&EPA
Environmental Protection
Agency :
Pttticides and Toxic SubstancM
W^hington DC 20460
20 1988
540/RS-88-077
Peaticidtf
Guidance for the
Reregistration of
Pesticide Products
Containing
OiK)RINATED ISOCYANURATES
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CHLORINATED ISOCYANURATES
AS THE ACTIVE INGREDIENT
CASE NUMBER, 0569
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CD
CD
in
CAS REGISTRY NUMBER 2782-57-2
EPA/OPP PESTICIDE CHEMICAL CODE 081401
CAS REGISTRY NUMBER 2244-21-5
EPA/OPP PESTICIDE CHEMICAL CODE 081403
CAS REGISTRY NUMBER 2893-78-9
EPA/OPP PESTICIDE CHEMICAL CODE 081404
CAS REGISTRY NUMBER 87-90-1
EPA/OPP PESTICIDE CHEMICAL CODE 081405
CAS REGISTRY NUMBER 30622-37-8
EPA/OPP PESTICIDE CHEMICAL CODE 081406
CAS REGISTRY NUMBER 51580-86-0
EPA/OPP PESTICIDE CHEMICAL CODE 081407
NOVEMBER 1987
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
ENVIRONMENTAL PROTECTION AGENCY
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TABLE OF CONTENTS
Page
I. Introduction , 1
II. Chemical (s) Covered by this Standard 3
A. Description of Chemical
B. Use Profile
III. Agency Assessment ........ 6
A. Summary
B. Kidney Toxicity Issue
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 14
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits ; ';
D. Required Labeling
V. Products Subject to this Standard . . . ........ 19
VI. Requirement for Submission of Generic Data 20
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . . 26
VIII,, Requirement for Submission of Revised Labeling 26
IX. Instructions for Submission . . . .. 27
A. Manufacturing use products (sole active)
B. Addresses
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APPENDICES
Page
DATA APPENDICES
Guide to Tables 29
table A.. . . . . . . 31
Table B. ...... 43
II. LABELING APPENDICES
Summary of label requirements and table 47
40-CFR 162.10 Labeling Requirements 55
Physical/Chemical Hazards Labeling Statements. ..... 64
Storage Instructions 65
Pesticide Disposal Instructions. . 66
Container Disposal Instructions 67
III.BIBLIOGRAPHY APPENDICES
Guide to Bibliography. .......... 68
Bibliography . 70
IV. FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet. . . . 75
EPA Form 8580-6 Certification of Attempt to Enter Into
an Agreement with Other Registrants
for Development of Data 76
Product Specific Data Report 77
Generic Data Exemption Statement 79
11
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I . INTRODUCTION
EPA has established the Registration Standards program in
order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient,
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies :
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support, continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained in
this document, but is available upon request!/, focuses on the
pesticide active ingredient. The scientific review primarily
discusses the Agency's evaluation of and conclusions from
available data in its files pertaining to the pesticide active
ingredient. However, during the review of these data the
Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
Registration Standard to end use products if necessary to
protect man and the environment.
EPA's reassessment results in the development of a;
regulatory position, contained in this Registration Standard,
\J The scientific reviews may be obtained from the National
Technical Information Service (NTIS), Attn: Order Desk>,5285
Port Royal Road, Springfield, VA 22161 (tel: 703/487-4:650) .
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on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, EPA may prescribe a variety of steps to
be taken by registrants to maintain their registrations in
compliance with FiFRA. These steps may include:
1. Submission of data in support of product registration;
2, Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to.
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use," the Agency may
propose additional regulatory actions, such as cancellation of
uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-In (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical,
toxicolbgical, and environmental characteristics and fate of a
pesticide. This Registration Standard lists the data EPA
believes are necessary to resolve our concerns about this
pesticide. These data are listed in the Tables A and B in
Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in issuance
by EPA of a Notice of Intent to Suspend the affected product
registrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible
unreasonable adverse effects of a pesticide at any time that
they become aware of such information. Registrants must notify
the Agency of any information, including interim or preliminary
results of studies, if that information suggests possible
adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of continued studies called in by the Agency
and continues as long as a product is registered under FIFRA.
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II. CHEMICALS COVERED BY THIS STANDARD
A. Description of Chemical
The following chemicals are covered by this registration
standard:
1. Common Names: Dichloro-s-triazinetrione,
dichloroisocyanuric acid.
Chemical Name: 1,3-Dichloro-s-triazine-2f4,6
(1H,3H,5H) trione.
CAS Registry No: 2782-57-2.
EPA/OPP Pesticide Chemical Code: 081401.
Empirical Formula: C3HN 3(^12.
Trade Name: ACL 70.
ji
2. Common Names: Potassium dichloro-s-triazinetrione;
Potassium, dichloroisocyanurate.
Chemical Name: 1,3-Dichloro-s-triazine-2,4,6
(1H,3H,5H) trione potassium salt.
. CAS Registry No: 2244-21-5.
EPA/O.PP Pesticide Chemical Code: 081403.
Empirical Formula: C3N3C>3Cl2K«
Trade Names: ACL 59; P.D.I.C.
3. Common Names: Sodium dichloro-s-triazinetrione;
Sodium- dichloroisocyanurate.
Chemical Name: 1,3-Dichloro-s-triazine-2,4,6
(1H,3H,5H) trione sodium salt.
CAS Registry No: 2893-78-9.
EPA/OPP Pesticide Chemical Code: 081404.
Empirical Formula: C3N303Ci2Na.
Trade Names: ACL 60; CDB 60; CDB 63; S.D.I.C.
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4. Common Names: "Trichloro-s-triazinetrione;
trichloroisocyanuric acid; trichloroisocyanurate.
Chemical Name: 1,3,5-trichloro-s-triazine-2,4,6
(1H,3H,5H) trione.
CAS Registry No: 87-90-1.
EPA/OPP Pesticide Chemical Code: 081405.
Empirical Formula: C3N303C13.
Trade Names: ACL 90 Plus; CDB 90; T.I.C.A.; TCCA.
5. Common Name: Penta-s-triazinetrione.
Chemical Name: [Mono-(1,3,5-trichloro)tetra
(l-potassium-3,5-dichloro)] penta-s-triazinetrione
CAS Registry No: 30622-37-8.
EPA/OPP Pesticide Chemical Code: 081406.
Empirical Formula: (C3N303C12K)4.C3N303CL3.
Trade Names: ACL 66; DS.
6. Common Names: Sodium dichloro-s-triazinetrione
dihydrate; sodium dichloroisocyanurate dihydrate.
Chemical Name: 1,3-Dichloro-s-triazine-2,4,6
(1H,3H,5H) trione sodium salt dihydrate.
CAS Registry No: 51580-86-0.
EPA/OPP Pesticide Chemical Code: 081407.
Empirical Formula: C3N303C12N2.2H20.
Trade Names: ACL 56; CDB Clearon; DICD.
The dechlorinated s-triazinetrione, isocyanuric acid,
is not being considered for reregistration under this
standard since it has no pesticidal properties per se. It
acts only as an inert chemical stabilizer for the
hypochlorous acid derived from other sources.
Description of Physical Characteristics of Chemicals:
Color: White.
Physical State: Crystalline Solid.
Odor: Slight odor of chlorine.
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Melting Point: 225-250° C with decomposition.
Bulk Density: Powder, 0.50-0.65 g/ml; regular, 0.82-1.0
g/ml; granular, 0.85-0.96 g/ml; extra granular, 0.92-0.95
g/ml.
Solubility: Dichloro-s-triazinetrione, 0.8 g/100 g water
at 25°C; potassium dichloro-s-triazinetrione, 9 g/100 g
water at 25°C; sodium dichloro-striazinetrione, 24.8
g/100 g water at 26.8°C; trichloro-s-triazinetrione, 1.2
g/100 g water at 25°C; penta-s-triazinetrione, 2% in
water at 30°C; sodium dichloro-s-triazinetrione dihydrate,
26.2 g/100 ml water at 25°C.
Vapor Pressure: Very low, impossible to measure.
Stability: Stable and relatively inert when dry.
B. Use Profile , t
Type of Pesticide: Disinfectant; sanitizer; algaecide;
fungicide.
Pests Controlled: Bacteria; algae; slime forming
microorganisms; mold and mildew.
Registered Uses: Swimming pools; industrial water cooling
systems; oil recovery systems; sewage systems; industrial
preservatives; food processing/service industries; laundry
sanitizer uses; household areas; mold and mildew; egg
sanitizing and poultry drinking water sanitization.
Predominant Uses: Major use is swimming pools (74%).
Minor uses include'recirculating cooling water systems
and food contact surface and laundry sanitizers.
Mode of Activity: Disinfection/Sanitization.
Formulation Types Registered: Solids; aqueous
dilutions.
Method of Application: Added as solids'to swimming pools
or industrial cooling water systems; aqueous solutions
applied by mopping, scrubbing, flooding, sponging,
spraying and immersing to food and non-food contact
surfaces.
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III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all of the data submitted to
support the registration of the chlorinated isocyanurates, as
we'll as open literature information relevant to these
chemicals. Based on a review of these data, EPA has reached
the following conclusions.
Isocyanurate related effects observed in subchronic
studies included hyperplasia of the urinary blader and calculi
in male mice and hyperplasia of the lining of the urinary
bladder in male rats. In a chronic study in rats, toxicity
secondary to formation of calculi in the kidney and urinary
bladder was observed in the male rats during the first 12
months of dosing at 5375 ppm. No effects were observed at
2400 ppm. No oncogenic effects were observed in lifetime
studies in mice and rats. The chlorinated isocyanurates do
not induce reproductive effects in rats, teratogenic effects
in rats or rabbits, and are not mutagenic. The chlorinated
isocyanurates have low oral and dermal toxicity and high
primary eye irritation toxicity. The chlorinated isocyanurates
are slightly toxic to birds, but are acutely toxic to fish and
invertebrates;
There are no significant human toxicological data gaps
for the chlorinated isocyanurates; only a primary eye
irritation study is required for the trichloroisocyanurate
group. The chronic effects from these chemicals to aquatic
organisms are not fully known, however.
The hypochlorous acid derived from the chemical reaction
of the chlorinated isocyanurates and water has been shown to
be chronically toxic to marine and estuarine invertebrates and
fish. A residue monitoring study is being required to measure
the exposure and risk of hypochlorous acid to aquatic
organisms.
There are no environmental fate data gaps for the
chlorinated isocyanurates. Available hydrolysis data and
the required residue monitoring study for hypochlorous acid
will adequately characterize the environmental fate of the
chemicals covered under this standard.
B. KIDNEY TOXICITY ISSUE
The original toxicological data base for the registration
of the isocyanurates was based on studies performed in
Industrial Biotest Laboratories (IBT). Although these studies
were later invalidated, the IBT chronic rat study indicated.
that the compound produced kidney toxicity.
