United Statw
Environmental Prottction
Agtncy
PMicidm
OffiMof
PwticidM and Toxic Subttin
Wathington DC 20460
July 1985
Guidance for the Reregistration
of Pesticide Products
Containing Sodium Omadine
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
SODIUM OMADINE
AS THE ACTIVE INGREDIENT
EPA CASE NUMBER: 209
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
July 16, 1985
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TABLE OF CONTENTS
Page
Introduction 1
1. Regulatory Position and Rationale 4
II. Requirement for Submission of Generic Data 42
III. Requirement for Submission of Product-Specific
Data 45
IV. Submission of Revised Labeling 45
A. Label Contents 46
B. Collateral Information 50
V. Instructions for Submission ...51
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APPENDICES
Page
II-l Guide to Bibliography 44
II-2 Bibliography 46
II-3 FIFRA S3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 48
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2 49
III-l Product Specific Data Report (End-Use Products) . . 60
IV-1 40 CFR 162.10 Labeling Requirements 62
IV-2 Table of Labeling Requirements 71
IV-3 Physical/Chemical Hazards Labeling Statement. ... 76
IV-4 Storage and Disposal Instructions 77
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA sec. 3(g)) directs EPA to reregister all pesticides as
expeditiously as possible.
To carry out this task, EPA has established the Regis-
tration Standards program, which will review all pesticide
products containing active ingredients first registered before
January 1, 1977. Pesticides will be reviewed in use clusters
which have been ranked to give earliest review to pesticides
used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. EPA's reassessment results in -the development
of a regulatory position, contained in a Registration Standard,
on each pesticide and its uses. The Agency may require the
registrant to modify product labels to provide additional
precautionary statements, restrict the use of the pesticide
to certified applicators, provide reentry intervals, modify
uses or formulation types, specify certain packaging limitations
or other requirements to assure that proper use of the pesticide
will not result in adverse effects on the environment.
The scientific review, which is not contained in this
Guidance Package but is available upon request, concentrates
on the technical grade of the active ingredient and identifies
missing generic data. However, during the review of these
data we are also looking for potential hazards that may be
associated with the end use (formulated) products that contain
the active ingredient. If we have serious concerns, we will
address end use products as part of the Registration Standards
program and will propose regulatory actions to the extent neces-
sary to protect the public.
EPA has the authority under FIFRA sec. 3(c)(2)(B) to
require registrants to submit data that will answer our
questions regarding the hazard that may result from the
intended use of a pesticide. Although sec. 3(c)(2)(B) provides
that all registrants are responsible for these data, the
Agency generally imposes generic data requirements only on the
registrants of the manufacturing use products (basic suppliers
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of the active ingredient) and other producers who do not
qualify for the formulator's exemption.*
A producer who wishes to qualify for the formulator's
exemption may change his source of supply to a registered
source, provided the source does not share ownership in
common with the registrant's firm. A registrant may do so
by submitting a new Confidential Statement of Formula, EPA
Form 8570-4, identifying the registered source of the active
ingredient, to the appropriate Product Manager within 90
days of receipt of this Guidance Document. The chart on the
following page shows what is generally required of those who
do and do not qualify for the formulator's exemption in the
Registration Standards program.
If you decide to request the Agency to cancel the regis-
tration of any of your products subject to the requirements
of this Guidance Document, please notify the Product Manager
named in the cover letter, within 90 days from the receipt
of this document. If you decide to maintain your product
registration(s), you must provide the information described in
the following pages within the timeframes outlined. EPA will
issue a notice of intent to cancel or suspend the registration
of any currently registered product which does not comply
with the requirements set forth in this Guidance Document.
You are reminded that FIFRA sec. 6(a)(2) requires you to
submit factual information raising concerns of possible
unreasonable adverse effects of a pesticide. You should
notify the Agency of interim results of studies in progress
if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S;
MAINTAIN
REQUIRED TO
REGISTRATION
Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active
Products*
Ingredient
These products must be reregis-
tered. To obtain reregistratior
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration or
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required ere
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed tc
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variet_.
of ways, including but not
limited to the Label Improvene:.
Program and special intent
to cancel notices.
.LOW produce a manufacturin;
required to be reregistered provided that
requirements specified in the Guidance
Such end
*End use products ofregistrants
use product will not be required to
registrant fulfills the requirements spe
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in
above. If there are no manufacturing use products registered by cu>
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements
I-A and B above, then the registrants in "II" lose their right to
qualify for the formulator's exemption and become subject to the
requirements in I-A and B.
who also
be
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REGULATORY POSITION AND RATIONALE
INTRODUCTION
This registration standard describes the regulatory
position of the Environmental Protection Agency
("The Agency") based on an evaluation of the two end-use
products, which are used to formulate other products, and
which contain sodium omadine as the sole active ingredient
and an evaluation of the other registered uses of sodium
omadine. It should be noted that there is no registered
manufacturing use product for this chemical; however, two
end-use products [90% soluble concentrate/solid (SC/S; EPA
Registration No. 1258-842) and a 40% liquid ready-to-use
(RTU; EPA Registration No. 1258-843)] are used to formulate
all other end-use products containing sodium omadine.
This standard applies to these two products and the data
requirements apply to all sodium omadine products as
outlined in Section I.E. of the table on the previous page.
Future requests for registrations of substantially
similar products will be covered by this standard.
Dissimilar products may be evaluated for registration. If
registered, the standard will be amended accordingly.
After briefly describing the chemical and its uses, this
chapter presents the regulatory position and rationale,
the criteria for registration, acceptable ranges and limits,
and labeling considerations.
In developing its regulatory position, the Agency
determines whether available data indicate that a pesticide
has met the criteria for unreasonable adverse effects found
in Section 162.11(a) of Title 40 of the U.S. Code of Federal
Regulations (CFR). Pesticides meeting these criteria are
candidates for a Special Review, an intensive risk/benefit
analysis. The Agency's determination as to whether any
criteria have been met and its rationale for any regulatory
action are summarized in the regulatory position of this
standard.
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DESCRIPTION OF CHEMICAL
Sodium omadine is the common name for l-hydroxy-2(1H)-
pyridinethione, sodium salt (CA). Other names are Sodium
2-pyridinethiol 1-oxide, Sodium l-hydroxypyridine-2-thione,
Sodium 2-mercaptopyridine-N-oxide, and Omadine® sodium.
The Chemical Abstract Service Registry Number (CAS) is
15922-78-8 and the Agency's Chemical Code Number is 088004.
Sodium omadine is a pale yellow free-flowing powder.
The melting point is between 252-257°C. The solubility of
sodium omadine at 25°C is 45.4% in water, 5.4% in ethanol,
1.1% in isopropanol, 0.13% in acetone, 28.6% in methanol
and 19.1% in ethylene glycol. Sodium omadine is stable at
100°C for 120 hours, and at pH's above 7 but is in equilibrium
with omadine acid below pH 7.
Sodium omadine is a broad spectrum antimicrobial
compound used as a preservative in certain manufactured
materials and as an additive in process fluids which may
otherwise be subject to deterioration through bacterial
and/or fungal growth. Sodium omadine is not registered
for any food uses. The 40% liquid RTU and 90% SC/S
products serve as both end-use products and formulating
use products. Other registered products are 4%, 5%, 5.9%,
and 6.4% a.i. flowables and a 2% a.i. wettable powder.
Four of the seven sodium omadine-containing products are
considered single active ingredient products. The
remaining three are formulated with 1 or 2 other actives
such as: sodium borate pentahydrate, hexahydrol,3,5-tris
(2 hydroxyethyl)-S-triazine, formaldehyde and benzyl
alcohol. End-use products (i.e., those not used as an MOP)
and products containing both sodium omadine and another
active ingredient will not be covered by this Standard.
Most products have multiple uses (see the "EPA Pesticide
Index", for a description of all uses).
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REGULATORY POSITION AND RATIONALE
Based on a review and evaluation of all available data
submitted to EPA and other relevant information on sodium
omadine, the Agency has made the following determinations:
1. The available toxicity data are insufficient to
fully assess toxicity and risk to humans. The
toxicology data base for sodium omadine is largely
inadequate due mainly to protocol description
deficiencies, data reporting inadequacies, and
procedural errors in experimentation. Based upon
the available data the Agency has determined that
none of the uses for sodium omadine are required
to be classified as "Restricted Use". Although
unacceptable for filling data requirements, many
studies contained some valid information. However,
in order to conduct a full risk assessment, addi-
tional toxicology studies are required as outlined
in the data tables.
Rationale
a. The available data indicate that sodium omadine
produces slight corneal opacity to slight lid
redness and eye discharge with a wide range of
concentrations (Toxicity Category III in all
cases). The 40% a.i. product is also categorized
as a mild dermal irritant (Toxicity Category III)
Available Oral and Inhalation Toxicity, Dermal
LDsor Dermal Irritation (for the technical
material), and Dermal Sensitization studies are
unacceptable; therefore, data gaps exist for
these requirements which must be satisfied.
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Sodium oroadine has been shown in a subchronic
feeding study in rats to produce hindlimb
paralysis and/or weakness at the lowest dosage
level tested (3mg/kg/day). Hindlimb paralysis
was also observed in an acute inhalation toxicity
study in rats, in a subacute 8-day dermal
study in rabbits, and possibly in a metabolism
study in swine. Sodium omadine has also been
shown to produce reproductive effects (consisting
of decreased pregnancy rate, decreased fetal
weights, decreased numbers of live fetuses,
and increased resorptions) in a rat reproduction
study. Although all of these studies do not
meet guideline requirements, the Agency,
nevertheless, is concerned about the potential
toxicological significance of these observations.
Additional studies in these areas are therefore
being required.
