528-H)
00088831 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)
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-feeding 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)
142
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nabara Standard
MRID CITATION
00088835 Saxton, A.D. (1972) A Cl4-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)
00088891 Haines, L.D.; Adler, I.L. (1973) Gas chromatographic determination
of ethylene thiourea residues. Journal of the Association of
Official Analytical Chemists 56(2):333-337. (Also in unpub-
lished submission received Dec 9, 1981 under 707-78; submitted
by Rohm & Haas Co., Philadelphia, Pa.; CDL:070519-F)
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)
00097051 E.I. du Pont de Nemours & Company, Incorporated (1950) Testimony
of G. Dragt: Analytical Methods. (Compilation; unpublished
study received May 24, 1960 under unknown admin, no.; CDL:
130674-A)
00097064 Union Carbide Corporation (1975) Acute Toxicity of Amersperse 280
to Oyster (Crassostrea virginica) Larvae. (Unpublished
study received Dec 11, 1975 under 1757-48; submitted by Drew
Chemical Corp., Boonton, N.J.; CDL:224506-^B)
00097231 Pease, H.L.; Holt, R.F.; Sutton, R. (1971) Sthylcr.e 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)
00107905 Conzelmann, P. (1982) Static 96-hour Marine Bioassay Testing
Vinings Antimicrobial Agent AMA-31 on Grass Shrimp: GSRI Project
No. 415-A60-41. (Unpublished study received Apr 22, 1982 under
9386-7; prepared by Gulf South Research Institute, submitted by
-Vinings Chemical Co., Atlanta, GA; CDL:247417-A)
143
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Nabam Standard
MRID CITATION
00107906 Conzelmann, P. (1982) Static 96-hour Marine Bioassay Testing Vin-
ings Antimicrobial Agent AMA-31 on Sheepshead Minnow: GSRI Proj-
ect No. 415-A60-41. (Unpublished study received Apr 22, 1982
under 9386-7; prepared by Gulf South Research Institute, sub-
mitted by Vinings Chemical Co., Atlanta, GA; CDL:247417-B)
00121050 Smith, R.; Finnegan, J.; Larson, P.; et al. (1953) Toxicologic
studies on zinc and di sodium ethylene bisdithiocarbamates.
Journal of Pharmacology and Experimental Therapeutics 109(2):
159-166. (Also in unpublished submission received Apr 29, 1963
under 7779-3; submitted by E.F. Houghton & Co., Valley Forge,
PA; CDL:008090-0)
00151954 Sernau, R. (198'5) Unscheduled DNA Synthesis Rat Hepatocyte Assay
with Nabam: Final Report: Project No. 752-110. Unpublished
study prepared by Hazleton Biotechnologies Corp. 15 p.
00151955 Tu, A. (1985) Evaluation of Nabam in the C3H-10T 1/2 Cell System
for Transformation and Promotion Activities: Final Report: Study
# 54189. Unpublished study prepared by Arthur D. Little, Inc.
28 p.
00152699 Ivett, J. (1985) Clastogenic Evaluation of Nabam, 30% Water
Solution in the Rat Bone Marrow Cytogenic Assay: Final Report:
Project No. 22202. Unpublished study prepared by Litton
Bionetics, Inc. 25 p.
00152700 Ivett, J. (1985) Clastogenic Evaluation of Nabam, 30% Water
Solution in an in vitro Cytogenetic Assay Measuring Sister
Chromatid Exchange in Chinese Hamster Ovary (CHO) Cells:
Amended Final Report: Project No. 20990. Unpublished study
prepared by Litton Bionetics, Inc. 36 p.
00152701 Cavagnaro, J.; Donoghue, E. (1985) Salmonella typhimuriurn/Mammalian
Microsome Plate Incorporation Assay with Compound Nabam: Final
Report: Project No. 752-108. Unpublished study prepared by
Hazleton Biotechnologies Corporation. 21 p.
00152702 Cavagnaro, J. (1985) Host Mediated Assay in Mice with Compound
Nabam: Final Report: Project No. 752-109. Unpublished study
prepared by Hazleton Labs., America, Inc. 31 p.
00153559 Cavagnaro, J. (1985) CHO/HGPRT Forward Mutation Assay: Nabam: Final
Report: Project No. 752-111. Unpublished study prepared by Ha-
zleton Biotechnologies Corp. 23 p.
144
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Mabam Standard
MRID CITATION
00156613 Puhl, R. (1986) Dermal Absorption of [Carbon-14] - Nabam in Male
Rats: Final Report: Study No. 6185-100. Unpublished study pre-
pared by Hazleton Laboratories America, Inc. 64 p.
00159693 Healy, M. (1986) Residues of Maneb and Its Metabolite E.T.U. Found
in Potatoes from a Field Experiment Conducted in Piscataquis
County, Maine during the 1985 Growing Season: Report #MTF-85-16.