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Since the public is widely exposed to isocyanurates
through their use in swimming pools, EPA presented the
information available at the time to the FIFRA Scientific
Advisory Panel (SAP) for their opinion. At an open meeting
held in Arlington, Virginia (January 17-18, 1980), the SAP
completed a review of the health risks associated with the
use of the chlorinated isocyanurates. (Fowler, 1980)*
The SAP concluded that the wide exposure of these
compounds in the environment,, coupled with an inadequate data
base from early toxicity studies, were causes for concern to
the panel. For these reasons, the SAP recommended an immediate
coordinated attempt by EPA and the chlorinated isocyanurate
industry to establish, if possible, whether these compounds
are toxic to the kidney. In addition to the prompt initiation
of investigative procedures for the definition of hazards, the
SAP indicated that the adoption by EPA of an appropriate
posture for expeditious regulatory action, should it be
necessary, was fully warranted. The SAP recommended that
additional contemporary assays to characterize the safety of
the chlorinated isocyanurates should be undertaken using
currently accepted protocols, including carcinogenic, mutagenic
and teratogenic assays. .
In response to these conclusions, EPA issued a Data Call-
in Notice in accordance with section 3(c)(2)(B) of FIFRA.
This notice required that the registrants of chlorinated
isocyanurates perform the animal studies recommended by the
SAP. Reports of these studies have been received and evaluated
for this standard.
The subchronic rat and mouse studies and the chronic rat
study reviewed in the development, of this standard provide
acceptable data for evaluating the kidney toxicity of the
chlorinated isocyanurates. In these studies sodium
isocyanurate was administered in the animals' drinking water
at doses up to and including the .limit of solubility of the
compound (5375 ppm) at pH 7.
In the subchronic mouse study/ the only compound-related
effect was bladder calculi in two male mice at the high dose,
associated with irritation of the bladder lining (LOEL 5375
ppm, NOEL 1792 ppm). The subchronic rat study showed ,
hyperplasia of the lining of the urinary bladder in the males
(LOEL 1792 ppm, NOEL 896 ppm). No effect was observed,in the
kidneys of either sex.
The chronic rat study provided significant information on
kidney toxicity. Compound-related gross and microscopic
lesions were found in the urinary^tract and heart, primarily
* Memo, H.W. Fowler, Advisory Report on Chlorinated
Isocyanurates, February 15, 1980.
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in males that died during the first 12 months of the study
after receiving 5375 ppm. Acute nephrosis and chronic
progressive nephropathy in the kidneys and inflammation,
hemorrhage and epithelial hyperplasia of the urinary bladder
in these males was considered related to calculi found grossly
in the kidney and bladder. Lesions in the heart, inflamation
(myocarditis and endocarditis), necrosis, and vascular
mineralization were secondary to the uremia caused by urinary
tract lesions. The LOEL for the study was 5375 ppm based on
decreased survival in males and lesions in the urinary tract
and heart; the NOEL was 2400 ppm (154 mg/kg/day).
The solubility of sodium isocyanurate and isocyanuric acid
in water at 25°C has been established as follows:
(Nelson, 1979)*
mg/liter(ppm)
pH Sodium Cyanurate Cyanuric Acid
4.4 4300 3700
7.2 8700 7400
7.7 8100 6900
8.6 7600 6500
Considering that the high dose sodium cyanurate was
ingested with the drinking water at saturation for pH 7 and
excreted in .the urine at a pH in the order of 4.4 where its
solubility is considerably less, precipitation and calculi may
form in the urine. This possibility was clearly observed in
the male rats at the high dose of the chronic study, but not
in the females. The male rat tends to retain a portion of
urine in its bladder at urination while the female voids
entirely. This retention favors calculi formation. Thus,
the toxicity observed in the urinary system of the male rat
can be attributed entirely to mechanical damage from calculi.
No evidence of direct kidney toxicity was shown in these
studies.
In conclusion, the only toxic effect demonstrated by
sodium cyanurate is the formation of "stones" in the kidneys
and urinary tract of male rats and mice fed saturated solutions
of sodium isocyanurate (5375 ppm) in their drinking water.
Kidney/urinary tract damage occurs secondary to stone formation
and is mechanical in nature. This effect does not pose a risk
to individuals using swimming pools treated with chlorinated
isocyanurates since final residual levels in swimming pools
are required to be maintained between 1-3 ppm available
chlorine. This level would be equivalent to 1.1-3.3 ppm
trichloroisocyanurate, the most widely used chlorinated
isocyanurate in swimming pools.
* Nelson, G.D. Memo, Solubility of Cyanuric Acid and its
Monobasic Sodium Salt, December 17, 1979, Monsanto.
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C. SCIENCE FINDINGS
1. Human Toxicity
The isocyanurates have been divided into three groups for
the purposes of acute testing based on structural and, to a
lesser degree, potential/actual effects due largely to the
level of chlorination of the triazine ring. These groups are:
(i) isocyanuric acid; (ii) the dichloroisocyanurate group
including the acid, the potassium and sodium salts, and the
dihydrated sodium salt; and (iii) trichloroisocyanuric acid.
A seventh compound, [mono(trichloro) tetra(monopotassium
dichloro)] penta-s-triazinetrione, contains moieties in groups
(ii) and (iii) and, accordingly, toxicology data required for
this compound can be extrapolated from data for groups (ii)
and (iii ) .
Since the chronic effects of chlorine to humans is well
known, EPA determined that for purposes of metabolism studies
as well as subchronic, chronic, teratogenic, and mutagenic
testing, isocyanuric acid would be representative of all the
chlorinated isocyanurates. By using the dechlorinated s-
triazinetrione as the test substance, the effects of the
triazinetrione moiety could be distinguished from those of the
chlorine. Sodium isocyanurate was considered to be
toxicologically equivalent to isocyanuric acid and, as such,
was selected as a suitable test substance for the development
of the toxicity data reviewed under this standard.
Acute Toxicity and Irritation Studies. The available data
indicate that the chlorinated isocyanurates have low acute
oral and dermal toxicity and high primary eye irritation
toxicity. Acute inhalation studies are not required because
vaporization and respirable dust are not expected. The
dichloro- and trichloroisocyanurates are very mild primary
dermal irritants and are not considered to be dermal
sensitizers. Since the toxicity produced by sodium
isocyanurate upon subchronic and chronic testing was only
mechanical damage from calculi, primary dermal irritation and
dermal sensitization studies are not required for the
chlorinated isocyanurates. Delayed neurotoxicity data are not
required because the chlorinated isocyanurates are not
organophosphates. All acute effects data requirements are
satisfied with the exception of primary eye irritation studies
for the trichloroisocyanurates group.
Subchronic Studies. In 13-week studies involving dosing of
sodium isocyanurate in the drinking water, the NOELs in rats
and mice were 896 ppm (72 mg/kg/day) and 1792 ppm (522 mg/kg/
day), respectively. The major toxic effects-observed were
hyperplasia of the urinary bladder and calculi in 2 of 40 male
mice and: hyperplasia in the lining of the urinary bladder in
the male? rats. A subchronic oral study in a nonrodent species
is not required due to the similarity between the metabolism
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of sodium isocyanurate in rats and dogs. Subchronic"dermal
(both 21- and 90-day) studies are not required because of the
lack of toxicity observed in subchronic oral (drinking water)
studies at doses far above use concentrations. Subchronic
inhalation and neurotoxicity studies are not required for the
reasons given under the associated acute topics. All
subchronic testing data requirements have been met.
Chironic Studies. The LOEL in rats was 5375 ppra (371 mg/kg/day
for males) based on decreased survival and lesions in the
heart and urinary tract of males dosed in the drinking water
for 2 years; the NOEL was 2400 ppm (154/mg/kg/day). Oncogenic
effects were not noted at any dose in the 2-year rat study or
in a 104-week mouse study involving dosing at up to 5375 ppm
(1523 or 1582 mg/kg/day for males and females, respectively)
in the drinking water. Note that 5375 ppm was reported to be
the limit of water solubility for sodium isocyanurate. A
chronic oral study in a nonrodent species is not required due
to the similarity between the metabolism of sodium isocyanurate
in rats and dogs. A three-generation rat reproductive study
indicated a NOEL of 5375 for both reproductive and offspring
effects; the LOEL and NOEL for adult toxicity were 5375 ppm
and 1200 ppm, respectively. The chronic toxicity of the
chlorinated ispcyanurates is adequately understood.
No additional chronic testing is required.
Teratogenicity Testing. The NOEL for both maternal and fetal
toxicity was >5 g/kg/day in rats. In rabbits, sodium
isocyanurate was not teratogenic; the NOELs for maternal and
fetal toxicity were 50 mg/kg/day and 200 mg/kg/day,
respectively. These studies are adequate; no additional
teratology studies are required.
Mutagenicity Testing^ Sodium isocyanurate is not mutagenic as
determined by studies designed to detect the potential to
induce gene mutation, structural chromosomal aberrations, or
altered sister chromatid exchange frequency. .These studies
are adequate; no additional mutagenicity studies are required.
Special.Studies. Metabolism studies in both the rat and dog,
following administration of [14C]sodium isocyanurate by the
oral and intravenous routes, demonstrated rapid absorption,
distribution, and excretion of unmetabolized isocyanurate.
Elimination half-lives in rats were 32-43 minutes following
5 mg/kg/ I.V. or oral administration and 122-148 minutes after
oral dosing at 500 mg/kg. At the 5 mg/kg dose, excretion was
largely via the urine with generally <5% via the feces. At
the 500 mg/kg oral dose, 55-70% (rats) or 27-86% (dogs) was
excreted in the feces and the remainder in the urine.
Radioactivity in tissues was less than or near the sensitivity
of the method regardless of dose regimen. These studies
adequately elucidate the absorption, metabolism, and excretion
:of the chlorinated isocyanurates. No additional metabolism
studies are required.
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2. Ecological Effects
Because of its known chronic effects to aquatic organisms,
chlorine is considered to be of greater toxicological
significance than the triazine moiety. Based on available
mammalian metabolism and oral and dermal toxicity studies, the
unsubstituted triazine ring is essentially nontoxic and rapidly
excreted in an intact form. It is, therefore, unlikely to
accumulate in mammals. Similiarly, EPA does not expect
accumulation to occur in fish or aquatic organisms, both due
to the fairly high water solubility of the unsubstituted ring
(ca. 2000 ppm) and because rapid excretion is also expected to
occur in fish and aquatic organisms. No ecological effects
data are required for the triazine moiety.
To determine the effect of hypochlorous acid on aquatic
organisms, trichloroisocyanuric acid (trichloro-s-
triazinetrione) was selected by EPA as the single test
substance to be used to represent all registered chlorinated
isocyanurates. Since this compound provides the highest
percentage available chlorine, it was considered to be the
most toxic chlorinated isocyanurate to aquatic organisms.
Sufficient data are available to determine that
trichloroisocyanuric acid is only slightly toxic to birds
(LDso to bobwhite quail 1674 mg/kg). Acceptable subacute
dietary toxicity studies on bobwhite quail and mallard ducks
indicate that trichloroisocyanuric acid is practically nontoxic
to upland gamebirds (LCsg = 7235 ppm and >10,000 ppm,
respectively). An avian hazard is not indicated by these
studies; no additional avian toxicity data are required.