A Teratology Study in rats (dermal application)
showed no teratogenic effects at 7 mg/kg/day.
In a rabbit Teratology Study (dermal application),
sodium omadine displayed dose-related maternal
toxic effects and potential teratogenic effects
at all dosage levels tested (0.5, 2.0, and 8.0
mg/kg/day). Since a NOEL could not be determined,
and malformations cannot be defined as teratogenic
until effects are seen in the absence of maternal
toxicity, an additional Teratology Study
(dermal exposure in rabbits) must be performed
using lower doses.
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d. A Gene Mutation Study using sodium omadine showed
no mutagenic effects at the highest dosage
tested (25 ug/plate [activated] and 3 ug/plate
[nonactivated]). However, because the full
mutagenic potential of a pesticide is unlikely
to be assessed in one particular mutagenicity
test, information from a battery of tests
(i.e., tests for chromosomal and other mechanisms
of mutageniciity) is required to more fully
evaluate the mutagenic potential of a pesticide.
Data gaps exist for the other mutagenicity
studies. This rationale also supports regulatory
positions 4, 6, and 8.
2. Exposure data are insufficient to assess the
potential exposure of workers (in particular,
metal workers) and the general public to sodium
omadine. The Agency is requiring exposure studies
for each registered use pattern. If these studies
show exposure at levels and durations of concern,
the Agency will require the submission of additional
chronic data.
Rationale
Some of the registered uses of sodium omadine are
likely to result in significant dermal and/or
inhalation exposure to persons using the products.
Of particular concern are household uses in laundry
rinses and the preservative use in metalworking
fluids. Metal machinists can potentially have
long-term exposure by the dermal route and by
inhalation of vaporized and aerosolized fluids.
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Textile workers may receive long-term dermal
exposure by handling textiles and equipment using
spin processing lubricants. Furthermore, if sodium
omadine is retained in cloth, the general public
may also receive long-term exposure through contact
with clothing.
To assess the potential exposure to end users,
Human Exposure Studies are being required for each
registered use. The decision whether to require
additional longterm studies (i.e. Chronic Toxicity
(2 sp.), Oncogenicity (2 sp.), and a General
Metabolism Study) will be contingent upon the
results of the Human Exposure Studies.
3. The Agency is concerned about the possibility of
nitrosamine formation during its use as a metal-
working fluid additive. Thus, special analyses
are being required of typical metalworking fluids
(at different stages of the fluid sample) to deter-
mine whether sodium omadine induces or contributes
to the formation of nitrosamines in metalworking
fluids .
Rationale
As a normal practice in the metal cutting industry,
nitrites and/or amine products are generally added
to metal working fluids to inhibit the growth of
bacteria responsible for deterioration and to
control the deteriorative changes associated with
the growth of these bacteria. Consequently,
nitrosamines are readily being formed in these
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10
fluids. Many of these nitrosamines are potent
carcinogens in animals and are suspected of
causing cancer in humans. The Agency, therefore,
is requiring data to determine if sodium omadine
at various stages of use induces or contributes to
the formation of nitrosamines in metalworking
fluids, one of the major use patterns of sodium
omadine. This study is required because there is
some concern that, in combination with metalworking
fluid containing nitrites and/or amine products,
sodium omadine induces or contributes to the
formation of nitrosamines.
4. Available data do not show that any of the risk
criteria listed in 162.11(a) of Title 40 of the
U.S. Code of Federal Regulations have been met or
exceeded for the uses of sodium omadine specified
in this standard.
Rationale
As noted above, available studies are largely
deficient or invalid. The Agency, therefore, is
requiring additional data in order to conduct a
full risk assessment of sodium omadine.
5. The wildlife and aquatic organisms data requirements
are only partially fulfilled. Hence, the Agency
could not fully assess the toxicity of sodium
omadine to nontarget organisms. When the additional
data outlined in the data tables are submitted, a
full assessment will be made.
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Rationale
The available wildlife and aquatic organism studies
show that sodium omadine is slightly toxic to
birds; slightly toxic to warmwater fish and very
toxic to coldwater fish; and very toxic to aquatic
invertebrates. The use patterns for sodium omadine
(classified as "indoor") are not expected to result
in direct discharge^/ to water sites; therefore,
little direct discharge caused exposure to this
compound in the environment is expected. Examples
of "outdoor" use patterns that result in direct
discharge of pesticides to water sites include
cooling tower use, oilfield uses, swimming pool
uses, and agricultural uses. This pesticide is not
currently registered for any such use. Because
indirect discharge^/ of sodium omadine is expected
to occur when users of the chemical dispose of
effluents containing the chemical, and during the
laundry rinse use, the Agency is requiring
additional studies to fully assess hazards to
wildlife and aquatic organisms arising from "indoor
uses" . This rationale also supports regulatory
positions 4, 6, 7, and 8.
_!/ Direct discharge means: release, treatment, or
~ application of a pesticide product to water sites
directly connected to bodies of water to which wild
animals, birds, fish, and similar organisms have free
access.
_2/ Indirect discharge means: release, treatment, or a
~ pplication of a pesticide product to water sites not
directly connected to bodies of water to which wild
animals, birds, fish, and similar organisms have free
access.
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6. No environmental fate data for sodium omadine are
currently available. However, as there are no
"outdoor" uses for sodium omadineonly a hydrolysis
study is being required at this time for the prese
nt use patterns. When the additional data are
submitted, an assessment of sodium omadine's persis-
tence in the environment will be made.
Rationale
The use patterns for sodium omadine are classified
as "indoor" uses. However, these "indoor" uses
may result in indirect discharge to water systems.
7. The available product chemistry data for sodium
omadine are insufficient to totally assess the
chemical's characteristics. The data gaps outlined
in the product chemistry data tables are required
to support the registration of sodium omadine products.
Rationale
Although some product chemistry data on sodium
omadine are lacking, some characteristics have
been described (see "Description of Chemical"
section). Because of the possibility of nitrosamines
forming during the manufacturing process of sodium
omadine, an analysis for nitrosamines in manufactured
products is being required, in addition to that dealing
with the metalworking fluid use.
8. MUPs containing sodium omadine may be registered
for sale, distribution and use, subject to the
terms and conditions specified in this standard.
Rationale
It is not the Agency's usual policy to cancel or
withhold registration merely because data are
missing or inadequate (See Section 3(c)(2)(B) and
3(c)(7) of FIFRA). Rather, publication of this
standard provides a mechanism for identifying data
requirements for registration under the standard
and allows for the upgrading of labels during the
period in which the required data are being developed.
These data will be evaluated when they are received.
They will affect the Agency's position on the
registration of sodium omadine.
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13
8. MUPs containing sodium omadine may be registered
for sale, distribution and use, subject to the
terms and conditions specified in this standard.
Rationale
It is not the Agency's usual policy to cancel or
withhold registration merely because data are
missing or inadequate (See Section 3(c)(2)(B) and
3(c)(7) of FIFRA). Rather, publication of this
standard provides a mechanism for identifying data
requirements for registration under the standard
and allows for the upgrading of labels during the
period in which the required data are being developed
These data will be evaluated when they are received.
They will affect the Agency's position on the
registration of sodium omadine.
CRITERIA FOR REGISTRATION UNDER THIS STANDARD
To be subject to this standard, products must meet
the following conditions:
1. Contain sodium omadine as the sole active
ingredient and,
2. Conform to the acute toxicity limits, product
composition, and use pattern requirements listed
in the Acceptable Ranges and Limits section of this
document.
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14
The applicant for registration or reregistration of
products subject to this standard must comply with all
terms and conditions described in it, including committing
to fill data gaps on the schedule required by this Agency.
All applicants for registration under this standard must
follow the instructions contained in this standard and
complete and submit the appropriate forms within the time
specified.
ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
a. Powder Formulations
Powdered MUPsjV must contain at least 90 percent
sodium omadine as the sole active ingredient.
Each MUP formulation proposed for registration
must be fully described with an appropriate
certification of limits. Any MUP not meeting
these requirements will be considered a new
product and will not be registerable under this
standard.
b. Liquid Formulations
Liquid MUPsV must contain at least 40 percent
sodium omadine as the sole active ingredient.
3/ No manufacturing use products are registered for sodium
omadine. The reference to MUP is the 90% SC/S and the
40% RTU liquid end-use products used as MUPs.
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15
Each MUP formulation proposed for registration
must be fully described with an appropriate
certification of limits. Any MUP not meeting
these requirements will be considered a new
product and will not be registerable under this
standard.
2. Acute Toxicity Limits
The Agency will consider for registration MUPs
provided the product is supported by toxicity data
and the labeling for the product bears appropriate
precautionary statements.
3. Use Patterns
To be registered under this standard, MUPs
containing sodium omadine may be labeled for
formulation into end-use products for use as:
a. a preservative in manufactured materials
including: casein aqueous dispersion solutions,
vinyl acetate latex emulsion, paints (in-can),
floor finishes, styrene acrylic polymers,
polyethylene emulsion polymers, acrylic emulsion
polymers, laundry rinse additives (incan),
aqueous based jet-printer inks.
b. a preservative in processing fluids including:
metal working cutting fluid (soluble oil,
synthetic, semi-synthetic) and aqueous synthetic
fiber lubricants (spin finishes).
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REQUIRED LABELING
All MUPs containing sodium omadine must bear
appropriate labeling as specified in 40 CFR 162.10, in
addition to the following specific labeling requirements.
a. Use Pattern Statement
-All MUPs must state that they are intended only
for formulation into end-use products for any of
the use patterns listed in section 3 of Acceptable
Ranges and Limits. A limiting factor will be the
data that support each use pattern. No use may be
included on the label where the registrant(s)
fail(s) to agree to comply with data requirements
in either TABLE A or TABLE B (and subtables) for
that use pattern.
b. Environmental Hazard Statement
MUPs must bear the label statement: This pesticide
is toxic to fish and freshwater invertebrates.
