United SIMM
4>EPA
Agency
Offlcaof
PMicidM and
Washington OC 20460
December 1986
Guidance for the
Reregistration of
Pesticide Products
Containing
Potassium permanganate
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
POTASSIUM PERMANGANATE
AS THE ACTIVE INGREDIENT
CASE NUMBER 0220
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
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TABLE OF CONTENTS
Page
Introduction 1
I. Regulatory Assessment 4
II. Requirement for Submission of Generic Data 37
III. Requirement for Submission of Product-Specific
Data 40
IV. Submission of Revised Labeling 40
A. Label Contents 41
B. Collateral Information 46
V. Instructions for Submission 47
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APPENDICES
Page
II-l Guide to Bibliography 50
II-2 Bibliography 52
II-3 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 53
II-4 Certification of Attempt to Enter Into an Agreement
with Other Registrants for Development of Data
EPA Form 8580-2 54
III-l Product Specific Data Report (End-Use Products) . . 55
IV-1 40 CFR 162.10 Labeling Requirements 57
IV-2 Table of Labeling Requirements 66
IV-3 Physical/Chemical Hazards Labeling Statement. ... 69
IV-4 Storage and Disposal Instructions 70
ii
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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 formulator1s 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 time frames 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 tactual information raising concerns ot 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.
*The formulator's exemption applies to a registrant of an
product if the source of his active ingredient(s): (1) is a
registered product and (2) is purchased from a source which
does not have ownership in common with the registrant's
firm.
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"PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Docume nt.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvemen
Program and special intent
to cancel notices.
* End use products of registrants who also produce a manufacturing
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing use product(s). Such end use products
will be subject to the labeling changes required for products in "II"
above. If there are no manufacturing use products registered by any
company end use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet the requirements :
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.
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REGULATORY ASSESSMENT
A. INTRODUCTION
This registration standard describes the regulatory
position and rationale of the Environmental Protection
Agency ("The Agency") based upon an evaluation of the
registered products which contain potassium permanganate
and their uses. It should be noted that there is no
registered manufacturing use product (MUP) for this
chemical; potassium permanganate, however, is commercially
available in several grades from domestic and foreign com-
panies. This standard addresses end-use products containing
potassium permanganate and manufacturing-use products (in
the event a prospective registrant wishes to register
potassium permanganate as an MUP).
Future requests for registration of substantially
similar products will be covered by this standard.
Dissimilar products must be evaluated In order to be
registered. If new products are proposed with disimilar
use patterns, formulation type, precautionary statments,
etc., 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 Halts, 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 of
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/rationale
section of this standard.
B. DESCRIPTION OF THE CHEMICAL
Potassium permanganate (KMn04> Is the potassium salt
of permanganic acid. A "common name" has not been established
by the American National Standards Institute, Inc. (ANSI)
or other official organizations concerned with the nomenclature
of pesticides. Therefore the chemical will be referred to
by its chemical name, "potassium permanganate". The Chemical
Abstract Service Registry Number (CAS) is 7722-64-7 and the
Agency's Chemical Code Number is 068501.
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Potassium permanganate in its pure form is a
crystalline dark purple granular material. Potassium
permanganate is thermally unstable. When heated, it
begins to decompose with the evolution of oxygen at ca
240°C. Potassium permanganate is decomposed by organic
solvents (e.g., alcohols) and reducing substances (e.g.,
iodate, oxalate, and ferrous salts), especially under
acidic conditions. In water, potassium permanganate is
very soluble (i.e., 6.38 gm/100ml at 20°C and 25 gin/100ml
at 65°C).
Potassium permanganate is an oxidant disinfectant
which is effective against a broad spectrum of microorganisms.
It is registered as a bactericidal, fungicidal, and algaecidal
agent in coaling towers, evaporation condensers, air wash
systems, ornamental ponds, fountains, and aquaria. Other
uses include treatment of potable and poultry drinking water;
and disinfection and sanitization of equipment in dairies
and food processing plants (see the "EPA Pesticide Index"
for a description of all uses).
There are twenty one registered products containing
potassium permanganate, four of which are intrastate
registrations. This standard applies to all those products
in which potassium permanganate is the single active ingre-
dient. Potassium permanganate is registered as the single
active Ingredient in eight products, and in combination with
other active ingredients in nine products. The multiple
active ingredient products include one or more of the follow-
ing ingredients: sodium hypochlorite, sodium carbonate,
and/or sodium phosphate; the standard does not apply to these
products.
C. REGULATORY POSITION AND RATIONALE
Based on a review and evaluation of all available data
submitted to EPA and other relevant information on potassium
permanganate, the Agency has made the following determinations:
1. Based on available data, the Agency is declaring
Potassium Permanganate as an inert ingredient at
concentrations of 1.0% or less and in combination
with an active ingredient (including sodium hypo-
chlorite, sodium carbonate and sodium phosphate).
Rationale; DataJ^/ available to the Agency indicate
that potassium permanganate at concentrations of
1.0% or less does not have any antimicrobial
y Smith, M.K.: "Qualitative Use Assessment (QUA) for
Potassium Permanganate (068501) as a Bactericidal
Agent." Science Support Branch, Benefits and Use
Division (EPA/OPP), November, 1984.
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activity. The potassium permanganate present in
the multiple ingredient products cited in this
standard functions simply as a color indicator,
imparting a pink color to the use solution; once
the solution becomes colorless it should be discarded.
When diluted as recommended, the sodium hypochlorite
present in these products provides "available chlorine'
in the form of hypochlorous acid at concentrations
ranging between 50-200 ppm. The available chlorine
is the antimicrobial agent responsible for bacteri-
cidal activity in these products.
Hence, registrants with multiple active ingredient
registrations described above must submit amendments
and revised labels removing potassium permanganate
as an active ingredient from their label ingredient
statement no later than 6 months from the issuance
date of this standard, or their products may be
subject to enforcement action . When these regis-
trations have been amended, these products will no
longer be subject to this standard. However, they
wil.l be subject to a standard dealing with the
active ingredient as listed on the revised label.
Alternatively, those registrants who select to retain
1% or less potassium permanganate as an active
ingredient In the ingredient statements must submit
documentation of efficacy at the claimed concentra-
tion using potassium permanganate alone. Products
documenting and listing potassium permanganate as
as active Ingredient will be subject to this stand-
ard. If they fail to convince the Agency of the
efficacy of potassium permanganate in their product,
they must amend their registration to remove potas-
sium permanganate from their label ingredient
statement as an active ingredient, or face possible
enforcement action.
One of the registered uses of potassium permanganate
includes use in poultry drinking water as a sanitizer
(Reg. No. 5587-49). This use would be expected to
cause minute residues of manganese (in a combined
form) in poultry and eggs. Under the Federal
Food, Drug and Cosmetic Act (FFDCA), a tolerance or
an exemption from the requirement of a tolerance
is required for such residues in poultry and eggs.
The Agency is requiring that the registrant peti-
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tioQ Che Agency for an exemption from Che require-
ment of a tolerance.
Rationale; Manganese has been demonstrated to be
an essential trace element In animals and man.