Sufficient data are available to demonstrate that
trichloroisocyanuric acid is highly toxic to fish; the LCso
is 0.33-0.37 ppm to rainbow trout and 0.20 ppm to bluegill
sunfish. Trichloroisocyanuric acid is highly toxic to
freshwater invertebrates (LC$Q to Daphnia magna is 0.19-0.8
ppm). Acute LCso studies utilizing a chlorinated isocyanurate
are not available for estuarine and marine organisms. However,
EPA believes that the toxicity of chlorinated isocyanurates is
due to the hypochlorous acid liberated in aqueous solution.
Therefore, numerous studies presented in the Ambient Water
Quality Criteria for Chlorine satisfy this requirement.
LC5QS ranged from 0.02 ppm (rainbow trout) to 0.09 ppm (shrimp)
chlorine in numerous marine and estuarine organisms (fish,
crustaceans, gastropods); this is considered highly toxic.
Hypochlorous acid is also considered to be highly
chronically toxic to marine and estuarine invertebrates and
fish. Water concentrations of 0.003-0.085 ppm hypochlorous
acid caused reduction in oyster shell deposition and altered
blood characteristics in fish. A 30-day American oyster study
revealed a maximum^ allowable toxic concentration (MATC) of
0.11-0.4 ppm hypochlorous acid. A 21-day MATC ranged.from
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0.11 ppm to 0.23 ppm for fathead minnow. The LC5Q for
trichloroisocyanuric acid was 0.08-0.37 ppm in rainbow trout.
. EPA does not have adequate data to.completely assess the
chronic effects of the hypochlorous acid liberated from the
chlorinated isocyanurates to aquatic organisms or to endangered
species. Therefore, a residue monitoring study is.being
required for hypochlorous acid to determine the exposure and
risk to aquatic organisms from the aquatic non-food uses of
these chemicals. If toxic concentrations of hypochlorous acid
are detected in effluent water, additional data will be
required to determine the effects on growth and development
(life cycle studies) of aquatic organisms.
Honey bee exposure is not expected to result from the
registered uses .of the chlorinated isocyanurates and nontarget
insect studies will not be required.
3. Environmental Fate
Acceptable hydrolysis data are available for sodium
cyanurate which is representative of all the chlorinated
isocyanurates. Based on the lack of toxicological or
ecological problems associated with the triazine moiety and
the requirement for residue monitoring studies to measure
hypochlorous acid activity in the aquatic environment, no
additional environmental fate data will be required for the
chlorinated isocyanurates.
Based on the available data, there are no apparent human
exposure, groundwater, reentry, or drift issues.
D. TOLERANCE REASSESSMENT
No tolerances have been established for the chlorinated
isocyanurates. Therefore, an ADI is not required and a
tolerance reassessment is not necessary.
industrial uses of the chlorinated isocyanurates in
agricultural premises (including dairy milk farm equipment) ,
in .food/feed handling establishments as sanitizing solutions
on food processing equipment and utensils, and on other food-
contact articles are regulated by the Food and Drug
Administration (FDA) according to 21 CFR 178.1010(b)(2) and
(c)(2). This regulation stipulates that aqueous solutions
containing dichloroisocyanuric acid, trichloroisocyanuric
acid, or the sodium or potassium salts of these acids, with
or without the bromides of potassium, sodium or calcium will
not provide more than 100 ppm of available halogen determined
as available chlorine.
. The provisions of the Federal Food, Drug, and Cosmetic
Act (Section 402) require the establishment of or exemption
from a tolerance for the use of chlorinated isocyanurate
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formulations as poultry drinking water sanitizers and as egg
sanitizers. However, based on the lack of mammalian metabolism
and oral and dermal toxicity demonstrated by the chlorinated
isocyanurates in the studies reviewed under this standard, EPA
will be willing to consider a request for an exemption from
the requirements of a tolerance for these uses.
Agricultural uses of the chlorinated isocyanurates for
the commercial treatment of eggs for human consumption are
also regulated under the United states Department of
Agriculture (USDA) egg grading and egg products inspection
programs. USDA requires that to be accepted under these
programs, all formulations must be in compliance with 21 CFR
178.1010 as sanitizing solutions for food contact surfaces.
E. SUMMARY OF DATA GAPS
The Agency has identified data necessary to evaluate the
environmental and human risks associated with the use of the
chlorinated isocyanurates and their salts. These data must
be developed in order to maintain registrations of products
or register new products containing these chemicals. The
following table summarizes the data gaps, including product
chemistry information. Please note that this is only a
summary and details can be obtained by referring to Table A.
Summary of Generic Data Gaps - Chlorinated Isocyanurates
158.120 Product Chemistry
All of the product chemistry data are required.
158.145 Wildlife and Aquatic Organisms
72-7 Simulated Field Testing (Residue Monitoring)
- Aquatic Organisms
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITION
Based on a review and evaluation of all available data on
the chorinated isocyanurates and their salts, the Agency has
made the following determinations. Refer to Section IV.D for
specific language for label revisions.
1. The Agency will not place the chlorinated isocyanurates
into Special Review.
Rationale ; The chlorinated isocyanurates do not exceed the
risk criteria for adverse effects in 40 CFR, Section 154.7.
Available data indicate that the chlorinated isocyanurates
do not pose a risk of serious acute injury to humans, avian
species and aquatic organisms. Because animal effects were
limited to hyperplasia of the urinary blader and calculi in
male mice and hyperplasia of the lining of the urinary bladder
in male rats at doses near the limit of their solubility,
these chemicals appear to produce no risk to humans.
2. The Agency has determined that the present precautionary
statements for persons handling or applying the chlorinated
isocyanurates are sufficient for the labels of manufacturing-
use products.
Rationale ; Available data indicate that the chlorinated
isocyanurates cause low acute oral and dermal toxicity
(Category III and IV) and high primary eye irritation toxicity
(Category I). The labeling of these product contain
statements, including the signal word "Danger" because of the
eye effects, that provide precautionary measures to ensure
safe handling of the pesticide products and provide the user
with first aid instructions.
3. The Agency has determined that nontarget insect studies
are not required.
Rationale ; Exposure to nontarget insect species is not
expected to result from the registered uses of the chlorinated
isocyanurates. Therefore, honey bee testing is not required.
4. The Agency will not impose a special label advisory
statement for endangered species at this time.
Rationale ; Because the chlorine^released from the chlorinated
isocyanurates is so volatile, the Agency does not expect
exposure to endangered species from the registered patterns of
use or from accidental spills. However, residue monitoring
studies are being required to determine if hypochlorous acid
residues resulting from the use of these chemicals may reach
surface water.
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If the estimated environmental concentrations of chlorine
residues resulting from the use of these chemicals exceed the
endangered species trigger for aquatic species (1/10 of the
LCso)? an Office of Endangered Species opinion will be
requested.
5. The Agency will not require the submission of
microbiological efficacy data in support of the antimicrobial
uses of the chlorinated isocyanurates.
Rationale; EPA has data in its files which adequately
demonstrate the efficacy of hypochlorous acid. Therefore, no
additional microbiological efficacy data will be required.
6. The Agency is requiring the establishment of or exemption
from a tolerance for the use of chlorinated isocyanurate
formulations as poultry drinking water sanitizers and as egg
sanitizers. If such a tolerance or exemption from a tolerance
is not proposed within 6 months from the date of issuance of
this standard, these uses will be cancelled.
Rationale; No tolerances have been established for the
chlorinated isocyanurates as poultry drinking water sanitizers
or as egg sanitizers and residue data do not exist to support
these uses which may result in isocyanurate residues in eggs
and poultry. However, based on the lack of mammalian
metabolism and oral and dermal toxicity demonstrated by the
chlorinated isocyanurates, EPA will be willing to consider a
request for an exemption of a tolerance for these uses.
7. While data gaps are being filled, currently registered
manufacturing-use products containing chlorinated
isocyanurate may be sold, distributed, formulated and used,
subject to the terms and conditions specified in this
standard. Registrants must provide or agree to develop
additional data, as specified in the Data Appendices, in
order to maintain existing registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration for previously registered use
patterns simply because data are missing or are inadequate
[see FIFRA sec. 3(c)(2)(B) and 3(C)(7)J. Issuance of this
standard provides a mechanism for identifying data needs
which then will be required to be submitted to maintain the
registration of pesticide products containing chlorinated
isocyanurate. These data will be reviewed and evaluated,
after which the Agency will determine if additional
regulatory changes are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this standard,
products must contain a chlorinated ispcyanurate as the sole
active ingredient, bear required labeling, and conform to the
.product composition, acute toxicity limits, and use pattern
requirements listed in this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this standard,
manufacturing-use products (MUPs) must contain one of the six
chlorinated isocyanurates described in Section II (A) as the
sole active ingredient. Each MUP formulation proposed, for
registration must be fully described with an appropriate
certification of limits, stating maximum and minimum amounts
of the active ingredient and inert ingredients which are
present in products, as well as impurities found at greater
than 0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing chlorinated
isocyanurates provided that the product labeling bears
appropriate precautionary statements for the acute toxicity
category in which each product is placed. :
3. Use Patterns
To be registered under this standard, manufacturing-use
products may be labeled for formulation into end-use products
intended for indoor and aquatic non-food use patterns only.
The Index to Pesticide Chemicals^/ lists all registered uses
and sites, as well as approved maximum application rates and
frequencies.
D. LABELING
All manufacturing-use products must bear appropriate
labeling as specified in 40 CFR162.10. Appendix II contains
information on label requirements.
No pesticide product containing a chlorinated isocyanurate
may be released for shipment by the registrant after 12 months
from the date of issuance of this standard unless the product
bears an amended label which complies with the requirements of
this standard.
Z/ The Index to Pesticide Chemicals may be obtained from the
National Technical Information Service (NTIS), Attn: Order Desk,
5285 Port Royal Road, Springfield, VA 22161 (tel : 703/487-4650)
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No pesticide product containing a chlorinated isocyanurate
may be distributed, sold, offered for sale, held for sale,
shipped, delivered for shipment, or received and (having so
received) delivered or offered to be delivered by any person
in channels of trade after 24 months from the date of issuance
of this standard unless the product bears an amended label
which complies with the requirements of this standard.
In addition to the above, the following information must appear
on the labeling:
1. Ingredients Statement
The ingredient statement for manufacturing-use
products must list the active ingredient as:
Dichloro-s-triazinetrione; or
Potassium dichloro-s-triazinetrione; or
Sodium dichloro-s-triazinetrione; or
Trichloro-s-triazinetrione; or
Penta-s-triazinetrione; or
Sodium dichloro-s-triazinetrione dihydrate.
2. Use Pattern Statements
All manufacturing-use products must state that they
are intended for formulation into end-use products for
acceptable use patterns. Labeling must specify site
categories which are listed in the Index to Pesticide
Chemicals. However, no use may be included on the label
where the registrant fails to agree to comply with the
data requirements in TABLE A for that use pattern.
3. Precautionary Statements For Manufacturing-Use
Products'
a. Labels for manufacturing-use products containing
chlorinated isocyanurates must bear statements
reflecting the acute eye irritation potential
(Category I) for these chemicals. Required
precautionary statements associated with this
category are specified in 40 CFR 162.10.
b. The signal word "Danger" is required on the front
panel of all manufacturing-use labels.