Do not discharge effluent containing this product
into lakes, ponds, streams, estuaries, oceans or
public water unless this product is specifically
identified and addressed in an NPDES permit. Do
not discharge effluent containing this product to
sewer systems without previously notifying the
sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office
of the EPA.
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The required statements listed in this Standard must
appear on the labels of all MUPs released for shipment after
April 1, 1986. The labels of all MUPs currently in the
channels of trade must be modified to include all the listed
statements by April 1, 1987. After review of data to be
submitted under this Standard, the Agency may impose
additional label requirements.
TOLERANCE REASSESSMENT
The registered uses of Sodium Omadine do not involve
direct application to a food or feed crop. Therefore,
tolerances for this chemical are not needed and have not
been set.
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EPA Index to Pesticide Chemicals
1088004 SODIUM 2-PYRIDINETHIOL 1-OXIDE*
TYPE PESTICIDE: Antimicrobial, Fungicide
FORMULATIONS:
SC/S (90%)
RTU (4%, 5%, 6.4%, 40%)
PRESENTATION OF INFORMATION: All final concentrations are expressed in
parts per million total active ingredient(s). Concentrations are rounded
to the nearest whole number when the value is less than 1,000 and to the
third significant figure when the value is greater than 1,000. Unless
otherwise stated, the dilutions are the ratio of the volume of the product
to be diluted to the volume of fluid in which the product is diluted. The
dilutions are rounded to the nearest whole number. In sites where product
weights are given, dosages are expressed as ounces (by weight) of active
ingredients per volume of fluid. In some instances dosages are given as a
percentage based on the total weight of the formulation.
When sodium 2-pyridinethiol 1-oxide is formulated with other active ingre-
dients separate ppm calculations are given in the following order: 1) 2-
pyridinethiol 1-oxide, and 2) other active ingredients.
GENERAL WARNINGS AND LIMITATIONS: Sodium 2-pyridinethiol 1-oxide is a
chelating agent and should not be used in the presence of other chelating
agents. It should not be used in the presence of any chlorine residuals.
Sodium 2-pyridinethiol 1-oxide may be formulated with formaldehyde. For-
maldehyde solutions are irritating to skin and eyes. Repeated contact
with undiluted solution can cause skin discoloration. Ventilate premises
to minimize fumes.
This pesticide is toxic to fish. Do not discharge effluent containing the
product into lakes, ponds, streams, estuaries, oceans or public water un-
less this product is specifically identified and addressed in a National
Pollution Discharge Effluent Standard permit. Do not discharge effluent
containing this product to sewer systems without previously notifying sew-
age treatment plant authorities. For guidance contact your State Water
Board or Regional Office of the EPA.
Apply product only as specified on the label and technical data sheet.
Read labels very carefully for specific warnings, human toxicity state-
ments, and environmental cautions.
Follow label directions for the disposal of the product container when
empty.
Definition of Terms:
ppm - parts per million
*omadine sodium
Issued: 3-22-85 V.1-088004-1
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19
Site, Efficacy,
Dosage and Formulation
EPA Index to Pesticide Chemicals
Use Directions
INDOOR
(Commercial and Industrial Uses)
(Industrial Preservatives and Additives)
/810160A
Industrial Processing
Chemicals
/810120A
Bacteriostat
450 ppm
(90% SC/S)
499 ppm
(40% RTU)
Latex and Resin Emul-
sions
General Instructions for Use: The products regis-
tered in this site are bacteriostats for use in
aqueous synthetic fiber lubricants (spin finishes),
Add product during the manufacture of the indus-
trial processing chemical or during its storage
for industrial application. Add product at the
recommended percentage based on the total weight
of the solution.
Preservation of aqueous synthetic fiber lubricants
(spin finishes).
Add 8 ounces (by weight) of product per 1,000
pounds of lubricant.
Add 20 ounces (by weight) of product per 1,000
pounds of lubricant.
General Instructions for Use: The products regis-
tered in this site are bacteriostats for use in
latex and resin emulsions.
Add product to the latex or resin emulsion at a
point during the manufacturing process where there
is sufficient time and agitation for good disper-
sion.
Bacteriostat
45 ppm
(90% SC/S)
46 ppm
(40% RTU)
Preservation of vinyl acetate latex emulsion.
Add 8 ounces (by weight) of product per 10,000
pounds of emulsion.
Add 18.4 ounces (by weight) of product per 10,000
pounds of emulsion.
Issued: 3-22-85
V.1-088004-2
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20
EPA Index to Pesticide Chemicals
'810070A
Site, Efficacy,
Dosage and Formulation
Metalworking Cutting
Fluids
Use Directions
Issued: 3-22-85
General Instructions for Use: The products regis-
tered in this site are microbistats for use in
metalworking cutting fluids. They control bacteria
and fungi which cause rancidity, foul odors, pH
drifts, and emulsion breakdown of cutting fluids.
Included in this section are the products for use
in straight cutting oils and for oil-water emulsion
cutting fluids (i.e. soluble, emulsifiable, and
synthetic cutting and grinding oils, fluids, cool-
ants, and lubricants).
The concentrations at which these products are in-
corporated into straight cutting oils are based on
the volume of the oil. Emulsion metalworking cut-
ting fluids are usually formulated as oil-based
concentrates. The concentrates are diluted with
water to yield the oil-water emulsion which is
circulated as the cutting fluid to the various
metalworking machines. The concentrations at which
these products are incorporated into emulsion cut-
ting fluids are based on the volume of final, di-
luted metalworking cutting fluid. Dosages are
based on weight of product to weight or volume of
fluid. If product weight could not be determined,
the dosages were based on volume of product to
volume of fluid.
The amount of product required will depend on the
type of system being treated, the nature and extent
of microbiological contamination, the degree of
control required, temperature and pH. Add product
according to one of the following methods of ap-
plication:
Contaminated systems: Product may be added to
disinfect contaminated fluids, but may require
excessively high doses. For best results, drain
and clean system, and recharge fresh fluid.
Fresh fluids:
Initial treatment. Add product to the initial
charge of fresh fluid. Heavily contaminated sys-
tems may require higher doses of product. For
emulsion cutting fluids, product is added (1) to
the oil concentrate, which is then diluted to ob-
tain the final use concentration, (2) to the water
phase during formulation, or (3) to the final di-
luted fluid. Product may be added directly to the
sump for individual machines, or to the discharge
V.1-088004-3
-------
Site, Efficacy,
Dosage and Formulation
EPA Index to Pesticide Chemicals
Use Directions
21
Metalworking Cutting Fluids (continued)
side of the reservoir for central machines. Prod-
uct directions recommend treatment be repeated at
intervals (usually once a week or less frequently).
Make-up fluids. Make-up fluids usually contain
the same level of product as the initial charge.
28 Microbicide/microbistat
24 Bacteriostat
YAIQBB Fungi
45 ppm
(90% SC/S)
27-40 ppm
(4% RTU)
46 ppm
(5% RTU)
45-64 ppm
445-635 ppm
(6.4% RTU)
46 ppm
(40% RTU)
22 ppm
(90% SC/S)
22 ppm
(5% RTU)
22 ppm
(40% RTU)
Preservation of metalworking cutting fluid.
Initial treatment.
Add 8 ounces (by weight) of product per 10,000
pounds of solution.
Add 128 fluid ounces of product per 1,000 to
1,500 gallons of fluid.
Add 147.2 ounces (by weight) of product per
10,000 pounds of solution.
Add 896 to 1,280 fluid ounces of product per
10,000 gallons of fluid.
Formulated with hexahydro-1,3,5-tris(2-hydroxy-
ethyl)-s-triazine.
Add 18.4 ounces (by weight) of product per
10,000 pounds of solution.
Subsequent treatment.
Add 4 ounces (by weight) of product per 10,000
pounds of solution.
Add 70.4 ounces (by weight) of product per
10,000 pounds of solution.
Add 8.8 ounces (by weight) of product per 10,000
pounds of solution.
Issued: 3-22-85
V.1-088004-4
-------
EPA Index to Pesticide Chemicals
310090A
Site, Efficacy,
Dosage and Formulation
Paints
Use Directions
General Instructions for Use: The product regis-
tered in this site is a microbistat for use in
paints during manufacture and in-can storage. This
product is not effective in protecting dried paint
films from bacterial or fungal attack.
The products in this site are for industrial use
only. They are added at a point in the paint manu-
facturing process where there is sufficient time
and agitation for good dispersion. Products are
added as a liquid, dry solid, or concentrated aque-
ous solution. Product directions may specify addi-
tion at a specific phase in the manufacturing proc-
ess or to the raw materials. Some products are
used as a mixture with other antimicrobial prod-
ucts. The exact product concentration required
will vary with the type of system to be treated,
the nature and extent of microbiological contamina-
tion, the degree of control required, temperature,
and pH. The exact amount of product required is
best determined by actual test.
28
24
ZZZQBB
Microbicide/microbistat
Bacteriostat
Fungi
40 ppm
800 ppm
(4Z RTU)
810110A Plastics and Polymers
Preservation of paints.
Add 0.1 percent of product based on the weight of
the formulation.
Formulated with benzyl alcohol and formaldehyde.
General Instructions for Use: The product regis-
tered in this site is a microbistat for use in
floor finishes, styrene acrylic polymers, poly-
ethylene emulsion polymers and acrylic emulsion
polymers.
Add product at any point of the manufacturing
process. Mix thoroughly to ensure even dispersion.
28 Microbicide/microbistat
.24 Bacteriostat
•ZZZQBB Fungi
40-80 ppm
800-1,600 ppm
(4Z RTU)
Preservation of polymers.