In the Agency's view, exemption from the requirement
of a tolerance for residues of manganese in poultry
and eggs, resulting from the registered use of
potassium permanganate as a sanitizer in poultry
drinking water, would be appropriate for the reasons
noted herein. Naturally occurring manganese is
usually in the +2, +3 or +4 valence state. Because
of the reactivity of permanganate ion, any resulting
residues of manganese in poultry or eggs would
involve lower (naturally occurring) valence states.
The poultry drinking water sanitizer provides 2.8
to 5.5 ppm permanganate ion when diluted. This
use essentially doubles the daily intake of manganese
by the chicken (estimated 0.08 0.1 mg/day).
Because of excretion and little uptake of manganese
from the gut, very little manganese is expected to
be retained by the chicken; and since the average
person in this country currently ingests 2.3 to
3.8 mg of manganese daily, the additional amount
resulting from this use would be minute, and not a
matter of concern.
3. There are two potassium permanganate products
registered for use in treating human drinking
water (Reg. No. 8429-6, 8429-7). The Agency has
determined that such potassium permanganate products
must bear labeling directions which would limit the
residues of manganese in the finished potable
water to not more than 0.05 mg/1.
Rationale; The level of 0.05 mg/1 has been estab-
lished in the National Secondary Drinking Water
Regulations as the recommended level for manganese
in drinking water. Consistent with that regulation,
the Agency is requiring the labels of potassium perman-
ganate products for potable water treatment to limit
residues of manganese in the finished potable water
to not more than 0.05 mg/1 (equivalent Co ca 0.23
ppm potassium permanganaCe).
4. Technical potassium permanganate and manufacturing-
use products containing potassium permanganate are
being placed in Toxiclty Category I on the basis of
eye and dermal corrosivity. They are subject to
Toxicity Category I precautionary labeling.
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Rationale; In Che case of potassium permanganate,
the technical and manufacturing-use products are
identical (i.e., at least 99.SZ KMn04>. Sufficient
data are available to show that technical potassium
permanganate is corrosive to the eye and skin. In
an eye irritation study using rabbits, 10 mg was
applied to each eye, and after 168 hours, all the
rabbits showed the maximum possible ocular score.
In a primary dermal irritation study, 0.5 gram
samples (moistened) were placed in contact with the
rabbit's skin for 24 hours. After 24 hours, destruc-
tion of the skin was observed, with ulcerations
into the peritoneal cavity. The damage was accom-
panied by hemorrhage. Due to the ocular and dermal
reactions, potassium permanganate is placed in
Toxicity Category I. The precautionary label
language which accompanies Toxicity Category I
(§162.10 of 40 CFR) therefore applies to these pro-
ducts for these routes of exposure.
The available toxicology data adequately define the
acute toxicity of the compound. Based on considera-
tions regarding the chemical reactivity of the
permanganate ion and the ubiquity of manganese,
there are no chronic or subchronlc coxicity data
requirements. However, to support each end-use
product, each registrant must submit or cite valid
acute toxicity data for each formulation.
Rationale; Sufficient data are available to show
that technical potassium permanganate is corrosive
to the eye and skin, and subject to Toxicity
Category I and its accompanying precautionary
labeling. The Agency also has data to satisfy the
requirements for acute oral toxicity of the technical
compound. As none of the compound's currently
registered uses would result in any significant
inhalation exposure, an acute inhalation toxicity
study is not required. Finally, since potassium
permanganate is not an organophosphate and does
not inhibit cholinesterase, a delayed neurotoxicity
study is not required. Thus, additional acute
toxicology studies are not required for the technical
grade of potassium permanganate.
Human and animal exposure to or contact with potassium
permanganate results in reduction of the permanganate
ion to the lower (naturally occurring) valence
states. As natural manganese in these lower valence
states is ubiquitous and dietary exposure to manganese
residues resulting from use of products with potassium
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permanganate is not a matter of concern, chronic
and subchronic toxicity studies are not necessary
or appropriate for potassium permanganate based
upon the manganese residues from products containing
potassium permanganate.
Before the Agency will register or reregister end-use
products (EPs) containing potassium permanganate,
registrants must submit or cite acute toxicity data
(oral, dermal skin irritation and eye irritation)
specific to the particular EPs. This is required
to establish the acute toxicity categories for those
potential routes of exposure, and thus enable the
Agency to prescribe appropriate precautionary state-
ments in accordance with Section 162.10 of 40 CFR.
6. Data on the environmental fate of potassium
permanganate are being required as outlined in the
data tables.
Rationale; No data are available to assess the
environmental fate of potassium permanganate.
When the required data are submitted, the behavior
of the chemical in the environment will be assessed.
Further regulatory requirements may be indicated
based on that review.
7. The wildlife and aquatic organisms data requirements
are only partially fulfilled. Hence, the Agency
could not fully assess the toxicity of potassium
permanganate to nontarget organisms. When the
additional data outlined in the data tables are
submitted, a full assessment will be made.
Rationale; The only available wildlife studies show
that the technical grade of potassium permanganate
is moderately toxic to warmwater fish species.
Additional studies are required to establish the
toxicity to avian species (LC5o's), and the toxicity
to a cold water fish and fresh water invertebrates
(LC5o's). If the required cold water fish LCso value
is less than 1 ppm, all labeling will be changed to
include the statement "This Pesticide is Toxic to
Fish".
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8. There is a possibility of contamination of groundwater
by potassium permanganate. The data currently
available to the Agency do not adequately charac-
terize this potential.
Rationale: Because of the nature of some uses of
potassium permanganate (i.e., water treatment com-
pound; see Pesticide Index for uses) groundwater
contamination may be possible. The submission of
the required environmental fate data for the tech-
nical grade of the active ingredient will enable
the Agency to more fully address this issue.
9. Potassium permanganate is not being classified for
Restricted Use.
Rationale; 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 potassium permanganate
specified in this standard to warrant restriction
of these uses.
10. EP's containing potassium permanganate may be
registered for sale, distribution and use, subject
to the terms and conditions specified in this
standard.
Rationale; Under FIFRA, the Agency normally does
not cancel or withhold registration because data
are missing or inadequate (for example, see Section
3(c)(2)(B) and 3(c)(7) of FIFRA). Issuance of this
standard provides a mechanism for identifying data
needs for registration under the standard and time
frames for generating the data. Labeling modifica-
tions are also required within a specified time.
These data will be reviewed and evaluated when they
are received and the Agency will determine at that
time if they will affect the registration of potas-
sium permanganate.
D. CRITERIA FOR REGISTRATION UNDER THIS STANDARD
Manufacturing use and end use products which are subject
to this standard, must meet the following conditions along
with the others noted in this standard:
1. Contain potassium permanganate as the sole active
ingredient, and
2. Bear required labeling as set forth in the Required
Labeling section of this standard.
3. Conform to the acute toxlcity limits, product
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composition, and use pattern requirements listed
in the Acceptable Ranges and Limits section of
this document*
The applicant for registration or reregistration of
products subject to this standard must comply with all
terms and conditions described in it, including a commitment
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 and information
within the time specified.
E. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
End-use products proposed for registration under
this standard must be substantially similar to
the formulations approved for potassium perman-
ganate. A product will be considered substan-
tially similar to a registered product if it
contains the same active Ingredients at approxi-
mately the same concentrations. End-use for-
mulations must contain potassium permanganate as
the sole active Ingredient in the following
percentages:
a. Pelleted/Tableted EPs must contain at least
40 percent potassium permanganate.
b. Liquid EPs must contain at least 1.2 percent
potassium permanganate.
c. Powder EPs must contain at least 41 percent
potassium permanganate.
d. Crystalline EPs must contain at least 95.00
percent potassium permanganate.