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c. The following environmental hazard statement must
appear on all manufacturing-use labels:
This pesticide is toxic to fish. Do not
discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or
public waters unless this product is
specifically identified and addressed in an
NPDES permit. Do not discharge effluent
containing this product to sewer systems without
previously notifying the sewage treatment plant
authority. For guidance contact your State
Water Board or Regional Office of the EPA.
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V. PRODUCTS SUBJECT TO THIS STANDARD
All manufacturing-use products containing one of the
chlorinated isocyanurates identified in Section II.A. are
subject to certain requirements for data submission or changes
in composition, labeling or packaging of the product. Products
are subject to the following requirements:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B3/
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data compensation
provisions) associated with reregistration.
Refer to Section IX for specific submission requirements and
timeframes.
3/ Data requirements are listed in the two Tables in Appendix
T of this Registration Standard. The Guide to Tables in that
Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registration
Standard. Table B lists product-specific data applicable to
manufacturing use products. The data in Tables A and B need
not be submitted by a producer who is eligible for the
formulator's exemption* for that active ingredient.
* If you purchase from another producer and use as the source
of your active ingredient only EPA-registered products, you
are eligible for the formulator's exemption for generic data
concerning that active ingredient (Table A) and product-
specific data for the registered manufacturing use product
you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption and
become subject to the data requirements in Table A.
2) If no producer subject to the generic data
requirements in Table A agrees to submit the required dat;
all previously eligible producers lose the exemption, and
become subject to those data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It refers
to the data listed in Table A, which are required to be
submitted by registrants to maintain in effect the registration
of products containing this active ingredient.4/
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is complying
with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both your
product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. In
such cases, the Agency generally will not grant a time
extension for submitting the data.
4/ Registrations granted after issuance of this standard will
be conditioned upon submission or citation of the data listed
in this Registration Standard.
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If you are not now eligible for a formulator's exemption,
you may qualify for one if you change your source of supply to
a registered source that does not share ownership in common
with your firm. If you choose to change sources of supply,
the Confidential Statement of Formula must identify the new
source(s) and you must submit a Formulator's Exemption
Statement form.
.If you apply for a new registration for products
containing this active ingredient after the issuance of this
Registration Standard, you will be required to submit or cite
generic data relevant to the uses of your product if, at the
time the application is submitted, the data have been submitted
to the Agency by current registrants. If the required data
have not yet been submitted, any new registration will be
conditioned upon the new registrant's submission or citation
of the required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data,, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency. "
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA Form
8580--1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been formed
which allows you to rely upon the data to be submitted. 'Such
evidence may be: (1) your letter offering to join in an
agreement and the other registrant's acceptance of your offer,
(2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
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The Agency will also require adequate assurance that the person
whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of
the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,as
a general policy, it will not suspend the registration of a
product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost sharing
program, but the other registrants developing the data have
refused to accept its offer. [If your offer is accepted, you
may qualify for Option 2 above by entering into an agreement
to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement to
be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii).
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The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option. In order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the
required data in the specified timeframe. In such cases, the
Agency generally will not grant a time extension for submitting
the data.
4. You request a waiver of the data requirement. If you
believe that a data requirement does not (or should not) apply
to your product or its uses, you must provide EPA with a
statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply.
Since the Agertcy has carefully considered the composition and
uses of pesticide products in determining that a data
requirement applies, EPA does not anticipate that many waivers
will be granted. A request for waiver does not extend the
timeframes for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label. •
6. .You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703/487-4650).
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Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Any protocol
must be conducted in accordance with the Good Laboratory
Practice Regulation (48 FR 53846). Normally, the Agency will
not extend deadlines for complying with data requirements when
the studies were not conducted in accord with acceptable
standards. The OECD protocols are available from OECD, 1750
Pennsylvania Avenue, N.W., Washington, D.C. 20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient,
studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to the
Product Manager listed at the end of this section and must be
made by the 90-day deadline for response. Once dates have
been committed to and EPA has accepted these commitments, any
subsequent requests for a time extension must be submitted in
writing, to the Office of Compliance Monitoring at the address
given in Section IX.C.
EPA will view failure to request an extension before the
data submission response deadline as a waiver of any future
claim that there was insufficient time to submit the data.
While EPA considers your request, you must strive to meet the
deadline for submitting the data.
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The extension request should state the reasons why you
believe that an extension is necessary and the steps you have"
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity
or adequacy of funding, since the Agency believes that with
proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRAsec. 3(c)(2)(B), an existing stocks provision for
registrants is not consistent with the Act. Accordingly, the
Agency does not anticipate granting registrants permission to
sell or distribute existing stocks of suspended product except
in rare circumstances. If you believe that your product will
be suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly demonstrating
to EPA that granting such permission would be consistent with
the Act. The following information must be included in any
request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required
for their sale or distribution; and
2. Demonstration that such a provision would be
consistent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your
manufacturing-use registrations in effect. Product-specific
data are derived from testing using a specific formulated
product, and, unlike generic data, generally support only
the registration of that product. All such data must be
submitted by the dates specified in this Registration
Standard. These data are listed in Table B.
In order to comply with the product-specific data
requirements, you must follow the same procedures as for
generic data. See Section VI.D, E, F, and G. You should
note, however, that product chemistry data are required for
every product, and the only acceptable responses are options
VI.D.I. (submit data) or VI.D.6.(cancellation of registration)
Failure to comply with the product-specific data
requirements for your products will result in suspension of
the product's registration.
VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions,
reflecting the Agency's assessment of the data supporting the
product and its uses. General labeling requirements are set
out in 40 CFR162.10 (see Appendix II - LABELING and SUMMARY).
In addition, labeling requirements specific to products
containing this pesticide are specified in Section IV.D of
this Registration Standard. Applications submitted in response
to this notice must include draft labeling for Agency review.
Refer to Section IX for specific submission requirements and
timeframes.
If you fail to submit revised labeling as required, which
complies with 40 CFR162.10 and the specific instructions in
Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division for
each product subject .to this registration standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5/
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Formulator's Exemption Statement, if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
e. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup Of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text.
2. Within 9 months from receipt of this document you must
submit to the Product Manager:
a. Application for Pesticide Registration (EPA
Form 8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Product Specific Data Report (EPA Form 8580-4).
5_/ If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is .not applicable
.or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary Sheet
(and any supporting information) to the Office of Compliance
Monitoring, which will be monitoring the data generated in
response to this notice. This submission is in addition to
responding to the Product Manager, and should be submitted to
the Office of Compliance Monitoring at the address given at
the end of this section. (Actual studies are not to be
submitted to the Office of Compliance Monitoring.)
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3. Within the times set forth in Table A, you must submit
to the Registration Division all generic data, unless you are
eligible for the formulator's exemption. If for any reason
any test is delayed or aborted so that the schedule cannot be
met, immediately notify the Product Manager and the Office of
Compliance Monitoring of the problem, the reasons for the
problem, and your proposed course of action.
B. Addresses
The required information must be submitted to the
following address:
Jeff Kempter (PM 32)
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data Integrity Assurance Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460.
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TGUIDE-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticides covered by this Registration Standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains products-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test, protocols set out in the Pesticide Assessment Guidelines,
which are available from the National Technical information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
D = Aquatic, non-food
I = Indoor
Any other designations will be defined in a footnote to the table.
-29-
-------
TGUIDE-2.
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its files that satisfy this data
requirement. These data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to" fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation. . ..-...-
5. Bibliographic citation (Column 5). If .the Agency has
acceptable data in its files, this column lists the identifying
Master Record Identification (MRID) number. Refer to the
Bibliography Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe: for submission (Column 7). If column 5 requires
that data be submitted, this column indicates when the data
are to be submitted, based on the issuance' date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory. .
-30-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement Test
Substance
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product Ingredients
62-1 - Preliminary Analysis TGAI
Physical and Chemical
Characteristics
63-2 - Color TGAI
63-3 .~ Physical State TGAI
63-4 -^ Odor TGAI
63-5 - Malting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, TGAI
Use
Patterns
- All
All
All
All
All
All
All
All
All
Does EPA Bibliographic Mast Additional Time Frame
Have Data?!/ Citationl/ Data be for
Submitted? Submission
N/A
N/A
N/A
N/A
N/A
N/A
: N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes2/
Yes3/
Yes4/
Yes
Yes
Yes
Yes
No5/
Yes
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
or Specific Gravity
63-8 - Solubility
TGAI or PAI
ALL
N/A
N/A
Yes
6 Months
-31-
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLORINATED ISOCYANURATES
Data Requirement Test Use Does EPA Bibliographic Mast Additional Time Frame
; Substance Patterns Have Data?V Citation!/ Data be for
' . • . Submitted? Submission
.§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-9 - Vapor Pressure PAI A11 N/A N/A Yes 6 Months
63-*-10;rDissociationConstant .PAI All N/A N/A Yes 6 Months
63-11 -OCtanol/Water Partition PAI All N/A N/A Yes 6 Months
Coefficient
;63-12 - pH . ;
63-13 - Stability
TGAI
TGAl
All
All
N/A
N/A
N/A
N/A
Yes
Yes
6 Months
6 Months
'_!/ .Not applicable. Although product chemistry data may been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ Complete information must be provided regarding the nature of the process (batch or continuous), the relative amounts
of beginning materials and the order in which they are added, the chemical equations for each intended reaction,
,; equipment used to process each intermediate and the final product, reaction conditions, the duration of each step of
the process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, producer, or supplier of each beginning material must be provided, along with information regarding the
properties of each beginning material used to manufacture each product;
3/ A detailed discussion of all impurities that are or may be present at X).l%, based on knowledge of the beginning
materials, chemical reactions (intended or side) in the manufacturing process, and any contamination during and after
production must be submitted.
4/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which
a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each analytical
method used.
5/ Not required because the technical material is a solid at roan temperature.
-32-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement Test
Substance
§158.130 Environmental Fate
Degradation Studies-Lab
161-1 - Hydrolysis TGAI or PAIRA
Photodegradation
161-2 - In Water TGAI or PAIRA
161-3 - On Soil TGAI or PAIRA
161-4 - In Air TGAI or PAIRA
Metabolism Studies-Lab
162-1 - Aerobic Soil TGAI or PAIRA
162-2 - Anaerobic Soil TGAI or PAIRA
'$• 162-3 - Anaerobic Aquatic TGAI or PAIRA
162-4 - Aerobic Aquatic TGAI or PAIRA
Mobility Studies
163-1 - Leaching and TGAI or PAIRA
Adsorption/Desorption
163-2 - Volatility (Lab) TEP
163-3 - Volatility (Field) TEP
Use
Patterns
D,I
D
N/A
N/A
N/A
N/A
D
D
N/A
N/A
N/A
Does EPA Bibliographic
Have Data? citation
Yes 00056478
NO
NO
NO
NO
NO
NO
NO .
NO
NO
NO .'•'•••
Must Additional Time Frame
Data be for
Submitted? Submission
Nol/
No2/
NoV
No4/
No V
N03/
No2/
Nq2/
NoV
N04/
N04/ .