Add 0.1 percent to 0.2 percent of product based on
the weight of the formulation.
Formulated with benzyl alcohol and formaldehyde.
Issued: 3-22-85
V.1-088004-5
-------
Site, Efficacy,
Dosage and Formulation
/810140A Speciality Products
EPA Index to Pesticide Chemicals
Use Directions
General Instructions for Use: The products regis-
tered in this site are bacteriostats for use in
aqueous based jet-printer inks.
Add product at any point of the manufacturing
process. The amount of product to be added to the
ink, to obtain the proper concentration of product
at the time the ink is used, will vary with the
shelf-life of the ink.
A24
Bacteriostat
Preservation of alkaline aqueous based jet-printer
inks.
450-4,500 ppm
(90% SC/S)
500-5,000 ppm
(40% RTU)
2,700 pptn
(90% SC/S)
Add 0.05 percent to 0.5 percent of product based
on the weight of the formulation.
Add 0.125 percent of product based on the weight
of the formulation.
Preservation of neutral or slightly acid aqueous
based jet-printer inks.
Add 0.3 percent of product based on the weight of
the formulation.
3,000 ppm
(40% RTU)
50 ppm
(40% RTU)
Add 0.75 percent of product based on the weight of
the formulation.
Preservation of laundry rinse additive.
Add 0.0125 percent of product based on the weight
of the formulation.
Issued: 3-22-85
V.1-088004-6
-------
24
EPA Index to Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation
&090.0015 90% soluble concentrate/solid
sodium 2-pyridinethiol 1-oxide (088004)
001258-00842
&204.0016 4% (0.373 Ib/gal) liquid-ready to use
sodium 2-pyridinethiol 1-oxide (088004)
benzyl alcohol (009502)
formaldehyde (045001)
000365-00079
&204.0016 4% liquid-ready to use
sodium 2-pyridinethiol 1-oxide (088004)
004808-00003
i205.0016 5% (0.427 Ib/gal) liquid-ready to use
sodium 2-pyridinethiol 1-oxide (088004)
001258-00972
i.206.4016 6.4% (0.623% Ib/gal) liquid-ready to use
sodium 2-pyridinethiol 1-oxide (088004)
hexahydro-l,3,5-tris(2-hydroxyethyl)-s-triazine (083301)
001258-00990
,240.0016 40% (4.16 Ib/gal) liquid-ready to use
sodium 2-pyridinethiol 1-oxide (088004)
001258-00843
90.0%
4.0%
60.0%
20.0%
84.0%
4.0%
5.0%
6.4%
63.6%
70.0%
40.0%
Issued: 3-22-85
V.1-088004-7
-------
25
EPA Index to Pesticide Chemicals
Appendix B
Listing of Registration Numbers by Site and Formulation
INDOOR
(Commercial and Industrial Uses)
(Industrial Preservatives and Additives)
/810160A Industrial Processing Chemicals
(90% SC/S)
001258-00842
(40% RTU)
001258-00843
/810120A Latex and Resin Emulsions
(90% SC/S)
001258-00842
(40% RTU)
001258-00843
/810070A Metalworking Cutting Fluids
(90% SC/S)
001258-00842
(4% RTU)
004808-00003
(5% RTU)
001258-00972
(6.4% RTU)
001258-00990
(40% RTU)
001258-00843
/810090A Paints
(4% RTU)
000365-00079
/810110A Plastics and Polymers
(4% RTU)
000365-00079
/810140A Speciality Products
(90% SC/S)
001258-00842
(40% RTU)
001258-00843
Issued: 3-22-85
V.1-088004-8
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
Guideline Citation and Test Guidelines Are Data Footnote
Name of Test Substance Status Required Number
Yes No
S158.120 Product Chemistry
product Identity:
61-1 - Identity of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing process
61-3 - Discussion of Formation of
impurities
Analysis and Certification of Product
ingredients
62-1 - Preliminary Analysis
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
TGAI R [_] [x]
TGAI R [?c] [""] 2
TGAI R [x] [~] 3
TGAI CR [x] [~] 4
TGAI R [~] [JC]
TGAI R [~] [x]
TGAI R [x] [~) 5
TGAI R [x] [~] 6
TGAI R [~] [x] 7
Data Must Be
Submitted Within
Time Frames Listed
Below I/
6 Months
6 Months
12 Months
6 Months
6 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
Guideline Citation and
Name of Test
Test
Substance
Guidelines
Status
Are Data
Required
Yes No
Footnote
Number
Data must Be
Submitted Within
Time Frames Listed
Below */
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density, or TGAI R
Specific Gravity
63-8 - Solubility TGAI or PAI R
63-9 - Vapor Pressure PAI R
,63-10 - Dissociation constant PAI R
63-11 - Octanol/water partition PAI R
coefficient
63-12 - pH TGAI R
63-13 - Stability TGAI R
Other Requirements:
64- 1 - Submittal of samples TGAI, PAI CR
M
[J
[J
[J
[x]
[x]
[J
[x]
[J
[x]
[x]
10
11
12
6 Months
6 Months
6 Months
TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Required
\J Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date is •
0 12 Month Due Date is .
2j The Agency requires data concerning reaction conditions, starting materials, and quality control.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
§158.120 Product Chemistry
(continued)
3/ A discussion of each Impurity believed to be present at X).l% and nitrosamines at any level.
kj Five or more batches must be analyzed for the active ingredient and each impurity requiring a certified limit.
V The odor must be more clearly described than "mild".
6/ Clarification of conflicting data must be made.
TJ Not required because the 90% product is a solid at room temperature.
8/ Clarification of test substance and reasons for discrepancies must be provided.
9/ Vapor pressure is not required because sodium omadine is a salt with a high melting point.
10/ Since sodium omadine is a salt, a dissociation constant is required.
ll/ Since sodium omadine is quite polar, the Agency will not require an octanol/water partition coefficient.
12/ The Agency requires that samples of technical and analytical grade sodium oraadine be submitted. The samples
must represent current production batches.
INJ
00
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
Data Requirement Composition
§158.135 Toxicology
Must Additional
Data Be Submitted
Does EPA Have Date Under FIFRA Section
To Satisfy This 3(c)(2)(B)? Time
I/ Use 2/ Requirement? (Yes, Bibliographic Frame for Data
Patterns No or Partially) Citation SubmissionV
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-6
- Oral LD5Q - Rat
- Dermal LDtjQ
- Inhalation 1X50 - Rat
- Primary Eye Irritation
- rabbit
- Primary Dermal Irri-
tation - rabbit
- Dermal Sensitization
-Guinea pig
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Ir IP
I, IP
Ir IP
Ir IP
I, IP
I, IP
NO
No
No
Yes
No
No
Yes
Yes
Yes
00092174, 00042376 No
Yes
Yes
9 Months
9 Months
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
- 90-Day Feeding -
-rodent,
-non-rodent
- 21-Day Dermal
- 90-Day Dermal
- 90-Day Inhalation -
TGAI
TGAI
TGAI
TGAI
TGAI
I
I
Ir I?
Ir IP
IP
No
No
No
NO
No
Yes
Yes
No
Yes
Yes
15 Months
18 Months
15 Months
15 Months
Rat
82-5 - 90-Day Neurotoxicity-
-Mammal
TGAI
Ir IP
No
Yes
9 Months
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
Data Requirement
I/ Use 2/
Composition pattern
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2 Time
Frame for Data
SubmissionV
.5158.135 Toxicol
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity
-rodent 1GAI
-non-rodent TGAI
83-2 - Oncogenicity Study
-rat TGAI
-mouse TGAI
83-3 - Teratogenicity
-rat TGAI
-rabbit TGAI
83-4 - Reproduction,
2-generation TGAI
MUTflGENICITY TESTING
84-2 - Gene Mutation TGAI
84-2 - Chromosomal Aberration TGAI
84-4 - Other Mechanisms of
Mutagenicity TGAI
I, IP
I, IP
I, IP
No
No
I NO
I5/, IP5/ NO
Yes
Partially
No
I, IP Yes
I, IP No
00056708, 00056701
00077157
00077156
00058358
I, IP
No
YesV
YesV
Yes4/
Yes7/
No
Yeg6/ 9 Months
Yes 39 Months
No
Yes
Yes
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_!/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3 c)(2)(B)?3/ Time
Frame for Data
__________^__ Submission3/
§158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism TGAI or PAIRA I, IP No YesV
- Human Exposure Studies As Appropriate I, IP No Yes7/
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient, radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: I=Indoor (domestic, household laundry); lP=lndustrial preservative (including
use in metal cutting fluids.
V ° 9 Month Due Date is .
0 15 Month Due Date is .
0 39 Month Due Date is
V Contingent upon results of human exposure studies.
5/ Mouse skin painting oncogenicity study.
6/ Route of administration to be dermal.
7/ 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 this standard. The data must be submitted no later than
6 months after the protocol review has been completed.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR SODIUM OMADINE TECHNICAL
Data Requirement
I/ Use 2/
Composition pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? Time
Frame for Data
Submission3/
S158.145 Wildlife and
Aquatic organisms
AVIrtN AND MAMMALIAN TESTING
71-1
71-2
71-3
71-4
71-5
- Avian Oral LDtQ
- Avian Dietary LC5Q
- wild Mammal Toxicity
- Avian Reproduction
- Simulated and Actual
TGAI l£/
TGAI iy
TGAI
TGAI
TEP
No
Yes
N/A
N/A
N/A
Yes 9 Months
00073656*, 00073657* No6/
NcV
NoV
NoV
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LC
50
72-2 - Acute LC5Q Freshwater
invertebrates
72-3 - Acute LC5Q Estuarine
and Marine Organisms
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
TGAI
TGAI
TGAI
TCAI
Partial
Yes
N/A
N/A
LAOMADOl**
LAOMAD02**
00103228*
Yes 9 Months
No
No5/
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR SODIUM OMADINE TECHNICAL
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
_!/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition" pattern"" No or Partially) Citation 3(c)(2)(B)? Time
Frame for Data
SubmissionV
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-5 - Fish - Life-Cycle TCAI N/A No5/
72-6 - Aquatic Organism TGAI, PAI OR N/A NcV
Accumulation Degradation
Product
72-7 - Simulated or Actual TEP N/A NoV
Field Testing -
Aquatic Organisms
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: I=Indoor (domestic, household laundry); IP=Industrial Preservative (including
~ use in metal cutting fluids.