Applicants who wish to register an end-use pro-
duct differing In composition from those stated
above, must satisfy whatever additional data
requirements apply to such modifications. If
such products are registered, the Agency will
amend the standard to Include such products.
Each EP formulation proposed for registration
must be fully described with an appropriate
certification of limits, stating maximum and
minimum amounts of the active ingredient which
may be present in products.
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2. Acute Toxicity Limits
The Agency will consider for registration MUPs
and EPs provided the product is supported by
toxicity data and the labeling for the product
bears appropriate precautionary statements,
consistent with the acute toxicity categories
under Section 162.10 of 40 CFR.
3. Use Patterns
To be registered under this standard, EPs con-
taining potassium permanganate may be labeled
for use as a bactericidal, fungicidal and
algaecidal agent in cooling towers, evaporative
condensers, air wash systems and ornamental
ponds, fountains, aquaria, and potable and
poultry drinking water, as applicable.
F. REQUIRED LABELING
Although there are no registered MUPs of potassium
permanganate, any future MUP registrations and all EPs
must bear appropriate labeling as specified in 40 CFR
162.10, in addition to the following specific labeling
requirements.
1. 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.
2. Precautionary Statements
a. All end-use products intended for uses
where there is likelihood for point source
discharge (i.e., cooling towers, ornamental
ponds, fountains, and potable and poultry
drinking water) must bear the following state-
ment:
"Do not discharge effluent containing this
product into lakes, ponds, streams, estuaries,
oceans or public water unless this product is
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specifically identified and addressed in an NPDES
permit. Do not discharge effluent containing
this product into sewer systems without previously
notifying the sewage treatment plant authority.
For guidance contact your State Water Board or
Regional Office of the EPA."
The statement "This Pesticide is Toxic to Fish-
is not required at this time. The toxic to fish
statement is only required on labeling when the
fish acute LCso value is 1 ppm or less. Potassium
permanganate's LCso value for warm water fish
species is 2.3 to 3.6 ppm. If the required cold
water fish LC5Q value is Ippm or less, all labeling
will be changed to include the "toxic to fish"
statement.
b. All end-use products Intended for uses
where there is likelihood for point source
discharge (i.e., cooling towers, ornamental
ponds, fountains, and potable and poultry
drinking water) must bear the statement:
"Do not contaminate water by cleaning of equip-
ment of disposal of waste."
c. All future MUPs must bear the statement:
"Corrosive to eyes and skin" and the signal
word "DANGER".
3. Use Directions
There are two potassium permanganate products
registered for use in treating human drinking
water (Reg. No. 8429-6, 8429-7). The Agency has
determined that such potassium permanganate pro-
ducts must bear approved labeling directions which
would limit the residues of manganese in the finish-
ed potable water to not more than 0.05 mg/1.
G. TOLERANCE REASSESSMENT
Under the Federal Food, Drug and Cosmetic Act (FFDCA),
a tolerance or an exemption from the requirement of a
tolerance is required for the residues of manganese in
poultry and eggs (which result from the poultry drinking
water use pattern). The Agency is requesting that the
registrant petition the Agency for an exemption from the
requirement of a tolerance (see Regulatory Position and
Rationale No. 2).
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(!•*)
EPA Index Co Pesticide Chemicals
a068501 POTASSIUM PERMANGANATE
TYPE PESTICIDE: Antimicrobial, Algaecide, Fungicide and Insecticide
FORMULATIONS;
PTT(40%, 80%)
Cr (95.64%, 98%)
SC/S (41%)
RTU (1.2%, 2.5%)
PRESENTATION OF INFORMATION: Whenever possible, final concentrations are
expressed in parts per million or ounces total active ingredient(s). Con-
centrations 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.
GENERAL WARNINGS AND LIMITATIONS; Potassium permanganate causes severe
burns of eyes, skin and mucous membranes. Contact with
combustible material may cause fire or explosion.
This product is toxic to fish. Do not discharge into lakes, streams, ponds
or public waters unless in accordance with an NPDES Permit. Strong oxidiz-
ing agent. Mix only with water. Use clean, dry utensils. Contamination
with moisture, organic matter, or other chemicals may start a chemical re-
action, with generation of heat, liberation of hazardous gases, and possi-
ble generation of fire and explosion.
Apply only as specified on the label and technical data sheets.
Read label very carefully for specific warnings, human toxicity statements
and environmental causes.
Follow label directions for the disposal of the product container when
empty.
Definition of Terms;
gal - gallon
tsp - teaspoon
oz - ounce
mg - milligram
fl.oz - fluid ounce
a.i. - active ingredient
Issued: 12-03-84 V. 1-068501-1
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Site, Efficacy,
Dosage and Formulaeion
AQUATIC NON-FOOD
(Aquatic Sites)
/65018MA Air Washer Water
Systems
(15)
EPA Index to Pesticide Chemicals
Use Directions
General Instructions for Use: The products regis-
tered for this site are intended to control the
growth of slime-forming bacteria, fungi and algae.
Badly fouled systems must be cleaned by any suit-
able means before treatment is begun. Make appli-
cation at a point in the system where the chemical
will be uniformly mixed.
Purple color of water indicates chemical activity
and should last at least 20 minutes. Add more
chemical if color disappears within 20 to 30 min-
utes after first treatment.
A28 Microbicide/microbistat
DBABAAA Slime-forming bacteria
FYAFQBB Slime-forming fungi
PKAAAAA Algae
54 ppm (3.6 oz of
a.i. per 500 gal
of water)
(80% P/T)
27 ppm (3.6 oz of
a.i. per 1,000
gal of water
(80% P/T)
Initial treatment.
Water treatment. Shock treatment. Close bleed-off
valve and drop briquette into pan near intake. Af-
ter treatment drain sump and remove dead algae from
slats and sump. Flush and refill with clean water.
Subsequent treatment.
Water treatment. Maintenance application. Close
bleed-off valve and drop briquette into pan near
intake. After treatment drain sump and remove dead
algae from slats and sump. Flush and refill with
clean water.
Issued: 12-03-84
V. 1-068501-2
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/65023MA
Site, Efficacy,
Dosage and Formulation
Aquaria Water Ponds
(Ornamental Fish
Ponds)
(16)
EPA Index Co Pesticide Chemicals
Use Directions
PKAAAAA
Algae
1 tsp of product
per 1 fl.oz of
water
(41Z SC/S)
4 ppm (1 tsp of
product per 4 gal
of water)
(1.2% RTU)
/65019MA
Commercial and Indus-
trial Water Cooling
Towers and Evapora-
tive Condensers
General Instructions for Use: The products regis-
tered for this site are intended to be used as al-
gaecides.
Add product as directed by label.
Water treatment. Algae control. For goldfish, add
4 to 5 drops per gallon. For tropical fish, add
up to 2 drops per gallon. For bait minnows, add 3
drops per gallon.
Water treatment.
weeks.
Algae control. Apply every 2
General Instructions for Use: The products regis-
tered for this site are intended to control the
growth of slime-forming bacteria, fungi and algae
which impair the efficiency of the system. Methods
of application may be slug feed treatment, inter-
mittent feed treatment, or continuous feed treat-
ment.