-33-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement
§158.130 Environmental Fate -
Dissipation Studies-Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-term
Accumulation Studies ,
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
; , '-• (Field)
165-3,- Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Target
Test
Substance
Continued
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
Use
Patterns
N/A
D
N/A
N/A
N/A
N/A
N/A
D
D
Does EPA Bibliographic
Have Data? Citation
NO
NO
No
No
No
NO
NO
NO
NO
Must Additional
Data be
Submitted?
No3/
N02/
No5/
NoV
No6/
No6/
N06/
N02/
N02/
Time Frame
for
Submission
Organisms
-34-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
§158.130 Environmental Fate - Continued
I/ The test substance for this requirement was sodium isocyanurate which is toxicologically equivalent to isocyanuric
acid, a chemical representative of all the chlorinated isocyanurates. Although isocyanurate acid is utilized as a
buffer to stabilize chlorine and has no pesticidal properties per se, it was selected as the test substance for this
study because by using the dechlorinated s-triazetrione, the effects of the triazinetrione moiety can be distinguished
from those of the chlorine.
2/ The environmental fate of hypochlorous acid, formed upon reaction with water of the chlorine portion of the
chlorinated isocyanurates, is known. In addition to hypochlorous acid, the triazine moiety is expected to result
from degradation of chlorinated isocyanurates in the-aquatic environment. Based on available mammalian metabolism
and oral and dermal toxicity studies, the unsubstituted triazine ring is essentially nontoxic. and rapidly excreted
in an intact form. It is, therefore, unlikely to accumulate in mammals. Similiarly, no accumulation in fish or
aquatic species is expected to occur, both due to the fairly high water solubility of the unsubstituted ring
(ca. 2000 ppm) and because rapid excretion is also expected to occur in fish and aquatic organisms. As a result of
the lack of toxicological or ecological problems associated with the triazine moiety, these data are not required.
V Not required because the chlorinated isocyanurates have ho soil application uses.
4/ Not required because the chlorinated isocyanurates are always applied and used in water solution.
5/ Not required because the chlorinated isocyanurates have no forestry uses.
6/ Not required because the chlorinated isocyanurates have no crop uses.
-35-
-------
. TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement Test
Substance
§158.135 Toxicology
Acute Testing
81-1 - Acute Oral Toxicity - Rat TGft.1
81-2 - Acute Dermal Toxicity TGAI
Use Does EPA Bibliographic
Patterns Have Data? Citation
All No
All No
Must Additional
Data be
Submitted
No2/
No2/
Time Frame
for
Submission
- Rabbit
81-3 - Acute Inhalation Toxicity TGAI
- Rat
81-7 -Delayed TGAI
Neurotoxicity - Hen
Subchronic Testing
82-1 - 90TDay Feeding / TGAI
..••;•':'"••'.' - Rcdeijt, and / V '• 'Y:": •'-•"'. '•'•'•,-•'.'
- Non-rodent (Dog)
82-2 -21-Day Dermal - Rabbit . . TGAI
82-3 - 90-Day. Dermal - Rabbit TGAI
B2.-4, - 90-Day inhalation TGAI
''. V' .•''•- Rat ; • •', .
82-5 - 90-Day Neurotoxicity TGAI
. , . - Hen' . :
All
All
All
All
All
All
All
No
No
Yesl/
No
No
No
No
No
No3/
No4/
00063477,00124782
No
No5/
No6/
No6/
Nb3/
!Sb4/
-36-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data
§158.
Requirement Test
Substance
135 Toxicology - Continued
Use Does EPA
Patterns Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
Chronic Testing .
83-1
83-2
83-3
83-4
- Chronic Toxicity - TGAI
2 species
- Rodent, and
- Non-rodent (Dog)
- Oncogenicity - TGAI
2 species
- Rat (preferred) , and
- Mouse (preferred)
- Teratogenicity - TGAI
2 species
- Rat
- Rabbit
- Reproduction - Rat TGAI
2-generation
All
Yesl/
No
All •
Yesl/
Yesl/
All
Yesl/
Yesl/
All Yesl/
00126362
00126362
00126361
00105168
00132510
00150286
t
No
No5/
No
No
No
No
No
Mutagenicity Testing
84-2
84-2
- Gene Mutation (Ames Test) TGAI
- Structural Chronoscmal TGAI
All Yesl/
All Yesl/
00094883
00091031
No
No
Aberration
084-4 - Other Genotoxic Effects
TGAI
All
Yesl/
-37-
00094882
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be . for
Submitted? Submission
§158.135 Toxicology - Continued
Special Testing
85-1 - General Metabolism PAI or PAIRA All
- Rat Yesl/ 00131014 No
- Dog Yesl/ 00128287 No
I/ The test substance for this requirement was sodiun isocyanurate which is toxicologically equivalent to isocyanuric
acid, a chemical representative of all the chlorinated isocyanurates. Although isocyanurate acid is utilized as a
buffer to stabilize chlorine and has no pesticidal properties per se, it was selected as the test substance for this
study because by using the dechlorinated s-triazetrione, the effects of the triazinetrione moiety can be distinguished
frcm those of the chlorine.
^/ Not required because 10 daily oral doses of 5 gm/kg/day produced no toxicity in the rat teratology study.
V Not required because sodium isocyanurate will not vaporize and is not expected to produce a respirable dust.
4_/ Not required because sodium isocyanurate is not an organophosphate inhibitor of cholinesterase, or related to such
inhibitors or metabolites of such inhibitors.
5/ Not required based on comparative metabolism studies in rat and dog.
6/ Not required based on the lack of toxicity demonstrated in oral drinking studies at doses far above use
concentrations.
-38-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement Test
Substance
§158.145 Wildlife and
Aquatic Organisms
Avian and Mammalian Testing
71-1 - Acute Avian Oral Toxicity TGAI
71-2 - Avian Subacute Dietary TGAI
Toxicity
- Upland Game Bird, and
- Waterfowl
71-3 - Wild Mammal Toxicity TGAI
71-4 - Avian Reproduction TGAI
- Upland Game Bird, and
- Waterfowl
71-5 - Simulated Field Testing TEP
- Mammals, and
- Birds
Use Does EPA Bibliographic Must Additional
Patterns Have Data? Citation Data be
Submitted?
D,I Yes 00132603,00150962 No
D Yes 00132426,00132427
00144301,00144302
00150963,00150964
• - No • '
NO
N/A NO Nql/
N/A 'NO
Nql/
Nql/
N/A NO
Nol/
Nol/
Time Frame
for
Submission
- Actual Field Testing
- Mammals, and
- Birds
TEP
N/A
NO
Nol/
-39-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
Aquatic Organism Testing
72-1 - Freshwater Fish Toxicity TGAI
- Coldwater Fish Species,
and
- Warmwater Fish Species
72-2 - Acute Toxicity to TGAI
Freshwater Invertebrates
72-3 - Acute Toxicity to TGAI
Estuarine and tferine
Organisms
- Fish
- MDllusk
- Shrimp
72-4 > Fish Early Life Stage, TGAI
and
- Acjuatic Invertebrate
Life-Cycle
72-5 -Fish -Life-Cycle : TGAI
D
D
Yes2/
Yes
Yes
00026193,00026195 Mb
00150965,00150966
00019383,00150967 No
00154329
40351801
D
Partially 40351801
Partially 40351801
No
Reserved3/
Reserved3/
-40-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
Data Requirement
Test
Substance
Use
Patterns
Does
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission
§158.145 Wildlife and
Aquatic Organisms - Continued
72-6 - Aquatic Organism
Accumulation
- Crustacean
- Fish
- Insect Nymph
- Mollusk
72-7 ~ Simulated or Actual
Field Testing
- Aquatic Organisms
TGAI, PAI or
Degradation
Product
D
No
TEP
No
Nq4/
No4/
Nq4/
Nq4/
Yes5/6/
24 Months
Protocol: 4 Months
-41-
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORINATED ISOCYANURATES
§158.145 Wildlife and Aquatic Organisms - Continued
I/ Not required because there is no expected exposure from the registered patterns of use.
2/ Only one species is required. . .
V Development of these data is contingent upon the results of the residue monitoring study for chlorine resulting from
treatment with the chlorinated isocyanurates (72-7).
4/ In addition to hypochlorous acid, the triazine moiety is expected to result from degradation of chlorinated
isocyanurates in the aquatic environment. Based on available mammalian metabolism and oral and dermal toxicity
studies, the unsubstituted triazine ring is essentially nontoxic and rapidly excreted in an intact form. It is,
therefore, unlikely to accumulate in mammals. Similiarly, no accumulation in fish or aquatic species is expected to
occur, both due to the fairly high water solubility of the unsubstituted ring (ca. 2000 ppm) and because rapid
excretion is also expected to occur in fish and aquatic organisms.
_5/ Simulated field testing is required as follows: Within 24 months a study monitoring chlorine in industrial effluents
and receiving waters is required where the pesticide is used as a microbiocide in cooling towers, pulp and paper
mills, and oil drilling operations. Based on use information (i.e., geographical sites, amount used), the registrant
is required to develop an acceptable protocol, within 120 days of receipt of this notice and prior to study
initiation, to sample a representative number of the above mentioned facilities in order to assess the release of
chlorine into the environment with regard to the National Criteria set for this chemical. Monitoring is required due
to the known acute and chronic effects of hypochlorous acid on aquatic organisms and possible effects on endangered
species. Any protocol developed for monitoring this chemical must consider the following requirements: (i) use of
standard analytical methods, i.e., HPLC or MSGC, to measure chlorine, (ii) sites selected for sampling must be where
chlorinated isocyanurates are currently being used and be representative of small and large facilities and/or volumes,
(iii) sites selected must also be representative of (a) a range in volume of the receiving water bodies of rivers and
(b) freshwater and estuarine ecosystems, (iv) samples taken for analysis must be taken before treatment, after
treatment and from receiving waters, (v) sampling should be done at regular intervals for a long enough period of
time to account for such things as seasonal and use variations. Actual field testing for fish and aquatic species
will be reserved pending the results of this study.
6/ The test material for this study is trichloroisocyanurate.
-42-
-------
. • . TABLE B ••..;••.
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORINATED ISOCYANURATES
Data Requirement
§158.120 Product Chemistry
Product Identity
61-1 - Product Identity and
Disclosure of
Ingredients
61-2 - Description of Beginning
Materials and
Manufacturing Process
61-3 - Discussion of Formation
of Impurities
Test
Substance
M?
MP
MP
Use
Patterns
All
All
All
Does EPA
Have Data?!/
N/A
N/A
N/A
Bibliographic
Citationl/
N/A
N/A
N/A
Must Additional
Data be
Submitted?
Yes2/
Yes3/
Yes4_/
Time Frame
for
Submission
6 Months
6 Months
:
6 Months
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits -
62-3 - Analytical Methods to
Verify Certified Limit
MP
-M?
M?
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
Yes5/
Yes6/
Yes?/
12 Months
12 Manths
12 Months
Physical and Chemical Characteristics
63-2 - Color
63-3 - physical State
63-4 - Odor
M?
M?