V Data must be submitted no later than 9 months from the date of this Standard.
4/ Data are required to support manufacturing use product or highest percent active ingredient end-use product.
5/ This data are not required to support manufacturing use products designed for the formulation of indoor end-use
~~ products.
6/ Only one LC5Q study need to be cited or provided.
* Study on its own fulfills guideline requirement.
** Study must be cited along with additional study to fulfill requirement.
-------
GENERIC DATA REQUIREMENTS FOR SODIUM OMADINE TECHNICAL
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)? Time
Frame for Data
Submissions/
Data Requirement
Composition"
Use 2/
Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or partially)
S158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - in Air
62 - METABOLISM STUDIES-LAB
163 - MOBILITY STUDIES
164 - DISSIPATION STUDIES-FIELD
65 - ACCUMULATION STUDIES
Other Requirements;
- Nitrosamine Forming potential
in Metal working fluids TGAI
TGAI or PAIRA
TGAI or PAIRA
N/A
N/A
I» IP
If IP
N/A
N/A
N/A
N/A
N/A
N/A
IP
NO
No
N/A
N/A
N/A
N/A
N/A
N/A
NO
YesV 9 Months
NO6
Yes
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled.
2/ The use patterns are coded as follows: I=lndoor (domestic, household laundry); lP=lndustrial preservative (including
~~ use in metal cutting fluids.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
~ ° 9 Month Due Date is . .
4/ The Agency requires data because the end-uses of this chemical may result in indirect-discharge to water systems (i.
~ the release, treatment, or application of a pesticide product to water sites not directly connected to bodies of
water to which wild animals, birds, fish, and similar organisms have free access).
5/ Contingent upon the results of the hydrolysis study.
67 The studies under this category of data requirements do not apply to the use patterns of this chemical, because
~ the use patterns do not impact KPA Guide lino requirements, there being no Lewd, feed, soil, water, ">r ve-jetatwe
-------
TABLE B-l
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
EPA REG. NO. 1258-843 (40% PRODUCT)
Guideline Citation and Test Guidelines Are Data Footnote
Name of Test Substance Status Required Number
Yes No
§158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP R [ ] [x]
MP R [x"j [~~] 2
MP R [x] [~] 3
MP CR [x] f~] 4
MP R [x"] f~] 5
MP R [x] [~] 6
MP R [~] [x]
MP R [~] [x]
MP R [x] [~] 7
Data Must Be
Submitted Within
Time Frames Listed
Below */
6 Months
6 Months
12 Months
12 Months
12 Months
-------
TABLE B-l
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
EPA REG. NO. 1258-843 (40% PRODUCT)
Guideline Citation and
Name of Test
§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 - Explodabillty
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Other Requirements:
64- 1 - Submlttal of samples
MP = Manufacturing-use Product; R -
_!/ Data must be submitted within the
0 6 Month Due Date Is
0 12 Month Due Date is
Test
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Required; CR -
indicated time
Guidelines
Status
R
CR
CR
CR
R
R
CR
CR
R
CR
Conditionally
frame, based
•
•
Are Data
Required
Yes
n
n
[x]
n
[x]
[x]
[x]
n
[x]
[x]
Required
on the date
Footnote
Number
No
[x]
[x]
M 8
[x] 9
n 10
n n
n 12
[x] 13
n u
n is
of the Guidance Document.
Data Must Be
Submitted Within
Time Frames Listed
Below lf
6 Months
6 Months
6 Months
6 Months
15 Months
6 Months
15 Months
6 Months
0 15 Month Due Date is
-------
TABLE B-l
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
EPA REG. NO. 1258-843 (40% PRODUCT)
§158.20 Product Chemistry
(continued)
2/ The Agency requires data concerning starting materials, reaction conditions, and quality control.
3/ The Agency requires a discussion of impurities suspected at X).l% and nitrosoamines at any level.
4/ Five or more batches must be analyzed for sodium omadine and all impurities needing a certified limit.
5/ The Agency requires upper and lower limits for sodium cmadine and inert ingredients and upper limits
~ for impurities at M).l%.
6/ The Agency requires enforcement methods for sodium omadine and impurities requiring certified limits.
7/ The odor must be more clearly described than "mild".
8/ The tendency of the 40% product to act as an oxidizing or reducing agent must be determined.
97 Not required because the product does not contain combustible liquids.
107 The impact explosion characteristics of the 40% product are required.
ll/ Commercially packaged material must be analyzed before and after _> 1 year storage at 20°C or 25°C
and 50% relative humidity or under expected warehouse storage conditions. Any physical changes
must be noted and degradation products must be determined.
12/ The viscosity of liquid products must be submitted.
T3/ Not required because the product is not an emulsifiable liquid and is not to be diluted with
petroleum solvents.
14/ If commercially packaged in contact with metal, plastic, or paper, the Agency requires data on the
corrosion characteristics.
15/ Current batch samples of the 40% product must be submitted.
-------
TABLE B-2
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
EPA REG. NO. 1258-842 (90% PRODUCT)
Guideline Citation and Test Guidelines Are Data Footnote
Name of Test Substance Status Required Number
Yes No
S158.120 Product Chemistry
Product Identity:
61-1 - Product Identity and Disclosure
of Ingredients
61-2 - Description of Beginning Materials
and Manufacturing Process
61-3 - Discussion of Formation of
Impurities
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to Verify
Certified Limit
physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
MP R I 1 [x]
MP R [x] [~] 2
MP R (x] [~] 3
MP CR [x] [~] 4
MP R [x] [~] 5
MP R [x] [~] 6
MP R t~] [x]
MP R [~] [x]
MP R [x] [~] 7
Data Must Be
Submitted Within
Time Frames Listed
Below I/
6 Months
6 Months
12 Months
12 Months
12 Months
6 Months
CO
-------
TABLE B-2
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
EPA REG. NO. 1258-842 (90% PRODUCT)
Guideline Citation and
Name of Test
S158.120 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 = Manufacturing-use Product; R =
I/ Data must be submitted within the
0 6 Month Due Date is
0 12 Month Due Date is
Test
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Required; CR =
! indicated time
Guidelines ,Are Data
Status Required
Yes No
R [~) [x]
CR M [x]
CR M M
CR n [x]
R [x] n
R [x] n
CR [~~] Ul
CR [ ] [x]
R [x] n
CR [x] n
Conditionally Required
trame, based on the date of the
.
Footnote
Number
9
8
10
11
12
12
13
14
Guidance Document.
Data Must Be
Submitted Within
Time Frames Listed
Below V
6 Months
6 Months
15 Months
15 Months
6 Months
0 15 Month Due Date is
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
EPA REG. NO. 1258-842 (90%)
S158.135 Toxicology - Continued
2f The Agency requires data concerning starting materials, reaction conditions, and quality control.
V The Agency requires a discussion of impurities suspected at >0.l% and nitrosoamines at any level.
k] Five or more batches must be analyzed for sodium omadine and all impurities needing a certified limit.
5/ The Agency requires upper and lower limits for sodium omadine and inert ingredients and upper limits
for impurities at J>0.1%.
6/ The Agency requires enforcement methods for sodium omadine and impurities requiring certified limits.
TJ The odor must be more clearly described than "mild".
8/ Not required because the product does not contain combustible liquids.
9/ The tendency of the 90% product to act as an oxidizing or reducing agent must be determined.
10/ The impact explosion characteristics of the 90% product are required.
11/ Commercially packaged material must be analyzed before and after >^ 1 year storage at 20°C or 25°C
and 50% relative humidity or under expected warehouse storage conditions. Any physical changes
must be noted and degradation products must be determined.
12/ Not required because the product is not a solid at room temperature.
13/ If commercially packaged in contact with metal, plastic, or paper, the Agency requires data on the
corrosion characteristics.
14/ Current batch samples of the 40% product must be submitted.
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TABLE B-3
PRODUCT SPECIFIC DATA REQUIREMENTS TOR MANUFACTURING-USE PRODUCTS CONTAINING SODIUM OMADINE
Data Requirement
Composition
I/
81-4 - Primary Eye Irritation
- rabbit MP
81-5 - Primary Dermal Irri-
tation - rabbit MP
81-6 - Dermal Sensitization
-Guinea pig MP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? Time
Frame for Data
Submission^
S158.135
Toxicology
ACUTE TESTING:
81-1 -
81-2 -
81-3 -
Oral LD5Q - Rat
Dermal LD50
Inhalation IC$Q - Rat
MP
MP
MP
No
Partially
No
Yes 9 Months
00042376, 00056679 Yes 9 Months
00056677
Yes 9 Months
Partially
No
No
00042376
YesV 9 Months
YesV 9 Months
Yes 9 Months
I/ Composition: MP=Manufacturing-use product.
:?/ Data must be submitted within the indicted tme frame, based on the date of the Guidance Document.
0 9 Month Due Date is .
3/ In addition, a second study at two times the frinal end-use dilution is required (in an appropriate vehicle depending
on the particular use).