Slug feed treatment. Treatment that involves addi-
tion of a specified dose to the system at 1 time.
Treatment may be repeated at intervals, usually
once a day or less frequently.
Intermittent feed treatment. Treatment that is on
a semi-continuous basis. Provides a continuous
dosage over a brief period and is repeated at
stated intervals.
Continuous feed treatment. Treatment that is on
an uninterrupted basis to provide a sustained con-
centration. Usually an initial slug dose is used
to establish control prior to continuous treatment.
When algal or microbial growth is noticed, an ini-
tial high concentration dosage is used and repeated
until control is achieved. When control is evi-
dent, a subsequent dosage of lower concentration
Issued: 12-03-84
V.1-068501-3
-------
Site, Efficacy.
Dosage and Formulation
(17)
EPA Index Co Pescicide Chemicals
Use Directions
Commercial and Industrial Water Cooling Towers and Evaporative Condensers
(continued) "~~~~
is used Co maintain control. Should algae or slime
become visible again, the initial slug dose should
be used, followed by Che maintenance procedure.
Purple color of water indicates chemical activity
and should last at least 20 minutes. Add more
chemical if color disappears within 20 to 30 min-
utes after first treatment.
A28 Microbicide/microbistat
DBABAAA Slime-forming bacteria
FYAFQBB Slime-forming fungi
PKAAAAA Algae
54 ppm (3.6 oz of
a.i. per 500 gal
of water)
(80% P/T)
62 ppm (2.5 gal of
product per 1,000
gal of water)
(2.5% RTU)
27 ppm (3.6 oz of
a.i. per 1,000
gal of water)
(80% P/T)
Initial treatment.
Water treatment. Shock treatment. Close bleed-off
valve and drop briquette into pan near intake. Af-
ter treatment drain sump and remove dead algae from
slats and sump. Flush and refill with clean water.
Water treatment. Shock treatment. Close bleed-off
valve and apply product directly into cooling ba-
sin. Watch for clogging in the circulation. When
algae is loosened and Che purple color disappears,
drain sump, remove debris and dead algae from slats
and sump. Flush and refill wich clean water.
Subsequent treatment.
Water treatment. Maintenance application. Close
bleed-off valve and drop briquette into pan near
intake. After treatment drain sump and remove dead
algae from slats and sump. Flush and refill with
clean water.
31 ppm (1.25 gal of Water treatment. Maintenance application. Initi-
product per 1,000 ate after shock treatment and repeat every 2 weeks
gal of water) or less if algae reappears.
(2.5% RTU)
Issued: 12-03-84
V.1-068501-4
-------
Sice, Efficacy.
Dosage and Formulation
/65015MA Human Drinking Water
(18)
EPA Index to Pesticide Chemicals
Use Directions
General Instructions for Use: The products in this
section are registered as algaecides for treatment
of municipal human drinking water systems (i.e.,
water supplies and components of the system).
PKAAAAA
Algae
4.4-4.5 ppm (1.1 Algae control. Product should be applied as early
mg of product per as possible in the treatment process. Application
gal of water) to the raw water intake should be applied contin-
OS. 642, 98% Cr) uously.
/65009MA
/65009HC
Poultry Drinking Water
A23
Sanitizer
272-543 ppm (0.648
to 1.296 grains
of product per
quart of water)
(40% P/T)
General Instructions for Use; The product in this
section is registered for sanitization of poultry
drinking water. Regular treatment of water helps
reduce contamination by pathogenic microorganisms
and slime-forming microorganisms.
Apply product only as specified on the label and
technical data sheet.
Sanitization of poultry water.
Issued: 12-03-84
V.1-06850L-5
-------
Site, Efficacy.
Dosage and Formulation
INDOOR
(Pets and Domestic Animals)
(Animals and Their Man-Made Premises)
(19)
EPA Index to Pesticide Chemicals
Use Directions
/540301A
Fish (Pets)
IIEAABA
IIAAABA
Anchorworms
Fishlice
1 tsp of product
per 1 fl.oz of
water (2-5 drops
per gal aquarium
of pond water)
(41% SC/S)
General Instructions for Use; The product regis-
tered in this site is intended to control crusta-
ceans.
Add product as directed by label.
Animal treatment. For goldfish, add 4 to 5 drops
per gallon. For tropical fish, add up to 2 drops
per gallon. For bait minnows, add 3 drops per
gallon.
Issued: 12-03-84
V.1-068501-6
-------
(20)
EPA Index Co Pesticide Chemicals
Listing of Registered Pesticide Products by Formulation
&040.0005 40% pelleted/tableted
potassium permanganate (068S01) 40.0%
005887-00001
&080.0005 80% pelleted/tableted
potassium permanganate (068501) 80.0%
009640-00037
&095.6408 95.64% crystalline
potassium permanganate (068501) 95.64%
008429-00007
&098.0008 98% crystalline
potassium permanganate (068501) 98.0%
008429-00006
&041.0015 41% soluble concentrate/solid
potassium permanganate (068501) 41.0%
008057-00001
&201.2016 1.2% liquid-ready to use
potassium permanganate (068501) 1.2%
008220-00001
&202.5016 2.5% liquid-ready to use
potassium permanganate (068501) 2.5%
001769-00191 010827-00062
9999999 State Label Registrations
AZ Reg. No.
037804-08405
CA Reg. No.
011012-06314
FL Reg. No.
036218-06323
MD Reg. No.
037916-09534
Issued: 12-03-84
V.1-068501-7
-------
/650L8MA
/65023MA
/650L9MA
/65015MA
/65009MA
/65009HC
(21)
EPA Index Co Pescicide Chemicals
Appendix B
Listing of Registration Numbers by Site and Formulations
AQUATIC SON-FOOD
(Aquatic Sites)
Air Washer Water Systems
(80% P/T)
009640-00037
Aquaria Water Ponds (Ornamental Fish Ponds)
(412 SC/S)
008057-00001
(1.2% RTU)
008220-00001
Commercial and Industrial Water Cooling Towers and Evaporative Condensers
(80% P/T)
009640-00037
(2.5% RTU)
001769-00191 010827-00062
Human Drinking Water
(95.642 Cr)
008429-00007
(98% Cr)
008429-00006
Poultry Drinking Water
(40% P/T)
005887-00001
INDOOR
(Pets and Domestic Animals)
(Animals and Their Man-Made Premises)
/54030IA Fish (Pets)
(41% SC/S)
008057-00001
Issued: 12-03-84
V.1-068501-8
-------
Keg. No.
402-65
875-41
875-62
1269-47
1270-70
5362-9
5736-37
9594-5
10183-6
EPA Index co Pesticide Chemicals
Auxiliary Documentation
% Potassium Permanganate Comments
0.01Z
0.01Z
0.004Z
0.01Z
0.01Z
0.01Z
0.015Z
0.01Z
0.01Z
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
percent too low to
be effective
Labe1 Improvement.
The words "organic matter" (occurring on label numbers 1769-191, 9640-37
and 10827-62) were interpreted to mean "slime-forming fungi and slime-
forming bacteria".