MP
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
' Yes '-:'• '. ' • '• '•
Yes
Yes
: . 6 Months
6 Months
6 Months
-43-
-------
TABLE B
.PRODUCT SPECIFIC DATA REQUIREMENTS FOR M/NUFACTU RING-USE PRODUCTS CONTAINING CHLORINATED ISOCYANURATES
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?!/
Bibliographic
Citationl/
Mist Additional
Data be
Submitted?
Time Frame
for
Submission
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-7 - Density, Bulk Density,
or Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
M?
M?
M3
M?
M?
M?
M>
M?
MP
All
All
All
All
All
All
All
All
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
Yes
Yes
No8/
Yes
Yes
Yes
No9/
Yes
6 Months
6 Months
6 Months
6 MDnths
15 Months
6 Months
6 Months
-44-
-------
. TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHLORINATED ISOCYANURATES
§158.120 Product Chemistry - Continued
I/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
. ~ these data must be resubmitted for each manufacturing use product. New requirements have been introduced and
previously submitted data must be updated. Therefore, bibliographic citations for the old data are not applicable.
2/ The chemical name and nominal concentration of each impurity for which a certified limit is required must be
submitted. In addition, the chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and
purpose of each active ingredient and each intentionally added inert must be provided. For the active ingredient,
the following must also be provided: the product name, trade name, and common name; the molecular, structural, and
empirical formulas; the molecular weight or weight range; and any experimental or internally assigned company code
numbers. .
V Complete information mast be provided regarding the nature of the process (batch or continuous), the relative amounts
of beginning materials and the order in which they are added, the chemical equations for each intended reaction,
equipment used to produce each intermediate and the final product, reaction conditions, the duration of each step of
the process, purification procedures, and quality control measures. In addition, the name and address of the
manufacturer, producer, or supplier of each beginning material nust be provided, along with information regarding the
properties of each beginning material used to manufacture each product.
4/ A detailed discussion of all impurities that are or may be present at _>0.1%, based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during and after
production must be submitted. .
5/ Five or more representative samples must be analyzed for the amount of active ingredient and each impurity for which
a certified limit is required. Complete validation data (accuracy, precision) must be submitted for each analytical
method used.
6/ Upper and lower limits for the active ingredient and each intentionally added inert, and upper limits for each
impurity present at _>0.1% (w/w) must be provided, certified, and validated by sample analysis using analytical
procedures for which accuracy and precision data have been provided.
7/ Analytical methods must be provided to determine the active ingredient for which certified limits are required.
~ Each method must be accompanied by validation studies indicating its accuracy and precision. These methods must be
suitable for enforcement of certified limits.
8/ Not required because there are no flammable liquids in the product.
9/ Not required because the product is not intended to be mixed with petroleum solvents.
-45-
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLORINATED ISOCYANURATES
Data
§158.
Requirement Test
Substance
135 Toxicology
Use Does EPA Bibliographic Must Additional
Patterns Have Data? Citation Data be
Submitted?
Time Frame
for
Submission
Acute Testing
81-1
81-2
81-3
81-4
81-5
81-6
-Acute Oral To xi city - Rat MP
- Acute Dermal Toxicity MP
- Rabbit
- Acute Inhalation Toxicity MP
- Rat
- Primary Eye MP
Irritation - Rabbit
- Primary Dermal MP
Irritation - Rabbit
- Dermal Sens it i zation - MP
Guinea Pig
All Yes 00150953,00150959 No
All Yes 00150954,00150960 No
All No Nol/
All Partially 00150955 Yes2/
All Yes 00150956,00150961 No
All Yes 00144720,00144721 No
9 Months
I/ Not required because chlorinated isocyanurates will not vaporize and are not expected to produce a
respirable dust.
2/ This study is only required for trichloroisocyanurate.
-46-
-------
. SUMMARY-1
. LABEL CONTENTS
.40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
. Item 2. COMPANY NAME AND ADDRESS - The name and address
of'the registrant or distributor is required on the label.
The name arid address should preferably be located at.the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." in addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by .the Agency.
[40 CFR 162.10(e)} .
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
• : -47- • '
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size '
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "Poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h).(l) (iii)]
Item 8.. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the. three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
-48-
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SUMMARY-3 .
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. . [40 CFR 162.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to'
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary'statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. .RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that, all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted :use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.ll(c). You will be notified of
the Agency's classification decision.
-49-
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted .use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-50-
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SUMMARY-5
Item 10A. REENTRY STATEMENT.- If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B.. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and .
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment.
[40 CFR 162.10]
COLLATERAL LABELING .
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-51-
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product nane
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/ gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-52^
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SUMMARY-7
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Re f erral
statement
Side/back panel
precautionary
statements
Hazards to
hunans and
domestic
animals
Environmental.
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der- '
mal, or inhala-
tion toxicity
All products i
in Categories
I, II, and III
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
/
Category I :
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-53-
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SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150 °F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the.
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The vrords "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling. "
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as wall as U.S. units
-54-
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§ 162.10 Title 40—Protection of Environment
0 162.10 Labeling requlremenU.
(a) General—<1) Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations In this Part. The contents of a
label must show clearly and promi-
nently the following:
<1) The name, brand, or trademark
under which the product Is sold as pre-
scribed in paragraph
-------
Chapter I—f nvlronmontol Protection Agoncy
9 16110
whom produced as prescribed in para-
graph (c) of this section:
(ill) The net contents as prescribed
In paragraph (d) of this section:
(lv) The product registration
number as prescribed in paragraph (e)
of this section:
(v) The producing establishment
number as prescribed in paragraph (f)
of this section:
(vi) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion:
(vti) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(vlli) The directions for use as pre-
scribed in paragraph (i) of this section;
and
(ix) The use classification^) as pre-
scribed In paragraph (j) of this section.
(2) Prominence and legibility. (1) All
words, statement*, graphic representa-
tions, designs or other Information re-
quired on the labeling by the Act or
the regulations In this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuouuiess (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary Individual under custom-
ary conditions of purchase and use.
(U) All required label text must:
(A) Be set In 6-polnt or larger type:
(B) Appear on a clear contrasting
background: and
(C) Not be obscured or crowded.
(3) Language to be tued. 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-li} General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of
-------
§ 162.10
Titl* 40—Protection of Environment
(v) Any sutement directly or Indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients 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;
(vli) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser.
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(be) Claims as to the safety of the
pesticide or its Ingredients, including
statements such as "safe." "nonpoison-
ous." "nonlnjurious." "harmless" or
"nontoxlc to humans and pets" with
or without such a qualifying phrase as
"when used as directed": and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product. Including but not limited to:
(A) "Contains all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(0) Final printed labeling. (1) Except
as provided in paragraph (aXflXll) of
this section; final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(il) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(11) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to 1162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
drers given on the label shall be con-
sid< red as the name and address of the
prt cucer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by • • V or "Sold by • • •" to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be in
terms of liquid measure at 68' F (20'C)
and shall be expressed in conventional
American units of fluid ounces, pints.
quarts, and gallons.
. (3) If the pesticide is solid or 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. i.e.. "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that it repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.," or the phrase "EPA Reg.
No." The registration number shall be
set In type of a size and style similar to
-57-
-------
Chapter I—Environmental Protection Agency
§ 16X10
other print on that put 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—41) Gener-
al The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all Inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the Inert ingredients by the
term "inert Ingredients." or the singu-
lar forms of these terms when appro-
priate. Both terms shall be In the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the Ingredient statement.
(2) Position of ingredient statement
(1) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes It Impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(11) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement The name used for each in-
gredient shall be the accepted
common name. If there is one. fol-
lowed by the chemical name. The
common name may be used alone only
If it is well known. If no common name
has been established, the chemical
name alone shall; be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cX0).
(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 percentage*.
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:
(!) In cases where it Is determined
that a pesticide formulation changes
chemical composition significantly.
the product must bear the following
statement In a prominent position on
the label: "Not for sale or use after
[date]."
(11) The product must meet all label
claims up to the expiration time indi-
cated on the label.
-58-
-------
§162.10
TWt 40—Protection of Environment
(7) Inert ingredient*. The Adminis-
trator may require the name of any
Inert ingredienUs) to be listed in the
Ingredient statement if he determines
that such ingredienUs) may pose a
hazard to man or the environment.
(h) Warningt and precautionary
$tatementi. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard Including hazard to children,
environmental hazard, and physical or
chemical hazard fall into two groups;
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
in the table below:
On) U>» "...
IntalMon LCi»......
Oumtt ID. ....
Er* •fee*
Stun «n«cta
i
Up to «id nfedng SO
me/kg
Up ID «nd mftrirg 2
ing/Mr.
Up to M nofcOng 200
mg/kg.
Caiu»n. eomnl
•mn 7dq*.
Ojimm
Tenacity c
II
F»om 50 tvu 500 rug/kg.!
From 2 »m 2 mg/Mv
ftvt 200 Wni 2000
CamMlOMOty
diyt. «rn»«on
pnong tor 7 cfcyi.
SaiKt iimuuit tl 72
hqin.- .
•Mgonn
III
From 500 Wu SOOO mg/
""»
From 2. *ni 20 mg/Mv...
From 2.000 tiu 20.000....
No oofnov opAcMyi
•imx 7 d«y»
Modtritt fruition •! 72
• Hon..
IV
GfMMf than 5000 mg/
k»
QrMMi twi 20 mg/Mw.
GrwMr mm 20.000
Nemukon.
72f»ur»
(i) Human hazard signal word—(A)
Toxirily Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear oh the front
panel the signal word "Danger." In ad-
dition if the product was assigned to
Toxicity Category I on the basis of Its
oral. Inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
crossbones shall appear in immediate
proximity to the word "poison."
(B) Toxicitv Category IL All pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicitv Category til. All pesti-
cide products meeting the criteria of
Toxicity Category in shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicitv Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable advene effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(11) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution. market-
Ing, storage or use is demonstrated by
the applicant to be extremely remote.
or if the nature of the pesticide is such
that It is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(Ill) Statement of practical treat-
m«nt—
-------
Chapter I—Environmental Protection Agency
§ 162.10
basis of oral, inhalation or dermal tox-
icity. The Agency may. however.
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiiiXA) of
this section. The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are. however, re-
quired elsewhere on the label In
accord with paragraph (hX2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
So* at liM rront panel « aquar*
ncnoa
5 end undar
AMve i to 10
AArjva 10 to IS . ,,
Adrrt IS to 30 ,
Ovw X
Pa
Raqurad
•en*
worn.*
apian
6
10
12
14
11
nta
"KaapOUt
Olreacnol
Cnttan
e
•
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 animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident.
injury or damage'. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Tonoty
category
i by tonofy category
Oral.
Stoi and ey« local erieca
iv
Fatal (pononoua) * iwaliOMd (nnated or abaorbed
tnrougn **i]. Do not braair* vapor (dual or epray
mot). Oo not gel « eyaa. on Hun. or on ooffwig
(Front panel Matamem of practeal twtmant re-
Corroawa. cauaa* aya
tmaoon). Oo not ga
May be fatal if e»e«e»ed (rriaua or
through ma etuM. Do not breame vapor* (dual or
tpray mat). Oo not gal: in ayea. on Hun. or on
doming. (Appropriate lirtt ari uatamanta reqund.l.