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42
REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA sec. 3(c)(2)(B). The
tables following this section list the data required for
maintaining the registrability of each product.
EPA has determined that additional generic data described
in Table A must be submitted to EPA for evaluation in order
to maintain in effect the registration(s) of your product(s)
identified as an attachment to the cover letter accompanying
this guidance document. As required by FIFRA sec. 3{c)(2)(B),
you are required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA how
you will satisfy the requirements of this Notice. Any such
suspension will remain in effect until you have complied with
the terms of this Notice.
B. What Generic Data*/ Must be Submitted. You may deter-
mine which generic data you must submit by consulting Table A
at the end of this chapter. That table lists the generic
data needed to evaluate the continued registrability of all
products, and the dates by which the data must be submitted.
The required studies must be conducted in accordance with
EPA approved protocols (such as those contained in the Pesticide
Assessment Guidelines £/ or data collected under the approved
protocols of the Organization for Economic Cooperation and
Development (OECD). If you do not wish to develop data
in support of certain uses appearing in your labeling, you
may delete those uses at the time you submit your revised
labeling.
For certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that type
^/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient, regardless
of the product's unique composition or specific use. Product-
specific data relate only to the properties or effects of a
product with a particular composition (or a group of products
with closely similar composition).
£/ The Pesticide Assessment Guidelines are available in hard
copy or microfiche from the National Technical Information
Service, 5285 Port Royal Road, Springfield, Va. 22161.
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43
for each major formulation category (e.g., emulsifiable concen-
trates, wettable powders, granulars, etc.) These are classified
as generic data and when needed are specified in Table A.
EPA may possess data on certain "typical formulations" but
not others. Note; "Typical formulation" data should not be
confused with product-specific data (Table B) which are
required on each formulation. Product-specific data are
further explained in Chapter III of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II-3] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe will
satisfy the requirement, or state that you will generate
the data by conducting testing. If the test procedures
you will use deviate from (or are not specified in) the
Pesticide Assessment Guidelines or protocols contained in
the Reports of Expert Groups to the Chemicals Group,
Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must enclose the
protocols you will use.
OR
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly develop (or
share in the cost of developing) the data. If you elect
this option, you must notify EPA which registrant(s) are
parties to the agreement.
OR
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for Develop-
ment of Data" (EPA Form 8580-6, Appendix II-4)*/
^J FIFRA sec. 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
(Footnote continued on next page)
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44
OR
4. Request that EPA amend your registration by deleting
the uses for which the data are needed. (This option is
not available to applicants for new products.)
OR
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed. (This option
is not available to applicants for new products.)
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required data
or how quickly the data must be submitted. If the test
procedures you plan to use deviate from (or are not specified
in) the registration guidelines or protocols contained in
the reports of the Expert Groups to the Chemical Groups,
Organization for Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must submit the protocol
foe Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product Manager.
(Footnote continued from previous page)
In EPA's opinion, joint data development by all regis-
trants subject to a data requirement or a cost-sharing agreement
among all such registrants is clearly in the public interest.
Duplication of testing could increase costs, tie up testing
facilities, and subject an unnecessarily large number of
animals to testing.
As noted earlier, EPA has discretion to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it should encourage joint testing rather than duplicative
testing, and that suspension should be withheld in certain cases.
to further this goal. Accordingly, if (1) a registrant has
informed us of his intent to develop and submit data required
by this Notice; and (2) a second registrant informs EPA that
it has made a bona fide offer to the first registrant to share
in the expenses of the testing [on terms to be agreed upon
or determined by arbitration under FIFRA Section 3(c)(2)(B)(iii)] ;
and (3) the first registrant has declined to agree to enter
into a cost-sharing agreement, EPA will not suspend the
second firm's registration.
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45
The extension request should state the reasons why you believe
that an extension is appropriate. While EPA considers your
request, you must strive to meet the deadline for submitting
the required data.
Ill. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: Unless stated otherwise in Section I, Regulatory
Position and Rationale, this Section applies only to manufac-
turing use products, not to end use products.
A necessary first step in determining which statements
must appear on your product's label is the completion and
submission to EPA of product-specific data* listed on the
form entitled "Product Specific Data Report" (EPA Form
8580-4, Appendix III-1) to fill gaps identified by EPA
concerning your product. Under the authority of FIFRA sec.
3(c)(2)(B), EPA has determined that you must submit these
data to EPA in order to reregister your product(s). All of
these data must be submitted not later than six months after
you receive this guidance document.
Table B--Product-Specific Data Requirements for Manufacturing
Use Products--lists the product specific data you must submit.
Data that are required to be submitted are identified in the
column of those tables entitled "Must Data By Submitted
Under §3(c)(2)(B)."
T \?. cr-sv^ CC.T /-^ r,5? PFVISET LA^TLING
Note: This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otherwise, the following information pertains
exclusively to manufacturing use products.
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the results of data concerning the product and its ingredients.
Labeling requirements are set out in 40 CFR 162.10 (see
Appendix IV-1) and are summarized for products containing
this active ingredient as part of this Guidance Document
(See Appendix IV-2). Applications submitted in response to
this notice must include draft labeling for Agency review.
*/ Product specific data pertain to data that support the
fbrmulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
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46
If you fail to submit revised labeling information
complying with this section (supplemented by requirements
described in Section I, Regulatory Position and Rationale),
EPA may issue a notice of intent to cancel the registration
under FIFRA sec. 6(b)(l).
A. 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 Appendix IV-2.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be acccptea if it is raise or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required cm 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. See Appendix IV-1. 140 CFR
162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency. See Appendix IV-1.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container
See Appendix IV-1. [40 CFR 162.10(f)l
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47
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. See Appendix IV-1. [40 CFR
162.10(g)]
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 ^anel
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. See Appendix IV-1.
[40 CFR 162.10U) (l).(ii) ) fc
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. See Appendix IV-1.
[40 CFR 162.10 (h)(1)(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 "P'ison" shell appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CFR 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. See Appendix IV-1. [40 CFR 162.10(h)(1)(iii)]
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48
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
See Appendix IV-1. [40 CFR 162 . 10( h) { 1 ) ( ii i ) ]
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. See Appendix IV-1. [40 CFR 162.10
(h)(2)) .
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. See Appendix IV-1. [40 CFR 162.10
(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix IV-1. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements relating
to f lammability of a product are required to appear on the
label if it meets tfce criteria in Appendix IV-3. The require-
ment 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 f lammability statements.
2. Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a product
is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of gases)
that will not ignite when a lighted match is placed
against the open cylinder valve.
b. A "non-flammable liquid" is one having a flashpoint
greater than 350°F (177°C).
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49
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches;
ii. There is no flashback; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C).
3. Declaration of non-flammability. Products which
meet the criteria for non-flammabillty specified
above may bear the notation "non-flammable" or "non-
flammable (gas, liquid, etc.)" on the label. It may
appear as a substatement to the ingredients statement,
or on a back or side panel, but shall not be highlighted
or emphasized (as with an inordinately large type
size) in any way that may detract from precaution.
4. Other physical/chemical hazard statements. When
chemistry data demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such statements
may address hazards of explosivity, oxidizing or reducing
capability, or mixing with other substances to produce
toxic fumes.
Item 9. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a biollation 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.
Item 10A. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the direc-
tions for use. This heading must be set in the same type
sizes as required for the child hazard warning. Refer to
Appendix IV-4 to determine the disposal instructions appro-
priate for your products.
Item 10B. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix IV-1. [40 CFR 162.10]
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50
B. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other graphic printed matter which is referred to
on the label or which is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
in connection with registration of the product. It should be
made part of the response to this notice and submitted for
review.
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51
V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Sodium
Omadine as an active ingredient.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division at
the address given at the end of this section the "FIFRA Section
3(c)(2)(B) Summary Sheet" EPA Form 8580-1. Refer to Appendix
II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. Within 6 months from receipt of this document you must
submit to the Product Manager on the Registration Division:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4
(Appendix III-l).
c. Two copies of any required product-specific data.
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. The labeling should be either typewritten
text on 8-1/2 x 11 inch paper or a mockup of the labeling
suitable for storage in 8-1/2 x 11 inch files. The draft
label must indicate the intended colors of the final label,
clear indication of the front panel label, and the intended
type sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80-152.99
(enclosed) for latest requirements.
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 agreed schedule cannot be
met, notify the Product Manager and the Office of Compliance
Monitoring.
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52
B. For Manufacturing Use Products containing Sodium Omadine
in combination with other active ingredients
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a data
requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. 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 agreed schedule cannot be
net, notify the Product Manager and the Office of Compliance
Monitoring.
C. For End Use Products containing Sodium Omadine alone or in
combination with other active ingredients:
1. Within 90 days from receipt of this document, you must
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet," EPA Form
8580-1. Refer to Appendix II-3 with appropriate attachments.
If on the Summary Sheet, you commit to develop the data,
request a minor chemical exemption, present arguments that a
data requirement is not applicable, or submit protocols or modified
protocols for Agency review, you must also 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 information 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.)
2. Within 6 months from receipt of this document you must
submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product-Specific Data Report, EPA Form 8580-4
(Appendix III-l).
c. Two copies of any required product-specific data.
(Refer to Table C).
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53
d. Two copies of draft labeling, including the label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and the results of
the short-term data, you may submit such labeling. End use
product labeling must comply specifically with the instructions
in Section I (Regulatory Position and Rationale) of this
guidance document. 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 inch files. The draft label
must indicate the intended colors of the final label, clear
indication of the front panel label, and the intended type
sizes of the text.
e. Evidence of compliance with data support requirements
of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR 152.80-152.99
(enclosed) for latest requirements.
3. Within the time frames set forth in Table A, sub
generic data, unless you are eligible for the formulator'
pxetnn t i nn .