Issued: 12-03-84
V.l-068501-a
-------
(23)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
Guideline Citation and
Name of Test
§158.120 Product Chemistry
Product Identity:
Test
Substance
61-1 - Product Identity and Disclosure TGAI
of Ingredients
61-2 - Description of Beginning Materials TGAI
and Manufacturing Process
61-3 - Discussion of Formation of TGAI
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
TGAI
TGAI
TGAI
TGAI
TGAI
Guidelines
Status
R
R
R
CR
R
R
R
R
R
Are Data
Required
Yes
[xj
n
D
[x]
M
[x]
M
(-j
Footnote
Number
No
n 2
D 2.3
[x]
IxJ 3
I")
[x]
n
[x]
IxJ
Data Must Be
Submitted Within
Time Frames Listed
Below I/
6 months
6 Months
6 Months
6 Months
-------
(24)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
Guideline Citation and
Name of Test
Test Guidelines
Substance Status
Are Data
Required
Yes No
Footnote
Number
Data must Be
Submitted Within
Time Frames Listed
Below I/
§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
fxl
Q
Q
[J
o
[x]
[J
['I
o
[x]
Ixl
[x]
[x]
Q
[x]
(*]
6 Months
6 Months
TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient; R = Required; CR = Conditionally Required
I/ Data must be submitted within 6 months after the date the Guidance Document is issued (i.e., June 30, 1986).
2/ A discussion of the formation of impurities in the commercially available technical grades of potassium perman-
~ ganate is not required. However, for the technical grade of potassium permanganate (TGAI) used in his product,
the registrant of an end-use product is required to submit detailed composition data which is available to him
from his supplier. This data should include information on the heavy metal impurities, if any, in the TGAI.
The registrant is required to submit generic data for the indicated physical/chemical characteristics.
-------
(25)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
158.120 Product Chemistry (Continued)
J}/ Potassium permanganate Is readily available commercially in several grades for various industrial uses.
~~ This data is not required for a technical grade or manufacturing use product not registered for pestlcidal use.
-------
(26)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
Data Requirement Coi
\J Use 2J
nposition Pattern
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
Must Additional Data
Be Submitted Under
PIFRA § 3(c)(2)(B)?
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-4
81-5
81-7
- Acute Oral Toxlclty - Rat
- Acute Dermal Toxic! ty
- Rabbit
- Acute Inhalation Toxlclty
- Eye Irritation -
Rabbit
- Dermal Irritation -
Rabbit
- Delayed
Neurotoxlcity
TGAI D
TGAI D
TGAI
TGAI D
TGAI D
TGAI
Yes 00100362
Yes 00100362
N/A
Yes 00100362
Yes 00100362
N/A
No
No
-
No
No
-
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding
- 21 -Day Dermal
- 90 -Day Dermal
- 90-Day Inhalation
- 90-Day Neurotoxiclty
TGAI
TGAI
TGAI
TGAI
TGAI
N/A3/
N/A3/
N/A3/
N/A3/
N/A3/
-
-
-
-
_
-------
(27)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
i/ Use 21
Data Requirement Composition Pattern
§158.135 Toxicology - Continued
CHRONIC TESTING:
83-1 - Chronic Toxicity TGAI
83-2 - Oncogenicity TGAI
83-3 - Teratogeniclty TGAI
83-4 - Reproduction TGAI
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
84-2 - Structural Chromosomal TGAI
Aberration
84-4 - Other Genotoxic Effects TGAI
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA
85-2 - Dermal Penetration Choice
86-1 - Domestic Animal Choice
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? (Yes, No Citation
or Partially)
N/A3/
N/A^/
N/A3/
N/A3/
N/A3/
N/A_3_/
N/A3/
N/A3/
N/A3/
N/A3/
-------
(28)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
§158.135 Toxicology - Continued
\J Composition: TGAI = Technical Grade Active Ingredient; PAI = Pure active Ingredient; PAIRA » Pure active ingredient,
radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis.
21 The use patterns are coded as follows: A<*Terrestrial, Food Crop; B=Terrest rial, Non-Food; C=Aqautlc, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
_3/ Human and animal exposure to or contact with potassium permanganate results in reduction of the permanganate Ion
to the lower (naturally occurring) valence states. As natural manganese in these lower valence states Is ubiquitous,
and dietary exposure to manganese residues resulting from use of products with potassium permanganate is not a matter
of concern, chronic and subchronic toxicity studies are not necessary or appropriate for potassium permanganate based
upon the manganese residues from products containing potassium permanganate.
-------
(29)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
y Use 2/
Data Requirement Composition Pattern
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Acute Avian Oral Toxicity TGAI D
71-2 - Avian Subacute Dietary TGAI D^/
Toxicity
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
71-5 - Simulated Field Testing TEP
AQUATIC ORGANISM TESTING
Does EPA Have
Data To Satisfy
This Require- Bibliographic
ment? (Yes, No Citation
or Partially)
No
No
N/A
N/A
N/A
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission 3/
Yes 9 Months
Yes 9 Month
72-1 - Freshwater Fish Toxicity TGAI
- Coldwater Fish Species,
and
- Warmwater Fish Species
72-2 - Acute Toxicity to TGAI
Freshwater Invertebrates
D
D
No
Yes
No
GS0220-001
GS0220-002, GS0220-003
Yes
No
Yes
9 Month
9 Month
-------
(30)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
I/ Use y This Require- Bibliographic FIFRA § 3(c)(2)(B)?
Data Requirement Composition Pattern ment? (Yes, No Citation Time Frame for Data
^__ or Partially) Submission V
S158.145 Wildlife and
Aquatic Organisms - Continued
72-4 - Fish Early Life Stage, TGAI - N/A
and
- Aquatic Invertebrate
Life-Cycle
72-5 - Fish - Life-Cycle TGAI N/A -
72-6 - Aquatic Organism TGAI, PAI OR N/A -
Accumulation Degradation
Product
72-7 - Simulated Field Testing/ TEP N/A -
Actual Field Testing
[[[
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
y The use patterns are ceded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C= Aquatic, Food Crop;
~ n=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
-------
(31)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
I/
Data Requirement
Composition
Use 2/
Pattern
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(c)(2)(B)?
Time Frame for Data
Submission •*/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradatlon
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
TGAI or PAIRA C,D
TGAI or PAIRA C.D
TGAI or PAIRA _
TGAI or PAIRA _
TGAI or PAIRA
TGAI or PAIRA
162-3 - Anaerobic Aquatic TGAI or PAIRA C,D
162-4 - Aerobic Aquatic TGAI or PAIRA C,D
MOBILITY STUDIES:
TGAI or PAIRA C,D
163-1 - Leaching and
Adsorption/Desorption
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
No
No
No
No
No
Yes
Yes
9 Months
9 Months
Yes 27 Months
Yes 27 Months
Yes*/ 12 Month
-------
(32)
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
Data Requirement
\_l Use 2J
Composition Pattern
Does EPA Have Must Additional Data
Data To Satisfy Be Submitted Under
This Require- Bibliographic FIFRA § 3(c)(2)(B)?
ment? (Yes, No Citation Time Frame for Data
or Partially) Submission 3/
§158.130 Environmental Fate - Continued
DISSIPATION STUDIES-FIELD:
164-1 -
164-2 -
164-3 -
164-4 -
164-5 -
Soil
Aquatic (Sediment)
Forestry
Combination and
Tank Mixes
Soil, Long-term
TEP
TEP C.D
TEP
- -
TEP
N/A
No - Yes 27 Months
N/A
N/A
N/A
ACCUMULATION STUDIES:
165-1 -
165-2 -
165-3 -
165-4 -
165-5 -
SUBPART
Rotational Crops
(Confined)
Rotational Crops
(Field)
Irrigated Crops
In Fish
In Aquatic Non-Target
Organisms
K - REENTRY:
Foliar Dissipation
Soil Dissipation
Dermal Exposure
inhalation Kxpo&urc
PAIRA
TEP
TEP
TGAI or PAIRA C,D
TEP C,D
TEP C,D
TEP C.D
TEP C,D
THP C,D
N/A
N/A
N/A
No - No£/
No - No5./
N/A
N/A
N/A
N/A
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR POTASSIUM PERMANGANATE
§158.130 Environmental Fate - Continued
J/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Doroestic Outdoor; I=Indoor.
V Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 9 Month Due Date is September 30, 1986.
0 12 Month Due Date is December 31, 1986.
0 27 Month Due Date is March 31, 1988.
£/ Adsorption/desorption test required.
5/ Waived because it is assumed that the chemical has a low potential for bioaccumulation in aquatic species
because of its appreciable water solubility and probably has a very low octanol/water partition coefficient.
-------
(33)
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING POTASSIUM PERMANGANATE
Guideline Citation and
Name of Test
§158.120 Product Chemistry
Product Identity:
Test
Substance^/
61-1 - Product Identity and Disclosure EP
of Ingredients
61-2 - Description of Beginning Materials EP
and Manufacturing Process
61-3 - Discussion of Formation of EP
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
EP
EP
EP
EP
EP
EP
Guidelines
Status
R
R
R
CR
R
R
R
R
R
Are Data Footnote
Required Number
Yes No
M
Ixl
[x]
n
[xj
n
[x]
IJ
[x]
[x]
n 3
n 3
(xl
n
[x]
n
[x]
n
Data Must Be
Submitted Within
Time Frames List
Below2/
6 Months
6 Months
12 Months
6 Months
6 Months
-------
(34)
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING POTASSIUM PERMANGANATE
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 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Mlscibility
63-20 - Corrosion Characteristics
Other Requirements:
64- 1 - Submit tal of samples
Test
Substance _|/
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Guidelines
Status
R
CR
CR
CR
R
R
CR
CR
R
CR
Are Data
Required
Yes 1
[xj
IxJ
n
n
n
fxl
n
n
Ix)
n
Footnote
Number
No
l~l
n
Ix) •
IxJ
IxJ
n
[xj
IxJ
n
IxJ
Data Must Be
Submitted Within
Time Frames List
Below2
6 Months
6 Months
15 Months
15 Months
Test Substance: EP = End-use Product. Guidelines Status R = Required; CR = Conditionally Required
\J Because there are no registered manufacturing use products for potassium permanganate, the Product Specific data re-
quirements are applied to the end-use products.
-------
TABLE R
PRODUCE SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING POTASSIUM PERMANGANATE
§158.120 Product Chemistry (Continued)
2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
0 6 Month Due Date is June 30, 1986.
0 12 Month Due Date is December 31, 1986.
0 15 Month Due Date is March 31, 1986.
V For the end-use product, information is required concerning the quality control procedures and a discussion of impuri-
ties that may form in the product during its commercial life.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR END-USE PRODUCTS CONTAINING POTASSIUM PERMANGANATE
Data Requirement
Composition"
I/
Does EPA Have
Data To Satisfy
This Require-
ment? (Yes, No
or Partially)
Bibliographic
Citation
Must Additional Data
Be Submitted Under
FIFRA § 3(C)(2)(B)?
Time Frame for Data
Submission 2/
S158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat EP
81-2 - Acute Dermal Toxicity EP
- Rabbit
81-3 - Acute Inhalation Toxicity EP
- Rat
81-4 - Primary Eye EP
Irritation - Rabbit
81-5 - Primary Dermal EP
Irritation - Rabbit
81-6 - Dermal Sensitization - EP
Guinea Pig
No
No
N/A
No
No
N/A
YesV
Yes3/
YesV
Yes3/
9 Month
9 Month
9 Month
9 Month
\J Composition: EP = End-use product. Because there are no registered manufacturing use products for potassium
permanganate, the Product Specific data requirements are applied to the end-use products.
2/ Data must be submitted within 9 months after the date the Guidance Document was issued (i.e., September 30, 1986).
3/ Toxicity data is required to enable the Agency to establish the acute toxicity categories for each end-use product,
and thus prescribe appropriate predautionary statements in accordance with Section 162.10 of 40 CPR.
ut
a\
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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 FZFRA 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 Data1/ 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
V 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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(38)
for each major formulation category (e.g., emulsiflable 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)V
*_/ 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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(39)
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
for Agency review prior to the initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time extension
which is made as an initial response to a section 3(c)(2)(B) notice
must be submitted in writing to the Product Manager. However, once
dates have been committed to and EPA has accepted those commitments,
any subsequent requests for a time extension must be submitted in
writing to the Office of Compliance Monitoring.
(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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C40)
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.
III. 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-l) 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).
n
IV. SUBMISSION OF REVISED LABELING
Note; This section applies to end use products only to the
extent described in Section I (Regulatory Position and
Rationale). Otnerwise, 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
formulation which is marketed; it usually includes product
chemistry data and acute toxicity data.
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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 accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. See Appendix IV-1. [40 CFR
162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on wnich 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 oc 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)]
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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 panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The Statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. See Appendix IV-1.
[40 CFR 162.10(h)(l)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. 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 "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. See Appendix IV-1. [40 CFR 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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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 flammability of a product are required to appear on the
label if it meets the 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 flammability 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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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-flanunability 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 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section I
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.ll(c). You will be notified of
the Agency's classification decision.
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A. Classification Labeling Requirements
If Section I of this Guidance Document indicates that
your product has been classified for restricted use, the
following label requirements apply:
1. Front panel statement of restricted use classification.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label.
The statement must be set in type of the same
minimum size as required for human hazard signal
word (see table in 40 CFR 162.10(h){1)(iv)
.b. Directly below this statement on the front panel,
a summary statement of the teems of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing'all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
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B. Compliance Schedules
No product with a use classified for restricted use
under this Standard may be released for shipment by the
registrant or producer after one year from the date of
issuance of this Standard, unless such product bears the
restricted use classification. All products still in
channels of trade after two years from the date of issuance
of this Standard must be labeled for restricted use.
Item 9B [There is no Item 9B].
Item 9C. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B [There is no Item 10B].
Item IOC. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix
IV-4 to determine the disposal instructions appropriate for
your products.
Item 10D. 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]
E. Collateral Labeling
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from
those accepted in connection with registration of the product.
It snould be made part of the response to this notice and
submitted for review.
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V. INSTRUCTIONS FOR SUBMISSION
A. For Manufacturing Products (MP) containing Potassium
Permanganate 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
S.ummary Sheet (and any supporting information) to the Office of
Compliance Monitoring, which1 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
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. Any person who cannot
meet the agreed schedule (regarding the submission of test data)
or desires changes in the test protocols must submit a written
request for change to the Office of Compliance Monitoring.