Marmtui if twaitowed (mnaied or aoaoread mrauglt ma
Mun) Avori Draaffmg vapor* (dual or vray mat].
*»oid comaei •» «un (VTM or domng). (Appro-
pnaia lirtl aM Hatamara raquvad.l.
(No praeautionary tutamanti raourad.I ..........................
and Hun damage (or Hur.
I .m eyea. on Hun. or on
or face afMid
glove* when nanotng KarmMl or fatal if
(Appropriate f**t aid statement reoured.l
Cauaaa eye (and Hun] tnuraon Do not gi
on Hun. or on ooomg. Harmtui it
propnata Drat ma awamara requrad.)
Avort contact OTV< Hun. eyea or cMwg *
1 contact •nmeduiety nuafi eye* or Hun won
water. Gel meat* anenaon it rmaaon
(No precautionary tiatementa reojuved.1
x ay«a.
(Ap-
i eaaa of
pianfyol
(li) rnrironmenta/ hazards. Where a
hazard exists to non target organisms
excluding humans and domestic ani-
mals, precautionary statements are re-
quired stating the nature of the
hazard and the appropriate precau-
tions to avoid potential accident.
injury or damage. Examples of the
hazard statements and the clrcum-
-60-
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§ 162.10
TltU 40—Protection of Environment
stances under which they are required
follow:
(A) If a pesticide Intended for out-
door use contains an active Ingredient
with a mammalian acute oral LDH of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide intended for out'
door use contains an active ingredient
with an avian acute oral LDH of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes,
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Requndtnt
(A)
U CONTAIN!**
Flu* porn «i or b«o» X' f. * to* • • ftaenoeck it
eny «•*>• openng.
nun pant efcov* W f. end not over W f or H We
of entrant th* Kern*
Al O0w presitraed contewjni .. .-. '
(B)NONMW
Al or Moo »' f „
Above JO' f end not over to' F....
Above to' f end not o**> ISC' f
Ext*m*tr flenvnebie Contents ifO* pretsm Keep *i
container EJVOKV* to temper»u»ei ebove 'W f m
(xrwng .
FUnwniM*. Contents und* prrum KMO my Ire
Eipmm to i»np*im*« *DO«« i»- F m*y c*u**
Contents t^ioer pressue Do not ue* or star* n*er n*el
Item* Do not puncu* or manent* eonUmer Em
Mmpemves ebov* 130' F nwy CIUM oirttng
MUKI2IO CONTAMtM
ErtenWy ftemrfMM*. Keep «w*y from fr*. eperks. en
•rfeoM.
FlenvneMe Keep evey Com hex end open Home
Do not uee or ettro neer heet or open lam*
•ey kom
m fteT-tt.
birmng.
or open
o*tf* to
1 heeled
(i) Direction for Vie—(1) General
requirement*—(I) Adequacy and clar-
ity of direction*. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable advene effects on the
environment.
(il) Placement of direction* for ute.
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 bag;
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that It is not necessary for such direc-
tions to appear on the label.
(ill) Exceptions to requirement for
direction for use—
-------
Chapter I—Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products In
their regular manufacturing processes,
provided that:
C) The label clearly shows that the
product Is intended for use only in
manufacturing processes and specifies
the type(s) of products Involved.
(2) Adequate information such as
technical data sheets or bulletins, is
available to the trade specifying the
type of product Involved and its
proper use in manufacturing process-
es;
(J) The product will not come Into
the hands of the general public except
after incorporation into finished prod-
ucts: and
«) The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects oh man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
U> The label clearly states that the
product is for use only by physicians
or veterinarians:
(21 The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment: and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
(C) Detailed directions for use may
be omitted from the labeling of pesti-
cide products which are Intended for
use only by formulators in preparing
pesticides for sale to the public, pro-
vided that:
11) There is information readily
available to the formulators on the
composition, toxicity. methods of use.
applicable restrictions or limitations.
and effectiveness of the product for
pesticide purposes:
(2) The label clearly states that the
product is intended for use only In
manufacturing, formulating, mixing.
or repacking for use as a pesticide and
specifies the type(s) of pesticide prod-
ucts Involved:
(J) The product as finally manufac-
tured, formulated, mixed, or repack-
aged is registered; and
(4) The Administrator determines
that such directions are hot necessary
to prevent unreasonable adverse ef-
fects on man or the environment.
(2) Content! of Directions for Ute.
The directions for use shall include
the following, under the headings "Di-
rections for Use":
(i) The statement of use classifica-
tion as prescribed in 162.UKJ) immedi-
ately under the heading "Directions
for Use."
(ii) Immediately below the state-
ment of use classification, the state-
ment "It is a violation of Federal law
to use this product in a manner incon-
sistent with its labeling."
(Ill) The site(s) of application, as for
example the crops, animals, areas, or
objects to be treated.
(iv) The target pestts) associated
with each site.
(v) The dosage rate associated with
each site and pest.
(vi) The method of application. In-
cluding instructions for dilution. If re-
quired, and type<3) of application ap-
paratus or equipment required.
(vll) The frequency and timing of ap-
plications necessary to obtain effective
rerults without causing unreasonable
adverse effects on the environment.
(vlli) Specific limitations on reentry
to areas where the pesticide has been
applied, meeting the requirements
concerning reentry provided by 40
CFR Part 170.
(ix) Specific directions concerning
the storage and disposal of the pesti-
cide and Its container, meeting the re-
quirements of 40 CFR Part 165. These
instructions shall be grouped and
appear under the heading "Storage
and Disposal." This heading must be
set in type of the same minimum sizes
as required for the child hazard warn-
ing (See Table In 1162.1(XhXl)(iv).)
(x) Any limitations or restrictions on
use required to prevent unreasonable
adverse effects, such as:
(A) Required intervals between ap-
plication and harvest of food or feed
crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use
on certain crops, animals, objects, or
in or adjacent to certain areas.
(D) [Reserved]
-62-
-------
§1*2.11
TltU 40—Protection of Environment
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Vie Classification.
By October 22.1976. all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs (jXI) and (2) of this sec-
tion. Any pesticide product for which
some uses are classified for general use
and others for restricted use shall be
separately labeled according to the la-
beling standards 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(s) and the other
bearing directions for restricted use Advertising. [Reserved]
(40 FR 38288. July 3, 1975; 40 FR 32329.
Aug. 1. 197S: 40 FR 38571. Aug. 21. 1975. U
amended at 43 FR S786. Feb. 9.1978]
-63-
-------
Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
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.
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.
-64-
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STOR-1
STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. .Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for domestic, use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions: .
All product labels are required to have 'appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
ciffect the container of the product .and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
sspilled, 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.
-65-
-------
PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended .solely for domestic
use, nust 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 vater, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity,. or Toxicity Category I or II on the basis of. acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. If these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance." .
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFR 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
. "Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal.facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and. discard in trash."
-65-
-------
CONT/DIS-1
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:'
Container Type
Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar) .
Rinse thoroughly before discarding in trash.
Do not reuse bag. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type,Fisted below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Glass containers
Triple rinse(or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in. a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused-^-, dispose of in the same manner.
Paper and
plastic bags
Completely .empty bag into application
equipment. Then dispose of .empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
but of smoke.
Compressed gas
cylinders
Return empty cylinder for reuse (or
similar wording)
W Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
-57-
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BIBGUIDE-1
GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant .by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this.
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the.
published literature, in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography.
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character.
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-68-
-------
BIBGUIDE-2 .
Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element i-s 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.
-69-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlorinated Isocyanurates Standard
MRID CITATION
00019383 LeBlanc, G.A. (1976) Trichloro-s-triazinetrione: Acute Toxicity of
ACL-85 to Daphnia magna. (Unpublished study received Aug 10,
1977 under 230-50; prepared by EG&G, Bionomics for Monsanto Co.,
submitted by FMC Corp., Industrial Chemical Group, Philadelphia,
Pa.; CDL:231918-H)
*
00026193 McCann, J.A.; Pitcher, F.G. (1973) Camp Rapid Algae Cure: Toxici-
ty to Rainbow Trout: Test No. 555. (U.S. Environmental Protec-
tion Agency, Pesticides Regulation Div., Agricultural Research
Center, Animal Biology Laboratory, unpublished report.)
00026195 McCann, J.A.; Pitcher, F.G. (1973) Spot-Out: Toxicity to Rainbow
Trout: Test No. 583. (U.S. Environmental Protection Agency,
Pesticides Regulation Div., Agricultural Research Center, Animal
Biology Laboratory, unpublished report.)
00056478 Hu, H.C. (1981) Hydrolysis Study of Aqueous Sodium Salt Solutions
of 2,4,6-Trihydroxy-l,3,5-triazine. (Unpublished study received
Jan 26, 1981 under unknown admin, no.; prepared by FMC Corp.,
submitted by Monsanto Co., Washington, D.C.; CDL:244259-A)
00063477 Rajasekaran, D.; Biava, C.; Thorstenson, J.H.; et al. (1981) 13-
week Toxicity Study in Rats: IRDC No. 167-151. (Unpublished
study received Apr 9> 1981 under unknown admin, no.; prepared by
International Research and Development Corp. and Univ. of Cali-
fornia, San Francisco Medical Center, submitted by Monsanto Co.,
Washington, D.C.; CDL:244797-A)
00091031 Sharma, R.K. (1981) An Evaluation of the Matagenic Potential of
Sodium Cyanurate Using the in vivo Rat Bone Marrow Cytogenetic
Assay: SRI Project LSC-2923, Task 2; Monsanto Study No. SR-80-
522. Final rept. (Unpublished study received Jan 4, 1982 under
524-107; prepared by SRI International, submitted by Monsanto
Co., Washington, D.C.; CDL:246547-A)
00094882 Stewart, B.E. (1981) An Evaluation of the Effect of Monosodium
Cyanurate on Sister Chromatid Exchange Frequencies in Cultured
Chinese Hamster Ovary Cells: SRI Project LSC-2923, Task 1.
Final rept. (Unpublished study received Feb 17, 1982 under
- 1258-984; prepared by SRI International, submitted by Olin
Corp., Stamford, Conn.; CDL:246826-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registratibas Under the Chlorinated Isocyanurates Standard
MRID . CITATION
00094883 Kirby, P.E.; Pizzarello, R.F.; Brauninger, R.M.; et al. (1981)
Evaluation of Test Article Cyanuric Acid (Sodium Salt) (MRI
#582) for Matagenic Potential Employing the L5178Y TK+/- Mata-
genesis Assay: Study No. 013-312-582-7. (Unpublished study
received Feb 17, 1982 under 1258-984; prepared by EG & G Mason
Research Institute, submitted by Olin Corp., Stamford, Conn.;
CDL:246826-B)
00105168 Schardein, J.; Laughlin, K.; Blair, M. (1982) Teratology Study in
the Rat with Monosodium Cyanurate: 167-159. (Unpublished study
received Jun 11, 1982 under unknown admin, no.; prepared by
International Research and Development Corp., submitted by
Monsanto Co., Washington, DC; CDL:247700-A)
00124782 Serota, D.; Fezio, W.; Hepner, K.; et al. (1982) Thirteen-week Tox-
icity Study in Mice: Monsodium Cyanurate : Project No. 2169-100.