D. For intrastate products containing Sodium Omadine either
as the sole active ingredient or in combination with
other active ingredients
These products are being called in for full Federal
registration. Producers of these products are being sent
a letter instructing them how to submit an application for
registration.
E. Applications and other required information should be
submitted to the following address:
John H. Lee
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St. , SW.
Washington, D.C. 20460
Phone No. (703 )-557-3675
The address for submission 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
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54
Appendix II-l
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(,d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
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55
Appendix II-l (continued)
a. Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
b. Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
-------
56
Appendix II-2
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Date Base Supporting
Registration Under the Sodium Omadine Standard
00042376 Vogin, E. E. (1968) Toxicity of Sodium omadine to Rabbits; Labora-
tory No. 88494. (Unpublished study including laboratory nos.
88496 C, 88496 d, 88496 e..., received Aug. 5, 1968 under 1248-5;
prepared by Food and Drug Research Laboratories, Inc., submitted
by American Chemical Co., Kansas City, Mo.; CDL 106554-C)
00053879 Olin Chemicals (19??) Zinc and Sodium Compounds of Omadine. New
York, N.Y.; Olin. (Technical bulletin; also In unpublished
submission received Apr. 26, 1967 under unknown admin, no.; CDL;
119362-A)
00056701 Benitz, K.F. (1973) Report on Histopathology of Tissues from Repro-
duction Study with Sodium omadine. (Unpublished study including
letter dated Mar. 6, 1973 from L. Goldberg to Richard Henderson,
received Nov. 16, 1976 under 1258-842; prepared by Albany Medical
College, Institute of Experimental Pathology and Toxicology,
submitted by Olin Corp., Stamford, Conn.; CDL:226871-88)
00056708 Coulston, F.; Goldberg, L. (1969) Study of Reproductive Effects of
Sodium omadine (In 43) in Rats. (Unpublished study received
Nov. 16, 1976 under 1258-842; prepared by Albany Medical College,
Institute of Experimental Pathology & Toxicology, submitted by
Olin Corp., Stamford, Conn., CDL:223405-D)
00058358 Barsky, F.C. (1976) In vitro Microbial Mutagenicity Studies of
2-Pyridinethiol-1-oxide, Sodium salt; Haskell Laboratory Report
No. 552-76. (Unpublished study received Apr. 4, 1978 under
1258-842; prepared by E.I. du Pont de Nemours and Co., submitted
by Olin Corp., Stamford, Conn.; CDL:233405-D)
00073656 Fink, R. (1976) Final Report: Eight-Day Dietary LC50 Bobwhite
puail; Project No. 133-103. (Unpublished study received Nov. 16,
1976 under 1258-842; prepared by Truslow Farms, Inc., submitted
by Olin Corp., Stamford, Conn.; CDL:226871-BO)
00073657 Fink, R. (1976) Final Report; Eight-Day Dietary UC^O Mallard Ducks;
project No. 133-104. (Unpublished study received Nov. 16, 1976
under 1258-842; prepared by Truslow Farms, Inc., submitted by
Olin Corp., Stamford, Conn.; CDL:226871-BP)
-------
Appendix II-2 (continued)
57
00077156 Palmer, A.K.; Allen, P.A.; Clark, R.; et al. (1980) Preliminary
Study To Compare the Effects of Three Soluable Omadines on
Embryonic and Foetal Development of the New Zealand White
Rabbit (Dermal Application): BMT/274/80435. (Unpublished
study received Jun. 30, 1981 under 1258-842; prepared by
Huntingdon Research Centre, England, submitted by Olin Corp,
Stamford, Conn.; CDL:245432-C)
00077157 Rodwell, D.E.; Janes, J.M.; Campbell, G.A.; et al. (1980) Tera-
tology Study in Rats: IRDC No.; 397-107. (Unpublished study
received June. 30, 1981 under 1258-842; prepared by International
Research and Development Corp., submitted by Olin Corp,. Stam-
ford, Conn.; CDL:245432-D)
00091486 E.R. Squibb & Sons (1954) Squibb 2-Pyridinethiol, 1-Oxide and De-
rivatives: Summary of Information. (Unpublished study received
Dec. 28, 1954 under unknown aomin. no.; submitted by Olin Corp.,
Stamford, Conn.,- CDL: 11 0380-A)
00092174 Vogin, E.E. (1967) Test for Mucous Membrane (Eye) Irritation...:
Laboratory No. 88496 c. (Unpublished study received Aug. 5, 1968
under unknown admin, no.; prepared by Food and Drug Research
Laboratories, Inc., submitted by Olin Corp., Stamford, Conn.;
CDL: 110392-A)
00103228 Union Carbide Corp. (1967) Acute Toxicity of Sodium Omadine, 40%
Aqueous Solution to Daphnia magna. (Unpublished study received
Jun. 3, 1982 under 1258-842; submitted by Olin Corp., Stamford,
Conn.; CDL:247630-A)
00108557 Olin Corp. (1977) Chemical Study: Sodium Omadine Powdered Indus-
trial Microbiostal. (Compilation; unpublished study received
Apr. 20, 1977 under 1258; CDL:233407-A)
LAOMAD01 McCann, J.A. (1975) Additive SO. 4.0%: Bluegill Sunfish (Lew-mis
nacrochirus); Test No. 896; U.S. Environmental Protection Agency,
Technical Service Div., Animal Biology Laboratory., Date 11-19-75.
LAOMAD02 McCann, J.A. (1976) Additive SO. 4.0%: Rainbow Trout (Salmo
gairdneri); Test No. 937; U.S. Environmental Protection Agency,
Technical Service Div., Animal Biology Laboratory., Date 02-02-76.
-------
OMB Approval Ho. 20OO-04S8
FIFHA SECTION 3(C){2)(B) SUMMARY SHEET
EPA REGISTRATION NO.,
PRODUCT NAME
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With napact to thi raquiramant to submit "jwiric" dtu imposad by ttw FIFRA action 3(CK2)(B) notici containid in the referenced
GuidMca Document, I am responding in thi following manner
01. I will submit dm in • timiiy mmmr to satisfy tht following raquiramants. If thi tm procedures I will urn dtvitn from (or ire not
spacifwd in) thi Registration Guidelines or thi Protocols contiintd in thi Ripora of Expin Groupt to thi Chimicik Group. OECD
Cnwnicals TMing Programmi, I wcloti thi protocol* that I will urn:
O 2. I him wtind into in •orwmmt with om or mori othir ngistnntf undir FIFRA notion 3(CX2)(B)(ii) to wiify the following data
nquinmmts. Thi »m, ind iny nquirid protxoil, will be submittid to EPA by:
NAME OF OTHER REGISTRANT
LJ1 I wcloei i complmd "Cinrficition of Animpt to Enter Into in Agmmmt with Other Registrants for Development of Dm" with
motet to thi following dm fBquinmwits:
O 4. I rtquBt thn you tmcnd my ngtttmion by dotting the following uset (thit option is not militate to ipplicinn for new products):
D 5. I requ«t votuntary eanetjilation of thi ngittntion of this product (This option is not iwiltbli to applicants for naw products.)
Mf OtrnUNTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
-------
APPENDIX
59
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
rTo qualify, citify ALL four Htms) FOR DEVELOPMENT OF DATA
1. 1 am duly authorized tu repf»wnt the following firm(s) who are subject to the require-
ment* of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
j i nu tirm or group ot firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enu
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following require:
items or data:
3. My firm has offered in writing to anttr into such an agreement. Copies of tht offers are attached. That offer was irrevocable and included an offer to >
boynd by an arbitration decision undir FIFRA Section 3(c)(2)(B)(iii) if final agreemint on all terms could not bt reached otherwise. This offer was mar
to the following firm(s) on the following date(s):
NAME OF FIRM
However, none of those firm(i) ace
•Pted my offer.
DATE OF OFFER
4. My firm requests that EPA not suspend the registration (s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data lifted in paragraph (2) above in accordance with the Notice. 1 understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statemr
does not apply to applicants for new products.) 1 give EPA permission to disclose this statement upon request.
TYPIO NAME
SIGNATURE PATE
IPAFwm
-------
60
Appendix III-l
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
Registration
Guideline No.
5158.20
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, "or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
PH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRIDt
Submit-
ting
Data
(At-
tached)
(For EPA Use Onl\
Accession Numbers
Assigned
-------
61
Appendix III-l (continued)
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
S158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flantnability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral ID-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID*
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
62
APPENDIX IV -1
§ 162.10 Title 40—Protection of Environment
• 1C2.10
(a) General—U> Content* 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 at pre-
scribed in paragraph (b) of this sec-
tion;
(ii) The name and address of the
producer, registrant, or person for
-------
Appendix IV-1 (continued)
63
Chapter I—Environmental Protection Agency
§
whom produced as prescribed in pan-
graph of this section;
(Hi) The net contents as prescribed
in paragraph (d) of this section;
(lv) The product registration
number as prescribed in paragraph (e)
of this section;
(v) The producing establishment
number as prescribed in paragraph (f)
of this section;
(vi> An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion:
(vii) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section;
(vili) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classlfication(s) as pre-
scribed in paragraph (J) of this section.