Unpublished compilation prepared by Healy and Associates in
cooperation with Bio/dynamics Inc. 28 p.
00160125 Puhl, R. (1986) The Metabolism of Nabam in Rats: Final Report:
Study No. 6185-101. Unpublished study prepared by Hazleton
Laboratories America, Inc. 95 p.
40065801 Bontoyan, W.; Looker, J.; Kaiser, T. et al (1972) Survey of
Ethylenethiorea in Commercial 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
Chromatography and Liquid Chromatography of Ethylenethiourea
in Fresh Vegetable Crops, Fruits, Milk, and Cooked Foods.
Journal of AOAC. 60(5): 1105-1110.
40118601 Nash, R. (1974) Pesticide Residues: Improved Gas-Liquid Chroma-
tographic Method for Determining Ethylenethiourea in Plants.
Journal of the AOAC (57:5) 1015-1021.
40118602 Kutz, F. (1979) K6r,orar,du«, to Nancy Beach, EPA Office of Special
Pesticide Review, dated March 12, 1979: EBDC/ETU Monitoring
Study: Residue Levels of Ethylenebisdithiocarbamate and
Ethylenethiourea in Sugar Beet Pulp, Molasses, Crystalline
Sugar, Animal Feed Components, and Cow's Milk. 12 p.
145
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V. FORMS APPENDICES
146
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QUa Aoofnvtl No.
FIFHA SECTION 3(C)(21(BJ SUMMARY SHEET
|PA MGISTNATlO* *0.
rnooucr
A^UCAMTt MAM«.
OATI CUIOAMC1 OOCUMCNT ISSUtO
Wit*
it ~|«n«n«" d*u trnoo»« frv ttM FIFKA action 3(O(2JIB)
ch« (oU««ini mcwiwt
m« rteiio«nnt did
MAMC or OTHCR
L- Z. I «r«aa i comWfrrd "C4rtrtiej«on a( Anrmoi to Enrar into MI Afrw«t<«ii with OlKv
rw«i»ct ro (Tit (ollowin) dm rtquirimmo:
or Ormagmmt at C«|u«( Olft YM «n*n4 m>
tv «*«M|
(O« fl»ti«n • not
> oroductii:
ftOM
preducn.)
Kfctmuim AUTMOMIZIO n VMUCNTATIVI
OATf
-------
OU8 AOOHH* No.
CERTIFICATION Of ATTEMPT TO INTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT Of DATA
1. I «m duly •uttoriud to reorMWt tfw following 'irm(i) wno «ft ajoftct to the require-
ment* of « Nooot under FlFRA Section 3(e)(2)(SI oonumec in « Gu«d«oce Document
to Mbmit s. toe following irqui'M
'l*mt or cutj.
3, U> I, in NM
Bound By *i
to mi
to i"ttt >«t» Mdi M tyt«mtm.
iteitaa untm FIFMA $«CTI«I
en i
o( ti%»
«rt micfit*. Ts«t oft«« «M
in4 ineiudtd •«« eHir to at
. Thit ett*f -«i mi«t
MAM« 0*
OATI
4. My firm reowciu ttvet EFAVnot Maeend the re«^rtnoon(tl
N**« *9re«d to «uomit m« d*t» Irtud in tnnejra^h C21
me wfwtncr my firm mwn juomit oaa to MOor»4i( ynoor FlFRA Stvoon 3(c)(2)(B). (Thtt imtm«nt
to di«OOM tha nitomom upon r«qu«(t.
TYFtO NAMC
OATI
-------
PRODUCT SPECIFIC DATA IEPCRT
EPA Reg. No.
Date
Guidance Document for
Registration
Guideline No.
SlSti.120
FROCXT
CHEHISTRY
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-H
63-12
Name of Test
-*-.. _
Identity of
ingredients
Statement of
ccGDoslticn
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-
denalty, or"
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/nater
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
149
-------
Registration
Guldtilne No.
63-13
63-11
03-15
63-16
o3-17
03-18
o3-19
oS-20
63-21
§158.135
TOXICOLOGY
61-1
61-2
61-3
81-<4
til-5
81-6
Name of Teat
Stability
Oxidising/ reducing
reaction
. Plamnabllity
ExDlodablllty
Storage stability
Viscosity
Miscibilicy
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxlclty, rat
Acute denual
toxicity, rabbit
Acute Inhalation,
toxicity i rat
Primary eye
Irritation, rabbit
Primary dermal
irritation
Eternal aenaitiza-
tlon
Test not
required
for my
product
listed
above
(check
below)
,
I ara complying with
data requirements by
Citing MEUD
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-
150
-------
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
aliove, 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 nunber(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)
151
EPA Form 8570-27
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