Final rept. (Unpublished study received Jan 6, 1983 under 524-
107; prepared by Hazleton Laboratories Anerica, Inc., submitted
by Monsanto Co., Washington, DC; CDL:249192-A)
00126361 Monsanto Co. (1983) Two Year Oncogenicity Study in Mice: Cyan-
urate. (Unpublished study received Feb 17, 1983 under 524-107;
CDL:249688-B)
00126362 Blair, M.; Jefferson, N.; Geil, R. (1982) Chronic Toxicity and
Oncogenicity Study in Rats: S-Triazinetriol: 167-157. (Unpub-
lished study received Feb 17, 1983 under 524-107; prepared by
International Research and Development Corp., submitted by Mon-
santo Co., Washington, DC; CDL:249688-C)
00128287 Chadwick, M.; Hayes, D.; McComish, M.; et al. (1982) Disposition
and Metabolism of 14C-labeled Sodium Cyanurate in Dog: C-86329.
(Unpublished study received Apr 29* 1983 under 524-107; prepared
by Arthur -p. Little, Inc., submitted by Monsanto Co., Washing-
ton, DC; CDL:250097-A)
00131014 Chadwick, M.; Hayes, D.; Branfman, A.; et al. (1983) Disposition
and Metabolism of 14C-labeled Sodium Cyanurate in Rat: C-86329.
Rev. (Unpublished study received Aug 29, 1983 under 524-107;
prepared by Arthur D. Little, Inc., submitted by Monsanto Co.,
Washington, DC; CDL:251124-A)
00132426. Fink, R. (1975) Eight-day Dietary LC50—Mallard Duck: ACL 85: Tri-
chloro-s-triazinetrione: Project No. 139-113. Final rept. (Un-
published study received Oct 12, 1983 under 230-47; prepared by
Truslow Farms, Inc., submitted by FMC Corp., Philadelphia, PA;
CDL:251626-E)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting.
Registrations Under the Chlorinated Isocyanurates Standard
MRID CITATION
00132427 Fink, R. (1975) Eight-day Dietary LC50—Bobwhite Quail: fCL 85:
Trichloro-s-triazinetrione: Project No. 139-112. Final
rept. (Unpublished study received Oct 12, 1983 under 320-47;
prepared by Truslow Farms, Inc., submitted by FMC Corp., Phila-
delphia, PA; CDL:251626-F) .
•
00132510 Consultox Laboratories, Ltd. (1974) Monosodium Cyanurate: Terato-
genicity Study in the Rabbit: CL 73: 101: 899. (Unpublished
study received Oct 12, 1983 under 230-47; submitted by FMC
Corp., Philadelphia, PA; CDL:251642-A)
00132603 Fink, R. (1976) Acute Oral LD50—Mallard Duck: PCL-85 : Trichloro-s-
triazinetrione: Project No. 139-120. Final rept. (Unpublished
study received Oct 12, 1983 under 230-47; prepared by Wildlife
International, Ltd., submitted by FMC Corp., Philadelphia, PA;
CDL:251626-G)
00144301 Beavers, J. (1984) A Dietary LC50 Study in the Mallard with Tri-
chloroisocyanurate Acid: Final Report: Wildlife International
Ltd. Project NO: 201-105. Unpublished study prepared by Wild-
life International Ltd. 14 p.
00144302 Beavers, J. (1984) A Dietary LC50 Study in the Bobwhite with Tri-
chloroisocyanurate Acid: Final Report: Wildlife International
Ltd. Project No: 201-104. Unpublished study prepared by Wild-
life International Ltd. 14 p.
00144720 Mappes, J. (1984) Dermal Sensitization Test Performed on Trichloro-
isccyanurate: Project No. 12066. Unpublished study prepared by
Bioassay Systems Corp. 17 p.
00144721 Mappes, J. (1984) Acute Dermal Toxicity and Dermal Sensitzation
Tests Performed on Sodium Dichloroisocyanurate : Project No.
12066. Unpublished study prepared by Bioassay Systems Corp.
25 p.
00150286 Schardein, J. (1985) Three Generation Reproduction Study in Rats
with Sodium Salt of Cyanuric Acid (S-Triazinetriol): Final
Report: Study No. 497-001. Unpublished study prepared by Inter-
national Research and Development Corp. 981 p.
00150953 Gargus, J. (1985) Acute Oral Toxicity Study in Rats, Dichlorocy-
anuric Acid, Sodium Salt, Dihydrate: Final Report: Project No.
2291-100. Unpublished study prepared by Hazleton Laboratories
America, Inc. 27 p.
-72-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlorinated Isocyanurates Standard
MKCD CITATION
00150954 Gargus, J. (1984) Acute Dermal Toxicity in Rats, Dichlorocyanuric
Acid, Sodium Salt, Dihydrate (Sodium Dichloro-s-triazinetrione)
Final Report: Project No. 2291-101. Unpublished study prepared
by Hazleton Laboratories America, Inc. 10 p.
00150955.Gargus, J. (1984) Primary Eye Irritation Study in Rabbits,
Dichlorocyanuric Acid, Sodium Salt, Dihydrate (Sodium Dichloro-
s-triazinetrione) : Final Report: Project No. 2291-102. Unpub-
lished study prepared by Hazleton Laboratories America, Inc.
14 p.
00150956 Gargus, J. (1984) Primary Dermal Irritation Study in Rabbits with
Dichlorocyanuric Acid, Sodium Salt, Dihydrate (Sodium Dichloro-
s-triazinetrione) : Final Report: Project No. 2291-103. Unpub-
lished study prepared by Hazleton Laboratories America, Inc.
14 p.
00150959 Gargus, J. (1985) Acute Oral Toxicity Study in Rats, Trichloro-
cyanuric Acid: Final Report: Project No. 2291-100. Unpublished
study prepared by Hazleton Laboratories America, Inc. 20 p.
00150960 Gargus, J. (1984) Acute Dermal Toxicity in Rats, Trichlorocyanuric
Acid (Trichloro-s-triazinetrionej : Final Report: Project No.
2291-101. Unpublished study prepared by Hazleton Laboratories
Anerica, Inc. 10 p.
00150961 Gargus, J. (1984) Primary Dermal Irritation Study in Rabbits with
Trichlorocyanuric Acid (Trichloro-s-triazinetrione) : Final
Report: Project No. 2291-103. 9 p.
00150962s Robaidek, E. (1985) Avian Single-dose Oral LC50 [in] Bob White
Quail (Colinus virginianus) : [Trichloroisocyanuric Acid] : Final
Report: Study No. 6026-435. Unpublished study prepared by
Hazleton Laboratories America, Inc. 26 p.
00150963 Robaidek, E. (1984) Avian Dietary LC50 [in] Mallard Duck (Anas
platyrhynchos) : [Trichloroisocyanuric Acid] : Final Report:
Study No. 6026-449. Unpublished study prepared by Hazleton
Laboratories America, Inc. 15 p.
00150964: Robaidek, E. (1984) Avian Dietary LC50 [in] Bob Vvhite Quail
• \... (Colinus virginianus) : [Trichloroisocyanuric Acid] : Final
Report: Study No. 6026-425. Unpublished study prepared by
Hazleton Laboratories America, Inc. 12 p.
-73-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Chlorinated Isocyanurates Standard
MRID CITATION
00150965 Barrows, B. (1984) The Acute Toxicity of TCCA/G (Trichlorocyanuric
Acid) to the Bluegill Sunfish, Lepomis macrochirus, in a Static
Test System: Biospherics Project No. 84E/058BG. Unpublished
study prepared by Biospherics, Inc. 11 p.
00150966 Barrows, GK. (1985) The Acute Toxicity of Trichlorocyanuric Acid
(TCCA/G) to the Rainbow Trout, Salmo gairdneri, in a Static Test
System: Biospherics Project No. 84E-058RT. Unpublished study
prepared by Biospherics, Inc. 11 p.
00150967 Barrows, B. (1985) The Static Acute Toxicity of TCCA/G (Trichloro-
cyanuric Acid) to the Water Flea, Daphnia magna Straus:
Biospherics Project No. 84E-058DM. Unpublished study prepared
by Biospherics, Inc. 11 p.
00154329 Surprenaht, D.; Hoberg, J. (1984) Acute Toxicity of
Trichloroisccyanurate to Daphnids (Daphnia magna) : Report
BW-84-10-1668. Unpublished study prepared by Springborn
Bionomics, Inc. 13 p.
40351801 U.S. EPA (1984) Anbient Water Quality Criteria for Chlorine - 1984.
Office of Water Regulations and Standards, Criteria and Standards
Division. Washington, DC. 57 p.
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OM3 'Approval iio.
(.expires
FIFHA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAM!-
APPLICANTS NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to thi nquiremint to submit "gtniric" data impoad by thi FIFRA action 3(C)(2)(B) notici contained in the refurenced
Guidance Document, I em responding in the following manner:
D1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified In) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2. I hav« entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
D 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrents for Development of Deta" with
respict to the following data requirements:
D 4. I request that you emend my registration by deleting the following uses (this option Is not available to applicents for new products):
D S. I request voluntary cancellation of the registration of this product (This option is not available to applicants for new products.)
REGISTRANT'!! AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 88801 (1042)
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OMB Approval No. 2070-0057 (Expires 11/30/89)
(To out/ify, ctrtifv ALL four items}
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duty authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to annr into such an agreement Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following data(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8S80-6 (10-82>
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PRODUCT SPECIFIC DATA FEPOKT
EPA Reg. No.
Date
Registration Standard for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling jpoint
Density, bulk-
density, or-
specif ic gravity
Solubility
Vapor pressure
Dissociation
constant
Octanol/water
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
MRID Numbers
Assigned
-77-
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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
Oxidi zing/reducing
reaction
Flammability
Explod ability
Storage stability
Viscosity
Miscibility
Corrosion
characteristics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
( check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached )
(For EPA Use Only)
MRED Numbers
Assigned
-78-
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OMB Approval No. 2070-0057 (Expires 11/30/89)
FORMULATOR'S EXEMPTION STATEMENT
(40 CFR 152.85)
EPA File Symbol/Reg. No. ._ Product Name
Applicant's Name and Address .
As an authorized representative of the applicant for registration of. the
product identified above, I hereby certify that:
(1) This product contains the active ingredient(s): '
(2) Each active ingredient listed in paragraph (1) is present solely
as the result of the incorporation into the product (during formulation or
packaging) of another product which contains that active ingredient, which
is registered under FIFRA sec. 3, and which is purchased by us from another
producer.
(3) Indicate by circling (A) or (B) below which paragraph applies:
(A) An accurate Confidential Statement of Formula (EPA Form 8570-4) for
the above identified product is attached to this statement. That formula
statement indicates, by company name, registration number and product
name, the source of the active ingredient(s) listed in paragraph (1).
OR
(B) The Confidential-Statement of Formula dated on file with
the EPA is complete, current and accurate and contains the information
required on the current CSF Form No. 8570-4. The registered source(s)
of the active ingredient(s) listed in paragraph (1) is/are listed below:
Active ingredient Source; Product name and Reg. No.
Signature
Date . Title
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