(2) Prominence and legibility, (i) All
words, statements, graphic representa-
tions, designs or other information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
oonspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) La.ngv.ayf to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as is considered necessary to
protect the public. When additional
text in another language is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placement of Label-
-------
Appendix IV-1 (continued)
64
§ 162.10
(v) Any statement directly or Indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients U 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;
(vli) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser;
(vdii) I*bel disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous." "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (axexii) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(ii) Has not been approved by the
Administrator through registration or
Title 40—Protection of Environment
supplemental registration as an addi-
tional name pursuant to S 162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dress given on the label shall be con-
sidered as the name and address of the
pn-cucer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by • • V or "Sold by to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tent*. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68* F C20'C)
and shall be expressed in conventional
American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units. l.e.. "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above 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 nffutrntion 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
-------
Appendix IV-1 (continued)
65
Chapter I—Environmental Protection Agency
S 162.10
other print on that part of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.", of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients," or the singu-
lar forms of these terms when appro-
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(I) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
Ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment rr.ust run parallel with other
text on the panel on which it appears,
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name, if there is one, fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cK6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(S) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where it is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
tdatel."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
-------
Appendix IV-1 (continued)
66
§ 16X10
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement il he determines
that such ingredient(s) may pose a
hazard to man or the environment.
in) Warning and precautionary
ttatements Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
THU 40—Protection of Environment
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
In the table below:
Tone**
I
IV
Or* LD.
Dm* LD.
Up K> w«3 nckiltne SO
Up ID an)
lot/ft*
Up to and noMng W)
Fiorn SO tn> SOC ma/kg.
ftom 3 tmi 2 «B/*W
Ham tea twi 1000
From WO Wu SOOO me'
•w
Ftom 2 tvu 20 mg/IMr .
tram 2JOOO tt\j 20.000 .
ND
MOO mg'
GiMWr v»n 20 mgrMw
GTMW ran 20.000
*._ — ^§M^.M«
BStsn VlfSJCB .
72
ModwMt (MMon « 72
Mam
MHO e> (torn iniMon at
72 Xom
(i) Human hazard sipnal word—(A)
Tarictfv Category /. All pesticide prod-
ucts meeting the criteria of Tozicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition If the product was assigned to
Toxicity Category I on the basis of its
oral. Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
in red on a background of distinctly
contrasting color and the skull And
erossbones shall appear in Immediate
proximity to the word "poison."
(B) Toxicity Category II. All pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicitv Category III. All pestl-
dde products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicitv Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) U$e of tignal toords. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable advene effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(11) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution. market-
Ing, storage or use is demonstrated by
the applicant to be extremely remote.
or if the nature of the pesticide is such
that It is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(Ill) Statement of practical treat-
ment-4At Toxicitv Category I. A
statement of practical treatment (first
aid or other) shall appear on the front
panel of the label of all pesticides fall-
Ing into Toxicity Category I on the
-------
Appendix IV-1 (continued)
67
er I—Environmental Protection Agoncy
§ 162.10
basis of oral, inhalation or dermal tox-
icity. The Agency may, however,
permit reasonable variations In the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicitv categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXlKiiiHA) of
this section. The applicant may, how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
So* ot labal Irontpanal maquara
net**
5 and undar
AW-r * T '0
Atx?"* m *) iv
Abm** 15 to 30
Ow 30
POi
Raqmd
•gnu
vord. a*
CapttlS
6
10
12
14
11
r>U
"KMCOUt
O< raaef> 01
ChH»*n
e
•
B
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(i) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
routead (nhalad or
< tnroupf! Hun) Do not bnvttna vapor [dun or lpr«y
{ rmt) DC not gw ri cya*. on alun. or on dotting
[Front pen* MMflwm or practcal xatrnam ra-
(nough in* tfun] Do not braMht MOOT* [dun or
W»r "•»} Oo nol oM in >yM on Mun. or on
' donng [Apprepnu* *r»l me (BMnana raqwx) ]
Mwmfu) MnortKCI tnrouoh th«
j dun] AvoO bnMtfwig vtpon (duct or tpriy nwt]
| Avort contact «im Hun ivfit or eMhng) [Appro-
, pn»t» t»n aid M*t«n<*nt nnund 1
[No pr*c*utnnan/ cuMmnts raqund } ..........................
CorroaM. raiiaai aya «nd (km damaga [o> Mir
Do not gat in aya*. on Hun. or on
«Vaar gogglaa or lac* HMW and rubbar
OKKOT «h«n handhng HarmU or taul K inafciiiafl
(A«proprMU «ra) art ctaiamant ragurad 1
aiaii *r* t«nd cMnl mMon Do not gat *t arm.
on don. or on oMhng. Harmful * nttemtH lAp-
1
Avort contact w«n akin. «yaa or oMvng m OM ol
contact «nmad»t«ry ftuafi ayat or Hun M» planty ol
•Mar G*t niaoical MMnton il
(No)
ntt
(ii) JFnt-irorimenfa/ 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 clrcum-
-------
Appendix IV-1 (continued)
68
§ 162.10
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDH of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for put-
door use contains an active ingredient
with a fish acute LCH of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for put-
door use contains an active ingredient
with an avian acute oral LDM of 100
ing/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
TrM« 40—Protection of Environment
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(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
pesticide are required as follows:
DOKM W F. * ran • i Hoofttoe* w
•fty iMrWQ OpWIQ
Plo^ OOM OBOM 20* F oix) not OMt 80' F or If *•
01 « n Own n* Horn*
(B)NOMMV
M or boto* 70* F
g|int JO' F orM not o*or W F
MOM W F oral not DMT ISO* f
UMZtD COMTM
Eoromoly «on
*r« opo**
eonlpyior E
bwrnng
Ftomrubi* C
E*xwn 1C
Comontt untfi
temt Do
•niponA**
uumzeoCoin
EnvMiy loi
Oo not MM of
NCM
mow* Contonti undc onnwr* Koop o«oy tarn
•ntf fwMcd fe^covt Do tot puncsuw v concrete
«aom IP tomporetivot ODOM IX' F nwy eouot
«noms una* prnowt Koop oxoy *ro>r HMI
UmioiiMoi otiov* 130' F may cauM Dintntj
pr Brooom Do not UM of Mora noc Kooi or opon
not pwvtm of »m *rt. oporu ond hoMod
lOpomymrnhMt ond aeon Rom*
•or* nov Moot or opon oomt
(i) Direction* for V*e-<\) General
requirement*—
-------
Appendix IV-1 (continued)
69
Chapter I—Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes,
provided that:
(/) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the type(s) of products involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product involved and its
proper use in manufacturing process-
es;
(J) The product will not come into
the hands of the general public except
after incorporation into finished prod-
ucts: and
(4) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
U) The label clearly states that the
product is for use only by physicians
or veterinarians;
(2) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment; and
(J) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
(1) There is information readily
available to the formulators on the
composition, toxicity, methods of use,
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes;
(2) The label clearly states that the
product is intended for use only in
manufacturing, formulating, mixing,
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts involved:
The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered: and
«> The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Contents of Directions for Use.
The directions for use shall Include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.HXJ) immedi-
ately under the heading "Directions
for Use."
(11) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(ill) The site(s) of application, as for
example the crops, *ni™>iit areas, or
objects to be treated.
(iv) The target pest(s) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application, in-
cluding instructions for dilution, if re-
quired, and type Specific directions concerning
the storage and disposal of the pesti-
cide and its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing (See Table in i 162.1(KhMlXiv).)
-------
Appendix IV-1 (continued)
70
§1*2.1!
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(J) Statement of Vtc Classification.
By October 22. 1B76. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
In paragraphs (JX1) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards act forth in this sub-
section, and shall be marketed as sepa-
rate products with different registra-
tion numbers, one bearing directions
only for general use
-------
APPENDIX IV-2
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 Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gal Ion
statement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ihs.
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,
ironed lately
before or
following
Reg. No.
Imnediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
limed lately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
APPENDIX IV-2 (continued)
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
aniiials
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
PIACEMENT 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.
-------
APPENDIX TV-2 (continued)
ITEM
1C
ID
IE
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of.
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
eqory I based
on oral, der-
mal , or inhala-
tion toxic ity
All products
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel .
All products
All products
in Categories
I, II, and III
All products
PIACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others;
Grouped with
side panel
precaut ionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
APPENDIX IV-2 (continued)
ITEM
RC
9A
9C
10A
IOC
10D
IABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PIACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-------
APPENDIX IV-2 (continued)
ITEM
RC
9A
9C
10A
IOC
10D
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
All
cholinesterase
inhibitors
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Must be set apart and clearly distin-
guishable from from other directions
for use.
May be in metric as well as U.S. units
-------
76
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B,
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Required Label Statement
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame.
None required.
-------
77
Appendix IV-4
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Above 10 to 15
Above 15 to 30
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
-------
78
Appendix IV-4
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement, "Do not contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control
Agency, or the Hazardous Waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
79
Appendix IV-4
(cont inued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
3. Products intended for domestic use only must bear the
following disposal statement: "Securely wrap original
container in several layers of newspaper and discard in
trash."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type
Statement
Non-aerosol products
(bottles, cans,_jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.'
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
-------
Appendix IV-4
(continued}
2. The labels for all other products must bear container dispo?
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
reused^, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke .
Return empty cylinder for reuse (or
similar wording)
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-------
O 1
Appendix IV-4
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (f)
when discarded.
•Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts); ~~
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aininopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
Dimethoate
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Faraphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octatnethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
82
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylroercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate '
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
-------
83
Appendix IV-4
(continued)
•Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrole
Benzene
Bis (2-e thy IhexyDptha late
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochlori.de
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3 ,4-metheno-2H-cyclobutaIc,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-DiChlorobenzene
p-DiChlorobenzene
Dichlorodifluoromethane (Freon 12*)
3,5-Dichloro-N-(1,1-dimethy1-2-propynyl) benzaroide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2r4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
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84
Appendix IV-4
(continued)
'Toxic* Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2f2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1,2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene ^
Trichloromonofluoromethane (Freon 11 )
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
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85
Appendix IV-4
(continued)
'Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;'
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
(Freon
12*)
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 1
Vinyl chloride
Xylene
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