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B. For Manufacturing Use Products containing Potassium
Permanganate 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. Any person who cannot
meet the agreed schedule (regarding the submission of test data)
or desires changes in the test protocols must submit a written
request for change to the Office of Compliance Monitoring.
C. For End Use Products containing Potassslum Permanganate
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
8S80-1. 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
subtni t :
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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d. Two copies of draft labeling, including Che label and
associated brochures. If current labeling conforms to the
requirements of this guidance document and Che 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 moctcup 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, submit all
generic data, unless you are eligible for the formulator's
exemption.
D. For intrastate products containing Potassium permanganate
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, ?M 31
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental ProCection 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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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.
-------
(51)
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 t'railing 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.
-------
(52)
Appendix II-2
MRID No.
00100362
GS0220-001
GS0220-002
GS0220-003
BIBLIOGRAPHY
West, B. (1962) To Investigate (a) the Oral Toxi-
clty and (b) Eye and Skin Irritation Potential of
the Subject Material in Order to Comply with the
Safety Labeling Requirements of the Federal Sub-
stances Labeling Act: Laboratory No. PT62-28.
(Unpublished study received Jun 19, 1967 under
8429-2; prepared by Rosner-Hixson Laboratorie,
submitted by Carus Chemical Co., Inc. LaSalle,
111.; CDL: 227435-A).
U.S.EPA. 1975. Report on the Toxicitry of Potas-
sium Permanganate 100% active ingredient to blue-
gill sunfish. (US.EPA, Chemical and Biological
Investigations Branch, Beltsville, Maryland,
Static-jar, 8/21/75. Unpublished report).
U.S.EPA. 1975. Report on the Toxicitry of Potas-
sium Permanganate 100Z active ingredient to blue-
gill sunfish. (US.EPA, Chemical and Biological
Investigations Branch, BeltsvilLe, Maryland,
Flow-through, Test No. MB 403, 8/21/75, Unpub-
lished Report).
Griffen, J. and C. Thompson. September 25, 1981.
Acute Toxicity of Cairox FF to Bluegill Sunfish
(Lepomis macrochirus). Study #27919. Prepared
by Analytical Bio-Chemistry Laboratories, Inc.
Submitted to Carus Chemical Co. La Salle, 111.
EPA Accession No. 253711.
-------
Q.Vtg ASSrS.*, •»; <;,
F1FHA SECTION 3(CJ(2)(S) SUMMARY SHEET
, APPUCANTS NAME
I
DATE GUIDANCE DOCUMENT ISSUES
Witn rooict to mi rtotiirwntnt to aibmrt "gtntnc" dm imooatf by tin F1FRA anon 3(C)(2)(8) none* eoramtd m tni rafvmctd
Guidinea Oocunnm. I am mending in tni following rntnntn
1. I will •ibfflit am in • flmrty tnarmr 10 mtah v\t following rtquinmiira. If tfti an nreetduno I will \im drntn from (or in not
B«ifnd mi (tit fltaatntion Cutdtiinct or ait Protocol* eanntmd in tfit Rtpore of Exoirt Grouos to tn« Chtmieau Grouo, OEC3
Chtniali Tifong Prognntini, I cidosi tttt protocol! ttut I wiil im:
_L I hivttnttnd into in igrttmtnt witn ont or mort otntr rvgotnnn unatr FIFBA action 3
-------
QMS
(54)
CERTIFICATION OF ATTEMfTTO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
To mtfry. «rT*y£ii *>****,) «* DEVELOPMENT OF DATA
1. 1 am duty autrwnred M res»**ant OH tellowtng finn(il who art wbiect to me reouire-
ment* of a Notice unoer PIPRA Section 3(e)<2)(8) contained in a Guidance Document
to suDmrt data concerning tne active ingrediam:
NAMf Of FIRM
(This ttrm or arouo o* tirrm » rtterreo 10 oetow ai "my firm".)
ACTIVE INGMEOlKNT
lUk COMPANY NUMBER
J
!
2. My firm is willing to dweloo ant submit the data u rwuirad by that Nonce, if nteeoary. However, my firm would orefar to ente-
into «n aore«ment wirn one or more otner registrants to develoo jointly, or to share in me eon of devetooing. me following reoyirec
itemi or data:
1. My firm hn oftand m wming to inter into such an agreement Coo in of The often m attached. Thn offerees imvecaoit and mtluaed in offc* TC 2-
Pound by en arartmion aecuen undir FIFfiA Section 31e)!2)lB)(iii) if final igrternem en all nrmt eauld not Bi nacnea otnerwise. Tnu otter w» mtti
n tnt fallowing ftrm(i) on tni following eatels):
MAMt
FIRM
DATt O*
ngwevy none o* mote firmm
oteemv otter
4. My firm reouests mat EPA not cusoend trie regittration{s) of my firm's prooucilsl, if any of tne firrru nimed in aaragnan (3i
have agreed to suomtt tne dan lined in oaragnor) (2) above in accordance wnn me Notice. I unoernand EPA will arometiy irrar
me wnctner my firni muit fuomit data to avoid susoenoon of itt reg«tration
-------
(55)
Appendix III-l
EPA Registration No.
PRODUCT SPECIFIC EHTA REPORT
Guidance Document for_
Date
Registration
Guideline No.
§158.20
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
Vaoor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pK
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
Assianed
-------
(56)
Appendix III-1 (continued)
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxidizing/reducing
reaction
Flaimiability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral LD-50,
rat
Acute dermal
LD-50
Acute inhalation,
LC-50 rat
Primacy 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 MRIDft
Suonit-
ting
Data
(At-
tached)
(For EPA Use Only)
Accession Numbers
Assigned
-------
(57)
APPENDIX IV -1
§ 1*2-10 Title 40—Protection of Environment
0182.10 Labeling rcquirmenu.
(a) General—41) Contents of tfu
label Every pesticide products shall
bear a label containing the informa-
tion specified by the Act and the regu-
lations in this Pan. The contents of a
label must show clearly and promi-
nently the following:
(1) The name, brand, or trademark
under vhich the product is sold as pre-
scribed in paragraph (b) of this sec-
tion:
(11) The name and address of the
producer, registrant, or person for
-------
Appendix IV-1 (continued)
(58)
Oiapte* I—Ifivironmentol Protection Agency
§ 167.10
whom produced u prescribed in paia-
graph (O of this section:
(Ul) The net contents as prescribed
In paragraph (d) of this section:
dv> The product registration
number as prescribed in paragraph (e>
or this section:
(v> The producing establishment
number as prescribed in paragraph (f)
or this section:
Not be obscured or crowded.
(3) Language to be tuetf. 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 (conciaued)
(59)
§ 1*2.10
(v> Any statement directly or indi-
rect y implying that the pesticide or
device a recommended or endorsed by
any agency of the Federal Govern-
ment:
(vt) The name of a pesticide which
contains two or more principal active
ingredient* if the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere In the labeling:
evil) A true statement used in such a
way as to give a false or misleading im-
pression 10 the purchaser.
(vUl) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions:
(Ixi Claims as to the safety of the
pesticide or its ingredients, including
statements such as "safe." "nonpoison-
ous." ••oomajunous," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed": and
(z) Non-numeneal 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"
Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
dre-s given on the label shall be con-
sidr red 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 appropnate 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 wtiotit or measure of con-
tentt. (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
tens of liquid measure at 68' F <20'C)
and shall be expressed in conventional
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide is solid or 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. Le.. "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 *<>«"»»»»* eon.
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 mi^^tim is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
Product registn.ti.on number.
The registration number assigned to
the pesticide product at the tune of
registration snail 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)
C60)
Chapter I—Environmental Pratactian Agency
§ 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—(.\~> 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
terra "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 must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must noc be placed in the
body of other text.
(3) Names to be tued 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 2S(cX6).
(4) Statements of percentages. The
percentages of Ingredients shall be
stated In terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentages.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(1) In eases where it Is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
[date]."
-------
Appendix IV-1 (continued)
(61)
§ 16X10
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert mgredienus) to be listed in the
Ingredient statement if he determines
that such mgredienus) may pose a
hazard to man or the environment.
(h) Warning* and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
Title 4O—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) Rewind 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:
uoieaM
•"»'•«.
UDBM
i Us town
"•"ft
M l«u 900 mt/tgj from MO mm MOO mg/
(1) Human hazard signal vord—
Toxintv Category I. All pestiade prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition IT 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
contracting color and the skull and
crossbones shall appear in Immediate
proximity to the word "poison."
(B) Toxieity 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) Toxintv Category III. All pesti-
cide products meeting the criteria of
Toxicity Category m shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxieity Category IV. All pesti-
ade products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(£) Use of signal words. Use of any
signal worries) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a labeL
(11) Child hazard warning. Every pes-
tiade 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-
ins, 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.
(IK) Statement of practical treat-
m«ni—
-------
Appendix IV-i (continued)
(62)
Chapter I—environmental Protection Agency
§ 162.10
basis of oraL inhalation or dermal tox-
teity. The Agency nay. 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 toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hxlXiiiXA) of
this section. The applicant may. how.
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label in
accord with paragraph (hX2) of this
section if they do not appear on the
front paneL
(iv) Placement and prominence. All
the require front panel warning state-
menu shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels
S*10_
10 10 19 ,
1 I
10 I
12 I
'•I
It I
*
10
12
(2) Other required warnings and pre-
cautionary statements* The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(1) Hazard, to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic ""•"•'• precau-
tionary statements are required indi-
cating the particular hazard, the
routets) of exposure and the precau-
tions to be taken to avoid accident.
Injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Or*
MHOMO Immta or
. mrouan iuil Do not gnM» «OT [«•
! mHj Oo not o* « •«•>. an
I auma.1
< mugn m* «M) Do not
inM) Oenoi an «
(ii> Environmental hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the circum-
-------
Appendix IV-1 (continued)
(63)
§ 142.10
nances under which they are required
follow:
(A) II a pesticide intended for out-
door us* contains an active ingredient
with a mammalian acute onl LD« of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" u required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LC. of 1 ppra or less.
the statement "This Pesticide u Toxic
to Pish" u required.
(C) If a pesticide Intended for out-
door use contains an active ingredient
with an avian acute oral LD. of 100
ing/kg or less, or a subacute dietary
LC. of 500 ppra or less, the statement
"This Pesticide u Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
Title 40— Protection of Environment
pesticide may result in fatality 10
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" u required.
(£) Por oses involving foliar applica-
tion to agricultural crops, foresu. or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) Por 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) Prtimeal or chemical hazards.
Warning statements on the flammaoil-
ity or explosive characteristics of the
pesticide are required as follows:
IAI
130" r mm,
Oo *•»<•§ or
Do not ownn or
asm m* IX' * "«T
(13 Directions for Uie- Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bar.
(B) The label bears * reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular" and
(C) The Administrator determines
that It is not necessary for such direc-
tions to appear on the label.
{ill) Exceptions to requirement for
direction for use—
-------
Appendix IV-1 (continued)
(64)
Chapter I—Environmental Protection Agency
§ 142.10
for use only by manufacturers of prod-
uct* other than pesticide products in
their regular manufacturing processes.
provided that:
U) The label clearly shows that the
product is intended for use only in
manufacturing processes and specifies
the typets) 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:
(31 The product will not come Into
the hands of the general public except
after incorporation into flushed prod-
ucts: and
<4) The Administrator determines
that such directions are not necessary
to prevent unreasonable advene ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the '•*«•""> of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
(J> 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 formulaton in preparing
pesticides for sale to the public, pro-
vided that:
-------
Appendix IV-1 (continued)
(65)
§162.11
<£) 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 U*e Classification.
By October 22. 1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (JX1) and (2) of this sec-
tion, Any pesticide product for which
some uses are classified for general use
and others for restncted use shall be
separately labeled according to the la-
beling standards set 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
IABF.LING REQUIREMENTS OF TUB FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
61)
7
7A
711
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statenent
Front panel
precautionary
statements
Keep Out of Reach
ot Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
ON LABEL
PREFERRED
Center front
panel
Dot ton front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size ami 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, prelurahly
blocked .
Note type size requirements.
Note type size requirements.
-------
APPENDIX IV-2 (continued)
ITEM
7C
7D
7E
8
8A
(II)
LABEL EIJFMENF
Skull & cross-
Ijones and word
POISON (in red)
Statement of
practical
treatment
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans ami
domestic
animals
Environmental
hazards
APPLICABILITY
OF RRQUIREMENF
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, li, aivl III
All prnducl.s
PU\CEMENT
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
ON LABEL
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 IJGO
caution where ajipli cable.
-------
APPENDIX IV-2 (continued)
ITEM
8C
9A
9C
10A
LOG
10L>
LABEL ELEMENr
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storayo and
disposal block
Directions
for use
APPLICABILITY
OF REQUlREMhXr
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
Cor 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
oo
-------
(69)
Appendix IV-3
PHYSICAL-CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B. Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and 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.
-------
(70)
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
roust be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
10 and under 6 point
Above 10 to 15 8 point
Above 15 to 30 10 point
Over 30 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their pcontinence.
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 con-tainer 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.
-------
C71)
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.'
H
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
statements
"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:
-------
(72)
Appendix IV-4
(continued)
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture* or rinsate is a violation of
Federatl 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 discardina in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
-------
(73)
Appendix IV-4
(continued)
2. The labels foe all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressea 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
foe 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)
i/ Manufacturer may replace this phrase with one indicating
~~ whether and how fiber drum may be reused.
-------
(74)
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-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
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
Famphur
Fluoroacetamide •
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methorny1
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
-------
(75)
Appendix IV-4
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propacgyl 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
-------
C76)
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Acetone
Accylonitrile
Amitrole
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-metheno-2H-cyclobuta [c ,d] -pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloiropropane (DBCP)
Dibutyl phthalate
S-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-DiChlorobenzene
p-DiChlorobenzene
Dichlocodifluoromethane (Freon 12 )
3/5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlocethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2/4-0)
1f 2-Oichloropropane
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
-------
(77)
Appendix IV-4
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Naleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-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
Re soreino1
Safcole
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
-------
(78)
Appendix IV-4
(continued)
'Toxic" Commercial Pesticide Products (RCRA "F" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlocodifluocomethane (Freon 12*)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1,1-Tcichlocoethane
1,1,2-Trichloroethane
Tcichlorofluoromethane (Freon
Vinyl chloride
Xylene
------- |